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
Status of claims
The amendment filed on Oct. 21, 2025 is acknowledged. Claims 1-6 have previously been canceled and new claim 13 has been added. Claims 7-13 are under examination in the instant office action.
Applicants' arguments, filed on Oct. 21, 2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. Responses are limited to Applicants' arguments relevant to either reiterated or newly applied 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 7-13 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 pre-AIA the applicant regards as the invention. All dependent claims are included.
While the preamble of the claim 1 has been amended to delete “preventing” and to recite “ameliorating a muscle weakness symptom in a patient having muscle weakness associated with diseases or syndromes associated with metabolic disorder”, the active step of the claimed method still recites “a patient in need of ameliorating or preventing a muscle weakness symptom in diseases or syndromes associated with metabolic disorder”. Thus, it is vague and confusing as to whether the preamble or the active step controls the metes and bounds of the claimed method. As such, one of ordinary skill in the art would not ascertain the scope of the patient population for the claimed method. For the examination purpose, the scope of the claims is interpreted based on the active step.
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 7-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, while being enabling for a method of ameliorating muscle weakness symptom of cancer cachexia by administering a compound of formula I, does not reasonably provide enablement for a method of preventing muscle weakness associated with claimed diseases or syndromes associated with a metabolic disorder regardless of its causes. The claims 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.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, state and predictability of the art, and relative skill of those in the art
The instant claims are directed to a method for muscle weakness symptom of diseases or syndromes associated with a metabolic disorder comprising administering to a patient a compound of formula I. The target patient population encompasses patients having different diseases or syndromes associated with various metabolic disorders, which include acquired metabolic disorders and inherited metabolic disorders. The inherited metabolic disorders are genetic conditions where the body has difficulty processing substances like carbohydrates, fats, or proteins. Accordingly, the instant claims encompass the prevention and treatment of those underlying metabolic disorders such as inherited metabolic disorders, which are known to be unpreventable.
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
That factor is outweighed, however, by the unpredictable nature of the art. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved", and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.), Nationwide Chemical Corporation, et al. v. Wright, et al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances), Ex parte Sudilovsky 21 USPQ2d 1702 (Appellant's invention concerns pharmaceutical activity. Because there is no evidence of record of analogous activity for similar compounds, the art is relatively unpredictable) In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian recombinant virus vaccine was uncertain).
The state of the art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e., what compounds can treat which specific disease or condition by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face. In addition, the term “prevention" actually means to anticipate or counter in advance, to keep from happening, etc. and there is no disclosure as to how one skilled in the art can reasonably establish the basis and the type of subject to which the instant compounds can be administered in order to have the "preventative" effect.
In regards to the treatment or prevention of muscle weakness caused by various metabolic disorders, metabolic disorders encompass a wide range of conditions, both inherited and acquired, that disrupt the body's metabolism and can lead to a variety of symptoms and complications. For example, metabolic disorders include acquired metabolic disorders such as diabetes, obesity, metabolic syndrome and cancer and inherited metabolic disorders such as amino acid metabolism disorders (Phenylketonuria and Maple Syrup Urine Disease), carbohydrate metabolism disorders (Galactosemia and Glycogen Storage Diseases), fatty acid and lipid metabolism disorders (lysosomal storage disorders) and mitochondrial disorders. Each condition has its unique characteristics, causes, and impacts on the body. There is not one class of compounds, let alone one compound, which can prevent or treat all of the metabolic disorders.
In addition, prevention involves “attacking” the underlying cause of those conditions or disorders, i.e., disrupting the mechanisms which give rise to such conditions or disorders. The skilled artisan is aware that the causes of those conditions or disorders are multivariate and some of their etiologies were unknown at the time of the invention herein. For purposes of enablement, the specification must provide reasonable detail in order for those skilled in the art to carry out the invention. In this case, the specification must disclose a means of preventing those conditions or disorders regardless of the underlying causes thereof. Neither the teachings in the art nor the teachings of the specification enable a person of ordinary kill in the art to practice the claimed method of preventing those underlying metabolic disorders when the underlying etiology of the disorder is multifaceted and has not been fully elucidated.
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statue.
