DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
1. The Election filed April 2, 2026, in response to the Office Action of February 18, 2026, is acknowledged and has been entered. Applicants elected without traverse Group III. Claims 25-41 are pending. Claims 15-40 have been withdrawn from further consideration by the examiner under 35 CFR 1.142(b) as being drawn to non-elected inventions. Claim 41 is currently under prosecution.
Claim Objections
2. Claim 41 is objected to because of the following informalities: Claim 41 recites acronyms for phrases not widely known and not defined by the claim, for example “DN”, “MNC”, and “CD45pos”. Examiner suggests spelling out the phrase to define the acronym, for example, “double negative (DN)”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
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.
3. Claim 41 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature/ a natural phenomenon) without significantly more. The claim(s) recite(s) a method for determining a Single Analyte Immune Data (SAID) score for a mammal with cancer, said method comprising:
measuring in a biological sample from the mammal, the following immunophenotypes:
PD1+CD3+DN (%CD3);
PD1+CD8+Naïve (%CD8);
Granulocytes (Grans) (cells/µL);
Neutrophils 15+16+ (cells/µL);
Grans (%CD45);
Eosinophils 15+16- (cells/µL);
PD1+CD3+ (%MNC); PD1+CD8+ (%CD3);
Intermediate Monocytes 14+16+ (cells/µL);
CD3 (%MNC); and
Monocytes (%CD45pos),
assigning a first score of -2.5 when said PD1+CD3+DN (%CD3) is 19 or above, or assigning a first score of 0 when said PD1+CD3+DN (%CD3) is less than 19; assigning a second score of +1 when said PD1+CD8+Naïve (%CD8) is 10 or above, or assigning a second score of 0 when said PD1+CD8+Naïve (%CD8) is less than 10; assigning a third score of +1 when said Grans (cells/µL) is 4500 cells/µL or above, or… assigning an eleventh score of -0.5 when said Monocytes (%CD45pos) is 35 or above, or assigning an eleventh score of 0 when said Monocytes (%CD45pos) is less than 35; and
calculating said SAID score by totaling said first score through said eleventh score.
Thus, the claim is directed to the judicial exception of naturally occurring immune cell phenotypes. This judicial exception is not integrated into a practical application because the claim recites only the detection or observation of a naturally occurring phenomenon/law of nature, which is data gathering to observe the naturally occurring phenomenon/law of nature without applying the data to a practical application.
The claim also recites “assigning” numerical scores when threshold levels of each immune cell phenotype are met, followed by totaling the scores to calculate said SAID score. Thus, the claim is also directed to an abstract idea of assigning numerical values to the immune cell phenotypes and totaling them to result in a final numerical value of the SAID score. This abstract idea is not integrated into a practical application because the claim recites only the detection or observation of a naturally occurring phenomenon/law of nature (immune cell phenotypes), which is data gathering to observe the naturally occurring phenomenon/law of nature without applying the data or score to a practical application. Attaching a numerical value to each immune cell phenotype and adding the numerical values up to represent a SAID score fails to apply the SAID score to a practical application.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite generic measurement and observation of naturally occurring immune cell phenotypes. The step of measuring the immune cell phenotypes is considered a known, routine step and is typically taken by those in the field to perform testing of a sample and are not elements that are sufficient to amount to significantly more than the judicial exception or abstract idea (see MPEP 2106.05(d)). For example, Azizi et al (Cell; 2018, 174:1293-1308) teaches measuring immune cell phenotypes form cancer patients utilizing commercially available antibodies including for PD-1 (Figures 2-6; Key Resources Table, “Antibodies”); Hartmann et al (Cell Reports, 2019, 28: 819–831) teaches measuring immune cell phenotypes from cancer patients utilizing commercially available antibodies including for PD-1 to determine immune signatures (Figures 1-6; Key Resources Table, “Antibodies for reference panel”); Krieg et al (Nature Medicine, 2018, 24:144-153) teaches measuring an immune cell phenotype signature predictive of cancer patient response to anti-PD-1 immunotherapy, including measuring PD-1 expression (Figures 1-6; Methods; Discussion); and Griffiths et al (PNAS, 2020, 117:16072-16082 and Supplementary Information) teaches measuring immune cell phenotype signatures in cancer patients in relation to anti-PD-1 immunotherapy response, including measuring PD-1 expression (Figures 1-5; Methods; Supplementary Figure S1-S7, S9, S16, Table S3 Thus, the prior art demonstrates routine methods for measuring the claimed immune cell phenotypes and teach the commercially available antibodies and reagents to do so. Further, the instant specification discloses that measuring the claimed immune cell phenotypes is known and practiced in the prior art based on each of the prior art “Literature” references cited in Table 1 teaching measurement of each immune cell phenotype:
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Routine data gathering in order to observe a natural phenomenon/ natural principle does not add a meaningful limitation to the method as it would be routinely used by those of ordinary skill in the art in order to observe the natural phenomenon/ natural principle, and it fails to narrow the scope of the claims such that others are not foreclosed from using the law of nature/natural phenomenon. Methods of detecting natural phenomenon preempt all practical uses of it as others must use/detect the natural phenomenon to apply it to any other correlations, diagnosis, prognosis, therapeutic response, monitoring, etc.
