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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/06/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 11 and all claims depending therefrom are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 11 recite the following new matter:
“…wherein a first roller, a second roller, and a third roller of the first plurality of rollers are configured to simultaneously engage the first bladder against a rigid structure, the rigid structure defining a void positioned along a pumping path of the irrigation pump head, and wherein, during rotation of the irrigation pump head, the second roller is positioned between the first and third rollers and passes over the void such that engagement of the first bladder by the second roller is reduced or eliminated before the second roller re-engages the first bladder after passing the void…”.
The portions of the written description relevant to this limitation are reproduced below, with emphasis added:
[0071] In an embodiment of the present invention, a peristaltic pump may consist of elements that pinch and articulate along the closed flexible fluid conduit created, in part, by an aspiration bladder, to force fluid through the conduit. At least two pinches, such as rollers, wipers, cams, or shoes, may sequentially engage and pinch the conduit against a rigid structure and articulate along the conduit length to cause fluid flow. Before the lead pincher disengages the conduit, a subsequent pincher may engage the conduit and articulate along it to ensure continued fluid flow. During disengagement, a momentary disruption of downstream flow may occur as fluid fills the void as the conduit regains its pre-deformed shape. Similarly, upstream flow may be disrupted as the subsequent pincher engages the conduit and fluid is displaced. These disruptions may result in flow and/or pressure pulses both upstream and downstream flow. The present invention may eliminate such pulses upstream of the pump rather than merely mitigating such pulsation.
[0072] As may be known to those skilled in the art, one typical method to mitigate such pulsation may involve shaping a rigid structure to control the manner in which the pinchers engage and disengage the conduit to lessen the severity of pulsation by increasing pulse duration. Similarly, larger sections of bladder tubing may be used, as well as varying pump speed to cancel out known pulsations. Pulsation may also be diminished by employing a void in a rigid structure portion such that as three pinchers are simultaneously engaging the flexible conduit, the middle pincher momentarily encounters the rigid structure void thus reducing or eliminating its pinch before fully re-engaging the conduit. […]
As seen above, Applicant's invention is disclosed, in para [0071], to "eliminate such pulses upstream of the pump rather than mitigating such pulsation" (emphasis added). Then, paragraph [0072] provides an example of "mitigating such pulsation" by the use of "a void in a rigid structure portion such that as three pinchers are simultaneously engaging the flexible conduit, the middle pincher momentarily encounters the rigid structure void thus reducing or eliminating its pinch before fully re-engaging the conduit". Accordingly, a skilled artisan would question whether Applicant's discussion of a middle roller, which momentarily encounters a rigid structure void to reduce or eliminate its pinch, is intended to be structure incorporated into Applicant's invention—or whether Applicant's invention is actually intended to work without this structure.
Further, even assuming that Applicant's invention were intended to provide pulsation mitigation in the manner disclosed in the written description, the written description does not sufficiently tie that structure to any specific embodiment in the disclosure that reasonably corresponds to the claimed invention. Moreover, the written description makes no mention of rollers that are claimed to be "configured to simultaneously engage the first bladder against a rigid structure" (rather, the three rollers simultaneously engaging the flexible conduit with the middle roller encountering the void in the rigid structure; see para [0072]) nor that the void of the rigid structure is "positioned along a pumping path of the irrigation pump head", as claimed.
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 1, 11 and all claims depending therefrom 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.
Claims 1 and 11 are rejected for reciting the indefinite limitation:
“…wherein a first roller, a second roller, and a third roller of the first plurality of rollers are configured to simultaneously engage the first bladder against a rigid structure, the rigid structure defining a void positioned along a pumping path of the irrigation pump head, and wherein, during rotation of the irrigation pump head, the second roller is positioned between the first and third rollers and passes over the void such that engagement of the first bladder by the second roller is reduced or eliminated before the second roller re-engages the first bladder after passing the void…”
It is unclear how the first, second and third rollers would simultaneously engage the first bladder against a rigid structure, while the second roller also passes over a void in the same structure (thus not engaging the first bladder against the rigid structure). Although it may be possible that the three rollers could simultaneously engage a first bladder against the rigid structure before rotation, and then encounter the void during rotation, a skilled artisan would not reasonably conclude that Applicant intended to recite such a limitation.
Further, a skilled artisan would not be able to determine what specific structure is positively recited in the claims to permit the first, second and third rollers to be "configured to simultaneously engage the first bladder against a rigid structure, the rigid structure defining a void positioned along a pumping path of the irrigation pump head" as claimed. For example, the claimed invention recites a rigid structure merely in the context of what the rollers are "configured to" do, but the rigid structure itself is not a positively recited feature. For this reason, the metes and bounds of the claimed invention are ambiguously defined.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 5, 9, 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (U.S. Pub. 2020/0256331 A1, hereinafter “Chen”), in view of Baxter (U.S. Pat. 9,291,159 B2, hereinafter “Baxter”), further in view of Farivar (U.S. Pub. 2014/0081197 A1, hereinafter “Farivar”), further in view of Koslov (U.S. Pub. 2006/0245964 A1, hereinafter "Koslov").
