DETAILED ACTION
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 amendment and response filed on 2/5/2026 have been received and entered into the case. Claims 13-23, 26-27, 29, 31, 34-36, 40-50, 55-57, 61-69, 71-72, 74, 77-78, 80-86, 88-89, and 102-108 have been canceled, Claims 109-113 have been added. Claims 1-12, 24-25, 28, 30, 32-33, 37-39, 51-54, 58-60, 70, 73, 75-76, 79, 87, 90-101, and 109-113 are pending, Claims 5-12, 24-25, 28, 30, 32-33, 37-39, 51-54, 58-60, 70, 87, and 90-101 have been withdrawn, and Claims 1-4, 73, 75-76, 79, and 109-113 have been considered on the merits, insofar as they read on the elected species of Crohn’s disease and in combination. All arguments have been fully considered.
Withdrawn Rejections
Rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn in view of applicant’s amendments.
Rejections of Claims 1-4 and 75-79 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicant’s amendments.
Rejections under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), fourth paragraph, are withdrawn since applicant’s arguments are found persuasive.
Rejections of Claims 77-78 under 35 U.S.C. 103 as being unpatentable over Pangborn et al (US 2008/0112944 A1; 5/15/2008.) in view of Ananthakrishnan et al (International Journal of Epidemiology. 2015;44(6):1995-2005.), Zyba et al (Am J Clin Nutr. 2019;110:1465-1475.) and Tourneau et al (J Natl Cancer Inst. 2009;101:708-720.) are withdrawn in view of applicant’s amendments – Claims 77-78 have been canceled.
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 73 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 pre-AIA the applicant regards as the invention.
Claim 73, the recitation of “in proximity to beginning of meal” on line 1-2 renders the claim indefinite. In the instant specification, para 0039 discloses that proximity to a meal refers to a period near in time to the beginning of a meal, e.g., greater than 60 minutes prior to beginning a meal and greater than 180 minutes after beginning a meal. It is unclear why 20 minutes prior to beginning a meal is not “a period near in time to the beginning of a meal”, but greater than 60 minutes is.
Claim Rejections - 35 USC § 103
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.
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 of this title, 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 1-4, 75-76, 79, and 109-113 are rejected under 35 U.S.C. 103 as being unpatentable over Pangborn et al (US 2008/0112944 A1; 5/15/2008.) in view of Ananthakrishnan et al (International Journal of Epidemiology. 2015;44(6):1995-2005.) and Zyba et al (Am J Clin Nutr. 2019;110:1465-1475.).
The instant claims recite a method for treating Crohn’s disease in a subject, comprising administering from about 400 FTU to about 5000 FTU of phytase per day to the subject.
Pangborn teaches methods for the treatment of a disorder including Crohn’s disease comprising administering a composition comprises phytase (para 0012, 0014-0015), wherein phytase is preferably added for its ability to digest phytic acid thus results in greater bioavailability of minerals such as zinc (para 0030). The composition is suitable for oral delivery, the specific concentrations of components included in the composition can vary, but generally correspond to those currently employed in commercially available nutritional supplements (para 0033), and the preferred dosage for the composition is one to two capsules, with the dosage varying with the size of the meal and/or the body weight of the patient (para 0036).
Pangborn does not teach the claimed daily dosage of phytase (claims 1-2 and 110) as well as the claimed schedule (claims 3, 75 and 111-112), zinc is administered in combination with phytase (claim 4) as well as the claimed amount of zinc (claim 109), and the Crohn’s disease is Granulomatous Colitis (claim 79).
