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 .
Response to Amendment
The amendment filed 12/9/2025 has been entered: Claims 1-14, 21, 23-26, 28, and 44-63 remain pending in the present application. Claims 15-20, 22, 27, and 29-43 have been canceled. Claims 44-63 are new. Claims 1 and 13 are amended. Claims 1-14, 21, 23-26, 28, and 44-63 are examined on the merits.
Applicant’s amendments have been acknowledged, and overcome each and every 101 rejection previously set forth in the non-final office action mailed 8/29/2025. All previous 101 rejections have been withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 44, requiring a single/wearable pump have necessitated a new grounds of rejection. As such, Applicant’s arguments regarding said new limitations, and those specifically directed to Pisano, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Ikeguchi remains as the primary reference in rejecting the present claims, for disclosing a majority of the claimed invention.
Bennett is being introduced as a secondary reference in the present rejection for disclosing and/or rendering obvious the newly amended limitations of claims 1 and 44, with Pisano no longer being relied upon.
Savage, Erbey, Bar, and Saroka remain in the present rejection for disclosing and/or rendering obvious the remaining limitations of the claims.
Applicant further argues Savage is directed to fluid delivery, rather than fluid removal, and thus would not be considered by one of ordinary skill in the art.
In response to Applicant's argument that Savage is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Applicant’s invention focuses heavily on garment features for wearable medical devices with fluid management. Savage is similarly directed to garment features for wearable medical devices with fluid management. One of ordinary skill in the art would appreciate the features of the garment, and the arrangements of common elements (pumps, batteries, etc.) would be analogous whether the device were intended for removing or delivering fluid. Savage is only relied upon for such garment limitations. There appears to be no evidence that the garment arrangement of Savage would be unsuitable for drainage systems, nor do there appear to be claimed garment features that would be suitable only for drainage systems.
Newly cited reference, Bennett, also establishes that drainage systems may also be made in a portable garment system, in the form of a holster.
In addition, Applicant’s own IDS submissions include fluid delivery systems (See Lamborne, an infusion catheter; Massengale, a fluid delivery catheter; Applicant also cites dialysis systems which also require fluid return/delivery).
Applicant’s arguments regarding the dependent claims being allowable on at least the same grounds as independent claims 1 and 44 are similarly not persuasive as claims 1 and 44 remain rejected as set forth below.
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.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “placement portion” in claim 4, where “portion” is the generic placeholder and “placement”, as well as the intended function of the pump and reservoir being positioned therein, are the function.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
The “placement portion” of claims 4 and 14 is interpreted as a pocket, compartment, opening (¶ 21 of Applicant’s specification), or any known equivalents capable of holding or attaching the pump and reservoir to the garment body.
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.
Claims 1-2, 21, 23, 25-26, 44-45, 58-59, and 61-62 are rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi (US 2003/0060806 A1), in view of Bennett (US 4,930,997 A).
Regarding claim 1, Ikeguchi teaches a urinary track fluid removal system (Figs. 1-2; Abstract) comprising a single pump (vacuum source 36) the pump having a fluid inlet in fluid communication with a urinary catheter (catheter 32); and a reservoir in fluid communication with the pump (collection bottle 34), wherein the pump is configured to apply negative pressure to the urinary catheter to remove fluid from the urinary tract (¶s 34-35).
Ikeguchi does not explicitly teach the pump being wearable, having a fluid outlet, the reservoir being in communication with the fluid outlet of the pump, and a wearable garment configured to be worn by a patient; the pump provided on the garment body, and the reservoir provided on the garment body.
However, Bennett teaches a fluid drainage system (Figs. 1 and 4; Abstract), thus being in the same field of endeavor, comprising a single, in-line pump with an inlet and outlet (rotary pump in Fig. 4; having inlets and outlets in the form of the tubing members on either side of the pump, directing aspirate from the patient), which is also wearable and portable (Fig. 17; Col. 21, lines 22-35 also describe how the entirety of the device is carried in the case).
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 the device of Ikeguchi to comprise the in-line pump of Bennett. Doing so would thus comprise pumps being in the upstream end of the fluid path leading to the reservoir such that the reservoir would be in communication with the outlet of the pump. Doing so would be advantageous as such a configuration would avoid needing to aspirate air residing in the collection reservoir before creating a vacuum (Col. 6, line 65 – Col. 7, line 39).
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ikeguchi to comprise the carrying case of Bennett. Doing so would comprise a wearable garment, comprising a garment body configured to be worn by a patient, the pump being wearable and provided on the garment body, and the reservoir provided on the garment body. Doing so would be advantageous in providing increased patient care in remote environments outside of a hospital (Col. 1, lines 20-25 of Bennett).
