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 light of the preliminary amendments to the claims filed 01/24/2025 wherein claim 1 was cancelled and claims 2-21 were added, claims 2-21 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a continuation of U.S. App. no. 18/220,543 filed 07/11/2023 and 15/572,267 filed 11/07/2017 which is a 371 of PCT/US2016/031503 filed 05/09/2016 which claims priority to U.S. Provisional App. no. 62/158,226 filed 05/07/2015.
Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112(a) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. V. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 62/158,226, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed application does not provide support in the specification for the limitations of claims 2-21 in the instant application. Regarding independent claims 2 and 8, Application no. '226 does not provide support for the structure of the removable tissue containment insert. Claims 3-7 and 9-21 do not receive priority by depending upon a claim that does not receive priority.
Claims 2-21 receive priority to the prior-filed application, filed on 05/09/2016.
Claim Objections
Claims 5 and 18 are objected to because of the following informalities:
Claim 5 recites the limitation “member grabble onto by a user” in ln. 4. This should read “member grabbable onto by a user”.
Claim 18 similarly recites the limitation “member grabble onto by a user” in ln. 3-4. This should read “member grabbable onto by a user”.
Appropriate correction is required.
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.
Claims 12 and 13 are 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 12 recites the limitation “disconnecting the suction line from the suction port and draining liquids including bone marrow from the internal reservoir of the tissue collection container through the suction port while the cap remains secured to the tissue collection container and while the tissue containment insert remains received in the internal reservoir of the tissue collection container”. The Applicant’s specification fails to disclose the steps of the method as claimed above, specifically disconnection of the suction line to drain the tissue collection container while the cap and tissue containment insert stay in place.
Claim 13 is rejected for depending upon a rejected claim.
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 2-21 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.
Claims 2 and 8 recite the limitation “the distal containment region” in ln. 18. There is insufficient antecedent basis for this limitation in the claims. For the sake of compact prosecution, the examiner is treating any recitation of the distal containment region as the bone containment region previously recited in claims 2 and 8.
Claims 3-7 and 9-21 are rejected for depending upon rejected base claims.
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 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.
Primary art: WO/2013/165616 A1 to Budyansky
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Ex. Fig. 1-2 of Budyansky Fig. 1 and 8E
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Ex. Fig. 3 of Budyansky Fig. 8B
Claims 2-11, 14-15, and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over WO/2013/165616 A1 to Budyansky, in view of U.S. Patent no. 8,840,614 B2 to Mikhail.
Regarding claim 2, Budyansky discloses a bone harvesting device (Fig. 1, bone harvesting device; Fig. 8-8A, bone harvesting device of Fig. 1 comprising plunger/tissue containment insert 25; Fig. 8B-E, bone harvesting device of Fig. 1 comprising a different embodiment of plunger/tissue containment insert 11 as plunger/tissue containment insert 803; para. 0040-0043; para. 0046-0048), comprising:
a hollow shaft (Fig. 1, hollow shaft 3; Ex. Fig. 2);
a tissue collection container coupled to a proximal end of the hollow shaft, the tissue collection container including an opening therein that opens to an internal reservoir of the tissue collection container, wherein, in use of the bone harvesting device, applying a suction force to the internal reservoir can draw harvested bone into the internal reservoir through the hollow shaft (Fig. 1, tissue collection container 2 coupled to proximal end of hollow shaft 3 at entry port 6; Ex. Fig. 1 showing proximal opening that opens to internal reservoir of tissue collection container 2; Ex. Fig. 2; para. 0040-0043);
a tissue containment insert received in the internal reservoir of the tissue collection container and removable therefrom through the opening (Fig. 1, tissue containment insert 11 received within tissue collection container 2; Fig. 8A showing tissue containment insert 25 removable through proximal opening; Ex. Fig. 2-3, tissue containment insert 803; para. 0040-0043; para. 0046-0048), the tissue containment insert including a distal wall section, a proximal wall section, and a longitudinally-extending side wall section that extends between the distal wall section and the proximal wall section to establish a bone containment region in the tissue containment insert for collecting bone between the distal wall section and the proximal wall section, the bone containment region including a closed first side that is provided by the longitudinally-extending side wall section and an open second side that allows for removal of harvested bone from the bone containment region (Fig. 8, tissue containment insert 25 comprising plunger plate/distal wall section 26 comprising hole 27; Fig. 8C-D, bone collected between walls of plunger 803; Ex. Fig. 3, distal wall section 26, stop disc/proximal wall section 801, longitudinally extending sidewall section made from section of grabbable extension member between distal wall section 26 and proximal wall section 801, bone containment region comprising closed first side of longitudinally extending sidewall section and opposite side opening; para. 0046-0048), wherein the distal wall section includes a hole therein that communicates with the hollow shaft when the tissue containment insert is received in the internal reservoir of the tissue collection container to permit harvested bone to move into the distal containment region from the hollow shaft (Fig. 8, tissue containment insert 25 comprising distal wall section comprising hole 27; Ex. Fig. 3; para. 0046-0048), and wherein a vent hole is located in at least one of the proximal wall section and the longitudinally-extending side wall section of the tissue containment insert (Ex. Fig. 3, hole in proximal wall section 801); and
a cap removably secured to the tissue collection container over the opening in the tissue collection container (Fig. 1, cap 8 removably secured to tissue collection container 2 over the proximal opening; Ex. Fig. 2; para. 0047).
