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 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.
The actuation member of claims 1-4,7-13,17-20 is interpreted under 112f. Claims 5-6,14-16 define the actuation member as a button and thus are not interpreted under 112f. Per paragraph 0043 of the instant specification, the actuation member may be a button, thumb actuated slider, a depressible end portion of the housing, rotational member where any suitable converts the rotational motion of the actuation member into linear motion, palm actuated enlarged member, push button, cam arrangement, rotating slide knob, paddles or projections. As such any prior art that teaches at least one of the aforementioned embodiments reads to the limitation of claims 1-4,7-13,17-20 .
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 6,8 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 6, the claim requires inhibiting the movement of “the button or slide”. The examiner notes that per claim 5 (from which claim 6 is dependent from) or any other claim, “a slide” is not claimed. Rather claim 5 only requires “a button”. As such it is interpreted that claim 6 requires inhibit movement of only “the button” as claimed.
Regarding claim 8, the claim requires “an end the pre-evacuated container provides the actuation device.” The examiner notes that per claim 1, the actuation device comprises a housing that receives the pre evacuated container within. As such the language of the pre-evacuated container providing the actuation device is unclear. It is interpreted that so long as the combined device comprises the pre-evacuated container having at least one end in the actuation device, the prior art reads to the claimed limitation.
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.
Claim(s) 1-3,7-12,17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grossman et al. US 2004/0116902 in view of Cunningham US 5588958 and further in view of Guirguis et al. US 2018/0228945, hereafter Grossman, Cunningham, and Guirguis, respectively. Grossman and Guirguis are provided in the IDS.
Regarding claim 1, Grossman discloses a drainage system for draining bodily fluid (abstract) and an actuation device comprising a pre-evacuated container therein (vacuum bottle (12) with a sealed vacuum in interior (13), see para. 0026), the actuation device comprising an actuation member (spike point (24), interpreted to be a slider per the 112f interpretation) that, upon actuation, is configured to reduce a distance between a seal of the pre-evacuated container and a piercing element such that the piercing element pierces the seal of the pre-evacuated container inside the container-receiving chamber (para. 0029 where the spike is moved to pierce the seal on the vacuum container to allow vacuum into the drainage line 26) thereby providing communication of a negative pressure inside the pre-evacuated container to a fluid-receiving passageway (26) to draw bodily fluid into the fluid-receiving passageway.
The examiner notes that however, Grossman fails to specifically teach the drainage system comprising: a fluid-receiving body having a fluid-receiving chamber located therein that is configured to receive a bodily fluid, a housing with a container-receiving chamber that is sized and configured to receive the pre-evacuated container, and the drain line draining toward the fluid- receiving body.
The examiner notes that per paragraph 0039 of Grossman, figure 4 shows an embodiment comprising an outlet port (for draining fluid from the vacuum bottle) covered by (32). While there is no disclosure of connection to another fluid receiving body, fluid can clearly be removed from the bottle to another location.
Cunningham teaches a fluid drainage device and is thus considered analogous to the claimed invention. Cunningham teaches that the device comprises a connector for drainage from a patient (12), where said connecter connects to a container (26, see column 2, lines 1-9). The drainage container is connected through one port (and tube (36)) to a vacuum device (40, see column 2, lines 22-26), and through another port (And tube (38)) a collection bag (76, see column 2 lines 54-67 and column 3 lines 1-8). Therefore as Grossman teaches a first drainage container with a port for further removing collected fluid, and Cunningham teaches a first drainage container connected to a second container in the form of a bag, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to connect the further draining port of Grossman to a bag for collection. Doing so would merely involve combining prior art elements according to known methods to yield predictable results, that being drainage from one container to a bag, and as such a prima facie case of obviousness exists. Said bag is interpreted a fluid-receiving body having a fluid-receiving chamber located therein that is configured to receive a bodily fluid per the claim limitation. Further, as the drain line drains to the first container, and then the fluid is further drained to the drainage bag, it is interpreted that the drain line drains toward the fluid- receiving body (the bag).
As detailed above, the prior art as applied further fails to teach a housing with a container-receiving chamber that is sized and configured to receive the pre-evacuated container.
