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 Status
Claims 1-10 are currently pending and under consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "the inlet side" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the outlet side" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the front end" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the rear end" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greene et al. (U.S. Patent No. 4,643,197) in view of Lane et al. (U.S. Patent No. 4,775,360) and Johnsen et al. (U.S. Publication 2021/0186469).
Regarding claim 1, Greene discloses a tissue separation filter assembly (10’ filter element consisting of 24, 26, 74) to separate tissue (74 filters tissue from liquid) mounted on a fluid outlet tube 70 attached to a cannula (Col 1 lines 21-22 carried through the endoscope thus endoscope has cannula for fluid flow therethrough) for an endoscope, the cartilage separation filter assembly comprising: an inlet three-way valve 66 connected to the fluid outlet tube 70; a main tubing portion 72 connected to the inlet three-way valve to filter cartilage tissue (diverts fluid to filter 74); a bypass tubing portion connected to the inlet three-way valve 62; and an outlet [three-way valve] Y-connection (point at which 68 meets 62) connected to the main tubing portion (fluidly connected to main tubing and the bypass tubing portion.
Greene does not expressly disclose the separated tissue being cartilage tissue, an outlet valve attached to the cannula, the cannula being for an arthroscope, or an outlet three-way valve connected to the main tubing portion and the bypass tubing portion
Regarding the limitation of an outlet valve being attached to the cannula, Johnsen, in the same filed of endeavor of in-line collection devices (element 13) attached to a surgical suction device (fig. 2) teaches providing an outlet valve 22 attached to a cannula 19 of an endoscope for the purpose of allowing an operator to control the provision of suction through the endoscope (¶0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid outlet tube to have been connected to an outlet valve attached to a cannula, as taught by Johnsen, for the purpose of allowing an operator to control the provision of suction through the endoscope (¶0038 of Johnsen).
Regarding the limitation of an outlet three-way valve, Greene discloses a connection between the main tubing and the bypass tubing portion occurring in a three-way connection, but does not expressly disclose the presence of a valve located at this position.
However, Lane, in the same field of endeavor of patient collection containers, discloses providing controllable valves 34 on both inlet 32 and outlet lines 38 to the collection container for the purpose of clamping off tubing to remove the container (Col. 7 lines 25-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Greene to have included a second valve associated with the outlet portion of the main line of the Greene, as taught by Lane, for the purpose of preventing suction from being applied to the canister through the outlet portion of the main line such that the container is completely isolated from suction and thus capable of allowing the removal of the filter trap container from the system while preventing suction from being applied through line 68.
While Greene in view of Lane do not expressly suggest the valve being a three-way valve, it would have been obvious to have substituted the outlet valve of Greene in view of Lane with the three-way valve 66 of Greene since these elements perform the same function of controlling fluid flow through a fluid flow pathway and simply substituting one fluid control valve means for another would yield the predictable result of allowing a(n) the control of fluid flow through the device pathways. See MPEP 2143.
Regarding the limitations of the tissue being cartilage and the device being an arthroscope, these limitations are considered functional language describing the procedure in which the filter assembly endoscope is to be used and the resulting tissue that is to be collected. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Greene in view of Johnsen and Lane suggest all the structure as claimed, and is further used for the collection of tissue aspirated from a patient through suction applied to an endoscope positioned within the patient. As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning as an arthroscopic device and suctioning cartilage).
Regarding claim 2, Greene in view of Johnsen and Lane suggest the cartilage separation filter assembly of claim 1. Greene further discloses the main tubing portion comprising: a main inlet tube 72 connected with an inlet three-way valve; a filter portion (24, 26, 74) connected with the main inlet tube (connected by element 30); a main outlet tube 68, the inlet side of which is connected with the filter portion (side within 24) and the outlet side of which is connected with the outlet three-way valve (outlets at junction which would be three-way valve as modified by Greene in view of Lane above).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greene et al. (U.S. Patent No. 4,643,197) in view of Lane et al. (U.S. Patent No. 4,775,360) and Johnsen et al. (U.S. Publication 2021/0186469) and further in view of Bark et al. (U.S. Patent No. 5,772,644).
Regarding claim 3, Greene in view of Johnsen and Lane suggest the cartilage separation filter assembly of claim 2. Greene further discloses the filter portion comprising: a filter tube 30 having a certain diameter (Fig. 7 larger diameter than 72) such that the main inlet tube is inserted at a certain length (Fig. 7 can be seen to be inserted into 30) on the inlet side, and the main outlet tube is inserted at a certain length on the outlet side (Fig. 7 inserted through 38 into chamber 24) and a filter (26, 24,74) which the front end is attached together to form an inlet between the main inlet tube and the filter tube (element 30 attached to element 24 and forms inlet between the main inlet tube and the filter tube), and the rear end (end facing inward to the cavity of the filter) consists of a mesh net (Col. 3 lines 18-20 mesh construction, as applied to filter 74) in the form of a pocket 76 extending to a certain length (extends across diameter of filter).