Budyansky differs from the instantly claimed invention in that Budyansky fails to disclose a plurality of vent holes explicitly sized to permit fluids to pass therethrough while keeping an amount of harvested bone contained in the distal containment region.
Budyansky discloses a filter covering the suction port designed to allow passage of blood, air, and other fluid and biological materials, but not particles of bone above a certain size (Fig. 1, filter 10 on cap 8; Ex. Fig. 2; Fig. 9, filter 10 on cap 8; para. 0040). Budyansky further discloses that the tissue collection container may be designed for operation without any filter by tuning the suction flow rate and the interior geometry of the tissue collection container to trap bone particles of a particular size range (para. 0049). Further still, Budyansky discloses that the distal containment region is meant to at least partially trap bone particles (para. 0046-0048; Fig. 8C-D).
Mikhail teaches a bone harvesting device comprising a tissue containment insert comprising a plurality of vent holes explicitly sized to permit fluids to pass therethrough while keeping an amount of harvested bone contained in the containment region (col. 3 ln. 57-67 and col. 4 ln. 1-6; col. 4 ln. 26-54; Fig. 1-2, tissue containment insert comprising holes 158; Fig. 3-5, bone harvesting device 100 comprising tissue containment insert 102).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the proximal wall section of the distal containment region of Budyansky to comprise a plurality of vent holes explicitly sized to permit fluids to pass therethrough while keeping an amount of harvested bone contained in the distal containment region as taught by Mikhail, because Budyansky discloses that the tissue collection container can be modified to trap bone particles of a particular size range and that the distal containment region is meant to trap bone particles (para. 0046-0049; Fig. 8C-D), and Mikhail teaches that providing a plurality of vent holes of a certain size can trap bone particles of a particular size range within a containment region (col. 3 ln. 57-67 and col. 4 ln. 1-6; col. 4 ln. 26-54).
Regarding claim 3, the cited prior art suggests the invention of claim 2. Budyansky further discloses: wherein the cap includes a suction port thereon (Fig. 1, cap 8 comprising suction port 7; Ex. Fig. 2; para. 0040-0043).
Regarding claim 4, the cited prior art suggests the invention of claim 2. Budyansky further discloses: wherein the hole in the distal wall section of the tissue containment insert and the open second side of the distal containment region are separated from one another along an exterior of the tissue containment insert (Ex. Fig. 3).
Regarding claim 5, the cited prior art suggests the invention of claim 2. Budyansky further discloses: wherein the tissue containment insert includes at least a first grabbable extension member extending axially in a proximal direction from the proximal wall section of the tissue containment insert, the first grabbable extension member grabbable onto by a user to facilitate removal of the tissue containment insert from the internal reservoir of the tissue collection container (Ex. Fig. 3, tissue containment insert 803 including first grabbable extension member extending along an axis in a proximal and distal direction from proximal wall section 801; para. 0048; grabbable section of first grabbable extension member extending axially in a proximal direction from proximal wall section 801 when proximal wall section 801 is snapped into slots 802; tissue containment insert is fully capable of being grabbed by a user).
