DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
If the status of the application as subject to AIA or pre-AIA is incorrect, any correction of the statutory basis (e.g., changing from AIA to pre-AIA ) for a rejection under 35 U.S.C. §§ 102 and/or 103 will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
The listing of claims filed 6 October 2022 has been examined.
Claims 1, 3–10, 19–21, 25, 27, 30, 32, 34, 37, 54, and 67 are pending.
Claims 1, 3–10, 19–21, 25, 27, 30, 32, 37, 54, and 67 are amended.
Claims 2, 11–18, 22–24, 26, 28, 29, 33, 35, 36, 38–53, 55–66, 68, and 69 are canceled.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6 October 2022 and 12 June 2023 are acknowledged and have been considered.
Claim Objections
Claims 32, 34, 37, and 54 is objected to for minor informalities.
Claims 32, 34, and 37 recite “the virus.” Claim 1, from which those claims depend, recites “a viral infection.” Accordingly, claims 32, 34, and 37 are not consistent with claim 1.
Claim 54 recites “an mTORC inhibitor” twice (lines 8, 12)(the amendment was duplicative). Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 7 and 32 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 7 recites “the additional compound.” Claim 7 depends on claim 1, which does not recite “an additional compound.” Claim 7, prior to the preliminary amendment, depended from “any one of claims 1–6.” Claim 6 recites “an additional compound.”
Because claim 1 does not provide antecedent basis support for “the additional compound” in claim 7 and because claim 7 previously depended on claim 6, it is unclear whether claim 7 should be interpreted as being dependent from claim 1 or claim 6.
Claim 32 depends from claim 1 and recites a step of “testing the subject for the presence of the virus” and a conditional step of “administering the compound if the subject tests positive for the presence of the virus.” The inference provided by the condition is that there need not be an administering step if the subject tests negative for the presence of the virus. It is unclear whether claim 32 requires the active administration step because it depends from claim 1 or whether claim 32 permits exclusion of the administration step based on the recitation of “administering the compound if the subject tests positive for the presence of the virus.” Because claim 32 appears to permit negating the positively recited step recited in claim 1, the claim fails to particularly point out and distinctly claim the subject matter the inventor regards as the invention. Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. § 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 3–10, 19–21, 25, 27, 30, 32, 34, and 37 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claims contain subject matter that was not described in the Specification in such a way as to reasonably convey to one of ordinary skill in the art that Applicant, at the time the application was filed, had possession of the claimed invention.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit stated “the hallmark of written description is disclosure.” A specification adequately describes an invention when it “reasonably conveys to those skilled in the art the inventor had possession of the claimed subject matter as of the filing date.” (Id.). “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011).
What is required to meet the written description requirement “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). In Ariad, the Federal Circuit explained what is required to meet the written description requirement:
This inquiry, as we have long held, is a question of fact. Ralston Purina, 772 F.2d at 575. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Capon v. Eshhar, 418 F.3d 1349, 1357–58 (Fed. Cir. 2005). Specifically, 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. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.” Id. at 1359.
(Ariad, at 1351).
The written description of a genus, such as a chemical genus, “requires a precise structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit commented on that case in the Ariad decision:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed.Cir.1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed.Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
(Ariad, at 1350).
The factors outlined in the above Federal Circuit cases are analyzed with respect to the claimed invention in turn below.
(A) The nature and scope of the claim invention in view of the specification: the claimed invention relates to a method of treating a viral infection by administering a kinase inhibitor. The broadest claims encompass any viral infection and any kinase inhibitor.
The disclosures in the Specification, however, are very specific. The Background section discusses the coronavirus disease (COVID-19), which is caused by severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2). (Spec., 1).
Each of the drawings in FIGs. 1–11B is related to SARS-CoV-2. (Id., 3–4).
The examples are related to SARS-CoV-2. (Id., 28–32). Most relevant is Example 1, which involves a screening methodology to determine the activity of “430 kinase inhibitors that are normally used for oncology and which have Phase I/II/III data attached” against cells exposed to SARS-CoV-2. (Id., 29). The Specification states, “The compounds hit few selected kinases and a very limited set of pathways (FIG. 4), suggesting the specific nature of the antiviral agents.” (Id., 29).
From a primary screen, 34 compounds were identified as having potential anti-SARS-CoV-2 activity based on inhibition of viral cytopathic effect in epithelial cells. (Id., 30). A secondary screening confirmed anti-SARS-CoV-2 activity for only 6 compounds: “Berzosertib (VE-822) and Vistusertib (AZD2014) antiviral activities are at IC50 of 25 nM. Nilotinib, NVP-BHG712, VPS34-INI and YM201636 have IC50 ranges between 250 nM-500 nM. These compounds exhibit as an antiviral agent against SARS-CoV-2 by limiting viral replication and cell death by directly acting or indirectly acting to inhibit critical cellular enzymes needed for viral replication. These kinase inhibitors are nucleoside analogues.” (Id.).
The Specification does not provide any studies, data, or working examples for treating a viral infection other than COVID-19 with any compound.
(B) The extent and content of the prior art are limited. COVID-19 was discovered in December, 2019. (Almeciga-Diaz, 2) (IDS). The instant application claims benefit to a provisional application filed in April, 2020. As of January 2020, there was no antiviral treatment for COVID-19. (Hongzhou Lu, 69) (IDS). Lu states, “In general, there are no specific antiviral drugs or vaccines for 2019-nCoV. All of the drug options come from experience treating SARS, MERS or some other new influenza virus previously.” (Id., 70).
