Prior Art Based on Inherency Does Not Extend to “Probably” Existing Subject Matter, but Is Limited to “Necessarily” Existing Subject Matter.
| March 21, 2019
Personal Web Technologies, LLC v. Apple, Inc.
March 12, 2019
Before Moore, Taranto and Chen. Opinion by Chen.
Summary
In September, 2013, Apple, Inc. (Apple) filed an inter parties review (IPR) proceeding before the U.S. Patent Trial and Appeal Board (PTAB) against Personal Web Technologies, LLC (Personal Web) asserting unpatentability of U.S. Patent No. 7,802,310. The PTAB held that the ‘310 patent was obvious. On appeal, the Federal Circuit overturned the Board’s holding of obviousness on the basis that the Board had relied upon purported “inherent” subject matter in a prior art document without sufficient evidence that the purportedly inherent subject matter “necessarily exists” based on the teachings of the reference.
Details
Procedural Background
In September, 2013, Apple, Inc. (Apple) filed an inter parties review (IPR) proceeding before the U.S. Patent Trial and Appeal Board (PTAB) asserting multiple grounds of unpatentability of U.S. Patent No. 7,802,310 owned by Personal Web Technologies, LLC (Personal-Web). The PTAB held that the ‘310 patent was obvious over U.S. Patent No. 5,649,196 (Woodhill) in view of 7,359,881 (Stefik). Personal-Web appealed the PTAB’s ultimate determination of obviousness.
Factual Background
The ‘310 patent is directed to “Controlling Access to Data in a Data Processing System.” In the prior art, problems arose due to conventional naming techniques in which data files are typically identified by a name and/or pathname or location. In particular, with convention systems, when a data item is transferred from a first device to a second device, if the same data item exists in the second device a duplicate copy will be created on the second device.
According to the invention of the ‘310 patent, a data file or element is given a unique name by creating a “unique identifier” that is added to the data item’s identification along with its user-defined name, location, etc. In particular, this unique identifier is created by applying a cryptograph hash function to the data item, but creates a unique identifier for the specific data item. Accordingly, if the data item is different (e.g., modified), it will have a different unique identifier. However, if the data item is the same (e.g., not modified), it will have the same unique identifier.
The key patent claim at issue – independent claim 24 – is set forth below for reference. And, a key element of this claim at issue in this litigation is highlighted below.
24. A computer-implemented method implemented at least in part by hardware comprising one or more processors, the method comprising:
(a) using a processor, receiving at a first computer from a second computer, a request regarding a particular data item, said request including at least a content-dependent name for the particular data item, the content-dependent name being based, at least in part, on at least a function of the data in the particular data item, wherein the data used by the function to determine the content-dependent name comprises at least some of the contents of the particular data item, wherein the function that was used comprises a message digest function or a hash function, and wherein two identical data items will have the same content-dependent name; and
(b) in response to said request:
(i) causing the content-dependent name of the particular data item to be compared to a plurality of values;
(ii) hardware in combination with software determining whether or not access to the particular data item is unauthorized based on whether the content-dependent name of the particular data item corresponds to at least one of said plurality of values, and
(iii) based on said determining in step (ii), not allowing the particular data item to be provided to or accessed by the second computer if it is determined that access to the particular data item is not authorized.
In holding that the claim was obvious over U.S. Patent No. 5,649,196 (Woodhill) in view of 7,359,881 (Stefik), the PTAB held that the Woodhill reference inherently taught the highlighted features above.
Discussion
The Federal Circuit reversed the Board’s decision on the basis that the Board’s inherency finding determination of the above-noted highlighted feature lacked substantial evidence.
- The Federal Circuit’s Discussion of the Law
The Federal Circuit explained that “[w]hile it is possible that Woodhill’s system utilizes an un-stated Binary Object Identifier lookup table to locate binary objects of a previous version of a file that is going to be restored …, mere possibility is not enough.” The Court further indicated that “[i]nherency . . . may not be established by probabilities or possibilities” and that “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.”
The Federal Circuit explained that for inherency “a party must ‘show that the natural result flowing from the [disclosure] as taught would result in [the claimed subject matter]” – i.e., in this case that the “natural result flowing from the operation as taught would result in the performance of the questioned function.”
The Federal Circuit held that because the claimed subject matter “does not necessarily exist in the” Woodhill reference, reliance on inherency for that feature in the obviousness analysis was improper.
2. The Federal Circuit’s Discussion of the Evidence
In concluding that the Board’s inherency finding determination was not based on substantial evidence, the Federal Circuit explained that the Woodhill reference did not inherently include “causing the content-dependent name of the particular data item to be compared to a plurality of values” for the following reasons.
The Woodhill reference teaches a distributed management system in which files are apportioned into binary objects. The system uses binary object identifiers to determine whether a binary object has changed from one version of a file to the next, and only those binary objects whose content has changed needs to be backed up, thereby reducing the amount of data being backed up. In Woodhill, the binary object identifier is based on the contents of the binary object, such that the binary object identifier changes when the contents is changed.
At the PTAB, the Board had agreed with Apple’s argument that in order to determine which data needs to be restored in Woodhill by an update request, the system “must be able to” reference local data files using the binary object identification information received and, thus, that Woodhill must maintain some sort of file system or other mapping that allows the binary object identification record to serve as a lookup for the requisite file data that is to be restored. Thus, the Board asserted that Woodhill must inherently teach the disputed feature.
However, the Federal Circuit explained that “an equally plausible” understanding of Woodhill is that the system uses conventional file names and locations to locate files and the binary object information to locate a given binary object within the file. The Federal Circuit further explained that the only disclosed use of the binary object identifier in Woodhill is to perform a one-to-one comparison with the binary object identifier in the backed-up version of the object, which occurs after the object has been identified.
Takeaways
- This case emphasizes that inherency requires the “necessary” existence of subject matter that is not expressly shown or described in a reference. Accordingly, this case may be helpful in contesting rejections where asserted subject matter is not emphatically necessarily present, but deemed to be probable or likely by the Patent Office.
- This case also demonstrates that one way to
argue against a finding of inherency is to set forth an “equally plausible”
alternative that is supported by the reference.
That is, by demonstrating that an “equally plausible” alternative
subject matter may exist, it can be argued that the Patent Office cannot
conclude that the asserted subject matter inherently exist.
