DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement filed May 20, 2025 fails to comply with the
provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the pages of the 1449 fail to provide the Application Serial Number to which the IDS pertains as per 37 CFR 1.98(a)(1)(i). Additionally, the pages of the IDS that consist of a copy of a PTO-892 from another case cannot be considered as these pages do not comply with the requirements of 37 CFR 1.98(a). It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based
on the time of filing the statement, including all certification requirements for statements
under 37 CFR 1.97(e). See MPEP § 609.05(a).
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,465,418.
Claims 1 and 17 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 12,465,418. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘418 patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Claim 1 of the instant application provides for “deploying using the needle electrode positioning motor, the one or more needle electrodes in the array of needle electrodes into the patient’s tissue, " Claim 17 of the instant application provides for “deploying, using the elongated member positioning motor, the one or more elongated members in the array of elongated members into the patient’s skin tissue,” whereas claim 1of patent '418 requires “deploying using the needle electrode positioning motor the one or more of the needle electrodes in the array of needle electrodes to variabley selected depths into the patient’s tissue.” Therefore, the claims of the instant application are merely broader with respect to the distal and proximal members and would therefore be encompassed by the claim language of the patent. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 12,465,418.
Claim 9 is rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 16 of U.S. Patent No. 12,465,418. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘418 patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Claim 9 of the instant application provides for “at least one controller …configured and operable to activate the needle positioning motor to deploy the one or more needle electrodes in the array of needle electrodes into the patient’s tissue, " whereas claim 16 of patent '418 requires “at least one controller…configured and operable to activate the needle positioning motor to deploy the one or more needle electrodes in the array of needle electrodes to variably selected depths into the patient’s tissue.” Therefore, the claims of the instant application are merely broader with respect to the distal and proximal members and would therefore be encompassed by the claim language of the patent. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claim Status
A complete action on the merits of claims 1-24 follows below.
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.
Claims 1-4, 6, 9-12, 14, 17-21, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Manstein (7,824,394) in view of the teaching of Mehta (2010/0217254).
Regarding claim 1, Manstein teaches a cosmetic method for treating a patient’s tissue ([Abstract] The present invention provides improved methods and apparatus for skin treatment and tissue remodeling), comprising:
providing an array of needle electrodes (350, Fig. 3);
deploying [[using the needle electrode positioning motor]], the one or more needle electrodes in the array of needle electrodes into the patient’s tissue ([Abstract] The apparatus includes an array of needles that penetrate the skin and serve as electrodes to deliver radio frequency current or other electrical or optical energy into the tissue being treated, causing thermal damage in controlled patterns);
providing a radiofrequency (RF) energy source coupled to the one or more needle electrodes in the array of needle electrodes (320, Fig. 3); and
applying, using the radiofrequency (RF) energy source, radiofrequency (RF) energy having a preselected value for a preselected period of time (Col. 6 lines 36-47 discusses current can be delivered to different needles at different times during treatment) the preselected value and period of time being configured to cause selective treatment of cells surrounding the one or more needle electrodes in the patient’s tissue (Col. 5 lines 25-30; The tissue damage is achieved by delivering localized concentrations of electrical current that is converted into heat in the vicinity of the tips of the electrode needles. Inducing regions of local thermal damage within the dermis results in an immediate shrinking of collagen, leading to beneficial skin tightening response).
Manstein does not teach providing a needle positioning motor configured and operable to deploy one or more of the needle electrodes in the array of needle electrodes to one or more depths into the patient’s tissue.
However, Mehta teaches a method within the same field of invention ([0002][0013] The systems of the present invention are also adapted to apply energy selectively to tissue to spare select tissue structures, to control creation of a lesion from a series of discrete lesions to a continuous lesion, and to selectively create fractional lesions to optimize effectiveness of the treatment). Mehta discusses linear actuators and motors for driving the probe array from the cartridge into the target region ([0087] and [0105]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Manstein to include a needle electrode positioning motor since the motor or drive unit can provide sufficient force, speed or impact to the probes to drive them into tissue [0105].
