DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Applicant's amendment and remarks, filed 12/15/25, are acknowledged.
Claims 14-15, 17, 20, 32-41, have been amended.
Claims 14-15, 17, 20, 30-32, 39-43 are pending.
Claims 42-43 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 14-15, 17, 20, and 30-32, 39-41 are being acted upon.
Claim 14 is objected to for the following informalities: The claim recites various VH and VL pairs, “respectively”, but does not indicate “respectively” in the last VH VL pair.
Claim interpretation
Claim 14 is directed to an -DC-ASGPR immunoglobulin or DC-ASGPR-binding fragment thereof having a myelin basis protein autoantigen attached to the immunoglobulin “or fragment”. This is being interpreted as referring to the fragment thereof from lines 1-2 of the claim. Likewise, the claim recites that the immunoglobulin “or fragment” comprises a specific VH an VL. Thus, the claim requires either an anti-DC-ASGPR immunoglobulin or a DC-ASGPR binding fragment therefore, wherein both embodiments, i.e. the immunoglobulin or the fragment thereof, are attached to myelin basic protein autoantigen and also comprise one of the specifically recited VH and VL pairs. Regarding the VH/VL pairs, the claims require that the immunoglobulin or the fragment has a VH and VL of, for example, SEQ ID NO: 5 and 6, respectively. The specification on pages 32-34 discloses, using underlining, which portions of each SEQ ID NO: recited in the present claims represent the VH and VL. Therefore, the claims are interpreted as requiring the underlined portion of each respective claimed VH and VL sequence as depicted on pages 32-34 of the specification.
In view of Applicant’s claim amendments, only the following rejections remain.
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 14-15, 17, 20, and 30-32, 39-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,016,915, in view of WO2006/004663 (of record) and Craig et al., 2006 (of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘915 patent claims a method employing a fusion protein comprising an anti-human DC-ASGPR antibody and one or more autoimmune antigens, wherein the antibody comprises a heavy chain of SEQ ID NO: 5, 7, 9, or 11, and a light chain of SEQ ID NO: 6, 8, 10, or 12, which are identical to SEQ ID NO: 5-12 of the instant claims. The ‘915 patent claims heavy and light chain pairings of SEQ ID NO: 5 and 6, 7 and 8, 9 and 10, or 11 and 12, respectively. The ‘915 patent claims that the autoantigen is myelin basic protein (an autoantigen associated with multiple sclerosis), SS-A protein (an autoantigen associated with SLE), or acetylcholine receptor (an autoantigen associated with MG). Furthermore, it would be obvious to include a cohesin or dockerin domain, as taught by Craig et al. and WO 2006/004663, for the same reasons set forth above.
Claims 14-15, 17, 20, and 30-32, 39-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,173,202, view of WO2006/004663 and Craig et al., 2006. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘202 patent claims a method employing a fusion protein comprising an anti-human DC-ASGPR antibody and one or more autoimmune antigens, wherein the antibody comprises a heavy chain of SEQ ID NO: 5, 7, 9, or 11, and a light chain of SEQ ID NO: 6, 8, 10, or 12, which are identical to SEQ ID NO: 5-12 of the instant claims. The ‘202 patent claims heavy and light chain pairings of SEQ ID NO: 5 and 6, 7 and 8, 9 and 10, or 11 and 12, respectively. The ‘202 patent claims that the autoantigen is myelin basic protein (an autoantigen associated with multiple sclerosis), SS-A protein (an autoantigen associated with SLE), or acetylcholine receptor (a autoantigen associated with MG). Furthermore, it would be obvious to include a cohesin or dockerin domain, as taught by Craig et al. and WO 2006/004663, for the same reasons set forth above.
Claims 14-15, 17, 20, and 30-32, 39-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,279,030, in view of WO2006/004663 and Craig et al., 2006. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘030 patent claims a method employing a fusion protein comprising an anti-human DC-ASGPR antibody comprising a heavy chain of SEQ ID NO: 5, 7, 9, or 11, which are identical to SEQ ID NO: 5, 7, 9, or 11 of the instant claims. The specification of the ‘030 patent discloses that said anti-DC-ASGPR antibodies comprise said heavy chains paired with a light chain of 6, 8, 10, or 12, respectively, and the claims of the ‘030 patent cover the same antibodies of the instant claims. The ‘030 patent claims that the autoantigen is myelin basic protein (an autoantigen associated with multiple sclerosis), SS-A protein (an autoantigen associated with SLE), or acetylcholine receptor (a autoantigen associated with MG). Furthermore, it would be obvious to include a cohesin or dockerin domain, as taught by Craig et al. and WO 2006/004663, for the same reasons set forth above.
