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 .
Claim Objections
Claims 1-13 are objected to because of the following informalities:
Claim 1, line 7: “the surface” should read --the eye surface--
Claim 2, line 1: “A system” should read --The system--
Claim 3, line 1: “A system” should read --The system--
Claim 4, line 1: “A system” should read --The system--
Claim 5, line 1: “A system” should read --The system--
Claim 5, line 4: “the launch” should read --launch--
Claim 5, line 5: “an impact attribute” should read --the impact attribute--
Claim 6, line 1: “A system” should read --The system--
Claim 7, line 1: “A system” should read --The system--
Claim 7, line 3: insert “or” after comma
Claim 8, line 1: “A system” should read --The system--
Claim 9, line 1: “A system” should read --The system--
Claim 10, line 1: “A system” should read --The system--
Claim 11, line 1: “A system” should read --The system--
Claim 11, line 4: “a user interface” should read --the user interface--
Claim 12, line 1: “A system” should read --The system--
Claim 13, line 1: “A system” should read --The system--
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 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 recites the limitation "the human " in line 14. There is insufficient antecedent basis for this limitation in the claim. It should read: “a human”.
Claim 1 recites the limitation “wherein the controller is operable to:… changing, by increasing or decreasing the first value of the impact attribute to set a second value for the impact attribute of the probe”. It is unclear what is meant by “operable to changing”. For this examination, the term “changing” is being interpreted as “change”.
Claim 5 recites the limitation "the current" in line 3. There is insufficient antecedent basis for this limitation in the claim. It should read: “a current”.
Claims 2-18 are rejected by virtue of their dependence from claim 1.
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.
Claims 1-6, 8-9, 11-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Makkeli (WO 2017103330) in view of Fresco (WO 02091902) and Gandhi (US 20120220892).
Regarding claim 1, Makkeli teaches a system for determining a touch sensitivity threshold at an eye surface, the system comprising: a housing comprising a probe (3) detachably arranged within the housing, wherein the probe (3) comprises a tip part (4) and a body part (31, 32), the tip part is fabricated using a bio-compatible material, and the body part is magnetic material, (Page 6, lines 11-15), and the probe is operable to impact the eye surface with a predefined impact attribute (Page 6 lines 10-34; Page 7, lines 1-8) and rebound from the eye surface (Page 7, lines 8-9); a probe attachment means operable to retain the probe within the housing (Page 7, lines 26-27, induction coil 102); and a probe release means operable to release the probe towards the eye surface, wherein the probe release means is a driver coil (releasing coil 8), wherein the driver coil is operable to produce a magnetic force to actuate the probe in a first direction to release the probe (3) from the housing; or in a second direction to retract the probe into the housing. (Page 8, lines 3-12).
However, Makkeli does not teach the remaining claim features.
Fresco, in a related field of endeavor, teaches an applanation tonometry system, for measuring pressure within an eye comprising feedback means to receive feedback from a human after the impact of the probe with the eye surface (Page 9, lines 28-33),
a controller (16, 130) operatively coupled to the probe attachment means, the probe release means and the feedback means (Page 8, lines 29-34), wherein the controller is operable to:
(a) set a first value for an impact attribute of the probe (Fig. 5, step 152, teaches storage of first off-set pressure magnitude);
(b) release the probe towards the eye surface, to impact the eye surface with the first value for the impact attribute (Page 20, paragraph 3; Fig. 5, step 158, teaches actuating plunger to apply reference pressure magnitude);
(c) from the human, receive a first feedback in response to the impact of the probe with the first value for the impact attribute at the eye surface (Page 9, lines 25-33 teaches closed-loop feedback control system whereby position of the plunger is controlled based on a predetermined target pressure; Page 16, microcontroller 130 generates digitized pressure reading corresponding to intraocular pressure; Page 20, paragraph 3 teaches reference pressure is converted to a corresponding reference pressure magnitude).
(d) change, by increasing or decreasing the first value of the impact attribute to set a second value for the impact attribute of the probe (Page 21, lines 3-5; Fig. 5, step 162, teaches microcontroller continuously monitors the reference pressure magnitude while continuing to increase the applanation pressure).
(e) release the probe towards the eye surface, to impact the eye surface with the second value for the impact attribute (Page 20, lines 34-35; Page 21, lines 1-2; Fig. 5, step 160 the microcontroller actuates the second plunger member 34 to apply a steadily increasing second applanation pressure).
