DETAILED ACTION
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 .
This Action is in response to the papers filed September 08, 2026.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/08/2026 has been entered.
Claims 1-3, 6, 8, 9, 21-22, and 24-29 are currently pending in the application. Claims 1 and 21 are amended, claims 5, 7, 10-13 and 23 are cancelled, and claims 28-29 are newly added as set forth in the claim set filed 09/08/2026. Claim 1 is independent.
Therefore, claims 1-3, 6, 8, 9, 21-22, and 24-29 are examined on the merits.
Priority
The present application is a CIP of US Application 17/592,803 filed February 4, 2022 and US Application 16/272,956 filed February 11, 2019 (now ABN).
Applicant’s claim for the benefit of a prior-filed parent provisional applications 63/305,836 filed 02/02/2022, 63/188,652 filed 05/14/2021, 63/146,538 filed 02/05/2021, and 62/723,469 filed 08/27/2018 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is August 27, 2018.
Response to arguments
Withdrawn objections/ Rejections in response to Applicants’ arguments or amendments
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1-3, 5-13 and 21-27 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second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn.
Applicant’s arguments and amendments filed 09/08/2026 have been considered and are persuasive. Applicant has amended to remove “and/or” as well as fix any antecedent basis issues.
Claim Rejections - 35 USC § 112 (a)
The rejection of claims 1-3, 5-13 and 21-27 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn.
Applicant’s arguments and amendments filed 09/08/2026 have been considered and are persuasive. Applicant has amended to narrow the scope of the dosage as well as the subject to mice.
Claim Rejections - 35 USC § 103
The rejection of claims 1-3, 7, 11, 22 and 25-27 under 35 U.S.C. 103 as being unpatentable over Mendell (Molecular Therapy Vol. 25 No 4 April 2017) in view of Mendez (Medical Microbiology and Immunology (2019) 208:349–363; IDS Reference), Morabito (Mucosal Immunology volume 10, pages 545–554 (2017)) and Warden (Journal of Biomedicine and Biotechnology Volume 2011, Article ID 124595, 16 pages) is withdrawn.
Applicant’s arguments and amendments filed 09/08/2026 have been considered and are persuasive. Applicant has amended to specifically require mice as well as dosages and 2A self-cleaving peptides. Moreover, the Examiner has modified the rejection to no longer rely on Mendez and the primary reference has changed.
The rejection of claims 6, 9, and 12-13 under 35 U.S.C. 103 as being unpatentable over Mendell (supra) in view of Mendez (supra), Morabito (supra) and Warden (supra) as applied to claims 1 and 15 above and in further view of de Jesus (EMBO Mol Med. 2012 Aug; 4(8): 691–704; IDS Reference) is withdrawn.
Applicant’s arguments and amendments filed 09/08/2026 have been considered and are persuasive. Applicant has amended to specifically require mice as well as dosages and 2A self-cleaving peptides. Moreover, the Examiner has modified the rejection to no longer rely on Mendez and the primary reference has changed.
The rejection of claims 5 and 10 under 35 U.S.C. 103 as being unpatentable over Mendell (supra) in view of Mendez (supra), Morabito (supra), Warden (supra), de Jesus (supra) as applied to claim 1 and 9 above and in further view of Podlevsky (Nucleic Acids Research, 2008, Vol. 36, Database issue D339-D343; IDS Reference) is withdrawn.
The rejection of Claim 8 under 35 U.S.C. 103 as being unpatentable over Mendell (supra) in view of Mendez (supra), Morabito (supra) and Warden (supra) as applied to claims 1 and 15 above and in further view of Rodino-Klapac (Muscle Nerve. 2009 Mar;39(3):283–296) is withdrawn.
Applicant’s arguments and amendments filed 09/08/2026 have been considered and are persuasive. Applicant has amended to specifically require mice as well as dosages and 2A self-cleaving peptides. Moreover, the Examiner has modified the rejection to no longer rely on Mendez and the primary reference has changed.