Regarding claim 6, the cited prior art suggests the invention of claim 5. Budyansky further discloses: wherein the first grabbable extension member is positioned entirely within the tissue collection container when the cap is removably secured to the tissue collection container (Fig. 1, plunger 11 positioned entirely within tissue collection container 2 when cap 8 is removably secured; Fig. 8D; Ex. Fig. 3).
Regarding claim 7, the cited prior art suggests the invention of claim 5. Budyansky further discloses: wherein the first grabbable extension member extends non-coaxially with a central longitudinal axis of the tissue containment insert (Ex. Fig. 3, tissue containment insert 803 including first grabbable extension member extending non-coaxially with a central longitudinal axis of tissue containment insert 803).
Regarding claims 8 and 21, Budyansky discloses
(Claim 8) a method of harvesting bone (para. 0040-0043; para. 0046-0048), comprising:
obtaining a bone harvesting device (Fig. 1, bone harvesting device; Fig. 8-8A, bone harvesting device of Fig. 1 comprising plunger/tissue containment insert 25; Fig. 8B-E, bone harvesting device of Fig. 1 comprising a different embodiment of plunger/tissue containment insert 11 as plunger/tissue containment insert 803; para. 0040-0043; para. 0046-0048), the bone harvesting device comprising:
a hollow shaft (Fig. 1, hollow shaft 3; Ex. Fig. 2);
a tissue collection container coupled to a proximal end of the hollow shaft, the tissue collection container including an opening therein that opens to an internal reservoir of the tissue collection container (Fig. 1, tissue collection container 2 coupled to proximal end of hollow shaft 3 at entry port 6; Ex. Fig. 1 showing proximal opening that opens to internal reservoir of tissue collection container 2; Ex. Fig. 2; para. 0040-0043);
a tissue containment insert received in the internal reservoir of the tissue collection container and removable therefrom through the opening (Fig. 1, tissue containment insert 11 received within tissue collection container 2; Fig. 8A showing tissue containment insert 25 removable through proximal opening; Ex. Fig. 2-3, tissue containment insert 803; para. 0040-0043; para. 0046-0048), the tissue containment insert including a distal wall section, a proximal wall section, and a longitudinally-extending side wall section that extends between the distal wall section and the proximal wall section to establish a bone containment region in the tissue containment insert for collecting bone between the distal wall section and the proximal wall section, the bone containment region including a closed first side that is provided by the longitudinally-extending side wall section and an open second side that allows for removal of harvested bone from the bone containment region (Fig. 8, tissue containment insert 25 comprising plunger plate/distal wall section 26 comprising hole 27; Fig. 8C-D, bone collected between walls of plunger 803; Ex. Fig. 3, distal wall section 26, stop disc/proximal wall section 801, longitudinally extending sidewall section made from section of grabbable extension member between distal wall section 26 and proximal wall section 801, bone containment region comprising closed first side of longitudinally extending sidewall section and opposite side opening; para. 0046-0048), wherein the distal wall section includes a hole therein that communicates with the hollow shaft when the tissue containment insert is received in the internal reservoir of the tissue collection container to permit harvested bone to move into the distal containment region from the hollow shaft (Fig. 8, tissue containment insert 25 comprising distal wall section comprising hole 27; Ex. Fig. 3; para. 0046-0048), and wherein a vent hole is located in at least one of the proximal wall section and the longitudinally-extending side wall section of the tissue containment insert (Ex. Fig. 3, hole in proximal wall section 801); and
a suction port in communication with the internal reservoir of the tissue collection container (Fig. 1, cap 8 comprising suction port 7; Ex. Fig. 2; para. 0040-0043);
connecting a suction line to the suction port (para. 0040-0043);
advancing a distal end of the hollow shaft through an access hole in cortical bone and into contact with harvestable bone (Fig. 1-2, distal end 5 of hollow shaft 5 advanced through hole in cortical bone 13 and into contact with cancellous bone 14; para. 0006; para. 0040-0043); and
applying suction to the internal reservoir via the suction line to draw harvested bone into the internal reservoir through the hollow shaft (para. 0040-0043);
(Claim 21) wherein the vent hole is located in the proximal wall section of the tissue containment insert (Fig. 8, tissue containment insert 25 comprising distal wall section comprising hole 27; Ex. Fig. 3, hole in proximal wall section 801; para. 0046-0048).
