A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/12/2025 has been entered.
DETAILED ACTION
1. The present application is being examined under the pre-AIA first to invent provisions.
2. Claim filed on 12/12/2025 is acknowledged.
3. Claims 1-3 and 18 have been cancelled.
4. Claims 4-17 are pending in this application.
5. Claims 5-9 remain withdrawn from consideration as being drawn to non-elected species.
Please note: As stated in the previous office actions, during the search for the elected species of patient population, prior art was found for the non-elected species recited in instant claims 10 and 16. Therefore, for the purpose of compact prosecution, claims 10 and 16 are examined in the current office action.
6. Applicant elected without traverse of a composition comprising 1.25 mg to 1.75 mg bremelanotide or a pharmaceutically acceptable salt of bremelanotide (as recited in claim 17) as species of composition comprising bremelanotide or a pharmaceutically acceptable salt of bremelanotide; and a female patient diagnosed with female sexual dysfunction, and wherein the female patient is anticipating sexual activity (as recited in claim 15) as species of patient population; and elected with traverse nausea as species of side effects in the reply filed on 3/25/2025.
Restriction requirement was deemed proper and made FINAL in the previous office actions. The instant claims 4-17 are drawn to a method for treating female sexual dysfunction in a female human patient in need thereof, the method comprising administering to the female human patient by subcutaneous injection a composition comprising bremelanotide or a pharmaceutically acceptable salt of bremelanotide, wherein the composition comprises no more than about 1.75 mg of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, wherein the method reduces or minimizes at least one side effect compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein the at least one side effect is one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, or hypertension. A search was conducted on the elected species; and prior art was found. Claims 5-9 remain withdrawn from consideration as being drawn to non-elected species. Claims 4 and 10-17 are examined on the merits in this office action.
7. With regards to interview request, the Examiner telephoned Applicant’s representative, Cody J. Madison, on 12/15/2025. Applicant’s representative states on the phone that Applicant would like to receive an office action before conducting the next interview. Therefore, a non-final office action is issued hereby.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 103
8. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
9. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
10. (Revised after further careful reconsideration) Claims 4 and 10-17 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over the NCT01382719 document (from ClinicalTrials.gov, 6/24/2011, pages 1-21, filed with IDS) in view of Perelman (J Sex Med, 2007, 4, pages 280-290, cited and enclosed in the previous office actions).
The instant claims 4 and 10-17 are drawn to a method for treating female sexual dysfunction in a female human patient in need thereof, the method comprising administering to the female human patient by subcutaneous injection a composition comprising bremelanotide or a pharmaceutically acceptable salt of bremelanotide, wherein the composition comprises no more than about 1.75 mg of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, wherein the method reduces or minimizes at least one side effect compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein the at least one side effect is one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, or hypertension.
The NCT01382719 document, throughout the literature, teaches a method for treating female sexual dysfunction in premenopausal women diagnosed with female sexual dysfunction and anticipating sexual activity, comprising administering to the female human patient by subcutaneous injection an aqueous solution comprising 1.75 mg bremelanotide, thereby treating female sexual dysfunction, wherein the female sexual dysfunction is female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD, for example, page 7, Section “Study Description”; and pages 9-11, Section “Arms and Interventions”. It reads on a composition comprising 1.25 mg to 1.75 mg bremelanotide or a pharmaceutically acceptable salt of bremelanotide (as recited in claim 17) as the elected species of composition comprising bremelanotide or a pharmaceutically acceptable salt of bremelanotide; and a female patient diagnosed with female sexual dysfunction, and wherein the female patient is anticipating sexual activity (as recited in claim 15) as the elected species of patient population. It meets the limitation “a method for treating female sexual dysfunction in a female human patient in need thereof, the method comprising administering to the female human patient by subcutaneous injection a composition comprising bremelanotide or a pharmaceutically acceptable salt of bremelanotide, wherein the composition comprises no more than about 1.75 mg of bremelanotide or a pharmaceutically acceptable salt of bremelanotide” recited in instant claim 4; and the limitations of instant claims 10 and 15-17.
