DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/15/25 has been entered.
Applicant’s arguments, see pages 6-7, filed 10/15/25, with respect to the rejection(s) of the claim(s) under 102, 103, and double patenting have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made to address the amended claims.
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.
Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) “detecting a significant difference” in the profiles which is a mental process that occurs by comparing the two previously obtained profiles. This judicial exception is not integrated into a practical application because the claims do not apply or use the judicial exception in any way. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps in addition to the judicial exception are mere data gathering steps set forth at an extremely high level of generality. In addition to the judicial exceptions some claims recite steps of isolating the relevant cells by FACS or by using antibodies, measuring expression profiles of the markers from hematopoietic phagocytic and non-phagocytic cells from an individual having cancer. These steps are pre-solution data gathering activities recited at an extremely high level of generality that are essential to gathering the data necessary for the practice of the “detecting” step. These step employs well-established routine and conventional techniques, which were known at the time the invention was made. See for example, Palmer et al. and Tang et al. who both exemplify methods where hematopoietic cells are sorted by FACS or the use of antibodies and then expression is measured by cell type. Taken together, these represent a state of the prior art where the basic techniques were routinely practiced. Furthermore, the specification teaches many methods for obtaining expression profiles that were well known in the art, see pages 28-34. The specification also teaches isolating desired cell types by FACS or by using antibodies were both well known (specification p. 5-6, 9). Furthermore, these steps are recited at such a high level of generality, they merely instruct a scientist to use any detection technique for any possible type of marker to obtain the necessary information for implementing the judicial exceptions. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or a transformation of a particular article, in this step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant’s invention, and at the time the application was filed, e.g., the routine and conventional techniques of detecting a protein using an antibody to that protein. Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not invoke any of the considerations that courts have identified as providing significantly more than an exception. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception as the combination of steps in addition to the judicial exception was routine and conventional. Thus, the claim as a whole does not amount to significantly more than the exception itself.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen can be reached at (571)-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/Primary Examiner, Art Unit 1682