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
The instant application is a 35 USC 371 National Stage entry of international application PCT/US2020/070073, which claims the benefit of an effective US filing date under 35 USC 119(e) from US Provisional Applications 62/851,386 and 62/987,932, filed May 22, 2019 and March 11, 2020, respectively.
Information Disclosure Statement
The information disclosure statements dated April 7, 2022; July 10, 2023; October 3, 2023 and March 10, 2023 were in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS documents were considered and signed copies of the 1449 forms are attached.
Election/Restrictions
Applicant’s election without traverse of the invention of Group I (claims 1-18, 20-21, 23 and 33), in the reply filed October 20, 2025 is acknowledged. Further, Applicant’s election without traverse of the compound recited in claim 33 (Formula (I) where E is azide, D is methylene, R is methylene, A is hydrogen and G is hydrogen) in the same reply is also acknowledged. Although Applicants indicate that claims 1-5, 11-12 and 33 read on the elected species, claim 4 requires a concatemer of 1-10 or more of the linkers (referring to variable D),while the instantly elected species requires D=CH2. Accordingly, claim 4 does not recite characteristics of the elected species.
Notably, in view of the claim amendment (dated March 19, 2026) to delete the requirement that Formula (I) is complexed to an agent, the inventions of Group I and III are now drawn to the same technical feature. Accordingly, the restriction between Groups I and III is withdrawn upon further consideration. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
It is noted that the requirement for an election of species is maintained. From within the rejoined claims, claims 27 and 28 read on the elected species and are therefore considered in the Office action herein.
In accordance with the MPEP, 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 and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). 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. Id. 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. Id.
As indicated above, the Examiner searched the claimed invention based on the elected species above, wherein: no prior art was discovered over the elected species. Accordingly, the scope of search and consideration has been expanded further to include the compound recited in the prior art rejection herein, having all the same features as the elected species except where E is C(=O)H.
Status of Claims
Currently, claims 1-15, 23, and 27-34 are pending in the instant application. Claims 4, 6-10, 13-15, 23, 30-32 and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention and/or species. Claims 1-3, 5, 11-12, 27-28 and 33 read on an elected invention and species and are therefore under consideration in the instant application to the extent that they read on the elected embodiment and extended scope described above.
Claim Objections
Claim 3 is objected to for containing an extra period within the text of the claim (see second-from-last line after “substituted heteroaryl.” Appropriate correction is required.
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 3, 4 and 12 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 3 and 12 each recite the broad recitations that R5 and R6 are alkyl. The claim also recite “such as methyl” which is the narrower statement of the range/limitation. Notably, none of the dependent claims correct the clarity issue with respect to the scope of the abovementioned variables. Claim 70 recites additional instances where the term “e.g.” is used to recite a narrow limitation following a claimed broad recitation. Each instance must be corrected. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language (“preferably” or “such as”) 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 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim depends from claim 1 which recites that in Formula I, E is selected from alkynes, azides, strained alkynes, dienes, dieneophiles, alkoxyamines, carbonyls, phosphines, hydrazides, thiols and alkenes. However claim 2 fails to further limit the formula of claim1 as there are entirely different functional groups recited for the definition of E which are not encompassed by those of claim 1. As a small example, claim 2 includes “substituted alkyl,” “substituted or unsubstituted aniline,” “substituted or unsubstituted SPh,” “substituted or unsubstituted nitrile oxide,” “substituted or unsubstituted nitrile,” etc. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-3, 5, 11-12 and 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aso et al.,
Aso et al. teaches the compound 2-ketoglutaraldehyde (see Abstract, p. 985). The prior art compound has the structure
PNG
media_image1.png
124
216
media_image1.png
Greyscale
, which reads on Formula I where G is H; R is methylene; A is H; D is methylene; and E is C(=O)H. The compound reads on Formula VI of claim 27 in the same way. Since the prior art teaches all required features of the instant claims, the 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 11-12 and 27-28, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of US Patent Application 19/302,667. Note that the rejection is provisional in nature because the copending claims have not, in fact, been patented.
Claims 1-5, 11-12 and 27-28, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of US Patent 12,428,666.
Although the claims at issue are not identical, they are not patentably distinct from each other because, the claims of the conflicting application and patent are drawn to the compound
PNG
media_image2.png
90
138
media_image2.png
Greyscale
, where specific anticipatory compounds are recited in conflicting claim 4 of the patent and claim 5 of the application. Accordingly, since the copending claims overlap with and completely encompass the instant claims, with anticipatory compounds taught in support of the claimed genus, a double patenting rejection is appropriate.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached Monday - Thursday 8:00 AM - 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, Fereydoun Sajjadi can be reached at 571-272-3311. 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.
/ALICIA L OTTON/Primary Examiner, Art Unit 1699
Prosecution Insights