BREATHE EASIER, THE CAFC PROVIDES GUIDANCE ON CONSTRUING THE CLAIMED CONCENTRATION OF A STABILIZER IN PATENTS FOR AN ASTHMA DRUG
| February 25, 2022
AstraZeneca v. Mylan Pharmaceuticals
Decided December 8, 2021
Taranto, Hughes, and Stoll. Opinion by Stoll. Dissent by Taranto
Summary:
AstraZeneca sued Mylan for infringement of its patents covering Symbicort pressurized metered-dose inhaler (pMDI) which is used for treating asthma. At issue in this case is how to construe the limitation “PVP K25 is present at a concentration of 0.001% w/w.” The district court construed the concentration using the ordinary standard scientific convention using only one significant figure to encompass the range from 0.0005% to 0.0014%. Based on this construction, Mylan stipulated to infringement. The district court then held a trial on validity and upheld the validity of the asserted claims. The CAFC affirmed the district court’s judgment of validity. But the CAFC disagreed with the construction of the concentration limitation. The CAFC held that the construction of the term should be narrower than the range provided by the ordinary meaning due to disclosures in the specification and arguments and amendments in the prosecution history. The CAFC construed the noted concentration of 0.001% to include the narrower range of 0.00095% to 0.00104%. Thus, the CAFC vacated the judgment of infringement and remanded for further proceedings on infringement.
Details:
The patents at issue in this case are U.S. Patent Nos. 7,759,328; 8,143,239; and 8,575,137 which cover the asthma inhaler Symbicort pMDI. A pMDI inhaler uses a propellant gas that is in liquid form under pressure in the pMDI device. When the inhaler is activated, the propellant causes the gas to come out as a spray making it easier to deliver the medication to the lower lungs. The representative claim is provided:
13. A pharmaceutical composition comprising
formoterol fumarate dihydrate, budesonide, HFA227, PVP K25, and PEG-1000,
wherein the formoterol fumarate dihydrate is present at a concentration of 0.09 mg/ml,
the budesonide is present at a concentration of 2 mg/ml,
the PVP K25 is present at a concentration of 0.001% w/w, and
the PEG-1000 is present at a concentration of 0.3% w/w.
Mylan appealed the district court’s stipulated judgment of infringement asserting that the district court erred in the construction of the concentration of PVP K25 of 0.001%. Mylan also appealed the district court judgement of nonobviousness.
The CAFC stated that as a matter of standard scientific convention, the noted concentration of 0.001% being expressed with only one significant digit would ordinarily encompass a range from 0.0005% to 0.0014%. AstraZeneca argued that this ordinary meaning controls absent lexicography or disclaimer. However, the CAFC stated that this is an acontextual construction that does not consider disclosures in the specification and arguments/amendments in the prosecution history. The CAFC stated that “[c]onsistent with Phillips, therefore, we must read the claims in view of both the written description and prosecution history.”
The CAFC stated that the testing evidence in the specification and prosecution history demonstrates that minor differences as small as ten thousandths of a percentage (four decimal places) in the concentration of PVP impact stability. The specification repeatedly describes formulations containing 0.001% PVP as providing the best suspension stability. This is also demonstrated in the data provided in the specification. The data includes formulations including PVP at concentrations of 0.0001%, 0.0005%, 0.001%, 0.01%, 0.03%, and 0.05%. The results show that the formulation containing 0.001% PVP was the most stable and that the formulation containing 0.0005% was one of the least stable formulations. The CAFC concluded that this data shows that PVP concentration of 0.001% is more stable than formulations with slight differences in PVP concentration (e.g., a concentration of 0.0005%, and that differences down to the ten-thousandth of a percentage (fourth decimal place) matters for stability.
In the prosecution history, the Applicant amended the claims to change ranges of the concentration to recite the exact concentration of PVP to 0.001% without using the qualifier “about,” and emphasized that 0.001% was critical to stability. The CAFC also stated that Applicant knew how to claim ranges and describe numbers with approximation using the term “about,” but the Applicant chose to claim the exact value. The CAFC concluded that this supports construing 0.001% narrowly, but that there should be some room for experimental error in the PVP concentration. The CAFC stated that the margin of error that is best supported by the intrinsic record is variations in the PVP concentration at the fourth decimal place (0.000095% to 0.000104%).
AstraZeneca argued that Mylan’s proposed construction is an attempt to limit the scope of the claims to the preferred embodiment. However, the CAFC stated that AstraZeneca’s proposed construction would read on two distinct formulations described in the specification (0.0005% PVP and 0.001% PVP), but the Applicant chose to claim only one of these formulations. The CAFC also stated that Applicant cancelled claims that included the 0.0005% PVP concentration and that this provides evidence that the formulations containing 0.0005% PVP are not within the scope of an asserted claim.
Regarding the nonobviousness determination by the district court, Mylan argued that the district court erred in finding that the prior art reference Rogueda taught away from the claimed invention. The CAFC citing Meiresonne v. Google, Inc., 849 F.3d 1379 (Fed Cir. 2017), stated that “a prior art reference is said to teach away from the claimed invention if a skilled artisan ‘upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken’ in the claim.”
The Rogueda reference included control formulations to compare with its novel formulations. Mylan relied on some of the control formulations as rendering the claims obvious. Rogueda disclosed that the novel formulations provided a “drastic” reduction in the amount of drug adhesion compared to the controls.
Mylan, citing Meiresonne, argued that the court’s precedent regarding “teaching away” is that a reference “that merely expresses a general preference for an alternative invention but does not criticize, discredit, or otherwise discourage investigation into the claimed invention does not teach away.” Mylan argued that Rogueda merely expresses a preference for the novel formulations over the control formulations citing a statement in the district court opinion that “Rogueda did not necessarily disparage the formulations in Controls 3 and 9.” However, AstraZeneca provided expert testimony stating that a skilled artisan looking at the adhesion results in Rogueda would conclude that the control formulations “were not suitable” and “clearly don’t work.” The district court credited the expert testimony that a skilled artisan would have known that the control formulations were unsuitable, and thus, discouraging investigation into these formulations, and concluded that Rogueda teaches away and does not render the claims obvious. The CAFC stated that there was no clear error in the district court’s determination and affirmed the validity of the claims.
Dissent
Judge Taranto dissented from the claim construction opinion. Judge Taranto stated that 0.001% should be construed to have its significant-figure meaning of 0.0005% to 0.0014% with the possibility of shrinking the lower end of the range to exclude the overlap area between the significant-figure interval of 0.001% (0.0005% to 0.0014%) and the significant-figure interval of 0.0005% (00045% to 0.00054%). Thus, if this exclusion is applied, the range would be 0.00055% to 0.0014%.
Judge Taranto takes the position that nothing in the specification or prosecution history warrants departing from the ordinary meaning. Judge Taranto pointed out that the specification, when referring to the formulations that were tested, states that several of the formulations were “considered excellent” and that the formulation with 0.001% PVP “gave the best suspension ability overall.” In the prosecution history, the Examiner stated the need for the Applicant to show criticality by showing unexpected results of a 0.001% concentration level compared to concentration levels “slightly greater or less” than 0.001% PVP. But it is unclear if the Examiner meant to include 0.0005% and other tested concentration levels tested within the meaning of “slightly greater or less.” The Examiner’s statement about criticality does not exclude 0.0005%.
Judge Taranto also stated that changing “0.001%” having one significant figure to “0.0010%” having two significant figures (as proposed by Mylan and adopted by the majority) requires rewriting the claim term, and that this rewriting is counter to the specification and prosecution history. The specification and prosecution history uniformly used only one significant figure when referring to PVP concentration. Just because four decimal places were used for some PVP concentrations does not mean that all concentration values should be read to express a degree of precision to four decimal places. The specification uses four decimal places to refer to the absolute concentration level in examples where this is unavoidable such as for 0.0001% and 0.0005%. However, absolute levels and degrees of precision are distinct.
Judge Taranto also addressed the fact that the range implied by 0.001% overlaps the range implied by 0.0005%. Judge Taranto stated that the overlap does not support adding an extra significant digit. Judge Taranto stated that “the most this overlap could possibly support would be an exclusion of the small range with the one significant-figure interval for which there is overlap resulting in the range of 0.00055% to 0.0014%. However, Judge Taranto pointed out that Mylan’s product is still within this narrower range, and thus, it is not necessary to decide whether the overlap-area exclusion is justified as a claim construction.
