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 with traverse of Species 1 in the reply filed on 4/17/2026 is acknowledged. The traversal is on the ground(s) that there is no demonstration of serious burden with an explanation. This is not found persuasive because the Election Restriction dated 2/19/2026 sets forth as the reasons each species is independent and distinct because “ach provides different and distinct structural features (e.g. position of the light source relative to the detector, configuration of the light source, including a beam splitter or not) that result in a different and distinct manner of function” (pg. 2 of Election Restriction). Thus, the search burden follows because the different position of the light source relative to the detector and the configuration of the light source of each species requires a different and distinct field of search that would not be overlapping.
The requirement is still deemed proper and is therefore made FINAL.
It is noted that while applicant has indicated that Claims 1-20 read on Species 1 (Figure 2), this is not true. Claims 8-9 and 18-19 clearly read on Figure 5 of Species 4 (includes collimating lens – 0032 of published spec).
Claims 8-9 and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed 4/17/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 1-7, 10-17, and 20 remain pending and under prosecution.
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 claims 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.
Claim 15 is 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.
The claim recites a light emitting diode in the hermetic cavity to transmit the intraocular pressure data. However, Claim 11, which Claim 15 depends on, already discloses a transmitter to output the data corresponding to the intraocular pressure. Thus, it is unclear if the light emitting diode is meant to be the same or different. The specification provides for the transmitter to be the light emitting diode (0025 published spec), however clarification is requested.
Additionally, it is unclear if “an external handheld reader” in Claim 15 is meant to refer to the external reader device already recited in Claim 11 or a different one. Clarification is requested.
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.
Claims 1, 4-7, 10-11, 14-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hastings et al (US Pub No. 20180344158 – cited by applicant) in view of Cao (US Pub No. 20160000344),
Irazoqui et al (US Pub No. 20140296687), and Pletcher et al ((US Pat No. 9735892 – cited by applicant).
In regard to Claim 1 and 11, Hastings et al disclose an intraocular implant comprising:
a pressure sensor 101 implantable in an eye (abst), wherein the pressure sensor comprises a substrate 200 having a first side coupled to a membrane 202 to define an optical cavity 203 with a depth that varies based on an intraocular pressure of the eye – “The flexible membrane 202 deflects in response to changes in intraocular pressure and these changes can be measured optically” (0067), best seen in Figure 7; and
a light source 102 and a detector 106 operable to interrogate the pressure sensor and obtain data corresponding to an intraocular pressure of the eye based on the interrogation – “pressure is measured optically by the system 100 using a light source 102 to illuminate the intraocular pressure sensor 101 with one or more wavelengths of incident light 103. A resultant light 113 (comprising reflected light or a combination of reflected and emitted light) is captured by a detector 106 and the signal from the detector 106 is processed by a processing device 107 to determine the intraocular pressure” (0065),
an external reader device 107 comprising a processor configured to receive output data corresponding to an intraocular pressure of the eye based on the interrogation and, based on the output, estimate the intraocular pressure of the eye – “The processing device 107 may be either internal or external to the assembly containing the detector 106. The processing device is connected to the detector by at least one of a physical electrical connection, a wireless connection, or a network connection all of which are familiar to those skilled in the art” (0091), “the processing device 107 processes the signal to determine intraocular pressure” (0085).
However, Hastings et al do not expressly disclose an enclosure coupled to a second side of the substrate to define a hermetic cavity comprising the light source and detector, nor a transmitter operable to the output the data. Thus, the Hastings et al disclose all the structure but does not disclose it disposed in an enclosure coupled to a second side of the substrate.
Cao teaches that it is well-known in the art to provide an analogous intraocular implanted a pressure sensor (abst) comprising at least one membrane 22 that functions as the pressure sensor – “Each cavity 30 of the sensing capacitor 24 is under vacuum 32 (e.g., gaseous pressure that is less then atmospheric pressure) through bonding of a SOI device layer so that deformation of the membrane 22 under vacuum provides an accurate IOP measurement” (0049).
Cao teaches that the entire device is MEM sized (0009) and includes an enclosure to device a hermetic cavity 16, best seen in Figure 5 (0044), to effectively shield the components “to ensure chronic implantation so as to provide long-term stable and continuous IOP measurements and profiles for time periods of months to years (e.g., 1, 5, 10, or 15 years)” (0018). Specifically, Cao teaches “the vertical stacking of the wafers is configured to create a hermetically sealed cavity between the first and second wafers… Additionally or alternatively, a titanium barrier may be disposed over the dielectric layer or the implantable device so as to further hermetically encapsulate the first and second wafers. A biocompatible polymer coating may be disposed over the titanium barrier. The present invention provides redundant hermetic sealing.” Thus, Cao et al teach the importance of a hermetic cavity within an enclosure to contain the necessary electronic components of the implanted intraocular pressure sensor.
Cao also teach a transmitter operable to output data corresponding to an intraocular pressure of the eye – “The interposer may further comprise at least one capacitor for supplemental energy storage and/or at least one coil configured to receive power and/or transmit data” (0020); “the second coil 60 may be configured for data transmission” (0057). This provides an effective structure for the desired data transmission.
Irazoqui et al teach that it is well-known in the art to provide an analogous intraocular implanted a pressure sensor comprising a MEMs pressure sensor 914 in addition to an addition of a light emitting diode (LED) 917 mounted on the entire sensor structure/substrate 910, best seen in Figure 21A – “a pressure-sensing implant, or pressure-sensing system 900 that is configured to be implanted in the eye of an animal… the pressure-sensing system 900 includes an integrated circuit (IC) 912, a MEMS pressure sensor 914, and an antenna 916, and an LED 917 that are mounted to or integrally formed with a substrate or tag 910” (0172). Thus, Irazoqui et al teach that a light source can be included within the implanted intraocular pressure sensor. Additionally, the size components of Irazoqui et al match that of Cao et al.
