DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
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.
Claims 1-8, 11-20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Braga et al. US 2019/0001030 A1 (hereinafter Braga).
Regarding claim 1, Braga discloses a liquid collection cannister 242 (Fig. 3 collection canister 242) comprising:
a first end 243 (Fig. 3 – left wall 243) and a second end 244 (Fig. 3 – right wall 244) connected by a body wall W+250 (see annotated Fig. below – canister interface 250 and body wall W) forming a cannister 242 (Fig. 3) for receiving fluid during use (Abstract – “a collection canister… operable to receive fluid”),
the body wall W+250 (see annotated Fig. 3 below) having one inlet 254 (Fig. 3 - inlet port 254) to be coupled with one or more aspiration tubing 230 (Fig. 2 – extension assembly 230, and Par. 86 – “Inlet port 254 receives exudate from the wound “w” through… extension assembly 230”),
at least one of the first end 243 (Fig. 3) or second end 244 (Fig. 3) having hydrophobic filters 262 (Fig. 3 – a pair of filters 262, and Par. 87 – “Filter 262 may be a hydrophobic… filter”) coupled to a vacuum inlet 252 (Fig. 3 – suction port 252, and Par. 88 – “air through suction port 252… to be drawn up passageways 264 from chamber 260 through filters 262”), the hydrophobic filters 262 (Fig. 3) configured to retain liquid in the cannister 242 (Fig. 3) and allow gas to be removed from the cannister 242 (Fig. 3) during use (Par. 88 – “Filters 262 prevent exudate from entering passageway 264 while allowing air to pass through”).
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Annotated Fig. 3 of Braga
However, Braga does not currently disclose at least one of the first end or second end having at least two hydrophobic filters.
Braga, in another embodiment, teaches at least one of the first end 543 (Fig. 5A-5B – left wall 543) or second end 544 (Fig. 5A – right wall 544) having at least two hydrophobic filters 572 (Fig. 5B – filter 572, and Par. 91 – “As shown in FIG. 5B, canister 542 has a left wall 543 with four filters generally shown as 572 located substantially at the comers of the left wall 543. Each filter 572 may have one or more filters that may be hydrophobic… Although FIG. 5B depicts the left wall having four filters, right wall 544 also has similar filters at its corners.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Braga to further include at least two hydrophobic filters in at least the first end or second end of the cannister, also as taught by Braga, in order to provide a cannister that can maintain a negative or reduced pressure when the cannister is tipped, tilted or inverted (Par. 91 of Braga) because the filters won’t all be covered by exudate (Par. 91 of Braga). One of ordinary skill in the art would also have been motivated to make the modification as Braga teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 2, Braga suggests the invention of claim 1. Braga further discloses wherein the first end 243 (Fig. 3) and second end 244 (Fig. 3) has at least one hydrophobic filters 262 (Fig. 3) coupled to a vacuum inlet 252 (Fig. 3-4 – filters 262 coupled to the suction port 252 via channels 256).
Regarding claim 3, Braga suggests the invention of claim 1. However, Braga does not currently disclose wherein the cannister is a cylinder.
Braga, in another embodiment, teaches wherein the cannister 602 (Fig. 6) is a cylinder (Fig. 6, and Par. 92 – “The base of canister assembly 600 may be circular”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cannister of Braga to be cylinder, also as taught by Braga, as Braga teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 4, Braga suggests the invention of claim 3. Braga further discloses wherein the cylinder 602 (Fig. 6) has a length and a radius (Fig. 6; Examiner contends that a cylinder inherently has a length and radius).
However, Braga does not disclose a length of 10 cm to 100 cm and a radius of 2 cm to 50 cm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the length and radius of the cannis to be of 10-100cm and 2-50cm respectively, in order to fit the particular procedure being done since this claimed dimension of the cylinder does not change the cannister ability to container liquid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 12 of Applicant’s PG-PUB), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 5, Braga suggests the invention of claim 1. Braga further discloses wherein the first end 243 (Fig. 3) comprises at least two hydrophobic filters 572 (Fig. 5A-5B, after modification as established in claim 1).
Regarding claim 6, Braga suggests the invention of claim 5. Braga further discloses wherein the at least two hydrophobic filters 572 (Fig. 5A-5B, after modification as established in claim 1) are positioned on opposite sides (Fig. 5B) of the first end 243 (Fig. 3 after modification by Fig. 5B; Par. 91 – “As shown in FIG. 5B, canister 542 has a left wall 543 with four filters generally shown as 572 located substantially at the comers of the left wall 543).
