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 .
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 5 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.
Regarding claim 5, Claim 5 recites the limitation " the inner chamber " in line 2. There is insufficient antecedent basis for this limitation in the claim. The Examiner suggests "an inner chamber ".
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Schwoebel et al. (WO2006128915A1, Machine Translation) herein known as Schwoebel, in view of Nash et al. (US20120129674-A1) herein known as Nash.
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(Fig. 1-2, Schwoebel)
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(Fig.5 , Schwoebel)
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(Fig.1 , Nash)
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(Fig. 2, Nash)
Regarding Claim 1, Schwoebel is directed to a multi-cylinder syringe for several substances, with at least one outer syringe cylinder having a syringe outlet, and with an inner syringe cylinder that is at least partially contained in the outer syringe cylinder and is displaceable in the longitudinal direction from a proximal extended state to a distal retracted state [0002].
Schwoebel disclose a separation syringe assembly (syringe 10) comprising: a syringe barrel assembly (12) and a plunger assembly (inner syringe cylinder 14) configured to travel relative to the syringe barrel (Fig 1-2; [0032],[ Figure 1 shows the multi-cylinder syringe 10 in its delivery state]; [0025], [The embodiment shown in the figures shows a multi-cylinder syringe 10 with an outer syringe cylinder 12, an inner syringe cylinder 14 and a rear piston 16, The multi-cylinder syringe 10 is designed as a two-cylinder syringe with two cylinders 12, 14]), the syringe barrel assembly having a distal end and a proximal end with a longitudinal axis extending therebetween ([0026], [The outer syringe cylinder 12 has an elongated cylindrical shape with a front, distal end 70 and a rear, proximal end 72]; [0022], [Fig. 2 shows the longitudinal section according to Fig. 1 with the inner syringe cylinder fully extended]), the syringe barrel assembly having an outer wall in the form of a hollow cylinder(Fig. 1-2; [0026],[ The outer syringe cylinder 12 has an elongated cylindrical shape with a front, distal end 70 and a rear, proximal end 72]), the plunger assembly having a proximal end and a distal end and aligned with the longitudinal axis (Fig 1-2; [0027], [The inner syringe cylinder 14 has an elongated and essentially cylindrical shape that fits into the cavity 18 of the outer syringe cylinder 12, with a distal front end 74 and a proximal rear end 76.]), the plunger assembly providing a first plunger (a front piston 30) and a second plunger (second outer plunger comprising outer surface 44 with arms 38) (Fig 1- 2; [0027],[ front piston 30 is integrally formed at the distal end 74 of the inner syringe cylinder 14]; [0028],[The inner syringe cylinder 14 has two detent elements 38 formed on its outer surface 44, each in the form of an elongated elastic spring arm]), the first plunger is a generally cylindrical hollow barrel (hollow barrel with chamber 22) having an entrance port (entrance port of 30 with valve 46) positioned about the longitudinal axis and near the distal end (distal end 74) of the first plunger and enclosed on the proximal end to form a container (container chamber 22) therein (Fig. 1-2 and 5; [0029], [ In the piston surface 48 of the front piston 30 facing the cavity 18, a pressure relief valve 46 is arranged, which connects the cavity 18 with the cavity 22., Figure 5 shows the front piston 30 with the valve 46 in a top view.]; [0032],[ rear piston 16 is half inserted into the inner syringe cylinder 14]), the second plunger provides a cylindrical body with an open distal end and concentrically aligned outside of the first plunger; ([0028],[The inner syringe cylinder 14 has two detent elements 38 formed on its outer surface 44, each in the form of an elongated elastic spring arm]).
However Schwoebel is silent to a cap provided at the distal end of the syringe barrel assembly; the distal end of the first plunger is complementary in shape to a corresponding face of the cap of the syringe barrel assembly; wherein the separation syringe is configured to be rotated about the longitudinal axis and thereby separate the contents within the hollow cylinder of the syringe barrel assembly into at least two concentric annular layers.
Nash is directed to a single use, sterile, self-contained, compact, easy to use centrifugal separation unit provides for quick, reliable platelet concentration from whole blood. The resultant PRP/PC can be immediately used for application to the patient. The unit is suitable for office, operating room, emergency use, or military field hospital use [0009].