Regarding claim 1, Chen discloses a system implemented in a surgical console (see para [0028]) for distributing fluid in a surgical cassette, comprising:
a first motor coupled with the controller; and a second motor coupled with the controller (see para [0004] disclosing a first motor to rotate a first plurality of rollers, and a second motor to rotate a second plurality of rollers);
a first drive shaft (not labeled in Fig. 9, but understood to be a shaft that rotates gear 944, causing rotation of gear 946 of pump head 903 to rotate the head 203; see para [0069] and Fig. 9) coupled with one the first motor;
a second drive shaft 742 (see Fig. 9 and para [0069]) coupled with the second motor;
at least one retention device configured to retain the surgical cassette when the surgical cassette is coupled with the surgical console (for example, a cassette receiving portion, not shown, and/or an alignment guide 119 of the pump 111; see para [0037]);
an irrigation pump head 903 (see Fig. 9) operable the first drive shaft (not labeled in Fig. 9, but understood to be a shaft that rotates gear 944, causing rotation of gear 946 of pump head 903 to rotate the head 203; see para [0069] and Fig. 9), the irrigation pump head comprising a first plurality rollers (see Fig. 9 showing circumferentially oriented rollers on the pump head 903), the irrigation pump head configured to rotate about a first pump head axis (i.e., the longitudinal axis of the first drive shaft), wherein each of the first plurality of rollers is configured to rotate about a respective roller axis (i.e., each roller has a longitudinal axis around which the roller rotates), and wherein each of the roller axes of each of the first plurality of rollers are configured to intersect the irrigation (“first”) pump head axis (see Fig. 9, Annotation “A”, above, showing an exemplary roller with an exemplary roller axis intersecting with the pump head axis; for simplicity, only one roller axis is shown, but it is understood that each of the other rollers, by virtue of their configuration, would also have a longitudinal axis that intersects the first pump head axis); and
a second pump head 203 (see Fig. 9) operable by the second drive shaft 742 (see Fig. 9 and para [0069]), the second pump head comprising a second plurality rollers 201 (see Fig. 2A), the second pump head configured to rotate about a second pump head axis (i.e., the longitudinal axis of the second drive shaft 742), wherein each of the second plurality of rollers is configured to rotate about a respective roller axis (i.e., each roller has a longitudinal axis around which the roller rotates).
However, in this embodiment shown in Fig. 9, it is not clear whether Chen discloses that the roller axes of the second plurality of rollers of the second pump head 203 are also configured to intersect the second pump head axis.
Chen discloses an alternative embodiment of the second pump head 203 in Fig. 10A (see para [0069] disclosing that pump head 203 engages a non-coplanar pump, and see para [0070] disclosing that Fig. 10A shows the pump head rollers engaging an alternatively designed non-coplanar pump substrate 1015) in which each of the roller axes of each of the second plurality of rollers are configured to intersect the second pump head axis (see Fig. 10A, Annotation “A”, below, showing only two rollers, though it is understood that each of the other rollers would also have a longitudinal axis that intersects the second pump head axis).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the second pump head 203, shown in Fig. 9, to have the configuration illustrated in Fig. 10A such that the roller axes of the second plurality of rollers of the second pump head 203 are also configured to intersect the second pump head axis, since the prior art of Chen as a whole suggests that the second pump head 203 can be either configured as shown in Fig. 9 or as shown in Fig. 10, and there would have been a motivation to choose either one of the configurations depending on the shape of the substrate to which the pump head is engaged, with a reasonable expectation of success.
Further, Chen discloses that when the cassette is retained by the at least one retention device, the rollers can be spring-biased to press the bladder against the rollers (see para [0037]).
However, Chen does not explicitly disclose a first plurality of springs respectively affixed to the first plurality of rollers, wherein the first plurality of rollers and the first plurality of springs are configured for compliant engagement with a first bladder of the surgical cassette when the surgical cassette is retained by the at least one retention device;
and a second plurality of springs respectively affixed to the second plurality of rollers, wherein the second plurality of rollers and the second plurality of springs are configured for compliant engagement with a second bladder of the surgical cassette when the surgical cassette is retained by the at least one retention device.
Baxter discloses a pump head 900 (see Fig. 11a) for use with a cassette 100a (see Fig. 3a) in a surgical console in the analogous art to Applicant’s invention (see Baxter at col. 1, lines 9-14), the pump head having a plurality of rollers and a respective plurality of springs affixed to the rollers (see Fig. 11c showing the pump roller assembly 900 with a plurality of rollers, and Fig. 12a showing one such roller 910a with a spring 937a affixed thereto via a hub engaging surface 968a and an axle 923a). The rollers and their respective springs are configured for compliant engagement with a bladder 103a (see Fig. 1b) of the surgical cassette when the surgical cassette is in the console (see col. 11, lines 12-20).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chen so that each of the rollers (which Chen already teaches may be spring-biased) incorporates its own spring affixed to the roller (as taught in Baxter), thereby resulting in a first plurality of springs associated with the first plurality of rollers and a second plurality of springs associated with the second plurality of rollers, with a reasonable expectation of success in providing the desired spring force to bias the rollers against the bladder when the cassette is retained in the console (see Chen at para [0037] and Baxter at col. 11, lines 12-20).
Further, Chen, in view of Baxter, does not appear to disclose a controller, such that the first and second motors are coupled with the controller.
