PTO Examiners are Entitled to Appropriate Deference

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In Nature Simulation Systems Inc. v. Autodesk, Inc., [2020-2257](January 27, 2022), the Federal Circuit reversed the district court’s judgement that U.S. Patent Nos. 10,120,961 and 10,109,105, both entitled
“Method for Immediate Boolean Operations Using Geometric Facets” were not invalid for indefiniteness.

The patents are for data structures and algorithms for the claimed method, which is described as a modification of a the Watson method a Boolean operation published in 1981 for analyzing and representing three-dimensional geometric shapes. There were two claim elements that the district court determined made the claims indefinite: “searching neighboring triangles of the last triangle pair that holds the last intersection point”; and “modified Watson method.” The district court held the claims indefinite based on the “unanswered questions” that were suggested by Autodesk’s expert.

In finding the claims indefinite, the district court declined to consider information in the specification that was not included in the claims. The Federal Circuit found that the district court misperceived the function of patent claims. The Federal Circuit also found that the applicant, in consultation with the examiner, amended the claim to add the disputed language. The Federal Circuit noted that the district court gave no weight to the prosecution history showing the resolution of indefiniteness by adding the designated technologic limitations to the claims. The court did not discuss the Examiner’s Amendment, and held
that since Dr. Aliaga’s questions were not answered, the claims are invalid.

The Federal Circuit said that “[a]ctions by PTO examiners are entitled to appropriate deference as official agency actions, for the examiners are deemed to be experienced in the relevant technology as well as the statutory requirements for patentability.” The Federal Circuit added “[t]he subject matter herein is an improvement on the known Watson and Delaunay methods, and partakes of known usages for established technologies. Precedent teaches that when ‘the general approach was sufficiently
well established in the art and referenced in the patent’ this ‘render[ed] the claims not indefinite.’”

The Federal Circuit concluded that ‘[I]ndefiniteness under 35 U.S.C. § 112 was not established as a matter of law,” and reversed the district court.

Ordinary Meaning Can Be Broader than Disclosed Embodiments

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In Evolusion Concepts, Inc. v. HOC Events, Inc., [2021-1963] (January 14, 2022) the Federal Circuit reversed the grant of summary judgment of non-infringement of U.S. Patent No. 8,756,845 on a “Method and Device for Converting Firearm with Detachable Magazine to a Firearm with Fixed Magazine,” , reversed the denial of summary judgment of direct infringement as to the independent claims 1 and 8, and remanded for further proceedings.

The district court held that the term “magazine catch bar” in the asserted claims of the ’845 patent excludes a factory installed magazine catch bar. Claim 15 requires removing “the factory installed magazine catch bar” and then installing “a magazine catch bar.” From this, the district the court concluded that the magazine catch bar that is installed must be “separate and distinct from the factory-installed magazine catch bar”; otherwise, “factory-installed” would be superfluous. Because a term that appears in multiple claims should be given the same meaning in all those claims, the court held that the term “magazine catch bar” in claims 1 and 8 similarly must exclude a factory-installed magazine catch bar. This claim construction precluded literal infringement because Juggernaut’s products use the factory-installed magazine catch bar. The court also determined that Juggernaut does not infringe under the doctrine of equivalents.

The Federal Circuit noted that the principle that the same phrase in different claims of the same patent should have the same meaning is a strong one, overcome only if it is clear that the same phrase has different meanings in different claims. The Federal Circuit noted that while claim 15 was directed to a method, claims 1 and 8 claimed a firearm and a device, respectively. The Federal Circuit said that nothing in the language of claims 1 and 8 limits the scope of the generic term “magazine catch bar” to exclude one that was factory installed—specifically, as Juggernaut asserts, factory installed as part of an original
firearm with a detachable magazine.

The Federal Circuit said that Juggernaut was correct that the meaning of the term in claims 1 and 8 could well be informed by a meaning of the term made sufficiently clear in claim 15, but Juggernaut was incorrect that the use of “magazine catch bar” in claim 15 narrows the meaning of the term to support the
urged exclusion of factory-installed magazine catch bars. The Federal Circuit agreed that claim 15 required removing a factory installed magazine catch but it did not require discarding that catch bar, or installing a different catch bar. The Federal Circuit concluded that the specification supports the ordinary-meaning interpretation of “magazine catch bar.” The Federal Circuit said the specification nowhere limits the scope of a “magazine catch bar” to exclude factory-installed ones from the assembly that achieves the fixed-magazine goal.