However, Pangborn does teach said methods are for the treatment of Crohn’s disease comprising administering phytase, wherein the specific concentrations of components can vary, but generally correspond to those currently employed in commercially available nutritional supplements, and the preferred dosage varies with the size of the meal and/or the body weight of the patient. Ananthakrishnan teaches daily total intake of zinc includes 10.0-11.2 mg/day, 11.0-12.8 mg/day, 12.9-18.5 mg/day (Table 1), intake of zinc is associated with a reduced risk of Crohn’s disease (p.2002 col left – para 2, p.2003 col right – para 2), in animal models of colitis (Granulomatous Colitis), administration of zinc reduces mucosal inflammation and myeloperoxidase activity (p.2002 col left – para 3), and zinc supplementation reduces intestinal permeability, which in turn is associated with reduced rate of relapse of Crohn’s disease activity (p.2002 col right – para 1). In addition, Zyba teaches administering to subjects 2 sachets with each comprises 588 FTU phytase per day, split between 2 separate meal times (p.1467 col left – para 2), and the administration of phytase demonstrates that the inclusion of phytase increases absorption of zinc (p.1471 col left – last para, col right – first para).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate zinc in combination with phytase, since Pangborn discloses methods for treating Crohn’s disease comprises phytase, Ananthakrishnan discloses that zinc intake is inversely associated with risk of Crohn’s disease, Pangborn and Zyba both disclose that phytase increases absorption of zinc. In addition, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize medication regimen, e.g., daily dosage and schedule of phytase, since Pangborn discloses that phytase is preferably added to a composition for treating Crohn’s disease for its ability to digest phytic acid thus results in greater bioavailability of minerals such as zinc, and that the preferred dosage varies with the size of the meal and/or the body weight of the patient. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references to administer an optimized amount of zinc in combination with an optimized amount of phytase for desired treatment duration based on the size of the meal and/or the body weight of a patient, with a reasonable expectation for successfully treating Crohn’s disease.
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Pangborn et al (US 2008/0112944 A1; 5/15/2008.) in view of Ananthakrishnan et al (International Journal of Epidemiology. 2015;44(6):1995-2005.) and Zyba et al (Am J Clin Nutr. 2019;110:1465-1475.) as applied to claims 1-4, 75-76, 79, and 109-113 above, further in view of myDr (https://mydr.com.au/medicine/when-to-take-your-medicine/. 2020;1-3.).
References cited above do not teach the phytase is administered in proximity to beginning of meal (claim 73).
myDr teaches that as a general rule medicine is taken one hour before eating or 2 hours after (p.1 para 3).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to administer phytase in proximity to beginning of meal, since myDr discloses that as a general rule medicine is taken one hour before eating or 2 hours after. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to administer phytase in proximity to beginning of meal with a reasonable expectation for successfully treating Crohn’s disease.
Response to Arguments
Applicant argues that para. [0039] of the specification as filed recites that "proximity to the beginning of a meal" may be "for example, from about 60 minutes prior to beginning a meal to about 180 minutes after beginning a meal".
These arguments are not found persuasive because the term “in proximity to beginning of meal” is not clearly defined in the instant specification. It is noted that the features upon which applicant relies (examples in the instant specification) are not definition and are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims.
Applicant argues that Pangborn does not: disclose any phytase dose in FTU/day; describe phytase as an active agent for treating Crohn's disease; or provide any teaching that phytase administration (as opposed to other enzymes or dietary management) has a therapeutic effect on Crohn's disease.
These arguments are not found persuasive because Pangborn does teach compositions and methods for treating disorders including Crohn’s disease (para 0012), wherein said compositions comprise additional components believed to be beneficial in the treatment of said disorders, preferably such components include phytase (para 0014). Phytase is preferably added for its ability to digest phytic acid, the inclusion of phytase results in greater bioavailability of minerals (para 0030). In addition, Ananthakrishnan teaches that intake of zinc is associated with a reduced risk of Crohn’s disease (p.2002 col left – para 2, p.2003 col right – para 2), and that zinc supplementation reduces intestinal permeability, which in turn is associated with reduced rate of relapse of Crohn’s disease activity (p.2002 col right – para 1). Finally, Zyba teaches administering to subjects 2 sachets with each comprises 588 FTU phytase per day, split between 2 separate meal times (p.1467 col left – para 2), and the administration of phytase demonstrates that the inclusion of phytase increases absorption of zinc (p.1471 col left – last para, col right – first para). Thus, it would have been obvious to one of ordinary skill in the art to optimize medication regimen – daily dosage and schedule of phytase, as evidenced by the combined teachings of Pangborn, Ananthakrishnan and Zyba.
Applicant argues that Ananthakrishnan (dietary zinc association) does not supply the missing teaching of Pangborn.
These arguments are not found persuasive because Ananthakrishnan is relied upon to demonstrate the administration of zinc.
Applicant argues that Zyba is in a different context (pediatric nutrition/absorption) and does not teach phytase as a Crohn's disease treatment or provide a reasonable expectation of success.
These arguments are not found persuasive because Zyba is relied upon to provide a motivation for optimizing daily dosage and schedule of phytase administration.
Conclusion
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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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