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 § 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.
Claim 9 is 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.
Claim 9 recites the limitation “where the lens used comprises a fiber-optic bundle with a smaller, miniature, tunable lens attached to the tip.” It is unclear how to interpret claim 9 because “the lens used” is a tunable lens according to claim 1, so that claim 9 must be read as where the <tunable lens of claim 1> comprises a fiber-optic bundle with a smaller, miniature, tunable lens attached to the tip. It is not clear how many tunable lenses are included in the device of claim 9 (one tunable lens of claim 1 plus a second tunable lens? one tunable lens of claim 1 that somehow further comprises another tunable lens?). It is further unclear how to interpret “smaller, miniature, tunable lens” because it is not clear what “smaller” is in comparison to. For the purposes of further examination, this claim will be interpreted to mean that the lens of claim 1 is attached to the tip of a fiber optic bundle.
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, 3-4, 7-8, and 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 Aschwanden et al. (EP 2 860 555 A1, Apr. 15, 2015) (hereinafter “Aschwanden”) and Amirana et al. (US 2015/0327753 A1, Nov. 19, 2015) (hereinafter “Amirana”).
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 is 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 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.
Further regarding claim 1: 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 for imaging ([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.
Amirana teaches an imaging probe encircled by a plastic balloon that can be inflated or deflated, and increased or decreased in size, through the application of air pressure ([0062], [0063]). Amirana further teaches that the balloon functions to displace blood within a body cavity to provide an optically uncluttered view of the tissue ([0063]).
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 system of Fisker and Aschwanden by including a balloon as taught by Amirana in order to provide an optically uncluttered view within a body cavity if blood is present in view of the further teachings of Amirana.
Regarding claim 3: Fisker, Aschwanden and Amirana teach the system according to claim 1. Amirana further teaches providing multiple wavelengths of illumination, including ultraviolet (UV), in a single probe to allow for different functionality within a single instrument ([0097]).
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 system of Fisker Aschwanden and Amirana by including additional wavelengths, such as UV, to expand the utility of the probe by providing different functionality with the same instrument as taught by Amirana.
Regarding claim 4: Fisker, Aschwanden and Amirana teach the system according to Claim 1. Fisker further teaches where the wavelength emitted by the illumination component is visible ([0151], [0155]).
Regarding claims 7, 8, and 11: Fisker, Aschwanden and Amirana teach 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, Aschwanden and Amirana would be capable of performing the intended uses set forth in claims 7, 8, and 11.
Claim(s) 2, 5-6, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fisker, Aschwanden and Amirana as applied to claim 1 above, and further in view of Gopinath et al. (US 2017/0010456 A1, Jan. 12, 2017) (hereinafter “Gopinath”).
Regarding claim 2: Fisker, Aschwanden and Amirana teach the system according to Claim 1, but are silent on where the wavelength illumination component is infrared.
Gopinath teaches imaging using either visible or infrared radiation ([0054]) and that illumination wavelength for biological imaging is a results effective variable ([0054] – “the person of ordinary skill in the art will select the wavelength(s) desirable for a particular application”). Therefore, 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 select a wavelength range, including infrared, which is desirable for a particular application as taught by Gopinath, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. In re Aller, 105 USPQ 233.
Regarding claims 5-6: Fisker, Aschwanden and Amirana teach 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, Aschwanden and Amirana 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, Aschwanden and Amirana that the probe should fit into “any small body cavity.”
Regarding claim 9, as best understood based on limitations which are indefinite: Fisker, Aschwanden and Amirana teach they system according to claim 1. Fisker further teaches that the probe should fit into “any small body cavity” ([0284]), but does not teach where the lens used comprises a fiber-optic bundle with a smaller, miniature, tunable lens attached to the tip.
Gopinath teaches a probe comprising a fiber-optic bundle with a “smaller, miniature” tunable lens attached to the tip ([0052]-[0053] – “endoscope for medical imaging”, figs. 1 and 21, [0100]).
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 system of Fisker, Aschwanden and Amirana by providing the probe with a fiber-optic bundle with a tunable lens attached to the tip as taught by Gopinath in order to reach interior body spaces in view of the teaching of Fisker that the probe should fit into “any small body cavity.”
Regarding claim 10: Fisker, Aschwanden and Amirana teach the system according to claim 1 but do not teach where the system utilizes spectroscopic imaging.
As a preliminary matter, Examiner notes that “utilizes spectroscopic imaging” does not appear to be any particular structural limitation on the system of claim 1, but instead limits the use of the system.
Gopinath teaches a probe comprising a tunable liquid lens which can be used with a number of imaging techniques, including spectroscopic imaging, based on the type of imaging desired ([0056]).
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 use the system of claim 1 with spectroscopic imaging as taught by Gopinath in order to provide the desired type of imaging corresponding to a particular use (e.g. target type).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 11,806,112. Although the claims at issue are not identical, they are not patentably distinct from each other because conflicting claim 8 fully anticipates every limitation of instant claim 1.
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