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 filed on 6/28/2024, is a national stage application of PCT/CA2022-051785, filed 12/07/2022, which claims the benefit of provisional application 63/294,375, filed 12/28/2021.
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.
Claims 29, 31, 34-37, 68 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.
By referring to compounds of formula (I), (II), (III), and (IV), but not listing the compounds in the claims, the claims are made incomplete. MPEP 2173.05(s) states “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.”” For the purposes of applying prior art, the examiner assumes the structure of the compounds of Formula (I), (II), (III), and (IV) are taken from pages 2-3 in the specification.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claims 29, 31, 34-37, 47-49, 69, 146 and 147 are rejected under 35 U.S.C. 103 as being unpatentable over Fortin (Samuel Fortin, WO 2019153073 A1, as cited on IDS dated 07/02/2024) in view of Schosserer (Markus Schosserer et al., “The Dual Role of Cellular Senescence in Developing Tumors and Their Response to Cancer Therapy”, Frontiers in Oncology, Volume 7, Issue 278, Pub. Date: 11/23/2017).
Fortin teaches compounds I, II, III, and IV, see below, administered for increasing the life span of a subject in need, specifically for slowing down the ageing process (Claim 3). Fortin teaches compound I, II, III, and IV in composition with at least one ingredient, including cannabinoids, and separate administration of each compound for slowing down the aging process (Claims 16 and 18).
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Fortin does not teach that slowing down the aging process is related to cellular senescence.
Schosserer teaches pharmacological methods to prevent senescence or to selectively kill senescent cells in tumors (Abstract). Schosserer teaches “that specific elimination of senescent cells is able to slow organismal aging”, and identifies “quercetin as a senolytic compound able to kill senescent cells (Pg. 9, Senolytics-Translation of Genetic Mouse Models into Clinical Applications).
The courts have found, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.)
Regarding Claim 29, a method for preventing cellular senescence would include every patient population.
Regarding claims 29, 31, 34-37, 47-49, 146 and 147, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to use the method disclosed in Fortin for slowing down aging with compounds I, II, III, and IV, and combine it with quercetin, a polyphenol, as claimed in the instant application because Schosserer teaches quercetin as a senolytic that kills senescence cells and slows the aging process. One of ordinary skill would combine compounds I, II, III, and IV and quercetin as taught in Fortin and Schosserer, because both compounds are taught by the prior art to be used for slowing down aging, and it would be obvious to use them together.
Regarding claim 69, it recites the intended biological test results of the method of Claim 31, but does not provide further limitations. The court noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Therefore, if the method of Claim 31 is rejected under obviousness, the limitations of Claim 69 that recite the intended results of the method of claim 31 in the present application are also rejected as obvious.
Claims 29, 31, 34, 47-49, 68, 146, and 147 are rejected under 35 U.S.C. 103 as being unpatentable over Fortin (Samuel Fortin, WO 2019153073 A1, as cited on IDS dated 07/02/2024) in view of Schosserer (Markus Schosserer et al., “The Dual Role of Cellular Senescence in Developing Tumors and Their Response to Cancer Therapy”, Frontiers in Oncology, Volume 7, Issue 278, Pub. Date: 11/23/2017) as applied to claim above, and further in view of Fortin-2015 (Samuel Fortin, WO 20150119591 A1, Pub. date: 04/30/2015) and Yousefzadeh (Matthew J. Yousefzadeh et al., “Fisetin is a senotherapeutic that extends health and lifespan”, Research Paper, Volume 36, Pgs. 18-28, Pub. Date: October 2018)
Fortin does not disclose an administration/dosage schedule for compounds (I), (II), (III), and (IV).
Schosserer does not teach an administration/dosage schedule for the polyphenol quercetin.
Fortin-2015 teaches MAG-DHA (instant compounds of formula (I)) (Pg. 7, [0093-0093]). Fortin-2015 teaches compounds to reduce or inhibit tumor growth, as cancer chemo preventative agents, administered in combination with corn oil to mice, at 618 mg/kg, for 48 days (Pg. 4, [0039] and Pg. 10, [0117]).
Fortin-2015 does not teach administration of a polyphenol.
Yousefzadeh teaches mice administered with 100 mg/kg of fisetin for 5 consecutive days to reduce cellular senescence (Pg. 23, 3. Results). Yousefzadeh also teaches “Fisetin, like some other flavonoids, is a topoisomerase inhibitor, which may also contribute to its anti-cancer activity [81]” (Pg. 26, 4. Discussion).
MAG-DHA (A compound of Formula (I)) disclosed in Fortin-2015, and administered for 48 days, falls within the range of 1-12 months disclosed in instant Claim 68, and fisetin taught in Yousefzadeh for slowing cellular senescence when administered for 5 days, falls within the range of 1-15 days disclosed in instant Claim 68.
The courts found that, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.
It would have been prima facie obvious for one of ordinary skill in the arts before the effective filing date to take the method disclosed in Fortin-2015 for administering MAG-DHA as a cancer chemopreventative agent for 48 days, and combine it with the method taught in Yousefzadeh for administering fisetin for 5 days to reducing cellular senescence and contribute to anti-cancer activity because both methods are taught by the prior art to be used for cancer therapy. It would be obvious to use fisetin and MAG-DHA at the same time because it is known in the art to tailor dosage length based on patient response.
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 29, 31, 34-37, 146 and 147 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, 14, and 17 of copending Application No. 19/107,867 in view of Schosserer (“Markus Schosserer et al., “The Dual Role of Cellular Senescence in Developing Tumors and Their Response to Cancer Therapy”, Frontiers in Oncology, Volume 7, Issue 278, Pub. Date: 11/23/2017).
Regarding instant claims 29, 31, 34-37, 146 and 147, claims 1, 2, 10, 14, and 17 in copending application ‘867 teaches compounds I, II, III, and IV, see below, as compounds used in a composition with at least one cannabinoid to treat cancer.
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Copending application ‘867 does not teach a method for slowing/delaying cellular senescence or a composition comprising a polyphenol.
Schosserer teaches senescence is frequently induced by current tumor therapies, being beneficial for arresting apoptosis-resistant cancer cells, but on the other hand inducing senescence in other cells and thereby promoting cancer relapse and secondary tumors (Pg. 10, Conclusion). Schosserer also discloses quercetin as a “senolytic” compound that eliminates senescent cells (Pg. 9).
The courts have found, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.)
It would have been obvious for one of ordinary skill in the art to take the method disclosed in copending application ‘867 for treating cancer with a composition comprising compounds I-IV and a cannabinoid, and combine it with the method disclosed in Schosserer for treating cancer induced cellular senescence with chemotherapy and quercetin as a senolytic, to arrive at the method for preventing/slowing cellular senescence with compounds I-IV and a polyphenol in the instant claims, because all the compounds are taught by the prior art to be used for cancer therapy, and it would be obvious to combine compounds I-IV, a cannabinoid, and quercetin used in cancer therapy.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/C.M.R./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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