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 the Claims
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/06/2026 has been entered.
Claim 7 is cancelled.
Claims 23-24 are withdrawn.
Claims 1-6 and 8-22 are under current examination. The claims were read in view of the species election of the species of tablets as the object produced and drops as the shape of the volume increment in the reply filed on 03/16/2025.
Claim Interpretation
A “volume increment” is interpreted as a discrete unit of volume that makes up a three-dimensional object. As per the instant specification, volume increments are also denoted as “voxels” (paragraph [0008]).
The term “several” in claim 14 is interpreted to mean “two or more”, as set forth in paragraph [0012] of the instant specification.
Claim Rejections - 35 USC § 112(a)-New Matter
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.
Claims 1-6 and 8-22 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “whereby a uniform release of the at least one pharmaceutical active agent occurs upon oral administration of the object to a person”. The specification at paragraphs [0011]-[0012] provides for a uniform release of active agent, and the specification at paragraph [0018] provides for oral administration. The specification does not provide for uniform release upon oral administration to a person. It is suggested that Applicant can omit the phrase “to a person” in claim 1.
Claims 2-6 and 8-22 are dependent on and require all of the limitations of claim 1, and thus also fail to comply with the written description requirement.
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 1-4, 6, and 9-22 are rejected under 35 U.S.C. 103 as being unpatentable over Stomberg et al. (WO 2017/158172 A1, published September 21, 2017; included on IDS submitted 03/23/2022, hereafter “Stomberg” as evidenced by Drugs.com (“What are enteric-coated tablets” https://www.drugs.com/medical-answers/enteric-coated-tablets-3566580/; of record) and as evidenced by Mayo Clinic (“How opioid use disorder occurs” https://www.mayoclinic.org/diseases-conditions/prescription-drug-abuse/in-depth/how-opioid-addiction-occurs/art-20360372; of record), in view of Brögmann et al. (WO 03/084504 A2, published October 16, 2003), hereafter “Brögmann”.
Regarding instant claim 1, Stomberg teaches a process for the preparation of a three-dimensionally printed pharmaceutical dosage form comprising a first and second pharmacologically active ingredient (see entire document, particularly abstract and claim 39). The pharmaceutical dosage form is preferably a tablet for oral administration (paragraphs [0099] and [0103]). Stomberg teaches that the dosage form is printed in voxels at predetermined locations with the pharmaceutical dosage form, and that a voxel is the minimum three-dimensional microstructure that can be printed in accordance with the resolution of the printing device (paragraphs [0018] and [0064]-[0065]). Stomberg teaches that the 3D printing process preferably involves fused deposition modeling (abstract) wherein a nozzle follows a tool-path controlled by a computer-aided manufacturing software package and is built from the bottom up, one layer at a time (paragraphs [0032]-[0034]). As the software creates a path by which the dosage form is printed in layers, it is interpreted that the software generates a two- or three-dimensional representation of the object (step (i)); this process is consistent with the instant specification at paragraph [0024], “a calculated three-dimensional picture of the object to be printed is typically generated by means of a well-established CAD program”.
As noted above, Stomberg teaches that pharmaceutical dosage form is built from the bottom up, one layer at a time, which is consistent with the recited printing a first predefined volume increment on a building platform (step (ii)), printing a further a further predefined volume increment onto or adjacent the first (step (iii)), and repeating until the object is formed (step (iv)). As the dosage form of Stomberg is printed in layers, it is interpreted that the volume increments contact each other. Stomberg teaches that filaments containing two different pharmacologically active ingredients can be deposited in the form of voxels (paragraph [0018]), and that the dosage form comprises at least two voxels composed of the second three-dimensionally printed pharmaceutical composition (paragraphs [0064] and [0069]). It is therefore interpreted that at least one of the first predefined volume increment and the further predefined volume increment contains a pharmaceutically active agent.
Stomberg teaches that in fused deposition modeling, a nozzle is heated to melt a filament, and small flattened strings of molten material (a flowable base material) form layers as the material hardens after extrusion (volume increments are joined together due to solidification by cooling) (paragraph [0034]). Stomberg teaches that suitable pharmaceutical compositions are those known to be suitable for processing by conventional hot melt extrusion technology (paragraph [0035]), and it is thus interpreted that the base composition is flowable at a printing temperature compatible with the pharmaceutical agents.
