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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the membrane and filters of claims 12 and 13 associated with one or more fluid collectors that are capped with the collected fluid analyzed, limitations of claims 12 and 13, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 30 in Fig. 6. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 15 is objected to because of the following informalities: please change “collectors ; ,” to “collectors;” in line 2. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: please change “configured detect” to “configured to detect” in line 2. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the fluid connectors" in line 16. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this will be interpreted as “the one or more fluid collectors” as such a limitation is in step “c.”
Claims 2-14 are rejected as dependents of claim 1.
Claim 2 recites the limitation "the fluid collector" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation is interpreted as “the one or more fluid collectors.”
Claim 2 recites the limitation "the sample" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the sensors" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the sensors” is interpreted as “sensors.”
Regarding claim 14, the limitation “additional complications” renders the claim indefinite as it is unclear what is encompassed by “additional.”
Claim 15 recites the limitation "the sample" in line 19. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 15, the limitation “the fluid collected in the one or more fluid collectors is stored in the one or more fluid collectors and capped with the cap” renders the claim indefinite. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In Katz, a claim directed to "[a] system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data" was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318, 97 USPQ2d at 1749. The limitation of current claim 15 claims both the apparatus and method steps of the apparatus, and similar to as in Katz, is indefinite as it is clear whether claims are directed to the capabilities of the device itself or require the specific method of use of the device.
Claims 16-20 are rejected as dependents of claim 15.
Regarding claim 16, the limitation “so that the one or more fluid collectors are shipped while in the container” render the claim indefinite as it claims both the apparatus and method steps of the apparatus, and similar to as in Katz, is indefinite as it is clear whether claims are directed to the capabilities of the device itself or require the specific method of use of the device.
Regarding claim 16, the limitation “device” combined with “providing a container” renders the claim indefinite, as the claim is directed to a device yet additional devices, such as a container, are also being provided to be used when a part of the device is detached from the device. Therefore, it seems like instead of a single device, this claim is directed to a kit or system.
Claims 17-19 are rejected as dependents of claim 16.
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) 1, 2, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck et al. (US 4,661,093) in view of Huck et al. (US 4,392,860).
Regarding claim 1, Beck discloses a method involving fluid collected from a wound site (see Abstract, Fig. 1), the method comprising the steps of: a) providing a pump unit (see Fig. 1) comprising: one or more pumps 4, one or more fluid collectors 2, and one or more drainage structures 3, 3’ each in communication with an exit site 1 of the wound site to draw the fluid through the one or more drainage structures into the pump unit and create a negative pressure at the exit site to remove and transport the fluid from the exit site and into the one or more fluid collectors (see Fig. 1; col. 5, lines 23-41), wherein the pump unit is configured to create a negative pressure (see Fig. 1; col. 5, lines 42-50, roller pump by turning creates suction that draws fluid via drain 1 and into fluid collector 2), wherein the fluid removal from the exit site is provided at a controlled and measured rate (see Fig. 1, controller 5 via sensors according to set minimum 27 and maximum 29 rotation speeds; col. 3, lines 10-30; col. 6, line 7 – col. 7, line 44); b) collecting the fluid within the one or more fluid collectors.
Beck does not disclose the method being a method of analyzing fluid collected from a wound site and involving c) removing the one or more fluid collectors; e) capping the one or more fluid collectors with a cap; and d) analyzing the collected fluid of step “b” once the fluid connectors are removed in step “c”.
Huck discloses a method of analyzing fluid collected form a wound site involves providing a self-contained unit with a fluid collector (see Fig. 1, col. 6, lines 13-20) attached to a drainage structure (see col. 5, lines 36-38 and lines 62-65, wound tubing), collecting the fluid within the fluid collector (see col. 5, lines 62-65), removing the fluid collector from the drainage structure (see col. 6, lines 30-33 and col. 4, lines 31-41); capping the fluid collector with a cap (see col. 6, lines 30-33 and col. 4, lines 31-41); and analyzing the collected fluid once the fluid collector is removed (see col. 6, lines 27-38, fluid sent to pathology lab). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method of Beck further include removing the fluid collector, capping the fluid collector, and analyzing the fluid in the fluid collector as disclosed by Huck in order to test the fluid and predictably determine pathology related information about the fluid, helping to study whether there are any apparent diseases that could be diagnosed to help the patient.
