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 .
Status of Claims
Claims 31-37 and 39-52 are pending and currently under examination. Claim 38 is canceled. Claims 51-52 are newly added. Claims 31-37 and 39-43 are amended.
Claims 44-46 are withdrawn as being directed to a non-elected species of a multi-layered structure with top surface areas that increase sequentially from the surface to the interior. Claims 47-50 are withdrawn as being directed to a non-elected species of a multi-layered structure with top surface areas that differ between the first and third layer and the second layer, i.e., do not decrease sequentially, from the surface to the interior. Thus, claims 44-50 are withdrawn, there being no linking or generic claim.
Claims 31-37, 39-43 and 51-52 are examined on their merits to the extent of the elected species.
Previous Rejections
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Rejections Withdrawn
Claim Rejections - 35 USC § 112(a)
In light of the amendments to the claims the rejection of claims 31-37 and 39-43 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention is withdrawn.
Claim Rejections - 35 USC § 103
In light of the amendments to the claims the rejection of claims 31-37 and 39-43 under pre-AIA 35 U.S.C. 103 as being unpatentable over Goole, J. et al. (2016, e-pub, January 3, 2016) “3-D Printing in Pharmaceutics: A New Tool For Designing Customized Drug Delivery Systems, “ Int. J. Pharm. 499:376-394 (5/5/2021 IDS) in view of Beyer et al. WO 2014/197999 (12/18/2014), Appel et al. EE 200300055 (12/15/2004) and Khan et al. A Novel Multilayered Multidisk Oral Tablet for Chronotherapeutic Drug Delivery, Biomed Res. Int 2013 Aug 20, 2013 is withdrawn.
New Rejections
Claim Rejections - 35 USC § 112(a)
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 31-37, 39-43 and 51-52 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 written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The response filed 7/8/2026 added amendments to claim 31 with limitations that introduce NEW MATTER into the claims. The limitation “the first layer will be exposed to the bodily fluid via the substantially planar top surface of the first layer prior to the second layer being exposed to the bodily fluid via the substantially planar top surface of the second layer” does not have clear support in the specification and claims as originally filed. There is no disclosure of the first layer being exposed to the bodily fluid via the substantially planar top surface of the first layer in the specification or originally filed claims. There is also no disclosure of the second layer being exposed to the bodily fluid via the substantially planar top surface of the second layer in the specification or originally filed claims.
Specifically, nowhere in the specification is the exposure to bodily fluid via the substantially planar top surface of the first layer concept recited or explained. Exposure to bodily fluid is mentioned and the release of a drug is also mentioned in paragraphs [0030], [179], [191], [207], [251], [285], but there is no discussion of exposure to bodily fluid via the substantially planar top surface of the first layer or exposure to bodily fluid via the substantially planar top surface of the second layer.
There is also no discussion of the interaction of the bodily fluid with the substantially planar top surface of either the first layer or second layer. While paragraph [0145] does teach that the surface of a layer of first erodible material admixed with a drug is planar, there is no discussion or mention that the exposure to bodily fluid occurs via the substantially planar top surface of the first layer.
Applicant has not pointed to any disclosure that provides either explicit or implicit support for the phrase ‘exposure to bodily fluid via the substantially planar top surface of the first layer” or exposure to bodily fluid via the substantially planar top surface of the second layer’, nor has applicant pointed to any disclosure that reasonable conveys to those skilled in the art that applicant was in possession of the dosage form in which there is exposure to bodily fluid via the substantially planar top surface of the first layer or second layer. Thus, one skilled in the art would not understand that applicant was not in possession of the currently claimed invention.
Obviousness is not the standard for the addition of new limitations to the disclosure as filed. It is noted that entitlement to a filing date does not extend to subject matter, which is not disclosed, but would be obvious over what is expressly disclosed. Lockwood v. American Airlines Inc., 41 USPQ2d 1961 (Fed. Cir. 1977).
Claim 31 recites limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in claim 31, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in present claim 31 in the specification or claims, as-filed, or remove these limitations from the claim in response to this Office Action.
Claims 32-37, 39-43 and 51-52 are rejected as depending from a rejected claim.
Claim Rejections - 35 USC §112(b)
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.
Claims 31-37, 39-43 and 51-52 are 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 31 is rejected under 35 USC 112(b) for reciting “desired release profile” in lines 1-2.
The phrase “desired release profile” in claim 31 is a relative term which renders the claim indefinite. The phrase “desired release profile” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One skilled in the art, therefore, would not be reasonably apprised of the metes and bounds of the claims.
For the purposes of this office action claim 31 will be interpreted to mean release profile.
Claims 32-37, 39-43 and 51-52 are rejected as depending from a rejected claim.
Response to Arguments
Applicants’ arguments of July 8, 2026 have been fully considered and are found to be sufficiently persuasive in light of the amendments to the claims.
Applicants note the amendments to claim 31, point out where support can be found for the amendments and request the withdrawal of the 112(a) rejection.
Response
The 112(a) rejection is withdrawn above.
With respect to the obviousness rejection Applicants argue that the cited references, taken alone or together, do not teach or suggest the dosage form of the amended claims.
Goole does not teach a multi-layered dosage form comprising a multi-layered structure comprising a plurality of layers, wherein each of the layers has the same drug mass fraction (mF). Applicants note that Goole’s layers in Figure 6 which shows a multi-layered structure for providing a linear drug release profile which requires different drug mass fractions. Nothing in Goole teaches a different multi-layered structure or a multi-layered structure wherein each layer has the same drug mass fraction and is configured to release the drug from a substantially planar top surface.
Applicants argue that the multi-layered structure of Goole is very different than the instant claims. The processes taught in Goole would not have led a skilled artisan to the specific structure of the drug dosage form structures such as the substantially planar surfaces recited in the claims.
Applicants argue that the teachings of Beyer do not remedy the differences between Goole’s multi-layered structure and the claimed invention. Applicants assert that Beyer does not teach about erodible materials and is silent about printing drug dosage forms, so one of ordinary skill would not have been led to apply the teachings of Beyer to modify the drug dosage forms of Goole to arrive at the subject matter of the instant claims.
Khan does not teach or suggest sequential, directional erosion through a plurality of layers with sequentially decreasing surface area of the planar top surface. Rather, an ordinarily skilled artisan would appreciate from Khan that in its dosage form, drug release starts from and occurs at all surfaces of the drug loaded disks after the protecting barrier layers surrounding them erode away.
Response
Applicants’ arguments are found to be persuasive in light of the amendments to the claims, particularly that the prior art does not teach sequential, directional erosion through a plurality of layers with sequentially decreasing surface area of the planar top surface. The rejections are withdrawn above.
However, the amendments to the claims have raised additional indefiniteness and written description issues. Please see the new rejections applied above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
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/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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