DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed May 18, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 2 and 12 are cancelled.
Claims 17 – 25 are newly added.
Claims 1, 3 – 11, and 13 – 25 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, 3 – 11, and 13 – 24 are rejected under 35 U.S.C. 103 as being unpatentable over Boonen (US 2018/0028652 A1, of record) in view of Johnson (US 10,005,846 B2, of record).
Boonen teaches a formulation containing an antibody (abstract).
Boonen teaches the formulation contains a buffering agent, such as citrate or histidine, to maintain the pH of the formulation (paragraph 0024). Boonen teaches that when the buffer is citrate, it is in the amount of 10 to 100 mM (paragraph 0025).
Boonen teaches the pH of the composition is between 4 and 7 (paragraph 0026).
Boonen teaches amino acids, such as glycine, and salts, such as sodium chloride, act as stabilizers in an antibody formulation (paragraphs 0007, 0068, 0069). Boonen teaches glycine is a popular stabilizer because it has cryoprotectant properties (paragraph 0008). Boonen teaches glycine in a concentration from 20 to 200 mM (paragraph 0018). This teaching of glycine concentration appears to be exemplary of a concentration of any stabilizer in the composition, as stabilizer sucrose is also taught in the amount of 20 to 200 mM (paragraphs 0007 – 0009, 0018 – 0019).
Boonen teaches the formulation may also include polysorbate surfactants in an amount of 0.01 to 10% (paragraphs 0022 – 0023).
Boonen teaches the formulation includes 50 to 300 mg/mL antibody (paragraphs 0020 – 0021, claim 4).
Boonen does not teach the antibody is an anti-TG2 antibody.
Johnson teaches the missing element of Boonen.
Johnson teaches human TG2 inhibitor antibodies (abstract).
Johnson teaches that TG2 is associated with many different disease states and there is a need for highly selective and efficacious TG2 inhibitors (column 4 lines 35 – 38). Johnson teaches an anti-TG2 antibody will bind to TG2 (column 4 lines 43 – 51).
The combination of Boonen and Johnson’s teachings renders instant claims 1, 3 – 11, and 13 – 24 prima facie obvious as combining prior art teachings according to known methods to yield predictable results (MPEP 2143(i)(a)). Boonen teaches a stable formulation for antibodies as active ingredients, and Johnson teaches human TG2 inhibitor antibodies. A person of ordinary skill in the art would be motivated to include Johnson’s teachings for anti-TG2 antibodies in the formulation of Boonen because Johnson teaches that TG2 is associated with many different disease states and there is a need for selective and effective TG2 antibodies (column 4 lines 35 – 38, 43 – 51). Furthermore, Boonen teaches that buffers and stabilizers are useful for long-term formulation stability and minimizing antibody degradation (paragraphs 0002 – 0010). The combination of Boonen and Johnson’s teachings would yield predictable results (i.e. a stable formulation containing anti-TG2 antibody) and is therefore prima facie obvious according to MPEP 2143(i)(a).
Boonen’s teaching for a formulation that contains an antibody, a citrate or histidine buffering agent, and stabilizers such as glycine or sodium chloride, where the pH is between 4 and 7 (abstract, paragraphs 0007 – 0008, 0018, 0024 – 0026, 0068 – 0069) in combination with Johnson’s teaching for an anti-TG2 antibody (abstract, column 4 lines 35 – 38, 43 – 51) reads on instant claim 1. Boonen’s teaching for a pH between 4 and 7 (paragraph 0026) overlaps on the claimed range of 5 to 7 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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Johnson’s teaching for an anti-TG2 antibody with at least one light chain variable region with SEQ ID 73 and one heavy chain region with SEQ ID 75, reads on instant claim 1 subsections 1 and 2, and claim 24. The instantly claimed SEQ ID 1 and 2 are identical to Johnson’s SEQ ID 73 and 75, as shown with sequence alignments below.
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Boonen’s teachings for buffering agents such as citrate or histidine, and a desired pH between 4 and 7 (paragraphs 0024 - 0026), read on instant claim 3. A pH range of 4 to 7 overlaps on the values of 5.5 +/- 0.2 and 6.5 +/- 0.2 as recited in claim 3. Furthermore, a person of ordinary skill in the art would have the necessary expertise to adjust the pH of buffering agents to reach the desired composition pH.
