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
Status of Claims
Claims 1-15 are the subject of this NON-FINAL Office Action. This is the first office action on the merits.
Election/Restrictions
Applicants’ election without traverse of chicken in the reply filed on 05/14/2026 is acknowledged. The election is withdrawn.
Claim Rejection - 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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Specifically, the claims are directed to the natural correlation between certain gene methylation levels and animal origin, without significantly more.
First, under Step 1, the claims are directed to a method to determine animal origin. Thus, the claims are directed to statutory methods.
Under step 2A, prong one, the claims are clearly directed to a method for determining an animal source or origin, by detecting gene methylation status, which is a natural correlation. See MPEP § 2106.04(b).
As to step 2A, prong two, none of the claims integrate the natural correlation into a practical application. The claims simply begin and end with the natural correlation, thus monopolizing the correlation itself. Although the claims require a “test methylation profile” and “panel of predetermined reference methylation profiles,” yet no actual profiles much less specific technique is claimed, nor disclosed. In addition, no actual comparison or “significantly similar” “profile” is claimed or disclosed. All of these are simply any and every assay, technique, profile, methylation site, etc. from any animal. In other words, the claim is so broad in scope that it encompasses any and all techniques and methylation sites from any and all animals. This is the epitome of monopolizing a natural correlation or phenomenon.
At best, claims 5-6 and 10-11 recites to determine halal or kosher status of the animal. However, these generic steps are recited at such a high level of generality that they encompass all possible methylation detection techniques and locations. In addition, it is completely unclear how determining halal or kosher status is any different technically from any other origin determination. The assays, techniques, etc. are any and all, again monopolizing the natural correlation or phenomenon.
As to step 2B, nor do any claims contain additional elements other than the natural correlation that yield improvements in a technology or technical field. The claims simply recite a natural correlation at a high level of generality such that the claims encompass the use of any and all routine and conventional methylation analyses (e.g. qPCR, sequencing, etc.). The claims lack any specificity whatsoever in the methylation assay. Without such specificity, the claims fail to recite any additional elements that amount to a specific improvement in an assay or analysis.
Thus, the claims fail to pass muster under Section 101.
Claim Rejections - 35 USC § 112- Indefiniteness
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.
Claims 1-15 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 pre-AIA the applicant regards as the invention.
In claim 1, 9 and 12, it is unclear how a supplier can be determined, or an animal certified merely by “reference methylation profiles” that are “from a different reference animal.” For example, to determine the origin of an animal, reference profiles would have to be known from specific locations/origins. Any “reference methylation profile” will not do, certainly not one merely from “different reference animals.”
In addition, one cannot determine the metes and bounds of “significantly similar” methylation profiles. Critically, he claims require “wherein if the test methylation profile of (a) is significantly similar to one of the predetermined reference methylation profiles,” then the test animal is confirmed as originating from a supplier, certified or slaughtered by a single cut. The specification is completely silent as to specific metes and bounds for “significantly similar.” This could mean any amount of similarity based on any measure. Without either of these defined, the meaning of this critical phrase is completely unclear. Instead of a clear definition, the specification vaguely states it “shall mean a similarity observed by statistical means (i.e. by using bioinformatics) and/or also by observation using the eye.” Again, no similarity is provided. No statistical means are required, nor visual observation. Applicants have merely provided a tautological “definition” that builds vaguery on top of vaguery. This will not do.
Finally, each independent claims recites “sample is confirmed of originating.” The meaning of “of” here is unclear.
In claim 3, “the panel of predetermined reference methylation profiles is distinct for different test animal-derived products,” which is confusing. Claim 1 encompasses determining sample origin by comparing methylation of sample to “a panel of predetermined reference methylation profiles of the same biological taxon of the test animal from which the product sample derives, wherein each of the predetermined reference methylation profiles is from a different reference animal.” In other words, a methylation profile from an animal sample with mere taxon similarity (e.g. any of life, domain, kingdom, phylum, class, etc.), but different animals at the same site. Thus, if the goal of claim 1 is to determine the origin of a sample, then how do different products from the same site yield this ability, much less different animals from the same domain, for example?
In claims 4 and 9, it is unclear what is certified because no certification is claimed.
