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 .
Status of the Claims
Claims 1-30 were originally filed December 21, 2023.
The amendment received February 20, 2024 canceled claims 2-26 and 28-30; amended claim 27; and added new claims 31-48.
Claims 1, 27, and 31-48 are currently pending.
Claims 27, 31, 32, and 36-41 are currently under consideration.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 27 and 31-48) in the reply filed on July 21, 2025 is acknowledged.
Claim 1 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 21, 2025.
Applicant’s election without traverse of adult human, insulin (6-14 mg), SBTI (75 mg), EDTA (150 mg), liquid capsule, oral, once daily, and treatment in the reply filed on July 21, 2025 is acknowledged.
Claims 33-35 and 42-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 21, 2025.
Priority
The present application is a CON of 17/206,574 filed March 19, 2021 which is a CON of 16/195,184 filed November 19, 2018 (now U.S. Patent 10,967,051) which is a CON of 14/759,060 filed July 2, 2015 which is a 371 (National Stage) of PCT/IL2014/050007 filed January 2, 2014 which claims the benefit of 61/763,996 filed February 13, 2013 and foreign priority to PCT/IL2013/050007 filed January 3, 2013.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 21, 2023 (2) are being considered by the examiner. Please note: only English language portions of the references were considered.
Drawings
No drawings are present.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The limitation “inhibiting the development of” NAFLD does not require the human subject to have NAFLD.
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 32 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. One of skill in the art would not be able to determine the scope of the presently claimed “liquid formulation”. For example, independent claim 27 requires a “water-free pharmaceutical composition” while claim 32 which depends on claim 27 requires a “liquid formulation”. Thus, it is unclear if the “liquid formulation” is water-free or not. It is also unclear if the “liquid formulation” limits the “water-free pharmaceutical formulation” or not (i.e. does “liquid formulation” broaden the scope of the “water-free pharmaceutical formulation”).
Claim 32 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.
Claim 32 recites the limitation "the pharmaceutical composition" in line 1. There is insufficient antecedent basis for this limitation in the claim. Utilization of “water-free pharmaceutical composition” is suggested.
Claim 36 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.
Claim 36 recites the limitation "the composition" in line 1. There is insufficient antecedent basis for this limitation in the claim. Utilization of “water-free pharmaceutical composition” is suggested.
Claim 36 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.
Claim 36 recites the limitation "chelator" in line 1. There is insufficient antecedent basis for this limitation in the claim. Utilization of a “chelator of divalent cations” is suggested.
Claim 37 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.
Claim 37 recites the limitation "the composition" in line 1. There is insufficient antecedent basis for this limitation in the claim. Utilization of “water-free pharmaceutical composition” is suggested.
Claim 38 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.
Claim 38 recites the limitation "said pharmaceutical composition" in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim. Utilization of “water-free pharmaceutical composition” is suggested.
Claim 39 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.
Claim 39 recites the limitation "said pharmaceutical composition" in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim. Utilization of “water-free pharmaceutical composition” is suggested.
Claim 40 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.
Claim 40 recites the limitation "the pharmaceutical composition" in line 1. There is insufficient antecedent basis for this limitation in the claim. Utilization of “water-free pharmaceutical composition” is suggested.
Claim 41 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.
Claim 41 recites the limitation "the composition" in line 1. There is insufficient antecedent basis for this limitation in the claim. Utilization of “water-free pharmaceutical composition” is suggested.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 27, 31, 32, and 36-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kidron et al. U.S. Patent Application Publication 2007/0087957 published April 19, 2007.
For present claims 27, 31, 32, and 36-40, Kidron teaches methods of orally administering to a human subject a capsule comprising insulin, omega-3 fatty acid including fish oil, chelators including EDTA or EGTA, and protease inhibitors including trypsin and/or chymotrypsin inhibitors including SBTI wherein the insulin is provided once or twice daily at 0.5-3 units (u)/kg or 0.1-5 u/kg, protease inhibitors are provided at 0.1 mg/dose unit up to 100 mg/dose unit, and the chelator (i.e. enhancer) is provided at 0.1 mg/dosage unit up to 100 mg/dosage unit (please refer to the entire specification particularly the abstract; paragraphs 2, 8-12, 23, 24, 26-34, 36-47, 51-58, 62, 63, 70-81, 85, 86, 88-92, 95, 105; claims). The human subject taught by Kidron may have diabetes (i.e. susceptible to developing NAFLD).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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."); and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
Therefore, the teachings of Kidron anticipate the presently claimed method.