Juggernaut argued that the disclosed embodiments do not illustrate OEM magazine catch bars, but the Federal Circuit said that cannot make a difference in this case. The Federal Circuit has repeatedly held that “it is not enough that the only embodiments, or all of the embodiments, contain a particular limitation to limit claims beyond their plain meaning.” The Federal Circuit thus construe the term “magazine catch bar” according to its ordinary meaning, which includes a factory installed magazine catch bar.

Silence is not only Golden, it is a Written Description, if the Skilled Artisan Would Understand it that Way

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In Novaritis Pharmaceuticals Corp. v. Accord Healthcare, Inc., [2021-1070](January 3, 2021) the Federal Circuit affirmed the district court’s determination that U.S. Patent No. 9,187,405 on a treatment for relapsing remitting multiple sclerosis (“RRMS”), is not invalid and that HEC’s Abbreviated New Drug Application infringes.

The’405 patent claimed a daily dosage of fingolimod “absent an immediately preceding loading dose,” which HEC challenged as lacking written description. The district court found sufficient written description in the EAE model and the Prophetic Trial, neither of which recited a loading dose.

On appeal, HEC attacked the expert testimony underlying the district court’s determination that the EAE experiment describes a 0.5 mg daily human dose as “undisclosed mathematical sleights of hand.” The Federal Circuit disagreed, noting a disclosure need not recite the claimed invention in haec verba. The disclosure need only clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed. The Federal Circuit said that to accept HEC’s argument would require it to ignore the perspective of the person of ordinary skill in the art and require literal description of every limitation, in violation of our precedent. The Federal Circuit found no clear error in the
district court’s reliance on expert testimony in finding description of the 0.5 mg daily human dose in the EAE experiment results.

The Federal Circuit also rejected HEC’s challenge to the negative limitation “absent an immediately preceding loading dose.” The Federal Circuit began by noting that it was well established that there is no “new and heightened standard for negative claim limitations.” Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1356 (Fed. Cir. 2015). The Court said that negative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation. Adding that a specification that describes a reason to exclude the relevant negative limitation is but one way in which the written description requirement may be met. The Federal Circuit said that the written description requirement
is satisfied where the essence of the original disclosure conveys the necessary information—regardless
of how it conveys such information, and regardless of whether the disclosure’s words are open to different interpretations.

The Federal Circuit pointed to expert testimony that one of ordinary skill in the art would understand the examples to exclude a loading does, so the specification’s apparent silence provided adequate written description of the negative limitation. The Court concluded that written description in this case, as in all cases, is a factual issue. In deciding that the district court did not clearly err in finding written description for the negative limitation in the ’405 patent, the court said that it was not establishing a new legal
standard that silence is disclosure. The Federal Circuit said that it was merely holding that on the record before it, the district court did not clearly err in finding that a skilled artisan would read the ’405 patent’s disclosure to describe the “absent an immediately preceding loading dose” negative limitation.

The Proper Claim Construction of a Term is Not Necessarily the Sum of its Parts

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In Intel Corp. v. Qualcomm Inc., [2020-1664] (December 28, 2021), the Federal Circuit affirmed the final written decision of the originally challenged claims of U.S. Patent No. 8,229,043, but vacated and remanded as to the substitute claims.

The Federal Circuit addressed first considered the phrase “radio frequency input signal” in ’043 patent claims 17, 19, and 21. Intel argued that the term should be given its ordinary meaning, while Qualcomm argued for a more specific construction. The Federal Circuit noted that ‘[e]ven without considering the surrounding claim language or the rest of the patent document, . . .it is not always appropriate to break down a phrase and give it an interpretation that is merely the sum of its parts.” The Federal Circuit said that the surrounding language points in favor of Qualcomm’s construction, adopted by the Board. The Federal Circuit said the linguistic clues suggested that “radio frequency input signal,” to the relevant audience, refers to the signal entering the device as a whole, not (as Intel proposes) to any radio frequency signal entering any component. The Federal Circuit said that the specification provides further support for the Board’s reading.

