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. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 13, 2026 has been entered.
Claims 1-65 have been canceled.
Claims 66-86 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 66-81 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 in conjunction with various legal citations have been fully considered but have not been found persuasive.
Applicant argues that the claims in the ‘388 Patent encompass an aqueous formulation having specific pH range and comprising specific amount of buffers while the instant claims are directed to a nucleic acid encoding an FcRn antagonist which is distinct from the claims in the ‘388 Patent. Applicant further argues that Ober does not teach the instant SEQ ID NOs: 1-3 or any oligonucleotide probe, primer or cDNA molecule clones that could be used to defined starting point to isolate a nucleic acid molecule. Applicant also asserts that the ‘388 Patent are later filed and later-expiring patent that is unrelated to the instant application.
Applicant states:
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Applicant asserts that the ‘388 Patent does not qualify as a nonstatutory double patenting reference to the instant applicant because it has a later patent term filing date compared to the instant application.
As such, 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 in the conflicting claims, 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. In contrast to applicant’s assertion that reference must teach or suggest all of the claimed limitation, note that Specific statements in the references themselves which would spell out the claimed invention are not necessary to show obviousness, since questions of obviousness involves not only what references expressly teach, but what they would collectively suggest to one of ordinary skill in the art. See In re Burckel is cited in MPEP 716.02
Here, 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 protein 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).
Applicant’s arguments about the prior art status of the ‘388 patent is immaterial to the issue at hand, because as has been discussed at length above, the instant claimed invention is rendered obvious by the invention of the ‘388 patent in view of the teachings of Ober. As such there is no reason to investigate if the disclosure of the ‘388 patent does or does not qualify as prior art as the differences between the issued claims and that which is presently claimed is supplied by the teachings of the prior art Ober. Further, the double patenting rejection of record is non-provisional, and thus issues concerning determining the earlier filed application as set forth in MPEP 804(I)(B)(1)(b) are not relevant as that guidance is limited only to provisional rejections.
Further, in contrast to applicant’s arguments relying on the lack of improper time-wise extension, note that improper time-wise extension is not the only reason for requiring a terminal disclaimer. 37 CFR 1.321(c)(3) requires that a terminal disclaimer filed to obviate a nonstatutory double patenting rejection based on commonly owned conflicting claims must also include a provision that any patent granted on that application be enforceable only for and during the period that the patent is commonly owned with the application or patent which formed the basis for the rejection.
Currently Office guidance set forth in MPEP 804(II)(B) states: “a rejection based on nonstatutory double patenting is based on a judicially create doctrine grounded in public policy so as to prevent the unjustified or improper time wish extension of the right to exclude granted by a patent”. Moreover, the guidance states: “a double patenting rejection also serves public policy interests by preventing the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention”.
In Ex parte Baurin, Appeal 2024-002920 (PTAB Dec. 18, 2025), the guidance for USPTO personnel is to continue following existing practice discussed in MPEP 804.
The instant application and the ‘388 Patent are commonly owned by Argenx BV but have different inventive entity (no common inventors). Given that the instant nucleic acid encoding the Fc domains consisting SEQ ID NOs: 1-3, vector, host cell, and methods of producing the Fc domains are rendered obvious by the Fc domains consisting identical SEQ ID NOs: 1-3 recited in the claims in the ‘388 Patent in view of Ober (see discussion above), the rejection has been maintained for the reasons of record.
5. Claims 80-82 and 84-86 are 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 or or the FcRn antagonist comprising an agucosylated N-linked glycan at EU position 297.
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). Yaman-Ohnuki et al. teach IgG1 has two N-linked glycan bount to the Fc region Asn297 and antibody-dependent cellular cytotoxicity (ADCC) is controlled almost solely by the absence of fucose on IgG1 (e.g. page 614). Yamane-Ohnuki et al. further teach an industrially applicable new host cell line CHO with FUT8 knockout for producing completely defucosylated antibodies with afucosylated N-glycan (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 aglycosylated 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. Once again, contrary to applicant’s arguments, note the issue here is not whether Ober and/or Yamane-Ohnuki anticipate the instant claims. Rather, the issue here is whether the claims in ‘388 Patent render the instant claims obvious in view of Ober and Yamane-Ohnuki.