Regarding claim 2, Beck and Huck disclose the limitations of claim 1 and Huck further discloses the fluid collector includes a tapered section ( see Fig. 1, curved edges at bottom) that would result in facilitating centrifugation of the sample within the fluid collector due to the tapering.
Regarding claim 5, Beck and Huck disclose the limitations of claim 1 and Huck further discloses removing the cap from the fluid collector (see col. 6, lines 30-33 and col. 4, lines 31-41).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck as applied to claim 1 above, and further in view of Langdon (US 5,386,735).
Regarding claim 3, Beck and Huck disclose the limitations of claim 1 but do not disclose cutting or tearing the one or more fluid collectors to create an opening by a tear or a cut and removing the fluid through the tear or the cut and placing the fluid into a vessel or a machine.
Langdon discloses cutting or tearing a fluid collector to create an opening by a tear or a cut and removing the fluid through the tear or the cut and placing the fluid into a vessel (see col. 10, lines 12-30). It would have been obvious to include such a step as that disclosed by Langdon in order to provide a fluid sample in case additional testing is needed or so that the sample and associated fluid collected can be more easily transported as it would be transported via a test tube.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck as applied to claim 1 above, and further in view of Kerr (US 2014/0243707).
Regarding claim 4, Beck and Huck disclose the limitations of claim 1 but do not disclose the one or more fluid collectors include a one-way valve that is configured to allow passage of a syringe needle through the one-way valve into the fluid so that a sample of the fluid is taken for further processing.
Kerr discloses a fluid collector 12 with a one-way valve 51 that is configured to allow passage of a syringe needle through the one-way valve into the fluid so that a sample of the fluid is taken for further processing (see par. 58). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the fluid collector further include the valve as disclosed by Kerr in order to allow for optional sampling, as disclosed by Kerr (see par. 58).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck as applied to claim 1 above, and further in view of Kantrowitz et al. (US 4,913,700).
Regarding claim 6, Beck and Huck disclose the limitations of claim 1 but do not disclose providing a container to receive the one or more fluid collectors so that the one or more fluid collectors are shipped while in the container.
Huck discloses transporting the device containing fluids that are tested to a laboratory for testing (see col. 6, lines 33-37). Kantrowitz transporting via shipping and to enclose in a sealed bag to maintain sterility during shipment to a laboratory (see col. 5, lines 14-17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to transport via shipping and enclose in a sealed bag during shipment to a laboratory as disclosed in Kantrowitz in order to transport and protect the device containing fluids during transportation to the laboratory.
Regarding claim 7, Beck, Huck, and Kantrowitz disclose the limitations of claim 6 and as Kantrowitz describes only a sealed bag (see col. 5, lines 14-17), this sealed bag is interpreted as a single bag, and therefore singled-bagged container.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck as applied to claim 1 above, and further in view of Bayon (US 2017/0281064).
Regarding claim 8, Beck and Huck disclose the limitations of claim 1 but do not disclose sensors located within the one or more fluid collectors, wherein parameters detected by the sensors are configured to detect or indicate infection, proteins, or cell surface receptors.
Bayon discloses sensors within a container for drained bodily fluids (see par. 19-20), wherein parameters detected by the sensors are configured for detecting infection (see par. 21, 23). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the fluid collector further include sensors such as those disclosed by Bayon to indicate infection and therefore help monitor a patient for early infection so that the infection could be addressed sooner (see Bayon, par. 3).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck and further in view of Kantrowitz as applied to claim 6 above, and further in view of Turner et al. (US 2011/0251569).
Regarding claim 9, Beck, Huck, and Kantrowitz disclose limitations of claim 6 but do not specifically teach determining, via sensors, when the one or more fluid collectors have reached capacity.
Turner discloses a wound treatment apparatus with sensors detecting whether the canister is full or an aspirant conduit is blocked (see par. 39) sot that is a user is appropriately informed of the status of treatment (see par. 12). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to further include determining, via sensors, when the canister is full (at capacity) or an aspirant/drainage structure/conduit is blocked, as disclosed by Turner, in order to keep a user appropriately informed of status of treatment.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck as applied to claim 1 above, and further in view of Karpowicz et al. (US 2007/0219532).
