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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 24, 2025 has been entered.
Summary
Claims 1-21 and 23-32 are pending in this office action. Claim 22 is cancelled. All pending claims are under examination in this application.
Priority
The current application filed on November 30, 2021 is a 371 of PCT/EP2020/065097 filed May 29, 2020. The current application claims foreign priority to EP19177751.5 filed on May 31, 2019.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 non-obviousness.
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 1-21 and 23-32 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (WO2018/151725A1) in view of Shi et al. (Pharmaceutics, Published April 2019), Fisher et al. (WO2017/112704A1), Schiller et al. (WO2018/046642A1), and Norman et al. (Advanced Drug Delivery Reviews, 2017).
[The Examiner is going to introduce each reference and then combine them in the rejection of the instant claims.]
1. Huang et al.
Huang et al. is considered to be the prior art closest to the present application and teaches printed support structures (see title). In addition, Huang et al. disclose an example device that includes at least one three-dimensional (3D) printed tablet and a 3D-printed production support structure. Each 3D-printed tablet includes an excipient material and an active ingredient. The 3D-printed support structure includes a 3D-printed planar structure comprising the excipient material and at least one 3D-printed connecting member comprising the excipient material. The planar structure includes at least one aperture, each aperture corresponding to one of the at least one 3D-printed tablet. The connecting member detachably connects the at least one 3D-printed tablet with the 3D-printed planar structure and positions the at least one 3D-printed tablets within the apertures (see abstract).
2. Shi et al.
Shi et al. teach drop-on-powder 3D printing of tablets with an anti-cancer drug, 5-fluorouracil (see title). Also, Shi et al. disclose that this study reports the first case of an innovative drop-on-powder (DoP) three-dimensional (3D) printing technology to produce oral tablets (diameters of 10 mm and 13 mm) loaded with an anticancer model drug, 5-fluorouracil (FLU). For this study, a composition of the powder carrier containing CaSO4 hydrates, vinyl polymer, and carbohydrate was used as the matrix former, whereas 2-pyrrolidone with a viscosity like water was used as a binding liquid or inkjet ink. All tablets were printed using a commercial ZCorp 3D printer with modification. The resultant tablets were subject to coating with various polymeric solutions containing the drug. The composition of the polymeric solutions was adjusted at drug: polymer(s) 1:1 (w/w) ratio. Either Soluplus® (SOL) alone or in combination with polyethylene glycol (PEG) was used to develop the coating solution of 2.5% (w/v) concentration. The particle size analysis, flow test, and particle morphology studies revealed mono-modal narrow size distribution, good flow properties, and porous loosely bound texture (of the tablets), respectively. Moreover, the advanced application of the fluorescence microscopy showed a homogenous distribution of the drug throughout the surface of the 3D printed tablets. The in vitro dissolution studies showed that the tablet compositions, dimensions, and the coating solution compositions influenced the release of the drug from the tablets. It can be concluded that our innovative DoP 3D printing technology can be used to fabricate personalized dosage forms containing optimized drug content with high accuracy and shape fidelity. This is particularly suitable for those drugs that are highly unstable in thermal processing and cannot withstand the heat treatment, such as in fused deposition modeling (FDM) 3D printing (see abstract).
3. Fisher et al.
Fisher et al. teach a hydrogel prodrug for treatment (see title). In addition, Fisher et al. disclose that aspects of the invention described herein include a hydrogel prodrug and methods of making a hydrogel prodrug for drug delivery. Also contemplated are methods of treating, inhibiting, ameliorating or inhibiting a disease or disorder. Without being limiting, the methods for treatment can be directed to a cancer, HIV, a virus, pain, a bacterial infection, a neurological disorder, hemorrhaging, multiple sclerosis, diabetes, high blood pressure, Alzheimer's, or inhibiting a fungal growth in a subject in need (see abstract).
4. Schiller et al.
Schiller et al. teach the process for the manufacture of a solid pharmaceutical administration form (see title). Furthermore, Schiller et al. disclose that the present invention relates to a process for the preparation of a solid pharmaceutical administration form using a 3D printing process as well. The process is a printing process that allows the production of solid pharmaceutical administration forms in a
flexible manner and in conformity with the high-quality standards required for the production of pharmaceuticals (see abstract).
