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 .
Claim Status
Claims 2-5 and 10 have been cancelled as requested in the amendment filed on 11/28/2025. Following the amendment, claims 1, 6-9, and 11-27 are pending in the instant application.
Claims 1, 6-9, and 11-27 are under examination in the instant office action.
Claim Rejections - 35 USC § 103 - Withdrawn
Claims 1, 6-8, 11, 13, 16, and 24-27 were rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/209926 A1 (previously cited on PTO-892; herein after referred to as "Pestell") in view of non-patent literature by Fox et. al. (Journal of Leukocyte Biology, 2015, 98, 59-71; previously cited on PTO-892; herein after referred to as "Fox"), non-patent literature by Adams et. al. (PNAS, 2014, 111(9), 3514-3519; previously cited on PTO-892; herein after referred to as “Cristofanilli”), and non-patent literature by Suenaga et. al. (European Journal of Cancer, 2019, 107, 100-114; previously cited on PTO-892; herein after referred to as "Suenaga").
Claims 9, 12, 17-19, and 23 were rejected under 35 U.S.C. 103 as being unpatentable over Pestell, Fox, Cristofanilli, and Suenaga, as applied to claims 1, 6-8, 11, 13, 16, and 24-27 above, and in further view of non-patent literature published by Adams et. al. (Cancer Epidemiol Biomarkers Prev, 2016, 25(7), 1037-1042; previously cited on PTO-892; herein after referred to as "Marks").
Claims 14-15 were rejected under 35 U.S.C. 103 as being unpatentable over Pestell, Fox, Cristofanilli, Suenaga, and Marks, as applied to claims 1, 6-9, 11-13, 16-19, and 23-27 above, and in further view of non-patent by Yamada et. al. (Clinical Anatomy, 2008, 21, 307-313; previously cited on PTO-892; herein after referred to as "Yamada").
Claims 20-22 were rejected under 35 U.S.C. 103 as being unpatentable over Pestell, Fox, Suenaga, and Marks, as applied to claims 1, 6-9, 11-13, 16-19, and 23-27 above, and in further view of non-patent literature by Adams et. al. (RSC Adv, 2016, 6, 6405-6414; previously cited on PTO-892; herein after referred to as "Stefansson").
Applicant’s arguments, see Pages 8-14 of Remarks, filed 11/28/2025, with respect to the above-listed claim rejections have been fully considered and are persuasive. The above-listed claim rejections have therefor been withdrawn.
Claim Rejections - 35 USC § 101 - Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1, 6-9, and 11-27 under 35 U.S.C. 101 is maintained, with additional arguments detailed below, because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Furthermore, the claims do not integrate said judicial exception in to practical application, and the claims do not recite additional elements that amount to significantly more than said judicial exception.
The 2019 Patent Subject Matter Eligibility Guidance (“Guidance”) provides a means of determining whether a particular claim is patent eligible under 35 U.S.C. 101. The Guidance requires an analysis of multiple steps, Steps 1, 2A, and 2B:
Step 1 - Following a determination of the broadest reasonable interpretation of a claim, is the claim drawn to a process, machine, manufacture, or composition of matter? If the answer to this inquiry is “Yes,” the analysis moves on to step 2A.
Step 2A - A two-prong analysis. For prong one, does the claim recite an abstract idea, law of nature, or natural phenomenon? If “Yes,” the analysis proceeds to prong two, which asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If “No,” the analysis moves on to step 2B.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? If “No,” the claim is not eligible subject matter under 35 U.S.C. 101.
With respect to claims 1, 6-9, and 11-27, the claims are drawn to a process, so the answer to Step 1 is “Yes.”
With respect to prong one of Step 2A, the answer is “Yes,” because the claims are drawn to a natural phenomenon, specifically, the correlation between levels/pools of CCR5 in circulating cells of a biological sample from a subject, wherein said circulating cells are CAMLs having the characteristics recited in instant claim 1, and overall survival and progression free survival.
