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 .
Claim Objections
Claims 20, 21 are objected to because of the following informalities: the two claims have the word “if” that should be “of”, as in “the intestinal tract of the animal”, and “the method of claim 19”. 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.
Claims 3-5, 10, 21, 22, 25 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.
Claims 3-5 recite the limitation "the commensal bacteria" and “the methanogenic archaea” in lines 1-2 of the claims. There is insufficient antecedent basis for this limitation in the claims as these limitations are only recited in Claim 2. For the purposes of search and examination, Claims 3-5 will be treated as if dependent from Claim 2, however this should be corrected by Applicant.
Claim 10 as amended recites the limitations "the (i) alpha-L-1,2 fucosidase…” and “(ii) the alpha-L-1,2-fucosidase….” There is insufficient antecedent basis for all of the amended limitations as these limitations are only recited in later claims.
Claims 21 and 22 recite the limitation “the methanogenic archaea” in lines 1-2 of the claims. There is insufficient antecedent basis for this limitation in the claims as this limitation is only recited in Claim 20.
Claim 25 recites the limitations "the alpha-L-1,2 fucosidase…”. There is insufficient antecedent basis for all of the amended limitations as these limitations are only recited in a later claim.
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.
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.
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 1-19 and 23-25, 28, 31 are rejected under 35 U.S.C. 103 as being unpatentable over Poulson et al. (USPA 2019/0022193) in view of Rieger et al. (2019).
Regarding Claims 1, 2, and 6, Poulson teaches a method comprising administering to an animal an effective amount of a glycoside hydrolase capable of removing at least one alpha-1,2-fucose moiety from an intestinal pathogen binding site, where the glycoside hydrolase is an alpha-L-fucosidase having alpha-1,2-activity (Paragraph 8) and also teaches evaluating hydrolysis activity of an alpha 1,2-fucosidase candidates towards porcine gastric mucin (Paragraph 242). Poulson teaches the glycoside hydrolase such as an alpha-L-fucosidase can be added to a food or feed additive at a level of at least 0.0001g/kg and up to levels of at least 25g/kg (Paragraph 211), which is the same amounts disclosed by Applicant for the claimed enzyme to be added to animal food or feed (Instant specification, Paragraph 144). Since Poulson teaches the same amount of claimed enzyme added to an animal food or feed, Poulson is deemed to teach the claimed “effective amount” to remove at least one alpha 1,2-fucose moiety from an intestinal binding site. Regarding the limitation of the removing from an intestinal mucin layer, Poulson teaches the removing of the at least one alpha-1,2-fucose moiety from an intestinal pathogen binding site, and teaches figures showing hydrolysis of porcine gastric mucin (Figure 7), and that fucosylated glycans are common within the gastrointestinal tract where they are found on cell surfaces and on mucins, where mucins are high molecular weight heavy glycosylated proteins found in both membrane-associated and secreted form (Paragraph 95) Poulson also teaches evaluating hydrolysis activity of an alpha 1,2-fucosidase candidates towards porcine gastric mucin (Paragraph 242). However, Poulson does not specifically teach from an intestinal mucin layer.
Rieger teaches that mucins are of great interest in intestinal research (Page 1, Column 1) and teaches that mucus, which is buildup of large glycoproteins called mucins and secreted from diverse epithelial cells throughout the gastrointestinal tract and its barrier building capacity represents one of the key mechanisms ensuring the protection of the mucosa from harmful as well as benign microbiota by preventing their translocation into the tissue (Page 1, Column 2). Therefore, since it would appear that a mucus layer made of mucins provides a barrier in the gastrointestinal tract and the location of where harmful bacteria can enter cells and tissue, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Poulson to have been acted on an intestinal mucin layer specifically.
Regarding the claimed method for improving gut health in an animal, where the improving gut health comprises one or more of the claimed parameters, Poulson in view of Rieger teach that it is contemplated that animal performance parameters will be improved by the disclosed method, and more specifically, as used herein, “animal performance” may be determined by the feed efficiency/weight gain of the animal and/or by the feed conversion ratio and/or by the digestibility of a nutrient in a feed (Poulson, Paragraph 174). Therefore, the above disclosure is seen to read on improving gut health by showing improvements in feed efficiency/weight gain/feed conversion ratio.
Regarding Claims 3-5, and 18, since Claim 2 does not require the limitations of the commensal bacteria or methanogenic archaea or the intestinal IgA being bound to fecal microbes, the prior art meets the limitations of Claims 3-5 and 18 as well since Claims 3-5 and 18 recite more specifics of the alternative limitations in Claim 2.
Regarding Claim 7, Poulson in view of Rieger teach where the alpha-L-fucosidase is selected from one of the two claimed glycoside hydrolase families (Poulson, Paragraph 170).
Regarding Claims 8-10, Poulson in view of Rieger teach where the method further comprises administering to the animal an effective amount of at least one direct fed microbial and at least one or more additional enzymes or proteases, whether or not encapsulated and maybe in the form of a granule (Poulson, Paragraph 173).
Regarding amended Claim 13, Poulson in view of Rieger teach the method is used for swine and other animals (Poulson, Paragraph 205).
