DETAILED ACTION
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 .
Claim Status
Claims 1-19 were previously pending.
By virtue of a preliminary amendment, filed 23 October 2024, Applicant canceled claims 1-19 and added claims 20-37.
Therefore, claims 20-37 are now pending and currently under examination.
Priority
Acknowledgement is made for Applicant’s claim to the following priority:
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Information Disclosure Statement (IDS)
The IDS (1) filed on 23 October 2024 has been considered by the examiner. A signed copy is enclosed.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section.”
Claim Rejections
Claim Rejections - 35 USC § 112(b)
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 20-37 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.
Claim 20 is drawn to a method of reducing a need for using a rescue medication or for using a second dose of a medication for treating cephalic pain within a period of 2 hours to 24 hours after a first dose of the medication comprising intranasally administering to a patient suffering from cephalic pain a pharmaceutical composition.
This claim is interpreted as a method of administering the claimed intranasal composition as a first dose, thereby eliminating a patient’s need for rescue medication or a second dose of the intranasal composition. However, the claim is not written in a way that reflects this as the claim does not clearly state whether the intranasal composition is: 1) the first claimed dose; 2) a treatment given before a first dose of a different medication; or 3) a treatment given after the first claimed dose of a different medication.
Claim 30 is drawn to a method of reducing a need for using a rescue medication or for using a second dose of a medication for treating cephalic pain within a period of 2 hours to 24 hours after a first dose of the medication, and wherein the patient continues to suffer from cephalic pain after the first dose of medication, comprising intranasally administering to a patient a pharmaceutical composition.
This claim is interpreted as a method of administering the claimed pharmaceutical composition after administering any medication as a first dose, thereby eliminating a patient’s need for rescue medication or a second dose of any medication. However, the claim is not written in a way that reflects this as the claim does not clearly state whether the intranasal composition is: 1) the first claimed dose; 2) a treatment given before a first dose of a different medication; or 3) a treatment given after the first claimed dose of a different medication.
The identity and temporal relationship of ‘the first dose of the medication’ to the recited step of ‘administering intranasally’ the pharmaceutical composition is unclear in claims 20 and 30. The claims do not specify whether the intranasally administered pharmaceutical composition constitutes the first dose, a second dose, or a rescue medication administered after the first dose. Consequently, it is unclear which administration begins the recited 2- to 24-hour period and which subsequent rescue medication or second dose is allegedly avoided or reduced.
Second, it is unclear what ‘reducing a need for’ using a rescue medication or a second dose of the medication entails. The only guidance provided by the disclosure states the need for a rescue medication is reduced by at least 50% or less ([0056]) and the need for a second dose of migraine medication is reduced by at least 30% or less ([0064]). This parameter lacks a defined comparison as normally medication is either taken or not taken. The specification only appears to discuss clinical study endpoints and specific percentage reductions, but the claims contain no numerical endpoint.
Due to the ambiguity of this claim, one of ordinary skill in the art could not reasonably determine the metes and bounds of the claim. Claims 20 and 30 do not identify: 1) the baseline against which the need is reduced; 2) the magnitude of reduction; 3) whether reduction is determined for an individual patient or patient population; 4) whether ‘need’ refers to the patient’s actual use of additional medication or a clinician determines whether the additional medication is unnecessary; or 5) whether subjective improvement alone establishes the reduced need.
Third, claims 23 and 33 identify the rescue medication as comprising sumatriptan. However, the claimed composition also comprises sumatriptan, therefore the two alternatives, rescue medication and second dose of the claimed intranasal composition, overlap. While this overlap does not itself make the claims indefinite, it reinforces the uncertainty regarding: 1) what specifically constitutes the first medication; 2) what specifically constitutes the rescue medication; and 3) whether a repeat dose of the claimed composition is a rescue medication, a second dose, or both.
Therefore, claims 20-37 are rejected under 35 USC 112(b). Claims 21-29 and 31-37 are included in this rejection for depending on, requiring every limitation of, and failing to cure the defect present in claims 20 and 30.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 20-37 are rejected under 35 U.S.C. 103 as being unpatentable over Gandhi (US2011/0077281 A1, published 31 March 2011) in further view of Raghuvanshi (US2017/0119738 A1, published 4 May 2017) and Munjal (“A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine,” published 1 March 2017).
Gandhi discloses a pharmaceutical composition for intranasal administration comprising a salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester, and optionally, at least one pharmaceutically acceptable excipient (abstract). Gandhi further discloses a method of treating a human suffering from cephalic pain by administering said composition ([0017]).
