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
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
2. Applicant’s amendment filed November 20, 2025 is acknowledged. Claims 1-41 and 61-63 are canceled. Claims 42-60 and 64-68 are amended. Claim 69 is newly added. Claims 42-60, 64-68 and new claim 69 are pending in this application and under examination in this office action.
3. Applicant’s arguments filed on November 20, 2025 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections/Objections Withdrawn
4. The rejection of claims 61-63 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is moot because the claims are canceled.
The rejection of claims 61-63 under 35 U.S.C. 103 as being unpatentable over Bigal et al. (US2015/0266948) in view of Allan et al. (US2011/0305711) and Kaisheva (US 2003/0138417) is moot because the claims are canceled.
Claim Rejections/Objections Maintained
In view of the amendment filed on November 20, 2025 the following rejections are maintained.
Claim Rejections - 35 USC § 103
5. 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 42-60 and 64-69 are rejected under 35 U.S.C. 103 as being unpatentable over Bigal et al. (US2015/0266948) in view of Allan et al. (US2011/0305711) and Kaisheva (US 2003/0138417).
Claims 42-60 as amended are drawn to a prefilled syringe or pen comprising a pharmaceutical formulation comprising:
(a) 50-160 mg/mL of an anti-CGRP antibody; (b) 5-20 mM of histidine buffer;
(c) 50-200 mM of NaCl; (d) 0.03-0.07% (w/v) of polysorbate-80 (PS-80); and
(e) a pH of 5.0-6.5, and wherein the anti-CGRP antibody comprises two light chains (LCs) and two heavy chains (HCs), the amino acid sequence of each LC given by SEQ ID NO: 3 and the amino acid sequence of each HC given by SEQ ID NO: 4, and wherein the pharmaceutical composition does not comprise any additional antioxidants.
Claims 64-69 as amended are drawn to a prefilled syringe or pen comprising a pharmaceutical formulation comprising: (a) 50-160 mg/mL of the same anti-CGRP antibody; (b) 10 mM of histidine buffer; (c) 150mMof NaCl; (d) 0.05% (w/v) of polysorbate-80 (PS-80); and (e) a pH from 5.5 to 6.
Response to Arguments
On p. 7-8 of the response, Applicant argues that the current formulation provides unexpected and surprising results and cite the office action dated 04/07/2022, p. 23-24 in support of the arguments.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2141, MPEP2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. Each case is judged by its own merits.
ii. In this case, Bigal et al. (US 2015/0266948) teach a pre-filled syringe or a prefilled receptacle ([0015]; [0063]; [0160]; [0208]; claim 17) comprising a pharmaceutical formulation comprising an anti-CGRP antibody, histidine, NaCl, polysorbate 80 and a pH of 5-7, 5, 5.5 or 6 and does not comprise any additional antioxidants for administration (paragraphs [0152]; abstract; paragraphs [0015]-[0019];[0027]; [0160]; [0166]-[0167]l [0171]; [0175]-[0176]; [0179]; [0181]; [0183]; [0186]-[0188];[0194]-[0196]; [0198]; [0201];[0204]; [0208] [0411], claims 1-2, 42).
The anti-CGRP antibody disclosed by Bigal is formulated at a concentration of 150 mg/mL, …10-150mg/ml, 10-100mg/ml, …50mg/ml, 75mg/ml, 100mg/ml, 125mg/ml, 150mgml, 175mg/ml…1-150mg/ml 1-250mg/ml, a dose ranging from 100-2000 mg or monthly doses of 125 mg (paragraphs [0015]-[0019];[0027]; [0166]-[0167]l [0171]; [0175]-[0176]; [0179]; [0181]; [0183]; [0186]-[0188];[0194]-[0196]; [0198]; [0201];[0204]; [0411], claims 1-2, 42), which are either within or overlapping with the claimed range of 50-160mg/ml, 100-160mg/ml, 100mg/ml or 120mg/ml recited in claims 42-45 64-65 and 69.
The histidine disclosed by Bigal is at a concentration of 1-20mM, 20mM, or 0.1-100mM (paragraphs [0151]; [0167]; [0173]; [0176]; [0179]-[0180]; [0183]; [0186]; [0329]; [0423]), which are either within or overlapping with the claimed range of 5-20mM, 10-15mM or 10mM recited in claims 46-48.