In claims 5-6 and 10-15, it is unclear how a product is certified as kosher or halal based only on test methylation profiles of “different reference animals” from the same generic taxon as the test animal. A taxon can be any of life, domain, kingdom, phylum, class, etc. The claims therefore encompass using reference methylation profiles from different animals from the same generic kingdom (e.g. mouse and blue whale, myxozoa and elephant, etc.). The absurdity should be clear on its face. In addition, the claims encompass any reference animals that are different. So if two different elephants from the same site are chosen and inevitably have two different methylation profiles, then Applicants somehow believe this is enough to determine an animal product origin. Stated differently, Applicants’ claims are so broad that they encompass the confusing situation in which multiple animals from the same location have different methylation profiles, some only 20uM in size (myxozoa), yet are determined to be kosher or halal. Finally, what counts as kosher or halal is never defined. Nor is it clear how the way an animal is treated (e.g. kosher or halal), much less the actual treatment required, is correlated with a methylation profile. At best, the specification asserts that the origin of an animal may be determined based on a methylation profile. But origin is all. Thus, it is completely unclear how a mere methylation profile can be used to determine whether an animal product is kosher or halal, which is a religious certification.
In claims 8 the word “preferably” renders the scope of the claims confusing because it is not clear if what follows is required are only optional.
Claim Rejection - 35 USC § 112 – Written Description
The following is a quotation 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.
Claims 1-15 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the full scope of the claimed invention.
The specification fails to demonstrate possession of any method to determine an animal supplier, or certify an animal as kosher or halal merely by “reference methylation profiles.” In fact, the specification never actually performs this, much less provides any proof-of-principle. Instead, the specification merely wishes or plans to do so. At best, Applicants have merely dashed together a 15-page specification that provides a plan to determine which methylation markers are correlated with which animal locations. The specification fails to disclose any methylation markers. The specification fails to disclose any methylation markers of any animals. The specification fails to disclose any methylation markers of any animals at any locations. The specification fails to disclose any methylation markers of any animals at any locations certified as halal or kosher. The specification is simply silent as to any specifics whatsoever.
Moreover, no specific “significantly similar” methylation profiles are disclosed. Again, the specification merely evinces a wish to figure these out later.
And the claims encompass determining any supplier or “certification,” yet provide a single hypothetical examples of determining the kosher or halal status of the animal product. However, the specification never explains what constitutes halal or kosher products. These are not universal standards, rather subjective religious standards that change from community to community. Thus, even the single possible example of determining an animal product origin lacks written description support.
In sum, the specification reads as a plan to determine methylation profiles in order to determine whether an animal product is kosher or halal.
Claim Rejections - 35 USC § 102
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:
Novelty; Prior Art.—A person shall be entitled to a patent unless—
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; or
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..
Claims 1, 3-4 and 8-9 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Wang et al, Wild or farmed? A pilot study on determining origin of wildlife meat using methylation rate of ACTN3 gene and American mink, Mammal Research 65(3):599-605, May 2020.
This and all art rejections are based on the general concept of using methylation to determine the origin of an animal product, which is encompassed by Applicants’ incredibly broad claims.
As to claim 1, Wang teaches a method of determining the supplier from which a test animal-derived product sample originates, the method comprising the steps of:
(a) determining a test methylation profile of one or more pre-selected methylation sites within the genomic material contained in the test animal-derived product sample (Methylation sites of ACTN3 promoter region in mink samples; Abstract; Tables 2-3); and
(b) comparing the test methylation profile determined in (a) with a panel of predetermined reference methylation profiles of the same biological taxon of the test animal from which the product sample derives, wherein each of the predetermined reference methylation profiles is from a different reference animal and/or different supplier (Methylation sites of ACTN3 promoter region in wild and farm mink samples; id.),
wherein if the test methylation profile of (a) is significantly similar to one of the predetermined reference methylation profiles, the test animal-derived product sample is confirmed of originating from a first supplier from which a first reference animal with the predetermined reference profile is obtained (id.).
As to claim 3, Wang teaches the panel of predetermined reference methylation profiles is distinct for different test animal-derived products (id.)
