DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant elected Invention I, without traverse, in the reply filed on 7/31/2026. With the cancelation of claims 136-146 (Inventions II-III) and addition of claims 147-153, claims 127-135 and 147-153 are pending and have been examined on the merits.
Priority
Th instant application is a continuation of Application No. 17/742753 (filed on 5/12/2022), which is a continuation of Application No. 16/422462 (filed on 5/24/2019), which in turn is a continuation of Application No. 13/836135 (filed on 3/15/2013). The latter application claims priority benefit of U.S. Provisional Application No. 61/653253 (filed on 5/30/2012) under 35 U.S.C. 119(e).
Information Disclosure Statement
The information disclosure statements (IDSs) filed on 11/06/2024 and 7/31/2026 comply with the provisions of 37 C.F.R. 1.97. All references cited in these IDSs have been fully considered.
Claim Objections
Claim 130 is objected to due to the following informalities: (i) the conjunction “and/or” in line 8 should be absent because “unexplained weight loss” is listed in the middle of a closed group of gastrointestinal symptoms (a closed group of alternatives should only use the conjunction “and” before the last limitation); (ii) unnecessary conjunction (“and”) before “irritable and fussy behavior in children” in line 11; (iii) lack of space after “skin” and before the open parenthesis symbol in line 14; and (iv) capitalization of the first word in the common noun “Vitamin B12 deficiency” in line 13 (“Vitamin” is not a proper noun and should therefore be in lowercase).
It is also recommended that the phrase “stools that float, are foul smelling, bloody, or “fatty”” in lines 7-8 of claim 130 be amended to “floating stool, foul smelling stool, bloody stool, fatty stool”.
Claim 132 is objected to because “the pharmaceutical composition comprises the protease” is needless as the parent claim already requires the pharmaceutical composition to comprise a protease. Thus, applicant should delete “the pharmaceutical composition comprises the protease, and”.
Appropriate corrections are required.
Claim Interpretation
Claim 130 recites “diarrhea which may be protracted or intermittent” in line 5. The phrase “which may be protracted or intermittent” is interpreted to mean the limitation is not required (i.e., diarrhea is not limited to being protracted or intermittent).
Similarly, the phrase “may also be increased or unchanged” after “decreased appetite” in line 6, the phrase “which may be protracted” after “malaise” in line 9, and the phrase “especially in the extremities and the head” after “tingling or numbness” in line 10 of claim 130 are each considered optional.
The term “sprinkles” in claims 149-150 is interpreted to refer to any formulation that can be scattered over a surface and includes small particles like powder, granules, and pellets.
Claim Rejections - 35 USC § 112
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 130 is rejected under 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 applicant regards as the invention.
Claim 130 recites “immunological or hormonal symptoms” followed by the phrase “and include, but are not limited to”. It is unclear what limitation(s) are part of immunological or hormonal symptoms (i.e., does said phrase encompass “bruising easily” only, or does it also include “hair loss” and other subsequent limitations?). In the interest of compact prosecution, the phrase is interpreted to only refer to “bruising easily” and is deemed optional.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 127-135 and 149-153 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Ortenzi et al. (Pub. No. US 2009/0117180 A1).
Ortenzi et al. discloses a composition comprising at least one digestive enzyme, as well as methods of preparing and using said composition (Abstract; par. [0017]-[0018]). Suitable digestive enzymes include lipases, amylases, proteases, and mixtures thereof like pancrelipase/pancreatin (par. [0020]-[0022], [0030], [0071]).
The method of use is directed to treating or preventing a disorder associated with digestive enzyme deficiency comprising administering the disclosed composition to a mammal in need thereof (par. [0017], [0086]). Disorders being treated include conditions in which the patient has no or low levels of digestive enzymes or in which patients require digestive enzyme supplementation like malabsorption associated with celiac disease (par. [0088]).
Ortenzi et al. reads on the instant application’s method as follows:
Regarding claim 127: administering the composition comprising at least one digestive enzyme to a mammal in need thereof (par. [0017], [0086]), wherein the composition can be provided as a pharmaceutical composition containing one or more pharmaceutically acceptable excipients (claims 1-2; par. [0051]) and in an amount depending on the intended result like treatment of a disorder associated with a digestive enzyme deficiency (par. [0087]-[0089]), is equivalent to the step “administering to the subject a therapeutically effective amount of a pharmaceutical composition”.
The at least one digestive enzyme being a mixture of enzymes or pancreatic extract having enzymatic activity such as pancrelipase/pancreatin, which comprises amylase, lipase, and protease (par. [0021]-[0022], [0030]), meets the requirement that the pharmaceutical composition “comprises digestive enzymes, wherein the digestive enzymes comprise a protease, an amylase, and a lipase”.
The method being directed to treating a digestive enzyme deficiency like malabsorption associated with celiac disease (par. [0088]) fulfills the claimed invention’s intended function of “treating the malabsorption of nutrients due to celiac disease in a subject”.
Hence, claim 127 is anticipated by Ortenzi et al..
Regarding claim 128: the embodiment of the composition being formulated as particles coated with an enteric coating (par. [0058], [0062], [0071]) satisfies “wherein the pharmaceutical composition further comprises an enteric coating or a lipid coating”.
Regarding claim 129: working examples demonstrate that administering pancrelipase/pancreatin significantly lessens malabsorption symptoms at the end of the treatment period (par. [0142], [0144]), thereby meeting “wherein the pharmaceutical composition is administered until a gastrointestinal symptom resulting from malabsorption of nutrients due to celiac disease is partially or completely resolved”.