The polysorbate 80 disclosed by Bigal is at a concentration of 0.2 or 0.1 or 0.25 mg/ml (see paragraphs [0151]; [0167]-[0169]; [0171]; [0174]-[0179]; [0181]; [0184]-[0186]), which are either within or overlapping with the claimed range of 0.03-0.07% or 0.05% recited in claims 42, 52-54.
The pH disclosed by Bigal includes pH 5-7, 5, 5.5 or 6 which are either within or overlapping with the claimed range of 5.0-6.5, 5.5-6 or 5.8 recited in claims 55-57, 64 and 66.
The anti-CGRP antibody formulation disclosed by Bigal is suitable for subcutaneous injection in claim 58 (see paragraphs [0015]-[0018]; [0031]; [0063]-[0066]; [0145]-[0150]; [0187]; [0193]-[0194-[0208]; ) and when stored in a prefilled syringe for 3 months at 25oC or 1 month at 40oC in claims 59-60
The antibody disclosed by Bigal comprises the amino acid sequence of SEQ ID NO:62 and 63 for VL and VH, which are 100% identical to the VL (instant SEQ ID NO:1) and VH (instant SEQ ID NO:2) encompassed within the LC (instant SEQ ID NO:3) and HC (instant SEQ ID NO:4) of the instantly claimed anti-CGRP antibody recited in instant claims 42 and 64 (see the sequence alignment).
The concentration ranges of anti-CGRP antibody, histidine, NaCl, polysorbate 80 and the pH disclosed by Bigal are either within or overlapping with the claimed range of recited in instant claims. Thus, the anti-CGRP formulation disclosed by Bigal would also possess the claimed features and biological properties recited in claims 59-60 and 68.
While Bigal does not explicitly teach the anti-CGRP antibody comprising a LC that is SEQ ID NO:3 and a HC that is SEQ ID NO: 4 recited in independent claims 42 and 64, Allan et al. teaches this limitation Allan teaches an anti-CGRP antibody comprising a LC comprising the amino acid sequence of SEQ ID NO:29, which is 100% identical to instant SEQ ID NO:3 and a HC comprising the amino acid sequence of SEQ ID NO:34, which is 100% identical to instant SEQ ID NO:4 (see the sequence alignment below) and a pharmaceutical composition comprising the anti-CGRP antibody and a method of treating osteoarthritis pain (see paragraphs [0022]; -[0029]; claims 1-26)
While Bigal does not explicitly teach that the dose ranges of the anti-CGRP antibody and the concentration ranges of a histidine buffer, NaCl, PS-80 (polysorbate 80) and the pH are exactly identical to the claimed ranges recited in independent claims 42 and 64, Kaisheva teaches these limitations and provides motivation and an expectation of success. Kaisheva teaches that stable liquid pharmaceutical formulations for immunoglobulin G antibodies comprise an antibody at concentrations of greater than 50 mg/ml or 100mg/ml, a histidine buffer at about 30-70 mM, NaCl at 75-150 mM, polysorbate at about 0.01-0.1%; 0.01-0.05% or 0.02-0.04%, and a pH of about 5.5-6.5 or 6-6.5 (see abstract; claims 2-5, 7-8,10-11 and 13; paragraphs [0014]; [0021]; [0048]-[0052]; [0054]; Examples 1-2 and 5-11). Kaisheva teaches that the stable liquid pharmaceutical formulation is stable at about 2-8oC for at least one year, stable at 23-27oC for at least 6 months (see paragraphs [0015]; [0025]; claims 10-11).
A person of ordinary skill in the art would have recognized that selecting and applying the known anti-CGRP antibody having the LC and HC of SEQ ID NOs: 3-4 and the known formulation and the known concentrations for making a stable liquid pharmaceutical composition comprising an antibody, a histidine buffer, NaCl, polysorbate 80 and a pH at 5-6.5 or 5.5-6 and the known technique disclosed by Allan and Kaisheva to the anti-CGRP antibody formulation of Bigal would have yielded the predictable result of generating a stable anti-CGRP pharmaceutical formulation comprising: (a) 50-160 mg/mL of an anti-CGRP antibody having the SEQ ID NOs:3-4 for LC and HC; (b) 5-20 mM of histidine buffer; (c) 50-200 mM of NaCl; (d) 0.03-0.07% (w/v) of polysorbate-80 (PS-80); and (e) a pH of 5.0-6.5 or a stable anti-CGRP pharmaceutical formulation comprising: (a) 50-160 mg/mL of the same anti-CGRP antibody having the SEQ ID NOs:3-4 for LC and HC; (b) 10 mM of histidine buffer; (c) 150mMof NaCl; (d) 0.05% (w/v) of polysorbate-80 (PS-80); and (e) a pH from 5.5 to 6, and resulted in an improved product with a stable liquid pharmaceutical formulations for immunoglobulin G antibodies.
