DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
none
Pending:
1-34
Withdrawn:
none
Examined:
1-34
Independent:
1 and 24
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"
x
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
102, 103
JE
Judicial Exception
x
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
x
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 9/30/2021 filing receipt, this application was filed 9/20/2021 and claims priority to as early as 7/25/2017.
No prior art has been applied to the following claims
No prior art is applied to claims 1-34 -- no rejections under 102 or 103. Close art, for example as cited on the IDSs, does not teach the instant generation of a biological aging clock from biological signature data using machine learning, and it is not clear that any combinable art of record would have rendered the claims obvious.
Claim objections
Claims 1 and 24 are 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
1, 24
A method of creating a biological aging clock for a subject
In claim 1, the preamble does not recite "predicted" but the "generating" step does. Thus, the objective set in the preamble does not correspond to the later claim steps. This inconsistency should be resolved. Also a 112/b rejection pertains below.
Claim 24 is objected to similarly.
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 1-34 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
1, 24
A method...
a biological aging clock for a subject...
(d)... a predicted biological aging clock of the subject
(e)... the biological aging clock
In claim 1, the relationships are unclear among the instances of "...aging clock" at least because there is unclear antecedent, i.e. step (e) vs. the preamble and vs. step (d). As one example, this rejection might be overcome by amending both the preamble and step (e) to "... predicted biological aging clock" and amending step (d) to "[[a]]the predicted biological aging clock." Claim 24 is rejected similarly.
1, 24
(e)... the biological aging clock that identifies a
predicted biological age of the subject
In claim 1, the recitation lacks antecedent. The entire recitation "the biological aging clock that identifies a predicted biological age of the subject" specifies a particular "clock" which has not been previously instantiated as recited here. Also, the recited "the" requires but lacks clear antecedent at least because the previously recited "clock" in (d) was not recited as one that "identifies..." as recited in (e). As one example, this rejection might be overcome by amending to "the predicted biological aging clock, which clock is indicative of Claim 24 is rejected similarly.
1, 24
based on the input
vectors by the machine learning platform
Not interpretable; possibly "the vectors input by..." or any equivalent. Claims 1 and 24 are rejected similarly.
4
the results
Requires but lacks antecedent -- possibly "the" should be deleted
6
is are
Not interpretable
7
senoremediation drug treatment protocol
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "protocol") and function and/or result (here "senoremediation drug treatment") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. [24]), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. MPEP 2181 pertains, and MPEP 2187, FP 7.34.23 lists options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
7
senolytic drug treatment protocol
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "protocol") and function and/or result (here "senolytic drug treatmen") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. [24]), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. MPEP 2181 pertains, and MPEP 2187, FP 7.34.23 lists options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
11, 13, 21, 26,
34
importance
The recited "importance" is a term of relative or vague degree or form of association, neither defined in the specification ([76]) nor having a well-known and sufficiently particular definition in the art and in the instant context. (MPEP 2173.05(b) pertains.) Claims 11, 13 and 26 are rejected similarly. Claims 17 and 30 define the term in the claim and therefore are not similarly rejected. Claims 21 and 34 are rejected similarly regarding "important" (two instances in each claim).
16, 29
inputting DNA methylation vectors of the subject into deep neural network model
Antecedent is unclear at least for lack of a proper grammatical article preceding "deep neural network," e.g. "a deep neural network model..."
Claims 16 and 29 are rejected similarly.
17, 30
deep feature selection protocol
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "protocol") and function and/or result (here "deep feature selection") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. [366, 415, 423]), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. MPEP 2181 pertains, and MPEP 2187, FP 7.34.23 lists options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
17, 30
gradient-based feature selection protocol
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "protocol") and function and/or result (here "gradient-based feature selection") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. [366, 415, 423]), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. MPEP 2181 pertains, and MPEP 2187, FP 7.34.23 lists options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
18, 31
activation function protocol
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "protocol") and function and/or result (here "activation function") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. [366]), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. MPEP 2181 pertains, and MPEP 2187, FP 7.34.23 lists options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
18, 31
optimizing algorithm protocol
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "protocol") and function and/or result (here "optimizing algorithm") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. [366]), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. MPEP 2181 pertains, and MPEP 2187, FP 7.34.23 lists options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
18, 31
regularization algorithm protocol
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "protocol") and function and/or result (here "regularization algorithm") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. [366]), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. MPEP 2181 pertains, and MPEP 2187, FP 7.34.23 lists options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
19, 32
best feature selection protocol
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "protocol") and function and/or result (here "best feature selection") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. [366]), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. MPEP 2181 pertains, and MPEP 2187, FP 7.34.23 lists options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
19
a set of identified important features
The relationship is unclear between these features those in claim 17.
