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 .
Applicant’s response (amendments and arguments) is acknowledged. The obviousness rejection is maintained (in line with the Interview Summary of the 7/23/25 interview) pending comparison data (with valid controls) evidencing secondary considerations of unexpected results, which remains absent.
Claims 1, 5, 12, 14, 16-18, 20 remain pending after the amendments and remain examined on the merits.
The examiner remains open to interview to advance prosecution on the merits.
Claim Rejections - 35 USC § 103 – Maintained
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, 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.
Claim(s) 1,5,12,14,16-18, 20 remain rejected under 35 U.S.C. 103 as being unpatentable over any of the 5 documents cited over the same claims by the International Authority in the equivalent PCT application:
PNG
media_image1.png
326
650
media_image1.png
Greyscale
Merely by example D5 teach compositions comprising the preference for casein as the proteinaceous source (page 5: “Preferably, the proteinaceous matter originates from dairy proteins, such as whey and casein.”) and the option for starch and sucrose comprised within the carbohydrate source (page 9 bottom to top of page 10: “The digestible carbohydrates positively influence the energy level of a subject, and add to the advantageous effect of the nutritional composition according to the invention. The digestible carbohydrate may comprise either simple or complex carbohydrates, or any mixture thereof. Suitable for use in the present invention are glucose, fructose, sucrose, lactose, trehalose, palatinose, corn syrup, malt, maltose, isomaltose, partially hydrolysed corn starch . . . “.).
In general, it is renown that a high protein diet/protein-containing compositions promote muscle formation as well as that similar high protein diets have an effect in preserving muscle in geriatric individuals as well as subjects with temporarily low muscular activity and other muscle disorders (see D1, par. 8, 29; D2, pag. 9; D3, example B; D4, pag. 3-4; D5, page 4). The method disclosed in the application is seen as a semantic alternative to the existing ones.
Additionally, and equally as to all the claims, while each of the documents does not per se employ the term “autophagy” (e.g. the body's natural clearing of damaged cells, in order to regenerate newer, healthier cells), each of these documents (abstract and background in each) teach the preparation and administration of therapeutic compositions comprising high protein added to a based composition and then administered, which – under the broadest reasonable interpretation of the claimed subject matter within these three (3) claims - will naturally promote protein synthesis at some level and since protein is needed for cell functioning, and part of cell functioning is removal of damaged cellular materials, such is a natural outgrowth of said administration.
As for claim 30, such would include administering such to anyone following severe trauma and/or nearing the end of life.
As for the amendment filed
Thus, the claims are prima facie obvious over each of the recited documents.
Response to Amendments and Arguments –
Comparison Data (With Valid Controls) Evidencing Secondary Considerations of
Unexpected Results - Remains Absent (See Also-Interview Summary of the 7/23/25 Interview)
Applicant’s amendments and arguments have been fully considered but remains unpersuasive (in line with the Interview Summary of the 7/23/25 interview), based on the teachings and suggestions by the prior art already of record, pending comparison data (with valid controls) showing evidence of secondary considerations of unexpected results of the point-specific ratio claimed v. valid controls. Applicant’s new amendments and reiteration of the previous arguments are not found persuasive absent such evidence. Thus, the previous response to arguments are equally maintained here and retained below rendering the amended claim scope still containing the same ratio and target without more, prima facie obvious:
At issue is whether PHOSITA can take anything from this specifically claimed range of 60:24 (protein:carbohydrate) versus the only far-off control tested against of 24:60 (protein:carbohydrate) and somehow take away whether the former yielded unexpected results over the latter when there is no other ‘high protein’ (valid) control tested there against? The Examiner still finds that the test protocol simply does not provide the evidentiary data needed to make any sort of determination as to unexpected results of a ratio of 60:24 protein: carbohydrate versus any other high protein ratio diet.
The only amendment relevant to the claim scope was to incorporate the term sarcopenia into claim 1 from claim 6, which was previously rejected, the claimed invention remains prima facie obvious over the prior art of record as the evidence of record does not provide any test data commensurate in scope with the broad range claimed that a protein:carbohydrate ratio diet of 60:24 somehow provided something unexpected versus 61:25 or 59:23 or beyond in either direction. In other words no valid controls have been employed that evidence that something unexpected occurs at Ratio X v. Ratio Y or Z. Thus it is maintained that high protein diets such as 60:24 protein:carbohydrate would be expected to induce autophagy in a patient in need thereof having sarcopenia (a known musculoskeletal disorder affecting muscle mass).
As previously stated: D5 alone merely by example teaches where the protein source comprises casein and the carbohydrate source comprises starch and sucrose.
Additionally, such is maintained as set forth in the last advisory action and maintained here, as no new arguments were filed with the RCE:
Applicant opens up the response on page 5, para 3, to the final Office action by stating that the proposed amendments (that the protein source must comprise at least casein and the carbohydrate source must comprise at least a combination of starch and sucrose) are "solely for clarification, not to avoid prior art" yet then goes on in each of page 6 (2nd to last para) and top of page 7 of the response to argue that the prior art of record does not teach or suggest a composition which requires those elements in the proposed amendments - the protein source must comprise at least casein and the carbohydrate source must comprise at least a combination of starch and sucrose.
[The amendments directed to] protein/carbohydrate simple substitution/routine optimization options for which applicant has not presented any evidence or arguments as to the criticality thereof v. any other protein/carbohydrate source. Just like applicant still has not presented any evidence/arguments as to the criticality of the 60/24 ratio rather than the 24/60 ratio for which is was only tested against re: protein:carbohydrate; carbohydrate:protein ratios.
