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
The Amendments and Remarks filed 8/18/25 in response to the Office Action of 2/18/25 are acknowledged and have been entered.
Claims 2, 8-11, 16, and 17 are pending.
Claims 2, 8, and 11 have been amended by Applicant.
Claims 2, 8-11, 16, and 17 are currently under examination.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The following Office Action contains NEW GROUNDS of rejections Necessitated by Amendments.
Rejections Maintained
Claim Rejections - 35 USC § 112
Claims 2, 8-11, 16, and 17 remain 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.
Factors to be considered in determining whether undue experimentation is required, are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). 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: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See also Ex parte Forman, 230 USPQ 546 (BPAI 1986).
The claims are drawn to methods wherein a decrease in expression of AXL and pSTAT3 in a tumor sample from a subject with lung cancer upon treating the sample with a combination of the AXL receptor tyrosine kinase inhibitor TP-0903 and the JAK1 inhibitor ruxolitinib indicates the lung cancer is responsive to treatment with TP-090 “or” ruxolitinib. It is unclear what is meant by “TP-090”. Applicant may have intended claim 2 to recite the AXL receptor tyrosine kinase inhibitor “TP-0903” instead of “TP-090.”
This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology". Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
Example 3 of the specification discloses a single drug treatment targeting AXL or JAK1 “is not effective” in repressing lung cancer progression (as acknowledged in the last paragraph on page 7 of the 8/18/25 Reply; see lines 25-26 on page 90 of the specification, in particular). Therefore, one of skill in the art would predict the method (which requires only a single drug treatment of “TP090” or the JAK1 inhibitor ruxolitinib) would not function as claimed.
The level of unpredictability for using a particular expression pattern of a particular molecule to detect any disease is quite high. The state of the prior art dictates that one of skill in the art would not predict that a particular expression pattern of a particular molecule is indicative of a particular diseased state without a demonstration that said particular diseased state (such as responsiveness to a particular combination of therapeutics) correlates with said particular expression pattern of said particular molecule. For example, Tockman et al (Cancer Res., 1992, 52:2711s-2718s) teach considerations necessary in bringing a cancer biomarker (intermediate end point marker) to successful application. Absent evidence demonstrating a particular expression pattern of a particular molecule correlating with a particular diseased state, one of skill in the art would not predict said particular expression pattern of said particular molecule correlates with said particular diseased state without undue experimentation. Experimentation to identify such a correlation would in itself be inventive.
In view of the teachings above and the lack of guidance, workable examples and or exemplification in the specification, it would require undue experimentation by one of skill in the art to determine with any predictability, that the method would function as broadly claimed.
Response to Arguments
In the Reply of 8/18/25, Applicant cites various results in the specification and argues one would be able to make and use the claimed invention because the results demonstrate that combined therapy is effective in suppressing lung cancer cells with activated AXL and pSTAT3.
The amendments to the claims and the arguments found in the Reply of 8/18/25 have been carefully considered, but are not deemed persuasive. In regards to the argument that one would be able to make and use the claimed invention because the results demonstrate that combined therapy is effective in suppressing lung cancer cells with activated AXL and pSTAT3, Applicant is arguing limitations not recited by the claims. The claims do not require administering a “combined therapy”; rather, the claims require only a single drug treatment of “TP090” or the JAK1 inhibitor ruxolitinib. Further, Example 3 of the specification discloses a single drug treatment targeting AXL or JAK1 “is not effective” in repressing lung cancer progression (as acknowledged in the last paragraph on page 7 of the 8/18/25 Reply; see lines 25-26 on page 90 of the specification, in particular). Therefore, one of skill in the art would predict the method (which requires only a single drug treatment of “TP090” or the JAK1 inhibitor ruxolitinib) would not function as claimed.
New Rejections Necessitated by Amendments
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 2, 8-11, 16, and 17 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 2, 8-11, 16, and 17 are rejected because steps “g)” and “h)” of claim 2 both recite the term “TP-090.” The metes-and-bounds of the claims are unclear because it is unclear what is meant by “TP-090.” However, it is noted that Applicant may have intended claim 2 to recite the AXL receptor tyrosine kinase inhibitor “TP-0903” instead of “TP-090.”
Conclusion
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 SEAN E AEDER whose telephone number is (571)272-8787. The examiner can normally be reached M-F 9am-6pm ET.
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, Samira Jean-Louis can be reached at (571)270-3503. 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.
/SEAN E AEDER/ Primary Examiner, Art Unit 1642