DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Continued examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous office action has been withdrawn pursuant to 37 CFR 1.114. MPEP 706.07(h) pertains.
Status of claims
Canceled:
none
Pending:
1-7
Withdrawn:
none
Examined:
1-7
Independent:
1 and 6-7
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
x
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
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 7/6/2021 filing receipt, this application claims priority to as early as 9/6/2018. At this point in examination, all claims have been interpreted as being accorded this priority date.
Withdrawal / revision of objections and/or rejections
In view of the amendment and remarks:
The 112/b rejections are withdrawn, except as noted below, and new rejections are applied.
The 112/a rejections are withdrawn, except as noted below, and new rejections are applied.
The 103 rejections are withdrawn.
Claim objections
Claims 1 and 6-7 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, 6-7
The left margins should be aligned among the "quantifying," "calculating," "predicting," etc. steps.
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 1-7 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.
It may be helpful to request an interview to discuss the below 112/b rejections.
The following issues cause the respective claims to be rejected under 112/b as indefinite:
Claim
Recitation
Comment (suggestions in bold)
1, 6-7
based on the expression ratio of extracellular domain and intracellular domain in the same protein
Antecedent status is unclear. Each of "extracellular domain" and "intracellular domain" should be preceded by a grammatical article, possibly "an." It similarly is unclear whether these "intracellular" and "extracellular" refer to the previously instantiated "different domains." Relatedly, it is unclear whether the recited "the same protein" refers to the previously recited "one protein."
Possibly the "one protein" comprising each of an "extracellular domain" and an "intracellular domain" should be instantiated in detail in the "staining" step and then clearly referenced in the later steps, following ordinary practice as to recitation of antecedents.
Claims 6-7 are rejected similarly.
1, 6-7
the comparison result
Requires but lacks clear antecedent
1, 6-7
predicting prognoses
It is unclear why "prognoses" is plural. In the specification, the term is plural because it is disclosed in the context of plural "patients" (pp. 21 and 30). However, the claims recite only one patient, "a human." Possibly the claims should recite "predicting a prognosis." There are two instances of the recitation in each claim. Contrast claim 5.
4
each of the staining reagents is a combination of a biological material recognition site and phosphor integrated dots integrated with fluorescent substances
Referring to a single "staining reagent," e.g. "each" of the plural "reagents," it is unclear why "dots" and "substances" each is plural. Possibly each should read "one or more dots" and "one or more substances." Possibly each should be singular when recited in the context of a singular "staining reagent." Support should be identified for any such amendment.
Also, "phosphor integrated" should be hyphenated, e.g. "phosphor-integrated."
4
calculating the ratio between numbers of bright spots
The recited "numbers" requires but lacks clear antecedent. The element was instantiated as singular, "a number of bright spots." Possibly the recited "for each of the domains" should be amended into the preceding "quantifying includes..." "wherein" clause.
6-7
...that acquires information from a tissue section of a
human by staining...
Claim 7 is rejected as directly reciting a machine and a process in the same claim. A claim to a machine, e.g. here a "computer readable medium," cannot directly recite process steps such as "acquires" and "staining." MPEP 2173.05(p).II pertains. It may suffice to add "configured to" before the process step so as properly focus on claimed structure. Regarding any software-embodied steps, it should be clear whether such steps are in fact software-embodied, and it should be clear whether such software is comprised by the claimed machine or manufacture.
Claim 6 is rejected similarly with regard to its recited "acquires."
These rejections are maintained.
6
...the device comprising:
...
predicting...;
comparing...; and
generating...
Claim 6 is rejected as directly reciting a manufacture and a process in the same claim. A claim to a manufacture, e.g. here a "device," cannot directly comprise process steps such as "predicting...," "comparing..." and "generating..." MPEP 2173.05(p).II pertains.
7
...the program making the computer function as...
Claim 7 is rejected as directly reciting a manufacture and a process in the same claim. A claim to a manufacture, e.g. here a "computer readable storage medium," cannot directly recite process steps such as "making." MPEP 2173.05(p).II pertains. It may suffice to add "configured to" before the process step so as properly focus on claimed structure, e.g. "...the program configured to make the computer function as..."
7
...the program making the computer function as:
...
predicting...;
comparing...; and
generating...
The relationship is unclear between the recited "the program making the computer function as:...," which, grammatically, should be followed by one or more nouns, and the subsequently recited verbs "predicting...," "comparing..." and "generating..." That is, "...function as... comparing..." is grammatically incorrect.
7
staining
Distinct from the above 112/b rejections, claim 7 also is rejected under 112/b corresponding to the below 112/a rejection. This rejection is maintained.
6-7
quantification unit
Claim 6 is indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "unit") and function and/or result (here "quantification") 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. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs, particularly not in the context of computer automated staining of a tissue section. 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.