Guirguis discloses a fluid drainage device and is thus considered analogous to the claimed invention. Guirguis discloses that the device comprises a container (30) for receiving a cartridge (40) containing a vessel (54). The vessel comprises a sealed vacuum (para. 0041) In use, the cartridge is loaded into the container, where the housing (comprising hub (42) comprises a mechanism to pierce the cover into the vessel and drain fluid into the vessel (para. 0041). The examiner notes that the container allows for connection to vessel for drainage and provides sensors for detecting features of the fluid in the vessel (para. 0040, 0062). Therefore, as Guirguis teaches that a pre-evacuated vessel for drainage may be loaded into a container such that, through sensors loaded on the container, the drained fluid can be monitored, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the pre-evacuated drainage “vessel” of Grossman with a container comprising sensors to load the “vessel” into, as a means to monitor the fluid collected. Doing so would merely involve combining prior art elements (container with sensors for monitoring fluid within a vessel loaded onto the container combined with a lone fluid collection vessel) according to known methods to yield predictable results (that being monitoring of fluid within a collection vessel), and as such a prima facie case of obviousness exists.
Regarding claim 2, Grossman, Cunningham, and Guirguis teach the drainage system of claim 1 but as applied above fail to teach the device further comprising a one-way valve located at an inlet of the fluid-receiving body that provides a single fluid flow direction into the fluid- receiving body.
The examiner notes that Guirguis teaches a fluid conduit (46,48,80 see figure 4) for connecting to the vessel opening (50 see figure 3) for drainage. Guirguis teaches that the opening of the vessel may comprise a one-way valve to prevent spillage when removing the vessel from the hub (para. 0041). Therefore it would have been obvious to one having ordinary skill in the art to provide the device of Grossman, Cunningham, and Guirguis with a one way valve at the inlet of the bottle to prevent spillage. Doing so would merely involve combining prior art elements according to known methods to yield predictable results, that being spillage prevention from the bottle out through the inlet drain line, and thus a prima facie case of obviousness exists.
Regarding claim 3, Grossman, Cunningham, and Guirguis teach the drainage system of claim 1, wherein the actuation device comprises the fluid-receiving passageway, the container-receiving chamber is liquidly isolated from the fluid- receiving passageway. The examiner notes that as detailed under the rejection of claim 1 and as seen in figure 1 of Grossman, the defined actuation device directly connects into the vacuum bottle. As the container receiving chamber (internal space of container) is external and the bottle is merely loaded into the container, the flow pathway is isolated from the container chamber. Thus the components are liquidly isolated.
Regarding claim 7, Grossman, Cunningham, and Guirguis teach the drainage system of claim 1 further comprising a pre-evacuated container having a negative pressure therein and a seal that prevents air from entering the pre-evacuated container. See rejection of claim 1, see also Grossman para. 0016-0018, where the device includes seal (32) on the bottle.
Regarding claim 8, Grossman, Cunningham, and Guirguis teach the drainage system of claim 7, wherein an end of the pre-evacuated container provides the actuation member. The examiner notes that per the 112b rejection, the claim is interpreted to read “provides the actuation member”. As seen in figure 1 of Grossman, the actuation member (spike with flange (30)) is seen on one end of the container. As such Grossman reads to the claimed limitation.
Regarding claim 9, Grossman, Cunningham, and Guirguis teach the drainage system of claim 1, wherein the housing has a fluid inlet that provides ingress of bodily fluid to the fluid-receiving passageway and a fluid outlet that provides egress of bodily fluid from the fluid-receiving passageway. As Grossman teaches the inlet conduit (and outlet conduit through combination with Cunningham) extending from the sealed bottle (and thus the tubes are external to the bottle), where said tube may not be attached to bottle prior to use (para. 0027) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to incorporate said external conduits within the housing of Guirguis upon combination of the prior arts, as the housing is also external to the vacuum bottle and connects with the bottle during use.
Regarding claim 10, Grossman, Cunningham, and Guirguis teach the drainage system of claim 9 further comprising a first drainage tube connected to the fluid inlet (Grossman 26)and a second drainage tube connected to the fluid outlet (see claim 1 rejection, incorporated upon combination with Cunningham).
Regarding claim 11, Grossman, Cunningham, and Guirguis teach the discloses drainage system of claim 10, wherein the fluid-receiving body is a bag that is in fluid communication with the second drainage tube. The examiner notes that as detailed under the rejection of claim 1, the fluid receiving body is a bag in communication with the second drainage tube.