Regarding claim 2, Manstein in view of Mehta teaches the limitations of claim 1 as previously rejected above. Manstein teaches deploying one or more of the needle electrodes in the array of needle electrodes to selected depths into the patient’s tissue such that at least the tip of one or more needle electrodes in the array of needle electrodes is deployed within (3) the collagen fiber region of the patients skin tissue (Col. 7 line 50 A typical depth for targeting collagen in the dermis is about 1500-2000 um); and wherein (3) a treatment of damaging and or ablating collagen fibers occurs when one or more needle electrodes of the array of needle electrodes is deployed in the collagen fiber region of the patient’s skin tissue (Col. 9 lines 20-26 treatments performed in accordance with the present invention may be used to target collagen in the dermis. This can lead to immediate tightening of the skin and reduction of wrinkles overlying the damaged tissue arising from contraction of the heated collagen. Over time, the thermal damage also promotes the formation of new collagen, which serves to Smooth out the skin even more).
Regarding claim 3, Manstein in view of Mehta teaches the limitations of claim 1 as previously rejected above. Manstein teaches wherein the patient’s tissue comprises face skin and/or forehead of the patient (Col. 6 lines 8-11 This permits penetration of the needle array to a uniform depth within the targeted tissue even if the surface of the skin is not planar, e.g., along the eye sockets).
Regarding claim 4, Manstein in view of Mehta teaches the limitations of claim 1 as previously rejected above. Manstein taches wherein one or more needles electrodes of the array of needle electrodes are partially insulated leaving only the tips of the one or more needle electrodes non-insulted (Col. 7 lines 1-3 Insulation 420 covers the shaft of needles 410 and 415 protruding from base 310 except for the region near the lower tip).
Regarding claim 6, Manstein in view of Mehta teaches the limitations of claim 1 as previously rejected above. Mehta teaches the step of removing using the needle electrode positioning motor, the one or more deployed needle electrodes from the patient’s tissue when the treating of the tissue has been completed (probes 104 are retractable [0081]…in certain variations the electrodes are only coupled to the power supply when in a treatment position and are incapable of delivering energy when in a retracted position [0116]).
Regarding claim 9, Manstein a device for treating a patient’s tissue ([Abstract] The present invention provides improved methods and apparatus for skin treatment and tissue remodeling), comprising:
an array of needle electrodes (350, Fig. 3);
deploy one or more of the needle electrodes in the array of needle electrodes to one or more depths into the patient’s tissue ([Abstract] The apparatus includes an array of needles that penetrate the skin and serve as electrodes to deliver radio frequency current or other electrical or optical energy into the tissue being treated, causing thermal damage in controlled patterns);
providing a radiofrequency (RF) energy source coupled to the one or more needle electrodes in the array of needle electrodes (320, Fig. 3); and
at least one controller in communication with the [[needle electrode positioning motor]] and the radio frequency (RF) energy source, configured and operable to activate the [[needle positioning motor]] to deploy one or more needle electrodes in the array of needle electrodes into the patient’s tissue (control module 330) ;and
activate the radiofrequency (RF) energy source to apply radiofrequency (RF) energy having a preselected value for a preselected period of time (Col. 6 lines 36-47 discusses current can be delivered to different needles at different times during treatment) the preselected value and period of time being configured to cause selective treatment of cells surrounding the one or more needle electrodes in the patient’s tissue (Col. 5 lines 25-30; The tissue damage is achieved by delivering localized concentrations of electrical current that is converted into heat in the vicinity of the tips of the electrode needles. Inducing regions of local thermal damage within the dermis results in an immediate shrinking of collagen, leading to beneficial skin tightening response).
Manstein does not teach a needle positioning motor configured and operable to deploy one or more of the needle electrodes in the array of needle electrodes to one or more depths into the patient’s tissue.
