DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed June 4, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 30, 2026, April 30, 2026, and May 14, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 11 and 14 are cancelled.
Claims 17 – 23 are newly added.
Claims 1 – 10, 12, 13, and 15 – 23 are examined here-in.
Claim Rejections - 35 USC § 103 (New, Necessitated by Amendment)
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 non-obviousness.
Claims 1 – 10, 12, 13, and 15 – 23 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US 2007/0053900 A1, of record) in view of White (US 10,751,415 B2).
Liu teaches highly concentrated antibody formulations, their method of manufacture, and method of using them to treat disease (abstract).
Liu teaches antibody formulations with 100 – 260 mg/mL antibody, 10 – 100 mM histidine, 50 to 200 mM arginine-HCl, and 0.01 – 0.1% polysorbate with a pH between 5.5 – 7.0 (paragraph 0012).
Liu teaches histidine is a suitable buffering agent, and that buffers are effective for maintaining a pH range which optimizes therapeutic effectiveness (paragraph 0211). Liu teaches buffering agents can be in a concentration of 50 to 250 mM (paragraph 0211).
Liu teaches arginine is an amino acid which is particularly suitable for highly concentrated antibody formulations and can act as a stabilizing agent to enhance solubility or prevent denaturation (paragraphs 0008, 0214).
Liu teaches the antibody formulation can be administered to treat disease (paragraph 0016). Liu teaches the formulation can be enclosed in a container such as a pre-filled syringe or an auto-injector (paragraph 0017).
Liu does not teach the antibody is an anti-TG2 antibody with a light chain having at least 80% identity or similarity to SEQ ID NO 3 and a heavy chain having at least 80% identity or similarity to SEQ ID NO 4.
White teaches the missing elements of Liu.
White teaches compositions with antigen binding domains comprising light and heavy chain moieties (column 3 lines 61 – 67, column 4 lines 58 – 62). White teaches that antibody therapy is a therapeutic approach for the prevention and treatment of cancer, autoimmune, and inflammatory diseases (column 1 lines 57 – 67).
White teaches light chains with SEQ ID 14 and SEQ ID 24, and heavy chains with SEQ ID 9 and SEQ ID 19 (column 4 lines 58 – 62).
The combination of Liu and White’s teachings renders instant claims 1 – 10, 12, 13, and 15 – 23 prima facie obvious as combining prior art teachings according to known methods to yield predictable results (MPEP 2143(i)(a)). A person of ordinary skill in the art would be motivated to include White’s teachings for different antibody sequences in the formulation of Liu because White teaches that antibody therapy is a well-known approach for the prevention and treatment of various diseases (column 1 lines 57 – 67). A person of ordinary skill in the art has the necessary expertise to make the specific selection of an antibody with light chains with SEQ ID 14 and SEQ ID 24, and heavy chains with SEQ ID 9 and SEQ ID 19 (column 4 lines 58 – 62) in order to target the complementary therapeutic binding site, i.e. treat a specific disease. Furthermore, Liu teaches that buffers and amino acids are effective for maintaining a pH range which optimizes therapeutic effectiveness, enhancing solubility, and/or preventing denaturation (paragraphs 0008, 0211, 0214). The combination of Liu and White’s teachings would yield predictable results (i.e. a stable formulation containing an antibody) and is therefore prima facie obvious according to MPEP 2143(i)(a).
Liu’s teaching for an antibody formulations with histidine buffer, arginine-HCl amino acid, and a pH between 5.5 – 7.0 (paragraphs 0008, 0012, 0211, 0214) in combination with White’s teaching for a therapeutic antibody having light chains with SEQ ID 14 and SEQ ID 24, and heavy chains with SEQ ID 9 and SEQ ID 19 (column 4 lines 58 – 62) reads on instant claim 1. Liu’s teaching for a pH between 5.5 and 7 (paragraph 0012) overlaps on the claimed range of 5 to 6 recited in claim 1. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
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A comparison between instant SEQ ID NO 3 and White’s SEQ ID 14 and SEQ ID 24 is shown below. SEQ ID NO. 3 has 86.4% sequence identity and 90.7% sequence similarity with SEQ ID 14 according to BLOSUM62 scoring. SEQ ID NO. 3 has 87.9% sequence identity and 92.1% sequence similarity with SEQ ID 24 according to BLOSUM62 scoring. Sequence identity or similarity greater than 80% reads on instant claim 1 part ii.