Nash discloses a separation syringe assembly (200) comprising: a syringe barrel assembly (206) ([0036]-[0037]; Fig 2) with a cap (cap 215) provided at the distal end of the syringe barrel assembly the distal end of the first plunger is complementary in shape to a corresponding face of the cap of the syringe barrel assembly (Fig 2, [0037]); wherein the separation syringe is configured to be rotated about the longitudinal axis and thereby separate the contents within the hollow cylinder of the syringe barrel assembly into at least two concentric annular layers ([0036], [FIG. 1a provides an illustration for description of the principle of operation of the devices covered in this invention. A chamber of essentially frusto-conical shape 1 contains a mixture of several liquids of differing densities and rotates about the longitudinal axis XX. The liquids 2, 3, and 4 separate into radially distinct layers as shown in section AA]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Schwoebel ‘s syringe assembly, as taught by Nash wherein a cap provided at the distal end of the syringe barrel assembly; the distal end of the first plunger is complementary in shape to a corresponding face of the cap of the syringe barrel assembly; wherein the separation syringe is configured to be rotated about the longitudinal axis and thereby separate the contents within the hollow cylinder of the syringe barrel assembly into at least two concentric annular layers, in order to have a single use, sterile, self-contained, compact, easy to use centrifugal separation unit (See Nash, [[0009]; abstract]), yielding nothing more than predictable results.
Regarding Claim 10, Modified Schwoebel teaches all the limitations in claim 1 as set forth above.
Schwoebel discloses wherein the first plunger further comprises at least one support element configured to stabilize the first plunger and limit the lateral movement of the first plunger relative to the syringe barrel (Fig 1; [0027], [The movement of the inner syringe cylinder 14 is limited by the fact that the annular projection 34 abuts the inner ring 36]).
Regarding Claim 11, Modified Schwoebel teaches all the limitations in claim 1 as set forth above.
Schwoebel discloses wherein the at least one support element is a stabilizing tab (annular projection 34 ) positioned between the outer wall and the inner wall ([0027], [The inner syringe cylinder 14 has an annular projection 34 proximal to the front piston 30, which interacts with an inner ring 36 formed on the inner wall 32 of the outer syringe cylinder 12 proximal to the front piston 30 to limit the movement of the inner syringe cylinder 14 in the proximal direction. The movement of the inner syringe cylinder 14 is limited by the fact that the annular projection 34 abuts the inner ring 36.])
However Modified Schwoebel is silent to a plurality of stabilizing tabs.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to recognize that applying plurality of the known technique (plurality of stabilizing tabs) would have yielded predictable results and resulted in an improved system (improve the stabilization of the first plunger and limit the lateral movement of the first plunger relative to the syringe barrel) (see Schwoebel, [0027]), (MPEP 2143(I)(D). Example 1-3).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Schwoebel et al. (WO2006128915A1, Machine Translation) herein known as Schwoebel, in view of Nash et al. (US20120129674-A1) herein known as Nash, as applied to the claim 1 above, and further in view of Woodell (US 2018/0196030) herein known as Woodell.
Regarding Claim 2, modified Schwoebel teaches all the limitations in the claim 1 as set forth above.
Schwoebel discloses the entrance port of the first plunger has a valve positioned adjacent to the entrance port ([0029], [The pressure relief valve 46 is designed as a double slot 52 in an elastic diaphragm 50 in the piston surface 48])
However modified Schwoebel is silent to wherein the valve is a one-way valve.
Woodell is directed to a multiple component fluid and a concentrator/separator and, more particularly, relates to a container operable with a centrifuge to separate and/or concentrate various biological components.
Woodell disclose one-way valve positioned adjacent the entrance port ([0048], [ A check valve 76 is operably connected to the bore 74. The check valve 76 allows a liquid to move from the plunger front face 60 to the back face 72 while not allowing the liquid to move from the back face 72 to the plunger front face 60. Therefore, the check valve 76 is substantially a one-way valve which allows a material to move in only one direction. The check valve 76 may also operate automatically allowing flow in only one predetermined direction. Alternatively, the check valve 76 may be operated manually and include a portion extending from the check valve 76 requiring manipulation to stop or start a flow through the check valve 76.]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify modified Schwoebel ‘s syringe assembly, as taught by Woodell wherein the valve is a one-way valve, in order to only allow fluid to move in one direction through the plunger (See Woodell, [0048],), yielding nothing more than predictable results.
Claims 3-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Schwoebel et al. (WO2006128915A1, Machine Translation) herein known as Schwoebel, in view of Nash et al. (US20120129674-A1) herein known as Nash, as applied to the claim 1 above, and further in view of Huang (CN 105596014 A, Machine Translation) herein known as Huang.
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(Fig.6, Huang)
Regarding Claim 3-4, modified Schwoebel teaches all the limitations in the claim 1 as set forth above.
