DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. This action is in response to the amendment filed on 27 April 2026. Applicant's arguments and amendments to the claims have been fully considered but do not place the application in condition for allowance. All rejections not reiterated herein are hereby withdrawn.
In particular, the previous rejection of claims 1-12 under 35 U.S.C. 112(b) has been obviated by the amendment to the claims.
The declaration under 37 C.F.R. 1.130 filed on 27 April 2026 is sufficient to overcome the rejection of claims 1-2, 4-5 and 10-12 under 35 U.S.C. 102(a)(1) as being anticipated by Cui et al (eLife. 10 September 2020; 9:e52253, p. 1-21 and “Figure 2- figure supplement 2”) and the rejection of Claims 3 and 6-9 under 35 U.S.C. 103 as being unpatentable over Cui et al. In view of the declaration, the Cui et al reference is not prior art to the claimed invention.
Claim Status
3. Claims 1-19 are pending.
Claims 1-12 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 13-19, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 02 July 2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 1-12 are allowed.
Claims 16-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 13-15 are rejected for the reasons set forth below.
Objection to Drawings
4. The drawings are objected to under 37 CFR 1.83(a). A set of drawings filed on 27 April 2026 includes figures presented in color.
MPEP 608.02, part VIII states:
Color drawings and color photographs are not accepted in utility applications filed under 35 U.S.C. 111 unless a petition filed under 37 CFR 1.84(a)(2) or (b)(2) is granted. Color drawings and color photographs are not permitted in international applications (see PCT Rule 11.13 ).
Unless a petition is filed and granted, color drawings or color photographs will not be accepted in a utility patent application filed under 35 U.S.C. 111. The examiner must object to the color drawings or color photographs as being improper and require applicant either to cancel the drawings or to provide substitute black and white drawings.
It is acknowledged that a petition for color drawings or color photographs was filed on 27 April 2026. However, a decision on the petition for color drawings has not yet been made. The objection to the drawings will be reconsidered dependent on the petition decision.
New Claim Rejections - 35 USC § 112(a) - Enablement
5. 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 13-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the methods of claims 16-19 , does not reasonably provide enablement for the claimed methods in which anti-cancer treatment responsiveness is determined based on any measured change in the device, including changes in the cartridge housing and micropillars. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The following factors have been considered in formulating this rejection (In re Wands, 858F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988): the breadth of the claims, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, the amount of direction or guidance presented, the presence or absence of working examples of the invention and the quantity of experimentation necessary.
The claims are drawn to a method of determining anti-cancer treatment responsiveness, comprising the steps of: providing the tumor-on-a-chip device of claim 11; administering an anti-cancer treatment to the device; and determining anti-cancer treatment responsiveness based on a measured change in the device.
The device of claim 11 comprises a cartridge housing; a central chamber embedded in the cartridge housing; and a first plurality of evenly spaced micropillars arranged in a substantially circular shape within the central chamber and a second plurality of evenly spaced micropillars arranged in a substantially circular shape within the first plurality of evenly spaced micropillars, wherein the device is configured to replicate or mimic a brain tumor and comprises tumor cells that are glioblastoma cells and further comprises tumor-associated macrophages.
Accordingly, the claims encompass methods that detect any type of change in the device, including changes in the cartridge housing and micropillars, as indicative of anti-cancer treatment responsiveness.
However, the specification does not teach a representative number of measurable changes in any part or aspect of the device that are indicative of responsiveness to an anti-cancer treatment.
Rather, the specification (para [0054]) teaches:
“Therapeutic responsiveness can be rated based on the number or percentage of live and dead brain tumor cells, T-cell motility, tumor-associated macrophage phenotype, cytokine levels, and the like.”
Thus, the specification teaches measuring changes associated with the tumor cells, endothelial cells or macrophages, or T cells present in the outer region (claim 12) following the administration of the anti-cancer treatment to the device.
The specification does not provide guidance as to how to predictably identity other types of changes in the device, including changes in the cartridge housing and micropillars, that can be used to determine responsiveness to an anti-cancer treatment.
Additionally, it is unpredictable as to the identity of a representative number of alternative changes in the device that could be measured as indicative of responsiveness to anti-cancer treatment. Undue experimentation would be required to identify a representative number of changes to the device (i.e., changes that are not a result of the anti-cancer treatment directly or indirectly affecting the cells present on the device) that could be used to ascertain responsiveness to an anti-cancer treatment.
As set forth in Rasmusson v. SmithKline Beecham Co., 75 USPQ2d 1297, 1302 (CAFC 2005), enablement cannot be established unless one skilled in the art "would accept without question" an Applicant's statements regarding an invention, particularly in the absence of evidence regarding the effect of a claimed invention. Specifically:
"As we have explained, we have required a greater measure of proof, and for good reason. If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to "inventions consisting of of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the "inventor" would be rewarded the spoils instead of the party who demonstrated that the method actually worked. That scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis."
Further, it is well established that '(t)o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.'" In re Wright 990 F.2d 1557, 1561. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) it was determined that '(t)he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art". The amount of guidance needed to enable the invention is related to the amount of knowledge in the art as well as the predictability in the art. Furthermore, the Court in Genetech Inc. v Novo Nordisk 42 USPQ2d 1001 held that '(I)t is the specification, not the knowledge of one skilled in the art that must supply the novel aspects of the invention in order to constitute adequate enablement.”
Herein, although the level of skill in the art is high, given the lack of disclosure in the specification and in the prior art and the unpredictability of the art, it would require undue experimentation for one of skill in the art to make and use the invention as broadly claimed.
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 CARLA J MYERS whose telephone number is (571)272-0747. The examiner can normally be reached M-Th 6:30-5:00 EST.
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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 on 571-272-0731. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARLA J MYERS/Primary Examiner, Art Unit 1682
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