With regards to the limitation “wherein the administering results in improved overall sexual function in the female human patient as measured by a Female Sexual Function Index total score improvement of 3 or greater” recited in instant claim 11, first, the dose of bremelanotide in the NCT01382719 document meets the limitation of the dosage recited in instant claim 4. Second, this is a result-oriented limitation. In the instant case, the method in the NCT01382719 document comprises the same active method step, i.e., the same patient population, the same compound at the same dosage and the same route of administration, therefore, administering the same compound at the same dosage to the same patient population via the same route of administration would lead to the same effect, i.e., improved overall sexual function in the female human patient as measured by a Female Sexual Function Index total score improvement of 3 or greater. Third, as evidenced by instant application, administering an aqueous solution comprising 1.75 mg bremelanotide via subcutaneous injection to premenopausal women having FSAD, HSDD, or mixed FSAD/HSDD results in improved overall sexual function as measured by a Female Sexual Function Index total score improvement of 3 or greater (see Figures 4B, 6A and 6B of instant application). Therefore, the treatment in the NCT01382719 document would result in improved overall sexual function as measured by a Female Sexual Function Index total score improvement of 3 or greater. Furthermore, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
With regards to the limitations recited in instant claims 12-14, first, these are all result-oriented limitations. In the instant case, the method in the NCT01382719 document comprises the same active method step, i.e., the same patient population, the same compound at the same dosage and the same route of administration, therefore, administering the same compound at the same dosage to the same patient population via the same route of administration would lead to the same effect, i.e., a variability in peak plasma concentration within 60 minute less than the variability in peak plasma concentration within 60 minutes after intranasal administration recited in instant claim 12; the variability in peak plasma concentration within 60 minutes after intranasal administration is a % CV greater than 30 recited in instant claim 13; and a peak plasma concentration of bremelanotide of at least 60 ng/mL recited in instant claim 14. Furthermore, as evidenced by Figure 3 of instant application, subcutaneous injection of an aqueous solution comprising 1.75 mg bremelanotide in the NCT01382719 document would result in a peak plasma concentration of bremelanotide of at least 60 ng/mL recited in instant claim 14. And further as evidenced by Table 3 on pages 26-27 and Example 2 of instant specification, one of ordinary skilled in the art would understand and reasonably expect that subcutaneous injection of an aqueous solution comprising 1.75 mg bremelanotide in the NCT01382719 document would result in a variability in peak plasma concentration within 60 minute less than the variability in peak plasma concentration within 60 minutes after intranasal administration recited in instant claim 12; and the variability in peak plasma concentration within 60 minutes after intranasal administration is a % CV greater than 30 recited in instant claim 13. In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
The difference between the reference and instant claims 4 and 10-17 is that the reference does not explicitly teach nausea as the elected species of side effects; and the limitation “wherein the method reduces or minimizes at least one side effect compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein the at least one side effect is one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, or hypertension” recited in instant claim 4.
However, Perelman teaches that the primary adverse effects reported to be associated with bremelanotide are nausea, vomiting, flushing, headache, nasal congestion, and transient (1–3 hours post single dose) increases in systolic blood pressure; and there may be potential, for dose reduction, to improve the adverse event profile while maintaining good efficacy outcomes, for example, page 285, right column, the 3rd paragraph.
With regards to the limitation “wherein the method reduces or minimizes at least one side effect compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein the at least one side effect is one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, or hypertension” recited in instant claim 4; first, this is a result-oriented limitation. In the instant case, the method in the NCT01382719 document comprises the same active method step, i.e., the same patient population, the same compound at the same dosage and the same route of administration, therefore, administering the same compound at the same dosage to the same patient population via the same route of administration would lead to the same effect, i.e., reducing or minimizing at least one side effect compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein the at least one side effect is one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, or hypertension. Second, as evidenced by Table 6 on pages 30-31 of instant specification, one of ordinary skilled in the art would understand and reasonably expect that subcutaneous injection of an aqueous solution comprising 1.75 mg bremelanotide in the NCT01382719 document would reduce or minimize side effects compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide recited in instant claim 4; and such side effects include nausea and many others. It reads on nausea as the elected species of side effects. Furthermore, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of the NCT01382719 document and Perelman to develop a method for treating female sexual dysfunction in a female human patient diagnosed with female sexual dysfunction and anticipating sexual activity, comprising administering to the female patient by subcutaneous injection an aqueous solution comprising 1.75 mg bremelanotide, wherein the female patient is premenopausal and with female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD, and wherein such treatment reduces or minimizes side effects, such as nausea, compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein such treatment results in improved overall sexual function as measured by a Female Sexual Function Index total score improvement of 3 or greater.
