DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/24/2024 have been considered by the examiner.
NPL documents which have been lined through have not been considered because there is no publication date listed.
Status of the Claims
The response and amendment filed 05/15/2024 is acknowledged.
Claims 1-14 are pending.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.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 1-14 are 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 pre-AIA the applicant regards as the invention.
Claim 1 includes the limitation of “low-viscosity.”
The phrase “low-viscosity” in claim 1 is a relative term which renders the claim indefinite. The term “low-viscosity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although the limitation refers to a property of the composition, i.e., viscosity, there are no conditions stated in the claim, e.g., temperature. Viscosities measured at different temperatures cannot be meaningfully compared. It is not clear what range the viscosity must be to be considered “low”, and at what temperature the viscosity must be measured for comparison. Dependent claims do not clarify this issue.
A person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement. See MPEP 2173.02, II
Clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 1-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Camurus, WO 2006075124 A1 (cited on Applicant’s IDS dated 09/24/2024).
Camurus teaches somatostatin analog formulations (Camurus, e.g., Title, Abstract, claims), which somatostatin analogs are formulated in low-viscosity pre-formulations containing a) at least one diacyl glycerol, b) at least one phosphatidyl choline, c) at least one oxygen containing solvent, and d) at least one somatostatin analog, wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid (Camurus, e.g., Abstract, claims). Ethanol is an oxygen containing solvent named in claim 5. Soy PC is a phosphatidyl choline named in claim 4. Glycerol dioleate (GDO) is a diacyl glycerol named in claim 3. A favored combination of components a, b and c are GDO, soy PC and ethanol (Camurus, e.g., pg. 17:1). Lanreotide and vapreotide are somatostatin analogs named in page 2, lines 7-9; page 27, lines 1-2; and claim 6.
Camurus further teaches a method for treating a human or animal comprising administering, e.g., i.m. or s.c., a pre-formulation comprising a low viscosity mixture of: a) at least one diacyl glycerol; b) at least one phosphatidyl choline; c) at least one oxygen containing organic solvent; d) at least one somatostatin analogue; whereby to form at least one liquid crystalline phase structure upon contact with an aqueous fluid in vivo following administration (Camurus, e.g., pg. 7:15 – pg. 8:5 and claims 7-17). The amounts recited in claims 6, and 8-10 are overlapping/within the ranges found on pg. 12, e.g., 24-31. The ratios of claims 7-10 are found on pg. 12:33-34. The conditions of claim 11 are found in claim 8. The routes of administration in claim 12 is found in claim 11. Pre-filled administration device is found in claim 12. Administering every 20 to 90 days is found in claim 14. The range recited in claim 14 significantly overlaps with the range taught in Camurus. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
Camurus teaches the term somatostatin analogues includes pharmaceutically acceptable salts and list examples of acceptable salts which include hydrochloride salts (a halide salt). See page 18, lines 16-21. Camurus teaches lanreotide and vapreotide as preferred somatostatin analogues (Camurus, e.g., page 18, line 32-page 19, line 1).
The difference between the claimed invention and the teachings of Camurus is that Camurus does not expressly teach administering the halide salt of lanreotide or vapreotide.
However, Camurus teaches the somatostatin analogues, octreotide, lanreotide and vapreotide. Camurus teaches the analogues include the salt of the somatostatin analogues, octreotide, lanreotide and vapreotide. Camurus teaches hydrochloride salt as an acceptable salt. Thus, based on the teachings of Camurus, the artisan having ordinary skill would have concluded the teaching of vapreotide and lanreotide to include pharmaceutically acceptable salts thereof and more particularly the hydrochloride salt because hydrochloride salt was taught by Camurus as an acceptable salt.
It would have been obvious before the presently claimed invention was made to practice a method of treatment comprising administering a pre-formulation comprising at least one diacyl glycerol, at least one phosphatidyl choline, at least one oxygen containing organic solvent and at least one somatostatin analogue where the pre-formulation forms or is capable of forming at least one liquid crystalline phase structure upon contact with an aqueous fluid where the somatostatin analogue is the hydrochloride salt (halide salt) of lanreotide or vapreotide to a human or non-human mammalian subject in need of treatment with the hydrochloride salt (halide salt) of lanreotide or vapreotide. The artisan would have had a reasonable expectation of success in selecting the hydrochloride salt (halide salt) of lanreotide or vapreotide as the somatostatin analogue because Camurus teaches lanreotide and vapreotide acceptable salts can be used in the method of treatment of a non-mammalian and mammalian subject in need of a somatostatin analogue and the hydrochloride salt is an acceptable biologically acceptable salt. The artisan would have been motivated to make the selection because Camurus teaches lanreotide and vapreotide as preferred somatostatin analogues and the hydrochloride salt is an acceptable salt.
