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 .
Priority
The instant application/claims are CIP of 17/334795 which is a CIP of 16/505680 which claims priority to provisionally filed 62/696857. A review of the parent applications does not reveal support for independent claim 1’s claim element of e.g. “AI operations”. Thus, the instant claims (only claim 1 is independent and all other claims ultimately depend from claim 1) all have later effective filing date of 12/13/2023. See MPEP 2152.01 “If the application is a continuation-in-part of an earlier U.S. application or international application, any claims in the new application not supported by the specification and claims of the parent application have an effective filing date equal to the actual filing date of the new application… As under pre-AIA law, the effective filing date of a claimed invention is determined on a claim-by-claim basis and not an application-by-application basis. That is, the principle that different claims in the same application may be entitled to different effective filing dates vis-à-vis the prior art remains unchanged by the AIA . See MPEP § 2133.01 for a discussion of relevant pre-AIA case law in the context of continuation-in-part applications.”
MPEP 2133.01: “When applicant files a continuation-in-part application, none of whose claims are supported by the parent application under pre-AIA 35 U.S.C. 112, first paragraph, the effective filing date is the filing date of the child CIP. Any prior art disclosing the invention or an obvious variant thereof having a critical reference date more than 1 year prior to the filing date of the child will bar the issuance of a patent under pre-AIA 35 U.S.C. 102(b). Paperless Accounting v. Bay Area Rapid Transit System, 804 F.2d 659, 665, 231 USPQ 649, 653 (Fed. Cir. 1986).”
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 15 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. Claim 15 recites “The soft-tissue laser coagulation device of Claim 10 and 11,”. See MPEP § 608.01(n). Accordingly, the claim has not been further treated on the merits.
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(s) 1-14, 16-19 is/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.
Claim 1 has a period after “AI operations”. It is unclear and thus indefinite whether the last line recitation of “an optical fiber bundle unit detachably coupled to the laser system.” is part of the claim. Each claim can only be one sentence (see MPEP 608.01(m)) and so a suggested edit is to delete this period and replace with semicolon (“;”).
Claim 3 recites a process step; “wherein the laser system is used to coagulate soft tissue operations digitally, systematically, and automatically in real time during surgery.”. It is improper/indefinite to claim a product and a process of using the product in the same claim; see MPEP 2173.05(p) II.
Claim 3 is a “use” claim without “setting forth any steps involved in the process” and so is indefinite; see MPEP 2173.05(q).
Claim 4 recites a process step; “wherein the laser system is used with a stable surgical platform including in robotic and minimally invasive procedures.”. It is improper/indefinite to claim a product and a process of using the product in the same claim; see MPEP 2173.05(p) II.
Claim 4 is a “use” claim without “setting forth any steps involved in the process” and so is indefinite; see MPEP 2173.05(q).
Claim 5 recites the limitation "the laser system’s coagulation operation" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites a process step; “wherein the laser system's coagulation operation is followed by tissue cutting/ablation using another laser, scalpel or monopolar.”. It is improper/indefinite to claim a product and a process of using the product in the same claim; see MPEP 2173.05(p) II.
Claim 9 recites the limitation "the feedback control algorithm" and “the conductive heat transfer equation” in lines 1-2. There is insufficient antecedent basis for these limitations in the claim.
The terms “significantly reduce” and “an instant in real time” in claim 12 is a relative term which renders the claim indefinite. The terms “significantly reduce” and “an instant in real time is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 14 recites the limitation "the tissue coagulation processes" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the optical fiber bunder unit " in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes below, it will be assumed this is a typo and supposed to be “the optical fiber bundle unit”.
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) 1-11, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuster (US 20210220667 A1; 7/22/2021) in view of Kim (US 20210282856 A1; 9/16/2021).