Regarding claim 10, Beck and Huck disclose the limitations of claim 1 but do not disclose measuring an output of the fluid and automatically relaying the output of the fluid measured to a caregiver, a doctor, or a nurse.
Karpowicz discloses a pump system for negative pressure wound therapy along with measuring an output of the fluid and automatically relaying the output of the fluid measured to a caregiver, a doctor, or a nurse (see par. 94, 96, and 102) in order to alert the caregiver of the state of operation. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include the measuring as disclosed by Karpowicz predictably helping in monitoring of the status of treatment.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck and further in view of Kantrowitz as applied to claim 6 above, and further in view of Hyde et al. (US 2015/0119652).
Regarding claim 11, Beck, Huck, and Kantrowitz disclose the limitations of claim 6 but do not disclose a shipping container and shipping information so that the one or more fluid collectors when placed int eh shipping container are shipped to a location on the shipping information.
Hyde discloses providing a shipping container including a delivery label (shipping information) so that items may be placed in the shipping container and shipped to a location on the shipping delivery label for testing (see par. 73). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include such a shipping container and shipping information for testing, as disclosed by Hyde, to predictably result with helping with the transport of the fluid for testing, which would be required for transportation to a lab for analysis (see rejection of claim 1).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck as applied to claim 1 above, and further in view of Herwig et al. (US 2018/0001000). Herwig is considered prior art as membranes and filters are not associated with a pumping unit with removal of the one or more fluid collectors, capping of the one or more fluid collectors with a cap, and analyzing the collected fluid like with Figures 27-38 in App. no. 16/100,188 until amendments were filed on February 4, 2022 associating membranes and filters with the method of analyzing fluid. This is especially true as the membranes and filters disclosure of drawings is related to a segmented reservoir as shown in Figure 6, which has a completely different structure as that of Figures 27-38.
Regarding claim 12, Beck in view of Huck disclose the limitations of claim 1 but do not disclose the one or more fluid collectors include membranes that are air-permeable and liquid-impermeable so that air escapes the one or more fluid collectors.
Herwig discloses a fluid collector with membranes that are air permeable and liquid impermeable so that air escapes the fluid collector (see Fig. 6, par. 51-52) to allow the escape of air. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the fluid collector have membranes that are air permeable and liquid impermeable so that air escapes the fluid collector, as disclosed by Herwig, this predictably resulting in a fluid collector that can collect more fluid as air is able to escape, making more room for fluid within the reservoir.
Regarding claim 13, Beck, Huck, and Herwig disclose the limitations of claim 12 but do not disclose filters that prevent fluid from backing up against the membranes.
Herwig further discloses including a filter that prevents fluid from backing up against the membranes (see Fig. 6). It would have been obvious to a person having ordinary skill in the art to include a filter that prevents fluid from backing up against the membranes, as disclosed by Herwig, in order to maximize gas release and minimize the leakage of fluid. While Herwig only discloses a filter (see par. 52, Fig. 6), Courts have found that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), and in this case duplicating the filters so that they would create the same benefit and each filter was associated with a membrane would not produce a new and unexpected result, and therefore would be obvious.
Claim(s) 12- 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck as applied to claim 1 above, and further in view of Baker et al. (WO 2010/12658).
Regarding claim 12, Beck in view of Huck disclose the limitations of claim 1 but do not disclose the one or more fluid collectors include membranes that are air-permeable and liquid-impermeable so that air escapes the one or more fluid collectors.
Baker discloses having a barrier means within an aspirant reservoir to allow gas to pass out of reservoir and contain aspirated/collected fluid (see page 5, lines 9-33; page 32, lines 24-27) comprising membranes that are air-impermeable and liquid-impermeable so that air escapes the one or more fluid collectors (page 5, lines 9-33). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the fluid collector, which is a reservoir, include membranes that are air permeable and liquid-impermeable so that air escapes the fluid collector, as disclosed by Baker, and predictably allowing for collection of fluid inside the reservoir.
Regarding claim 13, Beck, Huck, and Baker disclose the limitations of claim 12 but do not disclose filters that prevent fluid from backing up against the membranes, though Baker discloses combination of a hydrophobic filter, foam, sponge, etc. (see page 5, lines 9-33; page 32, lines 24-27) which could be interpreted as a filter and membrane combination with filters that prevent fluid from backing up against membranes. Motivation for adding such a combination is disclosed and addressed above in the rejection of claim 12. Courts have found that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), and in this case duplicating the filter/membrane so that they would create the same benefit would not produce a new and unexpected result, and therefore would be obvious.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck as applied to claim 1 above, and further in view of Brandon (US 2016/0038659).
