DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The preliminary amendment filed September 14, 2023, has been received and entered.
Claim 6 is cancelled.
Claims 1-5 and 7-12 are pending and examined on the merits.
Claim Rejections - 35 USC § 112
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 1-5 and 7-12 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.
Claims 1, 5, 7, and 12 are rendered indefinite by the recitation “(accession number: KCTC 14107BP).” It is unclear how the limitation in parentheses relates to the strain. It is unclear whether the term is necessary or optional. Since claims 1 and 7 are indefinite, then their respective dependent claims, claims 2-5 and 8-11, are rendered indefinite. Therefore, claims 1-5 and 7-12 are rejected under 35 U.S.C. 112(b). This rejection can be overcome by substituting the recitation with “deposited under accession number KCTC 14107BP.”
Claim 12 is rendered indefinite by the grammar (“comprising an active ingredient of a Lactobacillus plantarum GB104 (L. plantarum GB104) strain…or a culture product thereof”). It is unclear whether the active ingredient is (1) a component of the GB104 strain, (2) a component of the GB104 strain or a component of the culture product, (3) the GB104 strain, or (4) the GB104 strain or the culture product. For the purpose of applying prior art and the analysis under 35 U.S.C. 101 below, the active ingredient is being interpreted as the GB104 strain or the culture product.
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 1-5 and 7-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains 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.
The microorganism Lactobacillus plantarum GB104 is recited in the claims, and thus is essential to the claimed invention. Since the microorganism is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the microorganism is not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological material.
The specification does not disclose a repeatable process to obtain the microorganism, and it is not apparent if the biological material is readily available to the public. It noted that the deposit information for the microorganism is on page 5, sixth paragraph and page 16, last paragraph of the originally filed specification, but there is no indication in the specification as to public availability of the strain.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the specific strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this 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 effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. §1.807); and
(e) the deposit will be replaced if it should ever become inviable.
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.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claim has been analyzed for eligibility in accordance with their broadest reasonable interpretation. The claim is directed to a statutory category, i.e. a composition of matter (Step 1: YES).
The claim recites a Lactobacillus plantarum GB104 strain or a culture product thereof. Lactobacillus plantarum are well known as naturally occurring microorganisms, thus the claimed GB104 strain appears to be a naturally occurring microorganism, absent showing by Applicant that it is not naturally occurring (e.g., genetically modified microorganism). Since the GB104 strain appears to be a naturally occurring microorganism, then a culture of Lactobacillus plantarum GB104 strain, which is directed to the claimed ‘a culture product thereof,’ is a naturally occurring product. Also, the species Lactobacillus plantarum is well known in the art as producing various fermentation products including lactic acid. See page 206, first paragraph under the “Lactobacillus plantarum: Physiological and Biochemical Features” section of Todorov (Food Reviews International. 2010. 26: 205-229). Therefore, lactic acid must be a culture product of the GB104 strain. Lactic acid is directed to a naturally occurring product.
Claim 12 recites a pharmaceutical composition comprising the GB104 strain or a culture product thereof as an active ingredient (see interpretation of claim 12 set forth in the rejection under 35 U.S.C. 112(b)). Since the GB104 strain or a culture product thereof is the active ingredient of the pharmaceutical composition, then the GB104 strain or a culture product thereof itself is directed to a ‘pharmaceutical composition.’
As such, claim 12 recites a ‘product of nature’ exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application. The recitation of a pharmaceutical composition does not set forth a practical application of the product of nature (the GB104 strain or a culture product thereof, e.g., lactic acid). Thus claim 12 does not recite any ‘additional element’ other than the judicial exception that integrates the judicial exception into a practical application (Step 2A, Prong Two: NO). As such, claim 12 is directed to a judicial exception (Step 2A: YES).
Claim 12 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 12 does not recite any ‘additional element’ other than the judicial exception (Step 2B: NO). Accordingly, claim 12 is not eligible subject matter under 35 U.S.C. 101.
Notice Re: Prior Art Available Under Pre-AIA and AIA
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.
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.
Claim 12 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Todorov (Food Reviews International. 2010. 26: 205-229).