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A comparison between instant SEQ ID NO 4 and White’s SEQ ID 9 and SEQ ID 19 is shown below. SEQ ID NO. 4 has 86.3% sequence identity and 91.7% sequence similarity with SEQ ID 9 according to BLOSUM62 scoring. SEQ ID NO. 4 has 85.9% sequence identity and 91.9% sequence similarity with SEQ ID 19 according to BLOSUM62 scoring. Sequence identity or similarity greater than 80% reads on instant claim 1 part ii.
Liu’s teaching for histidine as buffering agent (paragraphs 0012, 0211) reads on instant claim 2.
Liu’s teaching the antibody formulation with histidine buffer has a pH between 5.5 – 7.0 (paragraphs 0012, 0211) overlaps on the values of 5.5 +/- 0.2 as recited in claim 3.
Liu’s teaching for 10 – 100 mM of histidine buffer (paragraph 0012) overlaps on the instantly claimed range of 10 to 100 mM recited in instant claim 4, 20 to 80 mM as recited in claim 16, and 40 to 60 mM as recited in claim 17. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Liu’s teaching for 50 to 200 mM arginine-HCl (paragraph 0012) overlaps on the instantly claimed range of 100 to 300 mM as recited in claim 5, 110 to 250 mM as recited in claim 18, and 120 to 200 mM as recited in claim 19.
Liu’s teaching for arginine-HCl (paragraph 0012) reads on claim 6.
Liu’s teaching that the antibody formulation includes 0.01 – 0.1% polysorbate (paragraph 0012) reads on instant claims 7 and 8. Liu’s teaching for 0.01 to 0.1% polysorbate (paragraph 0012) overlaps on the instantly claimed ranges of 0.005 to 0.1% w/v and 0.01 to 0.05% w/v/ as recited in claims 8 and 20.
Liu’s teaching for 100 – 260 mg/mL antibody (paragraph 0012) overlaps on the instantly claimed range of 50 to 300 mg/mL, 110 to 250 mg/mL, and 115 to 220 mg/mL as recited in instant claims 9, 21, and 22, respectively.
Liu’s teaching for an antibody formulations with 100 – 260 mg/mL antibody, 10 – 100 mM histidine, 50 to 200 mM arginine-HCl, and 0.01 – 0.1% polysorbate with a pH between 5.5 – 7.0 (paragraph 0012) in combination with White’s teaching for a therapeutic antibody having light chains with SEQ ID 14 and SEQ ID 24, and heavy chains with SEQ ID 9 and SEQ ID 19 (column 4 lines 58 – 62) reads on instant claim 10. Liu’s teaching for an antibody concentration of 100 – 260 mg/mL overlaps on the claimed amounts of 125 mg/mL (claim 10 parts i and ii), 150 mg/mL (parts iii and iv), 175 mg/mL (parts v and vi), and 200 mg/mL (parts vii and viii). Liu’s teaching for histidine concentration of 10 – 100 mM overlaps on the claimed amount of 50 mM histidine(claim 10 parts i – viii). Liu’s teaching for arginine-HCl in an amount of 50 to 200 mM overlaps on the claimed amounts of 125 mM arginine-HCl (claim 10 parts i, iii, v, and vii) and 150 mM arginine-HCl (parts ii, iv, vi, and viii). Liu’s teaching for 0.01 – 0.1% polysorbate overlaps on the claimed amount of 0.02 – 0.05% polysorbate (claim 10 parts i – viii).
Liu teaches antibody formulations are prepared by mixing the active ingredient with the necessary carriers, excipients, and stabilizers (paragraph 0209), reading on instant claim 12.
Liu’s teaching that the formulation can be enclosed in a container such as a pre-filled syringe or an auto-injector (paragraph 0017) reads on instant claim 13.
White’s teachings that antibody therapy is a therapeutic approach for the prevention and treatment of cancer, autoimmune, and inflammatory diseases (column 1 lines 57 – 67) with specific teachings of antibody with light chains with SEQ ID 14 and SEQ ID 24, and heavy chains with SEQ ID 9 and SEQ ID 19 (column 4 lines 58 – 62) in combination with Liu’s teaching for a stable liquid formulation for an antibody to treat a disease (abstract, paragraph 0016) reads on instant claim 15.
