DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
1-14
Pending:
15-25
Withdrawn:
none
Examined:
15-25
Independent:
15
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
x
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x
102, 103
JE
Judicial Exception
x
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
x
101 Other
N:N
page:line
x
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 11/15/2022 filing receipt, this application claims priority to as early as 1/24/2020. At this point in examination, all claims have been interpreted as being accorded this priority date.
Withdrawal / revision of objections and/or rejections
In view of the amendment and remarks:
The objection to the specification title is withdrawn.
The previous objections are withdrawn, however new objections are applied.
The 112/b, 112/a, 101 and 103 rejections are withdrawn, however new rejections are applied.
Rejections and/or objections not maintained from previous office actions are withdrawn. The following rejections and/or objections are either maintained or newly applied. They constitute the complete set applied to the instant application.
Claim objections
Claim 24 is objected to because of the following informalities. Appropriate correction is required. In each objection the claims are definite with respect to the issues cited here because interpretation would have been sufficiently clear to PHOSITA, but nonetheless the claims are objected to for consistency among the claims or as otherwise indicated. With regard to any suggested amendment below to overcome an objection, in the subsequent examination it is assumed that each amendment is made. However, equivalent amendments also would be acceptable. Any amendments in response to the following objections should be applied throughout the claims, as appropriate.
The following issues are objected to:
Claim
Recitation
Comment
24
cause the computer to
Should be followed by a colon
Claim rejections - 112/b
The following is a quotation of 35 USC 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 15-25 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable.
The following issues cause the respective claims to be rejected under 112/b as indefinite:
Claim
Recitation
Comment (suggestions in bold)
15
the methylation ratio
Requires but lacks clear antecedent
15
low methylated regions (LMRs)
The recited "low" is a term of relative or vague degree or form of association, neither defined in the specification (e.g. 1:26-31) nor having a well-known and sufficiently particular definition in the art and in the instant context. (MPEP 2173.05(b) pertains.) Although claims are interpreted in light of the specification, examples from the specification are not imported into the claims as limitations absent a clearly limiting definition in the specification. (MPEP 2145.VI pertains.)
22
every CpG
Requires but lacks clear antecedent, noting that "CpG" previously only was recited as an adjective. Possibly "CpG sites"
24
comprising computer instructions for use in performing the method of claim 15
The relationship is unclear between claims 15 and 24 at least because it is unclear whether the "instructions" of claim 24 must be configured according to all, some or any of the process steps of claim 15.
For example, the recited "for use..." reads on intended use.
Also, the recited "for use in performing the method of claim 15" reads on general-purpose operating system instructions without any of the specific steps of claim 1.
Also, it is unclear whether the instructions of claim 15 must perform the "providing..." and "measuring..." steps of claim 15. If yes, this may be recited more specifically along with identifying written description support for automation (e.g. robotic performance) of such physical steps.
24
wherein the computer
instructions cause the computer to
Claim 24 is rejected as directly reciting a machine/manufacture and a process in the same claim. A claim to a machine/manufacture, e.g. here a "medium," cannot directly recite a process step such as "cause." MPEP 2173.05(p).II pertains. It may suffice to add "configured to" before the process step so as properly focus on claimed structure. MPEP 2173.05(p).II pertains regarding a claim directed to both product and process.
24
receive methylation ratio
Not interpretable at least as grammatically incomplete for lack of a grammatical article. Also, the relationship to claim 15 is unclear.
24
the same set of specific CpG
sites
It is unclear whether "same" refers to the same set as in claim 15 vs. "same" between the first and second samples, etc. The relationship to claim 15 is unclear.
24
a penalized regression model
The relationship is unclear to the "model" of claim 15. If the same, then claim 24 should recite "the... model."
Similarly, the steps (i-ii) of claims 24 and the steps of claim 15 appear duplicative such that the relationships between them is unclear.
25
Table 1 and/or Table 2 and/or Table 3
Claim 25 recites: "Table 1 and/or Table 2 and/or Table 3," citing to the specification. MPEP § 2173.05(s) explains that where possible, claims are to be complete in themselves. Incorporation by reference to a specific table "'...is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.' Ex parte Fressola... (citations omitted)" (MPEP § 2173.05(s); also Rule 1.58(a) pertains). It is not clear that the instant claim recitation(s) constitute "exceptional circumstances." Any such citation to the specification, e.g. any recitation in a claim referring to a particular "Table..." in the specification, must be deleted. As one option to overcome this rejection, the referenced table(s) may be individually recited in the claim, for example as one or more text lists. Alternatively, an entire table may be copied into the claim.