Boonen’s teaching for citrate buffer concentration between 10 to 100 mM (paragraph 0025) overlaps on the instantly claimed range of 10 to 100 mM recited in instant claim 4, 20 to 80 mM recited in claim 17, and 40 to 60 mM recited in claim 18. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Boonen’s teaching for glycine and/or sodium chloride as stabilizers to be included in a concentration from 20 to 200 mM in an antibody formulation (paragraphs 0007, 0018, 0068, 0069) overlaps on the instantly claimed ranges of 150 to 350 mM, 200 to 300 mM, and 220 to 280 mM for glycine as recited in claims 5, 19, and 20.
Boonen’s teaching for glycine and/or sodium chloride as stabilizers to be included in a concentration from 20 to 200 mM in an antibody formulation (paragraphs 0007, 0018, 0068, 0069) overlaps on the instantly claimed ranges of 100 to 200 mM and 125 to 175 mM for NaCl as recited in claims 6 and 21, respectively.
Boonen’s teaching that the formulation may also include polysorbate surfactants in an amount of 0.01 to 10% (paragraphs 0022 – 0023) reads on instant claims 7 and 8. According to calculations by the Examiner, Boonen’s taught amount of 0.01 to 10% is approximately 0.1 to 100 mg/mL, overlapping on the instantly claimed 0.01 to 0.5 mg/mL as recited in claim 8.
Boonen’s teaching for an antibody concentration between 50 to 300 mg/mL (paragraphs 0020 – 0021, claim 4) overlaps on the claimed range of 10 to 200 mg/mL, 30 to 180 mg/mL, and 50 to 150 mg/mL as recited in instant claims 9, 22, and 23.
Boonen’s teaching for an antibody concentration between 50 to 300 mg/mL (paragraphs 0020 – 0021, claim 4), buffer concentration between 10 to 100 mM (paragraph 0025), pH between 4 and 7 (paragraphs 0024 - 0026), and glycine and/or sodium chloride as stabilizer in a concentration from 20 to 200 mM (paragraphs 0007, 0018, 0068, 0069) overlaps on the instantly claimed antibody concentration of 100 mg/mL, buffer of 50 mM, pH of 5.5 or 6.5, and 150 mM sodium chloride as recited in instant claims 10 and 11.
Johnson teaches the preparation of a formulation containing antibody and necessary substances can be prepared according to standard pharmaceutical techniques known to those of skill in the art, reading on instant claim 13.
Boonen teaches that the formulation may be contained in a device such as an autoinjector, a needless device, an implant, a patch, or a nebulizer, reading on instant claim 14.
The instant claim 15 recites “The stable liquid formulation according to claim 1, for use in therapy”. The limitation of “for use in therapy” is viewed an intended use limitation. Boonen and Johnson’s teachings for a stable formulation with anti-TG2 antibody appears to be capable of meeting the intended use for therapy in view of Johnson’s teaching that an anti-TG2 antibody will bind to TG2 and thus be able to treat various associated disease states (column 4 lines 35 – 38, 43 - 51). As such, the combination of Boonen and Johnson’s teachings read on instant claim 15.
Johnson’s teaching for a method of treating various diseases by administering a formulation with anti-TG2 antibody (column 39 line 58 - column 40 line 18, column 43 lines 23 - 28), in combination with Boonen’s teaching for a stable liquid formulation for an antibody to treat a disease (abstract, paragraph 0038) reads on instant claim 16.
Claims 1 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Boonen (as cited above) in view of White (US 10,751,415 B2).
Boonen’s teachings are discussed above.
Boonen does not teach light chain and heavy chain sequences matching SEQ ID 3 or SEQ ID 4.
White teaches the missing elements of Boonen.
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 Boonen and White’s teachings renders instant claims 1 and 25 prima facie obvious as combining prior art teachings according to known methods to yield predictable results (MPEP 2143(i)(a)). Boonen teaches a stable formulation for antibodies as active ingredients, and Johnson teaches human TG2 inhibitor antibodies. A person of ordinary skill in the art would be motivated to include White’s teachings for different antibody sequences in the formulation of Boonen because White teaches that antibody therapy is a well-known approach for the prevention and treatment of various diseases (column 1 lines 57 – 67). Furthermore, Boonen teaches that buffers and stabilizers are useful for long-term formulation stability and minimizing antibody degradation (paragraphs 0002 – 0010). The combination of Boonen 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).
