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 responsive to the amendment filed on 01/02/2026. As directed by the amendment: claims 12-14 have been amended. Thus, claims 1-14 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pg. 7, filed 01/02/2026, with respect to the rejection of claims 12-14 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 12-14 under 35 U.S.C. 112(b) has been withdrawn.
Applicant's arguments filed 01/02/2026 have been fully considered but they are not persuasive.
Applicant argues that Lisk does not disclose the preamble of the claim. Specifically, that Lisk does not disclose the motor is in the handle; a surgical hand instrument because fig. 6a only shows the separator component and fig. 7-11 only show portions of the instrument; the suction assembly is used to provide suction to the patient’s eye and this is not for free hand use. The Office respectfully disagrees. First, The Office notes that a preamble merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. Second, The Office maintains that Lisk does disclose the preamble. Lisk discloses that the invention is used with a handpiece 800 (see [0040]). Element 800 is specifically referred to as a hand piece meaning it would meet the definition of a surgical hand instrument. Furthermore, the fast that Lisk doesn’t show all of the elements of there invention in a single drawing does not negate the fact that they are all used as one instrument as disclosed in [0040]. There is no requirement that the prior art show the device as a whole in the figs. to be used as prior art. Finally, even though element 800 is connected to suction, it is still capable of freehand use if picked up by a user and held in their hand for use. The preamble, not the remainder of the claim, require that the device not be connected to suction. Furthermore, the specification does not provide a special definition for “freehand” as the term is not used therein at all. Thus, The Office maintains that Lisk discloses the preamble of the claim.
Applicant further argues that Lisk does not disclose a lifting component and that the slicing motion of Lisk is not a vibration with a lifting component. The Office respectfully disagrees. While Lisk does disclose a slicing motion, Lisk also discloses that the separator can vibrate vertically (see [0041]). This motion meets the claim language for “a lifting component that is perpendicular to a plane defined by said generally planar tip”. Should applicant wish to differentiate their lifting component from the vertical motion of Lisk, more specific claim language for the lifting component should be used.
Applicant also argues that the disclosed frequency range of Lisk (10Hz-10KHz) is broader than the claimed range of 200Hz to 500Hz / 200Hz to 300Hz and thus doesn’t disclose the claimed range. The Office respectfully disagrees. The disclosure of the frequency range of Lisk includes the range claimed by applicant, thus Lisk discloses the claimed ranges of 200Hz-500Hz and 200Hz-300Hz. Furthermore, Applicant places no importance on the narrower ranges even stating “The frequency range found to be effective is between 200-500 Hz, but all frequencies in the audible range can be reproduced with LRA devices and therefore frequencies between 20-20,000 Hz may be acceptable” in the specification. Moreover, if applicant’s argument was persuasive, to which The Office does not concede, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Applicant further argues that Lisk does not disclose a tip suitable for separation of an intrastromal layer as recited in claim 12 and is not capable of performing that function, The Office respectfully disagrees. Applicant has not specifically pointed out any reason as to why Lisk would not be capable of separating an intrastromal layer as recited in claim 12. The Office submits the tip of Lisk is used for separating layers of eye tissue and thus is capable of separating an intrastromal layer as recited in claim 12.
Applicant further argues The Office has not provided any support for Weiner being in the same field of endeavor as Lisk because it would operate at twice the frequency of Lisk. The Office notes that Weiner need not be in the same filed of endeavor as the primary reference Lisk but rather in the same field of endeavor / analogous to the invention. The device of Weiner is a vibrating tissue treatment device thus it is analogous art.
Applicant further argues that the dampening element as taught in Weiner would have no effect on Lisk and since Lisk is suctioned to a patient’s eye there is no need to reduce the vibrations from the actuator to a surgeon’s hand. The Office respectfully disagrees. The device of Lisk also vibrates, even if at a different frequency. Therefore, one of ordinary skill in the art would recognize that using a silicone ring (dampening element) as taught in Weiner in Lisk would also provide a dampening effect because it is well known that silicone absorbs vibrations. Furthermore, Weiner simply teaches that the silicone rings “dampen undesirable vibration and isolate the ultrasonic energy” ([0040]) not that the silicone rings reduce the vibrations from the actuator to a surgeon’s hand as argued by applicant. Moreover, One of ordinary skill in the art would recognize the benefit of dampening undesirable vibrations and find it obvious to modify Lisk with Weiner.
