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 .
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because abstract is 152 words, thereby exceeding the limit. 37 CFR 1.72 requires that the abstract may not exceed 150 words. Correction is required. See MPEP § 608.01(b).
Claim Objections
Claims 19, 21, and 25 are objected to because of the following informalities:
Claim 19 reads “downloading stimulation data” in line 2, but should read “download stimulation data”.
Claim 21 reads “from the connected, and” in line 6, but should read “from the connected device, and”.
Claim 25 reads “a magnet core is configured” in line 2, but should read “a magnet core that is configured”.
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 1-27 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 "orifice at the eyelid margin" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “orifice at an eyelid margin” and suggests amending to clarify.
Claims 2-3 are rejected based on their dependency on claim 1.
Claim 4 recites the limitation "control the operation" in line 5. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “control an operation” and suggests amending to clarify.
Claims 5-8 are rejected based on their dependency on claim 1.
Claim 9 recites the limitation "raise the position of the heating elements so that they project from the eyelid side of the underlid device to increase the local pressure" in lines 3-5. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “raise a position of the heating elements so that they project from the eyelid side of the underlid device to increase a local pressure” and suggests amending to clarify.
Claim 10 recites the limitation "decrease in the amount of heat" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “decrease in an amount of heat” and suggests amending to clarify.
Claim 11 recites the limitation "the magnetic attraction" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “a magnetic attraction” and suggests amending to clarify.
Claim 12 recites the limitation "the applied squeeze pressure" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret this claim as dependent from claim 11 and suggests amending to clarify.
Claims 13-15 are rejected based on their dependency on claim 1.
Claim 16 recites the limitation "that includes one or processors" in line 3. This limitation is rendered unclear. Examiner will interpret as “that includes one of processors” and suggests amending to clarify.
Claim 17 recites the limitation "controls the operation of the stimulator wand" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “controls an operation of the stimulator wand” and suggests amending to clarify.
Claims 18-22 are rejected based on their dependency on claim 1.
Claim 23 recites the limitation "tracking the position" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “tracking a position” and suggests amending to clarify.
Claim 24 recites the limitation "controls the operation" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “controls an operation” and suggests amending to clarify.
Claim 25 is rejected based on its dependency on claim 1.
Claim 26 recites the limitation "comprising the steps of" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “comprising steps of” and suggests amending to clarify.
Claim 26 recites the limitation "of the upper or lower" in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “of an upper or lower” and suggests amending to clarify.
Claim 26 recites the limitation "positioning the tip of the stimulator wand close to the outside surface" in line 6. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “positioning a tip of the stimulator wand close to the outer surface” and suggests amending to clarify.
Claim 27 recites the limitation "comprising the step of" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “comprising a step of” and suggests amending to clarify.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-17, 19-20, and 22-27 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 11,446,495 Azar et al., hereinafter “Azar”.
Regarding claim 1, Azar discloses a stimulator system (System shown in Figure 11A and Abstract) for massaging an eyelid (Col. 4, lines 30-34) to move meibum through a meibomian gland duct toward a gland duct orifice at an eyelid margin in order to clear meibum blockage in the gland duct (Col. 9, lines 2-5, Col. 12, lines 9-12, and Col. 14, lines 50-52; This is also an intended use limitation), comprising: an underlid device (Figure 3A, element 300, also shown in Figure 11A, element 200) configured to be positioned between the eyelid and the eyeball surface (See placement in Figure 8 that shows the underlid device between the sclera and lower eyelid), the underlid device comprising a ferromagnetic element (Col. 10, lines 22-25 and 37-42); a stimulator wand (Figure 10, element 1010 or Figure 11, element 1110) comprising an electromagnet (Figure 15A, element 1530 and Col. 11, lines 4-5) configured to produce an electromagnetic (EM) field (Col. 12, lines 22-33); wherein the stimulator wand is configured to be positioned against an outer surface of the eyelid (See Figure 11A), and the electromagnet is configured to be energized so that the EM field acts on the ferromagnetic element in the underlid device to magnetically couple the stimulator wand to the underlid device (Col. 9, lines 31-333, Col. 11, lines 41-43, and Col. 12, lines 34-28).
