DETAILED ACTION
Non-Final Rejection
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election without traverse of claims 36 and 39-49 (Group II) in the reply filed on 05/19/2026 is acknowledged.
Election of Species:
Applicant elected following species.
Claim 34: As the ERV transcript or protein: Env protein;
Claim 37: As the ERV: HERVK.
Claim 38: As the ERV: HERVKL
Claim 39: As the agent inhibiting the ERV: reverse transcriptase inhibitor;
Claim 40: As the reverse transcriptase inhibitor: abacavir;
Claim 43: As the agent: Antibody to Env;
Claim 44: As the progeria: HGPS; and
Claim 45: As the progeroid disease: Arthritis.
Applicant’s election of species in the reply filed on 05/19/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Claims
3. Claims 31-50 are pending as per claim listing filed on 05/19/2026.
4. Claims 31-35 and 37-38 (Group I) and claim 50 (Group III) inventions are withdrawn as
non-elected groups of invention due to Restriction/Election.
5. Claims 36 and 39-49 (Group II) are under examination.
Priority
6. This application is a continuation-in-part of Int'l Appl. No. PCT/CN2021/140550, filed December 22, 2021, which claims priority to Chinese Appl. No. 202110185630.0, filed February 10, 2021, and to Chinese Appl. No. 202011527970.9, filed December 22, 2020.
Acknowledgment is made of applicant's claim for foreign priority based on two applications filed in PEOPLE'S REPUBLIC OF CHINA on 12/20/2020 and 02/10/2021.
It is noted, however, that applicant has not filed a certified copy of the CN202011527970.9 and CN202110185630.0 applications as required by 37 CFR 1.55. Therefore, the applicant has not perfected priority to Chinese Appl. No. 202110185630.0, filed February 10, 2021, and to Chinese Appl. No. 202011527970.9, filed December 22, 2020.
Information Disclosure Statement
7. The information disclosure statement (IDS) submitted on 04/05/2023, 04/07/2023, 09/30/2024, 03/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objection to Specification
8. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The specification page no 70 recited https://github.com/FelixKrueger/TrimGalore).
Claim Rejections - 35 USC § 112
9. 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.
10. Claims 36 and 39-49 are 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.
This is a written description rejection.
Claim 36. A method for treating premature aging in a subject in need or a cell, tissue or organ thereof, or preventing or delaying the aging of a subject or a cell, tissue or organ thereof, or preventing or delaying aging of local tissues, including joint and skin, or treating progeroid diseases and aging-related diseases, or culturing isolated animal cell or cell population, or preventing or delaying cell senescence, the method comprising administering to the subject, or contacting the cell with, an agent inhibiting the activation of an ERV locus or an agent inhibiting the ERV, or a retrovirus inhibitor.
Claim 45. A method of treating progeroid diseases, or preventing or delaying aging in a subject, comprising contacting at least a part of the body fluid from the subject with an agent capable of binding to an ERV.
The independent claim 36 and dependent claims 39-44 are directed to a method for preventing the aging of a subject or a cell, tissue or organ thereof, inter alia, the method comprising administering to the subject, or contacting the cell with, an agent inhibiting the activation of an ERV locus or an agent inhibiting the ERV, or a retrovirus inhibitor.
The independent claim 45 and dependent claims 46-49 are directed to a method of treating progeroid diseases, or preventing or delaying aging in a subject, comprising contacting at least a part of the body fluid from the subject with an agent capable of binding to an ERV. The term “preventing” has a functional limitation.
As discussed in the indefinite rejection under 35 U.S.C. 112(b), the specification does not provide the definition of “preventing” of the aging of a subject or a cell, tissue or organ. Under BRI “preventing” reasonably encompass prevention of ageing in a healthy human being which is not exemplified in the specification; nor supported in the prior art that the preventing of aging has been reasonably achieved by administering to the subject, or contacting the cell with, an agent inhibiting the activation of an ERV locus or an agent inhibiting the ERV, or a retrovirus inhibitor.
