CLAIMS 1-20 ARE PRESENTED FOR EXAMINATION
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 .
Applicant’s Information Disclosure Statements filed January 09, 2026 have been received and entered into the application. As reflected by the attached, completed copies of form PTO/SB/08, the cited references have been considered by the Examiner.
Claim Rejection - 35 USC § 112
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 17-20 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.
Taking claim 18 as an example, claim 18 is indefinite for reciting the phrase “when the oral dosage is administered to a patient, the patient experiences less tachycardia…” because one of ordinary skill in the art could not reasonably determine the metes and bounds of this limitation. Specifically, it is not clear how the limitation in claim 18 further limits the dosage form in the kit of claim 1 with respect to either the patient population, the step of administration, the dosage form, the dosage amount or the objective of administration or else adds some type of functional-descriptive limitation to the claim.
The specification uses the term “tachycardia” on nine specific instances (see paragraphs 0031, 0033, 0034, 0151, 0153, 0369, 0372, 0466, and 0472. However, none of the uses or description of the limitation in claim 13 explains how a treatment method without tachycardia is achieved.
Paragraphs 0151 and 0152 of the Specification state:
“In some embodiments of the method described herein, administering results in substantially no cardiac effects. In some embodiments, the cardiac effects are selected from tachycardia, hypotension, premature ventricular contractions, and other tachyarrhythmias.
In some embodiments of the method described herein, administering results in hair regrowth with substantially no clinically significant hemodynamic changes in blood pressure. In some embodiments, administering results in hair regrowth with substantially no cardiac effects. In some embodiments, the daily dose of minoxidil or a pharmaceutically acceptable salt thereof results in substantially no cardiac effects or hemodynamic effects as compared to administration of an immediate-release oral minoxidil or a pharmaceutically”
Paragraph 0466 of the Specification demonstrates a clinical trial using 5 mg that 1 patient developed tachycardia, which appears contrary to claim 18’s intended result of the functional descriptive claim language.
Taken as a whole, it is still not clear how the disputed limitation of claim 18 further limits the dosage form in the kit of claim 1, and is therefore indefinite.
The same rationale can be equally applied to each of claims 17, 19 and 20.
Accordingly, the claims are deemed properly rejected.
Claim Rejection - 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 interpretation of claims 1-5 and 14-16:
For the purposes of consideration under 35 U.S.C. 102 below, it is deemed that in claim 1, “written instructions…pharmaceutically acceptable salt thereof” is printed matter not related to the dosage form of minoxidil present in the claimed kit and is owed no patentable weight in the Examiner’s analysis of anticipation.
The Examiner is guided in his above determination by the following:
Where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864.
"[O]nce it is determined that the limitation is directed to printed matter, [the examiner] must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." In re DiStefano, 117 USPQ2d 1265, 1268 (Fed. Cir. 2015).
Thus, no further comment regarding the subject matter of the written instructions of claim 1 or the recitations of claims 2-5 and 14-16, which are also considered to be written instructions, will be given by the Examiner in the following rejection. The claims themselves will nevertheless be included in the rejection.
Claims 1-5 and 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sinha, (U.S. 2024/0474594, (effective 09/29/21).
Sinha teaches a “package’, (see at least [0028], line 2; “package” is seen to read on the claimed term “kit”), comprising an oral dosage comprising “about 5 mg to about 10 mg” of minoxidil, ((which dosage range is seen to read each dosage amount between 5 and 10 mg and thus read on “about 8.5 mg” which is not presently given patentable weight, but is here addressed in anticipation of Applicant amending the claim so as to require such amount of minoxidil); see at least the abstract, [0013], [0012] and (claims 10 and 16 of Sinha)). Also, a 5-alpha reductase inhibitor such as finasteride may be present as a co-active ingredient, [0034])-([0035]). The dosage form, which may be provided as a tablet, ([0042]), may provide delayed, sustained or enteric release, ((e.g., each a modified release dosage form) [0043]).
Sinha fails to teach that when administered the dosage a patient would experience a lessening of a particular physiological event as set forth in each of claims 17-20. However, insofar as the Applicant’s dosage form is the same taught by Sinha, it must be so that the characteristics of the prior art dosage form would be as is presently claimed in each of claims 17-20. Nothing of record establishes this not to be true.
As set forth in the MPEP at 2112 (V), "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted).” The fairness of placing the burden on Applicant is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. See In re Brown, 459 F.2d 531, 59 CCPA 1036, 173 USPQ 685 (1972).
Accordingly, for the above reasons, the claims are deemed properly rejected.
Claim Rejection - 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.
Claim interpretation of claims 1-5 and 14-16:
For the purposes of consideration under 35 U.S.C. 103 below, it is deemed that in claim 1, “written instructions…pharmaceutically acceptable salt thereof” is printed matter not related to the dosage form of minoxidil present in the claimed kit and is owed no patentable weight in the Examiner’s analysis of obviousness.
