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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 4, 2025 has been entered.
Status of Claims
Claims 31-37 and 39-50 are pending and currently under examination. Claim 38 is canceled. Claim 31 is 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Claims 44-46 are withdrawn as being directed to a non-elected species of a multi-layered structure with top surface areas that increase sequentially from the surface to the interior. Claims 47-50 are withdrawn as being directed to a non-elected species of a multi-layered structure with top surface areas that differ between the first and third layer and the second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 Thus, claims 44-50 are withdrawn, there being no linking or generic claim.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 and 39-43 are examined on their merits to the extent of the elected species.
Information Disclosure Statement
The Information Disclosure Statement filed August 4, 2025 has been reviewed.
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Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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Rejections Withdrawn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
In light of the cancelation of the claim the rejection of claim 38 under 35 U.S.C. 112(b) 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn as moot
Claim Rejections - 35 USC § 103
In light of the amendments to the claims the rejection of claims 31-43 are rejected under pre-AIA 35 U.S.C. 103(a) 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) and Appel et al. EE 200300055 (12/15/2004) 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 and 39-43 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 8/4/2025 added amendments to claim 31 with limitations that introduce NEW MATTER into the claims. The limitation “and the second layer is exposed to the bodily fluid following complete erosion of the first layer” does not have clear support in the specification and claims as originally filed. There is no disclosure of a second layer being exposed to the bodily fluid following complete erosion of the first layer in the specification or originally filed claims. Specifically, nowhere in the specification is the concept of complete erosion of the first layer before the second layer is exposed to the bodily fluid disclosed. The reply filed 8/4/2025 pointed to paragraph [0162] of the published application for support. While paragraph [0162] does teach the erosion of the first layer before the second layer is exposed to bodily fluid, there is no requirement, discussion or mention that the first layer must be completely eroded before the second layer is exposed to bodily fluid. There is no indication from the specification that the complete erosion of the first layer is required before the second layer is exposed to the bodily fluid was ever contemplated by the Applicants.
Thus, paragraph [0162] reasonably provides support for the presence of some solvent impurity in the composition, however, this does not provide clear support of the composition being free of non-impurity solvent, or being free of solvent as perhaps implied by the phrase. The meaning of the term non-impurity solvent is not disclosed or defined in paragraph [0104] and thus, the scope of what is now being excluded is not adequately disclosed. Additionally, the amendment filed 4/1/2022 also introduced new claim 21 which recited that the composition is ‘free of solvent’, implying that the limitation ‘free of non-impurity solvent’ has a different meaning as the applicant was using these phrases separately.
Paragraph [0120] discloses a method of applying the composition to the nail and that the composition is not mixed with any additional components prior to the applying of the composition onto the nail. This does not provide adequate written support for the instant limitation wherein the composition is free of non-impurity solvent. The phrase non-impurity solvent is not disclosed in par [0120], solvent is not disclosed and the general concept that additional components are not added to the composition prior to applying the composition to the nail does not adequately convey that applicant had contemplated that the composition is free of non-impurity solvent, or that it is free of solvent, given that the disclosure at paragraphs [0014] and [0104] disclose that some residual or impurity solvent may in fact be present. Applicant has not pointed to any disclosure that provides either explicit or implicit support for the phrase ‘free of non-impurity solvent’, nor has applicant pointed to any disclosure that reasonable conveys to those skilled in the art that applicant was in possession of the claimed composition that is either free of non-impurity solvent or free of solvent. 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 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 1, 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 1 in the specification or claims, as-filed, or remove these limitations from the claim in response to this Office Action.
Claims 32-37 and 39-43 are rejected as depending from a rejected claim.
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 31-37 and 39-43 are rejected under pre-AIA 35 U.S.C. 103(a) 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.
Goole et al. (Goole) discloses a process for forming a drug dosage form by 3-D printing and a drug dosage formed from this process. (See Title/Abstract and Figure 6). Goole teaches that there are pragmatic tools in 3-D printing which can be used for designing customized drug delivery systems using 3D printing. (See Abstract). Google teaches that very complex release profiles (multiple-release patterns in the same dosage form) have been obtained with 3-D printing. (See Table 2 and Figure 6). Additionally, very simple release profiles such as enteric dual pulsatory dosage forms have also been used with 3-D printing. For example in Table 2, Goole teaches the printing of a drug into two sections or two layers which allows for erosional release twice in the intestines. In this way, the same amount of drug can be used in multiple layers (two layers in the instance of Table 2).
Regarding claim 31, Goole discloses a drug dosage form and a process for forming the drug dosage by 3D printing. The drug dosage form is formulated and configured to provide a desired drug release profile, wherein the drug dosage form comprises a multi-layered structure comprising a plurality of layers of a first erodible material admixed with a drug having a pre-determined drug mass faction, wherein the first erodible material is embedded in a second material not admixed with the drug. The process of forming the drug dosage by 3D printing has the steps of: dispensing the first erodible material admixed with the drug thereby printing the multi-layered structure; and dispensing the second material not admixed with the drug. (pp. 378-392 2. 3D printing technologies, Table 2 and Figure 6). Regarding claim 31, a decreasing surface area is inherent to the dosage forms discussed in Goole and is shown in Figure 6.
