Notice of Pre-AIA or AIA Status
The present reissue application of US Pat. No. 11,517,478 (“the ‘478 patent”) is being examined under the pre-AIA first to invent provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Reissue Applications
Applicant is reminded of the continuing obligation under 37 CFR § 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which the ‘478 patent is or was involved. These proceedings would include interferences, reissues, reexaminations and litigations.
Applicant is further reminded of the continuing obligation under 37 CFR § 1.56 to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Consent of Assignee
This application is objected to under 37 CFR § 1.172(a) as lacking a proper written consent of all assignees owning an undivided interest in the patent. The consent of the assignee must be in compliance with 37 CFR § 1.172. See MPEP § 1410.01. Specifically, there is no indication of record that the party who signed the submission is an appropriate party to sign on behalf of the assignee. See 37 CFR § 3.73.
The consent of assignee must be signed by a party authorized to act on behalf of the assignee. For applications filed on or after September 16, 2012, the consent may be signed by the assignee or a patent practitioner of record. For applications filed before September 16, 2012, the consent must be signed by the assignee. Where the assignee is a juristic entity, the consent may be signed by a person in the organization having apparent authority to sign on behalf of the organization, or a person who makes a statement of authorization to act on behalf of the assignee. Parties authorized to act on behalf of the assignee include, an officer (chief executive officer, president, vice-president, secretary, or treasurer), chairman of the board of directors but not the signature of an individual director, and modifications of these basic titles are acceptable, such as vice-president for sales, executive vice-president, assistant treasurer, vice-chairman of the board of directors. Additionally, in foreign countries, a person who holds the title "Manager" or "Director" is normally an officer and is presumed to have the authority to sign on behalf of the organization. A person having a title (administrator, general counsel) that does not clearly set forth that person as an officer of the assignee is not presumed to have authority to sign the submission on behalf of the assignee.
A proper assent of the assignee in compliance with 37 CFR §§ 1.172 and 3.73 is required in reply to this Office action.
Claim Objections
Claims 5-7 are objected to because of the following informalities: claims 5-7 provided in the preliminary amendment filed 12/05/2024 are not identical to claims 5-7 of the ‘478 patent. Appropriate correction is required.
Claim Rejections - 35 USC § 251
Original Patent
The following is a quotation of the first paragraph of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
MPEP 1412.01 states that the reissue claims must be for the same invention as that disclosed as being the invention of the original patent. MPEP 1412.01 further provides guidelines for determining whether the reissue claims are "for the invention disclosed in the original patent" as:
(A) the claims presented in the reissue application are described in the original patent specification and enabled by the original patent specification such that 35 U.S.C. 112, first paragraph is satisfied; and
(B) nothing in the original patent specification indicates an intent not to claim the subject matter of the claims presented in the reissue application.
The presence of some disclosure (description and enablement) in the original patent should evidence that applicant intended to claim or that applicant considered the material now claimed to be his or her invention.
Further, the Federal Circuit addressed the “original patent” requirement of 35 USC 251 in Antares Pharma, Inc. v. Medac Pharma Inc. and Medac GMBH, 771 F.3d 1354, 112 USPQ2d 1865 (Fed. Cir. 2014). In Antares the reissue claims covered embodiments of injection devices (not restricted to jet-injection devices) which the Applicant admitted was a different invention from what was originally claimed. Id. at 1356. The Federal Circuit adopted the Supreme Court's explanation of the “same invention” requirement as “if the original patent specification fully describes the claimed inventions, but not if the broader claims ‘are [] merely suggested or indicated in the original specification’ ”. Id. at 1359. The Federal Circuit further stated that although wording in 35 USC 251 was changed from “same invention” to “original patent” no change in substance was intended. Id. at 1360.
Based on Antares a review of the specification is necessary to determine whether the original specification adequately discloses the invention of the reissue claims. Like in Antares, the specification states that “[t]he above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments.” See the ‘478 patent, col. 4, ll. 43-47. However, the specification does not disclose a laser therapy instrument comprising a femtosecond laser, a phacoemulsification instrument and structures that provide power to and signal transmission between the instruments without a beam conducting device including an exit lens system and a device operably coupled to the beam conducting device that moves at least a part of the beam conducting device including the exit lens system into a common treatment area of a patient’s eye.