Regarding claim 12, Grossman discloses a method of forming a drainage system for draining a bodily fluid, the method comprising: connecting an actuation device that comprises an actuation member (spike point (24) interpreted to be a slider per the 112f interpretation) that, upon actuation, is configured to reduce a distance between a seal of the pre-evacuated container and a piercing element such that the piercing element pierces the seal of the pre-evacuated container inside the container-receiving chamber (para. 0029 where the spike is moved to pierce the seal on the vacuum container (vacuum bottle (12) with a sealed vacuum in interior (13), see para. 0026), to allow vacuum into the drainage line 26) thereby providing communication of a negative pressure inside the pre-evacuated container to a fluid-receiving passageway (26) to draw bodily fluid into the fluid-receiving passageway.
The examiner notes that however, Grossman fails to specifically teach the drainage system comprising: a fluid-receiving body and thus draining toward the fluid- receiving body. The examiner notes that per paragraph 0039 of Grossman, figure 4 shows an embodiment comprising an outlet port (for draining fluid from the vacuum bottle) covered by (32). While there is no disclosure of connection to another fluid receiving body, fluid can clearly be removed from the bottle to another location.
Cunningham teaches a fluid drainage device and is thus considered analogous to the claimed invention. Cunningham teaches that the device comprises a connector for drainage from a patient (12), where said connecter connects to a container (26, see column 2, lines 1-9). The drainage container is connected through one port (and tube (36)) to a vacuum device (40, see column 2, lines 22-26), and through another port (And tube (38)) a collection bag (76, see column 2 lines 54-67 and column 3 lines 1-8). Therefore as Grossman teaches a first drainage container with a port for further removing collected fluid, and Cunningham teaches a first drainage container connected to a second container in the form of a bag, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to connect the further draining port of Grossman to a bag for collection. Doing so would merely involve combining prior art elements according to known methods to yield predictable results, that being drainage from one container to a bag, and as such a prima facie case of obviousness exists. Said bag is interpreted a fluid-receiving body having a fluid-receiving chamber located therein that is configured to receive a bodily fluid per the claim limitation. Further, as the drain line drains to the first container, and then the fluid is further drained to the drainage bag, it is interpreted that the drain line drains toward the fluid- receiving body (the bag).
The prior art as applied further fails to teach a housing and thus fails to teach connecting a first drainage tube to an inlet of a housing of an actuation device, the actuation device comprising: the housing comprising a container-receiving chamber that is sized and configured to receive a pre-evacuated container therein, and placing a pre-evacuated container in the container receiving chamber.
Guirguis discloses a fluid drainage device and is thus considered analogous to the claimed invention. Guirguis discloses that the device comprises a container (30) for receiving a cartridge (40) containing a vessel (54). The vessel comprises a sealed vacuum (para. 0041) In use, the cartridge is loaded into the container, where the housing (comprising hub (42) comprises a mechanism to pierce the cover into the vessel and drain fluid into the vessel (para. 0041). The examiner notes that the container allows for connection to vessel for drainage and provides sensors for detecting features of the fluid in the vessel (para. 0040, 0062). Therefore, as Guirguis teaches that a pre-evacuated vessel for drainage may be loaded into a container such that, through sensors loaded on the container, the drained fluid can be monitored, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the pre-evacuated drainage “vessel” of Grossman with a container comprising sensors to load the “vessel” into, as a means to monitor the fluid collected. Doing so would merely involve combining prior art elements (container with sensors for monitoring fluid within a vessel loaded onto the container combined with a lone fluid collection vessel) according to known methods to yield predictable results (that being monitoring of fluid within a collection vessel), and as such a prima facie case of obviousness exists.
The examiner notes that upon combination, a step of loading the pre-evacuated container to the housing is taught. Further, as Grossman teaches the inlet conduit (and outlet conduit through combination with Cunningham) extending from the sealed bottle (and thus the tubes are external to the bottle), where said tube may not be attached to bottle prior to use (para. 0027) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to incorporate said external conduits within the housing and flow path (The examiner notes that Guirguis teaches a fluid conduit (46,48,80 see figure 4) for connecting to the vessel opening (50 see figure 3) for drainage) of Guirguis upon combination of the prior arts, as the housing is also external to the vacuum bottle and connects with the bottle during use. As such a step of connecting the drainage tube to the inlet of the housing would occur when the housing is placed on the device.
Regarding claim 17, Grossman, Cunningham, and Guirguis teach the method of claim 12, wherein the pre-evacuated container has a seal that prevents air from entering the pre-evacuated container. See rejection of claim 12, see also Grossman para. 0016-0018, where the device includes seal (32) on the bottle.