Budyansky differs from the instantly claimed invention in that Budyansky fails to disclose (Claims 8 and 21) a plurality of vent holes explicitly sized to permit fluids to pass therethrough while keeping an amount of harvested bone contained in the distal containment region.
Budyansky discloses a filter covering the suction port designed to allow passage of blood, air, and other fluid and biological materials, but not particles of bone above a certain size (Fig. 1, filter 10 on cap 8; Ex. Fig. 2; Fig. 9, filter 10 on cap 8; para. 0040). Budyansky further discloses that the tissue collection container may be designed for operation without any filter by tuning the suction flow rate and the interior geometry of the tissue collection container to trap bone particles of a particular size range (para. 0049). Further still, Budyansky discloses that the distal containment region is meant to at least partially trap bone particles (para. 0046-0048; Fig. 8C-D).
Mikhail teaches a bone harvesting device comprising a tissue containment insert comprising a plurality of vent holes explicitly sized to permit fluids to pass therethrough while keeping an amount of harvested bone contained in the containment region (col. 3 ln. 57-67 and col. 4 ln. 1-6; col. 4 ln. 26-54; Fig. 1-2, tissue containment insert comprising holes 158; Fig. 3-5, bone harvesting device 100 comprising tissue containment insert 102).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the proximal wall section of the distal containment region of Budyansky to comprise a plurality of vent holes explicitly sized to permit fluids to pass therethrough while keeping an amount of harvested bone contained in the distal containment region as taught by Mikhail, because Budyansky discloses that the tissue collection container can be modified to trap bone particles of a particular size range and that the distal containment region is meant to trap bone particles (para. 0046-0049; Fig. 8C-D), and Mikhail teaches that providing a plurality of vent holes of a certain size can trap bone particles of a particular size range within a containment region (col. 3 ln. 57-67 and col. 4 ln. 1-6; col. 4 ln. 26-54).
Regarding claim 9, the cited prior art suggests the invention of claim 8. Budyansky further discloses: wherein the opening in the tissue collection container is located at a proximal end of the tissue collection container (Ex. Fig. 1; Ex. Fig. 2).
Regarding claim 10, the cited prior art suggests the invention of claim 8. Budyansky further discloses: wherein the bone harvesting device further comprises a cap removably secured to the tissue collection container over the opening in the tissue collection container (Fig. 1, cap 8 removably secured to tissue collection container 2 over the proximal opening; Ex. Fig. 2; para. 0047).
Regarding claim 11, the cited prior art suggests the invention of claim 10. Budyansky further discloses: wherein the suction port is on the cap (Fig. 1, cap 8 comprising suction port 7; Ex. Fig. 2; para. 0040-0043).
Regarding claim 14, the cited prior art suggests the invention of claim 8. Budyansky further discloses: wherein the distal containment region has a fixed volume (para. 0048; Ex. Fig. 2-3, distal containment region has a fixed volume when proximal wall section 801 is installed and tissue containment insert 803 is within tissue collection container 2).
Regarding claim 15, the cited prior art suggests the invention of claim 8. Budyansky further discloses: removing harvested bone from the tissue containment insert through the open second side of the distal containment region (para. 0046-0048).
Regarding claim 17, the cited prior art suggests the invention of claim 8. Budyansky further discloses: wherein the hole in the distal wall section of the tissue containment insert and the open second side of the distal containment region are separated from one another along an exterior of the tissue containment insert (Ex. Fig. 3).
Regarding claim 18, the cited prior art suggests the invention of claim 8. Budyansky further discloses: wherein the tissue containment insert includes at least a first grabbable extension member extending axially in a proximal direction from the proximal wall section of the tissue containment insert, the first grabbable extension member grabbable onto by a user to facilitate removal of the tissue containment insert from the internal reservoir of the tissue collection container (Ex. Fig. 3, tissue containment insert 803 including first grabbable extension member extending along an axis in a proximal and distal direction from proximal wall section 801; para. 0048; grabbable section of first grabbable extension member extending axially in a proximal direction from proximal wall section 801 when proximal wall section 801 is snapped into slots 802; tissue containment insert is fully capable of being grabbed by a user).
