DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/23/2026 has been entered.
Claims 1-20 remain pending and under prosecution.
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim elements are interpreted under 112(f).
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.
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 1-9, 11-17, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Clement (US Pat No. 5256160 – cited by applicant) in view of VanderWoude et al (US Pub No. 2014/0323914 – cited by applicant) and Cushner et al (US Pub No. 20070270714 – cited by applicant).
In regard to Claim 1, Clement discloses a cassette for collecting a tissue sample from a fluid stream, the cassette comprising:
a body 744 comprising a shell defining an outlet opening 774b through which suction is to be drawn (Col.12: 54-57), and
a cap 742 coupled to the shell to define a void internal to the body, best seen in Figure 32,
wherein the cap comprises a head comprising a top face (near chambers 750a-f) and a bottom face, best seen in Figure 34, and
wherein the head defines plural voids (defining chambers 750a-e) that extend inwardly, best seen in Figure 32 (Col.12: 14-23), and
openings 750a-f extending through the top face and into a respective one of the plural voids, best seen in Figure 32 and 34 (Col.11: 27-36);
a catch tray 756a-e seated in each of the plural voids, best seen in Figure 32 (Col.12: 20-32); and
a valve 770 rotatably coupled to the top face – “rotation of the cap 770 relative sample trap body 740 will sequentially bring the conduit 772 into fluid communication with each of the chambers 750a-f as the cap 770 is rotated clockwise” (Col.11: 54-57) and
comprising an inlet fitting 774a on the head, best seen in Figure 32, and is configured to receive a proximal end of a suction line 776 (similarly defined as the medical instrument in the instant specification), best seen in Figure 32,
wherein the inlet fitting defines an inlet bore 772, best seen in Figure 32,
wherein the valve and the inlet fitting are configured to be rotated relative to the head to align the inlet fitting with one of the plural voids to place the inlet bore of the inlet fitting in registration with a corresponding one of the openings – “rotation of the cap 770 relative sample trap body 740 will sequentially bring the conduit 772 into fluid communication with each of the chambers 750a-f as the cap 770 is rotated clockwise” (Col.11: 54-57).
However, Clement does not expressly disclose a front face that is most distally located surface of the head, the head defines a plurality of voids that extend inwardly from the front face and the catch tray removably seated in each of the plurality of voids, and the inlet fitting extends distal to the front face of the head.
VanderWoude et al teach that it is well-known in the art to provide an analogous cassette 2600 for collecting a tissue sample from a fluid stream comprising a head 2640 with a top face and a bottom face, best seen in Figure 57, and
a front face (in the plane of webs 2644 and 2648, best seen in Figure 59 – 0441) that is most distally located surface of the head, best seen in Figure 57,
wherein the head define a void 2652 that extends inwardly from the front face to define a space for catch tray 2740, best seen in Figure 57 (0442, 0456-0458).
VanderWoude et al also teach catch tray 2740 removably seated in void 2652 to provide the option to add or remove the catch tray as desired – “During time periods in which there is no need to collect specimens from the stream flowing through fitting 2664 a catch tray is not seated in the tray holder 2740” (0456-0458).
VanderWoude et al also teach inlet fitting 2616 extends distal to the front face of the head, best seen in Figure 58-59 – “fitting 2616 extends forward from a location that is radially spaced away from the center longitudinal axis of the cassette 2600, the axis through plate 2614 around which the cassette 2600 is rotated when in the receptacle 1699” (0439).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing such that the head includes a front face that is most distally located surface of the head, the inlet fitting extends distal to the front face of the head, wherein the head defines plural voids that extend inwardly from the front face, and the catch tray removably seated in each of the plural voids as taught by VanderWoude et al to provide an effective configuration for the inlet fitting and catch trays in the front face of the head that enables each catch tray to be advantageously removably seated in each of the plurality of voids as desired.
