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 .
This is the first action on the merits.
Election/Restrictions
Applicant's election without traverse of Group (I) in the reply filed on December 19, 2025 is acknowledged. Group V, drawn to macrocyclic compounds of formula (I) and compositions thereof, embraced by claims 1-5 and 7 was elected by Applicant.
Applicant elected, without traverse, the following species, Example 9:
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and indicated claims 1-5 and 7 read on said species. The initial search did not reveal any applicable art references. Therefore, the search was expanded.
Claims 15-28 are pending and claims 15-19, 21 and 26-28 are under consideration. Claims 15-28 are new claims. Claims 20 and 22-25 are withdrawn based on the restriction requirement.
Priority
Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) (PROVISIONAL) or 119(a) (FOREIGN) or under 35 U.S.C. 120 (CONT/CIP), 121(DIV), or 365(c) (WO) is acknowledged. Applicant still has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(a) as follows: The later-filed application must be an application for a patent application (the parent for an invention which is also disclosed in the prior application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed foreign applications, Application No. 202010534755.5 and Application No. 202010754738.2, fail to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for any claims of this application based on the translations received on May 21, 2026. The present formula I is broader in scope than in either one of said foreign applications. The R1, R2, R3 and R4 variables are presently defined as amino substituted with C2-C6 alkenylacyl or C3-C6 cycloalkyl acyl, which are not found in either foreign application. Moreover, the last species in claim 19 is also not found in either foreign application. There may be other omissions as well. Thus, the effective filing date of the present claims 15-28 remains the immediate filing date of January 11, 2021.
Withdrawn Rejections/Objections
Any outstanding rejection or objection that is not maintained in this office action has been withdrawn or rendered moot in view of Applicant's amendments and/or remarks. However, all the rejections and objections presented herein are new since all the claims are new.
Claim Objections
Claim 1 is objected to because of the following informalities: the “C3-C6 cycloalkyl” should be replaced with “C3-C6 cycloalkyl” in the definition of R1. Appropriate correction is required.
Claim 19 is objected to as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 112
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.
Claim 28 is 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 pre-AIA the applicant regards as the invention.
Regarding claim 28, the terms “carboxyl” and “aldehyde” lack antecedent basis, see page 19, the definition of R1.
The rejection may be overcome by amending to C1-C6 aldehyde and C1-C6 carboxyl.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 15-17, 21 and 26-28 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a written description rejection.
The analysis for adequate written description considers the following:
(a) Actual reduction to practice;
(b) Disclosure of drawings or structural chemical formulas;
(c) Sufficient relevant identifying characteristics, such as (i) complete/partial structure, (ii) physical and/or chemical properties, and (iii) functional characteristics when coupled with known or disclosed correlation with structure; and
(d) Representative number of samples.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571,39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written basis for the scope of the compounds of formula (I), wherein R1-R2 form a ring, which demonstrate antiviral activity. The mere fact that Applicant may have discovered several specific compounds of formula (I), is not sufficient to claim the entire genus of benzo[5-6 membered monocyclic heterocycle].
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
The rejection is made under 35 USC 112 (a), as written description is lacking.
The rejection may be overcome by narrowing the scope of the rings formed between R1-R2.
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 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.
Claim Rejections - 35 USC § 102
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.
Claim(s) 15-18, 21, 26 and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schuetz et al. (European Journal of Medicinal Chemistry, 2020, 207, 112810, 1-19).
The reference teaches the following species:
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, see page 4. The compounds were tested in a toxicity assay as a pharmaceutical composition, see page 3 for the biological evaluation at 10 and 20 uM.
As noted in the priority section above, the translations received by the office do not provide adequate support for the present claims. As such, the effective filing date of the present claims 15-28 remains the immediate filing date of January 11, 2021.
Thus, the claims are anticipated by Schuetz et al.
Claim Rejections - 35 USC § 103
The rejection of claims 1-3, 7 and 12-14 under AIA 35 U.S.C. 103(a) as being unpatentable over Pan et al. (CN 107033157) is withdrawn based on Applicant’s remarks regarding Table 1 in the specification on pages 63-64, which provides unexpected results based on the R1 variable.
Double Patenting
The provisional rejection of claims 1-5, 7 and 12-14 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of copending Application No. 18717918, is withdrawn based on the termerinal disclaimer submitted.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 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, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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