The instant claim 36 has genera “premature aging” or “aging” and claim 45 has a genus “progeroid diseases”, or “aging” that comprise many species (conditions or aging diseases). When a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed. However, the presence of multiple species within a claimed genus does not necessarily demonstrate possession of the genus. See, In re Smyth, 178 U.S.P.Q. 279 at 284-85 (CCPA 1973) (stating “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 or combination claimed at a later date in the prosecution of a patent application.”); and University of California v. Eli Lilly and Co., 43 USPQ2d 1398, at 1405 (Fed Cir 1997)(citing Smyth for support). The applicable standard for the written description requirement can be found in MPEP§ 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004). To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. In the instant case, the working example(s) are not provided for “preventing of premature aging” that are reduced to the practice”.
Amgen Inc. vs Sanofi (2017-1480, Fed Cir, 2017) states that "an adequate written description must contain enough information about the actual makeup of the claim products - 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 material," which may be present in "function "terminology "when the art has established a correlation between structure and function" (page 17,1st paragraph).
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description” Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by 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 the applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3). In the instant case, the specification does not provide adequate written description of sufficient number of examples reduced to the practice. The legal standard for sufficiency of a patent's (or a specification’s) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the claimed subject matter", Vas-Cath, Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the applicant had possession at the time of invention of the claimed invention. The full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
11. Claims 36 and 39-49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for “treating or delaying premature aging in a subject in need or a cell, tissue or organ thereof,”, does not reasonably provide enablement for “preventing a premature aging”. 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 and use the invention commensurate in scope with these claims.
This is a scope of enablement rejection.
The instant specification does not reasonably provide enablement for a functional limitation “preventing premature aging in a subject in need or a cell, tissue or organ thereof”(instant claim 36), and treating progeroid diseases, or preventing or delaying aging in a subject (instant claim 45) as claimed in instant independent claims 36 and 45 and the claims depending thereof. The full scope of the claim comprises genetic identification of the condition, completely prevent premature aging in a healthy subject, effective amount of an agent administration for prevention of premature aging in a healthy subject, a subject can be a human or animal. The agent will not enable to treat all species of premature aging.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including the nature of the invention, the state of the prior art, the breadth of the claims, the amount of guidance in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, and the quantity of experimentation necessary. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of the invention: Claim 36. The instant claim 36 is directed to a method for treating premature aging in a subject in need or a cell, tissue or organ thereof, or preventing or delaying the aging of a subject or a cell, tissue or organ thereof, or preventing or delaying aging of local tissues, including joint and skin, or treating progeroid diseases and aging-related diseases, or culturing isolated animal cell or cell population, or preventing or delaying cell senescence, the method comprising administering to the subject, or contacting the cell with, an agent inhibiting the activation of an ERV locus or an agent inhibiting the ERV, or a retrovirus inhibitor.
The claim is directed to alternate limitations, inter alia, (i) a method for treating premature aging of subject or a cell, (ii) a method for preventing the aging of subject or a cell, (iii) a method for delaying the aging of subject or a cell, the method comprising administering to the subject, or contacting the cell with, an agent inhibiting the activation of an ERV locus or an agent inhibiting the ERV, or a retrovirus inhibitor.
Claim 45. The instant claim 36 is directed to (i) a method of treating progeroid diseases, or (ii) preventing or delaying aging in a subject, comprising contacting at least a part of the body fluid from the subject with an agent capable of binding to an ERV.
State of the prior art: At the time the invention no prior art is available to teach a method for preventing premature aging in a subject in need or a cell, tissue or organ thereof by administering to the subject, or contacting the cell with, an agent inhibiting the activation of an ERV locus or an agent inhibiting the ERV, or a retrovirus inhibitor. Preventing of progeroid diseases, or preventing aging in a subject, comprising contacting at least a part of the body fluid from the subject with an agent capable of binding to an ERV. The functional term “preventing” is practically impossible to achieve in a subject. See, 35 USC 112(b) and 112(a) written description rejection above.
Breadth of the claims: The claims 36 and 39-49 are very broad, encompassing a method for preventing premature aging in a subject in need or a cell, tissue or organ thereof by administering to the subject, or contacting the cell with, an agent inhibiting the activation of an ERV locus or an agent inhibiting the ERV, or a retrovirus inhibitor. Preventing of progeroid diseases, or preventing aging in a subject, comprising contacting at least a part of the body fluid from the subject with an agent capable of binding to an ERV. The claims are broad because the claims recite many alternative limitations by making use of “or”.