Regarding claim 19, the cited prior art suggests the invention of claim 18. Budyansky further discloses: wherein, during said applying suction, the first grabbable extension member is positioned entirely within the tissue collection container (Fig. 1, plunger 11 positioned entirely within tissue collection container 2 when cap 8 is removably secured; Fig. 8D; Ex. Fig. 3; para. 0040-0043).
Regarding claim 20, the cited prior art suggests the invention of claim 18. Budyansky further discloses: wherein the first grabbable extension member extends non-coaxially with a central longitudinal axis of the tissue containment insert (Ex. Fig. 3, tissue containment insert 803 including first grabbable extension member extending non-coaxially with a central longitudinal axis of tissue containment insert 803).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Budyansky and Mikhail as applied above, and further in view of U.S. Patent no. 9,581,942 A to Shippert.
Regarding claims 12-13, the cited prior art suggests the method of claim 8.
Budyansky further discloses that removing the tissue containment insert from the internal reservoir of the tissue collection container removes the collected tissue from the container (para. 0046-0048).
The cited prior art differs from the instantly claimed invention in that the cited prior art fail to disclose
(Claim 12) disconnecting the suction line from the suction port and draining liquids including bone marrow from the internal reservoir of the tissue collection container through the suction port while the cap remains secured to the tissue collection container and while the tissue containment insert remains received in the internal reservoir of the tissue collection container; and
(Claim 13) removing the tissue containment insert from the internal reservoir of the tissue collection container through the opening following said draining.
Shippert teaches a method of using a tissue collection aspiration system comprising disconnecting a tissue collection container from suction and draining the tissue collection container while the desired tissue is maintained within the tissue collection container, and removing the desired tissue from the tissue collection container following said draining (col. 25 ln. 54-67 and col. 26 ln. 1-34; Fig. 19A-B, device for collecting tissue 1504 comprising collection bag/tissue collection container 1904 connected to suction 1548; Fig. 20, method for collecting tissue comprising steps of decanting fluids 2008 and removing tissue from tissue collection container 2028). Shippert teaches that draining of the tissue collection container after disconnecting suction decants unwanted fluids from the desired tissue (col. 25 ln. 54-67 and col. 26 ln. 1-34).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Budyansky to further comprise the steps as taught by Shippert, because Shippert teaches that draining of the tissue collection container after disconnecting suction decants unwanted fluids from the desired tissue (col. 25 ln. 54-67 and col. 26 ln. 1-34).
Primary art: US/2007/0203471 A1 to Anspach
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Claims 8-9, 14, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US/2007/0203471 A1 to Anspach, in view of WO/2013/165616 A1 to Budyansky.
Regarding claim 8, Anspach discloses a method of harvesting bone (para. 0016-0023; Fig. 1-3), comprising:
obtaining a bone harvesting device (para. 0016-0023; Fig. 1-3, bone harvesting device 10), the bone harvesting device comprising:
a hollow shaft (para. 0016-0023; Fig. 3, hollow shaft 50);
a tissue collection container coupled to a proximal end of the hollow shaft, the tissue collection container including an opening therein that opens to an internal reservoir of the tissue collection container (para. 0016-0023; Fig. 1-3, tissue collection container 12 coupled to proximal end of hollow shaft 50 at inlet port 32 and comprising opening at proximal end 24 that opens to internal reservoir 14);
a tissue containment insert received in the internal reservoir of the tissue collection container and removable therefrom through the opening (para. 0016-0023; Fig. 2-3, disk/tissue containment insert 16; Ex. Fig. 4), the tissue containment insert including a distal wall section, a proximal wall section, and a longitudinally-extending side wall section that extends between the distal wall section and the proximal wall section to establish a bone containment region in the tissue containment insert for collecting bone between the distal wall section and the proximal wall section, the bone containment region including a closed first side that is provided by the longitudinally-extending side wall section and an open second side that allows for removal of harvested bone from the bone containment region (para. 0016-0023; Ex. Fig. 4, tissue containment insert 16 defines pockets/bone containment regions 22 from distal wall sections to proximal wall sections, bone containment regions have a closed first side at the longitudinally-extending side wall sections and open second sides), wherein the distal wall section includes