DETAILED ACTION
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 .
Claim Status
The amendments filed 07/06/2026 are entered. Claim 1 is amended. Claims 1, 3-5, 7, 9, and 12 are rejected.
Priority
The instant application is a 371 of PCT/KR2021/008000 (filed 06/25/2021). The effective filing date of instant claims 1-17 is 06/25/2021. Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted 07/06/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, each information disclosure statement is being considered by the examiner.
RESPONSE TO AMENDMENT
Withdrawn Objections/Rejections
Claim Rejections - 35 USC § 112(b)
The previous rejections of claim(s) 6, 14-16 under 35 USC § 112(b) is/are withdrawn in response to Applicant’s amendments to the claims. The Applicant has cancelled these claims.
Claim Rejections - 35 USC § 112(d)
The previous rejections of claim(s) 7 under 35 USC § 112(d) is/are withdrawn in response to Applicant’s amendments to the claims. The Applicant has cancelled this claim.
Claim Rejections - 35 USC § 112(a)
The previous rejections of claim(s) 1-10 and 12-17 under 35 USC § 112(a) is/are withdrawn in response to Applicant’s amendments to the claims. The Applicant has amended to claim the anti-FcRn antibody by the heavy and light chain CDR sequences that have written support from the specification.
Specification
The previous objection(s) to the Specification is/are withdrawn in response to Applicant’s amendments to the Specification, filed 07/06/2026.
Drawings
The previous objection(s) to the Drawings is/are withdrawn in response to Applicant’s amendments to the Specification, filed 07/06/2026.
Maintained Objections/Rejections
Nucleotide and/or Amino Acid Sequence Disclosure
ST.25 REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
The Incorporation by Reference statement in the Specification should recite 06/30/2023 as the date of creation. The date of creation is the date of creation of the sequence listing, i.e. the electronic version of the sequence data that accompanies the application, and is the day the Applicant submits the sequence data to the Office and the Office receives it (automatically, when electronically submitted).
The Incorporation by Reference statement in the Specification should recite a File Name, MUNO-009_01US_SeqList_ST25, as was previously reported. The previous instruction towards the name 18012600_2_1 was incorrect.
Claim Rejections - 35 USC § 103
The previous 35 USC § 103 rejections have been updated in response to the amendments.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-5, 7, 9, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morichika et al (High concentration antibody-containing liquid formulation; Patent No. US11008394B2; filing date: 04/22/2019; hereafter referred to as Morichika) in view of Chen et al (Influence of histidine on the stability and physical properties of a fully human antibody in aqueous and solid forms; Pharm Res 20, 1952-1960; published 12/2003, hereafter referred to as Chen), Kim et al (FcRn Antibody-binding for FcRn for Treating Autoimmune Diseases; Patent App No. KR20180093128A; publication date: 03/08/2019; hereafter referred to as Kim) and Bhambhani et al (Bhambhani et al, Formulation Design and High-Throughput Excipient Selection Based on Structural Integrity and Conformational Stability of Dilute and Highly Concentrated IgG1 Monoclonal Antibody Solutions, published 2011; hereafter referred to as Bhambhani), as evidenced by JPH0899902A (published 1996).
Regarding claim 1, Morichika teaches formulations that contain both arginine and methionine lead to less unwanted dimer formation than just arginine alone (Figures 2, 3, 7, and 8).
Accordingly, Morichika teaches compositions comprising of both arginine and methionine:
a pharmaceutical formulation having a pH of 6.0 comprising
180 mg/ml of an IgG1 antibody,
100 mM of arginine,
a buffer system comprising of 20 mM histidine and
0.05% (i.e. 0.5 mg/ml) of polysorbate 80 (Table 1-1, conditions A7-A9 and Table 3-1, conditions A25-A27).
Morichika further teaches these compositions comprising of three different concentrations of Methionine (Table 1-1, conditions A7-A9 and Table 3-1, conditions A25-A27).
Morichika further teaches that the antibody tested is an anti-IL-6 antibody from JPH0899902A. As evidenced by JPH0899902A, this antibody is a humanized IgG1 antibody (para. 34).
Morichika teaches polysorbate 80 in the formulations referenced instead of polysorbate 20, but claims polysorbate 20 or polysorbate 80 (col. 16, lines 49-51) as alternatives to each other.
Morichika does not explicitly teach 50 to 250 mM histidine.
