DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
none
Pending:
1-20
Withdrawn:
4 and 10-20
Examined:
1-3 and 5-9
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
x
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
x
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
XXDATE
date format
Priority
As detailed on the 5/9/2023 filing receipt, this application claims priority to no earlier than 3/15/2019. All claims have been interpreted as being accorded this priority date.
Restriction/election
Applicant’s 7/18/2024 and 9/25/2025 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 As listed above, claims are withdrawn as drawn to nonelected inventions pursuant to 37 CFR 1.142(b), and the remaining claims have been examined as listed above.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.
Objection to the specification title
The title should be amended to more specifically reflect the claims, particularly referencing steps/elements: setting the context of the invention, particular to all claims, and distinguishing the instant application from any related applications, for example: sncRNA, expression and training. The title should be "descriptive" and "as... specific as possible" (MPEP 606, 1st para. and 37 CFR 1.72; also MPEP 606.01 pertains).
Claim objections
Claims 1, 5-6 and 9 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, 5
sncRNA
Any abbreviation, not well-known, should be defined in the claims the first time it appears, e.g. "PCa" (claim 1), "snc" (claim 1), "sno" (claim 5) and "GG" (claim 8).
1
(b)... Classification algorithm
"Classification" should not be capitalized.
6
prostate derived
Should read "prostate-derived" with a hyphen
9
routine... test
Should be preceded by a grammatical article, e.g. "a"
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 1-3 and 5-9 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
a processor... configured to...
Claim 1 is to a 101 machine or manufacture, i.e. a "system" in this instance, limited according to its claimed physical structure, but it is not clear what is the structure associated with the recited "(a) interrogate..." and similar steps. The recited "system" and "processor" are not interpreted as requiring structure clearly linking the "system" to the recited steps in a structural sense appropriate to a claim to a machine or manufacture. This rejection might be overcome by, for example, reciting a data storage device, comprised by the "system," and instructions stored therein and configured according to the recited elements and steps. MPEP 2173.05(p).II pertains regarding a claim directed to both product and process.
1
(a)... for a set of informative sequences comprising a panel of hybridizing probes of SEQ ID NOs: 1-280 in a first high throughput microarray platform;
(c)... obtained in training data sets from patients known to have prostate cancer or patients with no prostate cancer;
It is unclear what physical structure comprised by the recited "system" corresponds to the recitations such that it is unclear whether and how the recitations limit the claim. Even if the claim is amended in response to the preceding rejection such that stored software comprised by the system is configured according to steps (a-d), it still would not be clear how that software corresponds to these recitations or that there is written description support for configuring that software according to these recitations, e.g. so as to enforce these recitations such that they would clearly limit the instant claim.
1
(a) interrogate...
It is unclear whether the step reads on data processing, physical assay (e.g. wet assay, e.g. the "OpenArray™ technology (ThermoFisher Scientific)" disclosed at [80]) or both. To the extent that the claim reads on physical assay, then:
(i) it is unclear what physical structure of the system corresponds to and causes to be limiting the recited physical steps and
(ii) it is unclear what robotic operation is required.
A corresponding 112(a) rejection applies below.
1, 8
(b) determine a test score (PCa score)
Claim 1 recites unclear optionality or conditionality at least because the relationship is unclear between the recited "test score" and the recited "(PCa score)" at least as to whether the parenthetical recites an option, a definition, or is merely an abbreviation for "test score." This same issue recurs with each recitation of "(PCa score)." MPEP 2111.04 and 2173.05(h).II pertain.
The following recitations similarly render their claims indefinite:
"...positive (known to have prostate cancer)" -- claim 1, (b), "wherein" clause
"...negative (known to have no prostate cancer)" -- claim 1, (b), "wherein" clause
"indolent (low grade or GG1)" -- claim 8
"intermediate/high grade (GG2-GG5)" -- claim 8
Relatedly regarding claim 1, it also is unclear whether the parentheticals in the "wherein" clause modify the preceding "cohort," "participants" or "biopsy," the latter being the most proximate but not clearly interpretable.
