DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after August 25, 2022, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention filed on 08/25/2022 in the matter of Application N° 17/802,510. Said documents are entered on the record. The Examiner further acknowledges the following:
Thus, claims 1, 4-6, 8-10, 12-17, and 19-24, represent all claims currently under consideration. Claims 1, 6, 10, and 17, are currently amended. Claims 2-3, 7, 11 and 18 is cancelled. New claims 22-24 are added.
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.
Claims 1, 4-6, 8-10, 12-17, and 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ikuta et al. (JP2000191516A).
Regarding claims 1, 6, 10, 15, 17, and 24, Ikuta et al. disclose wherein the coating film consisting of a metal oxide involves yellow iron sesquioxide, and iron sesquioxide. Based on 1% of the drug’s weight, the preparation contains at least 0.0001% of the colorant ingredient. It is preferably 0.001% by weight or more. It can be accurately determined within a range often utilized in formulation, and it is especially preferable to be 0.001% by weight or greater (See paragraph 0006 and 0007). A powder containing a photolabile medication is wet granulated with a coloring agent-containing binder to create an oral solid composition. A powder containing a medication that is unstable to light and wet-granulating is combined with a coloring ingredient to create an oral solid composition (See claims 1 and 2). When the coloring agent is added to the binding liquid during the granulation process, the surface of the “powder including a photo-unstable drug” is coated with yellow iron sesquioxide (metal oxide). To approximate the numerical range specified in the invention, a person skilled in the art might simply think of consulting the previously described disclosure and adjusting the amounts of yellow iron sesquioxide as necessary.
Regarding claims 4, 8, 12, 19, 22, and 23, Ikuta et al. teach wherein the metal oxide is yellow iron sesquioxide, and iron sesquioxide (See paragraph 0007). Iron sesquioxide means an oxide of iron with the formula Fe2O3. Fe2O3 is the chemical formula for iron(III) oxide. Therefore, iron sesquioxide = iron oxide (specifically iron(III) oxide). Ikuta et al. also teach how to use a specific coloring agent or add a colorant and titanium oxide to a binder solution during granulation and/or to a powder containing a light-unstable drug to perform wet granulation, or how to mix a colorant or titanium oxide into a powder containing a light-unstable drug to prevent a color change of the drug in the formulation due to light, prevent a decrease in the content, improve light stability, and further coat (See paragraph 0005).
Regarding claims 5, 9,14, and 21, claim 5 states that “coating is performed by sputtering,” yet this description just reveals how “coated bulk drug substance particles” are made, which is identical to the invention described in Ikuta et al. in that yellow iron sesquioxide or iron sesquioxide (metal oxide) is applied to the surface of a powdered (drug substance) photo-unstable drug. As a result, the phrase in question does not make a significant difference.
Regarding claims 13, 16, and 20, Ikuta et al. teach wherein different formulation techniques have been described to stabilize drugs that are unstable to light. A tablet stabilized by coating a photolabile bromocriptine mesylate with a coating agent comprising a coloring agent is described in Japanese patent application Laid-Open No. 4346929 (See paragraph 0002). But when it comes to tablets, there are more coating stages, which means more work and time are needed. The current invention’s oral solid formulation works well even in tablets (See paragraph 0003 and 0012).
It would have been obvious to one of ordinary skill in the art before the effective filing date that one would have understood that reciting sputtering merely specifies a method of forming the coating and does not result in a structurally or functionally distinct coated bulk drug substance particle. Since Ikuta et al. disclose applying iron sesquioxide to the surface of powdered, photo-unstable drug substances, the additional process limitation does not impart a significant difference.
Response to Arguments
Applicant's arguments filed 01/09/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). (i.e., Applicant contends that the amended claims are allowable over the prior art. The examiner disagrees. These features were not previously claimed and have now been considered and rejected above in view of Ikuta et al. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Barber whose telephone number is (703) 756-5302. The examiner can normally be reached on Monday through Friday from 6:30 AM to 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615