Farivar discloses a medical pump, comprising a controller 40 that can receive a user input to cease flow of at least one of pressurized gas or irrigation fluid into a delivery conduit 30 (see para [0020]); the controller 40 is connected with a pump 55 through an electrical communication link and the controller 40 can be configured to adjust the motor of the pump 66 to selectively control the flow of the irrigation fluid into the fluid inlet 26 of the receiving chamber 22 (see para [0026]).
A skilled artisan would have found it obvious at the time of the invention to modify the system of Chen, in view of Baxter, to incorporate a controller, as taught in Farivar, such that the first and second motors are coupled with the controller, for improved selective control over infusion in the cassette.
It is further noted that Chen, in view of Baxter, further in view of Farivar, discloses a first roller, a second roller, and a third roller of the first plurality of rollers (see three rollers in Fig. 9 of Chen), but does not appear to disclose that the first, second and third rollers are configured to simultaneously engage the first bladder against a rigid structure, the rigid structure defining a void positioned along a pumping path of the irrigation pump head, and wherein, during rotation of the irrigation pump head, the second roller is positioned between the first and third rollers and passes over the void such that engagement of the first bladder by the second roller is reduced or eliminated before the second roller re-engages the first bladder after passing the void.
Koslov discloses a peristaltic pump, suitable for a medical application (see para [0003]), comprising a bladder-like feature (such as flexible tubing) and teaches that a void 38 (see Fig. 1) may be provided in a rigid structure (wall of track 20; see Fig. 1), against which the feature is normally engaged, such that during rotation of the pump head, a middle roller 32 (see Fig. 1) between two other rollers 30, 34 (see Fig. 1) passes over the void in order to reduce or eliminate engagement of the tubing with the roller (see para [0034]) before re-engaging the tubing after passing the void (see paras [0034] and [0035]; as the middle roller 32 is disengaged from the tubing, the other two rollers are engaged with the tubing).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Chen, in view of Farivar, according to the teaching in Koslov, thereby reducing or eliminating a negative pulse (see Koslov at paras [0034]-[0035]).
Additionally, Examiner notes that Applicant's specification discloses various structures that "may be known to those skilled in the art" as "typical method[s] to mitigate … pulsation" (see instant specification at para [0072]). Included, by example, is structure understood to correspond to the claimed invention (i.e., the employment of a void in a rigid structure portion such that as three pinchers are simultaneously engaging the flexible conduit, and the middle pincher momentarily encounters the rigid structure void thus reducing or eliminating its pinch before fully re-engaging the conduit; see para [0072]). Although Applicant does not explicitly state that this structure is prior art (see MPEP 2129 discussing Applicant admissions of prior art), it constitutes a disclosure of the state of the art and of evidence of what would have been known (or at least what Applicant speculates to have been known) to an ordinarily skilled artisan at the time of the invention. Because Applicant admits that such a structure would have expectedly mitigated pulsation, a skilled artisan would have found it obvious to incorporate the structure in the prior art combination with a reasonable expectation of success in mitigating pulsation.
Regarding claim 4, Chen discloses that the first and second pump heads rotate about the same axis (i.e., pump heads 203 and 903 are located along the pump axis illustrated by the dashed axial line in Fig. 9). Moreover, modifying the system of Chen according to the teaching in Ozturk would not change the axis around which the first and second pump heads rotate.
Regarding claim 5, Chen discloses that the pump heads, by virtue of being driven by different motors, can be rotated at different speeds (see para [0069]).
Regarding claim 9, Chen discloses that a roller communicatively coupled to one of the irrigation pump head or aspiration pump head operably restricts fluid flow in channel in contact with the roller (see para [0069] disclosing that pump head 903 is configured to engage the coplanar pump of multi-pump 890 while pump head 203 is configured to engage the non-coplanar pump of multi-pump 890; each of these pumps has channels that the rollers compress to restrict fluid flow in the channel and provide the peristaltic pumping action).
Regarding claim 10, Chen discloses that the irrigation pump head and aspiration pump head do not share a horizontal plane (i.e., the irrigation and aspiration pump heads are laterally adjacent one another, and thus, do not share the same horizontal plane).
Regarding claim 21, it is noted that an obviousness rejection has been applied to Chen, modifying the second pump head 203 to have rollers arranged in a conical geometry (see Fig. 10A, Annotation “B”, above, showing exemplary rollers converging on the axis of rotation of the pump head, arranged in a triangular geometry with a circular base where multiple rollers would be arranged circumferentially, resulting in a conical geometry), but Chen does not appear to disclose that the first plurality of rollers of the first pump head 903 are also arranged in a conical geometry.
However, Chen teaches generally that a non-coplanar pump, in which the pump head can engage pump segments at a non-zero angle with respect to the axis of rotation of the roller head, may reduce the normal force applied on face 105 of cassette 100 (see Fig. 1B) when the pump's segments are engaged. The pump head 203 is an example of such a non-coplanar pump head, with its rollers arranged in a conical geometry, in order to engage a non-coplanar segment of tubing substrate 1015.