Pletcher et al teach that it is well-known in the art to provide an analogous intraocular implanted lens that includes electrical components such as a detector 406, sensor 408, in addition to others for the desired use and communication of the data gathered from the intraocular implanted lens, best seen in Figure 4 – “FIG. 4 is an illustration of a block diagram of a tag for a contact lens facilitating optical communication in accordance with aspects described herein. The tag 400 can be disposed on or within the contact lens in various aspects… the circuit 402 can include an optical communication device 404, a photodetector 406, a sensor 408, a memory 410 and/or a microprocessor 412… As such, in some aspects, the tag 400 can be configured to have a level of porosity such that fluids incident on the contact lens can be detected and sensing can be performed by the sensor 408. In some aspects, the tag 400 can be transparent or translucent such that the photodetector 406 can receive light for power generation” (Col.8: 37-Col.9: 4). Thus, Pletcher et al teach that a detector disposed on an analogous implanted intraocular lens.
Given that Hastings et al already disclose the structure of the light source and the detector to interrogate the pressure sensor and obtain data corresponding to an intraocular pressure of the eye based on the interrogation of Hastings et al, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Hastings et al such that an enclosure is coupled to a second side of the substrate of Hastings et al – it would be obvious to use the second side of the substrate that does not define the optical cavity of the pressure sensor – to define a hermetic cavity, as taught by Cao to effectively provide an optimal environment for necessary electronics of the pressure sensor, and comprising the light source as taught by Irazoqui et al and detector as taught by Pletcher et al, to effectively provide an integrated implanted device for the intraocular pressure sensor of Hastings et al, since the components of the light source and detector of Irazoqui et al and Pletcher et al, respectively, are taught in the same size range as the hermetic enclosure of Cao and thus would physically fit inside the enclosure of Cao, to provide a superior device that is integrated with the electrical components of the sensor system of Hastings et al and operates in the manner intended.
Additionally, it would have been obvious to one of ordinary skill in the art at the time of filing modify Hastings et al to include a transmitter operable to output data corresponding to an intraocular pressure of the eye disposed within the intraocular implant as taught by Cao to effectively enable the pressure data to be transmitted as desired to external devices, such as for processing to estimate the intraocular pressure as already taught by Hastings et al.
4, 14. Hastings et al in combination with Cao, Irazoqui et al, and Pletcher et al disclose the invention above but do not disclose the implant further comprises an application-specific integrated circuit and a battery positioned in the hermetic cavity. Cao disclose the analogous intraocular implanted a pressure sensor comprising an application-specific integrated circuit 14 (0044) and a battery positioned in the hermetic cavity to effectively power the electronics as is well-known in the art for the desired use (0020, abst). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Hastings et al as modified by Cao, Irazoqui et al, and Pletcher et al to include an application-specific integrated circuit and a battery positioned in the hermetic cavity as taught by Cao to effectively power the electronics for desired use.
5, 15. Hastings et al, Cao, and Irazoqui et al teach a light emitting diode 917 (taught by Irazoqui et al) in the hermetic cavity of Cao to optically transmit intraocular pressure data obtained by the interrogation of the pressure sensor to an external handheld reader device – “the LED can be used as a communication medium, for example, by flashing between on and off states to convey a digital code or pattern in which data is encoded” (0172 of Irazoqui et al).
6, 16. Hastings et al disclose the intraocular implant wherein the light source 102 is arranged orthogonal to the detector 109, best seen in Figure 1.
7, 17. Hastings et al disclose the intraocular implant wherein the light source is a single light source 102 having an emission spectrum that changes over time – “interference patterns associated with multiple, sequentially emitted wavelengths” (0057).
10, 20. Hastings et al disclose the intraocular implant wherein the pressure sensor is implanted in an anterior chamber of the eye (0093).
Claim(s) 2-3 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hastings et al in view of Cao, Irazoqui et al, and Pletcher et al, and further in view of Korb et al (US Pub No. 20130308095).
Hastings et al in combination with Cao, Irazoqui et al, and Pletcher et al disclose the invention above including a first light source 102 and a beam splitter 104 to perform the pressure sensing, best seen in Figure 1 (0066) but do not expressly disclose a second light source and that the beam splitter is positioned in the hermetic cavity and is non-polarizing.
Since Hastings et al already disclose using multiple wavelengths with the first light source (0057, 0059), it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a second light source to provide the second wavelength, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Korb et al teach that it is well-known in the art to provide an analogous interferometer eye system with a non-polarizing beam splitter 50 as an effective configuration for the beam splitter (0106). It is noted that applicant has not provided any criticality in the beam splitter being non-polarizing as solving a particular problem, conferring a specific advantage, or providing a desired result other than being a standard type. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Hastings et al in combination with Cao, Irazoqui et al, and Pletcher et al such that the beam splitter is non-polarizing as taught by Korb et al as effective form for said beam splitter in the device. Additionally, it would have been obvious to one of ordinary skill in the art at the time of filing to include the beam splitter within the hermetic cavity as taught by Cao above as an obvious component of the integrated implanted intraocular pressure sensor to enable interrogation of the pressure sensor, such that in combination, the first light source emits a beam of light having a first wavelength and the second light sources emits a beam of light having a second wavelength through the non-polarizing beam splitter to the detector to interrogate the pressure sensor, in a manner already taught by Hastings et al (0066).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791
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