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
Claims 1-2, 7-9, 13, 59, and 62 are pending and under examination.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
(Maintained) Claims 1-2, 7-9, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kweon et al. (US 20170333492 A1, published 23 November 2017) in view of Malo et al. (Intestinal alkaline phosphatase promotes gut bacterial growth by reducing the concentration of luminal nucleotide triphosphates, Am J Physiol Gastrointest Liver Physiol. 2014 May 15;306(10):G826-38. doi: 10.1152/ajpgi.00357.2013. Epub 2014 Apr 10).
Regarding claims 1, 7-8, and 13, Kweon teaches a method for treating metabolic diseases comprising administering isolated human commensal gastrointestinal bacteria Bacteroides acidifaciens to a subject in need thereof (Kweon claim 11). Kweon confirms that the Bacteroides acidifaciens is an intestinal symbiotic bacteria (i.e. from human GI-tract) (Kweon [0204]). Kweon teaches that isolated Bacteroides acidifaciens may be administered as the active ingredient in a pharmaceutical composition to treat metabolic diseases such as obesity, diabetes, and metabolic syndrome (Kweon claims 1-2), and that the diabetes can be type 1 or type 2 (Kweon [0029]).
However, Kweon does not teach their method to comprise co-administering bovine intestinal alkaline phosphatase (IAP).
Malo teaches that administering IAP can normalize gut flora and promote the growth of a wide range of intestinal commensal bacteria (Malo Pg. G826 para. 1). Malo also teaches that the IAP administered in their experiments was bovine IAP (bIAP) (Malo Pg. G827 para. 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to administer bovine intestinal alkaline phosphatase (bIAP) together with human commensal gastrointestinal bacteria Bacteroides acidifaciens to treat metabolic diseases, including obesity, type 1 and type 2 diabetes, and metabolic syndrome, in a subject in need thereof. One of ordinary skill in the art would have been motivated to so because adding bIAP to the composition comprising Bacteroides acidifaciens would advantageously promote the growth of intestinal symbiotic bacteria Bacteroides acidifaciens in the subject administered the composition. One of ordinary skill in the art would have a reasonable expectation of success because Kweon taught that compositions comprising Bacteroides acidifaciens can be used in a method of treating metabolic diseases and Malo taught that bIAP can advantageously promote the growth of a wide range of intestinal commensal bacteria, such as Bacteroides acidifaciens taught by Kweon.
Regarding claim 2, Kweon teaches that the administered bacterial composition may be from fecal microbiota transplanted (FMT) in their examples (Kweon [0099], [0177], and Fig. 21).
Regarding claim 9, Kweon teaches that the Bacteroides acidifaciens can be cultures of the bacteria (Kweon [0026]).
(Maintained) Claims 59 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Kweon in view of Malo as applied to claims 1-2, 7-9, and 13 above, and further in view of Mueller et al. (US 7202072 B2, published 10 April 2007).
Neither Kweon nor Malo explicitly teach that the bIAP comprises an amino acid sequence having at least about 97% sequence identity to instant SEQ ID NO: 11.
However, Mueller teaches an intestinal alkaline phosphatase comprising an amino acid sequence that aligns 100% to the amino acid sequence of instant SEQ ID NO: 11 (Mueller SEQ ID NO: 2, see alignment below Qy=instant SEQ ID NO: 11, Db = SEQ ID NO: 2 of Mueller). Mueller also teaches that their SEQ ID NO: 2 encodes a highly active bovine IAP (Mueller Col. 6 lns. 66-67).
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to use the bIAP having amino acid sequence SEQ ID NO: 2 of Mueller in the method of Kweon modified by Malo as discussed above. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Mueller taught that the bIAP of amino acid sequence SEQ ID NO: 2 is an advantageously highly active bovine IAP, and thus would have the advantageous benefit of greatly promoting the growth of the intestinal commensal bacteria Bacteroides acidifaciens used as the active ingredient in the method of Kweon in view of Malo.
Response to Arguments
Applicant's arguments filed 10 July 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that Kweon and Malo do not teach co-administering IAP with Bacteroides acidifaciens as part of a therapeutic method for treating the claimed metabolic disorders, and the Office Action does not identify any reason why one of ordinary skill in the art would have sought to modify Kweon's methods by co-administering IAP (Remarks pg. 3-4):
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The rejections are based on the combination of Kewon and Malo references that teach co-administration of bovine IAP together with Bacteroides acidifaciens. The previous Office Action provided a reason as to why one of ordinary skill in the art would have found it obvious to modify Kweon’s method, as seen on pg. 4 of the Office Action. It would have been prima facie obvious to one of ordinary skill in the art to administer bovine intestinal alkaline phosphatase (bIAP) together with human commensal gastrointestinal bacteria Bacteroides acidifaciens to treat metabolic diseases because adding bIAP to the composition comprising Bacteroides acidifaciens would advantageously promote the growth of intestinal symbiotic bacteria Bacteroides acidifaciens in the subject administered the composition. One of ordinary skill in the art would have a reasonable expectation of success because Kweon taught that compositions comprising Bacteroides acidifaciens can be used in a method of treating metabolic diseases and Malo taught that bIAP can advantageously promote the growth of a wide range of intestinal commensal bacteria, such as Bacteroides acidifaciens taught by Kweon.
Regarding Applicant’s arguments that Applicant's results that co-administration of IAP and Bacteroides acidifaciens favors the survival and expansion of the Bacteroides acidifaciens, which is unexpected in view of the cited art (Remarks pg. 4), Applicant's results are not unexpected in view of the cited art. The previous Office Action provides an obviousness rationale on pg. 4. Kweon taught that compositions comprising Bacteroides acidifaciens can be used in a method of treating metabolic diseases and Malo taught that bIAP can advantageously promote the growth of a wide range of intestinal commensal bacteria, such as Bacteroides acidifaciens taught by Kweon. Thus, when Kweon and Malo are combined, one of ordinary skill in the art would have concluded that co-administering bovine IAP together with Bacteroides acidifaciens would predictably enhance the survival and expansion of the Bacteroides acidifaciens.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander M Duryee whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/Alexander M Duryee/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/ Supervisory Patent Examiner, Art Unit 1657
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