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
This Office action is in response to the applicant’s communication filed 12/01/2025.
Status of the claims:
Claims 1 – 15 are pending in the application.
Claim 15 is withdrawn.
Claims 1 – 4, 6 – 8, and 13 are amended.
Claim Objections
The objections to claims 1 and 4 in the previous action dated 07/01/2025 have been withdrawn in light of the Applicant’s amendments filed 12/01/2025. Specifically, the objection to claim 2, regarding the phrase “The cataract surgery pack of claim 1, wherein does not”, the objection to claim 6, regarding the phrase “two or more sections to the cataract”, the objection to claim 7 regarding the phrase “the phaco cutter body”, and the objection to claim 13 regarding the phrase “an ultrasound interface” have been withdrawn as the appropriate corrections have been made.
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 – 14 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 4 both recite wherein the phaco cutter “does not utilize another tool or suction to hold the hard cataract nucleus”. However, Applicant’s disclosure does not appear to have support for *not* utilizing another tool to hold the hard cataract nucleus. Applicant’s disclosure paragraph [0023], claims 1, 3, and 6 recite using a lens loop and/or a spatula to remove (via picking up and holding) the cataract nucleus. Therefore, claims 1 and 4 are rejected for failing to comply with the written description requirement.
Claims 2 – 3 and 5 – 14 are rejected under 112(a) for being dependent upon rejected claims 1 and 4.
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 – 14 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 claims 1 and 4, the phrase “and does not utilize another tool or suction to hold the hard cataract nucleus” renders the claim indefinite because the phrase is a method step in an apparatus claim. For the purpose of examination, the Examiner will read the limitation to be functional.
Regarding claims 1 and 6, the phrase “and does not utilize another tool or suction to hold the hard cataract nucleus” renders the claim indefinite because it is unclear how the systems of claims 1 and claim 6 can *not* utilize another tool to hold the cataract nucleus and also require a lens loop configured to remove a portion of the cataract nucleus. For the purpose of examination, the Examiner will read the phrase to mean “and is configured to not utilize another tool or suction to hold the hard cataract nucleus when the phaco cutter is cutting the tissue”. (It should be understood that although the Examiner is interpreting the claim in this way, the 112(a) rejection for lack of written description would still apply to the claims for the phase amended this way).
Claims 2 – 3 and 5 – 14 are rejected for being dependent on an independent 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 following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 3 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller (US 2020/0383833 A1) (previously cited) and in view of Nun (US 6,328,747 B1) (previously cited) and Jacobovitz (US 2015/0320597 A1) (previously cited).
Regarding claims 1 – 3, Schaller discloses a cataract surgery pack (microsurgical instrument 2700) (abstract, paragraphs [0003], [0051], [0055], [0062], and [0131], and Figs. 1A-1B), comprising:
a portable rechargeable ultrasonic cutting handpiece for generating ultrasonic energy (reuseable portion 3210) (paragraphs [0058] and [0131]);
one removable phaco cutters (disposable portion 3205) with a phaco cutter tip (tip of configured to cut into a hard cataract nucleus (paragraphs [0004] and [0057]) and is configured to be used without utilizing another tool or suction to hold the hard cataract nucleus (Examiner’s note: Schaller does not disclose using suction or another tool to hold the cataract nucleus still; Schaller discloses using the aspiration for aspirating the tissue once the tissue has been cut – paragraph [0057]. Additionally, paragraph [0065] discloses wherein the user can use cutter-only function (i.e., utilizing the cutter without another tool or suction to hold the cataract). Lastly, it should be understood that the limitation is a functional limitation which requires only that the structure of the prior be capable of functioning in the manner claimed. With that said, there is nothing that prohibits or prevents the cutter of Schaller from being used without the utilization of another tool to hold the cataract) and an irrigation sleeve (irrigation sleeve 3128) (paragraph [0058] and Figs. 1A-1B).
However, Schaller is silent regarding [claims 1 and 2] (i) the one or more removable phaco cutters configured to not perform aspiration and does not include an aspiration tube or an aspiration port and (ii) a lens loop less than 2.5 mm wide, and (iii) [claim 3] a spatula less than 1mm wide to be inserted into an entry wound to assist to push the cataract nucleus slivers out of the eye.
As to the above, Nun teaches a cataract removing device for removing a cataract (abstract) wherein it is known in the art that the nucleus of the lens is broken into small fragments or dissolved using appropriate instruments (i.e., a blade with an ultrasonic transmitter) and then removed via suction or scooping (i.e., manual removal via a secondary device) (col. 1 lines 45 – 60 and col. 8 line 66 – col. 9 line 10).
