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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 5-19) in the reply filed on 3/30/2026 is acknowledged. Claims 1-4 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Interpretation
For clarity, the currently pending claims (5-19), do not require an “associated light source” or a “source-side coupler”, as these elements are part of a functional limitation. MPEP 2114 states: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.
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.
Claim 18 is 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.
The limitation “a temperature sensor configured to measure an ambient temperature value of an ambient environment of the fiber optic catheter apparatus; wherein the photodiode is configured to measure the power of the laser beam based on the measured ambient temperature value” is not sufficiently supported in the specification, in terms of HOW this function/effect is achieved. Specifically, the specification never provides any guidance/details on HOW the photodiode is configured to perform this function/effect. Furthermore, it seems as if this function is improperly attributed to the photodiode, when it seems as if a processor is actually required in order to perform the claimed function. Stated differently, it doesn’t appear that this is a particular structural configuration or type of photodiode, but instead a computer-implemented function. However, even if this function was properly attributed to a processor in the claims, the specification still lacks the necessary details/explanation as to HOW such a function/effect is achieved.
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 7 and 17-19 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 7] The limitation “wherein the information is transmitted via the electrically conductive pins using a serial communication circuit” is indefinite, as it is unclear what is structurally required, specifically it’s unclear if a serial communication circuit is positively recited, i.e. actually required by the claim language. For examination purposes, a serial communication circuit is not required, as this is currently written as a functional limitation, which would only require the capability of information being transmitted using a serial communication circuit; see MPEP 2114. The examiner would like to emphasize the difference in claim formatting between this claim (which does not require/recite a serial communication circuit) and claim 8, which clearly requires/recites a wireless radio transmitter or transceiver.
[Claim 17] The limitation “a photodiode configured to measure a power of a laser beam transmitted through the source-side coupler” is indefinite, as the scope of this limitation is unclear. Specifically, as discussed above, in the claim interpretation section, the source-side coupler is not required by the independent claim. Therefore, the scope of this limitation, which requires a photodiode that measures power a laser beam transmitted through this source-side coupler when such a source-side coupler is not required, is confusing. Stated differently, if the source-side coupler is not part of the claimed scope, then how can a photodiode that measures the power of the laser beam through this source-side coupler?
[Claim 18] The limitation “wherein the photodiode is configured to measure the power of the laser beam based on the measured ambient temperature value” is indefinite, as it is unclear what is structurally required in order to meet this limitation. A photodiode is configured to measure power in any/all situations, i.e. regardless of ambient temperature values. So what structural configuration/type of photodiode measures power based on measured ambient temperature values? As far as the examiner can tell, applicant’s disclosed photodiode is a generic/regular/normal photodiode, therefore any photodiode taught by the prior art inherently includes the necessarily structural elements/configurations to be capable of performing the claimed function.
[Claim 19] The limitation “wherein the fiber optic catheter apparatus is configured to receive power from electrical lines of the source-side coupler of the associated light source” is indefinite, as it is unclear what is structurally required. As discussed above (in the claim interpretation section), a source-side coupler is not required, and therefore the electrical lines of the source-side coupler are also not required. Therefore, it’s unclear what is structurally required in order to meet this functional limitation. The examiner contends that every/all/any laser-emitting catheter must be powered (from somewhere) in order to function, i.e. turn on. Therefore, seemingly any/all laser catheters are capable of being powered in the claimed manner; see MPEP 2114.
MPEP 2173.05 states “the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.”
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 4,919,508 to Grace et al. (Grace ‘508), in view of US 5,400,428 to Grace (Grace ‘428) and further in view of US 3,706,863 to Britton et al. or US 2014/0276603 to Magee et al.
[Claim 5] Grace ‘508 teaches a fiber optic catheter apparatus (Figs. 1 and 5-7; Col 4, line 37 to Col 6, line 2), comprising:
a catheter (fiberoptic catheter 22) including an optical fiber or optical fiber bundle terminating at an optical output aperture (distal end of 22, i.e. end inserted into patient 40; Fig. 1);
a coupler (female housing 44) including a plurality of pins (plungers 184); and
an electronic processor (microprocessor controller 280) programmed transmit information (“diameter or other characteristic of the catheter”) about the fiber optic catheter apparatus to an associated light source (laser 10; “Microprocessor 280 controls the laser power output to the fiberoptic catheter based on the information decoded from the fiberoptic coupler”) in response to a connection of the coupler (female housing 44) with a second coupler (male plug portion 30) via the pins (Col 4, line 45 to Col 5, line 20);
wherein a physical configuration of the plurality of pins encodes at least a portion of the information about the fiber optic catheter apparatus (“When a fiberoptic catheter is present, a combination of high and low signals will indicate the diameter or other characteristic of the catheter. A total of fifteen different combinations can be decoded from a four switch input circuit”).
