DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant amended claims 1 and 12-13, canceled claims 5, 6, and 17, and added claims 21-23. Claims 1-4, 7-16, and 18-23 are currently pending.
Response to Arguments
Applicant’s arguments, see page 7 of Applicant’s Remarks, filed 02/03/26, with respect to the rejection of claim 12 under 35 U.S.C. 112(b) as indefinite have been fully considered and are persuasive in light of the amendment to claim 12. Therefore, the rejection has been withdrawn.
Applicant’s arguments, see pages 7-8, with respect to the rejections of claims 1-2, 5, 7-12 under 35 U.S.C. 102(a)(1) as being anticipated by Tessier have been fully considered and are not persuasive.
Applicant argues that Tessier lacks a positioning means that actuates between first and second states, and is merely manipulated from a first state to a second state to affect movement of the inner cannula. Applicant further argues that the movement of the inner cannula is a spiraling movement, which is not translation along the longitudinal axis as claimed. However, as discussed below, because the handle is used to manipulate the position of the aspiration insert, it includes a positioning means. Furthermore, the handle, and therefore its positioning means, is configured to be both axially (or in other words longitudinally) and rotationally movable, and move the aspiration insert along with it (Page 13, lines 8-21). Therefore, when the positioning means of the handle is moved from a first longitudinal or rotational position/state to a second longitudinal or rotational position/state, the aspiration insert would be moved a certain distance in the longitudinal or rotational direction, and when the positioning means of the handle is moved from the second position/state back to the first position/state, the aspiration insert would be moved back that certain distance.
Applicant’s arguments, see pages 8-9, with respect to the rejections of claims 13, 15, 17, and 19-20 under 35 U.S.C. 102(a)(1) as being anticipated by Tessier have been fully considered and are persuasive in light of the amendment to claim 13. Accordingly, the rejections have been withdrawn. However, upon further search and consideration, new grounds of rejection have been made as indicated below.
Applicant’s arguments, see page 10, with respect to the rejections of claims 3-4, 14, and 16 under 35 U.S.C. 103 as being unpatentable over Tessier in view of Cook, of claim 6 as being unpatentable over Tessier in view of Satoh, and of claim 18 as unpatentable over Tessier in view of Kim have been fully considered. Because the rejection of independent claim 1 has been maintained, the rejections of claims 3-4 have also been maintained. In light of the amendment to independent claim 13, new grounds of rejection have been made of claims 14, 16, and 18 as indicated below.
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 19 is 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 19 recites that “the needle includes a third lateral hole and a fourth lateral hole” and that the aspiration insert includes a second aspiration window, such that when the aspiration window is aligned with the first lateral hole, the second aspiration is aligned with the third lateral hole, and when the aspiration window is aligned with the second lateral hole, the second aspiration window is aligned with the fourth lateral hole. Applicant amended independent claim 13, which claim 19 is dependent on, to include a third lateral hole such that the first, second, and third lateral holes are located at equivalent radial positions to each other on the needle. As written in the claims, it is not clear if the third hole recited by claim 19 is intended to be the same as the third hole recited by amended claim 13. As best understood by the examiner based on ¶0032-0038 of the present specification and Figs. 2A-3B, the needle includes holes which have equivalent radial positions at different longitudinal positions, like the holes of claim 13, and additional holes which are rotationally/radially offset from the holes at each longitudinal position such that the multiple aspiration windows of the aspiration insert can aspirate bone marrow from multiple radial positions at each longitudinal position. Therefore, as best understood by the examiner, the third hole recited by claim 19 is not intended to be the same as the third hole recited by amended claim 13. For the purpose of examination, claim 19 was interpreted as though it recited fourth and fifth lateral holes instead of third and fourth lateral holes.
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.
Claims 1-2 and 7-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tessier et al. (WO 2021/151061 A1).