The species Lactobacillus plantarum is well known in the art as producing various fermentation products including lactic acid. See page 206, first paragraph under the “Lactobacillus plantarum: Physiological and Biochemical Features” section of Todorov. Therefore, lactic acid is inherently directed to a culture product of any strain of Lactobacillus plantarum, including the Lactobacillus plantarum GB104 strain of instant claim 12. Lactic acid itself is directed to a pharmaceutical composition comprising lactic acid as an active ingredient. Therefore, instant claim 12 is anticipated.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 12 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 2 of copending Application No. 17/758,216 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
This pertains to the embodiment of claim 2 of `216 in which the pharmaceutical composition comprises, as an active ingredient, a Lactobacillus Plantarum strain (Accession No. KCTC 14107BP).
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 1-5 and 7-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 13-20, 22, and 23 of copending Application No. 17/758,216 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 2 of `216 meet limitations of instant claim 12, and claims 13-20, 22, and 23 of `216 render obvious instant claims 1-5 and 7-11.
Regarding instant claims 1-5, claims 13-20, 22, and 23 of `216 recite a method comprising administering the claimed L. plantarum strain (Accession No. KCTC 14107BP) or a culture thereof comprising the strain to a subject. In particular, see claim 13 of `216. The culture of the strain comprising the strain of claim 13 of `216 falls within the broader scope of “a culture product thereof” of instant claim 1. The step of claims 13-20, 22, and 23 of `216 meets limitations of the step of instant claim 1, differing from instant claim 1 in that the claims of `216 do not recite administering a “therapeutically effective amount” of the strain or the culture product thereof to the subject, wherein the therapeutic effect is preventing or treating cancer as set forth by the preamble of instant claim 1. Instead, claim 13 of `216 recites the intended use of preventing or treating a metabolic disease. In performing the method of claim 13 of `216, it would have been obvious to the person of ordinary skill in the art to perform routine optimization of the amount of the strain or a culture thereof to obtain the effect of preventing or treating a metabolic diseases. Such routine optimization would have rendered obvious administering the strain or a culture thereof in an amount that is suitable for the intended use of instant claim 1 of preventing or treating cancer. Since instant claim 1 and claim 13 of `216 recite the same strain and render obvious the same step, then claim 13 of `216 renders obvious instant claims 1 and 4 (further limitation regarding the intended use). Claim 14 of `216 also renders obvious instant claims 1 and 4 for the same reason. Claims 15-20 of `216 set forth inherent limitations of the claimed strain. Therefore, claims 15-20 of `216 also render obvious instant claims 1 and 4 for the same reason as set forth with respect to claim 13 of `216.
Further regarding instant claims 2 and 3, they set forth inherent limitations of the claimed strain. Therefore, claims 13-20 of `216 also render obvious instant claim 2 and 3.
Further regarding instant claim 5, claim 22 of `216 meets the claimed limitation of the strain comprised in a food composition. Therefore, claim 22 of `216 renders obvious instant claim 5.
Regarding instant claims 7-11, instant claim 7 recites the additional limitation of the subject being “other than a human being.” In practicing the method of claims 13-20, 22, and 23 of `216, it would have been prima facie obvious to practice the invention on any subject, including a subject other than a human being (e.g., a mammal). Therefore, claims 13-20, 22, and 23 of `216 render obvious instant claims 7-11, applying the same reasoning as applied with respect to instant claims 1-5. Further regarding instant claim 11, claim 23 of `216 meets the claimed limitation of the strain comprised in a feed composition. Therefore, claim 23 of `216 renders obvious instant claim 11.
Regarding instant claim 12, the Lactobacillus Plantarum strain of claim 1 of `216 is itself directed to a pharmaceutical composition comprising the GB104 strain as an active ingredient. Therefore, claim 1 of `216 renders obvious instant claim 12. Also, the pharmaceutical composition of claim 2 of `216 also renders obvious instant claim 12 since a culture thereof comprising the strain falls within the broader claimed scope of “a culture product thereof.” Thus, claim 2 of `216 also renders obvious instant claim 12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,350,301.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `301 are directed to the claimed pharmaceutical composition. In particular, claim 1 of `301 recites a composition comprising a GB104 strain deposited under accession number KCTC 14107BP. Thus, claim 1 of `301 recites a composition comprising the claimed Lactobacillus plantarum GB104 strain. Though the composition of claim 1 of `301 includes additional components, the composition falls within the broader scope of the embodiment of instant claim 12 of a pharmaceutical composition comprising a GB104 strain as an active ingredient. Therefore, each of claims 1-14 of `301 renders obvious instant claim 12, wherein the additional limitations of claims 2-14 fall within the broader scope of the claimed invention.