Generally for each recitation above, it is unclear what physical structure comprised by the recited "system" corresponds to the recitation such that it is unclear whether and how the recitation limits the claim.
1
(b)... wherein the first Classification algorithm is trained...
(c)... a score obtained...
It is unclear whether the recited "...algorithm is trained..." requires that this claim perform the training or reads on product-by-process (PbP) in which the training process is performed prior to the instantly-recited "processor... performing..." The recited "algorithm is trained" possibly should be interpreted as a product-by-process element, i.e. the recited "algorithm" limited according to any structure clearly required by the recited product-by-process limitation of having been "trained." It is not clear whether the recited process or step of having been "trained" is itself claimed and is limiting only to the extent that the structure of the "algorithm" is clearly required to be limited by that process or step. Regarding product-by-process limitations within a claim, MPEP 2113 pertains, as well as, for example, Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 9-28-2020, precedential).
The following recitations similarly render their claims indefinite:
"score obtained" -- claim 1, step (c)
"sncRNAs are extracted" -- claim 2
"each of the cDNA derived from sncRNAs obtained" -- claim 6
1
(c)... in training data sets...
The relationship is unclear between the step (b) "...trained..." and the step (c) "training data sets."
1
(c) ...from patients known to have prostate cancer or patients with no prostate cancer;
The recited "or" renders the claim indefinite as not clearly operative. It is not clear, for example, how the "training data sets" could be from only "patients with no prostrate cancer." It appears that this "or" should read "and" such that the data is from both patients with and patients without cancer.
1
(d)... has:
prostate cancer... in the training data set...; or
no prostate cancer... in the training data set...
For each instance of "the training data set," antecedent is unclear. There is previously recited only one instance of "data sets," and it is plural and was not recited with the here-recited "target population."
1-3
A system for classifying a human test subject as having prostate
cancer or no prostate cancer...
In claim 1, the relationships are unclear between the "test subject" (preamble), the "sncRNA sequences for a set of informative sequences..." (step (a)) and the "interrogated sequences" (step (b)). Claims 2-3 are rejected similarly regarding similar relationships to the recited "sample."
2
sncRNAs are extracted from a prostate derived biological sample and reversed transcribed to cDNAs
It is unclear what physical structure comprised by the recited "system" corresponds to the recitation such that it is unclear whether and how the recitation limits the claim. Depending on resolution of this rejection, a rejection under 35 USC 112(d) may apply due to the claim being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. MPEP 608.01(n).III pertains. Presently, it is assumed that recited "system" comprises stored software enforcing the recitation such that the recitation is limiting. Any amendment to overcome these rejections should be accompanied by identification of written description support.
3
wherein the prostate derived biological sample comprises sncRNA extracted from urinary exosome isolated from cell free urine
It is unclear what physical structure comprised by the recited "system" corresponds to the recitation such that it is unclear whether and how the recitation limits the claim. Depending on resolution of this rejection, a rejection under 35 USC 112(d) may apply due to the claim being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. MPEP 608.01(n).III pertains. Presently, it is assumed that recited "system" comprises stored software enforcing the recitation such that the recitation is limiting. Any amendment to overcome these rejections should be accompanied by identification of written description support.
5
the sncRNA comprises a miRNA and a snoRNA
It is unclear what physical structure comprised by the recited "system" corresponds to the recitation such that it is unclear whether and how the recitation limits the claim. Depending on resolution of this rejection, a rejection under 35 USC 112(d) may apply due to the claim being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. MPEP 608.01(n).III pertains. Presently, it is assumed that recited "system" comprises stored software enforcing the recitation such that the recitation is limiting. Any amendment to overcome these rejections should be accompanied by identification of written description support.
6
the hybridizing probes are specific for each of the cDNA derived from sncRNAs obtained from a prostate derived biological sample.