Regarding claim 1, Tessier discloses a surgical device (Figs. 1-3, feat. 10), comprising: a needle (Figs. 1-5, feat. 16; Page 15, lines 12-28) including a plurality of lateral holes defined at different positions longitudinally along a wall of the needle (Figs. 4-5, feat. 42; Page 15, lines 16-20), wherein each lateral hole of the plurality of lateral holes is located a certain distance from at least one adjacent lateral hole of the plurality of lateral holes (Figs. 4-5, feat. 42); an aspiration insert (Figs. 1-3, feat. 20; Figs. 10-14, feat. 70; Page 17, line 9 – Page 19, line 8) including an aspiration window that is sized to interface with one lateral hole of the plurality of lateral holes at a time (Figs. 10B and 14, feat. 76; Page 18, lines 1-16; Page 23, lines 9-15), wherein the aspiration insert is disposed in a lumen of the needle (Page 17, lines 9-12); and a handle including positioning means in communication with the aspiration insert (Figs. 3 and 10A, feat. 24A; Page 14, line 18 – Page 15, line 11; Page 17, lines 9-18; Page 21, lines 22-28: handle 24, 24A is used to manipulate the position of the aspiration stylet, and therefore includes positioning means), wherein the positioning means is configured to actuate between a first state and a second state to translate the aspiration insert a certain distance in a first direction along a longitudinal axis of the needle (Page 13, lines 8-21; Page 21, lines 22-28; Page 23, lines 9-15: handle 24 moves the inner cannula axially and rotationally).
Regarding claim 2, Tessier discloses the device of claim 1. Tessier further discloses that a vacuum source (Figs. 1-3, feat. 28; Col. 14, lines 6-17) is connected to an internal lumen (Figs. 10B-12, feat. 74B) of the aspiration insert to aspirate bone marrow from a patient (Figs. 1-3, feat. 20; Figs. 10-14, feat. 70; Page 17, line 9 – Page 18, line 16). Tessier further discloses that syringes are a conventional vacuum source (Page 1, lines 9-17). Therefore, Tessier further discloses a syringe connected to first end of the aspiration insert opposite to a second end of the aspiration insert inserted in the needle.
Regarding claim 7, Tessier discloses the device of claim 1. Tessier further discloses that the needle further includes an integrated trocar tip (Figs. 4-5, feat. 46; Page 15, lines 13-28).
Regarding claim 8, Tessier discloses the device of claim 1. Tessier further discloses that the needle further includes a gasket around the aspiration window (Figs. 10B and 14 feat. 80; Col. 22, lines 1-13).
Regarding claim 9, Tessier discloses the device of claim 1. Tessier further discloses that the plurality of lateral holes defined at the different positions along the longitudinal axis of the needle is grouped with a second plurality of lateral holes defined at the different positions longitudinally along the needle at a rotational offset around a circumference of the needle relative to the plurality of lateral holes (Figs. 4-5, feat. 42; Page 15, lines 12-28: the apertures 42 may be located at different axial and circumferential positions about the circumference of the outer cannula 16).
Regarding claim 10, Tessier discloses the device of claim 1. Tessier further discloses that the needle further includes a space of given length defined in the lumen between a trocar (Figs. 4-5 and 14, feat. 46; Page 15, lines 13-28) and a first set of lateral holes (Figs. 4-5, feat. 14, feat. 42), wherein the aspiration insert includes a seal spacing tip of the given length between a first end (Figs. 10B and 14, feat. 80) and the aspiration window (Figs. 10B and 14, feat. 76).
Regarding claim 11, Tessier discloses the device of claim 1. As discussed above with respect to claim 2, Tessier further discloses that a vacuum source (Figs. 1-3, feat. 28; Col. 14, lines 6-17) is connected to an internal lumen (Figs. 10B-12, feat. 74B) of the aspiration insert to aspirate bone marrow from a patient (Figs. 1-3, feat. 20; Figs. 10-14, feat. 70; Page 17, line 9 – Page 18, line 16). Tessier further discloses that syringes are a conventional vacuum source (Page 1, lines 9-17). Therefore, Tessier further discloses a negative pressure source connected to the aspiration insert. Tessier does not explicitly disclose a collection container connected to the aspiration insert. However, syringes have an internal volume constituting a container, and if a syringe attached to the aspiration insert is being used to apply negative pressure to aspirate material through the insert, then the material will be drawn into and collected in the internal volume of the syringe. Therefore, the syringe acting as a negative pressure source also acts as a collection chamber. Therefore, Tessier inherently discloses a collection container connected to the aspiration insert. Please see MPEP §2112.
