DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group 1 in the reply filed on 1/8/2026 is acknowledged.
Claims 18-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/8/2026.
Claims 1-17 remain pending and under prosecution.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore,
the base of Claim 1
the base is a ring of Claim 3
the cantilever tip faces inward from the ring perimeter of Claim 4
the cantilever tip faces outward from the ring perimeter of Claim 5
the self-sensing cantilever is coupled to the base at an incline of Claim 6
the base is coupled to a prism of an applanation tonometer of Claim 10
the prism comprises a contoured surface for assessing curvature of the corneal surface of Claim 11
must be shown with reference numbers or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 12-13 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding Claim 12, the claim given its broadest reasonable interpretation, reads on a portion of the human body such as a corneal lens of the human body (in claim 13). Claim 12 positively recites the corneal lens given the “coupled to a lens” language. To correct this, it is suggested the claim recite “configured to” language to avoid positive recitation of the human body.
Claim Objections
Claims 2 and 4-6 are objected to because of the following informalities:
The claims should recite “the at least one self-sensing cantilever” as introduced in Claim 1.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim elements are interpreted under 112(f).
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 4-5 and 12-13 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.
In regard to Claims 4-5, “the cantilever tip” lacks proper antecedent basis, as evidenced by the Drawing objection above. Since the disclosure is silent as to any further details, it is unclear what structure constitutes the cantilever tip as recited.
In regard to Claims 12-13, it is unclear if the lens recited is the same or different from the corneal surface recited in Claim 1. Clarification is requested.
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) 1-9 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Francois (US Pub No. 20170086668 – cited by applicant).
In regard to Claim 1, Francois discloses a device for determining one or more corneal biomechanical properties comprising:
at least one self-sensing cantilever 122 – “two piezoelectric cantilevers 122” (0062), best seen in Figure 7,
calibrated against a control of known biomechanical properties – “the motion of the inertial element 112 [microbubble] is sensed by the cantilever pairs, thus measuring angular acceleration” (0061, 0062) – thus the cantilever is considered calibrated against the control of the known biomechanical property of the inertial element and the lens 110, 210 on which the self-sensing cantilever and inertial elements are disposed (0062), as broadly as has been claimed,
wherein the self-sensing cantilever is coupled to a base 110, 210 (lens) configured to position the self-sensing cantilever adjacent to or in contact with a corneal surface – “MEMS-based position-sensing system and lenses, for example, contact lenses and intra-ocular lenses” (abst), best seen in Figure 1A-B and 2A-B (0060, 0066).
2. The device of claim 1, wherein the self-sensing cantilever comprises piezo-resistive electrical circuitry for determining cantilever deflection – “Conducting leads 124 connect the piezoelectric cantilevers 122 to micro-circuitry of the lens (not shown) and permit transfer of the signal from the piezoelectric cantilevers to said micro-circuitry” (0062).
3. The device of claim 1, wherein the base 110, 210 is a ring – ring-shaped microchannels 108a,b,c or 208a,b,c, best seen in Figure 1A-B or 2A-B, respectively – “the lens 110 provides three micro-channel structures for position-sensing capabilities… the micro-channels 108a, 108b, 108c” (0060, 0066), which comprise the self-sensing cantilever 122, shown disposed within microchannel 108a in Figure 7 (0062).
4. The device of claim 3, wherein the cantilever tip 122 faces inward from the ring perimeter of micro-channel 108, as broadly as has been claimed, best seen in Figure 7. See 112 rejection above.
5. The device of claim 3, wherein the cantilever tip 122 faces outward from the ring perimeter of micro-channel 108, as broadly as has been claimed, best seen in Figure 7. See 112 rejection above.
6. The device of claim 1, wherein the self-sensing cantilever 122 is coupled to the base 210 at an incline, best seen in Figure 2B – the self-sensing cantilever 122 is disposed within micro-channel 208a (as similarly disclosed in Figure 7), which is oriented at an incline or angle – “as shown in the illustrative FIG. 2B, the microchannel 208a is projected at an angle with respect to the lens” (0066).
7. The device of claim 1 further comprising a power source coupled to the base – “Powering the system described in herein can be accomplished in a myriad of ways described in the art. In one embodiment, photovoltaic or induction is the source of power” (0104).
8. The device of claim 1 further comprising a data storage and/or data transmission components 500, 600, best seen in Figure 5-6 – “implementations of the systems and techniques described here can be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and/or combinations thereof… including at least one programmable processor, which may be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system” (0100).
9. The device of claim 1 comprising a plurality of self-sensing cantilevers 122, wherein three pairs are shown in Figure 7 (0062).
12. The device of claim 1, wherein the base is coupled to a lens 110, 210, best seen in Figure 1A-B or 2A-B. See 112 and 101 rejections above.
13. The device of claim 12, wherein the lens 110, 210 is a contact lens or corneal lens, best seen in Figure 1-2 (abst). See 112 and 101 rejections above.
