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
Pursuant to the preliminary amendment dated 1/29/2024, claims 7, 9, 11-17, 25, 26, 37, 41-45, 47-49, 51-54 and 60 are cancelled and claims 6, 8, 10, 20, 24, 27, 28, 34-36, 38, 40, 55, 61 and 62 are amended. No claims are newly added.
Claims 1-6, 8, 10, 18-24, 27-36, 38-40, 46, 48-50, 55-59 and 61-64 are pending in the instant application and are examined on the merits herein.
Priority
The application is a National Stage entry of PCT/US2021/060251 filed on 11/22/2021, which claims priority to provisional application 63/118034 filed on 11/25/2020.
Information Disclosure Statement
The information disclosure statements (IDS) dated 1/29/2024 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Objection
Claim 59 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 24. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
Claim Rejections - 35 USC § 112—Second Paragraph
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.
Claims 2, 20-23, 31-36, 38-40, 46, 48-50, 55-58 and 61-64 are rejected 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.
Claims 2, 20-23 and 31 (and its’ dependents) are indefinite due to the recitation of the acronym “CEBPB” without a corresponding definition. While some acronyms are known to those or ordinary skill in the art, even those well-known acronyms may have multiple meanings. Furthermore, practitioners routinely define their own acronyms, which are not commonly known to those of ordinary skill in the art. Therefore, an acronym absent a definition renders a claim indefinite.
Claim 23 recites the limitation "the expression level of CEBPB". There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 20, 23 and 28-30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Garcia et al. (US 2021/0008086A1, filed 2018, PTO-892).
Garcia et al. discloses a method for increasing mass or thickness or contractile capacity of intestinal muscle, by administering a nutritional composition comprising 2’-fucosyllactoes (2’-FL, at 0.05-1 g/kg/day) and lacto-N-neotetraose. (¶0025-0029, 0108, 0185; Example 3; Figure 1) One of ordinary skill in the art recognizes that increasing mass or thickness or contractile capacity of intestinal muscle is equivalent to increasing strength of intestinal muscle.
With respect to claims 2, 20 and 23 the effect on CEBPB expression, this limitation is not accorded patentable weight because of the inseparable connection between an administered composition and the mechanism of action within the subject to which the composition is administered. The active method step in the instant claim is administering the 2’-FL composition whereas the increase in expression of CEBPB is an effect which will necessarily occur and does not delineate a manipulative difference between the instant method and the method of the prior art. Therefore, because the prior art teaches the same active step to administer the same composition, the properties applicant discloses and/or claims are necessarily present. Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993). See also MPEP § 2112.02.
Accordingly, the instant claims are anticipated by the prior art.
Claims 1-6, 8, 10, 18, 19, 20, 23, 24 and 28-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bueno et al. (WO 2016/029113A1, IDS).
Bueno et al. discloses a method for promoting muscle hypertrophy and/or preventing muscle atrophy, in adult human subjects, by administering a prebiotic, where 2’-fucosyllactose (2’-FL), at 0.1-5 g/day (exemplified at 1 g/day), is particularly envisioned as the prebiotic, where the therapeutic effect to the administered 2’-FL is in part due to increasing levels of beta-hydroxy-beta-methylbutyrate (HMB). (Claims 25-27, 30, 35-39 ; p. 7, Ln. 10-20; p. 25; Example 8) Bueno discloses that the adult human subjects may be afflicted with: 1) muscle wasting diseases such as cachexia, particularly wherein the cachexia is a co-morbidity of a disease or condition selected from cancer, human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), autoimmune disease including multiple sclerosis, chronic obstructive pulmonary disease (COPD), end stage renal disease (ESRD), tuberculosis, congestive heart failure and familial amyloid polyneuropathy, and/or liver failure; 2) sarcopenia (degenerative loss of skeletal muscle mass and strength associated with aging); 3) hyperglycemia or glucose intolerance, particularly associated with COPD, obesity, diabetes and cancer. (pp. 27-31)
With respect to claims 2, 20 and 23 and the effect on CEBPB expression, this limitation is not accorded patentable weight because of the inseparable connection between an administered composition and the mechanism of action within the subject to which the composition is administered. The active method step in the instant claim is administering the 2’-FL composition whereas the increase in expression of CEBPB is an effect which will necessarily occur and does not delineate a manipulative difference between the instant method and the method of the prior art. Therefore, because the prior art teaches the same active step to administer the same composition, the properties applicant discloses and/or claims are necessarily present. Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993). See also MPEP § 2112.02.
Accordingly, the instant claims are anticipated by the prior art.
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 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 22 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Bueno et al. (WO 2016/029113A1, IDS), in view of Matteini et al. (Aging Cell, 2016, PTO-892).
The disclosure of Bueno is referenced as discussed above. Bueno does not teach association with CCAAT/enhancer-binding protein-beta (CEBPB) level and muscle strength, nor methods of assessing muscle strength such as handgrip muscle strength.
Matteini et al. discloses that expression of CEBPB in blood leukocytes has been positively associated with muscle strength in humans, further supporting the possible link between gene variants and a decline in skeletal muscle function in older age groups… In addition to the CEBPB association with muscle discussed above, CEBPD has also been linked to differential expression of myostatin, a skeletal muscle inhibitory factor that can lead to muscle strength declines...Subtle alteration in expression of these factors may well alter muscle tissue maintenance with aging and would in turn lead to grip strength declines. (p. 797, Col. 1) Matteini further discloses that handgrip strength was measured using a dynamometer, to assess decline in muscle strength in the cohorts studied. (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Bueno to add a step of measuring expression level of CEBPB and assess muscle strength using a handgrip dynamometer, thereby arriving at the instant invention. One would be motivated to modify Bueno in this manner because Matteini teaches that CEBPB expression level is correlated with muscle strength and that in subjects with conditions with declining muscle strength (e.g. sarcopenia), CEBPB levels would be expected to be reduced relative to healthy subjects. Thus, expression level of CEBPB would be a useful diagnostic marker in the method of Bueno, to identify subjects in need of treatment with 2’-FL to promote muscle hypertrophy and/or prevent muscle atrophy. It would be further obvious to use a handheld dynamometer, in the method of Bueno, as a tool to measure muscle strength, as per the teachings of Matteini.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-3, 20-24, 28-30 and 59 of the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending application US 18/200765. Although the conflicting claims are not identical, they are not patentably distinct from each other because: The instant method is directed to administering 2’-FL to improve muscle strength or mobility. In comparison, the method of ‘765 is directed to administering 2’-FL to reduce exercise-induced injury or enhance muscle recovery in athletes after exercise. One of ordinary skill in the art recognizes that improving muscle strength and mobility is directly correlated with reduced incidence of exercise-induced muscle injury. Thus the method of ‘765 is an obvious variant of the instant method.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693