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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/16/2025 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, 10, 18 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 “the console is configured to determine whether the cassette is compatible with the console based on the type of the cassette” Although the original specification discloses determining whether the cassette is compatible with the console (see paras [31], [33], [36]), the specification does not convey that the “determining” is “based on the type of the cassette”. Moreover, since the claimed system “identifies the type of the cassette based on a configuration of the first body portion and the second body portion”, the specification lacks support for the determination of compatibility being specifically tied to the configuration of the first body portion and second body (which appears to be logically implied, if not required).
Examiner notes one section of the original specification that discloses “the system operates correctly based on the type of compatible cassette” (see para [11]) but does not mention the console determining (or being configured to determine) such compatibility.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-8, 10-12, 14-19, 21-24 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peterson et al (U.S. Pub. 2001/0031944 A1, hereinafter “Peterson”).
Regarding claim 1, Peterson discloses an eye surgical system 100 (see Fig. 1; even though Peterson does not specifically disclose the part of the body the surgical system is used for, it is capable of being used in the context of eye surgery), comprising:
a cassette 104 (see Fig. 1) having at least a first body portion having a first body portion depth (such as a projection 596 having a depth; see Figs. 19-21 (see annotated Fig. 22, below, showing the first body portion depth to be the depth of the projection relative to the rearmost plane of the cassette where the loop 642 of the cassette terminates) and a second body portion having a second body portion depth (such as a base plate 556 having a depth), and cassette tubing 110 (see Fig. 2), wherein the first body portion and second body portion define a type of the cassette (i.e., this type of cassette has the first and second body portions in the configuration shown in Peterson) and
a console 102 (see Fig. 1), wherein the console comprises a cassette receptacle (see Fig. 21 showing an outer housing 560 with an area for receiving a cassette base plate 542) configured to couple the cassette with the console, wherein the cassette receptacle comprises a cassette preload detection system (see “cassette identification system” disclosed in para [0346]);
wherein the first body portion and second body portion of the cassette are configured to be detected by the cassette pre-load detection system (i.e., when the cassette is installed in the module, the projection 596 on the cassette base plate contacts a corresponding plunger end of the aforementioned plungers, causing upward movement of each plunger such that the end of each plunger moves into a new position relative to a slotted optical sensor, causing a signal to be sent to the processor of the console 102 that a projection has been sensed; see paras [0346]-[0349]),
wherein the cassette pre-load detection system identifies the type of cassette based on a configuration of the first body portion and second body portions of the cassette coupled with the console (i.e., each of three plungers on the cassette identification system can engage the projection on one of three different cassettes, but the other two plungers are not engaged, such that the console 102 can identify the cassette according to which plunger has been engaged; see paras [0346]-[0349]),
wherein the cassette comprises one or more physical characteristics corresponding to the type of the cassette, wherein the one or more physical characteristics are selected from the group consisting of tubing diameter, tubing material, tubing thickness, tubing length, vacuum settings for use with the cassette, aspiration settings for use with the cassette, and system irrigation rate for use with the cassette (once the controller identifies the console based on its physical characteristics, it can control settings such as pump volume per pump actuation according to the type of cassette identified, as discussed in paras [0346]-[0349]; this pump volume per pump actuation is interpreted to be an “irrigation rate” of the desired drug therapy),
and wherein the console is configured to determine whether the cassette is cassette is compatible with the console based on the cassette type (i.e., see paras [0346]-[0349] disclosing that each of three plungers on the cassette identification system can engage the projection on one of three different cassettes, but the other two plungers are not engaged, such that the console 102 can identify the cassette according to which plunger has been engaged; this identification necessarily requires determining that the plunger has been engaged before identifying the type of cassette).
The limitation “in a case where the console is compatible with the type of cassette, the console is configured to use system settings associated with the cassette type” constitutes functional language contingent on whether the console is compatible with the type of the cassette; under the claim’s broadest reasonable interpretation, the claim requires structure for performing the function should the condition occur. See Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016). In this case, Peterson discloses that compatible cassettes are then used with system settings according to the cassette type, e.g., once the controller identifies the console based on its physical characteristics, it can control settings such as pump volume per pump actuation according to the type of cassette identified, as discussed in paras [0346]-[0349]).
Regarding claim 2, Peterson discloses that the cassette pre-load detection system comprises two detection switches (i.e., two of three plungers 530, 532, 534; see Fig. 19).
Regarding claim 3, Peterson discloses that the two detection switches are proximate to each other (see Fig. 19 showing proximally located plungers 530, 532, 534).