Greene does not expressly disclose the pocket being for filtering cartilage tissue from a fluid containing blood and cartilage tissue flowing from the main inlet tube, however, the limitations of “for filtering cartilage tissue from a fluid containing blood and cartilage tissue flowing from the main inlet tube” is considered functional language relating to the use of the suction device to remove blood containing cartilage from a patient during an arthroscopic procedure. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Greene in view of Johnsen and Lane suggest all the structure as claimed, and is further used for the collection of tissue and body fluids aspirated from a patient (Background of the invention first paragraph) through suction applied to an endoscope positioned within the patient. As such, it is capable of performing the functions as claimed (filtering cartilage tissue from a fluid containing blood and cartilage tissue flowing from the main inlet tube).
Greene does not expressly disclose the filter tube and the main inlet tube being attached by thermal fusion, the main outlet tube being attached by thermal fusion or the front end of the filter being attached together by thermal fusion to form the inlet between the main inlet tube and the filter tube.
However, Bark, in the same field of endeavor of patient bodily fluid collection, discloses a tissue separation filter portion Fig. 16 comprising: a filter tube (opening through which 55 is inserted) having a certain diameter (diameter of tube 55 due to heat sealing of one to another) such that a main inlet tube 55 is inserted at a certain length on the inlet side (Fig. 16 shows insertion of 55 with 58 inside pouch) and is attached to each other by thermal fusion (Col. 7 lines 54-67 and Col. 8 lines 1-29 heat sealing bonding of rear sheet and front sheet; at bottom edge of the pouch discharge tube…sealed to the edge of the pouch using one or more of the permanent attachment method), and a main outlet tube 38 is inserted at a certain length on an outlet side 64 and is attached to the outlet side by thermal fusion ((Col. 7 lines 54-67 and Col. 8 lines 1-29 heat sealing bonding of rear sheet and front sheet; at bottom edge of the pouch discharge tube…sealed to the edge of the pouch using one or more of the permanent attachment method); and a filter (pouch) which the front end 66 is attached together by thermal fusion (Col. 7 lines 54-67 rear sheet and front sheet bonded together by heat sealing) to form an inlet between the main tube and the filter tube (heat sealed around inlet tube 55 and thus forms inlet between main tube and filter tube), and the rear end consists of a filter sheet 32 extending to a certain length for filtering tissue from a fluid containing blood and tissue flowing from the main inlet tube (Col. 7 lines 1-12 body tissue retained on filter…Col. 6 lines 63-67 blood) that is suitable for having vacuum applied to it (Col. 6 line 17 vacuum) for the purpose of providing a low-cost, disposable filtering and retention device suitable for use during surgery that provides a quantitative sample of solid materials collected in a sealable pouch suitable for shipment to a laboratory with minimal exposure of hospital personnel.
It would have been obvious to one of ordinary skill in the art to have replaced the outer container portion (elements 24 and 26) of Greene for the heat weldable pouch of Bark for the purpose of providing a low cost unit that seals in the contents through the permanent seals such as to be suitable for shipment to a laboratory while minimally exposing the hospital personnel performing the surgical procedure.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greene et al. (U.S. Patent No. 4,643,197) in view of Lane et al. (U.S. Patent No. 4,775,360) and Johnsen et al. (U.S. Publication 2021/0186469) and further in view of Bark et al. (U.S. Patent No. 5,772,644) and Michaels (U.S. Publication 2011/0313375).
Regarding claims 4-5, Greene in view of Johnsen, Lane, and Bark suggest the cartilage separation filter assembly of claim 3. Greene further discloses providing a negative pressure from a suction source installed at the rear of the outlet three-way valve (Fig. 7 shows suction source installed downstream through tube 16)
Greene in view of Johnsen, Lane, and Bark does not expressly suggest providing first and second anti-deformation tubes of filter tube for preventing the inlet side of the filter tube from being squeezed by the negative pressure, or the negative pressure being applied by a pump.
