DETAILED ACTION
Claim Objections
Claim 4 is objected to because of the following informalities: "wherein the device wherein the plurality of cantilever sensors" should be “wherein the plurality of cantilever sensors”. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: “claim 16” should be “claim 16,”. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: “recommend a change a therapy” should be “recommend a change to a therapy”. Appropriate correction is required.
Claim 26 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. Claim 26 is dependent on both claim 25 while also referring back to claim 1. See MPEP § 608.01(n).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 8, 12, 14, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9, 12, 13, 16, 18, 28, and 29 of copending Application No. 17/799,100 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite a self-sensing cantilver coupled to a base positioned adjacent to a corneal surface, the base coupled to a contact lens, a plurality of such cantilevers, and obtaining IOP from corneal Young’s modulus together with the radius of curvature and thickness. The instant claims differ only in reciting the tip’s force application, which the copending claims inherently encompass.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 22 and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter.
Claims 22 and 23 are each drawn to “a software application” without any structural limitations and is thus directed to “software per se”, a product that has no physical or tangible form. Accordingly, it does not recite one of the four categories of patentable subject matter (see MPEP 2106.03). Applicant is advised to amend the claims to recite “A non-transitory computer-readable storage medium storing a software application for use …” instead. It is noted that the recitation of a device in the preamble (i.e. “for use with a device”) is an intended-use recitation and does not make the recited claims patent eligible subject matter.
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 21 and 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 21 recites “communicate with an external data”. It is unclear what “external data” is. For purposes of interpretation, it has been understood as “external device”, consistent with what is disclosed within the specification (e.g. [0011] of the printed publication).
Claim 27 recites “facilitate transmission of data from the device to a storage device”. As “a storage device” is already recited in the preamble, it is unclear whether the recited destination is the claimed storage device or to a separate, distinct storage device.
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, 2, 8, 13-14, 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Knight et al. (WO 2021/163535). It is noted that for ease of access, all citations are from paragraphs to the US counterpart to the stated PCT publication (US 2023/0070316)
As to claim 1, Knight teaches a device for assessing intra-ocular pressure (IOP) of a patient’s eye ([0031]), the device comprising: (a) a wearable contact lens ([0028] – device can be coupled to a contact lens); and (b) at least one cantilever sensor mounted to the contact lens ([0028] – contact lens with self-sensing cantilevers), the cantilever sensor configured to measure an elasticity of a cornea of the patient’s eye and/or an IOP of the patient’s eye ([0031]); wherein the contact lens is configured to position the at least one cantilever sensor adjacent to a surface of the cornea of the patient’s eye ([0028] – positioning the cantilevers adjacent to the corneal surface), and wherein the cantilever sensor comprises a cantilever tip configured to apply a force to the surface of the cornea ([0023]; [0037] – deflection of cantilever is proportion to the force the tip exerts).
As to claim 2, Knight teaches the cantilever is curved to conform to the surface of the cornea ([0023] – cantilever with tip exhibiting a radius of curvature; [0026] – the curvature addressing the contour of the ocular environment).
As to claim 8, Knight teaches the contact lens is a corneal contact lens ([0028]).
As to claim 13, Knight teaches an antenna coupled to the at least one cantilever sensor, the antenna configured to transmit data regarding measured elasticity and/or IOP to an external device ([0028] – wireless data transmission apparatus for transmitting to an external device).
As to claim 14, Knight teaches the antenna is configured to transmit data to the external device wirelessly ([0028]).
As to claim 18, Knight teaches the device is further configured to be calibrated to determine IOP based on one or more patient specific parameters ([0030-31], [0033]).
As to claim 19, Knight teaches the device is calibrated to determine IOP based on a measured corneal thickness of the patient’s eye ([0032])
As to claim 20, Knight teaches the device is calibrated to determine IOP based on a measured corneal radius of curvature of the patient’s eye ([0032]).