5. Norman et al.
Norman et al. teach a new chapter in pharmaceutical manufacturing: 3D-printed drug products (see title). Additionally, Norman et al. disclose that FDA recently approved a 3D-printed drug product in August 2015, which is indicative of a new chapter for pharmaceutical manufacturing. This review article summarizes progress with 3D printed drug products and discusses process development for solid oral dosage forms. 3D printing is a layer-by-layer process capable of producing 3D drug products from digital designs. Traditional pharmaceutical processes, such as tablet compression, have been used for decades with established regulatory pathways. These processes are well understood, but antiquated in terms of process capability and manufacturing flexibility. 3D printing, as a platform technology, has competitive advantages for complex products, personalized products, and products made on-demand. These advantages create opportunities for improving the safety, efficacy, and accessibility of medicines. Although 3D printing differs from traditional manufacturing processes for solid oral dosage forms, risk-based process development is feasible. This review highlights how product and process understanding can facilitate the development of a control strategy for different 3D printing methods. Overall, the authors believe that the recent approval of a 3D printed drug product will stimulate continual innovation in pharmaceutical manufacturing technology. FDA encourages the development of advanced manufacturing technologies, including 3D-printing, using science- and risk-based approaches (see abstract).
Combination of Huang et al., Shi et al., and Fisher et al.
Regarding instant claim 1, Huang et al., Shi et al., and Fisher et al. teach a method for producing a solid or semisolid pharmaceutical dosage form containing an active agent-free carrier structure and at least one pharmaceutical agent which is provided on at least a region of the carrier structure. The necessary citations within Huang et al., Shi et al., and Fisher et al. that correspond to instant claim 1 are compiled within Table I.
Table I
Instant Claim 1
Huang et al., Shi et al., and Fisher et al. Citations
A method for producing a solid or semisolid pharmaceutical oral dosage form containing an active agent-free dosage form base and at least one pharmaceutical agent which is provided on at least a region of the dosage form base, the method comprising:
Huang et al. disclose a method for producing a 3D-printed tablet according to the present claim 1 (see title and abstract within Huang et al.). According to this method, the active ingredient(s) (pharmaceutical or nutrient; see paragraphs [0012] and [0020] within Huang et al.) can be applied together with an excipient(s) (see paragraphs [0020-0021] within Huang et al.) in order to display information such as, for example, the prescribed dose or the patient's name (see paragraphs [0005-0006] and [0027-0029] within Huang et al.). The tablets can also be connected to one another via a separable connecting piece (see claims 1-15 and figures 1-9 within Huang et al.). Various methods such as fusion deposition modeling (FDM), multi-jet fusion (MJF), and selective laser sintering (SLS) can be used for the 3-D printed tablet (see paragraphs [0013]-[0016] within Huang et al.).
Shi et al. disclose the use of drop-on-powder 3D printing of tablets with an anti-cancer drug, 5-fluorouracil (see title and abstract within Shi et al.). Furthermore, Shi et al. disclose the production of oral tablets (see abstract within Shi et al.). Moreover, Shi et al. disclose a composition of the powder carrier containing CaSO4 hydrates, vinyl polymer, and carbohydrate was used as the matrix (see abstract within Shi et al.). Thus, the matrix is an agent-free dosage form base.
(i) providing at least one active agent-free dosage form base previously manufactured by a conventional process for pharmaceutical dosage forms and not by a 3D printing method, having a surface, in a printing device designed for 2D and/or 3D printing of at least one pharmaceutical active agent; and
Please see the discussion and citations directly above within Huang et al. and Shi et al.
Huang et al. disclose the excipient the 3D-printed tablets may be printed using both an excipient material and an active ingredient, such as a pharmaceutical or a nutritional agent (e.g., vitamins and minerals). Depending on the 3D printing technology being used, there may be more than one active ingredient. For example, in the case of MJF printing with multiple inkjet nozzles, the number of active ingredients would be limited only by the number of nozzles (see paragraph [0020] within Huang et al.). Furthermore, the excipient, or a carrier, is active agent free (see paragraph [0012] within Huang et al.)
