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 1-10, 12-14, 20-22, 24, 26, 27 and 30 are pending in the application. Claims 1-10 and 12-14 are rejected. Claims 20-22, 24, 26, 27 and 30 are withdrawn from further consideration.
Election/Restrictions
Applicant’s election of the species of the first compound listed in claim 5 to prosecute the invention of Group I, claims 1-10 and 12-14, in the reply filed on February 23rd, 2026 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 is not allowable. MPEP 803.02 states:
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. […]
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration. […]
If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush claim and claims to the elected species will be rejected, and claims to the nonelected species will be held withdrawn from further consideration.
As the 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has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration.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 1-10 and 12-14 have been examined to the extent that they are readable on the elected embodiment. Since the elected species is not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration.
Additional prior art was discovered incidental to the search of the elected species is applied below under 35 USC 102 in the interest of compact prosecution. Additional issues under 35 USC 112 that do not apply to the elected species were discovered incidental to the examination of the elected species and are similarly presented below.
Claims 20-22, 24, 26, 27 and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 February 23rd, 2026.
Claim Objections
Claim 9 refers to a compound of Formula (II) being selected from a group but where the recited the structures are not embraced by Formula (II) (but rather Formula (III)). While claim 9 still embraces a scope falling with the scope of the parent claim, “Formula (II)” should be replaced with “Formula (III)”.
Improper Markush Grouping
The nonstatutory Markush grouping rejection is based on a judicially approved “improper Markush grouping” doctrine. A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a “single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a “single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent. When an examiner determines that the species of a Markush group do not share a single structural similarity or do not share a common use, then a rejection on the basis that the claim contains an “improper Markush grouping” is appropriate. See the Federal Register, Vol. 76, No. 27, dated February 9, 2011, page 7166.
Claims 1-10 and 12-14 are rejected under improper Markush grouping as the claims contain an improper grouping of alternatively useable species. In the present case, at least (1) applies. It cannot be said that all members of the Markush group have a single structural similarity. While the structural formulas (I) and (II) possess a triazole ring in common, formulas (III)-(V) have no minimum structure in common with each other or with formulas (I) and (II). The core structure of formula (III) contains no heterocyclic group, the core structure of formula (IV) contains a pyridine ring and the core structure of formula (V) contains a pyrrolo[2,3-b]pyridine ring. These varying functional groups are not recognized to belong to the same physical or chemical class or to the same art-recognized class. For example, in the CPC classification system compounds containing a triazole ring are classified in C07D 249/00 and subgroups thereof, compounds containing a pyridine ring are classified in C07D 213/00 and subgroups thereof, compounds containing a pyrrolo[2,3-b]pyridine ring are classified in C07D 471/04 and compounds lacking a heterocyclic group are classified in various locations in C07C.
Therefore, it cannot be said that all members of the Markush group have a single structural similarity with respect to the functional groups present and the claims therefore are considered to contain an “improper Markush grouping”.
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 8 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 3 is rejected as indefinite since it provides a definition for variable “Rb1” but where this variable is not otherwise required in the claim. It is unclear if the structures are incomplete or if the definition is superfluous. Dependent claim 4 is rejected as indefinite for the same reason since it does not correct the issue.
Claim 8 is rejected as indefinite since it provides definitions for an embodiment of Formula (II) but provides a definition for the variable “n” that is not required in Formula (II). It appears that claim 8 was intended to define an embodiment of Formula (III).
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 8 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 8 defines an embodiment of Formula (II) and recites that Rb and Rc can join to form a ring, which is outside the scope defined 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 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) 1-10 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1069738-72-2, which entered STN on November 2nd, 2008.
CAS Registry No. 1069738-72-2 is drawn to the compound having the following formula:
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.
The compound above is recited as the first compound in instant claim 5 and corresponds to Applicant’s elected species. The compound is embraced by Formula (I) where Xa is S, Ra and Rb are substituted alkyl and Rc is substituted heterocycloalkyl. The compound is further embraced by claim 2 (first option for Ra-Xa where n is 1 and Ra1 is chloro, Rb is the third option and Rc is the first option where Rc1 is heteroaryl alkyl), claim 3 (Formula (Ia)), and claim 4. Regarding instant claims 6-10, these claims define embodiments within generic options of a parent claim that do not apply to the elected species and therefore do not exclude the elected species. Regarding instant claim 12, this claim only requires the presence of the compound itself, which is taught by the prior art.
Claim(s) 1-9 and 12-14 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent PGPub No. 2014/0235630 A1 by Wulf et al.
Wulf et al. teach the following compositions on page 15:
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The prior art further teaches the following composition on page 16:
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The compound 5-(2,6-dimorpholinopyrimidin-4-yl)-4-(trifluoromethyl)pyridin-2-amine has the following structure:
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The compound above is embraced by instant Formula (IV) of claim 1 where m is 0, n is 3, one instance of Ra is amino, another instance is substituted alkyl and the third is substituted heteroaryl. Regarding instant claims 2-9, these claims define embodiments with Formulas (I) and (II) and therefore do not exclude the species above. Accordingly, the prior art anticipates instant claims 1-9. The prior art teaches that compound B corresponds to olaparib on page 1:
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Accordingly, the prior art teaches a composition comprising both olaparib and a compound embraced by instant claim 1, further anticipating instant claims 12-14.
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, Renee Claytor can be reached at 571-272-8394. 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