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 .
Incomplete Disclosure
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Election/Restrictions
Applicant’s election of SEQ ID NO. 1 in the reply filed on 25 February 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Interpretation
Attention is directed to MPEP 904.01 [R-08.2012].
The breadth of the claims in the application should always be carefully noted; that is, the examiner should be fully aware of what the claims do not call for, as well as what they do require. During patent examination, the claims are given the broadest reasonable interpretation consistent with the specification. See In re Morris, 127 F.3d 1048, 44 USPQ2d 1023 (Fed. Cir. 1997). See MPEP § 2111 - § 2116.01 for case law pertinent to claim analysis.
It is noted with particularity that narrowing limitations found in the specification cannot be inferred in the claims where the elements not set forth in the claims are linchpin of patentability. In re Philips Industries v. State Stove & Mfg. Co, Inc., 186 USPQ 458 (CA6 1975). While the claims are to be interpreted in light of the specification, it does not follow that limitations from the specification may be read into the claims. On the contrary, claims must be interpreted as broadly as their terms reasonably allow. See Ex parte Oetiker, 23 USPQ2d 1641 (BPAI, 1992). In added support of this position, attention is directed to MPEP 2111 [R-11.2013], where, citing In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA 1969), is stated:
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.
Additionally, attention is directed to MPEP 2111.01 [R-01.2024], wherein is stated:
II. IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE SPECIFICATION
“Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.” Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004).
Attention is also directed to MPEP 2111.02 II [R-07.2022]. As stated herein:
II. PREAMBLE STATEMENTS RECITING PURPOSE OR INTENDED USE
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The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "'extraneous' limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation")… (Emphasis added)
Attention is directed to MPEP 2111 [R-10.2019]. As stated therein:
During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard:
The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1). (Emphasis added).
Claim Rejections - 35 USC § 112, (b) / Second Paragraph
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.
Standard for Definiteness.
Attention is directed to MPEP 2171 [R-11.2013]:
Two separate requirements are set forth in 35 U.S.C. 112(b) and pre-AIA 35 U.S.C. 112, second paragraph, namely that:
(A) the claims must set forth the subject matter that the inventor or a joint inventor regards as the invention; and
(B) the claims must particularly point out and distinctly define the metes and bounds of the subject matter to be protected by the patent grant.
The first requirement is a subjective one because it is dependent on what the inventor or a joint inventor for a patent regards as his or her invention. Note that although pre-AIA 35 U.S.C. 112, second paragraph, uses the phrase "which applicant regards as his invention," pre-AIA 37 CFR 1.41(a) provides that a patent is applied for in the name or names of the actual inventor or inventors.
The second requirement is an objective one because it is not dependent on the views of the inventor or any particular individual, but is evaluated in the context of whether the claim is definite — i.e., whether the scope of the claim is clear to a hypothetical person possessing the ordinary level of skill in the pertinent art.
Attention is directed to MPEP 2173.02 I [R-07.2022]:
During prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc). As the Federal Circuit stated in Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008):
“We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.”
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During examination, after applying the broadest reasonable interpretation to the claim, if the metes and bounds of the claimed invention are not clear, the claim is indefinite and should be rejected. Packard, 751 F.3d at 1310 (“[W]hen the USPTO has initially issued a well-grounded rejection that identifies ways in which language in a claim is ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention, and thereafter the applicant fails to provide a satisfactory response, the USPTO can properly reject the claim as failing to meet the statutory requirements of § 112(b).”); Zletz, 893 F.2d at 322, 13 USPQ2d at 1322.
