Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of Application, Amendments, and/or Claims
The Information Disclosure Statements (IDS) filed 20 February 2024, 14 January 2025, and 6 November 2025 have been entered. Applicants’ amendment of the claims filed 6 November 2025 has been entered.
Election/Restriction
In the response received on 6 November 2025, Applicants elected, with traverse, the species of:
A-a) a method for treating polyarticular juvenile idiopathic arthritis (pJIA);
B-b) wherein the pJIA is rheumatoid factor-positive polyarticular juvenile idiopathic arthritis;
C-b) wherein the antibody is administered in combination with at least one additional DMARD;
D-a) wherein the at least one additional DMARD comprises a synthetic disease-modifying antirheumatic drug (sDMARD); and
E-b) wherein the subject has a body weight of at least 30 kg.
Applicants traverse the requirement for the species election from Groups B and C/D. Applicants argue that examination of the claims directed to these species would not impose a serious burden on the Examiner. Applicants argue that the species in Group B represent subtypes of polyarticular juvenile idiopathic arthritis (pJIA); as shown in Example 1 of the present application, subjects involved in the pJIA clinical trial encompass all these three subtypes and their distinctions do not necessitate separate prior art searches or materially different examination procedures. Applicants argue that the species Groups C/D involve variations in administration that pertain to the same antibody and therapeutic method, differing only in the adjunctive use of at least one additional DMARD. Applicants argue that a single prior art search focused on antibody-based therapies for pJIA would adequately encompass all species in Groups B and C/D.
Applicants’ arguments have been fully considered but have not been found to be persuasive.
The species set forth in each of Groups B-D are independent or distinct, for example, the different types of juvenile idiopathic arthritis (JIA) (Group B) have mutually exclusive characteristics; also, treatment regimens with or without additional DMARD (Group C) are mutually exclusive. These species are not obvious variants of each other. There is a search and/or examination burden for the patentably distinct species for reasons as set forth in the previous Office Action (see p. 4-5). Should Applicants traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, Applicants should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the Examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AlA 35 U.S.C. 103(a) of the other species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-189 are cancelled. Claims 210-212 have been added. Claims 190-212 are pending and under examination to the extent they read on the elected species. Claims 190-194, 196-199, 201-207 and 210-211 read on the elected species, and claims 195, 200, and 208-209 and 212 are withdrawn as being drawn to nonelected species.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings (Figures 1-4, 8, 9A-9D, 10A-10B and 11A-11C) are objected to under 37 CFR 1.83(a) because they fail to show details as described in the specification. FIGs.1, 2 and 8 contain text that is unreadable or of insufficient clarity; and FIGs. 3, 4, 9A-9D, 10A-10B and 11A-11C have portions that are faded or blurry.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Sequence Listing
In the Sequence Listing, the sequence of SEQ ID NO: 7 is listed as “000”.
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:
U.S. Patent Application No. 16/779,187 is now patented. The first paragraph of the specification should be updated accordingly.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see, for example, p. 33, lines 30-31, and p. 156, line 16). Applicants are required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 194 and 210-211 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 194 recites “about 2 to about 17 years old”. The specification does not provide any indication as to what range is covered by the term “about” when referring to age.
Claims 210 and 211 recite “SEQ ID NO: 7”. However, the Sequence Listing does not have the sequence (see above “Sequence Listing” section). The metes and bounds of the claims are unclear.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 190, 192-194, 196-199, 201, 204-206 and 210-211 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn to a method for treating polyarticular juvenile idiopathic arthritis (pJIA) in a subject in need thereof, the method comprising administering to the subject an antibody that specifically binds to an interleukin 6 (IL-6) receptor, wherein the antibody comprises heavy chain complementarity determining regions (HCDRs) of a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 1 and light chain complementarity determining regions (LCDRs) of a light chain variable region comprising the amino acid sequence of SEQ ID NO: 2. The claims, as written, do not require all 6 CDRs (i.e., HCDR1, 2 and 3, and LCDR1, 2 and 3) from the heavy chain and light chain variable regions comprised in the antibody (for example, the claims read on an antibody comprising only 4 or 5 of the CDRs). While the specification describes antibodies that specifically bind to an IL-6 receptor and comprises HCDR1, 2 and 3 from the heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 1 and LCDR1, 2 and 3 from the light chain variable region comprising the amino acid sequence of SEQ ID NO: 2, the specification does not provide adequate written description of the genus of the antibodies as claimed. It is well established in the art that the formation of an intact antigen-binding site generally requires the association of the complete heavy chain and light chain variable regions of a given antibody, each of which includes three CDRs or hypervariable regions which provide the majority of the contact residues for the binding of the antibody to its target epitope (see Knappik et al., J. Mol. Biol., 2000, Vol. 296(1):57-86). The art teaches that even minor changes in sequence can result in major changes in function, especially if the minor sequence change occurs within an active site or alters the overall conformation of the molecule. For example, Rabia et al. (Biochem. Eng. J., 2018, Vol. 137:365-374) teaches that it is extremely challenging to define the sequence determinants of antibody specificity; most mutations that increase affinity – such as those that simply increase hydrophobicity or charge – also reduce specificity. The specification does not provide a written description that is sufficient to support the present claims. One skilled in the art would expect that replacing one or more of the CDRs, as encompassed in the present claims, would result in alteration in the binding specificity and other properties of an antibody. Without further testing, the skilled artisan cannot envision the detailed structures of the encompassed antibodies that can specifically bind to an IL-6 receptor, let alone the antibodies that can be used in a pharmaceutical setting as presently claimed.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making of the claimed product, or any combination thereof. In this case, there is no sufficient teaching regarding the correlation of structure and function. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed structures of the encompassed genus of antibodies, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that is part of the invention and reference to a method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Therefore, except for the antibodies that specifically bind to an IL-6 receptor and comprise HCDR1, 2 and 3 of the heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 1 and LCDR1, 2 and 3 of the light chain variable region comprising the amino acid sequence of SEQ ID NO: 2, there is no adequate written description for the full scope of the claimed antibodies in the disclosure.
Regarding claims 210 and 211, these claims are included in the rejection given the indefinite nature as set forth above in the 35 U.S.C. 112(b) section.
Double Patenting
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 190-194, 196-199, 201-207 and 210-211 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7-21 of U.S. Patent No.11,498,969. Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the ‘969 patent are drawn to a method for treating juvenile idiopathic arthritis (JIA) in a subject in need thereof comprising administering an effective amount of an antibody that specifically binds interleukin 6 (IL-6) receptor, wherein the antibody that specifically binds to the IL-6 receptor comprises heavy chain complementarity determining region (HCDR) sequences of SEQ ID NOs: 3, 4 and 5, and comprises light chain complementarity determining region (LCDR) sequences of SEQ ID NOs: 6, 7 and 8, and wherein the antibody is administered subcutaneously at a dose of from about 2 mg/kg to about 4 mg/kg once every other week or once every week. The claims also recite “wherein the JIA is polyarticular-course JIA (pcJIA)”, and “wherein the body weight of the subject is greater than or equal to 63 kg and the antibody is administered subcutaneously at a dose of 192.5 mg once every other week or once every week”. The claims of the ‘969 patent anticipate the instant claims, thus, the nonstatutory double patenting rejection is proper.
Conclusion
NO CLAIM IS ALLOWED.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Xiaozhen Xie, whose telephone number is 571-272-5569. The examiner can normally be reached on M-F, 8:30-5.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa L. Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/XIAOZHEN XIE/Primary Examiner, Art Unit 1674 December 12, 2025