However, Mehta teaches a device within the same field of invention ([0002][0013] The systems of the present invention are also adapted to apply energy selectively to tissue to spare select tissue structures, to control creation of a lesion from a series of discrete lesions to a continuous lesion, and to selectively create fractional lesions to optimize effectiveness of the treatment). Mehta discusses linear actuators and motors for driving the probe array from the cartridge into the target region ([0087] and [0105]) and control system/energy supply unit 90.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Manstein to include a needle electrode positioning motor since the motor or drive unit can provide sufficient force, speed or impact to the probes to drive them into tissue [0105].
Regarding claim 10, Manstein in view of Mehta teaches the limitations of claim 9 as previously rejected above. The limitations can be rejected similar to the claim 2 rejection.
Regarding claim 11, Manstein in view of Mehta teaches the limitations of claim 9 as previously rejected above. The limitations of claim 11 can be rejected similar to the claim 3 rejection.
Regarding claim 12, Manstein in view of Mehta teaches the limitations of claim 9 as previously rejected above. The limitations of claim 12 can be rejected similar to the claim 4 rejection.
Regarding claim 14, Manstein in view of Mehta teaches the limitations of claim 9 as previously rejected above. The limitations of claim 14 can be rejected similar to the claim 6 rejection.
Regarding claim 17, Manstein teaches a cosmetic method for treating a patient’s tissue ([Abstract] The present invention provides improved methods and apparatus for skin treatment and tissue remodeling), comprising:
providing an array of elongated members (350, Fig. 3);
deploying [[using the elongated member positioning motor]], one or more of the elongated members in the array of elongated members in to selected depths into the patient’s skin tissue ([Abstract] The apparatus includes an array of needles that penetrate the skin and serve as electrodes to deliver radio frequency current or other electrical or optical energy into the tissue being treated, causing thermal damage in controlled patterns);
providing a radiofrequency (RF) energy source coupled to the one or more elongated members in the array of elongated (320, Fig. 3); and
applying radiofrequency (RF) energy source having preselected values for a preselected period of time (Col. 6 lines 36-47 discusses current can be delivered to different needles at different times during treatment) the preselected value and period of time being configured to cause selective treatment of cells surrounding the one or more elongated members in the patient’s skin tissue (Col. 5 lines 25-30; The tissue damage is achieved by delivering localized concentrations of electrical current that is converted into heat in the vicinity of the tips of the electrode needles. Inducing regions of local thermal damage within the dermis results in an immediate shrinking of collagen, leading to beneficial skin tightening response).
Manstein does not teach providing an elongated member positioning motor coupled to the array of elongated members and withdrawing using the elongated member positioning motor, the one or more elongated members from the patient’s skin tissue when the treating of the skin has been completed.
However, Mehta teaches a method within the same field of invention ([0002][0013] The systems of the present invention are also adapted to apply energy selectively to tissue to spare select tissue structures, to control creation of a lesion from a series of discrete lesions to a continuous lesion, and to selectively create fractional lesions to optimize effectiveness of the treatment). Mehta discusses linear actuators and motors for driving the probe array from the cartridge into the target region ([0087] and [0105]) and withdrawing using the elongated member positioning motor (probes 104 are retractable [0081]…in certain variations the electrodes are only coupled to the power supply when in a treatment position and are incapable of delivering energy when in a retracted position [0116]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Manstein to include am elongated member positioning motor since the motor or drive unit can provide sufficient force, speed or impact to the probes to drive them into tissue [0105].
Regarding claim 18, Manstein in view of Mehta teaches the limitations of claim 17 as previously rejected. Manstein teaches wherein the one or more elongated members in the array of elongated members are one of partially uninsulated (Col. 7 lines 1-3 Insulation 420 covers the shaft of needles 410 and 415 protruding from base 310 except for the region near the lower tip).
Claim 19 recites the same limitations of claim 4 as previously rejected above.
Claim 20 recites the same limitations of claim 2 as previously rejected above.
Claim 21 recites the same limitations of claim 3 as previously rejected above.