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.
Claims 27, 31, 32, and 36-41 are rejected under 35 U.S.C. 103 as being unpatentable over Kidron et al. U.S. Patent Application Publication 2007/0087957 published April 19, 2007 and Saltiel et al. U.S. Patent Application Publication 2012/0208836 published August 16, 2012.
For present claims 27, 31, 32, and 36-41, Kidron teaches methods of orally administering to a human subject a capsule comprising insulin, omega-3 fatty acid including fish oil, chelators including EDTA or EGTA, and protease inhibitors including trypsin and/or chymotrypsin inhibitors including SBTI wherein the insulin is provided once or twice daily at 0.5-3 units (u)/kg or 0.1-5 u/kg, protease inhibitors are provided at 0.1 mg/dose unit up to 100 mg/dose unit, and the chelator (i.e. enhancer) is provided at 0.1 mg/dosage unit up to 100 mg/dosage unit (please refer to the entire specification particularly the abstract; paragraphs 2, 8-12, 23, 24, 26-34, 36-47, 51-58, 62, 63, 70-81, 85, 86, 88-92, 95, 105; claims). The human subject taught by Kidron may have diabetes (i.e. susceptible to developing NAFLD).
For present claims 27, 31, 32, and 36-41, Saltiel et al. teach methods of treating obesity and related disorders including NAFLD via administering antidiabetics including insulin to human subjects in dosage amounts of 0.001-10,000 mg/kg/day (please refer to the entire specification particularly the abstract; paragraphs 12, 66-69, 72, 73, ). Saltiel et al. also teach oral administration, capsules, EDTA, etc. (please refer to the entire specification particularly paragraph 99, 101, 103, 108, 113-116).
The claims would have been obvious because a particular known technique (i.e. utilizing antidiabetics including insulin to treat NAFLD) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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."); and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
Claims 27, 31, 32, and 36-41 are rejected under 35 U.S.C. 103 as being unpatentable over Kidron et al. U.S. Patent Application Publication 2007/0087957 published April 19, 2007 and Klein et al. U.S. Patent Application Publication 2012/0165251 published June 28, 2012.
For present claims 27, 31, 32, and 36-41, Kidron teaches methods of orally administering to a human subject a capsule comprising insulin, omega-3 fatty acid including fish oil, chelators including EDTA or EGTA, and protease inhibitors including trypsin and/or chymotrypsin inhibitors including SBTI wherein the insulin is provided once or twice daily at 0.5-3 units (u)/kg or 0.1-5 u/kg, protease inhibitors are provided at 0.1 mg/dose unit up to 100 mg/dose unit, and the chelator (i.e. enhancer) is provided at 0.1 mg/dosage unit up to 100 mg/dosage unit (please refer to the entire specification particularly the abstract; paragraphs 2, 8-12, 23, 24, 26-34, 36-47, 51-58, 62, 63, 70-81, 85, 86, 88-92, 95, 105; claims). The human subject taught by Kidron may have diabetes (i.e. susceptible to developing NAFLD).
For present claims 27, 31, 32, and 36-41, Klein et al teach methods of treating and/or preventing metabolic disorders including NAFLD in a human patient via administering insulin once or twice daily including orally and at dosages of 0.001 to 100 mg/kg in capsules (please refer to the entire specification particularly the abstract; paragraphs 1, 3, 14, 23, 27-29, 35, 64, 70, 77, 80, 230, 240, 245, 265-267). Klein et al. also teach oral antidiabetic drugs (please refer to the entire specification particularly paragraph 6, 23, 39, 227).
The claims would have been obvious because a particular known technique (i.e. utilizing antidiabetics including insulin to treat NAFLD) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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."); and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
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 27, 31, 32, and 36-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 19/042,433 in view of Klein et al. U.S. Patent Application Publication 2012/0165251 published June 28, 2012.
