FINAL 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/12/2026 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
This action is in response to papers filed 01/09/2026 in which the abstract was amended; claims 1-20 were canceled; and claims 21-40 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 21-40 are under examination.
Withdrawn Objection/Rejection
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New Objection
Claim Objections
Claim 38 is objected to because of the following informalities: please remove the “and” before “targeted therapies,” because “and combinations thereof” has been recited thereafter. Appropriate correction is required.
Modified Rejections
Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 103
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) 21-25, and 29-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (WO 2019/118519 A1) in view of Epner et al (US 2003/0129262 A1).
Regarding claims 21, 32-34, and 36-40, Li teaches a pharmaceutical composition for treating cancer comprising a food composition containing at least two amino acids including leucine and methionine, fats such as corn oil and soybean oil, carbohydrates, choline, vitamins, and minerals (Abstract; [0010]-[0089], [0109]-[0256], [0271]-[0284]; Examples 1-9 and 14-16 and Tables 2-3 and 5-7; claims 1-173). Li teaches the pharmaceutical composition further contains an anticancer therapeutic agent ([0082]; claim 91). Li teaches the food composition further contains additives, fillers and excipients ([0234]). Li teaches the food composition comprises 68.6% by weight of carbohydrate (Tables 3 and 5). Li teaches the food composition contains 10-20% by weight of amino acids ([0188]), which falls within or overlaps the claimed range of 4 to 40% of a mixture of amino acids. Li teaches the amino acids include at least two essential amino acid including methionine and leucine, wherein the amount of essential amino acids is approximately or no more than 3%, 4% or 5% by weight of the food composition ([0049] and [0181]-[0182]), which falls within or overlaps the claimed range of “2.5-6% by weight leucine and 0.1-0.6% by weight methionine. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight amounts of amino acids, leucine, and methionine in the diet composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
However, Li does not expressly teach the amounts of the mixture of vitamin minerals of claim 21.
Regarding the amounts of the mixture of vitamin minerals, Epner teaches a diet composition for treating cancer comprising a low level of methionine, mixtures of amino acids including leucine, fats, carbohydrates, vitamins, and minerals, wherein the total amount of vitamins and minerals in the composition is less than 2% by weight (Abstract; [0034]-[0115]; Tables 1-3; claims 46-57).
It would have been obvious to one of ordinary skill in the art to routinely optimize the amounts of vitamins and minerals in the composition of Li to an amount from 1 to 5%, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Epner provided the guidance for optimizing the amount of vitamins and minerals in a diet/food composition used for treating cancer, to an amount of less than 2% by weight, which is a range that overlaps the claimed range of from 1 to 5%. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight amount of vitamins and minerals in the diet composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
It is noted that the recitation of “for use in the treatment and/or prevention of cancer” as recited in claims 21 and all the limitations of pertaining to the treatment of claims 32-34, and 36-40, are recitations of intended uses that do not structurally change the structure of the claimed composition. As discussed above, Li in view of Epner teaches each and every structural limitations of claimed composition and the composition of Li in view of Epner is also used for treating cancer, and thus, would be capable of performing the intended uses as recited in claims 21, 32-34, and 36-40. It is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 22, Li teaches the amino acids are selected from leucine, isoleucine, valine, methionine, lysine, phenylalanine, tryptophan, threonine, histidine, asparagine, alanine, arginine, aspartic acid, cysteine, glutamic acid, glutamine, proline, glycine, tyrosine, and serine ([0172]-[0188]).
Regarding claims 23-25, Li teaches the amino acids are in free form and as a protein such as casein ([0114] and [0136]).
Regarding claim 29, Li teaches the carbohydrates include cellulose and starch (Tables 3 and 5).
Regarding claims 30 and 31, Li teaches the food composition is in the form of a solid, semi-solid or liquid such as shake, drink, and nutritional bar ([0051] and [0232]).
Regarding claim 35, Li teaches the food composition further contains water ([0219]).
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 before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (WO 2019/118519 A1) in view of Epner et al (US 2003/0129262 A1), as applied to claim 21 above, and further in view of Longo et al (US 2014/0227373 A1).
The composition of claims 21 is discussed above, said discussion being incorporated herein in its entirety.
However, Li and Epner do not expressly teach the amount of lipids of claim 26 and the lipids are selected from the group consisting of olive oil, coconut oil and salmon oil of claim 28.