Working examples: Reduction to practice by working example is not disclosed in the specification for claims 36 and 39-46 showing enablement for a method for preventing premature aging in a subject in need or a cell, tissue or organ thereof by administering to the subject, or contacting the cell with, an agent inhibiting the activation of an ERV locus or an agent inhibiting the ERV, or a retrovirus inhibitor. Preventing of progeroid diseases, or preventing aging in a subject, comprising contacting at least a part of the body fluid from the subject with an agent capable of binding to an ERV.
Guidance in the specification: The specification does not provide guidance regarding practice of the claimed method by reduction to practice by working example in the specification showing enablement for claims 36 and 39-46 showing enablement for a method for preventing premature aging in a subject in need or a cell, tissue or organ thereof by administering to the subject, or contacting the cell with, an agent inhibiting the activation of an ERV locus or an agent inhibiting the ERV, or a retrovirus inhibitor. Preventing of progeroid diseases, or preventing aging in a subject, comprising contacting at least a part of the body fluid from the subject with an agent capable of binding to an ERV.
Predictability of the art: The art on preventing premature aging in a subject in need or a cell, tissue or organ thereof is highly unpredictable.
Amount of experimentation: It is not known whether the claimed method could be reduced to practice for enablement for “preventing premature aging in a subject in need or a cell, tissue or organ thereof” as claimed in instant claims 36 and 39-46. The full scope of enablement of the claims would require an undue experimentation.
Given the breadth of the claims, the lack of guidance in the specification, and the lack of predictability of the art, it would require undue experimentation for one skilled in the art to make and use/practice the claimed method to the full scope the claimed inventions in claims 36 and 39-46 and therefore consequently raise doubt as to the enablement of full scope of the claims.
Claim Interpretation
12. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim 36. The instant claim 36 is directed to a method for treating premature aging in a subject in need or a cell, tissue or organ thereof, or preventing or delaying the aging of a subject or a cell, tissue or organ thereof, or preventing or delaying aging of local tissues, including joint and skin, or treating progeroid diseases and aging-related diseases, or culturing isolated animal cell or cell population, or preventing or delaying cell senescence, the method comprising administering to the subject, or contacting the cell with, an agent inhibiting the activation of an ERV locus or an agent inhibiting the ERV, or a retrovirus inhibitor.
The claim is directed to alternate limitations, inter alia, (i) a method for treating premature aging of subject or a cell, (ii) a method for preventing the aging of subject or a cell, (iii) a method for delaying the aging of subject or a cell, the method comprising administering to the subject, or contacting the cell with, an agent inhibiting the activation of an ERV locus or an agent inhibiting the ERV, or a retrovirus inhibitor.
The treatment or prevention requires effective amount administration.
Claim 45. The instant claim 36 is directed to (i) a method of treating progeroid diseases, or (ii) preventing or delaying aging in a subject, comprising contacting at least a part of the body fluid from the subject with an agent capable of binding to an ERV.
The instant independent claims 36 and 45 reads on many species of endogenous retroviruses.
Claim Rejections - 35 USC § 102
13. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection 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.
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 36, 39-40, and 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qu et al 2020 (CN111450098A, published 07/2/2020).
Qu et al 2020 is in the art and disclosed lamivudine a reverse transcriptase inhibitor previously used in AIDS-related treatment (an inhibitor of endogenous retrovirus), application of lamivudine in anti-aging, in delaying aging, wherein gene editing can be performed by means of a CRISPR/Cas9 system to achieve the effects of delaying aging, delaying cell aging, delaying the senescence of the mesenchymal stem cells and accelerating the aging process in a subject (mice) or isolated cells (See, abstract, and claims 1-10). The invention also screened out the small molecule lamivudine (3TC) that can delay the aging of cells, which can be used to improve the phenotype of the cell model with weakened cell proliferation ability, reduced in vivo retention ability, and accelerated aging process, which can delay the aging process and be used for related diseases treatment (see, abstract). Qu et al 2020 disclosed in progeria diseases like Hutchinson-Gilford Progeria Syndrome, mesenchymal stem cell populations also accelerate senescence with typical cellular senescence features. Qu et al 2020 disclosed application (reads on administration) of lamivudine in anti-aging and preparation of cell model for screening anti-aging drugs.
Claim Rejections - 35 USC § 103
14. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection 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.
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.
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.