Regarding claim 2, Azar discloses the underlid device (Figure 5A, element 500) further comprises one or more heating elements (Figure 5A, element 520) and an RF receiver antenna (Figure 5A, element 350) for powering the heating elements via an inducted current generated in the RF receiver antenna (Col. 11, lines 45-47 and 58-61), wherein the stimulator wand (Figure 15A, element 1500) comprises an RF transmitter antenna (Figure 15A, element 1520) configured to generate an RF signal that acts on the RF receiver antenna of the underlid device to induce the current in the RF receiver antenna (Col. 11, lines 45-53; Also note “to induce the current in the RF receiver antenna” is an intended use limitation, examiner suggests using “configured to” language to positively recite that limitation).
Regarding claim 3, Azar discloses the EM field produced by the electromagnet is oscillating and induces oscillatory movement in the underlid device configured to apply a massaging motion to the meibomian glands while, at the same time, heating the glands via the heating elements (Col. 12, lines 57-60 and Col. 14, lines 50-56).
Regarding claim 4, Azar discloses the underlid device (Figure 3B, element 300) further comprises an integrated circuit (IC) (Figure 3B, element 370) that is electrically connected to the RF receiver antenna (Figure 3B shows the electrical connection between 370 and 350) and to the heating elements (Col. 10, lines 11-13), the IC being configured to rectify power harvested via the RF receiver antenna, to distribute power to the heating elements (Col. 10, lines 11-13), and to control an operation of the heating elements (Col. 6, lines 33-36).
Regarding claim 5, Azar discloses the underlid device further comprises one or more temperature probes distributed on the underlid device (Col. 10, lines 13-15) and used by the IC to sense the temperature of the device for purposes of safety and control of the heating elements (Col. 10, lines 11-15; also note “for purposes of safety” is an intended use limitation, examiner suggests using “configured to” language to positively recite that limitation).
Regarding claim 6, Azar discloses the heating element (Figure 13A shows heating element on top of stack 1380) and ferromagnetic element are arranged in a thin stack on the underlid device (See Figures 13A and 14 heating element sits in a stack over element 1380; 1380 is a magnetic stack formed of 1385 which is the ferromagnetic element), wherein each thin stack comprises a reflective thermal heat shield (Figure 14, element 1375) positioned adjacent the heating element (See Figures 13A and 14; heating element sits on top of 1380 which contains the first stack being 1375, the heat shield) and a low absorption (k) thermal insulating material adjacent the ferromagnetic element (Figure 14, element 1390 is adjacent 1385).
Regarding claim 7, Azar discloses the underlid device (Figure 5A, element 500) comprises a body of overmold material that encapsulates the underlid device (Figure 5A, element 385).
Regarding claim 8, Azar discloses the body of overmold material (Figure 5A, element 385) comprises a silicone hydrogel material (Col. 5, lines 19-23).
Regarding claim 9, Azar discloses the underlid device (Figure 13C, element 1300) comprises recesses (Figure 13C, element 1395) formed around the heating elements on the eyelid side of the device (Figure 13C, element 1320; elements 1395 surround 1320), the recesses being configured to effectively raise a position of the heating elements so that they project from the eyelid side of the underlid device (See Figure 13C and Col. 10, lines 44-48) to increase a local pressure with which the heating elements are held against the eyelid and meibomian glands to improve heat transfer from the heating elements to the eyelid (Col. 10, lines 44-48; also note this is a statement of intended use, examiner suggests using “configured to” language to positively recite that limitation).
