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 .
The amendment filed 6/5/2026 has been entered. Claim 1 has been amended. Claims 1-19 are pending and are under examination.
Specification
The amendment to the specification is acknowledged.
Claim Rejections - Withdrawn
The rejection of claims 1-19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment to the claims.
Claim Objections
Claim 1 is objected to because of the following informalities: Please include the full meaning of “TRBV” as it occurs in the first mention in the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 102 Maintained
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.
The rejection of claim(s) 1-19 under 35 U.S.C. 102(a)(1) as being anticipated by Arase et al. PLOS ONE. DOI:10.1371/journal.pone.0160736 8/8/2016, 21 pages is maintained.
Claim 1: Arase et al disclose an enhancer of number of TCR clones, comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient. See p. 3 under administration of Lactobacillus casei strain Shirota (LcS YIT9029).
Claim interpretation: The claims are drawn to an enhancer of number of TCR clones, comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient, wherein after vaccination with CD4 positive T cells carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced.
The claims are drawn to composition of matter. The composition of matter comprises live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
The limitation drawn to “wherein after vaccination with CD4 positive T cells carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” is drawn toa process limitation drawn to vaccinating with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells.
However, the claimed composition comprises live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient. Since Arase et al discloses live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient, the live lactic acid bacteria is necessary also an enhancer of number of TCR clones claims as recited in the preamble in the claims. The properties of the live lactic acid bacteria belonging to the genus Lacticaseibacillus as an enhancer of TCR clones is inseparable. See In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01.
Claim 2: The limitation “wherein the virus is an influenza virus or a novel coronavirus (COVID-19)” is drawn to an intended use vaccinating with the virus. Arase et al disclose an enhancer of number of TCR clones, comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient. See p. 3 under administration of Lactobacillus casei strain Shirota (LcS YIT9029).
Claim 3. Arase et al disclose the lactic acid bacteria are classified into Lacticaseibacillus paracasei.
Claim 4: Arase et al disclose the lactic acid bacteria are Lacticaseibacillus paracasei YIT 9029.
Claim 5: The limitation “wherein the enhancer enhances the number of TCR clones carrying any one or more of TRBV6-2, TRBV9, TRBV10-3, or TRBV12-4 in addition to the TRBV19” is drawn to the intended use of the enhancer, comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient. Arase et al disclose an enhancer of number of TCR clones, comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient. See p. 3 under administration of Lactobacillus casei strain Shirota (LcS YIT9029).
Claim 6: The limitation “wherein the live lactic acid bacteria are ingested 2.0 x 10 to the power of 10 or more per day” is drawn to the intended use of the enhancer, comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient. Arase et al disclose that the LcS fermented milk comprises greater than 5 billion CFU/mL and mice were given 2 mL of the composition. See p. 3 under administration of Lactobacillus casei strain Shirota (LcS YIT9029).
Claim 7: Arase et al disclose a food product (fermented milk) comprising Lacticaseibacillus paracasei YIT 9029 as active ingredient. The limitation “for enhancing number of TCR clones” is drawn to an intended use of the enhancer, comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient. See p. 3 under administration of Lactobacillus casei strain Shirota (LcS YIT9029).
Claim 8: The limitation “wherein the virus is an influenza virus or a novel coronavirus (COVID-19)” is drawn to vaccinating with the virus. However, the claims are drawn to a composition of matter comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as active ingredient. Arase et al disclose that the lactic acid bacteria are classified into Lacticaseibacillus paracasei.
Claim 9: The limitation “wherein the virus is an influenza virus or a novel coronavirus (COVID-19)” is drawn to vaccinating with the virus. Arase et al disclose the lactic acid bacteria are Lacticaseibacillus paracasei YIT 9029.
Claim 10: The limitation “wherein the virus is an influenza virus or a novel coronavirus (COVID-19) is drawn to vaccinating with virus, and “wherein the enhancer enhances the number of TCR clones carrying any one or more of TRBV6-2, TRBV9, TRBV10-3, or TRBV12-4 in addition to the TRBV19” is drawn to an intended use of the enhancer, comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
Claim 11: The limitation “wherein the virus is an influenza virus or a novel coronavirus (COVID-19) is drawn to vaccinating with virus, and wherein the live lactic acid bacteria are ingested 2.0 x 10 to the power of 10 or more per day” is drawn to an intended use of the live lactic acid bacteria.
