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 .
Response to Amendment
The Amendments filed 08/29/2025 responsive to the Office Action filed 05/29/2025 has been entered. Claims 7, 21 and 22 have been amended. Claim 19 has been canceled. Claims 7, 9, 10, 12, 16-18, 21 and 22 are pending in this application.
Response to Arguments
Claim 21 has been amended to address the indefiniteness, thus the rejection of claim 21 under 112(b) has been withdrawn.
Applicant’s arguments, see Amendment, filed 08/29/2025 in pages 5-8, with respect to claim 7 under 103 rejection have been fully considered but are not persuasive.
Applicant argues that “Patel discloses several examples of systems (i.e., first and second reactive/active components) that can be used. Patel further discloses that "[t]he curable/polymerising/crosslinkable liquids can involve compounds which undergo condensation reactions triggered either by thermosetting reactions such as epoxy/amine or isocyanate/polyol/amine, etc., or by electromagentically triggered cationic systems such as epoxy plus cationic photo-initiators..." (emphasis added; see col. 5, Ins. 4-25 of Patel). Patel does not appear to disclose a system where the active component of the liquid reagent reacts and forms hydrogen bonds with hydroxyl groups of the first reactive component of the powder. Since Patel does not appear to teach or suggest hydrogen bonding, Applicant submits that one of ordinary skill in the art would not be motivated to replace any of the second active components of Patel's liquid reagent with the boric acid of the aqueous gel disclosed by Okano. It is therefore submitted that one of ordinary skill in the art would not be motivated to combine the teachings of Patel and Okano." (page 7)
These arguments are found to by unpersuasive because:
Patel teaches polyacrylic acid and polyvinyl alcohol as examples of suitable powders (co 4 li 52, 58-59) and alkylborates iodonium salts as examples of the curable/polymerising/crosslinkable liquids (co 5 li 12). Even though Patel does not explicitly teach the reaction forming hydrogen bonds, since the instant specification discloses boric acid and halide salts thereof as the crosslinker which can form hydrogen bonds with the hydroxyl groups of the polyhydroxylated swellable polymer (Pa [0025], [0026] and [0029]), Patel does not teach away the crosslinking reaction forming hydrogen bonds with hydroxyl groups of the first reactive component of the powder. Okano teaches a boric acid as a crosslinker for forming a crosslinked gel prepared by crosslinking a polyvinyl alcohol with a boric acid compound (Pa [0040]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Patel with the teachings of Okano and provide the boric acid with the crosslinkable liquids in order to form an organ model with the benefits of suppression of stickiness on its surface, lowering of water content and suppression of excess swelling when a gel being dried is supplied with water, as well as elasticity similar to an organ of a living body.
Applicant further argues that “Applicant further submits that one of ordinary skill in the art would not be motivated to combine the teachings of Patel and Okano, because modification of the liquid reagent of Patel to include the boric acid disclosed by Okano would render the Patel disclosure as being unsatisfactory for its intended purpose… Patel discloses that "using powders which have complimentary chemistry to the polymerising/crosslinking components in the jetted liquid, effective micro/nano- mixing and reaction can be effected[sic], yielding higher strength composite, without voids which can be initiating sources of fracture failure" (see col. 4, Ins. 23-27 of Patel). If the skilled artisan were to replace the crosslinking component of the liquid disclosed by Patel with boric acid, the chemistries between the crosslinking component and the powder would not be complimentary. As such, the resultant polymer may include voids, thereby initiating sources of fracture failure that would adversely affect strength.” (pages 7-8)
These arguments are found to by unpersuasive because:
Again, Patel teaches polyacrylic acid and polyvinyl alcohol as examples of suitable powders (co 4 li 52, 58-59) and alkylborates iodonium salts as examples of the curable/polymerising/crosslinkable liquids (co 5 li 12) which are disclosed in the instant specification (Pa [0025], [0026] and [0029]) as recited above, thus Applicant’s allegation “If the skilled artisan were to replace the crosslinking component of the liquid disclosed by Patel with boric acid, the chemistries between the crosslinking component and the powder would not be complimentary.” is groundless.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 7, 9, 12, 16, 18, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US 7,455,804) in view of Okano et al. (US 2012/0045743) (All of record).
