DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/8/2026 has been entered.
Response to Amendment
This action is in response to the remarks filed on 1/8/2026. Claims 2, 4-23 remain pending. Claims 1 and 3 are cancelled. Claims 19-23 are newly added which claims 20-23 are withdrawn from consideration for the reasons noted below. Claims 2-18 were previously added as new claims, of those, claims 4-5, 8 and 18 were withdrawn since those claims were submitted after receiving an office action on the merits for the originally presented invention which has been constructively elected by original presentation for prosecution on the merits.
Accordingly, claims 2, 6-7, 12-17 and 19 are examined on their merits.
Claims objections have been withdrawn in light of the applicant’s amendments to the claims.
Election/Restrictions
Newly submitted claims 20-23 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the new claims are directed to “biomarker of the illuminated tissue target to emit a fluorescence response”, “detecting the fluorescence response emitted by the at least one biomarker of the tissue target with an image sensor”, “capturing a thermal image of the tissue target with a thermal sensor” and “output co- registering fluorescence data based on the fluorescence response and thermal data based on thermal image, wherein the output co-registering the fluorescence data and the thermal data” which were not examined.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 20-23 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 2, 6-7, 12-17 and 19 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.
Claim 2 recites the limitation of “each one of the plurality of excitation light sources having a wavelength or wavelength band different from others of the plurality of excitation light sources” that, it is not clear if each and every light sources having a wavelength or wavelength band different from others. In others words, it is not clear if there are four light sources and each one of those four light sources having a wavelength or wavelength band different from others. It is also noted that if this is the case (each light having different wavelength), the specification does not seem to support this newly recited amendments.
The depending claims are also rejected by the virtue of their dependency.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2, 6-7, 12-17 and 19 are rejected under pre-AIA 35 U.S.C. 103 (a) as being unpatentable over Chhibber et al (US20070064985A1) in view of Kurtz (US 20060241495 A1).
Regarding claim 2, Chhibber teaches a method of obtaining diagnostic data regarding a tissue target (“subject 101, or part of it, that is captured in the images include both skin and non-skin portions or features, such as hair, clothing, eyes, lips, nostrils, etc. Furthermore, some of the objects surrounding the subject 101 may also be captured in the images. Therefore, the pixels in the first white-light and UV images” [0047]; “camera and that the subject is allowed to reach full fluorescence under UV illumination” [0049]), comprising:
triggering a plurality of excitation light source of a portable, handheld imaging system to illuminate the tissue target with excitation light emitted by the plurality of excitation light source each one the plurality of the excitation light source emitting one or more wavelengths or wavelength bands causing at least one biomarker of the illuminated tissue target to emit a fluorescence response (“captured by the camera and that the subject is allowed to reach full fluorescence under UV illumination” [0049]; “the UV light sources 120 are turned on to send a flash of UV light to the subject 101. The flash of UV light should include a band of UV wavelengths the can causes the skin associated with the subject 101 to fluoresce” [0050]), each one of the plurality of excitation light sources having a wavelength or wavelength band different from others of the plurality of excitation light sources (“FIG. 2A also shows a plurality of light sources 120 as parts of the digital camera 200, including, for example, two flash light sources 120 on two sides of the camera, a flash light source 120 on top of the camera, and optionally another flash light source 120 at the bottom of the camera. Having more than one flash light sources 120 allows more uniform exposure of the subject 101 to light during imaging and to allow different light sources to be configured to emit different colors or wavelengths of light, but the number of light sources 120 and their positions in system 100 can be varied without affecting the general performance of the system. In one embodiment, a portion of the light sources 120 are configured to illuminate the subject 101 with white light, and another portion of the light sources 120 are configured to emit ultraviolet (UV) light” [0039]);
detecting the fluorescence response emitted by the at least one biomarker of the tissue target with an image sensor of the portable, handheld imaging system (“an image acquisition device 110, at least one light source 120 coupled to the image acquisition device 110” [0037]; “first UV image is captured by the sensor 114” [0050]); and
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based at least in part on the detected fluorescence response and, with a processor of the portable, handheld imaging system (see re-produced figs 1 and 2A below; and “camera 200 is converted from a conventional, off-the-shelf digital camera, such as the one shown in FIG. 2C, by adding the light sources 120 on the sides and the bottom” [0041]), generating an output indicative of a presence of one or more of epithelialization, granulation, inflammation, reduced nicotinamide adenine dinucleotide (NADH), flavin adenine dinucleotide (FAD), bacteria, infection, reparation, and a healing response in the tissue target (“skin pixel has a white color and an intensity value exceeds 130, the skin pixel is likely one of a group of contiguous pixels that have captured fluorescence coming from an inflamed pore upon illumination by a UV flash. To confirm, surrounding skin pixels are also examined to see if some of them are also white in color and have intensity values over 130. If none or few of the pixels satisfy this criteria, the first skin pixel is not associated with an inflamed pore. Otherwise, an inflamed pore is identified, and in step 1330, the number of skin pixels associated with the inflamed pore is determined as a measure for the shape and size of the pore” [0064]; “skin condition includes at least one type of pores selected from the group consisting of: inflamed pores, bacteriostatic pores, sluggish oil flow, and deeply inflamed pores” also see claim 21 of Chhibber).