The rejection of claim 21 under 35 U.S.C. 103 as being unpatentable over Mendell (supra) in view of Mendez (supra), Morabito (supra) and Warden (supra) as applied to claim 1 above, and in further view of Brodie (WO2018211510A1; previously cited) is withdrawn.
Applicant’s arguments and amendments filed 09/08/2026 have been considered and are persuasive. Applicant has amended to specifically require mice as well as dosages and 2A self-cleaving peptides. Moreover, the Examiner has modified the rejection to no longer rely on Mendez and the primary reference has changed.
The rejection of claims 23 and 24 under 35 U.S.C. 103 as being unpatentable over Mendell (supra) in view of Mendez (supra), Morabito (supra) and Warden (supra) as applied to claim 1 above, and in further view of Liu (2017, Scientific Reports 7: 2193) is withdrawn.
Applicant’s arguments and amendments filed 09/08/2026 have been considered and are persuasive. Applicant has amended to specifically require mice as well as dosages and 2A self-cleaving peptides. Moreover, the Examiner has modified the rejection to no longer rely on Mendez and the primary reference has changed.
Maintained objections/ Rejections in response to Applicants’ arguments or amendments
Double Patenting
Claims 1-3, 6, 8, 9, 21-22, and 24-27 remain provisionally rejected and 28-29 are newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 16-18, 21-30 and 32-36 as per claims filed on 08/19/2025 of copending Application No. 17/592,803 (reference application).
This rejection has been modified as necessitated by Applicant’s arguments and amendments filed 09/08/2026.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘708 teaches a method for gene therapy via administering genetically modified viral vectors comprising one or more donor genes wherein the viral vector is a human cytomegalovirus (CMV) wherein the genes are TERT and FS344 and the administration route is intranasal or injection (Claim 14, 32, and 36).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
***
Claims 1-3, 6, 8, 9, 21-22, and 24-27 remain and 28-29 are newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,266,721 in view of Picker (US20130136768A1)
This rejection has been modified as necessitated by Applicant’s arguments and amendments filed 09/08/2026.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘721 teaches a method comprising administering a therapeutically effective amount of hTERT gene and Follistatin-344 gene via a viral vector (Claim 1, 3). Patent ‘721 teaches Follistatin-344 genes are administered in a nucleic acid selected from a plasmid, phage, bacterial artificial chromosome (BAC) or viral vectors (Claim 2-3)
However, Patent ‘721 does not teach that the vector is a CMV vector.
Picker teaches a recombinant RhCMV or HCMV vector comprising a nucleic acid sequence encoding a heterologous antigen, wherein the heterologous antigen is a human pathogen- specific antigen or a tumor antigen wherein the nucleic acid sequence can be hTERT (Claim 1, para. 0270).
Based on such teachings, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to utilize a human recombinant CMV viral vector as taught by Picker in place of the vector taught by Patent ‘721 with a reasonable expectation of success. Picker teaches that human CMV viral vectors are known in the art to drive expression of hTERT, therefore it is a known alternate vector for the same function and purpose.
While the limitation of intranasal administration is not present in Patent ‘721, Patent ‘721’s general administration is a genus to the present application’s species and therefore intranasal administration would be encompassed by the claims and Picker teaches that intranasal administration of CMV vectors are known in the art (para. 0283).
Therefore, the invention is rejected on the grounds of double patenting.
In response to Applicant’s arguments and amendments regarding the double patenting rejections,
Applicant argues that the present claims recite features not provided for by the other reference applications and patents such as CMV vectors. Examiner states that the claims of the referenced patents and applications are open and therefore not every step need be described for nonstatutory double patenting as the subject matter overlaps. Additionally, the obviousness type double patenting rejection addresses limitations not found within the referenced patent and no longer relies solely on Mendez.
