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
Claims 1-6, 15-16, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention I (Claims 1-6) and Species I (Claims 15-16 and 19), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/29/2025.
Applicant’s election without traverse of Invention II and Species II, claims 7-14, 17-18, and 20, in the reply filed on 12/29/2025 is acknowledged.
Claim Rejections - 35 USC § 103
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 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(s) 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Samec et al. (Publication No. US 2017/0000341 A1) in view of Araci et al. (Publication No. US 2019/0076021 A1), Berdahl et al. (Publication No. US 2020/0138669 A1), and Swift et al. (Patent No. US 4,697,622 A).
Regarding claim 7, Samec teaches a system for the treating an eye of a patient (Abstract; Figure 5), the system comprising:
a goggle (ophthalmic system 62; Paragraph 1738; Figure 5), the goggle configured to be positioned in close proximity to the eye (Figure 5), the goggle comprising:
an optical sensor (wearable camera; Paragraph 0072, 0075, and 1738; Figure 5),
a processor, wherein the processor receives data from the optical sensor (Paragraph 1741); and
a drug delivery apparatus for dispensing a drug into a volume of space in close proximity to the eye (outlets 22 with an atomizer; Paragraph 2125; Figure 5);
wherein the processor determines an IOP value based on the data from the optical sensor (Paragraph 1741); and
wherein the processor triggers the drug delivery apparatus to dispense a drug (obvious that processor would provide output for mist; Paragraph 2125).
Samec does not teach the optical sensor capable of capturing an image of a strain sensor and the processor determines the amount of strain experienced by the strain sensor.
However, Araci teaches the optical sensor capable of capturing an image of a strain sensor (images are taken by a wearable camera/optical sensor; Paragraph 0072 and 0075) and the processor determines the amount of strain experienced by the strain sensor (Paragraph 0014-0015 and 0075; Abstract).
Samec and Araci are considered to be analogous to the claimed invention because they are in the same field of eye diagnosis apparatuses. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Samec to incorporate the teachings of Araci and have the strain sensor lens of Araci to be worn by the user in the system of Samec, where the processor of Samec is able to do image analysis of the strain sensor, as taught by Araci. This would allow for continuous and non-invasive monitoring of intra-ocular pressure in the eye (Araci; Paragraph 0017).
The combination of Samec in view of Araci does not teach the drug delivery apparatus having a first body with a mist generator, a supply tube;
the drug delivery apparatus having a second body with a releasable fastener, a first needle and a second needle, a pump, a controller and a power source.
However, Berdahl teaches the drug delivery apparatus having a first body (manifold 149; Figure 1B; Paragraph 0101) with a mist generator (generator device making mist inside the fluid source 170; Paragraph 0085), a supply tube (pressure tube 117B supplies fluid to be delivered to the eye; Paragraph 0086; Figures 1A-1B);
the drug delivery apparatus having a second body (pump 150; Paragraph 0105; Figures 1A-1B) with a pump (fan 153; Paragraph 0105; Figures 1A-1B), and a power source (power source 152; Paragraph 0105; Figures 1A-1B). Berdahl further teaches a controller (processor module 140; Figures 1A-1B; Paragraph 0105), however, does not teach the controller being in the second body.
Samec in view of Araci and Berdahl are considered to be analogous to the claimed invention because they are in the same field of eye diagnosis/treatment apparatuses. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Samec in view of Araci to incorporate the teachings of Berdahl and have the drug delivery apparatus of Samec in view of Araci to have the components of the first body and second body of Berdahl. This would allow for the control of the generation of medication to the eye of the user, based on the control of the processor (Berdahl; Paragraph 0101 and 0105-0106).
Furthermore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the controller of Samec in view of Araci and Berdahl to be located in the second body of Samec in view of Araci and Berdahl, since it has been held that rearranging parts of an invention involves only routine skill in the art since the device would not perform differently than the prior art device, whether located in the first or second body, with the common function at either locations of controlling the pump to generate therapeutic fluid for eye treatment, In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
The combination of Samec in view of Araci and Berdahl does not teach a releasable fastener, a first needle and a second needle, in the second body.
However, Swift teaches a releasable fastener (frame 92 with cap 104 that acts as a releasable fastener for holding vial 95; Figure 5; Column 5, line 65 to Column 6, line 9), a first needle (fill needle 125; Figure 5; Column 6, lines 42-49) and a second needle (vent needle 134; Figure 5; Column 6, lines 50-60).
