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 Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Johnson is not relied upon to disclose the amended limitations of “a lens…positioned near a distal end of the probe” and “the optical fiber is configured to propagate light through a first opening in the lens” and that the pressure sensor is configured to directly sense IOP “through a second opening in at least one of the lens or a side wall of the probe”.
Applicant's arguments filed 11/19/2025 with regards to the rejection of claim 9 over Johnson have been fully considered but they are not persuasive. While Applicant has not provided substantial arguments pertaining to how Johnson does not teach, disclose or suggest the amended limitations of “the pressure sensor configured to…directly sense an IOP…through an opening in the sidewall of the distal end of the instrument”, the Examiner notes that Para. [0038] recites wherein the optical fiber (408) comprises the pressure sensor (412) at the distal end thereof. As shown in Fig. 4B, the distal tip of the optical fiber comprises a cavity (418) cut into the sidewalls of the optical fiber body of the probe which is where the pressure sensor is understood to reside per the disclosure in Para. [0038]). The disclose of Johnson is therefore understood to read on the amended limitations of claim 9, as currently presented.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 9-12 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson (US 2017/0312431 A1)(previously of record).
Regarding claim 9, Johnson discloses:
An instrument for ophthalmic surgery (surgical system 100, see Fig. 1 and including all components shown within Fig. 1 as recited in Para. [0029]), the instrument comprising:
a pressure sensor positioned near a distal end of the instrument (pressure sensor 412, see Figs. 4A-4B and Para. [0029], [0036] and [0038]-[0041]), wherein the pressure sensor is configured to:
be inserted into an intraocular space of an eye (see Para. [0036] and [0041] and Fig. 3), and directly sense an intraocular pressure (IOP) associated with the intraocular space of the eye (see Fig. 3 and Para. [0026], [0036], [0041] and [0058]) through an opening in a sidewall of a distal end of the instrument (see Para. [0038] and Fig. 4B showing wherein the pressure sensor is disposed within the body (408) within a cavity (418) defined within the sidewalls of said body).
Regarding claim 10, Johnson discloses the invention of claim 9, Johnson further discloses a power source coupled to the instrument for providing electrical power to the pressure sensor (see Para. [0030] and [0048]).
Regarding claim 11, Johnson discloses the invention of claim 9, Johnson further discloses wherein the pressure sensor comprises at least one of a microelectromechanical system (MEMS) pressure sensor, a piezoelectric pressure sensor, a potentiometric pressure sensor, an inductive pressure sensor, a strain gauge pressure sensor, and a capacitive pressure sensor (see Para. [0035], [0049] and [0051]).
Regarding claim 12, Johnson discloses the invention of claim 9, Johnson further discloses wherein the pressure sensor is disposed in the opening in the sidewall (see Fig. 4B and Para. [0038] mentioning wherein the pressure sensor is located at/within the distal tip cavity (418) of the optical fiber which may make up the body of the illumination device (112) as discussed in Para. [0041]).
Regarding claim 15, Johnson discloses the invention of claim 9, Johnson further discloses wherein the instrument comprises at least one of a vitrectomy probe, a phacoemulsification probe, a laser probe, a vacuum probe, an endoscopic visualization probe, or an endoilluminator (see Para. [0029]).
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 2017/0312431 A1)(previously of record) in view of Smith (US 2008/0246919 A1).
Regarding claim 1, Johnson discloses:
An endoilluminator (illumination device 112, see Fig. 3 and Para. [0029]), comprising:
a handpiece (see Para. [0029] mentioning2275 wherein a hand piece may be provided for manipulation of the illumination device); and
a probe coupled to a distal end of the handpiece (see Fig. 3 showing a distal probe end of the illumination device (112) that is coupled to the proximal handle, see also Para. [0029] and [0036]), the probe comprising, an optical fiber (see Para. [0041] mentioning wherein the illumination device may consist of an optical fiber as shown in Fig.4B) and a pressure sensor (pressure sensor 412, see Figs. 4A-4B and Para. [0036] and [0039]-[0041]), wherein:
the pressure sensor are positioned near a distal end of the probe (see Fig. 3-4B and Para. [0029] and [0038]-[0041] mentioning wherein the illumination device may consist of an optical fiber as shown in Fig. 4B), the pressure sensor is configured to be inserted into an intraocular space of an eye (see Para. [0036] and [0041] and Fig. 3), and the pressure sensor is configured to directly sense an intraocular pressure (IOP) associated with the intraocular space of the eye (see Fig. 3 and Para. [0026], [0036], [0041] and [0058]) through a second opening in at least one of the lens or a sidewall of the probe (cavity 418, see Fig. 4B).
However, Johnson does not expressly disclose:
wherein the probe comprises a lens positioned near or at the distal end of the probe;
wherein the optical fiber is configured to propagate light through a first opening in the lens; and
In the same field of endeavor, namely endo-illumination probe devices, Smith teaches an endo-illumination probe device (probe 160, see Fig. 8) comprising a light-emitting optical fiber cable (optical fiber 305, see Fig. 3A) disposed within the probe device; wherein the probe may further comprise a lens (lens 310, see Fig. 3A) positioned at the distal end of the optical fiber (see Fig. 3A showing wherein the lens is positioned at the distal end of the optical fiber) in the form of a hybrid, Fresnel-like lens which both refracts and diffracts the light beam passing therethrough which produces a more focused light beam to illuminate the target area (see Para. [0038]-[0040]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the distal end of the illumination device of Johnson to include a hybrid, Fresnel-like lens positioned therein as taught and suggested by Smith to, in this case, both diffract and refract the light beam passing through said beam to produce a more focused area of illumination within the target site (see Smith Para. [0038]-[0040]). The hybrid lens of Smith comprises a plurality of “openings” between adjacent teeth as shown in Smith Fig. 3B that provide the refractive/diffractive qualities.
