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 .
Priority
The present application, filed November 15, 2023, is a national stage application of PCT/JP2022/021101, filed May 23, 2022, and claims priority to foreign priority application JP2021-087255, filed May 24, 2021.
Status of the Application
Applicant’s preliminary amendment, received November 15, 2023, wherein claims 1-7 are amended, is acknowledged.
Claims 1-7 are pending and examined on the merits herein.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 4-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Claim 4 is drawn to a bacterium consisting of Aureobasidium pullulans APNN-M163 strain (accession number: NITE BP-03377). Claims 5-7 are drawn to a β-1,3-1,6-glucan having β-1,4 and β-1,2 bonds in addition to the β-1,3 and β-1,6 bonds. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Subject matter that is not patent eligible is determined by evaluating a claim for patentability based on the eligibility test set forth below:
(1) Is the claim directed to one of the four statutory categories, i.e., a process, machine, manufacture, or composition of matter? For claims 4-7, the answer is “Yes”. Claims 4 and 5-7 are drawn to compositions of matter.
(2a) Prong 1: Does the claim recite or involve a judicial exception? The answer is “Yes”. Claim 4 is drawn to a bacterium consisting of Aureobasidium pullulans APNN-M163 strain. Claims 5-7 are drawn to a β-1,3-1,6-glucan having β-1,4 and β-1,2 bonds in addition to the β-1,3 and β-1,6 bonds. The subject matter of claim 4 and claims 5-7 is a product of nature.
As evidence that Aureobasidium pullulans APNN-M163 strain is a product of nature, the instant specification provides that Aureobasidium pullulans APNN-M163 strain was identified by culturing a plant and starch-rich soil sample, identifying bacteria producing a viscous sample, further culturing said bacteria, and identifying strains producing polysaccharide (p. 7, Example 1, section (1)). The specification further provides that selected strains were mutation treated using ethyl methanesulfonate (EMS), UV, or nitrous acid, and mutation-treated strains were also sorted by measuring the amount of polysaccharide in the supernatant, as were the parent strains. The sorted strains were cultured, and useful bacteria were sorted according to type and amount of polysaccharides produced by the bacteria, and after identifying the type of polysaccharide by acid-catalyzed degradation and enzyme-catalyzed degradation, the APNN-M163 strain was isolated as a strain producing more β-glucan (p. 8, first three paragraphs).
In this instance, the APNN-M163 strain was isolated from a plant and starch rich soil sample. Although strains from this sample were mutated using the methods described above, it is not clear if strain APNN-M163 was a mutated strain or a parent strain that was not mutated but selected based on the type and polysaccharide it produced. Therefore, there is no evidence that the APNN-M163 strain differs from the strain as it exists in nature.
Claims 5-7 are drawn to a β-1,3-1,6-glucan having β-1,4 and β-1,2 bonds in addition to the β-1,3 and β-1,6 bonds. As evidence that such a β-glucan is a product of nature, the specification provides that a β-glucan sample produced by the APNN-M163 strain has the structure as shown (p. 9, [0033], Chem 2). This structure satisfies all limitations of claims 5-7. Accordingly, because this product is produced by APNN-M163, itself a product of nature (as described above), this polysaccharide is also a product of nature. Moreover, there is no evidence that this β-1,3-1,6-glucan includes any changes to its structure or physical properties that would amount to a product markedly different than the product as it exists in nature.
(2a) Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is “No.” Claim 4 is drawn to a bacterium consisting of Aureobasidium pullulans APNN-M163 strain. Claim 5 is drawn to a β-1,3-1,6-glucan having β-1,4 and β-1,2 bonds in addition to the β-1,3 and β-1,6 bonds. Claims 6 and 7 require the ratio of glucose units bound to adjacent glucose units at only 1st and 4th positions to total glucose units configuring the β-1,3-1,6-glucan ranges from 0.04 to 0.08 or is 0.04 or more and 0.08 or less. These claims do not recite additional elements that integrate the judicial exception into a practical application.
(2b) Does the claim as a whole recite additional elements that amount to something significantly more than the judicial exception(s)? The answer is “No.”
Claim 4 is drawn to a bacterium consisting of Aureobasidium pullulans APNN-M163 strain. Claim 5 is drawn to a β-1,3-1,6-glucan having β-1,4 and β-1,2 bonds in addition to the β-1,3 and β-1,6 bonds. Claims 6 and 7 require the ratio of glucose units bound to adjacent glucose units at only 1st and 4th positions to total glucose units configuring the β-1,3-1,6-glucan ranges from 0.04 to 0.08 or is 0.04 or more and 0.08 or less. However, the additional elements of claims 6-7 do not amount to something significantly more than the judicial exception.
