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 claims 1-9 in the reply filed on 08/06/2026 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/06/2026.
Specification
The disclosure is objected to because of the following informalities: In ¶0028, reference number 26 is used for both the memory and the RF antenna.
Appropriate correction is required.
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, and any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Therefore, the structure of the prism array of claim 2 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “26” has been used to designate both the memory and the RF antenna.
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 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a light engine configured to transmit electronic signals to the external light source” in claim 1
“a surgical console in communication with the external light source” in claim 9
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 3 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.
Regarding claim 3, the limitation “a peripheral retina area of the interior of the eye is illuminated via total internal reflection within the annular tube” raises clarity issues. It is unclear how this limitation should be interpreted and it is unclear as to what the metes and bounds of the above claim limitations are and would be needed to meet the above claim limitations.
Since the external light source is contained within the annular tube, it is unclear how the light can undergo total internal reflection within the annular tube and also illuminate the interior of the eye. If the light undergoes total internal reflection within the annular tube, then it would not leave the annular tube to then propagate to the eye, leading to a lack of clarity regarding the how the device can function. It is unclear whether there is total internal reflection within the annular tube or not.
For the purposes of examination, examiner assumes and suggests “a peripheral retina area of the interior of the eye is illuminated via
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, 4-5, and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yates (US 20140232985 A1).
Regarding independent claim 1, Yates discloses an illuminated contact lens system, comprising: a contact lens (3; Fig. 5; ¶0053) configured to be worn on a patient's eye (Fig. 5; ¶0053), and to refract directed light into the eye (Fig. 5; ¶0053); an external light source (10; Fig. 5; ¶0053; the light source 10 is separated from the contact lens 3, therefore it is external) configured to emit the directed light toward the eye (Fig. 5; ¶0053); and a light engine (17, processor, and computer; Fig. 5; ¶0056-¶0057, ¶0071) configured to transmit electronic control signals to the external light source (10) to thereby cause the external light source (10) to emit the directed light toward the eye (Fig. 5; ¶0056), thereby illuminating an interior of the eye (Fig. 5; ¶0053).
Regarding claim 4, Yates discloses the lens system of claim 1, as set forth above. Yates further discloses a control board in communication with the external light source (10), wherein the control board is configured to drive the external light source (10) in response to the electronic control signals from the light engine (17, processor, and computer) (¶0056-¶0057, ¶0071).
Regarding claim 5, Yates discloses the lens system of claim 4, as set forth above. Yates further discloses the control board (17) includes an antenna operable for wirelessly receiving the electronic control signals from the light engine (17, processor, and computer) (implicit from ¶0056-¶0057 and ¶0071 that there must be an antenna since the device can be used in telemedicine practices and data can be transmitted wirelessly).
Regarding claim 7, Yates discloses the lens system of claim 1, as set forth above. Yates further discloses the external light source (10) includes a light-emitting diode array (10; Fig. 5; ¶0053) having an adjustable setting that is responsive to the electronic control signals (¶0056), and wherein the adjustable setting includes at least one of a color, a temperature, or a brightness level of the light-emitting diode array (10) (¶0056).
Regarding claim 8, Yates discloses the lens system of claim 1, as set forth above. Yates further discloses the external light source (10) is operatively connected to the contact lens (3) to form an illuminated lens assembly (Fig. 5; ¶0053).
Regarding claim 9, Yates discloses the lens system of claim 1, as set forth above. Yates further discloses a surgical console (¶0071 and ¶0076 state the device is used for surgery and list console components that can be used with the device) in communication with the external light source (10) (¶0056-¶0057) and having a processor and a computer-readable storage medium (¶0056-¶0057, ¶0071), wherein the light engine (17, processor, and computer) includes the processor (¶0056-¶0057) and the computer-readable storage medium (¶0056-¶0057, ¶0071).
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) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Yates (US 20140232985 A1) in view of Ueda (JP 2003059329 A).
Regarding claim 2, Yates discloses the lens system of claim 1, as set forth above. Yates further discloses an annular tube (5; Fig. 5; ¶0050) containing the external light source (10) therewithin (Fig. 5; ¶0053). Yates does not disclose a prism array connected to the annular tube, wherein the prism array is configured to shape the directed light from the external light source into a conical distribution pattern when the prism array is illuminated by the directed light from the external light source.
