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 .
Priority
Acknowledgment is made of applicant’s claim for priority. The certified copy has been filed in national stage application of PCT/US2019/032831 filed on May 17th, 2019. The current application also claims benefit of provisional application 62673305, filed on May 18th, 2018. Examiner acknowledges the applicant’s claim for priority.
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, 2, 21, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 12 of U.S. Patent No. 11,571,586.
Current Application 18/404,041
Patent 11,571,586
Claim 1: A light delivery device for delivering light to a tissue of a patient, comprising:
Claim 1: A conformable light delivery device for increasing light penetration depth into a tissue, comprising
Claim 1: one or more tissue penetrating members, each tissue penetrating member having a distal end and a proximal end and configured to be inserted into the tissue,
Claim 1: a microarray of tissue penetrating members, each tissue penetrating member having a distal end and a proximal end,
Claim 1: wherein the one or more tissue penetrating members are configured to provide optical transmission through a surface that extends between the distal and proximal ends of each tissue penetrating member;
Claim 1: wherein the tissue penetrating members are at least partially optically transparent to provide optical transmission through a surface that extends between the distal and proximal ends of each tissue penetrating member;
Claim 1: a substrate supporting the one or more tissue penetrating members;
Claim 1: a substrate that supports the tissue penetrating members;
Claim 1: one or more optical sources supported by the substrate and in optical communication with the one or more tissue penetrating members;
Claim 1: and an optical source in optical communication with the microarray of tissue penetrating members
Claim 12: wherein the substrate has a bottom surface that supports the microarray of tissue penetrating members and a top surface that supports a plurality of optical sources
Claim 1: the one or more optical sources are configured to operably emit light;
Claim 1: wherein the microarray and the optical source are integrated or removably connected to each other … to increase the penetration depth of light into the tissue.
Claim 1: and an encapsulation layer disposed over the one or more tissue penetrating members.
Claim 1: wherein the microarray and the optical source are integrated … Claim 3: wherein the optical source is at least partially encapsulated in a transparent encapsulation layer.
Claim 2: wherein the one or more tissue penetrating members are configured to operably deliver at least a portion of the light emitted from the one or more optical sources into the tissue of the patient when the one or more tissue penetrating members are inserted into the tissue.
Claim 1: and wherein the microarray of tissue penetrating members are configured to penetrate the tissue during use and to increase the penetration depth of light into the tissue
Claim 21: wherein the one or more optical sources are integrated with the one or more tissue penetrating members.
Claim 1: the microarray and the optical source are integrated or removably connected to each other.
Claim 22: wherein the one or more optical sources are removably connected to the one or more tissue penetrating members.
Claim 1: the microarray and the optical source are integrated or removably connected to each other.
Although the claims at issue are not identical, they are not patentably distinct from each other because pending claim 1 recited subject matter that is fully encompassed by issued claims 12 except for the “an encapsulation layer disposed over the one or more tissue penetrating members,” which difference is covered by claim 3’s “wherein the optical source is at least partially encapsulated in a transparent encapsulation layer.” It would have been obvious to a person having ordinary skill in the art at the time of invention to have added an encapsulation layer to protect the microarray from handling and patient use, with a reasonable expectation of success. Applicant’s own specification at [0178] discloses “one or more encapsulation layers may be used to protect underlying components.” This characterizes encapsulation layers as a known and routine feature of light-delivery devices for the recited functions of protection.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 12 and 14 of U.S. Patent No. 11,571,586.
Claim 5: wherein the substrate is optionally a flexible substrate.
Claim 14: wherein the substrate is a flexible substrate.
