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 .
Response to Amendments
Applicant’s amendments to the claims of April 6, 2026, in response to the Office Action of October 6, 2026, are acknowledged.
Response to Arguments
The Objection to the drawings is withdrawn in view of the Applicant’s replacement drawings. The rejection of claim 10 under §112(b) is moot. The §103 rejection and Double Patenting rejections are addressed below.
Applicant traverses in view of amended claims. Applicant argues that the claims now require approximately 75% cyclobenzaprine and 25% mannitol and therefore render the rejections moot.
The examiner notes that the prior art teaches 60-90% cyclobenzaprine and 10-40% mannitol. See Nebuloni2014, e.g. As such, the amendment to the percentages of components does not distinguish over the combination of cited prior art.
Applicant further argues that symptoms of PASC are not generalized symptoms and argues that the symptoms are different for PASC.
The examiner notes that Choutka, as expounded on below, refers to the similarities among different PAISs, including PASC, as well as their symptoms.
Harris teaches cyclobenzaprine can be used to treat conditions associated with fibromyalgia syndrome, prolonged fatigue, chronic fatigue syndrome (CFS), pain, and others, e.g. See par. 4. Similarly, both Nebuloni references teach treating CFS, fibromyalgia syndrome, and pain, among others with cyclobenzaprine. Even further, cyclobenzaprine is known to treat sleep quality and disturbances. See Harris, par. 3.
Choutka teaches PAISs have relatively similar symptom profiles and overlap with clinical features of chronic fatigue syndrome (CFS). This suggests, according to Choutka, a common etiopathogenesis. Core symptoms of PAISs are characterized by fatigue, neurocognitive and sensory impairment, and myalgia. See p911, 3rd par. Further, PASC shares many similarities with chronic illnesses triggered by other pathogenic organisms, including myalgia, disproportionate levels of fatigue, and others. “These similarities suggest a unifying pathophysiology that needs to be elucidated….” The symptoms of a prominent subset of patients with PASC include: “unexplained exertion intolerance, debilitating fatigue, cognitive and sensory disturbances, headaches, myalgia, and recurrent flu-like symptoms. The core features of this syndrome share remarkable similarities with other PAISs discussed in this review, as well as with myalgic encephalomyelitis/chronic fatigue syndrome.” See p912, 2nd full par. The term CFS was originally coined to describe post-epidemic occurrence. Unrefreshing sleep is a prime manifestation of PAISs. See p912, 7th par. This is similar to SARS. “For example, a long-term study of 233 SARS survivors in Hong Kong reported that 27.1% met criteria for ME/CFS 4 years after acute infection. Another smaller study of 21 healthcare workers in Canada who were unable to return to work 1–3 years after SARS infection owing to health complications concluded that the symptoms of these individuals overlapped with the symptoms of ME/CFS and fibromyalgia.” See p917, 1st par. In conclusion, Choutka explains:
The overlap of symptoms, signs, and general features of the individual PAISs suggests the involvement of shared pathological pathways and the possibility that common diagnostic markers, or even a unified etiological model, might be established.
The overall clinical picture of many PAISs often overlaps with the presentation of post-infectious ME/CFS or fibromyalgia, or resembles other fatiguing, neurological, or rheumatic disorders. Exploiting existing knowledge of these conditions might help guide future scientific discovery and progress in clinical care.
As such, many similar and prominent symptoms associated with post-acute infections are known to be associated with general post-acute infections including SARS infection. Among the most prevalent of symptoms include chronic fatigue syndrome, myalgia, and others that are taught to be treatable, without limitation, with the claimed composition. The symptoms of PASC and PAISs are thought to result from a common or unifying pathogenesis. There a reasonable expectation of success in treating claimed symptoms with the claimed composition as it is specifically taught to treat prominent symptoms of PASC.
