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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 9/18/26. Claims 1-16 are pending while claims 1-6 and 15-16 are withdrawn. Claims 7-14 are considered on the merits.
Election/Restriction Requirement
Applicant’s election of Group II, claims 7-14 in the reply filed on 9/18/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse.
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 7-14 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.
Claim 7 administers a supplement “based on Enterococcus faecium”. The phrase ‘based on’ is confusing because it does not clearly limit this bacteria as part of the composition, but can include cell-free media where E. faecium was cultured, as well as components or metabolic products of E. faecium. This leaves the metes and bounds of the structure of the composition unclear.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 7, 9, 11, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (CN 114586888 A, published 2022) in light of support by The Merck Veterinary Manual (2025). Since Li et al. is in Chinese, an English translation is provided. All citations in this action are to that translation.
Li et al. teach administering chickens a feed additive comprising Enterococcus faecium and sodium butyrate to treat colibacillosis. (Li, pg. 2, middle) which is an inflammation in the intestinal mucosa caused by E. coli as supported by the Merk Veterinary Manual.
Therefore the invention as a whole is anticipated by the reference.
Claim Rejections - 35 USC § 103
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.
Claim(s) 7-9 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN 114586888 A, published 2022, in IDS 12/12/24) in view of Ubbink et al. (EP 1344458, 2002). Since Li et al. is in Chinese, an English translation is provided. All citations in this action are to that translation.
Li et al. teach administering chickens (e.g. livestock) a feed additive comprising Enterococcus faecium and sodium butyrate to treat colibacillosis (Li, pg. 2, middle).
Li et al. does not teach Enterococcus faecium NCIMB 10415. However this would be obvious in view of Ubbink et al. who teach Enterococcus faecium NCIMB 10415 formulated into pellets (Ubbink, Example 2) for treating livestock and pets (Ubbink 0029). The pets include cats and dogs (Ubbink, 0029). Specifically Ubbink et al. teach using Enterococcus faecium NCIMB 10415 in its commercially available form of LBC-ME10 which is microencapsulated (Ubbink, 0011, 0125). Ubbink et al. teach LBC-ME10 has good stability. E. faecium NCIMB10415 is a synonym for E. faecium SF68 as supported by Applicant’s Specification (pg. 3, lines 5-10).
It would be obvious to use microencapsulated Enterococcus faecium NCIMB10415 LBC-ME10 formulation in the invention of Li et al. since Ubbink et al. teach it is a suitable probiotic formulation with good stability to administer to both livestock, dogs, and cats. One of ordinary skill would recognize this as simply substituting one Enterococcus faecium for another, when both are taught as probiotics for livestock and other animals.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 7, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Early (GB2258170).
Early teach administering a pet supplement comprising Enterococcus faecium (pg. 17, lines 1-10) to treat gastroenteritis, colitis, or obesity (pg. 7, lines 10-20).
While Early does not expressly teach all the claim limitations in a single embodiment, it would be obvious for one of ordinary skill in the art to perform the claimed method after reviewing the entire disclosure. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by 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 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 1874238. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose methods of administering a composition comprising Enterococcus faecium NCIMB 10415 and sodium butyrate to treat the intestinal submucosa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
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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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