Regarding claim 2, Bennett further teaches the garment body configured as a holster (carrying case 104).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the device of Ikeguchi and Bennett to be configured as a wearable garment, as taught by Bennett. Doing so would comprise a wearable garment as a holster. Doing so would be advantageous in providing increased patient care in remote environments outside of a hospital (Col. 1, lines 20-25 of Bennett).
Regarding claim 21, the combination of Ikeguchi, and Bennett substantially disclose a system for removing fluid from a urinary tract comprising a wearable garment according to claim 1.
Ikeguchi further teaches a urinary catheter comprising a distal portion of the proximal portion comprising a drainage lumen (ureteral catheter 32 in Fig. 2, comprising distal portion 40, and proximal portion 46; ¶s 21 and 34 describe the lumen).
Regarding claim 23, Ikeguchi further teaches the urinary catheter being a ureteral catheter (Fig. 2 and ¶ 35) and the distal and comprises a retention portion (cage 82 in Figs. 4 and 5; also balloon 38 In Fig. 2), wherein the retention portion of the urinary catheter comprises an outer periphery which prevents mucosal tissue from a kidney, renal pelvis and/or uretero-renal pelvis junction from occluding one or more protected drainage holes or ports upon application of negative pressure through the catheter (¶s 21, 24, and 38).
Regarding claim 25, Ikeguchi further teaches the catheter may be used percutaneously (¶ 36).
Regarding claim 26, Ikeguchi further teaches the proximal portion configured to pass through a percutaneous opening (¶ 36) and the distal portion comprising a retention portion (cage 82 in Figs. 4 and 5; also balloon 38 In Fig. 2), wherein the retention portion of the urinary catheter comprises an outer periphery which prevents mucosal tissue from a kidney, renal pelvis and/or uretero-renal pelvis junction from occluding one or more protected drainage holes or ports upon application of negative pressure through the catheter (¶s 21, 24, and 38).
Regarding claim 44, Ikeguchi teaches a urinary track fluid removal system (Figs. 1-2; Abstract) comprising a pump (vacuum source 36) the pump having a fluid inlet in fluid communication with a urinary catheter (catheter 32); and a reservoir in fluid communication with the pump (collection bottle 34), wherein the pump is configured to apply negative pressure to the urinary catheter to remove fluid from the urinary tract (¶s 34-35).
Ikeguchi does not explicitly teach the pump being wearable, having a fluid outlet, the reservoir being in communication with the fluid outlet of the pump, and a wearable garment configured to be worn by a patient; the pump provided on the garment body, and the reservoir provided on the garment body.
However, Bennett teaches a fluid drainage system (Figs. 1 and 4; Abstract), thus being in the same field of endeavor, comprising a single, in-line pump with an inlet and outlet (rotary pump in Fig. 4; having inlets and outlets in the form of the tubing members on either side of the pump, directing aspirate from the patient), which is also wearable and portable (Fig. 17; Col. 21, lines 22-35 also describe how the entirety of the device is carried in the case).
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 the device of Ikeguchi to comprise the in-line pump of Bennett. Doing so would thus comprise pumps being in the upstream end of the fluid path leading to the reservoir such that the reservoir would be in communication with the outlet of the pump. Doing so would be advantageous as such a configuration would avoid needing to aspirate air residing in the collection reservoir before creating a vacuum (Col. 6, line 65 – Col. 7, line 39).
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ikeguchi to comprise the carrying case of Bennett. Doing so would comprise a wearable garment, comprising a garment body configured to be worn by a patient, the pump being wearable and provided on the garment body, and the reservoir provided on the garment body. Doing so would be advantageous in providing increased patient care in remote environments outside of a hospital (Col. 1, lines 20-25 of Bennett).
Regarding claim 45, Bennett further teaches the garment body configured as a holster (carrying case 104).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the device of Ikeguchi and Bennett to be configured as a wearable garment, as taught by Bennett. Doing so would comprise a wearable garment as a holster. Doing so would be advantageous in providing increased patient care in remote environments outside of a hospital (Col. 1, lines 20-25 of Bennett).
Regarding claim 58, the combination of Ikeguchi, and Bennett substantially disclose a system for removing fluid from a urinary tract comprising a wearable garment according to claim 1.
Ikeguchi further teaches a urinary catheter comprising a distal portion of the proximal portion comprising a drainage lumen (ureteral catheter 32 in Fig. 2, comprising distal portion 40, and proximal portion 46; ¶s 21 and 34 describe the lumen).
