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
Priority
This is a National Stage Entry under 35 U.S.C. 371 of International Patent Application No. PCT/US2021/058607, filed November 9, 2021, which claims the benefit under 35 USC 119(e) of US Provisional Patent Application No. 63/112,047, filed November 10, 2020 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 05/04/2023 is acknowledged. Claims 1, 3-10 and 12-18 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/06/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 3-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because based upon an analysis with respect to the claim as a whole, claims 1 and 3-8 are determined to be directed to laws of nature and natural products. The rationale for this determination is explained below:
The claimed invention is directed to a diagnostic kit for the non-invasive prediction of time-to-viral-rebound in an HIV subject after antiretroviral therapy (ART) interruption comprising reagents that detect and measure the metabolites and glycans comprising:
(a) Plasma A3G3S3 glycans, Pyruvic acid, Plasma T-antigen that binds the lectic MPA, Plasma T-antigen that binds the lectin ACA, Total fucose, L-glutamic acid, and (GlcNAc)n; or
(b) IgG A2 glycans, Plasma A3G3S3 glycans, Total Fucose, Core fucose, Plasma T-antigen that binds lectin ABA, (GlcNAc)n, and L-glutamic acid without significantly more.
The claims recite a kit comprising reagents that are naturally occurring in a subject. The specification discloses that “By “diagnostic reagent” as used herein is meant any compositions that can be used to detect or measure the levels of one or multiple metabolites or glycans in the subject’s 15 body. In one embodiment, the reagent is a lectin that detects the sugar on the glycan. In another embodiment, the reagent is an antibody or antibody fragment that detects the glycan/metabolite protein (page 13 lines 13-20).
This judicial exception is not integrated into a practical application because there is no additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is merely a kit comprising reagents that detect and measure naturally occurring metabolites and glycans in the subject, thus, does not add a feature that is more than well-understood, purely conventional or routine in the relevant field. See MPEP 2106.02(B): Bilski, 130 S. Ct. at 3230 (‘‘[A]ll members of the Court agree that the patent application at issue here falls outside of § 101 because it claims an abstract idea.’’). The abstract idea exception has deep roots in the Supreme Court’s jurisprudence. See Bilski, 130 S. Ct. at 3225 (citing Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174–175 (1853)). Bilski reaffirmed Diehr’s holding that ‘‘while an abstract idea, law of nature, or mathematical formula could not be patented, ‘an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.’’’ See Bilski, 130 S. Ct. at 3230 (quoting Diamond v. Diehr, 450 U.S. 175, 187 (1981)) (emphasis in original). The recitation of some structure, such as a machine, or the recitation of some transformative component will in most cases limit the claim to such an application. However, not all such recitations necessarily save the claim: ‘‘Flook established that limiting an abstract idea to one field of use or adding token postsolution components did not make the concept patentable.’’ See Bilski, 130 S. Ct. at 3231. For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
Claims 9-10 and 12-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because based upon an analysis with respect to the claim as a whole, claims 9-10 and 12-17 are determined to be directed to laws of nature and natural products. The rationale for this determination is explained below:
The claimed invention is directed to a method for predicting time-to-viral rebound in an HIV-infected subject’s sample, comprising detecting and measuring the levels of the combination of metabolites and glycans comprising:
(a) Plasma A3G3S3 glycans, Pyruvic acid, Plasma T-antigen that binds the lectic MPA, Plasma T-antigen that binds the lectin ACA, Total fucose, L-glutamic acid, and (GlcNAc)n; or
(b) IgG A2 glycans, Plasma A3G3S3 glycans, Total Fucose, Core fucose, Plasma T-antigen that binds lectin ABA, (GlcNAc)n, and L-glutamic acid without significantly more. The claims recite detecting and measuring the levels of a combination of metabolites and glycans. This judicial exception is not integrated into a practical application because there is no additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is merely a detection and measurements of naturally occurring metabolites and glycans in the subject. See MPEP 2106.02(B): Bilski, 130 S. Ct. at 3230 (‘‘[A]ll members of the Court agree that the patent application at issue here falls outside of § 101 because it claims an abstract idea.’’). The abstract idea exception has deep roots in the Supreme Court’s jurisprudence. See Bilski, 130 S. Ct. at 3225 (citing Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174–175 (1853)). Bilski reaffirmed Diehr’s holding that ‘‘while an abstract idea, law of nature, or mathematical formula could not be patented, ‘an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.’’’ See Bilski, 130 S. Ct. at 3230 (quoting Diamond v. Diehr, 450 U.S. 175, 187 (1981)) (emphasis in original). The recitation of some structure, such as a machine, or the recitation of some transformative component will in most cases limit the claim to such an application. However, not all such recitations necessarily save the claim: ‘‘Flook established that limiting an abstract idea to one field of use or adding token postsolution components did not make the concept patentable.’’ See Bilski, 130 S. Ct. at 3231. For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
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).
