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 .
Response to Amendment
Examiner acknowledges the reply filed 12/12/2025. Claims 1 and 11 were amended. No claims were newly added. Claims 2-3, 7-8 and 17-18 were previously canceled. The amendment was accompanied by Remarks, the contents of which are addressed in the Response to Arguments section of this Office action.
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.
The new matter is:
“…wherein sequential engagement of a first roller and a second roller of the first plurality of rollers deform the first bladder in a manner that incrementally displaces fluid toward a region of the first bladder located upstream of the first roller, such that the region receives substantially all fluid displaced by engagement of the second roller to reduce pulsation in a flow produced by the irrigation pump head and the first bladder;…”. This limitation is in claims 1 and 11.
Specifically, the original description lacks support for “incrementally displacing fluid toward a region of the first bladder located upstream of the first roller”.
Para [0071] of the written description, believed to be the only paragraph relevant to this limitation, states, in part:
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.
The written description lacks support for the region of the first bladder that is located upstream of the first roller, receives substantially all fluid displaced by engagement of the second roller; the written description only mentions momentary disruption of downstream flow may occur as fluid fills the void as the conduit regains its pre-deformed shape, and momentary disruption of upstream low as the subsequent pincher engages the conduit and fluid is displaced.
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.
Regarding claim 1, the limitation “at least one retention device configured to retain the surgical cassette when the surgical cassette is coupled with the surgical console” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 1 and 11 is also rejected for reciting the indefinite limitation “wherein sequential engagement of a first roller and a second roller of the first plurality of rollers deform the first bladder in a manner that incrementally displaced fluid…” because it is not clear what feature(s) are engaged (i.e., whether the first and second rollers are engaged to one another or to some other structure/structures), or whether “engagement” means something akin to “activated”. Similarly, the feature of “all fluid displaced by engagement of the second roller” is unclear because it is not clear what specific engagement occurs in this instance. Moreover, it is not clear what “fluid displaced by engagement of the second roller” refers to, because the claims require that fluid is displaced by sequential engagement of a first roller and a second roller, and so it is unclear how a person of ordinary skill in the art would be able to isolate only the fluid displaced by engagement of the second roller.
Claim 11 is also rejected for the newly added language, which begins “wherein sequential engagement...”. In contrast to the other method steps in claim 11, the newly added limitation is not recited as a method step, and it is unclear if it is part of any method step; therefore, it is unclear whether it covers mere function of the first and second rollers (i.e., using the device in the manner recited would result in reduced pulsation), or whether the recitation is required as a discrete step requiring sequential engagement of first and second rollers to deform the first bladder in the claimed manner. For this reason, the language in claim 11 fails to provide a clear-cut indication of the scope of the subject matter embraced by the claim.
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”).
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, such that the first and second motors are coupled with the controller, for improved selective control over infusion in the cassette.
Regarding the newly added limitation “wherein sequential engagement of a first roller and a second roller of the first plurality of rollers deform the first bladder in a manner that incrementally displaces fluid toward a region of the first bladder located upstream of the first roller, such that the region receives substantially all fluid displaced by engagement of the second roller to reduce pulsation in a flow produced by the irrigation pump head and the first bladder”:
The quoted limitation is functional because it recites features “by what [they do] rather than by what [they are]”. In re Swinehart, 439 F.2d 210, 212, 169 USPQ 226, 229 (CCPA 1971).
In this case, the prior art teaches all the structural limitations of the claim, and the limitation quoted above does not impart a clear structural limitation to the claimed invention (i.e., is the above-quoted function dependent on the structure of the first and second rollers, the material characteristics of the bladder, the operational characteristics [e.g., rotational speed] of the pump, the viscosity or the volume of the fluid, etc.?). In this case, since the prior art discloses all the structural limitations of the claimed invention, it would also be capable of performing the claimed function in the absence of any evidence to the contrary. For example, the prior art pump is capable of sequential engagement of the first and second rollers (the meaning of “engagement” is not clear; see the 35 U.S.C. 112(b) rejection, above), since Chen discloses two rollers in the first plurality of rollers that can sequentially engage and deform the first bladder; doing so would cause fluid toward the region of the first bladder upstream of the first roller in order to permit substantially all fluid displaced by engagement of the second roller to reduce pulsation in a flow produced by the irrigation pump head and the first bladder.
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 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, 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 the invention was filed to rotate the two motors of Chen, in view of Baxter, further in view of Farivar, 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, 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, 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, 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, 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.
Regarding claim 11, Chen discloses method of operation of a surgical console (see para [0028]) for distributing fluid in a surgical cassette, comprising:
coupling, by at least one retention device, the 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).
