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 .
Priority
This application is a CON of 16770847 filed 06/08/2020 (PAT 11912785).
16770847 is a 371 of PCT/US2018/000390 filed 12/06/2018.
PCT/US2018/000390 has PRO of 62708364 filed 12/06/2017.
Accordingly, claims 2-21 are afforded the effective filing date of 12/06/2017.
Status of the Claims
This action is in response to papers filed 10/23/2025 in which claims 1 and 22-29 were canceled; claims 14-21 were withdrawn; and claims 2-7, 10, and 11 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 2-13 are under examination.
Withdrawn Objections/Rejections
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 Any rejection and/or objection not specifically addressed below is hereby withdrawn.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.
Claim Objections
Claim 10 is objected to because of the following informalities: please remove “Asp-Asp-Asp-Asp” that is next to “SEQ ID NO:1”. Appropriate correction is required.
Maintained-Modified Rejections
Modification 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) 2-5 and 7-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piccariello et al (US 2004/0063628 A1) in view of Ulijn et al (US 2017/0188618 A1) and Ashmead et al (US 4,863,898).
Regarding claim 2, Piccariello teaches a composition containing a peptide such as Asp-Asp, Asp-Asp-Asp or Asp-Asp-Glu, and pharmaceutical drug or a nutrient (vitamins and minerals), wherein the peptide containing Asp is present in an amount of 0.07 or 0.93 mmol (Abstract; [0031], [0041], [0054], [0064]-[0065], [0076], [0097], [0106], [0135], [0139], [0152], [0187], [0197], [0332]-[0336]; claims 1, 3-8 and 12). Piccariello teaches the peptide protects the active agent (drug or nutrient) from degradation by covalently attaching the peptide to the drug ([0015], [0032] and [0070]). Piccariello teaches the drug or nutrient includes vitamins such as vitamin B, Vitamin C, Vitamin D and Vitamin E ([0102]; Table 1). Piccariello teaches the peptide have both free amino and free carboxyl terminals ([0031], [0038]-[0039], [0050], [0106]-[0110], [0115] and [0441]).
However, Piccariello does not teach the composition comprises a food product of claim 2; and the physiologically acceptable mineral of claim 2.
Regarding the composition comprises a food product of claim 2, Ulijn teaches a composition containing an emulsified food product, drug product, cosmetic product, or hair product, and a peptide such as tripeptide, tetrapeptide or pentapeptide, wherein the peptide contains aspartic acid (Abstract; [0001], [0003], [0007]-[0008], [0015], [0017], [0019], [0021], and [0070]-[0074]). Ulijn teaches the peptide stabilize the emulsified food product, drug product, cosmetic product, or hair product ([0001], [0003], [0082], [0088], and [0070]-[0074]).
It would have been obvious to one of ordinary skill in the art to incorporate a food product, cosmetic product, or hair product as the active agent in the composition of Piccariello so as to produce a desired food product, cosmetic product, or hair product, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Ulijn provided the guidance to do so by teaching that peptide such as tripeptide, tetrapeptide or pentapeptide having aspartic acid is used to stabilize food product, drug product, cosmetic product, or hair product, which is also in line with Piccariello, which indicate that the peptide in the composition is used for stabilizing the active agent of the drug product or nutrient product from degradation (Piccariello: [0005], [0117], [0030], [0032], [0058]-[0059], [0065] and [0090]). Thus, an ordinary artisan seeking to stabilize the active agent of a food product, cosmetic product, or hair product would have looked to incorporating the food product, cosmetic product, or hair product of Ulijn as the active agent in the composition of Piccariello with a reasonable predictability that the peptide in the composition would stabilize the food product, cosmetic product, or hair product from degradation, as both Piccariello and Ulijn recognized that peptide such as tripeptide, tetrapeptide or pentapeptide having aspartic acid is used for stabilizing drug product, a food product, cosmetic product, or hair product, thereby achieving Applicant’s claimed invention with reasonable expectation of success.
