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 .
Election/Restrictions
Applicant’s election without traverse of Inventive Group I in the reply filed on 01/06/2026 is acknowledged.
Claims 43, 44, and 49-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/06/2026
It is noted that Applicant elected to cancel claims 18, 35, and 36 per the Remarks dated 01/06/2026. Therefore claims 1, 7, 11, 14, 18, 24-33, and 35-38 are examined on the merits.
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, 7, 11, 14, 18, 24-33, and 35-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 13, 14, 19, 27, 28, and 29 of U.S. Patent No. US11117942B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Claim 1 discloses use of an AAV capsid comprising a feline or canine EPO, which is the main component of the pending claim 1
Claim 5 discloses use of SEQ ID NO. 4, which matches the pending SEQ ID NO. 1 as stated in pending claim 24
Claim 13 states use of a promoter, matching pending claim 27
Claim 14 states use of either a CB7, TBG, Nkcc2, uromodulin, Ksp-cadherin, or THP gene promoter, matching pending claims 28-32
Claim 19 states use of either an intron, Kozak sequence, polyA, or post-transcriptional regulatory elements, matching pending claim 33
Claim 27 states use of intravenous administration, matching pending claim 38
Claim 28 states use of a feline or canine subject, matching pending claim 1
Claim 29 states use of a feline EPO sequence, matching pending claim 1
Claims 7, 11, 14, 18, 25, 26, and 37 are all depending from independent claim 1, and therefore inherit all the limitations and merits of the claim. As such, claims 7, 11, 14, 18, 25, 26, and 37 are rejected on the same basis.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 7, 11, 14, 18, 24-33, and 35-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hinderer et al. (US 2018/0251508 A1)
Regarding claim 1: Hinderer discloses methods and compositions for the treatment of companion animals, particularly cats and dogs, with a sequence encoding EPO. (57) Specifically, Hinderer discloses the invention is intended to correct anemia in the animal (0015) in the form of a recombinant AAV vector (0016) and specifies that if the animal being treated is a feline, a feline EPO is used. (0020) In an embodiment of the invention, an AAV1 vector may be used. (0044) Regarding dose, Fig. 4 (pictured in a following rejection statement) has a range of doses including 3.0x10^8, which is within the claimed range of 2x10^8 and 2x 10^9 genome copies per kilogram of body weight. (0066)
Regarding claim 7: Hinderer discloses that the claimed study involves nine cats with anemia related to stage 3 chronic kidney disease, which is defined as a hematocrit of less than 29%. (0068)
Regarding claims 11 and 14: Hinderer teaches an example of the invention in which felines are treated with an AAV8 expressing a feline EPO, treated at various dosages. Fig. 4 represents the hematocrit of cats treated with feline EPO at varying doses over an extended period of time (0066), and is pictured below:
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As can be seen, administration of the construct raised hematocrit percentage well above 55% by day 70 at multiple doses. It is known in the art that hematocrit measures packed cell volume (PCV), therefore this reads on both claims 11 of raising the PCV from about 30% to about 55% by day 70 following administration (claim 11) and also on raising PCV% points from about 5 to about 30 by day 70. (claim 14)
Regarding claims 24 and 25: Hinderer teaches compositions and methods for treating companion animals, such as a dog or cat, with an AAV vector comprising a sequence encoding EPO. (57) Hinderer teaches that stable expression of EPO corrects anemia in the subject (0015) and specifically teaches use of feline EPO plasmids in SEQ ID NO. 2 (0042) which matches the claimed SEQ ID NO. 2 and SEQ ID NO. 4 (0018) which matches the claimed SEQ ID NO. 1. The alignment chart for the SEQ ID NO. 2 as disclosed by Hinderer, which fully matches the claimed SEQ ID NO. 2, is displayed below:
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The alignment chart for SEQ ID NO. 4 as disclosed by Hinderer which matches the claimed SEQ ID NO. 1 is displayed below:
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Regarding claim 26: Hinderer discloses that the coding sequences may be designed for optimal expression using codon optimization (0032) and further discloses an example of the invention in which the sequences were codon optimized. (0063)
Regarding claims 27-32: Hinderer teaches the following, found in claims 13-14 reading on the following claims:
Use of a promoter (claim 27)
Use of a CB7 promoter (claim 28)
Use of a TBG promoter (claim 29)
Use of the tissue-specific promoters Nkcc2 (kidney-specific), uromodulin (kidney-specific), Ksp-cadherin (kidney-specific), and/or a THP gene promoter (kidney-specific) (claims 30-32)
Regarding claim 33: Hinderer discloses that the capsid may further comprise sequences that enhance translation, including Kozak sequences, introns, and polyA signals. (0038) Claim 19 of the invention disclosed by Hinderer further states use of post-transcriptional regulatory elements.
Regarding claim 37: Hinderer discloses that the intended use for the pharmaceutical composition is to treat chronic kidney disease in a feline. (0053)
Regarding claim 38: Hinderer discloses multiple potential routes of administration for the claimed invention, including intravenous and intramuscular. (0047)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA M THUESON whose telephone number is (571) 272-3680. The examiner can normally be reached M-F 7:30-5 EST. 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, Tracy Vivlemore, can be reached on (571) 272-2914. 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.
/HANNA MARIE THUESON/ Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638