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 .
DETAILED ACTION
Claims 1, 8-15, 22, 27-31, 35 and 36 are pending in the application. Claims 1, 8, 22 and 27-31 are rejected. Claims 9-15, 35 and 36 are withdrawn from further consideration.
Election/Restrictions
Applicant’s election of the following species of formula II where:
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to prosecute the invention of Group I, claims 1, 8, 22 and 27-31 in the reply filed on August 25th, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species appears free of prior art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the scope of claims 8, 22 and 27-31, which scope is free of prior art, and further expanded to the species cited under 35 USC 102, which are not allowable.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 1, 8, 22 and 27-31 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 9-15, 35 and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 without traverse in the reply filed on August 25th, 2025.
While the search has been limited as discussed above, additional issues (under 35 USC 112(b)) beyond the searched scope were discovered incidental to the expanded search and are presented below in the interest of compact prosecution.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on January 27th, 2023.
Claim Objections
The word “and” should be added between the last two compounds recited in claim 31.
The embodiment beginning on Applicant labeled page 21 for variable R1 is not preceded by the word “or”.
The embodiment beginning on Applicant labeled page 44 for variable R2 is not preceded by the word “or”.
The first full embodiment beginning on Applicant labeled page 59 for variable R4 is not preceded by the word “or”.
Applicant is advised that should claim 27 be found allowable, claim 28 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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, 8, 22 and 27-30 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.
Claims 1, 8, 22 and 27-30 are rejected as indefinite since claim 1 recites that “Z5 is optionally present and if present is -C(=O)-” but where the general formula does not appear to otherwise require the presence of a variable Z5. Dependent claims are rejected as indefinite for the same reason since they do not obviate the issue.
Claim 1, 8, 22 and 27-30 are rejected as indefinite based on the definitions of X4-X6 that include CONX3. The group appears to contain an improper valence since: (1) if the oxygen is doubly bound to carbon, nitrogen would only have two bonds and (2) if the oxygen is singly bound to carbon, carbon would only have two or three bonds. Since the group is depicted as neutral, it is unclear what group is being claimed. Dependent claims are rejected as indefinite for the same reason since they do not fully obviate the issue.
Claim 1, 8, 22 and 27-30 are rejected as indefinite based on the definitions of X7 that include CONX8. The group appears to contain an improper valence since: (1) if the oxygen is doubly bound to carbon, nitrogen would only have two bonds and (2) if the oxygen is singly bound to carbon, carbon would only have two or three bonds. Since the group is depicted as neutral, it is unclear what group is being claimed. Dependent claims are rejected as indefinite for the same reason since they do not fully obviate the issue.
Claims 1, 8, 22 and 27-30 are rejected as indefinite based on lists of variables for the various categories of R1, R2, R3 and R4 involving variables m, j and k. See: Applicant labeled pages 4, 10, 13, 15, 27, 33, 35, 37, 57, 58 and 62 of the claim set dated January 27th, 2023. For example, the following instance at the end of the first definition of R1 in claim 1 ends as follows:
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The word “or” in the last line separates relative to the next definition of R1; however, the word “or” in the middle line separates each variable of this embodiment implying that only one definition must be fall within the recited scope. Accordingly, it is unclear what definitions are broadly permitted if only one definition must be met. It is suggested that Applicant replace the corresponding instances of “or” with “and”. Dependent claims are rejected as indefinite for the same reason since they do not fully obviate the issue.
Claims 1, 8, 22 and 27-30 are rejected based on the numerous recitations of variables that “comprise” certain options or where a variable “comprises” one or more options. It is unclear if Applicant is reciting an open-ended Markush type group or if Applicant is attempting to claim that a certain moiety must be part of the structure in any fashion. In addition for the former possibility, MPEP 2173.05(h) states: “If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022) (each independent claim recites "a selection from the group comprising a person, an animal, an animated character, a creature, an alien, a toy, a structure, a vegetable, and a fruit." … (emphasis added).” Applicant is directed to the following instances:
the definition of “m and n” on Applicant labeled page 7 of the claim set dated January 27th, 2023;
the definition of “Z” on Applicant labeled page 8 of the claim set dated January 27th, 2023;
the definition of “Z” on Applicant labeled page 13 of the claim set dated January 27th, 2023;
the definition of “W” on Applicant labeled page 19 of the claim set dated January 27th, 2023;
the definition of “W” on Applicant labeled page 35 of the claim set dated January 27th, 2023;
the definition of “W” on Applicant labeled page 48 of the claim set dated January 27th, 2023;
the definition of “X7” on Applicant labeled page 50 of the claim set dated January 27th, 2023;
the definition of “W” on Applicant labeled page 65 of the claim set dated January 27th, 2023; and
the definition of “Q” on Applicant labeled page 70 (claim 30) of the claim set dated January 27th, 2023.
In the absence of a clear indication from the specification regarding which possibility was intended, it is suggested that Applicant recite that each noted variable “is” the corresponding option or list. Dependent claims are rejected as indefinite for the same reason since they do not fully obviate the issue.