Comments
The majority appears to have been swayed by the fact that a formulation within the range of the ordinary meaning of the claimed concentration provided significantly different results. What is not clear is whether these different results, while not the best, could still be considered good. Judge Taranto pointed out that the specification stated that several of the tested formulations were considered excellent while the 0.001% was the best. When drafting and prosecuting patent applications, you need to be aware that your experimental data and amendments to the claims can be used to narrow the range afforded by the ordinary meaning of a certain value.
With regard to arguing non-obviousness due to a teaching away in the prior art, expert testimony can be critical and should be used to support your argument whether you are defending the validity of a patent or trying to invalidate.
REASONABLE-EXPECTATION-OF-SUCCESS REQUIREMENT CANNOT BE SATISFIED WHEN THERE IS NO EXPECTATION OF SUCCESS
| February 4, 2022
Teva Pharmaceuticals USA v. Corcept Therapeutics, Inc.
Decided December 7, 2021
Moore, Newman and Reyna (Opinion by Moore)
This precedential opinion illustrates the importance of preparing your expert for deposition. Although an expert declaration was effective in having a Post Grant Review instituted on claims 1-13 of U.S. Patent No. 10,195,214, the expert’s post-institution deposition testimony was instrumental in upholding the validity of the claims. This opinion not only addresses obviousness with respect to the reasonable expectation of success requirement, but also obviousness of ranges, a topic covered by Michael Caridi earlier this month in Indivior UK Ltd., v. Dr. Reddy’s Labs S.A., Dr. Reddy’s Labs, Inc.
Mifepristone was developed as an anti-progestin in the 1980s and was later discovered to likely inhibit the effect of cortisol on tissues, suggesting that it could be used to treat Cushing’s syndrome (a disease caused by excessive levels of cortisol). Corcept filed for a New Drug Application (NDA) for Korlym (a 300 mg mifepristone tablet) to control hyperglycemia secondary to hypercortisolism in certain patients with Cushing’s syndrome. The NDA application was approved with a few post marketing requirements, one including a drug-drug interaction clinical trial to determine a quantitative estimate of the change in exposure of mifepristone following co-administration of ketoconazole (a strong CYP3A inhibitor). A memorandum provided by the FDA explained that “[t]he degree of change in exposure of mifepristone when co-administered with strong CYP3A inhibitors is unknown. . .”.
In approving Corcept’s NDA, the FDA also approved the Korlym label recommending a dose of 300 mg once daily and allowing for increasing dosage in 300 mg increments to a maximum 1200 mg once daily. In addition, the label warned against using mifepristone with strong CYP3A inhibitors and limited the dose to 300 mg per day when used with strong CYP3A inhibitors.
Corcept conducted the drug-drug interaction study and collected data on co-administration of mifepristone with a strong CYP3A inhibitor and received the ‘214 patent.
Teva sought post-grant review after Corcept asserted the ‘214 patent in district court, arguing that the claims would have been obvious based on the Korlym label and the FDA memorandum, optionally in combination with FDA guidance on drug-drug interaction. Furthermore, Teva provided an expert declaration of Dr. Greenblatt opining that it was reasonably likely that 600 mg mifepristone would be well tolerated and therapeutically effective when co-administered with a strong CYP3A inhibitor.
The Patent Trial and Appeal Board (PTAB) found that Teva had failed to prove that claims 1-13 would have been obvious. The PTAB construed the claims to require safe administration of mifepristone, and that Teva failed to show that one of ordinary skill in the art would have had a reasonable expectation of success for safe co-administration of more than 300 mg mifepristone with a strong CYP3A inhibitor.
Teva asserted that the PTAB had committed two errors: (1) that the PTAB erred in requiring precise predictability rather than a reasonable expectation of success, and (2) that the PTAB erred when it found Teva had failed to prove the general working conditions (ranges) disclosed in the prior art encompassed the claimed invention. The CAFC did not agree.
1. Reasonable Expectation of Success
The reasonable expectation of success analysis must be tied to the scope of the claims.
Claim 1 is representative:
A method of treating Cushing’s syndrome in a patient who is taking an original once-daily dose of 1200 mg or 900 mg per day of mifepristone, comprising the steps of:
reducing the original once-daily dose to an adjusted once-daily dose of 600 mg mifepristone,
administering the adjusted once-daily dose of 600 mg mifepristone and a strongCYP3A inhibitor to the patient,
wherein said strong CYP3A inhibitor is selected from the group consisting of ketoconazole, itraconazole, nefazodone, ritonavir, nelfmavir, indinavir, boceprevir, clarithromycin, conivaptan, lopinavir, posaconazole, saquinavir, telaprevir, cobicistat, troleandomycin, tipranivir, paritaprevir, and voriconazole.
The claims require safe co-administration of a specific amount of mifepristone with a strong CYP3A inhibitor. Teva failed to establish that one would have reasonably expected co-administration of more than 300 mg mifepristone with a strong CPY3A inhibitor to be safe for treatment of Cushing’s syndrome. The PTAB went further to find that one of ordinary skill in the art would have had no expectation of success. Although not in the CAFC’s opinion, the deposition testimony of Teva’s expert (Dr. Greenblatt) was devastating.From the deposition:
[Patent Owner’s Counsel]: Well, okay. With all those assumptions built into this, was this — was the result set forth here that there was little to no increase in adverse events, was that result predictable?
[Dr. Greenblatt]: It’s — the result is neither predictable or unpredictable. It is what it is. It’s the study was done as mandated by the FDA to get at the truth, and here’s the outcome of the study.
[Patent Owner’s Counsel]: So a person of skill in the art would not have expected there to be no increase in adverse events?
[Dr. Greenblatt]: The study was done to, in part, to answer that question, not to address an expectation. I don’t believe that there would be any expectation. You don’t know what’s going to happen, which is why you do the study.
[Patent Owner’s Counsel]: So if the same testing had shown that a dose of 600 mg mifepristone could not be safely administered with ketoconazole, would that have been expected by a person of skill in the art?
. . .
[Dr. Greenblatt]: Yeah, the same answer. I don’t think there’s an expectation. You’re doing the study to find out what the result is to get the scientific truth.
The PTAB had discredited Dr. Greenblatt’s pre-institution testimony based on this post-institution testimony which unequivocally stated that one of ordinary skill would have no expectation as to whether 600 mg of mifepristone and ketoconazole would be safe. 2. Prior Art Range Precedence
Teva had asserted that the sole administration of mifepristone up to 1200 mg was an overlap in the range required by claim 1. This argument failed because the evidence of recorded only supported that the general working conditions for co-administration was shown to be 300 mg/day. As such, there was no overlap. Thus. The PTAB’s finding that the prior art ranges do not overlap was supported by substantial evidence.
Takeaways
- Make sure your expert is prepared.
- Obviousness based on the reasonable-expectation-of-success analysis must be tied to the scope of the claims.
- General working conditions in the prior art need to be analyzed with respect to the scope of the claims.
Federal Circuit Restricts Ranges for lack of Written Description
| January 19, 2022
Indivior UK LTD., v. Dr. Reddy’s Labs S.A., Dr. Reddy’s Labs, Inc.
Decided on November 24, 2021
Lourie, Linn and Dyk. Opinion by Lourie. Dissent by Linn.
Summary
The Federal Circuit Court affirmed a Patent Office ruling for an IPR finding that there is lack of written description support in an application for ranges in claims of a continuation patent thereby resulting in the claims being anticipated by prior art. The Court found that the Tables in the application, relied on for support, lacked sufficient clarity as the values therein did not constitute ranges but only specific, particular examples.
Details
Indivior owns USP 9,687,454 (the ’454 patent), directed to orally dissolvable films containing therapeutic agents. The ’454 patent issued as the fifth continuation of an application filed on August 7, 2009 to which Indivior claimed the filing date.
Dr. Reddy’s Labs (DRL) petitioned for inter partes review of claims 1–5 and 7–14 at the PTAB alleging that the polymer weight percentage limitations, added to the claims by amendment, do not have written description support in the application as filed and thus are not entitled to the benefit of its filing date. Specifically, the limitation in question of claim 1 reads:
…. about 40 wt % to about 60 wt % of a water-soluble polymeric matrix;…
Also in question was claim 8’s polymer weight percentage limitation of “about 48.2 wt %,” which the Board found that Tables 1 and 5 in the application disclose formulations from which a polymer weight of 48.2% could be calculated by a person of ordinary skill in the art.
Regarding claims 1, 7 and 12 recitations of polymer weight percentage limitations as ranges: “about 40 wt % to about 60 wt %” (claim 1) and “about 48.2 wt % to about 58.6 wt %” (claims 7 and 12), the Board found that the application does not “discuss or refer to bounded or closed ranges of polymer weight percentages.” The Board also found that a person of ordinary skill would have been led away from a particular bounded range by the application’s teaching that “[t]he film may contain any desired level of self-supporting film forming polymer.” Based thereon, the Board determined that claims 1–5, 7, and 9–14 do not have written description support in the application.
