DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
none
Pending:
1-25
Withdrawn:
2-3, 8, 11 and 13-21; also, elected are: the cell type is T cell, and the immune marker combination is CD3/CD8
Examined:
1, 4-7, 9-10, 12 and 22-25
Independent:
1
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
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.
101 Other
N:N
page:line
x
Double Patenting
XXDATE
date format
Priority
As detailed on the 4/17/2023 filing receipt, this application claims priority to no earlier than 6/30/2020. All claims have been interpreted as being accorded this priority date.
Restriction/election
Applicant’s 8/26/2025 and 1/16/2026 elections are acknowledged. Because no errors in the restriction requirement were alleged distinctly and specifically, the election has been treated as an election constructively without traverse (MPEP § 818.01(a)). As listed above, claims are withdrawn as drawn to nonelected inventions pursuant to 37 CFR 1.142(b), and the remaining claims have been examined as listed above. The restriction requirement is made final.
Claim objections
Claims 1, 10 and 23-25 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
A method of predicting the risk of recurrence and/or death
The preamble recites an objective, but it is not clear that the claim delivers that objective.
1
...comprising
Preferably a colon would follow "comprising" before the subsequent list of steps. The issue occurs before each sub-list after "determining..." and "determined to have..."
10
the density of CD3+ cells and the density of
CD8+ cells is determined
Improper subject-verb agreement; probably should read "are determined"
23
The method of claim 1 that comprises the steps of...
Should recited "...further comprises..."
23
...therapy b)...
Semi-colon needed before "b)"
24-25
0-I
Should be recited and labeled as "stage 0-I" consistent with at least 13:24-34 of the specification referring to stages 0, I, II and III. Or, another meaning of the terminology should be recited if applicable.
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.)
Claim 25 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, 4-7, 9-10, 12 and 22-25 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)
1
comprising
determining...;
treating...
The relationship is unclear between the "determining..." and "treating..." steps for lack of a grammatical conjunction specifying the relationship, e.g. as to "and" vs. "or."
1
treating, by radical surgery and/or adjuvant therapy
The "preoperative adjuvant therapy" appears to be required and therefore inconsistent with the recited "or."
7
the preoperative adjuvant chemotherapy
Requires but lacks clear antecedent, noting that claim 7 does not depend from either of claims 5-6.
22
the clinical response
Requires but lacks clear antecedent
22
the ycTNM scoring system
Requires but lacks clear antecedent
Claim rejections - 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 USC 102 and 103 is incorrect, any correction of the statutory basis 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 USC 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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 USC 102(b)(2)(C) for any potential 35 USC 102(a)(2) prior art against the later invention.
Claims 1, 5-7 and 22-25
Claims 1, 5-7 and 22-25 are rejected under 35 USC 103 as unpatentable over Clay (as cited on the attached "Notice of References Cited" form 892) in view of Li (as cited on the 12/28/2022 IDS).
Regarding claim 1, determining immune and clinical response reads on Clay "evaluating immunological responses" (Clay: abstract; and entire document). The recited treating reads on "immunotherapy" (Clay: abstract; and entire document).
Clay does not explicitly teach an arithmetic mean, but Li does as "mean" (Li: p. 978, §"Statistical analysis;" and entire document).
To the extent that the limitations of the claims throughout this rejection are not explicitly taught with the recited relationships and sequencing among limitations or are taught by different embodiments within the same reference, then in the absence of a secondary consideration to the contrary it would have been prima facie obvious to PHOSITA to try the recited combination of limitations as those limitations are taught individually as described above. Trying the recited combinations would have been examples of combining prior art elements, in some instances elements taught within the same reference, according to known methods to yield predictable results and choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (MPEP 2143.I pertains).
Claims 5-6 specify types of therapy, which limitation is taught as "chemotherapy" and "radiotherapy" (Li: p. 978, §"Patients;" and entire document).
Claim 7 specifies an immune marker assay, which limitation is taught as "evaluating immunological responses as intermediate markers" (Clay: abstract; and entire document).
Claims 22-25 specify a ycTNM scoring system as well as how and when immune response is assayed, which limitations are taught as "The pretreatment extent of the disease may be clinically (cTNM) or pathologically (pTNM) determined and when neoadjuvant therapy is given before surgical intervention, the “y” prefix is added to the TNM category" (Li: p. 977, last para.; and entire document). .
Combining Clay and Li
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the cancer-related teaching of Clay using the related teaching of Li. This would have been an example of using a known technique to improve a similar method.
Claims 9-10
Claims 9-10 are rejected under 35 USC 103 as unpatentable over Clay in view of Li as applied to claims 1 and 7 above and further in view of Hagland (as cited on the attached "Notice of References Cited" form 892).
Claims 9-10 specify immune markers as CD3+ and CD8+ cells, which limitation is taught by Hagland (Hagland: title; and entire document).
Combining Clay and Hagland
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the cancer-related teaching of Clay using the related teaching of Hagland. This would have been an example of using a known technique to improve a similar method.
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, 4-7, 9-10, 12 and 22-25 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 1, 4-7, 9-10, 12 and 22-25: 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 1 are interpreted as directed to the abstract idea of calculating response including the JE elements of "determining..." and "treating...," 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. The recited "treating, by... adjuvant therapy," in a BRI, reads on non-physical embodiments of adjuvant therapy, e.g. designation for follow-up monitoring.
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 calculating immune response, its arithmetic mean, and clinical response.
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.
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 1: 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: 4:27-33; 5:5-10; 8:21-33).
For example, regarding the second consideration at MPEP 2106.04(d)(2), the recited treatment is not clearly limited to physical embodiments and is not recited with adequate particularity.
[Step 2A, 2nd prong: claim 1: 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
All elements of claim 1 are part of a JE as identified above such that no element is recited which is additional to the identified JE(s). Therefore, no claim recites significantly more than the identified JE(s), and it is not clear that any claim is otherwise sufficiently analogous to controlling case law identifying an example of an eligible claim.
[Step 2B: claim 1: NO]
Summary and conclusion regarding claim 1
Summing up the above analysis of claim 1, 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 4, 6-7, 9-10, 12 and 22-25 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:
claims 5-6: types of therapy are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified by Clay (as cited on the attached "Notice of References Cited" form 892) and Li (as cited on the 12/28/2022 IDS), 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 1, 4-7, 9-10, 12 and 22-25
Instant claims 1, 4-7, 9-10, 12 and 22-25 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference application 18/003,999 in view of Clay (as cited on the attached "Notice of References Cited" form 892) and Li (as cited on the 12/28/2022 IDS).
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.
A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
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