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 .
Claims 1-20 are pending as originally filed and are considered herein.
Formalities:
The drawings of7/20/23 are objected to, for color drawings and for sequence identifiers, as noted below.
The specification is objected to for lacking a sequence identifier for the sequence in Figure 39, as well as lacking a sequence listing.
The priority is acknowledged: the present Application is a DIV of 16/482,497, filed 7/31/19 (now US PAT NO 11,753,619), which is a 371 of PCT/US2018/016503, filed 2/1/18, and claims benefit of (i) US 62/453,922 (2/2/17) and (ii) 62/578,721 (10/30/17).
There are no IDS filings as of this time.
Drawings
The drawings are objected to.
Figures 1, 25A, 25C, 26B-38, 46-47, and 61A-D are each executed in color
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Figure 39 contains a sequence that requires a sequence identifier. There is no sequence listing, nor an identifier either in (a) the drawing itself, or (b) in the brief description of the drawings.
See also, Attached PTO-2301.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 2 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 2 limits the linkage of the LacNAc to the antibody as being performed by a sialic acid linkage. However, whatever you call the linking process, the composition remains the same. 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.
Claims 7, 9 and 20 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 7 contains the trademark/trade name Trastuzumab. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an antibody and, accordingly, the identification/description is indefinite.
Claim 9 recites “a sialic acid bearing a new motif”. It is not clear what is being claimed. How can sialic acid bear a new motif – if it bears a new motif, how is it a sialic acid? Also, what is meant by motif? What motif? Is it merely any new structure? Again, it is not clear what is being claimed.
Claim 20 contains the trademark/trade name Trastuzumab. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an antibody and, accordingly, the identification/description is indefinite.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 10-12 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,753,619. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 10: Claim 1 is to an engineered cell, comprising an antibody covalently bound to the cell at a GlcNAC, via through a GDP-fucose via alpha-1,3 linkage.
Claim 11-12: Claim 2 teaches T, NK, and DC cells.
Claim 14: Claim 2 teaches DCs.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5, 10 and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zheng, et al. (2011) “Tracking N-Acetyllactosamine on Cell-Surface Glycans In Vivo”, Angewandte Chemie International: Glycobiology, 50: 4113-18.
Claim 1 and 10: Zheng teaches labeling cell-surface glycans with LacNAc, using a two-step method (e.g., Figure 1). It is further reported that CHO cells were so-linked through sialyl-LacNAc to anti-CD65s antibody VIM-2 (p. 4114, col. 2, paragraph 2).
Claim 5: VIM-2 is a full size antibody.
Claims 15-16: fluorescent probes are also attached (e.g., ABSTRACT).
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 1-20 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.
The claims are generic for the attachment points, the transferases, and/or the intermediate structures between the glycosylation and the attached molecule.
The specification teaches attachment of molecules to any surface glycan through any point of the glycan and through a fucose intermediate (e.g., Brief Description). The Examples use H. pylori α1,3-fucosyltransferase, which was discovered by Applicant to have a tolerance for large modification of the GDP-fucose to contain molecules as large as antibodies (e.g., p. 9). Applicants have also disclosed the same in their NPL, Li, et al. (2018) “A Single-Step Chemoenzymatic Reaction for Construction of Antibody-Cell Conjugates”, ACS Central Science, 4: 1633-41, and this ability of this particular enzyme is key to the ability to linking such molecules : “Here, we report the discovery of the remarkable substrate tolerance of Helicobacter pylori 26695 α1,3-FucT. This enables quantitative transfer of a full-length IgG antibody conjugated to the GDP-Fucose donor to LacNAc and α2,3 sialyl LacNAc, common building blocks of glycocalyx, on the cell surface of live cells within a few minutes (p. 1634, paragraph bridging columns). Additionally, Example 47 teaches that while CMP-sialic acid derivatives have shown some small compounds could be conjugated via sialyltransferases, larger molecules, e.g., antibodies, were not in the substrate scope of these enzymes, and thus, CS-Az-Tz and CS-Poc-Tz were synthesized, allowing for conjugation to the larger molecule antibodies, thus yielding the same conjugated linker in the sialyl-conjugated molecules. It should be noted that the methods of Claim 17 show these particular intermediates which allow such conjugates through sialic acids, meaning the generic claims do not require it.
The art recognizes that any particular modification may prevent production of the surface molecule that displays the glycan (e.g., Parmar, et al. (2015) “Ex vivo fucosylation of third-party human regulatory T cells enhances anti-graft-versus-host disease potency in vivo”, Blood, 125(9): 1502-06, teaching the butyl form will stop production of the protein, and hence, stop its display). Additionally, any particular modification may alter cell viability, cause cytotoxicity, as well as alter normal interactions to cause dysfunction which may prohibit the purpose of the particular displayed molecule (e.g., Armstrong, et al. (2016) “Strategies for cell membrane functionalization” Experimental Biology and Medicine, 241(10): 1098-106, Section labelled “The membrane an addressable canvas”).
Given the limitless variety of positions of attachment, and given the number of enzymes which may be involved, from a large number of species, and in view of the possibility of detrimental affects for any particular attachment, and showing of a single fucosyltransferase and particular modifications to attach via particular sialyltransferases, the Artisan would not have understood Applicant to have been in possession of the generic transferases, the generic attachment points, and the generic linking moieties.
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