As to claim 21, Knight teaches the wearable contact lens further comprises at least one application-specific integrated circuit (“ASIC”) operably coupled to the at least one cantilever sensor ([0023]), the ASIC configured to perform one or more of the following: control actuation of the at least one cantilever sensor ([0023]); control data flow to and from the at least one cantilever sensor ([0024]); receive electrical power from a battery or a capacitor ([0024]); and communicate with an external data via an antenna disposed on the wearable contact lens ([0028]).
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) 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knight et al. (WO 2021/163535) (see (US 2023/0070316) for citations) in view of Pugh (US 2015/0148648).
As to claim 3, while Knight teaches the device comprises a plurality of cantilever sensors ([0023] – plurality of cantilevers), it does not expressly teach that they are disposed outside a central optical zone of the contact lens. Hugh teaches ophthalmic lens with an intraocular pressure monitoring system (Abstract) and teaches that the sensors are placed outside the central optical zone ([0052] – electronic elements located outside of the optical zone), so that the device does not interfere with the patient’s sight ([0052]). Accordingly, it would have been obvious to modify Knight with Pugh to place the sensors outside the central optical zone so that they do not impair the vision of the user.
As to claim 4, Hugh teaches disposing the sensor a paracentral zone of the contact lens (Fig. 3 – 330, 331, 332 located in the paracentral zone; [0058] – media insert 320 in one of said layers 330-332).
As to claim 5, the above combination results in a plurality of sensors disposed outside the central optical zone of the contact lens (see claim 3). The above combination does not expressly teach computing an average elasticity of the cornea and/or an average IOP of the patient’s eye. However, Knight does point out that the use of an array of cantilevers provides additional data points for analysis with each sensor allowing continuous measurement ([0028]). The examiner gives official notice that averaging data is one of the most basic forms of analyzing multiple data points that were measured, which allows for smoothing of data to remove the effects of outliers, and would have been obvious to incorporate further into the combination.
As to claim 6, Knight teaches a processor ([0028]) which can be configured to compute said average elasticity and/or average IOP.
As to claim 7, Knight teaches an antenna ([0028] – wireless data transmission apparatus for transmitting to an external device), which can be configured to transmit data regarding the average elasticity and/or the average IOP to an external device.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knight et al. (WO 2021/163535) (see (US 2023/0070316) for citations) in view of Chen et al. (Capacitive contact lens sensor for continuous non-invasive intraocular pressure monitoring)
As to claim 9, Knight does not expressly teach that the corneal contact lens has a diameter of less than 14.5 mm. Chen teaches a contact lens for continuous intraocular pressure monitoring where the device has a diameter of 14 mm (Abstract). The examiner notes that typical contact lenses have a diameter between 13.8 and 14.5 mm. As such, it would’ve been obvious to modify Knight with Chen to utilize a contact lens diameter that is known to fit most people.
Claim(s) 10 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knight et al. (WO 2021/163535) (see (US 2023/0070316) for citations) in view of Abreu (US 2002/0049389).
As to claim 10, while Knight teaches that the device may comprise a skirt or other feature for contacting the sclera of the eye to aid in positioning ([0028]), it does not expressly teach that it is a scleral contact lens. Abreu teaches a contact device placed on the eye to detect various parameters (Abstract) including intraocular pressure ([0130]) and teaches that the contact device could be a scleral lens covering the whole anterior surface of the eye ([0146]). It would have been obvious to modify Knight with Abreu to utilize a scleral contact lens for various reasons, including as a treatment device for various eye-related conditions or as part of a cosmetic lens.
As to claim 16, Knight fails to teach the device further comprises a drug within the contact lens, the drug configured to be eluted from the contact lens to the patient. Abreu teaches the device could be used as a means of delivering drugs non-invasively ([0130-0132]). It would have been obvious to modify Knight with Abreu to allow treatment directly from the device.
As to claim 17, Abreu teaches the drug is eluted to the patient’s eye based upon a measured elasticity value and/or IOP value exceeding a threshold ([0130] – increased IOP).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knight et al. (WO 2021/163535) (see (US 2023/0070316) for citations) in view of Abreu (US 2002/0049389), and further in view of Legerton et al. (US 2010/0271589).