One of ordinary skilled in the art would have been motivated to combine the teachings of the NCT01382719 document and Perelman to develop a method for treating female sexual dysfunction in a female human patient diagnosed with female sexual dysfunction and anticipating sexual activity, comprising administering to the female patient by subcutaneous injection an aqueous solution comprising 1.75 mg bremelanotide, wherein the female patient is premenopausal and with female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD, and wherein such treatment reduces or minimizes side effects, such as nausea, compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein such treatment results in improved overall sexual function as measured by a Female Sexual Function Index total score improvement of 3 or greater, because Perelman teaches that the primary adverse effects reported to be associated with bremelanotide are nausea, vomiting, flushing, headache, nasal congestion, and transient (1–3 hours post single dose) increases in systolic blood pressure; and there may be potential, for dose reduction, to improve the adverse event profile while maintaining good efficacy outcomes.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of the NCT01382719 document and Perelman to develop a method for treating female sexual dysfunction in a female human patient diagnosed with female sexual dysfunction and anticipating sexual activity, comprising administering to the female patient by subcutaneous injection an aqueous solution comprising 1.75 mg bremelanotide, wherein the female patient is premenopausal and with female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD, and wherein such treatment reduces or minimizes side effects, such as nausea, compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein such treatment results in improved overall sexual function as measured by a Female Sexual Function Index total score improvement of 3 or greater.
Response to Applicant's Arguments
11. Applicant argues that the cited NCT01382719 document fails to teach the limitation “wherein the method reduces or minimizes at least one side effect compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein the at least one side effect is one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, or hypertension” recited in instant claim 4. Applicant further argues that “even if the Action were to argue that the limitation is the natural result of the combination of elements explicitly disclosed by the prior art, it would be incorrect. There is nothing in NCT01382719 to suggest that a reduction in at least one side effect compared to intranasal administration would be the natural result of any of the claim limitations disclosed or taught by NCT01382719. In fact, a person of ordinary skill in the art would not understand NCT01382719 to even implicitly or inherently disclose such a natural result. Permitting such a hindsight-driven reconstruction of the claimed invention through this type of inherency analysis is fundamentally improper.” Applicant maintains the arguments that the claimed result of reduced or minimized side effects compared to an administration method not disclosed in the cited prior art of NCT01382719 is unexpected. Applicant also argues that “the Action fails to establish a proper motivation to combine the references with a reasonable expectation of success.”
12. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about instant rejection:
First, the Examiner would like to point out that in the instant case, Perelman is cited to teach that the primary adverse effects reported to be associated with bremelanotide are nausea, vomiting, flushing, headache, nasal congestion, and transient (1–3 hours post single dose) increases in systolic blood pressure. The Examiner would also like to point out that as explicitly stated in Applicant’s Arguments/Remarks filed on 3/25/2025, “All of the side effects recited in claim 18 are known side effects of intranasal administration of bremelanotide” (see page 2). And in the instant case, the side effects recited in the cancelled claim 18 are identical to those recited in instant claim 4.
Second, the Examiner understands that the cited NCT01382719 document does not explicitly teach the side effects recited in instant claim 4, and the limitation “wherein the method reduces or minimizes at least one side effect compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein the at least one side effect is one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, or hypertension” recited in instant claim 4. However, the recited side effects are known in the art, as stated in both Perelman and Applicant’s Arguments/Remarks filed on 3/25/2025. Furthermore, as stated in Section 10 above, this is a result-oriented limitation. In the instant case, the method in the NCT01382719 document comprises the same active method step, i.e., the same patient population, the same compound at the same dosage and the same route of administration, therefore, administering the same compound at the same dosage to the same patient population via the same route of administration would lead to the same effect, i.e., reducing or minimizing at least one side effect compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein the at least one side effect is one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, or hypertension (the adverse effects known in the art, as stated in both Perelman and Applicant’s Arguments/Remarks filed on 3/25/2025). In addition, as evidenced by Table 6 on pages 30-31 of instant specification, one of ordinary skilled in the art would understand and reasonably expect that subcutaneous injection of an aqueous solution comprising 1.75 mg bremelanotide in the NCT01382719 document would reduce or minimize side effects compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide recited in instant claim 4; and such side effects include nausea and many others. And, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise. However, other than statements/arguments, Applicant fails to provide any evidence to prove otherwise.
