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 .
In view of the appeal brief filed on January 9, 2025 PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/REBECCA E EISENBERG/ Supervisory Patent Examiner, Art Unit 3781
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.
Claim 14 is 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.
Claim 14 calls for “… wherein the first electrode and the second electrode are positioned outside of the ophthalmic instrument.” This language is ambiguous since parent claim 6 describes “… an aspiration path through which a plurality of aspirated materials flow … wherein the first electrode and the second electrode are positioned opposite each other in the aspiration path …” Arranging an aspiration path inside the instrument suggests that the path comprises an internal passage or lumen. Placing the two electrodes both inside the path and outside the instrument appear mutually exclusive and contradictory.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-2, 4-7, 11, 13-19 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Heeren; Tammo (US 20150173948 A1) in view of Huiszoon; Ryan et al. (US 20190060556 A1).
Regarding claims 1 and 6, Heeren discloses a system for identifying material aspirated during an ophthalmic procedure (¶ [0001], vitrectomy probes, systems, and methods; ¶ [0006], [0022] FIG. 1 illustrates a vitrectomy surgical system 100);
the system comprising: an ophthalmic instrument for performing an ophthalmic procedure, the ophthalmic instrument comprising an aspiration path through which a plurality of aspirated materials flow away from an eye during the ophthalmic procedure (¶ [0030] FIG. 2 shows a cross-sectional view of the vitrectomy probe system 110 … As can be seen, the cutter 210 extends distally from a distal end 215 of the housing 230 and includes a distal portion 216; ¶ [0031] FIG. 3 … The distal portion 216 includes an outer port 302 in the outer cutting tube 212 that receives tissue, such as ophthalmic tissue, during use … The inner cutting tube 214 is located within an inner channel 306 of the outer cutting tube 212 … The inner cutting tube 214 has an inner bore 308); and
a circuit comprising: an electrode; wherein the electrode is positioned in the aspiration path such that each aspirated material of the plurality of aspirated materials contacts the electrode when the aspirated material flows away from the eye (¶ [0023] The console 102 further includes one or more processors 114 in communication with a memory 116 … these features may facilitate the monitoring, data processing, and control for one or more tissue sensors 150 disposed on the probe system 110; ¶ [0041] In other embodiments, as shown in FIG. 4, a tissue sensor 150' may be positioned on an outer surface 240 of an inner cutting tube 214' … Thus, the sensor 150' can measure characteristics of the tissue aspirated into the outer bore 302'); and
an alternating current impedance measuring component connected to the electrode (¶ [0029], the data transmission module 118 may be activated to communicate the sensed data from the sensor 150);
wherein, for each aspirated material of the plurality of aspirated materials, the alternating current impedance measuring component is configured to: measure an impedance of the aspirated material near the electrode as the aspirated material contacts the electrode (¶ [0038], Other tissue characteristics that may be sensed by the tissue sensor 150 include … the electrical impedance, and/or indicators of the structural composition (e.g., layered or anamorphic) of the tissue); and
identify the aspirated material based on the measured impedance (¶ [0041] In other embodiments, as shown in FIG. 4 … Thus, the sensor 150' can measure characteristics of the tissue aspirated into the outer bore 302').