Regarding claim 10, Azar discloses the RF signal can be modulated to increase/decrease its strength or amplitude in order to produce a corresponding increase/decrease in an amount of heat applied by the underlid device (Col. 11, lines 19-24; also note “in order to produce” is a statement of intended use, examiner suggests using “configured to” language to positively recite that limitation).
Regarding claim 11, Azar discloses a magnetic attraction between the stimulator wand and the underlid device creates a mechanical force that exerts pressure on the eyelid (Col. 10, lines 37-42), squeezing the eyelid between the stimulator wand and the underlid device (Col. 10, lines 37-42).
Regarding claim 12, Azar discloses the stimulator wand includes a pressure sensor (Figure 15C, element 1510 and Col. 10, line 64) configured to sense the applied squeeze pressure (Col. 11, lines 27-29).
Regarding claim 13, Azar discloses the stimulator wand is configured to modulate the magnetic field produced by the electromagnet in order to induce a corresponding pulsatory and/or vibrational movement of the magnetically coupled underlid device (Col. 10, lines 48-51, Col. 11, lines 50-53, and Col. 13, lines 4-5; also note “in order to induce a corresponding pulsatory and/or vibrational movement” is a statement of intended use, examiner suggests using “configured to” language to positively recite that limitation).
Regarding claim 14, Azar discloses the RF signal emitted by the stimulator wand is generated via an adjustable alternating current (AC) signal (Col. 11, lines 58-31), and the magnetic field emitted by the stimulator wand is generated via a switchable direct current (DC) signal (Col. 11, lines 58-31).
Regarding claim 15, Azar discloses the electromagnet comprises electromagnetic (EM) coil wrapped around a ferrite core (Col. 11, lines 4-5).
Regarding claim 16, Azar discloses the stimulator wand (Figure 15C, element 1500) includes an electronics module (Figure 15C, element 1540) comprising an application-specific integrated circuit (ASIC) (Col. 11, lines 6-9) that includes one of processors, memory devices, communication radios, and digital devices for switching/modulating power to the RF transmitting antenna and electromagnet (Col. 9, lines 39-44 and Col. 11, lines 6-9).
Regarding claim 17, Azar discloses the processor is configured to execute a software application that controls an operation of the stimulator wand and its components, the stimulator application, settings, and other data/applications being stored in the memory (Col. 9, lines 39-44, Col. 11, lines 9-15), and the communication radio is configured to communicate with a connected device running a custom application (Col. 12, lines 39-42 and Col. 13, lines 15-33).
Regarding claim 19, Azar discloses the communication radio is configured to download stimulation data from the stimulation wand to the connected device (Col. 13, lines 16-33).
Regarding claim 20, Azar discloses the downloaded data can include user inputs, stimulator settings safety settings and parameters, applied pressure, wand motion, treatment day/date/time, treatment schedule and reminders, treatment frequency and duration, and querying and recording effectiveness of treatment (Col. 13, lines 16-33; some of this data is included such as stimulator settings, treatment time, type of stimulation, effectiveness of treatment).
Regarding claim 22, Azar discloses the connected device comprises a smartphone (Col. 13, lines 16-33).
Regarding claim 23, Azar discloses the stimulator wand comprises an onboard accelerometer and/or gyroscope for tracking a position, attitude, and motion of the stimulator wand (Col. 12, lines 44-47).
Regarding claim 24, Azar discloses the stimulator wand (Figure 15A, element 1500) comprises a user interface to the electronics module (Figure 15A, element 1560), wherein the electronics module controls an operation of the RF antenna and EM coil in response to inputs received via the user interface (Col. 11, lines 4-15).
Regarding claim 25, Azar discloses the electromagnet comprises a magnet core (Col. 11, lines 4-5) that is configured to produce a magnetic field in which the electromagnetic field coupling (Col. 12, lines 22-33) and electromagnetic field gradient creates lateral forces on the underlid device to constrain movement of the underlid device (Col. 12, lines 36-38; also note “to constrain movement of the underlid device” is intended use language, examiner suggests using “configured to” language to positively recite that limitation).