Claim rejections - 112/a
The following is a quotation of 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.
Written description
Claim 24 is rejected under 112/a as failing to comply with the written description requirement. The claims read on subject matter which is not described in the specification in such a way as to reasonably convey to PHOSITA that the inventors, at the time the application was filed, had possession of the claimed invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted. With regard to any suggested amendment(s) below to overcome a rejection, equivalent amendments also would be acceptable.
Claim 24 recites "A non-transitory computer-readable storage medium comprising computer instructions for use in performing the method of claim 15," and claim 15 recites physical "providing..." and "measuring..." steps. The specification discloses "DNA methylation profiling process, preferably bisulfite sequencing..." (4:10) and "For example, methylation levels can be measured using the commercial IlluminaTM platform" (4:20), but the specification does not detail automation of this sequencing process, even the disclosed platform requiring human assistance. The written description provided is not clearly commensurate with the recited automated "identifying and determining methylation levels."
MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
As appropriate, this rejection may be overcome, for example, (i) by narrowing to clearly supported embodiments and/or (ii) by clarifying on the record where support can be found and how that support relates to the recitations.
In general, it is requested that any claim amendment in this regard be accompanied by citations to support in the original disclosure.
MPEP 2163 generally pertains.
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.
Claims 15 and 24
Claims 15 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Li (as cited on the 10/2/2025 "Notice of References Cited" form 892) in view of Horvath (as cited on the 10/2/2025 "Notice of References Cited" form 892).
Regarding claim 15, steps (a-d) read on Li (Li: p. 2, "Results;" and entire document).
Regarding the "wherein" clauses following step d), Li does not teach penalized regression, but Horvath does as "penalized regression models" (Horvath; p. 371, 1st col., 1st para.; and entire document).
The art is applied to claim 24 as described for claim 15.
Combining Li and Horvath
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the methylation analysis of Li using the related teaching of Horvath. As motivation to combine, an advantage taught by Horvath of modifying methods such as those of Li would have been the teaching of Horvath that "...advances in microarray technology... and development of biostatistics (in particular, penalized regression models...)..." (Horvath: p. 371, 1st col. 1st para.; and entire document). Thus, PHOSITA would have been motivated to modify Li using the above techniques of Horvath in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because Li and Horvath are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Horvath to the related teaching of Li.
Claims 16 and 21-23
Claims 16 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Horvath as applied to claim 15 above and further in view of Naue (as cited on the 10/2/2025 "Notice of References Cited" form 892).
Regarding claim 16, Li does not teach the recited exclusion, but Naue does as "...removed due to... Probes containing SNPs" (Naue: p. 20, 2nd col. 1st para.; and entire document) and "...removed due to... Probes hybridizing to the X or Y chromosome" (Naue: p. 20, 2nd col. 1st para.; and entire document).
Claim 21 specifies whole-genome bisulfite sequencing which reads on Naue: p. 20, §"2.2.2. Bisulfite conversion, PCR and MPS;" and entire document.
Claims 22-23 are obvious over Naue's "control probes analyzed for each sample avoiding normalization on biological effects" (Naue: p. 20, 2nd col. 1st para.; and entire document).
Combining Li and Naue
Previously cited references are combined as described above.
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the methylation analysis of Li using the related teaching of Naue. As motivation to combine, an advantage taught by Naue of modifying methods such as those of Li would have been the teaching of Naue that "...probes was removed due to different reasons..." (Naue: p. 20, 2nd col. 1st para.; and entire document). Thus, PHOSITA would have been motivated to modify Li using the above techniques of Naue in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because Li and Naue are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Naue to the related teaching of Li.
Claim 20
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Horvath as applied to claim 15 above and further in view of Gryzinska (as cited on the 10/2/2025 "Notice of References Cited" form 892).
Claim 20 recites specific ages which read on Gryzinska (Gryzinska: p. 557, §"Materials and Methods," 1st para.; and entire document).
