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 .
Applicant’s amendments filed 8/13/2025 have been entered.
Claims 1-19 are pending.
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,857,510 (‘510). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘510 teaches the use of Crofelemer to treat diarrhea associated with MVID (see claim 1). ‘510 teaches the dosage of Crofelemer employed (see claim 7). ‘590 teaches the age of the patients (see claims 5-6). ‘590 does not expressly teach other patient characteristics such as bowel resection or bowel transplant. ‘590 does not expressly teach the dosage form of enteric coating or not.
It would have been obvious to one of ordinary skill in the art at the time of filing to employ Crofelemer, regardless of being enteric coated or not, to treat MVID in the herein claimed patient populations.
One of ordinary skill in the art would have motivated to employ Crofelemer, regardless of being enteric coated or not, to treat MVID in the herein claimed patient populations. Crofelemer is well known to be effective in treating MVID, regardless of the patient characteristics, Crofelemer would be reasonably expected to be useful absent evidence to the contrary. As for the enteric coating, Crofelemer adsorption is not known to be affected by the GI pH. Therefore, employing Crofelemer, with or without enteric coating, would have been reasonably expected to be effective in treating diarrhea associated with MVID.
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) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/ 0338932 (‘932).
‘932 teaches a method of treating congenital diarrhea associated with microvillous inclusion disease (MVID) and congenital chloride diarrhea using a three-component composition (see the abstract, claims 1 and 17). ‘932 teaches one of three components is polyphenol, including Crofelemer (see claim 9 for example). ‘932 teaches “Crofelemer works by voltage- independently blocking two structurally unrelated chloride channels in the gut, namely the cystic fibrosis transmembrane conductance regulator ( CFTR ) with an in vitro maximum inhibition of about 60%, and the calcium - activated chloride channel anoctamin 1 , with a maximum inhibition of over 90%. The substance is hardly, if at all , absorbed from the gut into the bloodstream , and is consequently excreted with the stool (see [0067]). ‘932 teaches the age of the patients as suitable for all ages with various dosage being given (see [0089] – [0096]). ‘932 teaches the amount of the crofelemer as “ranging from 0.05 milligrams to 10 grams. This range includes all values and subranges therebetween, including 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 2000, 3000, 4000, 5000, 6000, 7000, 8000, 9000, 10,000 milligrams, or any combination thereof” (see [0040]).
‘932 does not expressly teach the patient characteristics such as bowel resection or bowel transplant. ‘932 does not expressly teach the dosage form of enteric coating or not. ‘932 does not expressly teach the exact dosage of Crofelemer.
It would have been obvious to one of ordinary skill in the art at the time of filing to employ Crofelemer, in the herein claimed dosage, with or without enteric coating, to treat congenital diarrhea, in the patients with herein claimed characteristics.
One of ordinary skill in the art would have been motivated to employ Crofelemer, in the herein claimed dosage, with or without enteric coating, to treat congenital diarrhea, in the patients with herein claimed characteristics. Crofelemer is well known to be effective in treating MVID or congenital chloride diarrhea, regardless of the patient characteristics, Crofelemer would be reasonably expected to be useful absent evidence to the contrary. As for the enteric coating, Crofelemer adsorption is not known to be affected by the GI pH as it is staying in the GI and not get absorbed. Therefore, employing Crofelemer, with or without enteric coating, would have been reasonably expected to be effective in treating diarrhea associated with MVID and/or congenital chloride diarrhea. In addition, the optimization of result effect parameters (e.g., dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As the dosage range taught in the cited prior art encompasses that of the instant claims, prima facie obviousness exists.
In addition, the improvement of diarrhea would be reasonably expected to reduce the fluid loss in the patients. Therefore, the parenteral nutrition requirements replacement can be reduced.
Response to Arguments
Applicant's arguments filed 8/13/2025 averring the cited prior art’s failure to teach the herein claimed limitations, have been fully considered but they are not persuasive. The examiner believes the limitations have been addressed in the rejection above.
No claims are allowed.
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 SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/ Primary Examiner, Art Unit 1627