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 .
Status of Claims
Claims 10-20 are pending in the instant application. Claims 1-9 are cancelled, claim 10-13 are amended and claims 16-20 are added via the amendment filed May 18th, 2026.
Priority
This is a 35 U.S.C. 371 National Stage filing of International Application No. PCT/US2022/037497 filed July 18th, 2022, which claims priority to 63/227,814, filed July 30th, 2021.
Withdrawn Rejections
Applicant’s arguments, filed May 18th, 2026 with respect to 102(a)(1) rejection of claims 1-4, 9 and 11-14 as being anticipated by Arrhenius have been fully considered and are persuasive. The 102 rejection of claims 1-4, 9 and 11-14 has been withdrawn.
Applicant has overcome this rejection by cancelling claims 1-9 and amending claim 10 to only recite compound 101.
Applicant’s arguments, filed May 18th, 2026 with respect to 102(a)(1) rejection of claims 1-4, 6-7 and 10 as being anticipated by CAS Registry No. 2325388-93-8 have been fully considered and are persuasive. The 102 rejection of claims 1-4, 6-7 and 10 has been withdrawn.
Applicant has overcome this rejection by cancelling claims 1-9 and amending claim 10 to only recite compound 101.
Applicant’s arguments, filed May 18th, 2026 with respect to 102(a)(1) rejection of claims 1-2, 4-5 and 8 as being anticipated by CAS Registry No. 21669427-96-6 have been fully considered and are persuasive. The 102 rejection of claims 1-2, 4-5 and 8 has been withdrawn.
Applicant has overcome this rejection by cancelling claims 1-9.
Applicant’s arguments, filed May 18th, 2026 with respect to 102(a)(2) rejection of claims 1-3, 12-13 and 15 as being anticipated by Morganroth have been fully considered and are persuasive. The 102 rejection of claims 1-3, 12-13 and 15 has been withdrawn.
Applicant has overcome this rejection by cancelling claims 1-9 and amending claim 10 to only recite compound 101.
Response to Remarks
Applicant’s arguments regarding the 102 rejections of claims 1-15 are moot, as Applicant’s amendments and cancellation of claims have overcome the rejections.
However, Applicant’s amendments have necessitated new rejections.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 18 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 18 fails to indicate what condonation is being treated, thus one skilled in the art would not know how to practice the method.
It is recommended that Applicant amend the claim to recite the condition to be treated with the administration of the composition according to claim 16.
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 19-20 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.
As the claim is written, it is unclear what result is to be achieved. It is unclear if the result is intended to be therapeutic and, if so, would the therapeutic intention apply to any and all types of cardiovascular and neurodegenerative diseases?
New Claim Rejections - 35 USC § 102
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.
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.
Claim 16 is newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2325388-93-8, which entered STN on June 6th, 2019, as necessitated by Applicant’s amendment.
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This compound is compound 102 of instant claim 16.
Regarding instant claim 16, which is drawn to a composition comprising the compound and a pharmaceutically acceptable excipient, the CAS Registry entry includes predicted properties including mass and molar solubilities at varying pH values. MPEP 2131.02 states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015)
In this situation, a person having ordinary skill in the art in viewing the properties of the Registry entry would at once envisage a composition with the compound and water, which is a pharmaceutically acceptable excipient.
New Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10-15 is/are newly rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb et al (US 2009/0163545 A1, published June 25th, 2009), as necessitated by Applicant’s amendment.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Goldfarb teaches the following compound (Table 1):
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.
This compound is nearly compound 101 of the instant invention.
Goldfarb also teaches a method of administering the compound above to subjects in need of treatment for heart disease and Alzheimer’s (paragraph [0042]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The instant claims encompass a compound that differs from the prior art compound (the compound above) by replacement of hydrogen with methyl, i.e. where the carbon of the phenyl ring adjacent to the imidazole has methyl instead of hydrogen (corresponding to compound 101 of instant claim 10).
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding the replacement of the hydrogen with methyl in the prior art compound, it is first noted that the prior art generally mentions changes to the structures of the compounds taught. Goldfarb teaches that the invention is also directed to the use of compounds with common substructures or scaffolds identified by analysis of the common structural features of the compounds identified in the present invention (paragraph [0016]).
Further, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its
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homologs because
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homologs
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often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210 at 1214. Furthermore MPEP 2144.09 (II) states: “Compounds which are […] homologs (…) 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 issue of patentability over the replacement of alkyl groups for hydrogen has arisen many times. For instance, the replacement of a methylene group with a dialkyl-substituted methylene group was determined to be prima facie obvious on the ground that “one skilled in the art would have been, prima facie, motivated to make the claimed compounds in the expectation that they, too, would possess antimicrobial activity." (In re Wood 199 USPQ 137).
Regarding claim 10, in the instant case, a person having ordinary skill in the art at the time the invention was made would have been motivated to synthesize the instantly claimed homologs with the reasonable expectation that it would have the same utility as the closest structurally related compounds taught by the prior art and with the motivation of obtaining additional useful compounds. Further, one of ordinary skill in the art would have found additional motivation to screen homologs of the prior art to arrive at the instant invention as both the prior art compounds and instantly claimed compounds have utility in treating various types of cardiovascular disease and neurodegenerative disease.
Regarding instant claim 11, which is drawn to a composition comprising the compound and a pharmaceutically acceptable excipient Goldfarb includes predicted properties of the compound in Table 1.
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015)
In this situation, a person having ordinary skill in the art in viewing the properties of the compound would at once envisage a composition with the compound and water, which is a pharmaceutically acceptable excipient.
Regarding claim 12, the prior art is silent regarding “inhibiting human epithelial 15-(S)-lipoxygenase”. However: “inhibiting human epithelial 15-(S)-lipoxygenase” will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (a compound of formula I) is being administered to the same subjects (any cell). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “inhibiting human epithelial 15-(S)-lipoxygenase”, by practicing the method taught by the prior art: "the administration of a compound of formula I to any cell", one will also be “inhibiting human epithelial 15-(S)-lipoxygenase” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“inhibiting human epithelial 15-(S)-lipoxygenase”) of the method taught by the prior art ("the administration of a compound of formula I to any cell).
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Regarding claims 13-15, as seen above, Goldfarb teaches the administration of the compound in a method of treating heart disease and Alzheimer’s.
Allowable Subject Matter
Claims 17 IS objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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