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 .
Detailed Action
Claims 1-2 are pending and now under consideration.
Priority
Applicants’ claim for the benefit of priority under 35 U.S.C. 119(e) is acknowledged. This application claims benefit of Provisional application: 63/510,162 filed on 06/26/2023.
Information disclosure statement
The information disclosure statement (IDS) submitted on 12/31/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
Objections-Specification
I. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. The specification contains hyperlinks to various site domains, for example, ¶ [0108], page 33 of the instant application. Applicants’ are required to thoroughly scrutinize the specification and delete all embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01. Appropriate correction is required.
II. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections: 35 USC § 112(b)
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 1-2 recite the phrase “…significant decrease in at least one of (i) the weight of the xenograft tumors and (ii) the number of HGSOC metastases in the mice, wherein the significant decrease identifies the chemical substance as a candidate drug capable of ameliorating HGSOC in a subject in need of such treatment…” is considered to be a relative term which renders the claim indefinite. Claims 1-2 do not recite the specific metric and does not provide a standard for ascertaining the requisite decrease in tumor burden or metastasis? of the claimed “…significant decrease …”. In the art what is considered “…significant decrease …” varies widely depending on the individual situation as well as the person making the determination. It is not clear to the examiner as to how “…significant decrease …”is measured? and encompassed in the above phrase. Thus, the scope of the claim is unclear, as written does not recite the specific conditions in the claimed “…significant decrease …” the applicants' intend to encompass. As such it is unclear what “…significant decrease …” of interest must be to be included within the scope of the claims and one of ordinary skill in the art would not be able to reasonably determine the metes and bounds of the claims. Furthermore no patentable weight is given to “the chemical substance as a candidate drug capable of ameliorating HGSOC in a subject in need of such treatment”, as claims are interpreted to be limited to a method of screening and not a method of making nor a method of use of “the chemical substance as a candidate drug capable of ameliorating HGSOC in a subject in need of such treatment”.
Examiner also would like to point out: “Although the claims are examined in the light of the specification, specification cannot be read into the claims, i.e., the limitations of the specification cannot be read into the claims (see MPEP 2111 R-5)”). Clarification and correction is required.
Claim Rejections: 35 USC § 112(a)
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.
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.
Enablement
I. Claims 1-2 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method for producing syngas
Claims 1-2 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of screening for a chemical substance comprising contacting an High-grade serous ovarian carcinoma (HGSOC) cell line expressing the reporter gene luciferase in a mouse xenograft model (see Fig. 1-7C of specification), the specification does not reasonably provide enablement for any chemical compound of undefined chemical structure and the use of said structurally and functionally undefined chemical compounds in the treatment of High-grade serous ovarian carcinoma (HGSOC) in a subject in need of such treatment irrespective of etiology and pathology (also see 35 U.S.C. 112(b) for claim interpretation). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims without undue experimentation.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988) as follows: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claim(s).
Claims 1-2, broadly encompass any chemical compound of undefined chemical structure and the use of said structurally and functionally undefined chemical compounds in the treatment of High-grade serous ovarian carcinoma (HGSOC) in a subject in need of such treatment irrespective of etiology and pathology (also see 35 U.S.C. 112(b) for claim interpretation). The scope of the claims does not commensurate with the enablement provided by the disclosure with regard to: i) any or all compounds with wide variety of structures from any source having any undefined function and the mode of action; or ii) in the use of said structurally and functionally undefined compounds in the treatment of High-grade serous ovarian carcinoma (HGSOC) in a subject in need of such treatment irrespective of etiology and pathology, that are broadly encompassed by the claims.
The disclosure is limited to a method of screening for a chemical substance comprising contacting an High-grade serous ovarian carcinoma (HGSOC) cell line expressing the reporter gene luciferase in a mouse xenograft model (see Fig. 1-7C of specification). However, the specification is silent on: any chemical compound of undefined chemical structure and the use of said structurally and functionally undefined chemical compounds in the treatment of High-grade serous ovarian carcinoma (HGSOC) in a subject in need of such treatment irrespective of etiology and pathology (also see 35 U.S.C. 112(b) for claim interpretation) in real-world medical situations, as the specification provides no specific steps or guidance of preparing said structurally and functionally undefined compounds by said process for administration to a patient in treatment of High-grade serous ovarian carcinoma (HGSOC) irrespective of etiology and pathology and specific route of administration including dosage. Therefore, it would require undue experimentation by the skilled artisan to make and use i.e., any chemical compound of undefined chemical structure and the use of said structurally and functionally undefined chemical compounds in the treatment of High-grade serous ovarian carcinoma (HGSOC) in a subject in need of such treatment irrespective of etiology and pathology (also see 35 U.S.C. 112(b) for claim interpretation). Because there is no such readily available guidance in prior art, nor does the specification provides one, it would be undue experimentation for those skilled in the art to make and use claimed candidate drug in the treatment of High-grade serous ovarian carcinoma (HGSOC) in a subject in need of such treatment irrespective of etiology and pathology for intended purposes.
