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/CN2022/083557 filed on 03/29/2022. Acknowledgment is made of applicant's claim for foreign priority based on the following FOREIGN APPLICATIONS:
PCTCN2022071548 filed on 01/12/2021
PCTCN2021083783 filed on 03/30/2021
PCTCN2021090945 filed on 04/29/2021
PCTCN2021128942 filed on 05/11/2021
PCTCN2021111479 filed on 08/09/2021
PCTCN2021130097 filed on 11/11/2021
PCTCN2021138806 filed on 12/16/2021
PCT CN2021143043 filed on 12/30/2021
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
Applicant’s amendment filed on April 16, 2026 cancelling claims 1-91 and adding new claims 92-111 has been entered. Claims 92-111 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 92-107) drawn to a compound of Formula I and compositions thereof, and compound 4 (as claimed in claim 103)
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as a species of a compound of Formula I in the reply filed on April 16, 2026 is acknowledged.
Claims 108-111 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 92-107 are currently presented for examination.
Applicant’s elected species was not found in the prior art and as such the search was expanded to include additional species.
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 92-102 and 105-107 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 92-102 and 105-107 of the instant application claim a compound of Formula I-1 having the following structure
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and compositions thereof, wherein each R₁ is independently selected from H, deuterium, and halogen; R₂ and R₃ are independently selected from the group consisting of O-(C₁-C₄ alkylene), -Tₐ-C₁- C₆alkyl-Tь-, and -Ta-O-Tb, wherein the C1-C₆alkyl is optionally substituted with one or more deuterium, or halo; Ta and Tb each independently are absent, -O-, C₁-C₆ alkyl, -O-(C₁-C₆ alkyl)-, or -(C₁-C₆alkyl)-O-; each R4 is independently selected from the group consisting of H, deuterium, halogen, and OR⁶; each R⁶ is independently selected from the group consisting of -H, deuterium, and C₁-₆alkyl, and each of which is independently optionally substituted with deuterium, or -OH; each X₁ is C=O; each X₂ is independently selected from -(C(R⁸)₂)(1-3), -NR⁸(C(R⁸)₂)(1-3), and -NH(C(R⁸)₂)(1-3); wherein each R⁸ is independently selected from the group consisting of H, deuterium, and C₁-C₆ alkyl; and each X₃ is COOR⁶, SO₂R⁶,
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or CN.
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 example of the compounds as claimed, and the lack of predictability in the art.
With respect to the breadth of the claims, the claims are drawn to numerous compounds which may contain numerous substituents. Thus the claims are deemed overly broad as they are drawn to an infinite number of compounds.
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 case, Applicant has described in the instant specification numerous compounds as claimed which demonstrate that Applicant was in possession of some of the compounds as claimed. Specifically, Applicant shows possession of compounds of Formula I-1 wherein each R₁ is independently selected from H and halogen; R₂-R₃ is O-(C2-C₄ alkylene)-O, O-(C2-C₄ alkylene), (C2-C₄ alkylene)-O, and C2-C₄ alkylene; each R4 is independently selected from the group consisting of H, halogen, and OR⁶; each R⁶ is independently selected from the group consisting of -H, and C₁-₆ alkyl; each X₁ is C=O; each X₂ is -(C(R⁸)₂)(1-3); wherein each R⁸ is independently selected from the group consisting of H and C₁-C₆ alkyl; and each X₃ is COOR⁶.
There is no disclosure of any other compound as claimed having the other substituents as claimed, and thus the instant specification does not provide any evidence that Applicant was in possession of all compounds as claimed 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, Applicant has taught how to prepare the compounds wherein each R₁ is independently selected from H and halogen; R₂-R₃ is O-(C2-C₄ alkylene)-O, O-(C2-C₄ alkylene), (C2-C₄ alkylene)-O, and C2-C₄ alkylene; each R4 is independently selected from the group consisting of H, halogen, and OR⁶; each R⁶ is independently selected from the group consisting of -H, and C₁-₆alkyl; each X₁ is C=O; each X₂ is -(C(R⁸)₂)(1-3); wherein each R⁸ is independently selected from the group consisting of H and C₁-C₆ alkyl; and each X₃ is COOR⁶, and furthermore have demonstrated STING binding activity for these compounds. Applicant has not provided any evidence that any other compound can be prepared or how to prepare them including the starting materials and reaction conditions necessary to synthesize the other compounds as claimed. Furthermore, other than the compounds specifically disclosed in the instant specification, Applicant has not demonstrated that any other claimed compound has any activity. Because the pharmaceutical arts is unpredictable, small modifications to a structure can have vastly different activity. Thus an ordinary skilled artisan would find the claims drawn to numerous compounds with various substituents highly unpredictable. For example, Applicant discloses compound 16 having the following structure
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does not bind STING (IC50 >150 nm) as compared to Applicant’s elected species having a similar structure
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but has potent STING binding activity with an IC50 of 0.18 nm (page 138 of specification). Thus, the claimed invention drawn to an infinite number of compounds is highly unpredictable.
Thus since Applicant has not described in adequate detail compounds other than those as detailed above wherein each R₁ is independently selected from H and halogen; R₂-R₃ is O-(C2-C₄ alkylene)-O, O-(C2-C₄ alkylene), (C2-C₄ alkylene)-O, and C2-C₄ alkylene; each R4 is independently selected from the group consisting of H, halogen, and OR⁶; each R⁶ is independently selected from the group consisting of -H, and C₁-₆alkyl; each X₁ is C=O; each X₂ is -(C(R⁸)₂)(1-3); wherein each R⁸ is independently selected from the group consisting of H and C₁-C₆ alkyl; and each X₃ is COOR⁶, and furthermore have not provided any evidence that any other 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 all compounds as claimed 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.
Claim Objections
Claims 103 and 104 are objected to as being dependent upon a rejected base claim.
Conclusion
Claims 1-91 are canceled. Claims 92-102 and 105-107 are rejected. Claims 103 and 104 are objected to. Claims 108-111 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.
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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.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
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