Therefore, claims 31-40, which are directed to a laser therapy instrument comprising a femtosecond laser, a phacoemulsification instrument and structures that provide power to and signal transmission between the instruments do not satisfy the “original patent” requirement.
Claims 31-40 are rejected under 35 USC 251 for not claiming subject matter directed to the invention disclosed in the original patent.
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 20-40 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. Specifically, both independent claims 20 and 31 recite “the laser therapy instrument comprising … a phacoemulsification instrument operably coupled to the laser therapy instrument.” The ‘478 patent specification does not describe how the laser therapy instrument both is comprised of the phacoemulsification instrument yet is then coupled to the phacoemulsification instrument.
Claims 31-40 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a laser therapy instrument that comprises a beam conducting device including an exit lens system, a device operably coupled to the beam conducting device that moves at least a part of the beam conducting device including the exit lens system into a common treatment area of a patient’s eye and comprising other instruments such as a phacoemulsification instrument, a femtosecond laser, and structures that provide power to and signal transmission between the instruments does not reasonably provide enablement for a laser therapy instrument comprising a femtosecond laser, a phacoemulsification instrument and structures that provide power to and signal transmission between the instruments without a beam conducting device including an exit lens system and a device operably coupled to the beam conducting device that moves at least a part of the beam conducting device including the exit lens system into a common treatment area of a patient’s eye. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
Turning to the ‘478 patent specification, there is no disclosure of a laser therapy instrument that does not include the laser arm. There is no disclosure in the ‘478 patent of a separate instrument apart from the laser therapy instrument for applying a laser to the eye of the patient. Further, every description in the ‘478 patent regarding the femtosecond laser is with respect to the laser therapy instrument with the laser arm. See the ‘478 patent, col. 1, ll. 29-31 stating, “[f]or intraoperative use in cataract surgery, the laser instrument is, for example, equipped with a femtosecond laser (briefly: fs-laser) and a phacoemulsification instrument.” and col. 6, ll. 51-57 stating, “[i]n another example embodiment, an ultrasonic phacoemulsification instrument is integrated into the invented laser therapy instrument. Such an ultrasonic phacoemulsification instrument must be provided anyhow, since a complete emulsification of the crystalline lens by application of femtosecond laser is not possible in case of 2nd to 4th degree cataracts.”
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 8-9 and 11-16 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US Pat. No. 2010/0094264 to Rathjen (“Rathjen ‘264”).
Regarding claim 1, Rathjen ‘264 discloses a laser therapy instrument (1) comprising: a beam conducting device (21,22,) including an exit lens system (42,43) that conducts a therapeutic laser beam to the common treatment area (see para. [0043-0044]), and a device (support arm 3 and application head 4) operably coupled to the beam conducing device that moves at least a part of the beam conducting device that includes the exit lens system (42,43), into the common treatment area prior to use of the laser therapy instrument and out of the treatment area after the use of the laser therapy instrument (see paras. [0050-0054]); the beam conducting device comprising a swivelable laser arm (3) including the exit lens system (42,43), with a swiveling mechanism being actuatable by a motor (see para. [0054]), and comprising a control (control unit 23) that controls the laser arm swiveling speed (see para. [0056]).
Regarding the claim limitations of “wherein the laser therapy instrument is structured for surgery on a cornea, a sclera, a vitreous body or a crystalline lens, and is used alternately with other instruments for eye diagnosis or eye therapy, in a common treatment area in which a patient or a patient's eye is positioned, the common treatment area being accessible to the laser therapy instrument and the other instruments in succession,” and “such that the treatment area, after at least the part of the beam conducting device including the exit lens system has been moved out of the treatment area, is freely accessible for using the other instruments;” these limitations are entirely functional and have been given limited patentable weight. Rathjen teaches an instrument structure for surgery (see Fig. 1) on at least a cornea, and can be used with other instruments at the discretion of the surgeon. The common treatment area is shown in Rathjen Figs. 1,2,7,8 as the area between and around the eye (6) and the instrument (41). While not shown in the figures, the common treatment area is accessible to other instruments before and after the laser arm (3) is moved into and out of position since this structure of the prior art is disclosed as being translated/rotated into position thereby making it capable of carrying out this function.
