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 .
The claim amendments dated 2/2/2026 are under consideration.
The amendments and arguments presented in the papers filed 2/2/2026 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 10/2/2025 listed below have been reconsidered as indicated.
a) The amendments to the specification addressing trade name or mark usage are acknowledged.
b) Any objections or rejections of claims 16, 17, 19 and 47 are moot in view of the cancellation of the claims.
c) The rejections of claims 14-15, 18, 40-42 and 44-46 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn in view of the amendments to the claims.
d) The rejections of claim 43 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, are withdrawn in view of the amendments to the claims.
e) The rejections of claim(s) 14, 18, 42, 43, 44 and 46 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Buggy (WO 2008/095050 A1), are withdrawn because Buggy is silent regarding predicting responsiveness to “monotherapy with surgery” and focuses on responsiveness to histone deacetylase inhibitors.
f) The rejections of claim(s) 14, 15, 18, 33, 41, 42, 43, 44 and 46 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kan (US 2012/0302572 A1) are withdrawn because Kan is silent regarding predicting responsiveness to “monotherapy with surgery” and focuses on responsiveness to an EGFR inhibitor or an IGF-1R kinase inhibitor.
The Examiner’s responses to the Remarks regarding issues not listed above are detailed below in this Office action.
New and Modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
Election/Restrictions
Applicant elected without traverse Group III, claims 14-19, 33 and 40-47, in the reply filed on 8/25/2025.
Claims 1-13, 20-32 and 34-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 8/25/2025.
Priority
The effective filing date of the present application is 4/9/2020.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
Claim Objections
Claim 18 is objected to because of the following informalities: the claim recites “the control level” rather than “the relevant control level” in line 1. It is suggested a single term consistently be used when referring to a particular claim element. Appropriate correction is required.
The following are new objections necessitated by the amendments.
Claim 14 is objected to because of the following informalities: the claim recites “in case expression of EPLIN”, which appears to be a typographical error. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: the claim recites “the control level” rather than “the relevant control level” in lines 3-4. It is suggested a single term consistently be used when referring to a particular claim element. 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 14, 15, 18, 33, 40, 41, 42, 43, 44 and 45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions without significantly more.
Claims 14, 15, 18, 33, 40, 41, 42, 43, 44 and 45 recite a series of steps and therefore are processes, one of the four statutory classes.
The claims recite:
“comparing the assayed expression level of EPLIN to a relevant control level” (claim 14);
“increased expression of EPLIN is indicative of negative response to said treatment” (claim 14);
“non-increased or decreased expression of EPLIN is indicative of positive response to said treatment” (claim 14); and
“predicting response to treatment on the basis of said comparison” (claim 14).
The steps of “comparing” and “predicting” broadly encompass abstract ideas in that they can be performed in a purely mental manner. The “comparing” step involves considering two data points and the “predicting” broadly encompasses making a determination based on the consideration of the two data points. Additionally, the “comparing” step broadly encompasses mathematical concepts as the basis for the comparison.
The statements regarding EPLIN expression levels and a response to treatment set forth the naturally occurring phenomenon that is the association between EPLIN expression levels and a patient’s response to treatment.
The claim includes the additional limitations of:
assaying a sample obtained from said subject for expression level of EPLIN (claim 14).
The judicial exceptions are not integrated into a practical application because the claims do not involve:
improvements to the functioning of a computer or to any other technology or technical field;
applying or using the judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition;
applying the judicial exception with, or by use of, a particular machine; or
effecting a transformation or reduction of a particular article to a different state or thing.
The above additional limitations add insignificant extra-solution activity to the judicial exceptions. The step is mere data gathering set forth at a high level of generality. See MPEP 2106.05(g).
While claim 14 sets forth a step of “treating a subject's cancer by monotherapy with surgery”, the step is not required in all embodiments of the claim. The step is limited to embodiments where the “expression of EPLIN is non-increased or decreased”. The claims encompass embodiments where the “comparing” step identifies increased expression and in those embodiments, no treatment is administered. It is these embodiments which fail to integrate the judicial exceptions.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims encompass assaying nucleic acids and proteins, which the courts have recognized as routine laboratory techniques. See MPEP 2106.05(d). It is noted the instant specification states that “standard methods known in the art” can be used to qualitatively and/or quantitatively determine expression increases or decreases (p. 9-10). Further, on p. 26 the specification acknowledges “Said determination may be executed at different molecular levels, preferably at mRNA, cDNA, or protein level as is well known in the art” and p. 30 describes generic and well-known techniques for determining EPLIN expression, e.g., PCR, DNA microarrays, etc.