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. Claims 66-86 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). Yaman-Ohnuki et al. teach IgG1 has two N-linked glycan bount to the Fc region Asn297 and antibody-dependent cellular cytotoxicity (ADCC) is controlled almost solely by the absence of fucose on IgG1 (e.g. page 614). Yamane-Ohnuki et al. further teach an industrially applicable new host cell line CHO with FUT8 knockout for producing completely defucosylated antibodies with afucosylated N-glycan (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 without fucose (afucosylatd Fc). As such, the claims in the ‘175 Patent would render the instant claims obvious.
Applicant’s arguments have been fully considered but have not been found persuasive.
Applicant asserts that in the Restriction Requirement set forth in the grand parent of the instant application USSN 14/580,771 (the ‘771 application), the Examiner states that the pending claims of the ‘771 application are separated into three groups:
Group I, drawn to an isolated FcRn antagonist
Group II, drawn to a method of inhibiting FcRn function
Group III, drawn to a nucleic acid, an expression vector, a host cell, and a method of producing an FcRn antagonist.
Applicant asserts that given that the Examiner determined earlier in the chain of instant application family that the claims drawn to nucleic acid, vector, host cell and a method of producing an FcRn antagonist are distinct from the method of inhibiting FcRn function, the claims drawn to a method of a method of treating pemphigus by administering an effective amount of a human FcRn antagonist in the ‘175 Patent (unrelated to the instant application family but share common assignee) are distinct from the instant claims.
This is not found persuasive for following reasons:
Contrary to applicant’s reliance on the restriction requirements in the chain of the instant application, it should be noted that the present case does not contain a benefit to the ‘175 Patent or vice versa. Therefore, nothing in the chain of the instant application or that of the ‘175 Patent, whether there was a restriction or not, allows for the 121 shield to apply to the present application.
35 USC 121 provides (in pertinent part): “. . .[i]f the other invention is made the subject of a divisional application which complies with the requirements of section 120 it shall be entitled to the benefit of the filing date of the original application. A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.”
The 121 safe harbor is only applicable to patents/applications in the same 120 benefit chain as the application under examination. That is, a restriction must be in the chain of the application under examination in order for an earlier issued patent to be unavailable for a nonstatutory double patenting rejection. There is insufficient evidence to show that the restriction requirements in the chain of the instant application would provide any additional benefit outside the mandate of Section 120. See Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008) and Amgen, Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009), the court indicated that the prohibition under 35 U.S.C. 121 does not apply to claims in a pending case which are directed to a non-elected invention of an application and the case is not a divisional of the application.
As such, the rejection is proper in spite of the restriction requirements set forth in the parents of the instant applications as the instant application was not filed as a result of a restriction requirement in the family that includes the ‘175 patent and the application which gave rise to the ‘175 patent was not filed in response to a restriction requirement filed in the instant application or its parent applications.
Further, applicant argues that like the ‘388 Patent discussed above, the ‘175 Patent is a later-filed patent and unrelated to the instant application. Applicant further asserts that the instant application published as US 2015/0218239 was cited by the Examiner who issued the ‘175 Patent and the claims of the ‘175 Patent was nonetheless found novel and non-obvious, indicating that applicant has not sought obvious modification to the claims of the instant application in the claims of the ‘175 Patent.
Furthermore, applicant asserts that the ‘175 Patent does not qualify as a nonstatutory double patenting reference because the Examiner acknowledged it has a later filing date. Therefore, applicant asserts that the rejection should be withdrawn.
This is not found persuasive for following reasons:
The Examiner’s rebuttal regarding arguments of the earlier filed of the ‘175 Patent are essentially the same as discussed above.
Further, contrary to applicant’s reliance on the prosecution history of the ‘175 Patent, e.g. the instant application not being cited by the Examiner for the ‘175 Patent as a prior art, note that such arguments are not persuasive because the prosecution history of the ‘175 Patent is immaterial to the issues at hand---- that the instant claims are rendered obvious by the claims set forth in the ‘175 Patent in view of Ober and Yamane-Ohnuki et al (see detailed discussion above).
As such, applicant’s arguments have not been found persuasive.
7. No claim is allowed.
8. All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(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
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