Regarding claim 8, Rathjen ‘264 discloses the laser therapy instrument as claimed in claim 1 and also teaches wherein the laser arm is further movable in a parallel movement of the entire laser arm, a telescoping extension or a combination of the foregoing. See Figs. 2-8
Regarding claim 9, Rathjen ‘264 discloses the laser therapy instrument as claimed in claim 1 and also teaches in which the laser arm that can be moved into and out of the common treatment area comprises an optical interface (viewing window 44) which, during fine adjustment of the laser arm and during laser treatment, enables observation of the patient's eye in a direct view or through a separate optical system (see paras. [0018] and [0046-0047]).
Regarding claims 11-12, Rathjen ‘264 discloses the laser therapy instrument as claimed in claim 1 and also teaches a motor drive coupled to the control and operably coupled to the exit lens system wherein the exit lens system can be positioned in the X, Y and Z spatial directions in addition to movement and also teaches a motor drive coupled to the control and operably coupled to the laser arm including the exit lens system wherein the laser arm can be positioned in X, Y and Z spatial directions in addition to movement (see paras. [0012], [0054] and [0057]).
Regarding claim 13, Rathjen ‘264 discloses the laser therapy instrument as claimed in claim 1 and also teaches an imaging system that images the eye to be treated, wherein the exit lens system for the therapeutic laser beam is used as an entrance optical system for imaging light (see para. [0047); and an image processing system that is connected to the imaging system (para. [0059]), and wherein, for the purpose of positioning the exit lens system relative to the eye, the image processing system is connected to the control that drives the laser arm, with a further control system that drives a patient couch or both of the foregoing (see paras. [0056-0057]).
Regarding claim 14, Rathjen ‘264 discloses the laser therapy instrument as claimed in claim 1 and also teaches an information acquisition, information transmission and information processing system that acquires, transmits and processes patient-related identification, diagnostic data, therapeutic data, or a combination of the foregoing, the system being operably coupled with other instruments for eye diagnosis or eye therapy (see para [0056]).
Regarding claims 15-16, Rathjen ‘264 discloses the laser therapy instrument as claimed in claim 1 and also teaches rollers, wheels or slide rails operable to change position before and after therapy relative to other instruments for eye diagnosis or eye therapy (see para. [0042]), further operable to provide stationary fixation throughout the therapy process, further operable to correct inclination during stationary fixation or a combination of the foregoing (see para. [0057]) in which the rollers, wheels or slide rails operable for inclination measurement and/or inclination correction are connected with the control to facilitate swiveling movement, positioning in the X, Y and Z spatial directions or both of the foregoing (see para. [0056]).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rathjen ‘264 in view of US Pub. No. 2003/0004502 to Clapham et al. (“Clapham”).
Regarding claim 2, Rathjen meets the claim limitations as described above for claim 1 but fails to teach “a manual or pedal switch that carries out a release of movement, and in which the speed of the movement varies with the distance between the exit lens system and the common treatment area or the eye, the movement being slowed down when the exit lens system approaches a working position at the eye” (claim 2).
Regarding the general limitations pertaining to the concept of “the movement being slowed down when the exit lens system approaches a working position at the eye;” this limitation would be readily obvious to one skilled in the art. One skilled in the art would understand that the eye surface is delicate and can be easily damaged. Therefore, one skilled in the art would incorporate slowing down the movement of the system when approaching the eye. The motivation for the incorporation would have been in order to decrease the chance of damaging the cornea and/or other structures of the eye during the procedure.
Furthermore, Clapham teaches a manual or pedal switch (see para. [0052]) that carries out a release of movement (see para. [0035]), and in which the speed of the movement varies with the distance between the exit lens system and the common treatment area of the eye (gross adjustment versus fine adjustment, see paras. [0066-0067]), the movement being slowed down when the exit lens system approaches a working position at the eye (para. [0067] stating, “the fine adjustment mechanism uses the same joystick and moves the laser optics at a slower speed.”)
It would have been obvious to one of ordinary skill in the art at the time of the invention, to modify the apparatus of Rathjen with the pedal switch which controls both gross and fine adjustment where fine adjustment is slower as the arm is brought closer to the eye, as taught by Clapham, in order to using it for enhancing the safety of the device and procedure to the patient as set forth above.
Claims 2-7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rathjen ‘264 in view of US Pub. No. 2006/0142657 to Quaid et al. (“Quaid”).
