Valen-tech

Happy Valentine’s Day! Here is a tribute to the inventors who make Valentine’s Day, and every day better for society.

U.S. Patent No. 5,160,087 protected a drinking straw for couples.
U.s. Patent No. 7,339,449 protects a Magnetic Woven Heart.
U.S. Patent No. 1,603,592 protected a greeting card perfect for the holiday.
U.S. Patent No. 4,194,629 protected a “Love Box.”
U.S. Patent No. D85,341, protected the name plate for a Love Tester.

Description of “a” Technique for Carrying Out “The Invention” Did Not Limit Claims

In Continental Circuits LLC v. Intel Corporation, [2018-1076] (February 8, 2019), the Federal Circuit, finding that the district court erred in its claim construction, vacated judgment of non-infringement and remanded the case for further proceedings.

The four patents in suit, U.S. Patents Nos. 7,501,582, 8,278,560, 8,581,105, and 9,374,912 all are directed to the problem of preventing delamination of multilayer electrical devices by forming a unique surface structure comprised of teeth that are preferably angled or hooked like fangs or canine teeth to enable one layer to mechanically grip a second layer having a tooth structure. The district court construed the claims to require that the structure be produced by a repeated desmear process.” The district court noted that the specification not only repeatedly distinguished the process covered by the patent from the prior art and its use of a single desmear process, but also characterized “the present invention” as using a repeated desmear process. Further the district court found that the prosecution history corroborated its construction, because the applicant relied upon repeated desmear processes.

The Federal Circuit found that the district court erred in its construction. The Federal Circuit first noted that none of the claims actually recited a repeated desmear process. Turning to the specification, the Federal Circuit found that none of the statements relied upon by the district court rose to the level of a clear and unmistakable disclaimer. The specification described the repeated desmear process as only “one technique” for forming the required teeth. The Federal Circuit further noted that the specification identified the repetition as “a way” of forming the teeth. The Federal Circuit concluded: “Overall, those statements simply describe how to make the claimed invention using the preferred Probelec XB 7081 in a “new” way that is different from the prior art pro-cess and are not statements clearly limiting the claimed “electrical device” to require a repeated desmear process.”

The Federal Circuit also noted that it has express rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment. The Federal Circuit also said that distinguishing the double desmear process as “contrary to” or “in stark contrast” with the single desmear process is also not clear and unmistakable limiting statements. The Federal Circuit explained that it as held that mere criticism of a particular embodiment is not sufficient to rise to the level of clear disavowal.

As to the use of “the present invention” in the description of the preferred embodiment, the Federal Circuit found that these also were not limiting. Explaining that while descriptions of the ‘present invention as a whole could limit the scope of the invention, use of the phrase “present invention” or “this invention” is not always so limiting, such as where the references are not uni-form, or where other portions of the intrinsic evidence do not support applying the limitation to the entire patent. The Federal Circuit said that in the case before it the references to the present invention do not characterize the present invention “as a whole,” and instead only disclose one way to carry out the present invention using Probelec XB 7081.

Turning to the prosecution history, the Federal Circuit did not agree that a clear disavowal exists in this prosecution history. The expert declaration cited by the district court, explained that the written description disclosed “a technique which forms the teeth” by “performing two separate swell and etch steps.” The Federal Circuit said that describing a particular claim term to overcome an indefiniteness or written description rejection is not the same as clearly disavowing claim scope, and in any event were directed to one technique for carrying out the invention.

The Federal Circuit concluded that to read a process limitation into a product claim it must be clear that the process steps are an essential part of the claimed invention. Because the patentee had not “made clear” that the repeated desmear process is “an essential part of the claimed invention,” it was improper for the district court to read this process limitation into the product claims for this additional reason.

Lastly the Federal Circuit explained the use of extrinsic inventor notes regarding the invention did not support varying the the construction from based upon the extrinsic evidence.

Abandoning Infringing Conduct Caused Loss of Standing to Appeal IPR

Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., [2017-1694] (February 7, 2019), the Federal Circuit dismissed the appeal of the PTAB Final Written Decision sustaining patentability of claims 1 through 15 (all the claims) of United States Patent No. 8,476,239, for lack of standing/jurisdiction and for mootness.