Regarding claims 20 and 30, Gandhi specifically discloses –
Treating a patient suffering from cephalic pain, including migraine, by intranasal administration of a pharmaceutical composition comprising a salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester, and optionally, at least one pharmaceutically acceptable excipient ([0017] and [0092]);
Whereby the pharmaceutical composition of Gandhi is –
Via intranasal administration ([0107]);
In the form of an aqueous solution ([0113]);
Contains sumatriptan, including sumatriptan base and physiologically acceptable salts or solvates ([0164]); citric acid monohydrate ([0164]); dodecyl maltoside, i.e., 1-O-n-Dodecyl-β-D-Maltopyranoside ([0045]-[0046]); isotonicity-adjusting agents such as sodium chloride ([0172]); a preferable pH of about 5 to 6 ([0067]); and an optional pharmaceutically acceptable excipient ([0173]). See also Example 1 ([0197]). Gandhi therefore discloses substantially all the composition and administration limitations of instant claims 20 and 30.
Regarding the recited osmolality, Gandhi does not expressly disclose the aqueous solutions have an osmolality of about 250 mOsmol/kg to about 350 mOsmol/kg as required by instant claims 20 and 30. However, this limitation is made obvious by Raghuvanshi.
Raghuvanshi discloses aqueous triptan formulations for treating migraine containing: a triptan ([0021]); sodium chloride as a stabilizing agent ([0031]); a pH value of about 4.0 to 7.5 ([0057]); and the formulation has an osmolality from about 250 mOsmol/kg to about 350 mOsmol/kg ([0056]).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to adjust the osmolality of Gandhi’s aqueous intranasal sumatriptan formulation to approximately 250-350 mOsmol/kg using a conventional osmotic agent such as sodium chloride, as taught by Gandhi as capable of adjusting formulations to approximately 250-350 mOsmol/kg. A skilled artisan would have been motivated to do so because Raghuvanshi discloses this osmolality range is suitable for aqueous triptan pharmaceutical formulations. Furthermore, it was known in the art at the time of the currently claimed invention that matching the isotonicity of nasal secretions reduces the risk of burning or mucosal dehydration upon administration. Therefore, selecting a physiologically compatible or substantially isotonic osmolality would predictably improve the physiological compatibility and patient tolerability, thereby provide a suitable aqueous formulation for administration. The adjustment would have involved routine optimization of a result-effective formulation variable using known osmotic agents.
Regarding the recited method steps, neither Gandhi nor Raghuvanshi disclose administration of the disclosed composition reduces the need for a rescue medication following treatment as required by instant claims 20 and 30. However, this limitation is made obvious by Munjal.
Munjal discloses DFN-02 as a novel, intranasal spray formulation comprising 10mg sumatriptan and permeation enhancing excipient 1-O-n-Dodecyl-β-D-Maltopyranoside (DDM) to be rapidly absorbed into the systemic circulation (abstract). Munjal further discloses a DFN-02 safety study whereby subjects were instructed to self-administer DFN-02 once into 1 nostril at the onset of acute migraine pain and if pain relief at 1-hour post-dose was insufficient, subjects were permitted to take either another dose of DFN-02 or rescue medication (p. 3). If a second dose of DFN-02 was taken and relief was still inadequate after 2 hours, rescue medication was permitted (p. 3). No more than 2 doses of DFN-02 were permitted in a 24-hour period (p. 3). Munjal reports at the end of the 6-month study period, the subjects using DFN-02 experienced migraine relief and rescue medication was only used in about 18% of attacks. Munjal further reports that although repeat dosing of DFN-02 was permitted at least 1 hour after the initial dose, approximately two thirds of qualifying attacks were treated with a single dose of DFN-02, suggesting a single dose provides subjects with adequate migraine relief (p. 7).
Munjal therefore expressly teaches administering the DFN-02 intranasal sumatriptan formulation reduces the need for a second dose or rescue medication during the claimed 2-to-24-hour period after the first dose.
The references concern the same field, the same triptan treatment objective, and substantially the same intranasal sumatriptan intranasal sumatriptan/DDM formulation. Munjal expressly confirms the expected clinical benefit of the known rapidly absorbed formulation includes a statistically significant reduction in rescue medicine and second dose usage following administration of a formulation comprising sumatriptan and DDM.
A person of ordinary skill would have had a reasonable expectation of success, before the effective filing date of the claimed invention, because Gandhi already taught that the formulation rapidly delivers a therapeutically effective amount of sumatriptan for treatment of cephalic pain while Munjal reported the claimed rescue/second dose outcome using DFN-02.
Regarding claims 21, 22, 31 and 32, Gandhi specifically discloses use of the formulation to treat cephalic pain such as cluster headaches and migraines ([0112]).
Regarding claims 23 and 33, neither Ghani nor Raghuvanshi expressly disclose the recited rescue medications. However, as taught by Munjal, the claimed rescue medications for migraine treatment were well-known in the art at the time of the claimed invention. Munjal specifically discloses the most commonly used rescue medications are ibuprofen, aspirin-acetaminophen-caffeine, and aspirin-butalbital (p. 5). Selecting one known rescue medication from among the conventional alternatives would have amounted to the predictable use of a known treatment according to its established function.