Regarding claim 12, Tessier discloses the device of claim 11. As discussed above, with respect to claim 11, Tessier discloses a syringe connected to the attached to the aspiration insert that acts as a negative pressure source and a collection container. Therefore, Tessier further discloses that the negative pressure source and collection container is a syringe.
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.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Tessier in view of Cook (US 10,485,558 B1).
Regarding claim 3, Tessier discloses the device of claim 1, but does not disclose an impact plate configured to connect to the handle in line with the needle to transfer percussive force applied along the longitudinal axis to a trocar tip of the needle.
Cook teaches a bone or bone marrow harvesting device (Figs. 1-2C, feat. 100; Col. 5, lines 27-55) comprising a needle (Figs. 1 and 6A-C, feat. 140; Col. 5, line 44 – Col. 6, line 5), corresponding to the needle of Tessier (Tessier: Figs. 1-5, feat. 16), which is coupled to a fitting (Figs. 1 and 5A-6C, feat. 130; Col. 7, line 61 – Col. 8, line 23) at its proximal end (Figs. 6A-C, feat. 142). The fitting has an impact surface (Figs. 5A-D, feat. 138; Col. 8, lines 15-23) which is hit with a mallet in order to drive the needle into the patient’s bony tissue (Col. 12, lines 7-17). The fitting further comprises attachment fittings (Figs. 5A-D, feats. 131 and 133) for connecting to handles (Fig. 1, feats. 110 and 150) at its proximal and distal ends (Col. 8, lines 24-36). Tessier discloses that their needle is positioned within the patient at a surgical site (Tessier: Figs. 1-5, feat. 16; Page 19, lines 9-24), but does not disclose how the needle is positioned within the patient. Tessier further discloses that the handle (Tessier: Figs. 1-3 and 10A, feat. 24A) is at the proximal end of the needle (Tessier: 16) and aspiration insert (Tessier: 70). Modifying the needle of Tessier to include a fitting with an impact surface at its proximal as taught by Cook would advantageously enable the needle to be driven into the patient’s tissue using a mallet as taught by Cook. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Tessier so that it includes an impact plate configured to connect to the handle in line with the needle to transfer percussive force applied along the longitudinal axis to a trocar tip of the needle in order to enable the needle to be driven into the patient’s tissue using a mallet as taught by Cook.
Regarding claim 4, Tessier discloses the device of claim 1, but does not disclose an impact plate integrated in the handle to transfer percussive force along the longitudinal axis to a trocar tip of the needle.