Boonen’s teaching for a formulation that contains an antibody, a citrate or histidine buffering agent, and stabilizers such as glycine or sodium chloride, where the pH is between 4 and 7 (abstract, paragraphs 0007 – 0008, 0018, 0024 – 0026, 0068 – 0069) 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 claims 1 subsections 3 and 4. A comparison of sequences for sequences is shown below.
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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 25.
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Examiner’s Reply to Attorney Arguments Dated May 18, 2026
Applicant’s arguments have been considered but are moot because the new grounds of rejection specifically addresses the claims as presently amended.
For the sake of compact prosecution, in response to Applicant’s argument that “the present application demonstrates an unexpected, technical effect for the selection of the anti-TG2 antibody in combination with the claimed formulation” (Remarks page 6) and allegations of unexpectedly high antibody concentration (Remarks page 7), the fact that the inventor has recognized an advantageous combination of prior art elements, cannot be the basis for patentability when the differences would otherwise be obvious (See MPEP 2145(ii)). In the instant case, the combination of Boonen and Johnson’s teachings addresses each of the necessary features of instant claims 1, 3 – 11, and 13 – 24. Boonen teaches a stable formulation for antibodies as active ingredients, and Johnson teaches human TG2 inhibitor antibodies. A person of ordinary skill in the art would be motivated to include Johnson’s teachings for anti-TG2 antibodies in the formulation of Boonen because Johnson teaches that TG2 is associated with many different disease states and there is a need for selective and effective TG2 antibodies (column 4 lines 35 – 38, 43 – 51). The combination of Boonen and Johnson’s teachings would yield predictable results (i.e. a stable formulation containing anti-TG2 antibody) and is therefore prima facie obvious according to MPEP 2143(i)(a). Expected beneficial results are evidence of obviousness according to MPEP 716.02(c)(ii). As discussed above, a person of ordinary skill in the art would expect that Boonen’s teachings for stable formulations containing antibodies as active ingredients in combination with Johnson’s teaching for human TG2 inhibitor antibodies to yield a stable formulation containing anti-TG2 antibody. A person of ordinary skill in the art would have similar expectations for the combinations of Boonen and White.
Applicant appears to argue that Boonen’s stabilizing effects are provided via a synergistic combination of sucrose and glycine (Remarks page 7). Although Boonen’s teachings may contain additional ingredients to those which are instantly claimed, the instant claims do not appear to specifically exclude any ingredients. According to MPEP 2111.03(i), the transitional term “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements. Furthermore, the instant specification states “other suitable stability agents include, but are not limited to , amino acids or proteins (e.g. glycine or albumin), salts (e.g. sodium chloride), and sugars (e.g. dextrose, mannitol, sucrose and lactose” on page 4 lines 33 – 35, thus suggesting the inclusion of additional unrecited ingredients. As such, Applicant’s arguments that Boonen’s stabilizing effects are provided via a synergistic combination of sucrose and glycine (Remarks page 7) and the implication that the inclusion of sucrose is somehow in opposition to the instant claims, do not render the instant claims non-obvious.
The new grounds of rejection in the pages above specifically addresses each feature of the claims as presently amended.
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. 18/703,675
Claims 1, 3 – 11, and 13 – 25 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 – 10, 12, 13, and 15 – 23 of copending Application No. 18/703,675.
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 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.
Conflicting 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.
The instant and conflicting claims differ because conflicting claim 1 recites a pH between 5.0 and 6.0 and an amino acid stabilizer.
The conflicting pH of 5.0 and 6.0 is overlapped by the instantly claimed pH of 5.0 and 7.0. 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 2 recites the buffer is a histidine buffer, reading on instant claim 1.
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, 16, and 17 recite buffer concentrations, reading on instant claims 4, 17, and 18.
Conflicting claims 7, 8, and 20 recite the formulation includes a polysorbate surfactant, reading on instant claims 7 and 8.
Conflicting claims 9, 21, and 22 recite antibody concentrations, reading on instant claims 9, 22, and 23.
Conflicting claim 13 recites an article of manufacture comprising a container and the liquid formulation, reading on instant claim 14.
Conflicting claim 14 recites the stable liquid formulation is for use in therapy, reading on instant claim 15.
Conflicting claim 15 recites a method for treating a disease or disorder by administering the stable liquid formulation, reading on instant claim 16.
Conflicting claim 23 reads on instant claim 25.
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 May 18, 2026
Applicant requests the provisional non-statutory double patenting rejection be held in abeyance (Remarks page 8). 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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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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