eDETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s amendment filed on March 8, 2024 is acknowledged.
Claims 1-163 have been canceled.
Claims 164-167 have been added.
Claims 164-167 are pending and currently under consideration.
3. 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.
4. 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.
(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.
5. Claim 166 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bosques et al. (US 2016/0229913).
Claims 166 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bosques et al. (US 2016/0229913).
The applied reference has a common assignee Momenta Pharmaceuticals Inc and at least one common inventor Calos J. Bosques with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Bosques et al. teach an amino acid sequence of SEQ ID NO:45 that is identical to the instant SEQ ID NO:70 except EU position 370 wherein instant SEQ ID NO:70 is amino acid D and the prior art SEQ ID NO:45 is amino acid E, see sequence alignment below:
Instant SEQ ID NO:70 alignments:
RESULT 1
US-15-141-413-45
; Sequence 45, Application US/15141413
; Patent No. 10239944
; GENERAL INFORMATION
; APPLICANT: Momenta Pharmaceuticals, Inc.
; APPLICANT:Bosques, Carlos J.
; APPLICANT:Huston, James S.
; APPLICANT:Lansing, Jonathan C.
; APPLICANT:Ling, Leona E.
; APPLICANT:Meador, James III
; APPLICANT:Ortiz, Daniel
; APPLICANT:Rutitzky, Laura
; APPLICANT:Schultes, Brigit C.
; TITLE OF INVENTION: COMPOSITIONS AND METHODS RELATED TO ENGINEERED Fc CONSTRUCTS
; FILE REFERENCE: 50937-012003
; CURRENT APPLICATION NUMBER: US/15/141,413
; CURRENT FILING DATE: 2016-04-28
; PRIOR APPLICATION NUMBER: PCT/US15/28926
; PRIOR FILING DATE: 2015-05-01
; PRIOR APPLICATION NUMBER: US 62/081,923
; PRIOR FILING DATE: 2014-11-19
; PRIOR APPLICATION NUMBER: US 61/987,863
; PRIOR FILING DATE: 2014-05-02
; NUMBER OF SEQ ID NOS: 46
; SOFTWARE: PatentIn version 3.5
; SEQ ID NO 45
; LENGTH: 227
; TYPE: PRT
; ORGANISM: Artificial Sequence
; FEATURE:
; OTHER INFORMATION: Synthetic Construct
US-15-141-413-45
Query Match 98.9%; Score 1216; DB 1; Length 227;
Best Local Similarity 99.1%;
Matches 224; Conservative 1; Mismatches 1; Indels 0; Gaps 0;
Qy 1 DKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVD 60
Qy 61 GVEVHNAKTKPPEEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAK 120
||||||||||| ||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAK 120
Qy 121 GQPREPQVCTLPPSRDELTKNQVSLSCAVDGFYPSDIAVEWESNGQPENNYKTTPPVLDS 180
|||||||||||||||||||||||||||||:||||||||||||||||||||||||||||||
Db 121 GQPREPQVCTLPPSRDELTKNQVSLSCAVEGFYPSDIAVEWESNGQPENNYKTTPPVLDS 180
Qy 181 DGSFFLVSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG 226
||||||||||||||||||||||||||||||||||||||||||||||
Db 181 DGSFFLVSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG 226
Bosques et al. also teach nucleic acid molecule encoding the amino acid sequence (e.g. see [0078]).
Bosques et al. teach that the EU position K370 can also be substituted by amino acid residue D (K370D), e.g. see [0053]. Thus, the amino acid sequence of SEQ ID NO: 45 disclosed in Bosques et al. would be identical to the instant SEQ ID NO:70 when K370 is substituted with amino acid residue D.
Therefore, the reference teachings anticipate the instant invention.
6. 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.
7. Claims 164 and 165 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of US 11,220,531 (the ‘531 Patent).
The instant claims are drawn to an Fc construct comprising a first polypeptide, a second polypeptide, a third polypeptide, a fourth polypeptide wherein each of the first and second polypeptide comprises the sequence of SEQ ID NO:78 with op to 10 single amino acid substitutions, provided that position 72 of SEQ ID NO:78 is a proline and position 319 of SEQ ID NO:78 is a proline and each of the third and fourth polypeptides comprises the sequence of SEQ ID NO:73, with up to 10 single amino acid substitutions, provided that position 72 of SEQ ID NO:73 is a proline.
The claims in the ‘531 Patent are drawn to an Fc construct comprising a first polypeptide, a second polypeptide, a third polypeptide, and a fourth polypeptide, wherein each of the first and second polypeptide comprises the sequence of SEQ ID NO:76 with up to 10 single amino acid substitutions provided that position 72 of SEQ ID NO:76 is a proline and position 319 is also a proline, and each of the third and fourth polypeptide comprises the sequence of SEQ ID NO:70, provided position 72 is a proline.
The instant SEQ ID NO:78 and the SEQ ID NO:76 in the ‘531 Patent are identical to each other except position 33. The instant SEQ ID NO:73 is identical to the SEQ ID NO:70 in the ‘531 Patent.
Although the claims at issue are not identical, they are not patentably distinct from each other because given the recitation of “up to 10 single amino acid substitutions” in the instant claims, the SEQ ID NO:76 and SEQ ID NO:70 in the ‘531 Patent are within the scope of the instant claims (see Office Action Attachments). Therefore, the claims in the ‘531 Patent would anticipate the instant invention.
8. Claims 164 and 165 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,827,682 (the ‘682 Patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims in the ‘682 Patent are drawn to the same or nearly the same Fc construct comprising identical first and second polypeptides (SEQ ID NO:78) and third and fourth polypeptide (SEQ ID NO:73). Therefore the claims in the ‘682 Patent would anticipate the instant invention.
9. Claims 166 and 167 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-5 of US 11,220,531 (the ‘531 Patent, drawn to an Fc construct); and
claims 1-9 of US 11,827,682 (the ‘682 Patent, claims drawn to an Fc construct and the method of treating an inflammatory or autoimmune disease by administering the Fc construct),
both in view of Bosques et al. (WO 2015/168643).
The instant claims are drawn to a nucleic acid molecule comprising a nucleotide sequence encoding the amino acid sequence of SEQ ID NOs: 78, 73, 76, or 70, and a cell comprising nucleic acid encoding SEQ ID NOs: 78 and 73, or 76 and 70.
The claims in the ‘531 Patent and the ‘682 Patent are drawn to an Fc construct have the same or nearly the same amino acid sequence as the instantly claimed SEQ ID NOs: 78, 73, 76, and 70. They differ from the instant claims by not reciting a nucleic acid and a cell.
Bosques et al. teach an Fc construct that are similar to the instantly recited Fc construct (e.g. see Fig 13 or copy below):
PNG
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302
294
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Greyscale
Bosques et al. further teach polynucleotide encoding the Fc construct and a host cell comprising the polynucleotide (e.g. see page 15). Bosques et al. teach that the Fc construct protein can be produced by expressing the polynucleotide in the host cells, following by secretion and purification (e.g. see page 26).
It would thus be obvious to one of ordinary skill in the art at the time the instant invention was filed to determine the nucleic acid molecule such as DNA encoding the Fc construct in the ‘531 Patent and the ‘682 Patent, and express the DNA in suitable host cells as disclosed by Bosques et al. in order to produce the Fc construct. As such, the claims in the ‘581 Patent and the ‘682 Patent would render the instant claims obvious.
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN DAHLE whose telephone number is (571)272-8142. The examiner can normally be reached Mon-Fri 6:30am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN W DAHLE/Primary Examiner, Art Unit 1641
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