CLAIMS 1-11, 17-19 AND 21-26 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 August 14, 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. In light of Applicant’s amendments, the rejection of the claims under 35 USC 112 as set forth in the previous Office action is withdrawn.
Claim Rejection - 35 USC § 103
Claims 1-11, 17-19 and 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha, (U.S. 2024/0474594) in view of Reynolds, Jordan et al., (US 6,448,323), each of record, for the reasons of record as set forth in the previous Office action as applied to claims 1-20, which reasons are here incorporated by reference and newly cited Pharmacia & Upjohn /Pfizer, Minoxidil (LONITEN) tablets — Prescribing Information (FDA label, rev. 2015). 2015., https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf, 16 pgs., (cited by Applicant, hereinafter “Minoxidil”, cited to address Applicant’s newly added language to claim 1, “thereof who is experiencing, or is at risk for experiencing, peripheral edema”).
Newly added claims 21-26 and the newly added language of claim 1, “comprising a release modifier” are noted and their respective limitations have been previously addressed in the previous Office action.
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
claims are not taught or suggested in the prior art. More specifically, Applicant continues, the
combination of references does not teach or suggest at least a patient "who is experiencing, or is at risk for experiencing, peripheral edema”.
The Examiner agrees with Applicant regarding a patient experiencing peripheral edema. However, insofar as generalized edema or swelling of the face, hands and ankles due to electrolyte and water retention was a well-recognized side effect of oral minoxidil, especially in the absence of a co-administered diuretic agent, (see Minoxidil at page 4, last paragraph and page 14, under the heading “Rapid weight gain of more than 5 pounds”, lines 2-3), and the patients of Sinha are administered oral minoxidil with no teaching of a co-administered diuretic agent taught, the newly added limitation of claim 1 is deemed to be at least inherent in the prior art teachings, i.e., the patients of Sinha would have been at some risk of peripheral edema.
Applicants have also argued that the presently claimed subject matter would not
have been obvious because claim 1 is not prima facie obvious at least because the
combination of references does not teach or suggest at least "wherein the dosage form comprising the release modifier results in Cmax of minoxidil or the pharmaceutically acceptable salt thereof of about 0.25 ng/ml to about 20 ng/ml," as now required by claim 1.
The Examiner agrees that the specific pharmacokinetic parameters as in the present claims are not taught or suggested in the prior art. However, such does not diminish the propriety of the present rejection because absent evidence to the contrary, the Examiner believes such characteristics to be necessarily present, i.e., inherent, in the prior art dosage form which meets each and every tangible limitation set forth for the dosage form in present claim 1. In particular, the dosage form of Sinha may be sustained release, oral and contain about 9 mg of minoxidil. Also, each and every tangible limitation present in claim 1 is clearly taught by Sinha, i.e., the dosage form comprising about 9 mg of minoxidil is orally administered to a patient in need of hair loss treatment who is at risk of peripheral edema. It must therefore necessarily follow that whether taught or recognized in the prior art or not, the same release characteristics present in current claim 1 would also be present in the prior art.
Applicant has also argued that the Examiner has not established an expectation of
inherency, i.e., basis in fact and/or technical reasoning. The Examiner believes that he has in
pointing out that Sinha teaches every one of the claimed tangible elements/features of the dosage
form, the patient and the route of administration as required in at least claim 1 so as to place such
in the possession of the public, i.e., anticipate these elements/features. It thus must necessarily
be so that the resultant pharmacokinetic characteristics would be the same, whether expressly taught by Sinha or not.
Where, as here, the claimed and prior art products are identical or substantially identical,
or are produced by identical or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily or inherently possess
the characteristics of his 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, and its fairness 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).
Applicant has further argued that there is no reasonable expectation of success that
merely modifying formulation variables as generally described in Sinha would result in a dosage
form that achieves the presently claimed pharmacokinetic/release characteristics. However, it is
not the Examiner's position that such modifying is taught by Sinha, but rather that each and
every tangible element/feature of the dosage form, the patient and the route of administration as
required in at least claim 1 is anticipated by Sinha.
Finally, Applicant has argued that the 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 claim 1, 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.
For the above reasons, the claims are deemed to remain properly rejected.
Double Patenting
Provisional
Claims 1-11, 17-19 and 21-26 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; 19/303,300; 19/315,441; 19/230,007, (claims 1-21); 19/409,546; 19/414,251 or 19/397,854 each of record, for the reasons of record as applied to claims 1-20, as set forth in the previous Office action 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 Examiner
previously addressed inherency or else the pharmacokinetic and other properties in the
copending claims. Also, newly added claims 21-26 are properly rejected here because the requirements of such are clearly encompassed by the copending claim sets and were previously addressed by the Examiner in the previous Office action.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Non-Provisional
Claims 1-11, 17-19 and 21-26 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), each of record, for the reasons of record as applied to claims 1-20, as set forth in the previous Office action 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 Examiner
previously addressed inherency or else the pharmacokinetic and other properties in the
copending claims. Also, newly added claims 21-26 are properly rejected here because the requirements of such are clearly encompassed by the patented claim set and were previously addressed by the Examiner in the previous Office action.
Accordingly, the claims are deemed properly rejected and none are currently in condition for allowance.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
September 09, 2026
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