Indivior appealed the Board’s decision as to claims 1, 7 and 12 while DRL cross-appealed as to the Board’s decision as to claim 8.
Discussion
Indivior’s Appeal – Claims 1, 7 and 12
Indivior argued that the Board erred in finding that the polymer range limitations in claims 1, 7, and 12 lack written description support in the application. Indivior specifically argued that Tables 1 and 5 disclose formulations with 48.2 wt % and 58.6 wt % polymer and that the application also discloses that “the film composition contains a film forming polymer in an amount of at least 25% by weight of the composition.” Indivior argued that the combination of these disclosures encompasses the claimed ranges. DRL, countered that the application does not disclose any bounded range, only a lower endpoint and some exemplary formulations from which a skilled artisan would not have discerned any upper range endpoint.
Regarding claim 1, the Court agreed with the Board that there is no written description support in the application for the range of “about 40 wt % to about 60 wt %.” The Court noted that the range was not expressly claimed in the application; nor are the values of “40 wt %” and
“60 wt %” and a range of 40 wt % to 60 wt %.
The CAFC went on to further note that not only was there no express description of these values, various other indications of the polymeric content of the film are present in the application, rendering it even less clear that an invention of “about 40 wt % to about 60 wt %” was contemplated as an aspect of the invention. Most specifically, the Court reiterated the PTAB’s reliance on the application’s paragraph 65 statement that “[t]he film may contain any desired level of . . . polymer.” The Court asserted that this statement is contrary to Indivior’s assertion that the level of polymer should be closed and between “about 40 wt % to about 60 wt %.” of claim 1.
Regarding the disclosures in Tables 1 and 5 of the application, the Court noted that in Table 1 there are four polymer components of the described formulations, polyethylene oxide, NF (MW 200,000); polyethylene oxide, NF (MW 100,000); polyethylene oxide, NF (MW 900,000); and HPMC, and when they are added up, each total is within the “about 40 wt % to about 60 wt %” range. However, the CAFC found that these values do not constitute ranges but only specific, particular examples.
Thus, the Court concluded that this was insufficient written description support for the claimed ranges, stating:
Here, one must select several components, add up the individual values, determine the aggregate percentages, and then couple those aggregate percentages with other examples in the ’571 application to create an otherwise unstated range.
As such the CAFC affirmed that the Board properly determined that claims 1, 7, and 12 do not have written description support in the application and are therefore anticipated by the prior art asserted during the IPR.
DLR’s Cross-Appeal – Claim 8
Regarding claim 8, which the Board had found sufficient written description for, the Court affirmed that determination, even though, as DRL argued, the number “48.2 wt %” is not explicitly set forth in the application. The Court noted that “even though one might see some inconsistency” between this result and their ruling as to claims 1, 7 and 12 since claim 8 does not recite a range, but only a specific amount, this can be derived by selection and addition of the amounts detailed in Tables 1 and 5 of the application.
Dissent
Judge Linn dissented from the majority as to affirming the Board’s decision on Indivior’s appeal, specifically taking exception to the majority’s interpretations of the often-cited written description cases In re Wertheim and Nalpropion.
Linn particularly noted that the majority too narrowly interpreted the disclosures of the application. Specifically, Linn referred to the noted paragraph 65 of the application as a truncated text “[t]he film may contain any desired level of … polymer” to wrongly suggest that the statements about film polymer levels of “at least 25%” or “at least 50%” fail to provide clear support for the claimed “about 40 wt % to about 60 wt %” range. He asserts that the quoted passage is taken out of context and ignores the remaining part of the sentence, which expressly links the aggregate polymer percentage to the key claimed characteristics of mucoadhesion and rate of film dissolution shared by films having the stated polymer levels. He quotes the full text from paragraph 65 noting that it states that “any film forming polymers that impart the desired mucoadhesion and rate of film dissolution may be used as desired.” Linn asserts that this statement does not suggest that any polymer percentage is acceptable but oppositely explicitly identifies the essential desired characteristics possessed by the films of the claimed invention and identifies the polymer levels needed to impart the characteristics.
As to the majority’s treatment of In re Werthiem, Linn notes that the majority cites no authority that written description support for a “closed range” requires a disclosure of a closed range rather than discrete values, and there is no logical reason why such a disclosure should be required as a strict rule to show possession. He remarks that in Wertheim, the CAFC had found “[b]roadly articulated rules are particularly inappropriate in this area.” Wertheim, 541 F.2d at 263-65 (Rich, J.) and an obvious example would be a disclosure with express embodiments of 5%, 6%, 7%, 8%, 9% and 10% of a particular substance, and a continuation application that claims a range of 5-10%. Relating this back to the discussion as to the disclosures of paragraph 65 of the application, he asserts that the paragraph does disclose a closed range of “at least 25%” and “at least 50%” and in light of In re Werthiem, those ranges are no different than if restated as “25%-100%” and “50%-100%,” respectively.
Hence, Linn concludes that he would reverse the Board’s holding that claims 1, 7 and 12 do not have written description support in the application and are thus anticipated by the prior art. Linn did concur-in-part as to the majority finding that Indivior was in possession of a film with 48.2 wt % polymeric matrix as claimed in claim 8.
Takeaway
- Care needs to be taken when patent prosecutors incorporate range limitations into the claims based on disclosures within Examples and Tables. The application should clearly contain evidence that the individual Examples may be formulated into the range claimed.
No Standing and No Vacatur for Patent Licensee Seeking Review of IPR Decisions
| December 28, 2021
Apple Inc. v. Qualcomm Incorporated
Decided on November 10, 2021
Newman, Prost, and Stoll. Opinion by Prost. Dissent by Newman.
Summary
For a second time involving the same parties who had entered a license agreement as part of settlement of global patent litigation, the Federal Circuit denied standing to appeal from the Patent Trial and Appeal Board (PTAB) where the underlying facts were identical to those in the previous case, except for the identity of patents at issue. The Federal Circuit also rejected the licensee’s request to vacate the PTAB decision which was found unappealable for lack of standing. The dissent argued that the mere existence of a license should not negate the licensee’s right to challenge the patent validity in Article III court.
Details
“Flashback” to Apple I
The Opinion begins by referring to Apple Inc. v. Qualcomm Inc., 992 F.3d 1378, 1385 (Fed. Cir. 2021) (“Apple I”), where Qualcomm sued Apple in a district court for infringement of patents; Apple sought an inter partes review (“IPR”) of those patents; the two companies settled all their litigation and entered a license agreement, leading to dismissal of the infringement action with prejudice; thereafter, Apple appealed a final decision of the IPR issued in favor of Qualcomm.
At issue in Apple I was Apple’s standing before the Article III court. There, Apple was found to lack standing because:
- No sufficient evidence or argument was presented that invalidity of any specific patent would change any aspect of the contractual relationship or royalty imposed on Apple.
- Apple’s evidence failed to identify any particular patent or potentially infringing activity that is tied to a risk of litigation after the license has expired.
- Apple’s invocation of the estoppel provision was insufficient to warrant standing.
Rehearing was denied en banc in Apple I.
No Standing in Deference to Apple I
The Federal Circuit dismissed for lack of standing following the precedent. Since “the operative facts are the same,” the difference in the patents between the two cases was “irrelevant.” Further, the court rejected Apple’s assertion that the previous case did not articulate the reason why a threat of litigation that would potentially result from Apple’s failure to pay the license fee and termination of the agreement does not suffice to establish standing.
Vacatur Denied
Apple asserted that if it lacks standing, the PTAB decisions should be vacated, which would otherwise frustrate future litigation involving the same patents. In so doing, Apple relied on the principle in United States v. Munsingwear, Inc., which allows vacatur of a judgement below where the case has become moot on appeal.
The Federal Circuit disagreed. First, Munsignwear was distinguished because it concerns mootness, rather than standing. The difference between the two doctrines resides in the timing: Standing relates to existence of controversy “at the outset” of the appeal whereas mootness considers existence of controversy “throughout the proceedings.” To the extent the dispute between the parties had disappeared before the appeal was filed, the case cannot “become moot.” Second, even if the mootness doctrine were applicable, the court stated that vacatur would still not be appropriate. Because the alleged mootness was caused by Apple’s own voluntary action (i.e., settlement), it could not claim the equitable remedy of vacatur.