However, Chen teaches minimal antibody aggregate formation (p. 1956, col. 2, para. 1) and lower viscosity (p. 1958, col. 1, para. 3) was observed at approximately 60 mM histidine. Chen teaches that this higher histidine concentration significantly improves the antibody’s aggregation (p. 1956, Figure 2) and reduces the formulation’s viscosity (p. 1958, Figure 5) compared to lower concentrations starting from 15 mM. Chen teaches that this concentration improves the antibody’s stability and reduces the formulation’s viscosity (see page 1958 and Figure 5).
Morichika in view of Chen does not explicitly teach the antibody is an anti-FcRn antibody and its CDR sequences.
However, Kim teaches the exact anti-FcRn antibody and its claimed CDR sequences. Kim teaches a pharmaceutical formulation wherein the anti-FcRn antibody, which is an IgG1 antibody, comprises the disclosed amino acid sequences for the variable heavy and light chain CDR1-3 (Paragraph 60), which are the same sequences for the instantly claimed variable heavy and light chain CDR1-3.
The sequence for heavy chain CDR1 is SEQ ID NO. 5 in the instant application has 100% homology to SEQ ID NO. 27 in Kim.
The sequence for heavy chain CDR2 is SEQ ID NO. 6 in the instant application has 100% homology to SEQ ID NO. 28 in Kim.
The sequence for heavy chain CDR3 is SEQ ID NO. 7 in the instant application has 100% homology to SEQ ID NO. 29 in Kim.
The sequence for light chain CDR1 is SEQ ID NO. 8 in the instant application has 100% homology to SEQ ID NO. 30 in Kim.
The sequence for light chain CDR2 is SEQ ID NO. 9 in the instant application has 100% homology to SEQ ID NO. 31 in Kim.
The sequence for light chain CDR3 is SEQ ID NO. 10 in the instant application has 100% homology to SEQ ID NO. 32 in Kim.
Kim teaches the addition of conventional pharmaceutically acceptable carriers, excipients, and additives (Paragraph 87), a buffer (Paragraph 87), a surfactant (Paragraph 87), and a formulation with a pH of 6.0 or 7.4 (Paragraph 117). Kim teaches the formulation composition comprising the anti-FcRn antibody as a formulation for injection (Paragraph 87).
Bhambhani teaches stability studies in formulations by IgG subclass, specifically for IgG1 due to shared structures that interact with excipients similarly (Abstract).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, to choose the formulations taught by Morichika and further improve it by increasing the histidine concentration according to Chen. It would have been obvious that polysorbate 20 can be used as an alternative to polysorbate 80, according to Morichika. It would have been obvious to use these formulations for other IgG1 antibodies, such as the anti-FcRn antibody disclosed by Kim in view of Bhambhani teaching antibody formulation stability characterized by IgG subclass (e.g. IgG1), implying some transferability of expected results within the IgG1 subclass even with varying Fab sequences.
One skilled in the art, before the effective filing date of the instant application, would be motivated to use the base formulation taught by Morichika because of the stability it confers on the antibody, and improve it with a higher histidine concentration, according to Chen, which improved aggregation and viscosity, which is sought after for high-concentration antibody formulations. One would be motivated to use a formulation that stabilizes one IgG1 antibody for another IgG1 antibody, such as the anti-FcRn antibody of Kim, for the same purpose, as there is a recognized need in the biopharmaceutical field to create formulations appropriate for maintaining the integrity of antibodies, especially at high concentrations, and one does not need to start from scratch in view of Bhambhani teaching the reasonably likely predictability of effects from excipients within the IgG1 subclass due to common relevant structures that interact with these excipients. One skilled in the art would recognize the formulations taught by Morichika in view of Chen as a finite number of formulations and would be motivated to choose them due to the advantages they confer to an IgG1 antibody.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success that the formulation arrived at by Morichika in view of Chen would be at least compatible with the antibody disclosed by Kim, in view of their shared IgG1 subclass; the teachings regarding the applicability of the effects of histidine on IgG in general, and not one particular IgG; and the applicability of formulas across IgG1 subclass.
Claims 3-5, 7, 9, and 12 depend on claim 1. The teachings of the references regarding claim 1 are incorporated in its entirety for the dependent claims and discussed further below, as is relevant for each claim.
