DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/09/2023 has been considered by the examiner.
Status of the Claims
The response and amendment filed 10/08/2025 is acknowledged.
Claims 1-18 and 20-21 are pending.
Applicant’s election without traverse of Group II, claims 10-15 in the reply filed on 10/08/2025 is acknowledged.
Claims 1-9, 16-18, and 20-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/08/2025.
Claims 10-15 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
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 12 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 pre-AIA the applicant regards as the invention.
Claim 12 includes the limitation “and or other similar excipients with similar functions to the disintegrant.” This renders the claim indefinite because it is not clear which excipients would meet the limitations of the claim. Further, the limitation is redundant with the term “disintegrant” recited in claim 11. The skilled artisan cannot reasonably understand the metes and bounds for which applicant is claiming protection. This rejection may be overcome by deleting the phrase.
Clarification is required.
Claim 14 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 pre-AIA the applicant regards as the invention.
Claim 14 includes the limitation “and or other similar excipients with similar functions to the binder.” This renders the claim indefinite because it is not clear which excipients would meet the limitations of the claim. Further, the limitation is redundant with the term “binder” recited in claim 13. The skilled artisan cannot reasonably understand the metes and bounds for which applicant is claiming protection. This rejection may be overcome by deleting the phrase.
Clarification is required.
Claim Rejections - 35 USC § 102
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 10-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johannesson, International Journal of Pharmaceutics, 597, 2021 (cited previously).
Johannesson teaches a 3d printed 8-layer tablet having a height of 3 mm (Johannesson, e.g., pg. 4, 2.8), i.e., an oral dosage tablet for hydrophobic active ingredients wherein each layer has a thickness of 0.375 mm. The layers are hydrophobic, e.g., comprising layers of lipid-based formulation LBF (Johannesson, e.g., abstract). The dosage form comprises a hydrophobic active agent and lipids, i.e., poorly water-soluble drug (Johannesson, e.g., pg. 2, c1, ¶ 2), e.g., fenofibrate (Johannesson, e.g., pg. 2, c1, ¶ 2). The dosage form, therefore, contains a plurality of lipid layers and a plurality of active ingredient layers comprising a hydrophobic active ingredient wherein each layer is within the claimed range recited in claims 10 and 15.
Applicable to claims 11-12: Johannesson teaches layers including a disintegrant, e.g., crosscarmellose sodium (Ac-Di-Sol). See Johannesson, e.g., pg. 2, 2.1 Materials, and pg. 4, 2.6 Preparation of emulsion gels. Crosscarmellose sodium meets the limitation of or other similar excipients with similar functions to the disintegrant.
Applicable to claims 13-14: Johannesson teaches the layers comprising a binder, e.g., methyl cellulose. See Johannesson, e.g., pg. 2, 2.1 Materials, and pg. 4, 2.6 Preparation of emulsion gels. Methyl cellulose meets the limitation of or other similar excipients with similar functions to the binder.
Johannesson anticipates the subject matter of instant claims 10-15.
Claims 10-15 are rejected under 35 U.S.C. 35 U.S.C. 102(a)(2) as being anticipated by Ouwerkerk, WO 2022086330 A1.
Ouwerkerk teaches tablets which are preferred for ease of administration and increased patient compliance (Ouwerkerk, e.g., pg. 3:22-27, Fig. 2, and pg. 14). The tablets comprise a plurality of layers (Ouwerkerk, entire document, e.g., pg. 11:7-15 and pg. 14:23-pg. 15:27, and pg. 18:27-pg. 19:17, and examples, e.g., pg. 21:5-10, seven layers). Layers comprise a lipid (Ouwerkerk, entire document, e.g., pg. 5:18-pg. 8:25). The API may be omitted from some or all layers for placebo effect or to retard dissolution of drug containing layers (Ouwerkerk, e.g., pg. 9:16-29 and pg. 14:23 – pg. 15:10). Ouwerkerk teaches formulating poorly-water soluble drugs, i.e., hydrophobic (Ouwerkerk, e.g., pg. 8:26-9:3, and pg. 10:9-21). Applicable to claims 10 and 15: Layers having a thickness ranging from 0.30-0.60 mm (Ouwerkerk, entire document, e.g., pg. 15:19-27). This range is entirely within the claimed ranges.
Applicable to claims 11 and 12: Ouwerkerk teaches drug containing layers further comprising a disintegrant, e.g., sodium starch glycolate (Ouwerkerk, e.g., pg. 12:13-29).
Applicable to claim 13-14: Ouwerkerk teaches the drug containing layer comprising a lipid, e.g., GELUCIRE 48/16, and/or plasticizer, e.g., polysorbate 80, which meet the limitation of a binder since the excipients physically make up the layer in which the drug is dispersed.
Ouwerkerk anticipates the subject matter of instant claims 10-15.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Alhnan, US 20190125681 A1 teaches the disintegrant PRIMOJEL, aka, sodium starch glycolate was a known disintegrant alternative for croscarmellose sodium (Alhnan, e.g., 00427 and 0686 and Table 17). Alhnan further teaches polyvinyl pyrrolidone (PVP) was a known binder alternative for cellulose derivatives (Alhnan, e.g., 0427). Further, Alhnan teaches the inclusion of PVP in drug containing layers was a technique known for facilitating drug dissolution (Alhnan, e.g., 0407, example 7, e.g., 0713 and 0730).
Kaiserman, WO 2021045753 A1 teaches formulating printed tablets wherein drug layers are combined with support layers, e.g., hydrophobic layers (Kaiserman, entire document, e.g., Figs. and 0051-0052). The claimed layer thickness is within/overlapping with the range suggested by Kaiserman, e.g., 0060 where 1 mil = 0.0254 mm. Thus, 2 microns to 15 mils is 0.002 mm to 0.381 mm.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615