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 .
The amendment filed February 2, 2026 has been entered.
Claim Rejections - 35 USC § 112
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 1-5 and 8-19 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 claim(s) 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. Amended claims 1 and 4 now require repeating step (d) zero to one or more times. There is no support in the application for the claimed range.
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.
Claims 1-5, 8-15 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rowe (2004/0091516) in view of Maniruzzaman (US 2023/0181532).
Claim 1: Rowe discloses a process for manufacturing a solid pharmaceutical administration form including an active ingredient (abstract). The process includes spreading a powder across a manufacturing area to create a powder bed (¶¶ 25-26); jet printing a medium including an active pharmaceutical ingredient onto the powder (¶¶ 25-26; fig. 2); jet printing a medium including a binding material onto the powder (¶¶ 25-26); repeating the spreading and printing steps (¶¶ 25-26); and separating the solid pharmaceutical administration form from the powder bed (¶¶ 25-26).
Rowe is silent as to the powder including mesoporous silica. However, in the same field of endeavor, Maniruzzaman discloses a process for manufacturing a solid pharmaceutical administration form including an active ingredient (abstract). The process includes 3D printing with a powder across a manufacturing area (¶¶ 3-4), wherein the powder includes mesoporous silica (¶¶ 103-105). As taught by Maniruzzaman, including mesoporous silica as an absorbent allows the active pharmaceutical ingredient to be retained on the surface of the absorbent and into the silica’s nanoscale pores and thereby achieve faster dissolution and better bioavailability (¶¶ 84, 104). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have included mesoporous silica in the process of Rowe to allow the active pharmaceutical ingredient to be retained on the surface of the absorbent and into the silica’s nanoscale pores and thereby achieve faster dissolution and better bioavailability.
Claim 2: Rowe discloses simultaneous printing with four fluid jets (¶ 45).
Claim 3: Rowe discloses fluid jet printing (¶¶ 25-26, 45).
Claim 4: Rowe discloses a process for manufacturing a solid pharmaceutical administration form including an active ingredient (abstract). The process includes spreading a powder across a manufacturing area to create a powder bed (¶¶ 25-26); jet printing a hot melt medium including an active pharmaceutical ingredient onto the powder (¶¶ 25-26, 32 80; fig. 2); repeating the spreading and printing steps (¶¶ 25-26); and separating the solid pharmaceutical administration form from the powder bed (¶¶ 25-26).
Rowe is silent as to the powder including mesoporous silica. However, in the same field of endeavor, Maniruzzaman discloses a process for manufacturing a solid pharmaceutical administration form including an active ingredient (abstract). The process includes 3D printing with a powder across a manufacturing area (¶¶ 3-4), wherein the powder includes mesoporous silica (¶¶ 103-105). As taught by Maniruzzaman, including mesoporous silica as an absorbent allows the active pharmaceutical ingredient to be retained on the surface of the absorbent and into the silica’s nanoscale pores and thereby achieve faster dissolution and better bioavailability (¶¶ 84, 104). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have included mesoporous silica in the process of Rowe to allow the active pharmaceutical ingredient to be retained on the surface of the absorbent and into the silica’s nanoscale pores and thereby achieve faster dissolution and better bioavailability.
Claim 5: Rowe discloses the medium including binder and API (¶¶ 25-26).
Claims 8-10: Rowe discloses drying after step b or c in low air pressure (¶¶ 26,60), and Maniruzzaman discloses heated surfaces (¶ 124).
Claim 11: Rowe discloses the pharmaceutical administration form is for oral use (¶ 78).
Claim 12: Rowe discloses immediate release (¶ 177).
Claims 13-14: Rowe is silent as to the claimed diameter ranges. However, absent evidence of unexpected results obtained from the claimed diameter, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have selected a suitable diameter to effectively provide a sizeable surface area for the active pharmaceutical ingredient to be absorbed onto the material. The optimization of a range or other variable within the claims that flows from the “normal desire of scientists or artisans to improve upon what is already generally known” is prima facie obvious. In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) (determining where in a disclosed set of percentage ranges the optimum combination of percentages lies is prima facie obvious). The discovery of an optimum value of a variable in a known process is usually obvious. In re Aller, 220 F.2d 454, 456 (C.C.P.A. 1955). See also In re Boesch, 617 F.2d 272, 276 (C.C.P.A. 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.”). See also In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (“‘[I]t is not inventive to discover the optimum or workable ranges by routine experimentation.’” (quoting Aller, 220 F.2d at 456)); In re Kulling, 897 F.2d 1147, 1149 (Fed. Cir. 1990) (finding no clear error in Board of Patent Appeals and Interferences’ conclusion that the amount of eluent to be used in a washing sequence was a matter of routine optimization known in the pertinent prior art and therefore obvious).
Claim 15: Maniruzzaman discloses the diameters of the pores in the mesoporous silica particles to be 10 nm (¶ 105).
Claim 18: Rowe’s multi-jet printhead operates the fluid jets individually and prints the API medium and the binder medium in separate passes/regions (¶¶ 45, 50-52).
