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 .
Status of the Claims
Claims 1-19, 23, 27, 28, 31, 37, 38, 42, and 43 are cancelled.
Claims 44-47 are added.
Claims 20, 21, 29, 30, 35, 36, and 39 are amended.
Claims 20-22, 24-26, 29, 30, 32-36, 39-41, and 44-47 are pending and examined on the merits.
Examiner Comments
Amended Claim 36 recites “the pump assembly are configured” which is treated to read as “the pump assembly is configured”.
Response to Arguments
Applicant’s arguments, see page 5, filed 29AUG2025, with respect to the rejection(s) of claim(s) 20-22, 24-30, 32-36 and 39-43 under 35 U.S.C. § 103 have been fully considered and are moot in view of new grounds of rejection prompted by Applicant’s amendment to claims. While the prior art as previously presented fails to teach the packaging of the device, a new ground(s) of rejection is made in view of Coulthard in view of Dacey and Bianchini.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 20-22, 24-26, 29, 30, 32-36, 39-41, and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coulthard et al. (US Pre-Grant Publication 2012/0109083), in view of Dacey et al. (US 20100234793 A1) and Bianchini et al. (US 20060278551 A1).
Regarding claim 20, Coulthard teaches a negative pressure wound therapy apparatus (100) comprising:
a pump assembly (at least (116)) [0029], the pump assembly comprising a source of negative pressure (micropump (116)) configured to be fluidically connected (at least via (164)) to the dressing (106) configured to be placed over a wound of a patient; and
a power source (at least (140) and (114) [0049]) comprising an energy harvester (RFID antenna (114)) [0025-0026] in electrical communication with the pump assembly (at least via controller (118), [0028]),
wherein the energy harvester is configured to receive radio frequency (RF) signals and to generate power (by capturing the energy) from at least some of the received RF signals for powering the source of negative pressure [0025-0026].
Coulthard teaches the use of capacitors for energy storage, but fails to teach the use of a supercapacitor. Coulthard additionally fails to teach packaging material for the device.
Dacey teaches a medical system wherein supercapacitors are utilized for energy storage [0250]. The energy stored in the supercapacitor as taught by Dacey is considered excess energy as it describes the energy transfer to both the device and to recharging a power source [0253] and in order to charge the supercapacitor, there must be excess power beyond what is required by the system. Dacey further teaches that components may be either electrically connected or inductively [0247, 0254]. As both direct (without the use of inductive power transfer) and indirect (inductive) energy, Dacey is considered to teach the energy harvester circuitry receives RF signals and stores energy in the supercapacitor without the use of inductive power transfer and wherein the supercapacitor and the pump assembly are electromagnetically connected through inductive power transfer when combined with the device of Coulthard.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the power storage capacitor of Coulthard with the supercapacitor of Dacey as it would be obvious to try when choosing from the finite number of identified power sources, with a reasonable expectation of successfully storing and delivering power MPEP 2143 I.
Bianchini teaches a packaging (10) which shields the contents from RF prior to use [0007] to prevent unintended actuation.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Coulthard in view of Dacey to incorporate packaging which shields the device from RF prior to use in order to ensure the device is not inadvertently actuated prior to use [Bianchini 0007].
By incorporating the packaging of Bianchini, the combined device is considered to teach a packaging enclosing at least the energy harvester circuitry, wherein the packaging is configured to shield the energy harvester circuitry from one or more radio frequencies.
Regarding claim 21, Coulthard further teaches wherein the power source is configured to provide power to operate the pump assembly (Abstract) [0025-0026].
Regarding claim 22, Coulthard further teaches wherein the pump assembly and the power source are at least partially embedded into the dressing (See embodiment of Figs. 9-11, showing a self-contained negative pressure dressing [0071-0072]), and further wherein the power source provides power to operate one or more components of the dressing, the one or more components of the dressing comprising at least one of sensors or communication devices (See [0079] disclosing sensors incorporated as part of the controller (316), which is itself powered by the power source [0081]).
Regarding claim 24, Coulthard further teaches wherein the energy harvester (312) is embedded within, incorporated into, or positioned on the dressing (See Figs. 9-11, [0071-0072]).
