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 . Claims 41-43 and 74-87 are pending in this application.
Response to Amendment
2. Applicant’s amendment filed 11/06/2025 in response to the previous Office Action (05/07/2025) is acknowledged. Rejections of claims 41, 52, 60 and 64-65 under 35 U.S.C. 102(a)(1), 112(a) and112(b) have been obviated by a claim amendment.
Election/Restrictions
3. Applicant’s election with traverse of species (1) Inflammation (i.e. a condition associated with senescence) in the reply filed on 04/09/2025 is acknowledged. The traversal is on the ground(s) that the additional species would not require an additional burden of search. The examiner disagrees with applicant’s argument. Note that applicant’s invention is very broad, since it covers the treatment of myriad diseases as set forth in the Restriction Requirement and in the International Search Report. Note that the compound used in the treatment is known in the art and the scope of claim 41 is so broad. Furthermore, coexamination of each of the additional species would require search of subclasses unnecessary for the examination of the elected claims. Searching for the additional species also would require additional search in the Chemical Abstract Database that is available commercially. Therefore, coexamination of each of these additional species would require a serious additional burden of search.
The requirement is still deemed proper and is therefore made FINAL.
The examiner searched the elected invention and found a prior art; thus, the search was stopped. If the examiner finds another prior art after response to this Office Action, the next Office Action will be Final. Since the taltirelin compound for the treatment of various diseases is known in the art, the examiner recommends that applicants review their invention.
4. The claims are drawn to multiple inventions for reasons set forth in the restriction requirement. The claims are examined only to the extent that they read on the elected invention. Cancellation of the non-elected subject matter is recommended in response to this Office Action.
It is recommended that applicants delete non-elected subject matter from the claims. As discussed with Mr. Guttman on 04/29/2025, the election of species is inflammation i.e. an inflammation associated with senescence. It is recommended that applicants delete claim 43 and amend claim 42 by deleting non-elected subject matter.
Claim Rejections - 35 USC § 102
5. 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.
6. 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.
7. Claims 41, 78 and 87 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanna et al. U.S. Pat. No. 9,169,279. Cited patent discloses the following prior art compound and its composition for the treatment of osteoporosis that is the same as applicants.
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Since said compound is the same as applicants and used in the treatment of osteoporosis, a 102(a)(1) rejection is proper.
Claim Rejections - 35 USC § 103
8. 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.
9. 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.
10. Claims 41 and 74-87 are rejected under 35 U.S.C. 103 as being unpatentable over Eto et al. Brain Research (2011) 1414, 50-57, and further in view of Sugano et al. U.S. Pat. No. 4,665,056 . Eto et al. teaches the treatment of inflammatory condition using taltirelin compound that is almost the same as applicants. Sugano et al. also teaches the treatment of and prophylaxis of central nervous system disorders. Both references are cited in the Internation Search Report. The International Search Report cites many references that disclose taltirelin compound for the treatment of myriad diseases.
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Applicants are claiming the treatment of inflammation associated with cell or tissue senescence that includes osteoarthritis, periodontitis, invertebral disk degeneration, osteosarcoma, osteoporosis, cleidocranial dysplasia syndrome, rheumatoid arthritis, lupus, Crohn's disease, inflammatory bowel disease, ulcerative colitis, multiple sclerosis, or fibrosis. The prior art teaches the treatment of inflammation in general and is silent whether the inflammation is associated with cell or tissue senescence or not. The compound used in the treatment of inflammation is the same as applicants. Sugano also teaches the treatment of central nervous system disorders that is closely related to the treatment of inflammation. It is obvious for one skilled in the art to try and treat various inflammatory diseases such as inflammation associated with a cell or tissue senescence knowing that the prior art compound was used in the treatment of inflammation, central nervous system disorders and also for the treatment of myriad diseases as cited in the International Search Report. As noted in the previous Office Action, taltirelin is known in the art and has been used in the treatment of various diseases.
Claim Rejections - 35 USC § 112
11. 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.
12. Claims 41 and 74-87 are 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 a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In claim 41, the phrase “the treatment of condition associated with inflammation of cell or tissue senescence…wherein the method is osteoarthritis… ” is not clear. How is the treatment of condition associated with inflammation of cell or tissue senescence different from the treatment of inflammation that is not associated with cell or tissue senescence? Who is need thereof?
Conclusion
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 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, JEFFREY MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Kahsay Habte/
Primary Examiner, Art Unit 1624
November 21, 2025
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