Regarding claim 14, Beck and Huck disclose the limitations of claim 1 but do not disclose a chemical or substance that indicates: infection, presence of a medical condition that naturally arises in response to a surgical procedure, initial pathology, or additional complications in the fluid collected from the wound site.
Brandon discloses a chemical or substance that indicates infection in fluid collected in a wound drainage container (see par. 35, 38), therefore allowing for early detection of infection and providing an opportunity to address the issue before further complications may arise (see par. 38). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method further include a chemical or substance that indicates infection, as disclosed by Brandon, providing an opportunity to address the issue before further complications may arise.
Claim(s) 15 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck and further in view of Bayon.
Regarding claim 15, Beck discloses a device (see Abstract, Fig. 1) comprising: a pump unit (see Fig. 1) including one or more pumps 4 configured to move fluid at a pre-set measured rate (see Fig. 1, controller 5 via sensors according to set minimum 27 and maximum 29 rotation speeds; col. 3, lines 10-30; col. 6, line 7 – col. 7, line 44); one or more fluid collectors 2 connected to receive and collect the fluid from the pump unit, wherein the one or more fluid collectors comprise: one or more drainage structures 1, 3, 3’ connected to the pump unit and extending to a location proximate to a wound site to draw fluid through the one or more drainage structures from the location proximate to the wound site to remove and transport the fluid from the wound site and into the one or more fluid collectors (see Fig. 1; col. 5, lines 23-41); and wherein the pump unit is configured to create a negative pressure between the one or more pumps and the one or more drainage structures to draw the fluid through the one or more drainage structures and create a positive pressure between the pump unit and one or more fluid collectors to transport the fluid from the wound site into the one or more fluid collectors (see Fig. 1; col. 5, lines 42-50, roller pump by turning creates suction that draws fluid via drain 1 and positive pressure pushes fluid into fluid collector 2); and wherein the fluid collected in the one or more fluid collectors is stored in the one or more fluid collectors (see Fig. 1).
Beck does not disclose and a cap configured to cover each of the one or more collectors; and capped with the cap so that the fluid in the fluid collectors is shippable to be analyzed at a different location than the sample was collected.
Huck discloses a method of analyzing fluid collected form a wound site involves providing a self-contained unit with a fluid collector (see Fig. 1, col. 6, lines 13-20) attached to a drainage structure (see col. 5, lines 36-38 and lines 62-65, wound tubing), collecting the fluid within the fluid collector (see col. 5, lines 62-65), removing the fluid collector from the drainage structure (see col. 6, lines 30-33 and col. 4, lines 31-41); capping the fluid collector with a cap (see col. 6, lines 30-33 and col. 4, lines 31-41); and analyzing the collected fluid once the fluid collector is removed (see col. 6, lines 27-38, fluid sent to pathology lab). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method of Beck further include removing the fluid collector, capping the fluid collector, and analyzing the fluid in the fluid collector as disclosed by Huck in order to test the fluid and predictably determine pathology related information about the fluid, helping to study whether there are any apparent diseases that could be diagnosed to help the patient. Consequently, the fluid collector would include a cap for capping.
Beck and Huck do not disclose one or more sensors located within each of the one or more fluid collectors.
Bayon discloses sensors within a container for drained bodily fluids (see par. 19-20), wherein parameters detected by the sensors are configured for detecting infection (see par. 21, 23). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the fluid collector further include sensors such as those disclosed by Bayon to indicate infection and therefore help monitor a patient for early infection so that the infection could be addressed sooner (see Bayon, par. 3).
Regarding claim 18, Beck, Huck, and Bayon disclose the limitations of claim 15 and as explained above, they disclose the sensor located within the fluid collector is configured to detect infection (see rejection of claim 15 above and Bayon, par. 21, 23).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck and further in view of Bayon as applied to claim 15 above, and further in view of Kantrowitz.
Regarding claim 16, Beck, Huck, and Bayon disclose the limitations of claim 15 but do not disclose providing a container to receive the one or more fluid collectors so that the one or more fluid collectors are shipped while in the container .