(f) from the human, receive a second feedback in response to the impact of the probe with the second value for the impact attribute at the eye surface (Page 9, lines 25-33 teaches closed-loop feedback control system whereby position of the plunger is controlled based on a predetermined target pressure; Page 16, microcontroller 130 generates digitized pressure reading corresponding to intraocular pressure; Page 20, paragraph 3 teaches reference pressure is converted to a corresponding reference pressure magnitude).
(g) repeat steps (d) to (f) until the touch sensitivity threshold is determined as: a lowest value of sensing of the probe based on the feedback. (Page 21, lines 3-5; Fig. 5, step 164, teaches once a slight increase in the reference pressure magnitude is detected by the microcontroller, it terminates the actuation of the plunger).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Makkeli to teach “a feedback means to receive feedback from the human after the impact of the probe with the eye surface; a controller operatively coupled to the probe attachment means, the probe release means and the feedback means, wherein the controller is operable to: (a) setting a first value for an impact attribute of the probe;
(b) releasing the probe towards the eye surface, to impact the eye surface with the first value for the impact attribute; (c) from the human, receiving a first feedback in response to the impact of the probe with the first value for the impact attribute at the eye surface; (d) changing, by increasing or decreasing the first value of the impact attribute to set a second value for the impact attribute of the probe; (e) releasing the probe towards the eye surface, to impact the eye surface with the second value for the impact attribute; (f) from the human, receiving a second feedback in response to the eye surface with the second value for the impact attribute at the eye surface; (g) repeating steps (d) to (f) until the touch sensitivity threshold is determined a lowest value of sensing of the probe based on the feedback” as taught by Fresco. Doing so provides a system that is useful in determining internal pressure of a subject’s eye, which can indicate existence and/or progress of conditions such as glaucoma. (Page 1, lines 8-16).
Gandhi, in a related field of endeavor, teaches wherein the feedback means is implemented as an input device comprising at least one of a user interface, a keypad, or an audio receiver. (Paragraphs [0035], [0081]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for determining a touch sensitivity threshold at an eye surface of Makkeli as modified to teach “wherein the feedback means is implemented as an input device comprising at least one of a user interface, a keypad, or an audio receiver” as taught by Gandhi. Doing so provides a system that interactively engages with the user to provide feedback in real-time.
Regarding claim 2, Fresco teaches wherein the controller is operable to increase the value of the impact attribute until the feedback corresponds to sensing at the eye surface. (Page 21, lines 3-5; Fig. 5, step 162, teaches microcontroller continuously monitors the reference pressure magnitude while continuing to increase the applanation pressure; step 164, teaches once a slight increase in the reference pressure magnitude is detected by the microcontroller, it terminates the actuation of the plunger).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for determining a touch sensitivity threshold at an eye surface of Makkeli to teach “wherein the controller is operable to increase the value of the impact attribute until the feedback corresponds to sensing at the eye surface” of Fresco. Doing so provides a system that is useful in determining internal pressure of a subject’s eye, which can indicate existence and/or progress of conditions such as glaucoma. (Page 1, lines 8-16).
Regarding claim 3, Makkeli teaches (Figure 1) wherein the housing has a tubular form-factor (tubular probe base 105). (Abstract).
Regarding claim 4, Makkeli teaches (Figure 1A) wherein the probe attachment means is an attachment coil (induction coil 102 intended to operate also as a retainer for holding the probe 3 in place). (Page 7, lines 24-25).
Regarding claim 5, Makkeli teaches (Figure 7) a probe measurement means, wherein the probe measurement means comprises a measurement coil (102) being operable to measure current resulting from the movement of the probe after launch and rebound of the probe respectively, (Page 7, lines 14-22), and wherein the probe measurement means is operable to determine the impact attribute of the probe associated with impact of the probe with the eye surface. (Page 7, lines 5-9).
Regarding claim 6, Makkeli teaches wherein the impact attribute comprises at least one of speed. (Page 3, lines 11-15; Page 7, lines 14-15).
Regarding claim 8, Fresco teaches (Figure 1) a tonometer pressure measurement device comprising a separator part (hands-free holder 12) operatively coupled to the housing (22) wherein the separator part maintains a predefined separation between the housing and the eye surface of the human. (Page 6, lines 8-14; Page 22, lines 6-9).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for determining a touch sensitivity threshold at an eye surface of Makkeli to teach “a separator part operatively coupled to the housing wherein the separator part maintains a predefined separation between the housing and the eye surface of the human” of Fresco. Doing so provides a predefined distance range from the surface of the eye from which the plunger may be displaced. (Page 9, lines 21-30).
Regarding claim 9, Makkeli as modified teaches all of the aspects of the claim invention except “a server arrangement communicatively coupled to the controller via a communication network, wherein the server arrangement comprises a database operable to store the touch sensitivity thresholds for a plurality of humans”.