In view of the great breadth of the claims, amount of experimentation required to make and use the claimed composition of the claimed process, the lack of guidance, working examples, and unpredictability of the art in predicting the use of the identified compounds in said process in the present invention i.e., in the treatment of High-grade serous ovarian carcinoma (HGSOC) in a subject in need of such treatment irrespective of etiology and pathology. For the above purpose, the claimed invention would require undue experimentation. As such, the specification fails to teach one of ordinary skill how to use the full scope of the process and the compounds and treatment conditions encompassed by the claims.
Thus, applicants have not provided sufficient guidance or shown any therapeutic procedures in their working examples to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims broadly including: any chemical compound of undefined chemical structure and the use of said structurally and functionally undefined chemical compounds in the treatment of High-grade serous ovarian carcinoma (HGSOC) in a subject in need of such treatment irrespective of etiology and pathology (also see 35 U.S.C. 112(b) for claim interpretation). The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 1924 (CCPA 1970)). Without sufficient guidance, determination of compounds identified by said process and for using said compositions in the treatment of said conditions is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly extensive and undue. See In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988).
Written Description
Claims 1-2 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, as containing subject matter which was not disclosed in the specification in such a way as to reasonably convey to one of skilled in the relevant art that the invention(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-2, as interpreted are directed to any chemical compound of undefined chemical structure and the use of said structurally and functionally undefined chemical compounds in the treatment of High-grade serous ovarian carcinoma (HGSOC) in a subject in need of such treatment irrespective of etiology and pathology (also see 35 U.S.C. 112(b) for claim interpretation). The specification does not contain any disclosure of any or all compounds with wide variety of structures from any source and in the use of treatment of High-grade serous ovarian carcinoma (HGSOC) in a subject in need of such treatment irrespective of etiology and pathology as claimed. Said genera encompasses a wide variety of structurally disparate compounds from any source identified by said process and the use of said structurally and functionally undefined compounds in the treatment of High-grade serous ovarian carcinoma (HGSOC) in a subject in need of such treatment irrespective of etiology and pathology.
The specification discloses and limited to a method of screening for a chemical substance comprising contacting an High-grade serous ovarian carcinoma (HGSOC) cell line expressing the reporter gene luciferase in a mouse xenograft model (see Fig. 1-7C of specification), which is insufficient to put one of skill in the art in possession of the attributes and features of all species within the claimed genus i.e., any chemical compound of undefined chemical structure and the use of said structurally and functionally undefined chemical compounds in the treatment of High-grade serous ovarian carcinoma (HGSOC) in a subject in need of such treatment irrespective of etiology and pathology (also see 35 U.S.C. 112(b) for claim interpretation).
A sufficient written description of a genus of may be achieved by a recitation of structural features common to members of genus, which features constitute a substantial portion of the genus. There is no recited structural feature of the genus in the specification, i.e., any chemical compound of undefined chemical structure and the use of said structurally and functionally undefined chemical compounds in the treatment of High-grade serous ovarian carcinoma (HGSOC) in a subject in need of such treatment irrespective of etiology and pathology (also see 35 U.S.C. 112(b) for claim interpretation) as claimed and included in the claimed genera. Therefore, one skilled in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “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”. As indicated in MPEP § 2163, 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, reduction to drawings, 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 that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, published in the Official Gazette and also available at <http://www.uspto.gov>.
Claim Rejections: 35 USC § 102 (AIA )
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.
(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.
I. Claim 1 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Liu et al., (Clin Cancer Res., 2017, Vol. 23(5): 1263-1273), said reference discloses a method i.e., establishment of patient-derived tumor xenograft model of epithelial ovarian cancer for preclinical evaluation of novel therapeutics/chemical compounds in mice (see Abstract; Materials and Methods, patient cells transduced/stably transfected with Firefly luciferase gene, pages 1264-1265 and entire document); said patient cells transduced/stably transfected with Firefly luciferase gene with histologic type High-grade serous ovarian carcinoma (HGSOC; Table 1, page 1266); reduction in tumor burden following drug treatment in luciferized xenograft mouse model (Fig. 4-5, pages 1270-1271). Therefore, Liu et al., (Clin Cancer Res., 2017, Vol. 23(5): 1263-1273) is deemed to anticipate claim 1 as written and when given the broadest reasonable interpretation.
II. Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Regev et al., (US 2021/0347847 A1), said reference discloses a method i.e., establishment of patient-derived tumor xenograft model of epithelial ovarian cancer for preclinical evaluation of novel therapeutics/chemical compounds in mice (see Abstract; Fig. 1, Fig. 4, Fig. 9, Fig. 18-19; and entire document); said patient cells transduced/stably transfected with Firefly luciferase gene with histologic type High-grade serous ovarian carcinoma (¶ [0403]; OVCAR8 cells ¶ [0438]; and HGSOC cells ¶ [0447]; Luciferase Assay ¶ [0445]; and reproduced below); reduction in tumor burden following drug treatment in luciferized xenograft mouse model (Fig. Fig. 12; ¶ [0447]; Claim 75). Therefore, Regev et al., (US 2021/0347847 A1) is deemed to anticipate claims 1-2 as written and when given the broadest reasonable interpretation.
Regev et al., (US 2021/0347847 A1)
[0403] In certain embodiments, screening methods employ PDX mouse models as described herein. In certain embodiments, PDX models can be treated with a chemotherapeutic agent (e.g., platinum based therapy). Agents can be screened for the ability to sensitize or over-come platinum resistance. In certain embodiments, tumor cells grown in culture can be screened as described herein for JSI-124. In certain embodiments 2D or 3D cultures are screened. In certain embodiments, OVACR4, OVACR8, OVASHO or TYKNU cells are screened. In certain embodiments, combination therapies are screened. In certain embodiments, ex vivo cultures of platinum resistant patients are screened. In certain embodiments, reporter cell lines expressing a reporter (e.g., luciferase) are used to screen for agents capable of modulating a gene signature as described herein. The reporter can be specific for a gene as described herein. One or more reporters for one or more genes may also be used. In certain embodiments, spheroid cultures are screened.
[0438] Cell culture. High-grade serous ovarian cancer cell lines Kuramochi, Ovsaho, Ovcar4, Ovcar8, and Tyknu were provided by the CCLE project at the Broad Institute. All cell lines were cultured in RPMI1640 Medium (Gibco), supplemented with 10% Fetal Bovine Serum (FBS) and 1% penicillin/streptomycin (Invitrogen), and were maintained in an incubator at 37° C. and 5% CO.sub.2. Sub-culturing of cell lines was done by detaching cells using 0.05% trypsin EDTA, quenching, washing and re-suspending the cell pellet in fresh media.
[0445] Luciferase assay. Heya8 cells were transfected with the STAT3 responsive luciferase reporter M67-luc (kindly provided by Jacqueline Bromberg, Memorial Sloan Kettering) and renilla luciferase (Promega) using lipofectamine 2000.sup.46. Cells were pretreated with 1 μM JSI-124 for 1 hour and then stimulated with 10 ng/mL oncostatin M (OSM; Peprotech) for 6 hours. Luciferase activity was measured using a dual luciferase kit (Promega) on a luminoskan luminometer. Firefly luciferase activity is normalized to renilla and expressed relative to media controls
.
[0447] Patient-derived xenograft model experiments. HGSOC PDX models derived from patients with different treatment histories were selected for implantation: DF20 (BRCAWT treatment-naïve, clinically platinum sensitive); DF101 (BRCA1 mutant, 2 lines of prior therapy, clinically platinum resistant); DF68 (BRCA1 mutant, 6 lines of prior therapy, clinically platinum resistant).sup.29. For all experiments, Applicants used NOD-SCID IL2Rγnull mice (NSG, Jackson Laboratory). For the carboplatin treatment study, to facilitate detecting minimal residual disease, Applicants used a subcutaneous (SC) model instead of an intraperitoneal (IP) mode.
Since the Office does not have the facilities for examining and comparing applicants’ process with the process of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed process of the prior art (i.e., that the process of the prior art does not possess the same material structural and functional characteristics of the process of the instant invention). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Claim Rejections: 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(a) 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.
Claims 1-2 are rejected under 35 U.S.C. 103(a) as being unpatentable over Liu et al., (Clin Cancer Res., 2017, Vol. 23(5): 1263-1273) and Regev et al., (US 2021/0347847 A1) as applied to claims 1-2 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Connolly et al., (Current Protocols in Pharmacol., 2009; 14.12.1-14.12.26, pages 1-26) and Miseirvitch S., (MS Thesis, Univ. of New Hampshire, USA., 2021, pages 1-88).
