Detailed Action
The present office action is in response to the reply filed on 14 Aug 2026.
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
Claims 1-4 and 9-10 of the pending application have been examined on the merits. Claims 5-7 are withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the amendments filed 14 Aug 2026.
Priority
Applicants identify the instant application, Serial #: 18/713,186, filed 24 May 2024, as a National Stage Entry of International Application #: PCT/CN2022/141359, filed 23 Dec 2022, which claims priority from Foreign Application #s: CN202211624621.8, filed 16 Dec 2022, and CN202210067669.7, filed 20 Jan 2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 24 May 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Acknowledgement is made of the remarks filed 14 Aug 2026. Applicant elects Group I, claims 1-4 and 8-10, and Compound No. 1 (below) with traverse.
PNG
media_image1.png
79
237
media_image1.png
Greyscale
After a search, the elected compound was found free of prior art. Examiner has expanded the Markush search to include the full scope of the generic claim. Prior art was found after a search for the generic claim.
The traversal is on the grounds that the art does not teach a compound which has the same definition as variable A in the instant claims.
This is not persuasive. Not all compounds have the same variable A and so A is not part of the core structure which is the technical feature linking Groups I and II. The core structure is circled in black, below and in the restriction requirement mailed 16 Jun 2026.
PNG
media_image2.png
222
604
media_image2.png
Greyscale
The requirement is still deemed proper and is therefore made FINAL.
Claims 5-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 14 Aug 2026.
Drawings
Acknowledgement is made of the drawings filed 24 May 2024.
The drawings are objected to because the sheets of drawings are not numbered 37 C.F.R. 1.84 states:
(t) Numbering of sheets of drawings. The sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1, within the sight as defined in paragraph (g) of this section. These numbers, if present, must be placed in the middle of the top of the sheet, but not in the margin. The numbers can be placed on the right-hand side if the drawing extends too close to the middle of the top edge of the usable surface. The drawing sheet numbering must be clear and larger than the numbers used as reference characters to avoid confusion. The number of each sheet should be shown by two Arabic numerals placed on either side of an oblique line, with the first being the sheet number and the second being the total number of sheets of drawings, with no other marking.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: The definition of R1 includes (CH2)qNR15. However, there is an open valence for nitrogen. Applicant may overcome this objection by correcting the valence for nitrogen. Appropriate correction is required.
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 8 is objected to because of the following informalities: The claim limits the salts of claim 1 to those where the hydantoin compound forms a salt with a metal ion or a pharmaceutically acceptable amine or an ammonium ion. However, “amine” does not form salts in the free base form, but rather in the ionic form, ammonium. Applicant may overcome this objection by cancelling “amine” from the claim. Appropriate correction is required.
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 3 and 9 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.
Factors to be considered in making the determination as to whether one skilled in the art would recognize the applicant was in possession of the claimed invention as a whole at the time of filing include:
Actual reduction to practice;
Disclosure of drawings or structural chemical formulas;
Sufficient relevant identifying characteristics such as:
Complete structure,
Partial structure,
Physical and/or chemical properties, or
Functional characteristics when coupled with a known or disclosed correlation between function and structure;
Method of making the claimed invention;
Level of skill and knowledge in the art;
Predictability in the art.
While all these factors are considered, a sufficient number for a prima facie case are discussed below.
The claims are drawn to "prodrug." Applicant provides no guidance as to prodrugs. The artisan understands that prodrug forms are generally determined a posteriori, and it is only through trial and error that prodrugs are identified. The artisan understands the concept of prodrugs, however the artisan does not per se understand what specifically describes a prodrug form. Han (AAPS Pharmsci, 2000, vol. 2, article 6), cited here for evidence, teaches there is no strict universal definition for a prodrug itself but that, in general, the prodrug is an inactivated form of the drug that activates in vivo to the active form (pg. 1, column 2). While some prodrugs are simply esters or salts, other prodrug forms are not chemically or structurally related to their active form, one example being glucose as the prodrug form of hydrogen peroxide (Table 1, pg. 5), as is hypoxanthine, thus posing a problem as to understanding what is the exact prodrug form of a compound, as hydrogen peroxide has two prodrug forms in the limited set of compounds exemplified in Han.
