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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 30 – 43 in the reply filed on July 1, 2026 is acknowledged.
Claims 1, 3 – 4, 30 – 46 are pending; claims 1, 3 – 4 and 44 – 46 are withdrawn; claims 30 – 43 have been considered on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 7, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 31 is objected to because of the following informalities:
In line 2, “species” should not be italicized.
Appropriate correction is required.
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.
Claim 37 is 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.
Claim 37 is drawn to a method of modulating an allergic immune response, however is rendered indefinite because the various recited diseases/conditions are not all types of allergic rhinitis. It is unclear if the alleviated symptoms are required to be in addition to allergic rhinitis or in lieu of allergic rhinitis. Clarification is required. For purposes of examination, the recited conditions are interpreted as distinct allergic diseases that are not required to coexist with allergic rhinitis, in other words wherein the claim depends on claim 35 rather than 36.
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.
Claims 30 – 35, 37 – 41 and 43 are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Vedel et al. (WO 2020/127637 and US 2022/0015998, both cited by US 2022/0015998) as evidenced by “Lactobacillus paracasei Lpc-37 bibliography” and “Wikipedia, Lacticaseibacillus paracasei”.
Regarding claims 30 – 31, Vedel teaches methods of administering a composition comprising effective amounts of Lactobacillus acidophilus and Lactobacillus paracasei (or Lacticaseibacillus paracasei, Lactobacilllus casei, sub. casei; see Lactobacillus paracasei Lpc-37 bibliography; Wikipedia, Lacticaseibacillus paracasei) to subjects exhibiting allergic immune responses, or a subject in need thereof (0009, 0109, 0126, 0132, 0142-0144, claim 13). Although the reference does not state the method modulates the allergic immune response, the method steps are the same in that the claimed compositions are administered for the same purpose to the same treating population. As such, when practicing the methods of Vedel, one is inherently practicing the claimed method.
Regarding claims 32 – 33, L. acidophilus La-14 and L. paracasei Lpc-37 are preferred strains (0142 – 0144).
Regarding claim 34, the compositions comprise at least 1x106 CFU probiotic strains (0031).
Regarding claims 35 and 37, symptoms of allergic diseases such as allergic skin, eczema and rashes (contact dermatitis) are alleviated (0109, 0114, claims 12 – 13).
Regarding claims 38 – 41, the reference does not teach the claimed effects on production of Th2, Th17, IL-5, IL13, IL17 or IL22). However, the method administers the same bacteria for the same conditions to the same treating population as claimed by applicant. Thus, the method of the prior art must also result in the effects claimed by applicant. Notwithstanding, the reference teaches the compositions are anti-inflammatory, indicating the claimed effects on at least IL-5, IL-17, per applicant’s specification, page 1.
Regarding claim 43, the compositions may be in the form of a cream (0095).
Therefore, the reference anticipates the claimed subject matter.
Claims 30 – 31 and 34 – 42 are rejected under 35 U.S.C. 102a1 as being anticipated by Steiner et al. (2021) as evidenced by “Lactobacillus paracasei Lpc-37 bibliography” and “Wikipedia, Lacticaseibacillus paracasei”.
Regarding claims 30 – 31, Steiner teaches multiple studies of administering Lactobacillus paracasei (or Lacticaseibacillus paracasei, Lactobacilllus casei, sub. casei; see Lactobacillus paracasei Lpc-37 bibliography; Wikipedia, Lacticaseibacillus paracasei) and Lactobacillus acidophilus to patients with allergic rhinitis (a subject in need of modulation of allergic immune response) alleviates symptoms thereof, indicating the allergic immune response has been modulated (p.809, Table 2).
Regarding claim 34, various amounts of bacteria are reported administered, including 108 – 3 x 1010, all of which are at least 1 x 106 CFUs (Table 2).
Regarding claims 35 – 37, symptoms of allergic rhinitis and allergic asthma are alleviated (p.809, Table 2).