Regarding claim 26, Azar discloses a method for treating meibomian gland dysfunction (MGD) (Abstract, Col. 9, lines 2-5, Col. 12, lines 9-12, and Col. 14, lines 50-52), comprising steps of: providing the stimulator system (System shown in Figure 11A and Abstract) recited of claim 2; inserting the underlid device in the underlid region of an upper or lower eyelid (Figure 20, element 1910); positioning a tip of the stimulator wand close to the outer surface of the eyelid proximate to the underlid region where the underlid device is positioned (See this placement in Figure 17A; Col. 12, line 65); activating the stimulator wand to initiate the transmission of RF energy to the heating elements to apply heat to the eyelid via the underlid device (Col. 12, line 66, also note “to apply heat” and “to initiate” are intended use language, examiner suggests using “configured to” language to positively recite those limitations); energizing the EM coil so that the electromagnet attracts the underlid device so that the stimulator wand and the underlid device are magnetically coupled and apply a squeeze pressure to the eyelid between the underlid device and the stimulator wand (Col. 13, lines 4-11); and modulating the EM current to produce pulsation in the squeeze pressure (Col. 13, lines 4-11, also note “to produce pulsation” is intended use language, examiner suggests using “configured to” language to positively recite that limitation).
Regarding claim 27, Azar discloses a step of utilizing the magnetic coupling between the stimulator wand and the underlid device to slide the underlid device along the eyelid to mechanically stimulate meibomian glands in a "wiping" motion for expressing the meibum from the glands and/or to move the underlid device to another treatment area by repositioning the stimulator wand (Col. 13, lines 9-16).
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.
Claim(s) 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 11,446,495 Azar et al., hereinafter “Azar”, in view of US 2017/0173262 Veltz et al., hereinafter “Veltz”.
Regarding claim 18, Azar discloses all the limitations of claim 16.
Azar does not disclose the communication radio is configured to upload program data, settings, software/firmware updates, and any other data from the connected device to the stimulator wand.
However, Veltz discloses a medical system (Abstract) and teaches the communication radio (Figure 2, elements 215 and 216 and Para 329 and 350) is configured to upload program data (Para 41; a user may input their data), settings (Para 14; the smart device can control the operation of the medical device via communications), software/firmware updates (Para 147-149), and any other data from the connected device to the stimulator wand (Para 372).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a communication radio capable of implementing changes as taught by Veltz, in the invention of Azar, in order to control all software applications using a smartphone of the user (Para 34).
Regarding claim 21, Azar discloses all the limitations of claim 17.
Azar does not disclose the connected device is configured to utilize internet connectivity to act as an interface between the stimulator wand and the internet, wherein the internet connectivity enables software/firmware updates, stimulator settings, and other data to be downloaded to the connected device from the internet and then uploaded to the stimulator wand from the connected device, and wherein the internet connectivity enables stimulator settings, logged stimulator data, and other date to be downloaded from the stimulator wand to the connected device, and uploaded from the connected device to the internet.
However, Veltz teaches the connected device is configured to utilize internet connectivity to act as an interface between the stimulator wand and the internet (Para 136), wherein the internet connectivity enables software/firmware updates (Para 147-149), stimulator settings (Para 14; the smart device can control the operation of the medical device via communications), and other data to be downloaded to the connected device from the internet (Para 372) and then uploaded to the stimulator wand from the connected device (Para 41; a user may input their data), and wherein the internet connectivity (Figure 2, elements 215 and 216 and Para 329 and 350) enables stimulator settings (Para 14; the smart device can control the operation of the medical device via communications), logged stimulator data (Para 41), and other date to be downloaded from the stimulator wand to the connected device, and uploaded from the connected device to the internet (Para 371).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a communication radio capable of implementing changes as taught by Veltz, in the invention of Azar, in order to control all software applications using a smartphone of the user (Para 34).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached on (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796