Claims 1, 3-10 and 12-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Giron et al. “Giron” (AIDS, 2020, 34(5):681-686, IDS of record dated 10/06/2023) in view of Mohamed et al. “Mohamed” (WO2019/140147, IDS of record dated 10/06/2023) and further in view of Hegedus et al. “Hegedus” (AIDS research and human retroviruses, 2017, 33(12):1236-1247, IDS of record dated 10/06/2023).
The claims are directed to a diagnostic kit for the non-invasive prediction of time-to-viral-rebound in an HIV subject after antiretroviral therapy (ART) interruption comprising reagents that detect and measure the metabolites and glycans comprising:
(a) Plasma A3G3S3 glycans, Pyruvic acid, Plasma T-antigen that binds the lectic MPA, Plasma T-antigen that binds the lectin ACA, Total fucose, L-glutamic acid, and (GlcNAc)n; or
(b) IgG A2 glycans, Plasma A3G3S3 glycans, Total Fucose, Core fucose, Plasma T-antigen that binds lectin ABA, (GlcNAc)n, and L-glutamic acid.
Regarding claims 1, 9, 13 and 18, Giron discloses a method for non-invasive prediction of time-to-viral-rebound in an HIV subject after antiretroviral therapy (ART) interruption (Abstract). Giron discloses non-invasive, plasma and IgG glycomic biomarkers that inform time-to-viral-rebound and viral setpoint in two geographically distinct cohorts comprising reagents that detect and measure the metabolites and glycans comprising Plasma T-antigen that binds the lectin MPA and Plasma T-antigen that binds the lectin ACS (Abstract). Giron discloses “For both plasma and bulk IgG, N-glycans were released using peptide-N-glycosidase F (PNGase F) and labeled with 8-aminopyrene-1,3,6-trisulfonic acid (APTS) using the GlycanAssure APTS kit (Thermo Fisher) whereby labeled N-glycans were analyzed using the 3500 Genetic Analyzer capillary electrophoresis system (page 682 column 2 paragraph 3). Giron discloses “Among the pre-ATI plasma glycomic signatures that informed a lower post-ATI viral setpoint was T-antigen (Galb1-3GalNAc) (page 683 column 2 paragraph 2, Fig. 1) and “To profile plasma total glycome, we also used the lectin microarray as it enables analysis of multiple glycan structures; it employs a panel of 45 immobilized lectins with known glycan-binding specificity (page 683 column 1 paragraph 1 and supplemental Table 3:Lectins used for 45 lectin microarray). Giron discloses plasma and IgG glycomic biomarkers of time-to-viral-rebound and viral setpoint in the Philadelphia cohort (Figure 1).
Giron does not disclose reagent that detect and measure the metabolites and glycans comprising Plasma A3G3S3 glycans, pyruvic acid and L-glutamic acid.
Mohamed, however, discloses methods for identifying, monitoring or treating HIV persistence, or the development of an HIV-comorbidity in an HIV+ subject involves certain selected glycan dysregulations (Abstract) including measurement of Plasma A3G3S3 glycans and states “Multiparametric flow cytometry was used to assess the percentage of three activation markers that have been associated with HIV latency, i.e., HLA-DR, CD69, and CD25 on CD4+ T cells. The percentage of sialylated glycans and galactosylated glycans” where glycans associated with anti-inflammatory activities exhibited significant positive correlations with CD4 count (page 40 lines 21-28) (instant claim 9: method for predicting; and instant claim 18: method for treating).