Huck discloses transporting the device containing fluids that are tested to a laboratory for testing (see col. 6, lines 33-37). Kantrowitz transporting via shipping and to enclose in a sealed bag to maintain sterility during shipment to a laboratory (see col. 5, lines 14-17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to transport via shipping and enclose in a sealed bag during shipment to a laboratory as disclosed in Kantrowitz in order to transport and protect the device containing fluids during transportation to the laboratory. Consequently, a bag, which is considered a container, configured to be sealed would be provided to receive the fluid collector which contains the fluid to be tested.
Regarding claim 17, Beck, Huck, Bayon, and Kantrowitz disclose the limitations of claim 16 and as Kantrowitz describes only a sealed bag (see col. 5, lines 14-17), this sealed bag is interpreted as a single bag, and therefore singled-bagged container.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck in view of Bayon and further in view of Kantrowitz as applied to claim 16 above, and further in view of Baker.
Regarding claim 19, Beck in view of Huck in view of Bayon in view of Kantrowitz disclose the limitations of claim 16 but do not disclose the one or more fluid collectors include membranes that are air-permeable and liquid-impermeable so that air escapes the one or more fluid collectors.
Baker discloses having a barrier means within an aspirant reservoir to allow gas to pass out of reservoir and contain aspirated/collected fluid (see page 5, lines 9-33; page 32, lines 24-27) comprising membranes that are air-impermeable and liquid-impermeable so that air escapes the one or more fluid collectors (page 5, lines 9-33). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the fluid collector, which is a reservoir, include membranes that are air permeable and liquid-impermeable so that air escapes the fluid collector, as disclosed by Baker, and predictably allowing for collection of fluid inside the reservoir.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Huck in view of Bayon and further in view of Kantrowitz as applied to claim 16 above, and further in view of Hammond et al. (US 2016/0262672).
Regarding claim 20, Beck in view of Huck in view of Bayon in view of Kantrowitz disclose the limitations of claim 16 but do not disclose the one or more fluid collectors include a fluorescent-based assay.
Bayon discloses biomarkers as sensors that are capable of detecting pH (see par. 5, 70) and located in container (see par. 20, 63). Hammond discloses the use of a fluorescent based assay to determine ph of wound exudate visually (see par. 5). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to visually indicate pH of wound exudate via fluorescent based assay as disclosed by Hammond, as Bayon discloses the use of sensors within a container, which would allow for testing pH of exudate, and this would predictably result in visual indication of pH, indicating helpful information of the exudate to help with indicating infection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-5, 8, 10, 12-15, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 10, 13-15, and 17-18 of U.S. Patent No. 11,577,017, hereinafter ‘017, in view of Huck.
Regarding claims 1-5, 8, 10, 12-15, and 18, the claims indicated in the table below of ‘017 disclose all limitations of the current application indicated below except for capping the one or more fluid collectors with a cap and analyzing the collected fluid once the one or more fluid collectors are removed in step “c.”
Huck discloses a method of analyzing fluid collected form a wound site involves providing a self-contained unit with a fluid collector (see Fig. 1, col. 6, lines 13-20) attached to a drainage structure (see col. 5, lines 36-38 and lines 62-65, wound tubing), collecting the fluid within the fluid collector (see col. 5, lines 62-65), removing the fluid collector from the drainage structure (see col. 6, lines 30-33 and col. 4, lines 31-41); capping the fluid collector with a cap (see col. 6, lines 30-33 and col. 4, lines 31-41); and analyzing the collected fluid once the fluid collector is removed (see col. 6, lines 27-38, fluid sent to pathology lab). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method further include removing the fluid collector, capping the fluid collector, and analyzing the fluid in the fluid collector as disclosed by Huck in order to test the fluid and predictably determine pathology related information about the fluid, helping to study whether there are any apparent diseases that could be diagnosed to help the patient.
application claims
1
2
3
4
5
8
‘017 claims
1
2
3
4
1
7
application claims
10
12
13
14
15
18
‘017 claims
10
13
14
15
17
18
Claims 6-7 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘017 in view of Huck and further in view of Kantrowitz.
Regarding claim 6, claim 1 of ’017 and Huck disclose the limitations of claim 1 but do not disclose providing a container to receive the one or more fluid collectors so that the one or more fluid collectors are shipped while in the container.
