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 a Non-Final Office Action.
Claims 1, 2, 8-26 and 29 are pending and under consideration.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 16, 2026 has been entered.
Information Disclosure Statement
The third-party information disclosure statement (IDS) submitted on July 28, 2023 (corrected from 2024) is in compliance with the provisions of 37 CFR 1.290. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the “or” after alkyl in the definition of Rb should be replaced with a comma. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claim 3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the limitation "0" in the definition of n, is withdrawn based on the amendments.
The rejection of claim 3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the limitation "methyl or ethyl" in the definition of R2, is withdrawn based on the amendments.
The rejection of claim 17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the limitation "cyano or C1-3 haloalkyl" in the definition of R1, is withdrawn based on the amendments.
The rejection of claim 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the limitation "cyano, halogen, C1-3 alkyl, C1-3 haloalkyl or C1-6 alkoxy" in the definition of R1, is withdrawn based on the amendments.
The rejection of claim 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the limitation "0 or 1… 2" in the definition of n, is withdrawn based on the amendments.
The rejection of claim 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the limitation "H” in the definition of R9, is withdrawn based on the amendments.
The rejection of claim 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the limitation "0” in the definition of n, is withdrawn based on the amendments.
The rejection of claim 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the limitation "provided that… R7 is not cyano … when R8 is H… R7 is H” in the proviso at the end of the claim, is withdrawn based on the amendments.
The rejection of claim 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the limitation " C3-8 cycloalkyl” in the definition of Rc, is withdrawn based on the amendments.
The rejection of claim 24 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the subformula "
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118
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”, is withdrawn based on the amendments.
The rejection of claim 24 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the subformula "
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”, is withdrawn based on the amendments.
The rejection of claim 5 under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for not further limiting claim 1, is withdrawn based on the amendments.
The rejection of claim 29 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the inhibition of Lp-PLA2 and the treatment of atherosclerosis and diabetic retinopathy, does not reasonably provide enablement for preventing diabetic retinopathy; or treating or preventing diabetic macular edema, diabetic nephropathy, diabetic neuropathy, diabetic peripheral neuropathic pain, diabetic foot, Alzheimer's disease, multiple sclerosis, amyotrophic lateral sclerosis, or Parkinson's disease, is withdrawn based on the amendments.
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the [fifth paragraph of 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 11 is rejected under 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 term benzoyl in the definition of L does not further limit 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.
To overcome the rejection, the phrase, “wherein L” may be replaced with “wherein Rc.”
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 § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 25 is rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Wan et al. (US 20170204108).
The present application claims compounds of formula (I), wherein U= CH2, X= CH2, Y= absent, Rx= H, R1= H, R2= methyl, Ra= H, n= 0, m= 1 or 2, Q= O, A= 2,6-diflurorphenyl-O-2-CF3-4-pyridyl, see compound 54 below from claim 25:
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.
The reference teaches compounds of formula (I), wherein U= CH2, X= CH2, Y= absent, Rx= H, R1= H, R2= H, Ra= H, n= 0, m= 1, Q= O, A= 2,6-diflurorphenyl-O-2-CF3-4-pyridyl:
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, see page 20, paragraph 0237.
The only difference between the claimed compound and the cited compound is the substitution at R2, H versus Applicant’s methyl. Since a methyl group is considered a homolog of hydrogen these compounds are considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Another comparison is provided below, wherein the present application claims compounds of formula (I), wherein U= CH2, X= CH2, Y= absent, Rx= H, R1= H, R2= methyl, Ra= H, n= 0, m= 1 or 2, Q= O, A= 3,4-difluorophenyl, see compound 62 below from claim 25:
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.
The reference teaches compounds of formula (I), wherein U= CH2, X= CH2, Y= absent, Rx= H, R1= H, R2= H, Ra= H, n= 0, m= 1, Q= O, A= 3,4-difluorophenyl:
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, see page 151, paragraph 2551 and page 152, paragraph 2571.
The only differences between the claimed compound and the cited compound are 1) the substitution at R2, H versus Applicant’s methyl; and 2) the substitution of the fluorine atom on the phenyl ring, 2-position versus Applicant’s 3-position.
Since a methyl group is considered a homolog of hydrogen and the difference in the substitution of the fluorine atom is a positional isomer, these compounds are considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Another comparison is provided below, wherein the present application claims compounds of formula (I), wherein U= CH2, X= CH2, Y= absent, Rx= H, R1= H, R2= methyl, Ra= H, n= 0, m= 1 or 2, Q= O, A= 2,6-diflurorphenyl-O-2-CF3-4-pyridyl:
, see compound 54 below from claim 25:
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.
