CAFC Affirms Prosecution Disclaimer and Non-Infringement in ANDA Case
| April 23, 2025
Case Name: AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD.
Decided: April 8, 2025
Before: MOORE, Chief Judge, CHEN, Circuit Judge, and MURPHY, District Judge. Opinion by Murphy.
Summary
The CAFC affirmed prosecution disclaimer and non-infringement in ANDA litigation, where the patentee’s sweeping disclaimer in the patent’s parent application applies to the continuation patent claims, despite the patentee’s belated efforts to take back disclaimer statements in a later, related application and to revise the scope of disclaimer to exclude the ANDA product.
Details
Azurity sued Alkem in the district court for an ANDA-induced infringement of certain claims of Azurity’s U.S. Patent No. 10,959,948 (“the ’948 patent”), directed to liquid vancomycin formulations for oral administration. The asserted claims use a close-ended “consisting of” transition and do not list propylene glycol, whereas Alkem’s ANDA product contains propylene glycol both as a co-solvent and as a component of the grape flavoring agent.
The district court found non-infringement where Alkem’s ANDA product contained propylene glycol, and Azurity, through prosecution history, had disclaimed any presence of propylene glycol from the patented formulations, with the disclaimer not overcome by certain language in the parties’ pretrial stipulation. At issue in the appeal are: (1) whether there was a clear and unmistakable disclaimer, (2) whether the stipulation precluded such disclaimer, and (3) whether the district court erred in finding no infringement. The CAFC addressed the issues in turn.
- Prosecution disclaimer
The CAFC went through prosecution history of Azurity’s relevant patent family.
The ’948 patent issued from application No. 16/941,400 (“the ’400 application”), which is a continuation of application No. 15/126,059 (“the ’059 application”). The ’059 application had been repeatedly rejected over a prior art reference Palepu which disclosed “a polar solvent including propylene glycol.” Throughout the prosecution, Azurity had made repeated attempts, through amendments and remarks, to distinguish over Palepu based on the absence of propylene glycol in the claimed invention.
Specifically, Azurity initially sought distinction using a negative limitation in some claims such as “wherein the oral liquid solution does not comprise a propylene glycol,” or introducing the close-ended “consisting of” language in other claims, such as “[a] liquid solution comprising a carrier consisting of” certain ingredients excepting propylene glycol. Both approaches failed as the Examiner found the negative limitation as lacking written description and the “consisting of” limitation with the preceding “comprising” transition as being indefinite. The §112 issues eventually forced Azurity to adopt the close-ended transition “consisting of” excluding unrecited propylene glycol from the claimed formulation, an amendment which led to allowance of the ’059 application. The claim amendments were accompanied by applicant’s repeated arguments, including a Rule 132 declaration by Azurity’s officer, emphasizing the claims’ lack of propylene glycol as a key distinction over Palelu. The Examiner expressly allowed the claims based on this exclusion.
The “consisting of” transition omitting propylene glycol was inherited by the ’400 application, which was allowed without rejection and resulted in the ’948 patent claims. For example, representative claim 5 recites a liquid formulation “consisting of: a buffering agent [selected from a recited group of buffering agents], water, a sweetener, a preservative [selected from a recited group of preservatives], vancomycin hydrochloride, and flavoring agent” (emphasis added), along with certain properties of the formulation.
Aside from the ’059 application, Azurity’s patent family includes No. 16/892,421 (“the ’421 application”)—the ’400 application’s grand-nephew claiming priority from the ’059 application. In the ’421 application, Azurity—after Alkem’s submission of Paragraph IV notice letter—apparently attempted to retract the disclaimer by stating: “For the record, Applicant did not disclaim propylene glycol when submitting the arguments in [the ’059 application], and reserves the right to claim propylene glycol in the instant and future cases in this patent family.”
Based upon the prosecution history, the CAFC found that Azurity clearly and unmistakably disclaimed any presence of propylene glycol from the ’948 patent. The CAFC was unpersuaded by Azurity’s non-disclaimer arguments including: (a) its “for the record” remarks made in the ’421 application are also relevant to the disclaimer analysis; and (b) the disclaimer of propylene glycol applies only to “the carrier” and not to “the flavoring agent.”
As for the “for the record” argument, the CAFC distinguished over the precedents where statements in the prosecution histories of patents from a common ancestor application may be relevant for claim interpretation in the related, later-issued patents. Here, the ’421 application and the ’400 application were prosecuted in parallel; there is no direct lineage from the ’421 application to the ’400 application; and the remarks at issue post-dated allowance of the asserted patent. To be consistent with the public notice function of the prosecution history, Azurity is barred from recanting its earlier disclaimer by the later, unilateral statement in the related application.
As for the “carrier” distinction, the CAFC pointed to the ’059 prosecution history where Azurity abandoned the “solution comprising a carrier consisting of” limitation in favor of the “consisting of” transition. While the CAFC acknowledged Azurity’s current argument that Palepu disclosed propylene glycol “only as a carrier” as opposed to a flavoring agent, such a distinction was never made during prosecution. “Just as the echo matches the shout,” the CAFC noted that the disclaimer scope is defined by the arguments as made, not as later refined.
- Pretrial stipulation
Azurity contended that a joint pretrial stipulation—stating that “suitable flavoring agents for use in the Asserted Claims include flavoring agents with or without propylene glycol”—precluded the application of the disclaimer. To Azurity, the stipulation would define the scope of “infringing flavoring agents” so that Alkem—with its product containing propylene glycol as part of the flavoring agent—could not rely on the disclaimer of propylene glycol, whereas Alkem argued that the stipulation was to simply clarify the general scope of the relevant flavoring agents in the field.
The CAFC sided with Alkem for several reasons. First, Azurity’s interpretation conflicted with another part of the stipulation stating that “Alkem does not dispute infringement except that it ‘contends that it does not infringe the Asserted Claims due to [the] presence of propylene glycol in Alkem’s ANDA Products.” Second, the disputed stipulation is set forth in a manner different from the rest of the undisputed facts each of which refers to meeting a limitation of any claim. Third, the disputed stipulation originated from Azurity’s concession over claim construction, admitting “that the plain and ordinary meaning of the claim term ‘flavoring agent’ includes flavoring agents without propylene glycol.” Based on the circumstances, the CAFC concluded that the stipulation does not preclude the disclaimer.
- The district court’s finding of non-infringement
After affirming the prosecution disclaimer and the pretrial stipulation, the CAFC found no error in the district court’s finding of non-infringement. The CAFC indicated that the existence of the prosecution history was a decisive factor. Absent the comprehensive disclaimer of any propylene glycol—either as an individual ingredient or as a concomitant of flavoring agent—Azurity may have had a colorable argument that propylene glycol would affect the flavoring of the product, and that propylene glycol and grape flavoring—both included in Alkem’s ANDA product—collectively are a flavoring agent, so as to read on the claimed “flavoring agent” while concurrently meeting the exclusion of “propylene glycol.” But the disclaimer precluded such a position.
Takeaways
This case underscores the lasting impact of prosecution history on claim scope, from an ancestor application to its descendent patent. Applicant cannot walk back a disclaimer in later, related applications—particularly those not in direct lineage. Also, in distinguishing prior art, care must be taken to avoid a broad, sweeping argument which could unknowingly over-restrict the claim scope to assert infringement.