Regarding claim 1, Schuster teaches a soft-tissue laser coagulation device (Abstract; Fig. 1-2; Fig. 11), comprising:
a laser system comprising (Fig. 1-2; Fig. 10):
a tissue sealing laser configured to emit a laser beam to seal the tissue (instant limitation(s) interpreted in light of instant specification which describes “tissue coagulation…due to tissue sealing laser sealing” in [0072] and [0128]; Schuster Fig. 1-2; Fig. 10-11; [0093] “coagulation of soft tissue”); and
optical sensors to obtain optical feedback signals for detection of tissue conditions and types (Fig. 1-2; Fig. 6; Fig. 8-9A; Fig. 10-11; [0093]-[0094]); and
a microprocessor with control algorithms and Al to control power levels of laser (Fig. 1-3; Fig. 10; [0093]-[0095]; [0108]); and
computer memory units to store laser-tissue interaction data for Al operations ([0108]).
Schuster does not teach an optical fiber bundle unit detachably coupled to the laser system. However, Kim teaches in the same field of endeavor (Abstract; Fig. 10) an optical fiber bundle unit detachably coupled to the laser system ([0089] “bundle”; [0098] “detached”; [0174]; claims 1-2; claim 20). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Schuster to include this feature as taught by Kim because this enables the laser to be single use and disposable for surgical purposes ([0098]).
Regarding claim 2, in the combination of Schuster and Kim, Kim teaches wherein the optical fiber bundle unit comprises:
a fiber optic sheathing coupled to the laser system ([0055]), the fiber optic sheathing containing a number of optical fibers configured to function as a delivery guide for sensor signals and for the laser beam to perform tissue sealing ([0089]; [0130]),
wherein one of the number of optical fibers of the fiber optic sheathing is configured to transmit a reflected laser beam, which is reflected by the tissue, from the tissue to a sensor detector of the laser system ([0089]; [0130]).
Regarding claim 3, in the combination of Schuster and Kim, Schuster teaches wherein the laser system is used to coagulate soft tissue operations digitally, systematically, and automatically in real time during surgery (Fig. 1; Fig. 3; Fig. 10-11; [0093]; [0124]).
Regarding claim 4, in the combination of Schuster and Kim, Schuster teaches wherein the laser system is used with a stable surgical platform including in robotic and minimally invasive procedures (Fig. 1-2).
Regarding claim 5, in the combination of Schuster and Kim, Schuster does not teach wherein the laser system's coagulation operation is followed by tissue cutting/ablation using another laser, scalpel or monopolar. However, Kim teaches in the same field of endeavor (Abstract; Fig. 10) wherein the laser system's coagulation operation is followed by tissue cutting/ablation using another laser, scalpel or monopolar ([0132]; claim 7). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Schuster and Kim to include this feature as taught by Kim because this enables both treatment steps from the same device ([0083]; [0086]; [0132]).
Regarding claim 6, in the combination of Schuster and Kim, Schuster teaches wherein the microprocessor stores control algorithms and Al software ([0095]; [0108]).
Regarding claim 7, in the combination of Schuster and Kim, Schuster teaches wherein the computer memories stores laser-tissue interaction database established from in-vitro and in-vivo laser-thermal operations ([0095]; [0108]).
Regarding claim 8, in the combination of Schuster and Kim, Schuster teaches wherein optical sensors selected provide optical feedback signals necessary for detection of tissue types and conditions during laser-thermal operations (Fig. 1-2; Fig. 6; Fig. 8-9A; Fig. 10-11; [0093]-[0094]; [0108]; [0117]-[0118]).
Regarding claim 9, in the combination of Schuster and Kim, Schuster teaches wherein sensor parameters for the feedback control algorithm are based on the conductive heat transfer equation ([0094]).
Regarding claim 10, in the combination of Schuster and Kim, Schuster teaches wherein the microprocessor, upon firing laser, gathers optical feedback data from optical sensors and references them to laser-tissue interaction data stored in computer memory units and subsequently executes the laser power level accordingly using Al (Fig. 1-2; Fig. 6; Fig. 8-9A; Fig. 10-11; [0093]-[0095]; [0108]; [0117]-[0118]).