Moreover, the examiner notes that the prior art does not teach treatment to be dependent or limited to symptoms of specific underlying conditions. The prior art teaches an ability to mitigate pain, fibromyalgia, sleep disturbances that cause fatigue, CFS, and many other symptoms known to be associated with the claimed subject population. Without such limitation provided by the cited prior art of which Applicant is assignee and co-inventor), the active steps claimed are obvious in view of their collective teachings. There is no reason to expect that cyclobenzaprine would lack a reasonable expectation of success in treating pain secondary to PASC or treating CFS secondary to PASC without basis in the prior art. The conditions taught to be treatable include vast and unrelated conditions, including GAD, chronic pain syndromes, any sleep disorder, CFS, fibromyalgia, and others.
With regard to new claim 58, the examiner notes that dosage titration is a common technique for optimization and 2.8 mg and 5.6 mg are each taught by the prior art as standard dosages forms available. Even further, Harris also teaches sublingual administration as a known and accepted route of administration. Administration of 2.8 mg daily followed by 5.6 mg daily is one example of an increase in dosage that can be achieved through optimization. The increase of 2.8 mg is a discrete dosage amount that is available as a unit dosage form. This, this amount of an increase would be routine absent evidence to the contrary.
The use of dipotassium hydrogen phosphate is taught by multiple prior art references for use in combination with the claimed API.
Status of the Claims
Claims 1, 8, 17, 19, 22, 25-29, 36, 40, 43, 54, and 56-58 are pending and examined.
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.
Claims 1, 8, 17, 19, 22, 25-29, 36, 40, 43, 54, and 56-58 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al., (US2019/0175525), in view of Nebuloni et al., (US2019/0022030)(“Nebuloni2019”), in view of Nebuloni et al., (US2014/0336264) (“Nebuloni2014”), and in view of Choutka et al., “Unexplained post-acute infection syndromes,” Vol 28, May 2022, 911-923 Nature Medicine, as evidenced by Cook et al., “PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions,” J Clin Epidemiol. 2016 May;73:89-102.
Harris teaches a eutectic complex of cyclobenzaprine HCl and mannitol for treating and preventing conditions including aggression, impairment of social functioning, akathisia, and others. See prior art claim 1. The composition can also contain a dibasic potassium salt, including potassium phosphate dibasic or dipotassium hydrogen phosphate. See par. 57 and Table 1. The cyclobenzaprine can be in an amount of 2.8 mg, 5.6 mg, 1 to 20 mg, and 0.1 to 30 mg. See prior art claim 5. The composition can be used to treat and prevent agitation, dementia, and neurodegenerative conditions. See prior art claim 1. It can be administered orally, sublingually, parenterally, and by most routes of administration. See prior art claims 23 and 24. The subject includes one experiencing or at-risk of psychosis, cognitive decline, and others. See prior art claim 34.
Nebuloni2014 teaches compositions for treating and preventing stress, sleep disorders, anxiety, depression, and other disorders, in humans. See Abstract and par. 104. The composition is eutectic comprising cyclobenzaprine HCl and mannitol, wherein the composition includes a basifying agent of dipotassium monohydrogen phosphate, disodium monohydrogen phosphate, and anhydrous trisodium citrate, and a concentration of 60-90% cyclobenzaprine and 10-40% mannitol. See priori art claim 1. Also see other basifying agents in par. 138. Components are milled/mixed in a granulator. Compositions can be administered on a daily basis. See par. 130. Conditions to be treated include sleep disorders and chronic pain. See par.’s 148 and 149. This includes insomnia. See par. 137. Treatment can be for weeks and up to 12 months or longer. See par. 130. Forms for administration include tablets, capsules, sprays, films, and others. See par.’s 128 and 129. Treatment of fatigue and chronic pain and widespread pain are recognized therapeutic uses. See par. 131. Pain can include joint swelling, headaches, fatigue, and other claimed forms of pain. See par. 132. Widespread pain is interpreted to not exclude pain in at least 4 regions of the body. See par. 131.
