THIS NON-FINAL REPLACES THE OFFICE ACTION MAILED 05/13/2026 AND THE PERIOD FOR REPLY HAS BEEN RESTARTED.
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 .
Status of Claims
The claims as presented in the Examiner’s Amendment filed 01/09/2026 have been examined. Claims 51-55 and 58-71 are pending. Previously withdrawn claims 56-57 were cancelled. Previously withdrawn claim 58 was rejoined. Claims 60-71 were added. Claims 51-55 and 58-71 have been examined.
Claim Objections
Claim 51 and 58 are objected to because of the following informalities:
Claim 51 recites “SASH1” and should be spelled out as “SAM and SH3 domain containing 1” for the first time it appears in the claim.
Claim 58 at line 3 recites “comprising” and should be corrected to recite “comprises”.
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.
Claims 51-55 and 58-71 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more. The claim(s) recite(s) “determining an expression level of SASH1…wherein an expression level indicates or correlates with relatively increased or decreased responsiveness of the cancer”. The claimed limitation of using the SASH1 expression level to indicate or correlate with relatively increased or decreased responsiveness of the cancer to the anti-cancer agent is a concept performed in the human mind belonging to the mental process grouping of the abstract ideas judicial exception (see MPEP § 2106.04(a)(2), subsection III). The judicial exception is not integrated into a practical application, such as requiring an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception (see MPEP § 2106.05(a)-(c), (e)-(h)) such that the invention does not preempt every observance of the natural phenomenon itself.
Eligibility Step 1:
Claim 51 is directed to a method of predicting the responsiveness of a cancer to an anti-cancer agent in a subject. Methods are one of the eligible statutory categories for invention (STEP 1: YES). However, eligibility of the claim is not self-evident, and therefore analysis must proceed to Step 2.
Eligibility Step 2A, Prong One:
The claim recites using the expression level of a SASH1 nucleic acid or protein to indicate or correlate responsiveness of the cancer to the anti-cancer agent, which is an abstract mental concept that belongs to enumerated group (III) of the Abstract Idea Groupings described in MPEP § 2106.04(a)(2). Therefore, the claims recite at least one judicial exception (STEP 2A, Prong One: YES).
Eligibility Step 2A, Prong Two:
According to Step 2A, Prong Two, set forth in MPEP 2106.04 II A (2), the claims are next evaluated with respect to whether the judicial exception is integrated into a practical application. This analysis turns to the additional steps/elements recited within the claim. Claim 51 recites the additional steps of determining an expression level and treating the cancer with the anti-cancer agent in the subject.
Regarding the additional steps cited in claim 51, determining an expression level is insufficient to integrate the judicial exception(s) because the purpose is merely to obtain data. This does not go beyond insignificant presolution activity, i.e., a mere data gathering step necessary to use the correlation, similar to the fact pattern in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) and Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015).
There are no other additional elements that apply, rely on or use the judicial exception such to integrate it into a practical application. For example, while the claim mentions the step of treating cancer with the anti-cancer agent in the subject, this step is merely an instruction to apply the application, i.e. treating with an anti-cancer agent, without any specificities to meaningfully limit the claim. As such, there are no additional elements that apply the abstract idea judicial exception to a particular treatment or which utilize a particular machine; there are no additional elements that effect a transformation; and, there are no additional elements that apply the judicial exception in some other meaningful way beyond generally linking it to a field, namely, assessing the responsiveness to an anti-cancer agent. In this way the claims, as drafted, do not integrate the judicial exception into a practical application that would overcome monopolizing the exception. ((STEP 2A, Prong Two: NO).
Eligibility Step 2B:
Lastly, the examiner cites publications within the field of technical expertise, that demonstrate the well-understood, routine, conventional nature of the additional element(s).
Regarding the steps/elements recited in addition to using expression levels, Korkola et al. (US 2013/0331405) teaches measuring the expression level of SASH1 in a sample from a patient (paragraph 0045) and based on the increase in expression level, determining whether the patient is suitable for treatment with an anti-cancer agent (paragraphs 0009-0011 and 0045-0046).
Therefore, the steps/elements recited in addition to the judicial exception were all well understood, routine, conventional activities in the field of assessing oral cancer prior to filing the application at hand (STEP 2B: NO).
The claimed steps/elements recited in addition to the judicial exception(s), alone or in combination, do not amount to significantly more than that which was routine and conventional in the art prior to filing.
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.
Claims 51-55 and 58-71 are 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 51 is indefinite because the claim states "wherein an expression level of the
SASH1 indicates or correlates with relatively increased or decreased responsiveness of the
cancer to the anti-cancer agent"; however, it is unclear how this responsiveness is determined
since both increase and decrease responsiveness is associated with an expression level of
SASH1.
