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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/JP2020/039870, filed 10/23/2020, which claims the priority benefit of JAPAN Application No. 2019-193743, filed 10/24/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/15/2022, 06/07/2023, 12/15/2023, 02/02/2024, 06/12/2024, 06/27/2024, 06/03/2025, and 12/03/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of claims
Claims 8-16 are currently pending and under examination. Claims 8-9 have been amended. Claims 1-7 have been cancelled. Claims 15-16 have been added.
Applicant’s arguments, filed 02/24/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. They constitute the complete set presently being applied to the instant application.
The obviousness and 35 U.S.C. 112(a) rejection below is repeated from the 12/12/2024 Office Action and modified in order to address the most recent amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first
paragraph, as failing to comply with the enablement requirement. Claims 8-14 contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification, while being enabled for treating cachexia, does not reasonably provide enablement for a method of preventing cachexia.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(A) The nature of the invention (B) Breadth of the claims:
The invention is drawn to a method for preventing or treating cachexia comprising administering a compound represented by General Formula (I). Prevention is suggested to include a level of protection against, up to and including complete protection against the development of a disease or condition which is unsupported by the disclosure. Giving the claims their broadest reasonable interpretation the term "prevention" includes any measure taken prior to the onset or occurrence of a disease or condition which precludes its coming into existence, absolutely and in all cases. Therefore, preventing cachexia renders the scope of the claims unreasonably broad.
(C) The state of the prior art (D) The predictability or unpredictability of the
art and (E) The relative skill of those in the art:
The state of the replete in terms of treating cachexia. There is no evidence in the prior art that the instant composition would be usable as a preventative composition, particularly for preventing cachexia. MPEP 2141.03 states (in part), "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). "[i]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. At 1396, 82 USPQ2d at 1396. The "hypothetical person having ordinary skill in the art' to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art." Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). There is no evidence in the prior art that the instant composition would be usable as a preventative composition, particularly for preventing, inhibiting and/or treating cachexia.
There is no evidence in the prior art that the instant composition would be usable as a preventative composition, particularly for preventing cachexia. "Preventing" connotes an absolute absence of a condition which cannot reasonably be achieved with regard to infections, with few exceptions (such as vaccines to prevent the development of pathogen-borne illnesses). In addition, there is no definitive method by which to determine whether a patient will develop a particular condition and, thus, be in need of preventive therapy. This is distinguished from preventing the relapse or recurrence of certain conditions, in which case an objective basis may exist to identify patients at risk of disease or infection, and could reasonably be construed as treatment. Prior to the initial onset or occurrence, however, even if a patient can be identified as having known risk factors for a condition, there is no certainty that the patient would in fact develop the condition. Further, the failure of a disease, infection, or condition to develop cannot
reliably be attributed to the claimed active agent(s). The non-development of a condition such as cachexia may be due to other factors such as lifestyle. In this sense, in the context of preventing a condition, the level of unpredictability is extremely high.
(F) The amount of direction or guidance presented:
The Specification fails to disclose how to prevent cachexia. No guidance is provided in the specification. The amount of direction or guidance is minimal or nonexistent with regards to preventing cachexia. Thus, with respect to the instant composition, there is a substantial gap between treatment and prevention especially when no working examples are provided. Consequently, it would require undue experimentation for the skilled artisan to discover how to make and use the instant invention in order to prevent cachexia.
(G) The presence or absence of working examples:
The specification does not disclose any evidence that cachexia can be prevented.
(H) The quantity of experimentation necessary:
In the instant case, there is a substantial gap between treatment and prevention in the case of cachexia. Consequently, a burdensome amount of research would be required by one of ordinary skill in the art to bridge this gap. Because "preventing" a condition by the administration of an active agent cannot be objectively measured or achieved with any certainty, coupled with a lack of guidance and direction provided by the instant disclosure, a skilled artisan could not practice the invention commensurate with the full scope of the claims without undue experimentation. This rejection can be overcome by amending the claims to omit the term "preventing."
Conclusion
Given the complete lack of guidance in applicant's instant disclosure, regarding preventing cachexia, an undue amount experimentation is required to realize the full scope of claims 8-14 would be required to discover how to use the invention as broadly claimed. Applicant has not described how to prevent cachexia, with a composition as recited by claims 8-14 of the instant application in such full, clear, concise, and exact terms as to enable any person skilled in the art to do so.