Copending Application No. 19/042,433 claims oral pharmaceutical compositions and methods of administering wherein the oral pharmaceutical compositions comprise insulin at 4-12 mg; a trypsin inhibitor including SBTI, KTI3, or BBI; EDTA; and an oil including fish oil.
Klein et al teach methods of treating and/or preventing metabolic disorders including NAFLD in a human patient via administering insulin once or twice daily including orally and at dosages of 0.001 to 100 mg/kg in capsules (please refer to the entire specification particularly the abstract; paragraphs 1, 3, 14, 23, 27-29, 35, 64, 70, 77, 80, 230, 240, 245, 265-267). Klein et al. also teach oral antidiabetic drugs (please refer to the entire specification particularly paragraph 6, 23, 39, 227).
The claims would have been obvious because a particular known technique (i.e. utilizing antidiabetics including insulin to treat NAFLD) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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."); and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
This is a provisional nonstatutory double patenting rejection.
Claims 27, 31, 32, and 36-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 6, 9, 10, 13, 15, 16, 22, 23, 27, 28, 31, 33-36, 40, and 41 of copending Application No. 18/921,419 in view of Klein et al. U.S. Patent Application Publication 2012/0165251 published June 28, 2012.
Copending Application No. 18/921,419 claims a composition and methods of orally administering wherein the composition comprises insulin; a protease inhibitor including SBTI; EDTA; and omega-3 fatty acid and/or fish oil.
Klein et al teach methods of treating and/or preventing metabolic disorders including NAFLD in a human patient via administering insulin once or twice daily including orally and at dosages of 0.001 to 100 mg/kg in capsules (please refer to the entire specification particularly the abstract; paragraphs 1, 3, 14, 23, 27-29, 35, 64, 70, 77, 80, 230, 240, 245, 265-267). Klein et al. also teach oral antidiabetic drugs (please refer to the entire specification particularly paragraph 6, 23, 39, 227).
The claims would have been obvious because a particular known technique (i.e. utilizing antidiabetics including insulin to treat NAFLD) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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."); and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
This is a provisional nonstatutory double patenting rejection.
Claims 27, 31, 32, and 36-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-45 of U.S. Patent No. 9,259,456 in view of Klein et al. U.S. Patent Application Publication 2012/0165251 published June 28, 2012.
U.S. Patent No. 9,259,456 claims oral dosages and methods of administering to patients wherein the oral dosages comprise insulin, SBTI, EDTA, and omega-3 fatty acid in gelatin coatings.
Klein et al teach methods of treating and/or preventing metabolic disorders including NAFLD in a human patient via administering insulin once or twice daily including orally and at dosages of 0.001 to 100 mg/kg in capsules (please refer to the entire specification particularly the abstract; paragraphs 1, 3, 14, 23, 27-29, 35, 64, 70, 77, 80, 230, 240, 245, 265-267). Klein et al. also teach oral antidiabetic drugs (please refer to the entire specification particularly paragraph 6, 23, 39, 227).
The claims would have been obvious because a particular known technique (i.e. utilizing antidiabetics including insulin to treat NAFLD) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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."); and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
Claims 27, 31, 32, and 36-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-45 of U.S. Patent No. 9,259,456 in view of Klein et al. U.S. Patent Application Publication 2012/0165251 published June 28, 2012.
U.S. Patent No. 9,259,456 claims oral dosages and methods of administering to patients wherein the oral dosages comprise insulin, SBTI, EDTA, and omega-3 fatty acid in gelatin coatings.
Klein et al teach methods of treating and/or preventing metabolic disorders including NAFLD in a human patient via administering insulin once or twice daily including orally and at dosages of 0.001 to 100 mg/kg in capsules (please refer to the entire specification particularly the abstract; paragraphs 1, 3, 14, 23, 27-29, 35, 64, 70, 77, 80, 230, 240, 245, 265-267). Klein et al. also teach oral antidiabetic drugs (please refer to the entire specification particularly paragraph 6, 23, 39, 227).
The claims would have been obvious because a particular known technique (i.e. utilizing antidiabetics including insulin to treat NAFLD) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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."); and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
Claims 27, 31, 32, and 36-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9,186,412 in view of Klein et al. U.S. Patent Application Publication 2012/0165251 published June 28, 2012.
