DETAILED 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. Claims 1-8, 12-14, 16, 20, 22, 26, 32, 34, 35, 41, 44, 46, 49, 56, 75, 76, 84 and 87 are pending upon entry of amendment filed on 5/10/24.
Applicant’s election of group I, claims 1-8, 12-14, 16, 20, 22, 26, 32, 34, 35, 41, 44, 46, 75 and 84 without traverse in the reply filed on 7/3/19 has been acknowledged.
Accordingly, claims 49, 56, 76 and 87 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claims 1-8, 12-14, 16, 20, 22, 26, 32, 34, 35, 41, 44, 46, 75 and 84 are under consideration in the instant application.
3. Applicant’s IDS filed on 5/10/24 has been acknowledged.
4. The oath filed on 3/12/25 has been acknowledged.
5. 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 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.
6. 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.
7. Claim(s) 1-8, 12-14, 16, 20, 22, 26, 32, 34, 35, 41, 44, 46, 75 and 84 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by U.S. Pub. 2009/0060921 (IDS reference).
The ‘921 publication teaches glycoprotein comprising anti-CD20 antibody and various types of N-glycan profiles of GlcNAc2ManGlcNS2(G0), Man3GlcNAc2, GlnNacMan3GlcNAc2, GlcNac1Man3GlcNAc2 and GlcNac1 is attached to a 1,6-mannose arm (note claim 8, p. 30) and a pharmaceutical composition thereof. Further, the ‘921 publication teaches glycan structures as in claims 5-8, 12, 16 in Fig 18,19, 53 and Table 3. Given that the specific glycan profiles and variations of glycan profile is taught, the receptor of carbohydrate binding is met and claim 46 is included in this rejection. The ’921 publication teaches glycan optimized antibody improves effector functions (p.2).
In addition, the main peaks of glycoproteins are described in Tables, and the peak area varies from 35-98%, claims 32 and 35 are included in this rejection. Therefore, the reference teachings anticipate the claimed invention.
8. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 1-8, 12-14, 16, 20, 22, 26, 32, 34, 35, 41, 44, 46, 75 and 84 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 60, 76, 77, 114-115, 119-121 of U.S. Application No. 18/404,577.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘577 application recite compositions or protein comprising antibody and a moiety binds carbohydrate or receptor thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. Claims 1-8, 12-14, 16, 20, 22, 26, 32, 34, 35, 41, 44, 46, 75 and 84 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20, of U.S. Pat 12,692,472 in view of in view of U.S. Pub. 2009/0060921 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘472 patent recite compositions or protein comprising antibody and a moiety binds carbohydrate or receptor thereof. The claims of the ‘472 patent recite GlcNAc on a polypeptide.
The claims of the ‘472 patent differ from the claimed invention in that they do not teach the polypeptide is an antibody.
The teachings of the ‘921 publications have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize antibody in the ‘472 patent into the GlcNAc on a polypeptide as in the ‘921 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the optimization of glycan in a fusion structure comprising antibody would improve effector function.
11. No claims are allowable.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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, 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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Yunsoo Kim
Patent Examiner
Technology Center 1600
September 28, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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