Therefore, in view of the foregoing, there is no indication that the bacterium consisting of Aureobasidium pullulans APNN-M163 strain of claim 4, or the β-1,3-1,6-glucan, having β-1,4 and β-1,2 bonds in addition to the β-1,3 and β-1,6 bonds of claims 5-7, possess markedly different characteristics than their naturally occurring counterparts existing in nature.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that biological material is required to practice the invention of claims 1-4. Accordingly, the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the biological material.
The process of isolating APNN-M163 disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material, and it is not apparent that the biological materials considered necessary to make and use the invention are both known and readily available to the public.
It is noted that Applicants have deposited biological material (see specification, p. 3, [0013]), but there is no indication in the specification as to public availability. Therefore, a deposit at a recognized depository may be made to obviate this rejection.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
Applicant has disclosed that the APNN-M163 strain was deposited at the Patent Microorganisms Depositary Center, on February 9, 2021 with the accession number: NITE P-03377 (p. 3, [0013] of the specification). However, there is no indication in the specification as to the public availability of this strain.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ikewaki (Ikewaki, N.; et al. BioRxiv 2021, doi:10.1101/2021.07.22.453362; available online July 23, 2021; cited in IDS received March 6, 2024).
Ikewaki teaches exopolysaccharides produced by Aureobasidium pullulans (p. 4, background section, lines 4-7). Specifically, Ikewaki teaches the structure of the beta glucan produced by from A. pullulans strain N-163 (structure shown on p. 18, first image), which has the same structure as the beta glucan from M-163 shown in the instant specification (specification, p. 9, [0033]). This structure has 1 glucose unit bound to adjacent glucose units at only 1st and 4th positions out of 15 total glucose units, and thus the ratio for this product required by claims 6 and 7 is 0.067. This structure satisfies all limitations of claims 5-7.
Thus Ikewaki anticipates claims 5-7.
Ikewaki was published July 23, 2021, after the filing date of the foreign priority application. However, Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
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 4-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6, and 10 of co-pending U.S. patent application 18/569553 (reference application, hereinafter ‘553; cited in IDS received March 6, 2024). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘553 anticipate the claimed invention.
The present application and ‘553 are each assigned to Sophy Inc.
The claims of ‘553 received December 14, 2023 are cited in this provisional nonstatutory double patenting rejection.
Claim 1 of ‘553 claims a composition for preventing and/or treating fibrosis, comprising a beta-glucan. Claim 2 of ‘553 claims the composition of claim 1, in which the beta-glucan comprises a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377).
Claim 4 of ‘553 claims the composition of claim 1, in which the beta-glucan consists of a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377) and a beta-glucan
produced by Aureobasidium pullulans AFO-202 (FERM BP-19327).
Claim 6 of ‘553 claims a composition for improving gut microbiota, comprising a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377).
Claim 10 of ‘553 claims a composition for balancing amino acids to beneficial levels, comprising a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377).
Strain N-163 recited in claims 2, 4, 6, and 10 of ‘553 has the same accession number, NITE BP-03377, as APNN-M163 recited in the present claims. In addition, the specification of ‘553 provides that Aureobasidium pullulans strain APNN-M163 is also referred to as "strain M163", or "strain N-163" (p. 10, [0011], lines 1-4).
MPEP 804(B) at 1 states: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999).” Accordingly, in view of the same accession number and strain name, Aureobasidium pullulans N-163 recited in the claims of ‘553 is the same strain as APNN-M163.
Moreover, the beta glucan produced by N-163, the same strain as APNN-M163, has the structure as required by claims 5-7, as evidenced by the instant specification.
MPEP 2112.01 (especially at I) citing In re Best, 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions or characteristics that are newly recited or is identical to an invention as instantly claimed. In such a situation, the burden is shifted to the applicants to show the invention of the applicant and the prior art are not the same or that the prior art invention does not inherently possess the characteristics of the claimed invention. In this instance, because claims 2, 4, 6, and 10 of ‘553 claim a beta-glucan produced by Aureobasidium pullulans N-163 (NITE P-03377), and the instant specifications provides that the beta-glucan produced by Aureobasidium pullulans APNN-M163 (NITE P-03377) has the structure required by present claims 5-7, claims 4-7 are anticipated by the claims of ‘553.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, and 10 of co-pending U.S. patent application 18/569553 (reference application, hereinafter ‘553; cited in IDS received March 6, 2024) in view of Inoko (Ikewaki, N.; et. al. Microbiology Immunology 2007, vol. 51, pp. 861-873; cited in IDS received March 6, 2024) and Fujii (U.S. Patent 6,956,120; cited in IDS received March 6, 2024).