Regarding amended Claim 16, Poulson in view of Rieger are taken as cited above in the rejection of Claim 1 and teach that it is contemplated that animal performance parameters will be improved by the disclosed method, and more specifically, as used herein, “animal performance” may be determined by the feed efficiency/weight gain of the animal and/or by the feed conversion ratio and/or by the digestibility of a nutrient in a feed (Poulson, Paragraph 174). Therefore, regarding the limitation of where the glycoside hydrolase is not administered for treatment or prevention of intestinal pathogenic infection and/or diarrhea, in light of the above disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the claimed method to have been used for improving animal performance by way of improving gut health/improvements in feed efficiency/weight gain/feed conversion ratio.
Regarding Claim 17, while Poulson in view of Rieger do not specifically teach a time frame as claimed for administering the glycoside hydrolase to the animal, since Poulson in view of Rieger teach the disclosed method can also be seen to improve animal performance and is used in animal feed, it would have been well within the skill of one of ordinary skill in the art to have fed an animal an animal feed including the disclosed glycoside hydrolase enzymes in order to exploit its known effects on animal performance and by monitoring animal weight gain, feed efficiency and feed conversion ratios.
Regarding Claim 19, Poulson in view of Rieger are taken as cited above in the rejection of Claim 1, teach and render obvious the claimed method of administering an effective amount of a glycoside hydrolase capable of removing at least one alpha-1,2-L-fucose moiety from an intestinal mucin layer. As set forth above, Poulson in view of Rieger teach an amount of the glycoside hydrolase enzyme as disclosed by Applicant, and teach using the same enzyme as well. Therefore, one of ordinary skill in the art would have reasonably expected that the method disclosed in the prior art would also result in other advantages or effects as recited by Applicant, and one of ordinary skill in the art would have reasonably expected the method taught in the prior art would also result in decreased methane emissions as well, by virtue of the same method being carried out. 'It is well settled that a patent cannot be properly granted for [an invention] which would flow naturally from the teaching of the prior art.' See Ex parte Obiaya, 227 USPQ 58, 60 (Bd.Pat. App. & Inter. 1985) as cited in MPEP 2145 II.
Regarding Claims 23, 24, 25, 28, Poulson in view of Rieger are taken as cited above in the rejection of Claims 6-10 and 13.
Regarding amended Claim 31, while Poulson in view of Rieger do not specifically teach a time frame as claimed for administering the glycoside hydrolase to the animal, since Poulson in view of Rieger teach the disclosed method can also be seen to improve animal performance and is used in animal feed, it would have been well within the skill of one of ordinary skill in the art to have fed an animal an animal feed including the disclosed glycoside hydrolase enzymes in order to exploit its known effects on animal performance and by monitoring animal weight gain, feed efficiency and feed conversion ratios.
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Poulson et al. (USPA 2019/0022193) in view of Rieger et al. (2019), and further in view of Samuel et al. (USPA 2013/0217592).
Regarding Claims 20-22, Poulson in view of Rieger are taken as cited above in the rejection of Claim 19. Poulson in view of Rieger do not specifically teach where the decreased methane emissions result from decreased growth of one or more methanogenic archaea in the intestinal tract of the animal, where the archaea comprise Methanobrevibacter spp. or M. smithii.
Samuel teaches that methanogens are members of the domaine Archaea, most predominantly presented by Methanobrevibacter smithii (Paragraphs 7-9) and that culture and non-culture based enumeration studies have demonstrated that members of the Methanobrevibacter genus are prominent gut mesophilic methanogens (Paragraph 10) and teaches that a focused set of nutrients are consumed for energy by methanogens and these compounds are typically converted to carbon dioxide and methane (Paragraph 11). Therefore, given the Examiner’s position as set forth in the rejection of Claim 19, one of ordinary skill in the art would have reasonably expected that the method disclosed in the prior art would also result in other advantages or effects as recited by Applicant, and one of ordinary skill in the art would have reasonably expected the method taught by the prior art would also result in decreased methane emissions as well, by virtue of the same method being carried out. 'It is well settled that a patent cannot be properly granted for [an invention] which would flow naturally from the teaching of the prior art.' See Ex parte Obiaya, 227 USPQ 58, 60 (Bd.Pat. App. & Inter. 1985) as cited in MPEP 2145 II. In addition, since the same method as Applicant is carried out and Samuel teaches that the methanogenic archaea comprising Methanobrevibacter spp and M. smithii are prominent gut mesophilic methanogens, and that methanogens consume nutrients and convert them to carbon dioxide and methane, one of ordinary skill in the art would have reasonably expected that where the method taught in the prior art naturally resulted in another benefit of reduced methane emissions, one of ordinary skill in the art would have reasonably expected that it would be due to decreased growth of the methanogenic archaea in the gut that produce the methane emissions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNA A WATTS whose telephone number is (571)270-7368. The examiner can normally be reached Monday-Friday. 9am-4:30pm.
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JENNA A. WATTS
Primary Examiner
Art Unit 1791
/JENNA A WATTS/Primary Examiner, Art Unit 1791 3/19/2026