Nebuloni2019 teaches compositions comprising eutectic cyclobenzaprine HCl and mannitol at claimed concentrations wherein the mannitol is β-mannitol. See prior art claim 54. It is taught for same uses, including insomnia, pain, fatigue, and others. See par. 171. Further, the concentrations include 60-90% cyclobenzaprine and 10-40% mannitol. See par. 5.
Harris and Nebuloni do not teach these symptoms in a subject with PASC, e.g.
Choutka teaches a prominent subset of patients with PASC experience fatigue, headaches, myalgia, and cognitive and sensory disturbances. See p913. Symptoms can be new onset following initial recovery from acute COVID-19 or persist from the initial illness. See p913. Choutka teaches that the UK NIH considers post-COVID syndrome for people who still have symptoms for more than 12 weeks after the start of acute symptoms. See p913. The examiner interprets this to include those that test positive for SARS-CoV-2 infection at least 3 months prior to treatment.
With regard to claim 17, the examiner notes that the claimed dosage amount is taught. There is not practical difference between administration of simultaneous or sequential doses as compared to a single dose when the amount administered is equivalent. See Clinical definitions.
With regard to claim 54, assessing a symptom based on a known scale does not alter the active steps of administration. Assessing a symptom can be a mental step of evaluation. As evidenced by Cook, PROMIS is a known scale for measuring pain, fatigue, negative affect, physical and social function, and others.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See M.P.E.P. § 2144.05.
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed methods in view of the cited prior art. One would be motivated to do so because the claimed eutectic composition comprising the claimed components at the claimed percentages and dosages and in the claimed forms are taught to treat claimed symptoms and conditions. Choutka teaches a prominent subset of patients with PASC experience fatigue, headaches, myalgia, and cognitive and sensory disturbances. Harris and Nebuloni teach treating subjects experiencing or at-risk of psychosis, cognitive decline, chronic pain, fatigue, insomnia, headaches, sleep disorders, and other symptoms taught be experienced by those with PASC. As such, there is a reasonable and predictable expectation of success that the compositions taught by the prior art to treat fatigue, insomnia, headaches, cognitive decline and other symptoms that are known to exist in a prominent number of subjects with PASC would treat those same symptoms when they arise from PASC, absent evidence to the contrary. The examiner interprets at-risk of PASC to include those that have or had a SARS-CoV-2 infection.
As such, no claim is allowed.
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.
Claims 1, 8, 17, 19, 22, 25-29, 36, 40, 43, 54, and 56-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,826,321, in view of Harris et al., (US2019/0175525), in view of Nebuloni et al., (US2019/0022030)(“Nebuloni2019”), in view of Nebuloni et al., (US2014/0336264) (“Nebuloni2014”), and in view of Choutka et al., “Unexplained post-acute infection syndromes,” Vol 28, May 2022, 911-923 Nature Medicine, as evidenced by Cook et al., “PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions,” J Clin Epidemiol. 2016 May;73:89-102, for the reasons set forth above. Overall, the claims of the ‘321 patent teach a method for treating many of the claimed symptoms with cyclobenzaprine at the claimed dosages of 2.8 mg and 5.6 mg. As such, the secondary references indicate that the eutectic composition would also treat these same conditions. Thus, the API taught by the ‘321 patent would be known to be usable in treating the claimed conditions in view of the cited prior art and in view of the secondary references set forth above. For example, psychosis and cognitive decline are associated with symptoms of dementia and neurodegeneration described to be treatable with the same API, same dosage, and same route of administration.