However, Clement does not disclose one of the catch trays is adapted to be removed from one of the plurality of voids with the valve positioned to direct the fluid stream through another one of the catch trays removably mounted in another one of the plurality of voids.
VanderWoude et al teach that the analogous cassette comprising valve 532, 530 comprising inlet fitting 486 connected to suction line 50 that is rotated (using knob 580) such that the fluid flow can be directed toward a bypass conduit 550 or tissue catch tray 600 within tissue trap container 650 to effectively enable the tissue catch tray to be independently removed and a new one reinstalled without having to turn off the suction function for more efficient sampling, best seen in Figure 15a, 16-17, and 19 (0229, 0245-0254 – "During this process of removing one tissue trap 598 from the cassette 420 and attaching a new trap 598, there is no need to turn off the suction pump 58. In other words, the new tissue traps 598 can be attached to the cassette 420 without disrupting the suction draw applied to the suction applicator”).
Cushner et al teach that it is well-known in the art to provide an analogous tissue sampling system comprising a plurality of tissue catch trays 100, each adapted to be removed from and reinstalled in manifold 400 as well as valve 410 that is positioned to direct fluid flow through another one of the desired removably mounted catch tray or bypass conduit 430, best seen in Figure 4 (0046). Thus, Cushner et al make obvious the combination of a bypass conduit, a valve, and a plurality of tissue catch trays that is adapted to be removed between which fluid flow is directed as desired.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Clement such that one of the catch trays is adapted to be removed from one of the plurality of voids with the valve positioned to direct the fluid stream through another one of the catch trays removably mounted in another one of the plurality of voids, as taught by Cushner et al, to advantageously enable the tissue catch tray to be independently removed and a new one reinstalled without having to turn off the suction function for more efficient sampling as taught by VanderWoude et al in Figure 15a, 16-17, and 19.
In regard to Claim 2, Clement as modified discloses the cassette of claim 1 but do not expressly disclose does not disclose a bypass bore extending through the top face and opening into a bypass conduit, wherein rotation of the valve and inlet fitting configured to place the inlet bore of the inlet fitting in registration with the bypass bore.
Clement teaches a different embodiment comprising bypass conduit 632a that is disposed between fitting 610 and outlet 621, 623, the bypass conduit forming a bypass flow path bypassing container 670 for collecting tissue as well as a valve 650 configured to direct flow into either the bypass conduit or the container for tissue collection through passage 626b and 632b, best seen in Figure 31 (Col.10: 1-Col.11: 15). The bypass conduit provides a bypass flow path that enables waste fluid to flow without being collected. It is noted that Clement also discloses the embodiment of Figure 32 with the same valve 650 enabled to change fluid flow.
VanderWoude et al teach that the analogous cassette comprising valve 532, 530 comprising inlet fitting 486 connected to suction line 50 that is rotated (using knob 580) such that the fluid flow can be directed toward a bypass conduit 550 or tissue catch tray 600 within tissue trap container 650 to effectively enable the tissue catch tray to be independently removed and a new one reinstalled without having to turn off the suction function for more efficient sampling, best seen in Figure 15a, 16-17, and 19 (0229, 0245-0254).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Clement as modified such that there is a bypass bore extending the top face (as similarly already taught by openings 750a-f in Clement) and opening into a bypass conduit as taught by Clement and VanderWoude et al such that rotation of the valve and inlet fitting is configured to place the inlet bore of the inlet fitting of Clement in registration with the bypass bore, as taught by VanderWoude et al to effectively provide a bypass flow path that enables waste fluid to flow without being collected as well as to effectively enable the tissue catch tray to be independently removed and a new one reinstalled without having to turn off the suction function for more efficient sampling.
4. Clement discloses the cassette of claim 1, wherein the head further comprises a finger 774a extending upwardly from the top face, best seen in Figure 32, wherein the valve 770 is rotatably coupled to the finger, best seen in Figure 32.
