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 .
Claims 1-3, 5-16 are pending and have been considered on the merits herein.
NOTE- applicants specification (p. 6, 3rd parag.) discloses that Lacticaseibacillus paracasei DG I-1572 DSM 34154 is present in a currently registered dietary supplement as Enterolactis® Plus and is also currently known by the registered trademark L. casei DG (CNCM I-1572) or L. paracasei DG (CNCM I-1572). It should be noted that the strain of bacteria L. casei DG® (CNCM I-1572) or L. paracasei DG® (CNCM I-1572) was redeposited on February 2, 2022 as Lacticaseibacillus paracasei DG I-1572 DSM 34154 following the reclassification of the genus Lactobacillus published by Zheng et al. in the scientific journal Int. J. Syst. Evol. Microbiol., 70(4):2782-2858, 2020. The above two designations are interchangeable with each other because they always refer to the same strain of bacteria.
Specification
The use of the term Enterolactis® Plus, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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, 2, 3 and 5, 16 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 2 and 3, it is not clear if applicants are claiming that the subject have elevated levels of each of the strains. The claims lack an “and” or “or” between Ruminococcus spp. and Blautia spp. to clearly define applicants invention.
For the purposes of applying prior art, claims 2 and 3 are given their broadest reasonable interpretation in light of the specification as it would be interpreted by one of ordinary skill in the art, which is that the claims read on elevated levels of one of the strains claimed. Thus, a prior art reference teaching elevated levels of at least one the claimed strains anticipates the claims.
Regarding claim 5, 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).
Claims 5 and 16 contain the trademark/trade name Enterolactis® Plus. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a supplement and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2-3, 5-16 is/are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Biffi et al. (WO2017212433 A1, IDS).
Biffi teaches a method of treating dysbiosis of intestinal microbiota in subjects with IBS comprising administering a pharmaceutically effective amount of Lacticaseibacillus paracasei DG I-1572 DSM34154 to the subjects (p. 5, lines 28-p. 6, lines 1-2). The subjects include those which are classified as non-constipated, i.e. IBS-D and IBS-M, for example (p. 8, Table II). The reference teaches that administration increases bacterial populations in the intestinal microbiota (Lactobacillus) and significantly decreases Ruminococcus, a pathobiont normally associated with IBS (p. 2, lines 9-24, Fig 2, p. 3, lines 9-31, p. 11, lines 4-10, 15, 16).
Regarding claims 2 and 3, WO433 teaches that the subjects have elevated levels of Ruminococcus in stools (p. 2, lines 19-21, Fig. 2, p. 3, lines 24-31, p. 7, lines 11-16, p. 9, lines 27-p. 10, lines 1-4, p. 11, lines 4-10, 15, 16).
Regarding claims 5, 16, the bacteria is administered orally as Enterolactis® Plus capsules (p. 6, lines 8-11, for example, p.7, lines 20-21, Table 1, p. 8, lines 7-8, p. 9, lines 2-6).
Regarding claims 6 and 9, the supplement is administered twice a day for a period of 4 weeks (p. 8, lines 7-14).
Regarding claims 8 and 14, given that the product administered is Enterolactis® Plus, the bacteria are taken to be in a solid powder, dry or lyophilized form.
Regarding claims 7, 12, 13, 15, the composition comprises 1x109 to 1x1011 viable cells per intake specifically at least 24 billion (p. 9,lines 1-4), wherein intake is at least 1-2 times per day (p. 6, lines 3-7).
Regarding claim 10, the subjects suffer from abdominal symptoms of IBS (p.2, lines 9-15, p. 9, lines 14-19, p. 10, lines 15-17, p. 11, lines 11-14).
Thus, the reference anticipates the claimed subject matter.
Claim(s) 1, 2-3, 5-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cremon et al. (Un. Euro. Gastro. J, 2018, IDS).
Cremon teaches a method of treating dysbiosis of intestinal microbiota in subjects with IBS comprising administering a pharmaceutically effective amount of Lacticaseibacillus paracasei DG I-1572 DSM34154 (LCDG) to the subjects (p. 605, Study design section). The subjects include those which are classified as non-constipated, i.e. IBS-D and IBS-M, for example (p. 608, Table 1). The reference teaches that administration increases bacterial populations in the intestinal microbiota (Lactobacillus, Parabacteroides and Oscillospira) and significantly decreases the elevated levels (including fecal levels) of Ruminococcus spp. (R. bromii and Ruminococcus spp.) (p. 606, Study assessment section, p. 607, analysis of bacterial composition of fecal samples, p. 609, Effect of treatment on the gut microbiota, p. 610, whole page and Table 2, 4).
Regarding claims 2-3, Cremon teaches that the subjects have elevated levels of Ruminococcus (including fecal levels) (R. bromii and Ruminococcus spp. )(p. 606, Study assessment section, p. 607, analysis of bacterial comp. of fecal samples, p. 609, Effect of treatment on the gut microbiota, p. 610, whole page, and Tables 2 and 4).
Regarding claims 5, 16, the bacteria is administered orally as Enterolactis® Plus capsules (p. 605, Study design section).
Regarding claims 6 and 9, the supplement is administered twice a day for a period of 4 weeks (p. 605, Study design section).
Regarding claims 8 and 14, given that the product administered is the Enterolactis® Plus, the bacteria are taken to be in a solid powder, dry or lyophilized form.
Regarding claims 7, 12, 13, 15, the composition comprises 24 billion viable cells and were administered twice daily (p. 605, Study design section).
Regarding claim 10, the subjects suffer from abdominal symptoms of IBS, i.e. abdominal pain and discomfort (p. 606, Patients and Study assessment section, p. 607 Effects of treatment section abdom. pain).
Regarding claim 11, the supplement was administered twice daily for a period of 8-12 weeks (p. 605-606, Study design section, Fig. 1).
Thus, the reference anticipates the claimed subject matter.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4, 5 of U.S. Patent No. 12447183. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed inventions are drawn to a method of administering to a subject having IBS, the bacteria L. casei DG I-1572. It is noted that the preamble of the instant claims is drawn to treating dysbiosis; however, the methods of the instant and reference claims are drawn to a single administration step to the same patient population, i.e. one having IBS. The subjects of the instant claims are classified as non-constipated IBS subjects however the species of IBS-D would anticipate the genus of a subject.
Claims 1, 5, 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 14, 15, 18-20 of copending Application No. 18280926 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed inventions are drawn to a method of administering to a subject having IBS, particularly IBS-D, the bacteria L. casei DG I-1572. It is noted that the preamble of the instant claims is drawn to treating dysbiosis; however, the methods of the instant and reference claims are drawn to a single administration step to the same patient population, therefore, one would necessarily be treating dysbiosis, in IBS of the subjects in ‘926.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5, 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4-7 of copending Application No. 18579158 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed inventions are drawn to a method of administering to a subject having IBS, particularly IBS-D, the bacteria L. casei DG I-1572. It is noted that the preamble of the instant claims is drawn to treating dysbiosis; however, the methods of the instant and reference claims are drawn to a single administration step to the same patient population, therefore, one would necessarily be treating dysbiosis, in IBS of the subjects in ‘158.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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/TIFFANY M GOUGH/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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