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 § 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.
Claim(s) 1-4, 6-7, 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manstein (US 20110009737 A1; 1/13/2011; cited in IDS).
Regarding claim 1, Manstein teaches a light delivery device for delivering light therapy to skin of a subject, the light delivery device comprising:
a light source configured to emit light (Fig. 6, 570; [0084]); and
one or more first piercing members extending from a distal surface of the light delivery device, the one or more first piercing members being light-transmissive and being configured to be inserted into a subdermal or intradermal portion of the skin of the subject as the distal surface is placed against the skin of the subject (Fig. 6, optical needles 520; [0097]; [0114]); and
one or more second piercing members extending from the distal surface of the light delivery device, the one or more second piercing members being configured to be inserted into a subdermal or intradermal portion of the skin of the subject as the distal surface is placed against the skin of the subject (Fig. 6, hollow needles 620; [0098]; [0114]);
wherein the one or more first piercing members are configured to, when inserted into the skin of the subject, deliver the light to the subdermal or intradermal portion of the skin of the subject (Fig. 6, optical needles 520; [0097]; [0114]); and
wherein the one or more of the first piercing members is a first material ([0024] optical delivery needle can be formed using a waveguide material”; [0071] “optical fibers”; [0079]) and the one or more of the second piercing members is a second material different than the first material ([0077] “array of needles used for a particular treatment may include, for example, any combination of solid electrodes, bifunctional needles, or hollow nonconductive needles.”; [0114] “a combination of conventional hollow needles, optical needles, and/or dual-function optical delivery needles that contain both a delivery lumen and a waveguide may be used in the various embodiments described herein that include a plurality of needles.”).
Regarding claim 2, Manstein teaches wherein the one or more second piercing members are opaque to the light ([0077] “array of needles used for a particular treatment may include, for example, any combination of solid electrodes, bifunctional needles, or hollow nonconductive needles.”; [0114] “a combination of conventional hollow needles, optical needles, and/or dual-function optical delivery needles that contain both a delivery lumen and a waveguide may be used in the various embodiments described herein that include a plurality of needles.”).
Regarding claim 3, Manstein teaches wherein the second material is a metal material ([0066] “wires”; [0077] “array of needles used for a particular treatment may include, for example, any combination of solid electrodes”).
Regarding claim 4, Manstein teaches wherein the first material comprises at least one of a polymer, ceramic, and glass material ([0024] optical delivery needle can be formed using a waveguide material”; [0071] “optical fibers”; [0079]; [0113] “material that can be used to form conventional optical fiber…polymer”).
Regarding claim 6, Manstein teaches wherein at least one of the first material and the second material is a composite material ([0113] “composite material”).
Regarding claim 7, Manstein teaches wherein the second material is an optically reflective material ([0066] “wires”; [0077] “array of needles used for a particular treatment may include, for example, any combination of solid electrodes”; metal would be understood to be used as the material and metal would be inherently optically reflective; see also [0113] “metal…surgical steel”; [0114] “a combination of conventional hollow needles, optical needles, and/or dual-function optical delivery needles that contain both a delivery lumen and a waveguide may be used in the various embodiments described herein that include a plurality of needles.”).
Regarding claim 13, Manstein teaches wherein a wavelength of the light emitted by the light source is in a range of approximately 280 nanometers to approximately 3000 nanometers ([0028] “between about 530 nm and about 560 nm”; [0088] “visible light”; [0105] “longer wavelengths (e.g., towards the red or infrared end of the optical spectrum”; MPEP 2131.03: A specific example in the prior art which is within a claimed range anticipates the range).
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manstein (US 20110009737 A1; 1/13/2011; cited in IDS) as applied to claim 1 above, evidenced by Wikipedia (Optical Fibers; https://en.wikipedia.org/wiki/Optical_fiber).
Regarding claim 5, Manstein teaches wherein the first material comprises at least one of a silica, quartz, polymethyl methacrylate (PMMA), polystyrene, and polycarbonate ([0024] optical delivery needle can be formed using a waveguide material”; [0071] “optical fibers”; [0079]; [0113] “material that can be used to form conventional optical fiber”; the recited material(s) are recognized as being used to form conventional optical fiber as evidenced by Wikipedia p. 3 paragraph 1 “right material to use for such fibers-silica glass…quartz”).
Claim(s) 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manstein (US 20110009737 A1; 1/13/2011; cited in IDS) as applied to claim 1 above, evidenced by McMillan (US 20100160904 A1; 6/24/2010).
