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 .
Election/Restrictions
Applicant’s election without traverse of Claims 1-17 in the reply filed on 05/11/2026 is acknowledged. Claims 18-20 have been canceled.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “inertial forces dominating viscous forces” which renders the claim indefinite because it is not clear what “dominating” mean. It can mean that inertial forces are higher than viscous forces; it can also mean that inertial forces are lower but have more effect than viscous forces. For the purpose of further examination, based on the broadest reasonable interpretation, either case is considered meeting the limitation. Claims 2-17 are rejected likewise as depending on claim 1.
Claim 14-15 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14-15 recites in line 3-4 , “ reaction product with a transverse dimension of ..”. The product of a reaction like this is going to be a compound. Individual compounds don’t have dimensions measured in centimeters. Further clarification is needed as what is considered to be the product of the reaction.
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 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.
Claim(s) 1-5,11,13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ozbolat et al (US 20160288414 A1).
Regarding Claim 1 Ozbolat discloses A method of moving materials to create a reaction product in a multilayer extrusion reactor apparatus, the method comprising: flowing a first fluid in a flow direction in a first conduit in the apparatus (Figure 21, [0124], crosslinker flow containing calcium chloride solution reads on the claimed first fluid), flowing a second fluid in a flow direction in a second conduit in the apparatus (Figure 21, [0124]; the biomaterial flow containing sodium alginate solution reads on the claimed second fluid), the first and second fluids miscible with one another ([0124]); shaping the first and second conduits to provide an interface region between the first and second fluids (Figure 21 showing the first and second fluids have a contact region as the interface region); the recited limitation that permitting a reaction to create a reaction product in the interface region, the reaction product mitigating flow- disrupting mixing between the first and second fluids, the Examiner submits that since the prior art Ozbolat teaches the same hydrogel product with similar first and second fluid in a similar process ([0033], [0079], spec), the same result is expected.
Further re: the limitation that the first fluid characterized by inertial forces dominating viscous forces of the first fluid. Ozbolat also teaches that the bioprinting is impacted by biomaterial rheological properties, dispensing pressure, crosslinking solution concentration, dispensing speed, coaxial nozzle size[0293]. These variables are related to the claimed inertial forces and viscous forces of the first fluid. A recognition in the prior art that a property is affected by the variable is sufficient to find the variable result-effective. In re Applied Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012). It would have been obvious to one of ordinary skill in the art at the time of filing to optimize these variables by routine experimentation and therefore arriving at the claimed flow of the first fluid characterized by inertial forces dominating viscous forces of the first fluid, with a reasonable expectation of successfully obtaining the desired bioprinting results. See MPEP 2144.05. "[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 (CCPA 1955).
Regarding Claim 2 Ozbolat discloses wherein flowing the first fluid in the flow direction comprises accelerating a velocity of the first fluid in the flow direction as the first fluid flows downstream in the flow direction (Figure 21 showing first fluid passes through a narrow volume through coaxial nozzle which causing its velocity to increase as acceleration is typically driven by changes in the pipe or channel's geometry).
Regarding Claim 3 Ozbolat discloses wherein accelerating the velocity of the first fluid in the flow direction as the first fluid flows downstream in the flow direction comprises providing a shape of the first conduit to have a cross- sectional area that decreases in the flow direction (Figure 21).
Regarding Claim 4 Ozbolat discloses wherein flowing the second fluid in the flow direction comprises accelerating a velocity of the second fluid in the flow direction as the second fluid flows downstream in the flow direction (Figure 21 showing secon fluid passes through a narrow volume through coaxial nozzle which causing its velocity to increase as acceleration is typically driven by changes in the pipe or channel's geometry).
Regarding Claim 5 Ozbolat discloses wherein accelerating the velocity of the second fluid in the flow direction as the second fluid flows downstream in the flow direction comprises providing a shape of the second conduit to have a cross- sectional area that decreases in the flow direction.
Regarding Claim 11 Ozbolat discloses crosslinker flow containing calcium chloride solution reads on the claimed first fluid), flowing a second fluid in a flow direction in a second conduit in the apparatus (Figure 21, [0124]; the biomaterial flow containing sodium alginate solution reads on the claimed second fluid), wherein flowing the second fluid comprises creating a two-dimensional flow where the second fluid has a velocity with a lateral and longitudinal component prior to the interface region (Figure 21, with inclined holding chamber for the second fluid where the flow rate will have X-Y (lateral and longitudinal) component).