Claims 1-5 and 7-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/227,022 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `022 render obvious instant claims 1-5 and 7-12.
Regarding instant claims 1-5, each of independent claims 1, 9, and 17 of `022 recite a method comprising administering to a subject a composition that comprises the claimed strain of L. plantarum GB104 strain deposited with accession number KCTC 14107BP, a lysate thereof, and/or a culture solution thereof, in addition to the composition comprising other components. The culture solution of the GB104 strain of the claims of `022 falls within the broader scope of “a culture product thereof” of instant claim 1. In administering to the subject a composition comprising the claimed GB104 strain or culture solution thereof, then the claims of `022 meet limitations of the step of instant claim 1, differing from instant claim 1 in that the claims of `022 do not recite administering a “therapeutically effective amount” of the strain or the culture solution thereof to the subject, wherein the therapeutic effect is preventing or treating cancer as set forth by the preamble of instant claim 1. Instead, claims 1, 9, and 17 of `022 recite the following different intended uses: inhibiting aging, preventing or treating muscle disorders, preventing or treating obesity. In performing the method of the claims of `022, it would have been obvious to the person of ordinary skill in the art to perform routine optimization of the amount of the strain or a culture solution thereof to obtain the effect of inhibiting aging, preventing or treating muscle disorders, or preventing or treating obesity. Such routine optimization would have rendered obvious administering the strain or a culture solution thereof in an amount that is suitable for the intended use of instant claim 1 of preventing or treating cancer. Since instant claim 1 and the claims of `022 recite the same strain and render obvious the same step, then at least independent claims 1, 9, and 17 of `022 render obvious instant claims 1 and 4 (further limitation regarding the intended use). Claims 2 and 14-16 of `022 also render obvious instant claims 1 and 4 for the same reason. Claims 3-8, 10-13, and 18-20 of `022 recite additional limitations that fall within the broader scope of the instant claims. Therefore, claims 3-8, 10-13, and 18-20 of `022 also render obvious instant claims 1 and 4 for the same reason as set forth with respect to the independent claims of `022.
Further regarding instant claims 2 and 3, they set forth inherent limitations of the claimed strain. Therefore, the claims of `022 also render obvious instant claims 2 and 3.
Further regarding instant claim 5, claim 8 of `022 recites that the composition is orally administered. In order to orally administer the composition, it would have been prima facie obvious to the skilled artisan to provide the composition as a food composition. Therefore, claim 8 of `022 renders obvious instant claim 5.
Regarding instant claims 7-11, instant claim 7 recites the additional limitation of the subject being “other than a human being.” In practicing the method of the claims of `022, it would have been prima facie obvious to practice the invention on any subject, including a subject other than a human being (e.g., a mammal). Therefore, claims 1-20 of `022 render obvious instant claims 7-10, applying the same reasoning as applied with respect to instant claims 1-5. Further regarding instant claim 11, claim 8 of `022 recites that the composition is orally administered. In order to orally administer the composition, it would have been prima facie obvious to the skilled artisan to provide the composition as a feed composition. Therefore, claim 8 of `022 renders obvious instant claim 11.
Regarding instant claim 12, though the claims of `022 are directed to methods, they each set forth a composition comprising Lactobacillus plantarum GB104 strain or a culture solution thereof. Though that composition comprises additional components, it falls within the broader scope of instant claim 12. Therefore, the claims of `022 render obvious instant claim 12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 7-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-34 and 36-50 of copending Application No. 18/837,017 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `017 render obvious instant claims 1-5 and 7-12.
Regarding instant claims 1-5, independent claim 32 of `017 recites a method for preventing or treating cancer comprising a first step of administering to a subject in need thereof an effective amount of a first active composition comprising a Lactobacillus plantarum strain, a culture of the strain, a lysate of the strain, or a mixture thereof. Claim 36 of `017 further limits the strain to a strain deposited with accession number KCTC14107BP which is the claimed strain. Though the claims of `017 comprise an additional step of administering a second active composition comprising an anticancer agent, claim 36 of `017 falls within the broader scope of instant claim 1 of a method for preventing or treating cancer in a subject in need thereof, comprising administering a therapeutically effective amount of a GB104 strain or a culture product thereof (the culture of the strain of claim 36 of `017 falls within that scope) as an active ingredient to the subject. Therefore, claim 36 of `017 renders obvious instant claim 1.