Goole teaches that the thickness of the top layer determines the release time delay and that the thickness of layers can determine how many active units of API releasing subunits can be incorporated into the layer. (See Table 2). Thus thickness as a variable is taught to be able to be manipulated to achieve the aims of the formulator.
Regarding claim 32, Goole discloses providing placebo layers as the top layer, i.e. not including an active drug (p. 379 last ¶ - p. 380 first ¶).
Regarding claim 33, Goole discloses that the thickness of the top layer determines the release time delay, so a top layer would have a thickness configured to delay the release of the drug dosage form for a desired amount of time. (p. 380).
Regarding claim 34, Goole discloses that the placebo layers are the same as the active layers (p. 379 last ¶ - p. 380 first ¶).
Regarding claim 35, Goole discloses alternative outer layers depending on the desired profile, e.g. the top layer is different than the active layer (p. 380+).
Regarding claim 36 Goole discloses additional drugs.(See Figure 10).
Regarding claim 37, Goole discloses that the first and second erodible material are the same and thus have the same erosion rate (pp. 378-392 2. 3D printing technologies).
Regarding claim 39, Goole discloses a second erodible material (pp. 378-392 2. 3D printing technologies).
Regarding claim 40, Goole discloses impermeable outer layers (p. 379, 2nd to last ¶). Impermeable reads on insulating material that forms a barrier as called for in instant claim 40.
Regarding claim 41, Goole discloses that a fast dissolving intermediate layer can be provided between two portions of the dosage to provide a breakaway feature (Table 2).
Regarding claim 42, Goole discloses that an intermediate material may be the same as the active material (pp. 378-392 2. 3D printing technologies).
Regarding claim 43, Goole discloses additional drug layers and additional layered structures. (FIG. 10+)
Goole does not teach a substantially planar top surface wherein each layer of the plurality of layers of the multi-layered structure is configured to release the drug from the substantially planar top surface. Goole teaches the same amount of drug in multiple layers (multiple being 2 layers) but does not teach the same drug mass fraction in each layer. Goole teaches the erosion of the first layer before the second layer, but does not teach the complete erosion of the first layer before the second layer is exposed to bodily fluids. These deficiencies are made up for with the teachings of Beyer et al., Appel and Khan et al.
Beyer et al. teaches generally the three-dimensional (3D) printing and generation of three-dimensional structures from digital files. (See [0002]). Beyer teaches that layers of materials may be 3D printed and stacked on top of each other and they may be substantially planar. (See [0059]). A multi-layered structure with each layer is configured to release the drug from the substantially planar top surface is called for in instant claim 31.
Appel teaches a controlled release dosage form that has a coated core with the core comprising a drug-containing composition and a water-swellable composition, each occupying separate regions within the core. (See Abstract). Appel teaches the concept that the drug mass fraction stays relatively constant and allows for the adaptation of the other ingredients in the layers to account for the desired release, while the drug mass fraction stays relatively constant.
Khan et al. (Khan) teaches a drug dosage form referred to as a Multilayered Multidisk Tablet (MLMDT) which comprises to drug containing layers that are enveloped between three polymeric barrier layers. The first barrier layer erodes exposing a disk which results in an immediate pulse of drug release. The second and third barrier layers (middle and bottom) swell and protect the remaining layer from releasing drug producing a lag. The first drug layer is completely eroded before the barrier layers erode and allow the drug in the second layer to release by being contacted by bodily fluids. (See paragraph 4 on page 2). Khan thus teaches that the bodily fluid contacts the first layer before contacting the second layer (i.e. the first layer is exposed to the bodily fluid prior to the second layer as called for in instant claim 31.) Khan also teaches that the bodily fluid contacts the second layer only after the first layer is completely eroded as called for in instant claim 31.
Khan teaches that this dosage form allows for two pulsatile doses that are separated by a gap in time which can allow for a break in drug administration during the overnight hours when a patient is sleeping, for example. (See paragraph 4 on page 2). Khan teaches drug dosage forms with substantially planar erodible layers that are configured expressly for drug release in Figure 1. Khan teaches that the drug release occurs from the substantially planar top surface of the drug containing layers as called for in claim 31. (See Figure 1).
