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 a preliminary amendment on 4/18/2025:
Claims 1-43 have been canceled.
Claims 44-73 have been added.
This application is a continuation of parent application 17/421,047, now US Pat 12,139,821.
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 44-63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,139,821 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the pending application having some of the same features and also broader than that of the claims in the ‘812 patent.
Claims 44-54 corresponds to claims 12-19 of the ‘821 patent.
Claims 55-63 corresponds to claims 1-11 of the ‘821 patent.
Claims 64-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,139,821 B2 in view of AHN (US 2020/0376170 A1).
Claims 1-11 of the ‘812 patent do not claim of a bath proximate to the reservoir to receive the ejected materials so that the polymer can coagulate, precipitate, or cross-link to form a stream of polymeric fibers travel toward a target.
See in AHN, the teaching of spinning with a rotating reservoir in forming a scaffold, see Fig. 1, and wherein, there is further a cross-linking bath [0102-0103], another embodiment of spinning to a precipitation bath [0194], and in [0204] of a wet rotating collection bath.
It would have been obvious for one of ordinary skill in the art to have modified the claimed invention of the ‘812 patent with an additional bath as taught by AHN, wherein it allows for one embodiment in enabling rapid carrier solvent dissolution, and precipitation and stabilization of the protein in their fibrous physiological structures, see [0521].
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) 44, 48-49, and 54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STERN (IT 1135500 B).
Re: 44, the STERN reference teaches of a system, comprising:
a reservoir (5) configured to hold a material including a polymer and rotatable about a rotation axis (see Figs. 1-5), the reservoir including:
an aperture (see apertures noted in marked up Figures below) configured to enable a gas to move through the reservoir; and
an orifice (see orifices noted in the marked up Figures below) disposed in a wall of the reservoir and configured for ejection of the material radially outward through the orifice as a stream during rotation of the reservoir; and
a gas flow source (18) configured to direct a flow of gas through the aperture of the reservoir during rotation of the reservoir, the gas flow source forming a gas flow in a first direction downstream of the reservoir that deflects the stream of material to form a focused stream of polymeric fibers in the first direction, the first direction having an orientation that is within 5 degrees of the rotation axis of the reservoir (see direction of gas flows 18 in the Figures as seen below, both having a first direction that is generally with the rotation axis, see Fig. 1 for the rotation, see near elements 2 and 9).
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Re: 48 (upon 44), wherein the first direction is within 2 degrees of the axis of rotation. (See Fig. 3 of STERN reference, wherein the flow is parallel with the axis and thereby within 2 degrees.)
Re: 49 (upon 44), wherein the first direction is substantially parallel to the axis of rotation. (See Fig. 3 of STERN reference.)
Re: 54 (upon 44), wherein the gas flow in the first direction downstream of the reservoir entrains the stream of material to form the focused stream of polymeric fibers. (See in Figs. 1-5 of the STERN reference, particularly of the gas flow that is downstream of the reservoir.)
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) 45-47, and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over the STERN reference, as applied to claim 44 above.
Re: 45 (upon 44), wherein the gas flow source includes a plurality of gas flow sources having a converging orientation to form the gas flow in the first direction.
STERN fails to teach of plurality of gas flow sources. However, as seen in the teaching by the STERN reference, see Figs. 1-5, wherein the different flows move in a first direction. Regarding the plurality of gas flow sources, these are seen as a duplication of the gas flow source part and it would have been obvious for one of ordinary skill in the art to have modified the STERN reference with such duplication for a multiplied effect of supplying gas.
Re: 46 (upon 44), wherein a total gas flow rate from the gas flow source is controllable to change a distance from the reservoir at which the stream of the polymeric fibers has a tightest focus.
This is seen as an intended use of controlling the gas flow and in which the structure of the STERN reference would be capable of operating in this manner, including teaching of varying the blower fan speed. This intended use does not provide additional structural limitations over the apparatus claims and whereby it would have been obvious for one of ordinary skill in the art for operating the gas flow rate.
Re: 47 (upon 45), wherein the plurality of gas flow sources comprises three gas flow sources. Regarding the plurality of gas flow sources, similar teaching as seen above for claim 45.
Re: 52 (upon 44), wherein the gas flow source is configured to enable control of a rate of flow of the gas to focus a lateral area of deposition of the polymeric fibers as the polymeric fibers travel toward a target. The gas flow rate can be varied as taught by STERN which encompasses the claimed control of the gas flow rate.
Claim(s) 53, 55-57, 59-60, 62-69, and 72-73 is/are rejected under 35 U.S.C. 103 as being unpatentable over the STERN reference as applied to claim 44 above, and further in view of PARKER (US 2015/0354094 A1).
Re: 53 (upon 44), further comprising a target rotation system configured to rotate a three-dimensional target during deposition to deposit the polymeric fibers on more than one side of the target. STERN does not teach of the target rotation system.
See teaching of PARKER of the collection device 106 for collecting of the fiber stream, see [0098-0100], for example listed, a beaker, tub, plate, bobbin, drum, etc, see [0098]. Further, as seen in the teaching of PARKER that includes rotation of the collection device, see [0160, 0166].