Regarding claim 8, Manstein teaches wherein the second material is an optically absorbent material ([0113] “metal…surgical steel”; [0114] “a combination of conventional hollow needles, optical needles, and/or dual-function optical delivery needles that contain both a delivery lumen and a waveguide may be used in the various embodiments described herein that include a plurality of needles.”; as evidenced by McMillan [0139] “Needle probes made of many metallic materials, including stainless steel, will absorb light”; it is inherent/known that surgical steel is a subset of stainless steel).
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.
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manstein as applied to claim 1 above, in view of Podmore (US 20200367961 A1; 11/26/2020; cited in IDS).
Regarding claim 9, Manstein does not teach a cartridge comprising the one or more first piercing members and the one or more second piercing members. However, Podmore teaches in the same field of endeavor ([0018]) a cartridge comprising the one or more first piercing members and the one or more second piercing members (Fig. 30; [0086] “treatment cartridge 810 ... Rather than a single or plurality of microneedles, in alternative embodiments, the cartridge 810 is equipped with ... a laser, larger needle or needles, or combinations thereof ... the cartridge 824 can additionally include a second or additional microneedles 820. The cartridge 810 further includes a piston or other pivoting structure (not shown) that functions to extend and retract the microneedle 820 or project the microneedle 820 at various angles in to the skin."). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Manstein to include these features as taught by Podmore because this enables an array of needles for treating various shapes and sizes as needed ([0085]); further, it would be obvious to make the needles separate from the applicator device via use of cartridge; MPEP 2144.04 Making Separable.
Regarding claim 10, in the combination of Manstein and Podmore, Podmore teaches wherein the cartridge comprises a needle holder to which the one or more first piercing members are attached (Fig. 12; Fig. 30; [0086] “cartridge…functions to extend and retract the microneedle”).
Regarding claim 11, the combination of Manstein and Podmore teaches wherein the needle holder is configured to align the one or more first piercing members relative to the light emitted by the light source (Manstein Fig. 6; [0097] “The exemplary apparatus 600 can be configured such that the needles 520 can be inserted into the tissue 305, and distal portions of the optical needles 520 can be positioned within or proximal to one or more volumes of filler material 610 provided within the tissue 305.”; [0105] “particular number and spacing of needles”; Podmore Fig. 30; [0086]; by having needles arrayed along with optical needles, alignment between the two is achieved by this structure).
Regarding claim 12, the combination of Manstein and Podmore teaches an optical transmission system for transmitting the light emitted by the light source to the one or more first piercing members, wherein the needle holder is configured to align the one or more first piercing members relative to the optical transmission system (Manstein Fig. 6; [0097] “The exemplary apparatus 600 can be configured as described herein to direct optical energy from the EMR source 570 through the waveguides or optical fibers 550 to distal portions of the optical needles 520, and into the filler material 610.; [0105] “particular number and spacing of needles”; Podmore Fig. 30; [0086]; by having optical needles arrayed and connected to light source, alignment is achieved by this structure).
Claim(s) 14-17, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manstein (US 20110009737 A1; 1/13/2011; cited in IDS) in view of Podmore (US 20200367961 A1; 11/26/2020; cited in IDS).
Regarding claim 14, Manstein teaches a light delivery device for delivering light therapy to skin of a subject (Fig. 6).
Manstein does not teach a cartridge mountable to a light delivery device for delivering light therapy to skin of a subject, wherein the cartridge comprises:
a housing mountable to the light delivery device.
However, Podmore teaches in the same field of endeavor ([0018]) a cartridge mountable to a light delivery device for delivering light therapy to skin of a subject (Fig. 12; Fig. 30), wherein the cartridge comprises:
a housing mountable to the light delivery device (Fig. 12; Fig. 30; [0086] “treatment cartridge 810 ... Rather than a single or plurality of microneedles, in alternative embodiments, the cartridge 810 is equipped with ... a laser, larger needle or needles, or combinations thereof ... the cartridge 824 can additionally include a second or additional microneedles 820. The cartridge 810 further includes a piston or other pivoting structure (not shown) that functions to extend and retract the microneedle 820 or project the microneedle 820 at various angles in to the skin."). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Manstein to include these features as taught by Podmore because this enables an array of needles for treating various shapes and sizes as needed ([0085]); further, it would be obvious to make the needles separate from the applicator device via use of cartridge; MPEP 2144.04 Making Separable.