It would have been obvious to generate non-invasive, plasma and IgG glycomic biomarkers that inform time-to-viral rebound and viral setpoint as disclosed by Giron (Abstract), whereby methods for identifying or monitoring or treating HIV persistence or the development of an HIV-comorbidity in an HIV+ subject involving certain selected glycan dysregulation including Plasma A3G3S3 glycan levels as disclosed by Mohamed (Abstract and page 40 lines 21-28). One of ordinary skill in the art would have been motivated with a reasonable expectation of success to combine the detection of Plasma A3G3S3 glycan levels in order to provide additional informative biomarkers for prediction treatment outcome of HIV patients. Additionally, Hegedus discloses metabolic tracer experiments for HIV infection status (Abstract) comprising measurement of Pyruvate and L-glutamic acid (page 1237 column 1 paragraph 2) where they state “glutamine metabolism of primary human CD4+ T cells is responsive to HIV-1 infection as evidence by increased intracellular glutamine concentrations and increased secretion of glutamine-derived glutamic acid” (page 1237 column 2 paragraph 4). Thus, since Giron teaches non-invasive, plasma and IgG glycomic biomarkers that inform time-to-viral-rebound and viral setpoint and Hegedus discloses pyruvic and glutamic acid levels associated with HIV status (Abstract and page 1237 column 2 paragraph 5), it would have been obvious to one of ordinary skill in the art that measurement of pyruvate and glutamic acid levels as taught by Hegedus could have been combined with the method of Giron to provide additional informative biomarkers for prediction treatment outcome of HIV patients and a diagnostic kit comprising reagents for performing the methods for the advantage of having a kit for easy distribution (instant claims 1 and 13, diagnostic and employment of a kit). Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 3, Giron discloses wherein each reagent detects and measures a single of said metabolites and glycans (page 683 column 1 paragraph 1).
Regarding claim 4, Giron discloses wherein each reagents is a lectin (page 683 column 1 paragraph 1).
Regarding claim 5, Giron discloses wherein each reagent is an antibody (page 682 column 2 paragraph 4 to page 685 column 1 paragraph 1).
Regarding claim 6, Giron discloses further comprising components necessary to perform a protein binding assay (page 683 column 2 paragraph 4 to page 685 column 1 paragraph 1).
Regarding claims 7, 14 and 15 Giron discloses further comprising components necessary to perform a lectin microarray, a lectin ELISA (page 683 column 2 paragraph 4 to page 685 column 1 paragraph 1).
Regarding claims 8, 16 and 17, Giron discloses further comprising components necessary to perform capillary electrophoresis or mass spectrometry (page 683 column 2 paragraph 4 to page 685 column 1 paragraph 1).
Regarding claims 10 and 12, with respect to time-to-viral-rebound and probability of viral rebound sensitivity percentages, it is not inventive and considered routine and obvious to determine optimal percentages by routine experimentation. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to achieve the maximum accuracy of the method. it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. According to section 2144.05 of the M.P.E.P., "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). It would have been obvious for one of ordinary skill to determine the appropriate percentages of the methods disclosed by the prior art by routine experimentation procedures known in the art. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9, 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of copending application No. 16/961,043. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims are directed to a method for predicting time-to-viral rebound in an HIV-infected subject’s sample, comprising detecting and measuring the levels of the combination of metabolites and glycans comprising:
(a) Plasma A3G3S3 glycans, Pyruvic acid, Plasma T-antigen that binds the lectic MPA, Plasma T-antigen that binds the lectin ACA, Total fucose, L-glutamic acid, and (GlcNAc)n; or
(b) IgG A2 glycans, Plasma A3G3S3 glycans, Total Fucose, Core fucose, Plasma T-antigen that binds lectin ABA, (GlcNAc)n, and L-glutamic acid.
The copending claims are directed to
1. An in vitro method for identifying or monitoring HIV persistence in an HIV+ subject comprising obtaining a biological sample from the HIV+ subject, contacting the biological sample with a lectin immobilized on a solid support, and detecting binding between a single glycan structure or multiple glycan structures and the lectin, thereby generating a glycomic signature characterized by the level of the single glycan structure or multiple glycan structures with the biological sample; wherein a modification of levels of the single glycan structure or multiple glycan structures within the sample compared with that from a control, is an indication of HIV persistence (instant claims 9 and 13-15).
5. The method according to claim 1, wherein the sample comprises: (a) the subject’s total plasma glycome, (b) the subject’s total IgG glycome, (c) the subject’s cell-surface glycome from all cells or from a selected cell type; or (d) the subject’s total exosome-bound glycome (instant claim 9).
There is no patentable difference between the claimed method and compositions and the copending method and compositions. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another in that the copending application No. 16/961,043 discloses the method steps of instant claims 9 and 13-15 comprising detecting and measuring the levels of metabolites and glycans while employing a protein binding assay and/or lectin microarray. Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672