Claim 1 of ‘553 claims a composition for preventing and/or treating fibrosis, comprising a beta-glucan. Claim 2 of ‘553 claims the composition of claim 1, in which the beta-glucan comprises a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377). Claim 3 of ‘553 claims the composition of claim 2, in which the beta-glucan further comprises
a beta-glucan produced by Aureobasidium pullulans AFO-202 (FERM BP-19327).
Claim 4 of ‘553 claims the composition of claim 1, in which the beta-glucan consists of a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377) and a beta-glucan
produced by Aureobasidium pullulans AFO-202 (FERM BP-19327).
Claim 6 of ‘553 claims a composition for improving gut microbiota, comprising a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377).
Claim 10 of ‘553 claims a composition for balancing amino acids to beneficial levels, comprising a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377).
As stated in the above provisional nonstatutory double patenting rejection, strain N-163 recited in claims 2, 4, 6, and 10 of ‘553 has the same accession number, NITE BP-03377, as APNN-M163 recited in the present claims, and the specification of ‘553 provides that Aureobasidium pullulans strain APNN-M163 is also referred to as "strain M163", or "strain N-163" (p. 10, [0011], lines 1-4). Accordingly, Aureobasidium pullulans N-163 recited in the claims of ‘553 is the same strain as APNN-M163.
The claims of ‘553 do not claim a method for producing β-1,3-1,6-glucan, comprising a step for culturing an Aureobasidium pullulans APNN-M163 strain (accession number: NITE BP-03377) in a culture medium, as recited in present claim 1. The claims of ‘553 also do not claim the beta glucan of present claims 5-7.
Inoko teaches the immunological actions of Sophy β-glucan, a type of β-1,3-1,6 glucan produced by the black yeast Aureobasidium pullulans (A. pullulans) strain AFO-202 (p. 861, Abstract, lines 1-3). Inoko teaches that Sophy β-glucan, the β-1,3-1,6 glucan synthesized
by Aureobasidium pullulans (A. pullulans) strain AFO-202, was prepared by Sophy Co. (Kochi,
Japan) using the latest biological culture and preparative techniques and cites U.S. Patent 6,956,120 (herein referred to as Fujii) (p. 862, right column, Materials and Methods section, lines 1-8). This is interpreted as teaching that the methods of Fujii apply to culturing A. pullulans AFO-202.
Fujii further teaches industrial and commercial applications of a β-1,3-1,6-glucan appearing in the medium of the black yeast, Aureobasidium (column 1, lines 9-12). Fujii suggests culturing A. pullulans on solid medium comprising potato-glucose-agar (column 6, lines 21-26) and in liquid medium comprising potato-glucose (column 6, lines 38-41).
It would therefore have been prima facie obvious to one of ordinary skill in the art to produce a beta-glucan product using Aureobasidium pullulans N-163 (NITE BP-03377) following the guidance of Inoko and Fujii, because claim 2 of ‘553 claims a composition for preventing and/or treating fibrosis comprising a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377). Accordingly, one of ordinary skill in the art would have recognized the utility of a beta glucan from A. pullulans N-163, and would have considered methods for producing beta glucans using A. pullulans known in the art, such as the culture methods and culture medium taught by Inoko and Fujii, because said conditions may also be effective for producing a beta-glucan from strain N-163.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, and 10 of co-pending U.S. patent application 18/569553 (reference application, hereinafter ‘553; cited in IDS received March 6, 2024) in view of Inoko (Ikewaki, N.; et. al. Microbiology Immunology 2007, vol. 51, pp. 861-873; cited in IDS received March 6, 2024) and Fujii (U.S. Patent 6,956,120; cited in IDS received March 6, 2024) as applied to claim 1 above, and further in view of Miyawaki (Miyawaki, K., et al. 4AOa06; 2010 Annual Meeting of the Japan Society for Bioscience, Biotechnology, and Agrochemistry (Tokyo) (2010); cited in IDS received November 15, 2023).
Miyawaki was cited in the IDS received November 15, 2023. Citations below refer to the English translation of Miyawaki included in the application file.
Claim 1 of ‘553 claims a composition for preventing and/or treating fibrosis, comprising a beta-glucan. Claim 2 of ‘553 claims the composition of claim 1, in which the beta-glucan comprises a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377). Claim 3 of ‘553 claims the composition of claim 2, in which the beta-glucan further comprises
a beta-glucan produced by Aureobasidium pullulans AFO-202 (FERM BP-19327).