Samec in view of Araci and Berdahl and Swift are considered to be analogous to the claimed invention because they are in the same field of eye diagnosis/treatment apparatuses. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Samec in view of Araci and Berdahl to incorporate the teachings of Swift and have the second body of Samec in view of Araci and Berdahl to have the frame with cap/releasable fastener and the first and second needle of Swift, with the first and second needle inside of the fluid source of Samec in view of Araci and Berdahl. This allows for the flow of medication at atmospheric pressure and easy attachment of vial to the apparatus (Swift; Column 2, lines 48-62).
The combination of Samec in view of Araci, Berdahl, and Swift teaches a releasable fastener, a first needle and a second needle, in the second body (see combination above).
Regarding claim 8, Samec in view of Araci, Berdahl, and Swift teaches the system of claim 7. Samec further teaches wherein the goggle further comprises a wireless communication module (goggle has processing and data module 70 with wireless communication links to a remote processing module; Paragraph 1428-1429; Figure 3A).
Regarding claim 9, Samec in view of Araci, Berdahl, and Swift teaches the system of claim 7. Samec further teaches wherein the optical sensor further comprises an image sensor and a light source (wearable camera 24 is an image sensor; Paragraph 1947; wearable device has a light source; Paragraph 1948).
Regarding claim 10, Samec in view of Araci, Berdahl, and Swift teaches the system of claim 9. Samec further teaches wherein the light source can be laser, RGB, infrared, or LED (light emitting diode) sources (Paragraph 1948).
Since the prior art of Samec recognizes light-emitting diodes (LED) is a type of light source and is analogous to the claimed invention in the field of ocular devices, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the light source of Samec to be an LED source, as taught by Samec, as it is merely the selection of functionally equivalent light sources recognized in the art, with the function of capturing images of the eye, and one of ordinary skill in the art would have a reasonable expectation of doing so. The simple substitution of one known element for another, substituting the light source to be an LED source of Samec, is obvious when predictable results are achieved, with the results of providing light for the image sensor to capture an image of the eye. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 - 97 (2007) (see MPEP § 2143, B.).
Regarding claim 11, Samec in view of Araci, Berdahl, and Swift teaches the system of claim 7. The combination of Samec in view of Araci, Berdahl, and Swift further teaches wherein the strain sensor is a microfluidic strain sensor (Araci; sensor 300; Figure 3; Abstract; Paragraph 0046) further comprising: a gas reservoir (Araci; gas reservoir 330; Figure 3; Paragraph 0046); a liquid reservoir (liquid reservoir 320; Paragraph 0046; Figure 3); and a channel having a first end connecting the gas reservoir, and a second end connecting to the liquid reservoir (Araci; channel 340 has a first end connected to gas reservoir and a second end connected to a liquid reservoir; Figure 3; Paragraph 0046).
Regarding claim 12, Samec in view of Araci, Berdahl, and Swift teaches the system of claim 11. The combination of Samec in view of Araci, Berdahl, and Swift further teaches wherein the liquid reservoir comprises a plurality of channels capable of deformation when subjected to strain, the deformation causing the channels to increase in volume (Araci; liquid reservoir 320 comprises multiple rings/channels that allows for volume deformation due to strain and increases volume; Figure 3; Paragraph 0046).
Regarding claim 13, Samec in view of Araci, Berdahl, and Swift teaches the system of claim 7. The combination of Samec in view of Araci, Berdahl, and Swift further teaches wherein the strain sensor is a shaped polymer sheet (Araci; sensor is on a PDMS contact lens made of a polymer sheet; Paragraph 0046; Figure 3) comprising a plurality of optical markers (Araci; multiple rings are the markers that indicate IOP fluctuations (Paragraph 0046; Figure 3), the markers having a pattern, the pattern subject to deformation when the strain sensor is subjected to strain (Araci; rings follow a concentric pattern that deforms when the sensor is strained; Figure 3; Paragraph 0046).
Regarding claim 14, Samec in view of Araci, Berdahl, and Swift teaches the system of claim 7. The combination of Samec in view of Araci, Berdahl, and Swift further teaches wherein the strain sensor is a pattern of reflected image of the eye (Araci; sensor has concentric rings that resembles the human eye; Figure 3; Paragraph 0046).