(C) The maturity of the science or technology relevant to the claimed invention is in its infancy. The COVID-19 pandemic had recently begun and was ongoing at the time of filing of the instant application. (Spec., 1). Applicant acknowledges: “an effective cure for COVID-19 and other coronaviruses has yet to be developed. Accordingly, there is an ongoing need for new methods of treating viral infections. (Id.).
(D) The predictability of the aspect at issue: the pharmaceutical art is generally recognized as unpredictable. In re Fisher, 427 F.2d 833, 839 (CCPA 1970). The art requires each potential drug candidate to be assessed for physiological activity. Id. The more unpredictable an area is the more specific disclosure is necessary to satisfy the statutory requirement. In this case, there is no evidence the claimed invention is more predictable than the art is generally.
The question of written description
When the on the above factors and evidence discussed therein are considered as a whole, the specification (in view of the prior art) does not adequately describe a representative number of species to support the claimed method of treating any viral infection with any compound that is known as or may be discovered as one of the inhibitors recited in the claims. The generic claims are not supported by a representative number of examples in the specification. The examples are specifically directed to treating SARS-CoV-2 with 6 compounds identified as potential drugs based on the screening methodology. There are no examples for a viral infection other than SARS-CoV-2. And the limited number of drugs identified via the screening is not commensurate in scope with the infinite number or compounds encompassed by the claims. Accordingly, the Specification would not reasonably convey to those skilled in the art the inventor had possession of the full scope of the claimed subject matter as of the filing date.
Examiner recommends limiting the claims to COVID-19, as recited in claim 25, and to the 6 compounds found to have anti-SARS-CoV-2 activity (Berzosertib (VE-822), Vistusertib (AZD2014), Nilotinib, NVP-BHG712, VPS34-INI, and YM201636).
Claim Rejections - 35 U.S.C. § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) 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.
Claims 54 and 67 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Charron et al., Eur. Respir. J. (2017), 50:1700188, pp.1-9 (“Charron”).
Charron discloses a treatment of COPD with compound RV568, a kinase inhibitor, formulated for inhalation. (Charron, Title, Abstract, p.2). Charron discloses an inhaler comprising the compound RV568. (Id., p.3) (“All delivered doses were administered using a Philips Respironics I-neb Adaptive Aerosol Delivery (AAD) system”).
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966); MPEP § 2141(II).
Claims 1, 3–5, 21, 25, 32, 34, and 37 are rejected under 35 U.S.C. § 103 as being unpatentable over Almeciga-Diaz et al., Preprints (April 9, 2020), pp.1–18 (“Almeciga-Diaz”) (IDS) in view of Sharp et al., Recommendations and Reports (2019), 68(1), pp.1–10 (“Sharp”) and Aoki et al., J. Antimicrobial Chemotherapy (2003), 51, 123–129 (“Aoki”).
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Almeciga-Diaz identifies Nilotinib as a drug having pharmacological activity against SARS-CoV-2, the pathogen known to cause the coronavirus disease, COVID-19. (Almeciga-Diaz, Table 1 and discussion, pp. 9–10). Nilotinib is a kinase inhibitor. (Id.).
Sharp discloses testing subjects with an illness for Zika virus.
Aoki discloses administering a drug to a subject within 2 days after the onset of symptoms of a virus.
Ascertaining the differences between the prior art and the claims at issue
Almeciga-Diaz does not disclose administering the drug to a subject, which is defined in the specification as a human or non-human animal. (Spec., 24). Almeciga-Diaz does not disclose testing the subject and administering the drug if the subject tests positive for a virus, within 1 or 2 days after the testing or exposure to the virus.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
None.
The question of obviousness
While Almeciga-Diaz does not disclose administering the drug to a subject, as required by claim 1, it would have been obvious for a person having ordinary skill in the art prior to the filing of the instant application to modify the disclosure in Almeciga-Diaz to arrive at the claimed method because the kinase inhibitor Nilotinib was identified as a drug having pharmacological activity against a viral infection caused by SARS-CoV-2.
While Almeciga-Diaz does not disclose testing or administering the drug to a subject after testing or exposure to the virus, as required by claims 32, 34, and 37, it would have been obvious for a person having ordinary skill in the art prior to the filing of the instant application to modify the disclosure in Almeciga-Diaz to arrive at the claimed method because Sharp discloses testing a subject for the presence of a virus and Aoki discloses treating the subject within 2 days after testing or exposure. Aoki concludes that early presentation, diagnosis, and treatment maximize the effects of the therapy.
One of ordinary skill in the art would have been motivated to combine the teachings of Almeciga-Diaz, Sharp, and Aoki with the knowledge of one of ordinary skill in the art because it was known prior to the time of filing the instant application, that new treatments for COVID-19 were needed in the midst of the pandemic, that testing for a virus is helpful for diagnosing the infection, and early administration of a drug after infection is helpful for the therapy. There would have been a reasonable expectation of success at arriving at the claimed invention because Almeciga-Diaz identified the same drug through a screening process, in a similar manner as that disclosed in the instant specification, and the high level of ordinary skill in the art would be capable of administering the drug to a subject to treat a disease.
Conclusion
No claims are allowed.
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/J.M.N./Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623