5. The cassette of claim 1, wherein Clement discloses the top face and the bottom face are planar, best seen in Figure 32-33, and wherein the front face 2640 as taught by VanderWoude et al in the manner above is arcuately shaped (Figure 57 of VanderWoude et al).
6. Clement discloses the cassette of claim 1, wherein the head 742 is formed with a recessed step (defined by wall 784), best seen in Figure 32,
which would be proximal to the front face of VanderWoude et al when combined in the manner above (since the front face 2640 of VanderWoude et al is the distal most component, best seen in Figure 57 of VanderWoude et al), and
wherein the openings 750a-f of Clement are defined within the recessed step, best seen in Figure 32.
7. Clement discloses the cassette of claim 6, wherein the recessed step (defined by wall 784) is arcuate in shape, best seen in Figure 32-33.
In regard to Claim 8, Clement in combination with VanderWoude et al and Cushner et al disclose the invention above but do not expressly disclose the valve further comprises a stop defining a hole that is aligned on a top-to-bottom plate in which the inlet fitting extends, wherein the stop is configured to block fluid flow through the head other than through the hole that is based on a position of the inlet fitting.
Cushner et al teach that it is well-known in the art to provide an analogous device for collecting a tissue sample from a fluid stream comprising a valve assembly 400 with stop 410 defining a hole 411 that is aligned on a top-to-bottom plate (element 410 is a plate) in which the inlet fitting (that connects to suction 120) extends, wherein the stop is configured to block fluid flow through the head other than through the hole, best seen in Figure 4 – “the valve aperture 411 of the valve device 410 is aligned with the bypass bore 430. As shown in FIG. 4, the valve device 410 may be further configured to selectively allow fluid communication between the collection tube A and the suction tube B via the bypass bore 430 so as to bypass one or more of the plurality of collection devices 100 disposed in parallel within the manifold device 400” (0041, 0045-0046).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Clement as modified by VanderWoude et al and Cushner et al such that the valve further comprises a stop defining a hole that is aligned on a top-to-bottom plate in which the inlet fitting extends, wherein the stop is configured to block fluid flow through the head other than through the hole as taught by Cushner et al to provide an effective configuration for a stop defining a hole that is aligned on a top-to-bottom plate that selectively enables communication between the hole and the selected opening or the bypass bore, such that in combination the position is based on a position of the inlet fitting, as taught by Clement.
In regard to Claim 9, Clement in combination with VanderWoude et al disclose the invention above but do not expressly disclose a lock feature located distal to the front face of the head, wherein the lock feature is configured to prevent removal of the catch tray corresponding to a position of the inlet fitting.
VanderWoude et al teach an o-ring 1866 located distal to the front face of head 1706
to prevent removal of catch tray 1850, 1880, best seen in Figure 39A-B (0361). Therefore, it would have been obvious to one of ordinary skill in the art at the time the of filing to modify Clement as modified by VanderWoude et al to include a lock feature located distal to the front face of the head in the manner taught by VanderWoude et al to effectively prevent removal of the catch tray corresponding to a position of the inlet fitting.
In regard to Claim 11, Clement discloses a cassette for collecting a tissue sample from a fluid stream, the cassette comprising:
a body 744 comprising a shell defining an outlet opening 774b through which suction is to be drawn (Col.12: 54-57), and
a cap 742 coupled to the shell to define a void internal to the body, best seen in Figure 32,
wherein the cap comprises a head comprising a top face (near chambers 750a-f) and a bottom face, best seen in Figure 34, and
wherein the head defines a plurality of voids (defining chambers 750a-e) that are arcuately arranged, best seen in Figure 33, and
openings 750a-f that open into a respective one of the plurality of voids, best seen in Figure 32 and 34 (Col.11: 27-36);
a catch tray 756a-e in each of the plurality of voids, best seen in Figure 32 (Col.12: 20-32); and
a valve 770 rotatably coupled to the head – “rotation of the cap 770 relative sample trap body 740 will sequentially bring the conduit 772 into fluid communication with each of the chambers 750a-f as the cap 770 is rotated clockwise” (Col.11: 54-57) and
comprising an inlet fitting 774a configured to receive a proximal end of a suction line 776 (similarly defined as the medical instrument in the instant specification), best seen in Figure 32,
wherein the inlet fitting defined an inlet bore 772, best seen in Figure 32,
wherein the valve and the inlet fitting are configured to be moved relative to the head in an arcuate translation motion about the arcuately-shaped front face to align the inlet fitting with one of the plural voids to place the inlet bore of the inlet fitting in registration with a corresponding one of the openings – “rotation of the cap 770 relative sample trap body 740 will sequentially bring the conduit 772 into fluid communication with each of the chambers 750a-f as the cap 770 is rotated clockwise” (Col.11: 54-57).