Heeren does not explicitly disclose first and second electrodes. Huiszoon discloses a system for detecting and/or treating bacterial biofilms (¶ [0002], [0024], [0027] Referring to FIG. 1 … system 100; ¶ [0076] FIGS. 9A-9C … urinary catheter 906);
the system comprising: a path through which a plurality of materials flow away from a patient (¶ [0076], The catheter 906 also has tubing with an inner volume 906b defined by sidewall 906a that extends through the patient's urethra 904 into the bladder 902 and terminates at end 906c with fluidic inlets/outlets); and
a circuit comprising: a first electrode and a second electrode; wherein the first electrode and the second electrode are positioned opposite each other in the path such that each material of the plurality of materials flows between and contacts the first electrode and the second electrode when the material flows away from the patient (¶ [0052] Referring to FIGS. 3A-3B … The device 300 includes an array 306 of interdigitated electrodes 306a, 306b on a substrate 302; ¶ [0077] A detection and treatment device 910 includes an array of interdigitated electrodes 916a, 916b formed on a flexible substrate 912, which may be disposed on an inner surface of catheter sidewall 906a); and
an alternating current impedance measuring component connected to the first electrode and the second electrode (¶ [0031], In response to commands from the controller 112, the voltage source 110 may apply the detection voltage to the electrodes 104, 106 and measure impedance between the electrodes 104, 106; ¶ [0060], FIG. 5B … employing an impedance converter (e.g., AD5933 impedance converter) as the voltage source instead of a potentiostat);
wherein, for each material of the plurality of materials, the alternating current impedance measuring component is configured to: measure an impedance of the material between the first electrode and the second electrode as the material flows between and contacts the first electrode and the second electrode; and identify the material based on the measured impedance (¶ [0031], In response to commands from the controller 112, the voltage source 110 may apply the detection voltage to the electrodes 104, 106 and measure impedance between the electrodes 104, 106; ¶ [0037], Thus, impedance detection of biofilm growth using electrodes 104, 106 can be used to provide feedback; ¶ [0047] Alternatively or additionally, the detected impedance can be compared at 208 … Decrease of the current impedance value as compared to the previous impedance values may be indicative of an increase in size of the bacteria cultures and/or the formation/growth of bacterial biofilm).
Huiszoon shows that measuring impedance requires a pair of electrodes, and demonstrates how to arrange electrodes in a catheter flow path. Huiszoon also demonstrates how to measure impedance with a commercially available integrated circuit (¶ [0060] an impedance converter (e.g., AD5933 impedance converter) as the voltage source). Heeren calls for measuring impedance, which relates inherently to AC or a time-varying signal (¶ [0038], Other tissue characteristics that may be sensed … the amount of reflectivity, the electrical impedance). This implies a need to establish a path through the target material, such as with a pair of electrodes.
A skilled artisan would have been able to modify Heeren with Huiszoon’s electrode pair by implementing Heeren’s tissue sensor 150' as a pair of electrodes, and optionally connecting them to an AD5933 chip. One would be motivated to modify Heeren with Huiszoon’s paired electrodes since Heeren is otherwise silent regarding how the tissue sensor 150' measures impedance. Therefore, it would have been obvious to modify Heeren with Huiszoon’s paired electrodes in order to measure impedance with electrodes suitable for a catheter.
Regarding claim 16, Heeren discloses a method of identifying material aspirated during an ophthalmic procedure (¶ [0001], vitrectomy probes, systems, and methods; ¶ [0006], [0022] FIG. 1 illustrates a vitrectomy surgical system 100);
the method comprising: aspirating material from an eye through an aspiration path (¶ [0031] FIG. 3 … The distal portion 216 includes an outer port 302 in the outer cutting tube 212 that receives tissue, such as ophthalmic tissue, during use … The inner cutting tube 214 is located within an inner channel 306 of the outer cutting tube 212 … The inner cutting tube 214 has an inner bore 308; ¶ [0032] The inner bore 308 is in fluid communication with an aspiration line (not shown in FIGS. 2 and 3) coupled to the suction port 234 of FIG. 2; ¶ [0033], The severed tissue is pulled through the inner bore 308 of the inner cutting tube 214 by the aspiration system);
wherein a plurality of aspirated materials contact an electrode positioned in the aspiration path (¶ [0023] The console 102 further includes one or more processors 114 in communication with a memory 116 … these features may facilitate the monitoring, data processing, and control for one or more tissue sensors 150 disposed on the probe system 110; ¶ [0041] In other embodiments, as shown in FIG. 4, a tissue sensor 150' may be positioned on an outer surface 240 of an inner cutting tube 214' … Thus, the sensor 150' can measure characteristics of the tissue aspirated into the outer bore 302'); and
measuring, for each aspirated material of the plurality of aspirated materials, an alternating current impedance of the aspirated material against the electrode as the aspirated material contacts the electrode (¶ [0029], the data transmission module 118 may be activated to communicate the sensed data from the sensor 150; ¶ [0038], Other tissue characteristics that may be sensed by the tissue sensor 150 include … the electrical impedance, and/or indicators of the structural composition (e.g., layered or anamorphic) of the tissue).