Written Description is Required When a Preamble is Limiting
| March 26, 2025
IN RE: XENCOR, INC
Date of decision: March 13, 2025
Panel: before Hughes, Stark and Schroeder (District Judge (Eastern District of Texas) sitting by designation), Opinion by Schroeder
Background
This precedential decision is from an appeal by Xencor from a decision by the Appeals Review Panel (ARP). The ARP was established July 24, 2023. The ARP may be convened by the Director sua sponte to review decisions of the Patent Trial and Appeal Board (PTAB or Board) in ex parte appeals, re-examination appeals, and reissue appeals.
The application at issue is 16/803,690, which is a continuation application having an earliest priority date of February 25, 2008. Claim 8 (a Jepson claim) and claim 9 are at issue:
8. In a method of treating a patient by administering an anti-C5 antibody with an Fc domain, the improvement comprising
said Fc domain comprising amino acid substitutions M428L/N434S as compared to a human Fc polypeptide,
wherein numbering is according to the EU index of Kabat,
wherein said anti-C5 antibody with said amino acid substitutions has increased in vivo half-life as compared to said antibody without said substitutions.
9. A method of treating a patient by administering an anti-C5 antibody comprising:
a) means for binding human C5 protein; and
b) an Fc domain comprising amino acid substitutions M428L/N434S as compared to a human Fc polypeptide,
wherein numbering is according to the EU index of Kabat, wherein said anti-C5 antibody with said amino acid substitutions has increased in vivo half-life as compared to said antibody without said substitutions.
The Examiner had rejected the claims as lacking written description. Xencor appealed to the Patent Trial and Appeal Board. The Board held that the preambles of the claims are limiting, and that Xencor had not shown that the application contained a sufficient written description for either claim. The Board decision also determined that Xencor had not shown that anti-C5 antibodies or methods of treating patients with anti-C5 antibodies were well-known in the art at the time of invention.
Xencor petitioned for reconsideration, and the Board again found against Xencor for the same reasons. Xencor appealed to the CAFC. Prior to being heard, the Patent Office requested remand to the ARP (presumably to address the preamble).
The decision of the ARP addressed whether written description was required for Jepson claim preambles. It found that Jepson preambles define the scope of the claim, and therefore a written description is required. The ARP found the preamble language “treating a patient” as limiting because it was necessary to give life, meaning, and vitality to both limitations “increased in vivo half-life” and “administering” (the sole method step).
The ARP decision then concluded the claims did not have sufficient written description. The specification did not provide a representative number of species to support the broad genus of anti C5 antibodies being claimed. The specification only disclosed one anti-C5 antibody (5G1.1). The ARP also adopted the Board’s findings that Xencor’s expert was not credible and that Xencor had not demonstrated that anti-C antibodies were well-known (in which case not requiring further support in the specification).
The ARP decision also found that “treating a patient” was not supported by an adequate written description since the specification does not describe what patients with what diseases or conditions can be successfully treated with an anti-C antibody.
Xencor appealed the decision of the ARP to the CAFC.
Discussion
The Director stated that the CAFC’s standard of review of ARP’s decisions is the same as for decisions from the Board. As such, legal determinations are reviewed de novo, while factual findings are reviewed for substantial evidence.
Xencor argues that the preamble “treating a patient” is not limiting, that the preamble of a Jepson claim does not require written description, and, in the alternative, written description was satisfied for the preambles of both claims.
Claim 9
With respect to a “method of treating a patient by administering an anti-C5 antibody”, Xencor argues the different sections of the preamble should be treated independently, that is “treating a patient” and “administering an anti-C5 antibody”, where the “treating a patient” is not limiting. As such, Xencor argues that only “administering an anti-C5 antibody” should be considered limiting.
The CAFC agreed with the Director that “treating a patient by” is limiting. The CAFC first noted that Xencor does not dispute that “administering an anti-C5 antibody” should be considered limiting. The CAFC noted that the phrases are connected by the term “by” which gives credence to the argument that the entire preamble should be considered limiting. The “treating a patient” is done by administering the anti-C5 antibody, which is not a mere statement of purpose or a statement of intended result. In addition, since the claim does not require a dosage and rate, a person of ordinary skill in the art would have read the claim language of “increased in vivo half-life” in conjunction with “treating a patient” in order to make sense. Still further, the preamble provides a “raison d’etre” (reason for being) for the claim. An increased in vivo half-life only makes sense with respect to a living being (otherwise it cannot be in vivo) and has a specific utility with respect to treatment. Lastly, the specification teaches longer in vivo half-lives allow more seldom injections such that the specification “gives further color to the language of the claims and the understanding we have of the language as limiting.”
The CAFC then considered whether the specification satisfied the written description requirement. No specific amount of efficacy is claimed, so no specific amount is required in the specification. The application does not define the meaning of “treating” and does not provide any data associated with treating any patient with any disease or condition with any anti-C5 antibody. As such, the specification does not limit the treatment to any specific disease. As such, “treating a patient” means “treating all patients and all diseases”. At best, the disclosure of three classes of diseases/conditions that might benefit from administration of various antibodies with an Fc modification and lists various unmodified antibodies that could be modified and used to that end. Such disclosure is found to be “inadequate to demonstrate possession of a method of treating any particular disease/condition with the claimed anti-C5 antibodies, let alone all diseases/conditions within the three enumerated classes.”
Xencor had argued that the claim does not require the treatment to be effective. However, the ARP merely required that the applicant had possession of a method of treating a patient with 5G1.1 and its equivalents and found that it did not.
Claim 8
Claim 8 raises the question of whether a Jepson claim requires written description since the preamble of a Jepson claim defines what the prior art is, followed by recitation of what the improvement is. Xencor argues that a written description is only needed for the improvement.
Under 35 U.S.C. 112, a specification must contain a written description of the invention. This requirement must “be met in some way so as to describe the claimed invention so that one skilled in the art can recognize what is claimed.”
Such a description is context-specific: “[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010); see also Univ. of Rochester, 358 F.3d at 923 (explaining that merely stating “automobile” in a claim would not have been sufficient written description at the time of invention of the automobile).
In a Jepson claim, the preamble is used to define the invention, thereby limiting the claim scope. The invention is not only the improvement but also the improvement as applied to the prior art. Simply asserting that something is well known in the art is not sufficient to show that the inventor had possession of the claimed invention. The CAFC gave an example:
For example, a patentee cannot obtain a Jepson claim with a preamble that says that a time machine is well-known in the art without describing a time machine, in sufficient detail to make clear to a person of ordinary skill in the art that the inventor is in possession of such a time machine. Adoption of Xencor’s position would leave the patent system vulnerable to such abuse.
Thus, an adequate written description for a Jepson claim requires the applicant to establish what is claimed to be well-known in the art is, in fact, well known in the art.
Takeaway
Claims need to be supported by a written description as required by 35 U.S.C. 112, including the preamble when the preamble is considered limiting.
Do not include language in a preamble of a Jepson claim if it is not well-known or not supported by the specification. For this application, perhaps simply stating a method of administering an anti-C5 antibody could have avoided the written description problem, but perhaps this could lead to other issues such as enablement.
