DETAILED ACTION
Note: 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 Claims
1. Claims 1, 4, 12-19, 21-30 are pending and currently under consideration for patentability.
Priority
2. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on October 2, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
4. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 102
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 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.
5. Claim(s) 12, 13, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gregory et al. (US PGPUB 2020/0222599 A1).
6. With regard to claim 12, Gregory discloses a negative pressure wound therapy device (100; abstract; [0002-0003]; [0057-0058]; Figs. 1, 3A, 3B, 11) comprising: a negative pressure source (pump assembly, 150 and pump, 390; [0029]; [0051]) configured to provide, via a fluid flow path, negative pressure therapy to a wound of a patient (wound cavity, 110) covered by a wound dressing (wound filler, 130 and wound cover, 120) in accordance with at least one parameter of therapy ([0003]); a pressure sensor (“one or more pressure sensors”) configured to measure a pressure in the fluid flow path ([0051]); and an electronic processing circuitry (general purpose controller, 310 and pump control processor, 370) configured to transmit data to and receive data from one or more remote computing devices ([0003-0004]; [0058-0058]) via a low latency, high speed communication protocol (Fig. 11; [0003-0004]; [0055]; [0074]), the electronic processing circuitry (310, 370) being further configured to: transmit the pressure in the fluid flow path measured by the pressure sensor ([0051]; step 1104; Fig. 11), thereby causing the one or more remote computing devices to determine an adjustment to the at least one parameter of therapy ([0052]; [0055]; [0057]; Fig. 11); receive from the one or more remote computing devices the adjustment of the at least one parameter of therapy (step, 1106; Fig. 11); and adjust the at least one parameter of therapy using the adjustment (step, 1108; Fig. 11; [0003-0004]; [0052]; [0057]; [0075-0076]).
7. With regard to claim 13, Gregory discloses that the low latency, high speed communication protocol comprises a 4G LTE or 5G cellular communication protocol ([0052]).
8. With regard to claim 17, Gregory discloses that the adjustment of the at least one parameter of therapy comprises at least one of changing a negative pressure set point, providing indication of an abnormal operating condition, or pausing provision of negative pressure therapy by the negative pressure source ([0028]; [0051-0052]; [0057]; [0073]; [0076-0078]).
9. With regard to claim 18, Gregory discloses that the communication electronic processing circuitry is configured to receive from the one or more remote computing devices a negative pressure wound therapy prescription (i.e. higher or lower negative pressure delivered to the wound; “pre-programmed”; “compliance monitoring”; [0052]; [0056]; [0058]; [0069]; [0077]); and cause wherein the negative pressure source is configured to provide negative pressure in accordance with the negative pressure wound therapy prescription ([0028]; [0051-0052]; [0057]; [0073]; [0076-0078]).
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.
10. Claim(s) 1, 4, 14-16, 21-26, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Gregory.
11. With regard to claims 1 and 21, Gregory discloses a negative pressure wound therapy system (abstract; [0002-0003]; [0057-0058]; Figs. 1, 3A, 3B, 11) comprising: at least one negative pressure wound therapy device (100) configured to provide, via a fluid flow path, negative pressure therapy to a wound of a patient (wound cavity, 110) covered by a wound dressing (wound filler, 130 and wound cover, 120) in accordance with at least one parameter ([0003]), the at least one negative pressure wound therapy device (100) being configured to measure a pressure in the fluid flow path (“one or more pressure sensors”; [0051]), and the at least one negative pressure wound therapy device (100) being configured to switch between different communication protocols ([0003-0004]; [0028]; [0052]; [0056-0057]); and a non-transitory computer readable medium storing instructions that, when executed by one or more processors of one or more remote computing devices ([0003-0004]; [0057-0058]), causes the one or more processors to: communicate with the at least one negative pressure wound therapy device (100) via a low latency, high speed communication protocol (Fig. 11; [0003-0004]; [0055]; [0074]); receive the pressure in the fluid flow path from the at least one negative pressure wound therapy device ([0003]; [0055]; [0074]; Fig. 11); based on processing the pressure in the fluid flow path, determine whether an adjustment to the at least one parameter of negative pressure therapy is needed ([0053]; [0055]; [0057]; Fig. 11); and in response to determining that the adjustment to the at least one parameter of negative pressure therapy is needed, communicate to the at least one negative pressure wound therapy device (100) a request to perform the adjustment, wherein, the at least one negative pressure wound therapy device (100) is configured to perform the adjustment in response to receiving the request (step, 1108; Fig. 11; [0003-0004]; [0052]; [0057]; [0075-0076]).