The combination of Manstein and Podmore teaches one or more first piercing members attached to the housing and extending from a distal surface of the cartridge (Manstein Fig. 6, optical needles 520; [0097]; [0114]; Podmore Fig. 12; Fig. 30; [0086]), the one or more first piercing members being a first material that is light-transmissive (Manstein Fig. 6, optical needles 520; [0097]; [0114]; [0024] optical delivery needle can be formed using a waveguide material”; [0071] “optical fibers”; [0079]); and
one or more second piercing members attached to the housing and extending from the distal surface of the cartridge (Manstein Fig. 6, hollow needles 620; [0098]; [0114]; Podmore Fig. 12; Fig. 30; [0086]), the one or more second piercing members being a second material different than the first material (Manstein ([0077] “array of needles used for a particular treatment may include, for example, any combination of solid electrodes, bifunctional needles, or hollow nonconductive needles.”; [0114] “a combination of conventional hollow needles, optical needles, and/or dual-function optical delivery needles that contain both a delivery lumen and a waveguide may be used in the various embodiments described herein that include a plurality of needles.”);
wherein the one or more first piercing members and the one or more second piercing members are configured to be inserted into a subdermal or intradermal portion of the skin of the subject as the cartridge is placed against the skin of the subject (Manstein Fig. 6; Podmore Fig. 30; [0086]); and
wherein the one or more first piercing members are configured to, when the cartridge is mounted to the light delivery device and when the one or more first piercing members are inserted into the skin of the subject, deliver light emitted by the light delivery device to the subdermal or intradermal portion of the skin of the subject (Manstein Fig. 6; Podmore Fig. 30; [0086]).
Regarding claim 15, in the combination of Manstein and Podmore, Manstein teaches wherein the one or more second piercing members are opaque to light ([0077] “array of needles used for a particular treatment may include, for example, any combination of solid electrodes, bifunctional needles, or hollow nonconductive needles.”; [0114] “a combination of conventional hollow needles, optical needles, and/or dual-function optical delivery needles that contain both a delivery lumen and a waveguide may be used in the various embodiments described herein that include a plurality of needles.”).
Regarding claim 16, in the combination of Manstein and Podmore, Manstein teaches wherein the second material is a metal material ([0066] “wires”; [0077] “array of needles used for a particular treatment may include, for example, any combination of solid electrodes”).
Regarding claim 17, in the combination of Manstein and Podmore, Manstein teaches wherein the first material comprises at least one of a polymer, ceramic, and glass material ([0024] optical delivery needle can be formed using a waveguide material”; [0071] “optical fibers”; [0079]; [0113] “material that can be used to form conventional optical fiber…polymer”).
Regarding claim 19, in the combination of Manstein and Podmore, Manstein teaches wherein at least one of the first material and the second material is a composite material ([0113] “composite material”).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manstein and Podmore as applied to claim 14 above, evidenced by Wikipedia (Optical Fibers; https://en.wikipedia.org/wiki/Optical_fiber).
Regarding claim 18, the combination of Manstein and Podmore teaches wherein the first material comprises at least one of a silica, quartz, polymethyl methacrylate (PMMA), polystyrene, and polycarbonate material (Manstein [0024] optical delivery needle can be formed using a waveguide material”; [0071] “optical fibers”; [0079]; [0113] “material that can be used to form conventional optical fiber”; the recited material(s) are recognized as being used to form conventional optical fiber as evidenced by Wikipedia p. 3 paragraph 1 “right material to use for such fibers-silica glass…quartz”).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manstein and Podmore as applied to claim 14 above, evidenced by McMillan (US 20100160904 A1; 6/24/2010).
Regarding claim 20, in the combination of Manstein and Podmore, Manstein teaches wherein the second material is an optically reflective material ([0066] “wires”; [0077] “array of needles used for a particular treatment may include, for example, any combination of solid electrodes”; metal would be understood to be used as the material and metal would be inherently optically reflective; see also [0113] “metal…surgical steel”; [0114] “a combination of conventional hollow needles, optical needles, and/or dual-function optical delivery needles that contain both a delivery lumen and a waveguide may be used in the various embodiments described herein that include a plurality of needles.”) or an optically absorbent material ([0113] “metal…surgical steel”; [0114] “a combination of conventional hollow needles, optical needles, and/or dual-function optical delivery needles that contain both a delivery lumen and a waveguide may be used in the various embodiments described herein that include a plurality of needles.”; as evidenced by McMillan [0139] “Needle probes made of many metallic materials, including stainless steel, will absorb light”; it is inherent/known that surgical steel is a subset of stainless steel).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
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