With respect to prong two of Step 2A, the claims do not recite additional elements that integrate the judicial exception into a practical application. In addition to the recited judicial exception, the claims recite the step of determining the number of CCR5 pools in circulating cells (i.e., CAMLs) in a biological sample; however, this step primarily relates to general methods of measuring CCR5 levels/pools in circulating cells in a biological sample and does not integrate the judicial exception into a practical application. The claims further recite comparing the results with a reference sample, which is an abstract step that is not sufficient to integrate the judicial exception into a practical application. It is further noted that claim 25, for example, recites administering generalized cancer treatment; however, generalized treatment does not integrate the recited judicial exception, for example, by applying or using said judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition.
Therefore, the answer to prong two of the Step 2A analysis is “No.”
With respect to Step 2B, as indicated above, the claims recite the step of determining the number of CCR5 pools in circulating cells in a biological sample; however, this step is considered a known, routine step taken by those in the field to perform testing of a sample and is not an element that is sufficient to amount to significantly more than the judicial exception (see MPEP 2106.05(d)). For example, Vaday et. al. (The Prostate, 2006, 66, 124-134) and Aldinucci and Colombatti (Mediators of Inflammation, 2014, 2014(292376), 1-12) implicate CCR5 and the CCL5-CCR5 axis in various cancers (pancreatic cancer and various hematological/solid cancers, respectively) wherein activation of CCR5 promotes cancer cell proliferation, cancer progression, and/or cancer cell migration. Vaday et. al. (The Prostate, 2006, 66, 124-134), Guglielmi et. al. (Blood, 2011, 118(4), 1177-1178), and Shirvani et. al. (Blood, 2011, 118(4), 1175-1176) further indicate the circulating CD4+ T cells and/or blood cells comprise detectable intracellular stores/pools of CCR5, which are detectable by antibody (e.g., anti-CCR5 mAb 2D7 as disclosed by both Guglielmi and Shirvani). Additionally, the mechanism(s) of CCR5 internalization by endocytosis have also been heavily studied; Signoret et. al. (Molecular Biology of the Cell, 2005, 16, 902-917), Signoret et. al. (Traffic, 2004, 5, 529-543), Signoret et. al. (Journal of Cell Science, 1998, 111, 2819-2830), Kershaw et. al. (Methods in Enzymology, 2009, 460, 357-377), Longden et. al. (British Journal of Pharmacology, 2008, 153, 1513-1527), Blanpain et. al. (Molecular Biology of the Cell, 2002, 13, 723-737), and Venkatesan et. al. (Molecular Biology of the Cell, 2003, 14, 3305-3324) all disclose mechanisms by which CCR5 is activated and subsequently internalized from the cell surface via endocytic pathways wherein said internalization occurs after CCR5 is bound/activated by an agonist (e.g., cytokines, agonist antibodies, etc.). 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. Thus, this step does not amount to an additional element that amounts to significantly more than the recited judicial exception. Accordingly, the answer to the Step 2B analysis is “No,” and therefore the claims are not eligible subject matter under 35 U.S.C. 101.
Additionally, it was noted above that claim 25 recites an additional step of “administering a therapeutically effective amount of a cancer treatment to the subject”, which is simply appending well-understood, routine, conventional activity of treating liver dysfunction. A treatment with a “therapeutically effective amount of a cancer treatment” is a treatment specified at a high level of generality. It is a limitation that is well-understood, routine, conventional activity in the field of treating cancer and does not amount to significantly more than the judicial exception (see MPEP 2106.05(d)). The step of “administering a therapeutically effective amount of a cancer treatment to the subject” recited in claim 25 is also a generic instruction to apply the judicial exception, or an insignificant extra-solution activity, and is not considered a practical application of the judicial exception. Applying or using the judicial exception to effect a particular treatment is considered a practical application, however, in the instant claims, a “therapeutically effective amount of a cancer treatment” is not considered a particular treatment (see MPEP 2106.05(f)). Therefore, the judicial exception is not integrated into a practical application.
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.
With regard to the above-listed claim rejection under 35 U.S.C. 101, Applicant argues the following:
The step of determining the number of CCR5 pools in CAMLs in a biological sample was not a well-understood, routine, and conventional data gathering step that was practiced by investigators prior to Applicant's invention. It was not until the work of the present inventors that it was discovered CAMLs could display CCR5 pools. Indeed, the Examiner has failed to point to any teaching to the contrary. Therefore, it cannot be said that the step of determining the number of
CCR5 pools in CAMLs in a biological sample was a well-understood, routine, and conventional data gathering step that was practiced by investigators prior to Applicant's invention. As such, Applicant argues that the answer to the Step 2B analysis should be "Yes," and the claims should be considered eligible subject matter under 35 U.S.C. 101.