Regarding claim 3, claim 4, and claim 9, as previously presented for claim 1, Morichika teaches the formulation comprises polysorbate, further comprises methionine (Paragraph 64, Tables 1-1 and 3-1), and comprises 180 mg/ml of the antibody. The teachings, motivations, and expectation of success in these limitations are previously presented for claim 1.
Regarding claims 5 and 12, Morichika further teaches the formulation prepared in the form of an injection, particularly suitable for subcutaneous injection (Paragraph 78).
Regarding claim 7, since osmolality is based on the solutes in a fluid, it can be calculated based on the concentration of solutes in a formulation. The osmolality range provided in the instant claim is measured from the formulation variants disclosed in the instant application. The calculated osmolality of a formulation with the same solutes within the same concentration ranges disclosed in the instant application will yield the same calculated osmolality as disclosed in the instant application. Therefore, the formulation as taught by Morichika in view of Kim and further in view of Chen, which teaches all the limitations of the instant application will yield an osmolality within the osmolality range of the instant application.
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, that these antibody formulations, which are based on Morichika, but modified with a higher histidine concentration in view of Chen and a different antibody in view of Kim could formulated as an injection, as all the histidine concentration reduced viscosity, which would be compatible with injection of high concentrations of antibody. Furthermore, because of the desired effects, the osmolarity that naturally flows from these formulations would also be obvious.
One skilled in the art, before the effective filing date of the instant application, would be motivated to formulate the antibody as a subcutaneous injection for easy administration of this therapeutic.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success that this formulation can be injected subcutaneously because of the low viscosity conferred by the formulation, leading to less pain and more distribution at the injection site.
New Objections/Rejections
Claim Rejections - 35 USC § 112(b)
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.
Claim 3 is 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 3 recites the limitation "the surfactant". There is insufficient antecedent basis for this limitation in the claim as the parent claim does not specifically recite “a surfactant”.
Claim Rejections - 35 USC § 112(d)
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 3 and 9 are 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. 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.
Claim 3 recites the surfactant is polysorbate, but polysorbate is already claimed in the parent claim. Therefore, claim 3 does not further limit its parent claim.
Claim 9 recites dependency on cancelled claim 8. This is interpreted as a typographically error and the claim is interpreted as depending on claim 1 for purposes of expediting examination.
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.
US 10544226 B2
Claims 1, 3-5, 7, 9, 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. US 10544226 B2 (Patent ‘226) in view of Morichika et al (High concentration antibody-containing liquid formulation; Patent No. US11008394B2; filing date: 04/22/2019; hereafter referred to as Morichika) in view of Chen et al (Influence of histidine on the stability and physical properties of a fully human antibody in aqueous and solid forms; Pharm Res 20, 1952-1960; published 12/2003, hereafter referred to as Chen), Kim et al (FcRn Antibody-binding for FcRn for Treating Autoimmune Diseases; Patent App No. KR20180093128A; publication date: 03/08/2019; hereafter referred to as Kim) and Bhambhani et al (Bhambhani et al, Formulation Design and High-Throughput Excipient Selection Based on Structural Integrity and Conformational Stability of Dilute and Highly Concentrated IgG1 Monoclonal Antibody Solutions, published 2011; hereafter referred to as Bhambhani), as evidenced by JPH0899902A (published 1996).
Patent ‘226 teaches the instantly claimed anti-FcRn antibody. The sequences of the heavy and light chain CDRs in claim 1 match 100% with the corresponding heavy and light chain CDRs sequences instantly claimed.
The rationale to formulate this antibody into the formulation taught by Morichika in view Chen is explained the 35 USC 103 rejection presented above and incorporated herein.
US 10336825 B2
Claims 1, 3-5, 7, 9, 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. US 10336825 B2 (Patent ‘825) in view of Morichika et al (High concentration antibody-containing liquid formulation; Patent No. US11008394B2; filing date: 04/22/2019; hereafter referred to as Morichika) in view of Chen et al (Influence of histidine on the stability and physical properties of a fully human antibody in aqueous and solid forms; Pharm Res 20, 1952-1960; published 12/2003, hereafter referred to as Chen), Kim et al (FcRn Antibody-binding for FcRn for Treating Autoimmune Diseases; Patent App No. KR20180093128A; publication date: 03/08/2019; hereafter referred to as Kim) and Bhambhani et al (Bhambhani et al, Formulation Design and High-Throughput Excipient Selection Based on Structural Integrity and Conformational Stability of Dilute and Highly Concentrated IgG1 Monoclonal Antibody Solutions, published 2011; hereafter referred to as Bhambhani), as evidenced by JPH0899902A (published 1996).