Regarding claim 59, Ikeguchi further teaches the urinary catheter being a ureteral catheter (Fig. 2 and ¶ 35) and the distal and comprises a retention portion (cage 82 in Figs. 4 and 5; also balloon 38 In Fig. 2), wherein the retention portion of the urinary catheter comprises an outer periphery which prevents mucosal tissue from a kidney, renal pelvis and/or uretero-renal pelvis junction from occluding one or more protected drainage holes or ports upon application of negative pressure through the catheter (¶s 21, 24, and 38).
Regarding claim 61, Ikeguchi further teaches the catheter may be used percutaneously (¶ 36).
Regarding claim 62, Ikeguchi further teaches the proximal portion configured to pass through a percutaneous opening (¶ 36) and the distal portion comprising a retention portion (cage 82 in Figs. 4 and 5; also balloon 38 In Fig. 2), wherein the retention portion of the urinary catheter comprises an outer periphery which prevents mucosal tissue from a kidney, renal pelvis and/or uretero-renal pelvis junction from occluding one or more protected drainage holes or ports upon application of negative pressure through the catheter (¶s 21, 24, and 38).
Claims 3-6, are rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi and Bennett, as applied to claim 1 above, and further in view of Savage (US 2016/0199576 A1).
Regarding claim 3, the combination of Ikeguchi and Bennett does not explicitly teach the pump is provided on a front portion of the garment body and the reservoir is provided on a back portion of the garment body.
However, Savage teaches a wearable fluid management system (Figs. 1-2B; Abstract), thus being in the same field of endeavor, and a pump (pump unit 140) and a reservoir (fluid reservoir 130) provided on a garment body, the garment to be worn by a patient (¶ 2), wherein the pump is provided on a front portion of the garment body and the reservoir is provided on a back portion of the body (Fig. 2A shows pump 140 on the front of the body and Fig. 2B shows reservoir 130 on the back of the body).
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 the device arrangement and garment body of Ikeguchi and Bennett to be configured as taught by Savage. Doing so would comprise the pump on the front portion of the garment and the reservoir on the back of the garment . Doing so would be advantageous in providing increased patient quality of life, independence, and mobility (¶ 103 of Savage).
Regarding claim 4, Savage teaches the pump and the reservoir are each positioned within a placement portion provided on the garment body (pouch 114; Figs. 2A and 2B show the reservoir being attached to the vest via reservoir support portion 130).
As previously stated, 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 the device arrangement and garment body of Ikeguchi and Bennett to be configured as taught by Savage. Doing so would comprise the pump and reservoir being positioned with a placement portion provided on the garment body on the front portion of the garment and the reservoir on the back of the garment . Doing so would be advantageous in providing increased patient quality of life, independence, and mobility (¶ 103 of Savage).
Regarding claim 5, Savage teaches the pump being contained with a compartment (pouch 114) and the reservoir comprising an attachment (¶s 195-196 describes how the fluid reservoir can be sandwiched between layers of the garment).
As previously stated, 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 the device arrangement and garment body of Ikeguchi and Bennett to be configured as taught by Savage. Doing so would comprise the placement portions being one of a pocket or attachment. Doing so would be advantageous in providing increased patient quality of life, independence, and mobility (¶ 103 of Savage).
Regarding claim 6, Savage teaches comprising a battery provided on the garment body and operatively coupled to the pump for providing power to the pump (¶ 204 describes power source 340).
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 the device of Ikeguchi and Bennett to comprise a battery provided on the garment body and operatively connected to the pump for providing power to the pump, as taught by Savage. Doing so would be advantageous in providing increased patient quality of life, independence, and mobility (¶ 103 of Savage, the battery being necessary to provide a portable device).
Claims 7, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi and Bennett as applied to claim 1 above, and further in view of Bar-Yoseph et al. (US 2011/0301662 A1), hereinafter Bar.
Regarding claim 7, the combination of Ikeguchi and Bennett do not explicitly teach a controller operatively connected to the pump; and at least one sensor configured to detect signal(s) representative of one of a hemodynamic parameter or a parameter representative of an amount of fluid retained within a patient’s body and communicate the signal(s) to the controller.
However, Bar teaches a urine stimulation system (Fig. 7; Abstract), thus being in the same field of endeavor, comprising a pump (¶s 526 and 699 describe pumping and suction) which uses a lung fluid monitoring system in order to trigger an increase in renal output to reduce fluid retention in the lungs (¶ 513).