Hence, in the absence of a showing of correlation between treatment/prevention of muscle weakness associated with different metabolic disorders encompassed by the claims and the effects of claimed compounds, one of ordinary skill in the art is unable to fully predict possible results from the administration of the compounds of the claims due to the unpredictability.
The breadth of the claims
The claims are extremely broad insofar as they embrace the general prevention and treatment of various unrelated metabolic disorders (e.g., diabetes mellitus, dyslipidemia, cancer, aging, inherited metabolic disorders, insulin resistance, conditions associated with metabolic syndrome, atherosclerotic disorders, etc.) with the claimed compound of formula (I).
The amount of direction or guidance present and the presence or absence ofworking examples
A disclosure should contain representative examples which provide reasonable assurance to one skilled in the art that the compounds which fall within the scope of a claim will possess the alleged activity. The only examples are related to malignant tumor and senescence-accelerated mouse models showing gripping force (muscle strength) weakness symptom wherein the compound 1-administered groups showed an increasing action on the gripping force (muscle strength) compared with the distilled water administered group. However, the disclosure does not provide how these effects correlate to the treatment or prevention of muscle weakness symptom associated with other unrelated metabolic disorders, which involve different etiology and pathology. In other words, the specification does not contain any evidentiary support that the claimed compound would be able to treat or prevent muscle weakness symptom regardless of the plethora of underlying metabolic disorders encompassed by the instant claims.
Also, reasonable guidance with respect to preventing a disease relies on quantitative analysis from defined populations which have been successfully pre-screened and are predisposed to the disease. This type of data might be derived from widespread genetic analysis, clusters, or family histories. The essential element towards the validation of a preventive therapeutic is the ability to test the drug on subjects monitored in advance of clinical disease and link those results with subsequent confirmation of the presence or absence of disease. This irrefutable link between antecedent drug or method of treatment and subsequent knowledge of the prevention of the disease is the essence of a valid preventive agent or method of treatment. Applicants have not provided any competent evidence or disclosed tests that are highly predictive for the preventive use of the instant compounds as claimed.
The quantity of experimentation needed
In view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which specific disorders or conditions can be treated or prevented by the compounds encompassed in the instant claims, with no assurance of success. One of ordinary skill in the art would need to determine what specific metabolic disorders are benefited by the administration of the compounds of the instant claims and would furthermore have to determine which of the claimed compounds would provide prevention of which disorders or conditions. The specification fails to provide sufficient support of the broad use of the compounds of the instant claims for the treatment or prevention of the various claimed disorders, as a result necessitating one of skill to perform an exhaustive search for which disorders or conditions can be treated by what compounds of the instant claims in order to practice the claimed invention. Only a majority of the claimed disorders or conditions are discussed here to make the point of an insufficient disclosure, it does not mean that the other diseases meet the enablement requirements.
Factors such as "sufficient working examples", "the level of skill in the art" and "predictability", etc. have been demonstrated to be sufficiently lacking in the instantly claimed methods. In view of the chemical nature of the invention and the lack of working examples regarding the activity of the claimed compounds, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable".
Response to Applicant’s arguments
Applicant argued that the deletion of “preventing” should obviate some concerns with respect to 35 USC 112. However, it is noted that claim 1 still recites “a patient in need of ameliorating or preventing a muscle weakness symptom in disease or syndrome associated with a metabolic disorder” in the active step of the method (see lines 9-11 of claim 1) while “preventing” has been deleted in the preamble. Thus, the claims as amended still encompass the method of “preventing”, and thus the above rejection is properly maintained for the scope of prevention.
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 Penna et al. (Front. Physiol., Volume 10:1-15, 17 February 2019).
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 or preventing a muscle weakness symptom in diseases or syndromes associated with a metabolic disorder. Thus, the target patient population of the claims as amended still encompasses a patient having a disease or syndrome associated with a metabolic disorder such as malignant tumor, cachexia, and cancer cachexia.
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 characterized with the loss of muscle mass and function (muscle weakness) as one of diseases or syndromes associated with a metabolic disorder, which has characteristics of anabolic resistance and hypercatabolism as evidenced by Penn et al. (abstract, p2, col 2, para 3, p8, col 1, para 1-2). Thus, the patient with cancer cachexia reads on claimed target patient population.
