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 the Claims
Claims 1-3, 6-12, 14, 17, 19, 21 and 23-28 are pending in the instant application and subject to examination herein.
Claim Rejections - 35 USC § 112(b) – Withdrawn
The prior rejection of claims 7 and 27 under U.S.C. § 112(b) is withdrawn in response to Applicant’s amendment of claims 7 and 27.
Claim Rejections - 35 USC § 112(d) – Withdrawn
The prior rejection of claims 23 and 28 under U.S.C. § 112(d) is withdrawn in response to Applicant’s amendment of claims 23 and 28.
Claim Rejections - 35 USC § 102 – Withdrawn
The prior rejection of claims 1, 6-11, 19, 24-26 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Huston (WO 2015/073836 A1) is withdrawn in response to Applicant’s amendment of claims 1 and 24.
The prior rejection of claims 1, 6, 8-10, 14, 23-28 under 35 U.S.C. 102(a)(1) as being anticipated by Veale (Veale, et al.; Medicinal Chemistry Communications, v9, pp2037-2044; 2018) is withdrawn in response to Applicant’s amendment of claims 1, 23-24 and 28.
The prior rejection of claims 1, 6, 8-10, 17 and 24 under 35 U.S.C. 102(a)(1) as being anticipated by Norcross (Norcross, et al.; Journal of Medicinal Chemistry, v59, pp6101-6120; 2016) is withdrawn in response to Applicant’s amendment of claims 1 and 24.
The prior rejection of claims 1, 6, 8-10, 21 and 23-28 under 35 U.S.C. 102(a)(1) as being anticipated by Spalenka (Spalenka, et al.; Antimicrobial Agents and Chemotherapy, v62, article e01640-17; pp1-10; 2018) is withdrawn in response to Applicant’s amendment of claims 1, 23-24 and 28.
Claim Rejections - 35 USC § 102 – Necessitated by Amendments
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.
Claims 1, 6, 9-11, 21 and 24-25 are anticipated by Tebbe.
Claims 1, 6, 9-11, 21 and 24-25 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tebbe (WO 2017/059191 A1).
Claim 1 is directed to a method of treating or inhibiting a parasitic disease in a subject comprising administering a composition comprising a compound of given formula, being a genus of pyrimidine/pyrimidinone compounds or super-annulated derivatives thereof, as shown in the table below. Claim 24 is directed to a compound of the same genus/structural formula as given in claim 1.
Tebbe discloses inhibitors of sepiapterin reductase (SPR) and uses of SPR inhibitors in the treatment of SPR-related diseases and/or disorders, including immunological disorders, including toxoplasmosis (paragraphs [0003]-[0005], [0067], [0070] and [0080]). Tebbe discloses compounds that anticipate the formulae of instant claims 1 and 24, including Tebbe’s compound Q-2801 shown in the table below (Table C, paragraph [0046], page 36):
Claim Number(s) of Instant Application
Instant Application
Tebbe
1, 24
PNG
media_image1.png
270
230
media_image1.png
Greyscale
wherein:
PNG
media_image2.png
206
376
media_image2.png
Greyscale
Thus, claims 1 and 24 are anticipated by the disclosure of Tebbe.
Claim 6 further limits claim 1 to wherein the subject suffering from the parasitic infection is human. Tebbe discloses that the preferred subject for treatments disclosed therein is human (paragraph [0066]).
Claim 9 further limits the method of claim 1 to wherein the composition to be administered comprises a pharmaceutically acceptable carrier, excipient or solvent. Claim 10 further limits claim 1 to wherein the composition is administered by any of a Markush group of administration routes that includes oral administration. Claim 11 further limits claim 10 to a Markush group of oral administration compositions that includes capsule and tablet. Tebbe discloses pharmaceutical compositions comprising a compound disclosed therein with a pharmaceutically acceptable excipient such as diluent or carrier (paragraph [0081]), and further discloses such compositions for oral administration in the form of capsules and tablets (paragraph [0088]).
Claim 21 further limits claim 8 to a disease caused by Toxoplasma gondii (i.e., toxoplasmosis), and is met by the disclosure of Tebbe.
Claim 25 further limits the genus of compounds of claim 24 to a narrower genus that is also met by Tebbe’s compound Q-280 shown in the table above.
Thus, claims 6, 9-11, 21 and 25 are anticipated by the disclosure of Tebbe.
Claims 24-25 are anticipated by Flaherty.
Claims 24-25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Flaherty (US 2021/0100797 A1)2.
The limitations of claims 24-25 are discussed in the rejection above and hereby incorporated into the instant rejection.