As to claims 4 and 9, Wang teaches the first supplier is certified, and the test animal-derived product sample has the same certification as the first reference animal from which the significantly similar predetermined reference profile is obtained (“certified” wild or farmed; id.)
As to claim 8, Wang the one or more pre-selected methylation sites in (a) are methylation sites associated with tissue specific gene expression, preferably wherein the pre-selected methylation sites are associated with gene expression of one distinct tissue (id.)
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.
Claim(s) 2, 5-7 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al, Wild or farmed? A pilot study on determining origin of wildlife meat using methylation rate of ACTN3 gene and American mink, Mammal Research 65(3):599-605, May 2020, in view of US 20100216136.
The prior art as a whole demonstrates that it would have been obvious to a skilled artisan in methylation detection analyses to apply the concept of methylation profiling for animal origin/location determination to familiar animal products such as kosher or halal with a reasonable expectation of success.
Wang does not explicitly teach to determine a kosher or halal supplier origin/location.
However, molecular analyses of halal or kosher status of animals products is an obvious extension of determining the origin of an animal product as in Wang. For example, US 20100216136 applies familiar PCR molecular analysis to determine whether a food product contains pig products (Abstract). It is well known that there are millions of people that maintain a halal and kosher diet. Thus, a skilled artisan would have been familiar with kosher and halal origin as an obvious animal source to test.
Double Patenting- Obvious Type
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Instant claims 1-15 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over conflicting claims 1, 6, 8-16, 18-20, 23-27 of US 18/018398, in view of US 20100216136.
The conflicting method claims teach the same method without explicitly teaching kosher or halal animal origins. However, the conflicting claims explicitly state to determine animal origin using methylation profiling, which as killed artisan would understand to include any and all origins such as kosher or halal animal origins. The conflicting claims state:
1. A method for identifying geographic origin of an individual
test subject or of an individual group of test subjects, the method comprising:
measuring methylation status of one or more pre-selected methylation sites within genomic material contained in a biological sample obtained from the individual test subject or in biological samples obtained from the individual group of test subjects;
determining from the methylation status measured in (a) a test methylation profile of the individual test subject or the individual group of test subjects; and
comparing the test methylation profile determined in (b) with one or more predetermined reference methylation profiles, wherein each of the one or more predetermined reference methylation profiles is specific for a distinct geographic origin of subjects or a group of subjects which are of the same biological taxon as that of the individual test subject or the individual group of test subjects;
wherein if the test methylation profile is significantly similar to one of the one or more predetermined reference methylation profiles, the individual test subject or the individual group of test subjects is determined to have a geographical origin similar to the subjects or group of subjects of the one or more predetermined reference methylation profiles, wherein the test methylation profile is significantly similar to one of the one or more predetermined reference methylation profiles if 90% or more of a methylation pattern of the test methylation profile is the same as that of one of the predetermined reference methylation profiles,
wherein the distinct geographic origin is distinguished from other distinct geographic origins by one or more environmental parameters; and
wherein the pre-selected methylation sites are CpG sites selected from genes or regions that show the highest degree of methylation variance during training of the method and have a minimum sequencing coverage of 5x, wherein genes that have an average methylation level of less than 0.1 or greater than 0.9 are excluded, and
wherein the individual test subject or subjects in the individual group of test subjects are crayfish, chicken or salmon.
Conflicting claims do not explicitly teach to determine a kosher or halal supplier origin/location.
However, molecular analyses of halal or kosher status of animals products is an obvious extension of determining the origin of an animal product as in conflicting claims. For example, US 20100216136 applies familiar PCR molecular analysis to determine whether a food product contains pig products (Abstract). It is well known that there are millions of people that maintain a halal and kosher diet. Thus, a skilled artisan would have been familiar with kosher and halal origin as an obvious animal source to test.
Thus, the conflicting claims, as understood by a skilled artisan, teach the claimed method of determining if an animal product is from a kosher or halal location.
Prior Art
The following prior art teaches that methylation sequencing depth/coverage and methylation “levels” (which have different definitions from different publications) are routinely optimized: WO 2013071876; US 20150052630; US 20100273164; US 20170362638; US 20190177792; US 20170220735.
Conclusion
No claims are allowed.
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/AARON A PRIEST/Primary Examiner, Art Unit 1681