It would have been obvious to apply the limitation of claim 36 of `017 to the other claims of `017. As such, each of claims 32-34 and 37-50 of `017 in view of claim 36 of `017 renders obvious instant claim 1.
Regarding instant claims 2 and 3, they set forth inherent limitations of the claimed strain. Therefore, at least claim 36 of `017 renders obvious instant claims 2 and 3.
Regarding instant claim 4, claim 46 of `017 is directed to the claimed limitation. Therefore, claim 46 of `017 in view of claim 36 of `017 renders obvious instant claim 4.
Regarding instant claim 5, claim 49 of `017 recites the embodiment in which the first active composition (which comprises the claimed strain or a culture of the strain) is orally administered. In order to orally administer the composition, it would have been prima facie obvious to the skilled artisan to provide the first active composition as a food composition. Therefore, claim 49 of `017 in view of claim 36 of `017 renders obvious instant claim 5.
Regarding instant claims 7-11, instant claim 7 recites the additional limitation of the subject being “other than a human being.” In practicing the method of the claims of `017, it would have been prima facie obvious to practice the invention on any subject, including a subject other than a human being (e.g., a mammal). Therefore, at least claim 36 of `017 renders obvious instant claims 7-9, applying the same reasoning as applied with respect to instant claims 1-5.
Further regarding instant claim 10, claim 46 of `017 is directed to the claimed limitation. Therefore, claim 46 of `017 in view of claim 36 of `017 renders obvious instant claim 10. Further regarding instant claim 11, claim 49 of `017 recites the embodiment in which the first active composition (which comprises the claimed strain or a culture of the strain) is orally administered. In order to orally administer the composition, it would have been prima facie obvious to the skilled artisan to provide the composition as a feed composition. Therefore, claim 49 of `017 in view of claim 36 of `017 renders obvious instant claim 11.
Regarding instant claim 12, though claim 36 of `017 is a method, it sets forth a composition (a first active composition) comprising Lactobacillus plantarum GB104 strain or a culture of the strain. Therefore, claim 36 of `017 renders obvious instant claim 12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 7-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41 and 45-62 of copending Application No. 19/113,171 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `171 render obvious instant claims 1-5 and 7-12.
Regarding instant claims 1-5, independent claim 41 of `171 recites a method of preventing or treating cancer comprising a first step of administering an effective amount of a first active substance comprising a Lactobacillus plantarum strain, a culture of the strain, a lysate of the strain, or a mixture thereof, to a subject in need thereof. Claim 45 of `171 further limits the strain to a strain deposited with accession number KCTC14107BP which is the claimed strain. Though the claims of `171 comprise an additional step of administering a second active substance comprising a cancer immunotherapeutic agent, claim 45 of `171 falls within the broader scope of instant claim 1 of a method for preventing or treating cancer in a subject in need thereof, comprising administering a therapeutically effective amount of a GB104 strain or a culture product thereof (the culture of a strain of claim 45 of `171 falls within that scope) as an active ingredient to the subject. Therefore, claim 45 of `171 renders obvious instant claim 1.
It would have been obvious to apply the limitation of claim 45 of `171 to the other claims of `171. As such, each of claims 41 and 46-62 of `171 in view of claim 45 of `171 renders obvious instant claim 1.
Regarding instant claims 2 and 3, they set forth inherent limitations of the claimed strain. Therefore, at least claim 45 of `171 renders obvious instant claims 2 and 3.
Regarding instant claim 4, claim 61 of `171 is directed to the claimed limitation. Therefore, claim 61 of `171 in view of claim 45 of `171 renders obvious instant claim 4.
Regarding instant claim 5, claims 54 and 55 of `171 recite the embodiment in which the first active substance (which comprises the claimed strain or a culture of the strain) is orally administered. In order to orally administer the composition, it would have been prima facie obvious to the skilled artisan to provide the first active substance as a food composition. Therefore, each of claims 54 and 55 of `171 in view of claim 45 of `171 renders obvious instant claim 5.