A comparison between instant SEQ ID NO 3 and White’s SEQ ID 14 and SEQ ID 24, and between instant SEQ ID NO 4 and White’s SEQ ID 9 and SEQ ID 19 is shown above. As discussed above, SEQ ID NO. 3 has 86.4% sequence identity and 90.7% sequence similarity with SEQ ID 14 according to BLOSUM62 scoring. SEQ ID NO. 3 has 87.9% sequence identity and 92.1% sequence similarity with SEQ ID 24 according to BLOSUM62 scoring. SEQ ID NO. 4 has 86.3% sequence identity and 91.7% sequence similarity with SEQ ID 9 according to BLOSUM62 scoring. SEQ ID NO. 4 has 85.9% sequence identity and 91.9% sequence similarity with SEQ ID 19 according to BLOSUM62 scoring. Sequence identity or similarity greater than 90% reads on instant claim 23.
Examiner’s Reply to Attorney Arguments Dated June 4, 2026
Applicant’s arguments have been considered but are moot because the new grounds of rejection specifically addresses the claims as presently amended. As discussed in the body of the rejection above, a person of ordinary skill in the art would be motivated to include White’s teachings for different antibody sequences in the formulation of Liu because White teaches that antibody therapy is a well-known approach for the prevention and treatment of various diseases (column 1 lines 57 – 67) and a person of ordinary skill in the art has the necessary expertise to make the specific selection of an antibody with light chains with SEQ ID 14 and SEQ ID 24, and heavy chains with SEQ ID 9 and SEQ ID 19 (column 4 lines 58 – 62) in order to target the complementary therapeutic binding site, i.e. treat a specific disease. Furthermore, Liu teaches that buffers and amino acids are effective for maintaining a pH range which optimizes therapeutic effectiveness, enhancing solubility, and/or preventing denaturation (paragraphs 0008, 0211, 0214). The combination of Liu and White’s teachings would yield predictable results (i.e. a stable formulation containing an antibody) and is therefore prima facie obvious according to MPEP 2143(i)(a).
Double Patenting
The judicially created doctrine for non-statutory double patenting rejections has been described in detail in the previous action.
Double Patenting over Application No. 18/703,661
Claims 1 – 10, 12, 13, and 15 – 23 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 3 – 11, and 13 – 25 of copending Application No. 18/703,661.
Although the claims at issue are not identical, they are not patentably distinct from each other because: instant claim 1 is drawn to a stable liquid formulation comprising an anti-TG2 antibody, a buffer keeping pH between 5.0 and 6.0, and an amino acid stabilizer; wherein the anti-TG2 antibody comprises light chain domain of SEQ ID NO 3 and heavy chain domain of SEQ ID NO 4.
Conflicting claim 1 is drawn to a stable liquid formulation comprising an anti-TG2 antibody, a buffer keeping pH between 5.0 and 7.0, and a stabilizer of glycine or NaCl; wherein the anti-TG2 antibody comprises light chain domains of SEQ ID NO 1 or 3 and heavy chain domains of SEQ ID NO 2 or 4.
The instant and conflicting claims differ because conflicting claim 1 recites a pH between 5.0 and 7.0 and a stabilizer of glycine or NaCl.
The conflicting pH of 5.0 and 7.0 is overlapped by the instantly claimed pH of 5.0 and 6.0. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Glycine is an amino acid stabilizer.
Conflicting claim 1 recites the buffer is a histidine buffer, reading on instant claim 2.
Conflicting claim 3 recites the histidine buffer pH keeps the pH at or about 5.5 +/- 0.2, reading on instant claim 3.
Conflicting claims 4, 17, and 18 recite the concentration of buffer, reading on instant claims 4, 16, and 17.
Conflicting claims 7, 8, and 20 recite the formulation optionally includes a polysorbate surfactant, reading on instant claims 7 and 8.
Conflicting claims 9, 22, and 23 recite the formulation contains antibody in various concentrations, overlapping on the claimed concentrations recited in instant claims 9, 21, and 22.
Conflicting claim 14 recites an article of manufacture comprising a container and the liquid formulation, reading on instant claim 13.
Conflicting claim 15 recites the stable liquid formulation is for use in therapy, reading on instant claim 14.
Conflicting claim 16 recites a method for treating a disease or disorder by administering the stable liquid formulation, reading on instant claim 15.
Conflicting claim 25 reads on instant claim 223.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner’s Reply to Attorney Arguments Dated June 4, 2026
Applicant requests the provisional non-statutory double patenting rejection be held in abeyance (Remarks page 9). According to MPEP 804(1), a complete response to a non-statutory double patenting rejection is either a showing that the claims subject to the rejection are patentably distinct from the reference claim or the filing of a terminal disclaimer. The Examiner notes that Applicant’s argument is not a showing that the claims are patentably distinct from the reference claims. As such, the non-statutory double patenting rejections are maintained.
Conclusion
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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