Claim 12: Arase et al disclose the lactic acid bacteria are classified into Lacticaseibacillus paracasei. The limitation “wherein the enhancer enhances the number of TCR clones carrying any one or more of TRBV6-2, TRBV9, TRBV10-3, or TRBV12-4 in addition to the TRBV19” is drawn to an intended use. Arase et al disclose the lactic acid bacteria are Lacticaseibacillus paracasei YIT 9029.
Claim 13: Arase et al disclose the lactic acid bacteria are classified into Lacticaseibacillus paracasei. The limitation “wherein the live lactic acid bacteria are ingested 2.0 x 10 to the power of 10 or more per day” is drawn an in intended use.
Claims 14: Arase et al disclose the lactic acid bacteria are Lacticaseibacillus paracasei YIT 9029. The limitation “wherein the enhancer enhances the number of TCR clones carrying any one or more of TRBV6-2, TRBV9, TRBV10-3, or TRBV12-4 in addition to the TRBV19” is an intended use.
Claim 15: Arase et al disclose the lactic acid bacteria are Lacticaseibacillus paracasei YIT 9029. The limitation “wherein the live lactic acid bacteria are ingested 2.0 x 10 to the power of 10 or more per day” is an intended use.
Claim 16: The limitation “wherein the enhancer enhances the number of TCR clones carrying any one or more of TRBV6-2, TRBV9, TRBV10- 3, or TRBV12-4 in addition to the TRBV19, and wherein the live lactic acid bacteria are ingested 2.0 x 10 to the power of 10 or more per day” is drawn to an intended use.
Claim 17: The limitation “wherein the virus is an influenza virus or a novel coronavirus (COVID-19)” is drawn to vaccinating with a virus. Wherein the lactic acid bacteria are Lacticaseibacillus paracasei YIT 9029, and wherein the enhancer enhances the number of TCR clones carrying any one or more of TRBV6-2, TRBV9, TRBV10-3, or TRBV12-4 in addition to the TRBV19” is drawn to an intended use.
Claim 18: The limitation “wherein the virus is an influenza virus or a novel coronavirus (COVID-19)” is drawn to vaccinating with a virus. Wherein the lactic acid bacteria are Lacticaseibacillus paracasei YIT 9029, and wherein the live lactic acid bacteria are ingested 2.0 x 10 to the power of 10 or more per day” is drawn to an intended use.
Claim 19: Arase et al disclose the food product (fermented milk) the lactic acid bacteria are Lacticaseibacillus paracasei YIT 9029. The limitation “for enhancing number of TCR clones according to claim 7, wherein the virus is an influenza virus or a novel coronavirus (COVID-19)” is drawn to vaccinating with virus as recited in claim 1.
Response to Applicants Argument
Applicants states that Arase discusses whether a disturbance in the mucosa-associated commensal bacteria is associated with the exacerbation of chronic colitis by repeated psychological stress, and whether this can be a target of probiotics and that in the abstract, Arase discloses that oral administration of a probiotic Lactobacillus strain was protective against the exacerbation of colitis and that on page 3, Arase discloses administration of Lactobacillus casei strain Shirota (LcS, also known as YIT9029).
Applicant respectfully traverses the rejection. Applicant argues that even if Arase generally discloses administration of Lactobacillus casei strain Shirota (YIT9029) in connection with modulation of inflammatory responses associated with colitis, Arase is silent as to the immunological characteristics of the claimed enhancer.
Applicant argues that the present disclosure evaluates enhancement of TCR clone populations, especially TCR clones carrying TRBV19, following vaccination and that such TCR clone analysis reflects antigen-recognition diversity and clonal expansion at the TCR sequence level.
Applicant argues in contrast, Arase evaluates inflammatory responses in a colitis model, including IFNy gene expression and CD4+ TCRβdim cell populations and that the analysis in Arase is directed to inflammatory pathology and immune regulation associated with colitis, rather than analysis of TCR repertoire diversity or TCR clonal expansion and that Arase reports no statistically significant change in CD4+ TCRβdim cell populations, and does not disclose any TCR sequence-level repertoire or clonotype analysis.
Applicant also notes that Arase does not disclose or suggest (i) enhancement of TCR clone populations carrying TRBV19; (ii) selective enhancement of TRBV19-associated TCR clones; (iii) analysis of TCR sequence diversity or clonal repertoire expansion; or (iv) enhancement of TCR clone populations following vaccination and Arase does not disclose any TCR sequence-level repertoire analysis or TCR clonotype analysis.
Applicant also argues that the technical meaning of "TCR" in Arase differs substantially from that in the present application and that in Arase, TCR-related terminology is used primarily as a phenotypic marker associated with inflammatory T-cell populations and that in contrast, the present application evaluates TCR clone diversity and antigen-recognition diversity based on TCR clonal sequence information and that even though both references refer to "TCR," the underlying technical concepts and evaluation parameters are fundamentally different.