However, applicant’s stated issue is to shape the directed light into a conical distribution pattern (instant application ¶0007), i.e., to direct and focus the light. Ueda teaches an external light source (4; Fig. 1; ¶0005) configured to emit directed light (Fig. 1), and further discloses an annular tube (5/6; Fig. 1; ¶0005) containing the external light source (4) therewithin; and a prism array (2; Fig. 1; ¶0005) connected to the annular tube (5/6) (Fig. 1; ¶0005), wherein the prism array (2) is configured to shape the directed light from the external light source (4) into a conical distribution pattern (Fig. 2; ¶0005; a ring-shaped Fresnel lens refracts light toward the ring center direction, the focusing direction of the light fluxes can be finely adjusted) when the prism array (2) is illuminated by the directed light from the external light source (4) (Fig. 1; ¶0005), i.e. the prism array (2) is to direct and focus the light.
Therefore, 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 Yates to incorporate the prism array as taught by Ueda for the purpose of directing and focusing light (¶0005 of Ueda).
Regarding claim 3, Yates in view of Ueda discloses the lens system of claim 2, as set forth above. Yates further discloses the external light source (10) is positioned and oriented relative to the contact lens (3) such that a peripheral retina area (101; Fig. 5; ¶0053) of the interior of the eye is illuminated (Fig. 5; ¶0053) via the annular tube (5) (Fig. 5).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yates (US 20140232985 A1) in view of Pawloski et al. (US 20030009155 A1), hereinafter Pawlowski, and further in view of Kelleher et al. (US 20200179168 A1), hereinafter Kelleher.
Regarding claim 6, Yates discloses the lens system of claim 4, as set forth above. Yates does not disclose the control board is configured as a proximity sensor that is operable for detecting when the external light source is separated from an external surface of the contact lens by a predetermined standoff distance, and for communicating an electronic proximity signal to the light engine that is indicative of the light source having reached the standoff distance.
However, Pawlowski teaches a similar lens system comprising a contact lens (4; Fig. 1; ¶0029) configured to be worn on a patient's eye (Fig. 1; ¶0029), and to refract directed light into the eye (Fig. 1; ¶0029); and an external light source (14; Fig. 1; ¶0029) configured to emit the directed light toward the eye (Fig. 1; ¶0029), wherein the external light source (14) is separated from an external surface of the contact lens (4) (Fig. 1; ¶0029). It has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. In re Dulberg 129 USPQ 348, 349 (CCPA 1961).
Further, Kelleher teaches a similar lens system comprising a lens (140; Figs. 4, 10; ¶0152); an external light source (120; Fig. 10; ¶0112) configured to emit the directed light toward the eye (Fig. 10; ¶0112), and further comprises a proximity sensor (238; Fig. 10; ¶0335) to sense the position of the device relative to the eye (¶0335) and for communicating an electronic proximity signal that is indicative of the device having reached a standoff distance (¶0336).
One would be motivated to have the external light source be separable from the contact lens for the purpose of accurately treating sites on an eye’s retina (¶0003 of Pawlowski) and to have a proximity sensor for detecting when the external light source is separated from an external surface of the contact lens by a predetermined standoff distance, and for communicating an electronic proximity signal to the light engine that is indicative of the light source having reached the standoff distance, for the purpose of determining the placement of the external light source (¶0335 of Kelleher).
Therefore, 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 Yates to incorporate the external light source be separable from the contact lens as suggested by Pawlowski for the purpose of accurately treating sites on an eye’s retina (¶0003 of Pawlowski) and to incorporate a proximity sensor for detecting when the external light source is separated from an external surface of the contact lens by a predetermined standoff distance, and for communicating an electronic proximity signal to the light engine that is indicative of the light source having reached the standoff distance as suggested by Kelleher for the purpose of determining the placement of the external light source (¶0335 of Kelleher).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kim et al. (US 20210353136 A1), Su (US 20150009473 A1), and Ben Nun (US 5450144 A) disclose similar illuminated contact lens assemblies comprising a contact lens and an external LED ring. Legerton (US 20130278887 A1) discloses an illuminated contact lens assembly with an LED ring, comprising a light engine and control board with an antenna. Baldwin (US 20100321491 A1) discloses an LED right with a prism array to shape the light into a conical distribution pattern.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATASHA NIGAM whose telephone number is (571)270-5423. The examiner can normally be reached Monday - Friday 9-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky Mack can be reached at (571)272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATASHA NIGAM/Examiner, Art Unit 2872 August 25th, 2026
/George G. King/Primary Examiner, Art Unit 2872
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