Combining Li and Gryzinska
Previously cited references are combined as described above.
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the methylation analysis of Li using the related teaching of Gryzinska. As motivation to combine, an advantage taught by Gryzinska of modifying methods such as those of Li would have been the teaching of Gryzinska that "Our findings suggest that in general the global DNA methylation level of Polbar chickens is age dependent" (Gryzinska: p. 562, 2nd para.; and entire document). Thus, PHOSITA would have been motivated to modify Li using the above techniques of Gryzinska in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because Li and Gryzinska are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Gryzinska to the related teaching of Li.
No prior art has been applied to the following claims
No prior art is applied to claims 17-19 and 25, and these claims are not rejected under 102 or 103.
Claim rejections - 101
35 USC 101 reads:
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.
For each rejection below, dependent claims are rejected similarly as not remedying the rejection, unless otherwise noted.
Judicial exceptions (JE) to 101 patentability
Claims 15-25 are rejected under 35 USC 101 because the claimed inventions are not directed to patent eligible subject matter. After consideration of relevant factors with respect to each claim as a whole, each claim is directed to one or more JEs (i.e. an abstract idea, a natural phenomenon, a law of nature and/or a product of nature), as identified below. Any elements or combination of elements beyond the JE(s) (i.e. "additional elements") are conventional and do not constitute significantly more than the JE(s). Thus, no claim includes additional elements amounting to significantly more than the JE(s), as explained below.
In Alice, citing Mayo and Bilski, two Mayo/Alice questions determine eligibility under 101: First, is a claim directed to a JE? And second, if so, does the claim recite significantly more than the JE?
MPEP 2106 organizes JE analysis into Steps 1, 2A (1st & 2nd prongs) and 2B as follows below.
MPEP 2106 and the following USPTO website provide further explanation and case law citations: www.uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter? -- MPEP 2106.I and 2106.03
[Step 1: claims 15-25: YES]
Step 2A, 1st prong: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea? -- abstract idea -- MPEP 2106.I and 2106.04
Preliminarily, in a 1st prong of Step 2A, elements of independent claim 15 are interpreted as directed to the abstract idea of correlating methylation with age including the JE elements of "wherein a penalized regression model is applied...," "...which are then correlated..." and "establishing...," each of which, including all recitation within each listed element, in at least some embodiments within a BRI, involves only manipulation of data. In a BRI, the recited "(a) identifying and determining..." reads on embodiments which can require either physical assay or only analysis of previously acquired data.
While manipulation of data is not per se directed to an abstract idea, in this instance the above-identified elements are directed to the abstract ideas identified below.
BRIs of the claims are analogous to an abstract idea in the form of at least a mental process, at least equivalent to a computer-implemented process, including obtaining and comparing intangible data (e.g. Cybersource, Synopsys and Electric Power Group). In a BRI, it is not clear that the claim embodiments are limited so as to require complexity precluding analogy to a mental process.
BRIs of the claims also are analogous to an abstract idea in the form of a mathematical concept, including mathematical relationships and calculations, as found in the following case law, as cited and discussed above: collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group) and/or obtaining and comparing intangible data (e.g. Cybersource, Ambry and Myriad CAFC) and/or execution of an algorithm to implement mathematical relationships and/or formulas, including image processing (e.g. TLI, Digitech, Benson, Flook, Diehr, FuzzySharp, In re Grams and In re Abele all as cited in MPEP 2106).
Instant examples of math concepts include the recited model application, correlation and establishing a clock.
The preceding case law examples are cited for the basic form of their identified abstract ideas, and analogy to these example abstract ideas need not be within the same technology field, 101 analysis generally being assumed to be neutral with respect to technology field.
Regarding inherency of abstract ideas, MPEP 2106.04.II.A.1 includes: "the claims in Alice Corp. v. CLS Bank, 'described' the concept of intermediated settlement without ever explicitly using the words 'intermediated' or 'settlement'" (emphasis added, p. 1). Similarly, inherency can effectively be recitation, as in, for example, "By claiming simply 'crystalline paroxetine hydrochloride hemihydrate' with no reference to how it was produced, SKB effectively claimed 'crystalline paroxetine hydrochloride hemihydrate whether non-naturally occurring or arising through natural conversion.' Claim 1, as issued, therefore combines patentable and unpatentable subject matter, and is invalid under Section 101." (capitalization added, SmithKline Beecham Corp. v. Apotex Corp., 365 F.3d 1306, 1321-33, Fed. Cir. 2004).