However, Clement does not disclose the head includes a front face extending between the top face and the bottom face and arcuately shaped and the catch tray removably seated in each of the plurality of voids.
VanderWoude et al teach that it is well-known in the art to provide an analogous cassette 2600 for collecting a tissue sample from a fluid stream comprising a head 2640 with a top face and a bottom face, best seen in Figure 57, and
a front face arcuately shaped (in the plane of webs 2644 and 2648, best seen in Figure 59 – 0441) extending between the top face and the bottom face, best seen in Figure 57,
wherein the head define a void 2652 that extends inwardly from the front face to define a space for catch tray 2740, best seen in Figure 57 (0442, 0456-0458).
VanderWoude et al also teach catch tray 2740 removably seated in void 2652 to provide the option to add or remove the catch tray as desired – “During time periods in which there is no need to collect specimens from the stream flowing through fitting 2664 a catch tray is not seated in the tray holder 2740” (0456-0458).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Clement such that the head includes a front face extending between the top face and the bottom face and arcuately shaped and the catch tray removably seated in each of the plural voids as taught by VanderWoude et al to provide an effective configuration for the catch trays that enables each to be advantageously removably seated in each of the plurality of voids as desired.
However, Clement does not disclose one of the catch trays is adapted to be removed from one of the plurality of voids with the valve positioned to direct the fluid stream through another one of the catch trays removably mounted in another one of the plurality of voids.
VanderWoude et al teach that the analogous cassette comprising valve 532, 530 comprising inlet fitting 486 connected to suction line 50 that is rotated (using knob 580) such that the fluid flow can be directed toward a bypass conduit 550 or tissue catch tray 600 within tissue trap container 650 to effectively enable the tissue catch tray to be independently removed and a new one reinstalled without having to turn off the suction function for more efficient sampling, best seen in Figure 15a, 16-17, and 19 (0229, 0245-0254 – "During this process of removing one tissue trap 598 from the cassette 420 and attaching a new trap 598, there is no need to turn off the suction pump 58. In other words, the new tissue traps 598 can be attached to the cassette 420 without disrupting the suction draw applied to the suction applicator”).
Cushner et al teach that it is well-known in the art to provide an analogous tissue sampling system comprising a plurality of tissue catch trays 100, each adapted to be removed from and reinstalled in manifold 400 as well as valve 410 that is positioned to direct fluid flow through another one of the desired removably mounted catch tray or bypass conduit 430, best seen in Figure 4 (0046). Thus, Cushner et al make obvious the combination of a bypass conduit, a valve, and a plurality of tissue catch trays that is adapted to be removed between which fluid flow is directed as desired.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Clement such that one of the catch trays is adapted to be removed from one of the plurality of voids with the valve positioned to direct the fluid stream through another one of the catch trays removably mounted in another one of the plurality of voids, as taught by Cushner et al, to advantageously enable the tissue catch tray to be independently removed and a new one reinstalled without having to turn off the suction function for more efficient sampling as taught by VanderWoude et al in Figure 15a, 16-17, and 19.