Regarding claims 2-7, Rathjen ‘264 fails to teach “a manual or pedal switch that carries out a release of movement, and in which the speed of the movement varies with the distance between the exit lens system and the common treatment area or the eye, the movement being slowed down when the exit lens system approaches a working position at the eye” (claim 2); “wherein the control that controls the laser arm swiveling speed varies the swiveling speed depending upon proximity of the exit lens system to the common treatment area” (claim 3); “wherein the control that controls the laser arm swiveling speed varies the swiveling speed to be slower when the exit lens system is in close proximity to the common treatment area than when the exit lens system is a greater distance from the common treatment area” (claim 4); “wherein the proximity to the common treatment area is sensed by proximity sensors that are in operable communication with the control that controls the laser arm swiveling speed” (claim 5); “wherein the control that controls the laser arm swiveling speed varies the swiveling speed to be slower when moving the exit lens system toward the common treatment area and to be faster when moving the exit lens system away from the common treatment area” (claim 6); and “further wherein the control that controls the laser arm swiveling speed varies the swiveling speed to be faster when moving the exit lens system away from the common treatment area” (claim 7).
Quaid teaches a haptic guidance system and method for performing procedures on a patient. As provided in para. [0179] the system, “is determined based on a proximity of a portion of the haptic device 30 (e.g., the tool 50) to a virtual (or haptic) boundary associated with the representation of the anatomy. Thus, if the tool 50 is disposed a sufficient distance from the haptic boundary, a controller commands no haptic forces, and the user is free to move the tool 50 as if exploring empty space. However, as the tool 50 approaches or contacts the haptic boundary, the controller commands torques to the motors so as to exert the appropriate wrench on the user's hand via the interface 37. Preferably, a magnitude of the force feedback increases as the tool 50 approaches the virtual boundary and does not present a discontinuous step that may induce oscillation or unwanted vibration. For example, as the tool 50 approaches the haptic boundary, the haptic device 30 may exert a force in a direction opposite a direction of movement of the user interface 37 such that the user perceives a repulsive or counteracting force that slows and/or stops movement of the tool 50.” Quaid also discloses a mode switch (25) for controlling movement. See para. [0124]).
Regarding the general limitations pertaining to the concept of “the movement being slowed down when the exit lens system approaches a working position at the eye;” this limitation would be readily obvious to one skilled in the art. One skilled in the art would understand that the eye surface is delicate and can be easily damaged. Therefore, one skilled in the art would incorporate slowing down the movement of the system when approaching the eye. The motivation for the incorporation would have been in order to decrease the chance of damaging the cornea and/or other structures of the eye during the procedure.
Furthermore, one skilled in the art would have found it obvious to incorporate the haptic system as taught by Quaid into the invention of Rathjen ‘264. Both devices are analogous in the surgical art employing the use of surgical/robotic arms; therefore, a combination is proper. Additionally, Quaid describes how the haptic system provides more control over the surgical device once in a boundary. The motivation for the incorporation would have been in order to provide a system that increases the protection of the patient’s body to the surgical instrumentation at close proximity to the patient.
Claim 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rathjen ‘264 in view of US Pub. No. 2009/0182310 to Gertner et al. (“Gertner”).
Regarding claim 10, Rathjen meets the claim limitations as described above for claim 1 but fails to disclose strain gauging sensors that are connected to the control for movement in such a way that the movement is stopped when strain measured exceeds a specified level.
However, Gertner teaches a method and system for performing an ocular irradiation procedure, wherein strain gauging sensors are provided that are connected to a control unit for the movement in such a way that the movement is stopped when strain measured exceeds a specified level (see para. [0117] stating, "In some embodiments of the invention a strain gauge is used to measure the resistance and/or change in resistance as the control arm 180 is deflected during positioning and/or stabilization of the contact device 110” and para. [0094] stating, "system 100 also includes a processor or control unit 115 which has a graphical user interface 117 for receiving instructions from, and presenting information such as alignment and system functionality data to, a system operator. Further, the control unit 115 is in electronic communication with one or more of the other components of system 100 described above, e.g., the motors controlling the beam-positioning assembly, the motors controlling the eye-positioning assembly, and sensors, detectors and beam sources for determining the position of the eye contact device in the external coordinate system, as described above.").