The disclosure of Liu et al., and Regev et al., are silent regarding “…(2) a cell line comprising cisplatin-resistant HGSOC (HGSOC-CPR) cells which have been transduced with Luc to form HGSOC-CPR Luc cells;… (2) a cell line comprising cisplatin-resistant OVCAR-8 (OVCAR-8- CPR) cells which have been transduced with Luc to form OVCAR-8-CPR Luc cells” (as in claims 1-2).
Regarding claims 1-2, Connolly et al., (Current Protocols in Pharmacol., 2009,. 14.12.1-14.12.26, pages 1-26) provide teaching, suggestion and motivation to a skilled artisan i.e., detail protocols regarding xenograft mouse models of epithelial ovarian cancer and non-invasive imaging modalities to monitor ovarian tumor growth in situ and application in evaluating therapeutic agents/drug screening, including bioluminescent imaging (BLI) of ovarian tumor xenografts and expression of luciferase in ovarian carcinoma cell lines of interest depending on the experimental need (see ¶ 14.12.13 pages 12-15; and entire document).
Regarding claims 1-2, Miseirvitch S., (MS Thesis, Univ. of New Hampshire, USA., 2021, pages 1-88) provides teaching, suggestion and motivation for generating cisplatin resistant ovarian cancer cells, i.e., “…(2) a cell line comprising cisplatin-resistant HGSOC (HGSOC-CPR) cells which have been transduced with Luc to form HGSOC-CPR Luc cells;… (2) a cell line comprising cisplatin-resistant OVCAR-8 (OVCAR-8- CPR) cells which have been transduced with Luc to form OVCAR-8-CPR Luc cells” and methods for generation of cisplatin resistant OVCAR-8 cells (OVCAR-8CR), an High-grade serous ovarian carcinoma (HGSOC) cell line expressing the reporter gene luciferase and for drug screening of compounds that resensitize OVCAR-8CR cells to cisplatin and inhibit the growth of said reference OVCAR-8CR cells (see Abstract; pages 19-21; Fig. 2.1, page 28; Fig. 2.2, page 30; Fig. 2.8, page 42; Fig. 2-9, page 45; and entire document).
Therefore, it would have been obvious to a person of ordinary skill in the art to combine and modify the teachings of Liu et al., Regev et al., and Connolly et al., and employ the cisplatin resistant OVCAR-8 cells (OVCAR-8CR), an High-grade serous ovarian carcinoma (HGSOC) cell line expressing the reporter gene luciferase and for drug screening of compounds that resensitize OVCAR-8CR cells to cisplatin and inhibit the growth of said reference OVCAR-8CR cells in mice having xenograft tumors cisplatin resistant OVCAR-8 cells (OVCAR-8CR), as taught in the references of Miseirvitch S., that teach structural and functional elements for drug screening of desired chemical products of interest depending on the experimental need. Motivation to generate such a modified process derives from the fact that identification of chemical compounds that inhibit or resensitize cisplatin resistant cancer cells is of clinical significance and of importance in identifying drugs that are useful for the treatment of ovarian cancer (Liu et al., Regev et al., Connolly et al., and Miseirvitch S.,). The expectation of success is high, because the combined teachings of Liu et al., Regev et al., Connolly et al., and Miseirvitch S., teach identification of chemical compounds that inhibit or resensitize cisplatin resistant cancer cells is of clinical significance and of importance in identifying drugs that are useful for the treatment of ovarian cancer and said references also provide the structural and functional elements of the instant invention (Teaching, Suggestion and Motivation).
Given this extensive teaching in prior art (Liu et al., Regev et al., Connolly et al., and Miseirvitch S.,) i.e., a method of screening a chemical substance as a drug candidate against High-grade serous ovarian carcinoma (HGSOC), comprising: providing mice having xenograft tumors caused by at least one of (1) a cell line comprising HGSOC cells which have been transduced with firefly luciferase gene (Luc) to form HGSOC-Luc cells, and (2) a cell line comprising cisplatin-resistant HGSOC (HGSOC-CPR) cells which have been transduced with Luc to form HGSOC-CPR Luc cells;… (also see rejection under 35 U.S.C. 112(b) for claims interpretation), as taught by the instant invention and as claimed in claims 1-2 is not of innovation but of ordinary skill in the art and the expectation of success is extremely high i.e., “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at, 82 USPQ2d at 1397”.
Therefore, claims 1-2 are rejected under 35 U.S.C. 103(a) as being unpatentable over Liu et al., (Clin Cancer Res., 2017, Vol. 23(5): 1263-1273) and Regev et al., (US 2021/0347847 A1) as applied to claims 1-2 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Connolly et al., (Current Protocols in Pharmacol., 2009; 14.12.1-14.12.26, pages 1-26) and Miseirvitch S., (MS Thesis, Univ. of New Hampshire, USA., 2021, pages 1-88).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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