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 .
DETAILED ACTION
Preliminary amendment filed on 04/22/2024 are acknowledged. Claims 3 and 8 were amended. Claims 1-8 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/US2021/012655, filed on 01/08/2021 which claims benefit to provisional application 62/959,510 filed on 01/10/2020.
Information Disclosure Statement
The information disclosure statement (IDS) dated 01/23/2024 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, the IDS document has been placed in the application file and the information therein has been considered as to the merits.
Claim Objections
Claims 2 and 4 are objected to because of the following informalities: the phrase “UPMP” in line 5 of claim 2 and line 2 of claim 4 should be “UMP”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 6 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 6 and 9, the phrase “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, and 5-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fang et al. (2018/0049460 A1, published 02/22/2018, PTO-892).
Fang is drawn to a nucleotide composition used as a food additive that consists of 58-72% CMP, 6-14% AMP, 10-18% UMP and 8-14% GMP, or consists of 58-70% CMP, 7.5-12.5% AMP, 12-16.5% UMP, 10-13% GMP and 0-2.5% IMP. The composition is used to prepare foods, such as an infant food and a dairy product, and achieves the following effects: improving immunostimulation, promoting growth and development, facilitating repair after intestinal injury, promoting the growth of intestinal beneficial microorganisms, and/or any combination thereof (abstract). Fang claims a nucleotide composition as a food additive, wherein on a weight basis, the composition substantially comprises components CMP, AMP, UMP and GMP, and wherein proportions of the components are 58-72% CMP, 6-14% AMP, 10-18% UMP, and 8-14% GMP and a sum of the components is 100% (claim 1). Fang discloses a composition wherein the CMP is 60%, AMP is 12%, UMP is 16% and GMP is 12% (claim 5). Fang teaches that the food may be an infant food (claim 12), in a form of a dairy product (claim 13), or in a form of milk powder or liquid dairy product (claim 14).
Regarding the instant claims 1 and 2 limitation of “for improving mitochondrial function”, it is noted that the prior art does not teach that the composition can be used in the manner instantly claimed, for improving mitochondrial function. However, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since the composition would be capable of performing the intended use. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Regarding instant claim 5, the claim depends from instant claim 1 and recites additional limitations wherein the drug is in the forms of powders, tablets, soft capsules, hard capsules, or oral liquids. However, instant claim 1 recites the alternative limitations that item may be a food item. Thus, the limitations of instant claim 5 is met by the prior art teaching the nutritional composition.
Regarding instant claim 8, the claim depends from instant claim 2 and recites additional limitations wherein the drug is in the forms of powders, tablets, soft capsules, hard capsules, or oral liquids. However, instant claim 2 recites the alternative limitations that item may be a food item. Thus, the limitations of instant claim 8 is met by the prior art teaching the nutritional composition.
Accordingly, the claims are anticipated by the art.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Fang et al. (US 2018/0049460 A1, published 02/22/2018, PTO-892) and Ying et al. (US 2017/0130254 A1, published 05/11/2017, PTO-892).
Claim 1 is rejected as discussed above.
The teachings of Fang are discussed above.
Fang does not teach the that the 5’-adenosine monophosphate is produced by means of enzymatic degradation of a ribonucleic acid as a raw material and has a purity of more than 99%.
Ying is drawn to a nucleotide production process (title). Ying discloses a process for the production of nucleotides comprising: decomposing RNA by using nuclease P1 to obtain nucleotides AMP, GMP, CMP and UMP, converting part or all of the nucleotide AMP into nucleotide IMP by using adenosine deaminase enzyme, separating the obtained nucleotides by using an ion exchange resin, and then concentrating and crystalizing to obtain purified nucleotides AMP, GMP, CMP, UMP, and IMP or purified nucleotides or purified nucleotides GMP, CMP, UMP and IMP (claim 1). Ying teaches that the purified nucleotides, including AMP, was greater than 99% (paragraph 0096). Ying teaches that the existing methods for producing nucleotides have some defects such as complexed production process, higher cost, being hard to separate, lower safety and purity, and being difficult to realize the industrial production and so on. The nucleotides, as biological products, have high nutrition and high medicinal value, which are commonly used for infant food and pharmaceutical industries, but the requirements of high purity and high quality make the existing process for producing nucleotides difficult to meet the demands of infant food and pharmaceutical industries. Therefore, developing a new process for producing nucleotides, which is simple, and has low cost, high safety and high purity, to meet the demands of infant food and pharmaceutical industries has become a subject to be solved urgently in this field (paragraph 0007).
