DETAILED ACTION
This Office action details a final action on the merits for the above referenced application No. Claims 1, 10-11, 13, 16, 27, 36, 46-49, 54-56, and 87-99 are pending in this application.
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 .
Status of Claims
Claims 1, 10-11, 13, 16, 27, 36, 46-48, and 54-56 are amended. Claims 2-9, 12, 14-15, 17-26, 28-35, 37-45, 50-53, and 57-86 are cancelled. Claims 87-99 are new.
Response to Amendment
The amendments filed on 3 Aug. 2026 have been entered.
Response to Arguments
In view of Applicants amendments, the rejection of claims 3, 11, 21, 47, and 83 under 35 USC 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn.
In view of Applicants amendments, the rejection of claims 1-3, 6-7, 9-10, 13, 48, 59, 64-65, 78, and 80-81 under 35 USC 102(a)(1),(2) as being anticipated by Soppimath et al. (WO 2011/116286 A1; published 22 Sep. 2011) is withdrawn.
In view of Applicants amendments, the rejection of claims 1-3, 6-11, 13, 46-48, 55-56, 59, 64-65, and 78-82 under 35 USC 103 as being unpatentable over Soppimath et al. (WO 2011/116286 A2; published 22 Sep. 2011) is withdrawn.
In view of Applicants amendments, the rejection of claims 1-3, 6-11, 13, 16, 21, 27, 36, 46-49, 54-56, 59, 64-65, 78-82, and 86 under 35 USC 103 as being unpatentable over Soppimath et al. (WO 2011/116286 A2; published 22 Sep. 2011), in view of Cohen et al. (WO 2006/1252276 A2; published 23 Nov. 2006) and Haberkorn et al. (WO 2019/154886 A2; published 15 Aug. 2019) is withdrawn.
In view of Applicants amendments, the rejection of claims 1-3, 6-11, 13, 16, 21, 27, 36, 46-49, 54-56, 59, 64-65, 78- 86 under 35 USC 103 as being unpatentable over Soppimath et al. (WO 2011/116286 A2; published 22 Sep. 2011), in view of Cohen et al. (WO 2006/1252276 A2; published 23 Nov. 2006) and Haberkorn et al. (WO 2019/154886 A2; published 15 Aug. 2019), in further view of Cyr et al. (WO 2011/147762 A2; published 1 Dec. 2011) and Anraku et al. (Int. J. Pharm.; published 2007) is withdrawn.
In view of Applicants amendments, the rejection of claims 1-3, 6-11, 13, 16, 21, 27, 36, 46-49, 54-56, 59, 64-65, 78- 86 on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of US patent No. 11,707,539 B2, in view of Soppimath et al. (WO 2011/116286 A2; published 22 Sep. 2011), Haberkorn et al. (WO 2019/154886 A2; published 15 Aug. 2019), and Cyr et al. (WO 2011/147762 A2; published 1 Dec. 2011) is withdrawn.
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.
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 47 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 for the reasons cited in the Office action filed on 14 Apr. 2026.
In claim 47, the recitation of “(weight:weight ratio)” is indefinite because it is not clear if the recitation is merely an example or a required limitation.
Applicants Arguments
Applicants assert that claim 47 has been amended to address the claim language objected to.
Applicant's arguments filed 3 Aug. 2026 have been fully considered but they are not persuasive. Amended claim 47 still recites “(weight: weight ratio)”, which is indefinite because it is not clear if what is inside the parentheses is a required limitation or an example.
New Grounds of Rejection
Claim Objections
Claim 1 is objected to because of the following informalities: in this case, each instance of “represent” or “represents” should be replaced with is or are. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 10-11, 13, 16, 27, 36, 46-49, 54-56, 87-91, and 93-99 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soppimath et al. (WO 2011/116286 A2; published 22 Sep. 2011), in view of Cohen et al. (WO 2006/125227 A2; published 23 Nov. 2006) and Haberkorn et al. (WO 2019/154886 A2; published 15 Aug. 2019).
