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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/22/26 has been entered.
Claims 1, 65, 68-69, 71, 77-78, 81, and 83 are amended.
Claims 72-76 and 79-80 are canceled.
Claims 84-88 are newly added.
Claims 1 and 65, 68-69, 71, 77-78, and 81-88 are pending, and are considered herein.
Claim Status, Canceled Claims
In light of the cancelation of Claims 72-76 and 79-80, all objections and rejections thereto, are withdrawn.
Claim Objections
Applicant is advised that should claim 77 be found allowable, claim 78 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 78 requires the non-autologous cell which is configured for avoiding synapse formation, is one of several immune cells. However, the configuration is present in the transmembrane protein itself, and the structure of the protein remains the same as the parent claim, Claim 77. Thus, despite a slight difference in wording, these claims have substantially the same scope.
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.
In light of the amendment, the rejections of Claims 77-78 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, are withdrawn.
To wit, the issue of autologous is no longer present.
Claim 69, 77-78, and 86 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.
Claim 69: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 69 recites the broad recitation “at least 80% identity to SEQ ID NO: 5”, and the claim also recites “comprises SEQ ID NO: 5” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 86: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 86 recites the broad recitation “at least 80% identity to SEQ ID NO: 206”, and the claim also recites “the amino acid sequence of SEQ ID NO: 206” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
In light of the amendments, the rejections of Claims 1 and 65, 68-69, 71, 77-78, and 81-83 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, for reasons of record, are withdrawn.
To wit, the amendments now link the protein to being on the surface of the cell and/or the structure is sufficiently distinct.
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 1, 68, 68-69, 71, 78, 81-88 remain/are newly 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, for the generic structure that binds CD45. 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.
The claims are generic for the means for binding CD45 (Claim 1), which may be a generic single chain antibody or VHH that binds CD45 or may be 80% identical to SEQ ID NO: 3 (Claim 69) which is a single chain antibody to CD45. Further the generic means for binding CD45 includes generic VHH (Claim 87) and any sequence 85% identical to SEQ ID NO: 85 (e.g., Claim 86). Claim 77 is generic for a cell comprising a generic transmembrane protein that is 80% identical to SEQ ID NO: 3 (E3/49K, a protein found in type D human adenoviruses). Claim 81 is generic for an single chain antibody that binds to CD45, comprising a VL and VH of an antibody. Claim 88 is generic for a protein having a VHH sequence that binds to CD45, while Claim 87 is similar but requires 85% similarity to SEQ ID NO: 206 (a VHH to CD45).
The specification describes SEQ ID NO: 206 as being a-CD45-h-VHH-67. The specification teaches that antibodies, nanobodies, and single chain antibodies binding to CD45 may be used (e.g., paragraphs 25 and 32), and demonstrates the use of the CD45-binding single chain antibody (e.g., Example 2), as well as the making of several nanobodies and single chain antibodies to CD45 (Examples 3-5), along with the use of UL11 and E3/49k binding regions (e.g., Example 2).
SEQ ID NO: 3 is taught to be the known E3.49K found in type D human adenoviruses (e.g., paragraph 57 and Figure 21).
SEQ ID NO: 5 is taught to be a-CD45-sc single chain antibody to CD45 (e.g., paragraph 60 and Figure 24).
However, even with all these disclosures, the same does not provide the essential structure required for the generic molecule that binds one of CD45, and/or having the relevant identidies does not provide the essential structure required for an the antibody or means for binding CD45, which binds to the appropriate portion of the CD45. To wit, expressed within the context of antibodies, but the same issue arises with any molecule that binds to CD45:
For a claim to a genus, a generic statement that defines a genus of substances
by only their functional activity does not provide an adequate written description of the
genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC
1997). The recitation of a functional property alone, which must be shared by the
members of the genus, is merely descriptive of what the members of the genus must
be capable of doing, not of the substance and structure of the members. The Federal
Circuit has cautioned that, for claims reciting a genus of antibodies with particular
functional properties (e.g., high affinity, neutralization activity, competing with a
reference antibody for binding), “[c]laiming antibodies with specific properties, e.g., an
antibody that binds to human TNF-α with A2 specificity, can result in a claim that does
not meet written description even if the human TNF-α protein is disclosed because
antibodies with those properties have not been adequately described." Centocor
Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
“[A] sufficient description of a genus . . . requires the disclosure of either a
representative number of species falling within the scope of the genus or structural
features common to the members of the genus so that one of skill in the art can
‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting
Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that
those species that are adequately described are representative of the entire genus.
AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir.
2014) (“The ’128 and ’485 patents, however, only describe species of structurally
similar antibodies that were derived from Joe-9. Although the number of the
described species appears high quantitatively, the described species are all of the
similar type and do not qualitatively represent other types of antibodies encompassed
by the genus.”). Thus, when there is substantial variation within the genus, one must
describe a sufficient variety of species to reflect the variation within the genus to
provide a "representative number” of species.
The “structural features common to the members of the genus” needed for one
of skill in the art to ‘visualize or recognize’ the members of the genus takes into
account the state of the art at the time of the invention. For antibodies, the Federal
Circuit has found that possession of a mouse antibody heavy and light chain variable
regions provides a structural "stepping stone" to the corresponding chimeric antibody,
but not to human antibodies. Centocor, 97 USPQ2d at 1875 (“[T]he application only
provides amino acid sequence information (a molecular description of the antibody)
for a single mouse variable region, i.e., the variable region that the mouse A2
antibody and the chimeric antibody have in common. However, the mouse variable
region sequence does not serve as a stepping stone to identifying a human variable
region within the scope of the claims.”). A chimeric antibody shares the full heavy
and light chain variable regions with the corresponding mouse antibody; that is, the
structure shared between a mouse and chimeric antibody would generally be
expected to conserve the antigen binding activity.
Lastly, even if a selection procedure is disclosed that was, at the time of the
invention, sufficient to enable the skilled artisan to identify antibodies with the recited
functional properties, the written description provision of 35 U.S.C § 112 is severable
from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876 (“The
fact that a fully-human antibody could be made does not suffice to show that the
inventors of the '775 patent possessed such an antibody.”)
In applicant’s case, Applicant has used known binding regions (e.g., UL11 and E3/49k), and made antibodies (e.g., a-CD45-sc and VHH), that bind to the appropriate CD45/CD148/CD43, and it is possible to use selex to design aptamers that bind to CD45/CD148/CD43, but this fails to provide the structure required for the scope of a generic molecule (or cell) that binds to CD45/CD148/CD43, thereby entering the synapse and squelching the immune response through localizing CD45/CD148/CD43 to the synapse and it’s subsequent phosphatase activity. It is noted that Applicant’s functional activity is merely descriptive of what the members be capable of doing, not the substance and structure of the members. The large variety of binding species described also fails to meet the representative number of species, as the species bind the CD45/CD148/CD43 but do not qualitatively represent other types of molecules/antibodies/aptamers/etc., in the genus. Lastly, even with selection procedures, while enabling of making the embodiments, the written description is severable from the enablement provision, and again, the generic structure required for the generas claimed is not sufficiently demonstrated.
The Art does not provide more with regard to any of these molecules or cells displaying the molecules.
Thus, aside from the specific embodiments made and disclosed, the Artisan would understand applicant to have been in possession of the generic molecule (or cell comprising the molecule) that binds CD45/means for language, and localizes it to the synapse, thereby squelching the immune response.
Response to Argument – Generic CD45/CD148/CD43 binding transmembrane proteins
Applicant’s argument of 5/22/26 has been considered but is not found persuasive.
Applicant argues that Applicant has amended the claims to limit it to CD45 and/or means for binding CD45 in Claim 1, citing Ex Parte Chamberlain (p. 7).
Such is not persuasive. Clearly as shown by the dependencies now, these generic structures for binding CD45 fall within the scope of the means for language by Applicant. Chaimberlain’s decision involved only that equivalents did not need to be described, and did not have the issue here: Applicant describes a generic structure that is not possessed, and the depending claims demonstrate the intent to include such in the scope of the claimed means for language.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
In light of the argument to “preventing cytotoxicity (argument of 5/22/26, pp. 6-7), the rejections of Claim(s) 1, 65, 67, 71-74, and 76 remain rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent No. 10,550,183 to Png, et al., are withdrawn.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638
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