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 .
Information Disclosure Statement
The information disclosure statement filed on July 17, 2025 has been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 10, claim 10 recites “The contact-based WAVS of claim 1, further comprising: the intervening connection arm.” The intervening connection arm recited in claim 10 appears to be the same intervening connecting arm recited in claim 1 and thus does not further limit claim 1. For the purposes of compact prosecution, Examiner will consider the intervening connecting arms of claims 1 and 10 to be the same structure. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 3-4, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (U.S. Patent Application Publication No. 2016/0353990 – cited by Applicant – hereinafter referred to as “Smith”).
Regarding claim 1, Smith teaches a contact-based wide-angle visualization system (“WAVS”) (Figure 1, [0032]) for use in an ophthalmic suite having a microscope (Figure 2 microscope 202, [0042]), the contact-based WAVS comprising:
a constant downforce (CDF) assembly (Figure 1 surgical microscope attachment 100, [0042]) having a proximal end (Figure 1 top of microscope attachment 100) and a distal end (bottom of microscope attachment 100), wherein the proximal end of the CDF assembly is configured to connect to an optical head of the microscope via an intervening connecting arm (Figures 1 and 2 mounting member 102, [0034]); and
a contact lens device that is connectable to the distal end of the CDF assembly (Figure 1 indirect contact lens 120, [0040]), and that includes a contact lens (concave portion 137, [0040]) configured to be worn on a cornea of a patient’s eye (Figure 1, [0040] concave portion 137 mates with the convex shape of the cornea) in the ophthalmic suite, wherein the CDF assembly is configured to (i) provide a constant downforce to the contact lens device ([0043] indirect contact lens 120 may be self-retaining due to the weight of the indirect contact lens 120 transmitted to the convex portion 137), and (ii) self-level and thereby maintain the contact lens device in an approximately parallel orientation relative to a floor of the ophthalmic suite ([0032] surgical microscope attachment forces indirect contact lens to remain upright and aligned with the optical axis of the eye of the patient which is orthogonal to the floor (Figure 2) and thus self-levels).
Regarding claim 3, Smith teaches all the limitations of the claimed invention with respect to claim 1. Smith further teaches the contact lens device includes:
a support frame configured to support the contact lens (Figure 1 retaining mechanism 114-3, [0033]); and
a support frame arm connected to the support frame and to the CDF assembly (Figure 1 arm member 114-2, [0033]).
Regarding claim 4, Smith teaches all the limitations of the claimed invention with respect to claim 1. Smith further teaches the CDF assembly includes a shaft (Figure 1 extension member 104, [0036]) that is circumscribed by a bearing housing containing instrument bearings (Figure 1 bearings 106, [0036]) therein, and wherein the bearing housing is translatable along a longitudinal axis of the shaft (Figure 1, [0035] extension member 104 translates vertically in direction 108, which is along axis of extension member 104).
Regarding claim 10, Smith teaches all the limitations of the claimed invention with respect to claim 1. Smith further teaches the intervening connecting arm (Figures 1 and 2 mounting member 102, [0034]).
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.
Claims 2, 5, 11-13, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. Patent Application Publication No. 2016/0353990) in view of Koester (U.S. Patent No. 4,964,717).
Regarding claim 2, Smith teaches all the limitations of the claimed invention with respect to claim 1. Smith fails to teach a gimbal connected to the distal end of the CDF assembly and to contact lens device, wherein the gimbal maintains the approximately parallel orientation by limiting a pitch and/or a roll of the contact lens device.
However, Koester teaches a system for stabilizing an eye contacting element (Abstract) with a gimbal (Figure 5b gimbal bearing comprising elements 16, 18, 21, 22, 24, and 26, Column 6 lines 12-35) connected to the distal end of the CDF assembly (Figure 5c gimbal bearing connected to support post 20) and to contact lens device (Figure 5a contact element structure 10), wherein the gimbal maintains the approximately parallel orientation by limiting a pitch and/or a roll of the contact lens device (Column 6 lines 12-35 gimbal permits rotation about two orthogonal axes and maintain contact with the eye while support post 20 remains stationary). Koester further teaches using a gimbal to allow for the contact element structure to track small movements of the eye (Column 6 lines 12-35). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the contact based WAVS system taught by Smith by adding the gimbal taught by Koester in order to allow imaging stability and the ability to track small eye movements (Koester Column 6 lines 12-35).
Regarding claim 5, Smith and Koester teach all the limitations of the claimed invention with respect to claim 4. Smith fails to teach one or more constant force springs connected to or surrounding the shaft. However, Koester teaches using a constant force spring connected to or surrounding the shaft (Column 8 lines 30-40 spring loaded linear bearing). Koester further teaches using a constant force spring to maintain sufficient but not excessive force on the cornea to ensure accurate tracking without damaging the cornea (Column 8 lines 34-40). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the WAVS system taught by Smith by adding a constant force spring as taught by Koester in order to maintain sufficient but not excessive force on the cornea to ensure accurate tracking without damaging the cornea (Koester Column 8 lines 34-40).
