DETAILED ACTION
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 . 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 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.
Election/Restrictions
Applicant’s election without traverse of Group I and the species of biologically active compound in the reply filed on 27 July 2026 is acknowledged. Claims 35, 39-40, and 43-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 1, 7, 11, 14-15, 19, 26, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Gillman et al. (US Patent 9,856,292) in view of Bjerregaard et al. (PCT Patent Application Publication WO 2021/089761).
Gillman et al. discloses cyclic peptide compounds useful for treating diseases including cancer and infectious diseases (abstract). Numerous such peptides are disclosed, and these include the elected species of biologically active compound (structure in columns 917-918). The peptide can be administered via numerous modes of administration, but none are exemplified (column 3, lines 21-29).
Gillman et al. does not teach formulating the peptide with nicotinamide and a salcaprozate salt, which are limitations recited by independent instant claim 1.
Bjerregaard et al. discloses pharmaceutical compositions with a peptide, an absorption enhancer, and a hydrotrope (page 2, lines 21-25). The balanced amounts of the absorption enhancer and hydrotrope provide for fast and efficient uptake of the active pharmaceutical ingredient (id.). For example, the composition comprises 0.5-100 mg of the active, 50-600 mg of sodium salcaprozate, 20-400 mg of nicotinamide, and optionally 0-15 mg lubricant (claim 6).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have used the formulation suggested by Bjerregaard et al. for delivering the active pharmaceutical agent disclosed by Gillman et al. Doing so would provide for fast and efficient uptake of the active pharmaceutical ingredient.
Instant claims 7, 11, and 14 further limit the biologically active compound, and the peptide disclosed by Gillman et al. reads upon these limitations.
Instant claims 15, 19, and 26 further limit the amounts of the ingredients. And the amounts are either read upon or overlap the taught ranges. And in cases involving overlapping ranges, where the instantly claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP 2144.05.
Instant claim 41 recites the combination of the three ingredients, and that it provides for specific bioavailability. While the combination of the references do not teach this outcome, the ingredients are suggested together, and thus the property of such a combination would be present.
Claims 3-4, 6, 30, and 32-33 (as well as above rejected claims 1, 7, 11, 14-15, 19, 26, and 41) are rejected under 35 U.S.C. 103 as being unpatentable over Gillman et al. (US Patent 9,856,292) in view of Bjerregaard et al. (PCT Patent Application Publication WO 2021/089761) as applied to claim 1 above, and further in view of Seth et al. (US Patent Application Publication 2015/0037376).
Instant claims 3-4, 6, 30, and 32-33 recite the further inclusion of protease inhibitors, which are not suggested by Gillman et al. or Bjerregaard et al.
Seth et al. discloses compositions comprising peptide active agents and suggests the inclusion of a protease inhibitor (abstract). The inclusion of the protease inhibitor protects the active from degradation and thus facilitate absorption in the subject (paragraph [170]). Specific protease inhibitors include soybean trypsin inhibitor (paragraph [171]). It is useful in at least 0.1 mg/dosage unit (paragraph [178]), an amount which overlaps the ranges instantly recited.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have included a protease inhibitor as suggested by Seth er al. in the formulation suggested by Gillman et al. and Bjerregaard et al. Doing so would protects the active from degradation and thus facilitate absorption in the subject.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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