A Patent of Few Words and a Defendant with a Few Parts cannot avoid a Trier of Fact
| February 22, 2019
Centrak, Inc. v. Sonitor Tech., Inc.
February 14, 2019
Before Reyna, Taranto and Chen. Opinion by Chen.
Summary:
The CAFC reversed and remanded a Motion of Summary Judgment finding that the District Court errored in focusing on the length of a written description and dismissing a plausible theory for direct infringement based on the final assembly being done by the defendant within a customer’s system.
Details
- Background
CenTrak, Inc. sued Sonitor Technologies, Inc. for alleged infringement of U.S. Patent No. 8,604,909 (’909 patent), which claims systems for locating and identifying portable devices using ultrasonic base stations. The district court granted Sonitor’s MSJ that the relevant claims are invalid for lack of written description and are not directly infringed because Sonitor does not individually provide for all the aspects of the claims.
The claims are directed to ultrasonic base stations which can be mounted in various fixed locations in a facility, such as rooms in a hospital, and the portable devices can be attached to people or assets that move between rooms. Each portable device is configured to detect the ultrasonic location codes from the nearby ultrasonic base stations and “transmit an output signal including a portable device ID representative of the portable device and the detected ultrasonic location code.” While the portable devices receive location codes from ultrasonic base stations via ultrasound, they might transmit location and device information via RF to an RF base station.
The asserted claims generally recite: (1) ultrasonic (US) base stations; (2) portable devices (tags); (3) a server; (4) radio frequency (RF) base stations; and (5) a backbone network that connects the server with the RF base stations.
All the claims of the ’909 patent are directed to “ultrasonic” components. However, the specification focuses on infrared (IR) or RF components. Only two sentences of the ’909 patent’s specification discuss ultrasonic technology:
Although IR base stations 106 are described, it is contemplated that the base stations 106 may also be configured to transmit a corresponding BS-ID by an ultrasonic signal, such that base stations 106 may represent ultrasonic base stations. Accordingly, portable devices 108 may be configured to include an ultrasonic receiver to receive the BS-ID from an ultrasonic base station.
In regard to lack of written description, Sonitor argued that the two sentences in the specification dedicated to ultrasound, did not show that the inventors had possession of an ultrasound-based RTL system.
Regarding invalidity, the district court ruled that while the specification “contemplated” ultrasound, “[m]ere contemplation . . . is not sufficient to meet the written description requirement.
In regard to infringement, the accused Sonitor Sense system includes three pieces of hardware sold by Sonitor: RF “gateways,” ultrasonic location transmitters, and portable locator tags. Sonitor also provides software for installation on a customer’s server hardware.
Sonitor’s main non-infringement argument was that Sonitor does not make, use, or sell certain elements recited in the claims, including the required backbone network, Wi-Fi access points, or server hardware.
CenTrak argues that the resulting system infringes the ’909 patent when the components Sonitor sells are integrated with a customer’s existing network and server hardware. CenTrak asserted only direct infringement. Since, Sonitor does not sell all of the hardware necessary to practice the asserted claims, so, on appeal, CenTrak only pursued a theory under 35 U.S.C. § 271(a) that Sonitor “makes” infringing systems when it installs and configures the Sonitor Sense system. In short, the crux of CenTrak’s assertion is that there is direct infringement when the party assembles components into the claimed assembly (i.e. the party “makes” the patented invention, even when someone else supplies most of the components).
The district court granted summary judgment of non-infringement. It held that a defendant must be the actor who assembles the entire claimed system to be liable for direct infringement, and CenTrak had not submitted proof that Sonitor personnel had made an infringing assembly.
CenTrak appealed both MSJ grants.
2. Opinion
In regard to invalidity, the CAFC held that, the district court leaned too heavily on the fact that the specification devoted relatively less attention to the ultra-sonic embodiment compared to the infrared embodiment. Quoting their ScriptPro LLC v. Innovation Associates, Inc., 833 F.3d 1336, 1341 (Fed. Cir. 2016), they reiterated that “a specification’s focus on one particular embodiment or purpose cannot limit the described invention where that specification expressly contemplates other embodiments or purposes.”
The Court explained that the real question is the level of detail the ’909 patent’s specification must contain, beyond disclosing that ultrasonic signals can be used, to adequately convey to a skilled artisan that the inventors possessed an ultrasonic embodiment. Citing their Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) en banc: “the 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.” They further noted per Ariad that the issue of whether a claimed invention satisfies the written description requirement is a question of fact.
The opinion details that the parties disputed the complexity and predictability of ultrasonic RTL systems, and the district court erred at the summary judgment stage by not sufficiently crediting testimony from CenTrak’s expert that the differences between IR and ultrasound, when used to transmit small amounts of data over short distances, are incidental to carrying out the claimed invention. The Court specifically noted the testimony from CenTrak’s expert that those details were not particularly complex or unpredictable, and Sonitor does not explain why a person of ordinary skill in the art would need to see such details in the specification to find that the named inventors actually invented the claimed system.
Hence, the Court concluded that:
…there is a material dispute of fact as to whether the named inventors actually possessed an ultrasonic RTL system at the time they filed their patent application or whether they were “leaving it to the . . . industry to complete an unfinished invention.”…
Here, as in ScriptPro, the fact that the bulk of the specification discusses a system with infrared components does not necessarily mean that the inventors did not also constructively reduce to practice a system with ultrasonic components … “the written description requirement does not demand either examples or an actual reduction to practice; a constructive reduction to practice” may be sufficient if it “identifies the claimed invention” and does so “in a definite way.” Ariad, 598 F.3d at 1352.
In regard to direct infringement, the Court noted that it is undisputed that Sonitor does not provide certain claimed elements in the accused systems, such as a backbone network, Wi-Fi access points, or server hardware. Moreover, the district court analyzed the evidence CenTrak offered and concluded that no reasonable jury could find that Sonitor “made” the claimed invention by performing installations relying on Centillion Data Systems, LLC v. Qwest Communications International, Inc., 631 F.3d 1279 (Fed. Cir. 2011) for the proposition that to “make” a system, a single entity must assemble the entire system itself.