Huck discloses transporting the device containing fluids that are tested to a laboratory for testing (see col. 6, lines 33-37). Kantrowitz transporting via shipping and to enclose in a sealed bag to maintain sterility during shipment to a laboratory (see col. 5, lines 14-17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to transport via shipping and enclose in a sealed bag during shipment to a laboratory as disclosed in Kantrowitz in order to transport and protect the device containing fluids during transportation to the laboratory.
Regarding claim 7, ‘017, Huck, and Kantrowitz disclose the limitations of claim 6 and as Kantrowitz describes only a sealed bag (see col. 5, lines 14-17), this sealed bag is interpreted as a single bag, and therefore singled-bagged container.
Regarding claim 9, claim 8 of ‘017 disclose the additional limitations required by this claim.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘017 in view of Huck and Kantrowitz as applied to claim 6 above and further in view of Hyde.
Regarding claim 11, ‘017, Huck, and Kantrowitz disclose the limitations of claim 6 but do not disclose a shipping container and shipping information so that the one or more fluid collectors when placed int eh shipping container are shipped to a location on the shipping information.
Hyde discloses providing a shipping container including a delivery label (shipping information) so that items may be placed in the shipping container and shipped to a location on the shipping delivery label for testing (see par. 73). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include such a shipping container and shipping information for testing, as disclosed by Hyde, to predictably result with helping with the transport of the fluid for testing, which would be required for transportation to a lab for analysis (see rejection of claim 1).
Claims 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of ‘017 in view of Huck as applied to claim 15 above and further in view of Kantrowitz.
Regarding claim 16, ‘017 and Huck disclose the limitations of claim 15 but do not disclose providing a container to receive the one or more fluid collectors so that the one or more fluid collectors are shipped while in the container .
Huck discloses transporting the device containing fluids that are tested to a laboratory for testing (see col. 6, lines 33-37). Kantrowitz transporting via shipping and to enclose in a sealed bag to maintain sterility during shipment to a laboratory (see col. 5, lines 14-17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to transport via shipping and enclose in a sealed bag during shipment to a laboratory as disclosed in Kantrowitz in order to transport and protect the device containing fluids during transportation to the laboratory. Consequently, a bag, which is considered a container, configured to be sealed would be provided to receive the fluid collector which contains the fluid to be tested.
Regarding claim 17, ‘017, Huck, and Kantrowitz disclose the limitations of claim 16 and as Kantrowitz describes only a sealed bag (see col. 5, lines 14-17), this sealed bag is interpreted as a single bag, and therefore singled-bagged container.
Claims 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of ‘017 in view of Huck and further in view of Kantrowitz as applied to claim 16 above and further in view of Baker.
Regarding claim 19, ‘017 in view of Huck in view of Kantrowitz disclose the limitations of claim 16 but do not disclose the one or more fluid collectors include membranes that are air-permeable and liquid-impermeable so that air escapes the one or more fluid collectors.
Baker discloses having a barrier means within an aspirant reservoir to allow gas to pass out of reservoir and contain aspirated/collected fluid (see page 5, lines 9-33; page 32, lines 24-27) comprising membranes that are air-impermeable and liquid-impermeable so that air escapes the one or more fluid collectors (page 5, lines 9-33). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the fluid collector, which is a reservoir, include membranes that are air permeable and liquid-impermeable so that air escapes the fluid collector, as disclosed by Baker, and predictably allowing for collection of fluid inside the reservoir.
Claims 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of ‘017 in view of Huck and further in view of Kantrowitz as applied to claim 16 above and further in view of Hammond and Bayon.
Regarding claim 20, ‘017 in view of Huck in view of Kantrowitz disclose the limitations of claim 16 but do not disclose the one or more fluid collectors include a fluorescent-based assay.
Bayon discloses biomarkers as sensors that are capable of detecting pH (see par. 5, 70) and located in container (see par. 20, 63). Hammond discloses the use of a fluorescent based assay to determine ph of wound exudate visually (see par. 5). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to visually indicate pH of wound exudate via fluorescent based assay as disclosed by Hammond, as Bayon discloses the use of sensors within a container, which would allow for testing pH of exudate, and this would predictably result in visual indication of pH, indicating helpful information of the exudate to help with indicating infection.
Conclusion
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/ARIANA ZIMBOUSKI/ Primary Examiner, Art Unit 3781
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