New grounds of objections/ Rejections in response to Applicants’ arguments or amendments
Claim objection
Claim 22 improperly states its intended Markush groups; the proper format requires the phrase “ a native CMV gene selected from the group consisting of”. Appropriate correction is requested.
Nonstatutory 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 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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-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 1-3, 6, 8, 9, 21-22, and 24-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,653,907.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘907 teaches “a method comprising: administering to a human a therapeutically effective amount of a human Telomerase Reverse Transcriptase (hTERT) gene in combination with a Follistatin-344 gene, wherein the hTERT gene is administered via intramuscular injection and the Follistatin-344 gene is administered via subcutaneous injection and intravenous injection, wherein the method provides one or more of (i) increasing telomere length in at least some cells of the human,(ii) decreasing muscle loss, maintaining muscle mass, or increasing muscle mass in the human, or (iii) improving blood glucose levels in the human.”
This claim encompasses broadly the scope of the present claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 6, 22, and 24-27 are newly rejected under 35 U.S.C. 103 as being unpatentable over Picker (US20130136768A1) in view of Liu (2017, Scientific Reports 7: 2193; previously cited) and de Jesus (EMBO Mol Med. 2012 Aug; 4(8): 691–704; IDS Reference).
Regarding claim 1-3, 22, 24, and 27, Picker teaches a human recombinant CMV vector which can comprise large gene cassettes for gene therapy expressing particular antigens or polynucleotides such as human TERT (Abstract, para. 0040, 0078, 0283). Picker teaches that this vector is administered to subjects which can be any mammal which encompasses both known and unknown individuals such as humans and mice and routes of administrations such as intranasal and intraperitoneal (para. 0205, 0283, 0311, 0315). Moreover, Picker teaches that the vectors encoding the heterologous antigen/polynucleotide is created through a BAC plasmid transfected into cells via methods known in the art in cell cultures (para. 0312-0314, 0375). Picker discloses that nucleic acids are fused to a non-essential MCMV protein such as IE2 (i.e. native CMV gene) (para. 0101, 0375, 0382). Picker utilized 5×105 pfu as a dosage (para. 383).
However, these references do not teach wherein one or more genes are fused to a native CMV gene via a sequence coding for a 2A self-cleaving peptide such as P2A.
Liu teaches that self-cleaving peptides such as P2A have been shown in studies to have high efficiency when utilized in polycistronic vectors (p. 2, 1st paragraph). “Overall, 2A peptides lead to relatively high levels of downstream protein expression compared to other strategies for multi-gene co-expression, and they are small in size thus bearing a lower risk of interfering with the function of co-expressed genes,” (p. 1, end of page).
Based on such teachings, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to fuse the genes of interest via a P2A self-cleaving peptide in the CMV viral vector with a reasonable expectation of success. As Liu teaches that self-cleaving peptides specifically ones such as P2A have been shown in studies to have high efficiency in vectors with more than one gene and these peptides lead to relatively high levels of downstream protein expression.
Regarding the characteristic of telomere length, the references do not teach that as a result of the vector being administered to a mouse, the telomere length increases.
De Jesus teaches a vector encoding mTERT administered to mice which resulted in delays in ageing, increasing median and maximum longevity, and increases average telomere length (p. 692, 2nd column, Figure 3; p. 697, 1st column).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to administer a vector encoding TERT to a mouse and have the average telomere length increase with a reasonable expectation of success as de Jesus teaches that their vectors encoding mTERT administered to mice increases telomere length.
Regarding claim 6, the combined teachings of Picker, Liu and de Jesus make obvious claim 1. Moreover, DeJesus teaches that the TERT is mTERT (p. 692, 2nd column).
Regarding claim 25, as the combined teachings of Picker, Liu and de Jesus make obvious claim 1 and teach each and every limitation of the method and vector, it would be obvious to one of ordinary skill in the art that the same steps and structure would yield the same results with a level of predictability. Thus, an artisan would expect the serum levels to be the same.
