DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/17/25 was received in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-11 and 16-20 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Pathak et al (US 2009/0011027 A1 hereafter Pathak).
Pathak teaches a suspension formulated using the 10mg hydrocodone bitartarate polistirex (lon Exchange resin Drug complex) and 500mg Acetaminophen [0073]. The hydrocodone resin conjugate is coated with sustained release coating material (Ethyl cellulose) [0073]. The suspension was prepared using xanthan gum as the suspending agent along with color, flavor, parabens (e.g., methylparaben abd propylparaben)(preservatives), high fructose corn syrup (viscosity builder and sweetener), propylene glycol (solvent and dispersing agent), and ascorbic acid (to adjust the pH of the suspension) [0074]. The hydrocodone bitartarate was conjugated with IRP 69 resin (porous copolymer of methacrylic acid and divinylbenxene) [0074].These disclosures render the claims anticipated.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim s 1-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over the combined disclosures of Pathak et al (US 2009/0011027 A1 hereafter Pathak) in view of Soscia eta l (US 2008/0075669 A1 hereafter Soscia).
As discussed above, Pathak discloses a sustained release composition comprising a plurality of sustained release beads comprising coated drug-resin complexes comprising a drug-resin complex and a release modifier coating. The reference is silent however to a specific disclosure where the populations of coated beads have different coating levels. The coating levels difference are known in the art as seen in the Soscia patent.
Soscia discloses a drug resin complex and a release modifying coating [abstract, 0043, 0046]. The drug resin includes at least a cationic or anionic exchange resin [0050-0051]. The active agents can include hydrocodone or codeine [0037]. The exchange resin is a polystyrene sulfonate resin [0051]. The drug : resin ratio in the drug-resin complex is 1:4 [Example 1]. The coatings, specifically pH dependent coatings are applied to the drug-resin complexes [Example 7]. These coatings can be applied in different populations at different concentration [Fig 11]. The coating can be ethyl cellulose [Fig 11]. The concentrations of one population 53.8% with another population with a coating of 69.6% [Fig. 11]. The different populations provide controlled release [Table 2]. It would have been obvious to include these similar components as they solve the same problem.
With these aspects in mind, it would have been obvious to combine the prior art with expected result of a stable drug composition. It would have been obvious to include different populations and coating levels of Soscia into the formulation of Pathak as they are made of the same materials and solve the same problem of controlled release of abuse potential drugs. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of stable drug formulation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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