Claims 14-15, 17, 20, and 30-32, 39-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,453,074 (of record). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘074 patent claims a method comprising attaching an anti-DC-ASGPR antibody to an antigen to form an antibody antigen complex, wherein the antigen is an autoantigen, and wherein the anti- DC-ASGPR antibody comprises a heavy chain of SEQ ID NO: 5, 7, 9, or 11, which are identical to SEQ ID NO: 5, 7, 9, or 11 of the instant claims. The ‘074 patent further claims that said antibody comprises an immunoglobulin light chain selected from SEQ ID NO: 6, 8, 10, or 12, and arriving at the claimed heavy and light chain pairs would involve selecting from a finite number of predictable options. The ‘074 patent claims that the autoantigen is myelin basic protein (an autoantigen associated with multiple sclerosis), native DNA (an autoantigen associated with SLE), or acetylcholine receptor (a autoantigen associated with MG). The ‘074 patent claims that the antigen is fused to the antibody, or alternatively, the antibody is attached or fused to a cohesion or a dockerin domain and the antigen is attached or fused to a cohesion or dockerin domain and forms a complex with the antibody.
Claims 14-15, 17, 20, and 30-32, 39-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-8, of U.S. Patent No. 8,236,934 (of record), in view of US 2004/0258688 and US 2006/0257412 (all of record).
The ‘934 patent claims an isolated immunoglobulin that binds human DC-ASGPR-specific comprising a heavy chain and a light chain, wherein the immunoglobulin heavy chain selected from the group consisting of SEQ ID NO: 5, 7, 9, or 11, wherein an antigen is attached to the immunoglobulin. The specification of the ‘934 patent discloses that the term antigen encompasses various autoantigens including SS-A, myelin basic protein, acetylcholine. Thus, “antigens” of the ‘934 cover the same autoantigens recite in the present claims. Furthermore, it would be obvious to use an autoantigen as the antigen the method claimed in the ‘934 patent based on the teachings of the ‘688 publication and the ‘412 publication. The ‘688 publication and the ‘412 publication teach that DC-ASGPR antibodies can be conjugated to autoantigens for delivery to dendritic cells of a patient with autoimmune disease for treatment. Furthermore, the '934 patent claims that the antibody is attached to a cohesin-dockerin domain, and that the antibodies comprise a light chain selected from SEQ ID NO: 6, 8, 10, or 12.
Claims 14-15, 17, 20, and 30-32, 39-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-8 of U.S. Patent No. 8,728,481 (of record), in view of US 2004/0258688 and US 2006/0257412 (all of record).
The ‘934 patent claims a method for increasing the effectiveness of antigen presentation by dendritic cells in an individual comprising: attaching ex-vivo a DC-ASGPR-specific fragment thereof to an antigen to form an antibody-antigen complex; and delivering an effective amount of the complex to the individual, wherein the antigen is processed and presented by a dendritic cell that has been contacted with the antibody-antigen complex, wherein the antibody or fragment thereof comprises an immunoglobulin heavy chain selected from the group consisting of SEQ ID NO: 5, 7, 9, or 11, wherein the antibody or fragment thereof targets a human DC-ASGPR. The specification of the ‘481 patent discloses that the term antigen encompasses various autoantigens including GAD65, myelin basic protein, etc. Thus, the autoantigens of the instant claims were intended to fall within the meaning of the term “antigen” in the claims of the ‘481 patent. Furthermore, it would be obvious to use an autoantigen as the antigen the method claimed in the ‘481 patent based on the teachings of the ‘688 publication and the ‘412 publication. The ‘688 publication and the ‘412 publication teach that DC-ASGPR antibodies can be conjugated to autoantigens for delivery to dendritic cells of a patient with autoimmune disease for treatment. Furthermore, the '481 patent claims that the antibody is attached to a cohesin-dockerin domain, and that the antibodies comprise a light chain selected from SEQ ID NO: 6, 8, 10, or 12.
Applicant’s statement that the rejections be held in abeyance until the time of allowance is acknowledged.
The following are new grounds of rejection necessitated by Applicant’s claims amendments.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 31-32, 39-41 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 31 recites that the autoantigen is smith protein, RNP, myelin basic protein, etc. Claims 32 recites that the autoantigen is myelin basic protein. Claims 39-41 recite that the autoantigen is associated with multiple sclerosis, SLE, or myasthenia gravis. However, claim 14, from which the claims depend, already is limited to a myeline basic protein autoantigen. Therefore, claims 31 and 39-41 are broader than the claim from which they depend, and claims 31-32, 39-41 also fail to further limit claim 14, from which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
No claim is allowed.
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 extension fee 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 date of this final action.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 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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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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