Regarding claim 11, Smith teaches a contact-based wide-angle visualization system (“WAVS”) (Figure 1, [0032]) for use in an ophthalmic suite having a microscope, the contact-based WAVS comprising:
a constant downforce (CDF) assembly (Figure 1 surgical microscope attachment 100, [0042]) having a proximal end (Figure 1 top of microscope attachment 100) and a distal end (bottom of microscope attachment 100), wherein the proximal end of the CDF assembly is configured to connect to an optical head of the microscope via an intervening connecting arm (Figures 1 and 2 mounting member 102, [0034]); and
a contact lens device that is connectable to the distal end of the CDF assembly (Figure 1 indirect contact lens 120, [0040]), and that includes a contact lens (concave portion 137, [0040]) configured to be worn on a cornea of a patient’s eye (Figure 1, [0040] concave portion 137 mates with the convex shape of the cornea) in the ophthalmic suite, a support frame configured to support the contact lens (Figure 1 retaining mechanism 114-3, [0033]), and a support frame arm connected to the support frame and to the CDF assembly (Figure 1 arm member 114-2, [0033]); and
wherein the CDF assembly is configured to provide a constant downforce to the contact lens device ([0043] indirect contact lens 120 may be self-retaining due to the weight of the indirect contact lens 120 transmitted to the convex portion 137), and self-level and thereby maintain the contact lens device in an approximately parallel orientation relative to a floor of the ophthalmic suite ([0032] surgical microscope attachment forces indirect contact lens to remain upright and aligned with the optical axis of the eye of the patient which is orthogonal to the floor (Figure 2) and thus self-levels).
Smith fails to teach a gimbal connected to the distal end of the CDF assembly and to contact lens device wherein the gimbal maintains the approximately parallel orientation by limiting a pitch and/or a roll of the contact lens device. However, Koester teaches a system for stabilizing an eye contacting element (Abstract) with a gimbal (Figure 5b gimbal bearing comprising elements 16, 18, 21, 22, 24, and 26, Column 6 lines 12-35) connected to the distal end of the CDF assembly (Figure 5c gimbal bearing connected to support post 20) and to contact lens device (Figure 5a contact element structure 10), wherein the gimbal maintains the approximately parallel orientation by limiting a pitch and/or a roll of the contact lens device (Column 6 lines 12-35 gimbal permits rotation about two orthogonal axes and maintain contact with the eye while support post 20 remains stationary). Koester further teaches using a gimbal to allow for the contact element structure to track small movements of the eye (Column 6 lines 12-35). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the contact based WAVS system taught by Smith by adding the gimbal taught by Koester in order to allow imaging stability and the ability to track small eye movements (Koester Column 6 lines 12-35).
Regarding claim 12, Smith and Koester teaches all the limitations of the claimed invention with respect to claim 11. Smith further teaches the CDF assembly includes a shaft (Figure 1 extension member 104, [0036]) that is circumscribed by a bearing housing containing instrument bearings (Figure 1 bearings 106, [0036]) therein, and wherein the bearing housing is translatable along a longitudinal axis of the shaft (Figure 1, [0035] extension member 104 translates vertically in direction 108, which is along axis of extension member 104).
Regarding claim 13, Smith and Koester teach all the limitations of the claimed invention with respect to claim 12. Smith fails to teach one or more constant force springs connected to or surrounding the shaft. However, Koester teaches using a constant force spring connected to or surrounding the shaft (Column 8 lines 30-40 spring loaded linear bearing). Koester further teaches using a constant force spring to maintain sufficient but not excessive force on the cornea to ensure accurate tracking without damaging the cornea (Column 8 lines 34-40). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the WAVS system taught by Smith by adding a constant force spring as taught by Koester in order to maintain sufficient but not excessive force on the cornea to ensure accurate tracking without damaging the cornea (Koester Column 8 lines 34-40).
