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 .
Drawings
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated, see paragraph [0020] of the application publication “a conventional OCT imaging”. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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 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.
Claims 14 and 18 are 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 claims 14 and 18, the phrase “e.g.” (for example) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 5, 10, 11, 13, 17, 19, 25, 26, 34, 35, and 39 are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Yellen et al. (US 2020/0268312 A1), hereinafter “Yellen”.
Regarding claim 1, Yellen discloses a characterization system (abstract, Fig. 16) comprising:
a stationary unit (Fig. 16, ref console) optically connected to a rotary unit (ref probe, note that the claim does not require the “rotary unit” to rotate; however, paragraph [0170] states that “the line may also be rotated by changing the positioning of the probe itself”, which is interpreted as the probe unit being a rotary unit),
wherein the rotary unit comprises a first optical channel (any of refs 1623A, 1622, 1612, 1621), a second optical channel (any of refs 1606, 1616, 1613, 1614, 1608, 1612, 1621) and a first detector (ref 1624),
wherein the stationary unit comprises a second detector (ref 1618), and
wherein the first optical channel is optically connected to the first detector for detecting light for a first characterization modality (paragraph [0229] “backscattered from the tissue was imaged”) and the second optical channel is optically connected to the second detector (ref 1618) for detecting light for a second characterization modality (paragraphs [0217], [0228], “a spectrometer for measuring a distinct spectral band in the backscatter light, a CCD camera for capturing a single-shot image of the backscattered light against the contrast background”).
Regarding claim 2, Yellen discloses two light sources (refs 1602, 1620) wherein the two light sources are optically connected to the second optical channel to provide illumination from the two light sources through the second optical channel (both light sources pass through refs 1621, 1612, 1629, which is part of the second optical channel).
Regarding claim 4, Yellen discloses two light sources (refs 1602, 1620) wherein only one of the two light sources is optically connected to the second optical channel to provide illumination from the only one of the two light sources (ref 1602 only is connected to refs 1604, 1606, 1616, 1613, 1614, 1608).
Regarding claim 5, Yellen discloses wherein the rotary unit comprises a third optical channel and only one of the two light sources is optically connected to the third optical channel (any of refs 1623A, 1623B, 1622, 1623A are a channel that only light from source 1620 passes).
Regarding claim 10, Yellen discloses wherein the first optical channel is also optically connected to the second detector (light from ref 1612, 1621 passes to detector ref 1618).
Regarding claim 11, Yellen discloses wherein the first optical channel comprises a single mode waveguide (paragraph [0068])and the second optical channel comprises a multimode waveguide (paragraph [0067]) or the first optical channel comprises a multimode waveguide and the second optical channel comprises a single mode waveguide (paragraphs [0067]-[0068]).
Regarding claim 13, Yellen discloses wherein the rotary unit comprises a wireless transmitter operable to wirelessly transmit data corresponding to signal detected by the first detector (paragraph [0127]).
Regarding claim 17, Yellen discloses wherein the rotary unit further comprises an information storage device operable to store data corresponding to signal detected by the first detector (paragraph [0229]; a CCD camera inherently contains RAM in order to serve as a high speed buffer)
Regarding claim 19, Yellen discloses wherein the rotary unit comprises a circuit operable to process signal detected by the first detector prior to transmission (paragraph [0229]; a CCD camera inherently contains a circuit in order to process the image).
Regarding claim 25, Yellen discloses wherein (i) the first characterization modality is optical coherence tomography, reflectance imaging, visible spectroscopy, NIRS, or Raman spectroscopy; (ii) the second optical channel is an illumination channel for the second characterization modality, which is different from the first characterization modality, and the second characterization modality is optical coherence tomography, reflectance imaging, visible spectroscopy, NIRS, or Raman spectroscopy; or (iii) both (i) and (ii) (paragraphs [0130], [0228]).
Regarding claim 26, Yellen discloses wherein the first optical channel is comprised in a first characterization modality subsystem for the first characterization modality and the second optical channel is comprised in a second characterization modality subsystem for the second characterization modality, which is different than the first characterization modality (paragraphs [0228]-[0229]).
Regarding claim 34, Yellen discloses wherein the first optical channel is a collection channel for the first characterization modality (refs 1622, 1623A, etc.) and the second optical channel is an illumination channel for at least the first characterization modality (refs 1616, 1613, 1614, etc; paragraphs [0228]-[0229]).
Regarding claim 35, Yellen discloses wherein rotary unit comprises a light source (ref 1620) and a third optical channel that is optically connected to the light source (refs 1623B, 1623A).
Regarding claim 39, Yellen discloses wherein the rotary unit comprises an interconnect and the first optical channel and the second optical channel are optically connected to the interconnect (ref 1612, paragraph [0228]).
Claims 1, 2, 4, 5, 10, 14, 15, 25, 26, 34, 39, 50, and 52 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bec et al. (US 2023/0172443 A1), hereinafter “Bec”.
Regarding claim 1, Bec discloses a characterization system (abstract, Fig. 1) comprising:
a stationary unit (Fig. 1, ref 123) optically connected to a rotary unit (ref 122, paragraph [0030]; note that the claim does not require the “rotary unit” to rotate; however, motor drive 122 includes a “rotary collimator” 124, therefore, the examiner broadly but reasonably interprets to motor drive unit to be a “rotary unit”),
wherein the rotary unit comprises a first optical channel (any of refs 108, 102, 103, 101, 102, 104, 110, 105, 106, 113, 114, 115, 116), a second optical channel (any of ref 111, 112, 127, 113, 114, 115, 116) and a first detector (refs 132, 133, 134, paragraph [0036]),
wherein the stationary unit comprises a second detector (ref 126, paragraph [0034]), and
wherein the first optical channel is optically connected to the first detector for detecting light for a first characterization modality (paragraphs [0035]-[0036]) and the second optical channel is optically connected to the second detector for detecting light for a second characterization modality (paragraph [0034]).