The ‘239 patent covered compounds under the generic name “abatacept” and the BMS brand name Orencia®, used in treatment of immune system disorders such as rheumatoid arthritis. Momenta’s proposed product failed its Phase 1 clinical trials and had been withdrawn, so BMS moved to dismiss the appeal because Momenta no longer had standing. Momenta responded that it had not abandoned its intent to produce a counterpart and that the ’239 Patent is an obstacle to these activities, and that it is injured by the estoppel provision of 35 U.S.C. § 315(e). Momenta cited to the “relaxed” standard for Article III compliance when the right of appeal is established by statute.

The Federal Circuit said that Congress cannot erase Article III’s standing requirements by statute. Noting that Momenta had initially stressed that it had spent millions of dollars in its development of a biosimilar, upon Momenta’s termination of all potentially infringing activity, Momenta has not shown “an invasion of a legally protected interest” that is “actual or imminent, not conjectural or hypothetical.” The Federal Circuit concluded that upon abandoning development of this product, Momenta has no legally protected interest in the validity of the ’239 Patent, and there is no real need to exercise the power of judicial review.

The Federal Circuit rejected the Momenta’s argument that the estoppel effect of the decision created stating, noting that estoppel cannot constitute an injury-in-fact when Momenta “is not engaged in any activity that would give rise to a possible infringement suit.”

The Federal Circuit further found that Momenta’s abandonment of the development of a biosimilar made the appeal moot: the cessation of potential infringement means that Momenta no longer has the potential for injury, thereby mooting the inquiry.

Diagnostic Method Ineligible; Patent Law Once Again Fails to Promote the Progress of Science

In Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, [2017-2508] (February 6, 2019), the Federal Circuit affirmed the district court’s holding that claims 6–9 of U.S. Patent 7,267,820 (the “’820 patent”) are invalid under
35 U.S.C. § 101 and dismissing Athena’s complaint under Rule 12(b)(6).

The inventors discovered the association between MuSK autoantibodies
and Myasthenia gravis, and in the ’820 patent disclosed and claimed methods of diagnosing neurological isorders such as MG by detecting autoantibodies that bind to a MuSK epitope.

The Federal Circuit agreed that the claims were directed to a natural law, specifically, the correlation between the presence of naturally-occurring
MuSK autoantibodies in bodily fluid and MuSK related neurological diseases like MG. The Federal Circuit said “This correlation
exists in nature apart from any human action. There can
thus be no dispute that it is an ineligible natural law.”

The Federal Circuit concluded that the claims were directed to a natural law because the claimed advance was only in the discovery of a natural law, and that the additional recited steps only apply conventional techniques to detect that natural law. This finding was bolstered by the truthful but unfortunate statements in the specification that “[t]he actual steps of detecting autoantibodies in a sample of bodily fluids may be performed in accordance with immunological assay techniques known per se in the art.”

The Federal Circuit said: “The claims here are directed to a natural law because they recite only the natural law together with standard techniques
for observing it. That the routine steps are set forth with some specificity is not enough to change that conclusion.”

Finally, the Federal Circuit rejected Athena’s argument that the claims were patentable because they required labeling MuSK with a manmade
substance, finding that the use of a man-made molecule is not decisive if it amounts to only a routine step in a conventional method for observing a natural law.

At step II of the aptly named Mayo test, the Federal Circuit found that the steps of the claims not drawn to ineligible subject matter, whether viewed individually or as an ordered combination, only required standard
techniques to be applied in a standard way. This was bolstered by the specification’s description of the steps as “conventional techniques.” The Federal Circuit refused to hold that performing standard techniques in a standard way to observe a newly discovered natural law provides an inventive concept.

Posted in 101

Groundhog Tech

Saturday is Groundhog Day, but despite having their own day, it seems that groundhogs have been largely ignored by inventors. Groundhogs are referenced in the claims of only four patents, and mentioned in only 106 U.S. patents (since 1976).

However there is a prominent piece of technology associated with Groundhog Day — familiar to horopalettologists (look it up):

the iconic flip clock — the Panasonic RC-6025 clock radio that restart’s Phil Conner’s day in the classic movie Groundhog Day. Split-flap flip clock displays (or leaf-type digital displays) were first patented in 1965:

U.S. Patent No. 3220174

While briefly popular, these displays were soon supplanted by LCD and then LED displays. However they still have a small but dedicated following, and vintage flip clocks, like the RC-6025, can sell for hundreds of dollars on eBay.