The CAFC found that Centillion does not rule out CenTrak’s infringement theory. In this case, Cen-Trak argued that the final, missing elements are the configuration that allows the location transmitters to work with the network and the location codes that are entered into the Sonitor server. According to CenTrak, admissible evidence that Sonitor is the “final assembler” raises a triable issue of fact on infringement even though Sonitor does not “make” each of the claimed components of the accused systems.
The Court further held that under Lifetime Industries, Inc. v. Trim-Lok, Inc., 869 F.3d 1372 (Fed. Cir. 2017), and Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1311 (Fed. Cir. 2005), a final assembler can be liable for making an infringing combination—assuming the evidence supports such a finding—even if it does not make each individual component element.
3. Decision
The CAFC found that the District Court errored in both: (1) finding a lack of written description as it relied too heavily on the briefness of the ‘909 patents comments on ultrasonic RTL systems rather than the amount of knowledge needed for a skilled artisan to consider; and (2) finding that there was no dispute of fact as to whether Sonitor was a “final assembler” by virtue of performing the final system installation for its customers. The Court therefore reversed and remanded.
Take away
- The measure of a sufficient written description is not in its length. Rather, the test is to the amount of disclosure necessary for a skilled artisan to discern that the inventor in fact possessed the invention.
- A case for direct infringement can be made even where the defendant does not “make all the parts” if there is sufficient evidence that the accused infringer is a “final assembler” in terms of actuating the combination of elements to infringe.
Tags: 35 U.S.C. §112 > direct infringement > summary judgment > written description
Creative Strategies of Attack
| February 19, 2019
Mylan Pharmaceuticals Inc., Breckenridge Pharmaceutical, Inc., Alembic Pharmaceuticals Ltd., v. Research Corporation Technologies, Inc.
February 1, 2019
Before Lourie, Bryson, and Wallach. Opinion by Lourie.
Summary
Creative strategies of attack can be made on a patent even when the challenger is apparently precluded by statute. In particular, this decision highlights that parties who would have been time barred in filing an inter partes review (IPR) petition, in this case, Mylan Pharmaceuticals, Breckenridge Pharmaceutical and Alembic Pharmaceuticals, can be joined in an IPR and then appeal an adverse decision, even though the original petitioner (Argentum) would lack Article III standing for an appeal in federal courts.
On the merits, this decision reiterates that all facts need to be considered in making a final obviousness determination, including establishing a motivation to modify a compound.
Background
The appellants (Mylan, Breckenridge and Alembic) appeal the final decision of the Patent Trial and Appeal Board (PTAB) in an IPR concluding that claims 1-13 of Reissue 38,551 are not unpatentable. The IPR was based on a petition filed by Argentum Pharmaceuticals who is not an appellant in the appeal. Upon institution of the IPR, the appellants (Mylan, Breckenridge and Alembic) filed their own petitions with concurrent motions for joinder. Each of these appellants had been sued for infringement of the ‘551 reissue in 2013, more than a year before the petitions were filed. Note that 35 USC 315(b) states:
An inter partes review may not be instituted if the petition requesting the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent. The time limitation set forth in the preceding sentence shall not apply to a request for joinder under subsection (c).(Emphasis added)
The PTAB permitted joinder. Subsequently, the PTAB rendered its decision on the merits concluding that each challenged claim had not been shown to be unpatentable. Mylan, Breckenridge and Alembic appealed the decision. Argentum, on the other hand, did not join the appeal as Argentum lacked standing under Article III of the Constitution (Argentum did not have any injury and therefore lacked entry into the federal appellate court system).
Discussion
Standing
RCT argues that the appellants lack standing because RCT had brought an infringement action against each appellant more than a year before the IPR petitions were filed. RTC argues that although the appellants were permitted to join, the initial petitioner’s IPR (filed by Argentum) was limited to an agency matter, and therefore there would be no Article III standing. The appellants, on the other hand, point out that they have an express, statutory right to appeal. The CAFC agreed. To reach this conclusion, the CAFC looked to the text of 35 USC 315(c) stating that a party may be joined. Then section 319 provides that “a party” may appeal.
Merits
The PTAB had accepted a certain compound (identified as compound 3l) as a lead compound, and concluded that the petitioners failed to establish motivation to modify that compound. The CAFC agreed that the appellants had failed to meet their burden to establish a motivation to modify. From the decision, it does seem like the arguments of obviousness were a stretch.
In this regard, the appellants first focused on a methoxyamino group in compound 3l as being uncommon and having potential synthetic and stability problems as a basis for a POSITA to have been motivated to modify in a certain way, and that the proposed modified compound would have been expected to have excellent potency.
The evidence presented by RCT, however, showed that compound 3l was actually stable and that the record was devoid of evidence of potential stability issues. In addition, RCT argued that the appellants did not provide any evidence that “only methylene would result in a more pharmaceutically common and acceptable compound and resolve the potential stability and synthesis concerns presented by the methoxyamino moiety.”
In conclusion, the CAFC concluded that the PTAB had appropriately considered all facts before making a final obviousness determination.
Although not in the decision, an examination of the history of the patent in suit is interesting. First, it is always interesting when a reissue is involved. Reissue is used to correct errors in a patent when the patent is considered defective or inoperative. The original patent issued as USP 5,773,475 on June 30, 1998. The reissue application was filed on the basis that the original patent was inoperative because priority to a provisional application was not perfected. This step was taken apparently due to some ambiguity when the American Inventors Protection Act of 1999 was enacted. This became an issue because the non-provisional application was filed a little over one year from the provisional filing date because the one year anniversary fell on a Saturday. The non-provisional application was filed on the succeeding Monday. 35 USC 119(e) (3) was amended to clarify that if the anniversary date fell on a Saturday, Sunday or Federal holiday, the filing on the next succeeding business day would be considered timely.
In addition, it is interesting to note that an ex parte reexamination was filed on April 9, 2018 as another attack on the reissue patent. The ex parte reexamination resulted in cancellation of claims 1-7, confirmation of patentability of claims 8-13, and a determination that newly added claims 14-28 are patentable. The same rejections appear to have been addressed in the ex parte reexamination as in the IPR proceeding. Note that the IPR was filed November 25, 2015, and then the ex parte reexamination was filed April 29, 2016. The PTAB had issued an order staying the ex parte reexamination proceeding until the PTAB had issued its final written decision in the IPR.