With respect to claims 7, Patel teaches a method of three-dimensional printing (“a process for forming a three-dimensional article in sequential cross-sectional layers in accordance with a model of the article”, co 1 li 64-66), the method comprising:
iteratively applying individual layers of a dry particulate build material to a powder bed (“defining a layer of powder material”, co 1 li 66-67; “powder material can be supplied to an enclosure and the article is formed on a platform within the enclosure. As each successive layer is formed, the platform is lowered into the enclosure and so a fresh supply of powder is placed on the previous layer. The powder can then be levelled off to the required thickness, eg. by a blade. In this way, the article is supported by the powder while it is being formed.”, co 6 li 19-25), wherein the dry particulate build material consists of a polyhydroxylated swellable polymer selected from the group consisting of polyvinyl alcohol, poly(acrylic acid), and a combination thereof (“Examples of suitable powders are polyacrylic acid,… polyvinyl alcohol,…blends of these compounds”, co 4 li 52, 58-59); and
based on a three-dimensional object model, iteratively and selectively jetting a crosslinking agent onto the individual layers (“applying a liquid reagent to the powder layer in a pattern corresponding to the respective cross-sectional layer of the model”, co 1 li 67-co 2 li 2), wherein the crosslinking agent comprises water and a crosslinker (“the liquid includes a viscosity-lowering diluent and a second active component”, co 2 li 21-22), and wherein the water swells the polyhydroxylated swellable polymer and the crosslinker reacts with hydroxyl groups of the polyhydroxylated swellable polymer to crosslink the polyhydroxylated swellable polymer, thereby forming a three-dimensional printed hydrogel (“the diluent also enables polymerising/crosslinkable liquids present in the dispensing liquid fluid to wet and penetrate the powder probably through polymer swelling/partial dissolving actions.”, co 4 li 15-21; “the diluent also enables polymerising/crosslinkable liquids present in the dispensing liquid fluid to wet and penetrate the powder probably through polymer swelling/partial dissolving actions. Thus, polymerising/crosslinking can take place at the surface of and within the powder as well as within the jetted liquid residing between the powder particles”, co 4 li 16-22; “The liquids can be … diluted liquids or as emulsions in water.”, co 5 li 26-28).
Patel does not explicitly teach that a crosslinker is selected from the group consisting of boric acid, citric acid, succinic acid, cationic calcium, cationic barium, and a combination thereof; the crosslinker reacts and forms hydrogen bonds with hydroxyl groups of the polyhydroxylated swellable polymer; and the powder bed is maintained at a temperature ranging from about 0°C to about 75°C during the three-dimensional printing.
In the same field of endeavor, a material for forming an organ model containing an aqueous gel, Okano teaches that the material for molding an organ model of the present invention contains an aqueous gel which comprises a polyvinyl alcohol having an average degree of polymerization of 300 to 3500 (Pa [0025]), and in the material for molding an organ model of the present invention, it is preferable that the aqueous gel is composed of a crosslinked gel prepared by crosslinking a polyvinyl alcohol with a boric acid compound from the viewpoint of suppression of stickiness on its surface, lowering of water content and suppression of excess swelling when a gel being dried is supplied with water, as well as elasticity similar to an organ of a living body, expanding of an incised portion similar to an organ of a living body when an incision is performed, approximation of water wettability and an incision feel to an organ of a living body (Pa [0040]), and the polyvinyl alcohol is gelled when the polyvinyl alcohol is contacted with the boric acid compound since the polyvinyl alcohol is crosslinked (Pa [0047]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Patel with the teachings of Okano and provide the boric acid with the crosslinkable liquids in order to form an organ model with the benefits of suppression of stickiness on its surface, lowering of water content and suppression of excess swelling when a gel being dried is supplied with water, as well as elasticity similar to an organ of a living body.
Okano further teaches that the temperature when the polyvinyl alcohol is contacted with the boric acid compound is not particularly limited, and is usually preferably from room temperature to 40° C. or so from the viewpoint of acceleration of crosslinking of the polyvinyl alcohol to increase production efficiency (Pa [0047]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Patel with the teachings of Okano and maintain the powder bed at a temperature range taught by Okano for the purpose of acceleration of crosslinking of the polyvinyl alcohol to increase production efficiency.
