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 .
Remarks
Claims 15-17 and 21-37, filed 04/29/2024, are currently pending and are under consideration.
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 15-17 and 21-37 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 15 recites the limitations " the skin" in line 3 and “the treatment area of the skin” in line 9. There is insufficient antecedent basis for these limitations in the claim.
Claim 16 recites the limitation “the locations” in line 2. There is insufficient antecedent basis for this limitation in the claim.
The term “substantially” in claims 16, 17, 32-36 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 28 recites the limitation “the frame” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 21-27, 29-31, and 37 are rejected based on their dependency on claim 15.
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.
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 15-17, 21-28, 31-33, and 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US Patent Application Publication 2015/0150629 – APPLICANT CITED ON 04/29/2024 IDS), hereinafter Anderson, further in view of Jagdeo et al. (US Patent Application Publication 2016/0317226 – APPLICANT CITED ON 04/29/2024 IDS), hereinafter Jagdeo.
Regarding claim 15, Anderson discloses a system of skin tightening (e.g. Abstract) comprising:
a laser configured to fractionally ablate two or more columns of tissue from a treatment area on the skin, thereby forming two or more columnar vacancies in the tissue of the treatment area, the columnar vacancies each having a perimeter defined by a first side and a second side opposite the first side, the first side and the second side each comprising an epidermal layer, a dermal layer, and a subcutaneous layer of tissue (e.g. Par. [0011]: using an ablative laser to form holes in the skin through the dermis; Par. [0052]: describing the shape the holes made; Fig. 1B: example of a shape with first and second opposite sides; Par. [0055]);
an adhesive configured to be applied to the skin and apply compressive force to each columnar vacancy to hold the first side and second side of the columnar vacancy together (e.g. Par. [0019]: photoactivated adhesive that applies compressive force); and
a light source configured to irradiate one or more closed columnar vacancies, wherein the adhesive is transparent to light having a wavelength for non-ablatively irradiating a closed columnar vacancy underlying the adhesive based at least in part on the fractional ablation and the imaging (e.g. Par. [0087]: irradiation of the closed holes through photoactivated adhesion)
However, Anderson fails to disclose an imaging system configured to image blood vessels in the treatment area of the skin and form a digitized map of vascularized and non-vascularized regions, one or more controllers operatively connected to the laser and the imaging system, the one or more controllers being configured to automatedly control imaging of the blood vessels in the treatment area and fractional laser ablation locations in the treatment area, and further configured to direct the laser to perform fractional ablation based at least in part on the imaging, and wherein the light source operatively controlled by the one or more controllers.
Jagdeo, in a similar field of endeavor, is directed towards tissue imaging. Jagdeo discloses an imaging system configured to image blood vessels in the treatment area of the skin and form a digitized map of vascularized and non-vascularized regions (e.g. Par. [0035]: images acquired with tissue locations and boundaries targeted; Par. [0039]: imaging of blood vessels; Par. [0046]: imaging module for visualizing blood vessels), one or more controllers operatively connected to the laser and the imaging system, the one or more controllers being configured to automatedly control imaging of the blood vessels in the treatment area and fractional laser ablation locations in the treatment area (e.g. Par. [0018]: controller to control imaging device and laser; Par. [0035]: “The controller preferably has an interface with the image devices as well as an interface with the laser delivery system so that images can be acquired, tissue locations and boundaries targeted, and laser settings calculated and configured”; Par. [0040]: “OCT serves as an adjunctive aid to help guide ablative laser setting selections or laser therapy setting selections by allowing real-time assessment of the treatment site”), and further configured to direct the laser to perform fractional ablation based at least in part on the imaging (e.g. Par. [0047]: imaging module guides laser module to perform fractional ablation), and wherein the light source is operatively controlled by the one or more controllers (e.g. Par. [0016]; Par. [0050]: control module controls the laser).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson to include the imaging system and a controller connected to the laser and imaging system as taught by Jagdeo because doing so would allow the laser treatment to be guided in real time through the imaging to optimize treatment outcomes (e.g. Jagdeo, par. [0050]: “This provides customized and optimized treatment settings for patients”).
Regarding claim 16, Anderson fails to disclose wherein the imaging system determines the locations of substantially non-vascularized areas within the treatment area of the tissue based on the imaged blood vessels. Jagdeo, in a similar field of endeavor, is directed towards tissue imaging. Jagdeo discloses wherein the imaging system determines the locations of substantially non-vascularized areas within the treatment area of the tissue based on the imaged blood vessels (e.g. Par. [0035]: regional modulation of laser ablation by targeting tissue locations; Par. [0047]: laser treatment provided that does not damage vasculature; Par. [0078]: determining laser parameters so as to not cause vascular damage).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Jagdeo to include the imaging system of Jagdeo because doing so would allow the laser treatment to be guided in real time through the imaging to optimize treatment outcomes (e.g. Jagdeo, par. [0050]: “This provides customized and optimized treatment settings for patients”).