Accordingly, the subject matter of claims 1-14 would have been prima facie obvious before the presently claimed invention was made, absent evidence to the contrary.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. U.S. Patent No. 8871712 in view of Camurus, WO 2006075124 A1 (cited on Applicant’s IDS dated 09/24/2024).
The patent claims a method for the treatment of a human or non-human mammalian subject in need thereof with a somatostatin analogue. The method comprises administering to the subject a formulation precursor (pre-formulation) having a viscosity of between 1-1000 mPas and comprising diacyl glycerol, phosphatidyl choline, an organic solvent and at least one somatostatin analogue having somatostatin activity is a cyclic peptide of 14 or fewer amino acids having at least one intra-molecular crosslink and a type-2 b turn. The precursor forms at least one liquid crystalline phase structure upon contact with an aqueous fluid. See claims 1 and 7.
The patent claims do not claim the somatostatin analogue is a halide salt of lanreotide or vapreotide.
Camurus teaches low viscosity pre-formulation comprising the same component as the formulation of reference claims, e.g., the Camurus pre-formulation comprises at least one diacyl glycerol, at least one phosphatidyl choline, at least one oxygen containing organic solvent and at least one somatostatin analogue where the pre-formulation forms or is capable of forming at least one liquid crystalline phase structure upon contact with an aqueous fluid (Camurus, e.g., abstract). Camurus teaches the somatostatin analogues include octreotide, lanreotide and vapreotide. See page 2, lines 7-9; page 27, lines 1-2; claim 6. Camurus teaches the term somatostatin analogues includes pharmaceutically acceptable salts and list examples of acceptable salts which include hydrochloride salts (a halide salt). See Camurus, e.g., page 18, lines 16-21. Lanreotide and vapreotide are preferred somatostatin analogues and clearly alternatives for octreotide. Camurus, e.g., pg. 18, line 32 – page 19, line 1. Camurus teaches administering the pre-formulation to a human or non-human mammalian subject in need of treatment with a somatostatin analogue. See page 9, lines 5-23.
It would have been obvious before the presently claimed invention was made to formulate an active salt lanreotide or vapreotide, such as the hydrochloride salt of lanreotide or vapreotide as the somatostatin analogue in the formulation administered in the method of reference claims with a reasonable expectation of success. The skilled artisan would have a reasonable expectation of selecting the lanreotide or vapreotide because they are cyclic peptide of 14 or fewer amino acids having at least one intra-molecular crosslink and a type-2 b turn with somatostatin activity and the hydrochloride salt because it is a biologically acceptable salt. The skilled artisan would have been motivated to make the selection because Camurus teaches lanreotide and vapreotide are preferred analogues and are indicated in the treatment of a variety of conditions wherein somatostatin analogues are administered over an extended period.
The reference claims teach the diacyl glycerol is glycerol dioleate. See claim 9.
The reference claims teach ethanol. See claim 9.
The reference claims teach formulation precursor comprising a mixture of 42 to 55.8 parts by weight of glycerol dioleate as component a), 30 to 46 parts by weight of phosphatidyl choline as component b), 5 to 10 parts by weight of ethanol as component c), and 0.5 to 6 parts by weight of octreotide as component d). See claim 9.
The reference claims do not teach soy PC in combination with a halide salt of lanreotide or vapreotide.
These defects are cured by the teachings of Camurus as enumerated above. Camurus teaches soy PC is highly effective. See page 15, lines 25-33.
It would have been obvious before the presently claimed invention was made to use soy PC because the soy PC can be used in formulations of the reference claims as demonstrated by Camurus. The skilled artisan would be motivated to make the selection because Camurus provides a clear teaching of a preference for soy PC is in formulations like those of the reference claims. The skilled artisan would have a reasonable expectation of selecting the lanreotide or vapreotide because they are cyclic peptide of 14 or fewer amino acids having at least one intra-molecular crosslink and a type-2 b turn with somatostatin activity and the hydrochloride salt because it is a biologically acceptable salt. The artisan would have been motivated to make the selection because Camurus teaches lanreotide and vapreotide are preferred analogues like octreotide and are indicated in the treatment of a variety of conditions wherein somatostatin analogues are administered over an extended period.
The reference claims teach the method of treatment is a method for the treatment of at least one condition selected from acromegaly, cancers, carcinomas, melanomas, tumors expressing at least one somatostatin receptor, sst(2)-positive tumors, sst(5)-positive tumors, prostate cancers, gastro-entero-pancreatic neuroendocrine (GEP NE) tumors, carcinoid tumors, insulinomas, gastrinomas, vasoactive intestinal peptide (VIP) tumors and glucagonomas, elevated growth hormone (GH), elevated insulin-like growth factor I (IGF-I), varicial bleeding (especially esophageal), chemotherapy induced gastro intestinal problems (such as diarrhea), lymphorrhea, diabetic retinopathy, thyroid eye disease, obesity, pancreatitis, and related conditions. See claim 8.