Regarding claim 25, Coulthard further teaches wherein the RF signals comprise intentionally broadcasted RF signals (the RF signal is produced by (110), or (306) in other embodiments [0071]).
Regarding claim 26, Coulthard in view of Dacey and Bianchini teach the method of Claim 20. Although Coulthard is silent as to the RF signals comprising environmental RF signals. The device of Coulthard in view of Dacey and Bianchini is structurally identical to the device as claimed and is therefore interpreted to perform in an identical manner. Furthermore, any RFID antenna is necessarily capable of receiving environmental RF signals within a range of frequency, and based on the signal power, provide such power to any connected electronics or elements. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 29, Coulthard teaches a method of operating a negative pressure wound therapy apparatus comprising:
providing negative pressure wound therapy from a pump assembly (116) fluidically connected to a dressing positioned over a wound of a patient (See Figs. 1, 9-11); and
operating the pump assembly with a power source (at least (140) and (114)) comprising an energy harvester (RFID antenna (114)) in electrical communication with the pump assembly (See at least [0077]),
wherein the energy harvester is configured to receive radio frequency (RF) signals and to generate power using at least some of the received RF signals (see at least [0025-0026, 0071-0072]).
Coulthard teaches the use of capacitors for energy storage, but fails to teach the use of a supercapacitor. Coulthard additionally fails to teach packaging material for the device.
Dacey teaches a medical system wherein supercapacitors are utilized for energy storage [0250]. The energy stored in the supercapacitor as taught by Dacey is considered excess energy as it describes the energy transfer to both the device and to recharging a power source [0253] and in order to charge the supercapacitor, there must be excess power beyond what is required by the system. Dacey further teaches that components may be either electrically connected or inductively [0247, 0254]. As both direct (without the use of inductive power transfer) and indirect (inductive) energy, Dacey is considered to teach the energy harvester circuitry receives RF signals and stores energy in the supercapacitor without the use of inductive power transfer and wherein the supercapacitor and the pump assembly are electromagnetically connected through inductive power transfer when combined with the device of Coulthard in view of Dacey and Bianchini.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Coulthard in view of Dacey and Bianchini to incorporate the inductive and non-inductive power transfer means of Dacey as it would be obvious to try when choosing from the finite number of identified power transfer means, with a reasonable expectation of successfully harvesting and delivering power MPEP 2143 I.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Coulthard in view of Dacey and Bianchini to incorporate a supercapacitor for storage in place of the capacitor taught by Coulthard [0025] as a simple substitution of one power storage device for another with a reasonable expectation of providing power to the device MPEP 2143 I.
Bianchini teaches a packaging (10) which shields the contents from RF prior to use [0007] to prevent unintended actuation.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Coulthard in view of Dacey to incorporate packaging which shields the device from RF prior to use in order to ensure the device is not inadvertently actuated prior to use [Bianchini 0007].
By incorporating the packaging of Bianchini, the combined device is considered to teach a packaging enclosing at least the energy harvester circuitry, wherein the packaging is configured to shield the energy harvester circuitry from one or more radio frequencies.
Regarding claim 30, Coulthard further teaches operating components of the dressing with the power source, the components of the dressing comprising at least one of sensors or communication devices [0079, additionally 0025-0026, 0071-0072]).
Regarding claim 32, Coulthard further teaches the energy harvester (shown as (312) in the embodiment of Figs. 9-11) is embedded within, incorporated into, or positioned on the dressing (See Figs. 9-11, [0071-0072]).
Regarding claim 33, Coulthard further teaches the RF signals comprise intentionally broadcasted RF signals (broadcast from 110 or 306).
Regarding claim 34, Coulthard is silent as to the RF signals comprising environmental RF signals. However, receiving RF signals from environmental sources is unavoidable depending on the frequency and amplitude of the signals. As such, any device comprising an RFID antenna necessarily receives certain environmental RF signals. Accordingly, the device and method of Coulthard is interpreted to meet the limitation as claimed. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)
Regarding claim 35, Coulthard further teaches the source of negative pressure is positioned within the dressing (See Figs. 9-11, [0071-0072]).
Regarding claim 36, Coulthard further teaches the dressing and the pump assembly are configured to be worn by the patient (See Figs. 9-11, [0071-0072]; at least implicitly in the fact that the dressing is self-contained and is intended to be placed on a wound site on a patient).