Regarding claim 11, in the combination of Schuster and Kim, Schuster does not teach wherein tissue coagulation processes from raw tissue to coagulation takes less than a few seconds in real time during surgery. For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Thus, the combination of Schuster and Kim as cited teaches the instant claim. However, to avoid doubt and for the sake of clarity of the record, Kim teaches in the same field of endeavor (Abstract; Fig. 10) wherein tissue coagulation processes from raw tissue to coagulation takes less than a few seconds in real time during surgery ([0138] “sealing laser can coagulate muscle tissue in 0.5~1 second”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Schuster and Kim to include this feature as taught by Kim because this enables tissue sealing procedure in a time effective manner ([0138]).
Regarding claim 18, in the combination of Schuster and Kim, Schuster teaches wherein the optical sensors comprise one or more of:
a pyrometer configured to detect a tissue temperature via one or more optical fibers of the optical fiber bundle unit,
a depth sensor configured to detect a distance by which a distal end of an optical fiber of the laser beam delivery unit is away from the tissue,
a thermocouple or a resistance temperature detector configured to detect a temperature of a distal end of an optical fiber used in tissue sealing
a photodiode (Fig. 6, camera; Fig. 9A, CMOS; Fig. 18, 212).
Regarding claim 19, in the combination of Schuster and Kim, Kim teaches wherein the optical fiber bundle unit is flexible and disposable (Fig. 1, 70 is depicted as flexible and bent; [0089] “disposable”).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuster and Kim as applied to claim 11 above, and further in view of Arya (US 20160346034 A1; 12/1/2016).
Regarding claim 12, the combination of Schuster and Kim does not teach wherein quantum computing significantly reduce the coagulation processes to an instant in real time during surgery. However, Arya teaches in the same field of endeavor ([013]-[0014]; [0017]) wherein quantum computing ([0046] “quantum computer”) significantly reduce the coagulation processes to an instant in real time during surgery (For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Schuster and Kim to include this feature as taught by Arya because this is a simple substitution of one type of computer with microprocessor/controller ([0046]).
Claim(s) 13, 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuster and Kim as applied to claims 1, 7 above, and further in view of Graham (US 20170325886 A1; 11/16/2017).
Regarding claim 13, the combination of Schuster and Kim does not teach wherein the laser system offers in-surgery biopsy in real time during surgery. However, Graham teaches in the same field of endeavor ([0144]-[0145]) wherein the laser system offers in-surgery biopsy in real time during surgery ([0157] “biopsy”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Schuster and Kim to include this feature as taught by Graham because this enables performing biopsy with the device ([0157]).
Regarding claim 16, in the combination of Schuster and Kim, Schuster teaches wherein the laser-tissue interaction data represent laser-thermal operations of tissue transitioning from raw to coagulation ([0093]-[0094]; [0108]; [0117]-[0118]).
The combination of Schuster and Kim does not teach to cauterization. Note that Schuster does teach “photo thermolysis” which could read on “cauterization” ([0093] “photo thermolysis”). However, to avoid doubt, Graham teaches in the same field of endeavor ([0144]-[0145] “Vaporization” reads on cauterization) wherein the laser-tissue interaction data represent laser-thermal operations of tissue transitioning from raw to coagulation to cauterization ([0144]; Table 1). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Schuster and Kim to include this feature as taught by Graham because this enables more laser treatment settings for the device ([0144]; Table 1).
Regarding claim 17, in the combination of Schuster, Kim, and Graham, Schuster teaches wherein the energy source for laser-thermal operations is from the tissue sealing laser (Fig. 10; [0093]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuster and Kim as applied to claim 1 above, and further in view of Patel (US 20230127514 A1; 4/27/2023).
Regarding claim 14, in the combination of Schuster and Kim, Schuster teaches wherein the tissue coagulation processes are autonomous (Fig. 3; Fig. 10).
The combination of Schuster and Kim does not teach where a time lag is compensated during telesurgery communication. However, Patel teaches in the same field of endeavor (Fig. 1-2; [0040]-[0041]) where a time lag is compensated during telesurgery communication ([0037] “work in concert to perform the operations”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Schuster and Kim to include this feature as taught by Patel because this enables separate devices to work together over computer network including Internet ([0037]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792