Claims 36 and 39-49 are rejected under 35 U.S.C. 103 as being unpatentable over Qu et al 2020 (CN111450098A, published 07/2/2020) and further in view of Tyagi et al 2017 (Retrovirology. 2017 Mar 22;14(1):21), Porchet et al 2019 (Clin Ther. 2019 Sep;41(9):1737-1746), Ivachtchenko et al 2018 (US20180030080A1, 02/01/2018) and Ochirov 2019 (PeerJ Preprints, No. e26998v2).
Claims 36: Qu et al 2020 (CN111450098A ) is in the art and disclosed lamivudine a reverse transcriptase inhibitor previously used in AIDS-related treatment (an inhibitor of endogenous retrovirus), application of lamivudine in anti-aging, in delaying aging, wherein gene editing can be performed by means of a CRISPR/Cas9 system to achieve the effects of delaying aging, delaying cell aging, delaying the senescence of the mesenchymal stem cells and accelerating the aging process in a subject (mice) or isolated cells (See, abstract, and claims 1-10). The invention also screened out the small molecule lamivudine (3TC) that can delay the aging of cells, which can be used to improve the phenotype of the cell model with weakened cell proliferation ability, reduced in vivo retention ability, and accelerated aging process, which can delay the aging process and be used for related diseases treatment (see, abstract). Qu et al 2020 disclosed in progeria diseases like Hutchinson-Gilford Progeria Syndrome, mesenchymal stem cell populations also accelerate senescence with typical cellular senescence features. Qu et al 2020 disclosed application (reads on administration) of lamivudine in anti-aging and preparation of cell model for screening anti-aging drugs.
Qu et al 2020 (CN111450098A) do not teach human endogenous retrovirus.
Tyagi et al 2017 is in the art and teaches instant claim 36 limitation inhibition of human endogenous retrovirus‑K by antiretroviral drugs (See, entire prior art).
It would have been obvious to one of the ordinary skills in the art to combine prior art teachings of Qu et al 2020 and Tyagi et al 2017 to arrive at invention of claim 36 with a reasonable success with a motivation the claimed premature aging or progeroid disease is to be treated for endogenous retrovirus by administering by antiretroviral drugs.
Claims 39-40: The combined prior art teachings of Qu et al 2020 and Tyagi et al 2017 teaches claim 36 as recited supra, however do not teach added limitations of instant claims 39, wherein the retrovirus inhibitor comprises a reverse transcriptase inhibitor, an integrase inhibitor and/or a protease inhibitor; and added limitations of instant claims 40, wherein the reverse transcriptase inhibitor includes nucleoside reverse transcriptase inhibitor such as enofovir, abacavir, stavudine (D4T), lamivudine (3TC) and/or zidovudine, and/or non-nucleoside reverse transcriptase inhibitor such as efavirenz, etravirine and/or nevirapine.
Ivachtchenko et al 2018 (US20180030080A1) is in the art and teaches HIV-1 reverse transcriptase (RT) inhibitor, protease inhibitors, and abacavir, lamivudine (3 TC), zidovudine (AZT) for treatment of a retrovirus HIV (see, abstract, Background/Summary para [0005]).
Claims 41-42: The combined prior art teachings of Qu et al 2020 and Tyagi et al 2017 and Ivachtchenko et al 2018 teaches the method of claim 39, however do not teach added limitation of claim 41, wherein the integrase inhibitor includes Raltegravir.
Tyagi et al 2017 is in the art and additionally teaches reverse transcriptase inhibitors Abacavir and Zidovudine, and integrase inhibitor Raltegravir could effectively block or inhibit human endogenous retrovirus‑K (HERV-K) infection and HERV-K production (see, abstract).
Tyagi et al 2017 further teaches added limitation of instant claim 42 protease inhibitor Lopinavir for inhibition of HERV-K (see, page 4, 6, Fig 7 and legends, table 1, Fig 6).
Claim 43: The combined prior art teachings of Qu et al 2020 and Tyagi et al 2017 teaches claim 36 as recited supra, however do not teach added limitations of instant claim 43, wherein a binding molecule capable of binding to a protein of the ERV such as Env protein, e.g., an antibody.
Porchet et al 2019 is in the art and teaches Temelimab/GNbAC1 is a humanized
immunoglobulin G4 monoclonal antibody antagonist of the human endogenous retrovirus W envelope protein (see, abstract).