Applicant also submits that a skilled artisan would not have predicted the enhancement of TRBV19-associated TCR clonal expansion as described in the present application based on the changes in IFNy expression or inflammatory cell populations described in Arase.
Applicants argument has been carefully considered but is not found persuasive.
The claims are drawn to an enhancer of number of TCR clones, comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient, wherein after vaccination with CD4 positive T cells carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced.
The claims are drawn to composition of matter. The composition of matter comprises live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
The limitation drawn to “wherein after vaccination with CD4 positive T cells carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” is drawn to vaccinating with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells.
However, the claimed composition comprises live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient. Since Arase et al discloses live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient, the live lactic acid bacteria is necessary also an enhancer of number of TCR clones claims as recited in the preamble in the claims. The properties of the live lactic acid bacteria belonging to the genus Lacticaseibacillus as an enhancer of TCR clones is inseparable.
A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
Applicants argument that the present disclosure evaluates enhancement of TCR clone populations, especially TCR clones carrying TRBV19, following vaccination and that such TCR clone analysis reflects antigen-recognition diversity and clonal expansion at the TCR sequence level is not persuasive because the claims are drawn to a process that evaluates enhancement of TCR clone populations, especially TCR clones carrying TRBV19, following vaccination and that such TCR clone analysis reflects antigen-recognition diversity and clonal expansion at the TCR sequence level.
Applicants argument that that Arase does not disclose or suggest (i) enhancement of TCR clone populations carrying TRBV19; (ii) selective enhancement of TRBV19-associated TCR clones; (iii) analysis of TCR sequence diversity or clonal repertoire expansion; or (iv) enhancement of TCR clone populations following vaccination and Arase does not disclose any TCR sequence-level repertoire analysis or TCR clonotype analysis is not persuasive because the composition of matter being claimed is live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
The recitation of “wherein after vaccination with CD4 positive T cells carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” is drawn to a process comprising vaccination with CD4 positive T cells carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells.
The claims are not drawn to a process of vaccination with CD4 positive T cells carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells but is drawn to a composition of matter comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
Furthermore, whether or not the technical meaning of "TCR" in Arase differs substantially from that in the present application does not take away from the fact that the claims are drawn to a composition of matter not a process of vaccination with CD4 positive T cells carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells.
For these reasons, the rejection is maintained.
Double Patenting Maintained
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 7754255 (‘255). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘255 claims disclose a fermented soy milk comprising live Lactobacillus casei YIT9029.
The limitation “wherein after vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” is drawn to vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells. However, the claim is a drawn to a composition of matter comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
Response to Applicants Argument
Applicant argues that the pending claims are patentably distinct from the claims of the ‘255 patent for similar reasons as discussed with respect to Arase et al and the claims of the ‘255 patent are silent as to the immunological characteristics of the claimed enhancer.
Applicants argument are carefully considered but are maintained for the same reasons for Arase et al as set forth above.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8778332 (‘332). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘332 claims disclose a food product comprising live Lactobacillus casei YIT9029.
The limitation “wherein after vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” is drawn to vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells. However, the claim is a drawn to a composition of matter comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
Response to Applicants Argument
Applicant argues that the pending claims are patentably distinct from the claims of the ‘332 patent for similar reasons as discussed with respect to Arase et al and the claims of the ‘332 patent are silent as to the immunological characteristics of the claimed enhancer.
Applicants argument are carefully considered but are maintained for the same reasons for Arase et al as set forth above.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11331353 (‘353). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘353 claims disclose a fermented milk comprising live Lactobacillus casei YIT 9029.
The limitation “wherein after vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” is drawn to vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells. However, the claim is a drawn to a composition of matter comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
Response to Applicants Argument
Applicant argues that the pending claims are patentably distinct from the claims of the ‘353 patent for similar reasons as discussed with respect to Arase et al and the claims of the ‘353 patent are silent as to the immunological characteristics of the claimed enhancer.
Applicants argument are carefully considered but are maintained for the same reasons for Arase et al as set forth above.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11457641 (‘641). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘641 claims disclose a fermented milk food comprising live Lactobacillus casei YIT 9029.
The limitation “wherein after vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” is drawn to vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells. However, the claim is a drawn to a composition of matter comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
Response to Applicants Argument
Applicant argues that the pending claims are patentably distinct from the claims of the ‘641 patent for similar reasons as discussed with respect to Arase et al and the claims of the ‘641 patent are silent as to the immunological characteristics of the claimed enhancer.
