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 .
DETAILED ACTION
A request for continued examination under 37 C.F.R. 1.114, including the fee set forth in 37 C.F.R. 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 C.F.R. 1.114, and the fee set forth in 37 C.F.R. 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 C.F.R. 1.114. Applicant’s submission filed May 1, 2026 has been received and entered into the present application.
Status of claims
The amendment filed on March 31, 2026 is acknowledged. Claims 1-6 have previously been canceled. Claims 7-13 are under examination in the instant office action.
Applicants' arguments, filed on March 31, 2026, have been fully considered but they are not persuasive or moot in view of a new ground of rejection. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied in view of the amendments. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 7-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2013/0310414 (hereafter, SUZUKI; cited in the IDS filed on 12/21/2022) as evidenced by Robert et al. (Biochemical and Biophysical Research Communications 435 (2013) 488–492) and Sara et al. (J Cachexia Sarcopenia Muscle. 2020 Mar 6;11(3):619–635; cited in the IDS filed on 6/2/2026).
The instant claims are directed to a method of ameliorating a muscle weakness symptom in a patient having muscle weakness associated with 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:
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to a patient in need of ameliorating a muscle weakness symptom in diseases or syndromes associated with a metabolic disorder, wherein the diseases or syndromes associated with a metabolic disorder are selected from the group consisting of cerebral apoplexy, chronic cardiac failure, chronic obstructive pulmonary disease, chronic kidney disease, type 2 diabetes, sepsis, osteoarthritis, osteoporosis, sarcopenia, malignant tumor, cachexia, disuse syndrome, locomotive syndrome, geriatric syndrome, and acquired immune deficiency syndrome. Thus, the target patient of the claimed method encompasses those having cachexia with muscle weakness symptom.
SUZUKI teaches a method of treating cachexia comprising administering a therapeutically effective amount of a compound of the following structure:
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(abstract and claims 1 and 9).
SUZUKI further discloses that R1 is cyclopropylmethyl, cyclobutylmethyl, cyclopentylmethyl or cyclohexylmethyl, and R2 is methyl, ethyl or propyl (claims 9-10).
SUZUKI further discloses that R1 is cyclopropylmethyl, R2 is methyl, and B is a trans-CH=CH- (claims 9 and 11).
SUZUKI specifically disclose that the compound is (-)-17-(cyclopropylmethyl)-3,14β-dihydroxy-4,5α-epoxy-6β-[N-methyl-trans-3-(3-furyl)acryl-amido]morphinan of the following structure:
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(claim 12), which is the same compound recited in the instant claim 10.
Also, SUZUKI teaches that the cachexia is cancer cachexia (claim 13). Cancer cachexia is a complex metabolic syndrome that is characterized by the loss of skeletal muscle mass and weakness, which compromises physical function, reduces quality of life, and ultimately can lead to mortality as evidenced by Roberts et al. (abstract and p488, introduction). Also, the loss of skeletal muscle tissue along with weakness and systemic inflammation is a key feature of cancer cachexia, which is caused by excessive protein degradation (hypercatabolism) and/or decreased protein synthesis (anabolic resistance) in skeletal muscle as evidenced by Sara et al. (abstract and p621, col 2, para 1). Thus, the patient with cancer cachexia is a patient having muscle weakness symptom, thus in need of ameliorating muscle weakness symptom as claimed. Also, the cancer cachexia is a metabolic disorder associated with anabolic resistance and hypercatabolism. Roberts et al. and Sara et al. are cited only as evidentiary references.
While SUZUKI is silent about the effect on “muscle weakness”, the prior art teaches administering the same compound to the same patient (those with cancer cachexia having muscle weakness symptom). Thus, ameliorating symptoms of the cancer cachexia such as muscle weakness, necessarily occurs. “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”).
As such, the instant claims are anticipated by SUZUKI.
Response to Applicant’s arguments
Responses are limited to Applicants' arguments relevant to either reiterated or newly applied rejections.
Applicant argued that the claimed patient population is not identical to that disclosed in Suzuki. Applicant further stated that Suzuki treats all cachectic patients while the present claims are limited to cachectic patients who have muscle weakness. Also, Applicant argued that the essential requirement for cancer cachexia is weight loss as evidenced by diagnostic criteria of cancer cachexia patients shown in Table 1 of Reference 14 and thus not all cachectic patient exhibit muscle weakness. In addition, Applicant further argued that the “patient having muscle weakness associated with cachexia” corresponds to a species when “cachectic patients” is considered as the genus and the genus or treatment for cachectic patients, does not anticipate the species.
