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
Instant application 17/766,149 filed on 04/01/2022 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1 -20 are pending.
The amendment filled on 05/23/2025 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/24/2024, 08/25/20223 and 07/12/2023 were in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election of Group 1, directed to products, in the reply filed on 05/23/2025 is acknowledged.
Applicant did not specify if the election is made with or without traverse. However, Applicant amended claims and limited X1 to S, N, NR2 and CR5 (deleted O) and pointed that the amended claims do not overlap with the disclosure of Nakamura (JP2007056005).
Since at the time of the restriction requirement, the claims recited X1 is O, S, N, NR2 and CR5, therefore, the restriction requirement is still deemed proper and is therefore made FINAL.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made in the reply filed on 05/23/2025
Regarding species election, Applicant’s election of compound 127 in the reply filed on 05/23/2025 is acknowledged.
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Applicant submitted that claims 1, 2, 3, 4, 6, 9, 10, 13, 14, 15, 16 and 17 read on the elected species.
Claims 5, 7, 8, 11 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made in the reply filed on 05/23/2025.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
A careful review of the prior art has indicated that elected species is free of the prior art. A claim directed to the elected species in independent form would be free of the prior art.
The examiner has moved onto alternative species:
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embodied within the general formula recited in the instant claim 1.
Claims 1, 2, 3, 4, 6, 9, 10, 13, 14, 15, 16 and 17 are under examination to the extend those claims read on selected species.
Claim Objections
Claim 16 is objected to for including unnecessary reference to the specification.
MPEP 2173.05(s) states: “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by referenceis a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd.Pat. App. & Inter. 1993)”
The structures and/or chemical names of the compounds recited in Table C1 could readily and practically be listed in the claim.
Claim Rejections - 35 USC § 112(b)
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, 9, 10, 13 and 15 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 2 and 3 recite the broad recitation X1 is NR2 (claim 2) and X2 is CR5 (claim 3), and the claims also recites optionally wherein R2 is H (claim 2) and optionally R5 is H (claim 3) which are the narrower statement of the range/limitation.
Similarly, claim 10 recite “optionally wherein one occurrence of Rb is….“ claim 13, recite “ optionally wherein X1 is…”, claim 15 recite “optionally wherein R2 is…”and claim 9 recite “Rb, such as …”.The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 1, 2, 3, 4, 6, 9 10, 13, 14, 15 and 17 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated 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 (Fed. Cir. 1997); In re Gostelli, 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 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, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, claim 1 is drawn to a compound of Formula I:
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The instant specification provides examples of compounds of Formula I (see Table C1) and data showing that the exemplified compounds inhibit STING (Table BA, pages 248-254).
However, in all examples provided in the instant specification, X1 is limited to NH and X2 is limited to CH. Further, in all examples R6 is limited to H.
Medicinal chemistry is unpredictable. As evidenced by Xue (Liang Xue, Ruixue Liu, Tingting Qiu, Huiying Zhuang, Hongwei Li, Lican Zhang, Ruijuan Yin, Tao Jiang, Design, synthesis, and activity evaluation of novel STING inhibitors based on C170 and H151, European Journal of Medicinal Chemistry,Volume 290,2025,117533) minor structural changes can lead to a significant difference in functional activity.
See conclusion in Xue:
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Without the Applicant providing adequate structure-function correlation for a representative number of species one cannot determine if all compounds recited in the instant claims would have STING inhibitory activity.
The description requirement of the patent statue 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, F.2d 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.
Examiner suggests limiting the compounds of Formula I to compounds with indole core (X1 is NH and X2 is CH) wherein R6 is H.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 6 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GB-1274081 (May 10, 1972).
This rejection applies to the expanded species:
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GB-1274081 discloses:
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that falls under the instant Formula I:
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wherein R1a, R1b, R1c and R1d are H; X1 is NR2, R2 is H, X1 is N, R6 is H, Q is NH, A is (Ya1)n-YA2, n=0 and YA2 is heteroaryl of 11 atoms wherein 1 ring atom are N and 1 rig atom is N(H).
Since the teachings of GB-1274081 meet all limitations of instant claims 1, 2, 4, 6 and 14, those claims are anticipated.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 3, 4, 6, 9 10, 13, 14, 15, 16 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-15 and 17 of copending Application No. 17/766,158 (reference application).
This rejection applies to the genus and expanded species.
The claims of copending Application No. 17/766,158 recite:
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Further, the claims of application No. 17/766,158 recite:
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The claims of the 17/766,158 application fail to recite an anticipatory specie but recites an overlapping genus and points to positions of substitution.
The instant claims are limited to Formula I wherein the positions corresponding to Z, Y1, Y2, Y3 in 17/766,158 bear carbon atoms (CR1d, CR1c, CR1d, CR1a) whereas the claims in 17/766,158 recite Z is selected from CR1, C(R3)2 C(R3)2, N and NR2 and Y1, Y2, and Y3 is selected from O, S, CR1, C(R3), N and NR2. Further, the claims of 17/766,158 recite Y4 is C or N whereas the instant Formula I limits this position to C.
Since there is a significant overlap in the genus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose the variables recited in claims of 17/766,158 to arrive at the compounds of instant Formula I.
Furthermore, starting from one of the following compounds recited in claim 16 of the 17/766,158 application:
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one of ordinary skill would be motivated to replace the nitrogen in the pyridine moiety (e.g., Z position in compound 206) for a carbon to arrive at the indole moiety present in compounds recited in instant claim 16 because claims of 17/766,158 recite CR1 (R1 is H) may be selected for Z position.
Further, one of ordinary skill would pick the Q-A variables from the list recited in claims of 17/766,158. The skilled artisan would have been motivated to prepare additional examples of STING inhibitors.
For example, one of ordinary skill would be inspired by compounds 145 and 216 recited claim 16 of 17/766,158 to arrive at the instant compound 129:
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MPEP 2144.04 states: “When chemical compounds have ‘very close’ structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Lintner, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972)”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Art Made of Record but not Applied
Claims of copending Application No. 18/271,186 recite:
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Doble patenting rejection over copending Application No. 18/271,186 has been considered but not made because the claims of 18/271,186 recite Formula I that necessarily bear Q1 ring substituted with Q2 ring (Rg) whereas the instant elected species bear halogen in R1b position (corresponding to the Q in 18/271,186).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 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, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S./ Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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