Detailed Action
The communications received 07/02/2024 have been filed and considered by the Examiner. Claims 1-23 are pending.
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 .
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.
Claims 1-23 are 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 the limitation "the material". There is insufficient antecedent basis for this limitation in the claim. In addition it is unclear if this limitation is meant to refer to “the solidifying material” or a new material. For purposes of examination this is understood to refer to “the solidifying material”. Claims 2-23 are similarly rejected as dependent claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10, 14, 16, 19, 21, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Angellini et al (US 2018/0021140 cited by the Applicant in the IDS filed 07/15/2025) hereinafter ANG.
As for claim 1, ANG teaches a method of making a three-dimensional object (a tissue) [Abstract], the method comprising:
A) positioning a nozzle (an injector) [Fig. 9 #950; 0115] within a carbomer gel [Fig. 11 #1150] inside a container [Fig. 11 #1110] of carbomer gel [0120];
B) changing a position of the nozzle within the carbomer gel while depositing solidifying material which becomes part of the three-dimensional object, through the nozzle, whereby the carbomer gel supports the solidifying material at the position at which the solidifying material is deposited, which is suspended within the carbomer gel [0120-123],
Wherein changing a speed of changing position of the nozzle comprises changing the volume of the material extruded per unit distance traveled as interrelated process variables (as the feature width is controlled via a combination of flow rate and tip speed, the flow rate understood to be the material extruded per unit distance, i.e. the amount that flows out) [0156]; and
C) solidifying the solidifying material in the carbomer gel to form a solid material [0118-122], the solid material being a three-dimensional object, wherein the carbomer gel does not scar (as it has appropriate yield stress characteristics which prevent ‘crevasses’) [0091], and wherein the carbomer gel is a water-based gel [0103-104].
As for claim 2, ANG teaches claim 1 and further wherein the nozzle is affixed to a multi-axis machine [Fig. 11 #1090] and wherein changing the position of the nozzle through the carbomer gel comprises moving one or more axes of the multi-axis machine to which the nozzle is affixed (xyz positioner understood to be mislabeled from 1190 as 1090) [0118-119].
As for claim 3, ANG teaches claim 1 and wherein depositing the solidifying material through the nozzle further comprises varying a rate at which the solidifying material is deposited (in order to control feature width flow rate is controlled) [0156].
As for claim 4, ANG teaches claim 1, and as the tip speed along with the flow rate are used to control the feature width, the position of the nozzle would change at varying speeds to accomplish the desired feature width [0156].
As for claim 5, ANG teaches claim 1, and that the container’s position can be altered via a platform [0119].
As for claim 6, ANG teaches claim 1 and wherein solidifying the solidifying material comprises exposing the solidifying material to light or heat (heating to crosslink or UV irradiation) [0137].
As for claim 7, ANG teaches claim 1 and although ANG does not explicitly mention allowing the solidifying material to cool, there is the use of heat to cross-link the solidifying material [0137]. As ANG is silent to any further additions of heat, it is understood that once heated for crosslinking, after crosslinking, the already extruded material would be allowed to cool as no further heating would need to be applied.
As for claim 8, ANG teaches claim 1, and wherein solidifying the solidifying material comprises exposing the solidifying material to light while depositing the solidifying material (as UV light is used, it is understood that the curing can occur simultaneously during deposition as “The acts performed as part of the method may be ordered in any suitable way… which may include performing some acts simultaneously…) [0082; 0161-162; 0333].
As for claim 9, ANG teaches claim 1 wherein the solidifying material is a polymer [0137].
As for claim 10, ANG teaches claim 9, and as the limitation pertaining to the rubber is further limiting an option of claim 9, it is understood that by not teaching the optional limitation of a rubber while still teaching any one of the other options of materials that the claim is met by ANG.
As for claim 14, ANG teaches claim 1 and the carbomer gel is understood to be a suspension (that includes microgels) [0075; 0087; 0100].