Applicant further argues The Office has not provided any support for Michelson being in the same field of endeavor as Lisk because it is used to treat cataracts. The Office notes that Michelson need not be in the same filed of endeavor as the primary reference Lisk but rather in the same field of endeavor / analogous to the invention. The device of Michelson is an eye treatment device thus is analogous art.
Applicant further argues The Office has not provided any support for Vaitekunas being in the same field of endeavor as Lisk because it is an ultrasonic device. The Office notes that Vaitekunas need not be in the same filed of endeavor as the primary reference Lisk but rather in the same field of endeavor / analogous to the invention. The device of Vaitekunas is a vibrating tissue treatment device thus it is analogous art.
Applicant further argues the motivation provided by The Office to modify Lisk with Liederman "providing instrument data in real time without transmitting or processing delays" is not relevant to Lisk because Lisk describes using a transparent separator or tooltip separator to allow a surgeon to visualize the separation of an epithelial layer from the surface of an eye. The Office respectfully disagrees. While Lisk does provide for visualization during the procedure having a haptic feedback that is not impacted by fluids, fogging, etc. of visual ones still allows the operator to have real time feedback during the procedure.
Applicant even further argues “There is no indication or reason to modify Lisk in view of Peyman. As described above, Lisk is for an entirely different function, i.e., separation of the epithelial layer from the Bowman's membrane. There is no way to use Lisk to separate a lenticule defined by a femtosecond laser, and no way to use Lisk in a smile procedure. Peyman stands for the unrelated proposition that a SMILE procedures involves removing a lenticule”. The Office respectfully disagrees. Simply stating that the two prior art device are used for different procedures does not provide a specific argument as to why they can not be combined, therefore it is unclear exactly what applicant is arguing here. This the rejection is maintained.
Claim Rejections - 35 USC § 102
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 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lisk et al. (US 20040260320 A1).
Regarding claim 1 Lisk discloses (fig. 6A and 7-11) a surgical hand instrument for separating tissue layers (see [0044]) comprising:
a handle 800 sized as a handheld surgical instrument for freehand use (see [0040] and fig. 8); an actuator (motor) mounted in said handle 800 (see [0040]);
a surgical implement 700 linked to said actuator (see [0040]), wherein said surgical implement exhibits a generally planar tip 600 suitable for separating tissue layers (see fig. 6A and [0037]);
wherein said actuator imparts vibration to said tip 600 (see [0041]) and wherein said actuator and said surgical implement are configured so that said vibration includes a lifting component (vertical motion) that is perpendicular to a plane defined by said generally planar tip (plane of top of 6A as seen in fig. 6A) and wherein said lifting component of said vibration has a frequency of 20 Hz to 20,000 Hz (see [0041]).
Regarding claim 2 Lisk further discloses (fig. 6A and 7-11) said lifting component of said vibration has a frequency of 200 Hz to 500 Hz (see [0041]).
Regarding claim 3 Lisk further discloses (fig. 6A and 7-11) said lifting component of said vibration has a frequency of 200 Hz to 300 Hz (see [0041]).
Regarding claim 12 Lisk discloses (fig. 6A and 7-11) an apparatus for separation of intrastromal tissue layers at (see [0003], [0030]-[0031] and [0045]) an intrastromal tissue separation plane defined by application of a laser (the apparatus is capable of being used when a laser is used to define an intrastromal tissue separation plane) comprising: a surgical implement having a generally planar tip 600 that vibrates (see [0041]), said tip having a vibration component (vertical) that is perpendicular to a plane defined by said substantially planar tip (plane of top of 6A as seen in fig. 6A) at a frequency in the range of 200 Hz to 500 Hz (see [0041)) and when said tip 600 acts to separate said intrastromal tissue when applied to said intrastromal tissue separation plane (see [0044]).
The language “an apparatus for separation of intrastromal tissue layers an intrastromal tissue separation plane defined by application of a laser” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Lisk meets the structural limitations of the claim, and the device is capable of being used when laser is used to define an intrastromal tissue separation plane (the device separates tissue thus would be capable of doing so when laser is used to define an intrastromal tissue separation plane).