Although the claims at issue are not identical, they are not patentably distinct from each other because pending claim 5 recited subject matter that is fully encompassed by issued claims 3 and 12, as seen above except for the “wherein the substrate is optionally a flexible substrate.”. This difference is covered by claim 14’s “wherein the substrate is a flexible substrate.” It would have been obvious to a person having ordinary skill in the art, at the time of invention, to have a flexible substrate with a reasonable expectation of success. This would have conformed better to a patient’s skin. Applicant’s own specification at [0012] discloses “the PLGA microneedles can bend allowing conformable contact with the skin”. This indicates the known and routine feature of flexible substrates to better conform to a patient. Applicant’s pending claim recites the same flexible structure as claim 14 with the addition of the word “optionally”, which makes the claims broader, not narrower.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3, 8, and 12 of U.S. Patent No. 11,571,586.
Claim 6: wherein the substrate is configured to improve light delivery.
Claim 8: wherein the light delivery device is flexible with a bulk bending stiffness selected so that the device is capable of conforming to a tissue surface during a light therapy application to reduce surface reflection and increase light delivery to a target.
Although the claims at issue are not identical, they are not patentably distinct from each other because pending claim 6 recited subject matter that is fully encompassed by issued claims 3 and 12, as seen above except for the “wherein the substrate is configured to improve light delivery.” This difference is covered by claim 8’s “wherein the light delivery device is flexible … to reduce surface reflection and increase light delivery to a target.” It would have been obvious to a person having ordinary skill in the art, at the time of invention, to have a flexible substrate with a reasonable expectation of success. This would have conformed better to a patient’s skin. Applicant’s own specification at [0012] discloses “the PLGA microneedles can bend allowing conformable contact with the skin”. This indicates the known and routine feature of flexible substrates to better conform to a patient.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3, 10, and 25 of U.S. Patent No. 11,571,586.
Claim 7: wherein the encapsulation layer is configured to make the one or more tissue penetrating members sturdier or biocompatible or prevent chipping.
Claim 25: “a bioactive agent releasably connected to the microarray of tissue penetrating members”
Although the claims at issue are not identical, they are not patentably distinct from each other because pending claim 7 recited subject matter that is fully encompassed by issued claims 3 and 12, as seen above except for the “wherein the encapsulation layer is configured to make the one or more tissue penetrating members sturdier or biocompatible or prevent chipping.” This difference is covered by claim 25’s “a bioactive agent releasably connected to the microarray of tissue penetrating members”. It would have been obvious to a person having ordinary skill in the art, at the time of invention, to have a bioactive agent on the surface of penetrating members to make the device more biocompatible for a patient, with a reasonable expectation of success. This would have conformed better to a patient’s skin. Applicant’s own specification at [0012] discloses “the PLGA microneedles can bend allowing conformable contact with the skin”. Use of a bioencapsulation layer in combination with the penetrating members would have been an obvious and suitable material selection during routine optimization.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3, 9, and 12 of U.S. Patent No. 11,571,586.
Claim 12: wherein the encapsulation layer is configured to match the refractive index of the tissue to enable more efficient light delivery.
Claim 9: the reduced surface reflection is by the substrate having a composition that provides an index of refraction that is within 10% of an index of refraction of a material from which the tissue penetrating members are formed
Although the claims at issue are not identical, they are not patentably distinct from each other because pending claim 12 recited subject matter that is fully encompassed by issued claims 3 and 12, as seen above except for the “wherein the encapsulation layer is configured to match the refractive index of the tissue to enable more efficient light delivery.” This difference is covered by claim 9’s “the reduced surface reflection is by the substrate having a composition that provides an index of refraction that is within 10% of an index of refraction of a material from which the tissue penetrating members are formed”. It would have been obvious to a person having ordinary skill in the art, at the time of invention, to reduce surface reflection by having a substrate composition that matches the tissue refractive index, with a reasonable expectation of success. This would have improved light delivery to a patient’s tissue. Applicant’s own specification at [0104] discloses “Matching epidermis and dermis refractive index enables the optimal dissipation of UVA1 and NBUVB light”. Thus, use of a penetrating member material similar to tissue would have been an obvious and suitable material selection that could be achieved through routine optimization.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 10 and 12 of U.S. Patent No. 11,571,586.