Fisher et al. disclose that the active ingredient (drug) includes synthetic derivatives (see paragraphs [0070] and [0081] within Fisher et al.). Additionally, the synthetic derivatives are manufactured into a therapeutic designed for delivery (hydrogel prodrug) via a cross-linking step with the aid of a 3D printer (see paragraph [0170] within Fisher et al.).
(ii) applying at least one patient- specific pharmaceutical active agent by 2D and/or 3D printing on at least one region of the surface of the dosage form base in the printing device.
The methodology disclosed directly above within Fisher et al. would allow a skilled artisan (POSITA; person of ordinary skill in the art) to select a commercially available drug or synthetic derivative and insert it into the 3D printer based on the needs of the patient.
Huang et al. disclose the excipient(s) or a carrier is formed into a tablet with an active ingredient(s) (see paragraphs [0012] and [0020-0021] within Huang et al.). Also, please see the discussion and citations within the above portion of Table I.
In the context of instant method claim 1, the desired purpose defines an effect that arises from, and is implicit in the method step(s). Thus, where the purpose is limited to stating a technical effect that inevitably occurs during the performance of the claimed method step(s), and is therefore inherent in that/those step(s), that technical effect is not limiting to the subject-matter of the claim. Thus, the present method claim, defining the application/use of the composition claims and defining its purpose as "use", is anticipated by any document of the state of the art describing a method of application/use although not mentioning this specific use.
Therefore, a skilled artisan (POSITA) would under routine experimentation be able to construct the method of instant claim 1 using the Huang et al., Shi et al., and Fisher et al. references.
[Huang et al., Shi et al., and Fisher et al. disclose all the elements of instant claim 1 within the remaining instant claims of this 35 U.S.C. 103 section.]
Regarding instant claims 2-4 and 23-25, Huang et al., Shi et al., and Fisher et al. teach wherein in step (ii) more than one active agent is applied, and the active agents are applied together in one step or in separate steps and within a certain region. Huang et al. disclose the use of one or more active agents (see paragraph [0020] within Huang et al.). Furthermore, Huang et al. disclose that because 3D printing relies on the printing of multiple thin layers (thus, indicating application in several partial steps and within the same region of the carrier structure), and the energy used to fuse or solidify the excipient material(s) is a controllable variable, the structure of the tablets can be customized to achieve desired effects, such as in-vivo release control, where the tablets are designed to be physically or chemically depleted, either completely or partially, for controlled release of the active ingredient(s) carried by the excipient materials, whether by degradation, dissolution, diffusion, sublimation or any other physical or chemical depleting process. Control over the level of fusing in the excipient material may be used to determine the density and porosity of the excipient material, which may be used to control the amount of active ingredient in each tablet. Additionally, in some examples using multiple excipient materials, different excipient materials may be printed in different layers or groups of layers to achieve different controlled release profiles (see paragraph [0023] within Huang et al.). During the layered printing of the tablets, controlled amounts of the active ingredient(s) may be deposited concurrently with the excipient material in each tablet, forming an internal component of each tablet to achieve a desired total dosage and dosage profile determined by the depletion rate of the excipient material. In some examples, the active ingredient(s) may be formulated as part of a printed ink, which may solidify within each tablet or remain in liquid form within each tablet (see paragraph [0024] within Huang et al.). Finally, Huang et al. disclose 3D-printed connecting members comprising the excipient material may detachably connect the 3D-printed tablets in a prescribed sequence and/or defined physical configuration such as, for example, a stack or planar array (see paragraph [0012] within Huang et al.).
