Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Non-Final Rejection
The Status of Claims:
Claims 1-15, 22-26 are pending.
Claims 1-7, 12, 14-15, 22-25 are rejected.
Claims 8-11, 13 are rejected.
Claim 26 is withdrawn from consideration.
DETAILED ACTION
1. Claims 1-15, 22-25 are under consideration in this Office Action.
Priority
2. It is noted that this application is a continuation of 16484074 08/06/2019 (PAT 11208384) , which is a 371 of PCT/GB2018/050342(02/07/2018), which claims benefit of 62/455,645(02/07/2017).
Drawings
3. The drawings filed on 2/14/23 are accepted by the examiner.
IDS
4. The IDS filed on 6/03/23 are reviewed by the examiner.
Election/Restriction
Applicant’s election without traverse of Group I (claims 1-15, 22-25) on 3/19/26 is acknowledged. Claim 26 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected group II, there being no allowable generic or linking claim.
Claim Objections
Claims objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The issue concerning the meaning of phrases “a small molecule”,” a nucleic acid therapeutic”, “a peptide therapeutic”, or “another biologic therapeutic that mimics” are discussed above. Claim 25 does not contain a complete generic formula.
According to the MPEP §2163 I. A. “the issue of a lack of adequate written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.” The MPEP states in §2163 II 3 ii) “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.” Applicants have disclosed no species and have made no assertion that there is any correlation between the biological function of radical ““a small molecule”, “a nucleic acid therapeutic”, “a peptide therapeutic”, or “another biologic therapeutic that mimics” and their corresponding structures.
The Court of Appeals for the Federal Circuit held in University of California v. Eli Lilly and Co. 43 USPQ2d 1398 at 1406. "[a] written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." In re Smythe, 480 F.2d 1376, 1383, Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . .")." Applicants' functional definitions in the claimed formula simply lack the precision required by the Court of Appeals for the Federal Circuit.
As discussed above the phrases “a small molecule”,” a nucleic acid therapeutic”, “a peptide therapeutic”, or “another biologic therapeutic that mimics” are not art recognized in the art of the biochemistry. According to the MPEP §2163.02 Standard for Determining Compliance With the Written Description Requirement,
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed". In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter". Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
Thus, the phrases “a small molecule”,” a nucleic acid therapeutic”, “a peptide therapeutic”, or “another biologic therapeutic that mimics” of ordinary skill in the art, who would use Applicants' compounds, would not know what each of the phrases “a small molecule”,” a nucleic acid therapeutic”, “a peptide therapeutic”, or “another biologic therapeutic that mimics” is meant . That ordinary person skilled in the art would not have understood the inventor to be in possession of the claimed phrases of “a small molecule”,” a nucleic acid therapeutic”, “a peptide therapeutic”, or “another biologic therapeutic that mimics” at the time of filing.
This case was filed before Applicants had a clear idea of the structures of their desired compounds, how to make their compounds, and use the *** made from them. The specification provides broad areas of future research and speculation, inviting undue experimentation in learning how to use Applicants' invention. Applicants may well now be developing practical applications of their meaning of the phrases , but the question here is what application they possessed at the time of filing. Anything is possible but as the U.S. Patent and Trademark Office, Board of Patent Appeals and Interferences wrote in Bindra v. Kelly, 206 USPQ 570 “Probable utility does not establish practical utility. Practical utility can, in our view, be established only by actual testing therefore, or by establishing such facts as would be convincing that such utility could be "foretold with certainty.” Blicke v. Treves, supra, 112 USPQ at 475.”
Applicants are reminded of what the U.S. Court of Appeals Federal Circuit wrote in University of California v. Eli Lilly and Co. 43 USPQ2d 1398, "In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus." "A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). "It is only a definition of a useful result rather than a definition of what achieves that result." "The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.")".
Claim Rejections - 35 USC § 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
5. Claim(s) 1-2, and 4-5 are rejected under 35 U.S.C. 102(a)(1) being anticipated clearly by Hussman ( Frontiers in Pharmacology (2020), 11, 1169).
Hussman discloses a screening of 290 compounds for antiviral activity against SARS-CoV and MERS-CoV,those promoting at least 50% viral inhibition in Vero E6 cells in vitro with little or no toxicity included selective estrogen receptor modulators (SERMs)(e.g., toremifene and tamoxifen), (see page 10, the left col, at the bottom & Table 1 ). These are inherently identical with the claims.
Claim(s) 1 and 25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rubin et al (US 2013/0280806 A1).
Regarding claim 1, Rubin discloses a method of treating or inhibiting a viral infection ( a coronavirus)(see page 92, claims 1 and 5). in a human subject by one or more of the ingredients of the pharmaceutical compositions ... use or sale for human administration (see page 35, paragraph# 0125).
Also, it provides a method of decreasing infection by a pathogen in a subject by decreasing the expression or activity of a gene or gene product set forth in Table 1, said method comprising administering to the subject an effective amount of a composition that decreases the expression or activity of a gene or a gene product set forth in Table 1(see page 30 , a paragraph#0094).
