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 .
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.
Claim(s) 2-6, 8-9, 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burnett 2009/0254179. Noting figures 1A and 7A for example, Burnett
discloses the invention as claimed comprising:
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Regarding claims 2-6, 8-9, Burnett discloses an implant comprising a shell (102), a core (106) within the shell, and a conductive layer (104; see [0034 which states that the hydrogel is conductive and [0040] which describes an aqueous filler) between the core and the shell; wherein the implant additionally comprises a sensor (110) for detecting a change in one or more electrical properties of the conductive layer (this is considered to be functional language. See MPEP 2114. Nevertheless Burnette discloses the function as claimed see [0042)) and wherein the conductive layer is adhered to the shell and comprising a coating on the innermost surface of the shell (this is interpreted because [0009] states " in further alternative embodiments, the hydrogel may consist of coating on the inside of implant shell and/or a coating on a silicone support structure within the shell " and see [0016 and 0040] which states in part "..in hydrogel-filled, or other hydrophilic fluid-filled, implant of the present invention in that the conductive filler provides for a simple, low-profile addition to the breast implant patch…”. Because the hydrogel is a filler and may be coated to the interior of the shell it may act as a conductive layer. Burnett et al. further discloses wherein the core comprises a gel-fill biomaterial (hydrogel see [0034]); wherein the conductive layer substantially covers the innermost surface of the shell. Burnett et al further discloses that the electrical property is a current across the conductive layer (see [0040]).
See MPEP 2173.05 "...D. "Substantially"
The term "substantially" is often used in conjunction with another term to describe a particular characteristic of the claimed invention. It is a broad term. In re Nehrenberg, 280 F.2d 161, 126 USPQ 383 (CCPA 1960). The court held that the limitation "to substantially increase the efficiency of the compound as a copper extractant" was definite in view of the general guidelines contained in the specification. In re Mattison, 509 F.2d 563, 184 USPQ 484 (CCPA 1975). The court held that the limitation "which produces substantially equal E and H plane illumination patterns" was definite because one of ordinary skill in the art would know what was meant by "substantially equal." Andrew Corp. V. Gabriel Electronics, 847 F.2d 819, 6 USPQ2d 2010 (Fed. Cir. 1988).
Burnette further discloses that the gel-fill biomaterial is selected from silicone,
saline or combinations thereof (see [0009] which states " hydrogels are over 90% water
or saline"); wherein the conductive layer is in electrical communication with the sensor
[0028]; wherein the conductive layer is connected to the sensor (see figures 1A and
7A), wherein connection of the sensor to the conductive layer is either direct or via a
tether.
The language of clam 11 is functional (see MPEP 2114) nevertheless Burnette further discloses “…a conductive pathway across the insulating shell allowing current to flow through the hydrogel, across the shell,..” (See [0016]) and thus is capable of performing the function as claimed.
Regarding claim 14, see [0043] discloses the use of RF as a communicating mechanism and that a variety of other mechanisms may be employed including auditory, acoustic, vibrational or other stimuli to alert the patient.
“…The sensor may, preferentially, be radio frequency (RF)-enabled and the implant status may be communicated externally by RF or by other wireless technology.”
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) 13, 15 are rejected under 35 U.S.C. 103 as being unpatentable over
Burnett 2009/0254179 ('179) in view of Burnett et al. 2009/0012372 ('372).
Regarding claim 13, Burnett ‘179 has been disclosed supra however does not specify that the sensor measures impedance, temperature or pressure. Burnett '372 teaches that sensors can measure pressure and impedance [0082]. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sensor of Burnet '179 to measure impedance, temperature or pressure in order to monitor and make sure the implant is functioning properly.
Regarding claims 15-18, Burnett ‘179 has been disclosed supra however does not specify he use of a hand-held receiver. Burnett et al. ‘372 teaches the use of a handheld receiver noting fig. 9. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sensor of Burnet '179 to measure the RFID chip to employ a capacitor or other temporary power storage device capable of storing energy received from external transmitter until a threshold is reached, at which point sensor is interrogated (see [0104-0105]).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Burnett 2009/0254179 ('179) in view Marquez et al. 2017/0258585.
