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 submission filed on 12/12/2023 is acknowledged.
Claims 1-5 are pending in this application, and have been examined on their merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/12/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 and 2 are objected because of the following informalities: claims recite limitations in the form of abbreviations such as “mTOR" which needs to be recited in full form for the first time they occur in the claim.
Appropriate correction is required.
Specification
The abstract of the disclosure is objected to because in line 4, the word “method” is used twice. For instance, “a method of using RNAi method by means of”. Applicants are suggested to remove one of the repeated words.
Appropriate correction is required.
Claim Rejections- 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected 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 which the inventor or joint inventor (or for application subject to pre-AIA 35 USC 112, the applicant), regard as the invention.
Claim 2 recites “…..wherein the mTOR shRNA is any one of shRNAs represented by SEQ ID NO: 1 to SEQ ID NO: 4.”
The phrase "represented by" in claim 2 is a relative term which renders the claim
indefinite. The phrase "represented by" is not defined by the claims, the specification does not
provide a standard for ascertaining the requisite degree, and an artisan of ordinary skill in the art
would not be reasonably apprised of the scope of the claimed invention. The metes and bounds of the claimed invention are not clear. An artisan of ordinary skill in the art would not be apprised of the exact scope of the claimed process as currently presented. Appropriate correction is required.
Applicants are advised to replace the phrase " wherein the mTOR shRNA is any one of shRNAs represented by SEQ ID NO: 1 to SEQ ID NO: 4 " with the phrase " wherein the mTOR shRNA sequence is selected from a group consisting of SEQ ID NO: 1 to SEQ ID NO: 4 ".
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.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application No. US 10583150 (“US150”, published on March 10, 2020) in view of International Patent Application Publication Number WO 2018013568 (“WO568”, published on January 18, 2018).
With respect to claim 1, US150 teaches a method for treating macular degeneration by administering to a patient a recombinant vector encoding a shRNA (shRNA-mTOR) with the ability to inhibit mTOR (see abstract and paragraph 14).
However, US150 does not teach the use of shRNA-mTOR in treating diabetic retinopathy.
WO568 teaches a composition and method for the treatment of eye diseases by administrating a therapeutically effective amount of autophagy stimulator. This treatment method slows the progression of eye diseases by stimulating autophagy (see abstract). Furthermore, WO568 teaches different eye diseases that can be treated by administrating the autophagy stimulator. The eye diseases are glaucoma, endoplasmic reticulum (ER) stress, autophagy deficiency, age-related macular degeneration (AMD), or diabetic retinopathy (see summary of the invention section, page 2 line 5; and also, in claim 7). WO568 further teaches that the autophagy stimulator was selected from beclin 1 protein, Tat-beclinl peptide (SEQ ID NO: l), Tat-Beclin 1 Dl l (SEQ ID NO: 10), trehalose, ISRIB, or an mTOR inhibitor (please see summary of the invention, page 2 line 9; and also, in claim 9).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the recombinant vector comprising mTOR-shRNA as described in US150 to treat the diabetic retinopathy disease of WO568 with a reasonable expectation of success. An artisan would have been motivated to do so with a reasonable expectation of success because WO568 teaches mTOR inhibitor can be used to treat multiple eye diseases (glaucoma, endoplasmic reticulum (ER) stress, autophagy deficiency, age-related macular degeneration (AMD), or diabetic retinopathy.
With respect to claim 2, US150 teaches the nucleotide sequence of SEQ ID NO:1 to be GAAUGUUGACCAAUGCUAU. This sequence is 100% identical to SEQ ID NO:4 of claim 2 (see below)-
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Claims 3 and 4 are directed to the recombinant vector, that is an adeno-associated virus (AAV), wherein the recombinant vector is rAAV2 or another serotype rAAV. Regarding claims 3 and 4, US150 teaches the use of a viral vector, AAV, for the delivery of mTOR inhibitor. Particularly, US150 used a vector derived from scAAV2 (self-complementary adeno-associated virus serotype 2 vector) for the delivery of mTOR inhibitor into the cells of a subject (see page 6, line 20-25; page 7, line 10-25).
With respect to claim 5, US150 teaches about the administration of mTOR inhibitor shRNA to a subject by using scAAV2 vector via intravitreal injection (see brief description of the figure 2 in page 3, line 49-53).
Therefore, it would have been obvious for an artisan to use AAV2 vector of US150 for delivering the shRNA sequence to a subject because US150 teaches that AAV2 vector can efficiently deliver genes and are non-immunogenic and non-cytotoxic.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SURAJ SAPKOTA whose telephone number is (571)270-0842. The examiner can normally be reached Monday-Thursday 7am-5pm.
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, Ram R Shukla can be reached at (571) 272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Suraj Sapkota
Patent Examiner
AU 1635
/RAM R SHUKLA/Supervisory Patent Examiner, Art Unit 1635
Prosecution Insights