Claim 51 at line 9 recites "treating the cancer with the anti-cancer agent in a subject"
which is confusing because it is unclear if the same subject that had their expression level
determined is the subject who is being treated with the anti-cancer agent.
Claim Rejections - 35 USC § 102
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) 58 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burgess et al. (Cell Death and Disease, 2016, IDS).
Claim Interpretation: Claim 58 is broadly drawn to a kit for use in the method of claim 51 comprising at least one reagent capable of determining the expression level of SASH1 protein or encoding nucleic acid in a cancer cell, tissues or organs of the subject. It is noted that the intended use of the kit of claim 58 does not limit the components of the kit itself, the only active component of the kit is a “reagent capable of determining the expression level of SASH1”.
Regarding claim 58, Burgess teaches throughout the publication a reagent capable of determining the expression level of a SASH1 protein or encoding nucleic acid in one or a plurality of cancer cells, tissues or organs of the subject (Figure 1, immunoblot of SASH1-depleted HeLa cells; Figure 2, supplementary Figure 5 and pages 2-3, ThermoScientific Subcellular Fractionation Kit comprising SASH1 antibody).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 51-52, 60-61 and 68-70 are rejected under 35 U.S.C. 103 as being unpatentable over Korkola et al. (US 2013/0331405, Pub Date: 06/12/2012).
Claim Interpretation: Claim 51 is broadly drawn to a method comprising determining the expression of SASH1 nucleic acid or protein in a cancer cell, tissue or organ of a subject and treating the cancer with an anti-cancer agent. It is noted that the intended use of the anti-cancer agent in the preamble (and dependent claim 52) is drawn to intended use and thus does not provide patentable weight to the anti-cancer agent. The anti-cancer agent has only actively been recited in the second broad step of treating the cancer with an anti-cancer agent.
Regarding claims 51-52, Korkola teaches methods for identifying a cancer patient suitable for treatment with 4-anilinoquinazoline kinase inhibitor, such as lapatinib, and an AKT inhibitor, comprising detecting modulated expression of HER2 and SASH1 or protein encoded thereof in samples such as cancer cell or cancer tissue of a cancer tumor. High levels of expression of HER2 and high levels of SASH12 indicate a patient that is suitable for treatment. (See abstract and paragraphs 0026, 0119). Korkola additionally teaches treating the cancer with the anti-cancer agent (paragraphs 0012, 0084-0091). While Korkola does not specifically state that their method is used to predict the responsiveness of a cancer to a cancer agent, Korkola does teach investigation of patients who are non-responsive or develop resistance to certain agents, such as Lapatinib, and adjusting treatment as appropriate (paragraphs 0004-0006). Korkola also states patients identified by their method will respond to the synergistic treatment of cancer with 4-anilinoquinazoline kinase inhibitor and an AKT inhibitor (paragraphs 0008 and 0023-0024, 0127). Therefore, Korkola discloses the claim as written.
Regarding claim 60, Korkola teaches the method wherein the cancer treatment comprises initiating, continuing, modifying or discontinuing the cancer treatment, based on the determination made (paragraph 0012).
Regarding claim 61, Korkola teaches the method wherein the cancer treatment comprises the administration of a therapeutically effective amount of the anti-cancer agent.
Regarding claims 68-70, Korkola teaches the method wherein the cancer is a cancer of the reproductive system such as breast cancer (paragraph 0013).
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over Korkola et al. (US 2013/0331405, Pub Date: 06/12/2012), as applied to claims 51, 68 and 70 above, and further in view of Burgess et al. (Oncotarget, 2016, IDS).
Korkola teaches the method as described above wherein the cancer can include breast cancer (paragraph 0013) but does not specifically teach that the breast cancer is ER positive or negative breast cancer. However, Burgess teaches throughout the publication that SASH1 is prognostic in breast cancer (abstract) and more specifically teaches at Figures 1 and 2, the analysis of ER positive and ER negative breast cancer cell lines for expression of SASH1 (see page 72809, Figures 1-2 and captions).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the method of Korkola, ER positive and/or ER negative breast cancer subtypes as taught by Burgess because it would have been desirable to extend the application of detection methods to additional breast cancer types since Burgess teaches the SASH1 can be a beneficial marker for prognosis in both ER negative and HER2positive breast cancer subtypes (see Figure 7, page 72815).
State of the Prior Art
The prior art does not teach the limitations of claims 53-55, 59 and 62-67, however these claims remain rejected based on the non-prior art rejections described above and/or their dependence on rejected claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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