Examiner’s response to the traversal of the 101 rejections
The Remarks summarize rejections under section 101 (p. 12-13).
The Examiner’s position is detailed above.
The Remarks argue claim 14 has been amended to be specific about the type of cancer treatment ("treatment of cancer comprising monotherapy with surgery"), as well as the type of cancer being treated and the type of sample being assayed ("the cancer is HNSCC" and "a HNSCC sample" assayed "for expression level of EPLIN"), it specifies the specific conditions that indicate negative and positive responses to the treatment ("increased expression of EPLIN" and "non-increased or decreased expression of EPLIN", respectively), and claim 14 includes a specific therapeutic treatment step (p. 13-14).
The arguments have been fully considered but are not persuasive. As noted in the above rejections, the step of “treating” is not performed in all embodiments. Those embodiment in which “increased expression of EPLIN” is the result of the “comparing” step do not require performing any step of “treating” the subject.
The Remarks argue claim 14 as a whole cannot reasonably be said to be "directed to" an abstract idea because claim 14 plainly is not directed to, and does not recite, a law of nature in itself (p. 14). The Remarks further argue, one skilled in the art would understand that that claim 14 as a whole cannot reasonably be performed solely as a mental process (p. 14). The Remarks also argue the features added to claim 14 integrate any allegedly abstract idea into a practical application, and involve "significantly more" than any allegedly abstract idea because it involves "applying or using the judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition" (p. 14).
The arguments have been fully considered but are not persuasive. The claims set forth judicial exceptions as identified in the above rejection. It is not the examiner’s position that the method as a whole can be performed in a purely mental manner. Rather, it is simply the steps of “comparing” and “predicting” that can be performed in a mental manner and thus, are abstract ideas. The judicial exception are not fully integrated as the claim encompasses embodiments in which “increased expression of EPLIN” is the result of the “comparing” step. These embodiments fail to integrate any of the judicial exceptions as they do not require any additional step beyond the “comparing” and “predicting” steps.
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.
Claim 15 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.
The following are new rejections necessitated by the amendments to the claims.
Regarding claim 15, the claim recites “the treatment is extended” and “comprises chemotherapy in combination with (i) dissection, or (ii) radiotherapy, or (iii) dissection and radiotherapy”. It is unclear what constitutes a “treatment” being “extended”. Does the claim require the patient to already be treated prior to the method, i.e., that treatment is “extended”? The recitation of “the treatment” refers to a “treatment” claim 14, which is comprises “monotherapy with surgery”. But claim 15 states the “treatment” comprises one or more of “dissection” and “radiotherapy”. It is unclear if claim 15 requires “monotherapy with surgery” as part of “the treatment” based on the reference to a “treatment” of claim 14.
Regarding claim 15, the claim recites “when the expression of EPLIN is increased as compared to the control level”. It is unclear if claim 15 requires an active method step of “treating a subject’s cancer by monotherapy with surgery and chemotherapy in combination with (i) dissection, or (ii) radiotherapy, or (iii) dissection and radiotherapy when the expression of EPLIN is increased as compared to the relevant control”.
Regarding claim 15, the claim recites “treating a subject’s cancer”. It is unclear if a “subject” subjected to “treating” is required to be “the subject” from which the HNSCC sample was obtained.
Examiner’s response to the traversal of the 112(b) rejections
The Remarks argue the amendments address the rejections (p. 15).
Claim 15 remains rejected for the reasons provided above as necessitated by amendment.
Conclusion
No claims allowed.
Examiner’s Note
The Examiner’s suggests the following claim as allowable subject matter:
A method of treating HNSCC cancer in a subject, wherein the method comprises:
assaying a HNSCC sample obtained from said subject for expression level of EPLIN;
selecting as a treatment either:
monotherapy with surgery when the expression of EPLIN is non-increased or decreased as compared to a relevant control level; or
EGFR chemotherapy or EGFR chemotherapy in combination with: dissection; radiotherapy; and/or radiotherapy, when the expression of EPLIN is increased as compared to the relevant control level; and
administering the selected treatment to the subject.
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 JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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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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/JOSEPH G. DAUNER/Primary Examiner, Art Unit 1682