With respect to claim 9, Okano as applied to claim 7 above further teaches that the concentration of the polyvinyl alcohol in the aqueous polyvinyl alcohol solution is preferably not less than 1% by weight and not more than 40% by weight from the viewpoint of sufficient dissolution of the polyvinyl alcohol in water, prevention of stickiness and increase in moldability (Pa [0030]), and the amount of the boric acid compound based on 100 parts by weight of the polyvinyl alcohol differs depending on the average degree of polymerization of the polyvinyl alcohol, and is preferably not less than 1 part by weight from the viewpoint of sufficient crosslinking of the polyvinyl alcohol, and not more than 60 parts by weight from the viewpoint of reduction of the amount of remaining unreacted boric acid compound (Pa [0046]).
water
polyvinyl alcohol
boric acid
Water based on a total weight of individual layer and crosslinking agent that is jetted
99
1
0.01
99/(99+1+0.01) * 100 = 99.0 wt%
60
40
24
60/(60+40+24) * 100 = 48.4 wt%
Since Okano teaches 48.4 ~ 99.0 wt% of water based on a total weight of individual layer and crosslinking agent that is jetted based on the calculation above, one would have found it obvious to jet the crosslinking agent onto the individual layers at a contone level so that the individual layers include the water contents taught by Okano for the purpose of forming an organ model. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
With respect to claim 12, Okano as applied to claim 7 above further teaches that the concentration of the polyvinyl alcohol in the aqueous polyvinyl alcohol solution is preferably not less than 1% by weight and not more than 40% by weight from the viewpoint of sufficient dissolution of the polyvinyl alcohol in water, prevention of stickiness and increase in moldability (Pa [0030]), and the amount of the boric acid compound based on 100 parts by weight of the polyvinyl alcohol differs depending on the average degree of polymerization of the polyvinyl alcohol, and is preferably not less than 1 part by weight from the viewpoint of sufficient crosslinking of the polyvinyl alcohol, and not more than 60 parts by weight from the viewpoint of reduction of the amount of remaining unreacted boric acid compound (Pa [0046]).
water
polyvinyl alcohol
boric acid
the crosslinker present in the crosslinking agent
99
1
0.01
0.01/(99+0.01) * 100 = 0.01 wt%
60
40
24
24/(60+24) * 100 = 28.6 wt%
Since Okano teaches 0.01 ~ 28.6 wt% of the crosslinker present in the crosslinking agent based on the calculation above, one would have found it obvious to use the boric acid in a range taught by Okano in the crosslinking agent for the purpose of forming an organ model. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
With respect to claim 16, Okano as applied in the combination regarding claim 7 above teaches that the powder bed is maintained at a temperature ranging from room temperature to 40° C (Pa [0047]). In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
With respect to claim 18, Okano as applied in the combination regarding claim 7 above teaches that the polyhydroxylated swellable polymer is polyvinyl alcohol having a weight average molecular weight ranging from about 13,215 Mw to about 154,175 Mw (“a polyvinyl alcohol having an average degree of polymerization of 300 to 3500”, Pa [0022]; one would appreciate that one unit mass of PVA is 44.05 g/mol). In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
With respect to claim 21, Patel teaches a method of three-dimensional printing (“a process for forming a three-dimensional article in sequential cross-sectional layers in accordance with a model of the article”, co 1 li 64-66), the method comprising:
iteratively applyinq individual layers of a dry particulate build material to a powder bed (“defining a layer of powder material”, co 1 li 66-67; “powder material can be supplied to an enclosure and the article is formed on a platform within the enclosure. As each successive layer is formed, the platform is lowered into the enclosure and so a fresh supply of powder is placed on the previous layer. The powder can then be levelled off to the required thickness, eg. by a blade. In this way, the article is supported by the powder while it is being formed.”, co 6 li 19-25), wherein the dry particulate build material consists of a polyhydroxylated swellable polymer selected from the group consisting of polyvinyl alcohol, poly(acrylic acid), and a combination thereof (“Examples of suitable powders are polyacrylic acid,… polyvinyl alcohol,…blends of these compounds”, co 4 li 52, 58-59); and
based on a three-dimensional object model, iteratively and selectively jetting an inkjettable crosslinking agent onto the individual layers (“applying a liquid reagent to the powder layer in a pattern corresponding to the respective cross-sectional layer of the model”, co 1 li 67-co 2 li 2), wherein the inkjettable crosslinking agent consists of water, a crosslinker (“the liquid includes a viscosity-lowering diluent and a second active component”, co 2 li 21-22),
wherein the crosslinker is a salt of boric acid (“alkylborates iodonium salts”, co 5 li 12),
and wherein the water swells the polyhydroxylated swellable polymer and the crosslinker reacts with hydroxyl groups of the polyhydroxylated swellable polymer to crosslink the polyhydroxylated swellable polymer, thereby forming a three-dimensional printed hydrogel (“the diluent also enables polymerising/crosslinkable liquids present in the dispensing liquid fluid to wet and penetrate the powder probably through polymer swelling/partial dissolving actions.”, co 4 li 15-21; “the diluent also enables polymerising/crosslinkable liquids present in the dispensing liquid fluid to wet and penetrate the powder probably through polymer swelling/partial dissolving actions. Thus, polymerising/crosslinking can take place at the surface of and within the powder as well as within the jetted liquid residing between the powder particles”, co 4 li 16-22; “The liquids can be … diluted liquids or as emulsions in water.”, co 5 li 26-28).