Regarding claim 17, Anderson fails to disclose wherein the one or more controllers are configured to direct the laser to perform fractional ablation on the substantially non-vascularized tissue in the treatment area. Jagdeo, in a similar field of endeavor, is directed towards tissue imaging. Jagdeo discloses wherein the one or more controllers are configured to direct the laser to perform fractional ablation on the substantially non-vascularized tissue in the treatment area (e.g. Par. [0016]; Par. [0050]: control module controls the laser; Par. [0047]: imaging module guides laser module to perform fractional ablation).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Jagdeo to include the controllers directing the laser to perform the fractional ablation of Jagdeo because doing so would provide the necessary laser treatment to the tissue.
Regarding claim 21, Anderson further discloses wherein the adhesive is transparent to light in the infrared and/or visible regions of the spectrum (e.g. Par. [0087]).
Regarding claim 22, Anderson further discloses wherein the light source is configured to generate light that can pass through the adhesive and has a therapeutic effect on the columnar vacancy (e.g. Par. [0087]).
Regarding claim 23, Anderson fails to specifically disclose wherein the light source comprises at least one of a non- ablative laser and a broad band light. Jagdeo, in a similar field of endeavor, is directed towards tissue imaging. Jagdeo discloses wherein the light source comprises a non- ablative laser and a broad band light (e.g. Par. [0047]: non-ablative laser beams, wavelengths of 400nm-2000nm).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the laser of Anderson in view of Jagdeo to include the non-ablative laser or a broad band light as taught by Jagdeo because doing so would allow the system to modify the targeted tissue in a desired manner.
Regarding claim 24, Anderson fails to disclose wherein the laser comprises a hybrid laser operable to produce laser beams having a plurality of differing wavelengths, such that the hybrid laser is capable of performing both fractional laser ablation of the skin at an ablative wavelength, and non-ablative irradiation at a different wavelength. Jagdeo, in a similar field of endeavor, is directed towards tissue imaging. Jagdeo discloses wherein the laser comprises a hybrid laser operable to produce laser beams having a plurality of differing wavelengths, such that the hybrid laser is capable of performing both fractional laser ablation of the skin at an ablative wavelength, and non-ablative irradiation at a different wavelength (e.g. Par. [0047]: laser module can produce both ablative and non-ablative laser beams).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the laser of Anderson in view of Jagdeo to include the laser capable of producing both the ablative and non-ablative laser beams as taught by Jagdeo because doing so would allow the system to modify the targeted tissue in a desired manner.
Regarding claim 25, Anderson fails to disclose wherein the fractional laser ablation is performed on a treatment area that is at least 50% non-vascularized tissue. Jagdeo, in a similar field of endeavor, is directed towards tissue imaging. Jagdeo discloses wherein the one or more controllers are configured to direct the laser to perform fractional ablation on the substantially non-vascularized tissue in the treatment area (e.g. Par. [0016]; Par. [0050]: control module controls the laser; Par. [0047]: imaging module guides laser module to perform fractional ablation).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Jagdeo to include the controllers directing the laser to perform the fractional ablation of Jagdeo because doing so would provide the necessary laser treatment to the tissue.
Anderson in view of Jagdeo discloses the claimed invention except for the treatment area being at least 50% non-vascularized tissue. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention as taught by Anderson in view of Jagdeo with the treatment area being at least 50% non-vascularized tissue, 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 routine skill in the art [In re Aller, 105 USPQ 233].
Regarding claim 26, Anderson further discloses wherein the adhesive is configured to close the columnar vacancy such that the epidermal layer, the dermal layer, and/or the subcutaneous layer of the first side of the columnar vacancy is aligned, respectively, with the epidermal layer, the dermal layer, and/or the subcutaneous layer of the second side of the columnar vacancy in a z-direction orthogonal to the surface of the skin (e.g. Par. [0088]).
Regarding claim 27, Anderson fails to specifically disclose a camera configured to receive light from the imaged treatment area. Jagdeo, in a similar field of endeavor, is directed towards tissue imaging. Jagdeo discloses a camera configured to receive light from the imaged treatment area (e.g. Par. [0039]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Jagdeo to include the camera as taught by Jagdeo because doing so would allow the laser treatment to be guided in real time through the imaging to optimize treatment outcomes (e.g. Jagdeo, par. [0050]: “This provides customized and optimized treatment settings for patients”).
Regarding claim 28, Anderson further discloses a deformable frame configured to have an open shape in an open position and a closed shape in a closed position when attached to a surface of the skin (e.g. Pars. [0077]-[0078]: surgical staples are used to apply and maintain a compressive force; Fig. 4A: open configuration; Figs. 4B-C: closed configuration),
wherein, in the closed position, the frame is configured to connect the first side of at least one of the columnar vacancies to the second side of the at least one columnar vacancy (e.g. Pars. [0077]-[0078]: surgical staples are used to apply and maintain a compressive force; Figs. 4B-C: closed configuration); and
wherein the epidermal layer, the dermal layer, and/or the subcutaneous layer of the first side of the columnar vacancy is aligned, respectively, with the epidermal layer, the dermal layer, and/or the subcutaneous layer of the second side of the columnar vacancy in a z-direction orthogonal to the surface of the skin, when the frame is in the closed position (e.g. Figs. 4B-C: vacancies 100 are aligned in a z-direction orthogonal to the surface of the skin when the frame 400, 460 is in a closed position).
