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 the species of claims 14-16, 20 in the reply filed on 5/4/2026 is acknowledged. After further consideration, the claims are drawn to a single administration step of an isolated microorganism, which is not administered to a specific patient population. Therefore, the single administration steps would necessarily perform the currently claimed functions of claims 13, 14, and 17, therefore, the species election is with withdrawn.
Claims 13-21 are pending and have been considered on the merits herein.
Claim Objections
Claims 16, 17, and 20 objected to because of the following informalities: the word “the” should be between “increases” and “number” . Additionally, the word Salmonella should be italicized in claim 17. Appropriate correction is required.
Claim Interpretation
The claims are directed to a method (of promoting gut mucosal immunity, protecting against a Salmonella infection, and restoring and/or increasing an intestinal epithelial barrier) comprising a single administration step with no particular patient population. When reading the preamble in the context of the entire claim, the recitation of promoting gut mucosal immunity, protecting against a Salmonella infection, and restoring and/or increasing an intestinal epithelial barrier is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Thus, a reference which teaches a method of orally administering an isolated Rouxiella badensis microbe, is interpreted to anticipate a method of promoting gut mucosal immunity, protecting against a Salmonella infection, restoring and/or increasing an intestinal epithelial barrier and wherein the number of Goblet and/or Paneth cells are increased.
Additionally, the intended use and function of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-08.2012]
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 and 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.5.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
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) 13-21 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Matar et al. (US20170106031) as evidenced by Matar et al. (US11122830 B2, IDS).
Matar teach a method of oral administration of a composition comprising the bacterial strain isolated from lowbush blueberries (Vaccinium angustifolium) deposited under the Accession Number 160103 provisionally classified as Serratia vaccinii (0004, as taught in Matar WO2004/101770, 0008, 0021-0023-0032, 0050, 0067-0069).
Regarding claims 15, 19, 21, Matar teaches the oral administration of the composition comprising the strain to mice for a period of two weeks and up to 5 weeks (0176, 0182), thus meeting applicants limitations of claims 15, 19, 21 of administering for at least 7 to 90 days.
Regarding claims 16 and 20, a "wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively
recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. The only method step is orally administering, and thus the “wherein the method increases number of goblet and/or Paneth cells in the small intestine epithelium” is only an intended result of administering the preparation
1614, 1620 (Fed. Cir. 2003)) as well as a function of the preparation. The method of Matar is drawn to the same method as claimed, i.e. oral administration of Rouxiella badensis. Thus, it is the Examiners position that these results are inherent to the administration step taught by Matar . One would necessarily expect to achieve the same results when practicing the method of Matar, which is the same as applicants claimed method.
*Applicants post-filing art Matar et al. (US11122830) confirms that the bacterial strain of US’031 is Rouxiella and is the same strain as that taught by the reference. See Matar who teach a bacterial strain isolated from the lowbush blueberry (Vaccinium angustifolium) which increases antioxidant content in its growth medium, having all the identifying characteristics of the bacterium deposited under Accession Number 160103, used in a probiotic composition and having a 16S rRNA gene sequence comprising the nucleotide sequence of SEQ ID NO:1 (col. 5, lines 1-37, col. 7, lines 1-11, additionally see all of columns 7 and 8 and sequence listing on p. 35 and 36 of US’830) classified as Rouxiella basensis subsp. acadiensis, which is identical to SEQ ID NO:1 of US’031
Thus, the strain of US’031 is Rouxiella basensis subsp. acadiensis as evidenced by Matar.
Thus, the reference anticipates the claimed subject matter.
Claim(s) 13-21 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Matar et al. (US20100092583 A1) as evidenced by Matar et al. (US11122830 B2, IDS).
Matar teach a method of oral administration of a composition comprising the bacterial strain isolated from lowbush blueberries (Vaccinium angustifolium) deposited under the Accession Number 160103 provisionally classified as Serratia vaccinii (abstract, 0013, 0014, 0004, 0016-0021, 0041, 0062, 0083, 0157-0166).
Regarding claims 15, 19, 21, Matar teaches the oral administration of the composition comprising the strain to mice for a period of 7 up to 3 weeks (0243, 0255, 0264), thus meeting applicants limitations of claims 15, 19, and 21 of administering for at least 7 to 14 days.
Regarding claims 16 and 20, a "wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively
recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. The only method step is orally administering, and thus the “wherein the method increases number of goblet and/or Paneth cells in the small intestine epithelium” is only an intended result of administering the preparation
1614, 1620 (Fed. Cir. 2003)) as well as a function of the preparation. The method of Matar is drawn to the same method as claimed, i.e. oral administration of Rouxiella badensis. Thus, it is the Examiners position that these results are inherent to the administration step taught by Matar . One would necessarily expect to achieve the same results when practicing the method of Matar, which is the same as applicants claimed method.
