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
Applicant's preliminary amendment filed on January 31, 2024 is acknowledged. Claim 2 has been canceled. Claims 3-15 were amended. Claims 1 and 3-19 are pending and are examined on the merits herein.
Priority
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Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 8, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because of the following informality:
Paragraph [0013] is missing a period after the word “mice”.
Appropriate correction is required.
Claim Objections
Claims 10 and 19 are objected to because of the following informalities:
Claim 10 is missing the word “claim” in between “of” and “9”.
Claim 19 is missing the word “of” in between “method” and “claim”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 1 and 3-19 are rejected under 35 U.S.C. 103 as being unpatentable over Chiorini (US 10,166,299; reference cited by Applicant) in view of Jasmer et al. (Journal of Clinical Medicine 2020).
Regarding claims 1, 4, 6, 7, 9, and 15, Chiorini teaches a method to protect a subject from Sjogren's syndrome comprising administering to the subject an AAV virion comprising an AAV vector that encodes aquaporin-1 (AQP-1) protein [abstract]. Further, Chiorini teaches a preventative for Sjögren's syndrome-related xerostomia. Such a preventative comprises an AAV vector, or a virion comprising such a vector, that encodes an AQP-1 protein [column 3, second to last full paragraph].
Regarding claims 3 and 18, Chiorini teaches a salivary gland cell transfected with an AAV vector that encodes an AQP-1 protein [column 3, last full paragraph].
Regarding claims 5 and 19, Chiorini teaches that an AQP-1 protein can have the sequence of a human AQP-1 protein [column 9, fourth paragraph].
Regarding claims 8 and 10, Chiorini teaches that AAV vectors of different serotypes that encode an AQP-1 protein include AAV2, AAV5, AAV6, and BAAV [column 14, fourth full paragraph].
Regarding claims 11, 12, 16, and 17, Chiorini teaches a method comprising administering an AAV virion comprising an AAV vector that encodes an AQP protein to a subject, wherein such administration maintains salivary gland function [column 18, second full paragraph].
Regarding claim 13, Chiorini teaches that administering an AAV virion comprising an AAV vector that encodes an AQP protein to a subject wherein such administration maintains salivary gland function in the subject. Chiorini further teaches that maintaining salivary gland function means that salivary gland function after administration of an AAV virion to a subject is equivalent to salivary gland function in that subject prior to administration of the AAV virion [column 18, second full paragraph].
Regarding claim 14, Chiorini teaches that subjects include humans [column 18, second full paragraph].
However, Chiorini does not teach administering ionizing radiation to the subject after administering a vector encoding an AQP protein to the subject (claim 1). Chiorini also does not teach that the patient has head and neck cancer (claim 15).
Jasmer et al. teaches that salivary glands sustain collateral damage following radiotherapy (RT) to treat cancers of the head and neck leading to complications including xerostomia [abstract]. Jasmer et al. also teaches that RT-induced salivary gland dysfunction results in hyposalivation and xerostomia. Further, it is estimated that >80% of HNC patients exhibit xerostomia and salivary gland hypofunction following RT [page 1].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to administer a vector encoding an AQP protein to a subject as taught by Chiorini before administering ionizing radiation to prevent or reduce radiation-induced salivary dysfunction because Chiorini taught a method to protect a subject from Sjogren's syndrome comprising administering to the subject an AAV virion comprising an AAV vector that encodes aquaporin-1 (AQP-1) protein specifically a preventative for Sjögren's syndrome-related xerostomia and Jasmer et al. taught that salivary glands sustain collateral damage following radiotherapy (RT) to treat cancers of the head and neck leading to complications including xerostomia. One of ordinary skill in the art would have made such a modification because it would have amounted to combining known prior art elements to yield the predictable result of preventing or reducing radiation-induced salivary dysfunction in a subject wherein the subject has head and neck cancer.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA TRAN whose telephone number is (571)270-0550. The examiner can normally be reached M-F 7:30 - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.T./
Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637
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