Regarding claim 12 Burnett ‘179 has been disclosed supra however does not specify that the sensor has a microchip and/or memory and/or radio-frequency identification circuit. Marquez et al. teaches that sensors may be used in conjunction with implants and that the sensor the sensor device (e.g., electrical sensor device) can comprise a piezoelectric sensor. For example, the piezoelectric sensor can be a component of a sensor microchip including circuitry housed within a protective housing (see [0009]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sensor of Burnet '179 to have a microchip and/or memory and/or radio-frequency identification circuit because Burnett et al. envisions the use of radio-frequency (see [0040]) and by utilizing a microchip would provide an (integrated circuit) to control the flow of electrical signals to process data, run software.
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 2-11, 13-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,102,523 (hereafter ‘523). Although the claims at issue are not identical, they are not patentably distinct from each other. For example regarding claims 2-3, current claim 2 recites:
2. (New) An implant comprising a shell, a core comprising a silicone gel-fill biomaterial within the shell, and a conductive layer between the core and the shell; wherein the
implant additionally comprises a sensor for detecting a change in one or more electrical properties of the conductive layer; and wherein the conductive layer is adhered to the shell and comprises a coating on an innermost surface of the shell.
Pat. ‘523 claims 1 and 2 recites”
“1. An implant comprising a shell, a core within the shell, and a conductive layer between the core and the shell; wherein the implant additionally comprises a sensor for detecting a change in one or more electrical properties of the conductive layer and wherein the conductive layer is adhered to the shell and comprises a coating on an innermost surface of the shell, and wherein the conductive layer comprises conducting material which is nanoparticulate.
2. An implant according to claim 1, wherein the core comprises a gel-fill biomaterial.”
It is obvious to one having ordinary skill in the art the current claim 2 is broader in scope and does not require the limitation of “wherein the conductive layer comprises conducting material which is nanoparticulate”. The patent would be utilized to reject the application claims.
Regarding claims 4-5 “ wherein the conductive layer partially covers the innermost surface of the shell.” See pat. ‘523 claim 4 which states that the conductive later substantially covers the inner most surface of the shell. It is obvious that the term “substantially” is broad and encompasses “partially”.
Regarding claim 6, see pat. ‘523 claim 1.
Regarding claim 7, see pat. ‘523 claim 6.
Regarding claim 8, see pat. ‘523 claim 7.
Regarding claim 9, see pat. ‘523 claim 8.
Regarding claim 10, see pat. ‘523 claim 9.
Regarding claim 11, see pat. ‘523 claim 10.
Regarding claim 12, see pat. ‘523 claim 11.
Regarding claim 13, see pat. ‘523 claim 11.
Regarding claim 14, see pat. ‘523 claim 12.
Regarding claim 15, see pat. ‘523 claim 13.
Regarding claim 16, see pat. ‘523 claim 14.
Regarding claim 17, see pat. ‘523 claim 15.
Regarding claim 18, see pat. ‘523 claim 16.
Regarding claim 19, see pat. ‘523 claim 18.
Regarding claim 20, see pat. ‘523 claim 19.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,102,523 (hereafter ‘523) in view of Marquez et al. 2017/0258585.
Regarding claim 12 pat. ‘523 has been disclosed supra however does not recite that the sensor has a microchip and/or memory and/or radio-frequency identification circuit. Marquez et al. teaches that sensors may be used in conjunction with implants and that the sensor the sensor device (e.g., electrical sensor device) can comprise a piezoelectric sensor. For example, the piezoelectric sensor can be a component of a sensor microchip including circuitry housed within a protective housing (see [0009]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sensor of Burnet '179 to have a microchip and/or memory and/or radio-frequency identification circuit because Burnett et al. envisions the use of radio-frequency (see [0040]) and by utilizing a microchip would provide an (integrated circuit) to control the flow of electrical signals to process data, run software.
Allowable Subject Matter
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art has been presented supra however does not disclose or teach in combination with the method limitations of claim 19, that the uncured silicone is devolatilized prior to adhering of the conductive layer.
Conclusion
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 September 24, 2026
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