The Federal Circuit concluded that in sum, while Intel’s interpretation may have superficial appeal, Qualcomm’s better reflects the usage of “radio frequency input signal” in the intrinsic record, and affirmed it.

On the question of obviousness, the Federal Circuit concluded that substantial evidence does not
support the Board’s determination that a skilled artisan would have lacked reason to combine the prior art to achieve substitute claims 27, 28, and 31. The Federal Circuit rejected the Board’s rationale for determining that it would not have been obvious to combine the references. The Federal Circuit noted that a rationale is not inherently suspect merely because it’s generic in the sense of having broad applicability or appeal.

Merry Christmas 2021

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Merry Christmas, and warm wishes that you can celebrate safely and happily with your friends and family, Celebrating Christmas is a long standing tradition, and the U.S. patent collection documents a steady stream of inventive effort to make Christmas happier and safer. Once of the earliest references to Chistmas in the patent collection is this patent from 1867 on a candllestick for a Christmas tree:

A few years later, an improved Candle Holder was patented with a more patriotic bent:

The fascination with open flames continued, and later that same year, a patent issued on a candle-powered Rotating Christmas Tree:

By 1872, someone finally came up with the idea of at least enclosing the flame in a Wax-Lantern, no doubt saving many trees (and Christmases):

However, candles remained in use and efforts continued to improve them in the 1870’s and 1880’s:

It wasn’t until 1891, when its was proposed to apply electric lighting to Christmas trees:

Best wishes to all for a happy holiday season, and an innovative 2022.

Happy Thanksgiving!

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The patent collection is an underused resource for solutions, and yes, it contains a solution to the biggest problem of the day. Back in 1980, Lucy Barmby invented a solution to overeating on Thanksgiving (and every other day):

Lucy Barmby’s U.S. Patent No. 4,344,424 on an Anti-Eating Face Mask.

Lucy may have solved the problem of turkey and pecan pie, but it looks as if gravy is still a threat. Beware, and have a happy holiday with family and friends.

To Claim a Range, Make it Clear You are a Claiming a Range

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In Indivior UK Limited v. Dr. Reddy’s Laboratories S.A., [2020-2073, 2020-2142] (November 24, 2021), the Federal Circuit affirmed the PTAB’s decision in an IPR that claims 1–5, 7, and 9–14 are unpatentable, and that DRL failed to demonstrate unpatentability of claim 8.

The ’454 patent, which generally describes orally dissolvable films containing therapeutic agents. The ’454 patent issued as the fifth continuation of U.S. Patent Application 12/537,571, which was filed on August 7, 2009. This appeal involves the question whether Indivior can get the benefit of that 2009 filing date for the claims of the ‘454 patent, and in particular support for the claimed ranges:

ClaimsRange
Claim 1about 40 wt % to about 60 wt %
Claim 7about 48.2 wt % to about 58.6 wt %
Claim 8about 48.2 wt %
Claim 12about 48.2 wt % to about 58.6 wt %

Invidior pointed out that Tables 1 and 5 of the ‘571 application disclose formulations with 48.2 wt % and 58.6 wt % polymer, and discloses that “the film composition contains a film forming polymer in an amount of at least 25%
by weight of the composition.” Indivior argued that the combination of these disclosures encompasses the claimed ranges, and therefore provides a written description of them. DRL contended that a skilled artisan would not have discerned the claimed ranges because the ’571 application does not disclose any bounded range, only a lower endpoint and some exemplary formulations. DRL contended that a skilled artisan would not have discerned any upper range endpoint.

Regarding claim 1, the Federal Circuit agreed with the Board that there was no written description support in the ’571 application for the range of “about 40 wt % to about 60 wt %,” noting that the range was not expressly claimed in the ’571 application; and that the values of “40 wt %” and “60 wt %” are not stated in the ’571 application.

Regarding claims 7 and 12, the Federal Circuit also agreed with the Board that there is no written description support for the range of “about 48.2 wt % to about 58.6 wt %” in the ’571 application, noting that this range also does not appear in the ’571 application. While the endpoints of this “range” could be discerned from the Tables, the Federal Circuit said that constructing a range from this data “amounts to cobbling together numbers after the fact.” The Federal Circuit said that Indivior failed to provide persuasive evidence demonstrating that a person of ordinary skill would have understood from reading the ’571 application that it disclosed an invention with a range of 48.2 wt % to 58.6 wt %.