With respect to claim 31, Goole teaches a simple release profile such as an enteric dual pulsatory dosage forms that have also been used successfully with 3-D printing in which the same amount of a drug is printed into two sections or two layers which allows for erosional release twice in the intestines, or two pulses of drug. Appel teaches the concept of the drug mass fraction staying relatively constant in each layer and allowing for the adaptation of the other ingredients in the layers to account for the desired release, so that the same amount of drug can be released in two pulses. This reads on each layer having the same drug mass fraction as called for in instant claim 1.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date following the Goole process to use a 3-D printing process and to embed a drug containing layer in a non-drug containing layer in light of Goole’s teachings that thickness as a variable is able to be manipulated to achieve the specific dosage and release aims of the formulator. A person of ordinary skill in the art would be motivated to make oral dosage forms using these processes because Goole teaches that very complex release profiles such as multiple-release patterns in the same dosage form have been obtained with 3-D printing.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date following the Goole process to use a 3-D printing process and to make a multi-layered structure with each layer being substantially planar as taught by Beyer in light of Beyer’s teaching that it is known to successfully make multi-layered structures with substantially planar top surfaces are known to be able to be made by 3D printing. A person of ordinary skill in the art would have had a reasonable expectation of success because Beyer teaches that multi-layered structures with substantially planar top surfaces are known to be able to be made by 3D printing and Goole teaches that oral dosage forms can be made using these 3D processes.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date following the Goole process to use a 3-D printing process and to make a two layered structure with each layer containing the same drug mass fraction in each layer as taught by Appel since Appel teaches that it is known to keep the drug mass fraction constant or the same between layers and
Goole’s teaches that it is known to successfully make multi-layered structures for pulsatile release with 3-D printing. A person of ordinary skill in the art would have had a reasonable expectation of success because Goole teaches that pulsatile release profiles have been successfully obtained using 3-D printing.
It would have been prima facie obvious for one of ordinary skill in the art following the Goole process before the earliest effective filing date to use a 3-D printing process and to make a multi-layered structure with two layers surrounded by three polymeric barrier layers, so as to allow for pulsatile doses that can be separated by a gap in time that would accommodate the overnight hours of a patient as taught by Khan. There would be a reasonable expectation of success because Khan teaches drug dosage forms with substantially planar erodible layers that are configured expressly for drug release.
Response to Arguments
Applicants’ arguments of August 4, 2025 have been fully considered and are found to be sufficiently persuasive in light of the amendments to the claims.
Applicants note the cancelation of claim 38 and request the withdrawal of the indefiniteness rejection.
Response
The indefiniteness rejection is withdrawn above.
With respect to the obviousness rejection Applicants note that independent claim 31 has been amended to recite where each layer of the plurality of layers of the multi-layered structure has a thickness and the same drug mass fraction.
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.
Response
Applicants’ arguments are only found to be partly persuasive in light of the amendments to the claims to require the first layer to be completely eroded before the second layer is exposed to bodily fluids. The rejections are withdrawn above and the Khan reference supplied this teaching. Khan et al. (Khan) teaches a drug dosage form referred to as a Multilayered Multidisk Tablet (MLMDT) which comprises to drug containing layers that are enveloped between three polymeric barrier layers. The first barrier layer erodes exposing a disk which results in an immediate pulse of drug release. The second and third barrier layers (middle and bottom) swell and protect the remaining layer from releasing drug producing a lag. The first drug layer is completely eroded before the barrier layers erode and allow the drug in the second layer to release by being contacted by bodily fluids. (See paragraph 4 on page 2).
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date following the Goole process to use a 3-D printing process and to make a multi-layered structure with two layers surrounded by three polymeric barrier layers, so as to allow for pulsatile doses that can be separated by a gap in time that would accommodate the overnight hours of a patient as taught by Khan. There would be a reasonable expectation of success because Khan teaches drug dosage forms with substantially planar erodible layers that are configured expressly for drug release.
However, Applicants arguments that the processes taught in Goole would not have led a skilled artisan to the claimed drug dosage forms are not found to be persuasive because Goole teaches much more than linear drug release profiles. As an initial matter Goole does not teach drug mass fractions in layers as asserted by Applicants. This is not supported by Goole Figure 6.
The teachings of Goole are also supported by the teachings of are Khan, which also teaches a dual pulsatile release drug dosage form. 3-D printing can make a number of different kinds of drug dosage forms, but specifically teaches the dual pulsatory dosage form. One such simple release profiles is an enteric dual pulsatory dosage form, and in Table 2, Goole teaches the printing of a drug into two sections or two layers which allows for erosional release twice in the intestines. In this way, the same amount of drug can be used in multiple layers (two layers in the instance of Table 2). Thus, Goole teaches a simple release profile such as an enteric dual pulsatory dosage forms that have also been used successfully with 3-D printing in which the same amount of a drug is printed into two sections or two layers which allows for erosional release twice in the intestines, or two pulses of drug. Appel teaches the concept of the drug mass fraction staying relatively constant in each layer and allowing for the adaptation of the other ingredients in the layers to account for the desired release, so that the same amount of drug can be released in two pulses.
With respect to the teaching of the substantially planar surfaces this teachings is supplied by Beyer. Beyer teaches that layers of materials may be 3D printed and stacked on top of each other and they may be substantially planar. (See [0059]). Since both Goole and Khan expressly teach drug dosage forms and particularly focus on dual pulsatile drug dosage forms, Beyer does not need to teach drug dosage forms itself. Indeed, Khan specifically teaches drug dosage forms with substantially planar erodible layers that are configured expressly for drug release in Figure 1. Thus, one of ordinary skill would 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.
Conclusion
No claims are allowed.
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/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619