The reissue patent was also granted 5 years of patent term extension. The reissue patent covers the drug lacosamide which is used to treat epilepsy.
Takeaway
Creativity and knowledge of the laws can open the way to challenge patents even when it does not seem possible.
It all begins with Claim Construction
| February 15, 2019
Duncan Parking v. IPS Group
January 31, 2019
Before Lourie, Dyk, and Taranto. Decision by Lourie.
Summary:
The trial judge construed the claims and subsequently granted summary judgment in favor of Defendant Duncan that the accused parking meters do not infringe U.S. Patent No. 8,595,054 owned by Plaintiff IPS. On appeal the CAFC determined that the trial judge had misconstrued the claims, vacated the summary judgment of non-infringement, and remanded the case to the trial judge for reconsideration of the infringement issue in light of the proper claim construction.
Details:
Claim 1 of the ‘054 patent recites:
- A parking meter device that is receivable within a housing base of a single space parking meter, the parking meter device including:
a timer;
a payment facilitating arrangement operable in cooperation with a non-cash payment medium for effecting payment of a monetary amount for a parking period;
a display configured to visually provide a balance remaining of the parking period;
a power management facility that supplies power to the timer, payment facilitating arrangement, and display;
a wireless communications subsystem configured to receive information relating to the non-cash payment medium in respect of the payment facilitating arrangement;
a keypad sensor that receives input comprising manipulation by the user;
a coin slot into which coins are inserted for delivery to the coin sensor and then to a coin receptacle; and
a lower portion and an upper portion;
wherein the keypad sensor operates the parking meter and determines parking time amount for purchase in accordance with the received input from the user;
wherein the display provides the amount of time purchased in response to the received input from the user;
wherein the upper portion of the parking meter device includes a solar panel that charges the power management facility;
wherein the lower portion of the parking meter device is configured to have a shape and dimensions such that the lower portion is receivable within the housing base of the single space parking meter; and
wherein the upper portion of the parking meter device is covered by a cover that is configured to accommodate the upper portion and that is engageable with the housing base of the single space parking meter such that the payment facilitating arrangement is accessible by the user for user manipulation effecting the payment of the monetary amount for the parking period when the lower portion of the parking meter device is received within the housing base and the upper portion is covered by the cover.
10 – parking meter device
34 – housing
36 – cover
41 – window
Duncan’s accused parking meter is shown below.
The trial judge court construed “receivable within” as “capable of being contained inside,” and applied this construction to require that the “entire lower portion” of the infringing product be “receivable within the housing base.” The trial judge granted summary judgment of non-infringement because it found that the keypad of the accused meter extends through an opening in the lower portion of the housing and, as a result, the lower portion of Duncan’s meter is not “receivable within” its housing base.
On appeal IPS argued that the trial judge had
- construed the claim term “receivable within,” in the claim limitation “a lower portion [of the parking meter device] . . . receivable within the housing base” too narrowly, requiring that the entire lower portion of the parking meter device be contained inside the parking meter housing;
- erroneously construed claim 1 to exclude a potential unclaimed “middle portion” of the device between the upper and lower portions; and
- excluded the preferred embodiment from the scope of claim.
On the latter point, IPS explained that the card slot and the coin slot (both parts of the device itself) cannot be part of the upper portion of the device because the upper portion must be covered by the cover panel. But they also cannot be a part of the lower portion of the device because they are not “receivable within” the housing base as per the district court’s claim construction. Instead, they are accessible through openings in the housing. Thus, either the coin slot and card slot comprise a “middle portion” not defined by the ‘054 claims or the ‘054 specification, or the trial judge’s construction of “receivable within” is too narrow.
DPT replied
- that the plain meaning of “within” is “inside,” and IPS choose not to modify the term with the words “generally” or “substantially”;
- that the trial judge’s claim construction does not actually exclude the preferred embodiment because the coin slot is still inside the housing base; while the coin slot of the preferred embodiment is accessible through an opening in the housing, it does not actually protrude through that opening; and
- that prosecution history estoppel bars IPS from asserting that claim 1 includes parking meter devices that are not entirely contained within a housing.
The CAFC touched on familiar issues, commenting on the trial judge’s approach to claim construction and then addressing the parties’ argument.
The Trial Judge’s Approach:
The trial judge construed the term “receivable within” as “capable of being contained inside,” but upon applying the claim construction in its infringement analysis added a requirement that the “entire” lower portion of the device must be contained within the housing, id. at 8, effectively altering the construction to “capable of being contained entirely inside.”
Dictionaries:
A reasonable meaning of the term “receivable within” in the context of the ’054 patent is “capable of being contained inside.” Receive, The New Oxford American Dictionary (2d ed. 2005) (defining “receive” as “to act as a receptacle for” and “receptacle” as “an object or space used to contain something”).
The suffix “-able” implies that the lower portion of the device is capable of being contained within the housing base. But this definition contains no limitation to “completely” or “entirely” contained, nor is there any evidence that persons of skill in the art would understand it to be so limited. Indeed, Duncan touted its accused meter because it “fits within” existing parking meter housings.
The ‘054 Specification:
The only use of the term “receivable” in the ‘054 specification does not imply any limitation to devices “entirely” contained by the housing (“The parking meter device in accordance with the invention may be receivable in a conventional single space parking meter housing, such as that supplied by Duncan Industries, POM or Mackay.”).
The trial judge’s claim construction did indeed exclude the preferred embodiment. The specification defines the coin slot as a part of the lower portion, even though it is not located “within” the housing base but is instead accessible through an opening. Whether the coin slot “protrudes” or not is beside the point; it is a part of the lower portion of the parking meter device but is not “capable of being contained [entirely] within” the housing base as required by the trial judge’s claim construction.
The ‘054 Prosecution History:
Duncan argued that a narrow construction was warranted by the ‘054 prosecution history because IPS had disavowed parking meter devices not fully enclosed by a housing in its response to an office action. Thus Duncan contended that by differentiating the prior art on the basis that it discloses an embodiment exposed to the elements, rather than one enclosed within a housing, IPS disavowed parking meter devices not entirely enclosed within a housing. IPS’s statements fall far short of a claim scope disavowal. IPS distinguished the cited prior art—an actual parking meter, not an insertable device—on the basis that it discloses a “self-contained unit,” as opposed to the claimed device, which is “a retro-fit upgrade to existing parking meters.”
