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 entry of PCT/US2020/041681 filed on 07/10/2020 which claims the benefit of U.S. Provisional Application No. 63/014,256 filed on 04/23/2020 and U.S. Provisional Application No. 62/872,499 filed on 07/10/2019.
Response to Amendment
Applicant’s amendment filed on March 10, 2026 amending claim 27 and adding new claim 28 has been entered. Claims 6, 10 and 14-26 are withdrawn. Claims 2-4, 7-9 and 11-13 were previously cancelled. Claims 1, 5, 27 and 28 are currently presented for examination and are being examined as they read on the elected species.
Response to Arguments
Due to Applicant’s amendment to claim 27, the previous objection to claim 27 is hereby withdrawn. However, Applicant’s amendment to claim 27 necessitates a new rejection under 35 USC 112(b).
Applicant's arguments filed March 10, 2026 with respect to the rejection under 35 USC 102(a)(1) have been fully considered but they are not persuasive.
Applicant argues that "increasing" lifespan means extending the length of time a subject remains alive, e.g., an increase in overall survival time relative to an appropriate baseline or control. Applicant argues that increasing lifespan is not defined as a consequence of curing or treating a particular pathology such as SMA, rather lifespan is an independent therapeutic objective, applicable even in subjects who are not suffering from a defined disease. Applicant argues that "increasing the lifespan" is tied to modulating molecular and gene-expression patterns (e.g., "longevity signatures") associated with aging, and by contrast, disease-specific survival reflects incidental life extension resulting from alleviation of a defined pathology (e.g., SMA), which the application expressly distinguishes from, defining lifespan extension as a stand-alone therapeutic objective.
These arguments are found not persuasive since the claims of the instant application merely recite “a method of increasing the lifespan of a mammalian subject comprising administering to the subject a therapeutically effective amount of selumetinib, thereby increasing the lifespan of the subject. The claims of the instant application do not exclude the treatment of diseases or disorders. Moreover, the claims of the instant application claim increasing the lifespan of any mammalian subject and do not claim administering the compounds to any particular subject. Thus, the claims are broad and merely require the administration of selumetinib which results in the increase of the lifespan. The claims nor the instant specification state that increasing the lifespan of a subject cannot be a consequence of treating a particular disease or disorder. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., increasing lifespan is not defined as a consequence of curing or treating a particular pathology such as SMA) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Moreover, Charbonnier et al. specifically teaches administering a therapeutically effective amount of the ERK inhibitor, Selumetinib, to said subject in need thereof and thus administration of the same compound as claimed will inherently increase the lifespan of the subject administered since a compound and its properties are inseparable. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963). In addition, it is not necessary that the prior art suggests the same advantage or result discovered by applicant when the steps of the claim are the same as those described or suggested by the prior art. See, e.g., In re Kahn, 441 F.3d 977, 987 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013 (CCPA 1972); In re Dillon, 919 F.2d 688 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991).
Applicant further argues that Charbonnier does not inherently disclose the claimed lifespan increase because Charbonnier teaches treatment of a specific pathological condition (e.g., SMA), where any observed survival benefit is contingent on amelioration of that disease and occurs only in diseased subjects. Applicant argues that because lifespan extension in Charbonnier is neither inevitable nor universal outside the disease context, it cannot be inherent in the claimed methods, which require purposeful induction of a longevity state rather than incidental survival following disease treatment.
These arguments are found not persuasive for the same reasons as detailed above. The claims of the instant application do not exclude the treatment of any particular disease or disorder and merely require increasing the lifespan of a mammalian subject comprising the administration of selumetinib. Charbonnier et al. specifically teaches administering a therapeutically effective amount of the ERK inhibitor, Selumetinib, to said subject in need thereof and thus administration of the same compound as claimed will inherently increase the lifespan of the subject administered since a compound and its properties are inseparable. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963). In addition, Charbonnier et al. specifically demonstrates that both U0126 and selumetinib MEK inhibitors increased the lifespan of SMA-like mice (Figures 4 A and M and page 27 line 23-page 28 line 6). Thus, Charbonnier et al. specifically demonstrates that administration of a therapeutically effective amount of selumetinib increases the lifespan of a mammalian subject.
For these reasons, the previous rejection under 35 USC 102(a)(1) is hereby maintained and reproduced below. New claim 28 is being rejected on the same grounds and further under 35 USC 112(b). Accordingly, this action is FINAL.
Claim Rejections - 35 USC § 112
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.
Claim 27 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 is indefinite since said claim recites “wherein the composition is formulated for administration to the human subject in combination with a meal.” It is unclear if this limitation means that the composition is formulated by incorporating the composition in a meal; or if the composition is administered separately but at the same time with a meal; or if the composition is formulated such that it is capable of being administered with a meal. For the sake of compact prosecution, claim 27 is being interpreted as the composition is formulated such that it is capable of being administered with a meal.
