DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
2. 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.
3. Claim 15 is 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.
4. Claim 15 recites the limitation "the active site sequence" in lines 3, 4, 7, 8, 11, 12, 15,16, 18, 19, 22, 23, 26, 27, 31, 32, 35, 36, 40, 41, 44, 45, 48, 49, 52, 53, 58, 59, 62, 63, 66, 67, 70, 71, 74, 75, 78, 79, 82, 83, 86, 87, 90, 91, 95, 96, 99, 100, 103, 104, 108, 109. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
5. 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.
6. 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.
7. 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.
8. 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.
9. Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (WO 2013/096000) in view of Oda et al. J. Biol. Chem. 269, 26518-26524, 1994 Cloning, nucleotide sequence, and expression of an isovaleryl pepstatin-insensitive carboxyl proteinase gene from Pseudomonas sp. 101.
Regarding Claim 1: Anderson discloses a method of improving the digestion of proteins [abstract]. Anderson discloses a food supplement that contains a protease and is ingested with food [abstract].
Anderson does not disclose one or more proteases having an amino acid sequence at least
substantially identical to an amino acid sequence selected from the group consisting of SEQ
ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10, SEQ ID NO: 12,
SEQ ID NO: 14, SEQ ID NO: 16, SEQ ID NO: 18, SEQ ID NO: 20, SEQ ID NO: 22, and SEQ
ID NO: 24
Oda discloses enzyme Seq 4 having 99.8% Seq identity to Seq ID 18.
At the effective filing date of the invention it would have been obvious to one of ordinary
skill in the art to modify the disclosure of Anderson, to include one or more proteases having an
amino acid sequence that was substantially identical to an amino acid sequence of SEQ ID NO: 18,
as in Oda, since Anderson discloses acid stable proteases useful in digesting food proteins in order to provide an improved sequence that increases the digestion of proteins in a food product in a subject through the ingestion of a supplement.
Regarding Claims 2, 3: Anderson as modified discloses as discussed above in claim 1. Anderson also discloses that the protein is pea or soybean (a legume based protein), rice, corn, wheat (a non-legume plant protein); or whey or casein (animal based) [0033; 0034].
Regarding Claim 4: Anderson discloses a method of improving the digestion of proteins [abstract]. Anderson discloses a food supplement that contains a protease and is ingested with food [abstract].
Anderson does not disclose one or more proteases having an active site sequence at least
substantially identical to an amino acid sequence selected from the group consisting of SEQ
ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10, SEQ ID NO: 12,
SEQ ID NO: 14, SEQ ID NO: 16, SEQ ID NO: 18, SEQ ID NO: 20, SEQ ID NO: 22, and SEQ
ID NO: 24.
Oda discloses enzyme Seq 4 having 99.8% Seq identity to Seq ID 18.
At the effective filing date of the invention it would have been obvious to one of ordinary
skill in the art to modify the disclosure of Anderson, to include one or more proteases having an
amino acid sequence that was substantially identical to an amino acid sequence of SEQ ID NO: 18,
as in Oda, since Anderson discloses acid stable proteases useful in digesting food proteins in order to provide an improved sequence that increases the digestion of proteins in a food product in a subject through the ingestion of a supplement.
Although the references do not disclose an “active site sequence”, the sequence 4 of Oda is 99.8% identical to the instant Seq18 and therefore would constitute also encompassing the active site since the active site is known to be the portion of the enzymes that forms the active site, which is the portion of the enzyme sequence that is crucial for its function or specificity.
Regarding Claims 5 and 6: Anderson as modified discloses as discussed above in claim 1. Anderson also discloses that the protein is pea or soybean (a legume based protein), rice, corn, wheat (a non-legume plant protein); or whey or casein (animal based) [0033; 0034].
Regarding Claim 7: Anderson as modified discloses as discussed above in claim 1. Anderson also discloses that the food supplement is ingested simultaneously with the food product [0033; 0035; 0056].
Regarding Claim 8: Anderson as modified discloses as discussed above in claim 1. Anderson also discloses that the food supplement is incorporated into the food product [0033; 0035; 0056].
Regarding Claim 9: Anderson discloses a food supplement that contains a protease [abstract]. Anderson discloses a food supplement that is incorporated into a food product [0033; 0035; 0056] and therefore discloses a food supplement comprising one or more of the claimed proteases.
Anderson does not disclose one or more proteases having an amino acid sequence at least
substantially identical to an amino acid sequence selected from the group consisting of SEQ
ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10, SEQ ID NO: 12,
SEQ ID NO: 14, SEQ ID NO: 16, SEQ ID NO: 18, SEQ ID NO: 20, SEQ ID NO: 22, and SEQ
ID NO: 24
Oda discloses enzyme Seq 4 having 99.8% Seq identity to Seq ID 18.
At the effective filing date of the invention it would have been obvious to one of ordinary
skill in the art to modify the disclosure of Anderson, to include one or more proteases having an
amino acid sequence that was substantially identical to an amino acid sequence of SEQ ID NO: 18,
as in Oda, since Anderson discloses acid stable proteases useful in digesting food proteins in order to provide an improved sequence that increases the digestion of proteins in a food product in a subject through the ingestion of a supplement.