Regarding instant claims 7-11, instant claim 7 recites the additional limitation of the subject being “other than a human being.” In practicing the method of the claims of `171, it would have been prima facie obvious to practice the invention on any subject, including a subject other than a human being (e.g., a mammal). Therefore, at least claim 45 of `171 renders obvious instant claims 7-9, applying the same reasoning as applied with respect to instant claims 1-5.
Further regarding instant claim 10, claim 61 of `171 is directed to the claimed limitation. Therefore, claim 61 of `171 in view of claim 45 of `171 renders obvious instant claim 10. Further regarding instant claim 11, claims 54 and 55 of `171 recite the embodiment in which the first active substance (which comprises the claimed strain or a culture of the strain) is orally administered. In order to orally administer the composition, it would have been prima facie obvious to the skilled artisan to provide the composition as a feed composition. Therefore, each of claims 54 and 55 of `171 in view of claim 45 of `171 renders obvious instant claim 11.
Regarding instant claim 12, though claim 45 of `171 is a method, it sets forth a composition (a first active substance) comprising Lactobacillus plantarum GB104 strain or a culture of the strain. Therefore, claim 45 of `171 renders obvious instant claim 12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 7-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26, 27, 31, 33-46, and 48 of copending Application No. 19/113,188 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `188 render obvious instant claims 1-5 and 7-12.
Regarding instant claims 1-5, independent claim 27 of `188 recites a method of preventing or treating cancer comprising administering an effective amount of a strain of Lactobacillus plantarum, a culture of the strain, a lysate of the strain, or a mixture of the foregoing, to a subject in need thereof. Claim 46 of `188 further limits the strain to a strain deposited under accession number KCTC14107BP which is the claimed strain. Claim 46 of `188 falls within the broader scope of instant claim 1 of a method for preventing or treating cancer in a subject in need thereof, comprising administering a therapeutically effective amount of a GB104 strain or a culture product thereof (the culture of a strain of claim 46 of `188 falls within that scope) as an active ingredient to the subject. Therefore, claim 46 of `188 renders obvious instant claim 1.
It would have been obvious to apply the limitation of claim 46 of `188 to claim 27 of `188 and its other dependent claims. As such, each of claims 27, 42-45, and 48 of `188 in view of claim 46 of `188 renders obvious instant claim 1.
Regarding instant claims 2 and 3, they set forth inherent limitations of the claimed strain. Therefore, at least claim 46 of `188 renders obvious instant claims 2 and 3.
Regarding instant claim 4, claims 44 and 45 of `188 are directed to the claimed limitation. Therefore, each of claims 44 and 45 of `188 in view of claim 46 of `188 renders obvious instant claim 4.
Regarding instant claim 5, claim 43 of `188 recites the administering step comprises oral administration. In order to orally administer the strain or culture of the strain, it would have been prima facie obvious to the skilled artisan to provide them in a food composition. Therefore, claim 43 of `188 in view of claim 46 of `188 renders obvious instant claim 5.
Regarding instant claims 7-11, instant claim 7 recites the additional limitation of the subject being “other than a human being.” In practicing the method of the claims of `188, it would have been prima facie obvious to practice the invention on any subject, including a subject other than a human being (e.g., a mammal). Therefore, at least claim 46 of `188 renders obvious instant claims 7-9, applying the same reasoning as applied with respect to instant claims 1-5.
Further regarding instant claim 10, claims 44 and 45 of `188 are directed to the claimed limitation. Therefore, each of claims 44 and 45 of `188 in view of claim 46 of `188 renders obvious instant claim 10.
Further regarding instant claim 11, claim 43 of `188 recites the administering step comprises oral administration. In order to orally administer the strain or the culture of the strain, it would have been prima facie obvious to the skilled artisan to provide the strain or culture in a feed composition. Therefore, claim 43 of `188 in view of claim 46 of `188 renders obvious instant claim 11.
Regarding instant claim 12, though claim 46 of `188 is a method, it sets forth Lactobacillus plantarum GB104 strain or a culture of the strain which is directed to the claimed composition. Therefore, claim 46 of `188 renders obvious instant claim 12.