Stomberg further teaches that voxels can have different volumes (paragraph [0071]) and that voxels can be positioned to adapt the release profile of active ingredients after oral intake of the dosage form to give a desired release profile, which is a function of distance of the voxel to the outer surface; the desired release profile can depend on the properties of the drug (potency, efficacy) and/or the patients’ needs (paragraph [0072]). The dosage form can provide prolonged release of the active ingredients (paragraph [0080]). Stomberg further teaches that content uniformity can be achieved by adjusting the concentrations of pharmacologically active ingredient in the filaments and amount of filament which is deposited (paragraph [0019]).
While Stomberg does not explicitly envision a tablet whereby the volume of the volume increments of the further predefined volume increment increases from the outside to the inside (instant claim 1), it would have been prima facie obvious to one of ordinary skill in the art to adjust the voxel volumes and distances to the outer surface in the method of Schiller such that the volume of the voxels increases from the outside to the inside. This could be achieved by routine optimization of the volumes and distances to the outer surface in order to achieve a desired release profile in an oral pharmaceutical dosage form according the properties of the drug and patients’ needs, as suggested by Stomberg. Per MPEP 2144.05 II. A., “"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Regarding instant claim 2, as noted above, Stomberg teaches printing in layers.
Regarding instant claim 3, as noted above, Stomberg teaches a process for the preparation of a three-dimensionally printed pharmaceutical dosage form comprising a first and second pharmacologically active ingredient (see entire document, particularly abstract and claim 39), that filaments containing two different pharmacologically active ingredients can be deposited in the form of voxels (paragraph [0018]), and that voxels comprising the second three-dimensionally printed pharmaceutical composition can be embedded within the first three-dimensionally printed pharmaceutical composition (paragraph [0068]). It is therefore interpreted that Stomberg contemplates a dosage form where both the first predefined volume increment and the further predefined volume increment contains an active agent.
Regarding instant claim 4, as noted above, Stomberg teaches that filaments containing two different pharmacologically active ingredients can be deposited in the form of voxels (paragraph [0018]), and that voxels comprising the second three-dimensionally printed pharmaceutical composition can be embedded within the first three-dimensionally printed pharmaceutical composition (paragraph [0068]). Thus, Stomberg teaches volume increments comprising different active agents.
Regarding instant claim 6, as noted above, Stomberg teaches that voxels can have different volumes (paragraph [0071]).
Regarding instant claim 9, Stomberg teaches the pharmaceutical compositions can form at least two voxels which are spatially separated from one another (paragraph [0064]) and preferably the second three-dimensionally printed pharmaceutical composition is embedded within the first composition; preferably the entire outer surface of each of at least two voxels is surrounded by the first composition (paragraphs [0068]-[0069]). Further, compositions that comprise the same excipients but no pharmacologically active ingredient may serve as another pharmaceutical composition (paragraph [0059]). Therefore, Stomberg suggests groups of volume increments that comprise different active agents and groups with and without active agent (i.e., an amount of active agent different from the first group).
Regarding instant claim 10, as noted above, Stomberg teaches a process for the preparation of a three-dimensionally printed pharmaceutical dosage form comprising a first and second pharmacologically active ingredient (see entire document, particularly abstract and claim 39), that filaments containing two different pharmacologically active ingredients can be deposited in the form of voxels (paragraph [0018]), and that voxels comprising the second three-dimensionally printed pharmaceutical composition can be embedded within the first three-dimensionally printed pharmaceutical composition (paragraph [0068]). It is therefore interpreted that Stomberg contemplates a dosage form where groups of volume increments contain different active ingredients.
Regarding instant claim 11, as noted above, Stomberg teaches printing in layers, and further teaches that different layers can be adjacent and/or parallel to one another; the first pharmaceutical composition at least partially surrounds the second (paragraph [0076]; see also Figures 5 and 6)), suggesting that volume increments of the first composition contact each other.
Regarding instant claims 12 and 13, as noted above, Stomberg teaches that preferably the second three-dimensionally printed pharmaceutical composition is embedded within the first composition; preferably the entire outer surface of each of at least two voxels is surrounded by the first composition (paragraphs [0068]-[0069]). Pharmaceutical compositions may not contain a pharmacologically active ingredient (paragraph [0059]). Preferably the second composition is located in the core (inner body) of the dosage form, and the first composition can comprise an enteric material (paragraph [0053]). As evidenced by Drugs.com, an enteric coating allows tablets to survive intact as they pass through the acidic stomach; they then dissolve in the less acidic small intestine to be absorbed (pg. 1). It is therefore interpreted that the core voxels of the second composition of Stomberg are shielded from an external acidic environment by the enteric material of Stomberg.
