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 .
Claim Interpretation
It is to be noted that as stated in present specification (see the 2nd paragraph on pg.44), a “low viscosity” HPMC (of claim 1) means HPMC having Mw less than or equal to 50,000 Daltons and a “high viscosity” HPMC (of claim 1) means HPMC having Mw greater than 50,000 Daltons.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The pre-amble of instant claim 1 recites “[a] method of preventing and/or treating pruritus in a patient in need thereof”. Also, at the end of claim 1, applicant recite “wherein pruritus is prevented and/or treated in the patient.” For the reasons explained below, present specification is not enabling for preventing or treating pruritus using instant oral drug delivery system comprising colesevelam:
Citing In re Wands, 858 F.2d 731, 737 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), MPEP 2164.01(a) sets out the following factors to consider when determining whether a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The nature of the invention: The claim is drawn to a method of preventing and/or treating pruritus in a patient in need thereof using an oral drug delivery system comprising colesevelam (as the active agent).
The breadth of the claims: in claim 1, applicant claim a method of preventing and/or treating pruritus in a patient in need thereof by using instant oral drug delivery system (as described in claim 1) comprising colesevelam as the active agent. Applicant also claim (on the last line of claim 1) that pruritus is prevented and/or treated in the patient. Additionally, “prevention” is defined (as obtained from the webpage https://medical-dictionary.thefreedictionary.com/prevention ) as the keeping of something (such as an illness or injury) from happening. Under the broadest reasonable interpretation, the term “prevention” includes any measure taken prior to the onset or occurrence of a disease or condition which precludes its coming into existence in all cases. Thus, preventing pruritus in a patient even before it happens renders the scope of instant claims unreasonably broad.
The state of the prior art: Although colesevelam was explored for the treatment for cholestatic pruritus because it is a bile acid sequestrant, clinical trials showed that it was no better than a placebo at reducing itch intensity in cholestatic pruritus (see Kuiper et al (“The Potent Bile Acid Sequestrant Colesevelam Is Not Effective in Cholestatic Pruritus: Results of a Double-Blind, Randomized, Placebo-Controlled Trial”, Hepatology, vol.52(4) (2010), pg.1334-1340). Furthermore, there is no established prior art on the prevention of pruritus.
The level of one of ordinary skill: A person with an advanced medical, pharmacological or dermatological training.
The level of predictability in the art: Kuiper’s clinical trials appear to be the only study done on the effectiveness of colesevelam in treating pruritus. Thus, the level of predictability is low. Additionally, “preventing” a disease or a condition from happening cannot be achieved generally. While the risk factors for developing pruritus are known, there is no definitive method for determining if a patient will develop pruritus prior to the initial onset or occurrence (this is distinguished from preventing the relapse or recurrence of the condition).
The amount of direction provided by the inventor: While applicant provide in present specification ample information about the disease itself and also teach how to manufacture their inventive oral drug delivery system comprising colesevelam, there is no working example (or any other evidence) provided in present specification, which makes the therapeutic effect of colesevelam in preventing and/or treating pruritus reasonably predictable.
The quantity of experimentation needed to make or use the invention: Since little is known in the prior art about the therapeutic effect of colesevelam in preventing and/or treating pruritus (and also since “preventing” pruritus cannot be achieved with any certainty) and the art is thus unpredictable, present specification would need more detail as to how to make and use the invention in order to be enabling.
In conclusion, analysis of the preceding Wands factors supports the conclusion that one of ordinary skill in the art would not be able to make and use the claimed invention without exercising undue experimentation; therefore, the claimed invention is not enabled.
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 8 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation "the one or more additional antipruritic agents" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Instant rejection can be overcome by changing the claim dependency of instant claim 8 from “claim 1” to --- claim 7 ---.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
August 8, 2026
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