Accordingly, a skilled artisan would have found it obvious at the time the invention was filed to modify the first pump head 903 to be arranged in a conical geometry as well (resulting in two non-coplanar pump heads in the system, i.e., the first pump head 903 and second pump head 203 both have their rollers arranged in a conical geometry), in order to better reduce the normal force applied on the face of cassette when the pump's segments are engaged, compared with only one non-coplanar pump head, with a reasonable expectation of success.
Claims 6, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Baxter, further in view of Farivar, further in view of Koslov, further in view of Ozturk et al (U.S. Pub. 2013/0072871 A1, hereinafter “Ozturk”).
Regarding claim 6, it is noted that Chen, in view of Baxter, further in view of Farivar, further in view of Koslov, does not appear to disclose that the pump heads can be rotated in different directions.
Ozturk discloses a system 1 (see Fig. 2) for distributing fluid in a surgical cassette (Ozturk discloses that the system is used to pump or dispense fluid for a variety of known fluid transfer applications “including dialysis machines, metering pumps, dosing pumps, heart bypass pump machines, drug dispensing systems, infusion pumps, aquariums, analytical instruments, food and pharmaceutical manufacturing operations, and so forth”; [see para [0006]], and so a skilled artisan would conclude that such a system could be used to distribute fluid in a surgical cassette), comprising pump heads 2 and 4, by virtue of being driven by different motors, that can be rotated at different speeds and directions as desired (see para [0031] disclosing that each of the drive shafts are able to rotate independently with respect to each other, allowing a user to actuate any one or more of motors 13, 15, 17, and 19 at the same time, at different times, at the same or different speeds, and in the same or different directions).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Chen, in view of Baxter, further in view of Farivar, further in view of Koslov, by permitting the motors to rotate in different directions, as taught in Ozturk, in order to independently control the direction of pumping of fluids within the multi-pump cassette, with a reasonable expectation of success.
Regarding claim 23, it is noted that Chen, in view of Baxter, further in view of Farivar, further in view of Koslov, does not appear to disclose that the first drive shaft is at least partially enclosed by the second drive shaft; instead, Chen discloses a first shaft (not shown, but understood to rotate gear 944, causing rotation of gear 946 of pump head 903 to ultimately rotate the head 203) and a second shaft 742 offset laterally from the first shaft (see Fig. 9).
Ozturk discloses a system 1 (see Fig. 2) for distributing fluid in a surgical cassette (Ozturk discloses that the system is used to pump or dispense fluid for a variety of known fluid transfer applications “including dialysis machines, metering pumps, dosing pumps, heart bypass pump machines, drug dispensing systems, infusion pumps, aquariums, analytical instruments, food and pharmaceutical manufacturing operations, and so forth”; [see para [0006]], and so a skilled artisan would conclude that such a system could be used to distribute fluid in a surgical cassette), comprising:
a first pump head (e.g., 2; see Fig. 4) operable by a first drive shaft 22 (see Fig. 4), the first pump head comprising a first plurality rollers (see Fig. 1 and para [0032] showing eight rollers on the pump head 2, and para [0026] disclosing that roller head 2 has a plurality of rollers attached thereto), the first pump head configured to rotate about a first pump head axis (i.e., the longitudinal axis of the first drive shaft 22), wherein each of the first plurality of rollers is configured to rotate about a respective roller axis (i.e., each roller has a longitudinal axis around which the roller rotates); and
a second pump head (e.g., 4; see Fig. 4) operably by a second drive shaft 24 (see Fig. 4), the second pump head comprising a first plurality rollers (see Fig. 1 showing eight rollers on the pump head 4, and para [0026] disclosing that roller head 4 has a plurality of rollers attached thereto), the second pump head configured to rotate about a second pump head axis (i.e., the longitudinal axis of the second drive shaft 24), wherein each of the second plurality of rollers is configured to rotate about a respective roller axis (i.e., each roller has a longitudinal axis around which the roller rotates);
wherein the second drive shaft is at least partially enclosed by the first drive shaft (see Fig. 4; see also para [0013] disclosing that “the pump includes a plurality of concentric, nested drive shafts, with each of the drive shafts adapted to drive a corresponding roller head”; see also para [0028]).
A skilled artisan would have found it obvious at the time the invention was filed to modify the system of Chen, in view of Baxter, further in view of Farivar, further in view of Koslov, so that the second drive shaft is at least partially enclosed by the first shaft, as taught in Ozturk, resulting in the first drive shaft and second drive shaft being concentric, nested drive shafts, in order to provide a more compact design for the pump (such as by eliminating the gear 944 by coupling the pump head 903 to a drive shaft into which drive shaft 742 is nested so that the second shaft is no longer laterally offset from the first shaft), with a reasonable expectation of success. Specifically, Ozturk teaches nesting drive shafts allows the motors, to which the drive shafts are attached, to be placed much closer together, allowing for easier use and operation and ultimately “providing a more compact design for the pump” (see para [0041]). Moreover, based on the teaching in Chen that the configuration shown in Fig. 9 “only illustrates one example of how the coplanar and non-coplanar pumps may be engaged”, modifying the first and second drive shafts of Chen, in view of Baxter, further in view of Farivar, according to the teaching in Ozturk would have been within the level of ordinary skill in the art and would not have required changing the principle operation of the two drive shafts (i.e., driving the rotation of the respective pump heads).