Regarding claim 39, Coulthard in view of Dacey and Bianchini fails to teach the two antennas comprise a first antenna supported by the dressing and a second antenna supported at least partially by the pump assembly.
Placement of one antenna on the dressing and the second on the pump assembly is considered obvious to try when considering the finite number of available positions for placement within the system as taught, said options being 1) both antenna on the dressing, 2) both antenna on the pump assembly, or 3) a first antenna supported by the dressing and the second antenna supported by the pump assembly. Therefore, one of ordinary skill would have found it obvious to place the antenna in the claimed configuration MPEP 2143 I.
Regarding claims 40 and 41, Coulthard in view of Dacey and Bianchini fails to teach the supercapacitor is configured to be remote from the pump assembly.
Coulthard further teaches a desire for remotely powering the device in order to allow the pump to be self-contained [0026]. It would have been obvious to a person having ordinary skill in the art to place the storage supercapacitor remotely from the pump assembly as it would be obvious to try when considering the finite possibilities of locating the power source locally or remotely and viewed in conjunction with the teachings of Coulthard MPEP 2143 I.
Regarding Claim 45, the device of Claim 20 is considered to teach that after the energy harvester circuitry has been removed from the packaging, the energy harvester circuitry receives the RF signals and captures the energy for powering the source of negative pressure, as the packaging would no longer provide shielding once removed, thereby allowing the device to operate as intended (i.e., harvesting energy).
Claim(s) 44 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coulthard in view of Dacey and Bianchini, and further in view of Bommer et al. (US 20140008989 A1).
Regarding Claim 44, Coulthard in view of Dacey and Bianchini fails to teach the energy harvester circuitry comprising two antennas being symmetrically positioned relative to a virtual ground node of the energy harvester circuitry, and wherein the two antennas are two identical antenna arrays mounted half wavelength of RF signals apart to capture a threshold potential difference.
Bommer teaches an energy capture device [Abstract] wherein the two antennas (460) are two identical antenna arrays mounted half wavelength of RF signals apart to capture a threshold potential difference [0041], the device allowing for harvesting energy from multiple directions and orientations [0030] (the device is considered to operate in the RF band [0069] as common Wi-Fi frequencies are 2.4 GHz and 5 GHz).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the antenna array of Coulthard in view of Dacey and Bianchini with the antenna array arrangement of Bommer to ensure power is created independent of the orientation [0039].
Regarding Claim 47, Coulthard in view of Dacey and Bianchini fails to teach the energy harvester circuitry comprising two antennas being symmetrically positioned relative to a virtual ground node of the energy harvester circuitry, and wherein the two antennas are two identical antenna arrays mounted half wavelength of RF signals apart to capture a threshold potential difference.
Bommer teaches an energy capture device [Abstract] wherein the two antennas (460) are two identical antenna arrays mounted half wavelength of RF signals apart to capture a threshold potential difference [0041], the device allowing for harvesting energy from multiple directions and orientations [0030] (the device is considered to operate in the RF band [0069] as common Wi-Fi frequencies are 2.4 GHz and 5 GHz).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the antenna array of Coulthard in view of Dacey and Bianchini with the antenna array arrangement of Bommer to ensure power is created independent of the orientation [0039].
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coulthard in view of Dacey and Bianchini, and further in view US 20140324001 A1 (Serrano).
Regarding Claim 46, Coulthard in view of Dacey and Bianchini fails to teach after the energy harvester circuitry has been removed from the packaging, the energy harvester circuitry receives the RF signals causing a timer to be started, and wherein the timer is indicative of loss of sterility of at least one component of the apparatus.
Serrano teaches a medical device which starts a timer once removed from its packaging [0025].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Coulthard in view of Dacey and Bianchini to provide healthcare professionals with an estimated time the device has been in use [Serrano 0025].
The combined device is therefore considered to teach after the energy harvester circuitry has been removed from the packaging, the energy harvester circuitry receives the RF signals causing a timer to be started, and wherein the timer is indicative of loss of sterility of at least one component of the apparatus.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20070293822 A1 and US 20150343173 A1 teach medical devices which initiate a time upon removal from their packaging.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HANS KALIHER/Examiner, Art Unit 3781 /CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781