At the time the specification was filed in 2008, the specification stated “the exact dose will depend on the purpose of treatment” and the characteristics of the patient. This likely raises questions whether the inventor was in possession of the claimed invention (treating all patients with all diseases).
In Re: Entresto -Written Description and Enablement Do Not Have To Be Complicated.
| January 16, 2025
In re: Entresto; Novartis Pharm. Corp. v. Torrent Pharma Inc. et al.
Date of Decision: January 10, 2025
Before: LOURIE, PROST, and REYNA.
Summary:
The Federal Circuit reversed a finding by the District of Delaware that the drug patent covering the heart drug, Entresto was invalid for failing to provide a written description of future embodiments wherein a combination of two drugs where formed in a chemical complex. The Federal Circuit found that the District Court had erred by interpreting the written description requirement as demanding that a future embodiment needed to be adequately described in the patent in order for the claim to be valid. Instead, the CAFC noted that any written description sufficient to describe the claim satisfies the requirement.
Background:
The U.S. District of Delaware determined that claims 1-4 of U.S. Patent 8,101,659 (“the ’659 patent”) owned by Novartis were shown to be invalid for lack of written description. The ‘659 patent covers the heart failure treatment drug, Entresto. Entresto combines two different drug therapies, valsartan and sacubitril, in a specific form known as a “complex,” which combines the two drugs into a single unit-dose-form through weak, non-covalent bonds. During the District Court proceeding there had been a dispute as to the claim construction of the aspect of claim 1 “wherein said [valsartan and sacubitril] are administered in combination.” The District Court gave the term its plain and ordinary meaning as Novartis had argued for.
As a result of this construction, the District Court interpreted the claim to cover valsartan and sacubitril as a physical combination and as a complex (i.e. as used in Entresto). Torrent argued that the ’659 patent was required to enable and describe such complexes, since a patent must enable and describe the full scope of the claims. However, overwhelming evidence (in the form of later patents) showed that the complex of the two drugs was not invented until after the ‘659 patent issued.
As to enablement, the District Court found that because enablement is judged as of the priority date, later-existing state of the art may not be properly considered in the enablement analysis. As to written description, the District found because it was undisputed that complexes were unknown to a person of ordinary skill in the art, “‘[Novartis] scientists, by definition, could not have possession of, and disclose, the subject matter of [such complexes]’ and therefore, ‘axiomatically, [Novartis] cannot satisfy the written description requirement’ for such complexes.”
Novartis appealed. MSN (one of the Torrent defendants) remained for the appeal arguing that either the District Court’s written description determination should be affirmed or the enablement determination reversed.[1]
Discussion:
The CAFC took immediate issue with the manner in which the District Court had interpreted the written description requirement, noting that: “The issue is not whether the ’659 patent describes valsartan-sacubitril complexes. Because the ’659 patent does not claim valsartan-sacubitril complexes, those complexes need not have been described.” (Emphasis in original).
The Court restated the settled law that: “A specification adequately describes an invention when it ‘reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.’” Juno Therapeutics,Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1335 (Fed. Cir.2021) (quoting Ariad Pharms. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc)). They then noted that the claim construction had given the term “administered in combination” its plain and ordinary meaning, and that the specification provided ample description of the two drugs being administered together. Therefore, concluding that the claim had adequate written description support and that the District Court had “erroneously conflated the distinct issues of patentability and infringement, which led it astray in evaluating written description.”
Turning to enablement, the CAFC reiterated that the same is true -that it is the claim that must be enabled and not future potential embodiments which are the subject of infringement. Thus, the Circuit Court affirmed the District’s interpretation of enablement.
The district court correctly recognized that valsartan-sacubitril complexes, which include the claimed invention along with additional unclaimed features, are part of a later-existing state of the art” that “may not be properly considered in the enablement analysis.”
Conclusion:
The CAFC concluded that the District Court had erred in finding there was insufficient written description support and reversed and affirmed the District Court’s finding that the claims of the ‘659 patent are enabled.
Take away:
- When reviewing issues of written description and enablement, the review must center on the claim language and the claim construction thereof being supported by the patent.
- Future embodiments of a claim which could not possibly be enabled or described within the patent may still infringe the claim if they read on all the terms thereof as construed. Enablement and written description are issues of patentability not infringement.
[1] Issues of obviousness and indefiniteness were also raised but are not covered herein.
Claim Construction and Doctrine of Equivalents: NexStep v. Comcast
| December 5, 2024
Case Name: Claim Construction and Doctrine of Equivalents: NexStep v. Comcast
Date of Decision: October 24, 2024
Panel: Before: REYNA, TARANTO, and CHEN, Circuit Judges.
Summary
The Federal Circuit affirmed the District Court’s rulings in favor of Comcast Cable Communications, LLC, in a patent infringement suit brought by NexStep, Inc. The court upheld the findings of non-infringement, affirming the District Court’s claim construction and judgment as a matter of law.
Background
NexStep filed a suit alleging that Comcast’s products infringed multiple patents, with U.S. Patent Nos. 8,885,802 (the ’802 patent) and 8,280,009 (the ’009 patent) at the center of the disputes.
The ’802 patent is directed to a “digital butler” system that enables audio-based control of devices using Voice over Internet Protocol (VoIP). The key issue revolved around the interpretation of the term “VoIP” as represented in claim 1 of the ’802 patent:
1. A remote control device with slaved audio input, the device including:
a wireless link transceiver;
at least one slaved audio input built into the remote control;
a navigation control built into the remote control;
hardware resources coupled between the wireless link transceiver, the slaved audio input and the navigation control;
a stack running on the hardware resources and exchanging packets with a master device; and
an encoder logic running on the hardware resources, logically coupled to the stack, adapted to encode signals from the slaved audio input into a remote control audio format, and adapted to send audio packets in the remote control audio format to the master device;
wherein the remote control depends on the master device to transcode input from the slaved audio input to VoIP from the remote control device format and relies on the master device to respond to control signals sent by the remote control device in the packets.
NexStep argued for a broad interpretation of the term “VoIP,” asserting that it should encompass any audio data transmission, not limited to two-way voice communication. This interpretation would set the scope of the ’802 patent’s claims to include Comcast’s products, which utilized one-way audio communication protocols. In contrast, Comcast argued for an industry-standard interpretation of VoIP as requiring two-way voice communication. The District Court adopted Comcast’s interpretation, concluding that VoIP referred specifically to two-way communication protocols, which excluded NexStep’s infringement claims and led to a summary judgment of non-infringement.
The ’009 patent describes a “concierge device” designed to initiate technical support for a consumer device with a single user action. Claim 1 of the ’009 patent is representative::
1. A method of initiating a support session for a consumer device using a concierge device, the method including:
associating the concierge device with a selected consumer device;
responsive to a single action performed by a user, the concierge device communicating with a home gateway, including
causing the home gateway to buffer consumer device identification information for the selected consumer device and determine a support center for a support session; and
causing the home gateway to initiate the support session for the consumer device and to forward automatically the consumer device identification information during the support session, thereby allowing the support session either
to bypass an automated attendant or interactive voice recognition system or
to initiate an automated support protocol.
NexStep claimed that Comcast’s app infringed this patent under the doctrine of equivalents. NexStep argued that the app’s multi-step troubleshooting processes were equivalent to the “single action” requirement described in the patent. The District Court found NexStep’s evidence insufficient, concluding that the expert testimony failed to provide the specific and detailed analysis required under the doctrine of equivalents. As a result, the District Court entered a judgment as a matter of law in favor of Comcast.