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 of this title, 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 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 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 8-16 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al., 2019 (US Patent 9,006,262 82) in view of Maletinska et al., (WO 2015/197037 A1) and further in view of Mann (US 2016/0067236 Al).
The instant claims are directed to a method of treating of preventing cachexia comprising
administering 0.1 μg to 100 mg a compound represented by General Formula (I) and 10 μg to 10000 mg anamorelin as a ghrelin receptor agonist in combination to a patient in need thereof.
PNG
media_image1.png
213
287
media_image1.png
Greyscale
.
Suzuki et al. teach a method of treating cachexia comprising administering a therapeutically effective amount of a compound of Formula (I) (Below) to a patient in need thereof which satisfies the structural limitations of formula 1 of the instant claims where B is a -CH=CH-, R1 is a CH2-cyclopropyl and R2 is Me.
PNG
media_image2.png
143
313
media_image2.png
Greyscale
PNG
media_image1.png
213
287
media_image1.png
Greyscale
Suzuki’s formula I (Left) Applicant’s formula I (Right)
Suzuki teaches ghrelin-like small molecule compounds are known to have an ameliorating effect on cachexia (col. 1, lines 39-45). Suzuki also discloses “The effectiveness of the compounds represented by Formula (I) or pharmacologically acceptable acid addition salts thereof in the treatment or prevention of cachexia, which are effective ingredients of the therapeutic or prophylactic agent for cachexia, can be evaluated by the effects thereof as described in Examples to prolong the lifetime or to suppress the body weight loss and the like in cancer-bearing animals.” (col. 7, lines 30-47). Suzuki also discloses that the compounds of formula I can be between 0.1 μg to 100 mg per dose and administered in a co-therapy with another pharmaceutical agent as “a combining ratio of the therapeutic or prophylactic agent for cachexia and the agents to be combined can be appropriately chosen depending upon the Subject of administration; the age, body weight and symptoms of the Subject of administration; the period of administration, their dosage forms, their methods of administration, the combination of drugs, and the like.” (col. 6, lines 29-62)
However, Suzuki et al. fails to disclose a ghrelin receptor agonist in combination to a
patient in need of treatment or prevention of cachexia, nor does Suzuki et al. teach a ghrelin receptor agonist that is anamorelin or a pharmacologically acceptable salt thereof.
Maletinska et al. teach a method of treating cachexia via the utilization of a ghrelin analog in claim 4. Maletinska states, "Stable agonists of gastrointestinal hormone ghrelin represent orexigenic compounds which increase food intake after peripheral administration.
Therefore, ghrelin agonist could be potentially useful for treatment of cachexia or anorexia," (description, paragraph 2). Maletinska et al., 2017 also states, "Anamorelin was
employed in pilot study in cachectic oncologic patients (Garcia et al, 2013), MK-677 was
tested in healthy volunteers aged 61-80 years (Nass et al, 2008). JMV1843 (macimorelin) is in ongoing phase II trial for its use for treatment of cancer- induced cachexia (Aeterna Zentaris; clinicaltrials.gov; NCT01614990)," (description, last paragraph). Maletinska et al. teaches ghrelin agonists are useful for the treatment of cachexia (page 1 first full paragraph).
However, Maletinska et al. fails to disclose administering anamorelin in a dose range of 10 μg to 10000 mg.
Mann et al teach methods of treating cancer related conditions using anamorelin (Abstract). Mann teaches pharmaceutical treatments using anamorelin, and relates particularly to the treatment of conditions and disorders associated with cancer cachexia [0001]. Mann also discloses a therapeutically effective amount of anamorelin as a dose of about 10 to 500 mg/day [0105]. Mann discloses patients may be receiving a co-therapy of chemotherapeutics while receiving treatment with a compound of formula I [0104].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify the teachings of Suzuki, to include the ghrelin agonist of anamorelin disclosed by Maletinska and Mann because a skilled artisan would have recognized that the ghrelin agonists effect on appetite would be beneficial in treating a subject with cachexia when administering a combination therapy with a compound of Suzuki’s formula 1. See MPEP 2144.05 and 2144.06.
A person of ordinary skill would have been motivated to do so because agonists of ghrelin increase food intake and thus are useful for treatment of cachexia. One would have had a reasonable expectation of success because all three references have described treatment of cachexia, ghrelin agonists and a combination therapies. Therefore, a person of ordinary skill would have had a reasonable expectation of success in treating cancer cachexia in a subject as a predictable result from administering 0.1 μg to 100 mg per dose of Suzuki’s formula I and 10 to 500 mg/day of anamorelin.