Regarding instant claims 7-9 and 27-29, Huang et al., Shi et al., and Fisher et al. teach wherein the at least one information structure encodes information on the kind or the nature of the active agents applied onto the dosage form base and/or on the amount(s) of the active agent(s) applied onto the carrier dosage form base and/or on the intended time point or intended time period of taking of the dosage form and/or the intended date of taking of the dosage form and/or on patient-related data and/or on the cost center and/or on the attending physician and/or on the pharmaceutical company providing the dosage form and/or on the medical unit dispensing the dosage form, patient related data, and/or QR codes, characters, or numbers. In the example of Figure 3 (within Huang et al.), there is illustrated additional printed information. As described below, such printed information in combination with customized 3D-printed pharmaceutical or nutrition tablets may be used to provide patient customized dosage sequence, dosage timing and dosage profile (see paragraph [0027] within Huang et al.). In one example, a patient may receive a medical prescription that defines when each dose is to be taken with respect to date and time of day, a total dose delivered by each tablet, and even a customized release profile for each tablet. That prescription may then be transmitted to a local or centralized 3D printing pharmaceutical facility for fulfillment. It will be appreciated from the foregoing disclosure of 3D printing of pharmaceuticals, that such customization is well within the boundaries of the disclosed technology, and tablets conforming to the prescription may be fabricated within a production support structure as previously described. In the example, illustrated in Figure 3 (within Huang et al.), rather than removing the 3D-printed tablets from the 3D-printed planar support structure after post-printing UCR operations, the 3D-printed tablets may remain attached to the 3D-printed planar support structure, which may be used as a component of final packaging for delivery of the prescription to the patient. For example, the entire 3D-printed structure could be placed in a blister pack, in a cardboard container or covered with plastic shrink wrap (see paragraph [0028] within Huang et al.). As illustrated in the example of Figure 3 (within Huang et al.), additional printed information may include the patient name and labels such as, for example, typical labels and typical arrows or other indicia that may indicate a prescribed sequence, such as the day, date and the time of day that the pharmaceutical should be taken, as well as the name of the patient to ensure that the medication is taken by the right person. In one example, the ink used for the printed information may include the active ingredient(s) as a component (see paragraph [0029] within Huang et al.). Additionally, a skilled artisan (POSITA) would add any pertinent information not disclosed within Huang et al.
Regarding instant claims 10-11 and 30-31, Huang et al., Shi et al., and Fisher et al. teach wherein the dosage form base is present as a tablet, capsule, suppository, plaster or thin film. Huang et al. disclose where the excipient (carrier) along with the active ingredient, form a tablet (see abstract within Huang et al.).
A skilled artisan (POSITA) could modify the oral tablets under routine experimental conditions to afford several of the items present within the Markush Group of instant claim 11.
Regarding instant claim 21, Huang et al., Shi et al., and Fisher et al. teach a solid or semisolid pharmaceutical dosage form prepared by the method of instant claim 10, having an active-agent free dosage form base and at least one pharmaceutical active agent applied to the active agent-free dosage form base. Please see the discussion and citations within instant claim 1 (Table I) and 10 for the necessary rejection text.
Huang et al., Shi et al., Fisher et al., and Schiller et al.
Regarding instant claims 5 and 26, Huang et al., Shi et al., Fisher et al. and Schiller et al. teach wherein the method further comprises applying at least one colored substance by 2D and/or 3D printing onto at least one region of the carrier structure such that the applied substance forms at least one information structure visible on the dosage form base. Schiller et al. within their 3D printing process disclose the use of energy absorbing materials that are especially suitable for the present invention are carbon black, pigments and inorganic salts, e.g. oxides and salts and alloys of iron, zinc, magnesium, aluminium or other metals, organic dyes and liquids (e.g. water) (see page 8, lines 24-27 within Schiller et al.). The energy absorbing materials within italics and boldface are colored, and thus satisfy the instant claim limitation.
Regarding instant claim 6, Huang et al., Shi et al., Fisher et al. and Schiller et al. teach wherein the at least one colored substance is applied together with the at least one pharmaceutical active agent. The combination of the Huang et al. and Schiller et al. disclosures satisfy this instant claim limitation. Please see the discussion and citations within instant claim 1 (Table I). Also, see the discussion and citations within instant claim 5. Additionally, the overall 3D printing process described by Schiller et al. disclose the application process (see page 5, lines 3-18 within Schiller et al.).