Conclusion:
Because the CAFC agreed with IPS that the district court’s claim construction of “receivable within” was erroneous, it vacated the trial judge’s grant of summary judgment of non-infringement of the ’054 patent and remanded the case to the trial judge for further proceedings.
Takeaways:
The scope of claims is determined on the basis of how they are written, not as how they might have been written.
Dictionaries are almost always important.
A claim construction that excludes a preferred embodiment in the specification from the claim scope is usually wrong.
Disavowal of claim scope in a prosecution history is rare.
Applicant should carefully review the PTO’s PTA especially when applicant filed corresponding applications in foreign patent offices
| February 4, 2019
Supernus Pharmaceuticals, Inc. et al. v. Iancu
January 23, 2019
Before Reyna, Dyk, and Schall. Opinion by Reyna.
Summary:
The Federal Circuit held that the PTO’s reduction of the patent term for a Supernus patent due to applicant delay (of filing an information disclosure statement after filing an RCE) is not correct because there is nothing Supernus could have done during the period of time from the filing of an RCE and the receiving of a communication from a foreign patent office to conclude the prosecution of the application.
Details:
Patent Term Adjustment (PTA) statute of 1999: 35 U.S.C. §154(b)
- §154(b)(1)(A)-(C): delays caused by the PTO
- Type A delay: the PTO fails to provide a notification under 35 U.S.C. §132 or a Notice of Allowance within 14 months of filing date.
- Type B delay: the PTO fails to issue a patent after 3 years have passed between the filing date and the date of allowance.
- Type C delay: for delays that are excluded from Type B delay due to derivation proceedings, secrecy orders, or successful appeals.
- §154(b)(2): delays caused by applicants
Supernus Pharmaceuticals, Inc. is the owner and assignee of U.S. Patent 8,747,897 (“the ’897 patent”), and United Therapeutics Corp. is the exclusive licensee of the ’897 patent.
Relevant timelines:
- 4/27/06: Supernus filed U.S. application and international application claiming priority from the U.S. application (international application gave rise to EP application).
- 8/20/10: the PTO issued a final OA.
- 2/22/11: Supernus filed an RCE.
- 10/13/11: the EPO issued the EP application as EP patent.
- 8/21/12: the EPO notified Supernus’s European patent counsel that a Notice of Opposition was filed by Sandoz to the EP patent.
- 9/11/12: Supernus received a letter from its European patent counsel regarding the EPO notification.
- 11/29/12 (79 days later from 9/11/12 and 100 days from 8/21/12): Supernus filed a supplemental IDS citing the EPO notification.
- 9/10/13: the PTO issued a first OA responding to Supernus’s RCE.
- 1/10/14: Supernus filed a response.
- 2/4/14: the PTO issued a Notice of Allowance.
- 6/10/14: the U.S. application issued as the ’897 patent (PTA of 1,260 days).
PTO
The PTO attributed 2,321 days to the PTO delay (1,656 days for Type A delay and 665 days for Type B delay). The PTO reduced 2,321 days by 175 days to account for overlapping Type A and Type B delays and 886 days for applicant delay. Out of 886 days, 646 days were assessed for the 2/22/11 filing of the RCE and the 11/29/12 filing of the IDS.
PTA of 1,260 days = 2,321 days – 175 days – 886 days.
Supernus filed a request for Reconsideration of PTA because the deduction of 646 days was improper. The PTO rejected the request because citing Gilead, filing the IDS after filing of the RCE “interferes” with the PTO’s ability to process an application.
District Court
Supernus appealed to the U.S. District Court for the Eastern District of Virginia. The district court granted summary judgment in favor of the PTO because the PTO did not err in the PTA calculation for the ’897 patent.
Federal Circuit
First of all, the Federal Circuit held that Gilead did not apply in this case. In Gilead, the patent owner brought an action challenging the PTO’s assessment of a 57-day applicant delay in calculating PTA reduction based on Gilead’s delay during examination between its reply to a restriction requirement and its submission of a supplemental IDS (disclosing other co-pending Gilead patent applications). However, the Federal Circuit held that the issue in this case is whether the PTO may reduce PTA by a period that exceeds the “time during which the applicant failed to engage in reasonable efforts to conclude prosecution.” (35 U.S.C. §154(b)(2)(C)(i)). The Federal Circuit held that Gilead did not answer this issue.
Supernus conceded that it failed to engage in “reasonable efforts” for the last 100 days of the 646-day period. However, Supernus argued that there was nothing Supernus could have done during the 2/22/11 filing of the RCE and the 8/21/12 receiving of the EPO communication.
The Federal Circuit agreed with Supernus’s arguments. The Federal Circuit held that there was no action Supernus could have done to advance prosecution of the patent during the 546-day period because the EPO communication did not exist yet. The Federal Circuit held that the PTO’s interpretation of the statute “would unfairly penalize applicants, fail to incentive applicants not to delay, and fail to protect applicants’ full patent terms.”
Finally, the Federal Circuit held that the PTO’s additional 546-day assessment is contrary to the plain meaning of the statute because “the 646-day total reduction is not equal to a period of time during which Supernus failed to engage in reasonable efforts to conclude the prosecution of the ’897 patent (35 U.S.C. §154(b)(2)(C)(i)). In addition, the Federal Circuit held that the PTO’s decision is not consistent with the intent of Congress because Congress intended that the PTA statute not adversely impact applicants who could have done nothing to advance the prosecution.
Therefore, the Federal Circuit held that the district court erred in granting summary judgment in favor of the PTO.
Takeaway:
Applicant should carefully review the PTO’s PTA especially when applicant filed corresponding applications in foreign patent offices and submitted IDSs to the PTO citing communications from foreign patent offices.
Applicant should advise foreign patent counsels to forward the communications from foreign patent offices as soon as possible for a timely filing of IDSs.
Tags: information disclosure statement (IDS) > patent term > Patent Term Adjustment (PTA) > PTA reduction > Type A delay > Type B delay > Type C delay
More than the mere look of a compound is required to establish obviousness
| January 22, 2019
Amerigen Pharmaceuticals v. UCB Pharma GMBH
January 11, 2019
Before Lourie, Chen and Stoll. Opinion by Lourie.