Regarding claim 24, it is noted that Chen, in view of Baxter, further in view of Farivar, further in view of Koslov, does not appear to disclose that the second drive shaft is at least partially enclosed by the first drive shaft; instead, Chen discloses a first shaft (not shown, but understood to rotate gear 944, causing rotation of gear 946 of pump head 903 to ultimately rotate the head 203) and a second shaft 742 offset laterally from the first shaft (see Fig. 9).
Ozturk discloses a system 1 (see Fig. 2) for distributing fluid in a surgical cassette (for the purpose of brevity, see rejection of claim 1, above) comprising:
a first pump head (e.g., 2; see Fig. 4) operable by a first drive shaft 22 (see Fig. 4), the first pump head comprising a first plurality rollers, the first pump head configured to rotate about a first pump head axis, wherein each of the first plurality of rollers is configured to rotate about a respective roller axis (for the purpose of brevity, see rejection of claim 1, above); and
a second pump head (e.g., 4; see Fig. 4) operably by a second drive shaft 24 (see Fig. 4), the second pump head comprising a first plurality rollers, the second pump head configured to rotate about a second pump head axis, wherein each of the second plurality of rollers is configured to rotate about a respective roller axis (for the purpose of brevity, see rejection of claim 1, above);
wherein the second drive shaft is at least partially enclosed by the first drive shaft (see Fig. 4; see also para [0013] disclosing that “the pump includes a plurality of concentric, nested drive shafts, with each of the drive shafts adapted to drive a corresponding roller head”; see also para [0028]).
A skilled artisan would have found it obvious at the time the invention was filed to modify the system of Chen, in view of Baxter, further in view of Farivar, further in view of Koslov, so that the second drive shaft is at least partially enclosed by the first shaft, as taught in Ozturk, resulting in the first drive shaft and second drive shaft being concentric, nested drive shafts, in order to provide a more compact design for the pump (such as by eliminating the gear 944 by coupling the pump head 903 to a drive shaft into which drive shaft 742 is nested so that the second shaft is no longer laterally offset from the first shaft), with a reasonable expectation of success. Specifically, Ozturk teaches nesting drive shafts allows the motors, to which the drive shafts are attached, to be placed much closer together, allowing for easier use and operation and ultimately “providing a more compact design for the pump” (see para [0041]). Moreover, based on the teaching in Chen that the configuration shown in Fig. 9 “only illustrates one example of how the coplanar and non-coplanar pumps may be engaged”, modifying the first and second drive shafts of Chen according to the teaching in Ozturk would have been within the level of ordinary skill in the art and would not have required changing the principle operation of the two drive shafts (i.e., driving the rotation of the respective pump heads).
Claims 11-13, 15, 19, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Baxter, further in view of Koslov.
Regarding claim 11, Chen discloses method of operation of a surgical console (see para [0028]) for distributing fluid in a surgical cassette, comprising:
Coupling a surgical cassette with the surgical console (for example, a cassette receiving portion, not shown, and/or an alignment guide 119 of the pump 111 which engages and retains the cassette in place in the console; see para [0037]);
compliantly engaging an irrigation pump head 903 (see Fig. 9; see also para [0063] disclosing that a first pump may be used for aspiration or irrigation) and an aspiration pump head 203 (see Fig. 9; see also para [0063] disclosing that a first pump may be used for aspiration or irrigation) respectively with a first bladder (active pump segments 803a-803b as well as transition regions 816a-816d) and a second bladder (pump segments 113a and 113b as well as transition regions 125a-125d) of the surgical cassette (see paras [0034]-[0036], [0058] and [0062]-[0066]),
the irrigation pump head 903 comprising a first plurality of rollers (see Fig. 9 showing circumferentially oriented rollers on the pump head 903),
and the aspiration pump head 203 comprising a second plurality of rollers 201 (see Fig. 2A);
rotating the irrigation pump head 903 by a first drive shaft (not labeled in Fig. 9, but understood to be a shaft that rotates gear 944, causing rotation of gear 946 of pump head 903 to rotate the head 203; see para [0069] and Fig. 9) about an irrigation pump head axis (i.e., the longitudinal axis of the first drive shaft);
rotating the first plurality of rollers about respective roller axes (i.e., each roller has a longitudinal axis around which the roller rotates), and wherein the roller axes of each of the first plurality of rollers are configured to intersect the irrigation pump head axis (see Fig. 9, Annotation “A”, below, showing an exemplary roller notated as “first pump head” with an exemplary roller axis intersecting with the pump head axis; for simplicity, only one roller axis is shown, but it is understood that each of the other rollers, by virtue of their configuration, would also have a longitudinal axis that intersects the irrigation pump head axis); and
rotating the aspiration pump head 203 (see Fig. 9; see also para [0063] disclosing that a first pump may be used for aspiration or irrigation) by a second drive shaft 742 (see Fig. 9 and para [0069]), the aspiration pump head comprising the second plurality of rollers 201 (see Fig. 2A), the aspiration pump head configured to rotate about a second pump head axis (i.e., the longitudinal axis of the second drive shaft 742);
rotating the second plurality of rollers about a respective roller axis (i.e., each roller has a longitudinal axis around which the roller rotates),
wherein the first pump head axis and second pump head axis are the same axis (illustrated by the dashed axial line in Fig. 9).