Regarding claim 2, Bec discloses two light sources (ref 128, 126, paragraphs [0034]-[0035]) wherein the two light sources are optically connected to the second optical channel to provide illumination from the two light sources through the second optical channel (both light sources pass through refs 113, 114, 115, 116, which is part of the second optical channel).
Regarding claim 4, Bec discloses comprising two light sources (ref 128, 126, paragraphs [0034]-[0035]) wherein only one of the two light sources is optically connected to the second optical channel to provide illumination from the only one of the two light sources (ref 126 only passes through ref 111, 112, 127).
Regarding claim 5, Bec discloses wherein the rotary unit comprises a third optical channel and only one of the two light sources is optically connected to the third optical channel (refs 101 and 102 or refs 103 and 104 or refs 105 and 106 are a channel that only light from source 128 passes).
Regarding claim 10, Bec discloses wherein the first optical channel is also optically connected to the second detector (light from ref 116, 115, 114 passes to detector ref 126).
Regarding claim 14, Bec discloses wherein the rotary unit comprises an electrical transmitter (e.g., transceiver) operable to electrically transmit data corresponding to signal detected by the first detector (e.g., by brushes, or by docking the electrical transmitter) (paragraphs [0035]-[0036]).
Regarding claim 15, Bec discloses wherein the rotary unit is operable to transmit data corresponding to signal detected by the first detector during rotation of the rotary unit (paragraphs [0035]-[0036], furthermore, the recitation “during rotation of the rotary unit” is a functional limitation that does not change the structure of the rotary unit. The examiner suggests an amendment “rotary unit configured to”).
Regarding claim 25, Bec discloses wherein (i) the first characterization modality is optical coherence tomography, reflectance imaging, visible spectroscopy, NIRS, or Raman spectroscopy; (ii) the second optical channel is an illumination channel for the second characterization modality, which is different from the first characterization modality, and the second characterization modality is optical coherence tomography, reflectance imaging, visible spectroscopy, NIRS, or Raman spectroscopy; or (iii) both (i) and (ii) (paragraph [0034]).
Regarding claim 26, Bec discloses wherein the first optical channel is comprised in a first characterization modality subsystem for the first characterization modality and the second optical channel is comprised in a second characterization modality subsystem for the second characterization modality, which is different than the first characterization modality (paragraphs [0034]-[0035]).
Regarding claim 34, Bec discloses wherein the first optical channel is a collection channel for the first characterization modality (refs 108, 109, etc.) and the second optical channel is an illumination channel for at least the first characterization modality (refs 111, 112, etc.; paragraphs [0034]-[0035]).
Regarding claim 39, Bec discloses wherein the rotary unit comprises an interconnect and the first optical channel and the second optical channel are optically connected to the interconnect (refs 121, 114, 115, 116, paragraph [0030]).
Regarding claim 50, Bec discloses wherein the rotary unit rotates at greater than 3,500 rpm, greater than 5,000 rpm, or greater than 6,000 rpm during operation (paragraph [0031], a rotary collimator can rotate at the claimed speeds, however, the recitation is a non-limiting function that does not change the structure of the device).
Regarding claim 52, Bec discloses wherein the system has a characterization sensitivity of greater than 100 dB for at least one of the first characterization modality and the second characterization modality (paragraph [0017], polarization sensitive optical coherence tomography (PS-OCT) imaging has a sensitivity greater than 100 dB).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Yellen as applied to claim 1 above, and further in view of Xu et al. (US 8953911 B1), hereinafter “Xu”.
Regarding claim 12, Yellen teaches wherein at least one of the first optical channel and the second optical channel comprises a waveguide within the rotary unit (as shown in Fig. 16, probe) but is silent regarding one or more than one optical waveguide connected in series.
However, Xu teaches a rotating imaging probe (abstract) including one or more than one optical waveguide connected in series (refs 12b, 100a, 100b, col. 15, lines 1-39).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Yellen with the teaching of Xu by including wherein at least one of the first optical channel and the second optical channel comprises more than one optical waveguide connected in series within the rotary unit in order to efficiently couple the light between the devices.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Yellen as applied to claim 1 above, and further in view of Tearney et al. (US 2021/0161373 A1), hereinafter “Tearney”.
Regarding claim 18, Yellen is silent regarding wherein the rotary unit further comprises an energy storage device (e.g., a battery) to provide power.
However, Tearney teaches a detachable optical probe (abstract, Fig. 2) including wherein the rotary unit further comprises an energy storage device (e.g., a battery) to provide power (paragraph [0064]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Yellen with the teaching of Tearney by including wherein the rotary unit further comprises an energy storage device (e.g., a battery) to provide power in order to operate the probe wirelessly.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zuluaga (US 6895137) teaches a spinning catheter that rotates at the disclosed rates.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC J BOLOGNA whose telephone number is (571)272-9282. The examiner can normally be reached Monday - Friday 7:30am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kara Geisel can be reached at (571) 272-2416. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC J BOLOGNA/Primary Examiner, Art Unit 2877