Regarding claim 31, Anderson further discloses wherein the open shape of the frame is a polygonal shape having an open internal area defined by edges of the frame (e.g. Fig. 4A).
Regarding claim 32, Anderson further discloses wherein the frame is unable to distort substantially in the z-direction during altering of the shape of the frame from the open shape to the closed shape (e.g. Figs. 4A-B: frame 400 does not distort substantially when moving from open to closed position).
Regarding claim 33, Anderson further discloses wherein the frame comprises one or more tabs, and the tabs prevent the frame from distorting substantially in the z-direction during altering of the shape of the frame from the open shape to the closed shape (e.g. Fig. 4C: tab 470; Par. [0078]).
Regarding claim 35, Anderson further discloses wherein the epidermal layers, the dermal layers, and/or the subcutaneous layers of the first and second sides of the columnar vacancy are substantially relaxed or untensioned when the frame is in the closed position (e.g. Fig. 4B: layers of skin attached in the closed position).
Regarding claim 36, Anderson further discloses wherein the epidermal layers, the dermal layers, and the subcutaneous layers of the first and second sides of the columnar vacancy are aligned to form a substantially planar and untensioned dermal-epidermal junction and a substantially planar and untensioned dermal-subcutaneous junction across the first and second sides of the columnar vacancy, when the frame is in the closed position (e.g. Fig. 4B: layers of skin attached in the closed position).
Regarding claim 37, Anderson further discloses wherein the frame includes one or more pins, staples, or anchors extending downwardly into a dermal or subcutaneous layer of the skin from a bottom of the frame that is in contact with and adhered to the surface of the skin (e.g. Pars. [0077]-[0078]; Figs. 4A-C).
Claims 29, 30, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US Patent Application Publication 2015/0150629 – APPLICANT CITED ON 04/29/2024 IDS), hereinafter Anderson, further in view of Jagdeo et al. (US Patent Application Publication 2016/0317226 – APPLICANT CITED ON 04/29/2024 IDS), hereinafter Jagdeo, as applied to claim 28 above, and further in view of Jackson et al. (US Patent Application Publication 2014/0228731 – APPLICANT CITED ON 04/29/2024 IDS), hereinafter Jackson.
Regarding claim 29, Anderson fails to disclose an apparatus configured to alter the shape of the frame from the open shape to the closed shape. Jackson, in a similar field of endeavor, is directed towards a radially tensioned skin treatment device. Jackson discloses an apparatus configured to alter the shape of the frame from the open shape to the closed shape (e.g. Par. [0016]: straining structure that applies pressure; Par. [0129]: open configuration shown in figs. 3A-3D and closed configuration shown in figs. 4A-4D; Fig. 3A: structure in an open position; Fig. 4A: structure in a closed position).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Jagdeo to include the structure as taught by Jackson because doing so would allow the device to generate the necessary strain to promote attachment of the wound edges.
Regarding claim 30, Anderson fails to disclose wherein the frame comprises two or more hinges defining two or more corners of the frame in the open position. Jackson, in a similar field of endeavor, is directed towards a radially tensioned skin treatment device. Jackson discloses wherein the frame comprises two or more hinges defining two or more corners of the frame in the open position (e.g. Par. [0138]: hinged walls).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Jagdeo to include the hinges in the frame as taught by Jackson because doing so would allow the device to go from an open to a closed configuration.
Regarding claim 34, Anderson fails to disclose wherein the apparatus is configured to alter the shape of the frame from the open shape to the closed shape, and the apparatus is configured to prevent the frame from distorting substantially in the z-direction during altering of the shape of the frame from the open shape to the closed shape. Jackson, in a similar field of endeavor, is directed towards a radially tensioned skin treatment device. Jackson discloses wherein the apparatus is configured to alter the shape of the frame from the open shape to the closed shape, and the apparatus is configured to prevent the frame from distorting substantially in the z-direction during altering of the shape of the frame from the open shape to the closed shape (e.g. Par. [0016]: straining structure that applies pressure; Par. [0129]: open configuration shown in figs. 3A-3D and closed configuration shown in figs. 4A-4D; Fig. 3A: structure in an open position; Fig. 4A: structure in a closed position without a substantial change in the z-direction).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Jagdeo and Jackson to include the apparatus going from an open to a closed configuration as taught by Jackson because doing so would allow the device to generate the necessary strain to promote attachment of the wound edges.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Levinson et al. (US 2015/0366719) is directed towards skin tightening.
Jackson et al. (US 2012/0226306) is directed towards devices for wound closures and strained skin treatment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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