Regarding claim 26, the combined teachings of Picker, Liu and de Jesus make obvious claim 1. Moreover, DeJesus teaches that administering mTERT to a mouse can result in over 2.4 fold increase in TERT mRNA in muscle tissue (Fig 1B) with a reasonable expectation of success.
Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art at the time of the effective filing date.
Claim 8, 9, 28 and 29 are newly rejected under 35 U.S.C. 103 as being unpatentable over Picker (US20130136768A1) in view of Liu (supra) and de Jesus (supra) as applied to claim 1 above, and in further view of Mendell (Molecular Therapy Vol. 25 No 4 April 2017; previously cited) and Rodino-Klapac (Muscle Nerve. 2009 Mar;39(3):283–296).
As discussed in the above 103 rejection and incorporated herein in its entirety, Picker, Liu and de Jesus make obvious a method of administering a HCMV vector comprising mTERT which increases telomere length and improves longevity in aging mice models.
However, these references do not teach wherein mFS344 is additionally administered within the vector with murine TERT.
Mendell teaches a method for treating sporadic inclusion body myositis which affects subjects most commonly after the age of 50 (i.e. age-related disease) with muscle weakness (Abstract, p. 870, 1st column). Subjects 50 years of age or older at the time of disease onset were injected directly with a recombinant rAAV1 vector comprising human follistatin 344 (FS344) for gene transfer (p. 871, 1st column).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to additionally have FS334 administered in the same vector as TERT with a reasonable expectation of success. An artisan would have been motivated to do so as Mendell teaches that administering follistatin 344 in aged subjects improves muscle weakness in conditions related to aging and deJesus teaches that TERT is also administered to aged mice improves neuromuscular coordination and other conditions related to aging.
However, these references do not teach utilizing murine FS344/follistatin instead of the human follistatin.
Rodino-Klapac teaches follistatin is highly conserved with overall species homology of 83% and 95% in mammals. (p. 3, 4th paragraph).
Based on such teachings, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to express mFS334 instead of hFS334 in the vector with a reasonable expectation of success. As Rodino-Klapac teaches that homology of follistatin are highly conserved across species, an artisan would find substituting mFS334 in place of hFS334 to be substituting known alternative species of FS334.
Regarding claims 28-29, as the combined teachings of Picker, Liu, de Jesus, Mendell, and Rodino-Klapac make obvious claim 1 and teach each and every limitation of the method and vector, it would be obvious to one of ordinary skill in the art that the same steps and structure would yield the same results with a level of predictability. Thus, an artisan would expect the serum levels and mRNA to be the same.
Therefore, the invention would have been obvious to one of ordinary kill in the art at the time of the effective filing date
Claim 21 are newly rejected under 35 U.S.C. 103 as being unpatentable over Picker (supra) in view of Liu (supra) and de Jesus (supra) as applied to claim 1 above, and in further view of Brodie (WO2018211510A1; previously cited).
As discussed in the above 103 rejection, Picker, Liu and de Jesus teach a method of treatment via direct injectable administration of CMV viral vectors comprising TERT as iterated above in the 103 rejection the content of which is incorporated herein, in its entirety.
However, these references do not teach that additionally Klotho gene is introduced via the viral vector.
Brodie teaches vectors which can be a viral vector such as adenoviral vectors and herpes viral vectors encoding multiple anti-aging genes such as Klotho (KL), TIMP2, and GDF11 which are administered to cells so that they express the anti-aging factor in a method of treating conditions related to anti-ageing (para. 0086, 0091, 0096).
Based on such teachings, it would be obvious to one of ordinary skill in the art to additionally include Klotho as taught by Brodie in the viral vector comprising TERT with a reasonable expectation of success. An artisan would be motivated to administer Klotho as well as TERT as Klotho is known to be an anti-aging gene and utilized in viral vectors to treat conditions associated with aging which are administered to subjects (para. 0086, 0091, 0096).
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date.
Conclusion
No claims are allowed.
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/ALEXANDRA F CONNORS/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