Heeren does not explicitly disclose that the sensor 150’ comprises first and second electrodes. Huiszoon discloses a method (¶ [0005],The method further includes, during a first time period, measuring a first impedance value; ¶ [0026], the disclosed systems, methods, and devices; ¶ [0027] Referring to FIG. 1 … a system 100; ¶ [0076] FIGS. 9A-9C … urinary catheter 906);
comprising: draining material through a path (¶ [0076], The catheter 906 also has tubing with an inner volume 906b defined by sidewall 906a that extends through the patient's urethra 904 into the bladder 902 and terminates at end 906c with fluidic inlets/outlets);
wherein a plurality of materials flow between and contact a first electrode and a second electrode positioned opposite each other in the path (¶ [0052] Referring to FIGS. 3A-3B … The device 300 includes an array 306 of interdigitated electrodes 306a, 306b on a substrate 302; ¶ [0077] A detection and treatment device 910 includes an array of interdigitated electrodes 916a, 916b formed on a flexible substrate 912, which may be disposed on an inner surface of catheter sidewall 906a); and
measuring, for each material of the plurality of materials, an alternating current impedance of the material between the first electrode and the second electrode as the material flows between and contacts the first electrode and the second electrode (¶ [0031], In response to commands from the controller 112, the voltage source 110 may apply the detection voltage to the electrodes 104, 106 and measure impedance between the electrodes 104, 106; ¶ [0037], Thus, impedance detection of biofilm growth using electrodes 104, 106 can be used to provide feedback; ¶ [0047] Alternatively or additionally, the detected impedance can be compared at 208 … Decrease of the current impedance value as compared to the previous impedance values may be indicative of an increase in size of the bacteria cultures and/or the formation/growth of bacterial biofilm).
Huiszoon demonstrates how to arrange electrodes inside a catheter flow path and also measures impedance with a commercially available integrated circuit. Regarding the rationale and motivation to modify Heeren with Huiszoon’s paired electrodes, see the discussion of claims 1 and 6 above.
Regarding claims 2, 4, 15, 17, and 18, Heeren does not explicitly disclose a pair of electrodes. Huiszoon discloses a system and method wherein the first electrode comprises a first flat plate and the second electrode comprises a second flat plate parallel to the first flat plate (¶ [0052] Referring to FIGS. 3A-3B … the electrodes can be formed of gold (with an adhesion layer of 20 nm of chromium between the substrate 302 and the electrodes 306a, 306b) having a height (h) of 200 nm, a width (w) of 300 μm, a length (1) less than 9 mm, and a gap (g) between adjacent electrodes of 300 μm; ¶ [0077] A detection and treatment device 910 includes an array of interdigitated electrodes 916a, 916b formed on a flexible substrate 912, which may be disposed on an inner surface of catheter sidewall 906a);
wherein the circuit is configured to supply alternating current through the first and second electrodes (¶ [0030], For example, the voltage source 110 can apply an AC voltage, or an AC voltage with a DC offset, between the electrodes 104, 106; ¶ [0044] The process 200 can proceed to 206, where a first voltage (V.sub.1) is applied … the first voltage may be an AC voltage signal);
wherein the first electrode and the second electrode are positioned inside of a tube (¶ [0077] A detection and treatment device 910 includes an array of interdigitated electrodes 916a, 916b formed on a flexible substrate 912, which may be disposed on an inner surface of catheter sidewall 906a);
further comprising, for each aspirated material of the plurality of aspirated materials, identifying the material between the first electrode and the second electrode based upon the measured alternating current impedance; wherein measuring the alternating current impedance of the material between the first electrode and the second electrode comprises supplying alternating current through the first and second electrodes (¶ [0031], In response to commands from the controller 112, the voltage source 110 may apply the detection voltage to the electrodes 104, 106 and measure impedance between the electrodes 104, 106; ¶ [0060], FIG. 5B … employing an impedance converter (e.g., AD5933 impedance converter) as the voltage source instead of a potentiostat).
Huiszoon measures impedance inside a lumen with a commercially available chip, and demonstrates how to arrange electrodes inside the lumen. Regarding the rationale and motivation to modify Heeren with Huiszoon’s electrode configuration, see the discussion of claims 1 and 6 above.
Regarding claims 5 and 21, Heeren and Huiszoon do not explicitly disclose a frequency from 200 kHz to 5 MHz or a two volt peak-to-peak signal.
