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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 22, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1 – 15 are examined here-in.
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11 seems to be missing articles “and” or “or” between the listing of item 1 and 2, then 2 and 3. Claim 11 also has a period in the middle of the claim, following the recitation of item 2. At present, this period is interpreted to be in error, and the claim is being examined as a list of 1), 2), 3), or 4). Ovals are included in the image below to show the location of missing “and” or “or”.
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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.
Claims 4, 5, 8, and 9 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 4, 5, 8, and 9 recite the term “preferably”. This term is considered indefinite since the scope of the claim cannot be determined. See MPEP 2173.05(c) and 2173.05(d).
Claim Rejections - 35 USC § 103
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 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US 2007/0053900 A1) in view of Johnson (US 10,005,846 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.
Johnson teaches the missing element of Liu.
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 Liu and Johnson’s teachings renders instant claims 1 – 15 prima facie obvious as combining prior art teachings according to known methods to yield predictable results (MPEP 2143(i)(a)). Liu 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 Liu 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, 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 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).
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 Johnson’s teaching for an anti-TG2 antibody (abstract, column 4 lines 35 – 38, 43 – 51) 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).
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 histidine (paragraph 0012) overlaps on the instantly claimed range of 10 to 100 mM recited in instant claim 4.
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.
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 range of 0.005 to 0.1% w/v as recited in claim 8.
Liu’s teaching for 100 – 260 mg/mL antibody (paragraph 0012) overlaps on the instantly claimed range of 50 to 300 mg/mL as recited in claim 9.
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) 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 (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 (claim 10 parts i, iii, v, and vii) and 150 mM (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).
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As written, claim 11 appears to have multiple typographical errors, including an erroneous period and missing articles “and” or “or”. At present, the period is interpreted to be an error, and the claim is being examined as a list of 1), 2), 3), or 4). Johnson teaches anti-TG2 antibody with at least one light chain variable region with SEQ ID 73 and one heavy chain region with SEQ ID 75, reading on instant claim 11. 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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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 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.
The instant claim 14 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. The combination of Liu 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 Liu and Johnson’s teachings read on instant claim 14.
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 Liu’s teaching for a stable liquid formulation for an antibody to treat a disease (abstract, paragraph 0016) reads on instant claim 15.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
Double Patenting over Application No. 18/703,661
Claims 1 – 15 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 – 16 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
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.
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 2 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 claim 4 recites the concentration of the buffer is from 10 to 100 mM, reading on instant claim 4.
Conflicting claims 7 and 8 recite the formulation optionally includes a polysorbate surfactant, reading on instant claims 7 and 8.
Conflicting claim 9 recites the formulation contains 10 to 200 mg/mL antibody, overlapping on the claimed range of 50 to 300 mg/mL as recited in instant claim 9.
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.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims are rejected. No claims are allowed.
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