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Although Chhibber teaches inflamed pores, bacteriostatic pores, and deeply inflamed pores (see [0064] and claim 21 of Chhibber), Chhibber does not point out the particulars of the “granulation” in the target tissue.
However, in the same field of endeavor, Kurtz teaches Wound Healing Monitoring and Treatment (title). Monitoring device for examining the state of tissues, and in particular a device that examines the condition of collagen structures within tissue using a light-based diagnostic device in close proximity with the skin of a patient [0001]. As wounds heal, they normally progress through a sequence of overlapping interactive phases, starting with coagulation and progressing through inflammation, proliferation (which includes granulation, angiogensis, and epithelialization), and remodeling [0006]. Portable optical devices for tissue diagnosis with a hand-held probe tethered to a mobile station to characterize the tissue [0012]. The exposure device is a handheld probe, comprising a multitude of light emitters. The light emitters, which typically are laser diodes, light emitting diodes (LEDs), or combinations thereof, usually provide light in the red-IR (.about.600-1200 nm) spectrum, because the tissue penetration is best at those wavelengths. In general, both laser light and incoherent (LED) light [0016]. A hand held probe, comprising at least one light emitter, but typically dozens or even 100 emitters, that is attached to a separate drive controller [0017]. Detection and tracking of capillary formation (angiogenesis) with the device of the present invention in tissue undergoing granulation and remodeling could also be useful in understanding tissue status [0051]. Diagnostic device 200 understands the conditions of the ECM in and around the wound. The clinician could determine that collagen forming in the ECM lacks sufficient structural integrity (relative to bundle length, diameter, density, orientation) for proper granulation, and then that the fibroblasts need directed stimulation to employ topical agents or growth factors that impact fibroblasts, or other processes such as angiogenesis, epithelialization, or granulation [0083].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with granulation as taught by Kurtz because it helps to understand the conditions of the ECM in and around the wound, the clinician could use this information in a variety of ways to improve the patient care. For example, the clinician could determine that collagen forming in the ECM lacks sufficient structural integrity (relative to bundle length, diameter, density, orientation) for proper granulation, and then that the fibroblasts need directed stimulation to induce stimulatory effects in fibroblasts, could be employed such as topical agents or growth factors that impact fibroblasts, or other processes such as angiogenesis, epithelialization, or granulation. ([0083] of Kurtz).
Regarding claim 6, Chhibber teaches wherein the tissue target is a wound in tissue (“captured fluorescence coming from an inflamed pore upon illumination by a UV flash. To confirm, surrounding skin pixels are also examined to see if some of them are also white in color and have intensity values over 130. If none or few of the pixels satisfy this criteria, the first skin pixel is not associated with an inflamed pore. Otherwise, an inflamed pore is identified, and in step 1330, the number of skin pixels associated with the inflamed pore is determined as a measure for the shape and size of the pore” [0064]).
Regarding claim 7, Chhibber teaches further comprising filtering the fluorescence response with an emission filter of the portable, handheld imaging system prior to detecting the fluorescence response with the image sensor (“light source 300 by changing a low-pass filter 310 in front of the light source 300 into a UV filter 310. In one embodiment, as shown in FIG. 3B, the UV filter is a bandpass filter” [0041]).
Regarding claim 12, Chhibber teaches wherein further comprising generating an output an indication of a bacterial presence in or on the tissue target (“skin condition can be displayed on a user interface using an image having the at least one type of skin condition highlighted, and/or with at least one number or chart quantifying the skin condition” [0012]; “skin condition includes at least one type of pores selected from the group consisting of: inflamed pores, bacteriostatic pores, sluggish oil flow, and deeply inflamed pores” also see claim 21 of Chhibber).
Regarding claim 13, Chhibber teaches wherein the portable, handheld imaging system further includes one or more of a white light source, a red-light source, a green light source, an ultraviolet light source, a near-infrared light source, and an infrared light source (“light sources 120 are configured to illuminate the subject 101 with white light, and another portion of the light sources 120 are configured to emit ultraviolet (UV) light.” [0039]).