Gandhi, in a related field of endeavor, teaches a server arrangement communicatively coupled to the controller via a communication network, wherein the server arrangement comprises a database operable to store the touch sensitivity thresholds for a plurality of humans. (Paragraphs [0030]-[0035]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the system for determining a touch sensitivity threshold at an eye surface of modified Makkeli as modified to teach “a server arrangement communicatively coupled to the controller via a communication network, wherein the server arrangement comprises a database operable to store the touch sensitivity thresholds for a plurality of humans” of Gandhi. Doing so provides the predictable result of transferring and storing data of test subjects for further study and evaluation.
Regarding claim 11, Makkeli as modified teaches all of the aspects of the claim invention except “wherein the feedback means is implemented as an input device, wherein the input device comprises a user interface or one or more buttons for tactile feedback”.
Gandhi teaches wherein the feedback means is implemented as an input device, wherein the input device comprises a user interface or one or more buttons for tactile feedback, wherein, the input device comprises at least one of the user interface. (Paragraphs [0033], [0081]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for determining a touch sensitivity threshold at an eye surface of Makkeli as modified to teach “wherein the feedback means is implemented as an input device, wherein the input device comprises a user interface or one or more buttons for tactile feedback, wherein, the input device comprises at least one of a user interface” of Gandhi. Doing so provides a system that interactively engages with the user to provide feedback in real-time.
Regarding claim 12, Makkeli as modified teaches all of the aspects of the claim invention except “wherein the input device is operable to receive feedback in the form of a binary response indicating "YES" or "NO" corresponding to the sensing or senselessness of the probe’s impact”.
Gandhi teaches wherein the input device is operable to receive feedback in the form of a binary response indicating "YES" or "NO" corresponding to the sensing or senselessness of the probe’s impact. (Paragraph [0081] the test subject may have to choose between two options: "felt vibrotactile stimulation" and "did not feel vibrotactile stimulation." Hence, for example, the test subject can press one of two buttons (actual or virtual) to input the feedback into the controller.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for determining a touch sensitivity threshold at an eye surface of Makkeli as modified to teach “wherein the input device is operable to receive feedback in the form of a binary response indicating "YES" or "NO" corresponding to the sensing or senselessness of the probe’s impact” as taught by Gandhi. Doing so provides a system that interactively engages with the user to provide feedback in real-time.
Regarding claim 13, Makkeli as modified teaches all of the aspects of the claim invention except “wherein the input device is operable to receive an input by way of buttons, joystick, slider to register the touch sensitivity corresponding to the impact of the probe, rendered on the user interface”.
Gandhi teaches wherein the input device is operable to receive an input by way of buttons, joystick, slider to register the touch sensitivity rendered on the user interface (Paragraphs [0035], [0081]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for determining a touch sensitivity threshold at an eye surface of Makkeli as modified to teach “wherein the input device is operable to receive an input by way of buttons, joystick, slider to register the touch sensitivity”, as taught by Gandhi, “corresponding to the impact of the probe” of Makkeli, “rendered on the user interface” of Gandhi . Doing so provides a system that interactively engages with the user to provide feedback in real-time.
Regarding claim 14, Makkeli does not teach “wherein the first value is increased or decreased within: a predetermined step size; progressive step sizes; regressive step sizes; or using Newton-Raphson technique”.
Fresco teaches wherein the first value is increased within progressive step sizes (Page 20, lines 31-33, Page 21, lines 1-2; Fig. 3, the microcontroller actuates second plunger member 34 to apply a steadily increasing second applanation pressure).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for determining a touch sensitivity threshold at an eye surface of Makkeli as modified to teach “wherein the first value is increased within progressive step sizes” as taught by Fresco. Doing so provides a reliable way to measure eye sensitivity threshold by automating how the pressure increases.
Regarding claim 15, Makkeli does not teach “wherein the controller is operable to change the first value for the impact attribute using a ramp-up pattern comprising equal or random progressive step sizes”.
Fresco teaches wherein the controller is operable to change the first value for the impact attribute using a ramp-up pattern comprising equal or random progressive step sizes (Page 20, lines 31-33, Page 21, lines 1-2; Fig. 3, the microcontroller actuates second plunger member 34 to apply a steadily increasing second applanation pressure).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for determining a touch sensitivity threshold at an eye surface of Makkeli as modified to teach “wherein the controller is operable to change the first value for the impact attribute using a ramp-up pattern comprising equal or random progressive step sizes” as taught by Fresco. Doing so provides a reliable way to measure eye sensitivity threshold by automating how the pressure increases.
