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 the Application
Claims 1, 3, 5, 23-25, and 73-75 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 10/09/2025 are acknowledged. Claims under consideration in the instant office action are claims 1, 3, 5, 23-25, and 73-75.
Applicants' arguments, filed 10/09/2025, have been fully considered and they are deemed to be persuasive. The rejection of claims 1, 3, and 5-8 under 35 USC 102 is withdrawn due to Applicant’s amendments.
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 3, 5, and 73-75 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 interrupting the binding of cetuximab to EGFR by administering compounds LW11, G4, LW23, LW24, LW25 and LW26, does not reasonably provide enablement for interrupting the binding of any systemically administered drug by administering any material. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). 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 USPQ2sd 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). Among these factors are: (i) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of interrupting the binding of a systemically administered drug by administering a material. The breadth of the claims thus covers that any material is capable of interrupting the binding of any systemically administered drug. For example, the breadth of the claims covers a wide range of materials and drugs.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Romano teaches a method of using “a topical preparation based on 3,4,5'-trihydroxystilbene-3-p-mono-d-glucoside (polydatin or piceid, or resvera-trol-3-B-mono-D-glucoside) a glycosylated derivative of resveratrol, for the prophylaxis and management of adverse skin and mucosal reactions in the therapy with tyrosine kinase inhibitor antitumor drugs, in particular tyrosine kinase inhibitors of EGF receptors (EGFR-TKI). The prophylaxis is performed by applying a polydatin-based topical preparation to the skin and/or mucous membranes at least once a day and before administration of the antitumor drug, to protect the skin from adverse effects of the anticancer treatment, such as skin rash, acneiform dermatitis, itching, ungual alterations, cutaneous xerosis or stomatitis.” (see abstract). Romano teaches “The mutant EGFR, as already noted, can be inhibited by both small inhibitory molecules of TK (such as, erlotinib, gefitinib and afatinib) and monoclonal antibodies (such as, cetuximab).” (pg. 4, lines 5-7). However, Romano is silent as to other materials other than polydatin for the interruption of binding systemically administered drugs or the prevention of skin toxicity that are not tyrosine kinase inhibitor antitumor drugs.
(5) The relative skill of those in the art:
Those of relative skill in the art are those with a level of skill of the authors of the references cites to support the examiner’s position (MD’s or those with advanced degrees and the requisite experience in medicine).
(6) The amount of direction or guidance presented and (7) the presence of absence of working examples:
The specification provides working examples only for interrupting the binding of cetuximab to EGFR by administering compounds LW11, G4, LW23, LW24, LW25 and LW26. Thus, the specification has only provided working examples with one systemically administered drug, but not for the interruption of other systemically administered drugs or the prevention of skin toxicity.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Romano above, and the high unpredictability in the art as evidenced therein, and the lack of guidance provided by the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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.
Claim 5 is 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.
The term “like” in claim 5 is a relative term which renders the claim indefinite. The term “like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what the toxicity is for “dermatomyositis-like rash”, “scleroderma-like changes”, and “seborrheic dermatitis like rash”.
Conclusion
Claims 3, 5, and 73-75 are rejected.
Claims 1 and 23-25 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691