Regarding the newly added limitation “wherein sequential engagement of a first roller and a second roller of the first plurality of rollers deform the first bladder in a manner that incrementally displaces fluid toward a region of the first bladder located upstream of the first roller, such that the region receives substantially all fluid displaced by engagement of the second roller to reduce pulsation in a flow produced by the irrigation pump head and the first bladder”:
The quoted limitation is functional because it recites features “by what [they do] rather than by what [they are]”. In re Swinehart, 439 F.2d 210, 212, 169 USPQ 226, 229 (CCPA 1971).
In this case, the prior art teaches all the structural limitations of the claim, and the limitation quoted above does not impart a clear structural limitation to the claimed invention (i.e., is the above-quoted function dependent on the structure of the first and second rollers, the material characteristics of the bladder, the operational characteristics [e.g., rotational speed] of the pump, the viscosity or the volume of the fluid, etc.?). In this case, since the prior art discloses all the structural limitations of the claimed invention, it would also be capable of performing the claimed function in the absence of any evidence to the contrary. For example, the prior art pump is capable of sequential engagement of the first and second rollers (the meaning of “engagement” is not clear; see the 35 U.S.C. 112(b) rejection, above), since Chen discloses two rollers in the first plurality of rollers that can sequentially engage and deform the first bladder; doing so would cause fluid toward the region of the first bladder upstream of the first roller in order to permit substantially all fluid displaced by engagement of the second roller to reduce pulsation in a flow produced by the irrigation pump head and the first bladder.
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 Ozturk et al (U.S. Pub. 2013/0072871 A1, hereinafter “Ozturk”).
Regarding claim 14, it is noted that Chen, in view of Baxter, 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, 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, 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, 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, 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 Objections
The objection has been withdrawn in light of the amendment to claim 11.
Claim Rejections - 35 U.S.C. §112
Applicant traversed the rejection of claim 1 under 35 U.S.C. §112(b), citing para [0048] and Fig. 3 as providing structures of “detents”, “notches” or “catch surfaces” that cooperate with a retention device. Applicant argued that a person of ordinary skill in the art would understand the structure of the retention device, itself, based solely on a written description of structures with which the retention device cooperates (see Remarks, pg. 8). Applicant contended that the detents, notches or catch surfaces “cooperate with console-side mechanical retention members, such as latches, protrusions, clamps or matching catch elements” (Id.). Therefore, Applicant appeared to argue that latches, protrusions, clamps or matching catch elements were implicitly disclosed in the written description as the structure of the retention device.
But this argument is not found persuasive.
The proper test for meeting the definiteness requirement is that the corresponding structure of a means-plus-function limitation must be disclosed in the specification itself in a way that one skilled in the art will understand what structure (or material or acts) will perform the recited function. See Atmel Corp. v. Information Storage Devices, Inc., 198 F.3d 1374, 1381, 53 USPQ2d 1225, 1230 (Fed. Cir. 1999).
But no such corresponding structure is disclosed in either the specification or the drawings. Applicant acknowledged that the retention device could be myriad entirely different structures including latches, protrusions, clamps, or matching catch elements, or some combination thereof. But the specification makes no mention of these structures, nor does it show them in any drawings. A skilled artisan would question which of these mechanisms, if any, Applicant actually possessed at the time of filing (for example, did Applicant possess a clamp or did Applicant possess a protrusion?). Although it is acknowledged that the specification need not identify every possible retention device (see Remarks, bottom of pg. 8 to top of pg. 9), it still must disclose a structure that will perform the claimed function.
The rejection of claim 11 under 35 U.S.C. 112(b) has been withdrawn in light of Applicant’s amendment to claim 11.
Claim Rejections -35 U.S.C. §103
Applicant traversed the rejection of claim 1 under 35 U.S.C. §103, contending that newly added limitations overcome the prior art of record because the prior art is silent as to the claimed fluid flow within the bladder (see Remarks, pg. 10).
Applicant argued that separately or together, the references do not teach sequencing designed to cause the upstream region of the bladder to receive substantially all displaced fluid (Id).
In this case, the prior art teaches all the structural limitations of the claim, and the limitation quoted above does not impart a clear structural limitation to the claimed invention (i.e., is the above-quoted function dependent on the structure of the first and second rollers, the material characteristics of the bladder, the operational characteristics [e.g., rotational speed] of the pump, the viscosity or the volume of the fluid, etc.?). In this case, since the prior art discloses all the structural limitations of the claimed invention, it would also be capable of performing the claimed function in the absence of any evidence to the contrary. For example, the prior art pump is capable of sequential engagement of the first and second rollers (the meaning of “engagement” is not clear; see the 35 U.S.C. 112(b) rejection, above), since Chen discloses two rollers in the first plurality of rollers that can sequentially engage and deform the first bladder; doing so would cause fluid toward the region of the first bladder upstream of the first roller in order to permit substantially all fluid displaced by engagement of the second roller to reduce pulsation in a flow produced by the irrigation pump head and the first bladder.
For this reason, the rejections are maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 02/04/2026