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. Applicant’s amendment filed on November 25, 2025 is acknowledged.
Claims 1-65 have been canceled.
Claims 66-85 are pending and currently under consideration.
3. 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.
4. Claims 63-81 and 83 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,591,388 (the ‘388 Patent) in view of Ober (US 2007/0041907, reference on IDS) for the reasons of record.
The instant claims are drawn to a nucleic acid encoding an FcRn antagonist, a vector, a host cell and a method of producing the FcRn antagonist. Claims 65 and dependent claims thereof further limit the FcRn antagonist to have the amino acid sequence set forth in SEQ ID NOs: 1, 2, or 3.
The claims in the ‘388 Patent are drawn to an aqueous formulation comprising a FcRn antagonist consists of a variant Fc region consists of amino acid sequences SEQ ID NOs: 1, 2, or 3 that are identical to the instantly recited SEQ ID NOs: 1, 2, or 3.
The claims in the ‘388 Patent differ from the instant invention by not reciting a nucleic acid encoding SEQ ID NOs: 1, 2, or 3, a vector, a host cell and a method of producing the FcRn antagonist.
Ober teaches an IgG1 molecule comprising Lys433 (433K), Phe434 (434F) and Tyr436 (436Y), wherein the IgG1 molecule further comprises Glu256 (256E), Tyr252 (252Y) and Thr254 (254T), and the IgG1 molecule can be an IgG1 heavy chain molecule or fragment thereof which does not have a light chain variable region (e.g. see [0014], [0054], FIGS 3A, 3B, 3E, and 3F, and claims 1-44). Ober teaches that such IgG1 molecule can block the FcRn function in a subject (e.g. see [0015]). Ober also teaches a pharmaceutical composition comprising the IgG1 (e.g. see [0016]).
Ober teaches the site directed mutagenesis to generate genes encoding the human Fc variant, clone it into a plasmid vector, transfect the vector into NSO host cells, and producing the Fc variant by culturing the host cell, and purifying the Fc variant (e.g. see Example 1).
It would thus be obvious to one of ordinary skill in the art to produce the FcRn antagonist having identical amino acid sequences to the instant SEQ ID NOs: 1, 2 or 3 by well-known cloning methods as disclosed by Ober which involved in cloning the DNA encoding the FcRn into a vector, transfect the vector into a well-known host cell and culturing the host cell under conditions such that the FcRn can be expressed by the host cell. An ordinary skill in the art would have been motivated to do so, and have a reasonable expectation of success, since the claims in the ‘388 Patent recite an FcRn antagonist of SEQ ID NOs: 1, 2, or 3 that are identical to the instantly recited proteins encoding by the nucleic acid. As such, making the FcRn antagonists recited in the ‘388 Patent by well-known cloning technique using DNA, vector, host cell, and methods of producing the FcRn by culturing the host cells following the teachings of Ober would be well within the skill of an ordinary artisan. As such, the claims in the ‘388 Patent would render the instant claims obvious.
Applicant’s arguments have been fully considered but have not been found persuasive.
Applicant argues that the ‘388 Patent does not recite nucleic acid molecule encode an FcRn antagonist.
Applicant further states:
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Therefore, applicant asserts that the rejection should be withdrawn.
This is not found persuasive for following reasons:
Once again, contrary to applicant’s reliance on formulations, note that the claims in the ‘388 Patent recites a FcRn antagonist consisting of SEQ ID NOs: 1-3 that are identical to the instant SEQ ID NOs” 1-3 encoded by the recited nucleic acid. The proteins of SEQ ID NOs: 1-3 in the ‘388 Patent will render the instant nucleic acids encoding the same protein of SEQ ID NOs: 1-3 obvious in view of the teachings of Ober described above regardless the buffers and pH of the formulations recited in the conflicting claims. Note that when the prior art teaches a prtein of interest and there would have been motivation to isolate the gene encoding the protein in light of instructions for cloning the gene, the claimed gene would have been the product not of innovation but of ordinary skill and common sense, See In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009).
Once again, MPEP 804 in CHART II-B provides guidance when examining an AIA application conflicting claim between an application and a patent regarding non-statutory double patenting rejection for different inventions (see copy below for applicant’s convenience).