14. The device of claim 1, wherein the control comprises corneal tissue – since the self-sensing cantilever 122 is disposed on a lens 110, 210 used on corneal tissue (abst), the cantilever is considered calibrated against the control of the known biomechanical property of corneal tissue as broadly as has been claimed (0062)
Claim(s) 1 and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Last et al (“The Applications of Atomic Force Microscopy to Vision Science”; Investigative Ophthalmology & Visual Science. 2010 Dec).
In regard to Claim 1, Last et al disclose a device for determining one or more corneal biomechanical properties comprising:
at least one self-sensing cantilever – best seen in Figure 2 – as used with AFM – “A variety of techniques have been used to measure mechanical properties of the cornea, such as tensile testing and bulge testing. These methods, however, do not have the force sensitivity necessary to measure the mechanical properties of distinct spatially limited regions within the cornea such as the basement membranes or Bowman's layer. The AFM can uniquely provide the elastic modulus measurements of these layers” (AFM Studies of the Eye – Cornea section)
calibrated against a control of known biomechanical properties – “Accurate determination of the elastic modulus requires accurate calibration of the system, including the scanner and the cantilever… Each cantilever must also be calibrated so that the deflection sensitivity and the spring constant are known,” (Assumptions and Challenges section),
wherein the self-sensing cantilever is coupled to a base – best seen in Figure 2 – configured to position the self-sensing cantilever adjacent to or in contact with a corneal surface – “Corneal epithelial and endothelial cells and surfaces have been characterized with AFM” (AFM Studies of the Eye – Cornea section).
15. The device of claim 1, wherein the control is a synthetic cornea – “understanding the behavior of retinal cells on synthetic surfaces is critical for tissue engineering applications. Although cell attachment and proliferation on the synthetic surfaces can be monitored with optical microscopy, AFM can be used to quantitatively determine the nanoscale roughness of the surface” (AFM Studies of the Eye – Retinal Cells section).
16. The device of claim 1, wherein the one or more biomechanical properties include corneal Young's modulus – “AFM force maps were also used to characterize the mechanical properties of human retinal pigment epithelium melanosomes from a 14-year-old donor and from a 76-year-old donor to evaluate potential age-related changes.72 These studies revealed that though the average Young's moduli of both sets of melanosomes were similar” (AFM Studies of the Eye – Retinal Cells section).
17. The device of claim 1, wherein the self-sensing cantilever has a tip radius less than 50 nm – “AFM cantilevers with varying tip shapes are available. The standard geometry is of an integrated pyramidal tip with an end radius of 20 to 30 nm” (Assumptions and Challenges – Tip and Cantilever Selection and Tip Functionalization section).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Last et al as applied to claim 1, further in view of Bruce et al (US Pub No. 20050182312).
Last et al disclose the invention above but do not expressly disclose the base is coupled to a prism of an applanation tonometer.
Last et al do disclose that the mechanical properties of the eye has a role in glaucoma, which is well-understood in the art as a condition of having elevated intraocular pressure – “This review will describe how mechanical properties measurements have impacted vision sciences, including studies on the lens, the corneal basement membranes, the trabecular meshwork and its role in glaucoma” (paragraph in beginning before AFM Operation section).
Bruce et al teach that it is well-known in the art to provide an applanation (contact) tonometer that uses an analogous self-sensing cantilever to determine intra-ocular pressure (abst) – “The MEMS device 10 senses the force applied to the patient's cornea by the contact end 6 of the device and creates an electric signal related thereto. The MEMS device 10 can be a micro-mechanical device such as those incorporating moving members such as deflecting micro-cantilevers” (0082). The tip 6 of the device is considered the prism.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Last et al such that the base is coupled to a prism of an applanation tonometer as taught by Bruce et al to effectively use the self-sensing cantilever of Last et al to measure intra-ocular pressure as an obvious application of the self-sensing cantilever applied to visual science (per the title of Last et al), because intra-ocular pressure is affected by the biomechanical properties that are measured by the self-sensing cantilever.
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Last et al in view of Bruce et al as applied to claim 10, further in view of McCafferty (US Pub No. 20180296090 – cited by applicant).
Last et al in combination with Bruce et al disclose the invention above but do not expressly disclose the prism comprises a contoured surface for assessing curvature of the corneal surface.
McCafferty teach that it is well-known in the art to provide an applanation tonometer with a prism (tip portion – 0005) 300, 500 having a contoured surface 304, 504, such as shown in Figure 3A-B or 5A-B, for assessing curvature of the corneal surface that reduces error of the tonometer measurement vs. that using a flat tip (abst, 0085-0088, 0093, 0095-0100).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Last et al as modified by Bruce et al such that the prism comprises a contoured surface for assessing curvature of the corneal surface as taught by McCafferty to effectively provide the applanation tonometer with a prism that reduces error of the tonometer measurement compared to that with a flat tip.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong Q NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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