Claim 16: wherein the encapsulation layer is configured to alter the wavelength(s), polarization, intensity or other light properties of the light originating from the one or optical sources prior to delivery into the tissue.
Claim 10: an optical dispersion element in optical communication with the tissue penetrating members to increase light … comprises one or more of: … a patterned optically opaque layer… or upconverting or downconverting phosphors
Although the claims at issue are not identical, they are not patentably distinct from each other because pending claim 16 recited subject matter that is fully encompassed by issued claims 3 and 12, as seen above except for the “wherein the encapsulation layer is configured to alter the wavelength(s), polarization, intensity or other light properties of the light originating from the one or optical sources prior to delivery into the tissue.” This difference is covered by claim 10’s “an optical dispersion element in optical communication with the tissue penetrating members to increase light … comprises one or more of: … a patterned optically opaque layer”. It would have been obvious to a person having ordinary skill in the art, at the time of invention, to use a phosphor converting or patterned optically opaque layer to alter wavelength and increase light intensity coming from the tissue penetrating members, with a reasonable expectation of success. Thus, use of a penetrating member layer that alters the optical activity would have improved the light delivery of the penetrating members into the tissue. Applicant’s own specification at [0104] discloses “Matching epidermis and dermis refractive index enables the optimal dissipation of UVA1 and NBUVB light” indicates how adjusting the refractive index would have been an obvious alteration that could be achieved through routine optimization.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 6 and 12 of U.S. Patent No. 11,571,586.
Claim 17: wherein the encapsulation layer is configured to absorb the light emanating from the one or more light sources to produce heating.
Claim 6: wherein the tissue penetrating members have an optical property that is optically matched to the optical source, wherein the optical property is selected from the group consisting of: optical transmission/output light spectrum; index of refraction; scattering, absorption, emissivity, fluorescence, heat generation; and thermal relaxation time of tissue.
Although the claims at issue are not identical, they are not patentably distinct from each other because pending claim 17 recited subject matter that is fully encompassed by issued claims 3 and 12, as seen above except for the “wherein the encapsulation layer is configured to absorb the light emanating from the one or more light sources to produce heating.” This difference is covered by claim 6’s “wherein the tissue penetrating members have an optical property that is optically matched to the optical source, wherein the optical property is … absorption… heat generation”. It would have been obvious to a person having ordinary skill in the art, at the time of invention, to absorb light and generate heat with the device, with a reasonable expectation of success. This would have altered the light delivery of a patient to improve the light delivery of the penetrating members into the tissue. Applicant’s own specification at [0104] discloses “Matching epidermis and dermis refractive index enables the optimal dissipation of UVA1 and NBUVB light” indicates how adjusting the light absorption and converting the light to heat would have been an obvious alteration that could be achieved through routine optimization.
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 11 and 15 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.
In claim 11, the antecedent basis for the limitation “the optical source” seems indefinite since claim 1 recites “one or more optical sources” and it is unclear if “the optical source” of claim 11 refers to one or all of the “one or more optical sources.”
In claim 15, the phrase “and or” seems indefinite as it is unclear which conjunction is applicable. For the purpose of examination, this limitation has been interpreted as “and/or”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-7, 13, and 16-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manstein et al. (US20110009737).