Regarding claim 17, Smith teaches a system (Figure 2) comprising:
a connecting arm (Figures 1 and 2 mounting member 102, [0034]) configured to connect to an optical head of a microscope (Figure 2 microscope 202, [0042]); and a contact-based wide-angle visualization system (“WAVS”) (Figure 1, [0032]) for use in an ophthalmic suite having a microscope (Figure 2 microscope 202, [0042]), the contact-based WAVS comprising:
a constant downforce (CDF) assembly (Figure 1 surgical microscope attachment 100, [0042]) having a proximal end (Figure 1 top of microscope attachment 100) and a distal end (bottom of microscope attachment 100), wherein the proximal end of the CDF assembly is configured to connect to the connecting arm (Figures 1 and 2 mounting member 102, [0034]), wherein the CDF assembly includes a shaft (Figure 1 extension member 104, [0036]) that is circumscribed by a bearing housing containing instrument bearings (Figure 1 bearings 106, [0036]) therein, and wherein the bearing housing is translatable along a longitudinal axis of the shaft (Figure 1, [0035] extension member 104 translates vertically in direction 108, which is along axis of extension member 104); and
a contact lens device that is connectable to the distal end of the CDF assembly (Figure 1 indirect contact lens 120, [0040]), and that includes a contact lens (concave portion 137, [0040]) configured to be worn on a cornea of a patient’s eye (Figure 1, [0040] concave portion 137 mates with the convex shape of the cornea) in the ophthalmic suite, wherein the CDF assembly is configured to provide a constant downforce to the contact lens device ([0043] indirect contact lens 120 may be self-retaining due to the weight of the indirect contact lens 120 transmitted to the convex portion 137), and to self-level and thereby maintain the contact lens device in an approximately parallel orientation relative to a floor of the ophthalmic suite ([0032] surgical microscope attachment forces indirect contact lens to remain upright and aligned with the optical axis of the eye of the patient which is orthogonal to the floor (Figure 2) and thus self-levels).
Smith fails to teach one or more constant force springs connected to or surrounding the shaft. However, Koester teaches using a constant force spring connected to or surrounding the shaft (Column 8 lines 30-40 spring loaded linear bearing). Koester further teaches using a constant force spring to maintain sufficient but not excessive force on the cornea to ensure accurate tracking without damaging the cornea (Column 8 lines 34-40). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the WAVS system taught by Smith by adding a constant force spring as taught by Koester in order to maintain sufficient but not excessive force on the cornea to ensure accurate tracking without damaging the cornea (Koester Column 8 lines 34-40).
Regarding claim 18, Smith and Koester teach all the limitations of the claimed invention with respect to claim 17. Smith fails to teach a gimbal connected to the distal end of the CDF assembly and to contact lens device, wherein the gimbal maintains the approximately parallel orientation by limiting a pitch and/or a roll of the contact lens device.
However, Koester teaches a system for stabilizing an eye contacting element (Abstract) with a gimbal (Figure 5b gimbal bearing comprising elements 16, 18, 21, 22, 24, and 26, Column 6 lines 12-35) connected to the distal end of the CDF assembly (Figure 5c gimbal bearing connected to support post 20) and to contact lens device (Figure 5a contact element structure 10), wherein the gimbal maintains the approximately parallel orientation by limiting a pitch and/or a roll of the contact lens device (Column 6 lines 12-35 gimbal permits rotation about two orthogonal axes and maintain contact with the eye while support post 20 remains stationary). Koester further teaches using a gimbal to allow for the contact element structure to track small movements of the eye (Column 6 lines 12-35). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the contact based WAVS system taught by Smith by adding the gimbal taught by Koester in order to allow imaging stability and the ability to track small eye movements (Koester Column 6 lines 12-35).
Regarding claim 19, Smith and Koester teach all the limitations of the claimed invention with respect to claim 17. Smith further teaches the contact lens device includes: a support frame configured to support the contact lens (Figure 1 retaining mechanism 114-3, [0033]).
Regarding claim 20, Smith and Koester teach all the limitations of the claimed invention with respect to claim 19. Smith further teaches the contact lens device includes: a support frame arm that is connected to the support frame and to the CDF assembly (Figure 1 arm member 114-2, [0033]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. Patent Application Publication No. 2016/0353990) in view of Metelski (U.S. Patent Application Publication No. 2005/0224664).
Regarding claim 6, Smith teaches all the limitations of the claimed invention with respect to claim 1. Smith fails to teach the CDF assembly includes a miniature gas spring. However, Metelski teaches a surgical stand arrangement (Figure 2) with a gas spring (Figure 2 gas spring 7, [0026]). Metelski further teaches using gas springs a energy storage element to provide lever support and low static friction (Abstract and [0003]). Furthermore, a change in size is generally recognized as being within the level of one having ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the WAVS system taught by Smith by adding a gas spring as taught by Metelski in order to add an energy storage element to provide lever support and low static friction (Abstract and [0003]).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. Patent Application Publication No. 2016/0353990) in view of Fukaya (U.S. Patent No. 5,420,716).
Regarding claim 7, Smith teaches all the limitations of the claimed invention with respect to claim 1. Smith further teaches a low-friction air cylinder (Figure 1 mounting member 102, [0035] mounting member 102 is a hollow cylinder), the low-friction air cylinder having a low-friction piston disposed therewithin (extension member 104, [0036] extension member 104 travels freely to other positions with very low friction). Smith fails to teach the CDF assembly includes a four-bar mechanism operatively connected to the piston wherein a longitudinal axis of the piston is laterally offset from the four-bar mechanism.
