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 .
DETAILED ACTION
Claim Status
Claims 1-3, 5-8 and 10-18 are pending. Claims 1-3, 5-8, 10-13 and 18 are being examined in this application. In the response to the restriction requirement, Applicants elected Group I, SEQ ID NOs: 1-2, and HLA-A*0201-positive patients having a lung tumor expressing TERT. Claims 14-17 are withdrawn as being drawn to a nonelected invention.
Examiner’s note
In view of the appeal brief filed on 10/14/2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5-8, 10-13 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The MPEP states:
“There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.”
(A) The breadth of the claims; and (B) The nature of the invention;
The claims are drawn to methods of prolonging survival of a HLA-A*0201 - positive patient having a lung tumor expressing Telomerase Reverse Transcriptase (TERT).
(D) The level of one of ordinary skill;
The skill of those skilled in the art is high.
(F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The MPEP (2164.02) states that " The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).” The MPEP further states that
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“Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”
In the instant application, the specification does not provide any guidance to allow for prolonging survival of a HLA-A*0201-positive patient having a lung tumor expressing Telomerase Reverse Transcriptase (TERT).
The specification teaches that “[T]he invention also pertains to a theranostic method to determine whether a HLA-A*0201-positive never-smoker or light-smoker patient having a NSCLC expressing TERT is more likely to respond to Vx-001, wherein the patient is more likely to be a good responder if the tumor is non-immunogenic” (para [0018]).
It is clear that not every HLA-A*0201-positive patient having a lung tumor expressing TERT would respond to vaccination by Vx-001.
Therefore, prolonging the survival of each and every HLA-A*0201-positive patient having a lung tumor expressing TERT is highly unpredictable.
Considering the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the invention as claimed.
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 1-3, 5-8, 10-13 and 18 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.
Claims 1-3 recite “A method of prolonging survival….”. The phrase “prolonging survival” is not defined in the instant specification. One of ordinary skill in the art would not know what is encompassed by said phrase.
Claims 1-3 recite the phrases “a former light smoker”. However, the specification fails to define said phrase. The specification teaches that a light smoker has been a smoker during less than 25 years or less than 30 years (para [0017]). One of ordinary skill in the art would not know which patient population is encompassed by said phrase.
Claims 5-8, 10-13 and 18, which depend from claims 1-3, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as these claims incorporate by dependency the indefiniteness of claims 1-3.
Claim Rejections - 35 USC § 103
The rejection of claims 1-3, 5-8, 10-13 and 18 under 35 U.S.C. 103 as being unpatentable over Kosmatopoulos in view of Bolonaki et al. and Vansteenkiste et al. is withdrawn in view of Applicant’s arguments.
Double Patenting
The rejection of claims 1-3, 5-8, 10-13 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 8663645 in view of Bolonaki et al. and Vansteenkiste et al. is withdrawn in view of Applicant’s arguments.
The rejection of claims 1-3, 5-8, 11-13 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12048737 is withdrawn in view of Applicant’s arguments.
The rejection of claims 1, 3, 5-8, 10-13 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 17/617690 in view of Bolonaki et al. is withdrawn in view of Applicant’s arguments.
The rejection of claims 1-3, 5-8, 11-13 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/744060 is withdrawn in view of Applicant’s arguments.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658