DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, 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, 2, 4, 7, 8, 14, 15, 18-20, 25, 33-36, 38, 44-47 and 50 are pending in the instant invention. According to the Amendments to the Claims, filed July 14, 2026, claims 14, 44 and 45 were amended and claims 3, 5, 6, 9-13, 16, 17, 21-24, 26-32, 37, 39-43, 48 and 49 were cancelled.
Status of Priority
This invention claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 63/504,824, filed May 30, 2023.
Restrictions / Election of Species
PNG
media_image1.png
248
244
media_image1.png
Greyscale
The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on July 14, 2026, is acknowledged: Group II - claims 1, 2, 4, 7, 8, 14 and 15. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Moreover, the inventor or joint inventor should further note that claims 18-20, 25, 33-36, 38, 44-47 and 50 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking claim.
Thus, a first Office action and prosecution on the merits of claims 1, 2, 4, 7, 8, 14 and 15 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying 6-((1r,4r)-4-phenylcyclohexyl)-5-(3-(trifluoromethyl)benzyl)pyrimidine-2,4(1H,3H)-dione of the Formula I.
The following title is suggested: PROCESS FOR PREPARING 6-((1r,4r)-4-PHENYLCYCLOHEXYL)-5-(3-(TRIFLUOROMETHYL)BENZYL)PYRIMIDINE-2,4(1H,3H)-DIONE.
Appropriate correction is required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, 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 reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to state reactions, reagents and/or process conditions for the method of preparing a substituted pyrimidine of the Formula I. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the reactions, reagents and/or process conditions for the method of preparing a substituted pyrimidine of the Formula I into the abstract, to overcome this objection.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a) and/or 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A process for preparing a compound of Formula I:
PNG
media_image2.png
321
316
media_image2.png
Greyscale
I
wherein the process comprises the following steps:
forming a first reaction mixture comprising a first solvent, an oxidizing agent selected from the group consisting of hydrogen peroxide, a hypochlorite, nitric acid, peroxydisulfuric acid, potassium chlorate, potassium permanganate, potassium peroxymonosulfate, and sulfuric acid, or a combination thereof, and a compound of Formula VIII:
PNG
media_image3.png
240
247
media_image3.png
Greyscale
VIII
wherein:
R is C1-12 alkyl;
to provide the compound of Formula I above.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The process of claim 1, wherein the process comprises a first solvent selected from the group consisting of acetone, N,N-dimethylacetamide (DMAc), N,N-dimethylformamide (DMF), dimethylsulfoxide (DMSO), ethyl acetate, isopropyl acetate, methyl acetate, N-methyl-2-pyrrolidone (NMP), 2-methyltetrahydrofuran (2-MeTHF), and tetrahydrofuran (THF), or a combination thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The process of claim 1, wherein R is C6-12 alkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The process of claim 1, wherein the compound of Formula VIII is:
PNG
media_image4.png
202
359
media_image4.png
Greyscale
.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The process of claim 1, wherein the process comprises an oxidizing agent selected from the group consisting of hydrogen peroxide, nitric acid, peroxydisulfuric acid, potassium chlorate, potassium permanganate, potassium peroxymonosulfate, and sulfuric acid, or a combination thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 14 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The process of claim 1, wherein the process comprises forming a first reaction mixture further comprising a strong acid.
Appropriate correction is required. See MPEP § 2173.02.
Claim 15 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The process of claim 14, wherein the process comprises a strong acid selected from the group consisting of benzenesulfonic acid, camphorsulfonic acid, chloric acid, ethanesulfonic acid, ethane-1,2-disulfonic acid, hydrobromic acid, hydrochloric acid, hypochlorous acid, hydrofluoric acid, methanesulfonic acid, naphthalene-2-sulfonic acid, naphthalene-1,5-disulfonic acid, nitric acid, perchloric acid, phosphoric acid, sulfuric acid, p-toluenesulfonic acid, trichloroacetic acid, trifluoroacetic acid, and trifluoromethanesulfonic acid, or a combination thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 1, 2, 4, 7, 14 and 15 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the phrase, oxidizing agent, in claim 1, is a relative phrase which renders the claim indefinite. The phrase, oxidizing agent, is not defined by the claim, 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. The specification, on page 10, uses open language, such as include, but are not limited to, to define the phrase, oxidizing agent, as hydrogen peroxide, etc.; however, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of preparing 6-((1r,4r)-4-phenylcyclohexyl)-5-(3-(trifluoromethyl)benzyl)pyrimidine-2,4(1H,3H)-dione of the Formula I has been rendered indefinite by the use of the phrase, oxidizing agent.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 2 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 2 recites the limitation, …wherein the first solvent comprises…, in line 1 of the claim.
Similarly, the inventor or joint inventor should further note that MPEP § 2111.03 states the transitional term, comprising, which is synonymous with including, containing, or characterized by, is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. {See Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004); Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948); and Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005)}.
Moreover, the inventor or joint inventor should further note that [A] Markush group must be definite and complete as to its membership. A Markush group is indefinite, and claims are rejected, where the Markush group is defined as comprising. {See Ex parte Morrell, 100 USPQ 317 (Bd. Pat. App. & Int. 1953)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 8 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 8 contains the trade name or trademark, OXONE®. The claim metes and bounds are uncertain, since (1) a trade name or trademark may not be used properly to identify any particular product, and (2) a trade name or trademark is used to identify a source of a product and not the product itself, respectively.
Similarly, the inventor or joint inventor should further note that a trade name or trademark does not adequately identify the product associated with the trade name or trademark, and consequently, the trade name or trademark, OXONE®, renders the claim indefinite.
Likewise, the inventor or joint inventor should further note that [W]here a trade name or trademark is used in a claim as a limitation to identify or describe a particular product, the claim does not comply with the requirements of 35 U.S.C. § 112, second paragraph. {See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Next, the inventor or joint inventor should further note that claim 8 also recites the limitation, …wherein the oxidizing agent comprises…, in lines 1-2 of the claim.
Then, the inventor or joint inventor should further note that MPEP § 2111.03 states the transitional term, comprising, which is synonymous with including, containing, or characterized by, is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. {See Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004); Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948); and Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005)}.
Moreover, the inventor or joint inventor should further note that [A] Markush group must be definite and complete as to its membership. A Markush group is indefinite, and claims are rejected, where the Markush group is defined as comprising. {See Ex parte Morrell, 100 USPQ 317 (Bd. Pat. App. & Int. 1953)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Claim 15 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 15 recites the limitation, …wherein the strong acid comprises…, in line 1 of the claim.
Similarly, the inventor or joint inventor should further note that MPEP § 2111.03 states the transitional term, comprising, which is synonymous with including, containing, or characterized by, is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. {See Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004); Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948); and Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005)}.
Moreover, the inventor or joint inventor should further note that [A] Markush group must be definite and complete as to its membership. A Markush group is indefinite, and claims are rejected, where the Markush group is defined as comprising. {See Ex parte Morrell, 100 USPQ 317 (Bd. Pat. App. & Int. 1953)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
Prosecution Insights