Claims 1, 8 and 22 are rejected as indefinite since an embodiment of R1 on Applicant labeled 9 of the claim set dated January 27th, 2023 defines variables A1 and A2 that are not otherwise required by the embodiment. The same issue exists for an embodiment of R2 on Applicant labeled 55 of the claim set dated January 27th, 2023. Dependent claims are rejected as indefinite for the same reason since they do not obviate the issue.
Claims 1, 8, 22 and 27-30 are rejected as indefinite based on the following middle option of Z within a definition for R1 on Applicant labeled page 20 of the claim set dated January 27th, 2023, a definition for R2 on Applicant labeled page 43 of the claim set dated January 27th, 2023 and a definition for R4 on Applicant labeled page 59 of the claim set dated January 27th, 2023:
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It is unclear which moiety is the point of attachment since previous instances are drawn is if bound via -CH2O- but where the subsequent instance is bound via a ring nitrogen. Since the point of attachment is not clearly depicted, it is unclear if Applicant is attempting to claim both or one but not the other. Dependent claims are rejected as indefinite for the same reason since they do not fully obviate the issue.
Claims 1, 8 and 22 are rejected as indefinite since embodiments for R1 on Applicant labeled pages 25 (second instance), 27, 28 (two instances), 30 and 31 (two instances) of the claim set dated January 27th, 2023 refer to “each n is independently an integer” but where the embodiments only contain one instance of “n”. Accordingly, it is unclear to which additional instance of “n” the embodiments are referring. Dependent claims are rejected as indefinite for the same reason since they do not obviate the issue.
Claim 1 is rejected as indefinite since the definition of L, K and J provides for an option (CH3)2 that does not contain an open valence to be present in a ring structure.
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 27 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 27 recites that “R1 is aryl or heteroaryl” but where the definitions of R1 in parent claim 1 only correspond to this scope where R1 is –(CH2)-Z but where the definition of Z does not provide for all types of aryl of heteroaryl rings. See page 10 of the claim set dated January 27th, 2023 where the broadest options for Z are limited by ring size for monocyclic rings and where substitution is limited. The same issue exists for the definition of R2 relative to the broadest embodiments in claim 1. 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 28 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 28 recites that “R1 is aryl or heteroaryl” but where the definitions of R1 in parent claim 1 only correspond to this scope where R1 is –(CH2)-Z but where the definition of Z does not provide for all types of aryl of heteroaryl rings. See page 10 of the claim set dated January 27th, 2023 where the broadest options for Z are limited by ring size for monocyclic rings and where substitution is limited. The same issue exists for the definition of R2 relative to the broadest embodiments in claim 1. 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 29 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 29 recites that “T is aryl or heteroaryl” but where the corresponding definition of T in parent claim 1 only recites options for T that are limited by ring size for monocycles. See page 27 of the claim set dated January 27th, 2023 for the broadest corresponding definition. The same issue exists for the definition of R2 relative to the broadest embodiments in claim 1. 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 30 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 30 recites that “T is aryl or heteroaryl” but where the corresponding definition of T in parent claim 1 only recites options for T that are limited by ring size for monocycles. See page 27 of the claim set dated January 27th, 2023 for the broadest corresponding definition. The same issue exists for the definition of R2 relative to the broadest embodiments in claim 1. Also claim 30 recites that “Q comprises C≡C” but where the corresponding definitions only recite that Q is CH=CH or C≡C. 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.
(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) 1 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent PGPub No. 2012/0010414 A1 b Yasuhara et al.
The prior art teaches the following compounds on page 36:
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The prior art compounds are embraced by formula (II) where A is a direct bond, B is N(R5), R5 is substituted alkyl, R1 is –(CH2)n-Z where n is 1 and Z is hydrogen, R2 is –(CH2)n-Z where n is 0 and Z is hydrogen, R3 is the ring depicted in claim 1 where G is CH, J and L are each (CH2)n where n is 2, and K is SO2, and R4 is hydrogen.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1791054-91-5, which entered STN on June 29th, 2015.
CAS Registry No. 1791054-91-5 is drawn to N-(tetrahydro-1,1-dioxido-3-thienyl)-1H-imidazole-5-carboxamide, which has the following structure:
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The prior art compound is embraced by formula (II) where A is a direct bond, B is N(R5), R5 is hydrogen, R1 is –(CH2)n-Z where n is 0 and Z is hydrogen, R2 is –(CH2)n-Z where n is 0 and Z is hydrogen, R3 is the ring depicted in claim 1 where G is CH, J and L are each (CH2)n where n is 1 or 2, and K is SO2, and R4 is hydrogen.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 8, 22 and 27-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 18, 19, 26, 27, 29, 31 and 47 of copending Application No. 18/835,417. Claim 29 of the patent recites a pharmaceutical composition containing a structure embraced by Applicant’s elected species.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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