It is unclear what physical structure comprised by the recited "system" corresponds to the recitation such that it is unclear whether and how the recitation limits the claim. Depending on resolution of this rejection, a rejection under 35 USC 112(d) may apply due to the claim being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. MPEP 608.01(n).III pertains. Presently, it is assumed that recited "system" comprises stored software enforcing the recitation such that the recitation is limiting. Any amendment to overcome these rejections should be accompanied by identification of written description support.
7
the hybridizing probes detect at least SEQ ID NOs: 2, 6, 14, 20, 31, 56, 64, 67, 79, 82, 91, 92, and 161
It is unclear what physical structure comprised by the recited "system" corresponds to the recitation such that it is unclear whether and how the recitation limits the claim. Depending on resolution of this rejection, a rejection under 35 USC 112(d) may apply due to the claim being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. MPEP 608.01(n).III pertains. Presently, it is assumed that recited "system" comprises stored software enforcing the recitation such that the recitation is limiting. Any amendment to overcome these rejections should be accompanied by identification of written description support.
8
...requires further testing to classify the human test subject as...; and... requires monitoring
It is unclear what physical structure comprised by the recited "system" corresponds to each recited instance of "requires" such that it is unclear whether and how the recitations limit the claim. Depending on resolution of this rejection, a rejection under 35 USC 112(d) may apply due to the claim being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. MPEP 608.01(n).III pertains. Presently, it is assumed that recited "system" comprises stored software enforcing the recitation such that the recitation is limiting. Any amendment to overcome these rejections should be accompanied by identification of written description support.
8-9
the human test subject determined
to have prostate cancer
Requires but lacks clear antecedent at least because previous recitation is insufficiently close to "human test subject determined
to have prostate cancer" -- possibly "...classified as having..." Claim 9 is rejected similarly.
9
routine
The recited "routine" is a term of relative or vague degree or form of association, neither defined in the specification nor having a well-known and sufficiently particular definition in the art and in the instant context. (MPEP 2173.05(b) pertains.)
Claim rejections - 112/d
The following is a quotation of 112/d:
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 112/d as being of improper dependent form for failing to further limit the subject matter of the claim upon which they depend. Claim 1, from which claim 7 depends, already requires the probes recited in claim 7. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements. MPEP 608.01(n).III pertains.
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
Claims 1-3 and 5-9 are 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 1 recites "(a) interrogate sncRNA sequences for a set of informative sequences comprising a panel of hybridizing probes of SEQ ID NOs: 1-280 in a first high throughput microarray platform," and, to the extent that this recitation reads on a physical (e.g. wet) assay, then it is not clear that there is written description support for the recited software-implemented embodiment of such an assay. Also, it is not clear that the recited "system" comprises physical structure corresponding to such an assay. The specification discloses "OpenArray™ technology (ThermoFisher Scientific)" ([80]), but:
the recited "system" does not clearly comprise such physical structure and
the specification does not detail robotic operation of such physical structure, e.g. interface with and control of such physical structure.
The written description provided is not clearly commensurate with the recitation. 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.) MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
As appropriate, these rejections 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.
Regarding issues of written description support stemming even from the original claims and original disclosure, MPEP 2161.01.I (e.g. 6th para.), 2163.I and 2163.I.A pertain: "[O]riginal claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed" (MPEP 2161.01.I,6th para.).
Scope of Enablement
Claims 1-3 and 5-9 are rejected under 112/a because the specification, while enabling for using the recited SEQ IDs in the combination of claim 1 to classify prostate cancer, does not reasonably provide enablement for detection of any prostate cancer based upon correlation expression profiles as compared to any training set. The specification does not enable any person skilled in the art to make the invention commensurate in scope with the claims. MPEP 2164 pertains.
Nature of the invention and breadth of the claims
The claims require knowledge of association between risk of prostate cancer by expression of the recited SEQIDs and classifying any sample using any training set.