Claim 4 of ‘553 claims the composition of claim 1, in which the beta-glucan consists of a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377) and a beta-glucan
produced by Aureobasidium pullulans AFO-202 (FERM BP-19327).
Claim 6 of ‘553 claims a composition for improving gut microbiota, comprising a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377).
Claim 10 of ‘553 claims a composition for balancing amino acids to beneficial levels, comprising a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377). The claims of ‘553 do not claim a method for producing β-1,3-1,6-glucan, comprising a step for culturing an Aureobasidium pullulans APNN-M163 strain (accession number: NITE BP-03377) in a culture medium, wherein the culture medium contains nitrate ion salt as a nitrogen source, as required by present claim 3.
Inoko and Fujii teach as described in the above provisional nonstatutory double patenting rejection.
Miyawaki teaches that A. pullulans is a microorganism that produces pullulan and beta-glucan (p. 1, first paragraph, lines 1-2). Miyawaki teaches that A. pullulans strain TRO126 does not produce beta-glucan efficiently in a medium containing ammonium sulfate (p. 1, first paragraph, lines 3-5). Miyawaki teaches that when culturing this strain in nitrate as the nitrogen source, the yield of beta-glucan increased compared with ammonia as the nitrogen source (p. 1, second paragraph, lines 6-8).
It would therefore have been prima facie obvious to one of ordinary skill in the art to produce a beta-glucan product using strain Aureobasidium pullulans N-163 (NITE BP-03377) following the guidance of Inoko and Fujii, because claim 2 of ‘553 claims a composition for preventing and/or treating fibrosis, comprising a beta-glucan produced by Aureobasidium pullulans N-163 (NITE BP-03377). Accordingly, one of ordinary skill in the art would have recognized the utility of a beta glucan from A. pullulans N-163, and would have considered methods for producing beta glucans using A. pullulans known in the art, such as the culture methods and culture medium taught by Inoko and Fujii, because said conditions may also be effective for producing a beta-glucan from strain N-163. Moreover, one of ordinary skill in the art would have contemplated these culture conditions with nitrate as a nitrogen source, because Miyawaki teaches improved production of beta-glucan from A. pullulans using nitrate as a nitrogen source in place of ammonia.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 4-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-5 of co-pending U.S. patent application 18/572416 (reference application, hereinafter ‘416; cited in IDS received March 6, 2024). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘416 anticipate the claimed invention.
Claim 1 of ‘416 claims a composition for improving, preventing and/or treating muscular
dystrophy and/or multiple sclerosis, comprising a beta-glucan. Claim 2 of ‘416 depends from claim 1 and requires the beta-glucan comprises a beta-glucan produced by Aureobasidium pullulans N-163 (NITE P-03377).
Claim 4 of ‘416 claims a method of improving, preventing and/or treating muscular dystrophy and/or multiple sclerosis in a subject, comprising administrating a composition comprising a beta-glucan to the subject in need thereof. Claim 5 of ‘416 depends from claim 4 and requires the beta-glucan comprises a beta-glucan produced by Aureobasidium pullulans N-163 (NITE P-03377).
Strain N-163 has the same accession number, NITE BP-03377, as APNN-M163 recited in the present claims. Moreover, the specification of ‘416 provides that Aureobasidium pullulans strain APNN-M163 is also referred to as "strain M163", or "strain N-163" (p. 6, [0009], lines 1-4).
MPEP 804(B) at 1 states: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999).” Accordingly, in view of the same accession number and strain name, Aureobasidium pullulans N-163 recited in the claims of ‘416 is the same strain as APNN-M163.
In addition, the beta glucan produced by N-163 has the structure as required by claims 5-7, as evidenced by the present specification.
MPEP 2112.01 (especially at I) citing In re Best, 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions or characteristics that are newly recited or is identical to an invention as instantly claimed. In such a situation, the burden is shifted to the applicants to show the invention of the applicant and the prior art are not the same or that the prior art invention does not inherently possess the characteristics of the claimed invention. In this instance, because claims 2 and 5 of ‘416 require a beta-glucan produced by Aureobasidium pullulans N-163 (NITE P-03377), and the instant specification provides that the beta-glucan produced by Aureobasidium pullulans APNN-M163 (NITE P-03377) has the structure required by present claims 5-7, claims 4-7 are anticipated by the claims of ‘416.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-5 of co-pending U.S. patent application 18/572416 (reference application, hereinafter ‘416; cited in IDS received March 6, 2024) in view of Inoko (Ikewaki, N.; et. al. Microbiology Immunology 2007, vol. 51, pp. 861-873; cited in IDS received March 6, 2024) and Fujii (U.S. Patent 6,956,120; cited in IDS received March 6, 2024).