Because Indivior did not contest that the claims would be anticipated without the benefit of the 2009 filing date the court affirmed the invaldity of the challenged claims, except claim 8, whose single data point was supported by the disclosure of the ‘571 patent.

This result is of course concerning to chemical practitioners who have or may one day fine the need to construct a range from disclosed datapoints. The Federal Circuit’s assurances that each case is fact specific is of little comfort if one find themselves in this predicament. The bottom line is if ranges are intended, ranges should be mentioned. It is unlikely that Invidior ever contemplated that the invention only worked at selected points, and not in between, Invidior apparently needed to make explicit what it thought was implicit. The issue in Invidior is not a problem in claiming ranges, but a problem in making clear that you are claiming ranges.

Arbitrator Decides Arbitratability

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In Rohm Semiconductor USA LLC v. Maxpower Semiconductor, Inc., [2021-1709] (November 12, 2021), the Federal Circuit affirmed the district court’s decision compelling arbitration and dismissing ROHM USA’s declaratory judgment action without prejudice.

In 2007, ROHM Japan and MaxPower entered into a technology license agreement (“TLA”). Under the TLA,
ROHM Japan and its subsidiaries (collectively “ROHM”) were permitted “to use certain power [metal oxide semiconductor field effect transistors (‘MOSFET’)]-related technologies of” MaxPower (“Licensor”) developed under a
Development and Stock Purchase Agreement in exchange for royalties paid to MaxPower. The TLA, as amended in 2011, includes an agreement to arbitrate “[a]ny dispute, controversy, or claim arising out of or in relation to this Agreement or at law, or the breach, termination, or validity thereof.” The arbitration agreement provides that arbitration is to be conducted “in accordance with the provisions of the California Code of Civil Procedure” (“CCCP”).

In 2019, a dispute arose between ROHM Japan and MaxPower concerning whether the TLA covers ROHM’s silicon carbide MOSFET products. In September 2020, MaxPower notified ROHM Japan of its intent to initiate arbitration. Shortly thereafter, on September 23, 2020, ROHM USA, a subsidiary of ROHM Japan, filed suit.

Rohm USA argued that the CCCP is ambiguous, containing two apparently conflicting provisions regarding who determines arbitrability, but the district court found, and the Federal Circuit agreed, that the provisions were not in conflict, and the provision allowing the arbitrator to determine arbitribility controlled.

Rohm USA further argued that even if §1297.161 applies, it states that “[t]he arbitral tribunal may rule on its own jurisdiction,” which Rohm USA says it merely allows the parties to agree to waive a court determination, which ROHM USA does not want to do. The Federal Circuit disagreed, noting that while Rohm USA is correct that
“may” is generally a permissive verb, “may” as used in §1297.161 does not mean “may also,” as ROHM USA
urges. MaxPower’s interpretation of the permissive “may” as “may, if arbitrability is disputed,” makes much more
sense in this context.

Thus the court concluded that the Arbitrator should determine whether the dispute was arbitrable.

Veterans: Thank You for your Service

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November 11 is Veteran’s Day, and a chance to thank all veterans for their service. Because of their willingness to defend us, we enjoy the freedom to live largely as we choose to and to pursue our interests. U.S. Patent No. 1,429,506 issued September 19, 1922, is, literally, a salute to veterans:

The invention is a doormat-operated animated figure, which issues a salute to someone who steps on the mat. The patent describes the figure as “an American Veteran of the World War,” not contemplating on December 4, 1919, when the application was filed, and the ink on the November 11, 1918, armistace barely dried, that we would soon again call on our soldiers to defend us in a second world war, and a number of other conflicts since.

To all verterans, thank you for your service and for our freedom.

Patent Venue Construed Strictly, Even in ANDA Litigation

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In Celgene Corp. v. Mylan Pharmaceutics Inc., [2021-1154] (November 5, 2021) the Federal Circuit affirmed the dismissal of a patent infringement action against defendants, MPI and Mylan Inc. for improper venue, and against defendant Mylan N.V. for failure to state claim upon which relief can be granted.

