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 .
According to a preliminary amendment filed on April 21, 2025, the applicants have canceled claims 10-24 and furthermore, have amended claims 3-4, 6-9, 27 and 30.
Claims 1-9 and 25-30 are pending in the application.
Claim Rejections - 35 USC § 112
4, The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-9 25 and 27-29 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is no written description for regenerating bladder tissue, self-renewal and cellular differentiation by every known AhR effector (agonists as well as antagonists) in the art. The only written description is for regenerating bladder tissue, self-renewal and cellular differentiation by AhR antagonist, StemRegenin 1 disclosed on pages 2-3 of the specification).
Claim Rejections - 35 USC § 102
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.
Claims 25-27 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Bernstein U.S. Patent 9,834,755 B2).
Bernstein discloses compositions and methods for enhanced generation of hematopoietic stem/progenitor cells. The method of enhanced generation of hematopoietic stem/progenitor cells disclosed in claims 1-4 and 8-17 by Bernstein anticipates the instant claims when AhR antagonist is represented by StemRegenin 1 in the instant claims.
Claims 28 and 30 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Jackson (stem cell Res.).
Jackson discloses targeting the aryl hydrocarbon receptor nuclear translocator complex with DMOG and StemRegenin 1 improves primitive hematopoietic stem cell expansion. The induction of self-renewal and differentiation of HSPCs by StemRegenin 1 (see abstract) disclosed by Jackson clearly anticipates the instant claims.
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.
11. 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.
12. Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Boitano (Science, cited on applicant’s form 1449) in view of Iannacone (Pediatric Res., cited on applicant’s form 1449).
Boitano teaches regeneration of human hematopoietic stem cells with AhR antagonist, StemRegenin 1 (see abstract). Boitano meets all the limitations of instant claims except that Boitano teaches regeneration of stem cells instead of urinary bladder cells. However, Iannacone teaches that the use of bone marrow stem cells has demonstrated significant advances in bladder tissue regeneration as multiple aspects of bladder tissue have been recapitulated including the urothelium, bladder smooth muscle, vasculature and peripheral nerves (see abstract). Therefore, it would have been obvious to one skilled in the art to regenerate bladder tissue with AhR antagonist StemRegenin 1 with reasonable expectation of success.
13. Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson (Stem Cell Res.) in view of Iannacone (Pediatric Res., cited on applicant’s form 1449).
Jackson discloses targeting the aryl hydrocarbon receptor nuclear translocator complex with DMOG and StemRegenin 1 improves primitive hematopoietic stem cell expansion.
The induction of self-renewal and differentiation of HSPCs by StemRegenin 1 (see abstract) disclosed by Jackson meets all the limitations of instant claim except that cells are HSPCs instead of instant epithelial or endothelial cells. However, Iannacone teaches that the use of bone marrow stem cells has demonstrated significant advances in bladder tissue regeneration as multiple aspects of bladder tissue have been recapitulated including the urothelium, bladder smooth muscle, vasculature and peripheral nerves (see abstract). Therefore, it would have been obvious to one skilled in the art to induce self-renewal and differentiation of epithelial cells or endothelial cells with AhR antagonist StemRegenin 1 with reasonable expectation of success.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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