Regarding Claim 13 Ozbolat discloses positioning the apparatus to incline upwards such that a second longitudinal end of the apparatus is laterally located higher than a first longitudinal end of the apparatus. (Figure 21, the second longitudinal end pertains to second solution holding container and first longitudinal end corresponds to first solution holding chamber).
Regarding Claims 14 and 15 Ozbolat discloses a method of moving materials to create a reaction product in a multilayer extrusion reactor apparatus, but did not disclose that creating the reaction product comprises creating the reaction product with a transverse dimension of 0.1m to 10m a lateral dimension of 0.1cm to 30cm at a rate in the longitudinal dimension of 0.1m/s to 50m/s and the method creating the reaction product comprises creating the reaction product with a transverse dimension of 30cm a lateral dimension of 0.5mm at a rate in the longitudinal dimension of 20cm/s or more. However, Where 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. It would have been obvious to one having ordinary skill in the art to have determined the optimum values of the relevant process parameters through routine experimentation in the absence of a showing of criticality as desired in the claimed range. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235. See MPEP 2144.05 II
Claim(s) 6-9, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ozbolat et al (US 20160288414 A1) in view of McQuade (US 20090273105).
Regarding Claim 6 Ozbolat discloses first and second conduits to provide an interface region between the first and second fluids (Figure 21 showing the first and second fluids have a contact region as the interface region) but did not disclose that wherein the interface region is located at least in part in a third conduit. In the related field of endeavor pertaining to the art, McQuade discloses the interface region is located at least in part in a third conduit (Figure 5, 7, [0030], [0031], [0041], [0042], microreactor has the central conduit considered as the third conduit ).
Further, Ozlobat discloses the method comprises accelerating a velocity of the reaction product in the flow direction as the reaction product flows downstream in the flow direction (Figure 21 showing fluid passes through a narrow volume through coaxial nozzle which causing its velocity to increase as acceleration is typically driven by changes in the pipe or channel's geometry).
It would be obvious for one ordinary skilled in the art to combine Ozlobat’s teaching with that of McQuade’s third interfacial conduit for enhancing the contact between two fluids for increasing interfacial surface area.
Regarding Claim 7 Ozlobat discloses the method comprises accelerating a velocity of the reaction product in the flow direction as the reaction product flows downstream in the flow direction (Figure 21 showing fluid passes through a narrow volume through coaxial nozzle which causing its velocity to increase as acceleration is typically driven by changes in the pipe or channel's geometry) but did not disclose that wherein accelerating the velocity of the reaction product in the flow direction as the reaction product flows downstream in the flow direction comprises providing a shape of the third conduit to have a cross-sectional area that decreases in the flow direction. In the related field of endeavor pertaining to the art, McQuade discloses the interface region is located at least in part in a third conduit (Figure 5, 7, [0030], [0031], [0041], [0042], microreactor has the central conduit considered as the third conduit ). Mcquade didn’t disclose particularly the shape of third conduit to have a cross-sectional area that decreases in the flow direction; however the court held that the configuration of the claimed container was found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. In re Dailey, 357 F.2d 669,149 USPQ47 (CCPA 1966). SEE MPEP 2144.04 1V
Regarding Claim 8 Ozlobat/McQuade disclose wherein the interface region is located at least in part in a third conduit (Figure 5, 7, [0030], [0031], [0041], [0042], microreactor has the central conduit considered as the third conduit, McQuade) and McQuade didn’t particularly disclose that the method comprises flowing the reaction product with a constant velocity in the flow direction as the reaction product flows downstream in the flow direction. However, the fluids in the microreactor after the reaction occurs exit out the port could have constant velocity based on the geometry of the third conduit and the exit port as fluid velocity is determined by the flow rate and the pipe's cross-sectional area: so keeping the flow rate and the cross sectional area constant throughout the process will yield a constant velocity.
It would be obvious for one ordinary skilled in the art to combine Ozlobat’s teaching with that of McQuade’s third interfacial conduit flowing the reaction product with a constant velocity in the flow direction for the purpose of homogenous mixing in the reactor.