Claims 1 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by an alternate interpretation of Lisk.
Regarding claim 1 Lisk discloses (fig. 6A and 7-11) a surgical hand instrument for separating tissue layers (see [0044]) comprising:
a handle 800 sized as a handheld surgical instrument for freehand use (see [0040] and fig. 8); an actuator (motor) mounted in said handle 800 (see [0040]);
a surgical implement 700 linked to said actuator (see [0040]), wherein said surgical implement exhibits a generally planar tip suitable for separating tissue layers (see annotated fig. 6A below and [0037]);
wherein said actuator imparts vibration to said tip (see [0041]) and wherein said actuator and said surgical implement are configured so that said vibration includes a lifting component (longitudinal motion) that is perpendicular to a plane defined by said generally planar tip (see annotated fig. 6A below) and wherein said lifting component of said vibration has a frequency of 20 Hz to 20,000 Hz (see [0041]).
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Regarding claim 11 Lisk further discloses (fig. 6A and 7-11) a vibrational translator, wherein said vibrational translator is a bend in said surgical implement located between said generally planar tip and a proximal portion of said surgical implement (see annotated fig. 6A below).
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Claim Rejections - 35 USC § 103
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.
Claim 4 is are rejected under 35 U.S.C. 103 as being unpatentable over Lisk in view of Wiener et al. (US 20090030351 A1).
Regarding claim 4, Lisk discloses the claimed invention substantially as claimed, as set forth above for claim 1. Lisk further discloses (fig. 6A and 7-11) said surgical implement 700 is slidable in a channel in said handle 800 (see fig. 9-11 and [0043]-[0044]).
Lisk is silent regarding a damping element to damp motion of said surgical implement.
However Wiener, in the same filed of endeavor, teaches (fig. 1) a surgical hand instrument comprising: a handle (16+58A; see [0030]); a surgical implement (104A+50A; see [0030]) linked to an actuator (transducer); a damping element (distal most 56A) to damp motion of said surgical implement (see [0040]); said damping element 56A is a shock absorber (silicon can absorb shocks), or a block of elastomer (silicone is an elastomer; see [0040]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lisk to have a silicone absorbing damping element to damp motion of said surgical implement as taught by Wiener, for the purpose of dampening undesirable vibration and isolate the ultrasonic energy from the outer portions of the device (see Wiener [0040]).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Lisk in view of Wiener as applied to claim 4 above, and further in view of Parham et al. (US 20130331872 A1).
Regarding claim 5, Lisk as modified discloses the claimed invention substantially as claimed, as set forth above for claim 4. Lisk as modified is silent regarding a seal in said channel between said surgical implement and said handle.
However Parham, in the same field of endeavor, teaches (fig. 10) a seal 216 in a channel that the surgical instrument 140 is in (see fig. 10 and [0057]), wherein the seal 216 is between said surgical implement and a handle 112 (see fig. 10 and [0116]-[0117]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lisk as modified to have a seal in said channel between said surgical implement and said handle as taught by Parham, for the purpose of preventing fluid from entering within the proximal portion of the handle to protect the transducer from fluid (see Parham [0116]).
Regarding claim 6, Lisk as modified discloses the claimed invention substantially as claimed, as set forth above for claim 5. Lisk as modified further teaches in Wiener said damping element 56A is a shock absorber (silicon can absorb shocks), or a block of elastomer (silicone is an elastomer; see [0040]). See also claim 4 above.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lisk in view of Wiener and Parham as applied to claim 5 above, and further in view of Michelson et al. (US 20220265298 A1).
Regarding claim 7, Lisk as modified discloses the claimed invention substantially as claimed, as set forth above for claim 5. Lisk as modified is silent regarding said actuator is a linear resonant actuator (LRA).
However Michelson, in the same filed of endeavor, teaches, a cutting device for eye surgery comprising an actuator, wherein the actuator is a linear resonant actuator (LRA)(see [0028]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lisk as modified to have said actuator be a linear resonant actuator (LRA) as taught by Michelson, since Michelson teaches a LRA is an alternative to a motor and produced similar frequencies to those in Lisk (see Michelson [0028]).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lisk in view of, Wiener, Parham, and Michelson as applied to claim 7 above, and further in view of Vaitekunas (US 5,449,370).
