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 .
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.
Election/Restrictions
Applicant’s election without traverse of claims 1-14 in the reply filed on 12/12/2025 is acknowledged.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2025.
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.
Claim 14 is 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.
Claim 14 recites the limitation “wherein the printing head comprises: a threaded stem portion and a head portion” in lines 1-2. However, as originally filed the disclosure only provides description of the micro-screw(s) having a threaded portion and head portion whereas the claim, as written, is broader requiring only the “printing head” which comprises the micro-screw (see claim 1) to have a threaded portion and a head portion.
For the purposes of examination, claim 14 has been interpreted as requiring the micro-screws to have the threaded portion and head portion (See, for example, paragraphs 0008-0016 and 0152 of the Specification as published).
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 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.
Claim(s) 1, 2, 4, 5, 6, 10, 11, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US20230356467A1 – hereinafter Yang1) in view of Yang (CN107866973A – hereinafter Yang2).
In reference to claims 1 and 11:
Yang1 discloses an additive manufacturing system (para 0001), comprising:
a material supply module for melting and pressurizing a printing material (para 0399);
a printing head comprising a micro-screw (para 0399)
a driving module for one or more of driving rotating motions of the micro-screw of the printing heads (para 0399) and driving vertical motions of the printing heads (para 0394);
Yang1 does not disclose a flow distribution module comprising a flow distribution plate, wherein the flow distribution plate comprises a plurality of channels for evenly dividing a single flow of the printing material into a plurality of flows or a printing module comprising a set of printing heads, wherein the set of printing heads configured to dispense the plurality of flows (claim 1) or wherein the plurality of channels comprises a main channel and a branch channel, wherein an inlet of the main channel is higher than an outlet of the branch channel (claim 11). However, this would have been obvious in view of Yang2. Yang 2 teaches an additive manufacturing system (para 0007). Yang2 further teaches a flow distribution module comprising a flow distribution plate (Fig. 3), wherein the flow distribution plate comprises a plurality of channels for evenly dividing a single flow of printing material into a plurality of flows (Fig. 3) and a printing module comprising a set of printing heads (Fig. 3 showing a left and right printing head), wherein the set of printing heads configured to dispense the plurality of flows (Fig. 2-3) wherein an inlet of the main channel is higher than an outlet of the branch channel (Fig. 3) allows for processing of multiple identical objects simultaneously or a single object individually (para 0008). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Yang1 with the flow distribution system of Yang2 in order to obtain a system capable of processing of multiple identical objects simultaneously or a single object individually.
Modified Yang1 does not explicitly disclose wherein the printing material comprises a pharmaceutically acceptable material, an inert material, or a combination thereof. However, “[e]xpressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim.” Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, “[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” See In re Young, 75 F.2d *>996<, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
In reference to claim 2:
In addition to the discussion of claim 1, above, modified Yang1 does not disclose wherein a pressure within the plurality of channels of the flow distribution plate is between 0-20 MPa. However, the cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
In reference to claim 4:
In addition to the discussion of claim 1, above, Yang1 further discloses wherein the flow distribution plate comprises a temperature control mechanism for maintaining a temperature of the flow distribution plate at a desired level (para 0399).
In reference to claim 5:
In addition to the discussion of claim 1, above, Yang1 further discloses the temperature control mechanism comprises one or more heaters (para 0400).
In reference to claim 6:
In addition to the discussion of claim 1, above, Yang1 further discloses wherein the one or more heaters are configured to operate in conjunction to maintain the temperature of the flow distribution plate (para 0400).
In reference to claim 10:
In addition to the discussion of claim 1, above, modified Yang1 further discloses wherein the flow distribution module comprises a base plate, and wherein the flow distribution plate and the printing heads are placed in the base plate (Yang2 Fig. 3).
In reference to claim 13:
In addition to the discussion of claim 11, above, modified Yang1 does not teach wherein a pressure of the main channel and a pressure of the branch channel are higher than 0 Mpa. However, the cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang1 and Yang2 as applied to claim 1, above, and further in view of Mandel (US20180111306A1).
In addition to the discussion of claim 1, above, modified Yang 1 does not disclose further comprising one or more pressure sensors at a channel of the printing head for detecting pressure of the melted printing material. However, this would have been obvious in view of Mandel. Mandel teaches a multi-nozzle additive manufacturing system comprising a flow dividing manifold (abstract). Mandel further teaches one or more pressure sensors at a channel of the printing head for detecting pressure of the melted printing material in order to detect clogged nozzles, generate an alarm, and take the system offline for maintenance (para 0032, Fig. 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the additive manufacturing system of Yang1 with the pressure sensor of Mandel in order to obtain a system which can detect clogged nozzles, generate an alarm, and take the system offline for maintenance.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang1 and Yang2 as applied to claim 1, above, and further in view of Lynn (US20200023579A1).
In addition to the discussion of claim 1, above, modified Yang1 does not teach wherein an inlet of the flow distribution plate comprises a sealing mechanism. However, this would have been obvious in view of Lynn. Lynn a multi-nozzle additive manufacturing system (abstract). Lynn further teaches utilizing a seal mechanism to contain thermoplastic material within the manifold (para 0028). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the system of modified Yang1 with the seal mechanism of Lynn in order to obtain a system which contains the thermoplastic material within the manifold.
Claim(s) 8, 9, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang1 and Yang2 as applied to claims 1 and 11, above, and further in view of Lewis (US20140314954A1).
In reference to claims 8 and 9:
In addition to the discussion of claim 1, above, modified Yang1 does not teach wherein the flow distribution plate comprises an upper plate and a lower plate (claim 8) or wherein the upper plate and the lower plate are separable, and when the upper plate and the lower plate are separated, each of the upper plate and the lower plate exposes inner surfaces of one or more channels and junctures in the flow distribution plate (claim 9). However, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). As applied to the instant application, Lewis teaches an additive manufacturing system (abstract). Lewis further teaches dividing a single flow of material into a first plurality of flows and dividing the first plurality of flows into two or more second flows (abstract, Fig. 1). Lewis further discloses wherein the flow distribution plate comprises an upper plate and a lower plate which are separable such that when the upper plate and lower plate are separated each of the upper plate and the lower plate exposes inner surfaces of one or more channels and junctures in the flow distribution plate (para 0066, Figs. 6A-6C, 6I). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the single bifurcation of modified Yang1 with the multi-bifurcation of Lewis because each element is known in the art for bifurcating material flows and the combination yields predictable results, i.e. the system uses a known mechanism for bifurcation.
In reference to claim 12:
In addition to the discussion of claim 11, above, modified Yang teaches wherein the main channel divides the single flow in a first plurality of flows (Fig. 2) but does not teach the branch channel is configured to divide each of the first plurality of flows into two or more second flows. However, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). As applied to the instant application, Lewis teaches an additive manufacturing system (abstract). Lewis further teaches dividing a single flow of material into a first plurality of flows and dividing the first plurality of flows into two or more second flows (abstract, Fig. 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the single bifurcation of modified Yang1 with the multi-bifurcation of Lewis because each element is known in the art for bifurcating material flows and the combination yields predictable results, i.e. the system uses a known mechanism for bifurcation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW L SWANSON whose telephone number is (571)272-1724. The examiner can normally be reached M-Th 0800-1900 and every other Friday 0800-1600.
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/ANDREW L SWANSON/ Examiner, Art Unit 1745