Regarding claim 25, Rubin discloses that the activity of a gene or gene product set forth in Table 1 can be decreased by contacting the cell with any composition that can decrease expression or activity. For example, the composition can comprise a chemical, a small or large molecule ( organic or inorganic), a drug, a protein, a peptide,.. and an antibody (see page 15, a paragraph#0062). These are identical with the claims.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
7. Claims 1-7, 12, 14-15, 22-23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Rubin et al (US 2013/0280806 A1) in view of Silvas et al ( Inhibitors of VPS34 and lipid metabolism suppress SARS-CoV-2 n.dication. bioRxiv Pre n·inC. Jul • 20, 2020).
Determination of the scope and content of the prior art
Rubin discloses a method of treating or inhibiting a viral infection in a human subject by one or more of the ingredients of the pharmaceutical compositions ... use or sale for human administration (see paragraph# 0125; claims 1 and claim 3).
Also, it provides a method of decreasing infection by a pathogen in a subject by decreasing the expression or activity of a gene or gene product set forth in Table 1, said method comprising administering to the subject an effective amount of a composition that decreases the expression or activity of a gene or a gene product set forth in Table 1(see page 30 , a paragraph#0094).
The current invention, however, differs from the prior art in that the claimed PIK3C3 inhibitor being PIK-III is unspecified in the prior art.
Silvas et al teaches that PIK3C inhibitor can inhibit COVID19 growth in human cells targeting replication of SARS coronavirus 2 (SARSCoV-2) that are urgently needed. Coronaviruses rely on host membranes for entry, establishment of replication centers and egress ... small molecule inhibitors were tested that target membrane dynamics or lipid metabolism. Included were inhibitors of the Pl3 kinase VPS34, which functions in autophagy, endocytosis and other processes ... VPS34 inhibitors, Orlistat and Triacsin C inhibited virus growth in Vero E6 cells and in the human airway epithelial cell line Calu-3, acting at a post-entry step in the virus replication cycle. Of these the VPS34 inhibitors exhibit the most potent activity (see page 2, abstract ); (VPS34 is same as PIK3C3)).
Furthermore, it teaches that VPS34 IN-1 (#17392), PIK-III (#17002), Triacsin C (#10007448), and 161 Orlistat (#10005426) were purchased from Cayman Chemical (see page 8, a section of compounds).
Ascertainment of the difference between the prior art and the claims
The difference between the instant application and the applied Rubin art is that the Rubin does not expressly teach the claimed PIK3C3 inhibitor being PIK-III. The deficiency of the Rubin is partly cured by the Silvas et al.
The difference between the instant application and the applied Silvas et al art
is that the Silvas et al does not expressly exemplify the claimed method of treating or inhibiting a viral infection in a human subject. The deficiency of the Silvas et al is cured by the Rubin art.
Resolving the level of ordinary skill in the pertinent art.
Regarding the Claim 2, with respect to the lack of disclosing the claimed PIK3C3 inhibitor being PIK-III, Silvas et al does teach that PIK3C inhibitor such as PIK-III can inhibit COVID19 growth in human cells, thereby using it for treating or inhibiting the viral infection in a human subject.
So, it would have been obvious to one of ordinary skill in the art, to have combined the teachings of Rubin with Silvas and optimized the method to use PIK3C3 as the gene, inhibition of which can be used for treating COVID19 infection, using routine experimentation.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Rubin expressly discloses the method of treating or inhibiting a viral infection in a human subject by one or more of the ingredients of the pharmaceutical compositions ... use or sale for human administration (see paragraph# 0125; claims 1 and claim 3).
Also, it provides the method of decreasing infection by a pathogen in a subject by decreasing the expression or activity of a gene or gene product set forth in Table 1, said method comprising administering to the subject an effective amount of a composition that decreases the expression or activity of a gene or a gene product set forth in Table 1(see page 30 , a paragraph#0094).
Although Rubin does not disclose the claimed PIK3C3 inhibitor being PIK-III, Silvas et al does teach that PIK3C inhibitor such as PIK-III can inhibit COVID19 growth in human cells targeting replication of SARS coronavirus 2 (SARSCoV-2).
Both of the Rubin and Silvas et al prior art are closely relate to each other with respect to inhibiting a viral infection by decreasing or inhibiting the activity of a gene.
Furthermore, Silvas et al does give a guidance that PIK3C3 inhibitors exhibit the most potent activity (see page 2, abstract ).
So, if the skilled artisan in the art had desired to develop the method of treating COVID19 infection using PIK3C3 as the gene for the inhibition, it would have been obvious to the skilled artisan in the art before the effective filing date of the claimed invention to be motivated to incorporate Silvas’s PIK-III into the Rubin’s method in order to enhance the treatment. This is because the skilled artisan in the art would expect such combined prior art to be feasible and successful as guidance shown the prior art.
Conclusion
Claims 1-7, 12, 14-15, 22-25 are rejected.
Claims 8-11, 13 are rejected.
Claim 26 is withdrawn from consideration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 6/08/2026
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