Cook teaches a bone or bone marrow harvesting device (Figs. 1-2C, feat. 100; Col. 5, lines 27-55) comprising a needle (Figs. 1 and 6A-C, feat. 140; Col. 5, line 44 – Col. 6, line 5), corresponding to the needle of Tessier (Tessier: Figs. 1-5, feat. 16), which is coupled to a fitting (Figs. 1 and 5A-6C, feat. 130; Col. 7, line 61 – Col. 8, line 23) at its proximal end (Figs. 6A-C, feat. 142). The fitting has an impact surface (Figs. 5A-D, feat. 138; Col. 8, lines 15-23) which is hit with a mallet in order to drive the needle into the patient’s bony tissue (Col. 12, lines 7-17). The fitting further comprises attachment fittings (Figs. 5A-D, feats. 131 and 133) for connecting to handles (Fig. 1, feats. 110 and 150) at its proximal and distal ends (Col. 8, lines 24-36). The handle which attaches to the proximal end (Figs. 1 and 3A-D, feat. 110; Col. 8, lines 24-36) is attached to a plunger insert (Figs. 1 and 4A-B, feat. 120) and includes an impact surface (111; Col. 7, lines 28-38) which may be used to drive an assembled plunger insert (Figs. 2A-C, feat. 120) and needle (140) through the bone using the impacts from a mallet (Col. 11, lines 56-65). Tessier discloses that their needle is positioned within the patient at a surgical site (Tessier: Figs. 1-5, feat. 16; Page 19, lines 9-24), but does not disclose how the needle is positioned within the patient. Tessier further discloses that the handle (Tessier: Figs. 1-3 and 10A, feat. 24A) is at the proximal end of the needle (Tessier: 16) and aspiration insert (Tessier: 70). Modifying the needle of Tessier to include a fitting with an impact surface at its proximal as taught by Cook would advantageously enable the needle to be driven into the patient’s tissue using a mallet as taught by Cook. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Tessier so that it includes an impact plate integrated in the handle to transfer percussive force along the longitudinal axis to a trocar tip of the needle in order to enable the needle to be driven into the patient’s tissue using a mallet as taught by Cook.
Claims 13, 15, and 19-23 rejected under 35 U.S.C. 103 as being unpatentable over Tessier in view of Molmenti et al. (US 2020/0289156 A1).
Regarding claim 13, Tessier discloses a method (Page 19, line 9 – Page 23, line 15) comprising: applying a negative pressure to a first bone marrow collection site (Page 20, line 11 – Page 21, line 21) via an aspiration insert (Figs. 10-14, feat. 70; Page 17, line 9 – Page 19, line 8) having an aspiration window (Figs. 10B and 14, feat. 76; Page 18, lines 1-16; Page 23, lines 9-15) aligned with a first lateral hole (Figs. 4-5 and 14, feat. 42; Page 15, lines 16-20) defined in a needle in which the aspiration insert is disposed (Figs. 4-5, feat. 16); actuating a positioning device between a first state and a second state (Figs. 3 and 10A, feat. 24A; Page 14, line 18 – Page 15, line 11; Page 17, lines 9-18) to retract the aspiration insert by a certain distance relative to the needle while the needle remains stationary relative to the first bone marrow collection site to move the aspiration window by the certain distance and align the aspiration window with a second lateral hole defined in the needle located the certain distance from the first lateral hole (Page 13, lines 8-21; Page 21, lines 22 – Page 22, line 13; Page 23, lines 9-15); and applying the negative pressure to a second bone marrow collection site via the aspiration insert when aligned with the second lateral hole defined in the needle (Page 20, line 11 – 28; Page. 22, lines 1-13; Page 23, lines 9-15), actuating the positioning device between the second state and a third state to retract the aspiration insert to move the aspiration window by the certain distance and align the aspiration window with a third lateral hole defined in the needle located the certain distance from the second lateral hole (Page 20, line 11 – 28; Page. 22, lines 1-13; Page 23, lines 9-15), wherein the first lateral hole, the second lateral hole, and the third lateral hole are located at equivalent radial positions to one another one a wall of the needle (Figs. 4-5, feat 42; Page 15, lines 16-20: apertures/lateral holes 42 can be arranged in any pattern, and a subset have equivalent radial positions in the wall of the needle); and applying the negative pressure to a third bone marrow collection site via the aspiration insert when aligned with the third lateral hole defined in the needle (Page 20, line 11 – 28; Page. 22, lines 1-13).
Tessier does not disclose actuating the positioning device between the first state and the second state to retract the aspiration insert by the certain distance relative to the needle while the needle remains stationary relative to the first bone marrow collection site to move the aspiration insert by the certain distance and align the aspiration window with a third lateral hole defined in the needle located the certain distance from the second lateral hole.