As for claim 16, ANG teaches claim 1 and as the nozzle is a needle, is it understood that the tip is substantially circular shaped [0081].
As for claim 19, ANG teaches claim 1 and as the positioner is an XYZ positioner that can work with a platform that can use relative rotation it is understood that throughout the translation of the needle for the 3D printing process that for at least a portion of time at least 3-4 axes of movement (XYZ and an axis of rotation) [0120] would be used which falls within the claimed range of 3-8 axes [0120].
As for claim 21, ANG teaches claim 1 and as the positioner is an XYZ positioner that can work with a platform that can use relative rotation it is understood that throughout the translation of the needle for the 3D printing process that for at least a portion of time at least 3-4 axes of movement (XYZ and an axis of rotation) [0120] would be used which falls within the claimed range of 3-6 axes [0120].
As for claim 23, ANG teaches claim 1 and that the position of the nozzle is changed to deposit solidifying material onto, around, or within another object with the carbomer gel (cells with solidifying material may be deposited around, within, onto, etc. as well as solidifying material can be deposited around, within, and onto already deposited solidified solidifying material, the Examiner notes that the needle is depicted injecting into an already formed substrate) [Fig.11 #1150 into 1160; Abstract; 0013; 0058; 0062].
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) 15 and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over ANG.
As for claim 15, ANG teaches claim 1 but does not teach that the carbomer gel has a viscosity between about 20,000-50,000 centipoise. However, ANG does teach that in order to prevent scarring (crevasses) that a material with low yield stress is required and that one of the variables which determines the yield stress is the viscosity [0085-86; 0091]. Therefore the viscosity is a routinely optimized variable.
In accordance with the MPEP, a routine optimization of variables to find workable ranges is prima facie obvious [MPEP 2144.05(II)].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived to range of 20,000-50,000 centipoise as this would have amounted to a routine optimization of the viscosity as it relates to the yield stress in order to have a Carbomer gel which will not acquire defects during the additive manufacturing process such as crevasses.
As for claims 20-22, ANG teaches claim 1 and as the positioner to position the nozzle is an XYZ positioner that can work with a platform that can use relative rotation it is understood that throughout the translation of the needle for the 3D printing process that for at least a portion of time at least 3-4 axes of movement (XYZ and an axis of rotation) [0120] however it does not teach that the simultaneous changing of the position would occur in greater than 5-8 axes (as required by claim 20) or in 6 axes (as required by claims 21-22).
However, ANG does teach that the key to “creating any shape desired” is the ability for the platform to drive the first material and XYZ positioner to drive the needle to be able to move relative to each other and thereby cause relative simultaneous displacement [0120].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have added more axes of motion to the platform in order to increase the relative simultaneous displacement and thereby allow for more custom desired shapes. As the maximum amount of axes of freedom possible for the platform are five (two rotational, and then xyz translation) this would result in a total number of axes of 8 which would result in a range of 3-8 axes of movement during the printing process which overlaps the claimed ranges.
In accordance with the MPEP, ‘ In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)’ therefore the overlapping range is obvious [see e.g. MPEP 2144.05(I)].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over ANG in view of Stieghorst et al (US 2017/0203509) hereinafter STI.
As for claim 11, ANG teaches claim 1 and a goal to produce tissue implants [0066]. However a hardness is not specified.
STI teaches that when additively manufacturing implants, that an acceptable Shore hardness is one that ranges from 10-90 Shore A (As Shore 00-10 pertains to very soft squishy materials and Shore 90D pertains to very hard rigid materials, Shore A is understood to be between the two as pertaining to flexible and elastic) [0011]. This allows for the production of an implant that has an appropriate hardness that is biocompatible [0008-11].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have used the Shore hardness of STI as the hardness of ANG as STI that this hardness range is used for implants which are biocompatible. As both STI and ANG pertain to the art of additive manufacturing of implants, they are analogous art and one of ordinary skill in the art expects success in the combination.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over ANG in view of Wendt (DE102016211472A1 refer to the supplied English translation) hereinafter WEN.