Using the known anti-CGRP antibody having the LC and HC of SEQ ID NOs: 3-4 and the known formulations and concentrations for making a stable liquid pharmaceutical composition comprising an antibody, a histidine buffer, NaCl, polysorbate 80 and a pH at 5-6.5 or 5.5-6 in the anti-CGRP antibody formulation of Bigal would generate the claimed pharmaceutical formulation comprising the claimed concentrations of anti-CGRP antibody, histidine buffer, NaCl, PS-80 and pH, and expand application of the anti-CGRP antibody formulation of Bigal to maintain a better shelf-life and stable liquid pharmaceutical formulations for the activity of the anti-CGRP antibodies. The concentrations for the anti-CGRP, histidine buffer, NaCl, PS-80 and pH in the stable liquid pharmaceutical formation of Bigal and Kaisheva are either identical to the claimed range or within the claimed range, the anti-CGRP formulation disclosed by Bigal and Kaisheva would also possess the claimed features and biological properties recited in claims 59-63 and 68.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known anti-CGRP antibody having the LC and HC of SEQ ID NOs: 3-4 and the known formulation and the known concentrations for making a stable liquid pharmaceutical composition comprising an antibody, a histidine buffer, NaCl, polysorbate 80 and a pH at 5-6.5 or 5.5-6 and the known technique disclosed by Allan and Kaisheva to the anti-CGRP antibody formulation of Bigal, and yield the predictable result of a better stable anti-CGRP pharmaceutical formulation comprising: (a) 50-160 mg/mL of an anti-CGRP antibody having the SEQ ID NOs:3-4 for LC and HC; (b) 5-20 mM of histidine buffer; (c) 50-200 mM of NaCl; (d) 0.03-0.07% (w/v) of polysorbate-80 (PS-80); and (e) a pH of 5.0-6.5 or a better stable anti-CGRP pharmaceutical formulation comprising: (a) 50-160 mg/mL of the same anti-CGRP antibody having the SEQ ID NOs:3-4 for LC and HC; (b) 10 mM of histidine buffer; (c) 150mMof NaCl; (d) 0.05% (w/v) of polysorbate-80 (PS-80); and (e) a pH from 5.5 to 6.
Further, routine optimization of Bigal’s and Kaisheva’s dose ranges of anti-CGRP antibody, a histidine buffer, NaCl, polysorbate 80 and a pH would have led to the claimed range of 50-160 mg/ml for an anti-CGRP antibody; the claimed range of 5-20 mM or 10mM for histidine buffer, the claimed range of 50-200 mM or 150mM for NaCl, the claimed range of 0.03-0.07% (w/v) or 0.05%(w/v) for polysorbate-80 (PS-80) and the claimed range of 5.0-6.5 or 5.5-6 for a pH because Bigal teaches an anti-CGRP antibody at 150 mg/mL, 10-150mg/ml,…50mg/ml, 75mg/ml, 100mg/ml, 125mg/ml, 150mgml, 175mg/ml…1-150mg/ml 1-250mg/ml, a dose ranging from 100-2000 mg; histidine at a concentration of 1-20mM, 20mM, or 0.1-100mM; polysorbate 80 at a concentration of 0.2 or 0.1 or 0.25 mg/ml and pH at 5-7, 5, 5.5 or 6; and Kaisheva teaches an antibody at concentrations of greater than 50 mg/ml or 100mg/ml, a histidine buffer at about 30-70 mM, NaCl at 75-150 mM, polysorbate at about 0.01-0.1%; 0.01-0.05% or 0.02-0.04%, and a pH of about 5.5-6.5 or 6-6.5. The person of ordinary skill in the art would have found it obvious to optimize within the range taught by Bigal and Kaisheva because Bigal and Kaisheva teach that this entire range stabilizes liquid pharmaceutical formulations for antibodies or anti-CGRP antibodies, and also teaches how to optimize the dose ranges to generate stable liquid pharmaceutical formulations for immunoglobulin G antibodies.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”; “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert.denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). See MPEP § 2144.05.