12. Clement as modified discloses the cassette of claim 11 but do not expressly disclose the head further defines a bypass bore that opens into a bypass conduit, wherein the valve and the inlet fitting are configured to be moved relative to the head in the arcuate translation motion about the arcuately-shaped front face to place the inlet bore of the inlet fitting in registration with the bypass bore.
Clement teaches a different embodiment comprising bypass conduit 632a that is disposed between fitting 610 and outlet 621, 623, the bypass conduit forming a bypass flow path bypassing container 670 for collecting tissue as well as a valve 650 configured to direct flow into either the bypass conduit or the container for tissue collection through passage 626b and 632b, best seen in Figure 31 (Col.10: 1-Col.11: 15). The bypass conduit provides a bypass flow path that enables waste fluid to flow without being collected. It is noted that Clement also discloses the embodiment of Figure 32 with the same valve 650 enabled to change fluid flow.
VanderWoude et al teach that the analogous cassette comprising valve 532, 530 comprising inlet fitting 486 connected to suction line 50 that is rotated (using knob 580) such that the fluid flow can be directed toward a bypass conduit 550 or tissue catch tray 600 within tissue trap container 650 to effectively enable the tissue catch tray to be independently removed and a new one reinstalled without having to turn off the suction function for more efficient sampling, best seen in Figure 15a, 16-17, and 19 (0229, 0245-0254).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Clement as modified such that there is a bypass bore extending the top face (as similarly already taught by openings 750a-f in Clement) and opening into a bypass conduit as taught by Clement and VanderWoude et al such that rotation of the valve and inlet fitting is configured to be moved relative to the head in the arcuate translation motion about the arcuately-shaped front face to place the inlet bore of the inlet fitting in registration with the bypass bore, as taught by VanderWoude et al to effectively provide a bypass flow path that enables waste fluid to flow without being collected as well as to effectively enable the tissue catch tray to be independently removed and a new one reinstalled without having to turn off the suction function for more efficient sampling.
13. Clement discloses a cassette of claim 11, wherein the head 742 is formed with a recessed step (defined by wall 784), best seen in Figure 32,
which would be proximal to the front face of VanderWoude et al when combined in the manner above and is arcuate in shape (since the front face 2640 of VanderWoude et al is the distal most component, best seen in Figure 57 of VanderWoude et al), and
wherein the openings 750a-f of Clement are defined within the recessed step, best seen in Figure 32.
In regard to Claim 14-15, Clement as modified disclose the invention but do not expressly disclose the valve further comprises a plate distal section, and an arcuate rim that extends from an undersurface of the plate distal section, wherein the arcuate rim is positioned distal to the arcuately-shaped front face, and a plate proximal section coupled to the plate distal section, and a stop coupled to the plate proximal section and formed as a curved plate, wherein the stop defines a hole.
VanderWoude et al teach that it is well-known in the art to provide an analogous valve 532, 530 comprising a plate distal section 447, best seen in Figure 19,
and an arcuate rim on 532 that extends from an undersurface of the plate distal section, best seen in Figure 19, and
a plate proximal section coupled to the plate distal section, best seen in Figure 19, and
a stop coupled to the plate proximal section and formed as a curved plate (panel 456 is curved, best seen in Figure 19), wherein the stop defines a hole 478, best seen in Figure 19, to effectively enable the desired flow of fluid (0245-0250).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Clement as modified by VanderWoude et al such that the valve further comprises a plate distal section, and an arcuate rim that extends from an undersurface of the plate distal section, and a plate proximal section coupled to the plate distal section, and a stop coupled to the plate proximal section and formed as a curved plate, wherein the stop defines a hole, as taught by VanderWoude et al to provide an effective configuration for the valve to enable the desired flow of fluid, where in combination, the arcuate rim is positioned distal to the arcuately-shaped front face, when combined with Clement as modified above as an obvious effect of the combination since a rim is typically placed at the distal most region.
