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 .
This action is in response to papers filed 9/28/2026.
Applicant’s election of the species of molecular measurement data and small molecular inhibition in the reply filed on 2/23/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 17-22 are pending. Claims 1-16 have been cancelled.
The following rejections are modified with response to arguments following.
This action is FINAL.
Withdrawn Rejections
The 35 USC 112b rejection made in the previous office action is withdrawn based upon amendments to the claims.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.
Claims17-22 are rejected under 35 U.S.C. 101 are rejected under 35 U.S.C. 101 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of an abstract idea without significantly more. The judicial exception is not integrated into a practical application, and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons that follow.
Note that the unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012).
The unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, No. 08-964, 2010 WL 2555192 (June 28, 2010) and in Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014).
Applicant’s attention is directed to the USPTO January 7, 2019 Revised Patent Subject Matter Eligibility Guidance (i.e., “PEG”) available at URL:
<https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf>.
Regarding Step 1 of the PEG, the claims are directed to the statutory category of a process.
Regarding Step 2A, prong one, the claims recite the judicial exception of an abstract idea. The step of “exposing a patient with an initial cancer treatment or treatment interval” is considered to have an embodiment of an abstract idea. As noted above this step can be interpreted as providing a prescription and as such would be considered abstract. The step of identifying does not require an active step of isolating the samples and as such can be interpreted as reading a data print out. The step of comparing would be considered data manipulation that can be performed by the mine. The step of administering the precision cancer therapy is considered an active step.
Regarding Step 2A, prong two, having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application.
Herein, the claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). The steps of administering the precision cancer therapy is considered an active step, is not considered an integration as rather, it is using any routine and conventional methods of treating patients with cancer therapy. It is noted that regardless of the comparison step, the patient is treated. As such this step is considered a general step of applying as it is not integrated into the judicial exception.
Regarding Step 2B, the next question is whether the remaining elements/steps – i.e., the non-patent-ineligible elements/steps - either in isolation or combination, amount to significantly more than the judicial exception.
Herein, the claims as a whole are not considered to recite any additional steps or elements that amount to significantly more than routine and conventional activity and do not add something “significantly more” so as to render the claims patent-eligible. The additionally recited steps are routine in the prior art. The claims are using a known method of analysis. Wu et al (WO2016048952 March 31, 2016) teaches that CLL is an disease wherein resistant clones leads to resistance to therapy (para 6). Wu et al. teaches changing treatment based upon this comparison (para 87). Wu et al. teaches that the therapy is targeted therapy including imatinib which is a small molecule inhibitor (para 100).
For the reasons set forth above, when the claims are considered as a whole, the claims are not considered to recite something significantly more than a judicial exception and thereby are not directed to patent eligible subject matter.
Response to arguments
The reply traverses the rejection. A summary of the arguments is provided below with response to arguetmsn following. The reply asserts that exposing has been removed (p. 4). Although this step is removed, the claims encompass a step of “based on a comparison” which would be considered an abstract step. This step can be done by the mind as it does not require any more than comparing characteristics.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 17-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al (WO2016048952 March 31, 2016).
With regard to claim 17, Wu et al. teaches that CLL is a disease wherein resistant clones leads to resistance to therapy (para 6). Wu et al. teaches exposing a patient with an initial cancer treatment (para 32). Wu et al. teaches blood samples before and after treatment (para 28-30, 32). Wu et al. teaches measuring data in these samples to determine resistant cancer subclones (para 49, 50 and 59). Wu et al. teaches measurement of DNA measurement data including mutation calling and somatic copy number (para 71-72). Wu et al. teaches changing treatment based upon this comparison (para 87). Although Wu et al. does not specifically recite “precision treatment”, the term would encompass a change of treatment to a treatment that was not used prior.
With regard to claim 18, Wu et al. teaches a method of comparing eradicated subclones, resistant subclones based upon sequence data (para 81-82).
With regard to claims 19-20, Wu et al. teaches that the therapy is targeted therapy including imatinib which is a small molecule inhibitor (para 100).
With regard to claim 21, Wu et al teaches converting subclones by inhibiting expression of a gene (para 47, 44, 87).
With regard to claim 22, Wu et al. teaches a method of converting resistant cancer cell subclones to eradicable based upon inhibiting expression as Wu et al. teaches imatinib, Wu et al. teaches a treatment for cancer cells that are resistant (para 28, 33-35).
Response to arguments
The reply traverses the rejection. A summary of the arguments is provided below with response to arguetmsn following. The reply asserts that Wu does not teach or suggest identifying molecular features of the eradicated cancer cell subclone that indicate one or more molecular targets for precision cancer therapy directed to converting the resistant cancer cell subclone to an eradicable cancer cell subclone (p. 5). The reply asserts that the therapies of Wu are not directed to converting a resistant cancer cell subclone to an eradicable cancer cell (p. 5). These arguments have been reviewed but have not been found persuasive. The therapy is not limited to therapies that “convert a resistant cancer cell subclone to an eradicable cancer cell” but rather administering a precision cancer therapy. Furhtermore the identifying step is based upon an comparison of the identifying step. As the prior art teaches the identifying step and comprising, the reference provides the steps of the claims broadly encompassed.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682