Claim 19: Rowe discloses the printed tablets were dried, with partial interlayer drying between passes (¶¶ 53, 60).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Rowe (2004/0091516) in view of Maniruzzaman (US 2023/0181532), as applied to claim 1 above, further in view of Dobry (US 2010/0028440).
Mofidified Rowe is silent as to drying in the presence of an entrainer. However, in the same field of endeavor, Dobry discloses a process for manufacturing a solid pharmaceutical administration form including an active ingredient and drying in the presence of an entrainer (¶¶ 25-35). As taught by Dobry, drying in the presence of an entrainer facilitates solvent removal. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have dried the tablets of Rowe in the presence of an entrainer in order to facilitate solvent removal, as taught by Dobry.
Response to Arguments
Applicant's arguments filed February 2, 2026 have been fully considered but they are not persuasive.
Applicant argues the following: (1) Maniruzzaman uses mesoporous silica in a different way (within hot-melt-extruded granules) and for a different purpose, so it would not have been obvious to use it as a powder bed in Rowe; (2) the claims require that loading/association of the API with the silica occur in situ within the additive manufacturing process itself, whereas Maniruzzaman performs that loading in a separate, prior HME step, and this “temporal and spatial relocation” is not taught; (3) Maniruzzaman teaches away because it indicates that drug absorption onto the silica is achieved through the shear-mediated melting and mixing of HME; and (4) the rationale for the combination is improper because the absorption advantage of Maniruzzaman is tied to HME. These arguments have been considered but are not persuasive.
The test for obviousness is not whether the features of the secondary reference may be bodily incorporated into the primary reference, nor whether the secondary reference uses the borrowed element in the same manner or for the same purpose. The test is what the combined teachings would have suggested to one of ordinary skill in the art. “It is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements.” In re Mouttet, 686 F.3d 1322, 1332, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012) (citing In re Etter, 756 F.2d 852, 859, 225 USPQ 1, 6 (Fed. Cir. 1985) (en banc)) (“Etter's assertions that Azure cannot be incorporated in Ambrosio are basically irrelevant, the criterion being not whether the references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole.”). See also In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981) (“The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.”); In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. 1983) (“[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.”); and In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”). The rejection of claim 1 does not import Maniruzzaman’s hot-melt extursion step into Rowe. Maniruzzaman is relied upon for the discrete teaching that mesoporous silica is an art-recognized, beneficial powder-bed excipient for pharmaceutical additive manufacturing.
Applicant’s second, third and fourth arguments are based on the assumption that the claims require API to be “loaded,” “associated with,” or “absorbed onto” the mesoporous silica during printing. They do not. Independent claim 1 requires only (a) spreading a powder comprising mesoporous silica to form a bed, (b) jet printing a medium comprising an API onto the powder, (c) jet printing a medium comprising a binding material onto the powder, (d)-(e) repeating, and (f) separating the form. Features not recited in the claim cannot distinguish over the prior art See In re Self, 671 F.2d 1344 (CCPA 1982) (limitations not appearing in the claims cannot be relied upon for patentability).
Maniruzzaman is not confined to hot-melt extrusion or to selective laser sintering. It expressly identifies “Binder Spraying/Jetting based 3D printing” in paragraph 3 as a powder-bed platform and states that, for such processes to run successfully, “the powders should have excellent flow characteristics for both selective laser sintering and binder jetting 3D printing.” (¶ 4; emphasis added). Rowe’s process is a binder/jetting powder-bed process where drops of liquid are dispensed onto a spread powder layer “by a technique similar to ink-jet printing (¶¶ 8, 25-26). Maniruzzaman thus directly contemplates the very type of process Rowe describes and teaches that its flowability-engineered silica and silicate powders are intended to serve it. Applicant’s assertion that Maniruzzaman “does not teach or even remotely suggest” spreading API onto a mesoporous-silica powder is contradicted by the reference’s own discloses of binder-jetting suitability for its flowable silica compositions.
For a reference to teach away, the reference must suggest that the claimed combination should be avoided as undesirable or ineffective. See In re Haruna, 249 F.3d 1327, 1335 (Fed. Cir. 2001); In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Maniruzzaman makes no such suggestion. Furthermore, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) (“a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.”) (internal quotations omitted) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)); and Schwendimann v. Neenah, Inc., 82 F.4th 1371, 1381, 2023 USPQ2d 1173 (Fed. Cir. 2023) (“Although Oez [the prior art] used a white pigment with a cross-linking polymer, it does not discourage a skilled artisan from using the white pigment without a cross-linking polymer or lead the skilled artisan in a direction divergent from the path taken in the Appealed Patents. Thus, Oez's disclosure is substantial evidence that supports the Board's finding that Oez does not teach away from the proposed combination.”). Maniruzzaman’s description of an HME-based loading route is not a statement that mesoporous silica cannot or should not be spread as a powder bed. To the contrary, Maniruzzaman affirmatively teaches the use of its silica powders in binder-jetting powder-bed printing in paragraphs 3-4. A reference cannot simultaneously endorse a use and teach away from it.
Conclusion
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 LARRY THROWER whose telephone number is (571)270-5517. The examiner can normally be reached 9am-5pm MT M-F.
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/LARRY W THROWER/Primary Examiner, Art Unit 1754
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