Molmenti teaches positioning devices (Fig. 9, feat. 900; ¶0005-0007, 0023, and 0058-0059) for incrementally advancing or retracting medical instruments with an elongate shaft (20; 0029), such as the aspiration insert of Tessier (Tessier: Figs. 1-3, feat. 20; Figs. 10A-B, feat. 70). The device comprises a positioning trigger (Fig. 9, feat. 64) which is pulled and released, thereby actuating between first and second states, to incrementally advance or retract the instrument (20) depending on whether the forward motion cams (930) or rearward motion cams (940) are actuated (¶0023 and 0058-0059). Molmenti teaches that such an incremental advancement/retraction device improves the control that the surgeon has over the position of the medical instrument (¶0001-0007, 0023, and 0061-0065). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Tessier so that it employs the positioning device taught by Molmenti so that actuating the positioning device between a first state and a second state retracts the aspiration insert by a certain distance relative to the needle to move the aspiration window by the certain distance and align the aspiration window with a second lateral hole defined in the needle located the certain distance from the first lateral hole and actuating the positioning device between the first state and the second state to retract the aspiration insert by the certain distance relative to the needle while the needle remains stationary relative to the first bone marrow collection site to move the aspiration insert by the certain distance and align the aspiration window with a third lateral hole defined in the needle located the certain distance from the second lateral hole in order to provide improved control over the location and motion of the aspiration insert and window relative to the needle as taught by Molmenti.
Regarding claim 15, Tessier in view of Molmenti the method of claim 13. As discussed above with respect to claim 11, Tessier further discloses that a vacuum source (Figs. 1-3, feat. 28; Col. 14, lines 6-17) is connected to an internal lumen (Figs. 10B-12, feat. 74B) of the aspiration insert to aspirate bone marrow from a patient (Figs. 1-3, feat. 20; Figs. 10-14, feat. 70; Page 17, line 9 – Page 18, line 16). Tessier further discloses that syringes are a conventional vacuum source (Page 1, lines 9-17). Therefore, Tessier further discloses that the negative pressure is applied by a syringe via the aspiration insert from the first bone marrow collection site and the second bone marrow collection site. Tessier does not explicitly disclose that the bone marrow aspirate is collected in the syringe applying the negative pressure. However, as discussed above, syringes have an internal volume constituting a container, and if a syringe attached to the aspiration insert is being used to apply negative pressure to aspirate material through the insert, then the material will be drawn into and collected in the internal volume of the syringe. Therefore, the syringe acting as a negative pressure source also acts as a collection chamber. Therefore, Tessier inherently discloses that the bone marrow aspirate is collected in the syringe applying the negative pressure. Please see MPEP §2112.
Regarding claim 19, Tessier in view of Molmenti suggests the method of claim 13. Tessier further disclose that the needle (Figs. 4-5, feat. 16) includes a fourth lateral hole and a fifth lateral hole (Figs. 4-5 and 13, feat. 42; Page 15, lines 16-20) and the aspiration insert (Figs. 10-14, feat. 70) includes a second aspiration window (Figs. 10B and 13, feat. 76; Page 18, lines 1-16; Page 22, line 1 – Page 23, line 24), wherein the second aspiration window is aligned with the fourth lateral hole when the aspiration window is aligned with the first lateral hole and the second aspiration window is aligned with the fifth lateral hole when the aspiration window is aligned with the second lateral hole (Page 23, lines 16-24: Aspiration insert 70 may have a plurality of aspiration windows 76 such that multiple lateral holes 42 at different depths may be simultaneously sampled).
Regarding claim 20, Tessier in view of Molmenti suggests the method of claim 13. Tessier further discloses that the vacuum source (Figs. 1-3, feat. 28; Page 14, lines 6-17) is connected to an internal lumen (Figs. 10B-12, feat. 74B) of the aspiration insert (Figs. 1-3, feat. 20; Figs. 10-14, feat. 70; Page 17, line 9 – Page 18, line 16) opposite from the end of the insert that is within the needle (Fig. 1, feats. 16 and 20). As discussed above with respect to claims 11 and 15, Tessier discloses a syringe as a conventional vacuum source, and inherently discloses that the syringe also acts as a collection container. Therefore, Tessier further discloses attaching a negative pressure source and collection container to a first end of the aspiration insert, wherein a second end of the aspiration insert is disposed in the needle.