Regarding claim 18, Grossman, Cunningham, and Guirguis teach the method of claim 12, wherein the housing has the fluid inlet that provides ingress of bodily fluid to the fluid-receiving passageway and a fluid outlet that provides egress of bodily fluid from the fluid-receiving passageway. As Grossman teaches the inlet conduit (and outlet conduit through combination with Cunningham) extending from the sealed bottle (and thus the tubes are external to the bottle), where said tube may not be attached to bottle prior to use (para. 0027) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to incorporate said external conduits within the housing of Guirguis upon combination of the prior arts, as the housing is also external to the vacuum bottle and connects with the bottle during use.
Regarding claim 19, Grossman, Cunningham, and Guirguis teach the method of claim 18 further comprising connecting a second drainage tube connected to the fluid outlet. The examiner notes that as detailed under the rejection of claim 12, upon combination with Cunningham, the device comprises and outlet connecting to a drainage bag. The examiner notes that the drainage tube must be connected to the fluid outlet in order for the device to function. Therefore there is at least a step of connecting the outlet to the second drainage tube, such that fluid can be removed (see fluid being removed per Grossman para. 0039.
Regarding claim 19, Grossman, Cunningham, and Guirguis teach the method of claim 19 further comprising connecting the second drainage tube to a fluid-collecting bag. The examiner notes that as detailed under the rejection of claim 12 and 18, upon combination with Cunningham, the device comprises and outlet connecting to a drainage bag. The examiner notes that the drainage tube must be connected to the fluid outlet and further to the drainage bag in order for the device to function. Therefore there is at least a step of connecting the outlet to the second drainage tube and further connecting said tube to the bag, such that fluid can be removed into the bag (see fluid being removed per Grossman para. 0039.
Claim(s) 4-5, 13-14,16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grossman in view of Cunningham and Guirguis and further in view of Dobbyn et al. US 2018/0281024 and Bocquet et al. US 4583971, hereafter Dobbyn and Bocquet, respectively.
Regarding claim 4, Grossman, Cunningham, and Guirguis teach the drainage system of claim 1, wherein the actuation member is movably connected to the housing and contacts the pre-evacuated container such that movement of the actuation member relative to the housing moves the pre-evacuated container toward the piercing element. The examiner notes that as detailed under the rejection of claim 1, Guirguis teaches (per paragraph 0041) that the container comprises a mechanism for piercing the seal of the vacuum containing vessel. As Grossman teaches a spike for breaking the seal of the bottle (and thus the spike is external to the bottle, where said spike may not be attached to bottle prior to use (para. 0027), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to incorporate said external spike and conduit within the housing of Guirguis upon combination of the prior arts as the housing is also external to the vacuum bottle and connects with the bottle during use. The examiner notes that Grossman teaches the actuation member is moveable connected to the bottle and the movement of the device (relative to the stationary housing of the combination) would cause the spike to move downward, piercing the bottle. However, the examiner notes that the container itself is not being moved toward the spike.
Dobbyn teaches a system for piercing containers and is thus considered analogous to the claimed invention. Dobbyn teaches that the piercing apparatus is repositioned through a manual process where a user operates the piercing apparatus component using a lever, handle, line, button, etc. to move the piercing element towards the container to pierce the container (para. 0107). Dobbyn teaches that alternatively the piercing apparatus component is stationary and instead the container is configured to move toward the piercing apparatus (para. 0107, 0108). Per these citations a container may be placed in an installed position with the apparatus and moved toward the stationary piercing component. Therefore, as Dobbyn teaches that an alternative to moving a piercing element with an actuator (lever, handle, button, etc.) to a container to pierce the container is instead to move the container toward a stationary needle, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the vacuum bottle a means to move the bottle into the needle, as Dobbyn teaches that such a configuration is a known to function to pierce to bottle. Doing so merely requires applying a known technique (using a movable container rather than a movable piercing element to pierce) to a known device (container with piercing device) ready for improvement to yield predictable results (that being piercing of the seal of the container.
The examiner notes however, that per the interpreted actuation member above, even upon combination with Dobbyn, the actuation member is not moveably connected to the housing such that movement of the actuation member relative to the housing moves the pre-evacuated container toward the piercing element.
