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 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 4 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 4 contains the trademark/trade name “Eudragit® E”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an animo methacrylate copolymer and, accordingly, the identification/description is indefinite.
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 10-19, 21, and 22 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Singh et al (US 2017/0049774).
With regards to claim 1, Singh et al discloses an osmotic agent comprising a core layer comprising a core of tofacitinib citrate, lactose as an osmogene, and hydroxypropyl methyl cellulose as a polymer, and a coating comprising cellulose acetate as the semipermeable membrane with Eudragit E PO as the corresponding acid-sensitive polymer (abstract, ¶¶ 54, 58, 64-66, examples 1(a) and 1(f), and claim 13).
With regards to claims 2 and 6, Example 1 includes citric acid as the organic acid.
With regards to claims 3 and 4, Eudragit E PO is used in Example 1.
With regards to claim 5, the Eudragit E PO is 5.71mg of the about 25mg coatings.
With regards to claim 10, cellulose acetate is used in Example 1.
With regard to claim 11, the cellulose acetate is 9.60mg of the about 25mg coatings.
With regards to claims 12 and 13, lactose (a sugar) and sodium chloride (a water soluble salt) are used in Example 1.
With regards to claim 14, 152.24mg of lactose and 50.1mg sodium chloride are present in the 200mg tablets.
With regards to claim 15, hydroxypropyl methylcellulose (hypomellose) is used in Example 1.
With regards to claim 21, tofacitinib is the active of Example 1.
With regards to claims 16 and 17, Example 1(a) include sodium lauryl sulfate.
With regards to claim 18, Example 1(a) includes polyethylene glycol.
With regards to claim 19, Example 1(a) includes magnesium stearate, a glidant (¶ 62).
With regards to claim 22, where the Examples have laser etched holes, it is expected that the micropores would not be visually identifiable where laser etched holes are expected to be microscopic sized.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7-9, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (US 2017/0049774).
Singh et al is discussed above, but does not disclose the instantly claimed ratios or release profiles.
With regards to claim 7, while the reference does not specially teach the ratio of organic acid to acid sensitive polymer, it does teach that the acidifying agents create an acidic microenvironment when solubilizing the drug (¶ 59). Thus, it would be obvious to vary the amount of organic acid based on the active used and the solubility needs of the tablet. That would then relate directly to the acid sensitive polymer and the release rate, which would be optimized based on the desired pharmacokinetics.
With regard to claims 8 and 9, the sustained release for the prior art table include requires, such as not more than 30% of the tofacitinib is release in 1 hour, and between 35% and 75% of tofacitinib is released in 2.5 hours (claims 5-7). Thus, it would have been obvious to adjust the release profile within the range required by the prior art.
With regards to claim 20, the reference does not specifically teach the thickness of the coating layers. But it would have been obvious to optimize the thickness of the coating layers based on the desired pharmacokinetics where the coating is used to control the release.
With regards to claim 22, while is reasonably expected that the laser drilled holes are not visually identifiable, the reference provides motivation to reduce the size where the purpose is to create a semipermeable coating where water readily diffuses through the means of the membrane, but solutes dissolved in water cannot readily diffuse with the osmotic pressure pushing the drug through openings (¶ 64). As such, the holes need to be slightly larger than a water molecule, but smaller than the active agent to be administered.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri (9am-6pm + mid-day flex).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
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