Dissent
The dissenting opinion noted that continuing controversy existed where Apple, although agreeing to settlement and license, still disputed the validity of the licensed patents, and the potentially infringing products will likely remain on the market after the termination of the contract, which does not cover the entire life of the patents as a result of Qualcomm’s refusal of Apple’s request otherwise. The dissent also argued that denial of the standing is contrary to the statutory purposes of estoppel and right of appeal provisions under the AIA. Furthermore, citing United States v. Arthrex, Inc., 141 S. Ct. 1970 (2021) (see Cindy Chen’s previous report), which required vacatur of PTAB decisions that are unreviewable by a principle agency officer, the dissent argued that the IPR decisions in the present case should be vacated if Apple is denied the constitutional right of judicial review.
Takeaway
- In addition to confirming that the patent licensee seeking appeal from the IPR lacks Article III standing in the circumstances of the case, the Federal Circuit found that such a party also forfeited its right to vacatur of the underlying IPR decision.
- Potential consequences of settlement and license where an IPR is pending could be grave; not only could it limit the party’s ability to prove a requisite injury for standing to appeal, but also it could foreclose the remedy of vacatur, thereby affecting future re-litigation.
Lets’ B. Cereus, No Reasonable Fact Finder Could Find an Expectation of Success Based on the Teachings of a Prior Art Reference That Failed to Achieve That Which The Inventor Succeeds
| December 6, 2021
University of Strathclyde vs., Clear-Vu Lighting LLC
Circuit Judges Reyna, Clevenger and Stoll (author).
Summary:
Here, the University of Strathclyde (Strathclyde herein after) appeals from a final written decision of the Patent Trail and Appeal Board holding claims 1 to 4 of U.S. Patent No. 9,839,706 unpatentable as obvious.
The patent relates to effective sterilization methods for environmental decontamination of air and surfaces of, amongst other antibiotic resistant Gram-positive bacteria, Methicillin-resistant Staphylococcus aureus (MRSA). Specifically, sterilization is performed via photoinactivation without the need for a photosensitizing agent.
Claim 1[1] is as follows:
1. A method for disinfecting air, contact surfaces or materials by inactivating one or more pathogenic Gram-positive bacteria in the air, on the contact surfaces or on the materials, said method comprising exposing the one or more pathogenic Gram-positive bacteria to visible light without using a photosensitizer, wherein the one or more pathogenic Gram-positive bacteria are selected from the group consisting of Methicillin-resistant Staphylococcus aureus (MRSA), Coagulase-Negative Staphylococcus (CONS), Streptococcus, Enterococcus, and Clostridium species, and wherein a portion of the visible light that inactivates the one or more pathogenic Gram-positive bacteria consists of wavelengths in the range 400-420 nm, and wherein the method is performed outside of the human body and the contact surfaces or the materials are non-living.
The Board determined that claim 1 above would have been obvious over Ashkenazi in view of Nitzan. Ashkenazi is an article that discusses photoeradication of a Gram-positive bacterium, stating that “In the case of P. acnes (leading cause of acne) or other bacterial cells that produce porphyrins…. Blue light may photoinactivate the intact bacterial cells.” However, as noted by the CAFC, the methods of Ashkenazi always contained a photosensitive agent. Ashkenazi taught that increasing the light doses, the number of illuminations, and the length of time the bacteria are cultured resulted in greater inactivation.
The Nitzan article studied the effects of ALA (photosensitive agent) on Gram-positive bacteria, including MRSA. In Nitzan, for all the non-ALA MRSA cultures, it was reported therein that a 1.0 survival fraction was observed, meaning there was “no decrease in viability…after illumination” with blue light.
The Board ultimately held that Ashkenazi and Nitzan taught or suggested all the limitations of claim 1, and that a person of ordinary skill in the art would have been motivated to combine these two references, and “would have had a reasonable expectation of successfully doing so.”
Although neither of the references achieved inactivation of any bacteria without using a photosensitizer, the Board nonetheless found that a skilled artisan would have reasonably expected “some” amount of inactivation because the claims “do not require any specific amount of inactivation.”
Ultimately, the CAFC disagreed with the Boards’ findings.
Initially, the CAFC emphasized that “[T]he substantial evidence standard asks ‘whether a reasonable fact finder could have arrived at the agency’s decision,’ and ‘involves examination of the record as a whole, taking into account evidence that both justifies and detracts from an agency’s decision.’” OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375, 1381–82 (Fed. Cir. 2019) (quoting In re Gartside, 203 F.3d 1305, 1312 (Fed. Cir. 2000)).
That, “An obviousness determination generally requires a finding that “all claimed limitations are disclosed in the prior art,” PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1194 (Fed. Cir. 2014); cf. Koninklijke Philips N.V. v. Google LLC, 948 F.3d 1330, 1337–38 (Fed. Cir. 2020).
“Whether the prior art discloses a claim limitation, whether a skilled artisan would have been motivated to modify or combine teachings in the prior art, and whether she would have had a reasonable expectation of success in doing so are questions of fact. Tech. Consumer Prods., Inc. v. Lighting Sci. Grp. Corp., 955 F.3d 16, 22 (Fed. Cir. 2020); OSI Pharm., 939 F.3d at 1382.
Here, “the only dispute is whether these references teach inactivating one of the claimed Gram-positive bacteria without using a photosensitizer.” The CAFC stated that the “Board’s finding that this was taught by the combination of Ashkenazi and Nitzan is not supported by substantial evidence.”
Claim 1 requires both (i) exposing the bacterial to 400 to 420 nm blue light without using a photosensitizers and (ii) that the bacteria are inactivated as a result. Here, Ashkenazi achieves inactivation after exposure to 407 to 420 nm blue light but with a photosensitizer. On the other hand, Nitzan provides an example in which MRSA is exposed to 407 to 420 nm blue light without a photosensitizer, but there is no evidence that Nitzan successfully achieved inactivation under the conditions.
The Board agreed with Clear-Vu’s argument that a skilled artisan would have prepared a MRSA culture according to the method described in Nitzan and applied Ashkenazi’s teaching that increasing the light energy, number of illuminations, and length of time the bacteria are cultured, and so arrived at the Patented claims.
However, the CAFC held that “given neither Ashkenazi nor Nitzan teaches or suggests inactivation of any bacteria without using a photosensitizer” they failed “to see why a skilled artisan would opt to entirely omit a photosensitizer when combining these references.” The CAFC stressed that Nitzan itself disclosed that a photosensitizer-free embodiment was “wholly unsuccessful in achieving inactivation.”
Again, the CAFC emphasized that claim 1 requires both (i) exposing the bacterial to 400 to 420 nm blue light without using a photosensitizers and (ii) that the bacteria are inactivated as a result, and declined Clear-Vu’s invitation to read the inactivation limitation in isolation divorced from the claim as a whole concluding that “Obviousness cannot be based on the hindsight combination of components selectively culled from the prior art to fit the parameters of the patented invention.”
Next, the CAFC analyzed the Board’s finding on reasonable expectation of success and again, declined to agree.
The Board had relied upon (i) both parties agreeing that MRSA naturally produces at least some amount of endogenous porphyrins and (ii) Ashkenazi’s teaching that “blue light may” inactivate “other bacterial cells that produce porphyrins.
Here, the CAFC focused on Nitzan, as evidence on record showing the opposite. The CAFC reaffirmed that “absolute predictability of success is not required, only a reasonable expectation.” In this case, where the prior art reference fails to “achieve that at which the inventors succeeded, no reasonable fact finder could find an expectation of success based on the teachings of that same prior art.”
Thus, the CAFC concluded that the Board’s finding was not supported by substantial evidence, and so reversed its obviousness determination.
Take-away:
- The substantial evidence standard asks ‘whether a reasonable fact finder could have arrived at the agency’s decision,’ and ‘involves examination of the record as a whole, taking into account evidence that both justifies and detracts from an agency’s decision.
- If a prior art reference fails to achieve that which the inventor succeeds, it can be argued that no reasonable fact finder could find an expectation of success based thereon.
[1] Claim 2 depends on claim 1. Claim 3 is independent, but contains the same contested features highlighted above in claim 1. Claim 4 is dependent on claim 3.
Prosecution history disclaimer dooms infringement case for patentee
| November 22, 2021
Traxcell Technologies, LLC v. Nokia Solutions and Networks
Decided on October 12, 2021
Prost, O’Malley, and Stoll (opinion by Prost)
Summary
Patentee’s arguments during prosecution distinguishing the claimed invention over prior art were found to be clear and unmistakable disclaimer of certain meanings of the disputed claim terms. The prosecution history disclaimer resulted in claim constructions that favored the accused infringer and compelled a determination of non-infringement.