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 the combination of Ikeguchi and Bennett to comprise the controller and lung fluid sensors of Bar. Doing so with thus comprise a controller operatively connected to the pump; and at least one sensor configured to detect signal(s) representative of one of a hemodynamic parameter or a parameter representative of an amount of fluid retained within a patient’s body and communicate the signal(s) to the controller (as the renal stimulation of Ikeguchi is achieved with the negative pressure pump). Doing so would be advantageous in reducing fluid retention in the lungs associated with the number of diseases (¶ 513 of Bar).
Regarding claim 11, the combination of Ikeguchi, Bennett, and Bar substantially disclose the invention of claim 7.
Bar further discloses at least one sensor configured to detect signal(s) representative of an amount of fluid in at least one long of the patient (¶ 513).
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 the combination of Ikeguchi, Bennett, and bar to further comprise the controller and lung fluid sensors of Bar. Doing so with thus comprise the sensor being configured to detect signal(s) representative of an amount of fluid in at least one lung of the patient. Doing so would be advantageous in reducing fluid retention in the lungs associated with the number of diseases (¶ 513 of Bar).
Regarding claim 12, the combination of Ikeguchi, Bennett, and Bar substantially disclose the invention of claim 11.
Bar further discloses a monitoring system where the controller is configured to receive and process signal(s) from a lung fluid sensor to determine if the amount of fluid in at least one lung of the patient is above, below, or at a predetermined value; and provide a control signal, determined at least in part from the signal(s) representative of the amount of fluid in the at least one long of the patient received from the at least one sensor, to provide renal stimulation when the amount of fluid in at least one lung of the patient is above a predetermined value and to see stimulation when the amount of fluid in the at least one lung of the patient is at or below the predetermined value (¶s 102 and 341 describes the controller operating using a feedback system to maintain physiological parameters, including lung fluid, and desired ranges; ¶ 409 describes the monitoring system; ¶ 513 describes how the feedback system can be lung fluid sensor based; ¶ 114 describes how the controller stores target values for input signals indicative of physiological parameters).
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 the combination of Ikeguchi, Bennett, and Bar to configure the controller to receive and process signals from the lung fluid sensor to determine if the amount of fluid in at least one lung of the patient is above, below, or at a predetermined value; and to provide a control signal determined at least in part by signals representing the amount of fluid in at least one lung, to control renal stimulation as taught by Bar. Doing so with thus the controller configured to provide a control signal to the pump to apply negative pressure to the urinary catheter to remove fluid from a urinary tract when the amount of fluid in the at least one lung of the patient is above the predetermined value and to cease applying negative pressure when the amount of fluid in the at least one lung of the patient is at or below the predetermined value (as the renal stimulation of Ikeguchi is the application of negative pressure). Doing so would be advantageous in reducing fluid retention in the lungs associated with the number of diseases (¶ 513 of Bar).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi, Bennett, and Bar as applied to claim 7 above, and further in view of Savage.
Regarding claim 8, the combination of Ikeguchi, Bennett, and Bar substantially disclose the invention of claim 7. The combination does not explicitly teach the controller being an external controller provided on the garment body and electrically coupled to the pump to provide an control signal to the pump.
Savage teaches a wearable fluid management system (Figs. 1-2B; Abstract), thus being in the same field of endeavor, and a pump (pump unit 140) and a reservoir (fluid reservoir 130) provided on a garment body, the garment to be worn by a patient (¶ 2), and a being an external controller provided on the garment body electrically coupled to the pump to provide a control signal to the pump (control board 1195 is externally separated from the pump 1150 by rear cover 1102; ¶ 231).
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 the device of Ikeguchi, Bennett, and Bar to be configured as a wearable garment wherein the controller is an external controller provided on the garment body, as taught by Savage. Doing so would be advantageous in providing increased patient quality of life, independence, and mobility (¶ 103 of Savage, the controller being necessarily configured to enable wearability).
Regarding claim 9, the combination of Ikeguchi, Bennett, and Bar substantially disclose the invention of claim 7. The combination does not explicitly teach the controller is a pump controller disposed on a printed circuit board within a housing of the pump.
Savage teaches a wearable fluid management system (Figs. 1-2B; Abstract), thus being in the same field of endeavor, and a pump (pump unit 140) and a reservoir (fluid reservoir 130) provided on a garment body, the garment to be worn by a patient (¶ 2), and a controller being provided on a printed circuit board within the housing of a pump (control board 1195 being within pump housing 1103 and 1101; ¶ 231).
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 the device of Ikeguchi, Bennett, and Bar to be configured as a wearable garment wherein the controller on a printed circuit board within a housing of the pump, as taught by Savage. Doing so would be advantageous in providing increased patient quality of life, independence, and mobility (¶ 103 of Savage, the controller being necessarily configured to enable wearability).