Discussion
A key issue in the ’802 patent was the construction of the term “VoIP.” The District Court adopted Comcast’s narrower interpretation, relying on intrinsic evidence, including the patent’s specification and claims, as well as extrinsic sources like technical dictionaries. The specification consistently associated “VoIP” with two-way communication, analogous to traditional telephony services. NexStep had also conceded during earlier proceedings that “VoIP” was a term of art with an industry-standard meaning, which undermined its argument for a broader construction at trial.
The Federal Circuit upheld the District Court’s construction, finding no clear error in its reliance on both intrinsic and extrinsic evidence. The Federal Circuit also rejected NexStep’s argument that the ’802 patent supported an unconventional definition of “VoIP,” noting that this argument was forfeited because it had not been raised earlier. The court further noted that NexStep’s contentions regarding the intrinsic evidence were plainly incorrect, as the written description consistently associates VoIP with telephony services that require the capability for two-way voice communication.
This construction was decisive for the infringement claims under the ’802 patent. Comcast’s products used one-way communication protocols that transmitted voice commands to its servers via HTTP, a method incapable of supporting two-way voice conversations. As a result, they did not meet the claim limitations under the District Court’s interpretation, leading to a summary judgment of non-infringement. The Federal Circuit affirmed this judgment, concluding that the interpretation of “VoIP” aligned with industry norms and the intrinsic record.
The dispute over the ’009 patent centered on the “single action” limitation, a key feature of the patent’s claims describing a “concierge device” designed to simplify the process of initiating customer support. NexStep argued that Comcast’s products infringed the ’009 patent under the doctrine of equivalents. It claimed that even if Comcast’s processes required multiple steps, they were equivalent to the claimed “single action” because they achieved the same result of initiating a customer support session..
At trial, NexStep relied on the testimony of its expert, Dr. Ted Selker, to establish equivalence. However, the District Court found the testimony deficient, describing it as overly conclusory and lacking the specificity needed to support a finding of infringement under the doctrine of equivalents. Dr. Selker failed to provide detailed comparisons between the accused multi-step processes and the claimed single action. Instead, he offered generalized statements about overall functionality, asserting that several user actions could collectively be viewed as a single action without substantiating this claim with particularized evidence showing how the accused products met the criteria of equivalency.
The District Court set aside the jury’s finding of infringement under the doctrine of equivalents and granted Comcast judgment as a matter of law. On appeal, the Federal Circuit affirmed this decision, emphasizing that the doctrine of equivalents requires rigorous proof, including a limitation-by-limitation analysis supported by detailed expert testimony. The court emphasized that NexStep’s evidence was insufficient to demonstrate that Comcast’s multi-step processes performed the same function, in the same way, to achieve the same result as the “single action” limitation in the patent claims. Without this specificity, the jury’s verdict lacked a proper evidentiary foundation.
The Federal Circuit emphasized the importance of presenting clear and particularized evidence to establish equivalency for each claim limitation. The court further noted, “Consistent with our precedent, the patentee was required to provide ‘particularized testimony and linking argument as to the insubstantiality of the differences between the claimed invention and the accused device.’ ”
Takeaways
- Claim terms should align with established industry meanings unless explicitly redefined in the specification.
- The doctrine of equivalents requires detailed, particularized testimony to demonstrate equivalency for each claim limitation.
Standing Reminder for Inter Partes Review Decisions
| October 28, 2024
Case Name: LATINUM OPTICS TECHNOLOGY INC. V. VIAVI SOLUTIONS INC.
Date of Decision: August 16, 2024
Panel: Moore, Taranto and Cecchi (sitting by designation)
Summary
This decision serves as a reminder that standing to appeal a decision of the Patent Trial and Appeal Board (PTAB) can be lost in an inter partes review (IPR). This is because the Federal Circuit’s jurisdiction to review final decisions of the PTAB is limited to cases and controversies under Article III of the U.S. Constitution. If a civil action is dismissed before a final decision in an IPR, it is necessary to show that there is still an injury in fact so that an appeal can be taken to the CAFC.
Background
Viavi owns U.S. patent no. 9,354,369 which relates to optical fibers. Viavi sued Platinum Optics Technology (PTOT) for infringement in two civil suits in the Northern District of California. Thereafter, PTOT filed an IPR of the ‘369 patent. In the civil suits, the patent infringement claims were dismissed with prejudice. The PTAB subsequently issued a final written decision holding that PTOT failed to show the challenged claims in the ‘369 patent were unpatentable. PTOT appealed the decision to the Federal Circuit.
Discussion
A party does not need to establish Article III standing to appear before an administrative agency (such as the PTAB), as set forth in Cuozzo Speed Techs., LLC v. Lee, 579 U.S. 261, 279 (2016). However, standing is required when the party seeks review of an agency’s final decision in a federal court (Phigenix, Inc. v. Immunogen, Inc., 845 F.3d 1168, 1171–72 (Fed. Cir. 2017)). The party seeking judicial review bears the burden of proving standing (JTEKT Corp. v. GKN Auto. LTD., 898 F.3d 1217, 1220 (Fed. Cir. 2018)). As set forth in JTEKT “[o]ur cases establish that typically in order to demonstrate the requisite injury in an IPR appeal, the appellant/petitioner must show that it is engaged or will likely engage ‘in an activity that would give rise to a possible infringement suit,’…or has contractual rights that are affected by a determination of patent validity”.
PTOT asserts that it has standing based on potential infringement liability stemming from supplying its bandpass filters accused in one of the civil suits to parts integrators overseas and due to developing new models of bandpass filters. A declaration from the Deputy Director of Operations Management of PTOT was submitted to support the argument of injury in fact based on development of new bandpass filters.
Although Viavi dismissed the patent infringement suits, PTOT maintains that it has suffered an injury in fact based on its continued distribution of bandpass filters. In support of this argument, PTOT relies on a letter sent by Viavi sent prior to the first and second civil suits being filed, and PTOT’s expectation that Viavi would sue a third time. The CAFC pointed out that mere speculation about the possibility of another suit, without more, is insufficient to confer standing, particularly since the letters were sent prior to the first two civil actions which were subsequently dismissed.
Regarding the declaration submitted to the record, there was no explanation regarding detailed plans for development of new filters, nor any details regarding the particulars of the new filters or how they might relate to the ‘369 patent. The CAFC acknowledged that IPR petitioners do not need to concede infringement but need to at least establish that its development activities “will cause a substantial risk of infringement or will likely cause Viavi to assert a claim of infringement.” As such, PTOT has failed to establish an injury in fact to confer standing.
Takeaways
Although 35 U.S.C. §141(c)) statutorily authorizes appeal of an adverse IPR decision to the Court of Appeals for the Federal Circuit, the court requires Article III injury in fact to establish standing.
If the civil suit(s) are dismissed, an injury in fact needs to be established to appeal a PTAB decision to the CAFC.
A declaration can be sufficient to establish standing if it identifies specific, concrete plans to develop a product which may implicate a patent in suit.
Liberal construction for pro se litigants does not mean ignoring the pleading requirements under the FRCP
| October 28, 2024
Case Name: MASSOUD HEIDARY v. AMAZON.COM, INC., RING, LLC.