a hole therein that communicates with the hollow shaft when the tissue containment insert is received in the internal reservoir of the tissue collection container to permit harvested bone to move into the distal containment region from the hollow shaft (para. 0016-0023; Ex. Fig. 4, distal wall section has a single hole between each individual part of the distal wall section in communication with the open second sides of the bone containment regions 22), and wherein a plurality of vent holes is located in at least one of the proximal wall section and the longitudinally-extending side wall section of the tissue containment insert (para. 0007; para. 0016-0023, each pocket 22 includes a plurality of apertures 39 that fluidly connect the pocket 22 with the central passageway 38; Ex. Fig. 4), the plurality of vent holes sized to permit fluids to pass therethrough while keeping an amount of harvested bone contained in the distal containment region (para. 0007; para. 0016-0023, each pocket 22 includes a plurality of apertures 39 that fluidly connect the pocket 22 with the central passageway 38; Ex. Fig. 4); and
a suction port in communication with the internal reservoir of the tissue collection container (para. 0016-0023; Fig. 2-3, outlet/suction port 34 connected to suction pump 52 by suction line 54);
connecting a suction line to the suction port (para. 0022); and
applying suction to the internal reservoir via the suction line to draw harvested bone into the internal reservoir through the hollow shaft (para. 0016-0023).
Anspach differs from the instantly claimed invention in that Anspach fails to disclose advancing a distal end of the hollow shaft through an access hole in cortical bone and into contact with harvestable bone.
Budyansky teaches a bone harvesting method comprising advancing a distal end of a hollow shaft of a bone harvesting device through an access hole in cortical bone and into contact with harvestable bone (para. 0006; para. 0040-0043; Fig. 1-2, distal end 5 of hollow shaft 5 advanced through hole in cortical bone 13 and into contact with cancellous bone 14). Budyansky further teaches that bone grafts are often harvested from cancellous bone and this is accessible through cortical bone (para. 0006; para. 0040-0043).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Anspach to comprise the step as taught by Budyansky, because Budyansky teaches that bone grafts are often harvested from cancellous bone and this is accessible through cortical bone (para. 0006; para. 0040-0043).
Regarding claim 9, the cited prior art suggests the invention of claim 8. Anspach further discloses: wherein the opening in the tissue collection container is located at a proximal end of the tissue collection container (para. 0016-0023; Fig. 1-3, tissue collection container 12 coupled to proximal end of hollow shaft 50 at inlet port 32 and comprising opening at proximal end 24 that opens to internal reservoir 14).
Regarding claim 14, the cited prior art suggests the invention of claim 8. Anspach further discloses: wherein the distal containment region has a fixed volume (para. 0016-0023; Ex. Fig. 4, tissue containment insert 16 defines pockets/bone containment regions 22 from distal wall sections to proximal wall sections, bone containment regions have a closed first side at the longitudinally-extending side wall sections and open second sides).
Regarding claim 16, the cited prior art suggests the invention of claim 8. Anspach further discloses: wherein the hole in the distal wall section of the tissue containment insert and the open second side of the distal containment region form a single continuous opening along an exterior of the tissue containment insert (para. 0016-0023; Ex. Fig. 4, distal wall section has a single hole between each individual part of the distal wall section in communication with the open second sides of the bone containment regions 22 to form single continuous openings for each bone containment region 22).
Regarding claim 18, the cited prior art suggests the invention of claim 8. Anspach further discloses: wherein the tissue containment insert includes at least a first grabbable extension member extending axially in a proximal direction from the proximal wall section of the tissue containment insert, the first grabbable extension member grabbable onto by a user to facilitate removal of the tissue containment insert from the internal reservoir of the tissue collection container (para. 0016-0023; Fig. 2-3, large diameter portion/first grabbable extension member 40 serving as a handle 42 extending along an axis in a proximal direction from proximal wall section of tissue containment insert 16; Ex. Fig. 4; tissue containment insert is fully capable of being grabbed by a user).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US/2006/0056270 A1 to Lee, US/2006/0106353 A1 to Geneve, U.S. Patent no. 4,886,492 A to Brooke each disclose a bone harvesting device comprising a tissue containment insert.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
17 September 2026
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