Regarding claims 38 – 41, the reference does not teach each of the claimed effects on production of Th2, Th17, IL-5, IL13, IL17 or IL22). However, the reference teaches administration of the same bacteria for the same conditions to the same treating population as claimed by applicant. Thus, the methods of the prior art must also result in the effects claimed by applicant. Notwithstanding, the reference teaches the compositions decrease IL-5, IL-13 (Table 1).
Regarding claim 42, the administered compositions include milk products (food products) and capsules (pharmaceutical compositions) (Table 2).
Therefore, the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 30 – 42 are rejected under 35 U.S.C. 103 as being unpatentable over Steiner et al. (2021) as evidenced by “Lactobacillus paracasei Lpc-37 bibliography” and “Wikipedia, Lacticaseibacillus paracasei”; in view of Vedel et al. (WO 2020/127637 OR US 2022/0015998, both cited by US 2022/0015998) OR Amazon Products (2016).
Regarding claims 30 – 31, Steiner teaches multiple studies of administering Lactobacillus paracasei (or Lacticaseibacillus paracasei, Lactobacilllus casei, sub. casei; see Lactobacillus paracasei Lpc-37 bibliography; Wikipedia, Lacticaseibacillus paracasei) and Lactobacillus acidophilus to patients with allergic rhinitis (a subject in need of modulation of allergic immune response) alleviates symptoms thereof, indicating the allergic immune response has been modulated (p.809, Table 2).
Regarding claims 32 – 33, Steiner does not teach the methods wherein the claimed strains are administered. However, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to use known strains in the art, particularly those known to be therapeutically active and safe for administration. In this regard, the claims strains were well known and used strains for therapeutic purposes. In support, Vedel teaches methods of administering L. acidophilus La-14 and L. paracasei Lpc-37 to subjects with allergic immune responses (0009, 0109, 0126, 0132, 0142-0144, claim 13), indicating the commercially available strains were well known and used in the art for therapeutic purposes; while oral combinations of the instant strains were known and used in the art (Amazon products) indicating the instant strains were known to be safe for oral consumption. Thus, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to use the well known and used strains, La-14 and/or Lpc-37, in the methods of Steiner with a reasonable expectation for successfully treating allergic rhinitis and asthma.
Regarding claim 34, various amounts of bacteria are reported administered, including 108 – 3 x 1010, all of which are at least 1 x 106 CFUs (Table 2).
Regarding claims 35 – 37, symptoms of allergic rhinitis and allergic asthma are alleviated (p.809, Table 2).
Regarding claims 38 – 41, the reference does not teach each of the claimed effects on production of Th2, Th17, IL-5, IL13, IL17 or IL22). However, the reference teaches administration of the same bacteria for the same conditions to the same treating population as claimed by applicant. Thus, the methods of the prior art must also result in the effects claimed by applicant. Notwithstanding, the reference teaches the compositions decrease IL-5, IL-13 (Table 1).
Regarding claim 42, the administered compositions include milk products (food products) and capsules (pharmaceutical compositions) (Table 2).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
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 30, 33, 35, 37 – 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims:
1 – 2, 6 – 7 of U.S. Patent No. 11318174; and 1 – 2 of U. S. Patent No. 11883446.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims each administer the same bacteria strain to the same treating population, e.g., a subject with asthma. Regarding claims 38 – 41, the patent does not claim each of the claimed effects on production of Th2, Th17, IL-5, IL13, IL17 or IL22). However, it claims administering the same bacterial strain for the same conditions to the same treating population as claimed by applicant. Thus, the methods of the patent must also result in the effects claimed by applicant.
Claims 30 - 33, 38 – 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 15, 29, 34 of copending Application No. 18/580 713 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims at issue are not identical, they are not patentably distinct from each other because the claims each administer the same bacteria strain to the same treating population. Regarding claims 38 – 41, the copending application does not claim each of the claimed effects on production of Th2, Th17, IL-5, IL13, IL17 or IL22). However, it claims administering the same bacterial strain for the same conditions to the same treating population as claimed by applicant. Thus, the methods must also result in the effects claimed by applicant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699
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