However, Michaels, in the same field of endeavor of patient matter collection subject to suction, teaches the use of multiple anti-deformation tubes 60 of a filter tube 28 for preventing lateral collapse along a longitudinal length of the filter tube (¶0009 segments of the bag coupled to the support elements do not laterally collapse).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the filter tube suggested by Bark to have included anti-deformation tubes along its longitudinal length for the purpose of controlling the lateral collapsibility of the tube during application of negative pressure as taught by Michaels. The control of lateral collapse across the longitudinal length would have resulted in prevention of lateral collapse at the inlet side and outlet side of the filter tube when negative pressure was applied.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greene et al. (U.S. Patent No. 4,643,197) in view of Johnsen et al. (U.S. Publication 2021/0186469).
Regarding claim 6, Greene discloses a tissue separation filter assembly (10’ filter element consisting of 24, 26, 74) to separate tissue (74 filters tissue from liquid) mounted on a fluid outlet tube 70, attached to a cannula (Col 1 lines 21-22 carried through the endoscope thus endoscope has cannula for fluid flow therethrough) for an endoscope, the cartilage separation filter assembly comprising: an Y-shaped inlet (three-way pathway tube presents Y-shape) connection tube 66 connected to the fluid outlet tube 70; a main tubing portion 72 connected to the Y-shaped inlet connection tube and provided with a main valve (Y-shaped inlet connection rotatable to act as valve) to regulate the flow of fluid through the Y-shaped inlet connection tube to filter cartilage tissue (rotation of valve regulates flow direction to divert fluid to filter 74); a bypass tubing portion 62 connected to the Y-shaped inlet connection tube and provided with a bypass valve to regulate the fluid of fluid (Y-shaped inlet connection acts as valve to either direct fluid through the filter or through the bypass and thus acts as a main valve and a bypass valve depending on positioning); and a Y-shaped outlet connection tube (point at which 68 meets 62) connected to the main tubing portion and the bypass tubing portion (fluidly connected to main tubing and the bypass tubing portion as seen in Fig. 7).
Greene does not expressly disclose the separated tissue being cartilage tissue, an outlet valve attached to the cannula, the cannula being for an arthroscope, or an outlet three-way valve connected to the main tubing portion and the bypass tubing portion
Regarding the limitation of an outlet valve being attached to the cannula, Johnsen, in the same filed of endeavor of in-line collection devices (element 13) attached to a surgical suction device (fig. 2) teaches providing an outlet valve 22 attached to a cannula 19 of an endoscope for the purpose of allowing an operator to control the provision of suction through the endoscope (¶0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid outlet tube to have been connected to an outlet valve attached to a cannula, as taught by Johnsen, for the purpose of allowing an operator to control the provision of suction through the endoscope (¶0038 of Johnsen).
Regarding the limitations of the tissue being cartilage and the device being an arthroscope, these limitations are considered functional language describing the procedure in which the filter assembly endoscope is to be used and the resulting tissue that is to be collected. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Greene in view of Johnsen and Lane suggest all the structure as claimed, and is further used for the collection of tissue aspirated from a patient through suction applied to an endoscope positioned within the patient. As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning as an arthroscopic device and suctioning cartilage).
Regarding claim 7, Greene in view of Johnsen suggest the cartilage separation filter assembly of claim 6. Greene further discloses the main tubing portion (68 and 72) comprising:
a main inlet tube 72 connected to the Y-shaped inlet connection tube (connected to 66) and provided with a main valve (66 acts as valve depending on positioning of y-shaped fluid flow pathway);
a filter portion connected to the main inlet tube (24 and 26);
and a main outlet tube 68, the inlet side of which is connected to the filter portion (Fig. 7 shows inlet side in filter portion) and the outlet side of which is connected to the Y-shaped outlet connection tube (68 ends in connect to 62 at Y-shaped outlet connection tube).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greene et al. (U.S. Patent No. 4,643,197) in view of Johnsen et al. (U.S. Publication 2021/0186469) and further in view of Bark et al. (U.S. Patent No. 5,772,644).
Regarding claim 8, Greene in view of Johnsen suggest the cartilage separation filter assembly of claim 7. Greene further discloses the filter portion comprising: a filter tube 30 having a certain diameter (Fig. 7 larger diameter than 72) such that the main inlet tube is inserted at a certain length (Fig. 7 can be seen to be inserted into 30) on the inlet side, and the main outlet tube is inserted at a certain length on the outlet side (Fig. 7 inserted through 38 into chamber 24) and a filter (26, 24,74) which the front end is attached together to form an inlet between the main inlet tube and the filter tube (element 30 attached to element 24 and forms inlet between the main inlet tube and the filter tube), and the rear end (end facing inward to the cavity of the filter) consists of a mesh net (Col. 3 lines 18-20 mesh construction, as applied to filter 74) in the form of a pocket 76 extending to a certain length (extends across diameter of filter).