In the instant type of data processing claims, the specification is not merely adding background explanation as to how a claimed process works, e.g. a physical process based on, involving or further explained by abstract ideas and natural laws. Rather, the specification is detailing the only disclosed way that a programmer may proceed from the recited inputs to the recited outputs, e.g. through actual performance of the disclosed judicial exceptions (JEs).
Regarding the "Meaning of 'Recites,'" MPEP 2106.04.II.A.1 states:
In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. While the terms "set forth" and "described" are thus both equated with "recite", their different language is intended to indicate that there are two ways in which an exception can be recited in a claim. For instance, the claims in Diehr, 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981), clearly stated a mathematical equation in the repetitively calculating step, and the claims in Mayo, 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012), clearly stated laws of nature in the wherein clause, such that the claims "set forth" an identifiable judicial exception. Alternatively, the claims in Alice Corp., 573 U.S. at 218, 110 USPQ2d at 1982, described the concept of intermediated settlement without ever explicitly using the words "intermediated" or "settlement."
While the "set forth" language approximates explicit recitation, it also is fundamental that all recitation must be interpreted and that to be patent eligible a claim must satisfy 101 according to its properly interpreted scope, e.g. for all embodiments on which the claim reads, e.g. according to any inherency pertinent to a given claim and disclosure accompanying that claim, i.e. consistent with the "described" meaning of "recites" as in the MPEP. Thus, within a BRI, the identified abstract idea elements read on one or more embodiments which only involve manipulation of data. It is not clear than any improvement argument clearly on the record causes a claim not to be directed to a JE for all embodiments within the scope of the claim.
As in Alice (at 306, as cited in the MPEP above) and Bilski (as cited in Alice, id), an abstract idea may comprise multiple abstract elements or steps (i.e. from Alice: "a series of steps" at 306) and need not be a single equation, relationship or principle.
It is not clear that the identified elements must represent other than an abstract idea according to any relevant analysis or case law.
[Step 2A, 1st prong, abstract idea: claim 15: YES]
Step 2A, 1st prong: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea? -- law of nature -- MPEP 2106.I and 2106.04
Preliminarily, at this 1st step of the analysis, elements of independent claim 15 are directed to a law relating methylation level to age, including the JE elements of "...correlated..." and "...establishing the... clock..."
A BRI of the instant claims is analogous to a law of nature as found, for example, in Mayo (as cited in the MPEP above). It is not clear than any improvement argument clearly on the record causes a claim not to be directed to a JE for all embodiments within the scope of the claim. It is not clear that the above identified law of nature including the identified elements, taken together and within a BRI, must in all embodiments represent other than a law of nature according to any relevant analysis or case law. Therefore, in answer to the 1st Mayo/Alice question, the above elements are directed to a law of nature.
[Step 2A, 1st prong, natural law: claim 15: YES]
Step 2A, 2nd prong: If the claims recite a judicial exception under the 1st prong, then is the judicial exception integrated into a practical application? -- MPEP 2106.I and 2106.04(d)
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
In Step 2A, 1st prong above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In Step 2B below, any remaining steps and/or elements are therefore in addition to the identified JE(s). Any such additional steps and additional elements are further discussed in Step 2B.
Here in Step 2A, 2nd prong, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
At this point in examination it is not yet the case that any of the Step 2A, 2nd prong considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record.
For example, regarding the first consideration at MPEP 2106.04(d)(1), the record, including for example the specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement (e.g. specification: 3:20-26).
[Step 2A, 2nd prong: claim 15: NO]
Step 2B: Do the claims recite a non-conventional arrangement of additional elements in addition to the identified JEs? -- MPEP 2106.I and 2106.05
Addressing the second Mayo/Alice question, all elements of claim 15 are part of one or more identified JEs (as described above), except for elements identified here as conventional elements in addition to the above judicial exceptions:
The recited instances of "providing..." and "measuring..." (steps a-d) are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified in MPEP 2106.05(d).II and 2106.05(f-g) and as exemplified by Li, Horvath, Naue and Gryzinska as cited above, and generally it is understood that the examples in the reference are well-known and routine
It is emphasized that, outside of an improvement argument, analysis of what is conventional generally pertains to the above-identified additional elements and not to elements identified as part of a JE.