Regarding Claim 10: Anderson discloses a food supplement that contains a protease [abstract]. Anderson also discloses that the food supplement is incorporated into the food product [0033; 0035; 0056] and therefore discloses a food supplement comprising one or more of the claimed proteases.
Anderson does not disclose one or more proteases having an active site sequence at least
substantially identical to an amino acid sequence selected from the group consisting of SEQ
ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10, SEQ ID NO: 12,
SEQ ID NO: 14, SEQ ID NO: 16, SEQ ID NO: 18, SEQ ID NO: 20, SEQ ID NO: 22, and SEQ
ID NO: 24
Oda discloses enzyme Seq 4 having 99.8% Seq identity to Seq ID 18.
At the effective filing date of the invention it would have been obvious to one of ordinary
skill in the art to modify the disclosure of Anderson, to include one or more proteases having an
amino acid sequence that was substantially identical to an amino acid sequence of SEQ ID NO: 18,
as in Oda, since Anderson discloses acid stable proteases useful in digesting food proteins in order to provide an improved sequence that increases the digestion of proteins in a food product in a subject through the ingestion of a supplement.
Although the references do not disclose an “active site sequence”, the sequence 4 of Oda is 99.8% identical to the instant Seq18 and therefore would constitute also encompassing the active site since the active site is known to be the portion of the enzymes that forms the active site, which is the portion of the enzyme sequence that is crucial for its function or specificity.
Regarding Claim 11: Anderson discloses as discussed above in claim 9. Anderson discloses that the food supplement also discloses a carrier, a preservative, a bulking agent, a stabilizer, a matrix modified, protein, a desiccant, an emulsifier [abstract; 0036].
Regarding Claim 12: Anderson discloses as discussed above in claim 9. Anderson discloses that the food supplement is in the form of a tablet, capsule, powder, liquid formulation [0033; 0040].
Regarding Claims 13, 14, 15: Anderson as modified discloses as discussed above in claim 9. Anderson also discloses that the protein is pea or soybean (a legume based protein), rice, corn, wheat (a non-legume plant protein); or whey or casein (animal based) [0033; 0034].
Regarding claim 15, although the references do not disclose an “active site sequence”, the sequence 4 of Oda is 99.8% identical to the instant Seq18 and therefore would constitute also encompassing the active site since the active site is known to be the portion of the enzymes that forms the active site, which is the portion of the enzyme sequence that is crucial for its function or specificity.
Regarding Claims 16-18: Anderson discloses a method of improving the digestion of proteins [abstract]. Anderson discloses a food supplement that contains a protease and is ingested with food [abstract]. Anderson discloses that the food supplement also discloses a carrier, a preservative, a bulking agent, a stabilizer, a matrix modified, protein, a desiccant, an emulsifier [abstract]. Anderson discloses combining matrix modifiers which ca ben interpreted as mixing [0071].
Anderson does not disclose one or more proteases having an amino acid sequence at least
substantially identical to an amino acid sequence selected from the group consisting of SEQ
ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10, SEQ ID NO: 12,
SEQ ID NO: 14, SEQ ID NO: 16, SEQ ID NO: 18, SEQ ID NO: 20, SEQ ID NO: 22, and SEQ
ID NO: 24
Oda discloses enzyme Seq 4 having 99.8% Seq identity to Seq ID 18. Oda discloses producing the protease recombinantly in E.coli [abstract; pg. 26518, col. 2].
At the effective filing date of the invention it would have been obvious to one of ordinary
skill in the art to modify the disclosure of Anderson, to include one or more proteases having an
amino acid sequence that was substantially identical to an amino acid sequence of SEQ ID NO: 18,
as in Oda, since Anderson discloses acid stable proteases useful in digesting food proteins in order to provide an improved sequence that increases the digestion of proteins in a food product in a subject through the ingestion of a supplement.
Regarding Claim 19: Anderson as modified discloses as discussed above in claim 18. Anderson does not disclose wherein the proteases are recombinantly produced using an expression cassette comprising a nucleic acid sequence at least substantially identical to an open reading from SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 5, SEQ ID NO: 7, SEQ ID NO: 9, SEQ ID NO: 11, SEQ ID NO: 13, SEQ ID NO: 15, SEQ ID NO: 17, SEQ ID NO: 19, SEQ ID NO: 21, and SEQ ID NO: 23.
Although Anderson as modified does not disclose at least one of the claimed expression cassettes, it would have been obvious to one of ordinary skill in the art to utilize an expression cassette that would amplify the production of the desired polypeptide. The specification does not provide an indication that the host would materially affect the claimed composition of process. See In re Herz, 537 F.2d 549, 551-52 (CCPA 1976) ("[I]t is necessary and proper to determine whether [the] specification reasonably supports a construction" that would exclude or include particular ingredients.).
Conclusion
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Felicia C Turner/Primary Examiner, Art Unit 1793