Regarding claim 5, Peterson discloses that the first body portion is configured to contact one of the two detection switches proximate to a top of the cassette body (i.e., the projection 596 contacts one of the plungers which is located near the top of the cassette body when the cassette is being inserted into the module 102).
Regarding claim 6, Peterson discloses that the detection switches comprise a microswitch, piezometer, or an optical switch (i.e., the detection switches comprise optical switches that correspond to slotted optical sensors; see para [0348]).
Regarding claim 7, Peterson discloses that the console 102 is configured to receive an indication of the type of cassette based on a detection of a depth of one of the first or body portions by the detection switches (i.e., the first body portion contacts the plunger on the cassette identification system, such that the type of cassette identified depends on the depth of the projection that is able to engage with its corresponding plunger; see para [0349], for example).
Regarding claim 8, Peterson discloses that the console is configured to receive an indication of the type of cassette based on the detection of the first body portion and the second body portion (as noted above, each of three plungers on the cassette identification system can engage a respective projection on one of three different cassettes, such that the console 102 can identify the cassette according to which plunger has been engaged; see paras [0348]-[0349]).
Regarding claim 10, Peterson discloses a surgical console 102 (see Fig. 1) configured to receive multiple types of eye treatment cassettes (as discussed above, each of three plungers on the cassette identification system can engage a respective projection on one of three different cassettes, such that the console 102 can identify the cassette according to which plunger has been engaged; see paras [0348]-[0349]), comprising:
a cassette receptacle (see Fig. 21 showing an outer housing 560 with an area for receiving a cassette), wherein the console is compatible with a first type of cassette and is not compatible with a second type of cassette (a skilled artisan would recognize that there exists a type of cassette that would not be possibly sized or shaped to be compatible with the cassette receptacle)
and a console controller (“control system” of the console 102; see para [0043]); for receiving an indication of the type of cassette received by the cassette receptacle and controlling the operation of the console (the control system of the console 102 uses the “cassette identification system” disclosed in paras [0346]-[0349] to control operation of the pump of the console based on the type of cassette that is attached to the console),
wherein the console is configured to sense first and second body portions of the cassette having respective first and second body portion depths of the cassette (see annotated Fig. 22, below, showing the first body portion depth to be the depth of the projection relative to the rearmost plane of the cassette where the loop 642 of the cassette terminates, and the second body portion depth to be the depth of the base plate 566 relative to the rearmost plane of the cassette; it is understood that the cassette pre-load detection system also contacts the base plate 566, as shown in Fig. 21), and to identify the type of cassette based on a configuration of the first body portion and second body portions of the cassette coupled with the console (i.e., each of three plungers on the cassette identification system can engage the projection on one of three different cassettes, but the other two plungers are not engaged, such that the console 102 can identify the cassette according to which plunger has been engaged; see paras [0346]-[0349]),
and wherein the first and second body portion define a type of cassette coupled with the console (i.e., each of three plungers on the cassette identification system can engage the projection on one of three different cassettes, but the other two plungers are not engaged, such that the console 102 can identify the cassette according to which plunger has been engaged; see paras [0348]-[0349]),
wherein the console is further configured to perform one of:
indicate whether the cassette is compatible with the console based on the cassette type; and
control one or more of system vacuum setting, system aspiration setting, and system irrigation rate based on the cassette type (i.e., each of three plungers on the cassette identification system can engage the projection on one of three different cassettes, but the other two plungers are not engaged, such that the console 102 can identify the cassette according to which plunger has been engaged and then set a pumping volume per pump actuation according to the type of cassette identified; once the controller identifies the console based on its physical characteristics, it can control settings such as pump volume per pump actuation according to the type of cassette identified, as discussed in paras [0346]-[0349]; this pump volume per pump actuation is interpreted to be an “irrigation rate” of the desired drug therapy),
and wherein the console is configured to determine whether the cassette is cassette is compatible with the console based on the cassette type (i.e., see paras [0346]-[0349] disclosing that each of three plungers on the cassette identification system can engage the projection on one of three different cassettes, but the other two plungers are not engaged, such that the console 102 can identify the cassette according to which plunger has been engaged; this identification necessarily requires determining that the plunger has been engaged before identifying the type of cassette).