Bocquet teaches a vial piercing system and is thus considered analogous to the claimed invention. Bocquet teaches a device comprising a container (36) and a spike (54), where in operation the container is moved toward to spike to be punctured (abstract, column 5 lines 24-39). The examiner notes that in to move the vial downwardly, the cap (28), specifically the central member (46) will be pushed down on to force the vial downward (see figure 3). As further seen in the figures, the container (36) is located within an outer housing (22), on which the cap is located. The examiner notes that as the cap portion is deformable and requires an external force to push on the move the container, it is interpreted that the cap acts as a button. Therefore, as Bocquet teaches that it is known in the art to provide an outer housing with a cap for receiving a container within, and where pushing on the cap allows for movement of the container toward a spike for piercing, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the housing of the combination of Grossman in view of Cunningham, Guirguis, and Dobbyn with the pushable cap structure as a means to push the container toward the piercing element of the device. As the combination teaches that moving the container toward the spike is a known alternative to pushing the spike toward the container, the combination with Bocquet merely relies on applying a known technique (a cap on an outer housing to move an inner container toward a spike) to a known device (a pierceable container and a spike, where it was found obvious to move the container toward the spike) ready for improvement to yield predictable results (that being piercing of the vacuum container).
Regarding claim 5, Grossman, Cunningham, Guirguis, Dobbyn and Bocquet teach the drainage system of claim 4, wherein the actuation member comprises a button that, when moved relative to the housing, moves the pre-evacuated container toward the piercing element. The examiner notes that as detailed under the rejection of claim 4, it was found obvious to provide a movement means such as cap to allow for movement of the container toward the needle. Per the rejection of claim 4, the cap is interpreted to be a button.
Regarding claim 13, Grossman, Cunningham, and Guirguis teach the method of claim 12, wherein the actuation member is movably connected to the housing and contacts the pre-evacuated container such that moving the actuation member relative to the housing moves the pre-evacuated container toward the piercing element. The examiner notes that as detailed under the rejection of claim 1, Guirguis teaches (per paragraph 0041) that the container comprises a mechanism for piercing the seal of the vacuum containing vessel. As Grossman teaches a spike for breaking the seal of the bottle (and thus the spike is external to the bottle, where said spike may not be attached to bottle prior to use (para. 0027), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to incorporate said external spike and conduit within the housing of Guirguis upon combination of the prior arts as the housing is also external to the vacuum bottle and connects with the bottle during use. The examiner notes that Grossman teaches the actuation member is moveable connected to the bottle and the movement of the device (relative to the stationary housing of the combination) would cause the spike to move downward, piercing the bottle. However, the examiner notes that the container itself is not being moved toward the spike.
Dobbyn teaches a system for piercing containers and is thus considered analogous to the claimed invention. Dobbyn teaches that the piercing apparatus is repositioned through a manual process where a user operates the piercing apparatus component using a lever, handle, line, button, etc. to move the piercing element towards the container to pierce the container (para. 0107). Dobbyn teaches that alternatively the piercing apparatus component is stationary and instead the container is configured to move toward the piercing apparatus (para. 0107, 0108). Per these citations a container may be placed in an installed position with the apparatus and moved toward the stationary piercing component. Therefore, as Dobbyn teaches that an alternative to moving a piercing element with an actuator (lever, handle, button, etc.) to a container to pierce the container is instead to move the container toward a stationary needle, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the vacuum bottle a means to move the bottle into the needle, as Dobbyn teaches that such a configuration is a known to function to pierce to bottle. Doing so merely requires applying a known technique (using a movable container rather than a movable piercing element to pierce) to a known device (container with piercing device) ready for improvement to yield predictable results (that being piercing of the seal of the container.
The examiner notes however, that per the interpreted actuation member above, even upon combination with Dobbyn, the actuation member is not moveably connected to the housing such that movement of the actuation member relative to the housing moves the pre-evacuated container toward the piercing element.
Bocquet teaches a vial piercing system and is thus considered analogous to the claimed invention. Bocquet teaches a device comprising a container (36) and a spike (54), where in operation the container is moved toward to spike to be punctured (abstract, column 5 lines 24-39). The examiner notes that in to move the vial downwardly, the cap (28), specifically the central member (46) will be pushed down on to force the vial downward (see figure 3). As further seen in the figures, the container (36) is located within an outer housing (22), on which the cap is located. The examiner notes that as the cap portion is deformable and requires an external force to push on the move the container, it is interpreted that the cap acts as a button. Therefore, as Bocquet teaches that it is known in the art to provide an outer housing with a cap for receiving a container within, and where pushing on the cap allows for movement of the container toward a spike for piercing, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the housing of the combination of Grossman in view of Cunningham, Guirguis, and Dobbyn with the pushable cap structure as a means to push the container toward the piercing element of the device. As the combination teaches that moving the container toward the spike is a known alternative to pushing the spike toward the container, the combination with Bocquet merely relies on applying a known technique (a cap on an outer housing to move an inner container toward a spike) to a known device (a pierceable container and a spike, where it was found obvious to move the container toward the spike) ready for improvement to yield predictable results (that being piercing of the vacuum container).