Regarding claim 14, Chhibber teaches further comprising illuminating the tissue target with white light emitted by the white light source (“light sources 120 are configured to illuminate the subject 101 with white light,” [0039]) and detecting optical signals reflected by the tissue target in response to illumination with the white light (“ digital camera 200 having an image sensor 112 and an optical assembly 114 in front of the image sensor 112 and configured to form an image of the subject 101 on the image sensor 114” [0038]) and receiving, at the processor of the portable, handheld imaging system, reflection data based on the detected reflected optical signals (“Digital camera 200 may also include other parts or components that are not shown, such as a shutter, electronics for allowing the computing device 130 to control the shutter and the light sources 120, and electronics for outputting captured digital images to the computing device 130 for analysis, etc.” [0040]).
Regarding claim 15, Chhibber teaches outputting measurements associated with characteristics of the tissue target based on the reflection data (“Programs 524 may be organized into modules each includes coded instructions, which, when executed by the CPU 510, cause the computing device 130 to carry out different aspects, modules, or steps of a method for analyzing skin conditions using digital images” [0043]).
Regarding claim 16, Chhibber teaches the tissue target comprises a wound and the measurements associated with characteristics of the tissue target include one or more of wound dimensions, wound shape, wound topography, wound anatomy, wound area, wound depth, wound volume, and wound margins (“inflamed pore is identified, and in step 1330, the number of skin pixels associated with the inflamed pore is determined as a measure for the shape and size of the pore, and an average of the intensity value associated with the number of skin pixels is computed as a quantitative indication of the severity of the pore” [0064]).
Regarding claim 17, Chhibber teaches wherein the tissue target is a wound and wherein generating an output based on the detected fluorescence response further comprises identifying one or more of a presence, a location, a population, a quantity, a distribution, a colonization, a contamination, a critical colonization, an infection, and an extent of one or more of bacteria, fungus, yeast, and other microorganisms present in or on the wound (“captured fluorescence coming from an inflamed pore upon illumination by a UV flash. To confirm, surrounding skin pixels are also examined to see if some of them are also white in color and have intensity values over 130. If none or few of the pixels satisfy this criteria, the first skin pixel is not associated with an inflamed pore. Otherwise, an inflamed pore is identified, and in step 1330, the number of skin pixels associated with the inflamed pore is determined as a measure” [0064]).
Regarding claim 19, Chhibber teaches based at least in part on the detected fluorescence response and, with the processor of the portable, handheld imaging system, generating an output indicative of a presence of one or more of epithelialization, reduced nicotinamide adenine dinucleotide (NADH), flavin adenine dinucleotide (FAD), reparation, and a healing response in the tissue target (“skin condition includes at least one type of pores selected from the group consisting of: inflamed pores, bacteriostatic pores, sluggish oil flow, and deeply inflamed pores” also see claim 21 of Chhibber).
Response to Arguments
Regarding the applicant’s arguments directed to the prior art rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the applicant’s arguments directed to election restriction have been fully considered but they are not persuasive.
The applicant argues the following;
As an initial matter, 37 CFR 1.75(c) states that "[o]ne or more claims may be presented in dependent form, referring back to and further limiting another claim or claims in the same application." See MPEP 608.01(i). Applicant further notes that the requirements to restrict inventions include two or more "independent and distinct inventions," see 37 CFR 1.142(a), thereby causing a search burden corresponding to two distinct inventions. Applicant submits that the inventions of the identified restricted claims, such as claims 4, 5, 8, and 18 on their face cannot be restricted for beinq"independent' from claim 2, since they actually depend from claim 2 - restrictinq claims 4, 5, 8, and 15 from claim 2 places the lanquaqe of 37 CFR 1.75(c) and 37 CFR
1.142(a) in a direct conflict with each other. In any event, Applicant addresses the withdrawn claims in turn below.
However, contrary to the applicant assertion, these claims are not restricted for being "independent' from claim 2, rather shift in invention as species. The applicant is also reminded that as clearly outlined in the MPEP 821.04(a) for rejoinder of species claims when a generic claim is allowable.
Rejoinder is the process of bringing previously withdrawn claims back into consideration for allowance. When a generic claim is determined to be allowable, species claims that depend from or otherwise require all the limitations of the allowable generic claim may be eligible for rejoinder. This allows applicants to obtain broader patent coverage by including previously restricted species claims within the scope of the allowed generic claim.
Therefore, once/if the independent claim 2 found to be allowable, the withdrawn species claims 4-5, 8 and 18 will be rejoined.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERKAN AKAR whose telephone number is (571)270-5338. The examiner can normally be reached 9am-5pm M-F.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797