Details
Traxcell Technologies LLC specializes in navigation technologies. The company was founded by Mark Reed, who is also the sole inventor behind U.S. Patent Nos. 8,977,284, 9,510,320, and 9,642,024 that Traxcell accused Nokia of infringing.
The 284, 320, and 024 patents are directly related to each other as grandparent, parent, and child, respectively. The three patents are concerned with self-optimizing wireless network technology. Specifically, the patents claim systems and methods for measuring the performance and location of a wireless device (for example, a phone), in order to make “corrective actions” to or tune a wireless network to improve communications between the wireless device and the network.
The asserted claims from the three patents require a “first computer” (or in some of the asserted claims, simply “computer”) that is configured to perform several functions related to the “location” of a mobile wireless device.
Central to the parties’ dispute was the proper constructions of “first computer” and “location”.
Nokia’s accused geolocation system was undisputedly a self-optimizing network product. Nokia’s system performed similar functions as those claimed in the asserted computers, but across multiple computers. Nokia’s system also collected performance information for mobile wireless devices located within 50-meter-by-50-meter grids.
To avoid infringement, Nokia argued that the claimed “first computer” required a single computer performing the claimed functions, and that the claimed “location” required more than the use of a grid.
On the other hand, wanting to capture Nokia’s products, Traxcell argued that the claimed “first computer” encompassed embodiments in which the claimed functions were spread among multiple computers, and that the claimed “location” plainly included a grid-based location.
Unfortunately for Traxcell, their arguments did not stand a chance against the prosecution histories of the asserted patents.
The doctrine of prosecution history disclaimer “preclud[es] patentees from recapturing through claim interpretation specific meanings disclaimed during prosecution”. Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003). “Prosecution disclaimer can arise from both claim amendments and arguments”. SpeedTrack, Inc. v. Amazon.com, 998 F.3d 1373, 1379 (Fed. Cir. 2021). “An applicant’s argument that a prior art reference is distinguishable on a particular ground can serve as a disclaimer of claim scope even if the applicant distinguishes the reference on other grounds as well”. Id. at 1380. For there to be disclaimer, the patentee must have “clearly and unmistakably” disavowed a certain meaning of the claim.
Of the three asserted patents, the 284 patent had the most protracted prosecution, with six rounds of rejections. And it was the prosecution history of the 284 patent that provided the fodder for the district court’s claim constructions. Incidentally, the 284 patent was also the only one of the three asserted patents prosecuted by the inventor, Mark Reed, himself.
During claim construction, the district court construed the terms “first computer” and “computer” to mean a single computer that could performed the various claimed functions.
The district court first looked to the plain language of the claims. The claim language recites “a first computer” or “a computer” that performs a function, and then recites that “the first computer” or “the computer” performs several additional functions. The district court determined that the claims plainly tied the claimed functions to a single computer, and that “it would defy the concept of antecedent basis” for the claims to refer back to “the first computer” or “the computer”, if the corresponding tasks were actually performed by a different computer.
The intrinsic evidence that convinced the district court of its claim construction was, however, the prosecution history of the 284 patent.
During prosecution, in a 67-page response, Mr. Reed argued explicitly and at length, in a section titled “Single computer needed in Reed et al. [i.e., the pending application] v. additional software needed in Andersson et al. [i.e., the prior art]”, that the claimed invention requiring just one computer distinguished over the prior art system using multiple computers. The district court quoted extensively from this response as intrinsic evidence supporting its claim construction.
The Federal Circuit agreed with the district court’s claim construction, quoting still more passages from the same response as evidence that the patentee “clearly and unmistakably disclaimed the use of multiple computers”.
Next, the district court addressed the term “location”. The district court construed the term to mean a “location that is not merely a position in a grid pattern”.
Here, the district court’s claim construction relied almost exclusively on arguments that Reed made during prosecution of the 284 patent. Referring again to the same 67-page response, the district court noted that Mr. Reed explicitly argued, in a section titled “Grid pattern not required in Reed et al. v. grid pattern required in Steer et al.”, that the claimed invention distinguished over the prior art because the claimed invention operated without the limitation of a grid pattern, and that the absence of a grid pattern permitted finer tuning of the network system.
And again, the Federal Circuit agreed with the district court’s claim construction, finding that “the disclaimer here was clear and unmistakable”.
The claim constructions favored Nokia’s non-infringement arguments that its system lacked the single-computer, non-grid-pattern-based-location limitations of the asserted claims. Accordingly, the district court found, and the Federal Circuit affirmed, that Nokia’s system did not infringe the 284, 320, and 024 patents.
Traxcell made an interesting argument on appeal—specifically, the disclaimer found by the district court was too broad and a narrower disclaimer would have been enough to overcome the prior art. Traxcell seemed to be borrowing from the doctrine of prosecution history estoppel. Under that doctrine, arguments or amendments made during prosecution to obtain allowance of a patent creates prosecution history estoppel that limits the range of equivalents available under the doctrine of equivalents.
However, the Federal Circuit was unsympathetic to Traxcell’s argument, explaining that Traxcell was held “to the actual arguments made, not the arguments that could have been made”. The Federal Circuit also noted that “it frequently happens that patentees surrender more…than may have been absolutely necessary to avoid particular prior art”.
Mr. Reed’s somewhat unsophisticated prosecution of the 284 patent was in sharp contrast to the prosecution of the related 320 and 024 patents, which were handled by a patent attorney. The prosecution histories of the 320 and 024 patents said very little about the cited prior art, even less about the claimed invention. In addition, whereas Mr. Reed editorialized on various claimed features during prosecution of the 284 patent, the prosecution histories of the 320 and 024 patents rarely even paraphrased the claims.
Takeaways
- Avoid gratuitous remarks that define or characterize the claimed invention or the prior art during prosecution. Quote the claim language directly and avoid paraphrasing the claim language, as the paraphrases risk being construed later as a narrowing characterization of the claimed invention.
- Avoid claim amendments that are not necessary to distinguish over the prior art.
- The prosecution history of a patent can affect the construction of claims in other patents in the same family, even when the claim language is not identical. Be mindful about how arguments and/or amendments made in one application may be used against other related applications.
DESIGN CLAIM IS LIMITED TO AN ARTICLE OF MANUFACTURE IDENTIFIED IN THE CLAIM
| November 8, 2021
In Re: Surgisil, L.L.P., Peter Raphael, Scott Harris
Decided on October 4, 2021
Moore (author), Newman, and O’Malley
Summary:
The Federal Circuit reversed the PTAB’s anticipation decision on a claim of SurgiSil’s ’550 application because a design claim should be limited to an article of manufacture identified in the claim. The Federal Circuit held that since the claim in the ’550 application identified a lip implant, the claim is limited to lip implants and does not cover other article of manufacture. The CAFC held that since the Blick reference discloses an art tool rather than a lip implant, the PTAB’s anticipation finding is not correct.
Details:
The ’550 application
SurgiSil’s ’550 application claims an ornamental design for a lip implant[1] as shown below:
The examiner rejected a claim of the ’550 application as being anticipated by Blick, which discloses an art tool called stump as shown below:
The PTAB
The PTAB affirmed the examiner’s decision and found that the differences between the claimed design in the ’550 application and Blick are minor.
The PTAB rejected SurgiSil’s argument that Blick discloses a “very different” article of manufacture than a lip implant reasoning that “it is appropriate to ignore the identification of manufacture in the claim language” and “whether a reference is analogous art is irrelevant to whether that reference anticipates.”
The Federal Circuit
The CAFC reviewed the PTAB’s legal conclusion that the article of manufacture identified in the claims is not limiting de novo. The CAFC ultimately held that the PTAB erred as a matter of law.
By citing 35 U.S.C. §171(a) (“Whoever invents any new, original and ornamental design for an article of manufacture may obtain a patent therefor, subject to the conditions and requirements of this title.”), the CAFC held that a design claim is limited to the article of manufacture identified in the claim.
The CAFC also cited a case called Curver Luxembourg, SARL v. Home Expressions Inc., 938 F.3d 1334, 1336 (Fed. Cir. 2019)[2] and the MPEP to hold that the claim at issue should be limited to the particular article of manufacture identified in the claim.
The CAFC held that since the claim identified a lip implant, the claim is limited to lip implants and does not cover other article of manufacture.
The CAFC held that since Blick discloses an art tool rather than a lip implant, the PTAB’s anticipation finding is not correct.
Therefore, the CAFC reversed the PTAB’s decision.
Takeaway:
- It would certainly be easier to obtain design patents going forward. Can Applicant obtain design patents by using a known design in the art and applying to a new article of manufacture?
- It would be difficult to invalidate design patents because prior arts from a different article of manufacture could not be used to invalidate them.