Claim 7 is rejected similarly and additionally because it is not clear how "computer readable medium" or a "computer" can comprise or function as a "quantification unit." In a BRI, "quantification unit" reads on machines which physically interact with proteins.
These rejections are maintained.
Each issue above causes the scope of the claim to be indefinite because it is unclear how the claim elements relate to each other and to the claim as a whole.
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.
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.).
Written description
Claims 1-7 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. This rejection is necessitated by the amendment and remarks.
Claim 7 regarding "device that acquires information ... by staining different domains"
Claim 7 recites "A non-transitory computer readable medium storing a program
for a computer of an information acquiring device that acquires information from a tissue section
of a human by staining different domains..." The specification discloses essentially the same language (e.g. [12-15, 29, 67, 73-74, 92-93]) without further disclosure as to how PHOSITA would make the device recited as performing "staining..." This is not only a matter of performing staining but also of creating a device to perform the staining, effectively in an automated manner. For PHOSITA-performed "staining..." via physical action on the tissue section, for example as in claim 1, it is understood that PHOSITA would have had knowledge to perform manual "staining...," including selecting, obtaining and manipulating reagents. However, in claim 6, for computationally-implemented, effectively automated "staining...," it is not clear that PHOSITA would have had knowledge to implement the required software and hardware, and it is not clear that such information is disclosed. The written description provided is not clearly commensurate with the recited automated "staining" to be provided. Relatedly, 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.
This rejection is maintained.
Claims 1-7 regarding "predicting prognoses based on the expression ratio of extracellular domain and intracellular domain in the same protein"
Claim 1 recites "predicting prognoses based on the expression ratio of extracellular domain and intracellular domain in the same protein..." The recited relationship between the ratio and the prognosis is disclosed in the context of PD-L1 and cancer (e.g. [242], referring to paragraphs as numbered in the US PGBPUB, as they also are cited in the 2/27/2026 Applicant remarks), but the claim is not so limited. The claim reads on any prognosis regarding any disease and any transmembrane protein. It is not clear that there is written description support for the entire claimed scope. It is not clear that from the disclosed example (e.g. [225-245]), PHOSITA would have known how to practice the claims for all prognoses, all diseases, and all transmembrane proteins with a reasonable expectation of success. The written description provided is not clearly commensurate with the claim.
Claims 6-7 are rejected similarly. Relatedly, MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
Dependent claims are rejected similarly.
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.
Claims 1-7 regarding "comparing the expression ratio with a predetermined threshold" and "predicting prognoses according to the comparison"
Claim 1 recites "comparing the expression ratio with a predetermined threshold..." and "predicting prognoses according to the comparison." It is unclear what if any disclosure in the specification supports the recitations. The written description provided is not clearly commensurate with the claim.
Claims 6-7 are rejected similarly. Relatedly, MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
Dependent claims are rejected similarly.
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.
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.
Response to arguments regarding Claim Rejections - 35 USC 101 -- Abstract idea
Applicant states (p. 8):
In view of the above [amendment], the claims are allowable.
Simply and directly asserting patent eligibility or practical application is not persuasive. The rejection is maintained and revised.
The Office conducts 101 analysis per relevant case law as captured and organized in MPEP 2106, which provides various paths to satisfying 101. It is important to identify which path is argued.
As described in the MPEP, certain conclusions, e.g. the final conclusion regarding 101, i.e. patent eligibility, but also the conclusion as to practical application leading to patent eligibility, are best analyzed via the paths discussed in MPEP 2106, rather than directly arguing either. For example, in Step 2A, 2nd prong, the MPEP identifies multiple possible considerations demonstrating practical application. The rationales of these considerations, each distinctly established via case law and discussed in MPEP 2106, provide a more robust and detailed argument leading to and supporting a conclusion of practical application and patent eligibility versus directly arguing these conclusions on their face.
Judicial exceptions (JE) to 101 patentability
Claims 1-7 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 1-7: 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 a ratio including the JE elements of "calculating...," "predicting...," "comparing..." and "generating...," 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.
Claims 6-7 are interpreted 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 ratio calculation, the prediction based on the ratio and the threshold 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 and 6-7: 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 claims 1 and 5-7 are directed to a law relating domain expression to prognosis, including the JE element of "...predicting prognoses..."
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 5-7: 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: [55]).
[Step 2A, 2nd prong: claims 1 and 6-7: 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 7 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:
Manual "staining" and "quantifying" are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified in MPEP 2106.05(d).II and 2106.05(f-g).
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 6-7: NO]
Summary and conclusion regarding claims 1 and 6-7
Summing up the above analysis of claims 1 and 6-7, 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
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 2-5 are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified by the art applied to these claims in the above 103 rejection, which examples are understood to be routine and well-known.
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 (previously 1672)