Regarding instant claim 14, as noted above, Stomberg teaches the pharmaceutical compositions can form at least two voxels which are spatially separated from one another (paragraph [0064]) and preferably the second three-dimensionally printed pharmaceutical composition is embedded within the first composition; preferably the entire outer surface of each of at least two voxels (several groups) is surrounded by the first composition (paragraphs [0068]-[0069]). Pharmaceutical compositions may not contain a pharmacologically active ingredient, and compositions preferably contain pharmaceutical excipients (paragraphs [0054], [0059]).
Regarding instant claim 15, as noted above, Stomberg teaches that pharmaceutical composition may not contain a pharmacologically active ingredient, and compositions preferably contain pharmaceutical excipients (paragraphs [0054], [0059]). Excipients result in a diluting effect (limiting the effect of the active agent) (paragraph [0018]) and the pharmaceutical dosage forms can be dissolved (paragraph [0074]).
Regarding instant claim 16, Stomberg teaches that the pharmacologically active ingredients are most preferably an opioid, an antiepileptic, or a psychostimulant (paragraphs [0026]-[0027]). As evidenced by Mayo Clinic, people who take opioids are at risk of opioid use disorder, often called opioid addiction (pg. 1, paragraph 1), and thus have addiction potential.
Regarding instant claims 17, as noted above, Stomberg teaches that preferably the second three-dimensionally printed pharmaceutical composition is embedded within the first composition; preferably the entire outer surface of each of at least two voxels is surrounded by the first composition (paragraphs [0068]-[0069]). Preferably the second composition is located in the core (inner body) of the dosage form, and the first composition can comprise an enteric material (paragraph [0053]). As evidenced by Drugs.com, an enteric coating allows tablets to survive intact as they pass through the acidic stomach; they then dissolve in the less acidic small intestine (that is, pH dependently) to be absorbed (pg. 1).
Regarding instant claim 18, as noted above, Stomberg teaches the pharmaceutical compositions can form at least two voxels which are spatially separated from one another (paragraph [0064]) and preferably the second three-dimensionally printed pharmaceutical composition is embedded within the first composition; preferably the entire outer surface of each of at least two voxels is surrounded by the first composition (paragraphs [0068]-[0069]). Pharmaceutical compositions may not contain a pharmacologically active ingredient, and can comprise an enteric material (paragraphs [0053], [0059]). As evidenced by Drugs.com, an enteric coating allows tablets to survive intact as they pass through the acidic stomach; they then dissolve in the less acidic small intestine to be absorbed (pg. 1), thus providing a retarded release.
Regarding instant claim 19, as noted above, Stomberg teaches that preferably the second three-dimensionally printed pharmaceutical composition is embedded within the first composition; preferably the entire outer surface of each of at least two voxels is surrounded by the first composition (paragraphs [0068]-[0069]). Preferably the second composition is located in the core (inner body) of the dosage form, and the first composition can comprise an enteric material (paragraph [0053]). As evidenced by Drugs.com, an enteric coating allows tablets to survive intact as they pass through the acidic stomach; they then dissolve in the less acidic small intestine to be absorbed (pg. 1). It is therefore interpreted that the enteric material provides the tablets with gastric juice resistance.
Regarding instant claims 20-21, as noted above, Stomberg teaches that the pharmaceutical dosage form is preferably a tablet (paragraph [0099]).
Regarding instant claim 22, Stomberg teaches that the tablet is preferably oblong (paragraph [0099]).
Stomberg does not explicitly teach a uniform release upon oral administration (instant claim 1).
Brögmann teaches pharmaceutical compositions comprising opioid analgesics such as morphine, oxycodone, etc. wherein active compounds are released in a sustained manner (see entire document, particularly abstract and claims 1 and 11); the composition is preferably a formulation for oral administration (pg. 28, lines 13-16). Brögmann teaches that sustained release formulations have the advantage of a uniform active compound in the blood, leading to long-lasting effect and reduced side effects, and the sustained release of an opioid analgesic can reduce the addictive potential of these active compounds (pg. 2, lines 5-23).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the release profile of the pharmaceutical dosage form in the method of Stomberg to have a sustained uniform release, as suggested by Brögmann. One of ordinary skill in the art would have been motivated to do so to achieve a dosage form for oral administration of an opioid that has long-lasting effects and reduced addictive potential, as suggested by Brögmann. There is a reasonable expectation of success as Stomberg teaches a process of preparing a dosage form with a preferable active ingredient of an opioid, and that the release profile of active ingredients can be modified to give a prolonged release.