Claims 1, 8, 17, 19, 22, 25-29, 36, 40, 43, 54, and 56-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,998,516, in view of Harris et al., (US2019/0175525), in view of Nebuloni et al., (US2019/0022030)(“Nebuloni2019”), in view of Nebuloni et al., (US2014/0336264) (“Nebuloni2014”), and in view of Choutka et al., “Unexplained post-acute infection syndromes,” Vol 28, May 2022, 911-923 Nature Medicine, as evidenced by Cook et al., “PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions,” J Clin Epidemiol. 2016 May;73:89-102, for the reasons set forth above. Overall, the claims of the ‘516 patent are directed to treating fibromyalgia and depression, which is inclusive of many symptoms instantly claimed. This includes fatigue, sleep disturbances, and pain as described therein. Thus, the same API is taught to treat the same symptoms at a same dose through same routes of administration. In view of the cited prior art, the formulations taught by the secondary references would be understood as interchangeable for treating the same symptoms/conditions.
Claims 1, 8, 17, 19, 22, 25-29, 36, 40, 43, 54, and 56-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,839,594, in view of Harris et al., (US2019/0175525), in view of Nebuloni et al., (US2019/0022030)(“Nebuloni2019”), in view of Nebuloni et al., (US2014/0336264) (“Nebuloni2014”), and in view of Choutka et al., “Unexplained post-acute infection syndromes,” Vol 28, May 2022, 911-923 Nature Medicine, as evidenced by Cook et al., “PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions,” J Clin Epidemiol. 2016 May;73:89-102, for the reasons set forth above. Overall, the claims of the ‘594 patent are directed to manufacturing a composition comprising a eutectic of cyclobenzaprine and β-mannitol at the claimed concentrations. In view of the secondary references above, it would be obvious to use the produced composition to treat the claimed subject population.
Claims 1, 8, 17, 19, 22, 25-29, 36, 40, 43, 54, and 56-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,864,175, in view of Harris et al., (US2019/0175525), in view of Nebuloni et al., (US2019/0022030)(“Nebuloni2019”), in view of Nebuloni et al., (US2014/0336264) (“Nebuloni2014”), and in view of Choutka et al., “Unexplained post-acute infection syndromes,” Vol 28, May 2022, 911-923 Nature Medicine, as evidenced by Cook et al., “PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions,” J Clin Epidemiol. 2016 May;73:89-102, for the reasons set forth above. Overall, the claims of the ‘175 patent are directed to a composition comprising a eutectic of cyclobenzaprine and β-mannitol at the claimed concentrations. In view of the secondary references above, it would be obvious to use the composition described therein to treat the claimed subject population for the reasons set forth above.
Claims 1, 8, 17, 19, 22, 25-29, 36, 40, 43, 54, and 56-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 10,117,936, in view of Harris et al., (US2019/0175525), in view of Nebuloni et al., (US2019/0022030)(“Nebuloni2019”), in view of Nebuloni et al., (US2014/0336264) (“Nebuloni2014”), and in view of Choutka et al., “Unexplained post-acute infection syndromes,” Vol 28, May 2022, 911-923 Nature Medicine, as evidenced by Cook et al., “PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions,” J Clin Epidemiol. 2016 May;73:89-102, for the reasons set forth above. Overall, the claims of the ‘936 patent are directed to a composition comprising a eutectic of cyclobenzaprine and β-mannitol at the claimed concentrations and a method of making the same. In view of the secondary references above, it would be obvious to use the composition described and produced by the means described therein to treat the claimed subject population for the reasons set forth above. Similar uses are described in the disclosure of the same including treating insomnia, fatigue, anxiety, and pain.
Claims 1, 8, 17, 19, 22, 25-29, 36, 40, 43, 54, and 56-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,956,188, in view of Harris et al., (US2019/0175525), in view of Nebuloni et al., (US2019/0022030)(“Nebuloni2019”), in view of Nebuloni et al., (US2014/0336264) (“Nebuloni2014”), and in view of Choutka et al., “Unexplained post-acute infection syndromes,” Vol 28, May 2022, 911-923 Nature Medicine, as evidenced by Cook et al., “PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions,” J Clin Epidemiol. 2016 May;73:89-102, for the reasons set forth above. Overall, the claims of the ‘188 patent are directed to a composition comprising a eutectic of cyclobenzaprine and β-mannitol at the claimed concentrations. In view of the secondary references above, it would be obvious to use the composition described therein to treat the claimed subject population for the reasons set forth above.