Claim Objections
Claim 28 is objected to because of the following informalities:
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
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See MPEP § 2173.05(s).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1, 5, 27 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Charbonnier et al. WO 2012/160130 A1.
Claims 1, 5, 27 and 28 of the instant application claim a method of increasing the lifespan of a mammalian subject comprising administering to the subject a therapeutically effective amount of selumetinib.
Charbonnier et al. teaches a method for treating spinal muscular atrophy and other related neuromuscular disorders in a subject in need thereof, said method comprising administering a therapeutically effective amount of an ERK inhibitor, such as Selumetinib, to said subject in need thereof (abstract and page 1 lines 4-7). Charbonnier et al. teaches that Spinal Muscular Atrophy (SMA) is a recessive neurodegenerative disease characterized by the selective loss of spinal motor neurons caused by mutation of the Survival-of-Motor- Neuron 1 (SMN1) gene and deficiency of the survival motor neuron (SMN) protein expression (page 1 lines 10-13). Charbonnier et al. teaches that to date there is no available therapy for SMA, which represents the leading genetic cause of death in childhood (page 1 lines 17-18).
Charbonnier et al. teaches provides new data showing that the pharmacological inhibition of ERK pathway, notably through the use of Selumetinib or related ERK inhibitors, can be an efficient treatment to alleviate SMA symptoms or related disorders associated to SMN deficiency resulting in loss of motor function in patients (page 3 lines 1-4). Charbonnier et al. teaches methods for treating a neuromuscular disorder associated to a SMN deficiency resulting in loss of motor function, said method comprising administering a therapeutically efficient amount of an ERK inhibitor in a subject in need thereof, wherein examples of neuromuscular disorders that can be treated are preferably spinal muscular atrophy or other related neuromuscular disorders resulting from a genetic mutation in SMN1 gene, and the ERK inhibitors for use in the method may be selected from MEK1/2 inhibitors, preferably from known MEK1/2 inhibitors with an IC50 of at least 1 μΜ, or less, including selumetinib (also known as AZD6244), U0126, PD98059, PD0325901, AZD8330(ARRY-42704), CI- 1040 (PD 184352), PD318088 (page 3 lines 7-18). In a preferred embodiment, said ERK inhibitors are selected from Selumetinib or its derivatives or pharmaceutically acceptable salts (page 3 lines 19-20 and page 7 lines 15-30).
Charbonnier et al. teaches that "treatment" refers to any methods appropriate to cure, ameliorate, stabilize and/or prevent a disease or one or more of the symptoms of such disease (page 4 lines 8-9).
Charbonnier et al. specifically demonstrates that both U0126 and selumetinib MEK inhibitors increased the lifespan of SMA-like mice (Figures 4 A and M and page 27 line 23-page 28 line 6).
Claims 1 and 27 of the instant application are anticipated since Charbonnier et al. specifically demonstrates that selumetinib administration increases the lifespan of a mammalian subject. Claim 5 is anticipated since Charbonnier et al. specifically teaches a method for treating spinal muscular atrophy and other related neuromuscular disorders in a subject in need thereof, said method comprising administering a therapeutically effective amount of the ERK inhibitor Selumetinib. Since a subject in need thereof having spinal muscular atrophy is a human, Charbonnier et al. specifically teaches treating a human. Thus administration of the same compound as claimed for the treatment of a human with spinal muscular atrophy will inherently increase the lifespan of the human as claimed. Thus since the steps of the method of Charbonnier et al. are the same as claimed which are administering to the subject in need thereof a therapeutically effective amount of selumetinib, increasing the lifespan of the human will inherently occur in the prior art as claimed.
With respect to the newly added limitation of claim 27 interpreted as the composition is formulated such that it is capable of being administered with a meal, said limitation is anticipated since Charbonnier et al. specifically teaches administration of a pharmaceutical composition comprising selumetinib and a pharmaceutically acceptable excipient and thus said composition is inherently capable of being administered with food (pages 11-13). Thus since Charbonnier et al. specifically teaches formulating the pharmaceutical composition as claimed in claim 27, comprising selumetinib and a pharmaceutically acceptable excipient, said composition is inherently capable of being administered with food as claimed.
Moreover, new claim 28 is anticipated since Charbonnier et al. specifically teaches administering a therapeutically effective amount of the ERK inhibitor, Selumetinib, to said subject in need thereof and thus administration of the same compound as claimed will inherently result in the same effects as claimed which is elevating expression of at least one gene as set forth in Tables 1-10 and/or suppressing expression of at least one gene as set forth in Tables 2-20, to thereby modulate a longevity signature in the subject. A compound and its properties are inseparable. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963). "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Thus the cited claims of the instant application are anticipated over the teachings of Charbonnier et al.
Conclusion
Claims 1, 5, 27 and 28 are rejected. Claims 6, 10 and 14-26 are withdrawn, Claims 2-4, 7-9, 11-13 are cancelled. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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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.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
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