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
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 17 July 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner except where lined through. English translations of the lined through documents were not provided. See attached copy of PTO-1449.
Status of Application
2. The instant application is a continuation of Application 17/186442 (now U.S. Patent 12,213,975) filed 26 February 2021, which is a national stage entry of PCT/US2019/048898 filed 29 August 2019. Claims 1, 3-4, 8, 10, 17-18, 20-21, 25, 27, 29-30, 34-35, 38, 40, 42, and 46 are currently pending. Claims 2, 5-7, 9, 11-16, 19, 22-24, 26, 28, 31-33, 36-37, 39, 41, and 43-45 are cancelled. Claims 1, 3-4, 8, 10, 17-18, 20-21, 25, 27, 29-30, 34-35, 38, 40, 42, and 46 are examined on the merits within.
Claim Rejections – 35 U.S.C. 112(b)
3. 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.
4. Claims 10 and 30 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.
5. Claims 10 and 30 contain the trademark/trade name Opadry II. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a film coating and, accordingly, the identification/description is indefinite.
Claim Rejections – 35 U.S.C. 102
6. 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.
7. Claim(s) 20, 25, 34, and 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Svenstrup et al. (WO2017005786).
Svenstrup et al. teach PDE9 inhibitors for use in treatment of sickle cell disease. See abstract. Svenstrup et al. teach the compound P3 (racemate) and enantiomerically pure variants of compound P3 (i.e., polymorph). See page 6. Figure 3 shows Compound P3 in monohydrate form.
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Svenstrup et al. teach oral administration including solid tablets. See page 13. Dosage includes amounts of 0.5 mg to 200 mg. See page 14. Coatings may be enteric. See page 13.
Suitable pharmaceutical carriers include lactose, magnesium stearate, and lower alkyl ethers of cellulose. See pages 14-15.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Thus the friability and disintegration time should be the same.
Thus the instant claims are anticipated by Svenstrup et al.
Claim Rejections – 35 U.S.C. 103
8. 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.
9. Claim(s) 1, 3-4, 8, 10, 17-18, 20-21, 25, 27, 29-30, 34-35, 38, 40, 42, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Svenstrup et al. (WO2017005786) in view of Bell et al. (U.S. Patent Application Publication No. 2004/0220186).
Svenstrup et al. teach PDE9 inhibitors for use in treatment of sickle cell disease. See abstract. Svenstrup et al. teach the compound P3 (racemate) and enantiomerically pure variants of compound P3 (i.e., polymorph). See page 6. Figure 3 shows Compound P3 in monohydrate form.
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Svenstrup et al. teach oral administration including solid tablets. See page 13. Dosage includes amounts of 0.5 mg to 200 mg. See page 14.
Suitable pharmaceutical carriers include lactose, magnesium stearate, and lower alkyl ethers of cellulose. See pages 14-15.
Typical oral dosages range from about 0.001 to about 100 mg/kg body weight per day. Typical oral dosages also range from about 0.01 to about 50 mg/kg body weight per day. Typical oral dosages further range from about 0.05 to about 10 mg/kg body weight per day. Oral dosages are usually administered in one or more dosages, typically, one to three dosages per day. The exact dosage will depend upon the frequency and mode of administration, the gender, age, weight and general condition of the subject treated, the nature and severity of the condition treated and any concomitant diseases to be treated and other factors evident to those skilled in the art. See page 13. Coatings may be enteric. See page 13.
Svenstrup et al. do not teach microcrystalline cellulose.
Bell et al. teach PDE9 inhibitors for treating a variety of diseases. See paragraph [0001]. Solid dosage forms for oral administration include capsules, tablets, powders, and granules. Lubricants include magnesium stearate. See paragraph [0075]. Fumed silica or silicon dioxide may be added to fast dispersing dosage forms. See paragraph [0077]. Suspending agents include microcrystalline cellulose. See paragraph [0082]. Release rate modifiers including hydroxypropyl methylcellulose. See paragraph [0076-0077]. Fillers include starches while disintegrating agents including potato or tapioca starch. See paragraph [0075].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one type of cellulose for another and one type of starch for another to yield predictable results because these are commonly known ingredients effectively combined with PDE9 inhibitors and lactose, magnesium stearate and silicon dioxides. It would have been well within the purview of the skilled artisan to modify the amount of each ingredient and dosing regimen to optimize the solid dosage formulation to achieve the desired effect. Since the prior art makes obvious the combination of ingredients, one would have expected the properties to be the same, i.e., friability and dissolution time.
Double Patenting
10. 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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
11. Claims 1, 3-4, 8, 10, 17-18, 20-21, 25, 27, 29-30, 34-35, 38, 40, 42, and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 21-27, and 30-36 of copending Application No. 18/033662 in view of Bell et al. (U.S. Patent Application Publication No. 2004/0220186).
The instant application and Application No. 18/033662 are directed to Compound 1. The only difference lies in the fact that Application No. 18/033662 is directed to a method of using the compound to treat cardiac diseases. Bell et al. teach that PDE9 inhibitors treat cardiovascular diseases. See Title. Compound 1 of the instant invention is a PDE9 inhibitor. Thus it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use compound 1 of the instant invention to treat cardiovascular disease. The dependent claims are included in this rejection for being directed to similar amounts and dosing regimens.
This is a provisional nonstatutory double patenting rejection.
12. Claim 1, 3-4, 8, 10, 17-18, 20-21, 25, 27, 29-30, 34-35, 38, 40, 42, and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,213,975.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and U.S. Patent No. 12,213,975 are directed to an oral tablet comprising Compound 1 and either pregelatinized starch or microcrystalline cellulose and colloidal silicon or magnesium stearate. The only difference lies in the fact that U.S. Patent No. 12,213,975 is specifically directed to microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate, while the instant application can use pregelatinized starch in replacement of or in addition to microcrystalline cellulose and only one of silicon dioxide and magnesium stearate are required. Thus the two are not patentably distinct. The dependent claims are included in this rejection for being directed to similar amounts of ingredients and additional components.
Correspondence
13. No claims are allowed at this time.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
