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 .
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) 1, 2, 4, 7-8, and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fisker et al. (US 2012/0092461 A1, Apr. 19, 2012) (hereinafter “Fisker”) in view of Hart et al. (US 2013/0002426 A1, Jan. 3, 2013) (hereinafter “Hart”) and Aschwanden et al. (EP 2 860 555 A1, Apr. 15, 2015) (hereinafter “Aschwanden”).
Regarding claim 1: Fisker teaches a system for the imaging and analysis of human lesions, comprising: an illumination component emitting light with a specific wavelength ([0244]); an imaging sensor ([0244]); a tunable liquid imaging lens ([0069]), and the imaging sensor captures a snapshot at each focal length setting ([0246], it is noted that “and the imaging sensor captures a snapshot at each focal length setting” is neither a structural limitation on the liquid lens nor on the imaging sensor and instead appears to describe only the use of the imaging sensor); and a driver accompanying the electrically tunable liquid imaging lens, wherein the driver is configured to control the effective focus of the electrically tunable liquid imaging lens, enabling the imaging sensor to capture lesion images within a fraction of a second from each other across a range of focus settings in order to produce a single, sharp, all- focus image ([0260]-[0270]; while Fisker does not explicitly describe a driver, this element is considered to be implicitly disclosed by the description of sweeping through the range of focal planes using the lens). Fisker further discloses an enclosure housing the tunable liquid imaging lens, the illumination component, and the imaging sensor ([0244] and [0284], housing 100 and probe housings shown in figs. 12-14). While Fisker teaches that the probe housing (“enclosure”) can include an elongate portion configured to be inserted into any small bodily cavity, particularly the ear, for imaging/surface scanning ([0162], [0284]), Fisker is silent on the enclosure being encircled by a plastic balloon that can be inflated or deflated, and increased or decreased in size, through the application of air pressure.
Hart, in the same field of endeavor, discloses a system for imaging the ear canal (fig. 2, [0046]) comprising a handheld probe (probe 206) having an illumination component, focusing lenses, an imaging sensor, a processor ([0048]), and an enclosure (while the enclosure is not labeled, fig. 2 shows a housing and rigid rod 214 may also be considered a housing for at least the scanning elements), wherein the enclosure is encircled by a plastic balloon (fig. 2 - at least a portion of the housing/enclosure of probe 206 is encircled by the balloon 202; [0042], [0056]; it is noted that while Hart does not use the term “plastic”, the term is not defined by the instant disclosure as being any particular material and the deformable material of Hart is reasonably assumed to be a polymer given the description of the material properties and the use, moreover there is no evidence of criticality or unexpected result) that can be inflated or deflated, and increased or decreased in size, through the application of air pressure ([0046], [0051]; [0043] - “any…gas” reasonably includes air, moreover there is no evidence of criticality or unexpected result). Hart further discloses that the characteristics of the membrane (“balloon”) such as coatings or patterns improve the performance of the scanning system ([0009]-[0011]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the imaging system of Fisker with an inflatable membrane as disclosed by Hart in order to improve the performance of the scanning system in view of the further teachings of Hart.
Further regarding claim 1: Fisker and Hart are silent on the details of the liquid lens.
Aschwanden, in the same problem solving area of liquid tunable lenses, teaches a liquid lens comprising a tunable liquid imaging lens having a bendable lens membrane, wherein a focal length of the tunable liquid imaging lens is controlled by fluid pressure on the bendable lens membrane so that as the fluid pressure is adjusted, multiple focal lengths are achieved ([0001]-[0002], [0009], [0064], [0069]). Aschwanden further teaches that this lens is very versatile and can be used in many applications including ophthalmology equipment and endoscopes ([0060]) and that the lens design provides a specific advantage in increasing the ratio between the clear aperture of the lens and the other lens diameter ([0006]-[0007]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the system of Fisker and Hart using the tunable liquid lens of Aschwanden in order to achieve the benefit if increased clear aperture to lens diameter ratio and in view of Aschwanden’s teaching that the lens is suitable for various medical imaging scopes including endoscopes.
