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 .
Election/Restrictions
Applicant’s election of immune response, CD45, and deescalated therapy regimen in the reply filed on 09/19/2025 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Claims 4-6, 10-16, 18 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/19/2025.
Claims 1-3, 7-9, 17, 19-20 are under examination. Claims 9 and 20 is under examination with respect to the elected biomarker, CD45.
Drawings
The drawings submitted on 04/29/2022 have been accepted.
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 1-3, 7-9, 17, 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
The claims recite a law of nature/natural phenomenon and an abstract idea. Claim 1 recites an abstract idea that is a mental process and includes mathematical concepts. The recitation of determining whether targeted therapy will provide a complement response in the individual is a mental process. The recitation of utilizing a trained classifier and the biomolecule expression measurements as features in the trained classifier is a mathematical concept requires mathematical calculations. Neither the claims nor the specification set forth limiting definitions for determining and the claims do not set forth how determining and utilizing a trained classifier is accomplished. The broadest reasonably interpretation of determining and utilizing a trained classifier is a step that can be accomplished mentally by evaluating data and critical thinking process wherein one mentally reads information in a database or report regarding expression levels that utilized a training classifier. Additionally the broadest reasonably interpretation of utilizing a trained classifier is a step that encompasses mathematical calculations using expression levels. Such determining encompasses process that may be performed mentally and this is an abstract idea. The step of utilizing a trained classifier encompasses a mathematical calculation and is an abstract idea.
Additionally claim 1 recites a law of nature/natural phenomenon. Claim 1 recites diagnostically determining pathological complete response of a breast cancer by obtaining measurements of a biomolecule. Claim 9 and 20 require CD45 biomolecule. The recited relationship is a natural phenomenon that exists apart from any human action. This type of correlation is a consequence of a natural process.
This judicial exception is not integrated into a practical application because the claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application. For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses 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.
While claim 1 recites utilizing a trained classifier, the claims do not reflect an improvement in the use of a classifier. The claim generically recites any classifier.
Claims 2-3 recite when it is determined that the targeted therapy will provide pathologic complete response, administering to the individual a deescalated therapy regimen. This is a conditional step and only occurs when the targeted therapy has a pathologic complete response.
As mentioned above, a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. When evaluating this consideration one must the following:
(i) the particularity or generality of the treatment or prophylaxis limitation;
(ii) whether the limitations have more than a nominal or insignificant relationship to the exception; and
(iii) whether the limitations are merely extra solution activity or field of use.
The steps of “administering to the individual a deescalated therapy regimen” is not particular i.e., specifically identified so that it does not encompass all applications of the judicial exception. In other words the claims broadly encompass any and all therapy regimens and further does not require administering the therapy to the subject. Administering a deescalated therapy regimen could encompass administering no therapy as the claim recites “deescalated therapy” which could encompass watch and wait approach. Additionally the treatment limitations do not appear to have a significant relationship to the exception.
In addition to the judicial exceptions the claims recite obtaining measurement of expression of a biomolecules (claim 1), elected immune biomarkers CD-45 (claim 8-9, 17 and 20), HER2+ breast cancer (claim 7) and type of cancer biopsy (claim 19). These additional steps/elements are not considered to integrate the judicial exception into a practical application because they merely add insignificant extra-solution activity (data gathering) to the judicial exception and further limit the judicial exception. As addressed in the instant specification methods of expression analysis are well-known in the art (see para 89 and 99).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claims as a whole are not considered to recite any additional steps or elements that amount to significantly more than well-understood, routine, and conventional activities in the art and do not add something significantly more so as to render the claims patent -eligible. The step of obtaining expression of a biomarker in a cancer biopsy, including the elected biomarker CD-45 merely instructs a scientist to use well-established routine and conventional nucleic acid techniques to gather samples for diagnostic analysis. As address in the instant specification methods of immunostaining expression analysis are well-known in the art (See para 89-101).
The step of determining a biomarker expression in a biopsy constitutes a data gathering step required to apply the law of nature/natural phenomenon. It is acknowledged that the claims name particular biomarkers, CD-45 whose level is to be determined however the claims do not require a particular, non-conventional primer or probe consisting of or comprising a specific nucleotide sequence or any other specific reagent that is used to accomplish such determining such that the claims would recite significantly more than the judicial exception. The targets to be detected are part of the judicial exception and thereby the naming of the targets does not add something “significantly more” to the recited judicial exceptions.
