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 group IX and species in the reply filed on January 19, 2026 is acknowledged.
Claims 1, 4-5, 11-17, 24-27, 74-75 are pending. Claims 2-3, 6-10, 18-23, 28-73 are canceled. Claims 75 is withdrawn. Claims 1, 4-5, 11-17, 24-27, 74 is examined.
Claim Rejections - 35 USC § 112
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 1, 4, 5, 11-17, 24-27, 74 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of treating specific cancer by administering a GPR174 inhibitor compound 10 claimed with structural limitations and adenosine A2A receptor inhibitor of specific compound, does not reasonably provide enablement for method of treating cancer generically by administering an generic inhibitors including comprising variant structure GPR174 inhibitor and generic adenosine A2A receptor inhibitor. 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.
The first paragraph of § 112 requires that the patent specification enable "those skilled in the art how to make and use the full scope of the claimed invention without `undue experimentation."' Genentech, Inc. v. Novo Nordisk AIS, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)); see also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). ("[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art."). Whether making and using the invention would have required undue experimentation, and thus whether the disclosure is enabling is a legal conclusion based upon several underlying factual inquiries. See In re Wands, 858 F.2d 731, 735, 736-37, 8 USPQ2d 1400, 1402, 1404 (Fed. Cir. 1988). As set forth in Wands, the factors to be considered in determining whether a claimed invention is enabled throughout its scope without undue experimentation include the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims.
Likewise, in Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991), the court affirmed the holding of invalidity of claims to analogs of the EPO gene under § 112 for lack of enablement where applicants had claimed every possible analog of the EPO gene but had disclosed only how to make EPO and a very few analogs. "[D]espite extensive statements in the specification concerning all analogs of the EPO gene that can be made, there is little enabling disclosure of the particular analogs and how to make them .... There may be many other genetic sequences that code for EPO-type products. Amgen has told how to make and use only a few of them and is therefore not entitled to claim all of them." Id., 927 F.2d at 1213-14, 18 USPQ2d at 1027.
Claims encompass a method of treating cancer generically by administering generic inhibitors including comprising variant structure GPR174 inhibitor and generic adenosine A2A receptor inhibitor. However, the specification does not teach the treatment of generic cancer with generic GPR174 and adenosine receptor A2A inhibitors. The specification teaches the method of treating with small molecule compound 10 which inhibit GPR174 and specific adenosine A2A receptor small molecule inhibitor . The state of the art is such that possibly small molecule inhibitor of GPR174 (Omeros Press Release, 2016). However, no treatment of generic cancer have been performed with GPR174 inhibitor in combination with generic adenosine receptor inhibitor.. The experimentation to show nexus to treatment of all cancer is unpredictable and undue because no nexus has been shown that any generic GPR174 inhibitor in conjunction with generic adenosine receptor A2A inhibitor treat any generic cancer. Furthermore, such generic inhibitors encompass a large genus of structural compounds that do not function as claimed. Furthermore, the working example teach the method using compound 10 GPR174 inhibitor compound 10 and adenosine A2A inhibitor to test in vivo and in vitro effects on cellular system. However, no examples are provided with the genus encompassed by the inhibitors of formula I Markush group of structures. No testing of the relationship of the structure of compound 10 with the Markush group structures of formula I which is enabled. No structure function relationship is provided between compound 10 and Markush group of formula I and effector effects. No structure function relationship of the generic inhibitor compounds is provided for the treatment of generic cancer. The working examples are drawn to relationship between compound 10 and immune checkpoint inhibitor function. However, no relationship between compound 10 and all generic cancers which are not affected by checkpoint inhibitor function.
Due to the large quantity of experimentation necessary to determine which generic compouds would function to inhibit GPR174 and can treat cancer, the lack of direction/guidance presented in the specification regarding same, the absence of sufficient working examples directed to same, the complex nature of the invention, the state of the prior art establishing that the generic inhibitors would function to treat cancer, and the breadth of the claims which fail to recite the requirement for a the relationship of generic Markush group of inhibitors and treatment of cancer, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Therefore, based on the above Wands analysis, a preponderance of the evidence supports a conclusion that one skilled in the art would not have been enabled to make and use the invention of claim without undue experimentation.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible.
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/MICHAEL D PAK/Primary Examiner, Art Unit 1674