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 .
Response to Amendment
Applicant's amendment and argument filed 07/17/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1 and 3-10 are being examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/17/206 is being considered by the examiner. The signed IDS form is attached with the instant office action.
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 1 and 3-10 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 claim(s) 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 inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites “weight loss in a mammal resulting from administration of a glucagon-like peptide 1 drug” and the application as filed does not have support for this limitation. Although the applicant points to paragraph [0018] which teaches that many people taking glucagon-like peptide 1 (GLP-1) drugs like Ozempic or Wegovy (semaglutide) and Mounjaro (trizapeptide) experience rapid weight loss, this is not the same as what is being claimed and although it may have been the intent of the applicant to have a use for the treatment in such a manner, this limitation was not described in the original filed application. Teaching that glucagon-like peptide 1 drugs cause weight loss is not the same as administering the egg yolk composition to patients who have lost muscle mass due to glucagon-like peptide 1 drugs. The limitation is therefore new matter.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 3-9 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph Mannello, Neerav Padliya, and Maghsoud Dariani (US20200138873A1). This rejection is maintained due to amendments and arguments filed on 07/17/2026.
Regarding claim 1, Mannello discloses a method for inhibiting or reversing sarcopenia in a mammal, said method comprising administering to the mammal a composition comprising egg yolk powder.
Regarding claims 4, Mannello discloses in one nonlimiting embodiment, the composition comprising egg yolk powder is FORTETROPIN administered orally on a daily basis (see 0035).
Regarding claims 4-6, Mannello discloses “dosages may be modified for efficacy, for example, may be administered at a higher or lower dosage or administered more than once daily” (see 0036). “In one nonlimiting embodiment, the composition comprising egg yolk powder is administered orally on a daily basis, one, two or three times a day” (see 0033).
Regarding claim 9-, Mannello discloses wherein Fortetropin is a fertilized egg yolk product (see 0027).
Manello does not specifically teach that the muscle loss and/or sarcopenia results from administration of a glucagon-like peptide 1 drug, semaglutide or tirzepatide, and/or low-calorie diet, or that the product comprises 33% protein, however Manello already discloses treating the same diseases and whether the disease was caused by a low-calorie diet or a drug that helps you lose weight the method of treating the sarcopenia or muscle loss by administering an egg yolk composition still would have been prima facie obvious because persons having skill in the art would want to treat the symptoms of muscle loss which is applicable to more than one scenario and/or patient population.
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to administer the method of treatment taught by Manello for treating sarcopenia and muscle loss due to drugs that cause low calorie diets because if muscle is lost during the low-calorie diet, then the treatment method for treating loss of muscle is prima facie obvious.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Joseph Mannello, Neerav Padliya, and Maghsoud Dariani (US20200138873A1) as applied to claims 1-9 above, and further in view of Waldemar Buxmann et. al. (US8815320B2). This is a new rejection due to amendments and arguments filed on 07/17/2026.
Mannello teaches the instantly claimed method however is silent on the preserving step of claim 10.
Buxmann teaches of “a process for producing a composition comprising biologically active follistatin, the process comprising: providing raw liquid egg yolk, raw liquid whole egg or raw liquid egg white originating from fertilized avian eggs and subjecting the raw liquid egg yolk, raw liquid whole egg or raw liquid egg white to a step of preservation while maintaining the temperature at or below 38° C., wherein the step of preservation is selected from subjecting the raw liquid egg yolk, raw liquid whole egg or raw liquid egg white to a high pressure treatment of at least 4500 bar for at least 1 min, from subjecting the raw liquid egg yolk, raw liquid whole egg or raw liquid egg white to a pulsed electric field treatment of at least 5 kV/cm at a flow rate of 30 L/h, and from a combination of the high pressure treatment and the pulsed electric field treatment to provide a preserved liquid egg yolk, preserved liquid whole egg or preserved liquid egg white” (see claim 1).
Therefore it would have been obvious to persons having ordinary skill in the art to rely on the preserving methods taught by Buxmann in the method treatments of Mannello because as Buxmann teaches both high pressure treatment and/or pulsed electric field treatment will preserve egg yolk derived products and incorporating this step into Mannello’s would have been prima facie obvious.
Response to Arguments
Applicant's arguments filed 07/17/2026 have been fully considered but they are not persuasive. The applicant argues that the Office does not articulate some reasonable expectation of success in using Mannello’s prior art in treating muscle loss for patients who have loss muscle mass due to administration of a glucagon-like peptide 1 drug. The Office articulated that the prior art teaches administering the same product for general muscle loss and therefore using it for muscle loss from a specific medication would have been prima facie obvious because the symptom is being treated and the modes of action do not appear to be separate from one another. Administering the same composition known for treating the same symptoms to patients in need of said treatment would result in the same treatment activities.
The applicant makes comparisons of their invention to known methods of protein intake in treating muscle loss and has included non-patent literature however it is unclear as to what they are attempting to argue here and how they expect the Office to respond to their comparison. The optimization or amount of the prior arts product would have been an obvious parameter of optimization given that the active component is taught for the same treatment.
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, 4-6 and 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11318171. Although the claims at issue are not identical, they are not patentably distinct from each other because both patent and application are directed to administration of the same product for treatment of the same disease. Although the patent is directed to amounts of the product being administered in amounts ranging from 50 to about 300 mg/kg/day this optimization/determination is one well within the purview of any skilled artisan and would have been prima facie obvious to arrive at. Also it would have been obvious to administer the product to patients who have lost muscle mass due to a specific drug administration because the symptom being treated is the same and the modes of activity are expected to be the same.
Response to Arguments
Applicant's arguments filed 07/17/2026 have been fully considered but they are not persuasive. The applicant argues that the amending of claim 1 by incorporation of non-rejected claim 2 renders the DP rejection moot however the administration of the same components for treatment of the same disease even if caused by medication would have been prima facie obvious as argued in the above rejections/response to arguments.
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 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 JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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