However, Fukaya teaches a four-bar mechanism with a laterally offset microscope (Figure 2, Column 3 lines 39-41). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the WAVS system taught by Smith by using the four-bar mechanism taught by Fukaya and offsetting the piston since a four-bar mechanism is a well-known mechanical arrangement used to provide a desired motion.
Regarding claim 8, Smith and Fukaya teaches all the limitations of the claimed invention with respect to claim 7. Smith further teaches an end of the piston is operatively connected to the contact lens device (Figure 1 extension member 104 is connected to indirect contact lens 120, [0040]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. Patent Application Publication No. 2016/0353990) in view of Fukaya (U.S. Patent No. 5,420,716) as applied to claim 8 above, and further in view of Airpot (Airpot Corp, Piston & Cylinder Sets Offer Designers Low Cost Components with Unmatched Capabilities, 2018).
Regarding claim 9, Smith and Fukaya teaches all the limitations of the claimed invention with respect to claim 8. Smith and Fukaya fail to teach the low-friction air cylinder is constructed from borosilicate glass. However, Airpot teaches a low-friction air cylinder constructed from borosilicate glass (First paragraph lines 1-2). Airpot further teaches using a borosilicate glass cylinder to provide low friction, prevent jerking, uncontrolled starts, and provide uniform smoothness (First paragraph lines 3-5). A prima facie case of obviousness exists when selecting a known material based on its suitability for its intended use. In re Leshin, 277 F.2d, 125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the WAVS device taught by Smith and Fukaya by constructing the air cylinder out of borosilicate glass as taught by Airpot in order to provide low friction, prevent jerking, uncontrolled starts, and provide uniform smoothness (First paragraph lines 3-5).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. Patent Application Publication No. 2016/0353990) in view of Koester (U.S. Patent No. 4,964,717) as applied to claim 11 above, and in further view of Metelski (U.S. Patent Application Publication No. 2005/0224664).
Regarding claim 14, Smith and Koester teach all the limitations of the claimed invention with respect to claim 11. Smith and Koester fail to teach the CDF assembly includes a miniature gas spring. However, Metelski teaches a surgical stand arrangement (Figure 2) with a gas spring (Figure 2 gas spring 7, [0026]). Metelski further teaches using gas springs an energy storage element to provide lever support and low static friction (Abstract and [0003]). Furthermore, a change in size is generally recognized as being within the level of one having ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the WAVS system taught by Smith by adding a gas spring as taught by Metelski in order to add an energy storage element to provide lever support and low static friction (Abstract and [0003]).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. Patent Application Publication No. 2016/0353990) in view of Koester (U.S. Patent No. 4,964,717) as applied to claim 11 above, and in further view of Fukaya (U.S. Patent No. 5,420,716).
Regarding claim 15, Smith and Koester teach all the limitations of the claimed invention with respect to claim 11. Smith further teaches a low-friction air cylinder (Figure 1 mounting member 102, [0035] mounting member 102 is a hollow cylinder, [0036] extension member 104 travels freely to other positions with very low friction). Smith and Koester fail to teach the CDF assembly includes a four-bar mechanism operatively connected to the low-friction air cylinder.
However, Fukaya teaches a four-bar mechanism (Figure 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the WAVS system taught by Smith by using the four-bar mechanism taught by Fukaya and connecting the air cylinder since a four-bar mechanism is a well-known mechanical arrangement used to provide a desired motion.
Regarding claim 16, Smith, Koester, and Fukaya teach all the limitations of the claimed invention with respect to claim 15. Smith further teaches the low-friction air cylinder has a piston (extension member 104, [0036] extension member 104 travels freely to other positions with very low friction) disposed therewithin and an end of the piston is operatively connected to the contact lens device (Figure 1 extension member 104 is connected to indirect contact lens 120, [0040]).
Smith and Koester fail to teach a longitudinal axis of the piston is laterally offset from the four-bar mechanism. However, Fukaya teaches a four-bar mechanism with a laterally offset microscope (Figure 2, Column 3 lines 39-41). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the WAVS system taught by Smith by using the four-bar mechanism taught by Fukaya and offsetting the piston since a four-bar mechanism is a well-known mechanical arrangement used to provide a desired motion.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mann (U.S. Patent Application Publication No. 2010/0265460) teaches microscope for wide-angle viewing of the eye with a similar mechanical arrangement to the instant invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX PARK RICKEL whose telephone number is (703)756-4561. The examiner can normally be reached Monday-Friday 8:30 a.m. - 6 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bumsuk Won can be reached at (571)272-2713. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Alex Rickel
Examiner
Art Unit 2872
/A.P.R./Examiner, Art Unit 2872
/WYATT A STOFFA/Primary Examiner, Art Unit 2881
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