Regarding claim 1, Manstein teaches a light delivery device for delivering light to a tissue of a patient, ([0002]” apparatus in which electromagnetic energy, e.g. optical energy, is provided proximal to a tip of one or more needles that are inserted into a biological tissue”) comprising: one or more tissue penetrating members, each tissue penetrating member having a distal end [i.e., tip] and a proximal end and configured to be inserted into the tissue, ([0002] “apparatus… is provided proximal to a tip of one or more needles that are inserted into a biological tissue”) wherein the one or more tissue penetrating members are configured to provide optical transmission through a surface that extends between the distal and proximal ends of each tissue penetrating member; ([0099] “The distal portion of the optical needles 520 can optionally include a plurality of emitting regions … EMR directed into the proximal end of the optical needle 520 can be emitted through the plurality of emitting regions 710 in addition to, or instead of, through the distal end”) a substrate supporting the one or more tissue penetrating members; ([0079] “such apparatus 500 can include a plurality of optical needles 520, which can be affixed to a substrate 510.”) one or more optical sources supported by the substrate and in optical communication with the one or more tissue penetrating members; ([0081] “the optical needle arrangement can include the fiber bundle 555, together with needles 520, substrate 510, and optical guides 550”) the one or more optical sources are configured to operably emit light; ([0084] “energy source can include one or more light-emitting diodes (LEDs)”) and an encapsulation layer [i.e., shell] disposed over the one or more tissue penetrating members. ([0080] “optical guide 550 can be provided near a tip of the optical needle 520, for example, in proximity to a distal end of the shell 530”)
Regarding claim 2, Manstein teaches all of the limitations of claim 1. Manstein also teaches wherein the one or more tissue penetrating members are configured to operably deliver at least a portion of the light emitted from the one or more optical sources into the tissue of the patient when the one or more tissue penetrating members are inserted into the tissue. ([0080] “Each optical needle 520 can thereby be configured to direct the optical energy through its length and into a target region of tissue 590 near the needle tip”)
Regarding claim 3, Manstein teaches all of the limitations of claim 1. Manstein also teaches wherein said surface between the distal and proximal ends of each tissue penetrating member is configured to continuously transmit the light over a longitudinal length ([0099] “EMR directed into the proximal end of the optical needle 520 can be emitted through the plurality of emitting regions 710” and [0084] “Energy provided to the target areas of the tissue using the exemplary needle arrays may optionally be continuous”)
Regarding claim 5, Manstein teaches all of the limitations of claim 1. Manstein also teaches wherein the substrate is optionally a flexible substrate. ([0066] “insulation 420 covers a shaft of needles… insulating materials for the insulation 420 can include, but are not limited to Teflon.RTM., polymers” are flexible materials)
Regarding claim 6, Manstein teaches all of the limitations of claim 1. Manstein also teaches wherein the substrate is configured to improve light delivery. ([0079] “such apparatus 500 can include a plurality of optical needles 520 which can be affixed to the substrate… The optical guide 550 can be, e.g., an optical fiber or a waveguide configured to propagate optical energy to a distal end of the optical guide 550” where affixing the substrate improves light delivery)
Regarding claim 7, Manstein teaches all of the limitations of claim 1. Manstein also teaches wherein the encapsulation layer is configured to make the one or more tissue penetrating members sturdier or biocompatible or prevent chipping. ([0024] “optical delivery needle can … include a material coating around the cylinder to provide mechanical strength”)
Regarding claim 13, Manstein teaches all of the limitations of claim 1. Manstein also teaches wherein the encapsulation layer is configured to control the direction of light leakage/delivery from the one or more tissue penetrating members either directing it sideways towards shallower tissue or forward towards deeper tissue. ([0099] “The distal portion of the optical needles 520 can optionally include a plurality of emitting regions … EMR directed into the proximal end of the optical needle 520 can be emitted through the plurality of emitting regions 710 in addition to, or instead of, through the distal end”)
Regarding claim 16, Manstein teaches all of the limitations of claim 1. Manstein also teaches wherein the encapsulation layer is configured to alter the … intensity or other light properties of the light originating from the one or optical sources prior to delivery into the tissue. ([0099] “The distal portion of the optical needles 520 can optionally include a plurality of emitting regions … EMR directed into the proximal end of the optical needle 520 can be emitted through the plurality of emitting regions 710 in addition to, or instead of, through the distal end”)
Regarding claim 17, Manstein teaches all of the limitations of claim 1. Manstein also teaches wherein the encapsulation layer is configured to absorb the light emanating from the one or more light sources to produce heating. ([0115] “optical energy absorbing element that can convert optical energy to thermal energy when irradiated. Such an absorbing element can be used to thermally cure a cosmetic filler material provided through the lumen, or to otherwise direct heat onto a material delivered through the lumen.”)