Summary
Amerigen appeals an inter parties review Decision by the U.S. Patent and trademark Office Patent Trial and Appeal Board (hereinafter “the Board”) that the U.S. Patent No. 6,858,650 (hereinafter ‘650) was not unpatentable as obviousness. The CAFC held that there was substantial evidence to support the Board’s findings. The CAFC affirmed the Board’s findings.
Details
The U.S. Patent No. 6,858,650 (hereinafter ‘650) claims some chemical derivative of 3,3‑diphenylpropylamines, including fesoterodine. Fesoterodine, an antimuscarinic drug with the following chemical structure:
“Fesoterodine is a prodrug of the active compound 5-hydroxymethyl tolterodine (hereinafter “5‑HMT”). A prodrug is an inactive molecule that, once inside the body, transforms to an active therapeutic agent.
5‑HMT is a metabolite of the compound tolterodine, an older antimusarinic drug….” Id. at 3. 5-HMT is an active metabolite, which has its own antimuscaranic activity and can contribute to the therapeutic effect of tolterodine. Tolterodine is converted to 5-HMT, once ingested by a patient, by cytochrome P450 2D6 (hereinafter “CYP2D6”). CYP2D6 converts the methyl group at the 5-position of the benzene ring of tolterodine to a hydroxylmethyl group in 5‑HMT. The following is the chemical structures of tolterodine and 5-HMT.
A noted distinction between 5-HMT and fesoterodine is present at the 2-position of the benzene ring. In fesoterodine, an isobutyryl ester is at the 2-position. In 5-HMT, the 2-postion is a hydroxyl group.
An inter partes review (IPR) of ‘650 was brought by Mylan Pharmaceuticals Inc. The Board instituted the review based on “(1)obviousness over the Detrol Label, Postlind, Bundgaard, Bundgaard PCT, and Berge; and (2) obviousness over Brynne, Bundgaard, Bundgaard PCT, and Johansson.” Id. at 4. After the institution of the IPR, Amerigen joined as a party to the proceeding.
In the IPR, Petitioners argued that there was sufficient motivation for a skilled artisan to modify 5-HMT. Petitioners’ Expert testified that 5-HMT had insufficient lipophilicity and this would cause bioavailability problems. Id. at 7. The Expert, citing Brynne as support, stated that tolerodine is 10-fold more lipophilic than 5-HMT. UCB argued that there was no basis to allege modification of 5-HMT due to a bioavailability issue. UCB argued that none of the cited art suggested an issue regarding absorption by 5-HMT and further argued that “the lipophilicity of 5-HMT relative to tolterodine…did not show that 5-HMT had a bioavailability problem.” Id. at 7. Further, UCB’s Expert testified to an analysis of 5‑HMT using the Rule of 5 by Lipinski, which assesses 4 inherent properties of a compound to predict a potential bioavailability problem, and found that none of properties indicated a bioavailability problem for 5-HMT. Id. at 7. Petitioner’s Expert agreed that a skilled artisan would use the Rule of 5 to determine if there a potential bioavailability problem.
The Board held that, while a skilled artisan would have reason to choose 5-HMT as a lead compound, said artisan would not have been motivated to modify 5-HMT to achieve a prodrug wherein the 2-position hydroxyl group is replaced with an alkyl ester of six or fewer carbons. Id. at 6 and 7. Moreover, the Board, crediting UCB’s Expert, held that a skilled artisan would not have been motivated to modify 5‑HMT due to a bioavailability issue. Further, the Board, found that:
- Since there is no bioavailability issue, a skilled artisan would not have any reason or motivation to achieve a 5-HMT prodrug;
- Designing a prodrug is difficult since a skilled artisan must consider toxicity, bioavailability, and other drug characteristics of two compounds, rather than just one;
- Petitioners failed to establish that an ester of 5-HMT would be inactive, an essential characteristic of a prodrug; and
- Petitioners did not present any prodrugs in the same chemical class, with the same mechanism of action or the in the same field of treatment.
Id. at 8. The Board concluded that it would not have been obvious to develop a prodrug of 5‑HMT. Furthermore, the Board held that achieving the compounds claimed in the ‘650 patent would not have been a matter of routine optimization; none of the cited art disclosed the molecule fesoterodine and that there were too many possibilities of molecular modifications of 5-HMT consistent with a prodrug design to render obvious the compounds claimed in the ‘650 patent. The Board, relying upon UCB’s Expert, held that a skilled artisan may consider esterifying the hydroxy groups at the 2-position and the 5-postion, but that even if said artisan only considered esterification of the 2-position hydroxy, there was not reason or motivation to achieve an ester of six carbons or less and further, even if all possible esters were limited to only alkyl esters of 6 carbons or less at the 2-position, there would still be 86 possibilities disclosed. The Board held it would not be routine to test each of the 86 possibilities. Id. at 9.
Amerigen appealed the holding of the Board and argued before the CAFC that the Board’s holding was improper because:
- The Board did not understand the argument regarding lipophilicity and that a skilled artisan would have motivation to increase lipophilicity of 5-HMT for its own sake (motivation)
- An excessive burden was place upon Petitioner to establish a motivation to make 5-HMT a prodrug (burden)
- The Board did not give sufficient consideration to their routine optimization argument (routine optimization)
Id. at 16 and 17. Further, Amerigen argued that the Board did not give sufficient consideration to their argument regarding the effect of a patent claiming 5-HMT. UCB argued that Amerigen did not present a legal error committed by the Board and that the Board’s findings were supported by substantial evidence. (Side Note – UCB also argued that Amerigen lacked standing to bring an appeal. The CAFC held that Amerigen had standing. This issue is not addressed herein).
The CAFC affirmed the Board’s decision, finding that there was sufficient evidence to support their factual findings. “A finding is supported by substantial evidence if a reasonable mind might accept the evidence as adequate to support the finding. Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938).” Id. at 17.
Regarding Amerigen’s first argument (motivation), the CAFC concluded that there was substantial evidence to support the Board’s holding that there is no reason or motivation to modify 5-HMT to increase lipophilicity. The CAFC noted the Board’s holding that UCB’s Expert “better addressed the bioavailability issue and that lipophilicity of 5-HMT relative to tolterodine did not demonstrate a bioavailability problem. We agree with UCB that a reasonable fact finder could have weighted Dr. Roush’s (UCB Expert) testimony over Dr. Patterson’s (Petitioner’s Exert).” Id. at 19. The CAFC also noted the Rule of 5 assessment of 5-HMT by UCB’s Expert that found that there was “no reason to suspect that 5-HMT would possess poor oral absorption.” Id. at 19.