Brrr!

With temperatures in parts of the U.S. lower than we have seen in decades, it seems appropriate to recognize the inventors whose work help us brave this weather weather.

First and foremost is Chester Greenwood, inventor of ear muffs, whose U.S. Patent No. 188,292, issued March 13, 1877:

Chester Greenwood’s patent in ear muffs.

Our thanks should also go to Joel Craddick, whose U.S. Patent No. 1,394,810, issued October 1921, on an “Electrothermal Garment” — among the earliest electrically heated clothing.

Joel Craddick’s patent on an electrothermal garment.

However, inventors’ work on protecting us from the cold continues to this day, and John Elson, Kerrie Gath, Clay Maranville, and Victoria Schein, were issued U.S. Patent No. 10,143,043 on a “Heated Seat Belt.” While when I am backing out of my driveway at 1° F I will be wearing a jacket so thick that I won’t be able to tell whether or not the seat belt is warm, I can still appreciate their thinking of us.


John Elson, Kerrie Gath, Clay Maranville, and
Victoria Schein’s U.S. Patent on a Heated Seat Belt.

Working Backwards with the Benefit of Hindsight, Does not Render Compound Obvious

In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, [2017-2596] (January 11, 2019), the Federal Circuit claims affirmed the PTAB’s determination that claims 1–5 and 21–24 of U.S. Patent 6,858,650 on an antimuscarinic drug marketed as Toviaz® to treat urinary incontinence were not unpatentable as obvious.

The Federal Circuit noted that its review of a Board decision is limited. The Federal Circuit reviews the Board’s legal determinations de novo, and the Board’s factual findings underlying those determinations for substantial evidence.  The Federal Circuit explained that a finding is supported by substantial evidence if a reasonable mind might accept the evidence as adequate to support the finding.

The Federal Circuit agreed that the Board did not legally err and that substantial evidence supports the Board’s findings.  As to Amerigen’s argument that a person of ordinary skill would have been motivated to modify 5-HMT to increase its lipophilicity, the Federal Circuit said that a a reasonable fact finder could have weighed UCB’s expert testimony over Amerigen’s, and concluded that substantial evidence supported the Board’s finding that a person of ordinary skill would not have been motivated to modify 5-HMT to increase its lipophilicity.

As to Amerigen’s argument that increasing lipophilicity “in and of itself” (i.e., independent of bioavailability concerns) would have motivated a person of ordinary skill to modify 5-HMT, the Federal Circuit noted that Amerigen did not present this theory to the Board, and could point to no evidence in the record to support of it, and did not explain why a skilled artisan would modify a drug to increase its lipophilicity independent of bioavailability.

As to Amerigen’s argument that a skilled artisan would have been motivated to modify 5-HMT because 5-HMT was patented at the time of invention, the Federal Circuit noted that there was no indication that such a motivation was sufficient to prove that the claimed compounds would have been obvious.  The Federal Circuit said:

Any 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.

Any 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.

The Federal Circuit said it considered Amerigen’s remaining arguments, and not find them persuasive, and thus affirmed the Board’s decision.

USPTO Cannot Reduce PTA for Time Where Applicant Could Not Act

In Supernus Pharmaceuticals, Inc., v. Iancu, [2017-1357] (January 23, 2019), the Federal Circuit reversed summary judgment for the USPTO because the denial of patent term adjustment in this case went beyond the period during which the applicant failed to undertake reasonable efforts and thereby exceeded the limitations set by the patent term adjustment statute.

On February 22, 2011, Supernus filed an RCE in response to a final rejection. On September 11, 2012, Supernus received a letter from its European patent counsel disclosing the EPO notification of an opposition against a European counterpart application on August 21, 2012. Seventy-nine days later, or 100 days from the EPO notification of the Opposition,
on November 29, 2012, Supernus submitted a supplemental IDS.

On September 10, 2013, the USPTO issued a first Office Action responding to Supernus’s RCE. On January 10, 2014, Supernus filed a response. On February 4, 2014, the USPTO issued a Notice of Allowance. On June
10, 2014, U.S. Patent No. 8,747,897 issued, reflecting a PTA of 1,260 days (2146 PTO delay days less 886 applicant delay days). 646 of the applicant delay days were for the period between the filing of the RCE and the filing of the supplemental IDS, although as Supernus pointed out, it could not file the supplemental IDS until the filing of the Opposition.