It would have been obvious to one of the ordinary skills in the art to modify the combined prior art teachings of Qu et al 2020 and Tyagi et al 2017 on chemotherapeutic anti-retroviral drug(s) and substitute the chemotherapeutic drug with endogenous retroviral envelope binding and neutralizing antibody Temelimab/GNbAC1 is a humanized
immunoglobulin G4 monoclonal antibody to arrive at invention of claim 43 with a reasonable success with a motivation the claimed premature aging or progeroid disease is to be treated for endogenous retrovirus by administering an alternative therapy the antibody disclosed by Porchet et al 2019 than antiretroviral chemotherapeutic drugs to broaden the treatment options.
Claims 45-49: The prior art teachings of Qu et al 2020 and Tyagi et al 2017 teaches A method of treating progeroid diseases, or delaying aging in a subject as recited supra are incorporated here in entirety. The combined prior art teachings however do not teach added limitations of instant claim 45-49, comprising an agent capable of binding to an ERV wherein a binding molecule capable of binding to a protein of the ERV such as Env protein, e.g., an antibody; wherein the agent is immobilized on a solid support, such as beads, or resin (claim 47 limitation); wherein the body fluid is blood, such as whole blood, plasma and serum, or cerebrospinal fluid (claim 48 limitation); further comprising obtaining the body fluid from the subject and/or the infusion of the processed body fluid back to the subject (claim 49 limitation).
Porchet et al 2019 is in the art and teaches Temelimab/GNbAC1 is a humanized
immunoglobulin G4 monoclonal antibody antagonist of the human endogenous retrovirus W envelope protein (see, abstract).
It would have been obvious to one of the ordinary skills in the art to modify the combined prior art teachings of Qu et al 2020 and Tyagi et al 2017 on chemotherapeutic anti-retroviral drug(s) and substitute the chemotherapeutic drug with endogenous retroviral envelope binding and neutralizing antibody Temelimab/GNbAC1 is a humanized
immunoglobulin G4 monoclonal antibody to arrive at invention of claim 43 with a reasonable success with a motivation the claimed premature aging or progeroid disease is to be treated for endogenous retrovirus by administering an alternative therapy the antibody disclosed by Porchet et al 2019 than antiretroviral chemotherapeutic drugs to broaden the treatment options. It would have been obvious to modify the design of treatment to coat the antibody or immobilize on a solid support, such as beads, or resin and treat the body fluid from the diseased subject ex-vivo with the antibody coated beads and reduce the load of the HERV or HERV Env and infuse the processed body fluid back to the subject. One of the ordinary would have a reasonable expectation of success given the applied prior art teachings and skills and knowledge of the ordinary in the art.
Claim 44. The method of claim 36, wherein the progeria is HGPS or WS, wherein the aging-related diseases is selected from arthritis, premature ovarian failure, hepatic fibrosis, pulmonary fibrosis, frailty and angiocardiopathy.
The combined prior art teachings of Qu et al 2020 and Tyagi et al 2017 teaches claim 36 as recited supra, however do not teach added limitations of instant claim 44, wherein the progeria is HGPS or WS, wherein the aging-related diseases is arthritis.
Ochirov 2019 is in the art and teaches the involvement of human endogenous retroviruses K (HERV-K) in aging processes via induction of inflammation, Hutchinson–
Gilford Progeria Syndrome (HGPS) chronic inflammation is induced. HERV-K is reported to be transcriptionally active in inflammatory diseases including Rheumatoid Arthritis (RA) and premature aging in Werner syndrome including chronic inflammation in the process of aging arthritis.
It would have been obvious to one of the ordinary skills to combine the prior art teachings of Qu et al 2020, Tyagi et al 2017, Porchet et al 2019, Ivachtchenko et al 2018, and Ochirov 2019 to arrive at the inventions of claims 36, and 39-49. There would be a reasonable expectation of success based on the applied prior arts as recited supra and knowledge and skills of the ordinary in the art. The motivation would be to develop methods to treat the endogenous retrovirus with more than one treatment options (i) chemotherapeutic agents (e.g. anti-retroviral drugs) and (ii) antibody binding to Env of endogenous retrovirus to treat the aging and related condition(s) (e.g. arthritis) or the progeroid disease in a subject. This is analogous to some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the invention as claimed in claims 36, and 39 -49. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) (see MPEP § 2143, example of rationales, A-G).