Direction provided by the specification and working example
The instant specification provides examples of using human patients and biopsies to determine correlations to particular risk of prostate cancer (example 2). The instant specification provides a specific correlation to classify the patients as high grade and not high grade based upon a particular aggregation to a particular test sample (example 1). However, this is not sufficient to provide guidance with regard to any sample and determining any risk of prostate cancer.
Relevant to the breadth of the claims, there is no analysis of any subjects and the expression of the sequences based upon comparison of any aggregation training set. There has been no analysis with regard to which aggregation training sets were predictive in any subject, and further the specification only provides a specific set with particular risk (high, low, etc.).
State of the art, level of skill in the art, and level of unpredictability
While the state of the art and level of skill in the art with regard to identification of expression levels in human samples is high, the unpredictability in associating any expression with a specific phenotype, as is encompassed by the claims, is even higher. The unpredictability is demonstrated by the related art and the instant specification.
Because the claims broadly encompass determining relative amount of expression, with no standard or references with regard to what would be considered, for example, it encompasses and "training set," it is relevant to point out that the prior art of Cheung (as cited on the 10/30/2025 IDS) teaches that there is natural variation in gene expression among different individuals. The reference teaches an assessment of natural variation of gene expression in lymphoblastoid cells in humans, and analyzes the variation of expression data among individuals and within individuals (p.422, last paragraph; Fig 1). The data indicates that, for example, expression of ACTG2 in 35 individuals varied by a factor of 17; and that in expression of the 40 genes with the highest variance ratios, the highest and lowest values differed by a factor of 2.4 or greater (Fig 3). It is thus unpredictable as to what ‘expression profile’ is required to establish that any expression is a marker of the presence of cancer or prognosis of cancer.
Slonim (as cited on the 10/30/2025 IDS) teaches that a common problem when developing classification schemes based on differential expression data is ‘overfitting’ the data. As a consequence, when using differential expression data to develop classification schemes, classification of the training samples may well be perfect but subsequent attempts to classify new test data fail miserably. Here there has been no attempt to validate the classification scheme based on the disclosed gene set, and so it remains highly unpredictable as to whether or not classification based on relative expression of this gene set would be successful.
Baker (as cited on the 10/30/2025 IDS) also cautions that, in the development of classifiers, a major problem is 'overfitting' meaning that if one investigates enough classification rules, then by chance one of them is likely to perform well, and that data from samples used to develop classifiers should be split to create samples for validations (p.512, right col., lns.1-8), and that larger sample sizes should be used (p.513, left col., lns.17-31).
Quantity of experimentation required
Undue experimentation would be required to make and use the claimed invention. Given that the claims read on any correlation of aggregation to any training set, one would have to perform large control studies and validation of results to determine which of the elected sncRNA occur and may be reliably and robustly associated with identifying subject as having prostate cancer.
Conclusion
Taking into consideration the factors outlined above, including the nature of the invention and breadth of the claims, the state of the art, the level of skill in the art and its high level of unpredictability, and the particular guidance in the specification including the examples, it is the concluded that an undue amount of experimentation would be required to make the invention as claimed.
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 1-3 and 5-9 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 1-3 and 5-9: 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 diagnosing prostate cancer including the JE elements of "(a) interrogate...," "(b) determine...," "(c) compare..." and "(d) classify...," 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.
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 "test score" determination and comparison.
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: claims 1-3 and 5-9: 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 sncRNA expression to prostate cancer diagnosis, including the JE element of "classify..."
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 1-3 and 5-9: 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: [11]).
[Step 2A, 2nd prong: claims 1-3 and 5-9: 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 claims 1-3 and 5-9 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.
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 1-3 and 5-9: NO]
Summary and conclusion regarding claims 1-3 and 5-9
Summing up the above analysis of claims 1-3 and 5-9, 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.
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 1-3 and 5-9
Instant claims 1-3 and 5-9 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference patent 11,661,633 (from application 16/819,070) as evidenced by Martens (as cited on the 10/30/2025 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.
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/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686