Third, with regards to Applicant’s arguments about unexpected results, as stated in the previous office action, in the instant case, it is unclear why and/or how one of ordinary skilled in the art would reach the conclusion that the claimed result of reduced or minimized side effects is unexpected. Further clarification is required. In addition, the Examiner would like to bring Applicant’s attention to MPEP § 716.02, which sets up the requirement and/or provides the guidelines on allegations of unexpected results. One of such requirements is comparing with the closest prior art, which is the NCT01382719 document. And in the instant case, Applicant fails to provide data regarding to such comparison.
Fourth, the Examiner would like to point out that Applicant appears to have no issue with the Examiner using inherency and/or being result-oriented limitation to reject instant claims 11-14. The limitations recited in instant claims 11-14 are not taught in the NCT01382719 document as well.
Fifth, in the event that in response to this office action, Applicant provides data and/or evidence to prove the limitation “wherein the method reduces or minimizes at least one side effect compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein the at least one side effect is one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, or hypertension” recited in instant claim 4 is not inherent and result-oriented, based on the data and/or evidence provided by Applicant, the instant claims will be rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph in the next office action.
Sixth, with regards to Applicant’s arguments about hindsight reasoning, in the instant case, Applicant fails to point to any facet of instant rejection that is not found in the cited prior art references. It is unclear to the Examiner which part of the instant rejection is not based on the combined teachings of the cited references. Merely pointing out the differences between each of the cited references and instant claimed invention is not proof of hindsight reasoning. Furthermore, the MPEP states “"[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971).” (see MPEP § 2145).
Seventh, with regards to Applicant’s arguments that “the Action fails to establish a proper motivation to combine the references with a reasonable expectation of success”, in the instant case, as stated above, Perelman is cited to teach that the primary adverse effects reported to be associated with bremelanotide are nausea, vomiting, flushing, headache, nasal congestion, and transient (1–3 hours post single dose) increases in systolic blood pressure. Furthermore, as explicitly stated in Applicant’s Arguments/Remarks filed on 3/25/2025, “All of the side effects recited in claim 18 are known side effects of intranasal administration of bremelanotide” (see page 2). In addition, other than statements/arguments, Applicant fails to provide any evidence and/or data to prove the method taught in the NCT01382719 document would NOT reduce or minimize side effects compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide recited in instant claim 4. Therefore, in the instant case, in view of the combined teachings of the cited prior art references as set forth in Section 10 above, one of ordinary skilled in the art would have been motivated and/or a person of ordinary skilled in the art would have reasonable expectation of success in developing the method recited in instant claims 4 and 10-17. And, with regards to the expectation of success, the MPEP states: “Absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. The Federal Circuit concluded that “[g]ood science and useful contributions do not necessarily result in patentability.” Id. at 1364, 83 USPQ2d at 1304.” (see MPEP § 2145).
Taken all these together, the rejection is deemed proper and is hereby maintained.
New Rejections
Claim Rejections - 35 U.S.C. § 102
13. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
14. Claims 4 and 10-17 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by the NCT01382719 document (from ClinicalTrials.gov, 6/24/2011, pages 1-21, filed with IDS), and as evidenced by Perelman (J Sex Med, 2007, 4, pages 280-290, cited and enclosed in the previous office actions).
The instant claims 4 and 10-17 are drawn to a method for treating female sexual dysfunction in a female human patient in need thereof, the method comprising administering to the female human patient by subcutaneous injection a composition comprising bremelanotide or a pharmaceutically acceptable salt of bremelanotide, wherein the composition comprises no more than about 1.75 mg of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, wherein the method reduces or minimizes at least one side effect compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein the at least one side effect is one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, or hypertension.
The NCT01382719 document, throughout the literature, teaches a method for treating female sexual dysfunction in premenopausal women diagnosed with female sexual dysfunction and anticipating sexual activity, comprising administering to the female human patient by subcutaneous injection an aqueous solution comprising 1.75 mg bremelanotide, thereby treating female sexual dysfunction, wherein the female sexual dysfunction is female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD, for example, page 7, Section “Study Description”; and pages 9-11, Section “Arms and Interventions”. It reads on a composition comprising 1.25 mg to 1.75 mg bremelanotide or a pharmaceutically acceptable salt of bremelanotide (as recited in claim 17) as the elected species of composition comprising bremelanotide or a pharmaceutically acceptable salt of bremelanotide; and a female patient diagnosed with female sexual dysfunction, and wherein the female patient is anticipating sexual activity (as recited in claim 15) as the elected species of patient population. It meets the limitation “a method for treating female sexual dysfunction in a female human patient in need thereof, the method comprising administering to the female human patient by subcutaneous injection a composition comprising bremelanotide or a pharmaceutically acceptable salt of bremelanotide, wherein the composition comprises no more than about 1.75 mg of bremelanotide or a pharmaceutically acceptable salt of bremelanotide” recited in instant claim 4; and the limitations of instant claims 10 and 15-17.