The additional steps and elements are recited at a high degree of generality and are all routine, well understood and conventional in the prior art. The recited steps and elements do not provide inventive concept necessary to render the claims patient eligible. There is no combination of elements 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. Many cited prior art references in this record demonstrate that these techniques were conventional at the time of the invention. The prior art of Halbert (US20130287772A1) demonstrated determining CD45 expression in breast cancer cells to determine therapy response. Thus the prior art and specification demonstrates it was routine, well-known and conventional in the art to determine expression of CD-45 in biological samples including biopsy. The dependent claims do not provide significantly more to the claims outside of the judicial exception as they encompass conventional techniques as described in the instant specification as noted above.
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.
Claims 1, 7-9, 17, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halbert (US20130287772A1).
Halbert teaches identifying a biosignature that is used for diagnosis and theragnosis of conditions and diseases. Halbert teaches identifying biosignature wherein the biosignature comprises a presence or level of a cell specific biomarker to determine responder or non-responder of disorder. Halbert teaches the subject is on an existing treatment for disease (see para 6 and 7). Halbert teaches theranose a breast cancer and the biosignature comprises CD45 and HER2+ (see para 19) (claims 7-9, 17, 20). Halbert teaches the biological sample can be a tissue sample or biopsy (see para 158). Halbert teaches identifying a subject as a non-responder or responder to a therapeutic agent comprises classifying the biosignature of the subject using a trained classifier (see para 15, 310, 319). Halbert teaches determining biosignature at different time points for a subject after initiating a particular treatment (see para 332). Halbert teaches determination is response to treatment is made based on a change in the amount of one or more components of biosignature at different time points (see para 333). Halbert teaches treatment can be measured as complete response (see para 916). Therefore, Halbert teaches obtaining a measurement of expression of CD45 in breast cancer in a cancer biopsy, teaches obtaining expression after initiation of targeted therapy, determining therapy response utilizing a trained classifier.
Claims 1-4, 8, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Allen (WO2018/132287 A1).
Allen teaches determining responsive to an immune checkpoint therapy by obtaining a sample from a subject having cancer, measuring the amount of the biomarker, copy number, comparing to a control sample, and determining response to therapy (see pg. 3, lines 16-30). Allen teaches the control sample is a cancerous sample from the patient obtained at an earlier point in time (see pg. 4, lines 23-25). Allen teaches the control sample is obtained before treatment and the patient sample is obtained after the patient has received immune checkpoint therapy (see pg. 4, lines 24-27) Allen teaches administering therapy including targeted therapy or hormonal therapy (see pg. 4, lines 18-21). Allen teaches the subject sample includes a biopsies (see pg. 6, lines 11) and teaches the cancer comprises breast cancer (see pg. 24, line 6). Allen teaches using the biomarker copy number and classifier for determining response (see pg. 115, lines 4-6).
With regard to claim 2-3, Allen teaches determining a suitable treatment regimen for the subject and includes a single therapy or combination of different therapies that is started, modified or ended based on the analysis of biomarker (single therapy, without chemotherapy). Allen teaches determining to provide targeted therapy (see pg. 30, lines 14-25). Allen teaches response can be assessed by pathological examination of tumor after biopsy and response includes pathological complete response (see pg. 38, lines 17-20). Allen teaches monitoring the patient over time by biomarker assessment (see pg. 62, lines 1-5) Thus, Allen teaches determining targeted therapy will provide pathologic complete response administering to the individual a deescalated therapy regimen (see pg. 99, line 30 to pg. 100 line 8) (see pg. 61, line 27-29).
With regard to claim 8, Allen teaches biomarkers include immune response biomarkers including CD4+ cells and includes expression of protein on cell surface (see pg. 31 lines 31-33 cont’d to pg. 42, lines 1-4).
With regard to claim 19, Allen teaches samples include FFPE tumor samples for biomarker analysis (see pg. 62 line26, ex 1, b)
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAE L BAUSCH/Primary Examiner, Art Unit 1699