Regarding instant claim 14, Huang et al., Shi et al., Fisher et al. and Schiller et al. teach wherein the colored filaments are applied together with the at least one pharmaceutical active agent. Please see the citations and discussion within instant claims 1 and 5 for the relevant rejection text.
Regarding instant claim 32, Huang et al., Shi et al., Fisher et al. and Schiller et al. teach wherein more than one colored substance is applied to the dosage form base, with each colored substance forming a different information structure encoding different information. Please see the discussion and citations within instant claims 5 and 7 for the necessary rejection text. A skilled artisan (POSITA) would under routine experimental conditions use a variety of colored substances (pigments / dyes) to designate different patient criteria.
Huang et al., Shi et al., Fisher et al., Schiller et al., and Norman et al.
Regarding instant claim 12, Huang et al., Shi et al., Fisher et al., Schiller et al., and Norman et al. teach wherein the method is a filament fused filament fabrication (FFF) method or a fusion layer modeling (FLM) method. Norman et al. disclose the fused filament fabrication (FFF) (see page 47, left column, 4; within Norman et al.).
Regarding instant claim 13, Huang et al., Shi et al., Fisher et al., Schiller et al., and Norman et al. teach wherein the method is a filament fused filament fabrication (FFF) and colored filaments are provided on the dosage form base such that the colored filaments form at least one information structure visible on the dosage form base. Norman et al. disclose the fused filament fabrication (FFF) (see page 47, left column, 4; within Norman et al.). Instant claim 5 establishes the use of pigments or organic dyes (colored substances). Additionally, Schiller et al. disclose a process for the manufacture of a solid pharmaceutical administration form comprising an active ingredient including the steps:
(a) spreading a powder comprising a fusible material and an active
ingredient across the manufacturing area to create a powder bed;
(b) jet printing a fluid comprising an energy absorbing material onto the
powder (colored material);
(c) irradiating the powder to induce heating of the energy absorbing
material in the powder and thereby to induce melting and fusing of the
fusible material present in the powder;
(d) spreading a layer of powder onto the surface of unfused and fused
powder and subsequently performing step (b) and step (c);
(e) repeating step (d) as often as needed to build up the solid
pharmaceutical administration form;
(f) separating the solid pharmaceutical administration form from the
powder bed.
(see page 5, lines 3-18 within Schiller et al.).
A skilled artisan (POSITA) would under routine experimental conditions use a variety of colored substances (pigments / dyes) to designate at least one information structure visible on the dosage form base.
Regarding instant claim 15, Huang et al., Shi et al., Fisher et al., Schiller et al., and Norman et al. teach wherein the active agent(s) and the colored substance(s) are present in one or more powder carrier substances. Please see the citations and discussion within instant claim 1 (Table I), 5, and 13. Depending on the 3D printing technique selected by the skilled artisan (POSITA), this claim limitation would be met under routine experimental conditions.
Regarding instant claims 16-18, Huang et al., Shi et al., Fisher et al., Schiller et al., and Norman et al. teach wherein in step (ii) single volume increments of a fluid are applied, wherein at least part of the applied volume increments of the fluid contains the active agent(s) and the color substance(s), and wherein the volume increments solidify after application. Norman et al. disclose that a powder bed is not necessary for 3D printing with inkjets. Inkjets can also print free form structures that solidify drop-by-drop, similar to stalagmites. Commonly jetted materials include molten polymers and waxes, UV-curable resins, solutions, suspensions, and complex multi-component fluids (containing the active agent(s)). Material jetting differs substantially from binder deposition, and it can be more challenging to implement. The entire formulation needs to be formulated for jetting and rapid solidification, and product geometry becomes highly dependent on droplet flight path, droplet impact, and surface wetting. One advantage material jetting has over binder jetting and other methods is resolution; ink jet droplets are about 100 μm in diameter and layer thicknesses for material jetting are smaller than the droplet diameter (due to surface wetting, solvent evaporation, or shrinkage). Recognizing this, researchers have printed microparticles for drug delivery using material jetting techniques (see page 41, left column, 2.4 Material jetting; within Norman et al.). Additionally, Huang et al. disclose apply a layering technique within 3D printing (see paragraph [0015] within Huang et al.). Furthermore, please see the discussion and citations within instant claims 5 and 13 for the relevant rejection text on using colored material.