Regarding claim 18, Manstein teaches all of the limitations of claim 1. Manstein also teaches wherein the one or more optical sources have an emission maximum in a visible range, an ultraviolet range, or infrared range of the electromagnetic spectrum. ([0105] “optical needles 520 can be selected or utilized based on … optical energy having longer wavelengths (e.g., towards the red or infrared end of the optical spectrum) … energy having shorter wavelengths (e.g., energy towards the blue or ultraviolet end of the optical spectrum)
Regarding claim 19, Manstein teaches all of the limitations of claim 1. Manstein also teaches wherein the one or more optical sources comprise … one or more light emitting diodes (LEDs). ([0084] “energy source can include one or more light-emitting diodes (LEDs)”)
Regarding claim 20, Manstein teaches all of the limitations of claim 19. Manstein also teaches wherein the one or more LDs or LEDs are optically aligned [i.e., facilitate connection] with the one or more tissue penetrating members. ([0081] “the optical guide 550 can be provided as part of a bundle 555 of such guides … can facilitate connection and separation of an optical needle arrangement”)
Regarding claim 21, Manstein teaches all of the limitations of claim 1. Manstein also teaches wherein the one or more optical sources are integrated with the one or more tissue penetrating members. ([0083] “needle 520 can also be provided, e.g., as a shell 530 which may be deposited or coated on a portion of the optical guide 550”)
Regarding claim 22, Manstein teaches all of the limitations of claim 1. Manstein also teaches wherein the one or more optical sources are removably connected to the one or more tissue penetrating members. ([0081] “the optical guide 550 can be provided as part of a bundle 555 of such guides … can facilitate connection and separation of an optical needle arrangement”)
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.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Manstein et al. (US20110009737) in view of Rylander et al. (US20110313298).
Regarding claim 4, Manstein teaches all of the limitations of claim 3. Manstein does not explicitly teach, as taught by Rylander wherein increased light intensity [i.e., light intensity per area] is introduced to surrounding tissue toward the distal end [i.e., tip] compared to the proximal end. ([0131] “The needle at the tip increased the light intensity per area”). It would have been prima facie obvious for a person having ordinary skill in the art to have modified Manstein with the teachings of Rylander, with a reasonable expectation of success, by tapering the optically active needle to provide increased density towards the distal end of the needle. This would have increased the precision of light delivery to targeted tissue by improving concentration. Manstein would have come across Rylander while attempting to solve the pain associated with needle treatment protocols, as Rylander teaches these laser “protocols can also be very painful and therefore generally may require an application of a significant amount of analgesia.” [0007]
Claims 8-11, 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Manstein et al. (US20110009737) further in view of Chen et al. (Pat. 6,096,066).
Regarding claim 8, Manstein teaches all of the limitations of claim 1. Manstein does not explicitly teach, as taught by Chen wherein the encapsulation layer is disposed between the substrate and the one or more optical sources, and at least partially encapsulates the one or more optical sources, ([Col. 4 56-60] “A droplet 26 of a flexible epoxy or other polymer is applied over each pair of light emitting sources 16 to protect them and flywire 24. This droplet is optically transparent or translucent”) thereby protecting them and/or providing desired mechanical parameters including bending… flexibility or softness. ([Col 3,60 -Col 4,11] “Flexible substrate 10 is less than 0.1 millimeter thick in a preferred form of the invention and is fabricated from a highly flexible thin film polymer such as silicone or polyurethane.”) It would have been prima facie obvious to one having ordinary skill in the art to have modified Mansfield with the teachings of Chen, with a reasonable expectation of success, by explicitly mounting the LEDs to a flexible substrate and provide an encapsulation layer that sits in between the optical source and penetrating members. This would have improved the flexibility of the device and more effectively adapting to a patient. Chen is adaptable to Manstein as both inventions are directed to delivering light therapy to subcutaneous tissue. Manstein would have come across Chen’s teaching while searching for ways to reduce skin irritation, as Chen indicates “however, it is common for the photoreactive agent to sensitize normal tissue” [0004].