After an giving an excellent summary of Hatch-Waxman Act litigation, the Federal Circuit recounted the history of the action. Celgene filed its first case in May 2017. The defendants-
appellees moved to dismiss for improper venue and failure to state a claim in August 2017. That motion was denied in March 2018 without prejudice so that the parties could engage in venue-related discovery.

After two years of that discovery, the defendants renewed their motion to dismiss. The district court concluded that venue was improper. Namely, the thin set of facts that Celgene had gathered after those two years—the presence of affiliated entities and employees in New Jersey—failed to show a “regular and established place of business” of the defendants in the district under 28 U.S.C. § 1400(b).

The Federal Circuit found that neither MPI nor Mylan had “committed acts of infringement” in New Jersey. The court noted that in Valeant, it said that “venue in Hatch-Waxman cases must be predicated on past acts of infringement.” For the purposes of the Hatch-Waxman Act, “it is the submission of the ANDA, and only the submission, that constitutes an act of infringement
in this context.” The question, then is where the submission occurred, and what acts it includes.

The Federal Circuit rejected the argument that the submission extends to whereever the generic drug woudl be marketed and sold. The Federal Circuit also rejected the argument that the submission included the act of sending the mandatory ANDA Notice, reiterating that it is the submission of the ANDA, and only the submission, that constitutes an act of infringement in this context.

The Federal Circuit also found that neither MPI nor Mylan had a regular and established place of business in New Jersey. There are three requirements for a regular and established palace of business: (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. The third requirement was the relevant one in this case. The place of business must be “of the defendant, not solely . . . of the defendant’s employee.” Accordingly, “the defendant must establish or ratify the place of business,” and it is “not enough that the employee does so on his or her own.”

As to the third requirement, the Federal Circuit noted that it has discussed four non-exhaustive relvant factors:

(1) “whether the defendant owns or leases the place, or exercises other attributes of possession or control over the place”; (2) “whether the defendant conditioned employment on” “an employee’s continued residence in the district” or “the storing of materials at a place in the district so that they can be distributed or sold from that place”; (3) “a defendant’s representations” about that place, including advertisements; and (4) “the nature and activity of
the alleged place of business of the defendant in the district in comparison with that of other places of business of the defendant in other venues.”

17 of MPI’s and Mylan’s tens of thousands of employees live in New Jersey, but MPI and Mylan showed that it did not require or instruct those employees to live in New Jersey, or pay for their homes, or require employees to store materials in their homes, or pay for secretarial or support staff. The Court found that a roster of employees who live in the state, a handful of business cards with employee names and New Jersey home addresses, and two LinkedIn
profiles mentioning New Jersey were all too speculative to show ratification of those addresses by MPI and Mylan.

The Federal Circuit also found that two small storage lockers rented by MPI sales or marketing employees to store product samples are not places “of the defendant.” Nor do they bolster that the employees’ homes were such places. Those lockers are rented in the employees’ own names. They are used to intermittently store and access product samples. There is no evidence, in contrast, that they are used like warehouses—for order fulfillment, wholesaling, retail, or the like.

Overall, the Federal Circuit concluded that the employee-associated locations are not
a regular and established place of business of the defendants under § 1400(b).

The district court also concluded that, for Mylan N.V., Celgene had failed to state a claim upon which relief could be granted. That is, the ANDA that Celgene itself included with its complaint sought approval only on behalf of MPI. And Celgene’s pleadings with respect to the involvement of Mylan N.V. in that submission were simply too speculative and conclusory.

The Federal Circuit noted that MPI, not Mylan N.V., was the entity that signed and physically submitted the ANDA. Thus the question was whether Celgene sufficiently plead that (1) Mylan N.V. was actively involved in and directly benefited from the ANDA (including in the agent–principal sense) or (2) MPI acted as Mylan N.V.’s alter ego in derogation of the corporate form.
The Federal Circuit found that Celgene’s pleadings fail under either theory.

As to the denial of leave to amend the Complaint, the Federal Circuit said that Celgene’s allegations in its complaint were conclusory and insufficient. It knew the basis for their deficiency for years, as the district court correctly concluded, yet made no attempt to amend them in a timely manner. Nor has Celgene argued on appeal that it showed good cause. In
our view, then, the district court did not abuse its discretion in denying Celgene’s request for leave to amend its complaint.