According to Ettamayer et al. (J Med Chem, 2004, 47:2393-2404), cited here for evidence, prodrugs are often accidental discoveries (pg. 2393, column 2). Furthermore, Testa et al. (Biochem Pharm, 2004, 68:2097-2106), cited here for evidence, teaches:
[A] number of challenges await medicinal chemists and biochemists carrying out prodrug research, such as the additional work involved in synthesis, physiochemical profiling, pharmacokinetic profiling and toxicological assessment. Two of these challenges are introduced here, namely biological variability and toxicity potential. The challenge of biological variety results principally but not only from the huge number and evolutionary diversity of enzymes involved in xenobiotic metabolism. Inter- and intra-species differences in the nature of these enzymes, as well as many other differences such as the nature and level of transporters, may render prodrug optimization difficult to predict and achieve. (pg. 2098, column 2)
Methods of making compounds, in general, are known to the artisan. However, the methods of making any specific prodrug are complex and poorly understood, requiring an undue amount of experimentation to determine if a compound is actually a prodrug, and the instant specification fails to provide guidance to overcome the complexity and difficulties known to the artisan, as discussed above.
Thus, the artisan would have increased difficulty in determining how to convert the claimed compounds into prodrugs.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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 2-3 and 9 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.
Regarding claim 2, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 3, the claim is directed to the “hydantoin compound or pharmaceutically acceptable salt thereof according to claim 1, wherein the compound further comprises a prodrug, a deuterated compound, or a solvate thereof.” The phrase “further comprises” indicates an open list, but the independent claim is directed only to a hydantoin compound of formula (I) or a pharmaceutically acceptable salt thereof, in a closed list form. Therefore, claim 3 lacks antecedent basis for the limitations of a “prodrug, deuterated compound, or a solvate thereof.”
Regarding claim 9, the claim is directed to a “pharmaceutical composition…comprising the hydantoin compound or the pharmaceutically acceptable salt, the prodrug, the deuterated compound, or the solvate thereof according to claim 1...” However, claim 1 is directed to a hydantoin compound of formula (I) or a pharmaceutically acceptable salt thereof, so claim 9 lacks antecedent basis for the limitations of a “prodrug, deuterated compound, or a solvate thereof.”
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.
Claim(s) 1-3 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 7,544,812, hereinafter ‘812.
The instant claims 1-3 are directed to compounds of formula (I) or pharmaceutically acceptable salts thereof:
PNG
media_image3.png
144
388
media_image3.png
Greyscale
Claim 8 limits the salts of the compounds of formula (I) to metal ions or ammonium ions and claim 9 is directed to a pharmaceutical composition of the compounds of claim 1 and a pharmaceutically acceptable carrier. Claim 10 limits the pharmaceutical composition of claim 9 to being a capsule, a powder, a tablet, a granule, a pill, an injection, a syrup, an oral liquid, an inhalant, and ointment, a suppository, or a patch.
‘812 teaches Examples 128, 134, and 135, pictured below (column 185, lines 30-50; column 194, lines 5-20; and column 196, lines 35-50):
PNG
media_image4.png
347
309
media_image4.png
Greyscale
PNG
media_image5.png
260
342
media_image5.png
Greyscale
PNG
media_image6.png
268
350
media_image6.png
Greyscale
‘812 further teaches the compounds of the reference are useful as PPAR modulators (column 4, lines 60-64). The reference further teaches salts of the compounds which includes metal salts and ammonium salts (column 8, lines 1-7). The compounds of the reference claim may be formulated in a composition comprising the compound and a pharmaceutically acceptable excipient, including carriers (column 12, lines 1-19). Further, these compositions may be formulated as tablets, pills, powders, granules, capsules, syrups, injections, or sprays (columns 12-14). However, the reference does not teach the same attachment pattern of the hydantoin core to the linker-phenyl substituent (circled in black below).
PNG
media_image7.png
347
309
media_image7.png
Greyscale
PNG
media_image8.png
260
342
media_image8.png
Greyscale
PNG
media_image9.png
268
350
media_image9.png
Greyscale
MPEP § 2144.09(II) states, “compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2 groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.”
The person of ordinary skill in the art would modify the hydantoin core, taught by ‘812, to facilitate a positional isomer which has a sufficiently close structural similarity that the person or ordinary skill in the art would have a presumed expectation of the compounds having similar properties. The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds would possess similar activity (i.e., they would be pharmacologically active PPAR modulators) with potential for better bioavailability and lower side effects. There would be a reasonable expectation of success in producing and using the instantly claimed compounds in view of the compound taught by ‘812.
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. 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.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Liu et al. (Eur J Med Chem, 2021, 218:113388) is considered pertinent for teaching PPAR modulators with similar substituents as the instant compounds.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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, Andrew Kosar can be reached at (571) 272-0913. 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.
/J.D.M./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
Prosecution Insights