Soppimath et al. teach stable formulations for bortezomib in which bortezomib as significantly improved stability. Bortezomib is approved for use in treating various neoplastic diseases and especially treatment of relapse multiple myeloma and mantle cell lymphoma (see [0003]). Bortezomib is susceptible to oxidative degradation due to reaction with alkyl peracids, alkyl peroxides or oxygen radical species ([0005]). Soppimath et al. teach formulations comprising bortezomib and heterobifunctional Lewis base in a ratio or 1:200 or 20:40. Preferred heterobifunctional Lewis bases include amino acids (N-acetylated amino acids) and dipeptides ([0012]-[0013], [0020]), which may be in the L-configuration. Formulations are stable for months at ambient temperature ([0018]). Preferred solvents include DMSO ([0022]). Contemplated amino acids include cysteine and methionine ([0025]). Contemplated peptides include glutathione ([0026]). Soppimath et al. teach aqueous solutions ([0029]). Compositions with 10% aqueous buffer showed a comparable stability to that of formulation with PG alone ([0041]). Bortezomib is present in a therapeutically effective amount to treat cancer ([0021]). Soppimath et al. teach a composition comprising ascorbic acid that provide high stability (pg. 16).
Soppimath et al. disclose a pharmaceutical composition comprising bortezomib (therapeutic boronic acid compound), PG, N-acetylcysteine (NAC), and an aqueous acetate buffer (see pgs, 14-15) and a composition comprising bortezomib, PG, acetate buffer, and sodium bisulfate. (Reads on a aqueous pharmaceutical comprising (a) a therapeutic boronic acid compound and (b) one or more sulfur compounds (MW less than 1500, GRAS, non-polymeric, comprise a sulfide) and (c) one or more stabilizer compounds that do not contain a sulfur containing compound (PG)). At table 6, bortezomib has a purity of 99% when stored at 25oC for 2 weeks. The composition was prepared by admixing (1) bortezomib and (2) NAC or sodium bisulfate.
Soppimath et al. do not teach the claim pharmaceutical composition comprising 2) N-acetyl methionine or L-glutathione optionally in an amount of at least 0.1 N in the composition and wherein the boronic acid compound is represented by instant formula I optionally further comprising ascorbic acid and wherein the composition is a diagnostic or treatment for a disease or disorder associated with expression of FAP in a subject and wherein the boronic acid is complexed with a radioisotope such as 90Y, 177Lu, 225Ac, 227Th, 131I or 211At, optionally wherein the mass ratio of 1) to 2) is 1:1 or 10:1 and wherein the boronic acid compound has at least 95% purity 2 d after preparation and storage at 25oC or a kit thereof further comprising instructions for use. Soppimath et al. do not further teach a method of treating a subject from a disease associated with FAP or a neoplasia or a tumor comprising administering a therapeutically effective amount of the pharmaceutical composition of claim 1.
Cohen et al. teach FAP inhibitor compounds and methods (see title). Cohen et al. teach N-acylated dipeptide proline boronate compounds for in vitro, in situ and in vivo diagnosis or treatment of mammalian cells or associated pathological condition (pg. 1). Cohen et al. teach tumors (pg. 1). Cohen et al. teach compounds of formula (II) wherein R6 and R7 may be F (pgs. 20-21). Cohen et al. teach the compounds
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125
201
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and
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228
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(pg. 25) and
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(pg. 27).
(the first compound reads on a compound of formula I
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wherein R1=Me; R2=-B(-Y1)(-Y2), Y1=Y2=OH; R3=H; R4=absent; X=O,and L=linker. )
Cohen et al. teach labelling of peptides and substrates by mixing appropriate reactive dye and peptides to be conjugated. Dyes include fluorescein (pg. 29). Peptides may be labeled at an amino terminus or internal amino acid (pg. 30). Cohen et al. teach a kit (pg. 45) and may include instructions (pg. 53, claim 47). Cohen et al. teach antioxidants including ascorbic acid and methionine (pg. 46).