Attention is also directed to MPEP 2173.02 III B, which states in part:
To comply with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, applicants are required to make the terms that are used to define the invention clear and precise, so that the metes and bounds of the subject matter that will be protected by the patent grant can be ascertained. See MPEP § 2173.05(a), subsection I. It is important that a person of ordinary skill in the art be able to interpret the metes and bounds of the claims so as to understand how to avoid infringement of the patent that ultimately issues from the application being examined. See MPEP § 2173.02, subsection II (citing Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470 (Fed. Cir. 1993)); see also Halliburton Energy Servs., 514 F.3d at 1249, 85 USPQ2d at 1658 (“Otherwise, competitors cannot avoid infringement, defeating the public notice function of patent claims.”). Examiners should bear in mind that “[a]n essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.” Zletz, 893 F.2d at 322, 13 USPQ2d at 1322 [Fed. Cir. 1989]. (Emphasis added)
Attention is also directed to MPEP 2173.04 [R-10.2019], which states in part:
A broad claim is not indefinite merely because it encompasses a wide scope of subject matter provided the scope is clearly defined. But a claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear. For example, a genus claim that covers multiple species is broad, but is not indefinite because of its breadth, which is otherwise clear. But a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim). (Emphasis added)
Holding and Rationale
Claims 10-19 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.
Claim 10 is indefinite with respect to what constitutes the metes and bounds of the genus of “test agent” and “human cells”.
Claim 10 is indefinite with respect to what constitutes the metes and bounds of “observing” and how one is “observing methylation”. For example, is the method limited to that which one can see via the unaided eye, or does it encompass embodiments where a dye and/or marker is used and is observed via the unaided eye, or does it encompass embodiments where some device, or combination of devices are used to detects unlabeled “methylation markers” (oligonucleotides), or does it encompass the use of a sequence-specific detectable label, e.g., a fluorescently labeled or a radioactive nucleotide, or does it encompass something else.
Claim 10 is indefinite with respect to whether the human cells are alive or are not alive, and/or may be a portion of a tissue section, e.g., keratinized stratified squamous epithelium (“skin” of claim 11), and/or may be part of an immortalized cell line.
Claims 11-19, which depend from claim 10, do not overcome all of the issues identified above, and, thusly, are similarly rejected.
Claim 12 recites the limitation "the mammalian cells" in lines 1-2; and claim 18 recites the limitation “the mammals” in line 2. There is insufficient antecedent basis for these limitations in the claims.
Claim 13 is indefinite with respect to what constitutes the lower limit of “less than 3,000 g/mol.”
Claim 17 is indefinite with respect to what constitutes the metes and bounds of “using a weighted average of methylation markers” and “using a regression analysis”. (Emphasis added)
Claim 19 is indefinite with respect to what version(s) and components of “ polymerase chain reaction process” is/are encompassed by the 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.
Standard for Obviousness.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Attention is directed to In re Jung, 98 USPQ2d 1174, 1178 (Fed. Cir. 2011) wherein is stated:
There has never been a requirement for an examiner to make an on-the-record claim construction of every term in every rejected claim and to explain every possible difference between the prior art and the claimed invention in order to make out a prima facie rejection. This court declines to create such a burdensome and unnecessary requirement. “[Section 132] does not mandate that in order to establish prima facie anticipation, the PTO must explicitly preempt every possible response to a section 102 rejection. Section 132 merely ensures that an applicant at least be informed of the broad statutory basis for the rejection of his claims, so that he may determine what the issues are on which he can or should produce evidence.” Chester, 906 F.2d at 1578 (internal citation omitted). As discussed above, all that is required of the office to meet its prima facie burden of production is to set forth the statutory basis of the rejection and the reference or references relied upon in a sufficiently articulate and informative manner as to meet the notice requirement of § 132. As the statute itself instructs, the examiner must “notify the applicant,” “stating the reasons for such rejection,” “together with such information and references as may be useful in judging the propriety of continuing prosecution of his application.” 35 U.S.C. § 132.
Attention is directed to the decision in KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007):
When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
It is further noted that prior art is not limited to the four corners of the documentary prior art being applied. Prior art includes both the specialized understanding of one of ordinary skill in the art, and the common understanding of the layman. It includes “background knowledge possessed by a person having ordinary skill in the art. . . [A] court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1396.
Suggestion, teaching or motivation does not have to be explicit and “may be found in any number of sources, including common knowledge, the prior art as a whole or the nature of the problem itself’” Pfizer, Inc. v. Apotex, Inc. 480 F.3d 1348, 82 USPQ2d 1321 (Fed. Cir. 2007) citing Dystar Textilfarben GMBH v. C. H. Patrick Co., 464 F.3d 1356 (Fed. Cir. 2006).
Holding and Rationale
Claims 10-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0222448 A1 (Horvath) in view of US 2015/0259742 A1 (Zhang et al.) and NIH BLAST (Sequence Search SEQ ID NO. 1; sequence submitted 15 March 2012; Senaldi et al, “The sequence of Homo Sapiens FOSMID clone W12-3577J19”).
Horvath, in paragraph [0009], teaches:
[0009] In another aspect of the present invention, a multi-tissue age predictor is provided that uses a set of CpG methylation markers for estimating age. An advantage of the multi-tissue age predictor lies in its wide applicability: for most tissues it does not require any adjustments or offsets. The invention allows for the comparison of the ages of different parts of the human body. Furthermore, the multi-tissue age predictor and CpG methylation markers allow for easily accessible tissues (e.g. blood, saliva, buccal cells, epidermis) to be used to measure age in inaccessible tissues (e.g. brain, kidney, liver). For example, the methods disclosed herein can be used to estimate the age of inaccessible human brain tissue by measuring the age of more accessible tissues such as blood, saliva, skin or adipose tissue. In further aspects, the sample comprises tissue culture cells or pluripotent stem cells (e.g. induced pluripotent stem (iPS) cells). Thus, in some aspects, a method of the embodiments can be used to determine the passage number or amount of time in culture for a population of tissue culture cells. In additional aspects, a method of the embodiments can be used to assess the differentiation status (or the pluripotency) of a population of cells comprising pluripotent stem cells (e.g. iPS cells). (Emphasis added)
Horvath, paragraph [0071], teaches:
[0071] In another aspect of the invention, a set of four methylation markers are disclosed that continuously relate to age in human blood, brain tissue, and saliva.
Horvath, at paragraph [0103], teaches:
[0103] An assay is provided for identifying a compound that increases memory function and/or decreases a subject's likelihood of developing an age-related cognitive decline. The assay comprises identifying a compound which counters the age-related increase or decrease of methylation in the identified markers. Age prediction methodologies are also relevant to healthcare applications. For example, significant DNA methylation differences are known to be associated with specific age-related disorders, for example in comparisons between the brains of people diagnosed with late-onset Alzheimer's disease and brains from controls. In this context, the identification of specific loci highly correlated with age can be used to enhance the understanding of aging in health and disease. In certain embodiments of the invention, age prediction methodologies can be used as part of clinical interventions tailored for patients based on their “bio-age”—a result of the interaction of genes, environment, and time—rather than their chronological age. For example, if a person's predicted age is higher than their real age, specific interventions could be designed to return the genome to a “younger” state. Age prediction methodologies can also pave the way for interventions based on specific epigenetic marks associated with disease, as occurs in certain cancer treatments.
Horvath, at paragraph [0026], teaches:
[0026] In certain aspects of the embodiments measuring methylation marker comprises, performing methylation specific PCR (MSP), real-time methylation specific PCR, methylation-sensitive single-strand conformation analysis (MS-SSCA), quantitative methylation specific PCR (QMSP), PCR using a methylated DNA-specific binding protein, high resolution melting analysis (HRM), methylation-sensitive single-nucleotide primer extension (MS-SnuPE), base-specific cleavage/MALDI-TOF, PCR, real-time PCR, Combined Bisulfite Restriction Analysis (COBRA), methylated DNA immunoprecipitation (MeDIP), a microarray-based method, pyrosequencing, or bisulfite sequencing. For example, measuring a methylation marker can comprise performing array-based PCR (e.g., digital PCR), targeted multiplex PCR, or direct sequencing without bisulfite treatment (e.g., via a nanopore technology). In some aspects, determining methylation status comprises methylation specific PCR, real-time methylation specific PCR, quantitative methylation specific PCR (QMSP), or bisulfite sequencing. In certain aspects, a method according to the embodiments comprises treating DNA in or from a sample with bisulfite (e.g., sodium bisulfite) to convert unmethylated cytosines of CpG dinucleotides to uracil. (Emphasis added)
The above showing is deemed to fairly suggest limitations of claims 18 and 19.