Regarding claim 21, Tessier discloses the device of claim 1, but does not disclose that the positioning means is configured to return to the first state from the second state after translating the aspiration insert the certain distance, wherein subsequent actuation of the positioning means from the first state to the second state translates the aspiration insert the certain distance again.
Molmenti teaches positioning devices (Fig. 9, feat. 900; ¶0005-0007, 0023, and 0058-0059) for incrementally advancing or retracting medical instruments with an elongate shaft (20; 0029), such as the aspiration insert of Tessier (Tessier: Figs. 1-3, feat. 20; Figs. 10A-B, feat. 70). The device comprises a positioning trigger (Fig. 9, feat. 64) which is pulled and released, thereby actuating between first and second states, to incrementally advance or retract the instrument (20) depending on whether the forward motion cams (930) or rearward motion cams (940) are actuated (¶0023 and 0058-0059). Molmenti teaches that such an incremental advancement/retraction device improves the control that the surgeon has over the position of the medical instrument (¶0001-0007, 0023, and 0061-0065). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device disclosed by Tessier so that the positioning means is configured to return to the first state from the second state after translating the aspiration insert the certain distance, wherein subsequent actuation of the positioning means from the first state to the second state translates the aspiration insert the certain distance again in order to provide improved control over the location and motion of the aspiration insert and window relative to the needle as taught by Molmenti.
Regarding claim 22, Tessier discloses a surgical device (Figs. 1-3, feat. 10), comprising: a needle (Figs. 1-5, feat. 16; Page 15, lines 12-28) including a first lateral hole, a second lateral hole, and a third lateral hole defined at different positions longitudinally along a wall of the needle and at an equivalent position radially along the wall of the needle, wherein the second lateral hole is disposed between the first lateral hole and the third lateral hole at a predefined distance from the first lateral hole and the predefined distance from the third lateral hole (Figs. 4-5, feat. 42; Page 15, lines 16-20); an aspiration insert (Figs. 1-3, feat. 20; Figs. 10-14, feat. 70; Page 17, line 9 – Page 19, line 8) including an aspiration window that is sized to interface with one lateral hole of the plurality of lateral holes at a time (Figs. 10B and 14, feat. 76; Page 18, lines 1-16; Page 23, lines 9-15), wherein the aspiration insert is disposed in a lumen of the needle (Page 17, lines 9-12); and a handle including positioning means in communication with the aspiration insert (Figs. 3 and 10A, feat. 24A; Page 14, line 18 – Page 15, line 11; Page 17, lines 9-18; Page 21, lines 22-28: handle 24, 24A is used to manipulate the position of the aspiration stylet, and therefore includes positioning means), wherein the positioning means is configured to actuate between a first state and a second state to translate the aspiration insert a certain distance in a first direction along a longitudinal axis of the needle (Page 13, lines 8-21; Page 21, lines 22-28; Page 23, lines 9-15: handle 24 moves the inner cannula axially and rotationally).
Tessier does not disclose that the positioning means is configured to actuate between a first state and a second state such that when the aspiration window interfaces with the first lateral hole when the positioning means is in the first state, the aspiration window interfaces with the second lateral hole when the positioning means is actuated to the second state and when the aspiration window interfaces with the second lateral hole when the positioning means is in the first state, the aspiration window interfaces with the third lateral hole when the positioning means actuates to the second state.