Regarding claim 2, the combination of Johnson and Smith discloses the invention of claim 1, Johnson further discloses wherein the pressure sensor comprises at least one of a microelectromechanical system (MEMS) pressure sensor, a piezoelectric pressure sensor, a potentiometric pressure sensor, an inductive pressure sensor, a strain gauge pressure sensor, and a capacitive pressure sensor (see Para. [0035], [0049] and [0051]).
Regarding claim 3, the combination of Johnson and Smith discloses the invention of claim 1, Johnson further discloses wherein the second opening is disposed in the sidewall of the probe adjacent the distal end (see Fig. 4B showing wherein the cavity (418) is disposed within and between the sidewalls of the probe body adjacent the distal-most end thereof).
Regarding claim 4, the combination of Johnson and Smith discloses the invention of claim 3, Johnson further discloses wherein the pressure sensor is disposed in the second opening (see Para. [0038] and Fig. 4B showing wherein the pressure sensor (412) is located within the distal end of the probe body).
Regarding claim 5, the combination of Johnson and Smith disclose the invention of claim 1, Johnson, as modified by Smith, further disclose wherein the second opening is in the lens (see Smith Fig. 3B showing a plurality of openings within the hybrid lens, as incorporated into the device of Johnson, between adjacent tooth members).
Regarding claim 6, the combination of Johnson and Smith discloses the invention of claim 1, Johnson further discloses wherein the pressure sensor is coupled to one or more electrical wires running substantially along a longitudinal direction of the optical fiber in the probe (see Para. [0030]-[0031] and [0035]).
Regarding claim 7, the combination of Johnson and Smith discloses the invention of claim 1, Johnson further discloses wherein the endoilluminator is coupled to a light source configured to drive light into the optical fiber (see Para. [0029]-[0031]).
Regarding claim 8, the combination of Johnson and Smith discloses the invention of claim 1, Johnson further discloses wherein the endoilluminator is coupled to a surgical console (console 102, see Fig. 1) providing electrical power to the pressure sensor (see Para. [0028]-[0031]).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 2017/0312431 A1)(previously of record) in view of Mathias (US 2025/0025334 A1)(previously of record), considered prior art due to a provisional patent application filed 10/4/2021.
Regarding claim 13, Johnson discloses all of the limitations of the invention of claim 9.
However, while Johnson discloses wherein the disclosed probe device(s) can represent any number of surgical instruments or devices including vitrectomy probes, illumination probes, aspiration probes, phacoemulsification probes, etc. (see Para. [0029]), Johnson does not expressly disclose wherein the instrument comprises at least one of a pair of forceps, a spatula, a hook, or a depressor.
However, in the same field of endeavor, namely surgical instruments and methods for performing vitrectomy procedures, Mathias teaches wherein, in performing a vitrectomy procedure (see Para. [0090]), it is common practice to include a pair of forceps (406, see Para. [0089]-[0090] and Fig. 4A) to allow for grasping of tissue and manipulation within the subretinal space (see Para. [0090]) and a micro vitreoretinal blade (see Para. [0090]) to make an incision within the eye to perform operations therein (see Para. [0090]) in performing said vitrectomy procedure.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the surgical system probes of Johnson to include a pair of forceps as a component thereof as taught and suggested by Mathias to, in this case, be used in the disclosed vitrectomy procedure to allow a user to grasp and manipulate tissue within the subretinal space (see Mathias Para. [0090]).
Regarding claim 14, Johnson discloses all of the limitations of the invention of claim 9.
However, while Johnson discloses wherein the disclosed probe device(s) can represent any number of surgical instruments or devices including vitrectomy probes, illumination probes, aspiration probes, phacoemulsification probes, etc. (see Para. [0029]), Johnson does not expressly disclose wherein the instrument comprises at least one of a pair of scissors or a knife.
However, in the same field of endeavor, namely surgical instruments and methods for performing vitrectomy procedures, Mathias teaches wherein, in performing a vitrectomy procedure (see Para. [0090]), it is common practice to include a pair of forceps (406, see Para. [0089]-[0090] and Fig. 4A) to allow for grasping of tissue and manipulation within the subretinal space (see Para. [0090]) and a micro vitreoretinal blade (see Para. [0090]) to make an incision within the eye to perform operations therein (see Para. [0090]) in performing said vitrectomy procedure.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the surgical system probes of Johnson to include a micro vitreoretinal blade as a component thereof as taught and suggested by Mathias to, in this case, be used in the disclosed vitrectomy procedure to allow a user to make an incision within the patient’s eye to insert instruments for manipulation of tissue therein (see Mathias Para. [0090]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2026/0014023 A1 to Hallen, US 2012/0310146 A1 to Easley, US 2011/0144745 A1 to Martin, US 2009/0182313 A1 to Auld, US 2005/0078910 A1 Hickingbotham, US 2023/0285108 A1 to Scheller, US 2015/0148711 A1 to Bujak, US 2008/0177257 A1 to Smith, US 2011/0132086 A1 to Wang, US 2021/0052152 A1 to Ochi, US 2018/0344153 A1 to Svetliza, US 2018/0084986 A1 to Ochi and US 2019/0274546 A1 to Elsheikh all disclose surgical endo-illumination probes comprising a lens at the distal end of an optical fiber for either focusing or dispersing a light beam to aid in viewing of a surgical site.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771