Regarding the physiologically acceptable mineral of claim 2, Ashmead teaches a formulation containing a mineral cation chelated with an amino acid or peptide ligands, wherein aspartic acid or dipeptide, tripeptide or quadrapeptide thereof, can be selected as the amino acid or peptide ligand (Abstract; columns 3-7; column 12, Example XVI; column 13, Examples XX and XXIV; claims 1-21). Ashmead teaches the mineral cation is selected from copper, zinc, iron, chromium, and manganese (column 5, lines 12-34). Ashmead teaches the amino acid chelate admixed with vitamin and other foodstuffs to be orally administered in the form of capsules, tablets, or syrups (column 7, lines 49-58). Ashmead teaches the formulation can further contain raw processed whole animal heart glandular substance, wherein the heart glandular substance innately contains metal ions such as iron (columns 6-7; column 12, Example XVI; column 13, Examples XX). It is noted that the mineral cation as taught by Ashmead meets the claimed “the physiological acceptable mineral is copper, ion, chromium, zinc, manganese, or a combination of the foregoing” and thus, the mineral cation of Ashmead would be “capable of degrading the food product, the cosmetic product, or the hair care product,” as claimed because "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
It would have been obvious to one of ordinary skill in the art to include a mineral cation such as copper, zinc, iron, chromium, or manganese in the composition/product of Piccariello in view of Ulijn, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Ashmead provided the guidance to do so by teaching that composition containing dipeptide, tripeptide or quadrapeptide such as those of Piccariello can further contain a mineral cation such as copper, zinc, iron, chromium, or manganese, and such addition of the mineral cation would aid the enhancing the absorption of the mineral cation into the biological organism and be efficiently transported to a selected tissue site, as the peptide would chelate the mineral cation to keep the mineral intact during transit to the desired tissue site (Ashmead: columns 3-4). Thus, an ordinary artisan seeking to improve absorption of the mineral cation into the biological organism and be efficiently transported to a selected tissue site, would have looked to including mineral cation such as copper, zinc, iron, chromium, or manganese in the composition/product of Piccariello in view of Ulijn, so as the peptide would protect the mineral cation from degradation (keep the mineral cation intact) during the transit to the desired tissue site, and achieve Applicant’s claimed invention with reasonable expectation of success.
With respect to the claimed “the effective amount of the one or more peptides slows metal catalyzed oxidative degradation of the food product” as recited in claim 2, it is noted that “effective amount” is recited generically and thereby, interpreted under broadest reasonable interpretation (BRI) in light of the specification as an amount “between about 0.02 mM and about 6 mM” as defined on page 16, lines 8-16 of the specification. As discussed above, Piccariello teaches a composition containing a peptide such as Asp-Asp, Asp-Asp-Asp or Asp-Asp-Gu, and active agent, wherein the peptide containing Asp is present in an amount of 0.07 or 0.93 mmol, and the protects the active agent from degradation by covalently attaching the peptide to the active agent. Thus, the amount of 0.07 or 0.93 mmol as taught by Piccariello meets the claimed “effective amount of the one or more peptides” as recited in claim 2, and thus, the claimed property of “slows metal catalyzed oxidative degradation of the food product” as recited claim 2 would have been implicit in the composition of Piccariello in view of Ulijn because "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Regarding claims 3 and 4, the recitations of “configured for human consumption” of claim 3 and “configured for consumption by another animal selected from a cat, a dog, a cow, a sheep, a pig and poultry” of claim 4, are recitation of intended use. Piccariello, Ulijn, and Ashmead are drawn to composition or product which are orally administered (Piccariello and Ashmead) or a food product (Ulijn) and thus, the composition/product of Piccariello in view Ulijn, and Ashmead would be capable of performing the claimed intended use of “configured for human consumption” of claim 3 and “configured for consumption by another animal selected from a cat, a dog, a cow, a sheep, a pig and poultry” of claim 4. 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 5, Ulijn teaches the food product is an emulsion, salad dressings, gravies and other sauces, whipped dessert toppings, peanut butter, and ice cream and the food product is packed such that it has a shelf life of 6-12 months ([0073]-[0090]), thereby the product would be sealed to maintain the shelf life/stability, and thus, Ulijn provides guidance and render obvious the storing of composition/product of Piccariello in view of Ulijn and Ashmead in a sealed packing medium.
Regarding claim 7, Ulijn teaches the food product is an emulsion, salad dressings, gravies and other sauces, whipped dessert toppings, peanut butter, and ice cream ([0073]-[0075]).
Regarding claim 8, as discussed above, Piccariello teaches a composition containing a peptide such as Asp-Asp, Asp-Asp-Asp or Asp-Asp-Gu, and active agent, wherein the peptide containing Asp is present in an amount of 0.07 or 0.93 mmol, and the protects the active agent from degradation by covalently attaching the peptide to the active agent. Thus, the claimed structural component of “the effective amount” recited in claim 8 has been met by Piccariello. Ulijn provided the guidance for incorporating a food product as the active agent in the composition of Piccariello. As such, the claimed property or function of “decreases the rate degradation of the food product, the cosmetic product, or the hair care product by at least 5%” would have been implicit in the composition/product of Piccariello in view of Ulijn and Ashmead, as it was also taught by Piccariello the peptide protects the active agent from degradation by covalently attaching the peptide to the active agent ([0015], [0032] and [0070]). It is noted that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) . Furthermore, "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 9, Ashmead teaches the peptide binds to metal salts including calcium salt and magnesium salt (column 5, lines 10-55; columns 7-8).
Regarding claims 10-11, as discussed above, Piccariello teaches a composition containing a peptide such as Asp-Asp, Asp-Asp-Asp or Asp-Asp-Glu.