It would have been obvious to one of ordinary skill in the art at the time the invention was made, to modify the apparatus of Rathjen '264 with a strain gauging sensors which via the processor control the motors, as taught by Gertner, in order to stop the movement when strain measured exceeds a specified level. The motivation for this incorporation would have been in order to enhance the safety of the device for the patient during the procedure.
Claims 17-18 and 20-30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rathjen ‘264 in view of US Pat. No. 6,251,113 to Appelbaum et al. (“Appelbaum”).
Regarding claims 17-18, Rathjen ‘264 meets the claim limitations as described above for claim 1 but fails to teach “a housing structured as a rack that accommodates various other instruments designed as slide-in modules” (claim 17) and “a phacoemulsification instrument, in which the phacoemulsification instrument comprises a slide-in module including an adjustable height support for a liquid container” (claim 18).
Regarding claims 20-24 and 29, Rathjen ‘264 meets most of these claim limitations as described above for claim 1 but fails to teach “a phacoemulsification instrument operably coupled to the laser therapy instrument” and “a mechanical coupling or adapter that couples the phacoemulsification instrument to the laser therapy instrument.”
However, Appelbaum teaches a housing structured as a rack (7) that accommodates various other instruments (13) designed as slide-in modules (see Figs. 1 and 3, col. 6, ll. 32-55 and col. 7, ll. 58-66) and a phacoemulsification instrument (325), in which the phacoemulsification instrument comprises a slide-in module including an adjustable height support (17) for a liquid container; removable covers that are removable to be sterilized. The rack and the slide in nature of the component is a mechanical adapter that couples the instruments together.
Regarding claims 25-27, Applebaum also teaches a tray (25); control of the height adjustment for the liquid by motor; and wherein the phacoemulsification instrument is ergonomically and conveniently placed within a user’s reach and so that the at least one handpiece is within reach of the common area (see Fig. 1).
At the time of the invention, one skilled in the art would have found it obvious to incorporate the housing with slide in rack, phacoemulsification instrument and height adjustable support for a liquid container into the invention of Rathjen ‘264. Both devices are analogous in the art of ophthalmologic surgical devices therefore, a combination is proper. Additionally, the motivation for the incorporation can be found in Appelbaum itself which describes how “[m]icrosurgical and ophthalmic systems are relatively costly and are often purchased by hospitals and clinics for sharing among many surgeons with different specialties. In eye surgery, for example, some surgeons may specialize in anterior segment procedures, while other surgeons may specialize in posterior segment procedures. Due to differences in these procedures, the control system will not be set up with the same operating characteristics for both procedures. Also, due to the delicate nature of eye surgery, the response characteristics or "feel" of the system can be a concern to surgeons who practice in several different hospitals, using different makes and models of equipment.” Further, Appelbaum states that “such systems provide improved uniformity of performance characteristics, while at the same time providing enough flexibility in the system to accommodate a variety of different procedures. The systems shown in these patents improve upon the prior art by providing a programmable and universal microsurgical control system, which can be readily programmed to perform a variety of different surgical procedures and which may be programmed to provide the response characteristics which any given surgeon may require. The control system is preprogrammed to perform a variety of different functions to provide a variety of different procedures.” See Appelbaum Background/Summary. Therefore, the motivation provided by Appelbaum and understood by one skilled in the art would have been to enhance the applicability of the one system to multiple procedures thereby reducing cost to the hospital system and increasing the amount of procedures available to the patient.
Regarding claim 28, Rathjen ‘264 teaches the laser therapy instrument as claimed in claim 20 but fails to teach structures that facilitate transmission of electric energy power supply to the phacoemulsification instrument; and structures that facilitate signal transmission between the laser therapy instrument and the phacoemulsification instrument so that the laser therapy instrument and the phacoemulsification instrument can jointly use control and indicating elements.
However, Appelbaum discloses in claim 18 that “each of the modules and the user interface includes a transceiver and a processor coupled to the transceiver for receiving data from and transmitting data to the data communications bus and wherein the data communications bus, the transceivers and the processors form a communications network whereby the modules communicate with each other and the user interface via the communications network.”
At the time of the invention, it would have been obvious to incorporate the structures that facilitate power and communication to and between the instruments of Rathjen ‘264 and Appelbaum in light of the teaching of these structures by Appelbaum itself. The motivation for the incorporation would have been in order to make the surgical system an integrated unit which would enhance the performance of the system to the surgeon.