The reference claims teach administration by i.m, s.c. or deep s.c. injection. See claim 10.
The reference claims teach administration by means of a pre-filled administration device. See claim 11.
The reference claims teach the method comprises administration every 20 to 90 days. See claim 13.
Accordingly, the subject matter of claims 1-14 would have been prima facie obvious before the presently claimed invention was made, absent evidence to the contrary.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. U.S. Patent No. 9974861 in view of Camurus, WO 2006075124 A1 (cited on Applicant’s IDS dated 09/24/2024).
The reference claims teach a method for the treatment of a human or non-human mammalian subject in need thereof with low-viscosity mixture comprising octreotide chloride. The method comprises administering to the subject low-viscosity mixture comprising glycerol dioleate, phosphatidyl choline, ethanol and octreotide chloride. The precursor forms at least one liquid crystalline phase structure upon contact with an aqueous fluid. See claims 1 and 15.
The reference claims do not claim the somatostatin analogue is a halide salt of lanreotide or vapreotide.
As enumerated above, Camurus teaches low viscosity pre-formulation comprising the same component as the formulation of the reference claims, e.g., the pre-formulation of Camurus comprises at least one diacyl glycerol, at least one phosphatidyl choline, at least one oxygen containing organic solvent and at least one somatostatin analogue where the pre-formulation forms or is capable of forming at least one liquid crystalline phase structure upon contact with an aqueous fluid. See the abstract. Camurus teaches the somatostatin analogues include octreotide, lanreotide and vapreotide. See page 2, lines 7-9; page 27, lines 1-2; claim 6. Camurus teaches the somatostatin analogues such as octreotide, lanreotide and vapreotide are indicated in the treatment of a variety of conditions where they are typically administered over an extended period. See page 2, lines7-9. Camurus teaches the term somatostatin analogues includes pharmaceutically acceptable salts and list examples of acceptable salts which include hydrochloride salts (a halide salt). See page 18, lines 16-21. Camurus teaches lanreotide and vapreotide as preferred somatostatin analogues. See page 18, line 32 – page 19, line 1. Camurus teaches administering the pre-formulation to a human or non-human mammalian subject in need of treatment with a somatostatin analogue. See page 9, lines 5-23.
It would have been obvious before the presently claimed invention was made to formulate a biological active salt lanreotide or vapreotide, including the hydrochloride salt of lanreotide or vapreotide as a substitute for octreotide chloride to practice a method of the reference claims with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of selecting the lanreotide or vapreotide because Camurus teaches they are preferred somatostatin analogues and the hydrochloride salt because it is a biologically acceptable salt. The skilled artisan would have been motivated to make the selection because Camurus teaches lanreotide and vapreotide are preferred analogues and are indicated in the treatment of a variety of conditions wherein somatostatin analogues are administered over an extended period.
The reference claims teach the formulation precursor comprising a mixture of 40-60 wt% parts by weight of glycerol dioleate as component a), 40-60 wt% phosphatidyl choline as component b), 3-10 wt% ethanol as component c), and 1-8 wt% octreotide chloride as component d) where the ration of a:b is 48:52 to 55:45. See claim 1.
The reference claims do not teach soy PC in combination with a halide salt of lanreotide or vapreotide.
These defects are cured by the teachings of Camurus as enumerated above. Camurus teaches soy PC is highly effective. See page 15, lines 25-33.
It would have been obvious before the presently claimed invention was made to use soy PC because the soy PC can be used in formulations of the reference claims as demonstrated by Camurus. The skilled artisan would be motivated to make the selection because Camurus provides a clear teaching of a preference for soy PC is in formulations like those of the reference claims. The skilled artisan would have a reasonable expectation of selecting the lanreotide or vapreotide because they are cyclic peptide of 14 or fewer amino acids having at least one intra-molecular crosslink and a type-2 b turn with somatostatin activity and the hydrochloride salt because it is a biologically acceptable salt. The artisan would have been motivated to make the selection because Camurus teaches lanreotide and vapreotide are preferred analogues like octreotide and are indicated in the treatment of a variety of conditions wherein somatostatin analogues are administered over an extended period.
The reference claims teach the method of treatment is a method for the treatment of at least one condition selected from acromegaly, cancer, elevated growth hormone, elevated insulin-like growth factor I, varicial bleeding, chemotherapy induced gastro intestinal problems, lymphorrhea, diabetic retinopathy, thyroid eye disease, obesity, and pancreatitis. See claims 16, 20 and 21.
The reference claims teach administration by i.m, s.c. or deep s.c. injection. See claim 17.
The reference claims teach administration by means of a pre-filled administration device. See claim 18.
The reference claims teach the method comprises administration every 20 to 180 days. See claim 19.
Accordingly, the subject matter of claims 1-14 would have been prima facie obvious before the presently claimed invention was made, absent evidence to the contrary.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615