While SUZUKI is silent about ameliorating muscle weakness symptom, the prior art teaches 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). 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”).
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 SUZUKI.
Response to Applicant’s arguments
Applicant argued that Suzuki merely discloses the inhibitory effect of the claimed compound on weight loss, a symptom of cancer cachexia and the resulting life prolonging effect and Penna et al. do not disclose that any compound that inhibits weight loss in cancer cachexia will treat muscle weakness in cancer cachexia. Applicant further stated that the cited documents do not inherently disclose the feature of the present invention. Also, Applicant argued that the therapeutic effect on weight loss in cancer cachexia does not necessarily correspond to the effect on muscle weakness in cancer cachexia. In addition, Applicant argued that the patient having muscle weakness associated with cachexia is a narrower patient population than the cachectic patients because in diagnostic criteria for cachexia, weight loss is an essential requirement, but muscle weakness and thus not all cachectic patient exhibit muscle weakness, citing Reference 14.
In response, SUZUKI explicitly teaches administering the claimed compound for treating cachexia such as cancer cachexia. Thus, the target patient of SUZUKI is a patient with cancer cachexia. Penn et al. is only cited as evidentiary reference for demonstrating that a patient with cancer cachexia is a patient having the loss of muscle mass and function (muscle weakness) (see abstract, p2, col 2, para 3, p8, col 1, para 1-2). Accordingly, the patient population with cancer cachexia is a patient in need of ameliorating or preventing muscle weakness associated with cancer cachexia. Even the reference 14, which applicant cited, supports this because it clearly states that cancer cachexia is a syndrome characterized by weight loss with accompanying loss of muscle and/or fat mass and leads to patient function and physical performance (see abstract). Also, the reference 14 explicitly disclose 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), on the contrary to applicant’s assertion that muscle weakness is not a diagnostic criteria for cachexia, Thus, the target patient of SUZUKI is the same as that of the claimed method.
While SUZUKI is silent about the effect on “muscle weakness”, administering the same compound to the same patient as taught by the prior art necessarily has the claimed effects (i.e., preventing or ameliorating muscle weakness) 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. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Also see In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
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”). However, Applicants did not provide any evidence that subject matter shown in the prior art does not possess the characteristic relied on.
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 900626 as evidenced by Penna et al. (Front. Physiol., Volume 10:1-15, 17 February 2019).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘626 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 characterized with the loss of muscle mass and function (muscle weakness) as one of diseases or syndromes associated with a metabolic disorder, which has characteristics of anabolic resistance and hypercatabolism as evidenced by Penn et al. (abstract, p2, col 2, para 3, p8, col 1, para 1-2). Thus, the patient with cancer cachexia reads on claimed target patient population.
While the claims of the patent are silent about ameliorating or preventing 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). 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”).
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 provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 8-16 of co-pending application 17/769454 as evidenced by Penna et al. (Front. Physiol., Volume 10:1-15, 17 February 2019).
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 and a ghrelin receptor agonist to a patient.
Cancer cachexia is characterized with the loss of muscle mass and function (muscle weakness) as one of diseases or syndromes associated with a metabolic disorder, which has characteristics of anabolic resistance and hypercatabolism as evidenced by Penn et al. (abstract, p2, col 2, para 3, p8, col 1, para 1-2). Thus, the patient with cancer cachexia reads on claimed target patient population.
While the claims of the co-pending application are silent about ameliorating or preventing 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). 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”).
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.
Claims 7-13 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 8-12 of co-pending application 18/286379 as evidenced by Penna et al. (Front. Physiol., Volume 10:1-15, 17 February 2019).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘379 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 to a patient.
Cancer cachexia is characterized with the loss of muscle mass and function (muscle weakness) as one of diseases or syndromes associated with a metabolic disorder, which has characteristics of anabolic resistance and hypercatabolism as evidenced by Penn et al. (abstract, p2, col 2, para 3, p8, col 1, para 1-2). Thus, the patient with cancer cachexia reads on claimed target patient population.
While the claims of the co-pending application are silent about ameliorating or preventing 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). 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”).
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 ‘379 application.
Response to Applicant’s arguments
Applicant stated that the same arguments as stated for the above 102 rejection, thus the same responses stated above are applied here.
Conclusion
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 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 date of this final action.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.