The USPTO stood by its interpretation of the PTA statute and corresponding regulations, bolstered by Gilead Sciences, Inc. v. Lee, denying Supernus request for consideration, and the district court affirmed the USPTO granting summary judgment. However, the Federal Circuit found Gilead was distinguishable because it involved a period of time where Gilead could have filed an IDS but did not. In the instant case, Supernus could not have disclosed the Opposition that was the subject matter of the supplemental IDS until the opposition had actually occurred.

The Federal Circuit said that any reduction to PTA shall be “equal to the
period of time during which the applicant fail[s] to engage in reasonable efforts to conclude prosecution of the application” citing 35 U.S.C. § 154(b)(2)(C)(i). The Federal Circuit said that the USPTO would exceed its statutory authority if it reduced PTA for longer than the time period during which the applicant failed engage in reasonable efforts to conclude prosecution of the application.

Supernus had conceded the 100 days delay in filing filing the supplemental IDS, but as to the remaining 546 days, these could not properly be attributed to applicant delay because they were before the event that precipitated the need to file the supplemental IDS.

Because Gilead involved different facts and a different legal question, Gilead was not controlling, and the district court erred in granting summary judgment, and because the proper framework for determining PTA was clear from the statute, the Federal Circuit reversed the grant of summary judgment.

While applicants must act diligently to preserve PTA, the statute does not permit the USPTO to take away PTA for periods of time where applicant could not take action. Gilead Sciences, Inc. v. Lee allows the USPTO to reduce PTA without having to prove that applicant inaction cause a delay, but there still has to be applicant inaction for a reduction in PTA.
It is disheartening that the USPTO always seems to be on the opposite side of applicants in PTA disputes, never seeming to give applicants (its customers) a break.

Posted in PTA

If a Sale Occurs in a Forest and No One is There to See it, is it Still a Sale? Yes.

In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Supreme Court affirmed the Federal Circuit that a non-disclosing sale is prior art under post AIA 35 USC §102(a)(1).

35 USC §102(a)(1) states:


A person shall be entitled to a patent unless . . . the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.” 35 U. S. C. §102(a)(1)

At issue was whether or the sale had to be one “available to the public,” given the language “or otherwise available to the public.” The Supreme Court observed that every patent statute since 1836 has included an on-sale bar. including the one immediately prior to the AIA. The AIA retained the on sale bar, and added a catch-all phrase. The Supreme Court concluded that this addition was not enough to change the meaning of “on sale.”

The Court noted that while it had never addressed the precise question presented, its precedents suggest that a sale or offer of sale need not make an invention available to the public. In light of this settled pre-AIA precedent on the meaning of “on sale,” the Court presumed that when Congress reenacted the same language in the AIA, it adopted the earlier judicial construction of that phrase. The new §102 retained the exact language used in its predecessor statute (“on sale”) and, as relevant here, added only a new catchall clause (“or otherwise available to the public”). The Court appeared to agree that the addition of a catchall phrase was a fairly oblique way of attempting to overturn a settled body of law.

The Supreme Court rejected Helsinn’s argument that this construction read out “otherwise” from the statute, and that the associated-words canon requires us to read “otherwise available to the public” to limit the preceding terms in §102 to disclosures that make the claimed invention available to the public. The Court first noted that that the language had acquired a well-settled judicial interpretation, and that the phase “otherwise available to the public” simply captures material that does not fit neatly into the statute’s enumerated categories but is nevertheless meant to be covered. The Court said that “Given that the phrase ‘on sale’ had acquired a well-settled meaning when the AIA was enacted, we decline to read the addition of a broad catchall phrase to upset that body of precedent.”

While the Supreme Court affirmed the Federal Circuit, it did not seem to agree with their rationale, which depended upon the fact that the sale itself was public, even if it was non-disclosing. By extension, it also seems that the Supreme Court would not limit “public use,” another phrase with a well-settled meaning, to disclosing public uses.

Nearly eight years after the passage of the AIA, we finally have some clarity on what is prior art under the statute. At the very least, it looks like the USPTO is going to have to rewrite MPEP 2152.02(d), and hopefully no patents improperly issued because of the Office’s misunderstanding of post-AIA prior art.