In regard to Claim 16, Clement discloses a cassette for collecting a tissue sample from a fluid stream, the cassette comprising:
a body 744 comprising a shell defining an outlet opening 774b through which suction is to be drawn (Col.12: 54-57), and
a cap 742 coupled to the shell to define a void internal to the body, best seen in Figure 32,
wherein the cap comprises a head comprising a top face (near chambers 750a-f) and a bottom face, best seen in Figure 34, and
wherein the head defines plural voids (defining chambers 750a-e) that extend inwardly, best seen in Figure 32 (Col.12: 14-23),
openings 750a-f extending through the top face and into a respective one of the plural voids, best seen in Figure 32 and 34 (Col.11: 27-36), and
a catch tray 756a-e seated in each of the plural voids, best seen in Figure 32 (Col.12: 20-32); and
a valve 770 movably coupled to the top face – “rotation of the cap 770 relative sample trap body 740 will sequentially bring the conduit 772 into fluid communication with each of the chambers 750a-f as the cap 770 is rotated clockwise” (Col.11: 54-57) and
comprising an inlet fitting 774a configured to receive a proximal end of a suction line 776 (similarly defined as the medical instrument in the instant specification), best seen in Figure 32,
wherein the inlet fitting defines an inlet bore 772, best seen in Figure 32,
wherein the valve and the inlet fitting are configured to be rotated relative to the head to align the inlet fitting with one of the plural voids to place the inlet bore of the inlet fitting in registration with a corresponding one of the openings – “rotation of the cap 770 relative sample trap body 740 will sequentially bring the conduit 772 into fluid communication with each of the chambers 750a-f as the cap 770 is rotated clockwise” (Col.11: 54-57).
However, Clement does not disclose the head includes a front face extending between the top face and the bottom face wherein the head defines plural voids that extend inwardly from the front face and the catch tray removably seated in each of the plural voids.
VanderWoude et al teach that it is well-known in the art to provide an analogous cassette 2600 for collecting a tissue sample from a fluid stream comprising a head 2640 with a top face and a bottom face, best seen in Figure 57, and
a front face (in the plane of webs 2644 and 2648, best seen in Figure 59 – 0441) extending between the top face and the bottom face, best seen in Figure 57,
wherein the head define a void 2652 that extends inwardly from the front face to define a space for catch tray 2740, best seen in Figure 57 (0442, 0456-0458).
VanderWoude et al also teach catch tray 2740 removably seated in void 2652 to provide the option to add or remove the catch tray as desired – “During time periods in which there is no need to collect specimens from the stream flowing through fitting 2664 a catch tray is not seated in the tray holder 2740” (0456-0458).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing such that the head includes a front face extending between the top face and the bottom face, wherein the head defines plural voids that extend inwardly from the front face, and the catch tray removably seated in each of the plural voids as taught by VanderWoude et al to provide an effective configuration for the catch trays in the front face of the head that enables each catch tray to be advantageously removably seated in each of the plural voids as desired.
However, Clement does not disclose a bypass bore extending through the top face and opening into a bypass conduit, wherein rotation of the valve and inlet fitting configured to place the inlet bore of the inlet fitting in registration with the bypass bore.
Clement teaches a different embodiment comprising bypass conduit 632a that is disposed between fitting 610 and outlet 621, 623, the bypass conduit forming a bypass flow path bypassing container 670 for collecting tissue as well as a valve 650 configured to direct flow into either the bypass conduit or the container for tissue collection through passage 626b and 632b, best seen in Figure 31 (Col.10: 1-Col.11: 15). The bypass conduit provides a bypass flow path that enables waste fluid to flow without being collected. It is noted that Clement also discloses the embodiment of Figure 32 with the same valve 650 enabled to change fluid flow.