Regarding claim 10, the combination of Ikeguchi, Bennett, and Bar substantially disclose the invention of claim 7.
Savage teaches a wearable fluid management system (Figs. 1-2B; Abstract), thus being in the same field of endeavor, and a pump (pump unit 140) and a reservoir (fluid reservoir 130) provided on a garment body, the garment to be worn by a patient (¶ 2) and the garment comprising at least one sensor provided on the garment body (¶s 33-35).
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 the device of Ikeguchi, Bennett, and Bar to comprise a biological sensor on the garment body, as taught by Savage. Doing so would be advantageous in detecting health issues and tracking patient treatment (¶ 109 of Savage).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi, Bennett, and Bar, as applied to claim 11 above, and further in view of Savage and Saroka et al. (US 2022/0218282 A1).
Regarding claim 13, the combination of Ikeguchi, Bennett, and Bar substantially disclose the invention of claim 11.
Savage teaches a wearable fluid management system (Figs. 1-2B; Abstract), thus being in the same field of endeavor, and a pump (pump unit 140) and a reservoir (fluid reservoir 130) provided on a garment body, the garment to be worn by a patient (¶ 2) and the garment comprising at least one sensor provided on the garment body (¶s 33-35).
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 the device of Ikeguchi, Bennett, and Bar to comprise a biological sensor on the garment body, as taught by Savage. Doing so would be advantageous in detecting health issues and tracking patient treatment (¶ 109 of Savage).
The combination still does not explicitly teach the sensors being external electromagnetic transducers comprising a first transducer configured to be positioned on an anterior portion of the torso of a patient, and a second transducer configured to be positioned on a posterior portion of a torso of the patient.
However, Saroka teaches a system for aligning chest sensors including those for lung fluid (Abstract and ¶ 46), thus being in the same field of endeavor, utilizing a device to be worn on a patient’s torso (Figs. 2-3) with front and rear electromagnetic (EM) sensors (204A and 204B) for determining the amount of fluid in the lungs of the patient (¶s 46 and 56-57).
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 the sensors of Ikeguchi, Bennett, Bar, and Savage to comprise EM transducers configured to be positioned on an anterior portion of the torso of the patient and on a posterior portion of the course of the patient, as taught by Saroka. Doing so would be advantageous in ensuring the lungs are targeted by the sensors based on anatomical landmarks (¶s 73-75 of Saroka) and providing improved sensing accuracy (¶ 57). The
Regarding claim 14, the combination of Ikeguchi, Bennett, Bar, Savage, and Saroka substantially disclose the invention of claim 13.
Savage further teaches the garment comprising at least one sensor provided on the garment body (¶s 33-35).
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 the device of Ikeguchi, Bennett, Bar, Savage, and Saroka to comprise a biological sensor on the garment body, as taught by Savage. Doing so would thus comprise the first external electromagnetic transducer and the second external electromagnetic transducer being positioned in a transducer placement portion provided on the garment body . Doing so would be advantageous in detecting health issues and tracking patient treatment (¶ 109 of Savage).
Claims 24 is rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi and Bennett, as applied to claim 23 above, and further in view of Erbey et al. (WO 2018/200050 A1).
Regarding claim 24, the combination of Ikeguchi and Bennett substantially disclose the invention of claim 23. The combination does not explicitly disclose the retention portion comprises a coil, and where the one or more protected drainage holes, ports, or perforations extend through a radially inwardly facing portion of the side wall of the coil.
However, Erbey teaches a ureteral catheter system (Figs. 7-7A; Abstract), thus being in the same field of endeavor, comprising a coil retention system where the drainage holes extend through radially inwardly facing portion of the side wall of the coil (Fig. 9B, drainage ports 132; ¶ 204).
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 the device of Ikeguchi and Bennett to comprise the coil with inwardly facing drainage holes, as taught by Erbey. So would be advantageous in preventing occlusion and reducing the risk of injury to tissue (¶ 204 of Erbey).
Claims 28 is rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi and Bennett, as applied to claim 26 above, and further in view of Erbey.
Regarding claim 28, the combination of Ikeguchi and Bennett substantially disclose the invention of claim 26. The combination does not explicitly disclose the a coil retention portion comprising at least a first coil having a first diameter and at least a second coil having a second diameter, the first diameter being greater than the second diameter.