Double Patenting
15. 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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . 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.
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16. Claims 36 and 39-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-33, 35, and 37 of copending Application No. 18/247,058 in view of Qu et al 2020 (CN111450098A, published 07/2/2020) and further in view of Tyagi et al 2017 (Retrovirology. 2017 Mar 22;14(1):21), Porchet et al 2019 (Clin Ther. 2019 Sep;41(9):1737-1746), Ivachtchenko et al 2018 (US20180030080A1, 02/01/2018) and Ochirov 2019 (PeerJ Preprints, No. e26998v2).
The instant claims 36 and 39-49 and co-pending reference claims 30-33, 35, and 37 are directed to a method a method for treating premature aging in a subject in need or a cell, tissue or organ thereof, or preventing or delaying the aging of a subject or a cell, tissue or organ thereof, or preventing or delaying aging of local tissues, including joint and skin, or treating progeroid diseases and aging-related diseases, or culturing isolated animal cell or cell population, or preventing or delaying cell senescence, the method comprising administering to the subject, or contacting the cell with, an agent inhibiting the activation of an ERV locus or an agent inhibiting the ERV, or a retrovirus inhibitor. The co-pending claims do not recite EVR and agent inhibiting the ERV, however, the instant claims and co-pending claims recite “comprising” and therefore can include additional limitations on an agent inhibiting cell senescence. Thus, the instant claims and co-pending claims are variants of each other and has claims of invention in the same or similar subject matter.
This is a provisional nonstatutory double patenting rejection.
17. Claims 36 and 39-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-10 of copending Application No. 19/503,635 in view of Qu et al 2020 (CN111450098A, published 07/2/2020) and further in view of Tyagi et al 2017 (Retrovirology. 2017 Mar 22;14(1):21), Porchet et al 2019 (Clin Ther. 2019 Sep;41(9):1737-1746), Ivachtchenko et al 2018 (US20180030080A1, 02/01/2018) and Ochirov 2019 (PeerJ Preprints, No. e26998v2).
The instant claims 36 and 39-49 and co-pending reference claims 6-10 are directed to a method a method for treating aging in a subject in need or a cell, tissue or organ thereof, or preventing or delaying the aging of a subject or a cell, tissue or organ thereof, or preventing or delaying aging of local tissues, including joint and skin, or treating progeroid diseases and aging-related diseases, or culturing isolated animal cell or cell population, or preventing or delaying cell senescence, the method comprising administering to the subject, or contacting the cell with, an agent inhibiting the activation of an ERV locus or an agent inhibiting the ERV, or a retrovirus inhibitor.
The co-pending claim 6 and dependent claims 7-10 are directed to a method of treating or preventing aging of aging of spinal cord or senescence of motor neurons in a subject in need thereof, comprising administering, such as intrathecal administering, to the subject a CHIT-1 inhibitor. The spinal cord or senescence of motor neurons of reference copending claims read on cell or tissues of instant claims.
The co-pending claims do not recite EVR and agent inhibiting the ERV, however, the instant claims and co-pending claims recite “comprising” and therefore can include additional limitations on an agent inhibiting cell senescence. Thus, the instant claims and co-pending claims are variants of each other and has claims of invention in the same or similar subject matter.
This is a provisional nonstatutory double patenting rejection.
18. Relevant Prior Arts (See form PTO-892 Notice of References):
Wang-Johanning et al 2012 (J Natl Cancer Inst. 2012 Feb 8;104(3):189-210).
Curtin et al 2015 (Mol Diagn Ther. 2015 Oct;19(5):255-65).
Tugnet et al 2013 (Open Rheumatol J. 2013 Mar 22;7:13-21).
Dreyfus et al 2011 (Autoimmun Rev. 2011 Dec;11(2):88-97).
Stayton et al 2020 (US20200405881A1, 12/31/2020).
Adamer et al 2020 (US20200385401A1, 12/10/2020).
Conclusion
19. No claim is allowed.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMADHAN J JADHAO whose telephone number is (703)756-1223. The examiner can normally be reached M-F 8:00-5:00.
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/SAMADHAN JAISING JADHAO/Examiner, Art Unit 1672
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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