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 .
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/20/2026 has been entered.
Claims 1-23, 27-29, and 34-37 have been cancelled.
Claims 24-26 and 30-33 are pending and under examination.
Claim Rejections - 35 USC § 103
2. 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.
3. Claims 24-26 and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Blasco et al. (WO 12/001170), in view of both de Jesus et al. (EMBO Mol. Med., 2012, 4: 691-704) and Tsakiri et al. (PNAS, 2007, 104: 7552-7557).
Blasco et al. teach a method for treating a condition associated with shortened telomers such as aging and age-associated conditions, the method comprising administering to aged mice and humans an AAV comprising a nucleic acid encoding TERT operably linked to the CMV promoter; the nucleic acid encoding TERT is flanked by AAV2 ITRs, it is packed by the AAV9 capsid, and it is set forth by SEQ ID NOs: 1 or 3 (human TERT variants 1 and 2) encoding the amino acid sequence set forth by SEQ ID NOs: 2 and 4 (claims 24-26 and 30-33) (see Abstract; p. 1, lines 5-8; p. 2, lines 9-23; p. 5, line 26 through p. 6, line 4; p. 7, lines 4-14; p. 13, lines 1-17; p. 19-20; p. 23, lines 18-21; p. 24, lines 22-30; p. 26, lines 21-23). The specification teaches that the recited SEQ ID NOs: 1 and 3 are the nucleic acid sequences of human TERT variants 1 and 2, which encode the amino acid sequence set forth by the recited SEQ ID NOs: 2 and 4 (see p. 10, lines 12-18).
Blasco et al. do not specifically teach treating idiopathic treating pulmonary fibrosis (claim 24). However, doing so is suggested by the prior art. For example, Blasco et al. teach that AAV9 administration results in lung expression (see p. 36, line 26 through p. 37, line 17). Similarly, de Jesus et al. teach that AAV9-TERT administration leads to TERT expression and telomerase reactivation in the lungs; de Jesus et al. teach that TERT gene therapy offers a therapeutic opportunity for the cases of human pulmonary fibrosis associated with shortened telomeres such as the idiopathic pulmonary fibrosis taught by Tsakiri et al. (see p. 693, Fig. 1; p. 699, column 1). Tsakiri et al. teach that mutant TERT is associated with familial idiopathic pulmonary fibrosis (an adult-onset disease) and suggests therapy by enhancing telomerase activity or delaying telomere shortening (see Abstract; paragraph bridging p. 7554 and 7555). Based on these teachings, applying the method of Blasco et al. to human patients affected by pulmonary fibrosis (including idiopathic pulmonary fibrosis) associated with shortened telomeres would have been obvious to one of skill in the art with the reasonable expectation that doing so would result in treating the disease in these patients. Since Blasco et al. teach that shortened/damaged telomeres cause loss of regenerative capacity (see p. 2, lines 9-28), one of skill in the art would have readily recognized that pulmonary tissue affected by fibrosis associated with shortened telomeres is characterized by defective regenerative capacity (claim 24)
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
Response to Arguments
4. The arguments of lack of guidance and expectation of success are not found persuasive because they are not supported by any evidence. Just because de Jesus and Tsakiri do not provide data does not mean that the references do not provide the guidance and the reasonable expectation of success necessary to arrive at the claimed invention. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Blasco and de Jesus teach that administering an AAV9-TERT results in lung expression and telomerase reactivation in the lungs. Thus, the cited prior art provides the guidance and the reasonable expectation of success required to reactivate TERT in the lungs and achieve therapy for any lung condition requiring TERT reactivation, including idiopathic pulmonary fibrosis which was taught by de Jesus and Tsakiri as being associated with shortened telomeres. Especially in view of Jesus and Tsakiri suggesting treating idiopathic pulmonary fibrosis by using AAV9-TERT.
For these reasons, the argument regarding the obvious to try rationale is not found persuasive. Clearly, the rejection is not based on this rationale.
The applicant argues that the speculative statements in the cited references are an invitation to engage in a significant amount of trial-and-error experimentation to provide a solution.
This is not found persuasive because it is just an argument not supported by any evidence. The cited prior art already provides the solution specifically, administering AAV9-TERT. The cited prior art also teaches that administering AAV9-TERT restores TERT activity in the lung, providing the reasonable expectation of success in arriving at the claimed method.
The argument that post-filing results in Provedano support the nonobviousness of the claimed invention is not found persuasive.
By teaching that administering AAV9-TERT (as suggested by the cited prior art) results in therapeutic effect, Provedano provides evidence for reasonable expectation of success.
Conclusion
5. All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILEANA POPA whose telephone number is (571)272-5546. The examiner can normally be reached 8:00 am to 4:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ILEANA POPA/Primary Examiner, Art Unit 1633