Regarding instant claim 19, Huang et al., Shi et al., Fisher et al., Schiller et al., and Norman et al. teach wherein step (ii) comprises the following partial steps: - applying a solution, suspension or emulsion containing the agent or agents onto at least a region of the carrier substance; and - evaporating the solution, suspension or emulsion such that the active agent(s) remain on the at least one region of the carrier structure. Schiller et al. disclose minimizing or avoiding of powder sticking to the object can be achieved by selective cooling of the surrounding powder bed, preferably by evaporation cooling. Agents that may be used as parting agent comprise volatile fluids, preferably pharmaceutically acceptable solvents such as water, methanol or ethanol, liquid alkanes such as pentane, hexane or heptane, more preferably water or ethanol (see page 11, lines 5-10 within Schiller et al.).
Regarding instant claim 20, Huang et al., Shi et al., Fisher et al., Schiller et al., and Norman et al. teach wherein the dosage form base absorbs part of the solution, suspension or emulsion during the evaporation step. Please see the discussion and citations within instant claim 19. Schiller et al. disclose the use of energy absorbing materials (see page 8, lines 24-27 within Schiller et al.). Carbon black (one of the energy absorbing materials within Schiller et al.) is known for its solvent absorbing properties (see PTO-892 NPL V) which could occur during evaporation.
Analogous Art
The Huang et al., Shi et al., Fisher et al., Schiller et al., and Norman et al. references are applicable to the endeavor of the instant application. Therefore, these teachings make the references relevant to instant claims 1-21 and 23-32.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the 3D-printer for pharmaceutical dosages disclosed by Huang et al. using the teachings of Shi et al., Fisher et al., Schiller et al., and Norman et al. to incorporate the necessary claim limitations.
The motivation to combine all of the above-mentioned references relies on the fact that each citation discloses text regarding 3D printing within the pharmaceutical industry. This overlap “links” the five references making them analogous art.
Starting with Huang et al., the skilled person only had to try the necessary claim limitations disclosed by Shi et al., Fisher et al., Schiller et al. and Norman et al. The combination of Huang et al., Shi et al., Fisher et al., Schiller et al., and Norman et al would allow one to arrive at the present application without employing inventive skill. This combination of the 3D-printer for pharmaceutical dosages taught by Huang et al. along with the use of the necessary claim limitations taught by Shi et al., Fisher et al., Schiller et al., and Norman et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the 3-D printer for pharmaceutical dosages disclosed by Huang et al. with the use of the necessary claim limitations taught by Shi et al., Fisher et al., Schiller et al., and Norman et al. This combined modification would have led to an enhanced 3-D printer for pharmaceutical dosages that would be beneficial for patients and consumers.
Response to Arguments
Applicant's arguments filed October 24, 2025 have been fully considered but they are not persuasive.
The Applicant’s claim amendments prompted the Examiner to necessitate a new ground of rejection, with the introduction of Fisher et al., to address all claim limitations in full.
Applicant Argument: The Applicant argues that the Huang et al. reference does not teach using previously manufactured pharmaceutical dosage forms and not by a 3D printing method (based on patient-specific needs).
Examiner’s Rebuttal: The argument is now moot. The Fisher et al. reference was added to the citations of record to address this new instant claim limitation. Fisher et al. disclose that the active ingredient (drug) includes synthetic derivatives (see paragraphs [0070] and [0081] within Fisher et al.). Additionally, the synthetic derivatives are manufactured into a therapeutic designed for delivery (hydrogel prodrug) via a cross-linking step with the aid of a 3D printer (see paragraph [0170] within Fisher et al.). The methodology disclosed directly above within Fisher et al. would allow a skilled artisan (POSITA) to select a commercially available drug or synthetic derivative and insert it into the 3D printer based on the needs of the patient.
Therefore, the 35 U.S.C. 103 rejection is maintained for instant claims 1-21 and 23-32.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615