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 .
Claims 102-106 and 111-125 are pending in this application and were examined on their merits,
The rejections of Claims 102-106 and 111-121 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inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, have been withdrawn due to the Applicant’s amendments to the claims filed 08/24/2026.
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.
Claim(s) 102-106 and 111-125 are rejected under 35 U.S.C. § 103 as being unpatentable over Hershko (WO 2013/114369 A1), cited in the IDS, in view of
Caccialupi et al. (2020), of record.
Hershko teaches an oral composition comprising the therapeutic protein insulin,
the chelator of divalent cations EDTA and an isolated BBI, the use of the composition in
preparing a medicament for oral administration of a therapeutic protein to a subject and
orally administering the oral composition to a subject (Pg. 56, Claim 1, Pg. 57, Claims
13 and 14 and Pg. 59, Claims 32-33), and reading on Claims 102 and 122.
With regard to Claims 102 and 122, the reference teaches embodiments comprising 50-100 mg isolated BBI, 100-200 mg EDTA and 8-32 mg of the therapeutic protein insulin, as well as an embodiment comprising 8 mg insulin, 150 mg EDTA and 75 mg total BBI and KTI (Pg. 22, Lines 20-23 and 27-28).
With regard to Claims 102 and 122-125, the reference further teaches that the BBI can be a recombinant BBI (Pg. 9, Lines 5-7) and each capsule can contain 50-100 mg of isolated BBI (Pg. 22, Lines 20-21).
The teachings of Hershko were discussed above.
Hershko did not teach wherein the isolated recombinantly-expressed BBI is expressed in a yeast expression system and the yeast expression system in Pichia pastoris, as required by Claims 102 and 122.
Caccialupi et al. teaches the recombinant expression of BBI in Pichia pastoris (Pg. 1060, Paragraph 2.4).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the instant invention to modify the generic recombinant expression of the BBI in the oral composition taught by Hershko with the expression of the recombinant BBI in the Pichia pastoris expression system taught by Caccialupi et al. because this would provide the artisan with a known and successfully used system for the production of recombinant BBI. Those of ordinary skill in the art would have been motivated to make this modification in order to produce the desired recombinant BBI. There would have been a reasonable expectation of success in making this modification because both references are drawn to the production and use of recombinant BBI.
With regard to Claims 104 and 105, the Hershko reference teaches the oral composition further comprises the trypsin inhibitor KTI3 (Pg. 56, Claims 5-6).
With regard to Claim 106, the Hershko reference teaches the KTI3 has been purified to at least 85% purity as measured by SDS-PAGE or purified to a protein content of greater than 95% as measured by BCA assay (Pg. 56, Claims 7-8).
With regard to Claims 107 and 108, the Hershko reference teaches the therapeutic peptide or protein is insulin (Pg. 57, Claim 12).
With regard to Claim 111, the Hershko reference teaches the chelator is EDTA (Pg. 57, Claim 14).
With regard to Claim 112, the Hershko reference teaches the oral composition is an oil-based liquid formulation (Pg. 56, Claim 1).
With regard to Claim 113, the Hershko reference teaches the oral composition comprises a polyethylene glycol (PEG) ester of a monoglyceride, a diglyceride, a triglyceride or a mixture thereof (Pg. 57, Claim 15).
With regard to Claim 114, the Hershko reference teaches the oil-based liquid composition comprises glycerol (Pg. 58, Claim 18) and gelatin (Pgs. 58-59, Claims 28 and 30).
With regard to Claims 115 and 116, the Hershko reference teaches the oil-based liquid composition comprises the non-ionic detergent polysorbate 80 (Pg. 58, Claims 23- 24).
With regard to Claim 117, the Hershko reference teaches the oil is a fish oil (Pg. 58, Claim 26).
With regard to Claim 118, the Hershko reference teaches the oil-based liquid
composition is water-free (Pg. 58, Claim 27).
With regard to Claims 119, 120 and 121, the Hershko reference teaches the oral
composition further comprises a pH-sensitive soft gelatin capsule that resists
degradation in the stomach (Pg. 58, Claim 28 and Pg. 59, Claim 29).
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/24/2026, with respect to the above withdrawn rejection have been fully considered and are persuasive. The remaining arguments have been considered insofar as they apply to the current rejections.
The Applicant argues that the amended claims are now commensurate in scope with the data presented in the Declaration and the invention is non-obviated (Remarks, Pg. 9, Lines 6-22 and Pg. 10, Lines 1-4).
This is not found to be persuasive for the reasoning provided in the above new rejection. Further, the data provided in the Declaration and Specification are not a
comparison with the closest subject matter which exists in the prior art.
As noted above, Hershko teaches an oral composition comprising the therapeutic protein insulin, the chelator of divalent cations EDTA and an isolated BBI, the use of the composition in preparing a medicament for oral administration of a therapeutic protein to a subject and orally administering the oral composition to a subject. The reference teaches embodiments comprising 50-100 mg isolated BBI, 100-200 mg EDTA and 8-32 mg of the therapeutic protein insulin, as well as an embodiment comprising 8 mg insulin, 150 mg EDTA and 75 mg total BBI and KTI (Pg. 22, Lines 20-23 and 27-28). The reference further teaches that the BBI can be a recombinant BBI. Thus, the closest prior art would be the composition of Hershko comprising 8-32 mg insulin, 100-200 mg EDTA and 50-100 mg of recombinant BBI. See the MPEP at 716.02(e). Finally, the Examiner notes that even if secondary considerations, such as a finding of unexpected results (indicia of non-obviousness) are established, the record may also establish such a strong case of obviousness that the objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness. Newell Cos. V. Kenney Mfg. Co., 864 F.2d 757, 769, 9 USPQ2d 1417, 1427 (Fed. Cir. 1988), cert. denied, 493 U.S. 814 (1989); Richardson-Vicks, Inc., v. The Upjohn Co., 122 F.3d 1476, 1484, 44 USPQ2d 1181, 1187 (Fed. Cir. 1997). In this instance, the only substantial difference between the primary reference and the claimed invention is the source of the recombinant BBI which is strongly obviated by Caccialupi.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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