Haberkorn et al. teach FAP inhibitors (see title). Haberkorn et al. teach kits with instructions (see abstract). Haberkorn et al. teach boronic compounds of formula (I) attached to a radioactive moiety, a chelating agent or a fluorescent agent (pgs. 2-3). Haberkorn et al. teach chelator and dye conjugates (pg. 44-57). Haberkorn et al. teach 225Ac and 177Lu (pg. 57). Haberkorn et al. teach FAPI-02 and FAPI-04 (pg. 55) and 177Lu-labeled FAPI-04 (see example 7). Haberkorn et al. teach radioisotopes including 90Y, 177Lu, 225Ac, 227Th, 131I, and 211At (pgs 57, 104, 112).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the compositions of Soppimath et al. (compositions comprising a sulfur containing stabilizer compound and a boronic acid containing compound) so that sulfur containing compound is L-glutathione or N-acetylmethionine as taught by Soppimath et al. because the L-glutathione or N-acetylmethionine would have been expected to provide equivalent sulfur containing stabilizer compound suitable for stabilizing the boronic acid containing compound against oxidative degradation. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Soppimath et al. so that the boronic acid containing compound is the FAP targeted boronic acid containing compound of Cohen et al. described above attached to a radioactive moiety such as 90Y, 177Lu, 225Ac, 227Th, 131I, and 211At to arrive at a compound of instant formula I where R is a radioactive moiety that is a diagnostic agent or therapeutic agent as taught by Cohen et al. and Haberkorn et al. because those boronic acid compounds and compositions would have been expected to advantageously enable compounds suitable for imaging and treating FAP associated disease and stabilized compositions thereof. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Soppimath et al. so that the obvious compositions further comprising one or more stabilizing compounds that do not include sulfur such as ascorbic acid as taught by Soppimath et al. because the ascorbic acid would have been expected to provide addition stabilization of boronic acid containing compound by a different mechanism. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Soppimath et al. by further forming a kit comprising the obvious pharmaceutical compositions with instructions for use as taught by Cohen et al. and Haberkorn et al. because the kit would have been expected to advantageously enable facile distribution and treatment of a disorder.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Soppimath et al. by further treating a subject suffering from FAP associated disease or disorder such as a neoplasia or tumor by administering to the subject a therapeutically effective amount of the obvious compositions as taught by Cohen et al. and Haberkorn et al. because treating would have been expected to advantageously enable effective treatment of those disorder using the boronic acid containing compound stabilized against oxidative degradation.
The amount of L-glutathione or N-acetylmethionine, the mass ratio of L-glutathione or N-acetylmethionine to boronic acid compound, and % purity 3 d after preparation and storage at 25oC are result-effective variables that a person of ordinary skill in the art would have been motivated to optimize at the time of invention. A person of ordinary skill in the art would have arrived at an amount of at least 0.1 N in the composition in order to arrive at an optimal stabilizing amount of the one or more stabilizing compounds in the composition. A person of ordinary skill in the art would have arrived at a mass ratio that is from 1:1 to 10:1 through routine experimentation in order to arrive at an optimal stabilizing ratio. A person of ordinary skill in the art would have arrived at an at least 95% purity 3 d after preparation and storage at 25oC in order to arrive at an optimal shelf-life.
Claim(s) 1, 10-11, 13, 16, 27, 36, 46-49, 54-56, and 87-99 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soppimath et al. (WO 2011/116286 A2; published 22 Sep. 2011), in view of Cohen et al. (WO 2006/125227 A2; published 23 Nov. 2006) and Haberkorn et al. (WO 2019/154886 A2; published 15 Aug. 2019), in further view of Osterkamp et al. (WO 2021/005125 A1; published 14 Jan. 2021; see attached 892).
Soppimath et al. teach as discussed above.
Soppimath et al. do not further teach 161Tb.
