Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 23-26 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 23 lacks proper antecedent basis for “the microwave antenna”. Claims 24-26 are rejected based on their dependency from claim 23.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-4, 7, 9-11, 13-15, 17-23 and 27-45 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Knowlton (2004/0210214).
Regarding claim 1, Knowlton provides a system for treating skin tissue (Abstract, for example) comprising a microwave energy generator (para. [0121], for example), a microwave antenna (18) configured for placement proximate skin tissue (Figure 1, for example), a cooling element (13) for placement in contact with tissue (para. [0104-0111]) and a suction element for drawing skin (i.e. elevating skin) in contact with the cooling element (para. [0116], for example). The microwave antenna is coupled to the energy generator to deliver energy to the skin tissue sufficient to create a thermal effect in target tissue within the skin tissue (para. [0099], for example).
Regarding claims 2 and 3, the antenna is a waveguide antenna (inherently). Regarding claim 4, there is an array of antennas (Figure 2b, for example). Regarding claim 7, the generator is configured to deliver energy at a frequency of 2.45 GHz (para. [0121]). Regarding claim 9, the cooling element is a coolant fluid delivered to a cooling plate (21). Regarding claims 10 and 11, the cooling element is a cooling plate (21) which is necessarily thermally conductive (i.e. to provide cooling) and substantially transparent to microwave energy (i.e. to deliver energy from antennas 18). Regarding claim 13, there is a flow chamber (14) adjacent to thermally conductive plate (21). Regarding claims 14, 15 and 17, there is a liquid coolant configured to flow through the chamber, the coolant selected from a variety of options including gas or liquid such as water and alcohol (Figure 2B and para. [0112]). Regarding claims 18-21, the suction element comprises a suction chamber (i.e. concave surface formed by plate 21 as seen in Figure 2B) having a tapered wall and connected to a vacuum source. See, also Figure 17 which shows the suction ports on the contact plate and Figure 19A which shows a taper for the wall. Regarding claims 21 and 22, Knowlton also provides a temperature sensor (23) in the form of a thermocouple (para. [0125], for example).
Regarding claim 23, Knowlton provide a microwave delivery device for non-invasively treating skin tissue comprising a thermally conductive plate (21) adjacent to a microwave antenna (18) as well as a suction chamber as addressed above. The contact plate is configured to contact tissue to provide cooling, and the suction is used to draw tissue to the contact plate as addressed above.
Regarding claim 27, Knowlton discloses a method for creating a subdermal lesion in skin tissue (para. [0011-0015] and [0225], for example) comprising delivering microwave energy to the skin tissue, applying a cooling element (i.e. contact plate) to the skin tissue and delivering sufficient microwave energy at a power, frequency and duration to create a lesion at an interface between the dermis and subcutaneous layer of the skin. See, for example, paragraphs [0023-0024], [0216] and [0260] which disclose the various different layers of skin tissue that may be treated. See, also, the above rejection with respect to claim 1 which discloses the structure of the microwave antenna(s) and cooling element.
Regarding claim 28, Knowlton discloses the device used to reduce sweat production (para. [0148], for example) comprising activating a vacuum pump (or suction) to acquire the skin in a suction chamber, cooling the skin with a cooling element (i.e. contact plate) and delivering microwave energy to treat a second (i.e. deeper) layer of skin containing sweat glands to thermally alter the sweat glands. See above rejection for discussion of the physical limitations (i.e. cooling element, antenna, suction, etc.). The sequence of steps is disclosed by Knowlton and would be inherent to the procedure being performed.
Regarding claim 29, Knowlton provide a method of treating skin comprising positioning a microwave energy delivery applicator over skin tissue (Figure 2b), securing the skin tissue proximate to the applicator with suction (as addressed previously), cooling the surface of the skin (as addressed previously) and delivering energy sufficient to create a thermal effect in target tissue within the skin (as addressed previously).
Regarding claim 30, positioning a microwave applicator over skin comprising positioning a microwave waveguide (i.e. antenna) over the skin as seen in Figure 2b, for example. Regarding claims 31 and 32, securing the skin comprises using suction as addressed in paragraph [0116] and Figure 17 in Knowlton, and as addressed previously. Regarding claim 33, the suction source draws tissue to the contact plate thereby elevating the skin surface. Regarding claim 34, the contact plate (21) is a cooling element placed in contact with the skin surface. Regarding claims 35-37, Knowlton expressly disclose the use of conductive and convective cooling of tissue (para. [0112], for example). Regarding claims 38-41, Knowlton discloses several of the same types of tissue (para. [0148], for example). Regarding claims 42-43, Knowlton discloses monitoring tissue temperature (see discussion of claims 21-22 above). Regarding claims 44-45, Knowlton discloses administering a medication, including anesthetics (i.e. lidocaine) to the patient (see para. [0112], for example).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 5 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Knowlton (‘214) in view of the teaching of Fink et al (7,410,485).
Knowlton discloses the use of a microwave antenna, but fails to expressly disclose the use of a single slot antenna as recited in claim 5.