To obviate the rejection, there must be at least one additional element or physical step that applies, relies on, or uses the natural principle so that the claim amounts to significantly more than the judicial exception itself. The claimed method currently fails to provide a practical application of the judicial exception and fails to add any elements that amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4. Claim 41 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 41 recites several phrases in parenthesis, for example, (%CD3), (%CD8), (cell/µL), (%CD45), (%MNC), and (%CD45pos), and it is not clear whether these recitations are intended to be part of the claim or not.
Claim 41 is also unclear with regard to what is being measured for the immune phenotypes and how the terms in parenthesis are related to the phenotypes. Further, the claim is unclear with regard to how the numerical values for the immune phenotypes are derived in order for one to determine the threshold values above and below as claimed and to assign the first through eleventh scores.
For example, claim 41 recites “PD1+CD3+DN (%CD3)”. What is being measured to observe that phenotype? The claim then recites “assigning a first score of -2.5 when said PD1+CD8+ (%CD3) is 19 or above, or assigning a first score of 0 when said PD1+CD8+ (%CD3) is less than 19”. It is unclear what value is measured that qualifies as “19 or above” and “less than 19” in order to determine what first score is assigned.
Claim 41 recites measuring immune cell phenotype “PD1+CD8+Naïve (%CD8)” and it is unclear what is being measured. How is the (%CD8) related to the PD1+CD8+Naïve cells, what values are measured, and what values qualify as less than or above 10 to assign the claimed second score?
Claim 41 recites “PD1+CD8+ (%CD3)” and it is unclear what is being measured because it lists PD1+ and CD8+ followed by “(%CD3)” even though CD3 is not listed as part of the phenotype. Is this phenotype required to be CD3+? Similarly, it is unclear what value is measured that qualifies as 26 or above, or less than 26 in order to receive the assigned eighth score.
Claim 41 recites “Granulocytes (Grans) (cells/µL)” and it is unclear what is being measured. Are the “(cells/ µL)” in parenthesis indicating the value of measurement for the granulocyte cells? What exactly is measured in µL of what? There is no previous mention of a sample comprising µL. Similar logic applies to “Neutrophils 15+16+ (cells/ µL)”, “Eosinophils 15+16+ (cells/ µL)”, and Intermediate Monocytes 14+16+ (cells/ µL)”.
Claim 41 recites “PD1+CD3+ (%MNC)” and it is unclear what is being measured. What is “(%MNC)” and how is that related to “PD1+CD3+”? It is unclear what value is measured that qualifies as 13 or above, or less than 13 in order to receive the assigned seventh score. Similar reasoning applies to the phrase “CD3 (%MNC)”.
Claim 41 recites “Monocytes (%CD45pos)” and it is unclear what is being measured. Are the monocytes required to be CD45 positive, and what is the percentage relative to? It is unclear what value is measured that qualifies as 35 or above, or less than 35 in order to receive the assigned eleventh score.
It is unclear what is being measured to arrive at the claimed numerical values used to assign a score, and the metes and bounds of the claimed invention cannot be determined. Clarification is required.
5. Conclusion: No claim is allowed. The closest prior art made of record but not relied upon are cited in the rejection under 35 U.S.C. 101. Azizi; Hartmann; Krieg; and Griffiths measure immune cell phenotypes from cancer patients, but do not teach or suggest assigning the first through eleventh scores and totaling them as instantly claimed.
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA B GODDARD whose telephone number is (571)272-8788. The examiner can normally be reached Mon-Fri, 7am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Laura B Goddard/Primary Examiner, Art Unit 1642
Prosecution Insights