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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 13-15, 17-18,21 -24, 27-29, 32-33, 36-37, 39 and 102 and species A) isolated polypeptide ofKLHL12 fragment B) SEQ ID NO: 25 C) a functional fragment of an antibody D) protein G E) fluorophore F) particle and G) wash buffer in the reply filed on 9/30/2025 is acknowledged. Since applicant elected the species isolated polypeptide ofKLHL12 fragment over the kit claims, only claim 102 directed to the isolated polypeptide ofKLHL12 fragment is under consideration in the instant Office Action.
Claims 13-15, 17-18,21 -24, 27-29, 32-33, 36-37 and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/30/2025.
Claim 102 and new claims 103-104 are under consideration in the instant Office Action.
Withdrawn Objections
The objections to the drawings are withdrawn in view of the new amendments to the specification submitted on 3/4/2026.
New Rejections Necessitated by Amendment
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.
Claim 104 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.
Claim 104 calls for the intended effect of the claimed KLHL-12 fragment being bound by an antibody and “… the binding exhibits a standard score for a signal-to-noise ratio of 25 or less (ZS).” It is unclear what is meant by the standard score or what the ZS found in parenthesis is since it does not appear to be an acronym. Therefore, it is unclear what limitations are being set forth in the instant claim.
MPEP § 2173.02 (II) states that one of the purposes of examination under 35 USC § 112, second paragraph is to determine whether the claim apprises one of ordinary skill in the art of its scope and, therefore, serves the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent. See, e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). See also In re Larsen, No. 01-1092 (Fed. Cir. May 9, 2001) (unpublished). If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993). In this case, others are not fairly apprised of the scope of the claimed KLHL-12 fragment and thus not fairly warned as to what constitutes infringement.
Modified Rejections Necessitated by Amendment
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.
Claim 102 and new claims 103-104 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claim recites one product that encompasses an isolated polypeptide comprising a Kelch-like 12 (KLHL12) fragment comprising an amino acid sequence of SEQ ID NO: 25, (the elected species) wherein the amino acid sequence begins at the first recited amino acid residue. The new claims 103-104 call for the KLHL-12 fragment to be chemically synthesized or recombinantly expressed or that this fragment is bound by an antibody. This judicial exception is not integrated into a practical application because this isolated polypeptide product is part of a naturally occurring protein KLHL12. The fact that the instantly claimed product is a peptide that is isolated from a naturally occurring peptide does not mitigate the fact that it is a naturally occurring product. Breaking bonds of amino acids (isolation) is not considered markedly different under the natural product rejection neither that the product is produced from a method but is indistinguishable from what occurs in nature. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim is towards products that are no different from the products found in nature.
The subject matter eligibility under 35 U.S.C. 101 of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products) was confirmed by the U.S. Supreme Court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. _, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012). "[L]aws of nature, natural phenomena, and abstract ideas" are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. __, __ (2010) (slip op., at 5). "Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work." Gottschalkv. Benson, 409 U. S. 63, 67 (1972).
In brief, in Prometheus, a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder is the focus. This method comprises a) administering 6-thioguanine to patients and b) determining the level of 6-thioguanine in the patients and c) correlate the level of 6-thioguanine, i.e. a certain level/red blood cells, with the decision whether a need for increase or decrease the amount of 6-thioguanine treatment in said patients.
In Prometheus, the Court found that "[i]f a law of nature is not patentable, neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Additionally, "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law". Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at __ (slip op., at 14) ("[T]he prohibition against patenting abstract ideas 'cannot be circumvented by’..., adding 'insignificant post-solution activity'" (quoting Diehr, supra, at 191-192)).
The Court also summarized their holding by stating "[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately."
Thus, if the claim recites or involves a judicial exception, such as a law of nature/natural principle or natural phenomenon (e.g., the law of gravity, F=ma, sunlight, barometric pressure, etc.), and/or something that appears to be a natural product (e.g., a citrus fruit, uranium metal, nucleic acid, protein, etc.), then the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself.
In the instant case, based upon an analysis with respect to the claim as a whole, claim 102 and new claims 103-104 are determined to be directed to judicial exception without significantly more. The rationale for this determination is explained below in view of controlling legal precedent set forth in 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618) dated December 16, 2014 and 2019 Revised Patent Subject Matter Eligibility Guidance (84 FR 50) dated January 07, 2019.
The instant claims 102-104 encompasses a product. (Step 1: Yes).