Before the CAFC, Amerigen argued that “there need not be a specific problem with bioavailability of 5-HMT for one of ordinary skill in the art to be motivated to modify 5-HMT to further improve its bioavailability.” Id. at 19. The CAFC determined that this was merely a conclusory argument that was insufficient to overcome the substantial evidence that supported the Board’s holding.
Regarding Amerigen’s second argument (burden), the CAFC held that the Board correctly found that Petitioners did not meet their burden of proof (“In an IPR, the petitioner has the burden of proving unpatentability by a preponderance of the evidence. 35 U.S.C. § 316(e).” Id. at 18.) Relying upon Bundgaard, the Board noted that a prodrug is an inactive drug. The Board also noted that Petitioners failed to present any evidence that an ester of 5-HMT would be inactive. The CAFC held that the “Board sensibly found that a skilled artisan would ‘seek some degree of certainty that a prodrug of a particular molecule would be inactive before embarking on the process of attempting to create the prodrug’ and the petitioners failed to provide any such certainty.” Id. at 21.
Before the CAFC, Amerigen argued that the Board impermissible placed too high of a burden on Petitioners by requiring them to present a prodrug that was analogous to 5-HMT. The Board had noted that Petitioners did not present any evidence of a prodrug that would be analogous to 5-HMT. The CAFC held that the Board did not commit an error. The Board did not require such evidence but merely found the lack of such evidence to further support UCB’s position. The CAFC held that the Board inquiring as to the existence or not of a prodrug, similar to the claimed compounds, is not a dispositive error.
Regarding Amerigen’s third argument (routine optimization), the CAFC held that there was sufficient substantial evidence to support the Board’s holding that the cited art did not render obvious achieving the claimed monoester substitution solely at the 2-position of a 5-HMT and that Amerigen did not establish a discernible error in the Board’s analysis.
The Board had found 1) in view of Bundgaard, a skilled artisan would consider diester substitutions as well as other prodrug moieties, 2) a skilled artisan would consider modifying the 5-position and/or the 2‑position, and 3) Bundgaard did not disclose isobutyryl ester of fesoterodine. The Board held it would not have been routine for a skilled artisan to achieve the claimed molecular modification to 5-HMT to achieve the claimed compounds of the ‘650 patent. Before the CAFC, Amerigen argued that “Bundgaard disclosed esters as prototypical prodrug moieties and that modifying the 2-position alone would have been the most obvious choice.” Id. at 22. The CAFC noted that the Board considered the disclosure of ester prodrugs by Bundgaard but also considered the disclosure by Bundgaard of many other prodrug substitutions. UCB’s Expert testified to at least 6 categories of additional substitutions. The Board held that modifications at the 5-position was as likely as modifications at the 2-position since the cited art “did not indicate a preference for either the 2- or 5-position, and the inventors themselves considered modifying the 5-position.” Id. at 22. The Board dismissed as unpersuasive testimony by Petitioner’s Expert that modifying only the 5-position would pose a risk of transesterification since the risk was not sufficiently explained.
Lastly, before the CAFC, Amerigen argued that the Board did not give sufficient weight to the Petitioner’s argument, presented in a single-sentence footnote in the petition, that a skilled artisan would have been motivated to modify 5-HMT because 5-HMT was patented at the time of invention. The CAFC held that even if a patent of 5-HMT provided a commercial motivation to modify 5‑HMT, such a motivation did not render the claimed compounds of the ‘650 patent obvious. The CAFC held that Amerigen did not meet its burden that “the ‘prior art would have suggested making the specific molecular modifications necessary to achieve the claimed invention.” Takeda Chem. Indus., Ltd. v. Alapharm Pty., Ltd., 492 F.3d 1350, 1356 (Fed. Cir. 2007) (emphasis added) (quoting In re Deuel, 51 F.3d 1552, 1558 (Fed. Cir. 1995)). A general motivation to modify 5-HMT based on a prior patent would not suffice….” Id. at 23.
The CAFC, affirming the holding of the Board, stated that “[A]ny compound may look obvious once someone has made it and found it to be useful, but working backwards from that compound, with the benefit of hindsight, once one is aware of it does not render it obvious.” Id. at 23.
Take away
- Ensure that there is a clearly identified reason for making the proposed modification. General assertions for making a proposed modification may not establish a prima facie case of obviousness
a. Ensure that the clearly identified reason is logical. Furthermore, ensure the alleged reason has a correlation to the cited feature.
2. Consider the breadth of the possibilities for a substitution presented in the cited art. The disclosure regarding a specific substitution may be exponentially greater when one considers more than one reference and/or more than one possible location of said substitution, e. 2‑position and/or 5-position of a benzene ring.
Issuance date or expiration date as the reference point for obviousness-type double patenting?
| January 11, 2019
Novartis Pharmaceutical Corp. v. Breckenridge Pharmaceutical Inc., et al
December 7, 2018
Before Prost, Wallach, and Chen. Opinion by Chen.
Summary
The Federal Circuit reversed the district court’s decision to invalidate U.S. Patent No. 5,665, 772 based on obviousness-type double patenting because a change in patent term law should not truncate the term statutorily as assigned to the pre-URAA ‘722 patent.
Details
Novartis owns U.S. Patent No. 5,665,772 (hereafter ‘722 patent), which claims the compound everolimus, and U.S. Patent No. 6,440,990 (hereafter ‘990 patent), which is directed to some methods of treatment using everolimus and some pharmaceutical compositions including everolimus. Everolimus is an active ingredient in Zortress® and Afinitor®, which are famous drugs for treating certain cancers and preventing rejection in kidney and liver transplantations. Plaintiff Novartis sues Defendants Breckenridge for infringing ‘772 patent after Defendants sought FDA approval to market generic versions of Zortress® and Afinitor®.