However, Gregory fails to explicitly disclose that at least one negative pressure wound therapy device is configured to switch between different communication protocols responsive to a detection of movement of the patient.
Nonetheless, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the at least one negative pressure wound therapy device disclosed by Gregory to be configured to switch between different communication protocols responsive to a detection of movement of the patient, since Gregory suggests in paragraph [0052] that its connectivity is used for various activities, such as pump assembly location tracking and asset tracking, which includes the claimed feature of patient movement detection. Additionally, it was well-known and common general knowledge in the art prior to the effective filing date of the claimed invention that a patient device which is being moved around necessarily needs to switch communication protocols for reasons of being out of range, confidentiality reasons and/or administrative reasons.
12. With regard to claim 14, while Gregory discloses that the electronic processing circuitry is configured to switch between different communication protocols ([0003-0004]; [0028]; [0052]; [0056-0057]), Gregory fails to explicitly disclose that at least one negative pressure wound therapy device is configured to switch between different communication protocols responsive to a detection of movement of the patient.
Nonetheless, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the at least one negative pressure wound therapy device disclosed by Gregory to be configured to switch between different communication protocols responsive to a detection of movement of the patient, since Gregory suggests in paragraph [0052] that its connectivity is used for various activities, such as pump assembly location tracking and asset tracking, which includes the claimed feature of patient movement detection. Additionally, it was well-known and common general knowledge in the art prior to the effective filing date of the claimed invention that a patient device which is being moved around necessarily needs to switch communication protocols for reasons of being out of range, confidentiality reasons and/or administrative reasons.
13. With regard to claim 22, Gregory discloses that the low latency, high speed communication protocol comprises a 4G LTE or 5G cellular communication protocol ([0052]).
14. With regard to claims 4, 15, 16, 23 and 24, Gregory, as modified in the rejections of claims 1, 14 and 21 above, discloses that the communication electronic processing circuitry is configured to switch from a low speed, low energy consumption communication protocol to the low latency, high speed communication protocol responsive to the detection of movement of the patient ([0003-0004]; [0028]; [0052]; [0056-0057]); and further suggests an LTE-M mode ([0052]).
However, Gregory fails to explicitly disclose that wherein the electronic processing circuitry is configured to switch from NB-IoT mode to LTE-M mode responsive to the detection of movement of the patient and switch from LTE-M mode to NB-IoT mode responsive to lack of the detection of movement of the patient.
Nonetheless, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the at least one negative pressure wound therapy device electronic processing circuity disclosed by Gregory to be configured to switch from NB-IoT mode to LTE-M mode responsive to the detection of movement of the patient and switch from LTE-M mode to NB-IoT mode responsive to lack of the detection of movement of the patient, since Gregory suggests in paragraph [0052] that its connectivity is used for various activities, such as pump assembly location tracking and asset tracking, which includes the claimed feature of patient movement detection. Additionally, it was well-known and common general knowledge in the art prior to the effective filing date of the claimed invention that NB-IoT modes are widely utilized for battery conservation and such a mode would be advantageous in non-active situations.
15. With regard to claim 25, Gregory discloses that the adjustment of the at least one parameter of therapy comprises at least one of changing a negative pressure set point, providing indication of an abnormal operating condition, or pausing provision of negative pressure therapy by the negative pressure source ([0028]; [0051-0052]; [0057]; [0073]; [0076-0078]).