Cohen et al. teach as discussed above.
Haberkorn et al. teach as discussed above.
Osterkamp et al. teach compound comprising FAP and use thereof (see title). Osterkamp et al. teach prolyl boronic acid derivatives as selective inhibitors for FAP (pg. 6). Osterkamp et al. teach 161Tb (pgs. 18, 79). Osterkamp et al. teach glutathione (pg. 108) and L-methionine (pgs. 112, 151-152). Osterkamp et al. teach kits with instructions (pg. 111). Osterkamp et al. teach treating FAP associated cancer (pg. 11, pg. 22).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Soppimath et al. so that the radionuclide is 161Tb as taught by Osterkamp et al. because the 161Tb would have been expected to provide a radionuclide suitable for treating FAP associated disorders.
Applicants Arguments
Applicants assert that Soppimath at [0041] states that the presence of a stabilizer/antioxidant like N-acetyl cysteine resulted in significant degradation of bortezomib. Soppimath unequivocally teaches away from selecting an N-acetylated sulfur-containing amino acid for use in combination with a boronic acid or ester. Cohen and Haberkorn are silent regarding the properties of N-acetylated sulfur containing amino acids when used in combination with a boronic acid or ester. One of ordinary skill would not have been motivated to include N-acetylmethionine in the now claimed compositions. L-glutathione contains a cysteine residue and one of ordinary skill in the art would not have predicted that L-glutathione would possess similar properties to N-acetyl cysteine with respect to stabilizing boronic acids and esters. Cohen and Haberkorn are silent regarding L-glutathione. One of ordinary skill would not have expected compound which are structurally similar to N-acetyl cysteine, such as N-acetylmethionine and L-glutathione, to be successful at preventing the degradation of boronic acids esters. The combination of Cyr and Anraku is silent regarding the compatibility of N-acetylmethionine or L-glutathione with boronic acids and esters.
Applicant's arguments filed 3 Aug. 2026 have been fully considered but they are not persuasive. At tables 6 and 7, Soppimath provides aqueous pharmaceutical compositions comprising a boronic acid compound (bortezomib) and a sulfur containing stabilizer compound (NAC) wherein the boronic acid compound in the compositions exhibited chemical purities of >95% for 2 and 6 weeks. At [0013], Soppimath teaches and suggests that N-acetyl methionine and L-glutathione are suitable Lewis base stabilizer compounds for use in the boronic acid containing compositions of the invention. Soppimath’s comment at [0041] that NAC resulted in significant degradation of the bortezomib is directed to the table 8 where the composition were stored for 2 month; however, none of the claims requires storage under the recited conditions for 2 months. Claim 48 requires at least a 95% purity 3 d after preparation and storage at 25oC. At table 6, Soppimath teaches that NAC enables this requirement for 2 weeks 25oC and 40oC. Soppimath at no place teaches away from N-acetylmethionine or L-glutathione and instead teaches towards N-acetylmethionine or L-glutathione as suitable stabilizer compounds for boronic acid containing compositions with a reasonable expectation of success. Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put into the last opening of a jig saw puzzle. It is not invention. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). When developing a pharmaceutical composition comprising a boronic acid containing compound such as those of instant formula I, it would have been obvious to a person of ordinary skill in the art before the effective filing date to add N-acetylmethionine or L-glutathione to the composition as taught by Soppimath because the N-acetylmethionine or L-glutathione would have been expected to advantageously provide enhanced stability by inhibiting oxidative degradation for at least 2 wks.
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.
Claims 1, 10-11, 13, 16, 27, 36, 46-49, 54-56, and 87-99 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,707,539 B2, in view of Soppimath et al. (WO 2011/116286 A2; published 22 Sep. 2011) and Osterkamp et al. (WO 2021/005125 A1; published 14 Jan. 2021; see attached 892).