Molmenti teaches positioning devices (Fig. 9, feat. 900; ¶0005-0007, 0023, and 0058-0059) for incrementally advancing or retracting medical instruments with an elongate shaft (20; 0029), such as the aspiration insert of Tessier (Tessier: Figs. 1-3, feat. 20; Figs. 10A-B, feat. 70). The device comprises a positioning trigger (Fig. 9, feat. 64) which is pulled and released, thereby actuating between first and second states, to incrementally advance or retract the instrument (20) depending on whether the forward motion cams (930) or rearward motion cams (940) are actuated (¶0023 and 0058-0059). Molmenti teaches that such an incremental advancement/retraction device improves the control that the surgeon has over the position of the medical instrument (¶0001-0007, 0023, and 0061-0065). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device disclosed by Tessier so that the positioning means is configured to actuate between a first state and a second state such that when the aspiration window interfaces with the first lateral hole when the positioning means is in the first state, the aspiration window interfaces with the second lateral hole when the positioning means is actuated to the second state and when the aspiration window interfaces with the second lateral hole when the positioning means is in the first state, the aspiration window interfaces with the third lateral hole when the positioning means actuates to the second state in order to provide improved control over the location and motion of the aspiration insert and window relative to the needle as taught by Molmenti.
Regarding claim 23, Tessier in view of Molmenti suggests the device of claim 22. Molmenti further teaches that the medical instrument is advanced and retracted incrementally (¶0023). Therefore, Tessier in view of Molmenti further suggests that the aspiration insert is configured to translate within the needle by the predefined distance each time the positioning means is actuated.
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Tessier in view of Molmenti and in further view of Cook.
Regarding claim 14, Tessier in view of Molmenti suggests the method of claim 13, but does not disclose before applying the negative pressure to the first bone marrow collection site: inserting the needle into a bone via percussive force applied to an impact plate connected to a surgical device in which the needle is included and detaching the impact plate from the surgical device once the needle is aligned to position the first lateral hole with the first bone marrow collection site and the second lateral hole with the second bone marrow collection site.
As discussed above, Cook teaches a bone or bone marrow harvesting device (Figs. 1-2C, feat. 100; Col. 5, lines 27-55) comprising a needle (Figs. 1 and 6A-C, feat. 140; Col. 5, line 44 – Col. 6, line 5), corresponding to the needle of Tessier (Tessier: Figs. 1-5, feat. 16), which is coupled to a fitting (Figs. 1 and 5A-6C, feat. 130; Col. 7, line 61 – Col. 8, line 23) at its proximal end (Figs. 6A-C, feat. 142). The fitting has an impact surface (Figs. 5A-D, feat. 138; Col. 8, lines 15-23) which is hit with a mallet in order to drive the needle into the patient’s bony tissue (Col. 12, lines 7-17). The fitting further comprises attachment fittings (Figs. 5A-D, feats. 131 and 133) for connecting to handles (Fig. 1, feats. 110 and 150) at its proximal and distal ends (Col. 8, lines 24-36). The handle which attaches to the proximal end (Figs. 1 and 3A-D, feat. 110; Col. 8, lines 24-36) is attached to a plunger insert (Figs. 1 and 4A-B, feat. 120) and includes an impact surface (111; Col. 7, lines 28-38) which may be used to drive an assembled plunger insert (Figs. 2A-C, feat. 120) and needle (140) through the cortical bone using the impacts from a mallet (Col. 11, lines 56-65). Cook further teaches that the proximal end handle (Figs. 1 and 3A-D, feat. 110) and its corresponding impact surface (111) may be removed once the device is in position in the bone (Col. 11, line 56 – Col. 12, line 6). As discussed above, Tessier discloses that their needle is positioned within the patient at a surgical site (Tessier: Page 19, lines 9-24) prior to the application of negative pressure via the aspiration insert (Tessier: Page 20, line 11 – Page 21, line 21), but does not disclose how the needle is positioned within the patient. Modifying the method of Tessier in view of Molmenti so that the needle is driven into the patient’s bone via impacts from a mallet applied to an impact plate advantageously enables the needle to be driven through the cortical bone as taught by Cook. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method suggested by Tessier in view of Molmenti so that it further comprises inserting the needle into a bone via percussive force applied to an impact plate connected to a surgical device in which the needle is included and detaching the impact plate from the surgical device once the needle is aligned to position the first lateral hole with the first bone marrow collection site and the second lateral hole with the second bone marrow collection site before applying the negative pressure to the first bone marrow collection site in order to enable the needle to be driven through the cortical bone as taught by Cook.