Regarding claim 7, Braga suggests the invention of claim 1. Braga further discloses wherein the second end 244 (Fig. 3) comprises at least two hydrophobic filters 572 (Fig. 5A-5B, after modification as established in claim 1).
Regarding claim 8, Braga suggests the invention of claim 7. Braga further discloses wherein the at least two hydrophobic filters 572 (Fig. 5A-5B, after modification as established in claim 1) are positioned on opposite sides (Fig. 5B) of the second end 244 (Fig. 3 after modification by Fig. 5B; Par. 91 – “Although FIG. 5B depicts the left wall having four filters, right wall 544 also has similar filters at its corners).
Regarding claim 11, Braga suggests the invention of claim 1. Braga further dislcoses wherein the hydrophobic filters 262 (Fig. 3) are three-dimensional hollow filter (Examiner notes that any physical object is three-dimensional, and Par. 85 – “the air in the passageway is drawn from the collection canister through the filter, the air in the collection canister is drawn through the inlet port”, which indicates that there are opening and gaps within the filter for passage of air).
Regarding claim 12, Braga suggests the invention of claim 1. Braga further discloses wherein the hydrophobic filters 262 (Fig. 4) are three-dimensional hollow filters (Examiner notes that any physical object is three-dimensional, and Par. 85 – “the air in the passageway is drawn from the collection canister through the filter, the air in the collection canister is drawn through the inlet port”, which indicates that there are opening and gaps within the filter for passage of air) that project from the first end 243 (Fig. 3) and the second end 244 (Fig. 3) into the cannister 242 (Fig. 3 – each filter 242 projects inwardly and toward the center of the cannister 242) and are operably coupled to the vacuum source 400 (Fig. 4).
Regarding claim 13, Braga suggests the invention of claim 1. Braga further discloses further comprising an aspiration tube 230 (Fig. 2) coupled to the inlet 254 (Fig. 3).
Regarding claim 14, Braga suggests the invention of claim 13. Braga further discloses further comprising a suction tip 220 (Fig. 2 – port assembly 220) coupled to the aspiration tube 230 (Fig. 2).
Regarding claim 15, Braga suggests the invention of claim 1. Braga further discloses an apparatus 240 (Fig. 2 – cannister assembly 240) for aspirating an airway of a patient (Fig. 2 – cannister assembly 240 with extension assembly 230 are capable of aspirate airways of patient given the negative pressure suction provided), the apparatus 240 (Fig. 2) comprising the liquid collection cannister 242 (Fig. 2-3) of claim 1 (see rejection of claim 1 above) operably coupled to a pump portion 400 (Fig. 4 – suction pump 400).
Regarding claim 16, Braga suggests the invention of claim 15. Braga further discloses wherein the pump portion 400 (Fig. 4) comprises a controller portion 246 (Fig. 10 – control unit 246), a vacuum source 1360 (Fig. 10 – suction pump 1360), and an optional power source (Examiner interprets this limitation as optional) configured to provide a vacuum to the liquid collection cannister 242 (Fig. 3) during use (Par. 75 – “define a vacuum chamber… to maintain negative pressure”).
Regarding claim 17, Braga suggests the invention of claim 16. Braga further discloses wherein the vacuum source 1360 (Fig. 10) is a diaphragm pump (Par. 99 – “Suction pump 1360 may be… a diaphragm pump”).
Regarding claim 18, Braga suggests the invention of claim 16. However, Braga does not disclose wherein the vacuum source is configured to generate a vacuum pressure of at least 400 to 550 mmHg.
Braga, in another embodiment, teaches wherein the vacuum source is configured to generate a vacuum pressure of at least 20 to 500 mmHg (Par. 136 – “Vacuum source or pump 3052 may be a miniature pump or micropump that may be biocompatible and adapted to maintain or draw adequate and therapeutic vacuum levels. The vacuum level of subatmospheric pressure achieved may be in the range of about 20 mmHg to about 500 mmHg”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vacuum pressure of Braga’s device from 20 to 500 mmHg to 400 to 550 mmHg, as applicant appears to have placed no criticality on the claimed range (Par. 15 of Applicant’s PG-PUB) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Braga would not operate differently with the claimed range since Braga’s working range overlaps with the claimed range.
Regarding claim 19, Braga suggests the invention of claim 15. Braga further discloses where the liquid collection cannister 242 (Fig. 3) has a storage volume (Examiner contends that a cannister inherently has a volume).