VanderWoude et al teach that the analogous cassette comprising valve 532, 530 comprising inlet fitting 486 connected to suction line 50 that is rotated (using knob 580) such that the fluid flow can be directed toward a bypass conduit 550 or tissue catch tray 600 within tissue trap container 650 to effectively enable the tissue catch tray to be independently removed and a new one reinstalled without having to turn off the suction function for more efficient sampling, best seen in Figure 15a, 16-17, and 19 (0229, 0245-0254).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Clement such that there is a bypass bore extending the top face (as similarly already taught by openings 750a-f in Clement) and opening into a bypass conduit as taught by Clement and VanderWoude et al such that rotation of the valve and inlet fitting is configured to place the inlet bore of the inlet fitting of Clement in registration with the bypass bore as taught by VanderWoude et al, to effectively provide a bypass flow path that enables waste fluid to flow without being collected as well as to effectively enable the tissue catch tray to be independently removed and a new one reinstalled without having to turn off the suction function for more efficient sampling.
However, Clement does not disclose one or more of the catch trays removably seated in each of the plural voids are removable without interrupting a flow of vacuum when the valve is aligned with the bypass bore.
VanderWoude et al teach that the analogous cassette comprising valve 532, 530 comprising inlet fitting 486 connected to suction line 50 that is rotated (using knob 580) such that the fluid flow can be directed toward a bypass conduit 550 or tissue catch tray 600 within tissue trap container 650 to effectively enable the tissue catch tray to be independently removed and a new one reinstalled without having to turn off the suction function for more efficient sampling, best seen in Figure 15a, 16-17, and 19 (0229, 0245-0254 – "During this process of removing one tissue trap 598 from the cassette 420 and attaching a new trap 598, there is no need to turn off the suction pump 58. In other words, the new tissue traps 598 can be attached to the cassette 420 without disrupting the suction draw applied to the suction applicator”).
Cushner et al teach that it is well-known in the art to provide an analogous tissue sampling system comprising a plurality of tissue catch trays 100, each adapted to be removed from and reinstalled in manifold 400 as well as valve 410 that is positioned to direct fluid flow through another one of the desired removably mounted catch tray or bypass conduit 430, best seen in Figure 4 (0046). Thus, Cushner et al make obvious the combination of a bypass conduit, a valve, and a plurality of tissue catch trays that is adapted to be removed between which fluid flow is directed as desired.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Clement such that one or more of the catch trays is removably seated in each of the plural voids when the valve is aligned with the bypass bore, as taught by Cushner et al, to advantageously enable the catch trays to be removable without interrupting a flow of vacuum for more efficient sampling as taught by VanderWoude et al in Figure 15a, 16-17, and 19.
In regard to Claims 3 and 17, Clement in combination with VanderWoude et al and Cushner et al disclose the invention above but do not expressly disclose the openings are located on opposing sides of the bypass bore.
Cushner et al teach that it is well-known in the art to provide an analogous device for collecting a tissue sample from a fluid stream comprising a valve assembly 400 that provides bypass bore 430 with openings 420 providing flow into sample collection containers 100 located on opposing sides of the bypass bore, best seen in Figure 4, as an effective configuration for the system (0041, 0045-0046). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Clement as modified by VanderWoude et al and Cushner et al such that the openings are located on opposing sides of the bypass bore as taught by Cushner et al as an effective configuration for the system.
18. Clement discloses the cassette of claim 16, wherein the head 742 is formed with a recessed step (defined by wall 784), best seen in Figure 32,
which would be proximal to the front face of VanderWoude et al when combined in the manner above (since the front face 2640 of VanderWoude et al is the distal most component, best seen in Figure 57 of VanderWoude et al), and
wherein the openings 750a-f of Clement and the bypass bore as taught by Clement and VanderWoude et al in the manner above are defined within the recessed step, as already similarly taught by said openings of Clement.
19. Clement discloses the cassette of claim 16, wherein the plural voids (defining chambers 750a-e) are arranged arcuately on the head 742, best seen in Figure 34, and wherein the valve 770 is movably coupled to the head to be moved in an arcuate translation motion, best seen in Figure 33 – “rotation of the cap 770 relative sample trap body 740 will sequentially bring the conduit 772 into fluid communication with each of the chambers 750a-f as the cap 770 is rotated clockwise” (Col.11: 54-57).