Regarding claim 16, Makkeli does not teach “wherein the controller is operable to change the first value for the impact attribute using a ramp-down pattern comprising equal or random regressive step sizes”.
Fresco contemplates wherein the controller is operable to change the first value for the impact attribute using a ramp-down pattern comprising equal or random regressive step sizes (Page 20, lines 31-33, Page 21, lines 1-2; Fig. 3, the microcontroller actuates second plunger member 34 to apply a steadily increasing second applanation pressure).
Although Fresco specifically teaches applying steadily increasing pressure to the eye, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for determining a touch sensitivity threshold at an eye surface of Makkeli as modified to teach “wherein the controller is operable to change the first value for the impact attribute using a ramp-down pattern comprising equal or random regressive step sizes”, as contemplated by Fresco. Using a step-by-step pattern—whether going up or down—requires ordinary programming skills and is a standard engineering method for fine-tuning electronic and mechanical controls.
Regarding claim 18, Makkeli teaches wherein the probe measurement means is operable to measure the current induced by movement of the probe to determine the impact attribute. (Page 7, lines 5-9, 14-22).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Makkeli in view of Fresco and Gandhi, further in view of Tolman (U.S. 2656715).
Regarding claim 7, Makkeli as modified teaches all of the aspects of the claim invention except “wherein the probe is associated with at least one of: a predetermined weight, or a predefined form-factor”.
Tolman, in a related field of endeavor, teaches an ocular tension indicator wherein the probe is associated with a predefined weight (Col. 1, lines 21-26).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for determining a touch sensitivity threshold at an eye surface of Makkeli as modified to teach “wherein the probe is associated with a predefined weight” of Tolman. Doing so provides a well-known design consideration to yield predictable results of measuring ocular pressure.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Makkeli in view of Fresco, and Gandhi, further in view of Brammer (U.S. 5433211).
Regarding claim 10, Makkeli as modified teaches all of the aspects of the claim invention except “wherein the server arrangement is operable to: determine a reference touch sensitivity threshold using the touch sensitivity thresholds of the plurality of humans; and store the reference touch sensitivity threshold within the database, and optionally the controller is further operable to: receive the reference touch sensitivity threshold from the server arrangement; determine a difference between the touch sensitivity threshold of the human and the reference touch sensitivity threshold; and correlate the difference with a potential medical condition for the human”.
Brammer, in a related field of endeavor, teaches a method of identifying vibrotactile perception thresholds of tactile nerve endings at a skin site of a subject. Brammer teaches a server arrangement (PC computer) is operable to determine a reference touch sensitivity threshold using the touch sensitivity thresholds of the plurality of humans; and store the reference touch sensitivity threshold within the database, and optionally the controller (20) is further operable to receive the reference touch sensitivity threshold from the server arrangement; determine a difference between the touch sensitivity threshold of the human and the reference touch sensitivity threshold; and correlate the difference with a potential medical condition for the human. (Abstract; Col. 2, lines 17-59; Col. 4, lines 4-30).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for determining a touch sensitivity threshold at an eye surface of Makkeli as modified to teach wherein “a server arrangement is operable to determine a reference touch sensitivity threshold using the touch sensitivity thresholds of the plurality of humans; and store the reference touch sensitivity threshold within the database, and optionally the controller is further operable to receive the reference touch sensitivity threshold from the server arrangement; determine a difference between the touch sensitivity threshold of the human and the reference touch sensitivity threshold; and correlate the difference with a potential medical condition for the human” of Brammer. Doing so provides a system that evaluates tactile performance and establishes diseases and conditions in which selective sensory loss occurs, for use in differential diagnosis, in both clinical and occupational medicine. (Col. 11, lines 44-53).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Makkeli in view of Fresco, and Gandhi, further in view of Abreu (WO 0025662).
Regarding claim 17, Abreu as modified teaches all of the aspects of the claim invention except “wherein the separator part is fabricated using a bio-compatible material.”
Abreu, in a related field of endeavor, teaches (Fig. 1) wherein the separator part (Abstract, encasement of contact device 2 placed on the front part of the eye 4) is fabricated using a bio-compatible material. (Page 32, lines 3-7).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for determining a touch sensitivity threshold at an eye surface of Makkeli as modified to teach “wherein the separator part is fabricated using a bio-compatible material”. Doing so provides a non-toxic, non-irritating, and chemically inert material that promotes the function of protecting and interfacing with biological tissue and provides a seal against fluid penetration. (Page 32, line 7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/ Examiner, Art Unit 3791
/ETSUB D BERHANU/ Primary Examiner, Art Unit 3791
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