The signal frequency and amplitude are interpreted as result-effective variables, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The signal frequency and amplitude can be adjusted to target specific tissues through routine experimentation. For example, Huiszoon suggests general ranges for the signal’s frequency and amplitude (¶ [0044], For example, the first voltage may be an AC voltage signal with an amplitude of 100 mV or less (for example, 50 mV or less, e.g., 5 mV) and a frequency of 2 kHz or less (for example, 100 Hz); ¶ [0046], The AC signal for the second voltage can have a frequency on the order of that of the first voltage (e.g., both at 100 Hz) or at a frequency higher than that of the first voltage (e.g., 1 MHz when the first voltage is at 100 Hz); ¶ [0058] As the biofilm grows, impedance between electrodes of the array 306 decreases in a frequency-dependent manner, which decrease may be attributed to changes in double-layer capacitance under 5 kHz. For example, a frequency of 100 Hz may be used for the detecting voltage between electrodes in order to maximize, or at least increase, signal-to-noise ratio).
Voltage too low
Tissues will attenuate the signal below a detectable level
Optimized range
Tissue will attenuate the incoming signal according to its composition, which can be measured in order to identify the tissue
Voltage too high
Electrodes will deliver too much energy to tissue and ablate the tissue or cause damage
Regarding the optimal frequency range, different tissues exhibit different frequency responses based on their composition. A skilled artisan would have been able to modify Heeren and Huiszoon by selecting a frequency range that corresponds to ocular tissues.
Therefore, it would have been obvious to adjust the frequency and amplitude in order to detect specific tissues and to avoid damaging adjacent tissues. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 7, 11, 13, 22 and 23, Heeren discloses a system for identifying material aspirated during an ophthalmic procedure as in claim 6, wherein the ophthalmic instrument comprises a vitrectomy instrument or an aspirating handpiece (¶ [0008] In an additional exemplary aspect, the present disclosure is directed to a vitrectomy surgical system including a vitrectomy probe; ¶ [0022], The surgical system 100 includes a vitrectomy probe system 110; ¶ [0030] FIG. 2 shows a cross-sectional view of the vitrectomy probe system 110; ¶ [0032] The inner bore 308 is in fluid communication with an aspiration);
wherein the electrode is part of the ophthalmic instrument (¶ [0041] In other embodiments, as shown in FIG. 4, a tissue sensor 150' may be positioned on an outer surface 240 of an inner cutting tube 214');
wherein the alternating current impedance measuring component is configured to distinguish the plurality of aspirated materials based on differences in the measured impedance (¶ [0038], Other tissue characteristics that may be sensed by the tissue sensor 150 include … the electrical impedance, and/or indicators of the structural composition (e.g., layered or anamorphic) of the tissue; ¶ [0041] In other embodiments, as shown in FIG. 4 … Thus, the sensor 150' can measure characteristics of the tissue aspirated into the outer bore 302');
wherein the plurality of aspirated materials are selected from the group consisting of: vitreous, BSS, lens material, oil, water, and air (¶ [0003], Vitreous humor and/or membranes are aspirated into the open port, and the inner member is actuated, closing the port … and the cut tissue is then aspirated away through the inner cutting member; ¶ [0021], the systems and methods described herein minimize the risk of inadvertently aspirating and cutting retinal tissue during removal of the vitreous; ¶ [0051], the surgeon cuts and aspirates away vitreous using the vitrectomy probe 110 to gain access to the area of interest).
Regarding claim 14, Heeren discloses that the electrode is positioned outside of the ophthalmic instrument (¶ [0023] The console 102 further includes one or more processors 114 in communication with a memory 116 … these features may facilitate the monitoring, data processing, and control for one or more tissue sensors 150 disposed on the probe system 110).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Heeren and Huiszoon in view of Ianchulev; Pravoslava (US 20140194859 A1).
Regarding claims 8-10, Heeren and Huiszoon do not explicitly disclose an ultrasonic, phacofragmentation or phacoemulsification handpiece. Ianchulev discloses a system for performing an ophthalmic procedure including an ophthalmic instrument comprising an ultrasonic handpiece, phacoemulsification handpiece or phacofragmentation handpiece (¶ [0075], One of the openings is for a phacoemulsification device as well for irrigation and aspiration; ¶ [0083], The instruments disclosed herein include one or more probes such as a phaco fragmentation probe, an irrigation probe, an aspiration probe and a capsule polishing probe, or any combination of these probes; ¶ [0085], In one aspect, the tip 1116 also includes phacoemulsification (phaco) capability in which the tool 1110 includes an ultrasonic feature … Tool 1118 can also be utilized for phacoemulsification; ¶ [0102] FIG. 19 illustrates the robotic control of this embodiment … The tip portion of the instrument 1100 … can be used including, but not limited to, a phaco fragmentation probe, an irrigation probe, an aspiration probe, and a capsule polishing probe).