[Step 2B: claim 15: NO]
Summary and conclusion regarding claim 15
Summing up the above analysis of claim 15, each viewed as a whole and considering all elements individually and in combination, no claim recites limitations that transform the claim, finally interpreted as directed to the identified JE(s), into patent eligible subject matter, and it is not clear that any claim is sufficiently analogous to controlling case law identifying an example of an eligible claim.
Remaining claims
Claims 16-20, 22-23 and 25 add elements which also are part of the identified JEs for the same reasons described above regarding the independent claims and therefore do not provide the something significantly more necessary to satisfy 101.
Elements of the following claims are additional elements but nonetheless are conventional elements of a laboratory or computing environment, conventional data gathering elements or conventional post-processing elements, as in the following specific examples which also are understood to be well-known and routine:
claim 21: "whole-genome bisulfite sequencing...," is a conventional element of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified by Naue, and generally it is understood that the examples in the reference are well-known and routine.
claim 24: "computer-readable storage medium...," is a conventional element of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified by Li, and generally it is understood that the examples in the reference are well-known and routine.
None of the dependent claim elements provides the something significantly more than the identified JE(s) necessary to satisfy 101.
Nonstatutory double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine to prevent the improper timewise extension of the "right to exclude" granted by a patent and to prevent multiple suits against an accused infringer by different assignees of the same invention (MPEP 804.II.B, 1st para.). A nonstatutory double patenting rejection is appropriate where the conflicting claims (instant v. reference) are not identical, but an examined-application claim (instant claim) is not patentably distinct from a reference claim because the instant claim is either anticipated by, or would have been obvious over, the reference claim (MPEP 804.II.B, 2nd para.).
In cases of double patenting rejections versus reference claims of pending applications, as opposed to claims of an issued patent, the rejections are provisional because the reference claims have not been patented. Presently, no rejections are provisional.
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 nonstatutory double patenting provided the application or patent of the reference claim either is shown to be commonly owned with the instant application or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must comply fully with 37 CFR 3.73(b).
Applicant may wish to consider electronically filing a terminal disclaimer (MPEP 1490.V pertains, along with https://www.uspto.gov/patents-application-process/applying-online/eterminal-disclaimer). Electronic filing may lead to faster approval of the disclaimer. Also, if filing electronically, Applicant is encouraged to notify the examiner by telephone so that examination may resume more quickly.
Double patenting rejections of instant claims 15-25
Instant claims 15-25 are rejected on the grounds of non-statutory double patenting as unpatentable over one or more claims in reference application 17/784,525 in view of Li (as cited on the attached "Notice of References Cited" form 892), Naue (as cited on the attached "Notice of References Cited" form 892), Horvath (as cited on the attached "Notice of References Cited" form 892) and Gryzinska (as cited on the attached "Notice of References Cited" form 892).
The instant and reference claims each take as input genomic DNA from avian specimens of varying age, determine methylation ratios and read coverages at CpG sites of "low methylation regions," perform penalized regression and output an avian methylation clock
Although the reference claims are not identical to the instant claims, in a BRI they also are not patentably distinct from the instant claims: either (i) because the instant claims recite obviously equivalent or broader limitations in comparison to the reference claims or (ii) because the instant claims recite limitations which are obvious over the cited art. It is not clear that the instant claims recite limitations which are narrower than limitations in the reference claims.
It would have been obvious in view of the cited art to modify reference claims to arrive at the rejected instant claims. Either the instant limitations are interpreted as reading on a reference limitation, or the instant limitations would have been obvious in view of the cited art. That is, to the extent that any instant claims are narrower than reference claims, then any such narrowing would have been obvious over the cited art.
Citations to art
In the above citations to documents in the art, rejections refer to the portions of each document cited as example portions as well as to the entirety of each document, unless otherwise noted in the situation of lengthy, multi-subject documents. Other passages not specifically cited within a document may apply as well.
Conclusion
No claim is allowed.
Applicant's amendments necessitated the new grounds for rejection in this 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 extension fee 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 date of this final action.
Inquiries
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The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
Prosecution Insights