As to claim 11, the above combination fails to expressly teach that the scleral contact lens comprises an outer scleral skirt formed of a first material that is different from a second material forming an inner portion of the scleral contact lens. Legerton teaches a way of making sceleral contact lens in which the lens material can be configured as hybrid bimodulus lenses ([0020]), which comprise a rigid center material surrounded by a soft flexible material ([0005]). It would have been obvious to modify the above combination with Legerton, to create a hybrid scleral contact lens, to allow for vision correction while still allowing for comfort.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knight et al. (WO 2021/163535) (see (US 2023/0070316) for citations) in view of Legerton et al. (US 2010/0271589).
As to claim 12, Knight fails to expressly teach the contact lens is a hybrid contact lens. Legerton teaches a way of making contact lens in which the lens material can be configured as hybrid bimodulus lenses ([0020]). It would have been obvious to modify Knight with Legerton, to create a hybrid scleral contact lens, to allow for vision correction while still allowing for comfort.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knight et al. (WO 2021/163535) (see (US 2023/0070316) for citations) in view of Wallace (US 2019/0150736).
As to claim 15, Knight does not teach the external device is configured to upload the transmitted data to a cloud database. Wallace teaches an IOP measuring device (Abstract) in which the IOP measurements are communicated/uploaded to a cloud-based database server ([0043]). It would have been obvious to modify Knight with Wallace to enable the transmission of data to remote physicians and/or for storage purposes.
Claim(s) 22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knight et al. (WO 2021/163535) (see (US 2023/0070316) for citations) in view of Lai et al. (US 2017/0280997).
As to claims 22 and 24, Knight teaches the device in full (see claim 1). It fails to expressly teach a software application including a patient user interface configured to cause one or more of the following actions to be performed in response to the measured elasticity value and/or the IOP value exceeding a threshold: (a) contact a physician, (b) recommend changing a therapy, or (c) make no changes.
Lai teaches an application ([0055]) including a patient user interface ([0035]) which warns the patient when the IOP is higher than a threshold value ([0056]) as well as the physician ([0058]). It would have been obvious to modify Knight with Lai to allow the physician to be alerted as soon as the IOP exceeds a threshold so that they can treat the patient quickly.
Claim(s) 23 and 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knight et al. (WO 2021/163535) (see (US 2023/0070316) for citations) in view of Gutierrez (US 2019/0380871).
As to claims 23 and 25, Knight teaches the device of claim 1. It fails to expressly teach a software application including a physician user interface configured to cause one or more of the following actions to be performed: (a) contact a patient, (b) recommend a change a therapy, or (c) make no changes.
Gutierrez teaches eye-mountable therapeutic devices (Abstract) including a physician user interface configured to recommend a change in therapy ([0057]). It would have been obvious to modify Knight with Gutierrez with the physician user interface to allow the physician to react to user’s condition to adjust therapy.
As to claim 26, Gutierrez teaches receive an indication of user input to change the therapy to a secondary therapy; and send instructions to the device of claim 1 to implement the secondary therapy ([0057] – change dosage and/or dosing schedule).
As to claim 27, Knight teaches the device of claim 1. Knight fails to expressly teach a storage device comprising a housing for holding the device, the housing configured to perform one or more of the following functions: store the device in a cleaning solution to clean the wearable contact lens and the at least one cantilever sensor of the device; store the device in a medicated solution to load the wearable contact lens of the device with the medicated solution while the device is stored in the housing; deliver electrical power to charge a power supply and/or a battery of the device while the device is stored in the housing; facilitate transmission of data from the device to a storage device; and facilitate transmission of data and/or instructions to the device from an external device.
Gutierrez teaches a storage container (130) comprising a fluid reservoir for storing the device overnight, the fluid reservoir containing cleaning solution, inductive chargers, and wireless communication devices ([0036]). It would have been obvious to modify Knight with Gutierrez to allow for cleaning and charging of the device when not in use.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 9/2/26
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