Regarding claim 16, Tessier in view of Molmenti suggests the method of claim 13, but is silent with respect to removing the needle from a bone that includes the first bone marrow collection site and the second bone marrow collection site in response to collecting a predefined amount of bone marrow aspirate from the first bone marrow collection site and the second bone marrow collection site.
As discussed above, Cook teaches a bone or bone marrow harvesting device (Figs. 1-2C, feat. 100; Col. 5, lines 27-55) comprising a needle (Figs. 1 and 6A-C, feat. 140; Col. 5, line 44 – Col. 6, line 5), corresponding to the needle of Tessier (Tessier: Figs. 1-5, feat. 16). In use (Fig. 8, feat. 800; Col. 11, line 35 – Col. 13, line 20), the needle is first positioned at the harvest site (Fig. 8, feats. 810-860; Col. 11, line 35 – Col. 12, line 17), bone marrow or soft bony tissue is then harvested (Fig. 8, feat. 870; Col. 12, lines 18-32), and then the needle is then removed from the collection site (Fig. 8, feat. 880-890; Col. 12, line 33 – Col. 13, line 9). Cook further teaches that once the needle has been removed from the collection site, any tissue remaining in the needle may then be harvested (Fig. 8, feat. 892; Col. 13, lines 10-20). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method suggested by Tessier in view of Molmenti so that removing the needle from a bone that includes the first bone marrow collection site and the second bone marrow collection site in response to collecting a predefined amount of bone marrow aspirate from the first bone marrow collection site and the second bone marrow collection site in order to harvest any tissue remaining in the needle as taught by Cook.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Tessier in view of Molmenti and in further view of Kim (US 2009/0112119 A1).
Regarding claim 18, Tessier in view of Molmenti suggests the method of claim 13. Tessier in view of Molmenti does not disclose holding the aspiration insert in place relative to the needle via an advancer release and an insert advancer while applying the negative pressure and not actuating the positioning device.
Kim teaches a needle biopsy device (Figs. 1-4, feat. 1; ¶0121-0124) comprising an outer cannula (Figs. 1-4, feat. 20; ¶0121), which is analogous to the needle of Tessier, and an inner biopsy needle (Figs. 1-4, feat. 10; ¶0121), which is analogous to the aspiration insert of Tessier. The inner biopsy needle comprises a locking pin (50) which locks into a slot (150) in the outer cannula in order to maintain the relative position, and therefore the advancement and retraction, of the inner biopsy needle relative to the outer cannula during various steps of the biopsy (¶0124). Because the locking pin and slot control the advancement and retraction of the inner biopsy needle relative to the outer cannula, they constitute an insert advancer and release, respectively. Tessier discloses that the aspiration stylet is positioned so that its aperture is in registration with the apertures of the outer needle (Tessier: Page 20, line 11 – Page 21, line 28) and that the aspiration stylet is moved to align the aspiration aperture sequentially with each of the apertures in the outer needle in order to aspirate from each of the apertures (Tessier: Page 23, lines 9-15), but is silent with respect to how the alignment is maintained. By modifying the device and method of Tessier in view of Molmenti to include the locking pin in the aspiration insert and the slot in the outer needle as taught by Kim, the relative positions of the aspiration insert and the outer needle would be able to be maintained such that the aspiration aperture registration with the needle apertures would also be maintained during steps such as aspiration. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method suggested by Tessier in view of Molmenti so that it includes holding the aspiration insert in place relative to the needle via an advancer release and an insert advancer while applying the negative pressure and not actuating the positioning device in order to maintain the relative positions of the aspiration insert and needle as taught by Kim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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