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/EP2022/058490 filed on 03/30/2022. Acknowledgment is made of applicant's claim for foreign priority based on applications filed in UNITED KINGDOM on 03/31/2021 and 10/06/2021. 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 1-31) drawn to a PARP7 inhibitor compound and compound 461 as a species of a PARP7 inhibitor compound in the reply filed on April 2, 2026 is acknowledged.
Claims 4, 37, 38 and 40-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim.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 1-3 and 5-31 are currently presented for examination.
Applicant’s elected species
PNG
media_image1.png
156
318
media_image1.png
Greyscale
was not found in the prior art. The closest related prior art is Perl et al. U.S. Publication No. 2021/0130342 A1 which discloses the following compound:
PNG
media_image2.png
218
454
media_image2.png
Greyscale
(page 23). However, said compound does not have a pyrazole ring fused to the pyridazine ring as claimed.
However, the claims are being rejected under 35 USC 112 as detailed below.
Claim Rejections - 35 USC § 112
Claims 1-3 and 5-31 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the formula as claimed in claims 1-3 and 5-31 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: Claim 1 of the instant application claims the following structure:
PNG
media_image3.png
192
246
media_image3.png
Greyscale
. Thus with the exception of a nitrogen in ring B, every part of the compound is variable. Thus the claims are drawn to numerous patentably distinct compounds. For example, ring A can be any ring known in the art including imidazole, pyrazole, oxazole, thiophene, phenyl, piperidine, etc. Furthermore, ring B can be any heterocycle ring containing at least one nitrogen atom, such as triazine, pyrazine, thiazole, pyridazine, pyrimidine, etc. In addition every part of R1 is variable, and thus there is not one single element shared for R1. The ring in R1 can be any heterocycle or carbocycle known in the art. Thus the compounds of the claims do not share a single structural similarity as required in a Markush claim.
With respect to claim 30 which is drawn to specific compounds, compounds 1-4, 13-43, 79-91, 93-116, 118-120, 122-124, 129-130, 139, etc. have the common feature of
PNG
media_image4.png
86
108
media_image4.png
Greyscale
, however claim 30 is also drawn to patentably distinct compounds such as compounds 5-12 and 44-49, etc. which have patentably distinct core structures, and compound 204 which contains
PNG
media_image5.png
98
112
media_image5.png
Greyscale
which is patentably distinct from the other compounds of the claim, as well as compound 144 which contains
PNG
media_image6.png
118
104
media_image6.png
Greyscale
and compound 128 which contains
PNG
media_image7.png
96
104
media_image7.png
Greyscale
which are patentably distinct from the other compounds of the claim. Thus the compounds of claim 30 are not drawn to compounds having a single structural component.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 11-13 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.
Claim 11 claims a compound according to claim 1, which compound comprises the following formula. However, there is no formula recited in the claims since the amendment to the claim deleted the formula previously presented. Thus claim 11 and claims depended upon claim 11 are rejected. For the sake of compact prosecution claim 11 is being interpreted as a compound according to claim 1, wherein m is 1, 2, or 3 and wherein R1….. and examined herewith.
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 1-3, 5-29 and 31 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 cited claims of the instant application are drawn to PARP7 inhibitor compounds having the following structure:
PNG
media_image3.png
192
246
media_image3.png
Greyscale
wherein R1 is
PNG
media_image8.png
178
300
media_image8.png
Greyscale
.
In the present case, the important factors leading to a conclusion of inadequate written description is the breath of the claims, the lack of sufficient working examples of a representative amount of compounds claimed, and the lack of predictability in the art.
With regard to the breadth of the claims, with the exception of a nitrogen in ring B, every part of the compound is variable. Thus the claims are drawn to an infinite number of compounds which include patentably distinct compounds. For example, ring A can be any ring known in the art including imidazole, pyrazole, oxazole, thiophene, phenyl, piperidine, etc. Furthermore, ring B can be any heterocycle ring containing at least one nitrogen atom, such as triazine, pyrazine, thiazole, pyridazine, pyrimidine, etc. Pages 14-15 of the instant specification teaches that ring A and B are fused and can be choses from an extremely large group. In addition every part of R1 is variable, and thus there is not one single element shared for R1. The ring in R1 can be any heterocycle or carbocycle known in the art. Thus the claims are 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); Eli Lilly, 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.
The instant specification does not provide sufficient evidence to demonstrate that Applicant was in possession of the entire scope of the compounds as claimed prior to the effective filing date of the instant application. Despite the claims being drawn to an infinite number of compounds, Applicant only provides support to demonstrate possession of a fraction of the claimed compounds. For example, support can only be found for ring B as
PNG
media_image9.png
86
66
media_image9.png
Greyscale
PNG
media_image10.png
88
64
media_image10.png
Greyscale
PNG
media_image11.png
100
70
media_image11.png
Greyscale
and
PNG
media_image12.png
90
64
media_image12.png
Greyscale
in the instant specification. However, the claims are drawn to compounds wherein ring B may contain rings atoms including O and S. There are no compounds disclosed in the instant specification wherein ring B contains an O or S atom. Furthermore, the only compounds as disclosed in the instant specification include compounds wherein ring A is selected from phenyl, pyrrolidine, piperidine, pyridine, pyrrole, morpholine, pyrazole, imidazole, piperazine, and thiophene. However, the instant claims encompass many rings other than those disclosed in the compounds exemplified in the instant specification. Furthermore, the scope of R1 as claimed is significantly broader than what is exemplified in the instant specification and thus R1 should be limited to the R1 groups of the compounds as claimed in claim 30 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, in the instant specification, Applicant states that the compounds should be chosen based on its ability to be a PARP7 inhibitor. It is further stated on page 14 that each of rings A and B are not necessarily limited, provided that they do not prevent the PARP7 inhibitory function from occurring. It would be unpredictable that all of the compounds as claimed would have the ability to inhibit PARP7. Moreover, a person of ordinary skill in the art would not be able to predict which compounds would inhibit PARP7 and thus practice the claimed invention without undue experimentation.
Thus since Applicant has not described in adequate detail compounds which represent the full scope as claimed 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 full scope of the compounds as claimed in the instant claims prior to the effective filing of the instant application. Thus all compounds as claimed 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 1-3 and 5-31 are rejected. Claims 4, 37, 38 and 40-50 are withdrawn. Claims 32-36 and 39 are canceled. 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