Furthermore, regarding instant claims 1-4, independent claim 26 of `188 recites a method comprising administering a strain of Lactobacillus plantarum, a culture of the strain, a lysate of the strain, or a mixture of the foregoing to a subject. Its dependent claim 31 further limits the strain to a strain deposited under accession number KCTC14107PB which is the claimed strain. The culture of that strain falls within the broader scope of “a culture product thereof” of instant claim 1. The step of claim 31 of `188 meets limitations of the step of instant claim 1, differing from instant claim 1 in that claim 31 of `188 does not recite administering a “therapeutically effective amount” of the strain or the culture of strain (directed to the claimed culture product) to the subject, wherein the therapeutic effect is preventing or treating cancer as set forth by the preamble of instant claim 1. Instead, claim 31 of `188 recites the intended use of improving compositions of intestinal metabolites of a subject. In performing the method of claim 31 of `188, it would have been obvious to the person of ordinary skill in the art to perform routine optimization of the amount of the strain or a culture of the strain to obtain the effect of improving compositions of intestinal metabolites of a subject. Such routine optimization would have rendered obvious administering the strain or a culture of the strain in an amount that is suitable for the intended use of instant claim 1 of preventing or treating cancer. Since instant claim 1 and claim 31 of `188 recite the same strain and render obvious the same step, then claim 31 of `188 renders obvious instant claims 1 and 4 (further limitation regarding the intended use).
It would have been obvious to apply the limitation of claim 31 to claim 26 of `188 and its other dependent claims 33-41. Therefore, each of claims 26 and 33-41 of `188 in view of claim 31 of `188 renders obvious instant claims 1 and 4.
Further regarding instant claims 2 and 3, they set forth inherent limitations of the claimed strain. Therefore, at least claim 31 of `188 renders obvious instant claims 2 and 3.
Regarding instant claims 7-10, instant claim 7 recites the additional limitation of the subject being “other than a human being.” In practicing the method of claims 26, 31, and 33-41 of `188, it would have been prima facie obvious to practice the invention on any subject, including a subject other than a human being (e.g., a mammal). Therefore, at least claim 31 of `188 renders obvious instant claims 7-10, applying the same reasoning as applied with respect to instant claims 1-4.
Regarding instant claim 12, though claim 31 of `188 is a method, it sets forth Lactobacillus plantarum GB104 strain or a culture of the strain which is directed to the claimed composition. Therefore, claim 31 of `188 renders obvious instant claim 12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kassayova (Anticancer Research. 2014. 34: 4969-4976) discloses Lactobacillus plantarum LS/07 strain that is effective in prevention and treatment of experimentally-induced breast cancer (page 4974, left column, second paragraph). This was determined through a preventive-curative study in female rats (page 4970, left column, third paragraph and right column, first paragraph). Thus Kassayova meets limitations of the claimed invention in that Kassayova discloses a method for preventing or treating cancer in a subject (a subject other than a human being) in need thereof, comprising administering a therapeutically effective amount of a strain of Lactobacillus plantarum as an active ingredient to the subject. However, Kassayova differs from the claimed invention in that there is insufficient evidence to support a conclusion that the LS/07 strain of Kassayova is the claimed L. plantarum GB104 strain.
Chuah (BMC Complementary and Alternative Medicine. 2019. 19: 114. 12 pages) discloses postbiotic metabolites (PM) produced by the following six strains of Lactobacillus plantarum: UL4, TL1, RS5, RI11, RG11, and RG14 (abstract). These PM are directed to a culture product of a Lactobacillus plantarum strain. It was determined that these PM exhibited selective cytotoxicity via antiproliferative effect and induction of apoptosis against malignant cancer cells in a strain-specific and cancer cell type-specific manner whilst sparing the normal cells (abstract). Therefore, it would have been obvious to apply these PM in a method for treating cancer in a subject in need thereof, comprising administering a therapeutically effective amount of the PM (directed to a culture product of a Lactobacillus plantarum strain) as an active ingredient to the subject, meeting limitations of the claimed invention. However, Chuah differs from the claimed invention in that there is insufficient evidence to support a conclusion that any of the L. plantarum strains of Chuan is the claimed L. plantarum GB104 strain. Because Chuah found that the cytotoxic effects of the PM are strain-specific, then it cannot be concluded that the PM of any of the L. plantarum strains of Chuan is directed to the claimed culture product.
Conclusion
No claims are allowed.
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/SUSAN E. FERNANDEZ/ Examiner, Art Unit 1651
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