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
This application is a national stage entry of PCT/CN2021/135633 filed on 12/06/2021. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in CHINA on 12/07/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-7) drawn to a triazolopyrazine compound represented by formula I, or stereoisomer, geometric isomer, tautomer, hydrate, solvate, and pharmaceutically acceptable salt or prodrug thereof and compound TDM-181021 as a species of a compound of formula I in the reply filed on June 11, 2026 is acknowledged.
Claims 6-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim.
Claims 1-5 are currently being examined as they read on the elected species.
Applicant’s elected species was not found in the prior art. However, claims 1-5 are being rejected for non-prior art issues under 35 USC 112(a).
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 includes low resolution figures of poor quality and thus are unclear. Appropriate correction is required.
Specification Objection
The disclosure is objected to because of the following informalities: Pages 3, 4, 6, 7 and 10 of the specification include low resolution figures of poor quality and thus are unclear. Furthermore, the general method for synthesizing compound 1 detailed on page 10 is illegible and it is impossible to determine what the figure is showing.
Appropriate correction is required.
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 1-5 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.
Claims 1-5 of the instant application claim a triazolopyrazine compound which is a compound represented by formula I
PNG
media_image1.png
146
224
media_image1.png
Greyscale
, or stereoisomer, geometric isomer, tautomer, hydrate, solvate, and pharmaceutically acceptable salt or prodrug thereof, wherein W is selected from a substituted or an unsubstituted aryl group or heteroaryl group; X is C or N; and R is H or any substituent group.
In the present case, the important factors leading to a conclusion of inadequate written description is the breadth of the claims, the lack of sufficient working examples of the compounds as claimed, and the lack of predictability in the art.
With regard to the breadth of the claims, the claims are drawn to an infinite number of compounds since W is selected from any substituted or any unsubstituted aryl group or heteroaryl group and R can be selected as any substituent group. Thus the choices for W and R encompass an infinite number choices.
35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111,1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim’s enablement is not equally conclusive of that claim’s satisfactory written description"). The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert, denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
An applicant shows possession of the claimed invention 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 v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaffv. Wells Bees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); EliLilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm.,927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). An application specification may show actual reduction to practice by describing testing of the claimed invention.
In the instant specification, Applicant has only provided evidence that two compounds, TDM-181020 (compound 1) and TDM-181021 (compound 2), which are stereoisomers of each other, were synthesized and studied (pages 10-14 of the specification). Thus the only compounds of Formula I exemplified in the instant specification are those wherein W is 1-methyl-pyrazole; X is C; and R is cyano. Therefore, despite the claims being drawn to an infinite number of compounds, the specification only demonstrates that Applicant was in possession of one compound and a stereoisomer thereof.
In addition to the broad scope of the claimed compounds, the claims also recite any tautomer, hydrate, solvate, or prodrug thereof. The specification does not provide any evidence that Applicant was in possession of any tautomer, hydrate, solvate, or prodrug thereof. Furthermore, the specification also does not provide any description of what is meant by tautomer, hydrate, solvate, or prodrug thereof. Thus, the specification does not describe and provide adequate instruction for how to prepare a tautomer, hydrate, solvate or prodrug thereof.
Therefore, with the exception of TDM-181020 (compound 1) and TDM-181021 (compound 2), the instant specification does not provide any evidence that Applicant was in possession of the claimed invention, including all claimed compounds, or any tautomer, hydrate, solvate, or prodrug thereof prior to the effective filing date of the instant application.
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held 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(1997); In re Gosteli, 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 invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. For example, disclosure of only a method of making the invention and the function may not be sufficient to support a product claim other than a product-by-process claim. See, e.g., Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at 1605; Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021. In the instant case, it would be highly unpredictable for a skilled artisan to prepare all compounds as claimed without proper guidance demonstrated in the instant specification. The specification provides guidance with respect to compounds 1 and 2 , but there is no guidance including starting reagents and reaction conditions for preparing other compounds or any tautomer, hydrate, solvate, or prodrug thereof. In addition, the instant specification states that the compounds have certain biological activity and it would be highly unlikely to predict the substituents of the compounds that will retain this activity. For example, even though compounds 1 and 2 are very similar in structure, compound 2 is shown to have improved inhibitory activity for Tyk2, Jak1 and Jak2 which demonstrates the unpredictability of the pharmaceutical arts. Thus it would be highly unpredictable that even compounds close in structure, let alone compounds having very distinct structures (as allowed for by the instant claims) would retain similar properties.
Thus since Applicant has not described in adequate detail compounds of formula I or any tautomer, hydrate, solvate, or prodrug thereof, other than compounds 1 and 2, and furthermore have not provided any evidence that such compounds exist, an ordinary skilled artisan could not completely envisage Applicants’ invention. Moreover, it is clear that the written description requirement has not been met since Applicant has not provided any evidence that Applicant was in possession of the claimed compounds, or any tautomer, hydrate, solvate, or prodrug thereof, other than compounds 1 and 2 prior to the effective filing date of the instant application. Thus the claims of the instant application are not supported by the instant specification and thus a rejection under 35 USC 112 (a) for failing to comply with the written description requirement is proper.
Conclusion
Claims 1-5 are rejected. Claim 3 is objected to. Claims 6-10 are withdrawn. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 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, Adam C. Milligan can be reached at (571)270-7674. 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.
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
Prosecution Insights