It would have been prima facie obvious to combine the teachings of Fang and Ying before the effective filing date of the claimed invention by selecting the enzymatically produced nucleotides, including AMP, with a purity above 99% as taught by Ying for the infant formula comprising the nucleotides as taught by Fang to arrive at the instant invention. It would have been prima facie obvious for a person of ordinary skill in the art to select the enzymatically produced nucleotides, including AMP, as taught by Ying for the infant formula taught by Fang because Ying teaches that infant formulas require high purity. One of ordinary skill in the art would have a reasonable expectation of success because Ying shows that the nucleotides, including AMP, can be produced enzymatically and purified with greater than 99% purity to meet the demand for nucleotides of high-purity in the infant food industries, and Fang teaches a nutritional composition comprising nucleotides that may be used for infant formula.
Instant claim 3 recites the additional limitation of wherein the 5'-disodium uridine is produced by means of enzymatic degradation of a ribonucleic acid as a raw material and has a purity of more than 99 %. However, instant claim 3 depends from instant claim 1 wherein instant claim 1 recites the alternative limitation of the food item comprising 5’-adenosine monophosphate or 5’disodium uridine. Thus, the limitations of instant claim 3 is met by the prior art teaching the 5’-adenosine monophosphate is produced by means of enzymatic degradation of a ribonucleic acid as a raw material and has a purity of more than 99 %.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Gil (AU 769645 B2, published 01/29/2004, PTO-892).
Gil is drawn to a product relating to milk and non-milk infant formulas that comprises at least one nucleoside selected from the group consisting of uridine, guanosine, adenosine, cytidine, and inosine (abstract). Gil demonstrated the use of a range of nucleosides/nucleotides in infant formulas with cow’s milk including uridine phosphate, guanosine phosphate, adenosine phosphate, cytidine phosphate and inosine phosphate (Table 2, page 13). The ranges given for each nucleotide in Table 2 encompasses the content percentages of the nucleotides of instant claims 2 and 4, wherein proportions of the components are 13.7-98.5% UMP, 1.0-64.1% GMP, 0-63.8% AMP, 0-68.3% CMP, and 0-47.4% IMP and a sum of the components is 100% (examiner conversions based off the data provided in Table 2).
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Gil et al. Content of nucleotides (Table 2, page 13)
It would have been prima facie obvious before the effective filing date of the claimed invention to select the content percentages of the nucleotides as disclosed by Gil to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to select the content percentages of the nucleotides because Gil teaches the range of nucleotides in infant formulas. Furthermore, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. 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). (MPEP § 2144.05(I)) Moreover, 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). (MPEP § 2144.05(II)) “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 Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
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, and 4-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 19/526,363. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to an intended use of a composition comprising 5’ monophosphate nucleotides to prepare functional foods comprising 15-78% of CMP, 6-44% of AMP, 7-40% of UMP, 7-51% of GMP, and 0 of IMP, or greater than 0 and no more than 2.5% of IMP and wherein the functional foods are in forms comprising powder, tablets, soft/hard capsules, dairy products, baked products, and liquid beverages. The instant claims are also directed towards a food item in the form of a powder comprising the same 5’ monophosphates in the same ranges and therefore the claims anticipate the instant claims.
Claims 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/526,363 in view of Ying et al. (US 2017/0130254 A1, published 05/11/2017, PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claim is drawn to an intended use of a composition comprising 5’ monophosphate nucleotides to prepare functional foods 15-78% of CMP, 6-44% of AMP, 7-40% of UMP, 7-51% of GMP, and 0 of IMP, or greater than 0 and no more than 2.5% of IMP. The copending application does not disclose that the 5’-adenosine monophosphate is produced by means of enzymatic degradation of a ribonucleic acid as a raw material and has a purity of more than 99%.Ying discloses a process for the production of nucleotides comprising: decomposing RNA by using nuclease P1 to obtain nucleotides AMP, GMP, CMP and UMP, converting part or all of the nucleotide AMP into nucleotide IMP by using adenosine deaminase enzyme, separating the obtained nucleotides by using an ion exchange resin, and then concentrating and crystalizing to obtain purified nucleotides AMP, GMP, CMP, UMP, and IMP or purified nucleotides or purified nucleotides GMP, CMP, UMP and IMP (claim 1). Ying teaches that the purified nucleotides, including AMP, was greater than 99% purity (paragraph 0096). Therefore, it would be obvious to one of ordinary skill in the art that a nucleotide, including AMP, that was enzymatically produced and purified could be selected as the nucleotides used in the functional foods. Thus, the claim of copending application 19/526,363 is obvious over the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/S.L.S./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
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