As for claim 12, ANG teaches claim 1 and a desire to product biosimilar implants [] but does not teach foam.
WEN teaches that one manner of producing bone implants (i.e. a component with controlled porosity) is by additively manufacturing with foam [0005; 0007].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have added the capability to extrude foaming components as taught by WEN to the implant producing process of ANG in order to allow ANG to produce implants such as bone. As both WEN and ANG pertain to the art of additive manufacturing of implants, they are analogous art and one of ordinary skill in the art expects success in the combination.
As for claim 13, ANG/WEN teaches claim 12 and although the combination fails to teach an exact density, it does teach that porosity (i.e. density) is optimized in order to better achieve a desired stiffness without adding too much additional weight [0042]. Therefore the density is a routinely optimized variable. In accordance with the MPEP, a routine optimization of variables to find workable ranges is prima facie obvious [MPEP 2144.05(II)].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived to range of 3-30 Ib/cubed feet as this would have amounted to a routine optimization of the density in order to achieve a desired stiffness without adding too much weight.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over ANG in view of Lewis et al (US 2018/0133670) hereinafter LEW.
As for claim 17, ANG teaches claim 1 but does not teach the solidifying material comprising two co-polymerizing compounds.
LEW teaches a method of additive manufacturing that comprise a wide variety of material properties [Abstract]. In LEW, two co-polymerizing compounds (two-part epoxy) are mixed in the nozzle [Fig. 1 #110 and 120; 0032; 0045] and deposited [0084]. LEW utilizes this material as one of many other materials in order to add functionality to devices including cell-laden tissue constructs [0029].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have added the features of LEW and the two co-polymerizing compounds of LEW in ANG in order to further imbue ANG’s tissue constructs with added functionality. As both LEW and ANG include additive manufacturing of tissue constructs, they are analogous art and one of ordinary skill in the art expects success in the combination.
As for claim 18, ANG/LEW teach claim 17 and in order for ANG/LEW to function they must include the features of LEW which allow the mixing which are a mixing portion in a nozzle in which the two compounds are mixed during their deposition [Fig. 1 #110-120; 0031-33; 0045].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12,042,999 hereinafter ‘999. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Claim 1 of ’999 discloses the method steps of claim 1.
Claim 2 of ‘999 discloses the method step of claim 2.
Claim 3 of ‘999 discloses the method step of claim 3.
Claim 4 of ‘999 discloses the method step of claim 4.
Claim 5 of ‘999 discloses the method step of claim 5.
Claim 6 of ‘999 discloses the method step of claim 6.
Claim 7 of ‘999 discloses the method step of claim 7.
Claim 8 of ‘999 discloses the method step of claim 8.
Claim 9 of ‘999 discloses the method step of claim 9.
Claim 10 of ‘999 discloses the method step of claim 10.
Claim 11 of ‘999 discloses the method step of claim 11.
Claim 12 of ‘999 discloses the method step of claim 12.
Claim 13 of ‘999 discloses the method step of claim 13.
Claim 14 of ‘999 discloses the method step of claim 14.
Claim 15 of ‘999 discloses the method step of claim 15.
Claim 16 of ‘999 discloses the method step of claim 16.
Claim 17 of ‘999 discloses the method step of claim 17.
Claim 18 of ‘999 discloses the method step of claim 18.
Claim 19 of ‘999 discloses the method step of claim 19.
Claim 20 of ‘999 discloses the method step of claim 20.
Claim 21 of ‘999 discloses the method step of claim 21.
Claim 22 of ‘999 discloses the method step of claim 22.
Claim 23 of ‘999 discloses the method step of claim 23.
Conclusion
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/ELISA H VERA/ Examiner, Art Unit 1748