Horvath, at paragraph [0094], teaches:
[0094] In addition to using art accepted modeling techniques (e.g. regression analyses), embodiments of the invention can include a variety of art accepted technical processes. For example, in certain embodiments of the invention, a bisulfite conversion process is performed so that cytosine residues in the genomic DNA are transformed to uracil, while 5-methylcytosine residues in the genomic DNA are not transformed to uracil. (Emphasis added)
The above showing is deemed to fairly suggest limitation of claims 17 and 18.
Zhang et al., at paragraph [0007], teach:
[0038] The invention provides for methods for predicting age of a subject based on the epigenome of the subject. The subject may be human, mammal, animal, plant, or any multicellular organism. Examples of suitable mammals include but are not limited human, monkey, ape, dog, cat, cow, horse, goat, pig, rabbit, mouse and rat. The age of a subject may be a chronological age or a molecular age, chemical age, methylomic age or biological age. The epigenome may be deoxyribonucleic acid (DNA) in which the DNA may be subjected to epigenetic modification. The epigenetic modification may be methylation of CpG residues. In one embodiment, the methylation is the covalent attachment of a methyl group at the carbon-5 (C-5) position of cytosine.
Zhang et al., at paragraph [0044], teaches of detecting a variety of methylation markers, including those on human chromosome 1.
A search of the nucleotide sequence of SEQ ID NO. 1 on the NIH National Library of Medicine, National Center of Biotechnology Information, finds that the nucleotide sequence of SEQ ID NO. 1 is on the human chromosome 1.
In view of the above presentation, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the method of Horvath to include other methylation markers, including that on human chromosome 1, as was used by Zhang et al., and which has the nucleotide sequence associated with SEQ ID NO. 1.
In view of the broad applicability of PCR to the detection of a variety of nucleic acid targets, one would have been amply motivated and would have had a most reasonable expectation of success, regardless of the linage of the human cells, and without regard to the type of compound(s) evaluated.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 10-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0222448 A1 (Horvath) in view of US 2015/0259742 A1 (Zhang et al.) and NIH National Library of Medicine, National Center of Biotechnology Information BLAST (Sequence Search SEQ ID NO. 1).
Claim Rejections - 35 USC § 101, Judicial Exception
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.
Effective December 16, 2014, subject matter eligibility determinations under 35 U.S.C. § 101 follow the procedure explained in the Federal Register notice titled 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618), which is found at: http://www.gpo.gov/fdsys/pkg/FR-2014-12-16/pdf/2014-29414.pdf. These guidelines were updated May 2, 2016, in the Federal Register notice titled May 2016 Subject Matter Eligibility Update, (81 FR 27381), which can be found at: https://www.gpo.gov/fdsys/pkg/FR-2016-05-06/pdf/2016-10724.pdf.
Additionally, attention is directed to Gottschalk, Comr. Pats. v. Benson, et al. (US, 1972) 175 USPQ 673, 675:
The Court stated in MacKay Co. v. Radio Corp., 306 U.S. 86, 94, 40 USPQ 199, 202, that “While a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.” That statement followed the long-standing rule that “An idea of itself is not patentable.” Rubber-Tip Pencil Co. v. Howard, 20 Wall. 498, 507. “A principle, in the abstract, is a fundamental truth; an original cause; a motive; and these cannot be patented, as no one can claim in either of them an exclusive right.” LeRoy v. Tatham, 14 How. 156, 175. Phenomena of nature, though just discovered, mental processes, abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work. As we stated in Funk Bros. Seed Co. v. Kalo Co., 333 U.S. 127, 130, 76 USPQ 280, 281, “He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end.” We dealt there with a “product” claim, while the present case deals only with a “process” claim. But we think the same principle applies. (Emphasis added)
Here the “process” claim is so abstract and sweeping as to cover both known and unknown uses of the BCD to pure-binary conversion. The end use may (1) vary from the operation of a train to verification of drivers’ licenses to researching the law books for precedents and (2) be performed through any existing machinery or future-devised machinery or without any apparatus. (Emphasis added)
Attention is also directed to the precedential decision in Ariosa Diagnostics, Inc., et al. v. Sequenom, Inc., et al. 115 USPQ2d 1152 (Fed. Cir. 2015):
In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012), the Supreme Court set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts. First, we determine whether the claims at issue are directed to a patent-ineligible concept. Id. at 1297. If the answer is yes, then we next consider the elements of each claim both individually and “as an ordered combination” to determine whether additional elements “transform the nature of the claim” into a patent-eligible application. Id. at 1298.