Additionally, Jacobovitz teaches a cataract surgery apparatus comprising cutting handpiece (nucleus chopper 100) with a phaco cutter (tip 106) (abstract, paragraphs [0063 – 0064], and Figs. 1 – 2) and wherein the diseased lens can be removed manually via a lens loop apparatus or a spatula (i.e., devices for scooping the lens material) (paragraphs [0009 – 0012] and [0088 – 0089]). Therefore, Jacobovitz teaches the manual removal (i.e., scooping) the lens material is done via a lens loop or a spatula.
It should be understood that Schaller, Nun, and Jacobovitz are known references in the art that teach devices and systems for the removal of cataracts via a cutter (abstract, paragraphs [0003], [0051], [0055], [0062], and [0131], and Figs. 1A-1B – Schaller ; col. 1 lines 45 – 60 and col. 8 line 66 – col. 9 line 10 – Nun ; abstract, paragraphs [0063 – 0064], and Figs. 1 – 2); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one means of removing the fragmented tissue for another (i.e., substituting the aspiration / aspiration tube / aspiration port of Schaller for the lens loop and the spatula of Jacobovitz), and the results of the substitution would have been predictable and resulted in the modified system of Schaller being able to function as intended to properly remove the ultrasonically fragmented pieces of tissue from the eye as suggested by Nun. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. It should be understood that with the combination made above, the device of Schaller is no longer configured to perform aspiration and no longer includes an aspiration port or an aspiration tube; additionally, because both the lens loop and the spatula are known tools known to be used to remove lens material after fragmentation it would be beneficial to include both devices in the cataract surgery pack so that the user may decide on the most appropriate tool to use which can depend on the patient and/or scenario.
Furthermore, although Jacobovitz does not explicitly disclose the lens loop being less than 2.5 millimeters wide or the spatula being less than 1 millimeter wide. There is no evidence of record that establishes that changing the width / diameter of the lens loop and the spatula would result in a difference in function of the either device of Jacobovitz. Further, a person having ordinary skill in the art, being faced with modifying the size of the lens loop and the spatula of Jacobovitz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended (i.e., to remove the fragmented tissue) being given the claimed sizes. Lastly, Applicant has not disclosed that the claimed range solves any stated problem, indicating that the diameter “may” be within the claimed range (e.g., specification at pg. 6 line 30 – pg. 7 line 4) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size of the lens loop and spatula of Jacobovitz used with the device of Schaller to have an diameter / width less than 2.5 millimeters and less than 1mm, respectively, as an obvious matter of design choice within the skill of the art.
Claims 4 – 6 and 9 – 14 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller (US 2020/0383833 A1) (previously cited) in view of Nun (US 6,328,747 B1) (previously cited), and Jacobovitz (US 2015/0320597 A1) (previously cited), and Kurwa (US 6,592,541 B1) (previously cited).
Regarding claims 4, 5, and 6, Schaller discloses a portable rechargeable ultrasonic apparatus (microsurgical instrument 2700) to remove a cataract nucleus (abstract, paragraphs [0003], [0051], [0055], [0062], and [0131], and Figs. 1A-1B), comprising:
an ultrasonic handpiece or body (device 2700) (paragraph [0127] and Fig. 1A);
an insulating sleeve (irrigation sleeve 3128), the insulating sleeve to cover a distal or far end of the ultrasonic handpiece or body (paragraph [0058] and Fig. 1A); and
a phaco cutter (disposable portion 3205) to connect to the ultrasonic handpiece or body (Examiner’s note: as stated in paragraph [0057] the shaft 2761 is a cutter tube; and as shown in Fig. 2A the shaft 2761 is a part of the disposable portion 3205), the phaco cutter to include a phaco cutter main body (body of disposable portion 3205) and a phaco cutter tip (tip of shaft elongate member 2755 / shaft 2761) (paragraph [0057]), wherein the phaco cutter tip is disposed at the distal end of the phaco cutter (paragraph [0053] and Fig. 2A), wherein the phaco cutter is configured to cut a cataract nucleus into two or more sections (multiple fragments) to be removed manually (paragraph [0057]) and is configured to be used without utilizing another tool or suction to hold the hard cataract nucleus (Examiner’s note: Schaller does not disclose using suction or another tool to hold the cataract nucleus still; Schaller discloses using the aspiration for aspirating the tissue once the tissue has been cut – paragraph [0057]. Additionally, paragraph [0065] discloses wherein the user can use cutter-only function (i.e., utilizing the cutter without another tool or suction to hold the cataract). Lastly, it should be understood that the limitation is a functional limitation which requires only that the structure of the prior be capable of functioning in the manner claimed. With that said, there is nothing that prohibits or prevents the cutter of Schaller from being used without the utilization of another tool to hold the cataract).