The limitation “only in a case where the console is compatible with the type of cassette, the console is configured to use system settings associated with the cassette type” constitutes functional language contingent on whether the console is compatible with the type of the cassette; under the claim’s broadest reasonable interpretation, the claim requires structure for performing the function should the condition occur. See Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016). In this case, Peterson discloses that compatible cassettes are then used with system settings according to the cassette type, e.g., once the controller identifies the console based on its physical characteristics, it can control settings such as pump volume per pump actuation according to the type of cassette identified, as discussed in paras [0346]-[0349]).
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Peterson, annotated Fig. 22, showing the back plane of the cassette, the first body portion depth and the second body portion depth
Regarding claim 11, Peterson discloses that the cassette type indication is generated by a cassette pre-load detection system (see “cassette identification system” disclosed in para [0346]).
Regarding claim 12, Peterson discloses that the indication is received from a detection switch (i.e., one of three plungers 530, 532, 534; see Fig. 19).
Regarding claim 14, Peterson discloses that the indication is generated by a detection switch in contact with at least one of the first and second body portions of the cassette (as discussed above, each of three plungers on the cassette identification system can engage a respective projection on one of three different cassettes, such that the console 102 can identify the cassette according to which plunger has been engaged; see paras [0348]-[0349]).
Regarding claim 15, Peterson discloses that the detection switch is a microswitch, piezometer, or an optical switch (i.e., the detection switches comprise optical switches that correspond to slotted optical sensors; see para [0348]).
Regarding claim 16, Peterson discloses that the indication is indicative of the depth of a body portion of the first cassette and depth of second body portion of a cassette (as discussed above, the depth of each projection on the cassette is used to engage the corresponding plunger on the console, such that the type of cassette identified depends on the projection that is able to engage with its corresponding plunger; see para [0349], for example).
Regarding claim 17, Peterson discloses the first type of cassette includes a cassette operable with the surgical console (such as cassette 104, which is operated with the surgical console, as shown in Fig. 1).
Regarding claim 18, Peterson discloses a method for identifying a type of eye treatment cassette, comprising:
receiving an eye treatment cassette 104 having cassette tubing 110 (see Fig. 2) in a cassette receptacle (see Fig. 21 showing an outer housing 560 with an area for receiving a cassette base plate 542) of a surgical console 102 of an eye surgical system (see Fig. 1);
receiving an indication of the type of cassette from a cassette pre-load detection system (see “cassette identification system” disclosed in para [0346]) having at least two detection switches (i.e., two of three plungers 530, 532, 534; see Fig. 19); and
enabling operation of the console based on the indication of the type of cassette (as noted above, each of three plungers on the cassette identification system can engage a respective projection on one of three different cassettes, such that the console 102 can identify the cassette according to which plunger has been engaged; when the cassette has been identified, the operation of the console can be initiated to a specific pumping volume per activation; further, see para [0342] disclosing that the control system can be used to prevent operation of the pump if an unauthorized cassette is attached to the console),
wherein the at least two detection switches are configured to sense first and second body portions, having respective first and second body portion depths, of the cassette (see annotated Fig. 22, above, showing the first body portion depth to be the depth of the projection relative to the rearmost plane of the cassette where the loop 642 of the cassette terminates, and the second body portion depth to be the depth of the base plate 566 relative to the rearmost plane of the cassette; it is understood that the cassette pre-load detection system also contacts the base plate 566, as shown in Fig. 21),
and wherein the first and second body portions define a type of cassette coupled with the console (i.e., each of three plungers on the cassette identification system can engage the projection on one of three different cassettes, but the other two plungers are not engaged, such that the console 102 can identify the cassette according to which plunger has been engaged; see paras [0348]-[0349]),
and wherein the cassette comprises one or more physical characteristics corresponding to the type of cassette, wherein the one of more physical characteristics are selected from the group consisting of tubing diameter, tubing material, tubing thickness, tubing length, system vacuum setting for use with the cassette, system aspiration setting for use with the cassette, and system irrigation rate for use with the cassette (i.e., each of three plungers on the cassette identification system can engage the projection on one of three different cassettes, but the other two plungers are not engaged, such that the console 102 can identify the cassette according to which plunger has been engaged and then set a pumping volume per pump actuation according to the type of cassette identified; once the controller identifies the console based on its physical characteristics, it can control settings such as pump volume per pump actuation according to the type of cassette identified, as discussed in paras [0346]-[0349]; this pump volume per pump actuation is interpreted to be an “irrigation rate” of the desired drug therapy), and
determining whether the cassette is cassette is compatible with the console based on the cassette type (i.e., see paras [0346]-[0349] disclosing that each of three plungers on the cassette identification system can engage the projection on one of three different cassettes, but the other two plungers are not engaged, such that the console 102 can identify the cassette according to which plunger has been engaged; this identification necessarily requires determining that the plunger has been engaged before identifying the type of cassette).