*Applicants post-filing art Matar et al. (US11122830) confirms that the bacterial strain of US’583 is Rouxiella and is the same strain as that taught by the reference. See Matar who teach a bacterial strain isolated from the lowbush blueberry (Vaccinium angustifolium) which increases antioxidant content in its growth medium, having all the identifying characteristics of the bacterium deposited under Accession Number 160103, used in a probiotic composition and having a 16S rRNA gene sequence comprising the nucleotide sequence of SEQ ID NO:1 (col. 5, lines 1-37, col. 7, lines 1-11, additionally see all of columns 7 and 8 and sequence listing on p. 35 and 36 of US’830) classified as Rouxiella basensis subsp. acadiensis, which is identical to SEQ ID NO:1 of US’583
Thus, the strain of US’583 is Rouxiella basensis subsp. acadiensis as evidenced by Matar.
Thus, the reference anticipates the claimed subject matter.
Claim(s) 13-21 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Matar et al. (WO2004/101770, IDS) as evidenced by Matar et al. (US11122830 B2, IDS).
WO’770 teaches an orally administered composition comprising bacteria isolated from lowbush blueberries (Vaccinium angustifolium) to be administered to treat and ameliorate diseases, disorders and conditions (p. 25, lines 17-26, 26, lines 23-p. 27) deposited under the Accession Number 160103 (p. 3, lines 13-27, p. 6, lines 1-6, p. 10-11) and to be provisionally classified as Serratia vaccinii.
Regarding claims 15, 19, 21, Matar teaches the oral administration of the composition comprising the strain to mice for a period of 7 days (p. 56, Ex. 7), thus meeting applicants limitations of claims 15, 19, 21 of administering for at least 7 to 14 days.
Regarding claims 16 and 20, a "wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively
recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. The only method step is orally administering, and thus the “wherein the method increases number of goblet and/or Paneth cells in the small intestine epithelium” is only an intended result of administering the preparation
1614, 1620 (Fed. Cir. 2003)) as well as a function of the preparation. The method of Matar is drawn to the same method as claimed, i.e. oral administration of Rouxiella badensis. Thus, it is the Examiners position that these results are inherent to the administration step taught by Matar . One would necessarily expect to achieve the same results when practicing the method of Matar, which is the same as applicants claimed method.
*Applicants post-filing art Matar et al. (US11122830) confirms that the bacterial strain of WO’770 is Rouxiella and is the same strain as that taught by the reference. See Matar who teach a bacterial strain isolated from the lowbush blueberry (Vaccinium angustifolium) which increases antioxidant content in its growth medium, having all the identifying characteristics of the bacterium deposited under Accession Number 160103, used in a probiotic composition and having a 16S rRNA gene sequence comprising the nucleotide sequence of SEQ ID NO:1 (col. 5, lines 1-37, col. 7, lines 1-11, additionally see all of columns 7 and 8 and sequence listing on p. 35 and 36 of US’830) classified as Rouxiella basensis subsp. acadiensis, which is identical to SEQ ID NO:1 of WO’770
Thus, the strain of WO’770 is Rouxiella basensis subsp. acadiensis as evidenced by Matar.
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 13-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9358262 as evidenced by Matar et al. (US11122830 B2).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to administering a composition comprising Serratia vaccinii, which has been demonstrated to be Rouxiella badensis See Matar who teach a bacterial strain isolated from the lowbush blueberry (Vaccinium angustifolium) which increases antioxidant content in its growth medium, having all the identifying characteristics of the bacterium deposited under Accession Number 160103, used in a probiotic composition and having a 16S rRNA gene sequence comprising the nucleotide sequence of SEQ ID NO:1 (col. 5, lines 1-37, col. 7, lines 1-11, additionally see all of columns 7 and 8 and sequence listing on p. 35 and 36 of US’830) classified as Rouxiella basensis subsp. acadiensis, which is identical to SEQ ID NO:1 of the instant application and SEQ ID NO:1 of US’262. Regarding claims 16 and 20, a "wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. The only method step is orally administering, and thus the “wherein the method increases number of goblet and/or Paneth cells in the small intestine epithelium” is only an intended result of administering the preparation 1614, 1620 (Fed. Cir. 2003)) as well as a function of the preparation. The method of Matar is drawn to the same method as claimed, i.e. oral administration of Rouxiella badensis. Thus, it is the Examiners position that these results are inherent to the administration step. One would necessarily expect to achieve the same results when practicing the claimed methods, which are the same. The examined claims are drawn to generically administering and thus, the patent claims drawn administering to a subject would anticipate the instant claims.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIFFANY M GOUGH/ Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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