Claim(s) 17-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Samec et al. (Publication No. US 2017/0000341 A1) in view of Berdahl et al. (Publication No. US 2020/0138669 A1), and Swift et al. (Patent No. US 4,697,622 A)
Regarding claim 17, Samec teaches a method of delivering a drug to an eye of a patient (device has medication dispensing module 21 for delivering medication to eye; Paragraph 1445 and 2120-2121; Figure 5), the method comprising:
interrogating, via a processor, a sensor, wherein the sensor contains a data set related to an intraocular pressure of the eye (Paragraph 1741);
determining, via the processor, the IOP pressure of the eye (Paragraph 1741);
comparing, via the processor and a memory device, if the data meets a threshold requirement for medication (obvious that processor would compare reading with a threshold stored in the memory device in the processing module 70; Paragraph 1419 and 2125); and
delivering a medication, via a drug delivery device, into a volume of air in close proximity to the eye (obvious that processor would provide output for mist; Paragraph 2125);
wherein the delivering of medication is performed by a drug delivery apparatus for dispensing a drug into a volume of space in close proximity to the eye (outlets 22 with an atomizer; Paragraph 2125; Figure 5). Samec does not teach comparing, via the processor and the memory device, if the IOP pressure meets a threshold requirement for medication, and the drug delivery apparatus having a first body with a mist generator, a supply tube and a fluid sensor; the drug delivery apparatus having a second body with a releasable fastener, a first needle and a second needle, a pump, a controller and a power source.
However, Berdahl teaches comparing, via the processor and the memory device, if the IOP pressure meets a threshold requirement for medication (Paragraph 0066 and 0076-0077), the drug delivery apparatus having a first body with a mist generator (manifold 149; Figure 1B; Paragraph 0101), a supply tube (pressure tube 117B supplies fluid to be delivered to the eye; Paragraph 0086; Figures 1A-1B); the drug delivery apparatus having a second body (pump 150; Paragraph 0105; Figures 1A-1B) with a pump (fan 153; Paragraph 0105; Figures 1A-1B), and a power source (power source 152; Paragraph 0105; Figures 1A-1B). Berdahl further teaches a controller (processor module 140; Figures 1A-1B; Paragraph 0105), however, does not teach the controller being in the second body.
Samec and Berdahl are considered to be analogous to the claimed invention because they are in the same field of eye diagnosis/treatment apparatuses. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Samec to incorporate the teachings of Berdahl and have the drug delivery apparatus of Samec to have the components of the first body and second body of Berdahl and the method of delivering treatment based on the IOP reading compared to a threshold, as taught by Berdahl, in the processor of Samec. This would allow for the control of the generation of medication to the eye of the user, based on the control of the processor (Berdahl; Paragraph 0101 and 0105-0106) and allows for the automatic delivery of treatment based on the change in IOP reading from the sensor (Berdahl; Paragraph 0076-0077).
Furthermore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the controller of Samec in view of Berdahl to be located in the second body of Samec in view of Berdahl, since it has been held that rearranging parts of an invention involves only routine skill in the art since the device would not perform differently than the prior art device, whether located in the first or second body, with the common function at either locations of controlling the pump to generate therapeutic fluid for eye treatment, In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
The combination of Samec in view of Berdahl does not teach a releasable fastener, a first needle and a second needle, in the second body.
However, Swift teaches a releasable fastener (frame 92 with cap 104 that acts as a releasable fastener for holding vial 95; Figure 5; Column 5, line 65 to Column 6, line 9), a first needle (fill needle 125; Figure 5; Column 6, lines 42-49) and a second needle (vent needle 134; Figure 5; Column 6, lines 50-60).
Samec in view of Berdahl and Swift are considered to be analogous to the claimed invention because they are in the same field of eye diagnosis/treatment apparatuses. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Samec in view of Berdahl to incorporate the teachings of Swift and have the second body of Samec in view of Berdahl to have the frame with cap/releasable fastener and the first and second needle of Swift, with the first and second needle inside of the fluid source of Samec in view of Berdahl. This allows for the flow of medication at atmospheric pressure and easy attachment of vial to the apparatus (Swift; Column 2, lines 48-62).
The combination of Samec in view of Berdahl, and Swift teaches a releasable fastener, a first needle and a second needle, in the second body (see combination above).
Regarding claim 18, Samec in view of Berdahl and Swift teaches the method of claim 17. Samec further teaches wherein the sensor comprises an image sensor (wearable camera; Paragraph 0072, 0075, and 1738; Figure 5).
Regarding claim 20, Samec in view of Berdahl and Swift teaches the method of claim 17. Samec further teaches wherein the processor is disposed in a handheld electronic device (processing module 70 is mounted to the frame of glasses – obvious that glasses of Figure 3A is a handheld electronic device containing electronic components for ocular sensing and drug delivery; Paragraph 1428; Figure 3A).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781