Patent ‘825 teaches the instantly claimed anti-FcRn antibody. The sequences of the heavy and light chain CDRs in claim 1 match 100% with the corresponding heavy and light chain CDRs sequences instantly claimed.
The rationale to formulate this antibody into the formulation taught by Morichika in view Chen is explained the 35 USC 103 rejection presented above and incorporated herein.
RESPONSE TO ARGUMENTS
Claim Rejections - 35 USC § 103
Applicant's arguments filed 07/06/2026 have been fully considered but they are not persuasive.
Applicant argues that Morichika describes nearly 200 combinations of surfactants and buffering agents alone, which is already too many to amount to a finite number of potential solutions (i.e. formulations) to choose from. This is not persuasive.
As discussed in the updated rejection presented above, 6 distinct formulations in Morichika are referenced, and they share one common base formulation and only differs by the methionine concentration, which is not distinctly required in the independent claim, but later claimed in claim 4. As explained in the rejection, there is clear motivation to choose these 6 formulations for their superior stability. Only polysorbate 20 was taught as an alternative to polysorbate 80, leading to 12 total formulations (6 with the original polysorbate 80 and 6 with the substituted polysorbate 20). Further, the improvement by Chen is directed to an increase to one specific histidine concentration, and provided motivated to use this higher concentration in place of a lower one. As such, the teachings of the Morichika in view of Chen regarding the formulation amounts to at most 12 distinct choices and the only decision would be whether to use the polysorbate 20 or polysorbate 80 formulation to arrive at the claimed invention, where it is likely that both can be compatible.
Applicant further argues that the histidine concentration taught by Morichika falls outside the claimed range. This is not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed in the updated rejection presented above, 60 mM as a histidine concentration is taught in Chen and the motivation and expectation of success of this improvement over the lower concentration taught by Morichika are also provided. The combination of references therefore teach the histidine concentration in the formulation, meeting the claimed limitations regarding histidine.
Applicant further argues that it is well known in the art that the stability of a pharmaceutical formulation containing antibody varies depending, at least in part, on the specific characteristics of said antibody. Applicant further argues that specifically the histidine concentration taught by Chen only showed stability in another antibody (not the one distinctly claimed) and therefore cannot be used to predict success for the claimed antibody. This is not persuasive.
First, the Applicant has provided no references or evidence supporting that there is any likely significant or unexpected differences between the substituted antibodies in the same formulation, especially in light of them both being IgG1 antibodies. MPEP 716.01(c) makes clear that arguments of counsel cannot take the place of evidence in the record.
Second, Applicant's argument relies on absolute predictability. MPEP 2143.02 teaches that obviousness does not require absolute predictability, but only a reasonable expectation of success is required. As discussed in the updated rejection presented above, there is reasonable expectation of predictability on how antibodies of the same subclass (e.g. IgG1) will behave in the same formulation, according to Bhambhani. Specifically regarding the histidine concentration, Chen teaches that the effect on histidine (reduced aggregation and reduced viscosity) is generalizable amongst antibodies. In conclusion, since the formulations reduced aggregation and viscosity for one IgG1 antibody, there is reasonable expectation it will do so for another IgG1 antibody.
Third, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). While the examiner appreciates that the disclosed invention may have a certain stability profile, this is not commensurate with the scope of the claim, as the claims do not recite any stability requirement and certainly not any degree of stability improvement. Therefore, the mere ability to place the anti-FcRn antibody taught by Kim in the formulation arrived at by Morichika in view of Chen is already enough to fulfill the reasonable expectation of success, and this reasonable expectation of success does not require any particular stability property nor degree of improvement. However, the presented rejection already goes further and explains the reasonable expectation of success that the antibody of Kim will achieving stability in the formulation arrived at by Morichika in view of Chen.
Conclusion
No claims are 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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIRATH CHHAY whose telephone number is (571)272-0682. The examiner can normally be reached Mon-Thu 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached at (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIRATH CHHAY/Examiner, Art Unit 1645 Tuesday, July 28, 2026
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 July 30, 2026
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