Regarding claim 30, Appelbaum discloses a monitor 5.
At the time of the invention, it would have been obvious to incorporate the monitor into the invention of Rathjen ‘264 as a way to interface with multiple instruments. Additionally, it would have been obvious to update the monitor as a touch screen display since it is obvious to update equipment with a more current equivalent.
Claims 31-39 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Appelbaum in view of US Pub. No. 2011/0028957 to Raksi et al (“Raksi”).
Regarding claim 31, Appelbaum discloses a therapy instrument to remove a cataract from an eye (function is considered inherent since the device discloses a phacoemulsification or phacofragmentation instrument which are used for removal of a cataract from an eye), wherein the therapy instrument is structured for surgery on a crystalline lens (see col. 6, ll. 49-55 stating, “[t]o optimize performance of instruments 19 during surgery, their operating parameters differ according to, for example, the particular procedure being performed, the different stages of the procedure, the surgeon's personal preferences, whether the procedure is being performed in the anterior or posterior portion of the patient's eye, and so on.”), and is used alternately with other instruments for eye diagnosis or eye therapy (see col. 6, ll. 45-49 stating, “These instruments 19 include vitrectomy cutters, phacoemulsification or phacofragmentation handpieces, electric microscissors, fiber optic illumination instruments, coagulation handpieces and other microsurgical instruments known in the art”, in a common treatment area in which a patient or a patient's eye is positioned (the surgical field), the common treatment area being accessible to the laser therapy instrument and the other instruments in succession (at the discretion of the surgeon); the laser therapy instrument comprising: a phacoemulsification instrument (325) mechanically (see module 13 connection to the instrument) and operably coupled (see Fig. 21 and neuron circuit 541) to the laser therapy instrument and structured to facilitate completion of the fragmentation of the crystalline lens and to irrigate and aspirate within a lens capsule to remove residue of the crystalline lens cortex and nucleus (considered capable of achieving this function, see below); and structures that provide power supply to the phacoemulsification instrument and signal transmission between the therapy instrument so that the phacoemulsification instrument and the therapy instrument jointly use control and indicating elements (see col. 36, l. 56 through col. 38, l. 8).
Regarding the functional claim language of “to remove a cataract from an eye,” “and is used alternately with other instruments for eye diagnosis or eye therapy, in a common treatment area in which a patient or a patient's eye is positioned, the common treatment area being accessible to the laser therapy instrument and the other instruments in succession,” and “to facilitate completion of the fragmentation of the crystalline lens and to irrigate and aspirate within a lens capsule to remove residue of the crystalline lens cortex and nucleus,” these limitations are all considered function and therefore have been given limited patentable weight. Appelbaum discloses the use of a phacoemulsification and phacofragmentation device; therefore, if not inherent it is considered obvious that the device is designed and structured to achieve these functions specific to removing a cataract from an eye.
Regarding the limitation of “a laser therapy instrument,” “a femtosecond laser structured to facilitate at least partial fragmentation of the crystalline lens,” Appelbaum does not teach these limitations.
However, Raksi discloses an optical system that includes a surgical laser for cataract removal. See Background of the Invention. Additionally, the system includes a femtosecond laser that is structured to facilitate at least partial fragmentation of the crystalline lens (see para. [0003]).
At the time of the invention, one skilled in the art would have found it obvious to incorporate the a femtosecond laser that is structured to facilitate at least partial fragmentation of the crystalline lens into the invention of Appelbaum. Both devices are analogous in the art of ophthalmologic surgical devices therefore, a combination is proper. Additionally, the motivation for the incorporation can be found in Appelbaum itself which describes how “[m]icrosurgical and ophthalmic systems are relatively costly and are often purchased by hospitals and clinics for sharing among many surgeons with different specialties. In eye surgery, for example, some surgeons may specialize in anterior segment procedures, while other surgeons may specialize in posterior segment procedures. Due to differences in these procedures, the control system will not be set up with the same operating characteristics for both procedures. Also, due to the delicate nature of eye surgery, the response characteristics or "feel" of the system can be a concern to surgeons who practice in several different hospitals, using different makes and models of equipment.” Further, Appelbaum states that “such systems provide improved uniformity of performance characteristics, while at the same time providing enough flexibility in the system to accommodate a variety of different procedures. The systems shown in these patents improve upon the prior art by providing a programmable and universal microsurgical control system, which can be readily programmed to perform a variety of different surgical procedures and which may be programmed to provide the response characteristics which any given surgeon may require. The control system is preprogrammed to perform a variety of different functions to provide a variety of different procedures.” See Appelbaum Background/Summary. Therefore, the motivation provided by Appelbaum and understood by one skilled in the art would have been to enhance the applicability of the one system to multiple procedures thereby reducing cost to the hospital system and increasing the amount of procedures available to the patient.