In response, Suzuki teaches treatment of patients with cachexia, in particular, cancer cachexia, which is a complex metabolic syndrome characterized by the loss of skeletal muscle mass and weakness as evidenced by Roberts et al. (see abstract, introduction, and Conclusion). Roberts et al. further disclose that cachexia is a complex metabolic syndrome associated with most advanced stage cancers characterized by progressive weight loss due to significant skeletal muscle wasting, with or without adipose tissue wasting and the muscle wasting causes associated muscle weakness (p488, col 1, para 1). Since the loss of skeletal muscle mass and weakness is the essential characteristic for cancer cachexia as evidenced by Roberts et al. the patient population of Suzuki is a cancer cachectic patient who has muscle weakness as a symptom as claimed. Accordingly, the patient population with cancer cachexia is a patient in need of ameliorating muscle weakness associated with cancer cachexia. Also, the patient population of Suzuki is a species of claimed patient population, not a genus because the instant claim is directed to the treatment of a general cachexia having muscle weakness while those of Suzuki is a cancer cachexia having muscle weakness.
Also, the reference 14 cited by Applicant clearly states that cancer cachexia is a syndrome characterized by weight loss with accompanying loss of muscle and/or fat mass (loss of fat mass is optional, not the loss of muscle) and leads to patient function and physical performance (see abstract). Also, the reference 14 explicitly discloses that cancer cachexia is diagnosed by an examination of weight loss, body mass index, and evidence of muscle depletion and the terms cachexia and sarcopenia describe debilitating disorders of muscle deficiency that reduce patient function and physical performance (muscle weakness) (see p2, table 1 and p3, para 3). In addition, Sara et al. teach that because cancer cachexia can co‐occur with obesity, fluid retention and large tumours, all of which can mask weight loss, this framework also recommends a direct measure of muscularity. Thus, the weight loss may not be the essential feature of cancer cachexia as Applicant asserted. Furthermore, Roberts et al. teach that cancer cachexia is characterized by the loss of skeletal muscle mass and weakness, which compromises physical function, reduces quality of life, and ultimately can lead to mortality as stated above. Accordingly, cancer patients with cachexia constitute a patient population characterized by muscle weakness as a key manifestation of cancer cachexia, thus the target patient of SUZUKI is the same as that of the claimed method.
In addition, Applicant argued that even where muscle weakness is present, treating cachexia does not necessarily ameliorate based on the anamorelin and enobosarm clinical evidence.
In response, Suzuki is directed to treating a cancer cachectic patient who has muscle weakness as symptom by administering the same compound as claimed. Thus, the effects of the same compound (i.e., ameliorating muscle weakness) in the same patient is necessarily present. The Examiner’s inherency is based on the fact that the cancer cachexia patient of the prior art has symptom of muscle weakness, thus when the same compound is administered to such patient, the same compound necessarily has claimed effects because products of identical chemical composition cannot have mutually exclusive properties and a chemical composition and its properties are inseparable. Furthermore, it is generally well settled in the courts that a mechanistic property of a chemical compound, or combination of chemical compounds, when administered under identical conditions, is necessarily present, despite the fact that such a property may not have been readily apparent to, or recognized by, one of ordinary skill in the art. In addition, the ineffectiveness of anamorelin and enobosarm on muscle weakness is irrelevant because they are different drug from the claimed compound and it does not change the fact that Suzuki teaches administering the same compound to the same cancer cachexia patient who has muscle weakness. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”). In this case, “ameliorating muscle weakness symptom” is a necessary feature or result of a prior-art embodiment (administering the same compound to the same patient). However, Applicants did not provide any evidence that subject matter shown in the prior art does not possess the characteristic relied on.
For the foregoing reasons, Applicant’s arguments have not been found to be persuasive.
Double Patenting Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 7-13 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of US patent 9006262 as evidenced by Robert et al. (Biochemical and Biophysical Research Communications 435 (2013) 488–492) and Sara et al. (J Cachexia Sarcopenia Muscle. 2020 Mar 6;11(3):619–635; cited in the IDS filed on 6/2/2026).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘262 patent are drawn to a method of treating cachexia such as cancer cachexia comprising administering a therapeutically effective amount of the same compound as claimed to a patient.
Cancer cachexia is a complex metabolic syndrome that is characterized by the loss of skeletal muscle mass and weakness, which compromises physical function, reduces quality of life, and ultimately can lead to mortality as evidenced by Roberts et al. (abstract and p488, Introduction). Also, the loss of skeletal muscle tissue along with weakness and systemic inflammation is a key feature of cancer cachexia, which is caused by excessive protein degradation (hypercatabolism) and/or decreased protein synthesis (anabolic resistance) in skeletal muscle as evidenced by Sara et al. (abstract and p621, col 2, para 1). Thus, the patient with cancer cachexia is a patient having a muscle weakness symptom, thus in need of ameliorating muscle weakness symptom as claimed. Also, the cancer cachexia is a metabolic disorder associated with anabolic resistance and hypercatabolism. Roberts et al. and Sara et al. are cited only as evidentiary references.