Regarding claim 23, Manstein in view of Mehta teaches the limitations of claim 17 as previously rejected above. Manstein teaches wherein the one or more elongated members in the array of elongated members comprise one or more needles (350, Fig. 3).
Regarding claim 24, Manstein in view of Mehta teaches the limitations of claim 1 as previously rejected above. Manstein teaches further comprising supply one or more substances into the skin through a hollow conduit formed in one or more of the array of needles (the channels 450 may be used to deliver a local analgesic solution from a source into tissue 305 to reduce or eliminate pain cause by the thermal damage process; Col. 8 lines 25-30).
Claims 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Manstein (7,824,394) in view of the teaching of Mehta (2010/0217254) and further in view of Hantash et al (2007/0142885).
Regarding claim 5, Manstein in view of Mehta fail to disclose the particular frequency range for the RF energy source. However, Hantash teaches a method within the same field of inventio (an array of needles deployed into tissue for fractional treatment of skin tissue[Abstract]). Hantash teaches using a similar frequency range for the RF energy source ( [0042] 0.1 to 10 MHz or from 0.4 to 3 MHz).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for the claimed radiofrequency range since Hantash provides its method can be used for revitalizing again skin using electromagnetic energy that is delivered using a plurality of needles that are capable of penetrating the skin to desired depths.
Regarding claim 13, Manstein in view of Mehta teaches the limitations of claim 9 as previously rejected above. The limitations can be rejected similar to the claim 5 rejection.
Claims 7, 15, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Manstein (7,824,394) in view of the teaching of Mehta (2010/0217254) and further in view of Cory (2008/0039914).
Regarding claim 7, Manstein in view of Mehta teaches the limitations of claim 1 as previously rejected above. Masntein does not teach further comprising the step of determining the one or more depths of the one or more needle electrodes in the array of needle electrodes deployed into the patient’s tissue by measuring tissue resistance with tips of the one or more needle electrodes.
However, Cory teaches a needle apparatus capable of measuring the depth of the needle in the tissue of a patient wherein the depth is determined by measuring the resistance of the length of the needle above the skin surface of the patient (Abstract; [0026] [0030]The needle unit may include an electrically resistive layer covering the needle, wherein the resistance of the resistive layer changes with the length of the resistive layer, and an electrical trace from an electrical connector provides a voltage from the voltage source, so as to maintain a constant current, to the electrically resistive layer).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention was made to measure electrical resistance of the circuit since Cory teaches this determines the insertion depth of the needle in the skin of a patient (Para. [0026]).
Regarding claim 15, Manstein in view of Mehta teaches the limitations of claim 9 as previously rejected above. The limitations of claim 15 can be rejected similar to the claim 7 rejection.
Regarding claim 22, Manstein in view of Mehta teaches the limitations of claim 17 as previously rejected above. The limitations of claim 22 can be rejected similar to the claim 7 rejection.
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Manstein (7,824,394) in view of the teaching of Mehta (2010/0217254) and further in view of Benja-Athon (6,122,547).
Regarding claim 8, Manstein in view of Mehta teaches the limitations of claim 1 as previously rejected above. Manstein does not teach further comprising the step of determining the kind of tissue into which tips of the one or more needle electrodes in the array of needle electrodes are deployed by measuring tissue resistance.
However, Benja-Athon teaches that different types of tissues possess different electrical resistance in the body of the patient, and one can register the change and flux in electrical current and change in voltage and resistance as the needle passes through various and different types of tissue (Col. 5 lines 50-55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine the kind of tissue by measuring tissue resistance to provide for a sufficient amount of current for treatment.
Regarding claim 16, Manstein in view of Mehta teaches the limitations of claim 9 as previously rejected above. The limitations of claim 16 can be rejected similar to the claim 8 rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASAMIN EKRAMI whose telephone number is (571)272-9803. The examiner can normally be reached 9:00-5:00.
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/Y.E/ Examiner, Art Unit 3794
/KAITLYN E SMITH/ Primary Examiner, Art Unit 3794
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