DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-8, 10, 13, 14, 21, 25, 59, and 61-66 are pending. Claims 9, 11, 12, 15-20, 22-24, 26-58, and 60 are cancelled. Examiner previously required a restriction (dated September 11, 2025). In response, Applicant elected, without traverse, Group I which encompasses claims 1-8, 10, 13, 14, 21, 25, 61, 62, 65, and 66. Accordingly, claims 59, 63, and 64 are withdrawn.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/IB2021/000708, filed on October 20, 2021. This application also claims the benefits of U.S. Provisional Application No. 63/094,808, filed on October 21, 2020.
In this office action, Examiner used the effective filing date of the International patent application PCT/IB2021/000708 (i.e., October 20, 2021) as the effective filing date of the instant application. This is because the provisional application does not provide written description support for the full scope of claim 1 of the instant application, for at least the following reason amongst potential others:
The provisional application does not provide written description support for the limitation:
“R is substituted alkyl, substituted heteroalkyl, or substituted heterocycloalkyl, the substituted alkyl being substituted with one or more substituent, at least one substituent being independently selected from the group consisting of… dithiolanyl sulfone… or the substituted heteroalkyl being substituted with one or more substituent, at least one substiuent being independently selected from the group consisting of dithiolanyl sulfone…when R is substituted alkyl and Lz is a bond… alkyl is substituted with one or more substituent, at least one substituent being independently selected from the group consisting of… dithiolanyl sulfone.”
Since claims 2-8, 10, 13, 14, 21, 25, 61, 62, 65, and 66 are all dependent on claim 1, these claims are also subjected to the same effective filing date of October 20, 2021.
Election/Restrictions
As a reminder, Applicant elected, without traverse, Group I which corresponds to claims 1-8, 10, 13, 14, 21, 25, 61, 62, 65, and 66. Applicant also elected the following species:
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199
327
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and indicated that this compound may read on claim 21. The elected species was not found in the prior art and, thus, the search was expanded.
Specification - Abstract
The abstract of the disclosure is objected to because it is not in compliance with 37 C.F.R. 1.72 (b). Specifically, the sheet presenting the abstract includes other parts of the application or other material. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 7, and 8 are objected to because of the following informalities:
In claim 1:
“when R is substituted alkyl and Lz is a bond, R is the substituted alkyl is substituted with…”
should read
“when R is substituted alkyl and Lz is a bond, R is the substituted alkyl and is substituted with…”
In claim 7:
“-O(C=O)(OCR8R9)z” should read “-O(C=O)(OCR8R9)z-”
In claim 8:
“-O(C=O)OCH(CH3)” should read “-O(C=O)OCH(CH3)-”
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 1, 10, 13, 14, 21, 25, 65 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.
The term “substituted” and the phrase “optionally substituted” in claims 1, 10, 13, 14, 21, and 25 with regard to alkyl, heteroalkyl, heterocycloalkyl, and cycloalkyl is a relative phrase which renders the claims indefinite. The term “substituted” and/or the phrase “optionally substituted” are not defined by the claims, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. Although the instant specification provides a large list of substituents that alkyl, heteroalkyl, heterocycloalkyl, and cycloalkyl can be substituted with, these substituents could also be further substituted. Neither the specification, nor the claims, explicitly limits the invention to any specifically disclosed or recited embodiments. Hence, claims 1, 10, 13, 14, 21, and 25 are rendered indefinite.
Claim 65 recites “wherein R is heterocycloalkyl which is N-substituted with alkyl further substituted with oxo and/or thiol.” The claim language, as currently worded, can be interpreted in at least the following ways:
R is heterocycloalkyl which is
N-substituted with alkyl AND
Oxo and/or thiol
OR
R is heterocycloalkyl which is N-substituted with alkyl wherein the N-substituted alkyl is further substituted with oxo and/or thiol.
Since claim 65 could have multiple interpretations, it is therefore rejected for being unclear.
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 6 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.
Claim 6 recites “wherein Lz is –(C=O)OCH2-, –(C=O)OCH2CH2-, or –(C=O)OCH2CH2CH2-.” Claims 6 is dependent on claim 4 which recites “wherein Lz is -(C=O)(OCR8R9)z-.” The alternatives for Lz recited in claim 6 falls outside the scope of claim 4. Hence, claim 6 is rejected for being of improper dependent form.
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.
Note on 35 USC § 102 and § 103 Rejections
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.
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.
Claims 1-5, 7, 8, 10, 13, 14, 21, 25, 61, 62, and 66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Holmes et al. (Holmes) (WO 2020212755 A1; published October 22, 2020).
Holmes discloses the following compounds:
Example 1 (i.e., compound 20 in Holmes, herein, referred to as Holmes-compound-20; see pg. 50)
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579
811
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which is a compound of instant formula (Ia’) wherein:
Lz = -(C=O)OCH(CH3)- and
R = alkyl substituted with dithiolanyl
and reads on instant claims 1, 3-5, 10, and 66.
Example 2:
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593
814
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which is a compound of formula (Ia’) wherein:
Lz = -O(C=O)OCH(CH3)- and
R = alkyl substituted with two -OH
and further reads on instant claims 7-8.
Example 3:
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59
810
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543
772
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which is a compound of formula (Ia’) wherein:
Lz = bond
R = heteroalkyl substituted with an oxo and two ester groups
and further reads on instant claims 2, 13, and 14.
Example 4:
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87
813
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477
612
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which is a compound of formula (Ia’) wherein:
Lz = bond
R = heteroalkyl substituted with an oxo and a heterocycloalkyl (wherein the heterocycloalkyl comprises 2 heteroatoms, both O, and is substituted with two alkyl groups)
and further reads on instant claims 21 and 25.
Holmes also discloses how Rabbit Cornea Homogenate stability of the test compounds was determined (pg. 79, Example 1: Rabbit Cornea Homogenate stability assay). To perform the assay, solutions comprising the test compounds (which includes, for example, Holmes-compound-20) were further diluted in HEPES pH7.5 buffer (which comprises pharmaceutically acceptable excipients like water) (pg. 79, para. 00268). Hence, the composition also reads on instant claims 61 and 62.
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 1-8, 10, 13, 14, 21, 25, 61, 62, and 66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-5, 7-11, 13-20 of U.S. Patent No. 10,875,845 B2 (‘845B2)
claim 1 U.S. Patent No. 11,634,411 B2 (‘411 B2)
claims 45-53, 55, 57-61, and 64 U.S. Patent Application No. 18/119,248 (‘248)
Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the instant claims and the two claim sets from the granted patents.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624