Regarding claim 130: examples of malabsorption symptoms treated by at least one digestive enzyme like pancrelipase/pancreatin include decreased bloating, flatulence, pain, and fat in stools (par. [0142]), which correspond to “wherein the gastrointestinal symptom is selected from a group consisting of… bloating, gas or indigestion… stools that float, are foul smelling, bloody, or "fatty"…”.
Regarding claim 131: the disclosed composition being formulated in an oral dosage form such as tablet or particles coated with an enteric coating (par. [0058]) suggests administering it orally to the subject, thus satisfying “wherein the pharmaceutical composition is administered to the subject orally”.
Regarding claim 132: the embodiment of the at least one digestive enzyme being a porcine pancreatic extract comprising proteases such as trypsin and chymotrypsin (par. [0020]-[0022], [0030]) meets “wherein the pharmaceutical composition comprises the protease, and the protease comprises a chymotrypsin, a trypsin, a papain, or a combination thereof”.
Regarding claim 133: pancrelipase/pancreatin is identical to “wherein the digestive enzymes are provided as pancreatin”.
Regarding claim 134: Ortenzi et al. provides example formulations having various protease to lipase ratios such as 1.8-6.2 and 2.0-8.2 (“Formulation 1” and “Formulation 4” in Table A, page 3), which reads on “wherein a total amount of protease and a total amount of lipase in the pharmaceutical composition in U.S.P. units are present in a ratio of protease to lipase of from 1:1 to 20:1 or from 4:1 to 10:1”.
Regarding claim 135: the prior art also teaches example dosage forms containing different dosages of pancrelipase/pancreatin per capsule such as 5,000 USP units and 20,000 USP units (“Composition 1” and “Composition 4” in Table 34, page 16), which reads on “wherein a total amount of the amylase in the pharmaceutical composition is from about 1,000 to about 15,000,000; from about 5,000 to about 1,000,000; from about 15,000 to about 750,000…”.
Regarding claim 149: the disclosed composition being an oral dosage form including tablets, capsules, particles coated with an enteric coating, controlled release capsules, and sachets (par. [0014]-[0015], [0058]-[0062]; claim 14) fulfills “wherein the pharmaceutical composition is formulated as a dosage formulation selected from the group consisting of pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, suppository and a combination thereof”.
Regarding claim 150: Ortenzi et al.’s teaching that the disclosed composition can be formulated as powder, micropellet, pellet, and sachet meets “wherein the pharmaceutical composition is formulated as a sprinkle”. As set forth above (see Claim Interpretation), the term “sprinkles” is interpreted to refer to any formulation that can be scattered over a surface and includes small particles like powder, granules, and pellets.
Regarding claims 151-153: oral dosage forms of the disclosed composition can comprise about 8,000-134,000 IU protease (par. [0031]) such as example Formulation 1 which contains 8,000-34,000 IU protease (Table A, page 3) and satisfies limitations “wherein a total amount of protease in the pharmaceutical composition ranges from about 5,000 to about 1,500,000 U.S.P. units/dose”, “…from about 1,000 to about 15,000,000 U.S.P. units/dose”, and “from about 1,500 to about 282,000 U.S.P. units/dose”, respectively.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 127-135 and 147-153 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ortenzi et al. (Pub. No. US 2009/0117180 A1) in view of Fallon et al. (Pub. No. US 2010/0260857 A1).
The teachings of Ortenzi et al. are set forth above and applied herein. Ortenzi et al. is found to anticipate claims 127-135 and 149-153.
Ortenzi et al. is comparable to the claims below:
Regarding claim 147: the pharmaceutical composition of claim 128 is additionally specified to comprise “lipid coating and the lipid coating comprises a soy oil”.
Ortenzi et al. is different from the instant claim in that it only teaches preparing the disclosed composition with an enteric coating.
According to Fallon et al., digestive enzymes are prone to rapid degradation and denaturing at ambient temperature, which get accelerated when exposed to high temperature, pressure, humidity, and light. Denaturation or destabilization can reduce the effectiveness of digestive enzymes. To address this problem and provide protection from unfavorable conditions, Fallon et al. teaches coating pancreatic/digestive enzymes with an emulsifiable lipid to produce lipid-coated enzyme compositions with improved shelf life (par. [0043], [0046]). The lipid coating also allows for controlled release of pancreatic/digestive enzymes in the gastrointestinal system (par. [0052]). The emulsifiable lipid is obtained from animal or vegetable, preferably a food grade emulsifiable lipid such as hydrogenated soy oil (par. [0018], [0095]).
A person with ordinary skill in the art at the time of invention would have been motivated by Fallon et al.’s teachings to modify Ortenzi et al.’s composition by coating the at least one digestive enzyme like pancrelipase/pancreatin with an emulsifiable lipid like hydrogenated soy oil. Such modification would provide several benefits including protection from denaturation and degradation, as well as controlled release of enzymes in the gastrointestinal tract. This is expected to ensure accurate dosing would be given to the mammal being treated. Obviousness is based on the rationale that some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Claim 147 is therefore obvious over Ortenzi et al. in view of Fallon et al..
Regarding claim 148: the soy oil in claim 147 is further defined as comprising “a hydrogenated soy oil”, which is fulfilled by Fallon et al.’s use of an emulsifiable lipid like hydrogenated soy oil as a coating.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
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