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 .
Status of Application, Amendments and/or Claims
The amendment and Applicant’s arguments, filed 20 November 2025, have been entered in full. Claims 2, 7, 10-17, 19 and 22 are canceled. Claims 1 and 3 are amended. New claim 23 is added. Claims 1, 3-6, 8, 9, 18, 20, 21 and 23 are under examination.
Claim Rejections-35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), First paragraph, Enablement
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, 3-6, 8, 9, 18, 20, 21 (and new claim 23) 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 basis for this rejection is set forth at pages 5-10 of the previous Office Action (20 August 2025)
APPLICANT’S ARGUMENT ONE: Applicant cites case law regarding enablement. Applicant states that the Office Action alleges the claims are not enabled because "The anti-inhibin-alpha antibody data presented in Figure 25, is not tantamount to showing that a composition comprising an anti-alpha inhibin antibody, can be delivered directly to a cancerous tumor that expresses inhibin and to endothelial cells in a subject."
Applicant argues that they disagree, but to solely to advance prosecution, independent claim 1 is amended to require "contacting a microenvironment comprising a cancerous tumor that expresses inhibin and endothelial cells with a composition comprising an anti-a-inhibin antibody directly."
Applicant notes at least paragraph [0058] of the instant specification discloses: "In one embodiment, disclosed methods and materials can directly target inhibin presence or functional activity in an environment that includes endothelial cells through utilization of an agent such as, and without limitation to, an antibody (or functional fragment thereof), a small molecule inhibitor, RNAi, or a soluble- binding partner or fragment thereof, directed at inhibin, and in one particular embodiment, directed at the a-subunit of inhibin. Inhibition of inhibin in the environment can affect the activity and/or expression of endothelial cell components involved in pathological angiogenesis. For instance, inhibition of inhibin can decrease SMAD1 and/or SMAD5 signaling in endothelial cells, which is a necessary component of angiogenesis. Other pathways can likewise be affected through the disclosed methods and materials. For instance, targeting of inhibin can affect the mitogen-activated protein kinase (MAPK) cascades, which have been shown to play a key role in transduction of extracellular signal to cellular response and to play an important role in cellular programs such as proliferation, differentiation, development, transformation, and apoptosis”.
Applicant notes that FIG. 25 and paragraph [0093] of the instant specification discloses: FIG. 25 illustrates three-dimensional capillary sprouting and tube formation of HMvEC-1 cells in the presence of conditioned media (CM) from shControl SKOV3 cancer cells or CM from shINHA SKOV3 cancer cells (top), in the presence of CM from shControl SKOV3 cells in the presence of 10 pg/ml IgG or anti-inhibin-a (middle), and in the presence of CM from shControl treated with (+) or without (-) 300 pM recombinant Inhibin A alone and anti-inhibin-a antibody (10 pg/ml) (bottom). The bar graphs represent the average number of meshes quantified and represent duplicate trials. As can be seen, tumor cell-produced inhibin increased endothelial cell angiogenesis and could be suppressed by blocking with an anti- inhibin antibody. The effect of tumor-produced inhibin can be recapitulated by using recombinant Inhibin."
Applicant submits that the instant specification enables a method of contacting a microenvironment comprising a cancerous tumor that expresses inhibin and endothelial cells with a composition comprising an anti-a-inhibin antibody directly, as set forth in amended independent claim 1.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
1. Firstly, the instant specification does not teach the limitation “microenvironment”. Please see the New Matter Rejection (below).
2. Secondly, the instant claims require that a composition comprising an anti-alpha-inhibin antibody is contacted directly to an environment (or microenviroment) that comprises cancerous tumors within or adjacent to endothelial cells, wherein the cancerous tumors express inhibin in a living subject.
The enablement rejection was made because the specification fails to teach how to take a composition comprising an antibody and contact it directly to an environment that comprises cancerous tumors within or adjacent to endothelial cells, wherein the cancerous tumors express inhibin in a living subject.
For example, please see wherein some of the claims recite renal cancer tumors, gastric cancer tumors and lung cancer tumors. The specification fails to teach how the anti-alpha-inhibin antibody is contacted directly with the lungs or how the anti-alpha-inhibin antibody is contacted directly with a kidney.
Applicant directs the Examiner’s attention to Figure 25. However, the employed assay is an in vitro assay for discerning angiogenesis. The enablement issue IS NOT whether the anti-alpha inhibin antibody has the biological function of reducing angiogenesis. The enablement issues IS regarding the route of in vivo administration.
This angiogenesis assay does not correlate with contacting directly an environment that comprises cancerous tumors within or adjacent to endothelial cells, a composition comprising an anti-alpha-inhibin antibody, wherein the cancerous tumors express inhibin in a living subject.
One skilled in the art would not accept the specification’s in vitro assay as reasonably correlating to the claimed method of delivering the antibody composition in vivo. The specification provides insufficient guidance with regard to these issues and provides no working examples which would provide guidance to one skilled in the art and no evidence has been provided which would allow one of skill in the art to predict the efficacy of the claimed methods with a reasonable expectation of success.
APPLICANT’S ARGUMENT TWO: Applicant states that the Office Action opines that "independent claim 1 reads on all cancerous tumors. The specification teaches the use of SKOV3 cells, which are ovarian cancer cells. The specification fails to teach that that inhibin is expressed (or overexpressed) in all cancerous tumors".
Applicant argues that independent claim 1 recites "a cancerous tumor that expresses inhibin...". Applicant maintains that the claim scope is limited to the subset of cancerous tumors that express inhibin. Applicant respectfully submits that one of ordinary skill in the art would not have had to perform any undue experimentation (In re Angstadt, 537 F.2d 498, 504 (CCPA 1976)).
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
1. Applicant argues that the scope is limited to cancerous tumors that express inhibin. However, the broadest claims do not recite which type of cancerous tumors express inhibin. Therefore, the method requires the skilled artisan to figure out all cancerous tumors that express inhibin, which would entail undue experimentation. The cited Hassanpour reference teaches that cancer in the broader sense refers to more than 277 different types of cancer disease.
The scientific reasoning and evidence as a whole indicates that the rejection should be maintained.
NEW CLAIM REJECTIONS/OBJECTIONS
Claim Rejections-35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), First paragraph, Written description, New Matter
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, 3-6, 8, 9, 18, 20, 21 and 23 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter Rejection.
The specification as originally filed does not provide support for the invention as now claimed:
“..contacting a microenvironment comprising a cancerous tumor..".
Applicant’s amendment, filed 20 November 2025, asserts that no new matter has been added, but does not provide sufficient direction for the written description for the above-mentioned “limitations”.
The Examiner cannot locate the limitation “microenviroment” in the specification, figures, or originally filed claims.
The specification as filed does not provide a written description or set forth the metes and bounds of this "limitation". The instant claims now recite limitations which were not disclosed in the specification as filed, and now change the scope of the instant disclosure as-filed.
Applicant is required to cancel the new matter in the response to this Office action. Alternatively, Applicant is invited to provide specific written support for the “limitations” indicated above or rely upon the limitations set forth in the specification as filed.
Conclusion
No claims are allowed.
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.
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/R.M.D/Examiner, Art Unit 1647 3/2/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647