However modified Schwoebel is silent to the separation syringe assembly of claim 1, wherein the first plunger has an inverse conical face at the distal end of the first plunger, with the entrance port provided at the peak of the inverse conical face (Claim 3), The separation syringe assembly of claim 3, wherein the cap is provided with a conical feature that is centrally aligned on an inside face of the cap, the conical feature capable of engaging with the inverse conical face of the first plunger (Claim 4).
Huang is directed to the field of medical equipment technology, and in particular to a double-cannula centrifugal syringe [0002], Huang also disclosed the purpose of this invention is to provide a double-tube centrifugal injector that is easy to operate and has higher work efficiency [0008].
Huang discloses the separation syringe assembly of claim 1, wherein the first plunger has an inverse conical face (inverse control face 102) at the distal end of the first plunger, with the entrance port provided at the peak of the inverse conical face (106 provided at the peak of 102) (Fig. 6; [0059],[ the first protrusion is a cone, and the outer piston 102 is a conical surface that matches the cone]; [0045], [The first connecting part 106 is located at the position of the outer piston 102 farthest from the first protrusion 104, and the first connecting part 106 connects the outer piston 102 vertically]) face (Claim 3).
Huang also discloses the separation syringe assembly of claim 3, wherein the cap is provided with a conical feature that is centrally aligned on an inside face of the cap, the conical feature capable of engaging with the inverse conical face of the first plunger (Claim 4) (Fig 6; [0045], [The outer cylinder 101 is also provided with an outer piston 102 that matches the first protrusion 104]; [0046], [The outer piston 102 inside the outer cylinder 101 matches the first protrusion 104. That is, if the first protrusion 104 is a cone, then the shape of the outer piston 102 is cone-shaped, so that the outer piston 102 can fit completely against the first protrusion 104])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify modified Schwoebel ‘s syringe assembly, as taught by Huang, wherein the first plunger has an inverse conical face at the distal end of the first plunger, with the entrance port provided at the peak of the inverse conical face (Claim 3), wherein the cap is provided with a conical feature that is centrally aligned on an inside face of the cap, the conical feature capable of engaging with the inverse conical face of the first plunger (Claim 4), in order to provide centrifugal that is easy to operate and has higher work efficiency (See Huang, [0008]), yielding nothing more than predictable results.
Regarding Claim 5, modified Schwoebel teaches all the limitations in the claims as set forth above.
However, Schwoebel is silent to discloses wherein the cap is further provided with a first access passage in fluid communication with the inner chamber and offset from the longitudinal axis.
Nash discloses wherein the cap is further provided with a first access passage in fluid communication with the inner chamber and offset from the longitudinal axis (Fig. 2; [0037], [end cap 215 has passages 216 and 217 bored within to permit the passage of red blood cells from 217 and plasma from passage 216. Passage 217 is shown passing through the outside skirt of the end cap that is in line with the outside wall of tapered barrel 206]; [0042], [plasma 230 is eliminated from port 2270).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Schwoebel ‘s syringe assembly, as taught by Nash, wherein the cap is further provided with a first access passage in fluid communication with the inner chamber and offset from the longitudinal axis, in order to have a single use, sterile, self-contained, compact, easy to use centrifugal separation unit (See Nash, [[0009]; abstract]), yielding nothing more than predictable results.
Regarding Claim 7, modified Schwoebel teaches all the limitations in the claims as set forth above.
However, Schwoebel is silent to wherein the cap is provided with a second access passage that is aligned with the longitudinal axis, the second access passage providing a pierceable septum.
Nash discloses wherein the cap is provided with a second access passage that is aligned with the longitudinal axis, the second access passage providing a pierceable septum (pierceable septum 214) (Fig 2; [0038]; [To use the device for preparing PRP, a syringe 233 with needle 234, filled with anti-coagulated whole blood is inserted into the device through elastomeric seal 214 to load the chamber with whole blood 229]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Schwoebel ‘s syringe assembly, as taught by Nash, wherein the cap is provided with a second access passage that is aligned with the longitudinal axis, the second access passage providing a pierceable septum, in order to have a single use, sterile, self-contained, compact, easy to use centrifugal separation unit (See Nash, [[0009]; abstract]), yielding nothing more than predictable results.
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Schwoebel et al. (WO2006128915A1, Machine Translation) herein known as Schwoebel, in view of Nash et al. (US20120129674-A1) herein known as Nash, and further in view of Huang (CN 105596014 A, Machine Translation) herein known as Huang, as applied to the claims above, and further in view of Woodell (US 2018/0196030) herein known as Woodell.
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(Fig.2, Woodell)
Regarding Claims 6, modified Schwoebel teaches all the limitations in the claims as set forth above.
However modified Schwoebel is silent to the separation syringe assembly of claim 5, wherein the first access passage features a luer fitting, and can be closed with a cap (Claims 6).
