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 .
Please note this application has been transferred to Examiner Karen Canella.
Claims 118, and 120 have been amended. Claims 122-140 have been added. Claims 118-140 are pending.
Acknowledgement is made of applicant’s election of invention of Group 3 and the species of FOLH1/PSMA without traverse, in the paper field 3/6/2016. After review and reconsideration, both of the Restriction Requirement and Election of Species Requirement of 12/10/2025 have been withdrawn.
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 118-125, 127-140 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.
(A)It is unclear if the parenthetical “(Gly268Ala)” in claim 118 is a claim limitation.
(B)Claims 118, 124 and 125 are vague and indefinite in the recitation of “allelic variant thereof”. One of skill in the art would understand that because the claims require particular glycosyltransferases, “allelic variants” which differ at the gene level will be encompassed by the parent glycosyl transferase. It is unclear what applicant intends as “allelic variants” which would not be the required glycosyltransferases.
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 118-140 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 instant claims are reliant upon a genus of “a therapeutic” comprising a targeting component which targets a tumor antigen, wherein the targeting component is an antibody, or antigen binding fragment thereof, a glucotransferase enzyme and a glycotransferase sugar nucleotide donor corresponding to the glucotransferase enzyme.
The targeting component is highly variant because it encompasses an antibody or antigen-binding fragment which targets a tumor associated antigen. The tumor associated antigen allows for binding to any tumor cell.
The specification provides a written description of the anti-PSMA antibody, J591, fused to glycotransferase B, wherein contact of a LNCaP, or CWR22Rv1 cell in the presence of the corresponding sugar converted the cell’s HBGA phenotype (paragraph [0250]). The specification provides a written description of the anti Her2 antibody, 4D5/trastuzumab fusions, wherein contact of the fusion protein with a MDA-MB361 in vivo led to HBGA expression at the plasma membrane of the tumor cells [paragraph [0254]). The specification provides a written description of an anti-CD19 antibody fusion with glycotransferase B , which in the presence of UDP-GAL converted multiple myeloma-S cells to high level HBGA expression (paragraph [0264]). Clearly, the glycotransferase portion of the fusion was internalized by the target binding portion of the fusion and was not degraded by the cellular lysosomes.
The art teaches, that in general, antibody-conjugates which bind to an internalizing receptor are transported with the cargo molecule to an endosome, followed by fusion with other vesicles that in the final stage, form a lysosome, wherein the proteases in the acidic environment digest the protein content of the lysosome (Carter and Senter, The Cancer Journal, 2008, Vol. 14, pp. 154-169). The art teaches that PSMA extracellular domain contains an internalization motif resulting in its internalization and endosomal recycling (Ceci and Fanti, Clinical and Translational Imaging , 2019, Vol. 7, pp. 377-379, see page 378, second column, lines 6-8 of the bottom paragraph). One of skill in the art would understand based on this disclosure that the instant conjugates would have to enter into the recycling pathway in order to be recycled to the plasma membrane and avoiding lysosomal degradation. Anilkumar et al (Cancer research, 2003, Vol. 63, pp. 2645-2648) teach that the protein, “filamin A” associates with the cytoplasmic tail of PSMA and modulates the internalization rate of PSMA and its localization to the REC which are tubules containing recycling receptors (pages 2645, bridging sentence between the first and second columns, and page 2648, first column, lines 6-8). One of skill in the art would understand based on this disclosure that the cellular context of the targeted receptor also controls the fate of the internalized ligand. Moody et al (Molecular Therapy, 2015, Vol. 23, pp. 1888-1898) teach that Her2 is considered as a difficult receptor for delivery of cargo to the lysosomes , in part because the majority of the endocytosed receptor recycles back to the plasma membrane (page 1889, first column, lines 3-9 of the 3rd full paragraph). One of skill in the art would understand from this disclosure that different internalizing receptors differ in the requirements for committing ligands to the lysosome or recycling to the plasma membrane. It appears that in these two targeted receptors, it would be expected that recycling of the conjugate would occur to some extent. Ingle et al (British Journal of Hematology, 2007, Vol. 140, pp. 46-58) teach that the co-expression of CD21 with CD19 inhibits internalization of anti-CD19 antibodies and cytotoxicity of anti-CD19 conjugates (Title). Based on this disclosure, one of skill in the art would appreciate that not all cells expressing CD19 would be amenable to the instant method. One of skill in the art would reasonably conclude that the cell expressing the targeted tumor antigen as well as the type of receptor controls the fate of internalized conjugates such that they are committed to the lysosome for degradation or recycled back to the plasma membrane. Thus, the description of the therapeutic targeting PSMA on PSMA positive cell lines, Her2 on Her2 positive cell lines and CD19 positive cell lines does not adequately described the genus encompassed by the claims. One of skill in the art could not envisage the required therapeutic for use in the method of treating cancer other than the specific examples of targeted receptors and specific cell lines describe in the specification. One of skill in the art would reasonably conclude that applicant was not in possession of the invention at the time of filing.
Further, claims 119-121, 124-140 do not require any attachment between the targeting component and the enzyme. The specification fails to provide any example wherein the targeting component is administered without any physical attachment to the glycosyltransferase enzyme. Tus the specification is lacking any written description of this embodiment. One of skill in the art would reasonably conclude that applicant was not in possession of the invention at the time of filing.
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 118, 119, 120, 121, 122, 124, 125, and 127 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 10, 12-14, 17, 19, 23, 28-35 of copending Application No. 18/869,725 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the claims of the application which are drawn to a bi-functional therapeutic for treating cancer because it would be obvious to use the bi-functional therapeutic in a method for treating cancer. Claim 13 of ‘725 teaches the limitations of instant claim 118 section a) (i) and (ii), wherein the targeting component is a single domain antibody and instant claims 124 and 125. Claim 8 of ‘725 teaches the limitations of instant claim 122. Claim 31 of ‘725 teaches the limitations of instant claim 118, section b) and claim 120. Claim 14 of ‘725 teaches the limitations of instant claim 127. Claim 29 of ‘725 teaches the limitations of instant claim 119. Claim 30 of ‘725 teaches the limitations of instant claim 121.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
All claims are rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Li et al (ACS Central Science, 2018, Vol. 4, pp. 1633-1641) teach an antibody conjugated to the GDP-fucose for addition to the glycocalyx of the cell though fucosyl transferase on the cells surface abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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