- Applicant should be careful to amend a title/claim and provide any description on title/terms in the claim in a design application because they could be used to construe an article of manufacture and to clarify the scope of a design patent claim.
- It may be difficult to enforce the design patent for a certain article of manufacture (i.e., “lip implant”) against a different article of manufacture (“art stump”).
[1] Website for SurgiSil: SurgiSil’s silicone lip implants are an alternative to “repetitive, costly, and painful filler injections,” but that they can be removed at any time.
[2] In this case, the CAFC held that a particular claim was limited to a wicker pattern applied to an article of manufacture recited in the claim (chair) and did not cover the use of the same pattern on another non-claimed article (i.e., basket).
Authentication method held patent-eligible at Alice Step Two
| October 14, 2021
CosmoKey Solutions GmbH & Co. v. Duo Security LLC
Decided on October 4, 2021
O’Malley, Reyna, and Stoll. Court opinion by Stoll. Concurring opinion by Reyna.
Summary
The United States District Court for the District of Delaware granted Duo’s motion for judgment on the pleadings under Rule 12(c), arguing that all claims of the patent in dispute are ineligible under 35 U.S.C. 101 as the claims are directed to the abstract idea of authentication and do not recite any patent-eligible inventive concept. On appeal, the Federal Circuit unanimously revered the district court decision, holding that the claims of the patent are patent-eligible under Alice Step Two because they recite a specific improvement to a particular computer-implemented authentication technique. Reyna concurred, arguing that he would resolve the dispute at Alice Step One, not Step Two.
Details
I. Background
(1) Patent in Dispute
CosmoKey Solutions GmbH & Co. (“CosmoKey’s”) owns U.S. Patent No. 9,246,903 (“the ’903 patent”), titled “Authentication Method” and purported to disclose an authentication method that is both low in complexity and high in security.
Claim 1 is the only independent claim of the ’903 patent and reads:
1. A method of authenticating a user to a transaction at a terminal, comprising the steps of:
transmitting a user identification from the terminal to a transaction partner via a first communication channel,
providing an authentication step in which an authentication device uses a second communication channel for checking an authentication function that is implemented in a mobile device of the user, as a criterion for deciding whether the authentication to the transaction shall be granted or denied, having the authentication device check whether a predetermined time relation exists between the transmission of the user identification and a response from the second communication channel,
ensuring that the authentication function is normally inactive and is activated by the user only preliminarily for the transaction,
ensuring that said response from the second communication channel includes information that the authentication function is active, and
thereafter ensuring that the authentication function is automatically deactivated.
(2) The District Court
CosmoKey brought a civil lawsuit against Duo Security, Inc. (“Duo”) for infringement of the ’903 patent at the United States District Court for the District of Delaware (“the district court”). Duo moved for judgment on the pleadings pursuant to Rule 12(c) of the Federal Rules of Civil Procedure, arguing that the claims of the ’903 patent are ineligible under 35 U.S.C. 101.
The district court agreed with Duo, holding that the patent claims were invalid. The district court reasoned that the claims “are directed to the abstract idea of authentication—that is, the verification of identity to permit access to transactions” at Alice Step One, and that “the [’]903 patent merely teaches generic computer functionality to perform the abstract concept of authentication; and it therefore fails Alice’s step two inquiry.” In so holding, the district court determined that the patent itself admits that “the detection of an authentication function’s activity and the activation by users of an authentication function within a predetermined time relation were well-understood and routine, conventional activities previously known in the authentication technology field.”
CosmoKey appealed the district court’s judgment.
II. The Federal Circuit
The Federal Circuit (“the Court”) unanimously revered the district court decision, holding that the claims of the patent are patent-eligible under Alice step two.
Before discussing Alice Steps One and Two, the Court referred to several cases in which the Court has previously considered the eligibility of various claims generally directed to authentication and verification under § 101. However, the Court compared the claims of the ’903 patent with none of those claims held patent-eligible or patent-ineligible. See Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1334 (Fed. Cir. 2016) (“The Supreme Court has not established a definitive rule to determine what constitutes an “abstract idea” sufficient to satisfy the first step of the Mayo/Alice inquiry. … Rather, both this court and the Supreme Court have found it sufficient to compare claims at issue to those claims already found to be directed to an abstract idea in previous cases.”).
(1) Alice Step One
The Court stated that the critical question at Alice Step One for this case is whether the correct characterization of what the claims are directed to is either an abstract idea or a specific improvement in computer verification and authentication techniques.
Interestingly however, the Court stated that it needs not answer this question because even if the Court accepts the district court’s narrow characterization of the ’903 patent claims, the claims satisfy Alice step two.
The Court noted in footnote 3 that this very approach was followed in Amdocs (Israel) Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1303 (Fed. Cir. 2016) (explaining that “even if [the claim] were directed to an abstract idea under step one, the claim is eligible under step two”).
(2) Alice Step Two
The district court recognized that the specification indicates that the “difference between [the] prior art methods and the claimed invention is that the [’]903 patent’s method ‘can be carried out with mobile devices of low complexity’ so that ‘all that has to be required from the authentication device function is to detect whether or not this function is active’” and that “the only activity that is required from the user for authentication purposes is to activate the authentication function at a suitable timing for the transaction.” But the district court cited column 1, lines 15–53 of the specification as purportedly admitting that detection of activation of an authentication function’s activity and the activation by users of an authentication function within a pre-determined time relation were “well-understood and routine, conventional activities previously known in the authentication technology field” (emphasis added).
The Court criticized the district court’s reliance on column 1, lines 15–53 as misplaced. The Court stated that, while column 1, lines 30–46 describes three prior art references, none teach the recited claim steps, and read in context, the rest of the passage cited by the district court makes clear that the claimed steps were developed by the inventors, are not admitted prior art, and yield certain advantages over the described prior art (emphasis added).
Duo also argued that using a second communication channel in a timing mechanism and an authentication function that is normally inactive, activated only preliminarily, and automatically deactivated is itself an abstract idea and thus cannot contribute to an inventive concept, and far from concrete (emphasis added). The Court disagreed, stating that the claim limitations are more specific and recite an improved method for overcoming hacking by ensuring that the authentication function is normally inactive, activating only for a transaction, communicating the activation within a certain time window, and thereafter ensuring that the authentication function is automatically deactivated (emphasis added). Referring to the Court’s recognition in Ancora Techs., Inc. v. HTC Am., Inc., 908 F.3d 1343 (Fed. Cir. 2018) that improving computer or network security can constitute “a non-abstract computer-functionality improvement if done by a specific technique that departs from earlier approaches to solve a specific computer problem,” the Court emphasized that, as the specification itself makes clear, the claims recite an inventive concept by requiring a specific set of ordered steps that go beyond the abstract idea identified by the district court and improve upon the prior art by providing a simple method that yields higher security (emphasis added).
II. Concurring Opinion
Judge Reyna’s concurrence challenged the Court’s approach of accepting the district court’s analysis under Alice step one and resolving the case under Alice step two. Judge Reyna argues that Alice Step two comes into play only when a claim has been found to be directed to patent-ineligible subject matter. He concluded that, employing step one, the claims at issue are directed to patent-eligible subject matter because, as the Court opinion stated, “[t]he ’903 Patent claims and specification recite a specific improvement to authentication that increases security, prevents unauthorized access by a third party, is easily implemented, and can advantageously be carried out with mobile devices of low complexity,” which is a step-one rationale.
Takeaway
· In the Alice inquiry, courts may assume that the claim in question does not pass Alice Step One without detailed analysis, and immediately move on to Alice Step Two.
· At both Alice Steps One and Two, the Court almost always inquires about improvements, i.e., the claimed advance over the prior art (“Under Alice step one, we consider “what the patent asserts to be the ‘focus of the claimed advance over the prior art.’”; “Turning then to Alice step two, we “consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible ap- plication.” … In computer-implemented inventions, the computer must perform more than “well-understood, routine, conventional activities previously known to the industry.””) (emphasis added). This approach may appear different from the views of the Supreme Court and the USPTO. See Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289, 1304 (2012) (“We recognize that, in evaluating the significance of additional steps, the § 101 patent-eligibility inquiry and, say, the § 102 novelty inquiry might sometimes overlap. But that need not always be so.””); MPEP 2106.04(d)(1) (“[T]he improvement analysis at Step 2A [(Alice Step One)] Prong Two differs in some respects from the improvements analysis at Step 2B [(Alice Step Two)]. Specifically, the “improvements” analysis in Step 2A determines whether the claim pertains to an improvement to the functioning of a computer or to another technology without reference to what is well-understood, routine, conventional activity.”) (emphasis added).