However, Schaller is silent regarding the cutter tip having a (i) [claim 4] width of 2.75mm to 3.25mm, a height of 3.5mm to 4.5mm, and a thickness of 0.2mm to 0.4mm (ii) wherein the phaco cutter is not configured to perform aspiration, (iii) [claim 5] wherein the phaco cutter does not include an aspiration port, channel, or a tube, and (iv) [claim 6] further including a lens loop to create a portable rechargeable assembly, wherein the lens loop is configured to be placed under each section of the two or more sections to the cataract nucleus to remove the two or more sections of the cataract nucleus.
As to (i), Kurwa teaches, in the same field of endeavor, a phacoemulsification cutter handpiece with a cutter tip for cutting into a nucleus of a cataract, wherein the cutter tip (solid blade) has a flat surface, a width (height) of 1 to 3 mm, a height (length) of 2 to 5 mm, and a thickness of 0.1mm to 0.6mm (abstract and col. 3 lines 14 – 33).
It should be understood that Schaller and Kurwa are known references in the art that teach a phacoemulsification cutter with a cutting tip (abstract, paragraphs [0003], [0051], [0055], [0062], and [0131], and Figs. 1A-1B – Schaller ; abstract and col. 3 lines 14 – 33 – Kurwa); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one cutting tip for another, and the results of the substitution would have been predictable and resulted in the modified device of Schaller being able to function as intended to properly break up the nucleus of a cataract. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. Additionally, the prior art discloses overlapping ranges and it would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05. Thus, the claimed limitations are considered obvious over the teachings of the prior art.
As to (iii) – (iv), Nun teaches a cataract removing device for removing a cataract (abstract) wherein it is known in the art that the nucleus of the lens is broken into small fragments or dissolved using appropriate instruments (i.e., a blade with an ultrasonic transmitter) and then removed via suction or scooping (i.e., manual removal via a secondary device) (col. 1 lines 45 – 60 and col. 8 line 66 – col. 9 line 10).
Additionally, Jacobovitz teaches a cataract surgery apparatus comprising cutting handpiece (nucleus chopper 100) with a phaco cutter (tip 106) (abstract, paragraphs [0063 – 0064], and Figs. 1 – 2) and wherein the diseased lens can be removed manually via a lens loop apparatus (i.e., a device for scooping the lens material) (paragraphs [0009 – 0012] and [0088 – 0089]). Therefore, Jacobovitz teaches the manual removal (i.e., scooping) of the lens material is done via a lens loop.
It should be understood that Schaller, Nun, and Jacobovitz are known references in the art that teach devices and systems for the removal of cataracts via a cutter (abstract, paragraphs [0003], [0051], [0055], [0062], and [0131], and Figs. 1A-1B – Schaller ; col. 1 lines 45 – 60 and col. 8 line 66 – col. 9 line 10 – Nun ; abstract, paragraphs [0063 – 0064], and Figs. 1 – 2); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one means of removing the fragmented tissue for another (i.e., substituting the aspiration / aspiration tube / aspiration port of Schaller for the lens loop of Jacobovitz) as suggested by Nun, and the results of the substitution would have been predictable and resulted in the modified system of Schaller being able to function as intended to properly remove the ultrasonically fragmented pieces of tissue from the eye. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. It should be understood that with the combination made above, the device of Schaller in view of Kurwa and Jacobovitz/Nun is no longer configured to perform aspiration and no longer includes an aspiration port or an aspiration tube and is considered to be a portable rechargeable assembly with the addition of the lens loop of Jacobovitz.
Regarding claim 9, as discussed above, the combination of Schaller, Kurwa, and Jacobovitz/Nun teaches the device of claim 4. Additionally, Schaller discloses wherein the ultrasonic handpiece (device 2700) includes a power interface (location where cable 2757 connects to the device 2700 – shown in Fig. 1A), a battery (paragraphs [0053] and [0131]), a display (touchscreen) (paragraph [0062]), an ultrasound generating device (motor) (paragraphs [0058] and [0103]), and an ultrasound interface (elongate member 2755) (paragraphs [0055] and [0127]).
