CLAIMS 1-9 AND 16-22 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 amendment, remarks and Information Disclosure Statement filed April 20,
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. Also, the claims have been amended as directed by Applicant.
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.
Claim 6 is 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.
Claim 6 merely recites a physiological result which follows the administration of minoxidil as per the method of claim 1, i.e., that the dosage form is devoid of cardiac effects. However, the recitation of such a result does not equate to a further limitation of the patient population, minoxidil dosage form or the step of administration as recited in claim 1 and thus the supposed further limited metes and bounds of claim 6 as compared to claim 1 would be unclear to one or ordinary skill in the art.
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.
Claims 1-9, 16, 17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha, (U.S. 2024/0474594) in view of Reynolds et al., each of record for the reasons of record as applied to claims 1-20 as set forth in the previous Office action dated January 16, 2026, which reasons are here incorporated by reference.
Newly added claim 21 is deemed properly rejected because in both Sinha and the present claims the same orally administered dosage form comprising about 8.5 mg is present. It thus must necessarily be the case that whether recognized explicitly or not in Sinha, the release characteristics of newly added claim 21 would be inherently present.
Applicant's remarks have been carefully considered, but fail to persuade the Examiner of
error in his determination of obviousness.
In particular, Applicants have argued that the presently claimed subject matter would not
have been obvious because claim 1 is not prima facie obvious at least because all elements of the
claim are not taught or suggested in the prior art. More specifically, Applicant continues, the
combination of Sinha and Reynolds or each alone does not teach or suggest the feature of "the human being experiences hair regrowth within about 6 months after the dosage form is first orally administered to the human being" as recited in amended claim 1. Applicant further argues that “Sinha teaches that ‘patients will notice a reduction in shedding, and a third will notice improved growth in 6 months or more’ (emphasis added). This is not ‘within about 6 months’ as required by amended claim 1. Furthermore, there is no clear evidence that the feature of ‘hair regrowth within about 6 months’ is in any way necessarily present in (or even expected from) Sinha even if might be argued, arguendo, that it may be present. Thus, the feature is not inherent”, (footnotes omitted; remarks at pg. 6.
Applicant’s arguments have been carefully considered, but fail to persuade the Examiner of error in his determination of obviousness.
As previously noted by the Examiner, Sinha teaches at [0023] that in the oral studies conducted to date, the appearance of hair growth is seen at 6 months and continues onward. The presently claimed “within about six months” is not seen distinguishable from hair growth at 6 months because Applicant’s claimed phrase would include 6 months exactly as well as some undefined variable time that is under or over 6 months given the claim term “about”. Further, it is reasonable to believe that hair just didn’t start regrowing at the “stroke” of 6 months’ time. It take time for hair to grow. Thus, no distinction can be seen between the 6 month hair growth taught by Sinha and the within “about” 4, 5 and 6 months hair growth as in present claims 1, 16 and 17. Applicant’s claims directed to within about 1, 2 or 3 months, (claims 18-20) are no longer subject to this rejection.
Regarding newly added claim 21, it is the Examiner’s position that the release characteristics therein would be inherent to the dosage form upon oral administration.
Applicant has also argued that as taught by Reynolds, there are numerous variables which
can affect a drug's release from HPMC, e.g., polymer level, molecular weight and solubility.
However, given that the Sinha discloses an identical dosage form and method steps, it is
immaterial that the release of a drug from HPMC can be varied as argued.
Finally, Applicant has argued that the release characteristics, and consequently the
resulting pharmacokinetic parameters of claim 1 are not inherent in the prior art because they
have shown that drug release rates cannot in fact necessarily be associated with only dosage
amounts and dosage form.
This argument is not persuasive because dosage form and a dosage amount are the only
two tangible requirements for the dosage form present in claim 1. While not expressly required
by Applicant's claims, it is noted that not only does Sinha teach a dosage form and dosage
amount, but also that the dosage form may be sustained release in nature and may contain
various excipient materials, including a release aid at paragraph [0047]. Applicant's argument
fails to take this teaching into consideration and thus does not persuade the Examiner of error in
his determination.
Accordingly, for the above reasons, the claims are deemed properly rejected.
Double Patenting
Provisional
Claims 1-9 and 16-22 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; 19/413,834; 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; 19/215,216, (claims 1-21); 19/315,441; 19/230,007, (claims 1-21); 19/409,546; 19/414,251 or 19/397,854, in view of Sinha, (cited above), each of record for the reasons of record as set forth in the previous Office action dated January 16, 2026, as applied to claims 1-20, which reasons are here incorporated by reference.
Applicant's remarks have been carefully considered, but fail to persuade the Examiner of
error in his determination of provisional double-patenting.
In particular, Applicant has merely referenced the amendments to claim 1 and asks for
reconsideration, (page 8 of Applicant's remarks). This does not persuade the Examiner of error
in his determination because the supposed errors in the Examiner's determination, even with the
newly added claim language, have not been specifically addressed by Applicant. The previous
claims had a supposed limitation regarding the pharmacokinetic characteristics of the dosage
form. Also, the co-pending claims read on minoxidil as the sole active agent by reciting “comprising”. The newly added language is similarly directed to such characteristics. It should also be noted that growth times as presently claimed also occur in many of the co-pending claim sets.
For the above reasons, the claims are deemed to remain properly rejected.
Non-Provisional
Claims 1-9 and 16-22 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 in view of Sinha, cited above, , each of record for the reasons of record as set forth in the previous Office action dated January 16, 2026, as applied to claims 1-20, which reasons are here incorporated by reference.
Applicant's remarks have been carefully considered, but fail to persuade the Examiner of
error in his determination of double-patenting.
In particular, Applicant has merely referenced the amendments to claim 1 and asks for
reconsideration, (page 8 of Applicant's remarks). This does not persuade the Examiner of error
in his determination because the supposed errors in the Examiner's determination, even with the
newly added claim language, have not been specifically addressed by Applicant. The previous
claims had a supposed limitation regarding the pharmacokinetic characteristics of the dosage
form. Also, the co-pending claims read on minoxidil as the sole active agent by reciting “comprising”. The newly added language is similarly directed to such characteristics. It should also be noted that growth times as presently claimed also occur in many of the co-pending claim sets.
For the above reasons, the claims are deemed to remain properly rejected.
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
June 17, 2026
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