Regarding claim 14, Grossman, Cunningham, Guirguis, and Bocquet teach the method of claim 13, wherein the actuation member comprises a button such that moving the button moves the pre-evacuated container toward the piercing element. The examiner notes that as detailed under the rejection of claim 13, it was found obvious to provide a movement means such as cap to allow for movement of the container toward the needle. Per the rejection of claim 13, the cap is interpreted to be a button.
Regarding claim 16, Grossman, Cunningham, Guirguis, and Bocquet teach the method of claim 14, wherein the button covers an opening to the container-receiving chamber through which a pre-evacuated container is received. The examiner notes that as detailed under the rejection of claim 14, the button is a cap on the defined outer container of the device of Bocquet. As seen in figure 1 of Bocquet, the cap is off, exposing the interior of the “outer housing” and the bottom of the vial. Therefore as the cap is placed over the rim (26, see column 4, lines 21-34) where the rim is an open space, it is interpreted that the cap covers an opening. The examiner notes that as it was found obvious to include the button cap configuration of Bocquet with the device of Grossman, Cunningham, and Guirguis per the rejection of claim 14, the combination of all arts teach the button covering an opening in the container receiving chamber.
Claim(s) 6,15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grossman in view of Cunningham, Guirguis, Dobbyn, and Bocquet and further in view of Marantis et al. US 2020/0391925, hereafter Marantis.
Regarding claim 6, Grossman, Cunningham, Guirguis, Dobbyn, and Bocquet teach the drainage system of claim 5, but fails to teach wherein the actuation device comprises a clip between the button and the housing that inhibits movement of the button or slide relative to the housing. The examiner notes that while the cap of Bocquet is welded on the housing (column 4 line 45-54) and thus is interpreted to be secured to the housing preventing movement of the cap relative to the housing, the weld cannot be interpreted as a clip.
Marantis teaches a container and is thus considered analogous to the claimed invention. Marantis teaches that the container of the system comprises a cap (80), where said cap is attached to bottle (B) by a fastener (para. 0072). Per Marantis para. 0072 said fastener may be a weld, adhesive or clip. Therefore as Marantis teaches that both welds and clips are a suitable attachment for connecting a cap to a bottle, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a clip as the attachment mechanism of the cap of the combination of Grossman, Cunningham, Guirguis, and Bocquet. Doing so would merely involve the simple substitution of one known element (weld) for another (Clip) to obtain predictable results (attachment of a cap to a bottle), and thus a prima facie case of obviousness exists. The examiner notes that as detailed above under the same rejection of claim 6, the weld is interpreted to prevent the movement of the cap relative to the housing, and as the clip is a suitable substitution for the weld per Marantis, the clip is interpreted to provide the same function.
Regarding claim 15, Grossman, Cunningham, Guirguis, Dobbyn, and Bocquet teach the method of claim 14 but fails to teach the method comprising inhibiting movement of the button relative to the housing using a clip located between the button or slide and the housing The examiner notes that while the cap of Bocquet is welded on the housing (column 4 line 45-54) and thus is interpreted to be secured to the housing preventing movement of the cap relative to the housing, the weld cannot be interpreted as a clip.
Marantis teaches a container and is thus considered analogous to the claimed invention. Marantis teaches that the container of the system comprises a cap (80), where said cap is attached to bottle (B) by a fastener (para. 0072). Per Marantis para. 0072 said fastener may be a weld, adhesive or clip. Therefore as Marantis teaches that both welds and clips are a suitable attachment for connecting a cap to a bottle, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a clip as the attachment mechanism of the cap of the combination of Grossman, Cunningham, Guirguis, and Bocquet. Doing so would merely involve the simple substitution of one known element (weld) for another (Clip) to obtain predictable results (attachment of a cap to a bottle), and thus a prima facie case of obviousness exists. The examiner notes that as detailed above under the same rejection of claim 6, the weld is interpreted to prevent the movement of the cap relative to the housing, and as the clip is a suitable substitution for the weld per Marantis, the clip is interpreted to provide the same function.
Conclusion
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781