DETAILED ACTION
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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/03/2026 has been entered.
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.
The previous rejection of claims 11,12,14-16 and 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in light of Applicant’s clarifying amendments.
Claims 11,12,14-16 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.
Step d is unclear with regard how transgenic (step d)i) or immunocompromised (step d)ii) fish relate to the rest of the method. It is not clear if the transgenic zebrafish are different fish than those used in steps a-c or if the xenograft models are transgenic for the transgenes recited in step d)i. Similarly, it is not clear if the immunocompromised zebrafish in d)ii are different fish than those used in steps a-c or if the xenograft models are immunocompromised. The claim becomes unclear at the recitation of “by using transgenic zebrafish hosts…”. In other words, it is unclear if the validation is a separate experiment (using new fish) or a continuation of the methods set forth in a-c (using the same treated or mock-treated xenograft models).
Claims 13-16 and 18 are also unclear as they depend from claim 11 and fail to add clarity.
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.
The rejection of claims 11,12,14-16 and 18 remain under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for
A method for identifying innate immunomodulators to boost tumor clearance using a zebrafish xenograft model comprising the steps of:
a) generating zebrafish xenograft model by injecting progressor tumor cells into a zebrafish embryo or larva;
b) treating the model by adding at least one test compound to the water housing the zebrafish model;
c) quantifying the engraftment rate of the treated model and selecting compounds that lead to at least a 20% reduction of engraftment in treated zebrafish compared to an untreated control; and
d) validating the selected compounds as innate immunomodulators to boost tumor clearance when,
i) the compound leads to a higher proportion of TNFa+/mpeg+ macrophages in the tumor microenvironment of the zebrafish model comprising progressor tumor cells than in the same model that is not treated with the compound, and/or
ii) the compound does not lead to a reduction in progressor cell engraftment when the model is immunocompromised as a result of a lack of neutrophils and/or macrophages;
does not reasonably provide enablement validating as so generally recited. 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/or use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01(a)). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
MPEP §2164.01(a), 4th paragraph, provides that, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1157, 1562; 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
The claim amendments have greatly clarified the claims and have addressed most aspects of the rejection set forth at pages 6-7 of the office action dated 05/05/2026. However, claim 11 remains overly broad in step d), especially with the recitation of the vague term “using”.
Step c now recites how to determine reduced engraftment, i.e. compare treated engraftment numbers to untreated controls wherein the engrafted cell number is reduced in the treated vs untreated control fish (see Specification at para 74). Step d appears to be a separate validation step where the mechanism of action of the compound is tested to determine if the compound reduces engraftment through immune modulation. As claimed, this step requires only “using”. A result should be correlated to validity. The remaining issue is with step d and what is being analyzed and how that translates into validation. The step is very broad with how transgenic hosts and immunocompromised hosts are used.
The relevance of the Declaration under 37 CFR 1.132 is not clear.
Conclusion
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
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