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 12/12/24. Claims 1-20 are pending and considered on the merits.
Claim Interpretation
This method contains the following intended result “for use to improve the enterocyte health and consequently wellness of the livestock or pets”. Initially the phrase “for use” reads as a contingent clause similar to “adapted for”, “wherein”, and “whereby”. MPEP 2111.04 I state such a clause “ in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Since this intended result is caused by the active steps of the method, art teaching administering the same composition to the same animals will also read on this intended result.
The term “incapsulated” is an alternative spelling of “encapsulated” as supported by Merriam-Webster. So while not incorrect, it is suggested the Applicant amend the Specification and Claims to use the more common “encapsulated” spelling.
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) 1, 3, 6, 7, 9, 12, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (CN 114586888 A, published 2022). 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 (Li, pg. 2, middle).
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) 1-4, 6-10, 12-14, 16-18, and 20 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 (Li, pg. 2, middle).
Li et al. does not teach Enterococcus faecium NCIMB10415. 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 dog (Ubbink, 0029). Specifically Ubbink et la. teach using Enterococcus faecium NCIMB10415 in its commercially available form of LBC-ME10 which is microencapsulated (Ubbink, 0011, 0125). Ubbink et al. teach LBC-ME10 has good stability.
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) 1-20 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), Ubbink et al. (EP 1344458, 2002) as applied to claims 1-4, 6-10, 12-14, 16-18, and 20 in further view of Wood et al. (WO 2019/178309). Since Li et al. is in Chinese, an English translation is provided. All citations in this action are to that translation.
Li et al. and Ubbink et al. teach a combination of microencapsulated Enterococcus faecium NCIMB 10415 and sodium butyrate into a pellet. However they do not teach encapsulated butyrate, but this is obvious in view of Wood et al. who teach probiotic compositions to treat livestock and pets (Wood, 0032, 0101) including Enterococcus faecium NCIMB 10415 (Wood, pg. 11, top line). These probiotic compositions can be dried and encapsulated to promote stability and viability (Wood, 0032).
Therefore it would be obvious to dry Enterococcus faecium NCIMB 10415 and sodium butyrate, then encapsulate this composition to promote stability and viability. One of ordinary skill would recognize this as simply use a known technique to improve the probiotic composition by making it more stable and viable (MPEP 2141 III (C-D)).
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.
Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18865311. 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
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