Regarding claim 9, Manstein teaches all of the limitations of claim 8. Manstein does not explicitly teach, as taught by Chen wherein the encapsulation layer is configured to provide substantial uniformity of light intensity of the light emitted from the one or more optical sources over the one or more tissue penetrating members, thereby preventing hot spots of light intensity in the tissue. ([Col. 4,64- Col. 5,11] “this thin layer and the droplet applied over each LED have an index of refraction that is generally matched to that of the patient's skin” prevents overexposure of skin regions) It would have been prima facie obvious to one having ordinary skill in the art to have modified Mansfield with the teachings of Chen, with a reasonable expectation of success, by explicitly providing substantial light uniformity form the optical sources by maintaining a similar index of refraction to a user’s tissue. This would have provided consistent light output for patient treatment.
Regarding claim 10, Manstein teaches all of the limitations of claim 9. Manstein does not explicitly teach, as taught by Chen wherein the substantial uniformity [i.e., index of refraction] is quantified, as a maximum light intensity that is less than 30% different from the average light intensity over the entire device illumination footprint. ([Col. 4,64- Col. 5,11] “this thin layer and the droplet applied over each LED have an index of refraction that is generally matched to that of the patient's skin”) MPEP 2144.05(I) states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” [In re Wertheim, 541 F.2d 257]. Configuring the encapsulation layer to provide uniformity of light intensity is a matter of routine optimization of a results effective variable for a person having ordinary skill in the art. There is no criticality of overlapping ranges of maximum light intensity differences and Applicant has not indicated in the specification that different ranges would produce unexpectedly different results than from the prior art range. One of ordinary skill in the art would have recognized the ranges as obvious variants that could be achieved through routine optimization.
Regarding claim 11, Manstein teaches all of the limitations of claim 8. Manstein does not explicitly teach, as taught by Chen wherein the encapsulation layer is configured to have a scattering surface [i.e., index of refraction] that scatters the light emitted from the optical source regardless of wavelength. ([Col. 4,64- Col. 5,11] “this thin layer and the droplet applied over each LED have an index of refraction that is generally matched to that of the patient's skin”) It would have been prima facie obvious to one having ordinary skill in the art to configure the surface of Chen’s translucent encapsulating layer as a scattering surface, with a reasonable expectation of success, in order to provide diffusive rather than directional illumination across the treatment site. This would have allowed for a diffusive, uniform control of the light intensity thorough the penetrating members.
Regarding claim 12, Manstein teaches all of the limitations of claim 1. Manstein does not explicitly teach, as taught by Chen wherein the encapsulation layer is configured to match the refractive index of the tissue to enable more efficient light delivery. ([Col. 4,64- Col. 5,11] “this thin layer and the droplet applied over each LED have an index of refraction that is generally matched to that of the patient's skin at the treatment site to which light therapy is to be administered by light emitting sources 16”) It would have been prima facie obvious to one having ordinary skill in the art to have modified Mansfield with the teachings of Chen, with a reasonable expectation of success, by explicitly creating an encapsulation layer that matches the refractive index of a user’s tissue. This would have provided efficient light output for patient treatment.