Regarding the claimed catheter-side coupler and the source-side coupler, it is noted that Grace ‘508 discloses the reverse arrangement, where the pins (plungers 184) are located in the source-side coupler (female 44) and not the catheter-side coupler (male 30). It would have been obvious to one of ordinary skill in the art to switch which coupler (male or female) the pins/plungers are located in, as a mere reversal or rearrangement of parts, and as understood by a POSITA when considered male and female couplers; see MPEP 2144.04. To further support this position, Grace ‘428 (Fig. 10) explicitly discloses the reverse arrangement where the catheter-side coupler (male coupling portion 1020) includes the pins (1002) that activate micro-switches in the source-side coupler (female coupling portion 1022); Col 10, lines 19-34. Therefore, it would be obvious to one of ordinary skill in the art to switch/reverse which coupler (male or female, i.e. catheter-side or source-side) the pins/plungers are located on in the device taught by Grace ‘508, so that the pins are located in the male/catheter-side coupler, as taught by Grace ‘428, as the function/result is the exact same on either coupler.
Regarding the electrically conductive pins and the clamed electrical connection between the two couplers, Grace is silent to the material of the pins/plungers. However, Britton, which is reasonably pertinent to the problem faced, teaches a similar arrangement where a spring-biased plunger (input switch actuator 22) activates a switch, and the plunger is specifically made of metal (flat metal stem 36), i.e. electrically conductive, to provide an electrical connection (At least Col 4, line 60 to Col 7, line 65). Alternatively, Magee discloses an intelligent catheter that identifies the attached catheter (Abstract) and specifically teaches “information stored on the identification module is accessed directly by the verification module via one or more pins in electrical communication with the identification module” (Par 0092); It’s clear that in order to be “in electrical communication with the identification module”, the pins must be made of an electrically conductive material. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the unknown material of the pins/plungers, taught by Grace, for metal, i.e. electrically conductive material, as taught by Britton or Magee, as this is a simple substitution of one known material for another to obtain predictable results. MPEP 2144.07 states “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination”.
[Claims 6 and 7] The examiner contends that the proposed combination of Grace ‘508, Grace ‘428 and Britton/Magee disclose all of the necessary structural elements and arrangement in order to provide the claimed function; see MPEP 2114. Specifically, by having electrically conductive pins, information is capable of being transmitted in the claimed manner.
[Claim 8] Grace ‘508 and Grace ‘428 are discussed above, but fail to explicitly teach a wireless radio transmitter or transceiver. However, Magee discloses wirelessly transmitting the data via radio-wave communications (Par 0088). Therefore, it would have been obvious to one of ordinary skill in the art to modify Grace ‘508 and Grace ‘428 to include wireless communication to transmit information regarding the attached catheter, as taught by Magee, as a known communication means for similar laser catheter systems.
[Claim 9] Grace ‘508 discloses that the pins/plungers (184) are configured to engage mechanical switches (248, 250, 252 and 254; Figs. 5 and 7) which include electrical wires (see circuit in Fig. 7 that shows electrical connection/wires between the switches and the rest of the device); and the electronic processor is configured to detect a configuration of the electrically conductive pins that engage the mechanical switches via signals generated by the electrical wires of engaged mechanical switches to determine an identification of a catheter type of the fiber optic catheter apparatus (Col 5, lines 1 to 44 discuss how the pins/plungers activate the switches to generate signals that are sent through the electrical connections/wires to the processor in order to identify information/characteristics about the attached catheter).
If applicant disagrees with this interpretation, Magee discloses that information is transmitted either wireless or by a wired connection (Pars 0016, 0053 and 0088). This “wired connection” implicitly/inherently requires electrical wires. Therefore, it would have been obvious to modify the device of Grace ‘508 and Grace ‘428 with the electrical wires/wired connection of Magee, as this is a common/known way to transmit information/identification of the attached catheter.
[Claim 10] In order to operate in the disclosed manner, the microprocessor (280) taught by Grace ‘508 inherently/implicitly includes a memory that stores memory content include the catheter type, e.g. “size, diameter or other characteristic of the fiber catheter being coupled to the laser light source”, and the transmitted information includes this memory content.
[Claim 11] As discussed above, in relation to claim 9, the electrical connections connecting the switches (248, 250, 252 and 254) to the rest of the device, as shown in the circuit of Fig. 7, are considered electrical wires, i.e. a wired connection. It’s clear that the number (and sequence/order) of activated switches engaged by pins (184) identifies the catheter type. Alternatively, as discussed in claim 9 above, Magee makes the claimed wired connection obvious.