Response to Arguments
Applicant's arguments filed 12/12/2024 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues the present invention has an unexpected technical effect.
In response to applicant's argument that present invention has an unexpected technical effect of improving cancer cachexia in a ghrelin-resistant state, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, a person of ordinary skill would have been motivated to combine a compound of Suzuki’s formula I with the disclosures of ghrelin agonists and anamorelin Maletinska and Mann given the prior art is directed towards the same purpose of treating cachexia (MPEP 2144.06).
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 8-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,006,262 82.
Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are generally drawn to a method of treating cachexia comprising administering a therapeutically effective amount of a compound of Formula (I) e.g. (-)-17-( cyclopropylmethyl)-3, 14β-dihydroxy-4, 5α-epoxy-6β-[N-methyl-trans-3-(3-furyl)acrylamido] morphinan. The patented claims require the use of a composition of the instant compound.
Regarding claim 8, Suzuki et al. (2019) teaches a method of treating cachexia comprising administering a therapeutically effective amount of a compound of Formula (I):
PNG
media_image3.png
143
311
media_image3.png
Greyscale
to a patient, wherein a double line consisting of a broken line and a solid line represents a double bond or single bond, R1 represents C4-C7 cycloalkylalkyl, R2 represents C1- C5 linear or branches alkyl, and B represents -CH=CH- or a pharmacologically acceptable acid addition salt thereof (claim 1 ).
Regarding claim 10, Suzuki et al., 2019 discloses the compound where R1 is
cyclopropylmethyl, cyclobutylmethyl, cyclopentylmethyl or cyclohexylmethyl, and R2 is
methyl, ethyl or propyl (claim 2).
Regarding claim 11, Suzuki et al., 2019 discloses the compound where R1 is cyclopropylmethyl, R2 is methyl, and B is -CH=CH- in trans-form (claim 3).
Regarding claim 12, Suzuki et al., 2019 discloses the compound of Formula (I) is (-)-17-( cyclopropylmethyl)-3, 14β-dihydroxy-4, 5α-epoxy-6β-[N-methyl-trans-3-(3-furyl)acrylamido] morphinan (claim 4).
Regarding claim 14, Suzuki et al., 2019 discloses the cachexia is cancer cachexia in claims 5-8 as applicable to the method described above.
Suzuki et al. does not disclose a ghrelin receptor agonist in combination to a patient in need of treatment or prevention of cachexia, nor does Suzuki et al. teach a ghrelin receptor agonist that is anamorelin or a pharmacologically acceptable salt thereof.
This limitation is remedied by Maletinska et al. which teaches a method of treating cachexia with the utilization of an anamorelin ghrelin agonist.
Regarding claims 8-9 and 13, Maletinska et al., 2017 teaches a method of treating cachexia via the utilization of a ghrelin analog in claim 4. Maletinska et al., 2017 states, "Stable agonists of gastrointestinal hormone ghrelin represent orexigenic compounds which increase food intake after peripheral administration. Therefore, ghrelin agonist could be potentially useful for treatment of cachexia or anorexia," (description, paragraph 2). Maletinska et al., 2017 also states, "Anamorelin was employed in pilot study in cachectic oncologic patients (Garcia et al, 2013), MK-677 was tested in healthy volunteers aged 61-80 years (Nass et al, 2008). JMV1843
(macimorelin) is in ongoing phase II trial for its use for treatment of cancer- induced cachexia (Aeterna Zentaris; clinicaltrials.gov; NCT01614990)," (description, last paragraph). Maletinska et al. teaches ghrelin agonists are useful for the treatment of cachexia (page 1 first full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of Suzuki et al. to include the ghrelin agonist of Maletinska et al. One would have been motivated to do so because agonists of ghrelin increase food intake and thus are useful for treatment of cachexia. One would have had a reasonable expectation of success because both references have described treatment of cachexia, so it would be prima facie obvious to arrive at the claimed subject matter of the instant claims by combining the teachings of both of these references for the treatment of cachexia.
Even though the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious to include the ghrelin agonist as taught by Maletinska et al. and arrive at the instant claims for treating cachexia.
