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 azeliragon and derivative thereof in the reply filed on 2026 March 23 is acknowledged. A search of the concept of a RAGE inhibitor has also been done. Claims 1-3, 7, 9-11, and 13-25 are pending and examined on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) submitted 2023 November 10 and 2025 April 30 were submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-3, 7, 9-11, and 13-25 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. BONGARZONE (Journal of Medicinal Chemistry, 2017, 60, 7213-7232) describes compounds 1-28 (pages 7220-7221, table 3; page 7219, figure 3; page 7223, figure 4; page 7224, figure 5; and page 7225, figure 6) are all RAGE inhibitors. When one compares compounds 1-11, the structural requirements are different in each compound. Compounds 1 and 2 differ by the presence an NEt2 versus a 4-methyl-piperazinyl group. In compounds 3-6, the phenyl substituents are different. There is common consensus to the structural metes and bounds of a RAGE inhibitor based on these compounds. Consequently the metes and bounds of a RAGE inhibitor are unclear.
PNG
media_image1.png
776
780
media_image1.png
Greyscale
PNG
media_image2.png
210
782
media_image2.png
Greyscale
PNG
media_image3.png
440
774
media_image3.png
Greyscale
PNG
media_image4.png
446
786
media_image4.png
Greyscale
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1, 3, 7, 10, 11, and 15 are rejected under 35 U.S.C. 103(a) as being unpatentable over BONGARZONE (Journal of Medicinal Chemistry, 2017, 60, 7213-7232) in view of EL-AGAMY (Cancer Chemotherapy and Pharmacology, 2019, 84, 1-14).
Determining the scope and contents of the prior art
BONGARZONE describes the following ideas: RAGE activation is associated with both cancer and neurodegeneration (page 7218, figure 2; page 7218, column 2 paragraph 2 to page 7219, column 1, paragraph 1; and page 7222, column 1, paragraph 2 to page 7225, figure 6. Compounds 1-28 (pages 7220-7221, table 3; page 7219, figure 3; page 7223, figure 4; page 7224, figure 5; and page 7225, figure 6) are all RAGE inhibitors.
EL-AGAMY (describes that cognitive decline is a common symptom associated with chemotherapy (page 3, figure 2; page 6, column 2, paragraph 1 to page 7, column 2, paragraph 3; page 9, column 2, last paragraph).
Ascertaining the differences between the prior art and the claims at issue
Bongarzone does not describe the explicit administration of compounds 1-28 in the treatment or prevention of cancer-related cognitive decline to a subject in need thereof.
Resolving the level of ordinary skill in the pertinent art
Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s, PhD’s, or those with advanced degrees and the requisite experience in preparation of compounds of the elected group).
Considering objective evidence present in the application indicating obviousness or nonobviousness
Bongarzone in view of El-Agamy implies that administration of a RAGE inhibitor can treat cognitive decline concurrently because RAGE is associated with treatment of neurodegeneration. El-Agamy describes that cognitive decline is a common symptom of chemotherapy. Consequently, there is a reasonable expectation of success that a RAGE inhibitor described by Bongarzone can treat cognitive decline.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Conclusion
Claims 1-3, 7, 9-11, and 13-25 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: BONGARZONE (Journal of Medicinal Chemistry, 2017, 60, 7213-7232) does not describe the explicit alleviation or prevention of cancer-related cognitive decline.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 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, Fereydoun Sajjadi can be reached at 571-272-3311. 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.
/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
Prosecution Insights