Regarding claims 24 and 34, Gandhi specifically discloses sumatriptan in doses of 5 mg, 10 mg, 15 mg, and 20 mg ([0197] for instance). These amounts fall within the instantly claimed range. See MPEP 2144.05.
Regarding claims 25 and 35, Gandhi specifically discloses the sumatriptan is a sumatriptan base ([0178]).
Regarding claims 26 and 36, Gandhi specifically discloses isotonicity-adjusting agents such as sodium chloride ([0173]).
Regarding claims 27 and 37, Gandhi specifically discloses 1-O-n-Dodecyl-β-D-Maltopyranoside is present in a concentration from about 0.02% to about 3.0%, which encompasses the instantly claimed range ([0068]). See MPEP 2144.05.
Regarding claim 28, Gandhi specifically discloses the pharmaceutical composition provides a Tmax value of less than 30 minutes upon administration ([0072]).
Regarding claim 28, Gandhi specifically discloses the pharmaceutical composition provides a Tmax value substantially equivalent to subcutaneous administration of said triptan ([0119]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to administer Gandhi’s aqueous intranasal composition to a patient suffering from migraine, including a patient having incomplete relief after an earlier dose, and to adjust the formulation to an osmolality of approximately 250-350 mOsmol/kg using sodium chloride as taught by Raghuvanshi. Gandhi teaches the formulation is used for rapid intranasal treatment of cephalic pain and provides a Tmax comparable to subcutaneous sumatriptan. Munjal expressly confirms that the known DFN-02 intranasal sumatriptan/DDM formulation significantly reduces use of a rescue medication or second dose during the 2-to-24-hour period following a first dose. The modification would therefore have involved use of a known physiologically compatible osmolality range in a known aqueous triptan formulation, with a reasonable expectation of retaining the formulation’s known rapid absorption and clinical efficacy. Therefore, the invention as a whole was prima facie obvious at the time it was invented.
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.
Co-pending application 18/782,922
Claims 20-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/782,922 (‘922; reference application) and in further view of Gandhi (US2011/0077281 A1, published 31 March 2011) in further view of Raghuvanshi (US2017/0119738 A1, published 4 May 2017) and Munjal (“A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine,” published 1 March 2017).
Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of ‘922 is drawn to a pharmaceutical composition for intranasal administration comprising a salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester and optionally at least one pharmaceutically acceptable excipient, wherein the said composition provides a Tmax value of less than 30 minutes upon said administration. The pharmaceutical composition of ‘922 is the genus of the composition used in the instantly claimed method.
It would have been obvious to use the composition of ‘922 to treat cephalic pain the instantly claimed method because Gandhi teaches intranasal sumatriptan/alkyl glycoside compositions are useful for that purpose. It further would have been obvious to select DDM as the alkyl glycoside, formulate the composition as the aqueous buffered citric acid formulation taught by Gandhi, and adjust its osmolality to about 250-350 mOsmol/kg using sodium chloride as taught by Raghuvanshi. These selections represent expressly taught species and routine optimization of an aqueous triptan formulation.
It would have further been obvious that effective treatment of migraine with the rapidly absorbed composition taught by Munjal would reduce the patient’s need for rescue medication or a second dose. Avoidance of rescue medication and repeat dosing was a conventional measure of sustained efficacy in acute migraine treatment as suggested by Munjal. The recitation of that expected treatment objective or result does not patentably distinguish the claimed method from the obvious therapeutic use of the copending claimed composition.
Accordingly, the presently claimed methods are not patentably distinct from claim 1 of copending application 18/797,812.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
US Patent 9,211,282
Claims 20-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of US Patent No. 9,211,282 (‘282) in further view of Raghuvanshi (US2017/0119738 A1, published 4 May 2017) and Munjal (“A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine,” published 1 March 2017).
Although the claims at issue are not identical, they are not patentably distinct from each other as the following claim mapping shows:
Instant Application Claim No.
‘282 Claim No.
Drawn to
20, 30
1, 16
An aqueous buffer pharmaceutical composition for intranasal administration comprising: a citric acid salt of sumatriptan or solvate thereof; DMM; and pH of 5.0-6.0.
The addition of an osmotic agent and osmolality between 250-350 mOsmol/kg is made obvious by ‘282 claims in view of Raghuvanshi, who expressly teaches these limitations in a similar composition as discussed in the 35 USC 103 rejection above.
The method of use is made obvious by ‘282 in view of Munjal, who expressly teaches identical clinical outcomes by administering a similar composition as discussed in the 35 USC 103 rejection above.
21, 31
1, 16, 21
A method of treating migraines.
22, 32
1, 16, 21
A method of treating migraines.