However, Erbey teaches a ureteral catheter system (Figs. 7-7A; Abstract), thus being in the same field of endeavor, comprising a coil retention system with a first coil having a first diameter, a second coil having a second diameter, and the first diameter being greater than the second diameter (¶ 26, the first and second coils may be interpreted interchangeably as the positions are interchangeable as stated; also ¶ 210).
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 the combination of Ikeguchi and Bennett to comprise the coil retention system with a first coil having a first diameter, a second coil having a second diameter, and the first diameter being greater than the second diameter, as taught by Erbey. Doing so would be advantageous in creating a funnel shape inhibits occlusion of the ureter, renal pelvis, or rest of the kidney while occlusion can be managed superlatively (¶ 287 of Erbey).
Claims 46-49, are rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi and Bennett, as applied to claim 44 above, and further in view of Savage.
Regarding claim 46, the combination of Ikeguchi and Bennett does not explicitly teach the pump is provided on a front portion of the garment body and the reservoir is provided on a back portion of the garment body.
Savage teaches a wearable fluid management system (Figs. 1-2B; Abstract), thus being in the same field of endeavor, and a pump (pump unit 140) and a reservoir (fluid reservoir 130) provided on a garment body, the garment to be worn by a patient (¶ 2), wherein the pump is provided on a front portion of the garment body and the reservoir is provided on a back portion of the body (Fig. 2A shows pump 140 on the front of the body and Fig. 2B shows reservoir 130 on the back of the body).
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 the device arrangement and garment body of Ikeguchi and Bennett to be configured as taught by Savage. Doing so would comprise the pump on the front portion of the garment and the reservoir on the back of the garment . Doing so would be advantageous in providing increased patient quality of life, independence, and mobility (¶ 103 of Savage).
Regarding claim 47, Savage teaches the pump and the reservoir are each positioned within a placement portion provided on the garment body (pouch 114; Figs. 2A and 2B show the reservoir being attached to the vest via reservoir support portion 130).
As previously stated, 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 the device arrangement and garment body of Ikeguchi and Bennett to be configured as taught by Savage. Doing so would comprise the pump and reservoir being positioned with a placement portion provided on the garment body on the front portion of the garment and the reservoir on the back of the garment . Doing so would be advantageous in providing increased patient quality of life, independence, and mobility (¶ 103 of Savage).
Regarding claim 48, Savage teaches the pump being contained with a compartment (pouch 114) and the reservoir comprising an attachment (¶s 195-196 describes how the fluid reservoir can be sandwiched between layers of the garment).
As previously stated, 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 the device arrangement and garment body of Ikeguchi and Bennett to be configured as taught by Savage. Doing so would comprise the placement portions being one of a pocket or attachment. Doing so would be advantageous in providing increased patient quality of life, independence, and mobility (¶ 103 of Savage).
Regarding claim 49, Savage teaches comprising a battery provided on the garment body and operatively coupled to the pump for providing power to the pump (¶ 204 describes power source 340).
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 the device of Ikeguchi and Bennett to comprise a battery provided on the garment body and operatively connected to the pump for providing power to the pump, as taught by Savage. Doing so would be advantageous in providing increased patient quality of life, independence, and mobility (¶ 103 of Savage, the battery being necessary to provide a portable device).
Claims 50, and 54-55 are rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi and Bennett as applied to claim 44 above, and further in view of Bar.
Regarding claim 50, the combination of Ikeguchi and Bennett do not explicitly teach a controller operatively connected to the pump; and at least one sensor configured to detect signal(s) representative of one of a hemodynamic parameter or a parameter representative of an amount of fluid retained within a patient’s body and communicate the signal(s) to the controller.
However, Bar teaches a urine stimulation system (Fig. 7; Abstract), thus being in the same field of endeavor, comprising a pump (¶s 526 and 699 describe pumping and suction) which uses a lung fluid monitoring system in order to trigger an increase in renal output to reduce fluid retention in the lungs (¶ 513).
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 the combination of Ikeguchi and Bennett to comprise the controller and lung fluid sensors of Bar. Doing so with thus comprise a controller operatively connected to the pump; and at least one sensor configured to detect signal(s) representative of one of a hemodynamic parameter or a parameter representative of an amount of fluid retained within a patient’s body and communicate the signal(s) to the controller (as the renal stimulation of Ikeguchi is achieved with the negative pressure pump). Doing so would be advantageous in reducing fluid retention in the lungs associated with the number of diseases (¶ 513 of Bar).
Regarding claim 54, the combination of Ikeguchi, Bennett, and Bar substantially disclose the invention of claim 50.
Bar further discloses at least one sensor configured to detect signal(s) representative of an amount of fluid in at least one long of the patient (¶ 513).