Flaherty discloses a genus of pyrimidinone compounds as adenylyl cyclase 1 (AC1) inhibitors, including multiple compounds that anticipate the genus of compounds of claim 24, such as Flaherty’s compound 53 shown in the table below (paragraph [0138]):
Claim Number(s) of Instant Application
Instant Application
Flaherty
24
PNG
media_image1.png
270
230
media_image1.png
Greyscale
wherein:
PNG
media_image3.png
216
216
media_image3.png
Greyscale
Thus, claims 24-25 are anticipated by the disclosure of Flaherty.
Claims 24-28 are anticipated by Watts.
Claims 24-28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Watts (US Patent No. 10,662,176 B2)4.
The limitations of claims 24-25 are discussed in the rejection above and hereby incorporated into the instant rejection.
Watts discloses a genus of pyrimidinone compounds as adenylyl cyclase 1 (AC1) inhibitors, including multiple compounds that anticipate the genus of compounds of claim 24, such as the example shown in the table below:
Claim Number(s) of Instant Application
Instant Application
Watts
24
PNG
media_image1.png
270
230
media_image1.png
Greyscale
wherein:
PNG
media_image4.png
232
196
media_image4.png
Greyscale
N-[1-(5-ethyl-6-methyl-4-oxo-1,4-dihydropyrimidin-2-yl)-3-methyl-1H-pyrazol-5-yl]-4-chlorobenzamide
(Col. 19, lines 1-17)
Thus, claim 24 is anticipated by the disclosure of Watts.
Claims 25-27 further limit claim 24, each to a narrower genus of compounds, and each is met by Watts’ compound 9 shown in the table above.
Claim 28 further limits claim 24 to a Markush group of specific compounds that includes Watts’ compound shown in the table above (instant claims page 17, bottom row).
Thus, claims 25-28 are anticipated by the disclosure of Watts.
Claims 24-25 and 27-28 are anticipated by Dziomko.
Claims 24-25 and 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dziomko (Dziomko, et al.; Khimiya Geterotsiklicheskikh Soedinenii, v7, pp963-967; 1981).
The limitations of claims 24-25 and 27-28 are discussed in the rejection above and hereby incorporated into the instant rejection.
Dziomko teaches the synthesis of a series of pyrimidinyl-pyrazolo-pyridine compounds and the synthetic intermediates in their preparation, including Dziomko’s compounds IV5 and X6 shown in the table below (page 963-structures, and page 966-synthetic procedures):
Claim Number(s) of Instant Application
Instant Application
Dziomko
24
PNG
media_image1.png
270
230
media_image1.png
Greyscale
wherein:
PNG
media_image5.png
162
214
media_image5.png
Greyscale
Dziomko’s compound IV
24
PNG
media_image1.png
270
230
media_image1.png
Greyscale
wherein:
PNG
media_image6.png
184
208
media_image6.png
Greyscale
Dziomko’s compound X
Thus, claim 24 is anticipated by the teaching of Dziomko.
Claims 25 and 27 further limit claim 24, each to a narrower genus of compounds, and each is met by Dziomko’s compounds IV and X.
Claim 28 further limits claim 24 to a Markush group of specific compounds that includes the compound structures matching to Dziomko’s compounds IV and X (page 17, top row).
Thus, claims 25 and 27-28 are anticipated by the teaching of Dziomko.
Claim Rejections - 35 USC § 103 – Withdrawn
The prior rejection of claims 1-3, 6-10, 12, 14 and 23-28 under 35 U.S.C. 103 as being unpatentable over Veale (Veale, et al.; Medicinal Chemistry Communications, v9, pp2037-2044; 2018) in view of Croft (Croft, et al.; Emerging Topics in Life Sciences, v1, pp613-620; 2017) is withdrawn in response to Applicant’s amendment of claims 1, 23-24 and 28.
Allowable Subject Matter
Claims 2-3, 7-8, 12, 14, 17, 19 and 23 are 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
THIS ACTION IS MADE FINAL. 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 W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 N-cyclopentyl-5-methyl-1-(4-methyl-6-oxo-1,6-dihydropyrimidin-2-yl)-1H-pyrazole-
4-carboxamide
2 Effective Filing Date: 10/07/2019.
3 N-(l-(6-ethyl-4-oxo-1,4-dihydropyrimidin-2-yl)-3 -methyl-1H-pyrazol-5 -yl)-2-fluorobenzamide
4 Effective Filing Date: 01/24/2019.
5 2-(5-amino-3-methyl-1H-pyrazol-1-yl)-5-ethyl-6-methyl-3,4-dihydropyrimidin-4-one
6 N-[1-(5-ethyl-4-methyl-6-oxo-1,6-dihydropyrimidin-2-yl)-3-methyl-1H-pyrazol-5-yl]acetamide