Prosecution Refreshers – Incorporating Foreign Priority Application by Reference, Translations, Means-Plus-Function
| October 7, 2021
Team Worldwide Corp. v. Intex Recreation Corp.
Decided September 9, 2021
Opinion by: Chen, Newman, and Taranto
Summary:
The claimed “pressure controlling assembly” was found to be a means-plus-function claim element. Because the specification did not disclose any corresponding structure to perform at least one of the associated functions for this pressure controlling assembly, the claim was held to be indefinite. The specification did not disclose any corresponding structure because the portions of the foreign priority application (that disclosed corresponding structure) were omitted in the US application, and there was no incorporation by reference of the foreign priority application.
Procedural History:
This is a non-precedential Federal Circuit decision for an appeal from a PTAB post-grant review (PGR) decision. Intex petitioned for a PGR on Team Worldwide’s USP 9,989,979 patent (filed Aug. 29, 2014). The ‘979 patent is a divisional application of an earlier pre-AIA application. The ‘979 patent, filed after the March 16, 2013 effective date for AIA, is subject to AIA’s PGR unless each claim is supported in its pre-AIA parent application under 35 USC §112(a) for written description support and enablement. However, the earlier pre-AIA application at least did not have written description support for the claimed “pressure controlling assembly.” Thus, the ‘979 patent was subject to AIA’s post-grant review. The PTAB held that “pressure controlling assembly” is a means-plus-function (MPF) claim element subject to interpretation under 35 USC §112(f) and the ‘979 claims are invalid as indefinite under 35 USC §112(b) because there is no corresponding structure disclosed in the specification for at least one of the claimed functions thereof. The Federal Circuit affirmed.
Background:
The ‘979 patent relates to an inflator for an air mattress. Representative claim 1:
1. An inflating module adapted to an inflatable object comprising an inflatable body, the inflating module used in conjunction with a pump that provides primary air pressure and comprising:
a pressure controlling assembly configured to monitor air pressure in the inflatable object after the inflatable body has been inflated by the pump; and
a supplemental air pressure providing device,
wherein the pressure controlling assembly is configured to automatically activate the supplemental air pressure providing device when the pressure controlling assembly detects that the air pressure inside the inflatable object decreases below a predetermined threshold after inflation by the pump, and to control the supplemental air pressure providing device to provide supplemental air pressure to the inflatable object so as to maintain the air pressure of the inflatable object within a predetermined range.
The ‘979 patent describes the pressure controlling assembly almost exclusively in functional terms, including the functions recited in claim 1. There is one sentence that states “[a]fter the supplemental air pressure providing device is in a standby mode, a pressure controlling assembly 121/122 as described starts monitoring air pressure in the inflatable object” (col. 4, lines 48-51). No explanation is provided about elements 121/122 shown in Fig. 2a:
Both the ‘979 and its parent application (having the same specification) claim foreign priority from CN 201010186302. However, neither US application incorporates the CN ‘302 application by reference.
According to a translation of CN ‘302 application, CN ‘302 does describe an “air pressure control mechanism” that includes “air valve plate 121” and “chamber 122” which move in response to changing air pressure within the attached inflatable device. CN ‘302 further describes a switch 13, see Fig. 1 (same drawings in both CN ‘302 and the ‘979 patent and its parent):
According to CN ’302, as translated, “[w]hen the air pressure value inside the inflatable product is greater than the reset mechanism’s preset value, the air pressure control mechanism shifts upward, the second switch 13 is closed by the projection pressing against it, and the automatic reinflation mechanism halts reinflation” and “[w]hen the air pressure value inside the inflatable product is less than the reset mechanism’s preset value, the air pressure control mechanism shifts downward, the projection is removed from second switch 13 causing it to disconnect, and the automatic reinflation mechanism starts reinflation.”
Neither the ‘979 patent, nor its parent application, includes the above-noted structures of an air valve plate for reference number 121 nor the chamber for reference number 122. Neither US applications mention any switch 13 nor the above-noted operations involving the switch 13 for starting or stopping reinflation. Reference number 13 is not at all described in the ‘979 specification, nor in its parent’s specification.
The court also noted that the original specification in both the ‘979 patent and its parent application did not even mention reference numbers 121 and 122. It was added to the specification during prosecution to overcome an Examiner’s drawing objection for including those reference numbers in a drawing that were not described in the specification.
MPF Primers:
- If a claim does not recite the word “means,” it creates a rebuttable presumption that §112(f) does not apply.
- A presumption against applying §112(f) is overcome “if the challenger demonstrates that the claim term fails to recite sufficiently definite structure or else recites function without reciting sufficient structure for performing that function.” Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc).
Decision:
Claim construction is reviewed de novo, considering the intrinsic record, i.e., the claims, specification, and prosecution history, and any extrinsic evidence.
For the claim itself, like the word “means,” the word “assembly” is a generic nonce word. “Like the claim term ‘mechanical control assembly’ in MTD Products, ‘the claim language reciting what the [pressure] control[ing] assembly is ‘configured to” do is functional,’ and thus the claim format supports applicability of §112(f).”
As for the specification, the court agrees with the PTAB that the specification’s “mere reference to items 121 and 122, without further description, does not convey that the term ‘pressure controlling assembly’ itself connotes sufficient structure.” The court also noted that the specification does not indicate that the patentee acted as his own lexicographer to define the “pressure controlling assembly” to be a structural term.
As for the prosecution history, the fact that the examiner cited prior art pressure sensors as disclosing the claimed “pressure controlling assembly” does not establish that the term itself connotes structure. While a pressure sensor may perform some of the functions of the “pressure controlling assembly,” the examiner’s reliance on a pressure sensor says nothing about the term itself connoting structure. The court also rejected giving weight to the fact that the examiner did not apply §112(f) for interpreting the subject term.
As for extrinsic evidence, Team’s expert testimony was deemed conclusory and unsupported by evidence. Team’s expert relied on a dictionary definition of “pressure control” – any device or system able to maintain, raise, or lower pressure in a vessel or processing system. However, such a definition sheds no light on “pressure controlling assembly” being used in common parlance to connote structure. Even the purported admissions by Intex’s expert (i.e., that the term controls pressure and is an assembly, that devices exist that sense or control pressure, and that a cited prior art reference depicted “an apparatus that controls the pressure”) merely indicates that devices existed that can perform some of the functions of the “pressure controlling assembly.” However, none of the experts’ testimony establish that “pressure controlling assembly” is “used in common parlance or by [skilled artisans] to designate a particular structure or class of structures.”
As for prior art references that refer to a “pressure controlling assembly,” the court agreed with the PTAB’s assessment that such extrinsic evidence “demonstrates, at best, that the term is used as a descriptive term across a broad spectrum of industries, having a broad range of structures. The record does not include sufficient evidence to demonstrate that the term ‘pressure controlling assembly’ is used in common parlance or used to designate a particular structure by [the skilled artisan].”
As for the functions claimed for the “pressure controlling assembly,” there was no dispute:
- monitoring air pressure in the inflatable object after the inflatable body has been inflated by the pump;
- detecting that the air pressure inside the inflatable object decreases below a predetermined threshold after inflation by the pump;
- automatically activating the supplemental air pressure providing device when the pressure controlling assembly detects that the air pressure inside the inflatable object decreases below the predetermined threshold after inflation by the pump; and
- controlling the supplemental air pressure providing device to provide supplemental air pressure to the inflatable object so as to maintain the air pressure of the inflatable object within a predetermined range.
The court agrees with the PTAB that the patent fails to disclose any corresponding structure for at least #3. Team’s expert’s conclusory testimony that a skilled artisan would recognize that 121 and 122 in Fig. 2a interacts with element 13 in Fig. 1 to activate the supplemental air pressure providing device is not supported by any evidence. Nothing in the patent describes 13 to be a switch, much less how it interacts with 121 and 122, whatever those are.
As for the fact that CN ‘302 is part of the prosecution history, the court noted that the content of any document or reference submitted during prosecution by itself is not sufficient to remedy this missing disclosure of corresponding structure. In reference to B. Braun Medical, Inc. v. Abbott Lab., 124 F.3d 1419, 1424 (Fed. Cir. 1997), Braun’s reference to the “prosecution history” is in reference to affirmative statements made by the applicant during prosecution (such as in an Amendment or in a sworn declaration regarding the relationship between something in a drawing and a claimed MPF claim element) linking or associating corresponding structure with a claimed function. “[W]e decline to hold that a Chinese-language priority document, whose potentially relevant disclosure was omitted from the United States patent application family, provides a clear link or association between the claimed ‘pressure controlling assembly’ and any structure recited or disclosed in the ‘979 patent.”
