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 .
Acknowledgments
In the reply, filed on February 17, 2026, Applicant amended claims 1, 11-12, and 14-15.
Applicant cancelled claims 5-6.
In the non-final rejection of November 21, 2025, Examiner noted that the information disclosure statement filed May 8, 2023, fails to comply with 37 CFR 1.98(a)(2). Applicant submitted a copy of EP 2320842. Concern is withdrawn.
Examiner advised that should claim 4 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Applicant cancelled claim 6. Concern is withdrawn.
Examiner objected to claims 11-12 and 14-15. Applicant amended claims 11-12 and 14-15. Objection is withdrawn.
Examiner rejected claims 11-15 under 35 U.S.C. 112(b). Applicant amended claim 11. Rejection is withdrawn.
Claim Objections
Claim 11 is objected to because of the following informalities:
In regards to claim 11, line 23, “the the material” should be changed to “the material”.
Appropriate correction is required.
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 1-4 and 7-10 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.
In regards to claim 1, line 6 recites: a pressure regulator “located within the irrigation conduit, within the irrigation tube”; however, such is new matter not described in the Specification. Claims 2-4 and 7-10 are rejected by virtue of being dependent upon claim 1.
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 1-2, 4, and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keh et al (US 2019/0099546).
In regards to claim 1, Keh et al teaches a system (Figure 8), comprising:
an ocular surgical handpiece (20) comprising an irrigation conduit (portions of 20 and/or Irrigation Line, as defined in dependent claims 2, 4, and 7 below) (Figure 8)
an irrigation tube (portions of Irrigation Line, as defined in dependent claims 2, 4, and 7 below) (Figure 8), configured to establish fluidic communication between a supply of irrigation fluid (30) and the irrigation conduit, such that the irrigation fluid flows distally from the supply, via the irrigation tube and the irrigation conduit, to an eye (10) of a patient (Figure 8)
a pressure regulator (862/820) located within the irrigation conduit, within the irrigation tube, or between the irrigation conduit and the irrigation tube (Figure 8), and configured to regulate an intraocular pressure of the eye by regulating the flow of the irrigation fluid within the irrigation conduit, within the irrigation tube, or between the irrigation conduit and the irrigation tube (Figure 8)
In regards to claim 2, Keh et al teaches wherein the irrigation tube comprises:
a proximal segment (labeled in Figure 8 below)
a distal segment (labeled in Figure 8 below), configured to couple with the irrigation conduit (20)
wherein the pressure regulator (862) is coupled with the irrigation tube between the proximal segment and the distal segment such that the pressure regulator regulates the flow within the irrigation tube (Figure 8)
PNG
media_image1.png
727
704
media_image1.png
Greyscale
In regards to claim 4, Keh et al teaches wherein the pressure regulator (862) comprises:
a proximal port (labeled in Figure 8 below) coupled with a distal end of the irrigation tube (labeled in Figure 8 below)
a distal port (labeled in Figure 8 below) configured to couple with the irrigation conduit (labeled in Figure 8 below) such that the pressure regulator regulates the flow between the irrigation conduit and the irrigation tube (Figure 8 below)
PNG
media_image2.png
666
838
media_image2.png
Greyscale
In regards to claim 7, Keh et al teaches wherein the irrigation conduit comprises:
a proximal segment (labeled in Figure 8 below), configured to couple with the irrigation tube (labeled in Figure 8 below)
a distal segment (labeled in Figure 8 below)
wherein the pressure regulator (862) is coupled with the irrigation conduit between the proximal segment and the distal segment such that the pressure regulator regulates the flow within the irrigation conduit (Figure 8)
PNG
media_image3.png
722
703
media_image3.png
Greyscale
In regards to claim 8, Keh et al teaches wherein the ocular surgical handpiece is a phacoemulsification handpiece (20) (paragraph [0023])(Figure 8).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Keh et al, as applied to claim 2 above.
In regards to claim 3, Keh et al is silent about wherein a length of the distal segment is less than 10 cm. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify a length of the distal segment, of the system of Keh et al, to be less than 10 cm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the system of Keh et al would not operate differently with the claimed length of the distal segment. Further, it appears that Applicant places no criticality on the range claimed for the length of the distal segment.