*See Previous Interview Summary.
In the next response criticality of both must be evidenced/argued for prosecution on the merits to advance, if such be found persuasive.
[NOTE: This suggestion was not found addressed in the current RCE filing.]
[As such] even merely an example; any protein powder with whey and sucrose and starch in it, that such is on the market a merely a matter of routine optimization of the type of protein and/or carb selection depending the the cost, choice, availability factors by the manufacturer or medical staff administering such.
The rejection is equally maintained as previously set forth, as to the protein to carbohydrate ratio of at least 60:24. The specification mentions this ratio only one time, in para 100, and para 98 directly above states that such is merely by example and not to be limiting.
PNG
media_image2.png
329
896
media_image2.png
Greyscale
Therefore, as there is no criticality identified as relevant to this ratio is identified and arriving at such would have merely been routine optimization of the protein and carbohydrate amounts/ratios found within the prior art references of record.
The above is equally supported in MPEP 2144.05 and the relevant case law thereto, relevant to the routine optimization of non-critical concentrations/ranges:
II. OPTIMIZATION OF RANGES
PNG
media_image3.png
18
19
media_image3.png
Greyscale
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
PNG
media_image3.png
18
19
media_image3.png
Greyscale
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Regarding the new amendment and arguments, applicant has too narrowly interpreted the disclosures of the prior art cited based on what one of ordinary skill in the art would have gathered was taught and/or suggested based on the broadest reasonable interpretation thereof against the backdrop of the skilled artisans understanding of the State of the Art. Here, as stated, under the broadest reasonable interpretation of the claimed subject matter within these claims – the compositions of the prior art will naturally promote protein synthesis at some level and since protein is needed for cell functioning, and part of cell functioning is removal of damaged cellular materials, such is a natural outgrowth of said administration. Thus, the rejection is maintained.
As was set forth in the previous advisory action and carried over here as till relevant after the newest amendment and arguments:
35 USC 103 Rejection - All Claims - Maintained for the Reasons of Record
Applicant's arguments have been fully considered but not found persuasive. Namely, over claims 29-30 for the reason set forth above. Additionally, over all claims as autophagy is a natural process of the body reusing old and damaged cell parts. Thus, as along as sufficient protein intake is maintained this natural process is maintained and each of the references teaches administration of protein in a subject in need thereof.
103 Arguments Not Commensurate in Scope With That Claimed
Applicant's argument on middle , page 8 is that it was surprisingly found that a high protein diet induced autophagy in skeletal muscle and that this synergistic induction in [skeletal] muscle [was] by the combination of high protein AND an autophagy inducer (emphasis by examiner).
The examiner notes that it appears this argument is based on the last two sentences of specification para 5, which states:
"[0005] [ ] As detailed in the experimental data set forth later herein, the inventors surprisingly found that a high protein diet induced autophagy in skeletal muscle. This synergistic induction in muscle by the combination of high protein and an authophagy [SIC] inducer is in contrast to what was seen in the liver."
HOWEVER, based on the arguments above, it does not appear the intended invention - or at least the asserted unexpected/synergistic/surprising result - has been claimed, as the arguments are directed to a combination product of a high protein element and an "autophagy inducer" element, yet there is no "autophagy inducer" element expressly claimed or expressly identified in the claims. Based on the arguments, this critical/essential element of the "autophagy inducer" has not been claimed, absent evidence to the contrary and that such is not taught and/or suggested in any of the references, which has not been specifically argued. As the arguments are not commensurate in scope with that claimed, they are not found persuasive.
*It is further noted that only paragraph 5 was found to recite this phrase "autophagy inducer". Therefore it unclear what falls within the scope of this phrase or intented definition thereof.
Applicant then states in the argument: See specification, paragraph [0035].
Para 35 simply states:
"[0035] An additional advantage of one or more embodiments provided by the present disclosure is to protect an ageing individual from muscle dysfunction, for example sarcopenia, frailty, inclusion body myositis, myopathy/myolysis induced by drugs such as corticosteroids or statins, or muscle wasting induced by immobilization or hospitalization."
HOWEVER, nothing in this passage defines or sheds light on the asserted 2nd element of the intended invention, namely, the "autophagy inducer".
Therefore, the arguments not being found persuasive or commensurate in scope with that claimed, the obviousness rejection is maintained for the reasons of record.
Prior Art Made of Record But Not Relied Upon, Previously Noted
But see the opposite asserted results in the animal model of Rinsch et al. (U.S. Patent Publication No. 20140018415) in para 237:[0237] A low protein diet has been shown in mice to lead to a prolonged induction of autophagy. In mice with DMD fed a low protein diet, an induction of autophagy leads to an improvement and management in the disease progression. Significant improvements in muscle function have been observed with an improvement of whole body tension, reduced muscle fibrosis, decreased collagen disposition, reduced accumulation of damaged organelles and reduced apoptosis of muscle fibers.
While an enablement rejection under 35 USC 112 is not equally raised here, the above findings do raise the question as to why similar diets are inducing potentially opposite effects within different animal models (e.g. mice versus human)?
Double Patenting – Provisional, Maintained, No Arguments, Request for Abeyance
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 5, 9-10, 12, 14, 16-18, 20 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over all pending claims of copending Application No. 16954694 (reference application, U.S. Patent Publication No. 20210085624). Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to the intended effect of inducing autophagy via high protein diets.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
THIS ACTION IS MADE FINAL. 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 MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MAURY A AUDET/Primary Examiner, Art Unit 1654
Prosecution Insights