Decided: October 15, 2024
Panel: LOURIE, PROST, and STARK, Circuit Judges.
Summary:
The Federal Circuit affirmed the district court’s decision to dismiss a patent infringement claim for improper venue and failure to state a claim by a pro se litigant against Amazon.com, Inc. and Ring, LLC. The Federal Circuit held that a liberal construction of pleadings by pro se litigants does not mean ignoring the pleading requirements under the FRCP.
Details:
Massoud Heidary (“Heidary”) appeals from a decision of the U.S. District Court for the District of Maryland dismissing his patent infringement claims for improper venue and failure to state a claim.
Heidary owns U.S. Patent No. 10,380,862 (“the ’862 patent”). This patent is directed to a “fire protection system” for suppressing fire spread by shutting of the fan in an HVAC system when a fire is detected by a smoke detector.
Claim 1 of the ’862 patent reads as follows:
1. A system for suppressing fire in a building, the system comprising:
a plurality of smoke detector units,
each smoke detector unit comprising:
a smoke detector,
a power supply,
an auxiliary power supply,
a camera connected to the smoke detector, and
a wireless transmission unit connected to the camera
a normally closed relay,
a fan controller connected to an HVAC unit,
a thermostat,
a display unit,
a micro-controller for display unit,
a wireless receiver for the micro-controller,
a telephone system,
wherein upon detection of a smoke by any one of the smoke detectors, the respective smoke detector passes a signal to a normally closed relay to open and to cut-off the power supply to the thermostat as well as fan controller thereby shutting off the fan unit; and activates the respective camera and the wireless transmission unit to transmit a signal to a wireless receiver connected to the micro-controller so as to display the location of the fire on the display unit connected to the micro-controller.
District Court
Heidary filed a patent infringement suit against Amazon.com, Inc. (“Amazon”) and Ring, LLC (“Ring”) on September 13, 2022. Heidary argued that Amazon sells two products that meet each and every limitation of claim 1 of the ’862 patent.
Ring filed a motion to dismiss Heidary’s complaint for improper venue under Rule 12(b)(3) and both Ring and Amazon filed a motion to dismiss for failure to state a claim under Rule 12(b)(6) of the FRCP.
The District Court granted Amazon and Ring’s motion and dismissed the complaint without prejudice.
CAFC
Heidary appealed the district court’s decision to dismiss the complaint for each of improper venue as to Ring and failure to state a claim.
Improper Venue
Under § 1400(b), “[a]ny civil action for patent infringement may be brought in the judicial district where the defendant resides or where the defendant has committed acts of infringement and has a regular and established place of business.” 28 U.S.C. § 1400(b). It is the plaintiff’s burden to establish proper venue. Westech, 927 F.3d at 1382.
A “domestic corporation ‘resides’ only in its State of incorporation for purposes of the patent venue statute.” TC Heartland LLC v. Kraft Foods Grp. Brands LLC, 581 U.S. 258, 262 (2017).
If the defendant does not reside in the relevant district, then venue is only proper if each of the following requirements are met: “(1) there must be a physical place in the district; (2) it must be a regular and established place of business; and (3) it must be the place of the defendant.” In re Cray Inc., 871 F.3d 1355, 1360 (Fed. Cir. 2017).
The Federal Circuit agreed with the district court decision that Heidary failed to establish that venue is proper for Ring because as a Delaware entity, Ring does not reside in the District of Maryland for patent venue purposes.
In addition, the Federal Circuit found that Heidary pleaded no facts and made no showing that Ring has a physical place of business in the District of Maryland.
Direct Infringement
With regard to pro se litigants, the Federal Circuit held that pleadings must be “construe[d] . . . liberally” for pro se litigants. Bing, 959 F.3d at 618.
However, the Federal Circuit that this liberal construction does not mean “overlooking the pleading requirements under the Federal Rules of Civil Procedure.” Id. (citing Weidman v. Exxon Mobil Corp., 776 F.3d 214, 219 (4th Cir. 2015)).
Therefore, the Federal Circuit held that a pro se litigant still must plead “factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678 (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556 (2007)).
The Federal Circuit held that Heidary’s complaint merely lists what he contends are the limitations of the patent and asserts that Amazon makes, sells, uses, offers to sell, or imports in the U.S. products that meet each and every limitation of claim 1 of his patent.
The Federal Circuit held that a screenshot that merely describes one of the accused products and summarily concludes that the accused products infringe claim 1 is not sufficient.
In addition, the Federal Circuit held that there is an apparent disconnect between the patent and the accused products because while the ’862 patent recites a system with multiple components, the accused products consist of only smoke detector.
Therefore, the Federal Circuit agreed with the district court decision that Heidary failed to state a claim of direct infringement.
Takeaway:
- Plaintiff needs to sufficiently show that if the defendant does not reside in the relevant district, venue is only proper if each of the following requirements are met: “(1) there must be a physical place in the district; (2) it must be a regular and established place of business; and (3) it must be the place of the defendant.
- Even pro se litigants are not immune to the pleading requirements under the FRCP.
When to Apply Printed Matter Doctrine to Communications and Program Code
| May 15, 2024
Case Name: IOENGINE v. INGENICO
Date of Decision: May 3, 2024
Panel: : Lourie, Chen, and Stoll
Summary:
The Federal Circuit reversed the Board’s preclusion of patentable weight to the limitations involving “encrypted communications” and “program code” under the printed matter doctrine. The court determined that neither “encrypted communications” nor “program code” constitute “printed matter” because these terms do not recite the communicative content or informational content of the “encrypted communications” and “program code.”
Procedural History:
This is a consolidated appeal of several Final Written Decisions in several inter partes reviews (IPRs) in which the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (the Board) found numerous claims in U.S. Patent Nos. 8,539,047, 9,059,969, and 9,774,703 unpatentable. Most of the Board’s unpatentability determinations were affirmed. However, the Federal Circuit reversed the Board’s unpatentability of a subset of the claims due to an error in the Board’s application of the printed matter doctrine.
Decision:
Representative claims 4 and 7 of the ‘969 patent (and claims 1 and 2 from which they depend) are as follows:
1. A portable device configured to communicate with a terminal comprising a processor, an input component, an output component, a network communication interface, and a memory configured to store executable program code, including first program code which, when executed by the terminal processor, is configured to present an interactive user interface on the terminal output component, and second program code which, when executed by the terminal processor, is configured to provide a communications node on the terminal to facilitate communications to the portable device and to a communications network node through the terminal network communication interface, the portable device comprising:
(a) an external communication interface configured to enable the transmission of communications between the portable device and the terminal;
(b) a processor; and
(c) a memory having executable program code stored thereon, including:
(1) third program code which, when executed by the portable device processor, is configured to provide a communications node on the portable device to coordinate with the communications node on the terminal and establish a communications link between the portable device and the terminal, and facilitate communications to the terminal and to a communications network node through the terminal network communication interface; and
(2) fourth program code which is configured to be executed by the portable device processor in response to a communication received by the portable device resulting from user interaction with the interactive user interface;
wherein the portable device is configured to facilitate communications through the communication node on the terminal and the terminal network interface to a communications network node.