Applicants argument are carefully considered but are maintained for the same reasons for Arase et al as set forth above.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 of U.S. Patent No. 10844347 (‘347). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘347 claims disclose a food product comprising live Lactobacillus casei YIT9029.
The limitation “wherein after vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” is drawn to vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells. However, the claim is a drawn to composition of matter comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
Response to Applicants Argument
Applicant argues that the pending claims are patentably distinct from the claims of the ‘347 patent for similar reasons as discussed with respect to Arase et al and the claims of the ‘347 patent are silent as to the immunological characteristics of the claimed enhancer.
Applicants argument are carefully considered but are maintained for the same reasons for Arase et al as set forth above.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12186350 (‘350). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘350 claims disclose a food comprising live Lactobacillus casei YIT 9029.
The limitation “wherein after vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” is drawn to vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells. However, the claim is a drawn to a composition of matter comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
Response to Applicants Argument
Applicant argues that the pending claims are patentably distinct from the claims of the ‘350 patent for similar reasons as discussed with respect to Arase et al and the claims of the ‘350 patent are silent as to the immunological characteristics of the claimed enhancer.
Applicants argument are carefully considered but are maintained for the same reasons for Arase et al as set forth above.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12188006 (‘006). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘006 claims disclose a food comprising live Lactobacillus casei YIT 9029.
The limitation “wherein after vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” is drawn to vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells. However, the claim is a composition of matter comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
Response to Applicants Argument
Applicant argues that the pending claims are patentably distinct from the claims of the ‘006 patent for similar reasons as discussed with respect to Arase et al and the claims of the ‘006 patent are silent as to the immunological characteristics of the claimed enhancer.
Applicants argument are carefully considered but are maintained for the same reasons for Arase et al as set forth above.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-15 and 19-22 of copending Application No. 17/431,249 (‘249). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘249 claims disclose a composition comprising live Lacticaseibacillus such as Lactobacillus casei YIT 9029.
The limitation “wherein after vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” is drawn to vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells. However, the claim is drawn to a composition of matter comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicants Argument
Applicant argues that the pending claims are patentably distinct from the claims of the ‘249 application for similar reasons as discussed with respect to Arase et al and the claims of the ‘249 application are silent as to the immunological characteristics of the claimed enhancer.
Applicants argument are carefully considered but are maintained for the same reasons for Arase et al as set forth above.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 4, 5, 11, 12 and 13 of copending Application No. 18/849,788 (‘788). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘788 claims disclose a fermented food composition comprising live Lacticaseibacillus such as Lactobacillus casei YIT 9029.
The limitation “wherein after vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” is drawn to vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells. However, the claim is drawn to a composition of matter comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicants Argument
Applicant argues that the pending claims are patentably distinct from the claims of the ‘788 application for similar reasons as discussed with respect to Arase et al and the claims of the ‘788 application are silent as to the immunological characteristics of the claimed enhancer.
Applicants argument are carefully considered but are maintained for the same reasons for Arase et al as set forth above.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 19/104,469 (‘469). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘469 claims disclose a fermented food composition comprising live Lacticaseibacillus such as Lactobacillus casei YIT 9029.
The limitation “wherein after vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” is drawn to vaccination with CD4 carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells. However, the claim is drawn to a composition of matter comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicants Argument
Applicant argues that the pending claims are patentably distinct from the claims of the ‘469 application for similar reasons as discussed with respect to Arase et al and the claims of the ‘469 application are silent as to the immunological characteristics of the claimed enhancer.
Applicants argument are carefully considered but are maintained for the same reasons for Arase et al as set forth above.
New Claim Rejections
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 1-19 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.
The claims are drawn to an enhancer of number of TCR clones, comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient, wherein after vaccination with CD4 positive T cells carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced.
The metes and bounds of the claims are confusing because it is not clear as claimed how the limitation “wherein after vaccination with CD4 positive T cells carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced” relates to the enhancer of number of TCR clones, comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient.
The claims are drawn to the statutory category of a composition of matter under 35 USC 101. However, if Applicant is intending to recite the intended use of the composition comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient, it is not clear how the lactic acid bacteria enhances the number of TCR clones because the claim does not recite that the lactic acid bacteria is administered to a subject or even to a subject that was vaccinated. For example, is the live lactic acid bacteria administered to a subject before or after or with vaccination of the same subject with CD4 positive T cells carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells?
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon/product of nature without significantly more.