U.S. Patent No. 9,186,412 claims oral dosages and methods of administering to patients wherein the oral dosages comprise insulin, SBTI, EDTA, and omega-3 fatty acid in gelatin coatings.
Klein et al teach methods of treating and/or preventing metabolic disorders including NAFLD in a human patient via administering insulin once or twice daily including orally and at dosages of 0.001 to 100 mg/kg in capsules (please refer to the entire specification particularly the abstract; paragraphs 1, 3, 14, 23, 27-29, 35, 64, 70, 77, 80, 230, 240, 245, 265-267). Klein et al. also teach oral antidiabetic drugs (please refer to the entire specification particularly paragraph 6, 23, 39, 227).
The claims would have been obvious because a particular known technique (i.e. utilizing antidiabetics including insulin to treat NAFLD) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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."); and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
Claims 27, 31, 32, and 36-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,420,721 in view of Klein et al. U.S. Patent Application Publication 2012/0165251 published June 28, 2012.
U.S. Patent No. 10,420,721 claims oral dosages and methods of administering to patients wherein the oral dosages comprise a protein having a MW of up to 100,000 Da (i.e. insulin), SBTI, EDTA, and omega-3 fatty acid in gelatin coatings.
Klein et al teach methods of treating and/or preventing metabolic disorders including NAFLD in a human patient via administering insulin once or twice daily including orally and at dosages of 0.001 to 100 mg/kg in capsules (please refer to the entire specification particularly the abstract; paragraphs 1, 3, 14, 23, 27-29, 35, 64, 70, 77, 80, 230, 240, 245, 265-267). Klein et al. also teach oral antidiabetic drugs (please refer to the entire specification particularly paragraph 6, 23, 39, 227).
The claims would have been obvious because a particular known technique (i.e. utilizing antidiabetics including insulin to treat NAFLD) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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."); and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
Claims 27, 31, 32, and 36-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,350,162 in view of Klein et al. U.S. Patent Application Publication 2012/0165251 published June 28, 2012.
U.S. Patent No. 10,350,162 claims oral dosages and methods of administering to patients wherein the oral dosages comprise exenatide (i.e. alternative for insulin), SBTI, EDTA, and omega-3 fatty acid from fish oil in gelatin coatings.
Klein et al teach methods of treating and/or preventing metabolic disorders including NAFLD in a human patient via administering insulin once or twice daily including orally and at dosages of 0.001 to 100 mg/kg in capsules (please refer to the entire specification particularly the abstract; paragraphs 1, 3, 14, 23, 27-29, 35, 64, 70, 77, 80, 230, 240, 245, 265-267). Klein et al. also teach oral antidiabetic drugs (please refer to the entire specification particularly paragraph 6, 23, 39, 227).
The claims would have been obvious because a particular known technique (i.e. utilizing antidiabetics including insulin to treat NAFLD) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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."); and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
Claims 27, 31, 32, and 36-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,967,051 in view of Kidron et al. U.S. Patent Application Publication 2007/0087957 published April 19, 2007.
U.S. Patent No. 10,967,051 claims methods of orally administering to a human subject a water-free pharmaceutical composition inside a capsule comprising insulin (8-32 mg), a protease inhibitor, and a chelator of divalent cations to treat NAFLD wherein administration is once or twice daily.
Kidron teaches methods of orally administering to a human subject a capsule comprising insulin, omega-3 fatty acid including fish oil, chelators including EDTA or EGTA, and protease inhibitors including trypsin and/or chymotrypsin inhibitors including SBTI wherein the insulin is provided once or twice daily at 0.5-3 units (u)/kg or 0.1-5 u/kg, protease inhibitors are provided at 0.1 mg/dose unit up to 100 mg/dose unit, and the chelator (i.e. enhancer) is provided at 0.1 mg/dosage unit up to 100 mg/dosage unit (please refer to the entire specification particularly the abstract; paragraphs 2, 8-12, 23, 24, 26-34, 36-47, 51-58, 62, 63, 70-81, 85, 86, 88-92, 95, 105; clai