Regarding Claim 9 Ozlobat discloses wherein the interface region is located at or downstream of a slice of the apparatus (Figure 21). McQuade disclose wherein the interface region is located at least in part in a third conduit (Figure 5, 7, [0030], [0031], [0041], [0042], McQuade didn’t particularly disclose that the method comprises flowing the reaction product with a constant velocity in the flow direction as the reaction product flows downstream in the flow direction. However, the fluids in the microreactor after the reaction occurs exit out the port could have constant velocity based on the geometry of the third conduit and the exit port as fluid velocity is determined by the flow rate and the pipe's cross-sectional area: so keeping the flow rate and the cross sectional area constant throughout the process will yield a constant velocity.
It would be obvious for one ordinary skilled in the art to combine Ozlobat’s teaching with that of McQuade’s third interfacial conduit flowing the reaction product with a constant velocity in the flow direction for the purpose of homogenous mixing in the reactor.
Regarding Claim 16 Ozbolat discloses a method of moving materials to create a reaction product in a multilayer extrusion reactor apparatus, the method comprising: flowing a first fluid in a flow direction in a first conduit in the apparatus (Figure 21, [0124], crosslinker flow containing calcium chloride solution reads on the claimed first fluid), flowing a second fluid in a flow direction in a second conduit in the apparatus (Figure 21, [0124]; but did not disclose that one or both of the first fluid and the second fluid further comprise additives. In the related field of endeavor pertaining to the art, McQuade discloses wherein one or both of the first fluid and the second fluid further comprise additives and aligning the additives by accelerating one or both of the first fluid and the second fluid (Figure 3, [0015], showing solute particle s are added in the fluid; Figure 5 showing pumps are used to accelerate and inject the fluids in the reactor).
It would be obvious for one ordinary skilled in the art to combine the teaching of Ozbolat with that of McQuade’s teaching of adding solute to the fluid for the purpose of improving rheological properties in the reaction product.
Claim(s) 10, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ozbolat et al (US 20160288414 A1) in view of Cronin (US 20150010461)
Regarding Claim 10 Ozbolat discloses a method of moving materials to create a reaction product in a multilayer extrusion reactor apparatus, the method comprising: flowing a first fluid in a flow direction in a first conduit in the apparatus (Figure 21, [0124], but did not disclose that flowing the first fluid comprises creating a two-dimensional flow where the first fluid has a velocity with a lateral and longitudinal component prior to the interface region. In the related field of endeavor pertaining to the art, Cornin discloses inclined solution holding chamber where the first fluid is placed (Figure 1C, [0428], with inclined holding chamber for the second fluid where the flow rate will have X-Y (lateral and longitudinal) component)
It would be obvious for one ordinary skilled in the art to combine Ozlobat’s teaching with that of Cornin’s inclined holding chamber for the purpose of facilitating emptying the holding chamber from the fluid solution so that any residual waste is minimized before entering the mixing chamber.
Regarding Claim 12 Ozbolat discloses a method of moving materials to create a reaction product in a r extrusion reactor apparatus, the method comprising: flowing a first fluid in a flow direction in a first conduit in the apparatus (Figure 21, [0124]), but did not disclose that flowing the reaction product such that the reaction product has a two- dimensional flow that has a velocity with a lateral and longitudinal component. In the related field of endeavor pertaining to the art, Cornin discloses channel path could have 2-D configuration, which could have a two-dimensional flow for the reaction product ([0079]-[0080]).
It would be obvious for one ordinary skilled in the art to combine Ozlobat’s teaching with that of Cornin’s two-dimensional flow of the reaction product for the purpose of complex fluid interactions for optimizing product yield.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ozbolat et al (US 20160288414 A1) in view of CN 111269438 hereinafter CN’438, translation attached.
Regarding Claim 17, Ozbolat discloses a method of moving materials to create a reaction product in an extrusion reactor apparatus but did not disclose that creating the reaction product comprises strain hardening the reaction product. In the related field of endeavor pertaining to the art, CN’438 discloses creating the reaction product comprises strain hardening the reaction product (page -2, translated).
It would be obvious for one ordinary skilled in the art to combine Ozlobat’s teaching with that of CN’438 teaching for the purpose of controlling the regulation and control of the modulus transition of the material (page-2, translated)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBJANI ROY whose telephone number is (571)272-8019. The examiner can normally be reached 9:30-5:30 pm.
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/DEBJANI ROY/Examiner, Art Unit 1741
/ALISON L HINDENLANG/Supervisory Patent Examiner, Art Unit 1741
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