20. Clement discloses the cassette of claim 16, wherein the plural voids (defining chambers 750a-e) are arranged linearly on the head (void 750a is linearly arranged with void 750d), best seen in Figure 34, and wherein the valve 770 is movably coupled to the head to be moved linearly in said similar manner (Col.11: 54-57).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Clement in view of VanderWoude et al and Cushner et al, further in view of Christensen et al (US Pub No. 20060058702).
Clement in combination with VanderWoude et al and Cushner et al disclose the invention above but do not expressly disclose the head further comprises indentations, and wherein the valve further comprises a tab configured to engage the indentations and provide varying resistance as tactile feedback as to a setting of the valve.
Christensen et al teach that it is well-known in the art to provide a valve for a medical device comprising a head 498 further comprises indentations 572, 574, and wherein the valve further comprises a tab 558 configured to engage the indentations and provide varying resistance as tactile feedback as to a setting of the valve, best seen in Figure 29-30 – “Ramps 572 and 574 are arranged to cause a small structural interference with post 558a… As illustrated, when valve 515 is rotated to move post 558a to a drain position at 558a', post 558a engages and scrapes past ramp 572 gradually increasing an interference, until post 558a is disposed substantially in the drain position. When near the drain position, the ramp drops off in a radial direction and quickly reduces the formed structural interference, producing tactile feedback in the form of a sensation that is perceptible to a valve operator, and which may include an audible ‘click’” (0120).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Clement as modified by VanderWoude et al and Cushner et al such that the head further comprises indentations, and wherein the valve further comprises a tab configured to engage the indentations as taught by Christensen et al to effectively provide varying resistance as tactile feedback as to a setting of the valve for the user.
Response to Arguments
In regard to Claim 1, applicant contends that Clement does not teach the inlet fitting extending distal to the front face. It is submitted that VanderWoude et al teach this feature, best seen in Figure 58-59 – “fitting 2616 extends forward from a location that is radially spaced away from the center longitudinal axis of the cassette 2600, the axis through plate 2614 around which the cassette 2600 is rotated when in the receptacle 1699” (0439), as now indicated in the above rejection.
Applicant contends that the device of Clement and VanderWoude et al are “structurally incompatible” and that the rejection “does not reasonably identify how these disparate devices can be combined structurally without changing the principal mode of operation of Clement” (Remarks pg. 7). It is noted that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In other words, the combination is made obvious in light of the instant claims. The instant rejection does not require removal of cap 770 of Clement despite any assertion that this is the only manner of modification with VanderWoude et al (Remarks pg. 7). For example, MPEP 2141 states that "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle."Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ."Id. at 418, 82 USPQ2d at 1396.”
Applicant contends similarly with regard to Clement. Applicant contends that “the Final Office Action provides no rationale as to how a skilled artisan would structurally modify the tubular collection devices 100 of Cushner, which are clipped into a tray (with C-clips or the like), with the slidably removable catch tray of VanderWoude, then further modify the combined device with the enclosed multi-chambered device of Clement” (Remarks pg. 8). Again, it is noted that since the claims merely require the catch trays be “removable” without any underlying structure, Cushner et al has been set forth to teach multiple catch trays that are each removable while a valve is directing flow toward another catch try or a bypass bore as desired, as broadly as has been claimed. Furthermore, it is noted that VanderWoude et al disclose the tissue catch tray able to be independently removed and a new one reinstalled without having to turn off the suction function for more efficient sampling, best seen in Figure 15a, 16-17, and 19 (0229, 0245-0254 – "During this process of removing one tissue trap 598 from the cassette 420 and attaching a new trap 598, there is no need to turn off the suction pump 58. In other words, the new tissue traps 598 can be attached to the cassette 420 without disrupting the suction draw applied to the suction applicator”). Therefore, the rejection is maintained.
Conclusion
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791