Regarding claim 10, as discussed above, the combination of Schaller, Kurwa, and Jacobovitz/Nun teaches the device of claim 4. Additionally, Schaller discloses further comprising an external power source (wall socket) (paragraph [0053]), the external power source (wall socket) to connect to the power interface and to recharge the battery (paragraphs [0053] and [0131]).
Regarding claim 11, as discussed above, the combination of Schaller, Kurwa, and Jacobovitz/Nun teaches the device of claim 4. Additionally, Schaller encompasses, or, in the alternative, makes obvious wherein the battery (battery) provides DC power to the display and the ultrasound generating device (motor) (Examiner’s note: as stated in paragraph [0103] the motor is a DC motor, and in order to power the DC motor, the battery must be a DC battery; additionally, it would be obvious for the battery to provide DC power to the DC motor for the purpose of being able to power the DC motor. Therefore, Schaller encompasses or in the alternative makes obvious a DC battery. Furthermore, as stated in paragraph [0131] the instrument, which includes the touch screen (i.e., the display), is powered by the battery).
Regarding claim 12, as discussed above, the combination of Schaller, Kurwa, and Jacobovitz/Nun teaches the device of claim 4. Additionally, Schaller discloses further comprising a contact switch (trigger 3125) to turn on or off the portable rechargeable ultrasonic apparatus (paragraph [0107]).
Regarding claim 13, as discussed above, the combination of Schaller, Kurwa, and Jacobovitz/Nun teaches the device of claim 4. Additionally, Schaller discloses wherein the ultrasound generating device (motor) to generate the ultrasonic energy and to transfer the ultrasound energy to the ultrasound interface (elongate member 2755) (paragraphs [0103] and [0127]).
Regarding claim 14, as discussed above, the combination of Schaller, Kurwa, and Jacobovitz/Nun teaches the device of claim 4. Additionally, Schaller discloses wherein the ultrasound interface (elongate member 2755) is coupled to the phaco cutter (tip of shaft elongate member 2755 / shaft 2761) and provides the ultrasound energy to the phaco cutter (paragraph [0057] and [0127]).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller (US 2020/0383833 A1) (previously cited) in view of Nun (US 6,328,747 B1) (previously cited), and Jacobovitz (US 2015/0320597 A1) (previously cited), and Kurwa (US 6,592,541 B1) (previously cited), as applied to claim 4 above, and further in view of Kadziauskas et al (US 2006/0253056 A1) (previously cited).
Regarding claim 7, as discussed above, the combination of Schaller, Kurwa, and Jacobovitz/Nun teaches the device of claim 4.
However, the combination of Schaller, Kurwa, and Jacobovitz/Nun is silent regarding (i) wherein the phaco cutter body may be shaped with a curve to angle the phaco cutter tip at a range of a 35-degree to 50- degree angle with respect to the ultrasonic handpiece.
As to the above, Kadziauskas teaches, in the same field of endeavor, a phaco cutter (phacoemulsification needle 50) connected to a hand piece (abstract and paragraph [0026]) including a phaco cutter main body (needle body 12) and a phaco cutter tip (curved body portion 52) wherein the phaco cutter body may be shaped with a curve (arc 54) (paragraphs [0035 – 0036] and Fig. 4). Although Kadziauskas is silent regarding the specific degree of curvature, Kadziauskas does teach, in paragraph [0040], wherein the angle of curvature or arc 54 may vary in the angle depending on the specific use of the needle.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the cutter tip of Schaller in view of Kurwa, Jacobovitz/Nun to be curved relative to the cutter body, as taught by Kad, for the purpose of aiding in the accessing of the cortex material in difficult to access locations within the eye (paragraph [0040] – Kad). Additionally, there is no evidence of record that establishes that changing the angle of the modified cutter tip of Schaller in view of Kurwa, Jacobovitz/Nun, and Kadziauskas to an angle within the claimed range would result in a difference in function of the modified device. Further, a person having ordinary skill in the art, being faced with modifying the cutter tip of Schaller in view of Kurwa, Jacobovitz/Nun, and Kadziauskas, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle “may” be within the claimed range, (e.g., 30-50 degrees, specification at page 8 lines 9 – 12) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the angle of curvature of Schaller in view of Kurwa, Jacobovitz/Nun, and Kadziauskas to have an angle between 35 and 50 degrees as an obvious matter of design choice within the skill of the art.
