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 1-5, 11-13, 16, and 18-20 have been cancelled. Claims 21-23 have been newly added.
Applicant's arguments filed 12/15/2025 have been fully considered.
The rejection of claims 2-3, 6-8, 10, and 17 under 35 U.S.C. 102(a)(1) as being anticipated by Van Der Vliet et al. (U.S. Patent No. 10,501,540) is withdrawn in view of the claim amendments. Van Der Vliet et al. discloses an ISVD (also referenced as a VHH) of SEQ ID NO: 50. This sequence has an asparagine (N) (i.e. a glycosylation acceptor site) at AHo position 97. An asparagine at this position is no longer encompassed by independent claim 10.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 8/4/2025 is again acknowledged.
Claims 14-15 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/4/2025.
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.
Claim 21 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.
Claim 21 is confusing in reciting “the amino e acids” in multiple places. It is unknown what this means and may have been a word processing error.
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.
Claims 6-8, 10, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated b Buyse et al. (U.S. Patent Application Publication 2018/0044407, of record).
Buyse et al. discloses a heavy chain immunoglobulin single variable domain (ISVD) (that has been modified to have a glycosylation site. (SEQ ID NO: 99 unmodified sequence, SEQ ID NO: 101 modified sequence.) The glutamate (E) at Kabat position 85 (corresponding to Aho position 99) is substituted with an asparagine (N) to form an N-linked glycosylation site. See Examples 1 and 2 and Table 1 of Buyse et al. This polypeptide meets the limitations of instant claim 10. Expression vectors and host cells for recombinant production of the glycosylated ISVD are disclosed. Host cells such as mammalian cells and yeast cells are disclosed that will attach glycans to the recombinant ISVDs. See at least paragraphs [0049-54]. Pharmaceutical compositions are disclosed. See at least paragraph [0015].
Alignment of SEQ ID NO: 101 (Qy) and SEQ ID NO: 99 (Db) (NDT glycosylation site underlined below, where N is at Kabat position 85 (corresponding to Aho position 99) of Buyse et al. (U.S. Patent Application Publication 2018/0044407).
Qy 1 HHHHHHEVQLVESGGGLVQPGNSLRLSCAASGFTFSSFGMSWVRQAPGKGLEWVSSISGS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 HHHHHHEVQLVESGGGLVQPGNSLRLSCAASGFTFSSFGMSWVRQAPGKGLEWVSSISGS 60
Qy 61 GSDTLYADSVKGRFTISRDNAKTTLYLQMNSLRPNDTAVYYCTIGGSLSRSSQGTLVTVS 120
|||||||||||||||||||||||||||||||||| |||||||||||||||||||||||||
Db 61 GSDTLYADSVKGRFTISRDNAKTTLYLQMNSLRPEDTAVYYCTIGGSLSRSSQGTLVTVS 120
Qy 121 S 121
|
Db 121 S 121
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6-10, 17, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Buyse et al. (U.S. Patent Application Publication 2018/0044407, of record) as applied to claims 6-8, 10, and 17 above, and further in view of Callewaert et al. (WO 2018/206734, of record).
Buyse et al. is applied above but does not disclose the limitations of instant claims 9 and 21-23.
Callewaert et al. discloses recombinantly producing proteins in glyco-engineered cells, including those with engineered glycosylation sites. See at least abstract and claims. In particular, at least claim 9 discloses the limitations of instant claim 9. At least claims 1 and 4-5 of Callewaert et al. discloses limitations in instant clam 21. Claim 4 discloses the glycosylation motifs recited in instant claim 10 as amended. At least claims 11-12 disclose limitations in instant claims 22-23. Modification of ISVDs with glycans is useful to prevent binding by pre-existing autoantibodies. See at least page 2.
It would have been obvious to produce the ISVD of SEQ ID NO: 101 of Buyse et al. recombinantly (i.e. using a polynucleotide and expression vector) in a glyco-engineered cell as taught by Callewaert et al., with or without adding additional glycosylation sites as taught by Callewaert et al. as recited in instant claim 21, in order to produce ISVD having glycans as recited in instant claims 22-23, as taught by Callewaert et al. One would have been motivated to do so for the advantages taught by Callewaert et al. with respect to pre-existing autoantibodies.
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 6-10, 17, and 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,891,451 in view of Buyse et al. (U.S. Patent Application Publication 2018/0044407, of record)
The issued claims disclose the limitations of instant claim 21 (see issued claim 1) Issued claim 2 permits an additional glycosylation site. Expression vectors as in instant claim 6 are disclosed in issued claim 3. Cells as in instant claims 7-9 are disclosed in issued claims 4-6. The characteristics of instant claims 22-23 are disclosed in issued claims 8-9. The issued claims do not disclose an asparagine at Aho position 50 and/or position 52 and/or position 99.
Buyse et al. is applied as above and discloses a heavy chain immunoglobulin single variable domain (ISVD) (that has been modified to have a glycosylation site. (SEQ ID NO: 99 unmodified sequence, SEQ ID NO: 101 modified sequence.) The glutamate (E) at Kabat position 85 (corresponding to Aho position 99) is substituted with an asparagine (N) to form an N-linked glycosylation site. See Examples 1 and 2 and Table 1 of Buyse et al. Expression vectors and host cells for recombinant production of the glycosylated ISVD are disclosed. Host cells such as mammalian cells and yeast cells are disclosed that will attach glycans to the recombinant ISVDs. See at least paragraphs [0049-54]. Pharmaceutical compositions are disclosed. See at least paragraph [0015].
It would have been obvious to produce the ISVD of SEQ ID NO: 101 of Buyse et al. recombinantly (i.e. using a polynucleotide and expression vector) in a glyco-engineered cell as claimed by Callewaert et al., with the glycosylation sites as taught by issued claim 1. One would have been motivated to do so as issued claim 2 suggests adding an additional glycosylation site. The issued claims encompass modifying any ISVD, including that of Buyse et al.
Conclusion
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 MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Marianne P Allen/Primary Examiner, Art Unit 1647
mpa