Claim 1 of ‘416 claims a composition for improving, preventing and/or treating muscular
dystrophy and/or multiple sclerosis, comprising a beta-glucan. Claim 2 of ‘416 depends from claim 1 and requires the beta-glucan comprises a beta-glucan produced by Aureobasidium pullulans N-163 (NITE P-03377).
Claim 4 of ‘416 claims a method of improving, preventing and/or treating muscular dystrophy and/or multiple sclerosis in a subject, comprising administrating a composition comprising a beta-glucan to the subject in need thereof. Claim 5 of ‘416 depends from claim 4 and requires the beta-glucan comprises a beta-glucan produced by Aureobasidium pullulans N-163 (NITE P-03377).
Strain N-163 has the same accession number, NITE BP-03377, as APNN-M163 recited in the present claims. Moreover, the specification of ‘416 provides that Aureobasidium pullulans strain APNN-M163 is also referred to as "strain M163", or "strain N-163" (p. 6, [0009], lines 1-4). Accordingly, Aureobasidium pullulans N-163 recited in the claims of ‘416 is the same strain as APNN-M163.
Inoko and Fujii teach as described in the above provisional nonstatutory double patenting rejections.
It would therefore have been prima facie obvious to one of ordinary skill in the art to produce a beta glucan product using Aureobasidium pullulans N-163 (NITE BP-03377) following the guidance of Inoko and Fujii, because the claim 2 of ‘416 claims a composition for improving, preventing and/or treating muscular dystrophy and/or multiple sclerosis produced by A. pullulans N-163 (NITE P-03377). Accordingly, one of ordinary skill in the art would have recognized the utility of a beta glucan from A. pullulans N-163, and would have considered methods for producing beta glucans using A. pullulans known in the art, such as the culture methods and culture medium taught by Inoko and Fujii, because said conditions may also be effective for producing a beta-glucan from strain N-163.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-5 of co-pending U.S. patent application 18/572416 (reference application, hereinafter ‘416; cited in IDS received March 6, 2024) in view of Inoko (Ikewaki, N.; et. al. Microbiology Immunology 2007, vol. 51, pp. 861-873; cited in IDS received March 6, 2024) and Fujii (U.S. Patent 6,956,120; cited in IDS received March 6, 2024) as applied to claim 1 above, and further in view of Miyawaki (Miyawaki, K., et al. 4AOa06; 2010 Annual Meeting of the Japan Society for Bioscience, Biotechnology, and Agrochemistry (Tokyo) (2010); cited in IDS received November 15, 2023).
Claim 1 of ‘416 claims a composition for improving, preventing and/or treating muscular
dystrophy and/or multiple sclerosis, comprising a beta-glucan. Claim 2 of ‘416 depends from claim 1 and requires the beta-glucan comprises a beta-glucan produced by Aureobasidium pullulans N-163 (NITE P-03377).
Claim 4 of ‘416 claims a method of improving, preventing and/or treating muscular dystrophy and/or multiple sclerosis in a subject, comprising administrating a composition comprising a beta-glucan to the subject in need thereof. Claim 5 of ‘416 depends from claim 4 and requires the beta-glucan comprises a beta-glucan produced by Aureobasidium pullulans N-163 (NITE P-03377).
Inoko and Fujii teach as described in the above provisional nonstatutory double patenting rejections.
Miyawaki teaches as described in the above provisional nonstatutory double patenting rejection.
It would therefore have been prima facie obvious to one of ordinary skill in the art to produce a beta-glucan product using Aureobasidium pullulans N-163 (NITE BP-03377) following the guidance of Inoko and Fujii, because the claims of ‘416 claim a composition for improving, preventing and/or treating muscular dystrophy and/or multiple sclerosis comprising a beta-glucan from N-163. Accordingly, one of ordinary skill in the art would have recognized the utility of a beta glucan from A. pullulans N-163, and would have considered methods for producing beta glucans using A. pullulans known in the art, such as the culture methods and culture medium taught by Inoko and Fujii. Moreover, one of ordinary skill in the art would have contemplated these culture conditions with nitrate as a nitrogen source, because Miyawaki teaches improved production of beta-glucan from A. pullulans using nitrate as a nitrogen source in place of ammonia.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Conclusion
No claims are allowed.
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/B.M.B./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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