Prosecution Insights
Last updated: August 18, 2026
Application No. 18/547,969

PHOTO-ECMO APPARATUS, SYSTEMS, AND METHODS

Non-Final OA §103
Filed
Aug 25, 2023
Priority
Feb 25, 2021 — provisional 63/153,410 +2 more
Examiner
LE, QUYNH DAO
Art Unit
3781
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
THE GENERAL HOSPITAL Corporation
OA Round
3 (Non-Final)
33%
Grant Probability
At Risk
3-4
OA Rounds
6m
Est. Remaining
40%
With Interview

Examiner Intelligence

Grants only 33% of cases
33%
Career Allowance Rate
15 granted / 45 resolved
-36.7% vs TC avg
Moderate +6% lift
Without
With
+6.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
33 currently pending
Career history
85
Total Applications
across all art units

Statute-Specific Performance

§101
2.5%
-37.5% vs TC avg
§103
64.2%
+24.2% vs TC avg
§102
13.3%
-26.7% vs TC avg
§112
18.1%
-21.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 45 resolved cases

Office Action

§103
even if they’re already 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 . Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/23/2026 has been entered. Response to Amendment The amendments filed on 06/23/2025 has been entered. Claim 1 has been amended; claims 2-6, 13, 22-27, 29, and 31-32 have been cancelled; claims 17-21, 28, and 30 have been withdrawn. Accordingly, claims 1, 7-12, 14-21, 28, and 30 are pending and under consideration. Response to Arguments Applicant’s arguments filed 06/23/2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Zapol et al. WO 2020010286 A1 (newly cited), as cited in the IDS, in view of Lo et al. US 8,270,781 B2 (newly cited). See rejection of claims below. 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. Claims 1, 14, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Zapol et al. WO 2020010286 A1 (newly cited, hereinafter Zapol), as cited in the IDS, in view of Lo et al. US 8,270,781 B2 (newly cited, hereinafter Lo). Regarding claim 1, Zapol discloses an apparatus 100 (Fig. 1 – extracorporeal phototherapy system 100) for removing CO from blood (Title – “system for extracorporeal carbon monoxide removal”), the apparatus 100 (Fig. 1) comprising: a housing 102 (Fig. 1 – oxygenator 102) configured to house blood obtained from a body of a subject within an interior of the housing 102 (Fig. 1, and Par.76 – “The whole blood removed from the patient may flow through the oxygenator 102”); a plurality of gas-permeable tubules 116 (Fig. 1 – plurality of microporous hollow fiber membrane 116, and Par. 70 – “the plurality of microporous hollow fiber membranes 116 may be designed to allow diffusion of O2 and CO”) disposed within the interior of the housing 102 (Fig. 1), wherein the plurality of gas-permeable tubules 116 (Fig. 1) are configured such that the blood surrounds the outsides 118 (Fig. 2 – external surfaces 118) each of the plurality of gas-permeable tubules 116 (Fig. 1, and Par. 70 – “the plurality of microporous hollow fiber membranes 116 may be designed to allow diffusion of O2 and CO between blood flowing over the external surfaces 118 and gas flowing (e.g., O2) through the internal channels 120”); a light source 106 (Fig. 1 – light source 106) disposed outside the housing 102 (Fig. 1) and, the light source 104 (Fig. 1) being configured to emit light into the interior of the housing 102 (Fig. 1, and Par. 65 – “the second light source 106 may be arranged to emit light onto a second side 110 of the oxygenator 102.…”) such that the emitted light interacts with the blood from the body of the subject (Par. 83 – “The photons emitted by… the second light source 106 may be absorbed by COHb in the blood”). However, Zapol does not disclose an optical intrusion coupled to the housing and configured to project into the housing and to be immersed in the blood, wherein the optical intrusion comprises a fiber optic extending into the interior of the housing, and wherein the optical intrusion is configured to transmit light from outside the housing into the interior of the housing; and a light source optically coupled to the optical intrusion and being configured to emit light that is transmitted via the optical intrusion. Lo, in the same field of endeavor of optical system in fluid channels (Abstract), teaches an optical intrusion 44 (Fig. 3a and Fig. 6 – first waveguide 44) coupled to the housing 40 (Fig. 3a – device 40) and configured to project into the housing 40 (Fig. 3a), wherein the optical intrusion 44 (Fig. 3a and Fig. 6) comprises a fiber optic 86 (Fig. 6 – optical fiber 86) extending into the interior of the housing 40 (Fig. 6, and Col. 12, line 37-40 – “laser excitation light from a source 84 is coupled by way of multi-mode optical fiber 86 to one of the two waveguides 42, 44 (in this case the waveguide 44)”), and wherein the optical intrusion 44 (Fig. 3a) is configured to transmit light from outside the housing into the interior of the housing 40 (Col. 12, line 37-40); and a light source 84 (Fig. 6 – light source 84) optically coupled to the optical intrusion 44 (Fig. 6) and being configured to emit light that is transmitted via the optical intrusion 44 (Fig. 6 and Col. 12, line 37-40). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the housing of Zapol to further include an optical intrusion with an fiber optic extending as taught by Lo, in order to receive and deliver light (Abstract) as the use of optical waveguide eliminates the needs for lenses and precision mechanism for optical alignment (Col. 3, line 18-21 of Lo). The optical intrusion 44 of Lo incorporated into the housing 102 of Zapol will then provide precise delivery of light into the interior of housing 102, especially into the depth of housing 102. Since the housing 102 already houses blood such that blood flows over the exterior surfaces 118 of the membrane 116 (Par. 70 of Zapol), the incorporated optical intrusion 44 of Lo will also project into the housing 102 and be immersed in blood. Thus, the limitation is met. Regarding claim 14, Zapol in view of Lo suggests the invention of claim 1. The combination further discloses wherein the optical intrusion 44 (Fig. 6 of Lo) comprises a fluorescent material (Col. 7, line 46-48 of Lo – “the two waveguides 42, 44 and 62, 64 near the ends of the respective vertical sections 48, 68 of the respective fluidic channels 50, 70 deliver optical power for fluorescent excitation”). Regarding claim 15, Zapol in view of Lo suggests the invention of claim 1. The combination further discloses wherein the light source 106 (Fig. 1 of Zapol) comprises at least one of an LED or a laser (Par. 66 of Zapol – “…the second light source 106 may each be in the form of an array of one or more light emitting diodes (LEDs)”). Regarding claim 16, Zapol in view of Lo suggests the invention of claim 1. The combination further discloses wherein the light source 106 (Fig. 1 of Zapol) emits light between 400-700 nm (Par. 66 of Zapol – “…the second light source 106 may each be configured to output light at with a wavelength between than 600 nm and 650 nm”). Claims 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zapol in view of Lo as applied to claim 1 above, and further in view of Gilmore et al. US 5,263,925 A (previously cited, hereinafter Gilmore). Regarding claim 7, Zapol in view of Lo suggests the invention of claim 1. However, the combination does not disclose wherein the optical intrusion comprises a tapered structure extending into the interior of the housing. Gilmore, in the same field of endeavor of treatment of blood with irradiation (Abstract), teaches wherein the optical intrusion 42 (Fig. 10 – concave lenses 42) comprises a tapered structure 42 (Col. 5, line 1-8 – concave lenses) extending into the interior of the housing 21 (Fig. 10 – cell 21). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the optical intrusion of the combined device to have a tapered structure as taught by Gilmore, in order to closely directing the rays from fiber optic to the tubules/channels (Col. 5, line 1-8 of Gilmore). Regarding claim 8, Zapol in view of Lo in view of Gilmore discloses the invention of claim 7. The combination further discloses wherein the tapered structure 42 (Fig. 42 of Gilmore) is hollow (Col. 12, line 42- 44 of Lo – “In the present embodiment, to secure the connection between the optical fiber 86 and the waveguide 44, a multi-mode fiber is inserted into the waveguide channel”). Examiner notes that once the modification is made as discussed in claim 1, the optical intrusion 44 of Lo will be incorporated into the housing 102 of Zapol, including the hollow structure to receive a fiber optic. Regarding claim 9, Zapol in view of Lo in view of Gilmore suggests the invention of claim 7. The combination further discloses wherein the tapered structure 42 (Fig. 10 of Gilmore) is solid (Par. 53 of Leonard – light pipes 404 can be solid state light sources). Regarding claim 10, Zapol in view of Lo in view of Gilmore suggests the invention of claim 7. The combination further discloses wherein the tapered structure 42 (Fig. 10 of Gilmore) is part of the housing 102 (Fig. 3a of Lo – the waveguide 44 is part of the device 40). Examiner notes that once the modification is made as discussed in claim 1, the integrated optical intrusion 44 of Lo will be incorporated into the housing 102 of Zapol. Regarding claim 11, Zapol in view of Lo in view of Gilmore suggests the invention of claim 7. However, the combination does not currently disclose wherein the tapered structure has a shape of at least one of a wedge, a cone, or a pyramid. Lo, in the same field of endeavor of optical system in fluid channels (Abstract) and in another embodiment, teaches wherein the tapered structure 77 (Fig. 4 – waveguides 77) has a shape of at least one of a wedge, or a pyramid (Fig. 4 – wedge configuration). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tapered structure of the combination to other tapered structure as claimed, as it is a matter of engineering design to reconfigure the taper in different ways, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tapered structure of the combination to be wedge-shaped as taught by Lo, in order to concentrate light for delivery. Regarding claim 12, Zapol in view of Lo in view of Gilmore suggests the invention of claim 1. However, the combination does not disclose wherein the optical intrusion comprises a plurality of tapered structures. Gilmore, in the same field of endeavor of treatment of blood with irradiation (Abstract), teaches wherein the optical intrusion 42 (Fig. 10 – concave lenses 42) comprises a plurality of tapered structures 42 (Col. 5, line 1-8 – concave lenses). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the optical intrusion of the combined device to have tapered structures as taught by Gilmore, in order to closely directing the rays from fiber optic to the tubules/channels (Col. 5, line 1-8 of Gilmore). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Li et al. US 10,004,917 B2 teaches tapered waveguides of a prosthetic device. Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /QUYNH DAO LE/Examiner, Art Unit 3781 /JESSICA ARBLE/Primary Examiner, Art Unit 3781
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Prosecution Timeline

Aug 25, 2023
Application Filed
Sep 10, 2025
Non-Final Rejection mailed — §103
Dec 05, 2025
Response Filed
Mar 23, 2026
Final Rejection mailed — §103
Jun 23, 2026
Request for Continued Examination
Jun 26, 2026
Response after Non-Final Action
Aug 05, 2026
Non-Final Rejection mailed — §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
33%
Grant Probability
40%
With Interview (+6.5%)
3y 6m (~6m remaining)
Median Time to Grant
High
PTA Risk
Based on 45 resolved cases by this examiner. Grant probability derived from career allowance rate.

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