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The instant application and the ‘388 Patent are commonly owned by Argenx BV but have different inventive entity (no common inventors). Given that the Fc domain consisting of SEQ ID NOs: 1, 2, and 3 recited in the ‘388 Patent are rendered obvious by the instant nucleic acid encoding the identical Fc domains consisting SEQ ID NOs: 1-3, vector, host cell, and methods of producing the Fc domains in view of Ober as discussed above, the rejection has been maintained for the reasons of record.
As such, applicant’s arguments have not been found persuasive.
5. Claims 80-82, 84, and 85 stand rejected on the ground of nonstatutory double patenting as being unpatentable over 1-21 of U.S. Patent No. 11,591,388 (the ‘388 Patent) in view of Ober (US 2007/0041907, reference on IDS) as applied to claims 66, 68, and 79 above, and further in view of Yamane-Ohnuki et al. (Wiley Periodicals, Inc, 2004, August 6, pages 614-622) for the reasons of record.
The instant claims are drawn to a nucleic acid encoding an FcRn antagonist, a vector, a host cell and a method of producing the FcRn antagonist. Claims 65 and dependent claims thereof further limit the FcRn antagonist to have the amino acid sequence set forth in SEQ ID NOs: 1, 2, or 3.
The claims in the ‘388 Patent are drawn to an aqueous formulation comprising a FcRn antagonist consists of a variant Fc region consists of amino acid sequences SEQ ID NOs: 1, 2, or 3 that are identical to the instantly recited SEQ ID NOs: 1, 2, or 3.
The claims in the ‘388 Patent differ from the instant invention by not reciting a nucleic acid encoding SEQ ID NOs: 1, 2, or 3, and a host cell that is a FUT8-knock-out CHO cell line.
The teachings of Ober have been discussed above.
Yamane-Ohnuki et al. teach that CHO cell lines are one of the most universal hosts in biopharmaceutical production and have several advantages for use in industry such as high growth rate, high productivity, ease of genetic manipulation, good proliferation in large-scale suspension culture, and adaptability to protein-free media (e.g. see middle paragraph in the right col. in page 614). Yamane-Ohnuki et al. further teach an industrially applicable new host cell line CHO with FUT8 knockout for producing completely defucosylated antibodies (e.g. see Abstract). Yamane-Ohnuki et al. teach that the new CHO with FUT8 knockout have the great advantage of providing uniformity to biopharmaceutical N-linked glycosylation (e.g. see last paragraph on the left col. of page 621).
It would thus be obvious to one of ordinary skill in the art to produce the FcRn antagonist consisting SEQ ID NOs: 1-3 (Fc variants) in the ‘388 Patent by determining the nucleic acid encoding the SEQ ID NO:1-3, inserting the nucleic acid in a vector, and transfect to a host cell including known and established CHO cell with FUT8 knockout as disclosed in Ober and Yamane-Ohnuki et al.
An ordinary skill in the art would have been motivated to do so, and have a reasonable expectation of success, since Ober teaches recombinantly producing Fc variant consisting identical substitutions as those in the instant SEQ ID NOs: 1-3 by determining the nucleic acid encoding a protein, inserting the nucleic acids into a vector and expressing the proteins in a host cell such as CHO cells that are known to be one of the most universal hosts in biopharmaceutical production and Yamane-Ohnuki et al. teach a new and improved CHO host cells with FUT8 knock out for production of uniformed biopharmaceutical N-linked glycosylation. As such, the claims in the ‘388 Patent would render the instant claims obvious.
Applicant’s arguments and the Examiner’s rebuttals regarding the conflicting ‘388 Patent are essentially the same as discussed above. Applicant further argues that the claims in the ‘388 Patent and Ober do not disclose host cell that provides altered glycosylation of the FcRn antagonist expressed and Yamane-Ohnuki does not teach SEQ ID NOs: 1-3. Therefore, applicant asserts that the rejection should be withdrawn.
This is not found persuasive for the reasons stated above. Further contrary to applicant’s arguments, note that the issue here is whether the cited claims in ‘388 Patent render obvious the instant claims; the issue is not whether they anticipate the instant claims. Here, the claims in the ‘388 Patent would render the instant claims obvious for the reasons given in details above. Therefore, the rejection is maintained for the reasons of record.