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 the combination of Ikeguchi, Bennett, and bar to further comprise the controller and lung fluid sensors of Bar. Doing so with thus comprise the sensor being configured to detect signal(s) representative of an amount of fluid in at least one lung of the patient. Doing so would be advantageous in reducing fluid retention in the lungs associated with the number of diseases (¶ 513 of Bar).
Regarding claim 55, the combination of Ikeguchi, Bennett, and Bar substantially disclose the invention of claim 54.
Bar further discloses a monitoring system where the controller is configured to receive and process signal(s) from a lung fluid sensor to determine if the amount of fluid in at least one lung of the patient is above, below, or at a predetermined value; and provide a control signal, determined at least in part from the signal(s) representative of the amount of fluid in the at least one long of the patient received from the at least one sensor, to provide renal stimulation when the amount of fluid in at least one lung of the patient is above a predetermined value and to see stimulation when the amount of fluid in the at least one lung of the patient is at or below the predetermined value (¶s 102 and 341 describes the controller operating using a feedback system to maintain physiological parameters, including lung fluid, and desired ranges; ¶ 409 describes the monitoring system; ¶ 513 describes how the feedback system can be lung fluid sensor based; ¶ 114 describes how the controller stores target values for input signals indicative of physiological parameters).
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 the combination of Ikeguchi, Bennett, and Bar to configure the controller to receive and process signals from the lung fluid sensor to determine if the amount of fluid in at least one lung of the patient is above, below, or at a predetermined value; and to provide a control signal determined at least in part by signals representing the amount of fluid in at least one lung, to control renal stimulation as taught by Bar. Doing so with thus the controller configured to provide a control signal to the pump to apply negative pressure to the urinary catheter to remove fluid from a urinary tract when the amount of fluid in the at least one lung of the patient is above the predetermined value and to cease applying negative pressure when the amount of fluid in the at least one lung of the patient is at or below the predetermined value (as the renal stimulation of Ikeguchi is the application of negative pressure). Doing so would be advantageous in reducing fluid retention in the lungs associated with the number of diseases (¶ 513 of Bar).
Claims 51-53 are rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi, Bennett, and Bar, as applied to claim 50 above, and further in view of Savage (US 2016/0199576 A1).
Regarding claim 51, the combination of Ikeguchi, Bennett, and Bar substantially disclose the invention of claim 50. The combination does not explicitly teach the controller being an external controller provided on the garment body and electrically coupled to the pump to provide an control signal to the pump.
However, Savage teaches a wearable fluid management system (Figs. 1-2B; Abstract), thus being in the same field of endeavor, and a pump (pump unit 140) and a reservoir (fluid reservoir 130) provided on a garment body, the garment to be worn by a patient (¶ 2), and a being an external controller provided on the garment body electrically coupled to the pump to provide a control signal to the pump (control board 1195 is externally separated from the pump 1150 by rear cover 1102; ¶ 231).
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 the device of Ikeguchi, Bennett, and Bar to be configured as a wearable garment wherein the controller is an external controller provided on the garment body, as taught by Savage. Doing so would be advantageous in providing increased patient quality of life, independence, and mobility (¶ 103 of Savage, the controller being necessarily configured to enable wearability).
Regarding claim 52, the combination of Ikeguchi, Bennett, and Bar substantially disclose the invention of claim 50. The combination does not explicitly teach the controller is a pump controller disposed on a printed circuit board within a housing of the pump.
However, Savage teaches a wearable fluid management system (Figs. 1-2B; Abstract), thus being in the same field of endeavor, and a pump (pump unit 140) and a reservoir (fluid reservoir 130) provided on a garment body, the garment to be worn by a patient (¶ 2), and a controller being provided on a printed circuit board within the housing of a pump (control board 1195 being within pump housing 1103 and 1101; ¶ 231).
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 the device of Ikeguchi, Bennett, and Bar to be configured as a wearable garment wherein the controller on a printed circuit board within a housing of the pump, as taught by Savage. Doing so would be advantageous in providing increased patient quality of life, independence, and mobility (¶ 103 of Savage, the controller being necessarily configured to enable wearability).
Regarding claim 53, the combination of Ikeguchi, Bennett, and Bar substantially disclose the invention of claim 50.
Savage teaches a wearable fluid management system (Figs. 1-2B; Abstract), thus being in the same field of endeavor, and a pump (pump unit 140) and a reservoir (fluid reservoir 130) provided on a garment body, the garment to be worn by a patient (¶ 2) and the garment comprising at least one sensor provided on the garment body (¶s 33-35).
