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 .
Priority
The instant application, filed May 4, 2026, is a CON of PCT/CN2024/136693, filed December 4, 2024, which claims foreign benefit of applications PCT/CN2023/136412, filed December 5, 2023 and PCT/CN2024/105568, filed July 15, 2024.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on July 24, 2026 and September 11, 2026 were in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS documents were considered and signed copies of the 1449 forms are attached.
Restrictions/Elections
Applicant’s election of the invention of Group I (claims 92-104, drawn to a compound of formula (IVa)) in the reply filed on September 23, 2026 is acknowledged. Further, Applicant’s election of Compound C-12 as the elected species in the same reply is also acknowledged. Upon further consideration, the requirement for restriction and species election has been reconsidered in view of the fact that search and examination of the claims could be conducted without serious burden. The requirement is withdrawn.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on [ 4 ] is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Status of Claims
Currently, claims 92-108 are pending in the instant application and under consideration herein.
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 92-108 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 92, the claimed Formula (IVa) contains a variable Rua. The Rua variable is defined twice with two distinct definitions. First, the variable is defined to be hydrogen or 5-10 membered heterocyclyl; next, the variable is defined as just being 5-10 membered heterocyclyl. This renders the claim unclear because the same variable cannot simultaneously have two distinct definitions. The distinct definitions constitute a broad and narrow recitation within the same claim. Appropriate correction is required.
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 105-106 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of treating the listed diseases or disorders is not enabling for the claimed prophylactic treatment of the same, especially as it pertains to any form of type 1 diabetes mellitus. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
As stated in the MPEP 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue."
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
1. The nature of the invention
2. The state of the prior art
3. The predictability or lack thereof in the art
4. The amount of direction or guidance present
5. The presence or absence of working examples
6. The breadth of the claims
7. The quantity of experimentation needed, and
8. The level of skill in the art
The Nature of the Invention and Breadth of the Claims
The instant claims are drawn to a method for treating and/or preventing the claimed GLP-1 associated diseases and disorders such as type 1 diabetes mellitus, Type 1b diabetes mellitus, latent autoimmune diabetes, obesity, overweight, and various forms of Type 2 diabetes mellitus.
The Amount of Direction / Guidance Present and the Presence or Absence of Working Examples
The specification fails to set forth any working examples commensurate in scope the claimed invention. That is, the specification does not show any examples where compounds of formula IVa were used to treat or prevent any of the claimed diseases, or even the receptor modulating activity purported in the specification. See MPEP 2164.02 (“Compliance with the enablement requirement of 35 USC 112, first paragraph, does not turn on whether an example is disclosed … Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”). The specification merely states that the compounds are agonists of GLP-1 and are useful to treat the claimed diseases, but such isnot “reasonably correlated” to the vast numbers of diseases listed in the specification or the vast number of compounds encompassed by the claimed formula. See MPEP 2164.02 (“The issue of “correlation” is related to the issue of the presence or absence of working examples. “Correlation” as used herein refers to the relationship between in vitro … assays and a disclosed or a claimed method of use. An in vitro … example, in the specification, in effect, constitutes a “working example” if that example “correlates with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute “working examples.” … For a claimed genus, representative examples together with a statement applicable to the genus as a whole will ordinarily be sufficient if one skilled in the art … would expect the claimed genus could be used in the manner without undue experimentation”). Further, there is no evidence to support the assertion that agonism of the GLP-1 receptor would be successful in preventing the onset of any of the claimed diseases. The limited amount of in vitro testing performed in the disclosure does not reasonably correlate with the large number of diseases that fall with the scope the claims nor the large number of compounds that fall within the scope. That is, the limited testing set forth in the specification does not constitute a “working example” within the meaning of MPEP 2164.02 let alone a “representative” set of examples that would be required the describe this very large genus.
The State of the Prior Art and the Predictability or lack thereof in the art
With respect to the prevention of Type I diabetes. It is recognized in the art that the cause of Type 1 diabetes is unknown, but that it is most likely autoimmune in nature and further that there is no way to prevent an individual from developing type 1 diabetes (PubMed Health, “Type 1 diabetes,” June 28, 2011). Absent evidence of the correlation of the limited in vitro results to the prevention of diseases that are currently not viewed as being preventable, the instantly claimed methods recite subject matter that contravenes the knowledge in the relevant art. That is, Applicants limited disclosure is not representative of this enormous genus especially when said genus encompasses a large amount of unpredictable art.
The level of the skill in the art
The level of skill in the art is high, with the skilled artisan typically having an advanced degree such as a Ph.D. or MD.
The quantity of experimentation needed
As a result of the broad and unpredictable nature of the invention and the lack of specific guidance from the specification, it is respectfully submitted that the quantity of experimentation needed to make and or use the invention would be great. Note that there must be sufficient disclosure, either through illustrative examples or terminology, to teach those of ordinary skill how to make and use the invention as broadly as it is claimed. In re Vaeck, 947 F.2d 488, 496 & n.23, 20 USPQ2d 1438, 1445 * n.23 (Fed. Cir. 19991). Also note that the amount of guidance or direction needed to enable the invention is inversely related to the degree of predictability in the art. In re Fisher, 839, 166 USPQ 24. Thus, although a single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements, in cases involving unpredictable factors, such as most chemical reactions and physiological activity, more teaching or guidance is required. In re Fishcher, 427 F.2d 839, 166 USPQ 24; Ex Parte Hitzeman, 9 USPQ 2d 1823. Here, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases can be treated or prevented by the compound encompassed in the instant claims, with no assurance of success.
Conclusion
In conclusion, the specification fails to provide sufficient support of the method for preventing or prophylaxis of the claimed diseases, as a result necessitating one of skill to perform an exhaustive undertaking in order to practice the instantly claimed invention. “A patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001.
Conclusion
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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