Claims 8-14 are provisionally rejected on the ground of nonstatutory double patenting over claim 7-12 of copending Application No. 18012099.
Although the claims at issue are not identical, they are not patentably distinct from each other.
The subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application since the referenced copending application and the instant application are claiming common subject matter, such as:
Claim 7 of Application No. 18012099 teaches a method of ameliorating or preventing a muscle weakness symptom in diseases or syndromes associated with a metabolic disorder, which comprises administering a compound represented by formula (I) or a pharmacologically acceptable acid addition salt thereof wherein a double line of a dotted line and a solid line represents a double bond or a single bond, R1 represents a cycloalkylalkyl having 4 to 7 carbon atoms, R2 represents a linear or branched alkyl having 1 to 5 carbon atoms, and B represents a -CH=CH-, to a patient in need of ameliorating or preventing a muscle weakness symptom in diseases or syndromes associated with a metabolic disorder.
Claim 8 of Application No. 18012099 teaches the method according to claim 7, wherein R1 is a cyclopropylmethyl, a cyclobutylmethyl, a cyclopentylmethyl or a cyclohexylmethyl, and R2 is a methyl, an ethyl or a propyl.
Claim 9 of Application No. 18012099 teaches the method according to claim 7, wherein R1 is a cyclopropylmethyl, R2 is a methyl, and B is a trans-CH=CH-.
Claim 10 of Application No. 18012099 teaches the method according to claim 7, wherein the compound represented by the above formula (I) is (-)-17-(cyclopropylmethyl)-3, 14β-dihydroxy-4, 5α-epoxy-6β-[N-methyl-trans-3-(3-furyl)acrylamide ]morphinan represented by formula (2).
Claim 11 of Application No. 18012099 teaches the method according to claim 7, wherein the metabolic disorder is anabolic resistance.
Claim 12 of Application No. 18012099 teaches the method according to claim 7, wherein the metabolic disorder is hypercatabolism.
Paragraph 0045 of Application No. 18012099 teaches muscle weakness is a symptom and associated with cancer cachexia and paragraph 0014 of Application No. 18012099 teaches metabolic disorders include anabolic resistance and hypercatabolism that include muscle weakness symptoms, therefore implying this method is treating cachexia.
Claims 8-14 are provisionally rejected on the ground of nonstatutory double patenting over claim 7-12 of copending Application No. 18286379.
Although the claims at issue are not identical, they are not patentably distinct from each other.
The subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application since the referenced copending application and the instant application are claiming common subject matter, such as:
Claim 7 of Application No. 18286379 teaches a method of treating or preventing
cachexia accompanied by ghrelin resistance, the method comprising a step of administering an opioid K receptor agonistic compound. Claim 8 of Application No. 18286379 teaches the method according to claim 7, wherein the opioid K receptor agonistic compound is a compound represented by General Formula (I) or a pharmacologically acceptable acid addition salt thereof
wherein a double line composed of a dotted line and a solid line represents a double bond or a single bond, R1 represents a cycloalkylalkyl having 4 to 7 carbon atoms, R2 represents a linear or branched alkyl having 1 to 5 carbon atoms, and B represents a -CH=CH.
Claim 9 of Application No. 18286379 teaches the method according to claim 8, wherein R1 is a cyclopropylmethyl, a cyclobutylmethyl, a cyclopentylmethyl, or a cyclohexylmethyl, and R2 is a methyl, an ethyl, or a propyl.
Claim 10 of Application No. 18286379 teaches the method according to claim 8, wherein R1 is a cyclopropylmethyl, R2 is a methyl, and B is a trans-form -CH=CH-.
Claim 11 Application No. 18286379 teaches the method according to claim 8, wherein the compound represented by General Formula (I) is (-)-17-( cyclopropylmethyl)-3, 14β-dihydroxy-4, 5
α
-epoxy-6β-[N-methyl-trans-3-(3-furyl)acrylamide ]morphinan.
Claim 12 Application No. 18286379 teaches the method according to claim 7, wherein the cachexia is cancer cachexia.
This is a provisional double patenting rejection because the patentably indistinct
claims have not in fact been patented.
Terminal Disclaimer
The double patenting rejection will be maintained until a terminal disclaimer is filed or the instant claims amended to overcome the double patenting rejection.
Conclusion
All claims are rejected, no claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.V./Examiner, Art Unit 1623
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
Prosecution Insights