The examiner maintains that the use of any well-known type of microwave antenna would generally be obvious to those of ordinary skill in the art. Applicant’s disclosure of the use of numerous different types of antennas indicates that the specific type of antenna is not specifically important and that many different types of antennas are equally substitutable. To that end, Fink et al disclose a directional microwave antenna applicator used to treat tissue and specifically teach that it is known to provide a single slot antenna used to guide microwave energy to tissue (col. 18, lines 10-20).
To have provided the Knowlton device with a single slot microwave antenna to direct microwave energy to tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Fink et al fairly teach it is known to use such a microwave energy antenna to control the application of microwave energy to tissue and further since applicant’s disclosure indicates many different types of microwave antennas are acceptable for the given procedure.
Claim 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Knowlton (‘214) in view of the teaching of van der Weide et al (2007/0049918).
Knowlton discloses the use of a microwave antenna, but fails to expressly disclose the use of a dual slot antenna as recited in claim 6.
The examiner maintains that the use of any well-known type of microwave antenna would generally be obvious to those of ordinary skill in the art. Applicant’s disclosure of the use of numerous different types of antennas indicates that the specific type of antenna is not specifically important and that many different types of antennas are equally substitutable. To that end, van der Weide et al disclose a directional microwave antenna applicator used to treat tissue and specifically teach that it is known to provide a variety of different types of antenna, including triaxial, dipole and dual slot antennas (para. [0011], for example).
To have provided the Knowlton device with a dual slot microwave antenna to direct microwave energy to tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since van der Weide et al fairly teach it is known to use such a microwave energy antenna to control the application of microwave energy to tissue and further since applicant’s disclosure indicates many different types of microwave antennas are acceptable for the given procedure.
Claims 8 and 12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Knowlton (‘214) in view of the teaching of Berube et al (6,527,768).
Knowlton discloses the use of a microwave antenna, but fails to expressly disclose the specific wavelength used to treat tissue, or a ceramic plate for the tissue contacting/cooling surface.
Berube et al disclose another microwave antenna applicator and specifically teach that it is known to use a frequency up to 5.8GHz to treat tissue (col. 5, line 60 to col. 6, line 12). Berube et al also disclose a contact plate (30) for contacting tissue, and specifically teach the contact plate made be made from a ceramic (col. 7, lines 65-67, for example).
To have provided the Knowlton device with any acceptable, and well-known, frequency range to treat tissue would have been an obvious consideration for one of ordinary skill in the art, particularly since Berube et al fairly teach it is known to use microwave energy at a frequency of 5.8 GHz for the treatment of tissue. To have further provided the contact plate of Knowlton with a surface made from a ceramic would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Berube et al fairly teach it is known to provide the contact plate of a microwave device made from such a material.
Claim 16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Knowlton (‘214) in view of the teaching of Tierney et al (5,733,316).
Knowlton discloses a variety of material that may be used as a coolant, including liquids, gases, water and alcohol (see above discussion). Knowlton fails to expressly disclose the use of deionized water.
Again, the examiner maintains that the use of any well-known type of fluid for cooling would be an obvious consideration for the skilled artisan, particularly since Knowlton and applicant’s disclosure both recite numerous different fluids for cooling. Tierney et al disclose another device for the application of microwave energy to tissue including a cooling medium, and specifically teach that it is known to use a deionized water as the cooling medium (col. 7, line 34).
To have provided the Knowlton device, which discloses several different alternatives for a cooling medium including water, with deionized water as a cooling medium would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Tierney et al fairly teach it is known to use deionized water as a cooling medium for a microwave applicator device.
Claims 24-26 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Knowlton (‘214) in view of the teaching of Burton et al (5,496,271).
Knowlton fails to disclose a shield on the microwave applicator for controlling the direction of energy delivery. The examiner maintains that it is generally known in the art to provide microwave antennas with a shield to control the direction of microwave energy.
To that end, Burton et al disclose another microwave applicator for treating tissue. The applicator includes an antenna, as well as a shield, which may include either a microwave absorbing or a microwave reflecting material, to control the direction of the microwave energy and prevent the treatment on non-intended tissue. See, for example, column 13, lines 5-40.
To have provided the Knowlton microwave antenna with a shield to contain excess energy fields and control the direction of the microwave energy would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Burton et al fairly teach that it is generally known to use a shield to control the application of a microwave field to tissue. It is knotted that Burton et al disclose the use of both reflective and/or absorbing material to shield the microwave antenna.
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.
Claims 1-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,186,015. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘015 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘015 claims. Here, the more specific patent claims encompass the broader instant application claims. 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.
Claims 1-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,419,678. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘678 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘678 claims. Here, the more specific patent claims encompass the broader instant application claims. 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.
Claims 1-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,463,429. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘429 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘429 claims. Here, the more specific patent claims encompass the broader instant application claims. 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kim et al (2011/0313412) disclose another device comprising a housing having a microwave applicator, the housing attached to a suction source to draw tissue into contact with the applicator for treating skin tissue. See Figures 1, 4 and 5, for example.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/July 27, 2026
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