Next, Step 2, is the two-part analysis from Alice Corp. (also called the Mayo test) to determine whether the claim is directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions). (In Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014) the Supreme Court sets forth a two-step test for determining patent eligibility. First, determine if the claims encompass a judicial exception (a natural phenomenon/law of nature/abstract idea). If so, then ask whether the remaining elements/steps, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to ‘“transform the nature of the claim’ into a patent-eligible application.” Id. at 2355 (quoting Mayo, 132 S. Ct. at 1297). Put another way, there must be a further “inventive concept” to take the claim into the realm of patent eligibility. Id. at 2355. In the recent Myriad v Ambry case, the CAFC found claims (drawn to methods comprising obtaining tissue samples, analyzing sequences of cDNA and comparing germline sequences of a gene to wild-type sequences) to encompass the abstract mental processes of ‘comparing’ and ‘analyzing’. Recitation of specific techniques (in Myriad claims 7 and 8 further recited hybridization and PCR) were deemed not “enough” to make the claims patent-eligible since the claims contained no otherwise new process. The elements/steps recited in addition to the judicial exception did nothing more than spell out what practitioners already knew). The instant claim encompasses the a naturally occurring protein and their fragments, and thus are a judicial exception. The product is naturally occurring human KLHL12 protein and a fragment that is isolated from the whole protein as evidenced by the claim and the specification as filed and the prior art, Lim et al., US2017/0307607 (IDS 11/11/24). Lim teaches the KLHL12 and KLHL12 fragments that are human and thus a judicial exception (Step 2A/1: Yes). Next, prong two of Step 2A requires identifying whether there are additional elements recited in the claim beyond the judicial exception(s) and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. “Integration in to a practical application” requires an additional element or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such as the claim is more than a drafting effort designed to monopolize the exception. In the instant case, the claim does not recite any additional elements to integrate the judicial exception into a practical application because all the claim involves a natural product. (Step 2A/2: No). The second step is determining if the claims recite or involve judicial exceptions, such as laws of nature, natural phenomena, or natural products. In this case, the claim calls for specific products that do not structurally change the instantly claimed substance, only specifically call out the naturally occurring products. The instant specification does not teach anything beyond claimed products that encompass the natural products. The claim fails to include any limitations which would distinguish the claimed products from those which occur in nature since they are towards an KLHL12 fragment that does not change or effect the structure or function of the claimed products. The fact that the instantly claimed product is a peptide fragment that is isolated from a naturally occurring source does not mitigate the fact that it is a naturally occurring product. Breaking bonds of amino acids (isolation) is not considered markedly different under the natural product rejection. In the absence of the hand of man, naturally occurring products are considered non-statutory subject matter. While the new claim 103 calls a peptide that was produced via chemical synthesis or recombinantly expressed, this still reads on naturally occurring product since it will still result in a fragment of naturally occurring protein and therefore, still a natural product. Specifically, the claim, as written, do not sufficiently distinguish over the proteins that exist naturally because the claim does not particularly point out any non-naturally occurring differences between the claimed product and the naturally occurring product.
The claim reads on a natural product because it comprises naturally occurring components that are not markedly different from the naturally occurring products. Isolating the products (peptides) does not significantly change it structure or function. There are no steps that change this from a natural product. The instant claim does not recite any elements in addition to the natural products that impose meaningful limits on the claim scope and would substantially foreclose others from using these natural products. The intended use of this composition does not further limit or change the basic structure of these naturally occurring products. The composition does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee. See Myriad, 133 S. Ct. at 2117.
The natural products are found in nature and do not differ from what is found in nature.
Note that the recited products cannot add significantly more to satisfy step 2B since the claim fails to integrate the products in a practical application since the claimed products are known to occur in nature. In the final step it must be determined if the claim as a whole amounts to something significantly more than the judicial exception. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claim 102 fails to include any limitations which would distinguish the claimed proteins from those which occur in nature since they all still encompass embodiments that read on natural products. The new dependent claims also fail in differentiating the claimed product from the natural product. In the absence of the hand of man, naturally occurring products are considered non-statutory subject matter. (Step 2B: No).
Thus, for reasons fully explained above, claim 102 and new claim 103-104 do not satisfy the requirement of 35 U.S.C. 101 and are therefore rejected.
Response to Arguments
Applicant's arguments filed 3/4/2026 have been fully considered but they are not persuasive. Applicant argues that a PTAB decision in Ex Parte Chai Ezerzer and Nicholas Harris overcomes the natural product rejection over the claimed KLHL12 fragment. Applicant’s citation of another patent application is not persuasive regarding the prosecution of the present application, since each patent application is prosecuted on its own merits and what was done in a previous case does not constitute imprimatur for the prosecution of further cases. In re Gyurik, 596 F.2d 1012, 201 USPQ 552 (CCPA 1979); In re Attwood, 267 F.2d 954, 122 USPQ 378 (CCPA 1959); In re Freedlander, 136 F.2d 759, 760, 58 USPQ 402, 403 (CCPA 1943).
Applicant appears to be arguing that since the instantly claimed product is a fragment and not the full protein that it is significantly different from its form found in nature. This is not found persuasive because the Supreme Court's opinion in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013), controls in these circumstances. In Myriad, the Court considered claims directed to isolated DNA encoding the BRCA1 polypeptide and fragments of at least 15 nucleotides of that DNA. Id. at 2113. The Court held that "Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention." Id. at 2117. "Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes 'new ... composition[s] of matter,' § 101, that are patent eligible." Id. "Nor are Myriad's claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a [non-naturally] occurring molecule." Id. at 2118. This is directly analogous to the instant claims. Whereas Myriad chose small segments from larger genes, the instant claims are directed to a small segment from a larger protein and there is no evidence of record to indicate that this peptide has any characteristic distinct from its function in the full protein. To elaborate, merely synthesizing the peptide of SEQ ID NO: 25, which is the handiwork of nature, and not the product of human ingenuity, using routine and conventional methodology (e.g., solid phase peptide synthesis) such that the peptide is at one point attached to a solid phase support and later released in the form of a solution and then perhaps lyophilized to produce a freeze-dried solid for storage does not transform the naturally occurring product into patentable eligible subject matter. It is not inventive to discover a naturally occurring peptide and then simply proceed by making more of the same, especially when the same peptide when produced synthetically using routine and conventional methodology necessarily produces the peptide. Therefore, the arguments are not found persuasive and the rejection is maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Advisory Information
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.Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURORA M. FONTAINHAS whose telephone number is 571-272-2952. The examiner can normally be reached on Monday - Friday (8AM - 4PM).
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, Jeffrey Stucker can be reached on (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
Prosecution Insights