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 .
Response to Arguments
Applicants’ claim amendments and Remarks of 07/24/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
Claim 4 is canceled. Claims 1, 5-6, 12-14, and 16 are currently amended.
In regard to the obviousness rejection, this rejection is withdrawn. Applicants Remarks with Examiner’s Reply are summarized below:
Applicants submit that the pending claims are directed to a method for preventing or treating lung metastases in a pancreatic cancer patient.
This is claim 16 moved into claim 1.
Applicants submit that preventing or treating lung metastases is sperate and distinct method from treatment of primary pancreatic tumor itself. This is because of the teachings of Applicant cited reference, Weber.
As treating lung metastases is sperate and distinct from treatment of primary pancreatic tumor, the rejection no longer comes the scope of the instant claims.
Applicants point out that SHARAITE is published after the effective filing date.
Applicants cite the case law OSI v. Apotex in order to support that the prior art must demonstrate efficacy of claimed composition for the treatment of the claimed indication.
The arguments in reference to OSI v. Apotex are noted. It is respectfully pointed out that this cases in not cited in the MPEP. As such, it is not clear that the facts of OSI v. Apotex align with those of the instant application. The Applicant has only provided a couple of sentences from the case, but has not addressed the fact patterns within the case. And it is further not clear if the cited portion is the opinion of the Court.
Response to Arguments
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, 5-14 and 16 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.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The nature of the invention: The nature of the invention pertains a method for preventing or treating lung metastases in a pancreatic cancer patient in need thereof. From Applicant’s remarks above and the cited reference Weber, preventing or treating lung metastases is sperate and distinct method from treatment of primary pancreatic tumor itself.
The breadth of the claims: The breadth of the claims is drawn to a method of administering a CDK4/6 inhibitor and a MEK inhibitor.
The predictability or unpredictability of the art: GROOT discloses that After surgery for PDAC, most patients will develop disease recurrence (abstract), however, GROOT’s paper was focused on attempting to describe predictors of disease recurrence (location, timing, etc.). GROOT discloses that specific recurrence patterns were shown to have unique RFS curves. This seems to suggest that there is no effective method for reliably preventing lung metastases.
The amount of direction or guidance presented: No guidance is presented in the Instant Specification on how to prevent lung metastases in pancreatic cancer patients with the instant combinations. Applicants do not show any data or evidence that the composition of the claims had been tested for this purpose.
The presence or absence of working examples: No working examples are shown in the Instant Specification for preventing lung metastases in pancreatic cancer patients. Applicants do not show any data or evidence that the composition of the claims had been tested for preventing. Applicants do not provide guidance for how the instant composition would be work preventively. Lack of a working example is a factor to be considered, especially in a case involving an unpredictable art. See MPEP § 2164.02.
The quantity of experimentation necessary: The quantity of experimentation would be “undue” because of the amount of time and resources needed to experimentally find the amounts of the instant combination needed to prevent lung metastases in pancreatic cancer patients.
The artisan would not be able to anticipate the amount or specific combination of CDK4/6 and MEK inhibitors of the instant combination in order to prevent lung metastases in pancreatic cancer patients without undue experimentation, absent working examples from Applicants or the art. Preventing lung metastases in pancreatic cancer patients is unpredictable.
Moreover, the lack of a working example is noteworthy. There are no teachings or guidance in the specification which would lessen the amount of experimentation to a reasonable amount. Additionally, a person of ordinary skill in the art would have to engage in undue experimentation to create an effective preventative treatment for lung metastases in pancreatic cancer patients, with no assurance of success.
Thus, Claims 1-3, 5-14 and 16 are rejected as lacking enablement.
Conclusion
Claims 1-3, 5-14 and 16 are rejected.
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 GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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, Andrew Kosar can be reached at 571-272-0913. 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.
/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
Prosecution Insights