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 .
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 6 is objected to because of the following informalities: the claim does not need to list every value above “at least 72%,” since it would be exceptionally clear to the ordinary artisan that “at least 72%” would include all of the values that follow. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-6, and 8-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The independent claims are drawn to compositions and methods that include limitations drawn to an amino acid sequence, defined as SEQ ID No 1, and sequences with at least 70% homology to the claimed sequence, wherein the polypeptide must exhibit diamine oxidase ability; other than SEQ ID No 1, there are no explicitly described sequences with diamine oxidase ability. The provided claims are not in compliance with the written description requirement because the instant specification has not provided reasonable evidence to suggest that the Applicants were in possession of a reasonable number of embodiments to show possession of the entire genus, at the time of filing.
First, it must be noted that it is clear from the instant application, and the prior art, that SEQ ID No 1 is fully described and enabled for diamine oxidase activity; however, there is no evidence provided that any mutations within the claimed range would provide for sequences with diamine oxidase activity. SEQ ID No 1 is 671 amino acids, which means that providing homology as low as 70% means that as many as 201 amino acids can be modified, which can be interpreted as additions, deletions, and/or mutations; this number of possible amino acid sequences would be a greater number than there are atoms in the universe. There is no direction in the instant specification that would provide the skilled artisan with enough guidance to generate the claimed sequences, wherein they also possess diamine oxidase activity. Since the instant specification does not provide for a reasonable number of embodiments, to show possession, or provide clear direction to the skilled artisan to generate sequences that possesses diamine oxidase activity, it appears as though the Applicant was not in possession of a reasonable number of sequences to show possession of the entire genus. See MPEP 2163, and the most recent 35 USC 112(a) Written Description guidance and chemical/biological arts examples, which is provided on the USPTO website.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 provides for SEQ ID No 1, or sequences that possess at least 70% homology to SEQ ID No 1 and have diamine oxidase activity; claim 5 is dependent on claim 3, which provides for the same variations of SEQ ID No 1. Based on this, it is unclear how claim 5 further limits claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, and 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more. The claim(s) recite(s) SEQ ID No 1, which is a naturally occurring enzyme found in Yarrowia lipolytica P01f. This judicial exception is not integrated into a practical application because the claims provide for the sequence/enzyme, per se, but do not provide for any additional ingredients that would change the nature of the claimed enzyme.
The Applicant is directed to MPEP 2106 for the analysis of the claims under 35 USC 101, especially the flow chart found in section III. Since the claims are drawn to a composition, the claims provide for a statutory category, and as such, the answer to step 1 is “yes.” The second step asks if the claims are directed to a product of nature; since the claims are drawn to an enzyme that is naturally found in Y. lipolytica, the answer to step 2A is “yes.” In addition to the instant specification describing this enzyme as being isolated from a naturally occurring yeast, and is not engineered, the IDS reference Nunez, et al (Encyclopedia of Dairy Sciences, 2nd Edition, Elsevier, Boston, 2011 [IDS Reference]) indicates that this enzyme is naturally found in Y. lipilytica and wherein the yeast can be isolated from cheese. See page 452, right column, first [incomplete] paragraph. Based upon this, it is clear that the yeast strain and the enzyme are products of nature. The next step requires the Examiner to perform a markedly different characteristic analysis. See MPEP 2106.04(c). Claim 1 provides for a “functional food,” and claim 4 provides for the enzyme, per se. When considering claim 1, there is no evidence to suggest that the claimed diamine oxidase provides for any unexpected behaviors or kinetics other than the predicted diamine oxidase activity, even when in contact with a food product.
It must also be considered that the claims provide for an isolated enzyme. Based upon guidance regarding Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013), even though the claimed enzyme is isolated, which provides for “hand of man,” the enzyme is identical to its natural counterpart, and provides for identical diamine oxidase behaviors, regardless of it being inside or outside the yeast cell. Since both the “function food” and enzyme, per se, would provide for diamine oxidase activity that is identical to that of the natural counterpart, the claimed compositions must be considered products of nature.
Claim Rejections - 35 USC § 102/103
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 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.
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, 3-9, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Nunez, et al (Encyclopedia of Dairy Sciences, 2nd Edition, Elsevier, Boston, 2011 [IDS Reference]). Nunez teaches that the yeast Y. lipolyitica has been isolated from certain cheeses, wherein Y. lipolytica naturally produces the enzyme diamine oxidase. See page 452, right column 1st [incomplete] paragraph. Although Nunez does not provide for any sequence data, based upon an assessment from the instant specification, it seems like the enzyme of the claims provides for the same behaviors as the enzyme described in Nunes. As such, it would be reasonable to suggest that the Y. lipolytica enzyme disclosed in Nunez, wherein this enzyme possesses diamine oxidase activity, is the same as the Y. lipolytica enzyme claimed. If the Applicant can provide evidence that these enzymes are different, it would appear as though the claimed enzyme provides for the same behaviors and can be considered an obvious variant of that disclosed in Nunez.
With respect to claim 1, Nunez provides for Y. lipolytica diamine oxidase, and cheese. Nunez notes that the cheese includes decarboxylated amino acids, thereby confirming diamine oxidase activity. See page 452, right column, 1st [incomplete] paragraph. Y. lipolytica provides for the claimed enzyme with [an assumed] 100% homology.
With respect to claims 3 and 5-7, the cheese described in Nunez appears to provide for the claimed method. That is to say, the cheese is the claimed “biogenic amine-containing product,” and Y. lipolytica provides for the claimed enzyme with [an assumed] 100% homology.
With respect to claim 4, Nunez describes the diamine oxidase enzyme that is found in Y. lipolytica, and as such, appears to anticipate the claim. If it can be shown that the enzyme is not that claimed, it would be obvious to use this enzyme, since it has known utility in the art.
With respect to claims 8 and 9, as discussed above, Nunez teaches that the enzyme is found in Y. lipolytica, which is found in cheese. As such, Nunez teaches the claimed enzyme in cheese.
With respect to claims 13-15, Nunez teaches the claimed biogenic amines, and indicates that they act as substrates to diamine oxidase enzymes. See page 452, Table 1.
Claim Rejections - 35 USC § 103
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Nunez, et al (Encyclopedia of Dairy Sciences, 2nd Edition, Elsevier, Boston, 2011 [IDS Reference]) and Izquierdo-Casas, et al (Clinical Nutrition, 38, 152-158, 2019). See the discussion of Nunez above. Although Nunez appears to describe the claimed enzyme, there is nothing in the cited prior art that suggests using the enzyme in a method for treating or preventing a disease/condition related to a buildup of biogenic amines.
Izquierdo-Casas teaches methods of treating migraine headaches with diamine oxidase supplementation; Izquierdo-Casas notes that these headaches are related to a buildup of the biogenic amine - histamine. See page 152, “Summary” section. Although it is unclear what the origin of the diamine oxidase enzyme is, it seems reasonably clear that as long as the enzyme exhibits diamine oxidase activity, it should predictably provide for the same outcomes as those disclosed in Izquierdo-Casas. As such, even if Izquierdo-Casas does not teach the claimed enzyme source, or teaches an enzyme with a different sequence, it would continue to be obvious to the ordinary artisan that all diamine oxidases, regardless of source and sequence, would be expected to behave identically to others defined as “diamine oxidases.” This class of enzymes behave predictably, and the ordinary artisan would understand the subtle differences in kinetics between sources. The claimed method appears to be an obvious variant of Izquierdo-Casas, wherein the instant method uses an obvious variant enzyme, as compared to Izquierdo-Casas.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lyte (PGPUb 2023/0011355).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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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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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651