Regarding claims 2 and 4: Fisker, Hart and Aschwanden disclose the system of claim 1. Hart incorporates by reference to Hart et al. (US 2010/0019170, corresponding to US 12/508,955) ([0001]). Hart, by way of incorporation of Hart et al., discloses the use of any wavelength including visible and infrared wavelengths (Hart et al. [0032]). Fisker further teaches where the wavelength emitted by the illumination component is visible ([0151], [0155]).
Regarding claims 7, 8, and 11: Fisker, Hart and Aschwanden disclose the system according to claim 1. The specific body tissues scanned (skin, cervical, mouth, throat, and anal cancers; infected wounds and traumatic injury wounds) and the use of the system (“where the system is used to take three- dimensional images of lesions throughout the human body, including confined spaces”), are considered to be the intended use of the claimed system in the absence of any particular structural limitations related to any of these applications. Applicant is reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the system of Fisker, Hart and Aschwanden would be capable of performing the intended uses set forth in claims 7, 8, and 11.
Regarding claim 10: Fisker, Hart and Aschwanden disclose the system of claim 1. Hart incorporates by reference to Hart et al. (US 2010/0019170, corresponding to US 12/508,955) ([0001]). Hart, by way of incorporation of Hart et al., discloses the use of spectroscopic imaging (Hart et al. [0124] - “imaging the target surface with spectroscopic hardware”).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fisker, Hart and Aschwanden as applied to claim 1 above, and further in view of Lepple-Wienhues (US 2017/0049309 A1, Feb. 23, 2017) (hereinafter “Lepple-Wienhues”).
Regarding claim 3: Fisker, Hart and Aschwanden disclose system according to claim 1. Hart incorporates by reference to Hart et al. (US 2010/0019170, corresponding to US 12/508,955) ([0001]). Hart, by way of incorporation of Hart et al., discloses the use of a variety of possible light sources (Hart et al. [0032] - “…this may include light emitting diodes, incandescent bulbs or lamps, laser light sources, or any other broadband light source, broadband visible light source, narrowband light source or any combination of the foregoing that emits photons at the desired wavelength(s).” as well as “any range of electromagnetic wavelengths”). Hart further discloses imaging via a window in the inflatable membrane to guide the probe and allow the user to avoid hitting an obstruction such as the eardrum (“tympanic membrane”) ([0063]).
However, Fisker, Hart and Aschwanden do not specifically mention where the wavelength illumination component emits ultraviolet light.
Lepple-Wienhues, in the same problem-solving area of otoscopy, discloses using UV light to help locate objects in the ear canal including the eardrum ([0003], [0010]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the wavelength illumination component of Fisker, Hart and Aschwanden to emit ultraviolet light in order to aid in identifying and locating the eardrum to improve collision avoidance.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fisker, Hart and Aschwanden as applied to claim 1 above, and further in view of Gopinath et al. (US 2017/0010456 A1, Jan. 12, 2017) (hereinafter “Gopinath”).
Regarding claims 5-6: Fisker, Hart and Aschwanden disclose the system according to claim 1. Fisker further teaches that the probe should fit in “any small bodily cavity” ([0284]), but is silent on the tunable lens used being less than two millimeters in diameter.
Gopinath teaches a tunable lens which may be two millimeters (where the claimed range of two to twenty includes two) or less than two millimeters in diameter ([0065]).
It would have been prima facie obvious for a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Fisker, Hart and Aschwanden by implementing the tunable lens to be two millimeters or less than two millimeters in diameter as taught by Gopinath based on the desired use in view of the teachings of Fisker, Hart and Aschwanden that the probe should fit into “any small body cavity.”
Response to Arguments
Rejection of claim 9 under 35 U.S.C. §112(b) is withdrawn in light of the cancelation of the claim.
Double Patenting rejection is withdrawn in light of the Terminal Disclaimer filed 05/01/2026.
Applicant’s arguments, see Remarks, filed 05/01/2026, 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 new prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799
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