23, 33
16
The method of use is made obvious by ‘282 in view of Munjal, who expressly teaches identical clinical outcomes by administering a similar composition reduces use of the claimed rescue medications as discussed in the 35 USC 103 rejection above.
24, 34
1
Sumatriptan in an amount of 2.5 mg to 25 mg is made obvious ‘282 in view of Munjal, who teaches sumatriptan in a dose of 10 mg as discussed in the 35 USC 103 rejection above.
25, 35
1
Sumatriptan base is made obvious by ‘282 in view of Raghuvanshi, who expressly teaches triptan bases are suitable for use in similar compositions.
26, 36
1
Osmotic agent sodium chloride is made obvious by ‘282 in view of Raghuvanshi, who expressly teaches sodium chloride as an osmotic agent suitable for use in similar compositions.
27, 37
1, 9
DMM in an amount of 0.05% to 3.0%.
28
1
Tmax value of less than 30 minutes upon administration.
29
1
Inherent property of an identical composition.
Therefore, the claims of ‘282 in further view of Raghuvanshi and Munjal make obvious that which is instantly claimed in claims 20-37.
US Patents 9,610,280 B2, 9,974,770, 10,603,305 B2, 11,337,962 B2, 11,337,962 B2, and 12,090,139 B2
Claims 20-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over the various claims of U.S. Patent Nos. listed below in view of Gandhi (US2011/0077281 A1, published 31 March 2011) in further view of Raghuvanshi (US2017/0119738 A1, published 4 May 2017) and Munjal (“A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine,” published 1 March 2017).
9,610,280 B2: claims 1-16, drawn to a pharmaceutical composition comprising citric acid salt of sumatriptan or solvate thereof, an alkyl glycoside or saccharide ester, and optionally a pharmaceutically acceptable excipient, and method of using said composition to treat cephalic pain;
9,974,770 B2: claims 1-20, drawn to a method a treating cephalic pain by intranasally administering a pharmaceutical composition comprising citric acid salt of sumatriptan or solvate thereof, an alkyl glycoside or saccharide ester, and optionally a pharmaceutically acceptable excipient;
10,603,305 B2: claims 1-21, drawn to a pharmaceutical composition comprising citric acid salt of sumatriptan or solvate thereof, DDM, and optionally a pharmaceutically acceptable excipient, and method of using said composition to treat migraine or cluster headaches by intranasally administering said composition;
11,337,962 B2: claims 1-11, drawn to a pharmaceutical composition for intranasal administration comprising citric acid salt of sumatriptan or solvate thereof, DDM, and a pharmaceutically acceptable vehicle; and
12,090,139 B2: claims 1-13, drawn to a pharmaceutical composition comprising citric acid salt of sumatriptan or solvate thereof, DDM, and optionally a pharmaceutically acceptable excipient, and method of using said composition to treat migraine by intranasally administering said composition.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the previously issued patents above are drawn to a pharmaceutical composition for intranasal administration comprising a salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester and optionally at least one pharmaceutically acceptable excipient and/or a method of treating cephalic pain by intranasally administering said composition.
The previously issued patents are drawn to a genus of the instantly claimed intranasal sumatriptan composition and a method of use. In view of the previously cited references, the aforementioned claims of US Pat. Nos. 9,610,280 B2, 9,974,770 B2, 10,603,305 B2, 11,337,962 B2, and 12,090,139 B2 make obvious that which is instantly claimed in claims 20-37. The previously cited references Gandhi, Raghuvanshi, and Munjal teach an identical composition to what is used in the instantly claimed method and its intranasal use for treating identical conditions. Further, the claimed reduction in subsequent medication use was shown as an expected clinical result or conventional efficacy objective of performing that known treatment. Therefore, it would have been obvious to use the claimed composition and/or method of US Pat. Nos. 9,610,280 B2, 9,974,770 B2, 10,603,305 B2, 11,337,962 B2, and 12,090,139 B2 to treat cephalic pain; select DDM as the optimal mucosal permeation enhancer; formulate the composition as the aqueous buffered citric acid formulation; adjust pH to 5.0 to 6.0; and adjust osmolality to about 250-350 mOsmol/kg using sodium chloride. These selections represent expressly taught species and routine optimization of an aqueous triptan formulation.
It would have further been obvious that effective treatment of migraine with the rapidly absorbed composition taught by Munjal would reduce the patient’s need for rescue medication or a second dose. Avoidance of rescue medication and repeat dosing was a conventional measure of sustained efficacy in acute migraine treatment as suggested by Munjal. The recitation of that expected treatment objective or result does not patentably distinguish the claimed method from the obvious therapeutic use of the claimed compositions and/or methods in US Pat. Nos. 9,610,280 B2, 9,974,770 B2, 10,603,305 B2, 11,337,962 B2, and 12,090,139 B2.
Conclusion
Claims 20-37 are rejected. No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A. Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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