It would have been obvious for one of ordinary skill in the art to have modified the STERN reference with collecting the fiber deposition stream on a target rotation system as taught by PARKER, as known manner of collecting the formed fibers, as per KSR, see MPEP 2143, as combining prior art elements according to known methods to yield predictable results.
Re: 55, the claimed method having the limitations similar as those set forth in claim 44, with the additional limitation of collecting the focused fiber deposition stream on a target surface. The STERN reference does not teach of this additional feature.
See teaching of PARKER of the collection device 106 for collecting of the fiber stream, see [0098-0100], for example listed, a beaker, tub, plate, bobbin, drum, etc, see [0098].
It would have been obvious for one of ordinary skill in the art to have modified the STERN reference with collecting the fiber deposition stream on a target surface as taught by PARKER, as known manner of collecting the formed fibers, as per KSR, see MPEP 2143, as combining prior art elements according to known methods to yield predictable results.
Re: 56 (upon 55), wherein the first direction is substantially parallel to the rotation axis of the reservoir. (See Fig. 3 of STERN reference.)
Re: 57 (upon 55), wherein the flow of gas comprises a plurality of flows of gas that converge and form a combined gas flow in the first direction. (See teaching of different flows of gas that combine to a gas flow in the first direction, see Figures 1-5 of the STERN reference.)
Re: 58 (upon 55), a method, wherein the focused fiber deposition stream has a substantially tangential orientation to the target surface during fiber collection. (See teaching by PARKER of the collection device movement in both linearly and rotational, [0160, 0166].)
Re: 59, the STERN reference teaches of a method as described in claim 55.
The STERN reference does not teach of forming a three-dimensional tissue scaffold, and of the method where the target surface is a three-dimensional shape for a tissue scaffold. However, the combined teaching of the STERN reference with PARKER teaches of this formation. (See PARKER teaching of cell-scaffold for the fibers formed, see [0160], of the mesh structure formed.)
Re: 60 (upon 59), further comprising: rotating the target for deposition on more than one side of the three-dimensional shape. (See PARKER [0160], particularly in light of collection device being oscillated, and further of the collection device that can be moved in a rotational manner [0166].)
Re: 62 (upon 55), wherein the target surface is moved linearly during deposition of the fiber. (See teaching by PARKER with the collection device being moved linearly, see [0160, 0166].)
Re: 63 (upon 55), the method, wherein directing the polymeric fiber includes entraining the polymeric fiber. (similar to claim 54.)
Re: 64, a system, similar to that of claim 44, but with the additional limitation of a bath disposed proximate to the reservoir, the bath configured to receive the ejected materials such that the polymer can coagulate, precipitate, or cross-link to form a stream of polymeric fibers. The STERN reference does not teach of this additional feature.
See teaching of PARKER of the liquid 106 and collecting of the fiber stream, with a collection bath for crosslink polymers or proteins or precipitate solid fibers, see [0098, 0105, 0294].
It would have been obvious for one of ordinary skill in the art to have modified the STERN reference with the additional bath as taught by PARKER as it enables for on-contact cross-linking or precipitation to fabricate polymeric fibers from polymer solutions, see [0298].
Re: 65 (upon 64), wherein the gas flow source is configured to enable control of a rate of flow of the gas to focus a lateral area of deposition of the polymeric fibers as the polymeric fibers travel toward a target. (similar to claim 52, see teaching by STERN concerning changing the gas flow rate including varying the blower fan speed.)
Re: 66 (upon 64), the system, further comprising a target rotation system configured to rotate a three-dimensional target during deposition to deposit the polymeric fibers on more than one side of the target. (See PARKER teaching of collection device that includes both linear and rotational movement, which encompasses the claimed target rotation system, [0160, 0166].)
Re: 67 (upon 66), the system, wherein the three-dimensional target is disposed in the bath, the three-dimensional target being at least partially submerged in the bath. (See teaching of PARKER of the collection device 106 that includes liquid.)
Re: 68 (upon 64), wherein a total gas flow rate from the gas flow source is controllable to change a distance from the reservoir at which the stream of polymeric fibers has a tightest focus. (similar to claim 46, includes teaching by STERN of the varying the gas flow by changing the blower fan cell speed.)
Re: 69 (upon 64), wherein the gas flow source includes three gas flow sources. (Similar to teaching of claim 47.)
Re: 72 (upon 64), wherein the gas flow source comprises a plurality of gas flow sources having a converging orientation to form the combined gas flow in a first direction, the first direction being substantially parallel with respect to the rotation axis. (similar to combination of claims 45 and 49.)
Re: 73 (upon 64), wherein the gas flow source is configured to entrain the ejected material in the direction different that the direction of the ejected material. (similar to claims 54 and 63.)
Allowable Subject Matter
Claims 50-51, 61, and 70-71 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art references of the STERN and PARKER references above fail to teach of the particular flow blocking structure that is disposed upstream of the gas flow source of claims 50-51, and 70-71, and lacking the teaching of the partially blocking the flow of gas from upstream of the reservoir to reduce an effect of the airflow upstream of the gas flow source.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMMANUEL S LUK whose telephone number is (571)272-1134. The examiner can normally be reached Monday-Friday 9 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xiao S Zhao can be reached at 571-270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMMANUEL S LUK/Primary Examiner, Art Unit 1744