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Stomberg, as evidenced by Drugs.com and Mayo Clinic, in view of Brögmann as applied to claims 1-4, 6, and 9-22 above, and further in view of Prasittisopin et al. (WO 2017/111708 A1, published June 29, 2017; of record), hereafter “Prasittisopin” and Peter et al. (US 2018/0370147 A1, published December 27, 2018; of record), hereafter “Peter”.
The teachings of the modified Stomberg are set forth above.
Stomberg and Brögmann do not teach the limitation of instant claim 5 that the volume increments of the first predefined volume increment and the further predefined volume increment have a same shape or the limitation of instant claim 8 that the shape of the volume increments are drops.
Prasittisopin teaches methods of three-dimensional printing a layered structure using at least one predefined voxel shape (abstract), and that suitable voxel shapes can be selected based on the relationship between the physical shapes of the voxels and the final structure; other factors such as the structure size, level of strength required, and construction time may also be considered (pg. 6, lines 25-30). In a preferred embodiment, each voxel has the same shape (pg. 7, lines 27-28).
Peter teaches 3D printed articles with high accuracy in details by placing voxels or strands at target locations (see entire document, particularly abstract). Voxels in the shape of droplets are used (paragraphs [0022] and [0077]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method of Stomberg in view of Brögmann with voxels of the same shape of droplets, as suggested by Prasittisopin and Peter. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to use a voxel shape known for printing highly accurate detail in 3D objects, as suggested by Peter, and to select a consistent voxel shape that complements the final structure shape, size, and strength required, as suggested by Prasittisopin. There is a reasonable expectation of success as Stomberg teaches a method comprising the printing of layers of voxels and suggests that the shape of the extrusion dies used in the printing process and the shape of the pharmaceutical form can be varied (paragraphs [0043] and [0102]).
Response to Arguments
Applicant’s arguments filed 02/06/2026 have been fully considered.
Regarding the rejections 35 U.S.C. § 103, Applicant argues that Schiller’s fabrication method does not provide for building a dosage form from individual volume increments by directly printing them on the building platform, and that, as Schiller teaches solidification by irradiation, it does not read on the instant claims which recite “which base composition solidifies after printing by cooling” and that volume increments are “joined together due to solidification by cooling”.
Applicant’s arguments with respect to Schiller have been considered but are moot because the new ground of rejection does not rely on Schiller for any teaching or matter specifically challenged in the argument.
Applicant further argues, regarding the prior art of Stomberg, that Stomberg discloses only two different voxels can have a different volume, and there is no indication of any purpose or effect from having different volumes; it appears that the only reason for this disclosure is to expand on the disclosure of the prior paragraph which discloses voxels having the same volume. Applicant argues that regulating release profiles by placing voxels at different shortest distance to the surface of the dosage form does not disclose or suggest a dosage form where a uniform release of the active pharmaceutical is accomplished by providing increasing volumes of volume increments from the outside to the inside of the object whereby a uniform release of the at least one pharmaceutical active agent occurs upon oral administration of the object to a person.
These arguments are unpersuasive. The Examiner notes that, per MPEP 2123 I., patents are relevant as prior art for all they contain, and “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).” Here, Stomberg reasonably suggests at least two voxels with different volumes (paragraph [0071]) and the variation of the distance of active agents from the surface of the dosage form to achieve a desired release profile (paragraph [0072]). One of ordinary skill in the art would recognize that the volume of voxels directly impacts the distance of the components from the exterior of the dosage form, and would be motivated to routinely optimize the volume and positioning of the voxels to achieve a desired release profile according the properties of the drug and patients’ needs, as suggested by Stomberg. Further, as set forth in the rejections above, an ordinary skilled artisan would be motivated to particularly achieve a sustained uniform release profile, as the prior art of Brögmann teaches that this allows for oral administration of an opioid with long-lasting effects and reduced addictive potential.
Regarding the nonstatutory double patenting rejections over claim 1 of copending Application 17/783,818 in view of Schiller, Applicant argues that they will address the issue further if needed when all other issues are resolved, as it is not known what the claims of the copending application will cover if issued.
In response, the Examiner notes that the nonstatutory double patenting rejections are withdrawn in view of the amendments to the instant claims and to those of copending Application 17/783,818.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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