Regarding claims 8-9, Lisk as modified discloses the claimed invention substantially as claimed, as set forth above for claim 7. Lisk as modified is silent regarding a control circuit connected to said actuator; said control circuit further comprises a feedback controller configured to increase power output in proportion to resistance in movement of said actuator.
However Vaitekunas, in the analogous art of vibrating surgical instruments, teaches a control circuit (see fig. 6 and col. 3 ln. 7-8) connected to an actuator (generator 62, see fig. 6); said control circuit further comprises a feedback controller (feedback mechanism) configured to increase power output in proportion to resistance in movement of said actuator (see col. 2 ln. 41-51 and col. 6 ln. 9-18).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lisk as modified to have a control circuit connected to said actuator; said control circuit further comprises a feedback controller configured to increase power output in proportion to resistance in movement of said actuator as taught by Vaitekunas, for the purpose of being able to adjust the energy level of the vibrating tip in accordance with the load to provide a relatively stable level of energy to the tip (see Vaitekunas col. 2 ln. 41-51).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lisk in view of Wiener, Parham, Michelson and Vaitekunas as applied to claim 9 above, and further in view of Leiderman et al. (US 20220104884 A1).
Regarding claim 10, Lisk as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9. Lisk as modified is silent regarding said control circuit further comprises a haptic driver having closed loop frequency control.
However Leiderman, in the analogous art of vibrating surgical instruments, teaches a control circuit further comprises a haptic driver having closed loop frequency control (see [0009]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lisk as modified to have said control circuit further comprises a haptic driver having closed loop frequency control as taught by Leiderman, for the purpose of providing instrument data in real time without transmitting or processing delays (see Leiderman [0057]).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lisk in view of Peyman (US 20220409362 A1).
Regarding claims 13-14, Lisk discloses the claimed invention substantially as claimed, as set forth above for claim 12. Lisk does not expressly disclose said apparatus is used to separate a lenticule defined by application of femtosecond laser pulses in a refractive lenticule extraction procedure; said lenticule extraction procedure is a small incision lenticule extraction procedure.
However Peyman, in the same filed of endeavor, teaches of an apparatus used to separate a lenticule defined by application of femtosecond laser pulses in a refractive lenticule extraction procedure; said lenticule extraction procedure is a small incision lenticule extraction procedure (see [0560]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lisk to have said apparatus is used to separate a lenticule defined by application of femtosecond laser pulses in a refractive lenticule extraction procedure; said lenticule extraction procedure is a small incision lenticule extraction procedure as taught by Peyman, for the purpose of being able to use the device in addition procedures, such as SMILE (see Peyman [0560]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 12 of U.S. Patent No. 11,642,246 B1. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims of the instant application are in the scope of the claims of 11,642,246 as outlined below:
Claims of 18/717012
Claims of 11,642,246
1
1
2
1
3
1
4
5
11
12
Claim 5-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,642,246 B1 in view of Parham.
Regarding claim 5, claim 5 of U.S. Patent No. 11,642,246 claims the claimed invention substantially as claimed, as set forth above for claim 4. claim 5 of U.S. Patent No. 11,642,246 fails to claim a seal in said channel between said surgical implement and said handle.
However Parham, in the same field of endeavor, teaches (fig. 10) a seal 216 in a channel that the surgical instrument 140 is in (see fig. 10 and [0057]), wherein the seal 216 is between said surgical implement and a handle 112 (see fig. 10 and [0116]-[0117]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify claim 5 of U.S. Patent No. 11,642,246 to have a seal in said channel between said surgical implement and said handle as taught by Parham, for the purpose of preventing fluid from entering within the proximal portion of the handle to protect the transducer from fluid (see Parham [0116]).
Claims 6-10 depend from claim 5 and are further claimed in 11,642,246 as outlined below (note claims 6, 7, 9, and 10 all depend from claim 5 of 11,642,246):
Claims of 18/717012
Claims of 11,642,246
6
7
7
6
8
6
9
9
10
10
Claims 1-3 and 11 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 8, and 11 of U.S. Patent No. 11,540,948 B1. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims of the instant application are in the scope of the claims of 11,540,948 as outlined below:
Claims of 18/717012
Claims of 11,540,948
1
1
2
7
3
8
11
11
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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