Patel does not explicitly teach that the crosslinker reacts and forms hydrogen bonds with hydroxyl groups of the polyhydroxylated swellable polymer.
In the same field of endeavor, a material for forming an organ model containing an aqueous gel, Okano teaches that the material for molding an organ model of the present invention contains an aqueous gel which comprises a polyvinyl alcohol having an average degree of polymerization of 300 to 3500 (Pa [0025]), and in the material for molding an organ model of the present invention, it is preferable that the aqueous gel is composed of a crosslinked gel prepared by crosslinking a polyvinyl alcohol with a boric acid compound from the viewpoint of suppression of stickiness on its surface, lowering of water content and suppression of excess swelling when a gel being dried is supplied with water, as well as elasticity similar to an organ of a living body, expanding of an incised portion similar to an organ of a living body when an incision is performed, approximation of water wettability and an incision feel to an organ of a living body (Pa [0040]), the boric acid compound includes, for example, a salt of boric acid (Pa [0043]) and the polyvinyl alcohol is gelled when the polyvinyl alcohol is contacted with the boric acid compound since the polyvinyl alcohol is crosslinked (Pa [0047]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Patel with the teachings of Okano and provide a salt of boric acid with the crosslinkable liquids in order to form an organ model with the benefits of suppression of stickiness on its surface, lowering of water content and suppression of excess swelling when a gel being dried is supplied with water, as well as elasticity similar to an organ of a living body.
With respect to claim 22, Okano as applied in the combination regarding claim 21 above further teaches that the crosslinker is the salt of boric acid, and wherein the salt of boric acid is sodium tetraborate (“borax”, Pa [0108]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US 7,455,804) in view of Okano et al. (US 2012/0045743) as applied to claim 7 above, and further in view of Leppiniemi et al. (NPL- ACS Appl. Mater. Interfaces 2017, 9, 21959−21970) (All of record).
With respect to claim 10, Patel as applied in the combination regarding claim 7 above further teaches that after 3 dimensional construction, the excess powder is removed (co 6 li 26-27), thus one would have found it obvious to remove the three-dimensional printed hydrogel from the powder bed in order to remove the excess powder thereon, but the combination does not explicitly teach rinsing the three-dimensional printed hydrogel with water.
In the same field of endeavor, 3D printing of hydrogel, Leppiniemi teaches that
certain specimens were cross-linked and then rinsed with Milli-Q water (page 2196, co 2 li 1-3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the combination with the teachings of Leppiniemi and performing rinsing the hydrogel with Milli-Q water in order to wash it so that the unbound powder is removed.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US 7,455,804) in view of Okano et al. (US 2012/0045743) as applied to claim 16 above, and further in view of Feng et al. (US 2019/0039295) (All of record).
With respect to claim 17, Okano as applied in the combination regarding claim 7 above suggests that the powder bed is maintained at a temperature ranging from about 30° C. to about 40° C (“from room temperature to 40° C. or so”) from the viewpoint of acceleration of crosslinking of the polyvinyl alcohol to increase production efficiency (Pa [0047]), thus, even though the combination does not explicitly teach heating the powder bed to maintain the temperature ranging from about 30°C to about 40°C, one having the ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to heat the powder bed in order to maintain it at the temperature ranging from about 30° C. to about 40° C for the purpose of acceleration of crosslinking of the polyvinyl alcohol to increase production efficiency.
However, the combination does not explicitly teach that the heating is accomplished with a heating lamp, an oven, a heated support bed, or combinations thereof.
In the same field of endeavor, 3-dimensional printing, Feng teaches that an overhead heating source 176, e.g., heating lamps, are used to heat up the powder bed material to a printing temperature (Pa [0046]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the combination with the teachings of Feng and provide the overhead heating lamp with the powder bed in order to heat up the powder bed material to a printing temperature.
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 YUNJU KIM whose telephone number is (571)270-1146. The examiner can normally be reached on 8:00-4:00 EST M-Th; Flexing Fri.
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/YUNJU KIM/Primary Examiner, Art Unit 1742