The reference teaches compounds of formula (I), wherein U= CH2, X= CH2, Y= absent, Rx= H, R1= H, R2= H, Ra= H, n= 0, m= 1, Q= O, A= 2,6-diflurorphenyl-O-2-CF3-4-pyridyl:
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,
see page 20, paragraph 0237.
The only differences between the claimed compound and the cited compound are 1) the substitution at R2, H versus Applicant’s methyl; and 2) the size of the fused ring on the left side of the molecule, a five-membered ring versus Applicant’s six-membered ring. Since a methyl group is considered a homolog of hydrogen and the difference in the size of the ring are also considered homologues, these compounds are considered equivalent.
The reference teaches the same utility as Lp-PLA2 inhibitors, see the abstract.
Thus, said claims are rendered obvious by Wan et al.
Claim 25 is rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Xiao et al. (US 20230242532).
The present application claims compounds of formula (I), wherein U= CH2 or absent, X= CH2 or absent, Y= absent, Rx= H, R1= H, R2= absent, Ra= H, n= 1 or 2, m= 1 or 2, Q= O, A= 2-flurorphenyl-O-2-CF3-4-pyridyl or 2-flurorphenyl-O-2-methyl-4-pyridyl, see compounds 118 and 120 below from claim 25:
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The reference teaches compounds of formula (I), wherein U= CH2, X= CH2, Y= absent, Rx= H, R1= H, R2= absent, Ra= H, n= 2, m= 1, Q= O, A= 2-flurorphenyl-O-2-CF3-4-pyridyl or 2-flurorphenyl-O-2-methyl-4-pyridyl:
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, see page 30, compounds 4 and 7.
The difference between the claimed compounds and the cited compound is the substitution on the phenyl ring of A, fluorine atom at the 5-position versus Applicant’s H. The genus on page 2 of the ‘532 publication teaches that the Ar may be optionally substituted with halogen, see paragraph 0028. Furthermore, there are guideposts with a H at the 5-position, e.g., see page 30, compound 2. Therefore, H and fluorine are considered equivalent at this position.
The reference teaches the same utility as Lp-PLA2 inhibitors, see the abstract.
Thus, said claims are rendered obvious.
Claims 1, 2, 8-12, 16-21, 24, 26 and 29 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Xiao et al. (US 20230242532).
The present application claims compounds of formula (I), wherein one of U or X is absent, U= CH2 or absent, X= CH2 or absent, Y= absent, Rx= H, R1= H, R2= absent, Ra= H, n= 1 or 2, m= 1 or 2, Q= O, A= 2-flurorphenyl-O-2-CF3-4-pyridyl or 2-flurorphenyl-O-2-methyl-4-pyridyl:
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The reference teaches compounds of formula (I), wherein U= CH2, X= CH2, Y= absent, Rx= H, R1= H, R2= absent, Ra= H, n= 2, m= 1, Q= O, A= 2-flurorphenyl-O-2-CF3-4-pyridyl or 2-flurorphenyl-O-2-methyl-4-pyridyl:
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, see page 30, compounds 4 and 7.
The main difference between the claimed compounds and the cited compound is U= CH2 and X= CH2 versus Applicant’s one of U or X is absent for Y to be absent. These compounds are homologues based on the size of the rings and are considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
The genus on page 2 of the ‘532 publication teaches that X1 or X2 is oxygen or N(methyl), see column 2, paragraph [0026]. Therefore, these atoms or groups are considered equivalent.
The reference teaches the same utility as Lp-PLA2 inhibitors, see the abstract.
Therefore, the instant invention is prima facie obvious from the teachings of the prior art.
Thus, said claims are rendered obvious.
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, 2, 8-26 and 29 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14, 17 and 19-23 of copending Application No. 18289475. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application is drawn to compounds of formula (I) and methods of intended use of said compounds, see the bottom-left formula. The claims in the ‘475 application are drawn to compounds of formula (I), see bottom-right formula.
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The only difference between the two formulas is the size of the center fused ring, a 6-membered versus Applicant’s 5-membered. These compounds are homologues and are considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
The compounds are drawn to the same utility.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Applicant states, “[T]his provisional obviousness-type double patenting rejection will be addressed, and Applicant will consider filing a terminal disclaimer once allowable subject matter has been indicated.”
Therefore, the rejection is maintained.
Conclusion
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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