2. The portable device according to claim 1, wherein the fourth program code which, when executed by the portable device processor, is configured to cause a communication to be transmitted to the communication network node.
4. The portable device according to claim 2, wherein the communication caused to be transmitted to the communication network node facilitates the transmission of encrypted communications from the communication network node to the terminal.
7. The portable device according to claim 2, wherein the communication network node comprises a database and the communication caused to be transmitted to the communication network node facilitates the download of program code on the communication network node to the terminal.
The Board held that certain claims were anticipated by one of the cited references because no patentable weight was given to limitations that recite “encrypted communication” and “program code” (illustrative claims 4 and 7 reproduced above) under the printed matter doctrine.
The Federal Circuit reversed the Board’s determination of unpatentability of such claims because the Board erred in applying the printed matter doctrine to “encrypted communication” and “program code.”
Refresher on The Printed Matter Doctrine:
- “printed matter” is not patentable subject matter, and limitations that recite “printed matter” are not given patentable weight
- while this doctrine started out with literally “printed” material (information printed on paper), it has evolved over time to encompass “conveyance of information using any medium,” and “any information claimed for its communicative content”
- the printed matter doctrine prohibits patenting printed matter unless it is “functionally related” to its “substrate” (“substate” includes the structural elements of the claim)
- To determine the existence of a functional relationship, the court considers whether the printed matter merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to create a new functionality in a claimed device or to cause a specific action in a claimed process.
The Federal Circuit applied a two-step test to determine whether a limitation should be accorded patentable weight under the printed matter doctrine.
Step 1: determine whether the limitation in question is directed toward printed matter. The focus is on whether the limitation is claiming certain informational content or “matter claimed for what it communicates.”
Examples of “printed matter” provided by the court include: an FDA label providing dosage instructions for using a medical product; a label instructing a patient to take a drug with food; instructions on how to perform a DNA test; and numbers printed on a wristband.
Only if the limitation in question is determined to be “printed matter,” then Step 2 asks “whether the printed matter nevertheless should be given patentable weight … if the claimed informational content has a functional or structural relation to the substrate.”
Here, claims 4 and 7 are illustrative of the issue regarding application of the printed matter doctrine. Claim 4 depends from claim 2 which causes a communication to be transmitted from the portable device to a communication network node. Claim 4 recites “wherein the communication caused to be transmitted to the communication network node facilitates the transmission of encrypted communications from the communication network node to the terminal.” The Board held that the “encrypted communications” in claim 4 claimed only the communicative content (i.e., “printed matter”) whose transmission is being facilitated and there is “no functional relationship of the encrypted data to the communication carrying it.”
However, the Federal Circuit disagreed. The court clarified that “printed matter is matter that is claimed for its communicative content – i.e., the content specifically being communicated.”
The fact that there is a communication itself is not content; content is what the communication actually says. Nor is the form of a communication, such as whether the communication is encrypted, considered to be content. Printed matter encompasses what is communicated – the content or information being communicated – rather than the act of a communication itself.
With regard to claim 7, the Board likewise applied the printed matter doctrine to decline giving patentable weight to the “program code” limitation. Claim 7 also depends from claim 2 and recites that “the communication caused to be transmitted to the communication network node facilitates the download of program code on the communication network node to the [portable device’s] terminal.” The Board held that the “program code” is printed matter “because it claims the content of the information that is downloaded” and that downloaded code has no functional relationship with the portable device or the portable device’s terminal.
Again, the Federal Circuit disagreed. The court found that the “program code” is not being claimed for its communicative content. No informational content contained within the “program code” is being claimed. Nothing is recited about the contents of the claimed “program code.”
Takeaways:
For application of the printed matter doctrine to preclude patentable weight for a limitation containing the printed matter, the focus is on whether the claim reciting, or relies on, the communicative content of that “printed matter” – “the content specifically being communicated.” This case draws a clear distinction between “communication” or “program code” versus the communicative content or information being communicated or conveyed in that “communication” or “program code.”
Software Patents Demand Specific, Technologically Grounded Claims
| May 3, 2024
AI Visualize, Inc. vs. Nuance Communications, Inc. and Mach7 Technologies, Inc.
Decided: April 4, 2024
Before: MOORE, Chief Judge, REYNA, and HUGHES, Circuit Judges.
Summary
The Federal Circuit upheld a district court decision that dismissed AI Visualize’s patent infringement lawsuit against Nuance Communications and Mach7 Technologies. The court agreed with the lower court’s finding that the patents claimed patent-ineligible subject matter under 35 U.S.C. § 101, focusing on abstract ideas without enough inventive concept to warrant patent protection.
Background
AI Visualize asserted that Nuance Communications and Mach7 Technologies had infringed on its patents related to the visualization of medical scans through a web-based portal. The patents at issue include four patents: U.S. Patent Nos. 8,701,167; 9,106,609; 9,438,667; and 10,930,397. All these patents share a common specification that describes systems and methods aimed at improving the access and visualization of volumetric medical data, such as that obtained from MRI and CT scans, through a web-based portal. The patented technology demonstrates a centralized system that processes medical scan data and visualizes it remotely, allowing efficient transmission of three-dimensional views over low-bandwidth connections, thus facilitating better diagnostic capabilities across diverse medical environments.
The central dispute revolved around whether the patented methods and systems constituted an abstract idea under the Alice two-step framework. Nuance and Mach7 argued that the patent claims failed to transform this abstract idea into a patent-eligible application due to lack of an inventive concept. The district court agreed, finding that the patents were directed to the basic concept of manipulating and displaying data, a task it considered routine and conventional in the field.
Claim 1 of the ‘609 patent, representing the first group of claims, was central to this dispute.
1. A system for viewing at a client device at a remote location a series of three-dimensional virtual views over the Internet of a volume visualization dataset contained on at least one centralized database comprising:
at least one transmitter for accepting volume visualization dataset from remote location and transmitting it securely to the centralized database;
at least one central data storage medium containing the volume visualization dataset;
a plurality of servers in communication with the at least one centralized database and capable of processing the volume visualization dataset to create virtual views based on client request;
a resource manager device for load balancing the plurality of servers;
a security device controlling the plurality of communications between a client device, and the server; including resource manager and central storage medium;
at least one physically secured site for housing the centralized database, plurality of servers, at least a resource manager, and at least a security device;
a web application adapted to satisfy a user’s request for the three-dimensional virtual views by: a) accepting at a remote location at least one user request for a series of virtual views of the volume visualization dataset, the series of views comprising a plurality of separate view frames, the remote location having a local data storage medium for storing frames of views of the volume visualization dataset, b) determining if any frame of the requested views of the volume visualization dataset is stored on the local data storage medium, c) transmitting from the remote location to at least one of the servers a request for any frame of the requested views not stored on the local data storage medium, d) at at least one of the servers, creating the requested frames of the requested views from the volume visualization dataset in the central storage medium, e) transmitting the created frames of the requested views from at least one of the servers to the client device, f) receiving the requested views from the at least one server, and displaying to the user at the remote location the requested series of three-dimensional virtual views of the volume visualization dataset by sequentially displaying frames transmitted from at least one of the servers along with any frames of the requested series of views stored on the local data storage medium.
Discussion
The Federal Circuit’s analysis focused on whether the district court was correct in its application of the Alice two-step test for patent eligibility. This two-step framework is critical for determining whether a patent’s claims involve patent-eligible subject matter under Section 101.