With regards to the limitation “wherein the method reduces or minimizes at least one side effect compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein the at least one side effect is one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, or hypertension” recited in instant claim 4; first, as evidenced by Perelman, the primary adverse effects reported to be associated with bremelanotide are nausea, vomiting, flushing, headache, nasal congestion, and transient (1–3 hours post single dose) increases in systolic blood pressure (see for example, page 285, right column, the 3rd paragraph). Second, this is a result-oriented limitation. In the instant case, the method in the NCT01382719 document comprises the same active method step, i.e., the same patient population, the same compound at the same dosage and the same route of administration, therefore, administering the same compound at the same dosage to the same patient population via the same route of administration would lead to the same effect, i.e., reducing or minimizing at least one side effect compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein the at least one side effect is one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, or hypertension. Furthermore, as evidenced by Table 6 on pages 30-31 of instant specification, one of ordinary skilled in the art would understand and reasonably expect that subcutaneous injection of an aqueous solution comprising 1.75 mg bremelanotide in the NCT01382719 document would reduce or minimize side effects compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide recited in instant claim 4; and such side effects include nausea and many others. It reads on nausea as the elected species of side effects. In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
With regards to the limitation “wherein the administering results in improved overall sexual function in the female human patient as measured by a Female Sexual Function Index total score improvement of 3 or greater” recited in instant claim 11, first, the dose of bremelanotide in the NCT01382719 document meets the limitation of the dosage recited in instant claim 4. Second, this is a result-oriented limitation. In the instant case, the method in the NCT01382719 document comprises the same active method step, i.e., the same patient population, the same compound at the same dosage and the same route of administration, therefore, administering the same compound at the same dosage to the same patient population via the same route of administration would lead to the same effect, i.e., improved overall sexual function in the female human patient as measured by a Female Sexual Function Index total score improvement of 3 or greater. Third, as evidenced by instant application, administering an aqueous solution comprising 1.75 mg bremelanotide via subcutaneous injection to premenopausal women having FSAD, HSDD, or mixed FSAD/HSDD results in improved overall sexual function as measured by a Female Sexual Function Index total score improvement of 3 or greater (see Figures 4B, 6A and 6B of instant application). Therefore, the treatment in the NCT01382719 document would result in improved overall sexual function as measured by a Female Sexual Function Index total score improvement of 3 or greater. Furthermore, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
With regards to the limitations recited in instant claims 12-14, first, these are all result-oriented limitations. In the instant case, the method in the NCT01382719 document comprises the same active method step, i.e., the same patient population, the same compound at the same dosage and the same route of administration, therefore, administering the same compound at the same dosage to the same patient population via the same route of administration would lead to the same effect, i.e., a variability in peak plasma concentration within 60 minute less than the variability in peak plasma concentration within 60 minutes after intranasal administration recited in instant claim 12; the variability in peak plasma concentration within 60 minutes after intranasal administration is a % CV greater than 30 recited in instant claim 13; and a peak plasma concentration of bremelanotide of at least 60 ng/mL recited in instant claim 14. Furthermore, as evidenced by Figure 3 of instant application, subcutaneous injection of an aqueous solution comprising 1.75 mg bremelanotide in the NCT01382719 document would result in a peak plasma concentration of bremelanotide of at least 60 ng/mL recited in instant claim 14. And further as evidenced by Table 3 on pages 26-27 and Example 2 of instant specification, one of ordinary skilled in the art would understand and reasonably expect that subcutaneous injection of an aqueous solution comprising 1.75 mg bremelanotide in the NCT01382719 document would result in a variability in peak plasma concentration within 60 minute less than the variability in peak plasma concentration within 60 minutes after intranasal administration recited in instant claim 12; and the variability in peak plasma concentration within 60 minutes after intranasal administration is a % CV greater than 30 recited in instant claim 13. In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
Therefore, the method in the NCT01382719 document meets the limitations of instant claims 4 and 10-17.
Since the reference teaches all the limitations of instant claims 4 and 10-17; the reference anticipates instant claims 4 and 10-17.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658