ii. In response to Applicant’s arguments related to unexpected results, note that evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978). See MPEP 716.02(c)-I. Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. See: MPEP §716.02. In addition, “A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue.” In re Corkill, 711 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). See MPEP 716.02(a)-I. Further, evidence of unexpected results is frequently in the form of a direct comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See: e.g., In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
In this case, Applicants fails to provide evidence of side-by-side comparisons to demonstrate unexpected results as claimed. “Evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978).” See MPEP 716.02(c)-I. Since Applicant fails to provide any evidence as discussed above to support any unexpected results as claimed, the claimed conjugate is obvious over the prior art, absent evidence to the contrary.
Double Patenting
6. 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 42-60 and 64-69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No.11498959 in view of Bigal et al. (US2015/0266948), Allan et al. (US2011/0305711) and Kaisheva (US 2003/0138417). The references of Bigal, Allan and Kaisheva are necessitated by Applicants’ amendment to the claims. The rejection is maintained for the reasons of record and the reasons set forth below.
Claims 1-32 of US11498959 claim a pharmaceutical formulation comprising: a) an anti-CGRP antibody at a concentration of 50-160 mg/mL, 50-150 mg/mL, 100-160mg/L, 50mg/mL, 100mg/mL, 120mg/mL or 150mg/mL, b) a histidine buffer at a concentration of 5-20 mM, 10-15mM, c) NaCl at a concentration of 50-200 mM, 125-175 mM or 150mM, d) PS-80 at a concentration of 0.03-0.07% (w/v), 0.05%(w/v) , and e) a pH at 5.0 to 6.5, wherein the anti-CGRP antibody comprises two light chains (LC) and two heavy chains (HC), the amino acid sequence of the two light chains given by SEQ ID NO: 3 and the amino acid sequence of the two heavy chains given by SEQ ID NO: 4 and wherein the pharmaceutical formulation does not comprise any additional antioxidants.
The pharmaceutical formulation of the ‘959 patent contains the same ingredients: the same anti-CGRP comprising the same amino acid sequences for VL and VH or LC and HC at a range of 50-160mg/l, which meets the claimed range of 50-160mg/l and the same dose ranges for the histidine buffer (5-20mM), NaCl (50-200mM), PS-80 (0.03-0.07%(w/v) and a pH of 5-6.5. In addition, the claimed pharmaceutical formulation does not recite any additional antioxidants. The concentrations for the anti-CGRP, histidine buffer, NaCl, PS-80 and pH in the pharmaceutical formation of the ‘959 patent are either identical to the claimed range or within the claimed range, the anti-CGRP formulation disclosed by the ‘959 patent would also possess the claimed features and biological properties recited in claims 59-60 and 68.
While The claims of the ‘959 patent does not recite the limitation “prefilled syringe or pen” or the dose ranges of the anti-CGRP antibody and the concentration ranges of a histidine buffer, NaCl, PS-80 (polysorbate 80) and the pH are exactly identical to the claimed ranges recited in independent claims 42 and 64, Bigal, Allan and Kaisheva teach these limitations and provide motivation and expectation of success for the reasons set forth above under the 103 rejection. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known prefilled syringe or pen comprising an anti-CGRP antibody having the LC and HC of SEQ ID NOs: 3-4 and the known formulation and the known concentrations for making a stable liquid pharmaceutical composition comprising an antibody, a histidine buffer, NaCl, polysorbate 80 and a pH at 5-6.5 or 5.5-6 and the known technique disclosed by Bigal, Allan and Kaisheva to the anti-CGRP antibody formulation of the 959 patent, and yield the predictable result of a better stable anti-CGRP pharmaceutical formulation comprising: (a) 50-160 mg/mL of an anti-CGRP antibody having the SEQ ID NOs:3-4 for LC and HC; (b) 5-20 mM of histidine buffer; (c) 50-200 mM of NaCl; (d) 0.03-0.07% (w/v) of polysorbate-80 (PS-80); and (e) a pH of 5.0-6.5 or a better stable anti-CGRP pharmaceutical formulation comprising: (a) 50-160 mg/mL of the same anti-CGRP antibody having the SEQ ID NOs:3-4 for LC and HC; (b) 10 mM of histidine buffer; (c) 150mMof NaCl; (d) 0.05% (w/v) of polysorbate-80 (PS-80); and (e) a pH from 5.5 to 6.