16. With regard to claim 26, Gregory discloses that the instructions further cause the one or more processors to communicate to the at least one negative pressure wound therapy device (100) a negative pressure wound therapy prescription (i.e. higher or lower negative pressure delivered to the wound; “pre-programmed”; “compliance monitoring”; [0052]; [0056]; [0058]; [0069]; [0077]); and cause wherein the negative pressure source is configured to provide negative pressure in accordance with the negative pressure wound therapy prescription ([0028]; [0051-0052]; [0057]; [0073]; [0076-0078]).
17. With regard to claims 29 and 30, Gregory fails to explicitly disclose that in response to detecting a failure in communication via the low latency, high speed communication protocol, communication with the at least one negative pressure wound therapy device is performed using a short range wireless communication protocol via another negative pressure wound therapy device or another computing device different from the one or more remote computing devices.
However, Gregory discloses that the communications processor (330) can utilize multiple antennas (340) for sending and receiving data to one or more types of known short and long range wireless connections for different various activities ([0052]); and that the system can be configured to alert a user, such as patient or medical care provider, to a variety of operating or failure conditions of the system ([0039]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the at least one negative pressure wound therapy system disclosed by Gregory to switch between different communication protocol in response to detecting failure in another communication protocol, in order to act as a fail-safe for continuing communication protocols of therapy even if another available communications protocol were to lack connection during use, with a reasonable expectation of success, in view of Gregory’s suggestions in paragraphs [0039] and [0052].
18. Claim(s) 19 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Gregory, as applied to claims 18 and 26 above, and further in view of Duesterhoft et al. (US PGPUB 2013/0271278 A1).
19. With regard to claims 19 and 27, Gregory is silent in regard to the electronic processing circuitry being configured to determine a verification of the negative pressure wound therapy prescription by a healthcare provider at the negative pressure wound therapy device prior to causing the negative pressure source is configured to provide negative pressure in accordance with the negative pressure wound therapy prescription responsive to verification of the negative pressure wound therapy prescription by a healthcare provider at the negative pressure wound therapy device.
Within the same field of negative pressure wound dressing therapy systems, Duesterhoft discloses computational methods and systems for reporting information regarding appurtenances to wound dressings (abstract; Fig. 6) wherein electronic processing circuitry (local unit, 540) is configured to determine a verification of a negative pressure wound therapy prescription (“program”) by a healthcare provider at the negative pressure wound therapy device (“verified by an initial interrogation”) prior to causing the negative pressure source is configured to provide negative pressure in accordance with the negative pressure wound therapy prescription responsive to verification of the negative pressure wound therapy prescription by a healthcare provider at the negative pressure wound therapy device ([0174]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the electronic processing circuitry disclosed by Gregory to include a determination of a verification of the negative pressure wound therapy prescription by a healthcare provider, similar to that disclosed by Duesterhoft, in order to ensure that the patient information and wound therapy prescription are a verified match prior to starting therapy – ensuring that the patient receives the proper therapy, as suggested by Duesterhoft in paragraph [0174])
20. Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Gregory, as applied to claim 21 above, and further in view of Brandolini et al. (CN 111093728 A).
21. With regard to claim 28, Gregory is silent in regard to the at least one negative pressure wound therapy device comprising a plurality of negative pressure wound therapy devices configured to be controlled by the one or more processors.
However, within the same field of negative pressure wound therapy systems, Brondolini discloses a device for operation, monitoring, and control in a wound treatment system (abstract), wherein a plurality of negative pressure wound therapy devices are configured to be controlled by one or more processors (Fig. 4; [0073-0075]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the at least one negative pressure wound therapy device disclosed by Gregory to be a plurality of negative pressure wound therapy devices configured to be controlled by the one or more processors, similar to that disclosed by Brandolini, in order to separately monitor and provide independent treatment to wounds at multiple locations on a patient’s body, with a reasonable expectation of success, as suggested by Brandolini in paragraphs [0073-0074].
Conclusion
22. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Karpowicz et al. (US PGPUB 2011/0077605 A1) discloses a pump system for negative pressure wound therapy.
Allen et al. (US PGPUB 2017/0053073 A1) discloses a system and method for implementing wound therapy protocols.
23. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas Weiss can be reached on (571)270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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