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 the device of Ikeguchi, Bennett, and Bar to comprise a biological sensor on the garment body, as taught by Savage. Doing so would be advantageous in detecting health issues and tracking patient treatment (¶ 109 of Savage).
Claims 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi, Bennett, and Bar, as applied to claim 54 above, and further in view of Savage and Saroka.
Regarding claim 56, the combination of Ikeguchi, Bennett, and Bar substantially disclose the invention of claim 54.
However, Savage teaches a wearable fluid management system (Figs. 1-2B; Abstract), thus being in the same field of endeavor, and a pump (pump unit 140) and a reservoir (fluid reservoir 130) provided on a garment body, the garment to be worn by a patient (¶ 2) and the garment comprising at least one sensor provided on the garment body (¶s 33-35).
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 the device of Ikeguchi, Bennett, and Bar to comprise a biological sensor on the garment body, as taught by Savage. Doing so would be advantageous in detecting health issues and tracking patient treatment (¶ 109 of Savage).
The combination still does not explicitly teach the sensors being external electromagnetic transducers comprising a first transducer configured to be positioned on an anterior portion of the torso of a patient, and a second transducer configured to be positioned on a posterior portion of a torso of the patient.
However, Saroka teaches a system for aligning chest sensors including those for lung fluid (Abstract and ¶ 46), thus being in the same field of endeavor, utilizing a device to be worn on a patient’s torso (Figs. 2-3) with front and rear electromagnetic (EM) sensors (204A and 204B) for determining the amount of fluid in the lungs of the patient (¶s 46 and 56-57).
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 the sensors of Ikeguchi, Bennett, Bar, and Savage to comprise EM transducers configured to be positioned on an anterior portion of the torso of the patient and on a posterior portion of the course of the patient, as taught by Saroka. Doing so would be advantageous in ensuring the lungs are targeted by the sensors based on anatomical landmarks (¶s 73-75 of Saroka) and providing improved sensing accuracy (¶ 57). The
Regarding claim 57, the combination of Ikeguchi, Bennett, Bar, Savage, and Saroka substantially disclose the invention of claim 56.
Savage further teaches the garment comprising at least one sensor provided on the garment body (¶s 33-35).
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 the device of Ikeguchi, Bennett, Bar, Savage, and Saroka to comprise a biological sensor on the garment body, as taught by Savage. Doing so would thus comprise the first external electromagnetic transducer and the second external electromagnetic transducer being positioned in a transducer placement portion provided on the garment body . Doing so would be advantageous in detecting health issues and tracking patient treatment (¶ 109 of Savage).
Claims 60 is rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi and Bennett, as applied to claim 59 above, and further in view of Erbey.
Regarding claim 60, the combination of Ikeguchi and Bennett substantially disclose the invention of claim 23. The combination does not explicitly disclose the retention portion comprises a coil, and where the one or more protected drainage holes, ports, or perforations extend through a radially inwardly facing portion of the side wall of the coil.
However, Erbey teaches a ureteral catheter system (Figs. 7-7A; Abstract), thus being in the same field of endeavor, comprising a coil retention system where the drainage holes extend through radially inwardly facing portion of the side wall of the coil (Fig. 9B, drainage ports 132; ¶ 204).
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 the device of Ikeguchi and Bennett to comprise the coil with inwardly facing drainage holes, as taught by Erbey. So would be advantageous in preventing occlusion and reducing the risk of injury to tissue (¶ 204 of Erbey).
Claims 63 is rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi and Bennett, as applied to claim 61 above, and further in view of Erbey.
Regarding claim 63, the combination of Ikeguchi and Bennett substantially disclose the invention of claim 61. The combination does not explicitly disclose the a coil retention portion comprising at least a first coil having a first diameter and at least a second coil having a second diameter, the first diameter being greater than the second diameter.
However, Erbey teaches a ureteral catheter system (Figs. 7-7A; Abstract), thus being in the same field of endeavor, comprising a coil retention system with a first coil having a first diameter, a second coil having a second diameter, and the first diameter being greater than the second diameter (¶ 26, the first and second coils may be interpreted interchangeably as the positions are interchangeable as stated; also ¶ 210).
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 the combination of Ikeguchi and Bennett to comprise the coil retention system with a first coil having a first diameter, a second coil having a second diameter, and the first diameter being greater than the second diameter, as taught by Erbey. Doing so would be advantageous in creating a funnel shape inhibits occlusion of the ureter, renal pelvis, or rest of the kidney while occlusion can be managed superlatively (¶ 287 of Erbey).
Conclusion
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 ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781