Woodell is directed to a multiple component fluid and a concentrator/separator and, more particularly, relates to a container operable with a centrifuge to separate and/or concentrate various biological components.
Woodell disclose discloses wherein the first access passage features a luer fitting (luer fitting of 20) and can be closed with a cap (cap 96) (Claims 6) (Fig. 2; [0053], [The outboard side of the plasma collection valve 20 may include external threads 94 to mate with internal threads of a plasma valve cap 96. Therefore, the plasma collection valve 20 may be selectively opened and closed via the plasma valve cap 96).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify modified Schwoebel ‘s syringe assembly, as taught by Peled, wherein the first access passage features a luer fitting, and can be closed with a cap (Claims 6), in order for the luer fitting to be selectively opened and closed via valve cap (See Woodell, [0053]), yielding nothing more than predictable results.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Schwoebel et al. (WO2006128915A1, Machine Translation) herein known as Schwoebel, in view of Nash et al. (US20120129674-A1) herein known as Nash, and further in view of Huang (CN 105596014 A, Machine Translation) herein known as Huang, and further in view of Woodell (US 2018/0196030) herein known as Woodell, as applied to the claims above, and further in view of Jan et al. (WO 2012021167 A2) herein known as Jan.
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(Fig.10 ,Jan)
Regarding Claims 8, modified Schwoebel teaches all the limitations in the claims as set forth above.
However modified Schwoebel is silent to the separation syringe assembly of claim 6, wherein the cap is provided with a counterbalance that is offset from the longitudinal axis in the same amount as the first access passage and in an opposite direction, the counterbalance having a weight that is the same as the luer fitting and cap.
Jan is directed to a centrifuge including integrated separation of blood components so that the separated products remain spinning within the centrifuge during the separation process (Abstract).
Jan discloses wherein the cap is provided with a counterbalance that is offset from the longitudinal axis in the same amount as the first access passage and in an opposite direction, the counterbalance having a weight that is the same as the luer fitting and cap( [[0051], [Fig. 10 illustrates a centrifuge with adjustable counterweights. The size and type of a syringe are defined to design the centrifuge and the balancing container. The balancing valve and container may be avoided if the centrifuge has adjustable counterweights on the axle (or if the mass permits no counterbalance])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify modified Schwoebel ‘s syringe assembly, as taught by Peled, wherein the cap is provided with a counterbalance that is offset from the longitudinal axis in the same amount as the first access passage and in an opposite direction, the counterbalance having a weight that is the same as the luer fitting and cap , in order to balance the valve (See Jan, [[0051]), yielding nothing more than predictable results.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Schwoebel et al. (WO2006128915A1, Machine Translation) herein known as Schwoebel, in view of Nash et al. (US20120129674-A1) herein known as Nash, as applied to the claim 1 above, and further in view of Peled (US 2019/0336646 A1) herein known as Peled.
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(Fig. 3A, Peled)
Regarding Claim 9, modified Schwoebel teaches all the limitations in the claim 1 as set forth above.
However modified Schwoebel is silent to the separation syringe assembly of claim 1, wherein the first plunger and second plunger are capable of independent axial translation along the longitudinal axis.
Peled is directed to a triple-chambered container includes: a main container body with a first chamber which has an opening at its distal end; a main barrel formed and movable longitudinally within the first chamber; a second barrel formed within the main barrel [0007].
Peled discloses wherein the first plunger( plunger 35), and second plunger (plunger 34) are capable of independent axial translation along the longitudinal axis (Fig 3.A; [0041], [ Fig. 3A illustrates. A main plunger 35, movable in directions 37 within the main barrel volume 32, is itself substantially hollow on its inside as shown by the volume 38 but includes a second plunger 34 such that the usable volume 38 to hold fluids in the space surrounding the second plunger 34. The second plunger 34 is itself movable within the volume 38 in the same directions 37 as main plunger 35])
Peled also discloses the container has at least three separate volumes which can be isolated or open to the ingress or egress of liquids [0044].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify modified Schwoebel ‘s syringe assembly, as taught by Peled, wherein the first plunger and second plunger are capable of independent axial translation along the longitudinal axis, in order to ingress or egress of liquids (See Peled, [0044]), yielding nothing more than predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOUD MOTAZ ABDEL LATIF whose telephone number is (571)272-6535. The examiner can normally be reached Monday-Friday 8:30-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin L Lebron can be reached at 571-272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAHMOUD MOTAZ ABDEL LATIF/
Examiner, Art Unit 1773
/BENJAMIN L LEBRON/Supervisory Patent Examiner, Art Unit 1773
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