Claims 1-22 of U.S. Patent No. 11,707,539 B2 claim boronic acid compounds such as a boronic acid compound of formula
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wherein the boronic acid compound further comprises a radionuclide including 90Y, 177Lu, 225Ac, 161Tb, 227Th, 131I or 211At. (The boronic acid compounds read in part on boronic acid compounds of instant formula I wherein R1=Me, R2=-B(OH)2, R3=H, R4=H, X=O, L=Linker and R=radionuclide=90Y, 177Lu, 225Ac, 161Tb, 227Th, 131I or 211At).
Claims 1-22 of U.S. Patent No. 11,707,539 B2 do not claim an (aqueous) pharmaceutical composition and/or kit further comprising N-acetylmethionine or L-glutathione optionally in an amount of at least 0.1 N and optionally having a mass ratio from 1:1 to 10:1 and optionally wherein the boronic acid compounds has at least 95% purity after 3 d of preparation and storage at 25oC optionally further comprising one or more stabilizer compounds that do not comprise a sulfur such as ascorbic acid. Claims 1-22 of U.S. Patent No. 11,707,539 B2 do not claim a method of treating a disease or disorder associated with FAP expression or a neoplasia or a tumor.
Soppimath et al. teach as discussed above.
Osterkamp et al. teach as discussed above.
It would have been obvious to a person of ordinary skill in the art to modify claims 1-22 of U.S. Patent No. 11,707,539 B2 so that compositions comprising the boronic acid compound further contain L-glutathione or N-acetyl methionine (N-acetylated methionine) and optionally forming a kit with thereof and instructions and optionally further comprise ascorbic acids and optionally wherein the boronic acid compound have at least 95% purity 3 d after preparation and storage at 25oC as taught by Soppimath et al. and Osterkamp et al. because those compositions and kit would have been expected to advantageously enable a composition comprising a therapeutic boronic acid compound having enhanced stability against oxidative degradation.
The amount of the one or more sulfur containing compounds is result effective variable that a person of ordinary skill in the art would have been motivated to optimize at the time of invention. MPEP 2144.05.II. A person of ordinary skill in the art would have arrived at an amount of at least 0.1 N in the composition in order to arrive an optimal stabilizing amount of the one or more sulfur containing compounds in the composition. The mass ratio of the one or more sulfur containing compounds to the boronic acid compounds is a result effective variable that a person of ordinary skill in the art would have been motivated to optimize at the time of invention. A person of ordinary skill in the art would have arrived at a mass ratio that is from 1:1 to 10:1 in order to arrive at an optimal stabilizing ratio.
It would have been obvious to a person of ordinary skill in the art to further modify claims 1-22 of U.S. Patent No. 11,707,539 B2 so the composition is for use or used in a method of treating a subject suffering from a disease or disorder associated with expression of FAP or a neoplasia or a tumor comprising administering an effective amount of the the obvious compositions as taught by Soppimath et al. and Osterkamp et al. because those compositions and methods would have been expected to provide enhanced treatment of FAP associated disorders, neoplasia, and/or tumors by using a stabilized therapeutic boronic acid compound.
Applicants Arguments
Applicants assert that the claims of the ‘539 patent only recite certain compounds and are silent regarding N-acetylmethionine or L-glutathione. The shortcomings of Soppimath, Haberkorn, and Cyr are set forth above. One of ordinary skill would not have been motivated with a reasonable expectation of success to select N-acetylmethionine or L-glutathione for use as a stabilizer with the claimed boronic acids or esters.
Applicant's arguments filed 3 Aug. 2026 have been fully considered but they are not persuasive. The ‘539 patent claims pharmaceutical compositions comprising a boronic acid compound wherein the boronic acid compound reads on a compound of formula I. Soppimath is not deficient for the reasons discussed above. A recognized advantage is the strongest reason to combine. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the claims of the ‘539 patent so that the compositions further include N-acetylmethionine or L-glutathione as taught by Soppimath because adding the N-acetylmethionine or L-glutathione would have been expected to advantageously enable enhanced stability against oxidative degradation.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618
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