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 .
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.
Enablement
Claims 1, 9, 11, 14, and 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 a method or composition for treating epidermolysis bullosa acquisita (EBA) with the recited anti-collagen type VII (col7) antibody 16A1C8 does not reasonably provide enablement for treating any skin blistering disease with the recited anti-collagen type VII (col7) antibody 16A1C8. 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 specification teaches that the mouse IgG2c anti-collagen type VII (col7) antibody 16A1C8 either alone or in combination with a second anti-col7 antibody 9D8H4 was effective at suppressing rabbit anti-col7 antiserum (RaCol7)-induced epidermolysis bullosa acquisita (EBA) when injected prior to or along with RaCol7 in an FcγRIIB-independent manner (Examples 4-5). The anti-col7 antibody 16A1C8 has the VH and VL chains of SEQ ID NOs: 3 and 11 of the instant claims (Page 15 of Specification).
For the treatment of a particular skin blistering disease, a non-pathogenic monoclonal antibody that targets an antigen not involved in the pathogenesis of the skin blistering disease is not reasonably expected to be therapeutically effective. In particular, epidermolysis bullosa acquisita is caused by autoantibodies against anti-collagen type VII which bind fibrils that anchor hemidesmosomes to the basement membrane (Stevens et al, see entire document, of record). The claimed antibody 16A1C8 (VH/VL chains of SEQ ID NOs: 3 and 1, respectively) targets collagen type VII, which is involved in the pathogenesis of epidermolysis bullosa acquisita (EBA) (see Examples 4-5 and Page 15 of the Specification). As stated previously, the anti-collagen VII antibody 16A1C8 cannot be used to treat every skin blistering disease absent of evidence provided to the contrary in either the specification or scientific literature demonstrating the role of collagen type VII in other skin blistering disorders besides EBA. Thus, artisans would not reasonably the claimed antibody that targets anti-collagen type VII (which is involved in EBA) to be able to treat any other skin blistering disease in a subject such as bullous pemphigoid (caused by autoantibodies against BP180, or collagen type XVII) commensurate in scope of the claims.
Further, EpCAM is a transmembrane protein (Keller et al, see Abstract) whereas type VII collagen is not (Chung et al, see entire document, in particular “The Biology of Type VII Collagen” section). Thus, the claimed anti-type VII collagen antibody16A1C8 cannot be used to bind to an epithelial cell adhesion molecule commensurate in scope of claims 1, 9, and 11 nor can it be used to treat a skin blistering disorder identified as being associated with an EpCAM per claim 1.
Therefore, the specification is not enabling over the full scope of the claims.
Examiner suggestion: Applicant may overcome the rejection by amending claims 1, 9, and 11 to limit the skin blistering disease treated by the claimed methods and compositions to epidermolysis bullosa acquisita (EBA). Further, Applicant can specify that the claimed antibody binds to type VII collagen rather than an EpCAM and remove steps a-b of claim 1 since an EpCAM cannot be used to identify or treat a disease, in this case EBA, with an antibody that targets type VII collagen.
Response to Arguments
Applicant’s arguments filed 10/08/2025 with respect to rejections made under 35 USC 101 and 35 USC 112(a) written description have been fully considered and are persuasive. These rejections have been withdrawn.
Applicant did not address the rejection made under 35 USC 112(a) enablement previously set forth. As discussed above, the anti-EpCAM antibody 16A1C8 cannot be used to treat every skin blistering disease absent of evidence provided to the contrary in either the specification or scientific literature demonstrating the role of collagen type VII in other skin blistering disorders besides EBA. Thus, artisans would not reasonably the claimed antibody that targets anti-collagen type VII (which is involved in EBA) to be able to treat any other skin blistering disease in a subject such as bullous pemphigoid (caused by autoantibodies against BP180, or collagen type XVII) commensurate in scope of the claims.
Conclusion
No claims are allowed.
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/LIA E TAYLOR/Examiner, Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641