Regarding claim 12, Piccariello teaches the peptide has a free amino terminal ([0031], [0038]-[0039], [0050], [0106]-[0110], [0115] and [0441]).
Regarding claim 13, as discussed above, Piccariello teaches a composition containing a peptide such as Asp-Asp-Glu.
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piccariello et al (US 2004/0063628 A1) in view of Ulijn et al (US 2017/0188618 A1) and Ashmead et al (US 4,863,898), as applied to claims 2 and 5 above, and further in view of Shimono et al (US 2011/0064861 A1).
The composition of claims 2 and 5 are discussed above, said discussion being incorporated herein in its entirety.
However, Piccariello, Ulijn, and Ashmead do not teach the packing medium is a canned packing medium of claim 6.
Regarding claim 6, Shimono teaches a food product comprising a short peptide containing Asp and Glu, wherein the good product is canned foods, snacks such as potato chips, rice crackers or cookies, noodle soups/sauces such as udon (thick wheat flour noodle) soups, soba (thin wheat flour noodle) soups, somen (Japanese vermicelli) soups, ramen (Chinese noodle) soups, chanpon (mixed Chinese noodle) soups and pasta sauces, rice-based foods such as rice balls, pilaf, fried rice, mixed boiled rice, porridge of rice and vegetables and boiled rice with tea, prepared foods such as spring rolls, steamed dumplings, Chinese-style dumplings, curries, stews and fried foods, processed livestock products such as hamburgers, sausages, hams and cheeses, processed vegetable products such as kimchi (pickled cabbage) or Japanese pickles, seasonings such as soy sauce, sauces, dressings, miso (fermented bean paste), mayonnaise and tomato ketchup and soups such as consommé soups, clear soups, miso soup, and potage soups (Abstract; [0018]-[0032], [0041] and [0052]).
It would have been obvious to one of ordinary skill in the art to pack or store the composition/product of Piccariello in view Ulijn, and Ashmead in a canned packing medium, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Shimono indicated that food product containing short peptides having Asp and Glu, can be a canned food. Thus, an ordinary artisan would have looked to known packaging in the art for storing food product containing peptides including canned packing medium, and achieve Applicant’s claimed invention with reasonable expectation of success.
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 10/23/2025 have been fully considered but they are not persuasive.
Applicant argues that “[n]one of cited references compositions as recited in Claim [2] "...wherein the effective amount of the one or more peptides slows metal catalyzed oxidative degradation of the food product.” Applicant alleges that “a person of skill reviewing Piccariello would necessarily note that its
covalently bound peptide-drug conjugates are designed to resist degradation by sterically shielding the active ingredient or altering its polarity or conformation so that enzymes can't easily attack it. As such, such a person of skill would conclude that the degradation that Piccariello prevents is enzymatic and biological, not chemical oxidation caused by metals. As such, a person of skill would receive no guidance from Piccariello in terms of generating peptides capable of preventing metal-catalyzed oxidative degradation, as recited in currently amended Claim 2.” (Remarks, pages 10-11).
In response, the Examiner disagrees. As discussed above in the pending 103 rejection, it is noted that “effective amount” is recited generically and thereby, interpreted under broadest reasonable interpretation (BRI) in light of the specification as an amount “between about 0.02 mM and about 6 mM” as defined on page 16, lines 8-16 of the specification. As discussed above, Piccariello teaches a composition containing a peptide such as Asp-Asp, Asp-Asp-Asp or Asp-Asp-Gu, and active agent, wherein the peptide containing Asp is present in an amount of 0.07 or 0.93 mmol, and the protects the active agent from degradation by covalently attaching the peptide to the active agent. Thus, the amount of 0.07 or 0.93 mmol as taught by Piccariello meets the claimed “effective amount of the one or more peptides” as recited in claim 2, and thus, the claimed property of “slows metal catalyzed oxidative degradation of the food product” as recited claim 2 would have been implicit in the composition of Piccariello in view of Ulijn because "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
As a result, for at least the reason discussed above, claims 2-13 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.
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 2-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11912785.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘785 significantly overlap with the subject matter of instant claims, i.e.,. compositions comprising an effective amount of one or more peptides, or a pharmaceutically acceptable salt thereof, wherein each of the one or more peptides consist of two to five amino acid residues, at least two of the residues are aspartic acid, and the one or more peptides do not contain histidine; a food product, a cosmetic product, or a hair care product; and a physiologically acceptable mineral, wherein the physiologically acceptable mineral is intentionally added to the composition or is endogenously present in the composition, wherein the physiologically acceptable mineral is copper, iron, chromium, zinc, manganese, or a combination of the foregoing.
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 11912785.
Response to Arguments
In the Remarks filed 10/23/2025, Applicant did not address or provide rebuttal for the double patenting rejection.
As a result, the double patenting rejection is maintained for the reason of record, and pending filing of a terminal disclaimer.
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