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Chen, Fig. 9, Annotation “A”. First pump head 903 showing an exemplary roller with an exemplary roller axis intersecting with the first pump head axis.
However, in this embodiment shown in Fig. 9, it is not clear whether Chen discloses that the roller axes of the second plurality of rollers of the second pump head 203 are also configured to intersect the second pump head axis.
Chen discloses an alternative embodiment of the second (aspiration) pump head 203 in Fig. 10A (see para [0069] disclosing that pump head 203 engages a non-coplanar pump, and see para [0070] disclosing that Fig. 10A shows the pump head rollers engaging an alternatively designed non-coplanar pump substrate 1015) in which each of the roller axes of each of the second plurality of rollers are configured to intersect the second pump head axis (see Fig. 10A, Annotation “A”, below, showing only two rollers, though it is understood that each of the other rollers would also have a longitudinal axis that intersects the second pump head axis).
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Chen, Fig. 10A, Annotation “A”. Exemplary rollers have a longitudinal axis that intersects the second pump head axis.
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the aspiration pump head 203, shown in Fig. 9, to have the configuration illustrated in Fig. 10A such that the roller axes of the second plurality of rollers of the aspiration pump head 203 are also configured to intersect the second pump head axis, since the prior art of Chen as a whole suggests that the aspiration pump head 203 can be either configured as shown in Fig. 9 or as shown in Fig. 10, and there would have been a motivation to choose either one of the configurations depending on the shape of the substrate to which the pump head is engaged, with a reasonable expectation of success.
Further, Chen does not explicitly disclose a first plurality of springs respectively affixed to the first plurality of rollers, wherein the first plurality of rollers and the first plurality of springs are configured for compliant engagement with a first bladder of the surgical cassette when the surgical cassette is retained by the at least one retention device;
and a second plurality of springs respectively affixed to the second plurality of rollers, wherein the second plurality of rollers and the second plurality of springs are configured for compliant engagement with a second bladder of the surgical cassette when the surgical cassette is retained by the at least one retention device.
Baxter discloses a pump head 900 (see Fig. 11a) for use with a cassette 100a (see Fig. 3a) in a surgical console in the analogous art to Applicant’s invention (see Baxter at col. 1, lines 9-14), the pump head having a plurality of rollers and a respective plurality of springs affixed to the rollers (see Fig. 11c showing the pump roller assembly 900 with a plurality of rollers, and Fig. 12a showing one such roller 910a with a spring 937a affixed thereto via a hub engaging surface 968a and an axle 923a). The rollers and their respective springs are configured for compliant engagement with a bladder 103a (see Fig. 1b) of the surgical cassette when the surgical cassette is in the console (see col. 11, lines 12-20).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chen so that each of the rollers (which Chen already teaches may be spring-biased) incorporates its own spring affixed to the roller (as taught in Baxter), thereby resulting in a first plurality of springs associated with the first plurality of rollers and a second plurality of springs associated with the second plurality of rollers, with a reasonable expectation of success in providing the desired spring force to bias the rollers against the bladder when the cassette is retained in the console (see Chen at para [0037] and Baxter at col. 11, lines 12-20).
It is further noted that Chen, in view of Baxter, further in view of Farivar, discloses a first roller, a second roller, and a third roller of the first plurality of rollers (see three rollers in Fig. 9 of Chen), but does not appear to disclose that the first, second and third rollers are configured to simultaneously engage the first bladder against a rigid structure, the rigid structure defining a void positioned along a pumping path of the irrigation pump head, and wherein, during rotation of the irrigation pump head, the second roller is positioned between the first and third rollers and passes over the void such that engagement of the first bladder by the second roller is reduced or eliminated before the second roller re-engages the first bladder after passing the void.
Koslov discloses a peristaltic pump, suitable for a medical application (see para [0003]), comprising a bladder-like feature (such as flexible tubing) and teaches that a void 38 (see Fig. 1) may be provided in a rigid structure (wall of track 20; see Fig. 1), against which the feature is normally engaged, such that during rotation of the pump head, a middle roller 32 (see Fig. 1) between two other rollers 30, 34 (see Fig. 1) passes over the void in order to reduce or eliminate engagement of the tubing with the roller (see para [0034]) before re-engaging the tubing after passing the void (see paras [0034] and [0035]; as the middle roller 32 is disengaged from the tubing, the other two rollers are engaged with the tubing).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Chen, in view of Farivar, according to the teaching in Koslov, thereby reducing or eliminating a negative pulse (see Koslov at paras [0034]-[0035]).
Additionally, Examiner notes that Applicant's specification discloses various structures that "may be known to those skilled in the art" as "typical method[s] to mitigate … pulsation" (see instant specification at para [0072]). Included, by example, is structure understood to correspond to the claimed invention (i.e., the employment of a void in a rigid structure portion such that as three pinchers are simultaneously engaging the flexible conduit, and the middle pincher momentarily encounters the rigid structure void thus reducing or eliminating its pinch before fully re-engaging the conduit; see para [0072]). Although Applicant does not explicitly state that this structure is prior art (see MPEP 2129 discussing Applicant admissions of prior art), it constitutes a disclosure of the state of the art and of evidence of what would have been known (or at least what Applicant speculates to have been known) to an ordinarily skilled artisan at the time of the invention. Because Applicant admits that such a structure would have expectedly mitigated pulsation, a skilled artisan would have found it obvious to incorporate the structure in the prior art combination with a reasonable expectation of success in mitigating pulsation.