While the claims of the patent are silent about the effects on the muscle weakness symptom, the claims of the patent recite administering the same compound to the same patient (those with cancer cachexia). Thus, ameliorating symptoms of cancer cachexia, including muscle weakness, necessarily occurs.
“[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”). Furthermore, it is generally well settled in the courts that a mechanistic property of a chemical compound, or combination of chemical compounds, when administered under identical conditions, is necessarily present, despite the fact that such a property may not have been readily apparent to, or recognized by, one of ordinary skill in the art.
As such, the instant claims are anticipated by the claims of the patent.
Claims 7-13 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5 of US 12721845 as evidenced by Robert et al. (Biochemical and Biophysical Research Communications 435 (2013) 488–492) and Sara et al. (J Cachexia Sarcopenia Muscle. 2020 Mar 6;11(3):619–635; cited in the IDS filed on 6/2/2026).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘845 patent are drawn to a method of treating cachexia accompanied by ghrelin resistance such as cancer cachexia comprising administering a therapeutically effective amount of the same compound as claimed to a patient.
Cancer cachexia is a complex metabolic syndrome that is characterized by the loss of skeletal muscle mass and weakness, which compromises physical function, reduces quality of life, and ultimately can lead to mortality as evidenced by Roberts et al. (abstract and p488, Introduction). Also, the loss of skeletal muscle tissue along with weakness and systemic inflammation is a key feature of cancer cachexia, which is caused by excessive protein degradation (hypercatabolism) and/or decreased protein synthesis (anabolic resistance) in skeletal muscle as evidenced by Sara et al. (abstract and p621, col 2, para 1). Thus, the patient with cancer cachexia is a patient having a muscle weakness symptom, thus in need of ameliorating muscle weakness symptom as claimed. Also, the cancer cachexia is a metabolic disorder associated with anabolic resistance and hypercatabolism. Roberts et al. and Sara et al. are cited only as evidentiary references.
While the claims of the patent are silent about the effects on the muscle weakness symptom, the claims of the patent recite administering the same compound to the same patient (those with cancer cachexia). Thus, ameliorating symptoms of cancer cachexia, including muscle weakness, necessarily occurs.
“[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”). Furthermore, it is generally well settled in the courts that a mechanistic property of a chemical compound, or combination of chemical compounds, when administered under identical conditions, is necessarily present, despite the fact that such a property may not have been readily apparent to, or recognized by, one of ordinary skill in the art.
As such, the instant claims are anticipated by the claims of the ‘845 patent.
Claims 7-13 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 8-12 and 14-16 of co-pending application 17/769454 as evidenced by Robert et al. (Biochemical and Biophysical Research Communications 435 (2013) 488–492) and Sara et al. (J Cachexia Sarcopenia Muscle. 2020 Mar 6;11(3):619–635; cited in the IDS filed on 6/2/2026).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘454 application are drawn to a method of treating cachexia such as cancer cachexia comprising administering a therapeutically effective amount of the same compound as claimed in combination with anamorelin or a pharmaceutically acceptable salt thereof to a patient.
Cancer cachexia is a complex metabolic syndrome that is characterized by the loss of skeletal muscle mass and weakness, which compromises physical function, reduces quality of life, and ultimately can lead to mortality as evidenced by Roberts et al. (abstract and p488, Introduction). Also, the loss of skeletal muscle tissue along with weakness and systemic inflammation is a key feature of cancer cachexia, which is caused by excessive protein degradation (hypercatabolism) and/or decreased protein synthesis (anabolic resistance) in skeletal muscle as evidenced by Sara et al. (abstract and p621, col 2, para 1). Thus, the patient with cancer cachexia is a patient having a muscle weakness symptom, thus in need of ameliorating muscle weakness symptom as claimed. Also, the cancer cachexia is a metabolic disorder associated with anabolic resistance and hypercatabolism. Roberts et al. and Sara et al. are cited only as evidentiary references.
While the claims of the co-pending application are silent about ameliorating or preventing the muscle weakness symptom, the claims of the patent recite administering the same compound to the same patient (those with cancer cachexia). Thus, ameliorating or preventing symptoms of cancer cachexia, including muscle weakness, necessarily occurs.
“[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”). Furthermore, it is generally well settled in the courts that a mechanistic property of a chemical compound, or combination of chemical compounds, when administered under identical conditions, is necessarily present, despite the fact that such a property may not have been readily apparent to, or recognized by, one of ordinary skill in the art.
As such, the instant claims are anticipated by the claims of the ‘454 application.
Response to Applicant’s arguments
Applicant provided the same arguments as stated for the above 102 rejection, thus the same responses stated above are applied here.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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