Applicant’s argument has been fully considered, but is deemed not persuasive.
With regard to Applicant’s argument, it is noted that additional arguments by way of prior art citations have been added to the maintained claim rejection under 35 U.S.C. 101, as presented above. Specifically, it is noted that novel judicial exceptions are still judicial exceptions (see MPEP 2106.04): The Supreme Court’s decisions make it clear that judicial exceptions need not be old or long-prevalent, and that even newly discovered or novel judicial exceptions are still exceptions. For example, the mathematical formula in Flook, the laws of nature in Mayo, and the isolated DNA in Myriad were all novel or newly discovered, but nonetheless were considered by the Supreme Court to be judicial exceptions because they were "‘basic tools of scientific and technological work’ that lie beyond the domain of patent protection." Myriad, 569 U.S. 576, 589, 106 USPQ2d at 1976, 1978 (noting that Myriad discovered the BRCA1 and BRCA1 genes and quoting Mayo, 566 U.S. 71, 101 USPQ2d at 1965); Flook, 437 U.S. at 591-92, 198 USPQ2d at 198 ("the novelty of the mathematical algorithm is not a determining factor at all"); Mayo, 566 U.S. 73-74, 78, 101 USPQ2d 1966, 1968 (noting that the claims embody the researcher's discoveries of laws of nature). The Supreme Court’s cited rationale for considering even "just discovered" judicial exceptions as exceptions stems from the concern that "without this exception, there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and thereby ‘inhibit future innovation premised upon them.’" Myriad, 569 U.S. at 589, 106 USPQ2d at 1978-79 (quoting Mayo, 566 U.S. at 86, 101 USPQ2d at 1971). See also Myriad, 569 U.S. at 591, 106 USPQ2d at 1979 ("Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry."). The Federal Circuit has also applied this principle, for example, when holding a concept of using advertising as an exchange or currency to be an abstract idea, despite the patentee’s arguments that the concept was "new". Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 714-15, 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). Cf. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) ("a new abstract idea is still an abstract idea") (emphasis in original). The cited prior art as pertains to the maintained claim rejection under 35 U.S.C. 101 establish that (i) CCR5 and related proteins/molecules are implicated in various cancers, specifically as pertains to cancer cell proliferation, migration, and cancer progression; (ii) detecting CCR5 is well-established and routine in the art with respect to circulating cells, including the detection of intracellular stores/pools through the use of antibodies (e.g., anti-CCR5 mAb 2D7); and (iii) the mechanism of internalization of CCR5 is also well-established wherein the activation of CCR5 (e.g., via agonist binding) results in internalization via endocytic pathways. As such, the step of determining the number of
CCR5 pools in circulating cells in a biological sample argued by Appellants is considered known, routine steps and are 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. The discovery that CAMLs (a specific type of circulating cell) can display CCR5 pools constitutes a novel judicial exception, but a judicial exception all the same; it is thus maintained that the instant claims are (i) drawn to a judicial exception (i.e., a natural phenomenon), (ii) the instantly claimed methods do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception wherein the recitation of the step of determining the number of CCR5 pools in circulating cells (i.e., CAMLs) in a biological sample relates to general methods of measuring CCR5 levels/pools in circulating cells in a biological sample and does not integrate the judicial exception into a practical application.
In view of the above, the rejection of claims 1, 6-9, and 11-27 under 35 U.S.C. 101 is maintained, with additional arguments presented above.
Claim Rejections - 35 USC § 112 - New
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.
Claim 12 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.
As currently presented, claim 12 depends on claim 10 which has been cancelled. As such, it is unclear as to which currently pending claim instant claim 12 should depend from. Applicant is advised to correct the dependency of claim 12.
Conclusion
Claims 1, 6-9, and 11-27 are pending. Claims 1, 6-9, and 11-27 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA RAE STONEBRAKER whose telephone number is (571)270-0863. The examiner can normally be reached Monday-Thursday 7:00 am - 5:00 pm.
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/ALYSSA RAE STONEBRAKER/Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642