21, 34
adding 0.5 years pseudocount to whole age years of subjects to obtain updated DNA methylation data;
preparing a training data set and verification data set from updated DNA methylation data;
Not interpretable at least due to improper use of grammatical articles, e.g. in the "preparing" step, "a" should precede "verification...," and "the" should precede "updated..." The relationship is unclear between the instances of "updated DNA methylation data" in the "adding" and "preparing" steps.
Claims 21 and 34 are rejected similarly.
21, 34
train...
The relationship of this step/verb to the other recited steps/verbs is unclear at least due to the different grammatical form of this instance, e.g. "train" vs. "training."
Claims 21 and 34 are rejected similarly.
21, 34
with training data set
Not interpretable at least for lack of a proper grammatical article before "training data set."
Claims 21 and 34 are rejected similarly.
21, 34
training second deep neural network
Not interpretable at least for lack of a proper grammatical article before "second deep neural network."
Claims 21 and 34 are rejected similarly.
25
top ranked important features
Claim interpretations
The following claim interpretations apply:
Claim
Recitation
Comment
1, 22
machine learning platform
Definite under 112/b after properly invoking 112/f. Recites means (or an equivalent, nonce term, here "platform") and function and/or result (here "machine learning") without specifying steps or structure to prevent invoking. However, it is clear that the specification discloses sufficient structure, material, or acts and not just function, as exemplified at [74-76]. MPEP 2181.III-IV pertain. Claim 22 is interpreted similarly.
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 1-34 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 1 and 24: 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 1 are interpreted as directed to the abstract idea of designing a biological clock including the JE elements of "creating...," "inputting...," "generating...," and "preparing...," each of which, including all recitation within each listed element, in at least some embodiments within a BRI, involves only manipulation of 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. Also, "preparing" a report is not output in the same way that would be "printing" or otherwise outputting a report, such that "preparing..." is not an additional element.
Claim 24 is analyzed similarly.
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 creating input vectors, inputting the vectors into a machine learning platform and generating a predicted biological aging clock based on the input vectors, the machine learning platform being analogous to a math function having the vectors as inputs and the clock as output, as well as relationships inherent in recitations as the only supported embodiments.
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: claims 1 and 24: 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 1 are directed to a law relating biological data to age, including the JE element of "generating..."
Claim 24 is analyzed similarly.
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: claims 1 and 24: 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: [2-17]).
[Step 2A, 2nd prong: claims 1 and 24: 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 claims 1 and 24 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 "receiving..." is a conventional element 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).
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: claims 1 and 24: NO]
Summary and conclusion regarding claims 1 and 24
Summing up the above analysis of claims 1 and 24, 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 2-8, 10-22 and 25-34 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 9: "obtaining the biological sample..." and "performing a measurement..." are conventional elements of a laboratory environment and/or a conventional data gathering/input elements, as exemplified in MPEP 2106.05(d).II and 2106.05(f-g) and
claim 23: "performing a therapeutic regimen..." is conventional as exemplified by Justice (as cited on the attached "Notice of References Cited" form 892): "Therapies targeted at fundamental processes of aging" (Justice: abstract) and "Successive trials would iteratively refine the most effective interventions, doses, timing of interventions, and populations to target in subsequent larger studies." (Justice: p. 1416, 2nd col.).
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 1-34
Instant claims 1-34 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference patents 10,325,673 (from application 16/104,391); 10,665,326 (from application 16/415,855) in view of Justice (as cited on the attached "Notice of References Cited" form 892).
Each reference patent and application as well as the instant application recite claims which involve receipt of signature data, vectorization, machine learning processing and generation of a biological 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.
Combining a reference claim and Justice to arrive at an instant claim
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the breast cancer prognostic reference claim using the related teaching of Justice. As motivation to combine, an advantage taught by Justice of modifying methods such as those of the reference claim would have been the teaching of Justice that "Therapies targeted at fundamental processes of aging may hold great promise..." (Justice: abstract; and entire document). Thus, PHOSITA would have been motivated to modify the reference claim using the above techniques of Justice in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because the reference claim and Justice are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Justice to the related teaching of the reference claim. One would have had a reasonable expectation of success in doing so because the reference claim and Justice generally are drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Justice to the reference claim.
Prior art made of record but not relied upon
Additional art is listed on the attached form 892, made of record but not relied upon, and also is considered pertinent to applicant's disclosure.
Conclusion
No claim is allowed.
A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
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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