Response to Arguments
On p. 8 of the response, Applicant requests the rejection be held in abeyance until allowable subject matter is indicated.
In response, the rejection of claims 42-60 and 64-69 on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of US11498959 in view of Bigal, Allan and Kaisheva is maintained of record until a terminal disclaimer is filed.
Double Patenting
7. Claims 42-60 and 64-69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No.9073991 or claims 1-7 of U.S. Patent No. 9505838 in view of Bigal et al. (US 2015/0266948), Allan et al. (US2011/0305711) and Kaisheva (US 2003/0138417). The rejection is maintained for the reasons of record and the reasons set forth below.
Response to Arguments
On p. 8 of the response, Applicant argues that the rejection should be withdrawn for the same reasons set forth above.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §804, MPEP §2141, MPEP2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. The claims of the ‘991 patent or the ‘838 patent claim an anti-CGRP antibody and a pharmaceutical composition comprising the claimed anti-CGRP antibody and a pharmaceutically acceptable carrier, diluent or excipient, wherein the anti-CGRP antibody comprises SEQ ID NOs: 29 and 34 for LC and HC, which are identical to instant SEQ ID NOs:3-4 and anti-CGRP antibody recited in the pharmaceutical formulation recited in instant claims.
While the claims of the ‘991 patent or the ‘838 patent do not recite the limitation “prefilled syringe or pen” or the dose ranges of the anti-CGRP antibody and the concentration ranges of a histidine buffer, NaCl, PS-80 (polysorbate 80) and the pH are exactly identical to the claimed ranges recited in independent claims 42 and 64, Bigal, Allan and Kaisheva teach these limitations and provide motivation and expectation of success for the reasons set forth above under the 103 rejection. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known prefilled syringe or pen comprising an anti-CGRP antibody having the LC and HC of SEQ ID NOs: 3-4 and the known formulation and the known concentrations for making a stable liquid pharmaceutical composition comprising an antibody, a histidine buffer, NaCl, polysorbate 80 and a pH at 5-6.5 or 5.5-6 and the known technique disclosed by Bigal, Allan and Kaisheva to the anti-CGRP antibody formulation of the ‘991 patent or ‘838 patent, and yield the predictable result of a better stable anti-CGRP pharmaceutical formulation comprising: (a) 50-160 mg/mL of an anti-CGRP antibody having the SEQ ID NOs:3-4 for LC and HC; (b) 5-20 mM of histidine buffer; (c) 50-200 mM of NaCl; (d) 0.03-0.07% (w/v) of polysorbate-80 (PS-80); and (e) a pH of 5.0-6.5 or a better stable anti-CGRP pharmaceutical formulation comprising: (a) 50-160 mg/mL of the same anti-CGRP antibody having the SEQ ID NOs:3-4 for LC and HC; (b) 10 mM of histidine buffer; (c) 150mMof NaCl; (d) 0.05% (w/v) of polysorbate-80 (PS-80); and (e) a pH from 5.5 to 6.
Double Patenting
8. Claims 42-60 and 64-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 50, 53, 76, 79-80 and 84-85 of copending Application No. 17554713. The rejection is maintained for the reasons of record and the reasons set forth below.
Response to Arguments
On p. 8-9 of the response, Applicant requests the rejection be held in abeyance until allowable subject matter is indicated.
In response, the provisional rejection of Claims 42-60 and 64-69 on the ground of nonstatutory double patenting as being unpatentable over claims 50, 53, 76, 79-80 and 84-85 of copending Application No. 17554713 is maintained of record until a terminal disclaimer is filed.
Conclusion
9. NO CLAIM IS ALLOWED.
10. THIS ACTION IS MADE FINAL. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chang-Yu Wang whose telephone number is (571)272-4521. The examiner can normally be reached on Monday-Thursday, 7:00am-5:30pm EST.
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Chang-Yu Wang
March 7, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675