In the first step of the Alice analysis, the court examines whether the claims at issue are directed to an abstract idea. For AI Visualize’s patents, the Federal Circuit assessed whether the system and method for visualizing medical scans, as claimed, merely recited an abstract concept without applying or using it in a uniquely technological manner.
The court found that the patents were primarily directed to the abstract idea of manipulating and displaying data, specifically the storage, retrieval, and graphical representation of medical imaging data. The court referenced their conclusion in Hawk Tech. Sys., LLC v. Castle Retail, LLC, 60 F.4th 1349 (Fed. Cir. 2023), noting that “converting information from one format to another . . . is an abstract idea.”
Having determined that the claims were directed to an abstract idea, the court then proceeded to step two of the Alice test, which involves determining whether the claim elements, either individually or as an ordered combination, add something significantly more to the abstract idea to transform the claim into patent-eligible subject matter. This “something more” must be an inventive concept that is not merely an instruction to implement or apply the abstract idea on a generic computer or using generic technology.
In reviewing AI Visualize’s claims, the court concluded that the methods described for processing and visualizing medical data did not involve an inventive concept sufficient to warrant patent protection. The claims were found to involve routine and conventional computer functions that are generic enough to be performed on any computer network. This included the creation of virtual views from medical data, transmitting these views over low-bandwidth networks, and enabling remote access via a web portal—none of which constituted a technological improvement over existing practices.
AI Visualize cites several sections of the specification to argue that creating virtual views offers a technical solution to a technical problem. This includes a section that explains how dynamic and static virtual views are formed by selecting related image frames from a volume visualization dataset. However, the court declined to consider details from the specification that are not specifically claimed.
Moreover, the court noted that the claimed invention did not solve a technical problem in an innovative way but rather applied a known solution (data manipulation and visualization) to a practice long prevalent in the field of computer systems.
The decision reaffirms the strict standards imposed by the Federal Circuit for patent eligibility under Section 101, emphasizing that a patent’s claims must do more than simply apply an abstract idea using conventional and well-understood applications. They must demonstrate a specific, inventive concept that enhances the technological process in a non-obvious way. This ruling highlights the challenges patent applicants face in securing protection for software-based innovations, particularly those that could be viewed as abstract ideas without clear, specific, and technologically rooted implementations.
Takeaway
- The decision reinforces the importance of demonstrating a specific, technologically rooted inventive concept in patent claims, particularly in fields involving software and data manipulation.
- Patents that broadly claim the performance of “abstract ideas” such as data retrieval and display without a clearly defined inventive mechanism are likely to face challenges under 35 U.S.C. § 101.
- It is essential to provide detailed technical descriptions in patent applications and include technological specificity in the patent claims to effectively present the unique contributions.
Tags: abstract idea > Data Manipulation > Mayo/Alice Test > patent eligibility
Result-Effective-Ugh…a Bridge Too Far?
| April 25, 2024
Pfizer Inc. v. Sanofi Pasteur Inc.
Decided: March 5, 2024
Result-Effective Variable; Obviousness
Before LOURIE, BRYSON, and STARK, Circuit Judge. Opinion drafted by LOURIE.
Summary:
Pfizer appealed to the Federal Circuit following rulings from five inter partes review proceedings petitioned by Sanofi challenging all claims of Pfizer’s U.S. Patent No. 9492559 (‘559 Patent). The ‘559 Patent claims immunogenic compositions comprising glycoconjugates of various Streptococcus pneumoniae serotypes for use in pneumococcal vaccines. Independent claim 1 is as follows (emphasize added):
- An immunogenic composition comprising a Streptococcus pneumoniae serotype 22F glycoconjugate, wherein the glycoconjugate has a molecular weight of between 1000 kDa and 12,500 kDa and comprises an isolated capsular polysaccharide from S. pneumoniae serotype 22F and a carrier protein, and wherein a ratio (w/w) of the polysaccharide to the carrier protein is between 0.4 and 2.
The Board instituted review based on each petition and issued final written decisions which, taken together, found all claims unpatentable. Pfizer raised four challenges on appeal. The first, which will be the only challenge discussed herein, alleged that the Board erred in determining that the ‘559 Patent was obvious based on prior art references PCT Patent Application Publication 2007/071711 (“GSK-711”) and U.S. Patent Application Publication 2011/0195086 (“Merck-086”).
The Board recognized that neither GSK-711 nor Merck-086 disclosed any molecular weight for a S. pneumoniae serotype 22F glycoconjugate, as required by claim 1 of the ’559 Patent, but nevertheless concluded that, based on the evidence of record, glycoconjugate molecular weight is a result-effective variable that a person of ordinary skill in the art would have been motivated to optimize to provide a conjugate having improved stability and good immune response. It is here that Pfizer argued the Board erred, because it is undisputed that the prior art does not disclose any molecular weight for the claimed serotype 22F glycoconjugate, there could be no presumption of obviousness. The CAFC disagreed.
The CAFC begin by stating that “the determination whether or not a claimed parameter is a result-effective variable is merely one aspect of a broader routine optimization analysis.”
The CAFC followed that “an overlap between a claimed range and a prior art range creates a presumption of obviousness that can be rebutted with evidence that the given parameter was not recognized as result-effective. See Genentech, Inc. v. Hospira, Inc., 946 F.3d 1333, 1341 (Fed. Cir. 2020) (citing E.I. DuPont, 904 F.3d at 1006); In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012).” However, they emphasized that this “does not mean that the determination whether or not a variable is result-effective is only appropriate when there is such an overlap.” Rather that “a routine optimization analysis generally requires consideration whether a person of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to bridge any gaps in the prior art to arrive at a claimed invention. Where that gap includes a parameter not necessarily disclosed in the prior art, it is not improper to consider whether or not it would have been recognized as result-effective. If so, then the optimization of that parameter is “normally obvious.” In re Antonie, 559 F.2d 618, 620 (CCPA 1977).”
Thus, the CAFC concluded that the Board did not err in considering, as part of its obviousness analysis, whether or not the claimed molecular weight of a S. pneumoniae serotype 22F glycoconjugate was a result-effective variable, dispute the cited references being silent thereon.
It was ultimately concluded that “substantial evidence supports the Board’s conclusion that the molecular weight recited in claim 1 would have been obvious over the references.” Such evidence included the fact that GSK-711 gave the molecular weights for fourteen other S. pneumoniae serotype glycoconjugates, and that Expert Testimony showed that, at the time of the invention, conjugation techniques and conditions were routine such that a person of ordinary skill in the art would have understood the claimed molecular weight to be “typical of immunogenic conjugates.”
Comments:
An argument against a Result-Effective Variable assertion may be weakened, even when the prior art is silent on said variable, if a PHOSITA can bridge the gaps in the teaching with a reasonable success based on the evidence overall. Thus, it may be necessary to demonstrate more than simply the variable not being recognized by the reference. That is, one may also have to show there is no reasonable expectation of success in said variable
Written Description Compliance Requires Lack of Different Inventions Achieved by Claimed and Disclosed Ranges
| April 19, 2024
RAI STRATEGIC HOLDINGS, INC. v. PHILIP MORRIS PRODUCTS S.A
Decided: February 9, 2024
Chen, Stoll, and Cunningham. Opinion by Stoll.