The only question before the district court was whether the ‘990 patent could serve as an obviousness-type double patenting reference against the ‘772 patent? The ‘772 patent was filed on April 7, 1995 and issued on September 9, 1997. Because it was filed before June 8, 1995, the URAA’s effective date, the patent term is 17 years from the issuance date. Furthermore, Novartis obtained a five-year patent term extension under 35 U.S.C. §156 of the Hatch-Waxman Act. So the actual expiration date for the ‘722 patent is September 9, 2019. The ‘990 patent was filed on May 23, 1997 and issued on August 27, 2002. Because it was filed after the URAA’s effective date and claimed the same priority as the ‘722 patent from a September 24, 1993 PCT filing date. So the expiration date for the ‘990 patent is September 24, 2013. The following diagram illustrates the dates for each patent:
That is, the ‘990 patent issues later, but expired earlier, than the ‘772 patent. There is a terminal disclaimer filed in ‘990 patent.
Defendants relied heavily on decision in a previous federal circuit case, Gilead Sciences, Inc., v. Natco Pharma Ltd. 753 F. 3d 1208 (Fed. Cir. 2014). The following diagram illustrates the relevant dates of two patents in dispute:
Gilead held that the proper reference point for an obviousness-type double patenting inquiry is the expiration dates, rather than the issuance dates, of the patents in question. Thus, a patent (‘375 patent) that issues after but expires before another patent (‘483 patent) can qualify as a double patenting reference against the earlier-issuing, but later-expiring patent (‘483 patent). However, the Federal Circuit distinguishes this case from Gilead because the two patents in Gilead were all filed post-URAA while, in the present case, one patent was filed pre-URAA and the other patent was filed post-URAA. The URAA transition statute changed the term of a U.S. patent from 17 years from the issuance date to 20 years from the filing date of the earliest U.S. or PCT application to which priority is claimed, excluding provisional applications.
Defendants also relied on another previous case, Abbvie, Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, 764 F. 3d 1366 (Fed. Cir. 2014). The following diagram illustrates the relevant dates of two patents in dispute:
AbbVie also held that claims of the ‘422 patent (second issued, second-expiring) were invalid over the ‘766 patent (first-issued, first-expiring) for obviousness type double patenting. The court explained that the patent owner had impermissibly sought an undue patent term extension for its later-expiring, patentably indistinct claims by choosing to claim different priority dates for its patent applications. However, the Federal Circuit distinguishes this case from Abbvie because the two patents in Abbvie were all filed post-URAA.
The Federal Circuit’s rationale seems to place a lot of weight on the fact that Novartis did not engage in any gamesmanship such as the structuring of priority claims among related patents to obtain the benefit of one patent gaining a later expiration date. Furthermore, the URAA transition statute expressly provides that the term of a patent issuing from an application filed before June 8, 1995 shall be the greater of the 20-year term from the earliest priority date or 17 years from grant, subject to any terminal disclaimers. Thus, the Federal Circuit applies traditional, pre-URAA obviousness-type double patenting practice to the pre-URAA patent. That is, the ‘772 patent’s issuance date is used as the reference point for the obviousness-type double patenting analysis. Since the ‘990 patent is issued later than the ‘772 patent, the ‘990 patent is not a proper obviousness-type double patenting reference for the ‘772 patent.
Furthermore, the Federal Circuit considers that the holding is consistent with the core principle underlying the double patenting doctrine: giving one invention and nonobvious variants of that invention the same patent term. Here, critically, Novartis did not seek to extend its patent rights over its invention beyond one patent term, 17 years from issuance of the ‘772 patent.
Take away
- Is issuance date or expiration date as the reference point for obviousness-type double patenting? It depends. If the challenged patent is filed before June 8, 1995, the reference point for obviousness-type double patenting is the issuance date. If the challenged patent is filed after June 8, 1995, the reference point for obviousness-type double patenting is the expiration date.
Surnames are registrable on Principal Register with sufficient evidence of acquired distinctiveness
| December 19, 2018
Schlafly, et al. v. Saint Louis Brewery, LLC
November 26, 2018
Before Newman, Mayer, and Stoll. Opinion by Newman.
Summary
A surname can be registered as a trademark on the Principal Register upon showing of acquired distinctiveness.
名字から成る商標は、識別性を獲得していれば、主登録簿へ登録することが可能である。
Tags: 15 U.S.C. Section 1052(f) > acquired distinctiveness > secondary meaning > Section 2(f) of the Lanham Act
In widely watched biotech case, skepticism by others in the art and other factors give rise to a lack of a reasonable expectation of success, and thus a lack of interference-in-fact
| December 17, 2018
Regents of the University of California et al. v. Broad Institute, Inc., et al.
September 21, 2018
Before Prost, Schall and Moore. Opinion by Moore.
Summary
The CAFC upheld the PTAB’s decision of the lack of an interference-in-fact between UC’s claims generically directed to the CRISPR-Cas9 gene editing system in any context and Broad’s claims directed to the CRISPR-Cas9 system in eukaryotes specifically. The CAFC affirmed the PTAB’s weighing of substantial evidence with respect to the likelihood of success of one skilled in the art based on UC’s claims, in view of statements by the inventors and experts, as well as the details of other gene editing system. The CAFC dismissed UC’s arguments regarding an alleged “specific instructions” test and evidence of simultaneous invention.
To narrow, or not to narrow a claim without lexicography or disavowal in a patent specification: the U.S. Supreme Court is asked to answer the question.
| December 11, 2018
Cave Consulting Group, LLC v. OptumInsight, Inc., 725 Fed. App’x 988 (Fed. Cir. 2018) (nonprecedential) (Case No. 2017-1060)
March 21, 2018 (Rehearing Denied: August 14, 2018; Petition for A Writ of Certiorari Filed: November 2, 2018)
Before Lourie, Dyk and Taranto, Circuit Judges. Court opinion by Lourie.
Summary
In a nonprecedential opinion, in view of the specification’s consistently limiting description, the Federal Circuit reversed the district court’s claim construction of “weighted episode of care statistics” recited in a disputed independent claim as including direct standardization where some of dependent claims specifically provide that the calculating of weighted episode of care statistics utilizes direct standardization. Accordingly, the Court vacated the judgment of infringement and award of damages because the error in the claim construction is dispositive of the infringement issue based on undisputed facts. A petition for a writ of certiorari has been filed to ask the U.S. Supreme Court if narrowing claims without lexicography or disavowal in a patent specification may be justified.
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