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 .
Applicants preliminary amendment filed November 16, 2023 has been received and entered. New claim 14 has been added. Accordingly, claims 1-14 are pending in the instant application.
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.
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.
1. Claims 1-14 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 specification lacks complete deposit information for the deposit of CGMCC 15139 and DSM 27447, it is not clear that host cells possessing the identical properties of CGMCC 15139 and DSM 27447 are known and publicly available or can be reproducibly isolated from nature without undue experimentation.
Exact replication of a host cell is an unpredictable event. Although applicant has provided a written description of a method for selecting the claimed cell, this method will not necessarily reproduce host cells which are chemically and structurally identical to those claimed. Undue experimentation would be required to screen all of the possible species to obtain the claimed host cells.
Because one skilled in the art could not be assured of the ability to practice the invention as claimed in the absence of the availability of the CGMCC 15139 and DSM 27447 host cells a suitable deposit for patent purposes, evidence of public availability of the CGMCC 15139 and DSM 27447 host cells or evidence of the reproducibility without undue experimentation is required.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of deposit and the complete name and full street address of the depository is required. As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1) The name and address of the depository;
2) The name and address of the depositor;
3) The date of deposit;
4) The identity of the deposit and the accession number given by the depository;
5) The date of the viability test;
6) The procedures used to obtain a sample if the test is not done by the depository; and
7) A statement that the deposit is capable of reproduction.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
2. Claims 13-14 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.
Regarding claims 13-14, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Simply stated, limitations are either required or not, there are no preferable limitations in a claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
3. Claim(s) 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao et al.
The claims are drawn to a method for improving intestinal immunity using a composition, wherein the composition comprises a Lactobacillus paracasei subsp. paracasei strain, wherein the Lactobacillus paracasei subsp. paracasei strain has a deposit number of CGMCC 15139 or DSM 27447.
Zhao et al (CN 110892914) disclose of the use of Lactobacillus paracasei subsp. paracasei strain, wherein the Lactobacillus paracasei subsp. paracasei strain has a deposit number of CGMCC 15139 or DSM 27447. (See claim 1). Zhao et al further disclose of administering the strain DSM 27447 to increase the activity of Th1 cells. (See claim 5). Zhao et al further disclose of administering the composition in the amount of 3.88 x 106 CFU. (See claims 4-5).
Accordingly, Zhao et al disclose of each and every limitation of the instantly filed claims.
4. Claim(s) 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsai et al.
The claims are drawn to a method for improving intestinal immunity using a composition, wherein the composition comprises a Lactobacillus paracasei subsp. paracasei strain, wherein the Lactobacillus paracasei subsp. paracasei strain has a deposit number of CGMCC 15139 or DSM 27447.
Tsai et al (CN 107916236) disclose of the use of Lactobacillus paracasei subsp. paracasei strain, wherein the Lactobacillus paracasei subsp. paracasei strain has a deposit number of DSM 27447. (See claim 1). Tsai et al further disclose of administering the strain DSM 27447 to modulate an immune response. (See claim 7). Tsai et al further disclose of administering the composition in the amount of 1010 CFU. (See Example 7).
Accordingly, Tsai et al disclose of each and every limitation of the instantly filed claims.
5. Claim(s) 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al.
The claims are drawn to a method for improving intestinal immunity using a composition, wherein the composition comprises a Lactobacillus paracasei subsp. paracasei strain, wherein the Lactobacillus paracasei subsp. paracasei strain has a deposit number of CGMCC 15139 or DSM 27447.
Liu et al (CN 110882280) disclose of the use of Lactobacillus paracasei subsp. paracasei strain, wherein the Lactobacillus paracasei subsp. paracasei strain has a deposit number of CGMCC 15139 or DSM 27447. (See claim 1). Liu et al further disclose of administering the strain DSM 27447 to increase intestinal propulsion rate. (See claim 4). Liu et al further disclose of administering the composition in the amount of 103 to 1010 CFU. (See claims 5-6).
Accordingly, Liu et al disclose of each and every limitation of the instantly filed claims.
6. Claim(s) 1-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Liu et al.
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The claims are drawn to a method for improving intestinal immunity using a composition, wherein the composition comprises a Lactobacillus paracasei subsp. paracasei strain, wherein the Lactobacillus paracasei subsp. paracasei strain has a deposit number of CGMCC 15139 or DSM 27447.
Liu et al (US Publication 2023/0000932; filed November 19, 2020, with priority to November 20, 2019) disclose of the use of Lactobacillus paracasei subsp. paracasei strain, wherein the Lactobacillus paracasei subsp. paracasei strain has a deposit number of CGMCC 15139 or DSM 27447. (See claim 1). Liu et al further disclose of administering the strain DSM 27447 to promote anti-inflammatory responses. (See claim 6). Liu et al further disclose of administering the composition in the amount of 106 to 109 CFU. (See claim 7).
Accordingly, Liu et al disclose of each and every limitation of the instantly filed claims.
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.
7. Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8-9, 12 and 15 of copending Application No. 17/778,609 (reference application)(allowed not yet issued). Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly filed claims drawn to methods for improving intestinal immunity using a composition, wherein the composition comprises a Lactobacillus paracasei subsp. paracasei strain, wherein the Lactobacillus paracasei subsp. paracasei strain has a deposit number of CGMCC 15139 or DSM 27447 are anticipated by the claims of ‘609 drawn to a method of preventing bloody stools using a composition, wherein the composition comprises a Lactobacillus paracasei subsp. paracasei strain, wherein the Lactobacillus paracasei subsp. paracasei strain has a deposit number of DSM 27447.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark NAVARRO whose telephone number is (571)272-0861.
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/ALBERT M NAVARRO/Primary Examiner, Art Unit 1645 November 14, 2025