Regarding claim 32, Applebaum in view of Rashi teach the laser therapy instrument as claimed in claim 31 and Appelbaum further teaches the phacoemulsification instrument further comprises a slide-in module (13).
Regarding claim 33, Applebaum in view of Rashi teach the laser therapy instrument as claimed in claim 31 and Appelbaum further teaches the phacoemulsification instrument includes an adjustable height support (17) for a liquid container.
Regarding claim 34, Applebaum in view of Rashi teach the laser therapy instrument as claimed in claim 31 and Appelbaum further teaches wherein the phacoemulsification instrument includes at least one handpiece (539) operably connected via at least one cable to the slide-in module (see col. 36, l. 56 through col. 38, l. 8).
Regarding claim 35, Applebaum in view of Rashi teach the laser therapy instrument as claimed in claim 32 and Appelbaum further teaches wherein the phacoemulsification instrument further comprises an accommodation facility (17) for a liquid container connected to the slide-in module via a hose through which liquid is supplied (considered inherently necessary in order for the device to function as disclosed).
Regarding claim 36, Applebaum in view of Rashi teach the laser therapy instrument as claimed in claim 34 and Appelbaum further teaches wherein the phacoemulsification instrument further comprises a tray (25) configured to support the at least one handpiece.
Regarding claim 37, Applebaum in view of Rashi teach the laser therapy instrument as claimed in claim 35 and Appelbaum further teaches wherein the phacoemulsification instrument further comprises a mechanism for height adjustment of the liquid container manually or by a motor (see col. 7, ll. 46-49 stating, “According to the invention, a control circuit 105 (see FIGS. 37, 126-136) controls foot control assembly 15 and a control circuit 107 (see FIGS. 38 and 137-146) controls IV pole assembly 17.”).
Regarding claim 38, Applebaum in view of Rashi teach the laser therapy instrument as claimed in claim 34 and Appelbaum further teaches wherein the phacoemulsification instrument is ergonomically and conveniently placed within a user's reach and so that the at least one handpiece is within reach of the common treatment area (see tray 25).
Regarding claim 39, Applebaum in view of Rashi teach the laser therapy instrument as claimed in claim 31 and Appelbaum further teaches further comprising a mechanical coupling or adapter that couples the phacoemulsification instrument to the laser therapy instrument (module 13).
Claims 30 and 40 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rathjen ‘264 in view or Appelbaum as pertaining to claim 30 and Appelbaum in view of Rashi as pertaining to claim 40 in further view of US Pat. No. 5,098,426 to Sklar et al. (“Sklar”).
Regarding claim 30, Appelbaum discloses a monitor 5.
At the time of the invention, it would have been obvious to incorporate the monitor into the invention of Rathjen ‘264 as a way to interface with multiple instruments.
Regarding claims 40, Applebaum in view of Rashi teach the laser therapy instrument as claimed in claim 31 and Appelbaum further teaches further comprising a monitor (5).
Neither combinations teach a touch screen that facilitates control the laser therapy instrument and the phacoemulsification instrument.
However, Sklar discloses a touch screen for use with precision laser surgery. See Sklar, col. 4, ll. 51-56 stating, “A number of different systems can be used for conveying to the computer the desired procedure. One is to use commercially available touch screens with a special light pencil. Alternatively, a trackball or joy stick can be used. The surgeon can then either draw freehand his proposed operation;”
At the time of the invention, it would have been obvious to update the monitor of Appelbaum with a touch screen display as taught by Sklar since one skilled in the art would understand that a touch screen could enhance the performance of the device during the procedure thereby reducing time and thereby increasing safety to the patient.
Conclusion
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/CATHERINE S WILLIAMS/ Reexamination Specialist, Art Unit 3993
Conferees:
/MATTHEW J KASZTEJNA/ Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/ SPRS, Art Unit 3993
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