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 .
Claim Status
Applicant’s remarks and amendments, filed 9 June 2026 in response to the non-final rejection mailed 9 March 2026, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 9 June 2026 replaces all prior versions and listings of the claims.
Claims 1, 2, and 5-9 are pending. Claims 3 and 4 are canceled by Applicant’s amendment. Claim 1 is amended. Claims 1, 2, and 5-9 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s amendments to Claim 1 and cancellation of Claim 4 has overcome the claims objection in regards to minor informalities. The objection to the claims has thus been withdrawn.
Applicant’s arguments and amendments, on page 6 of the reply filed 9 June 2026 with respect to the rejections of Claim 4 under 35 USC § 112(a) and 35 USC § 112(b) have been fully considered. The rejections of Claim 4 are withdrawn due to cancellation of the claim.
Information Disclosure Statement
The listing of references in the Rule 132 Declaration is not provided with an accompanying information disclosure statement (IDS). 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, the Declaration and arguments therein have been fully considered, however, unless the references cited in the Declaration have been cited by the examiner on form PTO-892 or previously of record listed on an IDS, they have not been considered, and should the application eventually be passed on to issue, these references will accordingly not appear on the face of such patent which may issue therefrom.
Specification
(maintained)
The use of the term FORTETROPIN®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Please note that the referenced patents (US 8,815,320 B2; US 10,165,785 B2; and US 11,051,524 B2) do not provide an ingredient list for the stated product and only indicate the presence of follistatin and indicate that the process comprises a further step of mixing or encapsulation with various ingredients (see e.g., ‘785 patent, col. 4., lines 38-54).
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 1, 2, and 5-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
In the instant case, Claim 1 comprises the limitation “…subjected to a step of preservation comprising high pressure treatment and/or pulsed electric field treatment.” This limitation, however, is not present in the instant disclosure and is essential subject matter which is incorporated by reference (see e.g., instant specification, page 8) and is a critical aspect of the pending claims. The Office may require applicant to insert material incorporated by reference into the specification (see 37 CFR 1.57(g)). Please note that such an amendment must be accompanied by a statement that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. § 112(a) for the reasons set forth above.
Claim Rejections - 35 USC § 102
(grounds modified as necessitated by amendment)
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.
(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, 2, 5, 6, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mannello et al. (US 2021/0030840 A1) as evidenced by Buxmann et al. (US 8,815,320 B2).
The instant claims are as of record, drawn to a method of managing and/or alleviating one or more symptoms of a muscular dystrophy or other genetic condition associated with a muscular disorder comprising oral administration to a subject in need an effective amount of a composition comprising an egg yolk derived product originating from fertilized avian egg subjected to a step of preservation comprising high pressure treatment and/or pulsed electric field treatment.
Mannello et al., however, anticipate the claims by teaching a method for alleviating or inhibiting (managing or alleviating) a negative effect on quality of life in an aging or chronically ill mammal (subject in need) comprising administration of a composition comprising egg yolk powder (Mannello et al., pg. 7, Claim 1; as required for instant Claim 1). The composition reduces muscle loss (weight loss) and weakness (Mannello et al., pg. 7, Claim 3; as required for instant Claims 5 and 6) and the negative effect may be lean body mass wasting (weight loss) associated with a chronic disease such as muscular dystrophy or spinal muscular atrophy (Mannello et al., pg. 7, Claim 8; as required for instant Claims 1, 5, 6, and 9). The fertilized egg yolk derived product may be FORTETROPIN®, which is obtained using the method of Buxmann et al. (Mannello et al., pg. 1, [0014]; see e.g., instant specification at pg. 8, ln. 1-7; as required for instant Claim 1), wherein fertilized avian egg yolks are subjected to high pressure treatment or puled electric field treatment (Buxmann et al., col. 7, Claim 1). The composition is administered in an amount effective to alleviate said negative effects (Mannello et al., pg.1, [0017]; pg. 2, [0032]) and may be administered orally one to three times daily (up to three times a day; Mannello et al., pg. 2, [0031]; as required for instant Claims 1 and 2).
Claim Rejections - 35 USC § 103
(grounds modified as necessitated by amendment)
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.
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.
Claims 1, 2, and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mannello et al. (US 2021/0030840 A1) as evidenced by Buxmann et al. (US 8,815,320 B2) as applied to Claims 1, 2, 5, 6, and 9 above, and further in view of NYU Langone (Types of Muscular Dystrophy, 2016, 5 pages).
The claims and teachings of Mannello et al. as evidenced by Buxmann et al. are as of record.
Mannello et al. (as evidenced by Buxmann et al.) does not teach wherein the muscular dystrophy is Duchenne or facioscapulohumeral muscular dystrophy.
NYU Langone, however, teaches that Duchenne muscular dystrophy is the most common type diagnosed in childhood and weakens muscles of the body (NYU Langone, page 1; as required for instant Claim 7). Additionally, facioscapulohumeral muscular dystrophy weakens muscles of the face, shoulder blades, and upper arms and usually appears before age 20 (NYU Langone, page 3; as required for instant Claim 8).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to use the method of Mannello et al., which is broadly applied to muscular dystrophy in general and reduces muscle weakness, for a patient with the specific conditions of Duchenne or facioscapulohumeral muscular dystrophy because both affect young people and have muscle weakness as a symptom. A skilled artisan would therefore be motivated to apply the method of Mannello et al., and composition thereof, to those with Duchenne or facioscapulohumeral muscular dystrophy because they both affect young people and could do so with a reasonable expectation of success because the method of Mannello et al. is applied to muscular dystrophy in general and reduces muscle weakness.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (of method of use thereof), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
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 1, 2, 5, and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 4-6, 9, and 10 of copending U.S. Patent Application No. 19/558,906 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because while the methods are drawn to different intended uses (e.g., managing and/or alleviating one or more symptoms of muscular dystrophy or other genetic condition associated with a muscular disorder (and specific conditions of instant Claims 7-9) versus reducing muscle loss and/or inhibiting sarcopenia (loss of skeletal muscle mass) due to weight loss), the single step method of administration of a composition comprising an egg yolk derived produce to a subject (of instant Claim 1; e.g., the mammal of ‘906 Claim 1) in need thereof. The composition is administered up to three times per day (of instant Claim 2 and ‘906 Claims 4-6). Additionally, the composition has the same effect upon administration of reducing muscle loss (‘906 Claim 1 and weight loss of instant Claim 5) and comprises a fertilized egg yolk derived product (‘906 Claims 9 and 10 and fertilized avian egg of instant Claim 1; see e.g., ‘906 specification [0025] and instant specification page 8, ln. 1-7).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments and declaration filed 9 June 2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to Claims 1, 2, and 5-9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s amendment of instant Claim 1 to require oral administration and a specific preparation method of the composition used in the claimed method necessitated the application of new prior art different from that which was discussed in the arguments and the declaration (e.g., efficacy of oral administration).
Additionally, 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., specific levels of follistatin in the blood; quality of life and functional improvements; running distance; time to exhaustion; no change in force; increased muscle protein levels; high skeletal muscle expression of proteins) are not recited in the rejected claim(s). 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).
Conclusion
No claims are currently 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 JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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