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Mayo made clear that transformation into a patent-eligible application requires “more than simply stat[ing] the law of nature while adding the words ‘apply it.’” Id. At 1294. A claim that recites an abstract idea, law of nature, or natural phenomenon must include “additional features” to ensure “that the [claim] is more than a drafting effort designed to monopolize the [abstract idea, law of nature, or natural phenomenon].” Id. at 1297. For process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful. See Parker v. Flook, 437 U.S. 584, 591 (1978) (“The process itself, not merely the mathematical algorithm, must be new and useful.”). (Emphasis added)
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Thus, in this case, appending routine, conventional steps to a natural phenomenon, specified at a high level of generality, is not enough to supply an inventive concept.
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Sequenom and amici encourage us to draw distinctions among natural phenomena based on whether or not they will interfere significantly with innovation in other fields now or in the future. The Supreme Court cases, however, have not distinguished among different laws of nature or natural phenomenon according to whether or not the principles they embody are sufficiently narrow. See, e.g., Parker v. Flook, 437 U.S. 584 (1978) (holding narrow mathematical formula unpatentable). In Parker v. Flook, the Supreme Court stated the issue in the case as follows: “The question in this case is whether the identification of a limited category of useful, though conventional, post-solution applications of such a formula makes respondent’s method eligible for patent protection.” Id. at 585. The answer to that question was “no” because granting exclusive rights to the mathematical formula would be exempting it from any future use.
Claims 10-18 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.
As noted in Sequenom:
First, we determine whether the claims at issue are directed to a patent-ineligible concept. Id. at 1297.
As seen in the Interim Guidelines, one asks the question
Is the claim to a process, machine, manufacture or composition of matter?
In the present case, the claims are drawn to “a method of observing effects of a test agent on genomic methylation associated epigenetic aging of human cells”.
Next, one applies the tests set forth in Mayo:
Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea?
In the present case, the claim(s) is/are directed to an abstract ides. In support of this position attention is directed to the aspect that the claims encompass virtually any “test agent” on any type of “human cells”, and that one is to perform the step of “observing methylation” which has been construed as encompassing any known or future developed device as well as using the unaided eye. It is further noted that the claim method requires “correlating methylation observed”. The aspect of correlating is deemed to constitute a natural phenomenon. The aspect of the cells being of different lineages speaks to another natural phenomenon. The aspect of performing “regression analysis” (claim 17) is deemed to constitute another abstract idea.
Having answered the first test in Mayo, one turns to the second test:
Does the claim recite additional elements that amount to significantly more than the judicial exception?
As noted above in Sequenom,
For process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful. See Parker v. Flook, 437 U.S. 584, 591 (1978) (“The process itself, not merely the mathematical algorithm, must be new and useful.”). (Emphasis added)
In the present case, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the step of bisulfite treatment was known ( US 2016/0222448 A1 (Horvath)) as was polymerase chain reaction (US 5,800,992 (Fodor et al.)).
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 10-18 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradley L. Sisson whose telephone number is (571)272-0751. The examiner can normally be reached Monday to Thursday, from 6:30 AM to 5 PM..
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/Bradley L. Sisson/Primary Examiner, Art Unit 1682