6. This is a New Ground of Rejection necessitated by applicant’s submission of the new IDS. Claims 66-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of US 12,403,175 (the ‘175 Patent, reference on newly submitted IDS) in view of Ober (US 2007/0041907, reference on IDS) and Yamane-Ohnuki et al. (Wiley Periodicals, Inc, 2004, August 6, pages 614-622).
The instant claims are drawn to a nucleic acid encoding an FcRn antagonist, a vector, a host cell and a method of producing the FcRn antagonist. Claims 65 and dependent claims thereof further limit the FcRn antagonist to have the amino acid sequence set forth in SEQ ID NOs: 1, 2, or 3.
The claims in the ‘175 Patent are drawn to a method of treating pemphigus by administering an effective amount of a human FcRn antagonist efartigimod (a modified human IgG1 Fc region having human IgG1 from residue D220-K447 having identical substitutions and sequence to the instant SEQ ID NO:2).
The claims in the ‘175 Patent differ from the instant claims by not reciting nucleic acid, expression vector, host cell including FUT8-knock out CHO cell line.
Although the claims at issue are not identical, they are not patentably distinct from each other because it was well known that the FcRn antagonist efartigimod in the ‘755 Patent can be made using established cloning techniques.
For example, Ober teaches an IgG1 molecule comprising Lys433 (433K), Phe434 (434F) and Tyr436 (436Y), wherein the IgG1 molecule further comprises Glu256 (256E), Tyr252 (252Y) and Thr254 (254T), and the IgG1 molecule can be an IgG1 heavy chain molecule or fragment thereof which does not have a light chain variable region (e.g. see [0014], [0054], FIGS 3A, 3B, 3E, and 3F, and claims 1-44). Ober teaches that such IgG1 molecule can block the FcRn function in a subject (e.g. see [0015]). Ober also teaches a pharmaceutical composition comprising the IgG1 (e.g. see [0016]).
Ober teaches the site directed mutagenesis to generate genes encoding the human Fc variant, clone it into a plasmid vector, transfect the vector into NSO host cells, and producing the Fc variant by culturing the host cell, and purifying the Fc variant (e.g. see Example 1).
Yamane-Ohnuki et al. teach that CHO cell lines are one of the most universal hosts in biopharmaceutical production and have several advantages for use in industry such as high growth rate, high productivity, ease of genetic manipulation, good proliferation in large-scale suspension culture, and adaptability to protein-free media (e.g. see middle paragraph in the right col. in page 614). Yamane-Ohnuki et al. further teach an industrially applicable new host cell line CHO with FUT8 knockout for producing completely defucosylated antibodies (e.g. see Abstract). Yamane-Ohnuki et al. teach that the new CHO with FUT8 knockout have the great advantage of providing uniformity to biopharmaceutical N-linked glycosylation (e.g. see last paragraph on the left col. of page 621).
It would thus be obvious to one of ordinary skill in the art to produce the FcRn antagonist consisting efgartigimod having identical amino acid sequences to in the ‘175 Patent by determining the nucleic acid encoding the efgartigimod, inserting the nucleic acid in a vector, and transfect to a host cell including known and established CHO cell with FUT8 knockout as disclosed in Ober and Yamane-Ohnuki et al.
An ordinary skill in the art would have been motivated to do so, and have a reasonable expectation of success, since Ober teaches recombinantly producing Fc variant consisting identical substitutions as those in the instant SEQ ID NO:2 by determining the nucleic acid encoding a protein, inserting the nucleic acids into a vector and expressing the proteins in a host cell such as CHO cells that are known to be one of the most universal hosts in biopharmaceutical production and Yamane-Ohnuki et al. teach a new and improved CHO host cells with FUT8 knock out for production of uniformed biopharmaceutical N-linked glycosylation. As such, the claims in the ‘175 Patent would render the instant claims obvious.
7. No claim is allowed.
8. Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on November 25, 2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
9. 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.
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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/CHUN W DAHLE/Primary Examiner, Art Unit 1641