Takeaways:
- This case is a good refresher for MPF interpretation.
- 37 CFR 1.57 addresses the situation where there is an inadvertent omission of a portion of the specification or drawings, by allowing a claim for foreign priority to be considered an incorporation by reference as to any inadvertently omitted portion of the specification or drawings from that foreign priority application. 37 CFR 1.57(a) (pre-AIA) would apply to the parent application of the ‘979 patent. 37 CFR 1.57(b) (AIA) would apply to the application leading to the ‘979 patent. However, any amendment made pursuant to 37 CFR 1.57 must be made before the close of prosecution. It is unclear why the applicant did not use the provisions of 37 CFR 1.57 in this case. Once the application is issued into a patent, as was the case here, the incorporation by reference provisions of 37 CFR 1.57 no longer apply. As noted in MPEP 217(II)(E), “In order for the omitted material to be included in the application, and hence considered to be part of the disclosure, the application must be amended to include the omitted portion. Therefore, applicants can still intentionally omit material contained in the prior-filed application from the application containing the priority or benefit claim without the material coming back in by virtue of the incorporation by reference of 37 CFR 1.57(b). Applicants can maintain their intent by simply not amending the application to include the intentionally omitted material.” Presumably, because the applicant for the ‘979 patent and its parent never took advantage of 37 CFR 1.57 during prosecution, the missing subject matter was treated as “intentionally omitted material” and does not come back into the patent by virtue of 37 CFR 1.57.
- The specification of the ‘979 patent and of its parent did not include any incorporation by reference of its foreign priority application. The applicant also did not take advantage of 37 CFR 1.57 during prosecution (see above). Accordingly, the foreign priority application was deemed “omitted from the United States patent application family.” And, just having it in the file wrapper at the USPTO is still not enough. The applicant, during prosecution, must correct any missing link between any MPF claim elements and its corresponding structure in the specification. Here, IF the Chinese priority application had been incorporated by reference or IF 37 CFR 1.57(a) (pre-AIA) and 37 CFR 1.57(b) (AIA) were used, an amendment to the specification to ADD inadvertently omitted English language translations of the corresponding structure from the priority application could have been submitted. Such amendments to the specification would not be deemed “new matter” because of the incorporation by reference of the foreign priority application.
- Always check the English language translation. It seems odd that no one noticed the omission of any description of the elements 121, 122, and 13 from the Chinese priority application. During the prosecution of the parent and the ‘979 patent, the Examiner identified at least a dozen different reference numbers that were not described in the specification. When preparing an application, or translating one, the specification should be checked for a description for each and every reference number used in the drawings.
Tags: Foreign Priority > Incorporation by reference > means-plus-function > translation
CLAIMS SHOULD PROVIDE SUFFICIENT SPECIFICITY TO IMPROVE THE UNDERLYING TECHNOLOGY
| September 30, 2021
Universal Secure Registry LLC, v. Apple Inc., Visa Inc., Visa U.S.A. Inc.
Before TARANTO, WALLACH, and STOLL, Circuit Judges. STOLL
Summary
The Federal Circuit upheld a decision that all claims of the asserted patents are directed to an abstract idea and that the claims contain no additional elements that transform them into a patent-eligible application of the abstract idea.
Background
USR sued Apple for allegedly infringing U.S. Patent Nos. 8,856,539; 8,577,813; 9,100,826; and 9,530,137 that are directed to secure payment technology for electronic payment transactions. The four patents involve different authentication technology to allow customers to make credit card transactions “without a magnetic-stripe reader and with a high degree of security.”
The magistrate judge determined that all the representative claims were not directed to an abstract idea. Particularly it was concluded that the claimed invention provided a more secure authentication system. The magistrate judge also explained that the non-abstract idea determination is based on that “the plain focus of the claims is on an improvement to computer functionality itself, not on economic or other tasks for which a computer is used in its ordinary capacity.” However, the district court judge disagreed and concluded that the asserted claims failed at both Alice steps and the claimed invention was directed to the abstract idea of “the secure verification of a person’s identity.” The district court explained that the patents did not disclose an inventive concept—including an improvement in computer functionality—that transformed the abstract idea into a patent-eligible application.
The Federal Circuit concluded that the asserted patents claim unpatentable subject matter and thus upheld the district court’s decision.
Discussion
The Federal Circuit addressed all asserted patents. The claims in the four patents have fared similarly. The discussion here is focused on the ‘137 patent. The ’137 patent is a continuation of the ’826 patent and discloses a system for authenticating the identities of users. Claim 12 is representative of the ’137 patent claims at issue, reciting
12. A system for authenticating a user for enabling a transaction, the system comprising:
a first device including:
a biometric sensor configured to capture a first biometric information of the user;
a first processor programmed to: 1) authenticate a user of the first device based on secret information, 2) retrieve or receive first biometric information of the user of the first device, 3) authenticate the user of the first device based on the first biometric, and 4) generate one or more signals including first authentication information, an indicator of biometric authentication of the user of the first device, and a time varying value; and
a first wireless transceiver coupled to the first processor and programmed to wirelessly transmit the one or more signals to a second device for processing;
wherein generating the one or more signals occurs responsive to valid authentication of the first biometric information; and
wherein the first processor is further programmed to receive an enablement signal indicating an approved transaction from the second device, wherein the enablement signal is provided from the second device based on acceptance of the indicator of biometric authentication and use of the first authentication information and use of second authentication information to enable the transaction.
Claim 12 recites a system for authenticating the identities of users, including a first device. The first device can include a biometric sensor, a first processor, and a first wireless transceiver, where the device utilizes authentication of a user’s identity to enable a transaction.
The district court emphasized that the claims recite, and the specification discloses, generic well-known components—“a device, a biometric sensor, a processor, and a transceiver—performing routine functions—retrieving, receiving, sending, authenticating—in a customary order.”
The Federal Circuit agreed with the district court and found that the claims of ‘137 patent include some limitations but still are not sufficiently specific. The Federal Circuit cited their previous decision, Solutran, Inc. v. Elavon, Inc (Fed. Cir. 2019) that held claims abstract “where the claims simply recite conventional actions in a generic way” without purporting to improve the underlying technology. The Court explained that claim 12 does not tell a person of ordinary skill what comprises the secret information, first authentication information, and second authentication information.
USR cited Finjan, Inc. v. Blue Coat Systems, Inc (Fed. Cir. 2018), arguing that the claim is akin to the claim in Finjan whose claims are directed to a method of providing computer security by scanning a downloadable file and attaching the scanned results to the downloadable file in the form of a “security profile.” However, the Court differentiated Finjan, explaining that Finjan employed a new kind of file enabling a computer system to do things it could not do before, namely “behavior-based” virus scans. In contrast, the claimed invention combines conventional authentication techniques to achieve an expected cumulative higher degree of authentication integrity. The claimed idea of using three or more conventional authentication techniques to achieve a higher degree of security is abstract without some unexpected result or improvement. The Court also acknowledged that some of the dependent claims provide more specificity on these aspects, but still concluded the claimed is still merely conventional and the specification discloses that each authentication technique is conventional.
The district court also turned to Alice step two to determine that claim 12 “lacks the inventive concept necessary to convert the claimed system into patentable subject matter.” USR asserted that the use of a time-varying value, a biometric authentication indicator, and authentication information that can be sent from the first device to the second device form an inventive concept. The Federal Circuit rejected this argument, explaining that the specification makes clear that each of these devices and functions is conventional because the patent acknowledged that the step of generating time-varying codes for authentication of a user is conventional and long-standing. USR further argued that authenticating a user at two locations constitutes an inventive concept because it is locating the authentication functionality at a specific, unconventional location within the network. However, the Court found that the specification of the patent suggests that the claims only recite a conventional location for the authentication functionality and thus rejected the argument. The court further stated that there is nothing in the specification suggesting, or any other factual basis for a plausible inference (as needed to avoid dismissal), that the combination of these conventional authentication techniques results in an unexpected improvement beyond the expected sum of the security benefits of each individual authentication technique.
The Federal Circuit ruled that all the patents simply described well-known and conventional ways to perform authentication and did not include any technological improvements that transformed those abstract ideas into patent-eligible inventions. The Court also cited several of its previous decisions related to patent invalidity under Alice, noting that “patent eligibility often turns on whether the claims provide sufficient specificity to constitute an improvement to computer functionality itself.”
Takeaway
- An abstract idea is not patentable if it does not provide an inventive solution to a problem in implementing the idea.
- Claims may be abstract even when they are directed to physical devices but include generic well-known components that perform conventional actions in a generic way without improving the underlying technology or only to achieve an expected cumulative improvement.