The claims are drawn to an enhancer of number of TCR clones, comprising live lactic acid bacteria belonging to the genus Lacticaseibacillus as an active ingredient, wherein after vaccination with CD4 positive T cells carrying TRBV19 or a virus carrying an epitope recognized by CD8 positive T cells, the number of TCR clones carrying TRBV19 is enhanced.
The claims (claim 3-4, 8-9, 12-15, 17 and 18) state that the lactic acid bacteria are classified into Lacticaseibacillus paracasei or are Lacticaseibacillus paracasei YIT 9029.
Patent Subject Matter Eligibility Analysis (MPEP 2106).
STEP 1: The claims are drawn to a composition of matter. The composition of matter is the live lactic acid bacteria belonging to the genus Lacticaseibacillus.
STEP 2A PRONG ONE – THE CLAIM RECITES A JUDICIAL EXCEPTION -SEE MPEP 2106.4
The live lactic acid bacteria belonging to the genus Lacticaseibacillus, Lacticaseibacillus paracasei and Lacticaseibacillus paracasei YIT 9029 are products of nature because these bacteria naturally exist.
See In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1335-1336 (Fed. Cir. 2014) (“Natural phenomena, including naturally occurring organisms, are not patentable.”). Further, the Supreme Court precedent teaches that neither isolating natural products nor combining them together represents an act of invention that would transform these naturally occurring products into patent eligible subject matter unless their combination results in something "markedly different”. See Ass 'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107, 2117 (2013).
The recitation of “enhancer of number of TCR clones” is drawn to an inherent characteristic of the product of nature. In Marden, where the court held a claim to ductile vanadium ineligible, because the "ductility or malleability of vanadium is . . . one of its inherent characteristics and not a characteristic given to it by virtue of a new combination with other materials or which characteristic is brought about by some chemical reaction or agency which changes its inherent characteristics". In re Marden, 47 F.2d 958, 959, 18 CCPA 1057, 1060, 8 USPQ 347, 349 (CCPA 1931).
The claimed lactic acid bacteria do not show a marked difference as compared to its natural counterpart.
The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75.
Thus, in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the natural counterpart. Such characteristics that can result in a markedly different characteristic from the natural occurring counterpart include genetic modification. In Chakrabarty, the Supreme Court identified a claimed bacterium as a nature-based product having markedly different characteristics. This bacterium had a changed functional characteristic, i.e., it was able to degrade at least two different hydrocarbons as compared to naturally occurring Pseudomonas bacteria that can only degrade a single hydrocarbon. The claimed bacterium also had a different structural characteristics, i.e., it was genetically modified to include more plasmids than are found in a single naturally occurring Pseudomonas bacterium. The Supreme Court considered these changed characteristics to be "markedly different characteristics from any found in nature" due to the additional plasmids and resultant capacity for degrading multiple hydrocarbon components of oil. Diamond v. Chakrabarty, 447 U.S. 303, 310, 206 USPQ 193, 197 (1980).
If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by the inventor’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception. MPEP 2106 (c).
Regarding a food product comprising the lactic acid bacteria (claim 7 and claim 19) , there is no evidence that combining the lactic acid bacteria with a food results in markedly different characteristic of the bacteria. Food is recited as a high level of generality. Since there is no natural counterpart of a combination of food and the lactic acid bacteria. Each of the components in the food is compared to their respective natural counterpart. As set forth above, the bacteria is a product of nature. An example of a food is milk or vegetables.
There is no evidence that combining the lactic acid bacteria and the naturally occurring food results in a markedly different characteristic of the lactic acid bacteria and/or the food. Each nature based product continues to function as it were in the mixture or combination without a difference in function or chemical properties.
In addition, the number or amount of patent ineligible products in the composition (claim 6, 11, 13, 15, 16, and 18) does not lend markedly different characteristics from the naturally occurring counterpart.
STEP 2A PRONG TWO – THE CLAIM DOES NOT RECITE ADDITIONAL ELEMENTS THAT INTEGRATE THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION. SEE MPEP 2106.4
The claims do not recite additional elements that integrate the judicial exception into a practical application such a particular treatment or prophylaxis for a disease or medical condition i.e. affirmatively reciting an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of said action is a step of administering the composition to a subject or object and not merely an intended use of the composition. See MPEP 2106.04(d)(2).
STEP 2B – THE CLAIMS DO NOT AMOUNT TO SIGNIFICANTLY MORE. SEE MPEP 2106.05.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
In conclusion, the claims do not qualify as eligible subject matter under 35 USC 101.
Status of Claims
Claims 1-19 are rejected.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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