Summary
The CAFC addressed a question of written description compliance where a numerical range set forth in a patent claim is narrower than and encompassed by a disclosed range in the specification. The CAFC found that the written description requirement is met under fact-specific circumstances where substantial evidence indicates that a skilled artisan would see no different inventions resulting from the claimed range and the disclosed range.
Details
RAI appealed a final written decision by the Patent Trial and Appeal Board in a post-grant review (PGR) finding certain claims of RAI’s U.S. Patent No. 10,492,542 (“the ’542 patent”) unpatentable. RAI challenged, among other issues,[1] the Board’s finding that claims 10 and 27 of the ’542 patent lack adequate written description under 35 U.S.C. § 112.
The ’542 patent relates to electrically powered “smoking articles” which, as in e-cigarettes, use an electrical heating element to heat tobacco or like substance to form an inhalable vapor or aerosol. Claims 10 and 27—added by preliminary amendment in the underlying application which is a continuation from a former application having no such claims in the original filing—specify that the heating element has a certain range of length, which is not disclosed verbatim in the specification.
The written description requirement is a question of fact subject to substantial evidence review. The CAFC prefaced the written description analysis with the general threshold for compliance: the disclosure must “reasonably convey[ to a skilled artisan] that the inventor had possession of the claimed subject matter as of the filing date.” The CAFC then discussed precedents finding written description support, or lack thereof, for claimed ranges that are narrower than ranges described in specifications.
Courts finding adequate written description: Wertheim, Blaser, Kolmes[2]
In Wertheim, the parameter at issue was “solids content of the concentrated coffee extract.” The claimed range “between 35% and 60%” was found adequately supported by the specification disclosing a broader range of “25% to 60%” along with specific examples where the parameter was either “36% or 50%.” The Wertheim court held that presence of a clear indication that “the broad described range pertains to a different invention than the narrower (and subsumed) claimed range” (emphasis added) would negate adequacy of written description, whereas absence of such indication would support written description compliance.
Two subsequent courts followed Wertheim. InBlaser, the claimed range of temperature for heating a reaction blend for acylation, “80º to 200º C.” was found adequately supported by the disclosure of a broader range of “between 60º and 200º C.” In Kolmes, the claimed range of wrapping rate for cut-resistant yarn, “8–12 turns per inch,” was found adequately supported by the disclosure of a broader range of “4–12 turns per inch, with 8 turns per inch being preferred.”
Courts finding no adequate written description: Baird, Indivior[3]
Baird involved a patent application which included claims copied from an issued patent for an interference proceeding, i.e., the applicant was not the original author of the copied claims. The parameter at issue was a quench bath temperature in production of stretch-orienting polypropylene. The claimed range was “from about 40[º F] to … about 60 [º F].” While this range was explained in the issued patent as having certain criticality, the applicant’s specification disclosed a broader range of “between 32º F and 176º F,” while silent on the narrower range. Finding lack of adequate support, the Baird court reasoned that the copied claim pertained to a “different” invention from that disclosed in the specification.
In Indivior, the parameter at issue was a concentration of certain polymers in thin film formulation. Disputed claims recited two numerical ranges: (A) “about 40 wt % to about 60 wt %” and (B) “about 48.2 wt % to about 58.6 wt %.” The specification disclosed broader ranges—or lower bounds without express upper bounds—of “at least 25” and “at least 50,” as well as specific instances of “48.2” and “58.6” gleaned from data tables. The specification also stated that the parameter may be at “any desired level.” The claimed range (A) failed the written description requirement because the specification did not literally recite the range or the endpoints, while the “any desired level” statement obscured the scope of the invention. The claimed range (B) also failed the written description requirement because, although the endpoints were disclosed at least implicitly, it was unclear that the specification described the range bound by these endpoints.
Application to Claims 10 and 27 of the ’542 patent
After summarizing the precedents, the CAFC turned to the claims at issue. Claims 10 and 27 both recite that a heating member used in the smoking device has “a length of about 75% to about 85% of a length of the disposable aerosol forming substance.” The specification describes four progressively narrow, nested ranges for the parameter: “about 75% to about 125%,” “about 80% to about 120%,” “about 85% to about 115%,” and “about 90% to about 110%.” The Board’s finding of no written description was driven by the fact that the upper endpoint “85%” of the claimed range does not have a corresponding upper endpoint in any of the disclosed ranges.
The CAFC found that the written description requirement is met. To reach the conclusion, the CAFC centered its analysis on “different invention” test set forth in Wertheim, restating that “[t]he specification need not expressly recite the claimed range to provide written description support.” The factual inquiry looked to specific factors, including:
- Express disclosure in the specification: Although the claimed range itself is not literally disclosed, both of its endpoints are identified as part of the disclosed ranges.
- Predictability and complexity of the invention: Since the smoking device invention relates to a relatively predictable, electro-mechanical field, and the claim language is simple, the level of clarity or details required to satisfy the written description requirement is low.
- Lack of indication that the claimed parameter affects the invention: The specification nowhere indicates that “operability, effectiveness, or any other parameter” of the invention is impacted by changing the claimed parameter.
Based thereon, the CAFC found no “different invention” arising from the claimed range than that disclosed in the specification.
The CAFC distinguished Indivior and Baird relied upon by the Board. Unlike Indivior, the ’542 patent discloses the endpoints and contains no inconsistent statements regarding the range (e.g., that “any desired level” may work); plus the predictability of the electro-mechanical invention is higher than the chemical invention set forth in the Indivior claims. Also, unlike Baird where the claimed range was shown to have criticality over the boarder disclosed range, no evidence was presented in the present case that the broader disclosed range operates differently than the claimed range.
Additionally, the CAFC dismissed an expert testimony offered by Phillip Morris pointing to different center points of the disclosed range (100%) and the claimed range (80%). The expert evidence was not enough to overcome the intrinsic evidence and the case law supporting adequacy of the written description.
Takeaways
This case exemplifies one way in which a court may apply case-by-case analysis of written description compliance. Where the claimed range is narrower than and subsumed in the disclosed range, the “different invention” test may not only examine the express disclosure and the nature of the technology, but also may consider whether varying the parameter inside and outside the claimed range would make any difference.
While the test could be useful in establishing written description support—given that a patent specification typically describes numerical ranges in connection with one general inventive concept—caution should be used in asserting lack of different inventions emanating from different numerical ranges; such admission might be used by an opponent to support obviousness of the claimed range. The dilemma may be avoided, for example, by drafting an original disclosure to describe both commonalities and differences across broad and narrow ranges as well as specific values of a key parameter.
[1] RAI’s other argument challenged the Board’s obviousness finding of other claims of the ’542 patent, which was affirmed by the CAFC on appeal.
[2] In re Wertheim,541 F.2d 257 (C.C.P.A. 1976), In re Blaser, 556 F.2d 534 (C.C.P.A. 1977), and Kolmes v. World Fibers Corp., 107 F.3d 1534 (Fed. Cir. 1997).
[3] In re Baird,348 F.2d 974 (C.C.P.A. 1965), and Indivior UK Ltd. v. Dr. Reddy’s Laboratories S.A., 18 F.4th 1323 (Fed. Cir. 2021).
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