Regarding claims 12 and 13, Chen discloses that the first drive shaft is operated on by a first motor, and the second drive shaft is operated on by a second motor (see Fig. 9, Annotation “B”, below).
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Chen, Fig. 9, Annotation “B”. First and second motors are called out.
Regarding claim 15, Chen discloses that the shaft 742 and the shaft operating the gear 944 are operated or rotated by different motors (e.g., actuators), each of which may have a different motor speed, such that the pump heads can operate at different speeds (see para [0069]).
Regarding claim 19, Chen discloses that a roller communicatively coupled to one of the irrigation pump head or aspiration pump head operably restricts fluid flow in channel in contact with the roller (see para [0069] disclosing that pump head 903 is configured to engage the coplanar pump of multi-pump 890 while pump head 203 is configured to engage the non-coplanar pump of multi-pump 890; each of these pumps has channels that the rollers compress to restrict fluid flow in the channel and provide the peristaltic pumping action).
Regarding claim 20, Chen discloses that the irrigation pump head and aspiration pump head do not share a horizontal plane (i.e., the irrigation and aspiration pump heads are laterally adjacent one another, and thus, do not share the same horizontal plane).
Regarding claim 22, it is noted that an obviousness rejection has been applied to Chen, modifying the second pump head 203 to have rollers arranged in a conical geometry (see Fig. 10A, Annotation “B”, above, showing exemplary rollers converging on the axis of rotation of the pump head, arranged in a triangular geometry with a circular base where multiple rollers would be arranged circumferentially, resulting in a conical geometry), but Chen does not appear to disclose that the first plurality of rollers of the first pump head are also arranged in a conical geometry.
However, Chen teaches generally that a non-coplanar pump, in which the pump head can engage pump segments at a non-zero angle with respect to the axis of rotation of the roller head, may reduce the normal force applied on face 105 of cassette 100 (see Fig. 1B) when the pump's segments are engaged. The pump head 203 is an example of such a non-coplanar pump head, with its rollers arranged in a conical geometry, in order to engage a non-coplanar segment of tubing substrate 1015.
Accordingly, a skilled artisan would have found it obvious at the time the invention was filed to modify the first pump head 903 to be arranged in a conical geometry as well (resulting in two non-coplanar pump heads in the system, i.e., the first pump head 903 and second pump head 203 both have their rollers arranged in a conical geometry), in order to better reduce the normal force applied on the face of cassette when the pump's segments are engaged, compared with only one non-coplanar pump head, with a reasonable expectation of success.
Claims 14, 16 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Baxter, further in view of Koslov, further in view of Ozturk et al (U.S. Pub. 2013/0072871 A1, hereinafter “Ozturk”).
Regarding claim 14, it is noted that Chen, in view of Baxter, further in view of Koslov, does not appear to disclose that the second drive shaft is at least partially enclosed by the first drive shaft; instead, Chen discloses a first shaft (not shown, but understood to rotate gear 944, causing rotation of gear 946 of pump head 903 to ultimately rotate the head 203) and a second shaft 742 offset laterally from the first shaft (see Fig. 9).
Ozturk discloses a system 1 (see Fig. 2) for distributing fluid in a surgical cassette (for the purpose of brevity, see rejection of claim 1, above) comprising:
a first pump head (e.g., 2; see Fig. 4) operable by a first drive shaft 22 (see Fig. 4), the first pump head comprising a first plurality rollers, the first pump head configured to rotate about a first pump head axis, wherein each of the first plurality of rollers is configured to rotate about a respective roller axis (for the purpose of brevity, see rejection of claim 1, above); and
a second pump head (e.g., 4; see Fig. 4) operably by a second drive shaft 24 (see Fig. 4), the second pump head comprising a first plurality rollers, the second pump head configured to rotate about a second pump head axis, wherein each of the second plurality of rollers is configured to rotate about a respective roller axis (for the purpose of brevity, see rejection of claim 1, above);
wherein the second drive shaft is at least partially enclosed by the first drive shaft (see Fig. 4; see also para [0013] disclosing that “the pump includes a plurality of concentric, nested drive shafts, with each of the drive shafts adapted to drive a corresponding roller head”; see also para [0028]).
A skilled artisan would have found it obvious at the time the invention was filed to modify the system of Chen, in view of Baxter, further in view of Koslov, so that the second drive shaft is at least partially enclosed by the first shaft, as taught in Ozturk, resulting in the first drive shaft and second drive shaft being concentric, nested drive shafts, in order to provide a more compact design for the pump (such as by eliminating the gear 944 by coupling the pump head 903 to a drive shaft into which drive shaft 742 is nested so that the second shaft is no longer laterally offset from the first shaft), with a reasonable expectation of success. Specifically, Ozturk teaches nesting drive shafts allows the motors, to which the drive shafts are attached, to be placed much closer together, allowing for easier use and operation and ultimately “providing a more compact design for the pump” (see para [0041]). Moreover, based on the teaching in Chen that the configuration shown in Fig. 9 “only illustrates one example of how the coplanar and non-coplanar pumps may be engaged”, modifying the first and second drive shafts of Chen according to the teaching in Ozturk would have been within the level of ordinary skill in the art and would not have required changing the principle operation of the two drive shafts (i.e., driving the rotation of the respective pump heads).