Greene does not expressly disclose the pocket being for filtering cartilage tissue from a fluid containing blood and cartilage tissue flowing from the main inlet tube, however, the limitations of “for filtering cartilage tissue from a fluid containing blood and cartilage tissue flowing from the main inlet tube” is considered functional language relating to the use of the suction device to remove blood containing cartilage from a patient during an arthroscopic procedure. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Greene in view of Johnsen and Lane suggest all the structure as claimed, and is further used for the collection of tissue and body fluids aspirated from a patient (Background of the invention first paragraph) through suction applied to an endoscope positioned within the patient. As such, it is capable of performing the functions as claimed (filtering cartilage tissue from a fluid containing blood and cartilage tissue flowing from the main inlet tube).
Greene does not expressly disclose the filter tube and the main inlet tube being attached by thermal fusion, the main outlet tube being attached by thermal fusion or the front end of the filter being attached together by thermal fusion to form the inlet between the main inlet tube and the filter tube.
However, Bark, in the same field of endeavor of patient bodily fluid collection, discloses a tissue separation filter portion Fig. 16 comprising: a filter tube (opening through which 55 is inserted) having a certain diameter (diameter of tube 55 due to heat sealing of one to another) such that a main inlet tube 55 is inserted at a certain length on the inlet side (Fig. 16 shows insertion of 55 with 58 inside pouch) and is attached to each other by thermal fusion (Col. 7 lines 54-67 and Col. 8 lines 1-29 heat sealing bonding of rear sheet and front sheet; at bottom edge of the pouch discharge tube…sealed to the edge of the pouch using one or more of the permanent attachment method), and a main outlet tube 38 is inserted at a certain length on an outlet side 64 and is attached to the outlet side by thermal fusion ((Col. 7 lines 54-67 and Col. 8 lines 1-29 heat sealing bonding of rear sheet and front sheet; at bottom edge of the pouch discharge tube…sealed to the edge of the pouch using one or more of the permanent attachment method); and a filter (pouch) which the front end 66 is attached together by thermal fusion (Col. 7 lines 54-67 rear sheet and front sheet bonded together by heat sealing) to form an inlet between the main tube and the filter tube (heat sealed around inlet tube 55 and thus forms inlet between main tube and filter tube), and the rear end consists of a filter sheet 32 extending to a certain length for filtering tissue from a fluid containing blood and tissue flowing from the main inlet tube (Col. 7 lines 1-12 body tissue retained on filter…Col. 6 lines 63-67 blood) that is suitable for having vacuum applied to it (Col. 6 line 17 vacuum) for the purpose of providing a low-cost, disposable filtering and retention device suitable for use during surgery that provides a quantitative sample of solid materials collected in a sealable pouch suitable for shipment to a laboratory with minimal exposure of hospital personnel.
It would have been obvious to one of ordinary skill in the art to have replaced the outer container portion (elements 24 and 26) of Greene for the heat weldable pouch of Bark for the purpose of providing a low cost unit that seals in the contents through the permanent seals such as to be suitable for shipment to a laboratory while minimally exposing the hospital personnel performing the surgical procedure.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greene et al. (U.S. Patent No. 4,643,197) in view of Johnsen et al. (U.S. Publication 2021/0186469) and further in view of Bark et al. (U.S. Patent No. 5,772,644) and Michaels (U.S. Publication 2011/0313375).
Regarding claims 9-10, Greene in view of Johnsen and Bark suggest the cartilage separation filter assembly of claim 8. Greene further discloses providing a negative pressure from a suction source installed at the rear of the outlet three-way valve (Fig. 7 shows suction source installed downstream through tube 16)
Greene in view of Johnsen and Bark does not expressly suggest providing first and second anti-deformation tubes of filter tube for preventing the inlet side of the filter tube from being squeezed by the negative pressure, or the negative pressure being applied by a pump.
However, Michaels, in the same field of endeavor of patient matter collection subject to suction, teaches the use of multiple anti-deformation tubes 60 of a filter tube 28 for preventing lateral collapse along a longitudinal length of the filter tube (¶0009 segments of the bag coupled to the support elements do not laterally collapse).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the filter tube suggested by Bark to have included anti-deformation tubes along its longitudinal length for the purpose of controlling the lateral collapsibility of the tube during application of negative pressure as taught by Michaels. The control of lateral collapse across the longitudinal length would have resulted in prevention of lateral collapse at the inlet side and outlet side of the filter tube when negative pressure was applied.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhou (Chinese Publication 113,197,600) discloses tissue filter comprising three-way valve
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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