Regarding claims 26-28, Longo teaches a diet composition comprising amino acids including methionine and leucine, fats, carbohydrates, vitamins, and minerals (Abstract; [0010] and [0053]-[0076]; claims 1-38). Longo teaches the fats include olive oil and coconut oil ([0061]-[0062], [0068], [0075], claim 37). Longo teaches the diet composition contains the fats in an amount from about 0 to 22 percent of the total calories contained in the diet ([0075]; claims 35, 37, and 38).
It would have been obvious to one of ordinary skill in the art to incorporate olive oil and coconut oil as the fats in the composition of Li, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Longo provided the guidance to do so by teaching that olive oil and coconut oil as the fats in the composition of Li so as to provide a resultant low protein diet composition (Longo: [0061]-[0062], [0068], [0075], claim 37). Thus, an ordinary artisan seeking to produce a low protein diet composition would have looked to incorporating olive oil and coconut oil as the fats in the composition of Li, and achieve Applicant’s claimed invention with reasonable expectation of success.
It would also have been obvious to one of ordinary skill in the art to routinely optimize the amount of lipids (fats) included in the composition of Li to an amount of 14% by weight, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Longo teaches that a low protein diet composition can be optimize to contain fats such as include olive oil and coconut oil in an amount from about 0 to 22 percent of the total calories contained in the diet, which is an amount range which encompassed the claimed amount of 14% by weight. As such, "[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). See MPEP §2144.05 (I)-(II).
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 before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 01/09/2026 have been fully considered but they are not persuasive.
Applicant argues that page 28 of the specification discloses composition containing leucine in an amount from 2.5% to 6% by weight provided superior results in cancer treatment. Applicant alleges that “[t]hese effects of controlling the amount of leucine in diet compositions and, particularly, limiting leucine to 2.5% to 6% by weight are not disclosed or suggested by the cited references.” (Remarks, pages 10-12).
In response, the Examiner disagrees. Applicant’s alleged superior results as shown in page 28 of the specification are considered, but found insufficient to obviate the 103 rejection over Li and Epner.
First, it is noted that the artificial diet composition of claim 1 is much broader than the diet compositions of P2 and P9 from page 20 of the specification to which Applicant alleged as used for showing unexpected superior results. MPEP §716.02(d) states: [w]hether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100°C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110°C and 130°C. The court affirmed the rejection of claims 1-7 and 9-10 because the term "elevated temperatures" encompassed temperatures as low as 60°C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100°C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.).
Second, Applicant’s alleged unexpected superior results as shown in page 28 of the specification are also not persuasive and insufficient to obviate the 103 rejection over Li and Epner because as discussed above in the standing 103 rejection, Li teaches a pharmaceutical composition for treating cancer comprising a food composition containing at least two amino acids including leucine and methionine, fats such as corn oil and soybean oil, carbohydrates, choline, vitamins, and minerals (Abstract; [0010]-[0089], [0109]-[0256], [0271]-[0284]; Examples 1-9 and 14-16 and Tables 2-3 and 5-7; claims 1-173). Furthermore, Li also established that the composition is effective in treating cancer by significantly decreasing tumor volume (Li: [0008], [0126], [0191], [0196]-[0201], [0205]-[0211], [0240]-[0241], and [0312]-[0330]). Additionally, as discussed in the 103 rejection, Li teaches the amino acids include at least two essential amino acid including methionine and leucine, wherein the amount of essential amino acids is approximately or no more than 3%, 4% or 5% by weight of the food composition ([0049] and [0181]-[0182]), which falls within or overlaps the claimed range of “2.5-6% by weight leucine and 0.1-0.6% by weight methionine. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight amounts of amino acids, leucine, and methionine in the diet composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II). Thus, it appeared that Applicant’s alleged superior results with respect to anticancer activity have also been recognized by Li. As such, with any alleged arguments/evidence of unexpected results, said alleged unexpected results must be compared to the closest prior art. MPEP §716.02(e) states: [a]n affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979).
As a result, for at least the reasons discussed above, claims 21-40 remain rejected as being obvious and unpatentable over the combined teachings of the cited prior arts in the pending 103 rejections as set forth in this office action.
Conclusion
No claim is allowed.
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.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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