Claims 1, 8, 17, 19, 22, 25-29, 36, 40, 43, 54, and 56-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,636,408, in view of Harris et al., (US2019/0175525), in view of Nebuloni et al., (US2019/0022030)(“Nebuloni2019”), in view of Nebuloni et al., (US2014/0336264) (“Nebuloni2014”), and in view of Choutka et al., “Unexplained post-acute infection syndromes,” Vol 28, May 2022, 911-923 Nature Medicine, as evidenced by Cook et al., “PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions,” J Clin Epidemiol. 2016 May;73:89-102, for the reasons set forth above. Overall, the claims of the ‘408 patent are directed to a composition comprising a eutectic of cyclobenzaprine and β-mannitol at the claimed concentrations. In view of the secondary references above, it would be obvious to use the composition described therein to treat the claimed subject population for the reasons set forth above.
Claims 1, 8, 17, 19, 22, 25-29, 36, 40, 43, 54, and 56-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,026,898, in view of Harris et al., (US2019/0175525), in view of Nebuloni et al., (US2019/0022030)(“Nebuloni2019”), in view of Nebuloni et al., (US2014/0336264) (“Nebuloni2014”), and in view of Choutka et al., “Unexplained post-acute infection syndromes,” Vol 28, May 2022, 911-923 Nature Medicine, as evidenced by Cook et al., “PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions,” J Clin Epidemiol. 2016 May;73:89-102, for the reasons set forth above. Overall, the claims of the ‘898 patent are directed to a composition comprising a eutectic of cyclobenzaprine and β-mannitol at the claimed concentrations and a method of making the same. In view of the secondary references above, it would be obvious to use the composition described and produced by the means described therein to treat the claimed subject population for the reasons set forth above. Similar uses are described in the disclosure of the same including treating insomnia, fatigue, anxiety, and pain.
Claims 1, 8, 17, 19, 22, 25-29, 36, 40, 43, 54, and 56-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,357,465, in view of Harris et al., (US2019/0175525), in view of Nebuloni et al., (US2019/0022030)(“Nebuloni2019”), in view of Nebuloni et al., (US2014/0336264) (“Nebuloni2014”), and in view of Choutka et al., “Unexplained post-acute infection syndromes,” Vol 28, May 2022, 911-923 Nature Medicine, as evidenced by Cook et al., “PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions,” J Clin Epidemiol. 2016 May;73:89-102, for the reasons set forth above. Overall, the claims of the ‘465 patent are directed to a composition comprising a eutectic of cyclobenzaprine and β-mannitol at the claimed concentrations and a method of making the same. In view of the secondary references above, it would be obvious to use the composition described and produced by the means described therein to treat the claimed subject population for the reasons set forth above. Similar uses are described in the disclosure of the same including treating insomnia, fatigue, anxiety, and pain.
Provisional Double Patenting Rejection:
Claims 1, 8, 17, 19, 22, 25-29, 36, 40, 43, 54, and 56-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-7, 9-20, 35, and 36 of copending Application No. 18/265,525. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘525 application are directed to treating fibromyalgia or symptoms thereof, including pain and sleep disturbance and fatigue with the claimed composition. These symptoms are the same as those presently claimed for treatment. As such, it would be obvious to treat the same symptoms with the same composition with a reasonable expectation of success.
Claims 1, 8, 17, 19, 22, 25-29, 36, 40, 43, 54, and 56-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 42-60 of copending Application No. 18/988,194. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘194 application are directed to treating fibromyalgia or symptoms thereof, including pain and sleep disturbance and fatigue with the claimed composition. These symptoms are the same as those presently claimed for treatment. As such, it would be obvious to treat the same symptoms with the same composition with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
As such, no claim is allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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