However, Braga does not currently disclose a storage volume of at least 0.2 L to 10 L.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the volume of Braga’s cannister to be of at least 0.2L to 10L, in order to fit the particular procedure being done since this claimed dimension of the cannister does not change the cannister ability to container liquid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 15 of Applicant’s PG-PUB), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 20, Braga suggests the invention of claim 15. Braga further discloses further comprising a suction tip 220 (Fig. 2 – port assembly 220) attachment operably coupled to the inlet 254 (Fig. 2-3) of the liquid collection cannister 242 (Fig. 2-3, and Par. 86 – “Inlet port 254 receives exudate from the wound “w” through the wound port assembly 220”).
Regarding claim 22, Braga suggests the invention of claim 15. Braga further discloses wherein the apparatus 240 (Fig. 2) has an overall dimension (Examiner contends that the apparatus inherently has dimensions).
However, Braga does not disclose an overall dimension of 3 cm to 100 cm x 5 cm to 50 cm x 5 cm to 50 cm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the overall dimension of Braga’s cannister assembly to be of 3 cm to 100 cm x 5 cm to 50 cm x 5 cm to 50 cm, in order to fit the particular procedure being done since this claimed dimension of the cannister does not change the cannister ability to container liquid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 50 of Applicant’s PG-PUB), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 23, Braga suggests the invention of claim 15. Braga further discloses wherein the apparatus 240 (Fig. 2) has an overall weight (Examiner contends that the cannister assembly inherently has a weight).
However, Braga does not disclose an overall weight of 0.25 kg to 10 kg.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the overall weight of Braga’s cannister assembly to be of 0.25 kg to 10 kg, in order to fit the particular procedure being done since this claimed size/dimension of the cannister does not change the cannister ability to container liquid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 50 of Applicant’s PG-PUB), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Braga as applied to claim 1 above, and further in view of Johnson, III et al. US 6,093,230 A (hereinafter Johnson).
Regarding claim 9, Braga suggests the invention of claim 1. However, Brag does not disclose wherein the hydrophobic filters are paper filters.
Johnson, in the same field of endeavor of filters for medical suction canisters (Col. 1, line 8-10), teaches wherein the hydrophobic filter 46 (Fig. 4 – filter 46) are paper filter (Col. 4, line 44-60 – “The aerosol trap 46 (FIG. 4) preferably includes a first filter… The first filter is preferably a paper material...)”.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the filters of Braga to be paper filters as taught by Johnson, in order to provide an efficient trap of microorganisms and particulates (Col. 4, line 60-64 of Johnson). One of ordinary skill in the art also would have had the technological capability to recognize that paper filters are bio-degradable, thus helping with environmental waste.
Regarding claim 10, Braga suggests the invention of claim 1. However, Braga does not currently disclose wherein the hydrophobic filters comprise a paper filter on a mesh support.
Johnson, in the same field of endeavor of filters for medical suction canisters (Col. 1, line 8-10), teaches wherein the hydrophobic filters comprise a paper filter (Col. 4, line 44-60 – “The aerosol trap 46 (FIG. 4) preferably includes a first filter… The first filter is preferably a paper material…”) on a mesh support (Col. 1, line 57-60 – “The aerosol trap is a combination of two discs of filter material positioned on each side of a polyethylene web or grid”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the filters of Braga to be paper filters as taught by Johnson, in order to provide an efficient trap of microorganisms and particulates (Col. 1, line 61-62 of Johnson, and Col. 4, line 60-64 of Johnson).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Braga as applied to claim 1 above, and further in view of Lipsky et al. US 4,490,138 A (hereinafter Lipsky).
Regarding claim 21, Braga suggests the invention of claim 20. However, Braga does not disclose wherein the suction tip includes a filter for trapping debris.
Lipsky, in the same field of endeavor of pharyngeal suction devices (Abstract), teaches wherein the suction tip 40 (Fig. 6 – sleeve 40) includes a filter 50+52+54 (Fig. 5-6 – members 50, 52, 54) for trapping debris (Col. 5, line 12-15 – “Almost all material which is small enough to pass through the suction device will pass through the passages, but larger material, which could clog the device, will not”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the suction tip of Braga to further include a filter as taught by Lipsky, in order to prevent larger material from passing and clogging the device (Col. 5, line 12-15 of Lipsky).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Reinboth US 20180050135 A1
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/QUYNH DAO LE/Examiner, Art Unit 3781 /JESSICA ARBLE/Primary Examiner, Art Unit 3781