Regarding claim 8, as discussed above, it would have been obvious to modify the device of Schaller in view of Jacobovitz/Nun and Kadziauskas with the cutter blade of Kurwa. Additionally, Kurwa further teaches wherein the cutter blade is flat (Examiner’s note: as stated in col. 3 lines 20 – 22 the cutter blade has a face edge with a square surface area, therefore, the cutter blade is flat at the face edge. Furthermore, because the cutter tip is flat, the cutter tip is configured to lie flat on a surface of the cataract nucleus at the face edge; therefore, the modified device of Schaller is configured as claimed).
Response to Arguments
Applicant's arguments filed 12/01/2025 have been fully considered but they are not persuasive. More specifically:
Regarding Applicant’s argument “Schaller does not disclose, teach or suggest wherein the phaco cutter tip is configured to cut a hard cataract nucleus into two or more sections to allow the two or more sections to be removed manually and is not configured to perform aspiration and does not utilize another tool or suction to hold the hard cataract nucleus. The claimed subject matter in claim 4 cannot utilize suction since it is not configured to perform aspiration.”, “Accordingly, Nun does not disclose, teach or suggest wherein the phaco cutter tip is configured to cut a hard cataract nucleus into two or more sections to allow the two or more sections to be removed manually and is not configured to perform aspiration and does not utilize another tool or suction to hold the hard cataract nucleus. Nun's device is a) not configured to perform aspiration; b) requires another tool because Nun's device requires a cryogenic tip to hold the hard cataract nucleus and a drill; and c) is not connected to an ultrasonic handpiece. For the reasons discussed immediately above, Applicant respectfully submits that amended independent claim 4 distinguishes over any combination of Nun and/or Schaller, whether proper or otherwise.”, and “However, Jacobovitz does not make up for the deficiencies of Schaller and/or Nun. Jacobovitz does not disclose wherein the phaco cutter tip is configured to cut a hard cataract nucleus into two or more sections to allow the two or more sections to be removed manually and is not configured to perform aspiration and does not utilize another tool or suction to hold the hard cataract nucleus, as is recited in amended independent claim 4. Jacobovitz's device includes 2 sharp cutting hooks that can be used like knifes to cut through the cataract nucleus, however this is only utilized for soft cataract nucleus, but cannot be used if the cataract nucleus is hard (which is why ultrasound is needed). In other words, the Jacobovitz device is just scratching the surface of the cataract nucleus and never gets deep enough if the cataract nucleus is at all hard. Further, if you push the Jacobovitz device too hard, it can actually tear the fine zonules that hold the cataract nucleus in position and dislocate the cataract nucleus into the retina. This is completely different from the claimed subject matter which utilizes ultrasound to divide the cataract nucleus.”, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The rejection of claims 1 and 4 rely on the combination of the references listed above. Additionally, the Examiner is relying on Nun solely to show that it is known within the phacoemulsification art to utilize manual removing of the lens material in place of aspiration and the Examiner is relying on Jacobovitz solely to teach in the lens loop and spatula for the manual removal of the lens material; the Examiner is not relying on either of the phacoemulsification / cutters of Nun and Jacobovitz. Furthermore, the modified comprised a cutter configured to cut into hard cataract and configured to not perform aspiration and does not utilize another tool or suction to hold the cataract. Therefore, all arguments are not persuasive.
Regarding to Applicant’s argument that “Even if a combination is theoretically possible, obviousness still requires that a PHOSITA would have a reasonable expectation of success in combining the features or teachings of the references. In this case, the references have incompatible disclosures and/or also are teaching away from each other. Schaller is requiring suction to hold onto the hard cataract nucleus; Nun is teaching utilizing a cryogenic ("cryo") tip to adhere to the cataract nucleus and then applying a separate mechanical drill to drill into the nucleus as shown below.”, no where in the disclosure of Schaller does Schaller disclose relying on the aspiration / suction force to hold onto the hard cataract nucleus. Moreover, neither Schaller or Nun teach away from modifying the system of Schaller to replace the aspiration with manual removal of the cataract material, as neither recite or suggest that aspiration is fundamentally crucial to the functioning of the system of Schaller, and that replacing the aspiration with the manual removing tools would make the system of Schaller in operable for its intended purpose. Futhermore, it should be noted that merely, saying that the modification would result in the inoperability of the device is not sufficient to show inoperability of the device. Furthermore, the examiner notes that the arguments of the attorney can not take place of evidence. See In Re Schulze, 346, F.2d 600,602, 145 USPQ 716, 718 (CCPA 1965)
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771