Response to Arguments
Applicant's arguments filed February 17, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: Claim 1, as amended recites in part: "a pressure regulator located within the irrigation conduit, within the irrigation tube, or between the irrigation conduit and the irrigation tube, and configured to regulate an intraocular pressure of the eye by regulating the flow of the irrigation fluid within the irrigation conduit, within the irrigation tube, or between the irrigation conduit and the irrigation tube. " Keh does not disclose or suggest these features. Keh describes a pressure sensor 862 located in an irrigation line. (FIG. 8) The sensor 862 is not a regulator. The regulator 820 of Keh controls the pressure in irrigation supply 30 and is located on or in the irrigation supply per FIG. 8. Keh describes the function of the pressure regulator 820 as follows: "pressure regulator 820 [[to]] vent[s] excess pressure until the irrigation pressure is substantially equal to the desired pressure. If, for example, the irrigation pressure measurement is lower than the desired pressure, then the algorithm may increase the irrigation pressure by commanding the pressure regulator 820 to increase pressure until the irrigation pressure is substantially equal to the desired pressure." 1[0085] Thus, not only is the pressure regulator of Keh not located as stated in claim 1, but it does not function by regulating the flow of the irrigation fluid within the irrigation conduit, within the irrigation tube, or between the irrigation conduit and the irrigation tube (Remarks and Arguments, pages 7-8). Examiner disagrees. A pressure regulator is known in the art to have a sensing element (https://www.beswick.com/resources/the-basics-of-pressure-regulators/)(https://automationforum.co/what-is-a-pressure-regulator-and-how-does-it-work/#htoc-what-is-a-pressure-regulator). Thus, pressure sensor 862 of Keh et al is a component of a pressure regulator 862/820 and is located at least between the irrigation conduit and the irrigation tube (Figure 8, as defined in dependent claim 4).
Allowable Subject Matter
Claims 11-15 are allowed.
In regards to claim 11, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a method for controlling intraocular pressure, as claimed, specifically including wherein the pressure regulator comprises a pressure-regulator conduit, through which the irrigation fluid flows, an irrigation-fluid chamber in fluidic communication with the pressure-regulator conduit, and a control chamber, configured to contain a gas at a predefined threshold pressure, and wherein the pressure regulator comprises a diaphragm disposed between the irrigation-fluid chamber and the control chamber at a position that varies with a pressure differential between the control chamber and the irrigation-fluid chamber, a stopper, and a shaft that couples the stopper with the diaphragm; and wherein, when a pressure within the irrigation-fluid chamber exceeds the threshold pressure, the diaphragm pulls the stopper into the pressure-regulator conduit via the shaft, thereby slowing the flow of the irrigation fluid and regulating the intraocular pressure of the eye by regulating the flow of the irrigation fluid within the irrigation conduit, within the irrigation tube, or between the irrigation conduit and the irrigation tube.
Keh et al teaches a method for controlling intraocular pressure, the method comprising:
providing a surgical system (Figure 8) comprising:
an ocular surgical handpiece (20) having an irrigation conduit (within 20) and an aspiration channel (within 20)
an irrigation tube (Irrigation Line) and an aspiration tube (Aspiration Line), wherein the irrigation tube and the aspiration tube are each coupled with a proximal end of the ocular surgical handpiece and coupled with the irrigation conduit and the aspiration channel, respectively (Figure 8)
at least one pump (810) coupled with the ocular surgical handpiece via the aspiration tube and configured to aspirate irrigation fluid and material from a lens of an eye (10)
coupling a proximal end of the irrigation tube with a supply (30) of the irrigation fluid, thereby establishing fluidic communication between the supply and the irrigation conduit such that the irrigation fluid flows distally from the supply to the eye, via the irrigation tube (Figure 8)
coupling a pressure regulator (862/820) with the irrigation conduit or the irrigation tube (Figure 8)
supplying the irrigation fluid to the eye (paragraph [0036])
activating the ocular surgical handpiece to emulsify the lens of the eye (paragraph [0039])
activating the at least one pump to aspirate the material from the lens and the irrigation fluid (paragraph [0038])
providing the threshold pressure to the pressure regulator (paragraph [0085])
However, Keh et al is silent about wherein the pressure regulator comprises a pressure-regulator conduit, through which the irrigation fluid flows, an irrigation-fluid chamber in fluidic communication with the pressure-regulator conduit, and a control chamber, configured to contain a gas at a predefined threshold pressure, and wherein the pressure regulator comprises a diaphragm disposed between the irrigation-fluid chamber and the control chamber at a position that varies with a pressure differential between the control chamber and the irrigation-fluid chamber, a stopper, and a shaft that couples the stopper with the diaphragm; and wherein, when a pressure within the irrigation-fluid chamber exceeds the threshold pressure, the diaphragm pulls the stopper into the pressure-regulator conduit via the shaft, thereby slowing the flow of the irrigation fluid and regulating the intraocular pressure of the eye by regulating the flow of the irrigation fluid within the irrigation conduit, within the irrigation tube, or between the irrigation conduit and the irrigation tube.
Thus, claim 11 is allowed. Claims 12-15 are allowed by virtue of being dependent upon claim 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 SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
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, Kevin C Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
Prosecution Insights