The Examiner is guided in his above determination by the following:
Where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864.
"[O]nce it is determined that the limitation is directed to printed matter, [the examiner] must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." 117 USPQ2d at 1268. In re DiStefano, 117 USPQ2d 1265, 1268 (Fed. Cir. 2015).
Thus, no further comment regarding the subject matter of the written instructions of claim 1 or the recitations of claims 2-5 and 14-16, which are also considered to be written instructions, will be given by the Examiner in the following rejection. The claims themselves will nevertheless be included in the rejection.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha, (U.S. 2024/0474594, (effective 09/29/21), for the reasons set forth above as applied to claims 1-5 and 13-20 under 102, which reasons are here incorporated by reference, in view of Reynolds et al., "Investigation of the Effect of Tablet Surface Area/Volume on Drug Release from Hydroxypropylmethylcellulose Controlled-Release Matrix Tablets", Drug Development and Industrial Pharmacy, 28(4), 457-466 (2002), (hereinafter “Reynolds”, cited by Applicant) and Jordan et al., (US 6,448,323, cited by the Examiner).
It is noted that Sinha further teaches that the dosage form may be provided as a tablet, ([0042]), may provide delayed, sustained or enteric release, [0043], and contain one or more diluents, carriers, excipients, fillers, disintegrants, solubilizing agents, dispersing agents, lubricants, glidants, binders, release aids, coatings etc.,([0042] and [0046]-[0047]).
The differences between the above and the claimed subject matter lie in that Sinha fails to teach (a) hydroxypropyl methylcellulose as being present in the oral dosage form, (b) polyvinyl alcohol as the coating material; and (c) the proportioning of release modifier, glidant, lubricant, filler and coating as in present claims 7-12.
However, 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 because (a) Sinha explicitly teaches; extended release dosage forms, [0043]; that among the auxiliary agents present, carriers/excipients may be used, (e.g., [0046]); that the compositions he teaches may be produced in accordance with general practice in the pharmaceutical industry, ([0045]); and that large macromolecules such as polysaccharides can be used as carrier compounds for the compositions, ([0049]). One of ordinary skill in the art would have been motivated to employ hydroxypropyl methylcellulose as an extended-release carrier in the compositions of Sinha because Reynolds teaches that “hydrophilic polymers, such as hydroxypropyl methylcellulose (HPMC), are commonly used as rate-controlling polymers for controlled drug release from matrix-type dosage forms”.
Sinha teaches coatings in general for the pharmaceutical dosage forms, such as tablets, and polyvinyl alcohol would have been one choice of various coatings available to one of ordinary skill in the art, (see Jordan at the abstract, for example, where an example of a polyvinyl alcohol-containing film coating for pharmaceutical tablets is disclosed). In the absence of evidence to the contrary, the selection of any particular coating from those known would have been a routine matter in the and well within the scope and spirit of the invention disclosed by Sinha.
Sinha teaches each of the claimed auxiliary agents of claims 7-12 and the determination of the optimum amount/proportions to employ to provide a dosage form useful for delivering a particular active agent or agents would have been a routine matter in the art and certainly a skill well within the purview of an artisan possessing ordinary skill in the art.
Accordingly, for the above reasons, the claims are deemed properly rejected.
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 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.
Provisional
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as
being unpatentable over claims 1-20, (unless otherwise specified), of copending Application
Nos. (reference applications): 19/094,703; 19/422,011; 19/427,955; 19/413,834; 19/242,858;
19/404, 931; 19/241,304; 19/230,051; 19/236,933; 19/235,535; 19/250,029; 19/324,046;
19/234,212; 19/329,476, (claims 1-19); 19/245,208; 19/303,300; 19/315,441; 19/230,007,
(claims 1-21); 19/409,546; 19/414,251; 19/430,022; 19/569,918 or 19/397,854.
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims only fail to include a kit means for packaging the dosage form of the methods claimed. It is believed that a mere packaging would have been at least required in the pharmaceutical industry for ensuring the integrity of the dosage forms after manufacture. Also, the written subject matter of the claims not present in the co-pending claims is not given any patentable weight for the reasons explained above under the rejections under 102 and 103.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Non-Provisional
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1-28 of U.S. Patent No. 12,268,688, (cited by Applicant).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims only fail to include a kit means for packaging the dosage form of the methods claimed. It is believed that a mere packaging would have been at least required in the pharmaceutical industry for ensuring the integrity of the dosage forms after manufacture. Also, the written subject matter of the claims not present in the patented claims is not given any patentable weight for the reasons explained above under the rejections under 102 and 103.
Accordingly, the claims are deemed properly rejected and none are currently in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYMOND J HENLEY III whose telephone number is (571)272-0575. The examiner can normally be reached M-F 6-2:30pm EST.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629
October 01, 2026
