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 .
Status of the Claims
Claims 1-9 are pending.
Claims 2-6 and 9 are withdrawn (see restriction/election).
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a CIP of national stage entry of and claims priority to PCT/CN23/79290 filed on 3/02/2023 and further claims priority to FOR application number CN202210214316.5, filed 3/4/2022. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
All references from IDS(s) received on 7/10/2023 and 7/19/2023 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election of Group I with traverse in the reply filed on 3/16/2026 is acknowledged.
Although the applicant elected with traverse, the only grounds for traversal is that the Examiner has failed to articulate facts from which to conclude a serious search and/or examination burden would be placed upon the office if the claims were not restricted. The Examiner argues that the Applicant hasn’t explained why the groups would not be a search/or examination burden. See MPEP 818.01.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2-6 and 9 (Groups II-III) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected process of making and method of use, there being no allowable generic or linking claim.
Applicant’s election of A. 11-bromoundecanoic acid and B. tumors with traverse in the reply filed on 3/16/2026 is acknowledged.
Although the applicant elected with traverse, the only grounds for traversal is that the Examiner has failed to articulate facts from which to conclude a serious search and/or examination burden would be placed upon the office if the claims were not restricted. The Examiner argues that the Applicant hasn’t explained why the groups would not be a search/or examination burden. See MPEP 818.01.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1 and 7-8 will be examined upon their merits.
No anticipatory art was found, however an obviousness-type 103 rejection is made below.
Claim Rejections - 35 USC § 112(a)
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 7-8 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. See MPEP 2163.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, the claims of the present invention embrace compounds of Formula I, including any “prodrugs”, thereof.
The specification fails to
Show possession of the full scope of what constitutes as a prodrug in the context of the invention
Fails to establish a structure/function correlation for these terms, or provide a representative number of examples to establish possession of the structural space that would entail the BRI of prodrugs or their compound structures, as they have not provided any examples of either.
Status of the prior art/Lack of structure function correlation/Lack of representative number of examples
The art teaches that prodrugs may have their own pharmacological activity. Zhang et al. (Acta Pharmaceutica Sinica B 2018; 8(5):72-732) teaches that prodrugs of a drug can be completely new drug candidates away from the parent drug, therefore emphasizing the importance of designing prodrugs in a manner that requires the causes that necessitate the use of the prodrug approach be defined and clearly understood. Without definitive boundaries the Examiner can only assume a prodrug can be as broad as using a macromolecular moiety.
One of ordinary skill would not expect these compounds to necessarily have similar properties and a person skilled in the art would not be able to determine whether the structure or function of the claimed invention would be maintained. Specifically, in view of the teachings of Zhang, if small structural changes to compounds within the field of the invention cause a change in the order of magnitude, a person skilled in the art could not predict what would be expected of large structural changes. In the absence of a disclosed structure, there can be no correlation between the function and structure of the claimed “prodrug” in the instant application.
With respect to the representative numbers of examples, the specification has only a few structural examples but lacks any representative examples of structures of prodrugs. Therefore, the specification has failed to provide a representative number of examples to establish possession of the structural space that would entail the BRI of prodrugs or their compound structures, as they have not provided any examples of either.
This rejection would be overcome by amending the claims to remove the term “prodrug.” The dependent claims allow for prodrugs of the compounds in the claims to be within the scope of the claim.
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 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang, H. et al. (AUTOPHAGY, 2021, VOL. 17, NO. 10, 2783–2799; cited in IDS filed 7/19/2023; “Hwang”) in further view of Zielonka, J. et al. (Chem. Rev. 2017, 117, 15, 10043–10120; cited in IDS filed 7/19/2023; “Zielonka”).
Hwang teaches sertraline as an anti-depressant drug that also modulates AMPK-MTOR signaling-mediated autophagy via targeting mitochondrial VDAC1 protein. Hwang also teaches autophagy is often dysregulated in cancer and neurodegenerative diseases (Abstract).
Hwang fails to teach sertraline conjugated to a triphenylphosphine (TPP) moiety.
Zielonka teaches the most effective way to deliver drugs specifically to mitochondria is by covalent linking a lipophilic cation such as an alkyltriphenylphosphonium moiety to a pharmacophore of interest (Abstract). Zielonka also teaches the conjugation of various known drugs to TPP for the treatment of a variety of diseases such as neurodegeneration and cancer (Abstract).
Zielonka fails to teach sertraline as one of the drugs conjugated to TPP.
However, it would be obvious to extract the teachings of Zielonka of TPP-conjugated drugs for treatment of neurodegeneration and cancer, and substitute one of the known drugs for another that is known to play a role in treatment of neurodegeneration and cancer, such as sertraline, as taught by Hwang.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 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.
Examples of 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.
Applying KSR example rationale (B), it would have been prima facie obvious to extract the teachings of Zielonka of TPP-conjugated drugs for treatment of neurodegeneration and cancer, and substitute one of the known drugs for another that is known to play a role in treatment of neurodegeneration and cancer, such as sertraline, as taught by Hwang. Therefore, claims 1 and 7-8 would be obvious to a person skilled in the art at the time.
Conclusion
Claims 1 and 7-8 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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