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 .
Information Disclosure Statement
The information disclosure statement filed May 8, 2023, fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered:
No copy of EP 2320842 has been provided in the application file for consideration
Claim Objections
Applicant is advised that should claim 4 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Applicant is 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. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 11-12 and 14-15 are objected to because of the following informalities:
In regards to claim 11, line 20, “aspiration channel” should be changed to “the aspiration channel”.
In regards to claim 11, line 13, “the pump” should be changed to “the at least one pump”.
In regards to claim 11, line 14, “irrigation fluid” should be changed to “the irrigation fluid”.
In regards to claim 11, line 21, “a flow” should be changed to “the flow”.
In regards to claim 12, line 30, “coupling” should be changed to “the coupling”.
In regards to claim 14, line 1, “coupling” should be changed to “the coupling”.
In regards to claim 15, line 6, “activating” should be changed to “the activating”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 11-15 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.
In regards to claim 11, line 11 recites “a lens”. Claim 11, line 24 previously recites “lens material”. It is unclear whether the two terms are related or different. Claims 12-15 are rejected by virtue of being dependent upon claim 11.
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 and 4-8 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 and 4-7 below) (Figure 8)
an irrigation tube (portions of Irrigation Line, as defined in dependent claims 2 and 4-7 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), 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)
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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)
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In regards to claim 5, Keh et al teaches wherein the pressure regulator (862) comprises:
a distal port (labeled in second copy of Figure 8 above) coupled with the irrigation conduit (labeled in second copy of Figure 8 above)
a proximal port (labeled in second copy of Figure 8 above) configured to couple with a distal end of the irrigation tube (labeled in second copy of Figure 8 above) such that the pressure regulator regulates the flow between the irrigation conduit and the irrigation tube (Figure 8)
In regards to claim 6, Keh et al teaches wherein the pressure regulator (862) comprises:
a proximal port (labeled in second copy of Figure 8 above) configured to couple with a distal end of the irrigation tube (labeled in second copy of Figure 8 above)
a distal port (labeled in second copy of Figure 8 above) configured to couple with the irrigation conduit (labeled in second copy of Figure 8 above) such that the pressure regulator regulates the flow between the irrigation conduit and the irrigation tube (Figure 8)
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)
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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.
Allowable Subject Matter
Claims 9-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to claim 9, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a system, as claimed, specifically including wherein the pressure regulator is shaped to define: 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 such that, when a pressure within the irrigation-fluid chamber exceeds the threshold pressure, the diaphragm pulls the stopper into the pressure-regulator conduit, thereby slowing the flow of the irrigation fluid.
Keh et al teaches a pressure regulator (862/820).
However, Keh et al is silent about wherein the pressure regulator is shaped to define: 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 such that, when a pressure within the irrigation-fluid chamber exceeds the threshold pressure, the diaphragm pulls the stopper into the pressure-regulator conduit, thereby slowing the flow of the irrigation fluid.
Thus, claim 9 objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim 1. Claim 10 is objected to by virtue of being dependent upon claim 9.
Claims 11-15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
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 a 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 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 lens material from 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 a lens of the eye (paragraph [0039])
activating the pump to aspirate the emulsified lens and 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 a 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 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b), set forth in this Office action. Claims 12-15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b), set forth in this Office action, by virtue of being dependent upon claim 11.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783