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 Claims 14-17 are withdrawn as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112
The rejection of claims 1-3, 5-8, 10-13 and 18 under 35 USC 112(b) is withdrawn in view of Applicant’s arguments.
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.
This rejection is maintained.
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.
Response to Arguments
Applicant’s arguments filed on 5/11/2026 have been fully considered but they are not persuasive.
Applicant argues that “[t]he Specification does provide guidance to allow for prolonging survival of a HLA-A*0201-positive patient having a lung tumor expressing Telomerase Reverse Transcriptase (TERT). Specifically, Applicant discovered that to allow for prolonging survival, a patient that is a never-smoker or a former light smoker (less than 25 years) could be selected and administered Vx-001. No undue experimentation is required. Applicant does not claim that every HLA-A *0201-positive patient having a lung tumor expressing TERT responds to vaccination by Vx-001. Rather, a patient that is a never-smoker or a former light smoker (less than 25 years) is one that responds to vaccination by Vx-001.
Applicant’s arguments have been considered but are not persuasive.
As previously discussed, 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]).
The phrase “more likely to respond” clearly implies that NOT every HLA-A *0201-positive patient having a lung tumor expressing TERT, whether a never-smoker or light-smoker, would respond to vaccination by Vx-001.
Therefore, the claims are not enabled.
For these reasons, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 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
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