Regarding claim 15, Manstein teaches all of the limitations of claim 1. Manstein does not explicitly teach, as taught by Chen wherein the encapsulation layer is configured to cover the one or more tissue penetrating members to remove water [i.e., moisture readily conveyed] from the tissue to reduce inflammation [i.e., irritation] and or blistering via osmosis. ([Col 5. 6-14] “the flexible patch includes a plurality of horizontal slots 48 and vertical slots 46 that extend through the flexible substrate and thin layer 28. Each of these slots comprise open passages through which air and moisture are readily conveyed when flexible patch 40 is applied to the treatment site on the patient's body. By providing such passages, irritation and heat buildup at the treatment site covered by flexible patch are minimized”). It would have been prima facie obvious to a person having ordinary skill in the art to have modified Manstein with the teaching of Chen, with a reasonable expectation of success, by including a perforated substrate to allow for moisture to escape the patient’s skin surface. This would have reduced skin irritation and risk for inflammation.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Manstein et al. (US20110009737) in view of McAllister et al. (WO 2016/168847). For the prior art rejection below, US20180133447 has been used as an equivalent document for WO 2016/168847.
Regarding claim 14, Manstein teaches all of the limitations of claim 1. Manstein does not explicitly teach, as taught by McAllister wherein the encapsulation layer is configured such that the one or more tissue penetrating members are covered with a drug/biologic or another active ingredient that has tissue effect by itself or being activated by the light. ([0040] “barrier material, for example, may … coat at least a portion of the microneedles”) It would have been prima facie obvious for a person having ordinary skill in the art to have modified Manstein with the teachings of McAllister, with a reasonable expectation of success, by coating the perforation members with a bioactive drug to increase the time a user can use the perforation members. This would have increased the light delivery to targeted tissue by improving the length a user can wear this device. Manstein would have come across McAllister while attempting to solve the pain associated with needle treatment protocols, as McAllister teaches “a substrate or other structure, following penetration of a biological tissue with microneedles, can be uncomfortable and/or inconvenient for a patient and/or subject to external forces that undesirably change the location or characteristics of the microneedles.” [0004]
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Manstein et al. (US20110009737) in view of Rylander et al. (US20110313298).
Regarding claim 23, Manstein teaches all of the limitations of claim 14. Manstein does not explicitly teach, as taught by Rylander wherein the one or more tissue penetrating members and the substrate are disposable and replaceable. ([0152] “it is preferred that the device be discarded after a single-patient treatment”) It would have been prima facie obvious for a person having ordinary skill in the art to have modified Manstein with the teachings of Rylander, with a reasonable expectation of success, by tapering the optically active needle to provide increased density towards the distal end of the needle. This would have increased the precision of light delivery to targeted tissue by improving concentration. Manstein would have come across Rylander while attempting to solve the pain associated with needle treatment protocols, as Rylander teaches these laser “protocols can also be very painful and therefore generally may require an application of a significant amount of analgesia.” [0007]
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kaplan et al. (US20130338632) discloses a microneedle array containing a variety of prong orientations.
Rodgers et al. (US20130041235) discloses a device containing a flexible substrate, stretchable electronic circuit, a removable and dissolvable transfer substrate, sensing electrodes, reference electrodes, and contact layers such as a polymer layer for epidermal electronics.
Vila Echague et al. (US20080269735) discloses an apparatus for treating biological tissue using a base member, a plurality of needles, and a plurality of fiber optics.
Nizamoglu, S., Gather, M., Humar, M. et al. Bioabsorbable polymer optical waveguides for deep-tissue photomedicine. Nat Commun 7, 10374 (2016). https://doi.org/10.1038/ncomms10374 (Year: 2016)
Moonseok Kim, Jeesoo An, Ki Su Kim, Myunghwan Choi, Matjaž Humar, Sheldon J. J. Kwok, Tianhong Dai, and Seok Hyun Yun, "Optical lens-microneedle array for percutaneous light delivery," Biomed. Opt. Express 7, 4220-4227 (2016) (Year: 2016)
McCall, J., Kim, Ti., Shin, G. et al. Fabrication and application of flexible, multimodal light-emitting devices for wireless optogenetics. Nat Protoc 8, 2413â2428 (2013). https://doi.org/10.1038/nprot.2013.158 (Year: 2013)
Conclusion
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/R.A.S/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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