[Claim 12] Grace ‘508 discloses “microprocessor 280 controls the laser power output to the fiberoptic catheter based on the information decoded from the fiberoptic coupler”, therefore the operating parameters must be stored in memory.
[Claims 13-16] Grace ‘508 and Grace ‘428 are discussed above, but fail to explicitly disclose the specific information/characteristic transmitted relates to the number of uses (flag; claims 13-14), a fault condition (claim 15) or a validation code (claim 16). However, in the same field of endeavor, Magee discloses a similar catheter system (Figs. 1-2 and 8; Pars 0057-63 and 0076-77) including a coupler (108) that identifies the attached catheter. It is emphasized that Magee explicitly teaches using a similar pin signaling configuration (Pars 0092-93). Furthermore, Magee discloses identifying the current number of uses of the attached catheter by counting each use (each “count” is interpreted as a set flag stored in memory). Magee further discloses other information that can be identified, and a verification module (208) that compares this identified information to use restrictions (Par 0076) and prohibits/disables use of the catheter when further use is impermissible (Par 0077). The examiner interprets the situation when the verification module determines a violation of a user restriction, i.e. impermissible/prohibited further usage, as a fault condition. Stated differently, the violation of a use restriction is considered a fault. Conversely, when the verification module determines that further use is permissible, i.e. does not violate a use restriction, this is considered a validation code. It’s clear from Magee that all of this information related to usage of the catheter is stored in memory (220; At least Pars 0056, 0062 and 0074-75). Therefore, it would have been obvious to one of ordinary skill in the art to modify the device taught by Grace ‘508 and Grace ‘428 to include the usage information taught by Magee, including the number of uses, a fault condition and a validation code, as known and desirable information to know about an attached catheter in order to provide substantial benefits for patient health and safety (Par 0026 of Magee).
[Claim 17] Grace ‘508 discloses a photodiode (total energy detector 292) configured to measure a power of a laser beam through the catheter (including the source-side/female coupler). While Grace ‘508 doesn’t explicitly disclose the energy detector as a photodiode, it’s clear that it is an optical detector that receives the light/laser beam and determines the energy/power thereof. The examiner considers this a photodiode, however if applicant disagrees, the examiner takes official notice that photodiodes are a common, well-known and pervasive type of optical sensor for measuring the power of a light/laser beam. Therefore, it would have been obvious to choose/try any optical energy detector, including a photodiode, as this is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success
[Claim 19] As discussed above, neither the source-side coupler or the electrical lines thereof are required. The examiner takes the position that the catheter taught by Grace ‘508 is capable of being powered in the claimed/hypothetical manner. Specifically, the catheter must receive power from somewhere in order to operate, and hypothetical electrical lines in the source-side coupler are possible/capable of providing this power.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Grace ‘508, Grace ‘428 and Britton/Magee as applied to claim 17 above, and further in view of US 5,725,523 to Mueller.
Grace ‘508, Grace ‘428 and Britton/Magee are discussed above, but fail to teach a temperature sensors that measures ambient temperature of the catheter. It is noted/emphasized that Grace ‘508 teaches/suggests the claimed photodiode (total energy detector 292; see claim 17 above). Also, as further discussed in the 112b rejection, this photodiode is inherently capable of measuring the power of the laser beam in any condition/situation, including based on the measured ambient temperature. In the same field of endeavor, Mueller discloses a laser catheter that includes sensors for determining ambient temperature (Col 12, lines 3-19). Therefore, it would have been obvious to one of ordinary skill in the art to modify the device taught by Grace ‘508, Grace ‘428 and Britton/Magee to include an ambient temperature sensor, as taught by Mueller, as this combining prior art elements according to known methods to yield predictable results, as ambient temperature is a useful/necessary parameter in various laser catheter procedures, as taught by Mueller. The examiner contends that in the proposed combination, the energy detector/photodiode of Grace ‘508 is inherently capable, i.e. includes all of the necessary structural elements/configuration, to measure the power based on the ambient temperature; MPEP 2114.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2014/0276690 to Grace discloses: “The catheter size information receiver 632 can be any configuration. For example, it can be based on a lookup table using an identifier of the catheter. The identifier can be provided by a pin sequence or configuration on the proximal end of the catheter. The sequence and/or configuration of pins is mounted to the proximal end of the catheter. The pin arrangement or sequence actuates switches in the catheter's coupler to generate a signal, which is forwarded to the controller 604. Using a lookup table in memory 608 and the signal, the controller 604 can identify the type and/or model of the catheter and therefore the appropriate catheter specifications, requirements, and other operating information. Each type and/or model of catheter has a unique pin sequence to actuate different switches for generating different signals” (Par 0058)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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