Regarding claim 16, it is noted that Chen, in view of Baxter, does not disclose rotating the first pump head and second pump head in different directions.
Ozturk discloses that the pump heads 2 and 4, by virtue of being driven by different motors, can be rotated at different speeds and directions as desired (see para [0031] disclosing that each of the drive shafts are able to rotate independently with respect to each other, allowing a user to actuate any one or more of motors 13, 15, 17, and 19 at the same time, at different times, at the same or different speeds, and in the same or different directions).
A skilled artisan would have found it obvious at the time the invention was filed to rotate the two motors of Chen, in view of Baxter, further in view of Koslov, in different directions, as taught in Ozturk, in order to independently control the direction of pumping of fluids within the multi-pump cassette, with a reasonable expectation of success.
Regarding claim 25, it is noted that Chen, in view of Baxter, further in view of Koslov, does not appear to disclose that the first drive shaft is at least partially enclosed by the second drive shaft; instead, Chen discloses a first shaft (not shown, but understood to rotate gear 944, causing rotation of gear 946 of pump head 903 to ultimately rotate the head 203) and a second shaft 742 offset laterally from the first shaft (see Fig. 9).
Ozturk discloses a system 1 (see Fig. 2) for distributing fluid in a surgical cassette (Ozturk discloses that the system is used to pump or dispense fluid for a variety of known fluid transfer applications “including dialysis machines, metering pumps, dosing pumps, heart bypass pump machines, drug dispensing systems, infusion pumps, aquariums, analytical instruments, food and pharmaceutical manufacturing operations, and so forth”; [see para [0006]], and so a skilled artisan would conclude that such a system could be used to distribute fluid in a surgical cassette), comprising:
a first pump head (e.g., 2; see Fig. 4) operable by a first drive shaft 22 (see Fig. 4), the first pump head comprising a first plurality rollers (see Fig. 1 and para [0032] showing eight rollers on the pump head 2, and para [0026] disclosing that roller head 2 has a plurality of rollers attached thereto), the first pump head configured to rotate about a first pump head axis (i.e., the longitudinal axis of the first drive shaft 22), wherein each of the first plurality of rollers is configured to rotate about a respective roller axis (i.e., each roller has a longitudinal axis around which the roller rotates); and
a second pump head (e.g., 4; see Fig. 4) operably by a second drive shaft 24 (see Fig. 4), the second pump head comprising a first plurality rollers (see Fig. 1 showing eight rollers on the pump head 4, and para [0026] disclosing that roller head 4 has a plurality of rollers attached thereto), the second pump head configured to rotate about a second pump head axis (i.e., the longitudinal axis of the second drive shaft 24), wherein each of the second plurality of rollers is configured to rotate about a respective roller axis (i.e., each roller has a longitudinal axis around which the roller rotates);
wherein the second drive shaft is at least partially enclosed by the first drive shaft (see Fig. 4; see also para [0013] disclosing that “the pump includes a plurality of concentric, nested drive shafts, with each of the drive shafts adapted to drive a corresponding roller head”; see also para [0028]).
A skilled artisan would have found it obvious at the time the invention was filed to modify the system of Chen, in view of Baxter, further in view of Koslov, so that the second drive shaft is at least partially enclosed by the first shaft, as taught in Ozturk, resulting in the first drive shaft and second drive shaft being concentric, nested drive shafts, in order to provide a more compact design for the pump (such as by eliminating the gear 944 by coupling the pump head 903 to a drive shaft into which drive shaft 742 is nested so that the second shaft is no longer laterally offset from the first shaft), with a reasonable expectation of success. Specifically, Ozturk teaches nesting drive shafts allows the motors, to which the drive shafts are attached, to be placed much closer together, allowing for easier use and operation and ultimately “providing a more compact design for the pump” (see para [0041]). Moreover, based on the teaching in Chen that the configuration shown in Fig. 9 “only illustrates one example of how the coplanar and non-coplanar pumps may be engaged”, modifying the first and second drive shafts of Chen, in view of Baxter, according to the teaching in Ozturk would have been within the level of ordinary skill in the art and would not have required changing the principle operation of the two drive shafts (i.e., driving the rotation of the respective pump heads).
Response to Arguments
Applicant’s arguments have been fully considered, and are addressed in the order in which they appeared in Applicant’s Remarks:
Claim Rejections - 35 U.S.C. §112
Applicant traversed the rejection of claims 1 and 11 under 35 U.S.C. §112(a). The previous rejection has been withdrawn in light of the amendment to claims 1 and 11 that deleted the rejected subject matter. However, a new ground of rejection has been applied.
Claim Rejections -35 U.S.C. §103
Applicant traversed the rejection of claims 1, 11 and all claims depending therefrom under 35 U.S.C. §103, contending that newly added limitations overcome the prior art of record.
A new ground of rejection has been applied, as necessitated by the amendment.
Conclusion
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 05/20/2026
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