The limitation “only in a case where the console is compatible with the type of cassette, the console is configured to use system settings associated with the cassette type” constitutes functional language contingent on whether the console is compatible with the type of the cassette; under the claim’s broadest reasonable interpretation, if the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed. See Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016).
Regarding claim 19, Peterson discloses that the at least two detection switches are proximate to each other (see Fig. 19 showing proximally located plungers 530, 532, 534).
Regarding claim 21, Peterson discloses that a body portion of the cassette is configured to contact one of the at least two detection switches (as discussed above, each of three plungers on the cassette identification system can engage a respective projection on one of three different cassettes, such that the console 102 can identify the cassette according to which plunger has been engaged; see paras [0348]-[0349]).
Regarding claim 22, Peterson discloses that the first body portion and second body portion of the cassette are configured to contact, respectively, each of one of two of the at least two detection switches (see para [0345] disclosing that a single cassette can have two projections, which would be understood to engage two of the three plungers 530, 532, 534).
Regarding claim 23, Peterson discloses that the detection switches comprise a microswitch, piezometer, or an optical switch (i.e., the detection switches comprise optical switches that correspond to slotted optical sensors; see para [0348]).
Regarding claim 24, Peterson discloses that the console receives the indication of the type of cassette based on a detection of a depth of the first or second body portion of the cassette by the at least two detection switches (as discussed above, the depth of each projection on the cassette is used to engage the corresponding plunger on the console, such that the type of cassette identified depends on the projection that is able to engage with its corresponding plunger; see para [0349], for example).
Response to Arguments
Applicant's arguments filed in the Remarks have been fully considered.
Claim Rejections -35 U.S.C. § 102
Applicant traversed the rejection under 35 U.S.C. 102 as being anticipated by Peterson. Applicant argued that Peterson is not capable of being used for eye surgery (see Remarks, pg. 9).
Examiner notes that, with respect to claims 1 and 10, the single reference to an eye surgical system appears in the preamble of the claimed invention. Applicant did not argue that the preamble terminology “eye surgical system” limits the structure of the claimed invention. Instead, Applicant argued that the system of Peterson is not able to be used for eye surgery because it is only a drug pump (Id.).
Examiner notes that an “eye surgical system” is a broad term that does not necessarily require it to comprise “all functions that are critical to an eye surgery procedure” as alleged by Applicant (see Remarks, pg. 9); rather, an “eye surgical system” can comprise any function that is critical, or even non-critical, to an eye surgery procedure.
Notably, “eye surgery” covers a large variety of procedures including laser eye surgery, eye muscle surgery, corneal surgery, refractive surgery, glaucoma treatment, plastic surgery around the eye, lacrimal repair, vitrectomy, eyelid surgery, etc. Before, during or after these procedures, known medications may be delivered to provide certain functions such as patient comfort (e.g., anesthetics), enhance visualization of the surgical field (e.g., steroids) or reduce the possibility of infections (e.g., antibiotics).
The system of Peterson would have been recognized by a person of ordinary skill in the art as being capable of use “for” an eye surgical procedure in order to provide, for example (but not limited to) targeted medication therapy in the manner described above.
Applicant further argued that Peterson does not disclose or suggest claim 1, in particular the limitation "wherein the console is configured to determine whether the cassette is compatible with the console based on the type of the cassette and only in a case where the console is compatible with the type of cassette, the console is configured to use system settings associated with the cassette type.” 1
However, the Remarks did not appear to address why Peterson does not disclose or suggest these features. Rather, Applicant’s arguments concern whether or not Peterson discloses that the console operates if the cassette fails to engage one of the plungers on the cassette identification system (see Remarks, pg. 10). But Examiner acknowledges that claim amendments, dated 07/02/2025, removed the language of “operate” and “does not operate” from claim 10. The Office action has been corrected to address the amendment dated 07/02/2025. For this reason, Applicant’s argument is moot; absent any other substantive arguments, the rejections are maintained.
Claims 2-3, 5-8, 11-12, 14-16, 19 and 21-24 were alleged to be patentable based on independent claims 1, 10 and 18, but were not otherwise argued on their merits.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
01/14/2026
1 Claim 1 does not recite “…only in a case…”; this language appears in claims 10 and 18.