Ianchulev incorporates common ophthalmic surgery tools into an aspiration handpiece. One would be motivated to modify Heeren and Huiszoon with Ianchulev’s ultrasonic, phacoemulsification or phacofragmentation features to perform other surgical tasks during an operation. Therefore, it would have been obvious to modify Heeren and Huiszoon with Ianchulev’s ultrasonic, phacoemulsification or phacofragmentation features in order to perform multiple surgical tasks during a single operation.
Response To Arguments
Applicant' s arguments filed 09 January 2025 regarding the rejection of claims 1-2, 4-11, 13-19 and 21-23, under 35 USC § 103 over Heeren, Ørntoft, Kovalcheck, Prats, Chon and Khatchatrian, have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 103 over Heeren, Huiszoon and Ianchulev (see above).
Applicant' s arguments regarding Ørntoft, Kovalcheck, Prats, Chon and Khatchatrian have been considered but are moot because the references are no longer cited in the current rejection.
Applicant submits that more specifically, the Examiner has not factually demonstrated that the two electrodes of Orntoft "are positioned in the aspiration path such that each aspirated material of the plurality of aspirated materials flows between and contacts the first electrode and the second electrode when the aspirated material flows away from the eye," as required by claim 1 (App. Br. p. 9).
Applicant asserts that however, the Examiner has not supplied any disclosure of measuring impedance "for each aspirated material of a plurality of aspirated materials...as the aspirated material flows between and contacts the first electrode and the second electrode," as required by claim 1 (App. Br. p. 10).
Examiner responds that Huiszoon is cited in the new grounds of rejection as teaching a pair of electrodes which are exposed to materials flowing through a lumen. Huiszoon discloses interdigitated electrodes which are arranged inside a catheter lumen (¶ [0052] interdigitated electrodes 306a, 306b; ¶ [0077], interdigitated electrodes 916a, 916b).
Applicant contends that in similar fashion, the Examiner has not supplied any alleged disclosure of configuration to "identify the aspirated material based on the measured impedance," as set forth in claim 1 (App. Br. p. 10). Examiner replies that Heeren is cited as identifying materials based on their impedance. Heeren explicitly discloses that the system senses the material’s impedance as a way to identify the material (¶ [0038], The tissue sensor 150 comprises any type of sensor … to determine whether the tissue is a target tissue or a non-target tissue … Other tissue characteristics that may be sensed by the tissue sensor 150 include, by way of non-limiting example, the amount of reflectivity, the electrical impedance).
Applicant submits that the Examiner has not demonstrated that "the first electrode and the second electrode are positioned inside of an aspiration tube," as required by claim 15 (App. Br. p. 13). Examiner responds that Huiszoon is cited in the new grounds of rejection as teaching paired electrodes positioned inside of a tube (¶ [0077] A detection and treatment device 910 includes an array of interdigitated electrodes 916a, 916b … on an inner surface of catheter sidewall 906a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mora Lopez Carolina EP 4610344 A1
Pearson, Robert M. et al. US 20030130711 A1
Kassab, Ghassan S. US 20050203434 A1
Abboud; Marwan et al. US 20070255162 A1
Gelbart; Daniel et al. US 20090192441 A1
Kaushal; Shalesh et al. US 20100063498 A1
Almasri; Mahmoud et al. US 20160299138 A1
Myers; Amanda et al. US 20160338639 A1
Wang; Xiaobo et al. US 20180246079 A1
Lopez; Carolina Mora US 20200018742 A1
Ashida; Nobuyuki US 20200166472 A1
Li; Nan et al. US 20210364494 A1
Examiner has applied new grounds of rejection not necessitated by amendment. Therefore, the finality of the previous Office Action applied 16 August 2024 is withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Tel 571-272-2590
Fax 571-273-2590
Email Adam.Marcetich@uspto.gov
The Examiner can be reached 8am-4pm Mon-Fri.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application is assigned is 571-273-8300.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights