DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This Office Action is in response to the amendment filed on 04/08/2026. As directed by the amendment, claim 19 was cancelled, claim 16 was amended, and claim 21 has been added. Thus, claims 1-18, 20, and 21 are currently pending in this application.
Response to Arguments
Applicant's arguments filed 04/08/2026 have been fully considered but they are not persuasive.
On pages 9-10, applicant argues that the filter of Weaver does not an integrated filter having a proximal filter diameter and a distal filter diameter wherein the proximal filter diameter is greater than the distal filter diameter and the second diameter, but instead teaches the opposite configuration. However, examiner would like to emphasize that “proximal” and “distal” are relative terms, since one end of the filter could be proximal or distal depending on what the filter is proximal towards. The claim only recites proximal and distal with respect to the filter itself, which allows for the assembly 460 of Weaver to still read on this limitation. Therefore, examiner maintains the rejection.
On pages 10-11, applicant argues that Anukhin does not teach a coating to trap particulates as air flows through the integrated filter. Examiner respectfully disagrees with this argument. Anukhin teaches in page 9 paragraph 1 "Various beneficial agents may be applied to the filter material or the body 111 of the filter 100 to facilitate lysing of particulates and/or to facilitate a reduction in body lumen growth around the filter 100 while in place for long periods of time". The coating taught by Anukhin reasonably traps particulates since lysing of the particulates requires trapping the particulates before they are broken down. Therefore, examiner maintains the rejection.
On pages 11-13, applicant argues that a POSITA would have no motivation to combine the prior art references. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one skilled in the art would have necessary motivation to reasonably make the modifications described below. To address the specific example provided by the applicant on page 13 of the response, one would be motivated to modify Walvekar with the helical device of Kilbride because this helical shape of Kilbride can help better distribute the flow more evenly through the filter because of the channels created by the helical shape, as cited in the previous office action. In response to applicant's argument that all the prior art cited are 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, all the devices of the prior art relate to filtering a bodily fluid or liquid, which makes it reasonable for one skilled in the art to combine their specific teachings.
On page 13, applicant argues that the prior art does not teach the amended claim 16. The prior rejection has been modified to address the amendments as described below, and to address the modified understanding of claims 17-18 which are dependent on the amended claim 16.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 17 and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 17 limits that the integrated helical filter is positioned in the tapered segment, but claim 16 already has a narrower scope wherein the filter is position partially in the distal segment and tapered segment. Therefore, claim 17 does not further limit claim 16. Examiner suggests cancelling claim 17.
Claim 18 limits that the filter is positioned in at least one of the proximal segment or the distal segment. However, claim 16 has a narrower scope than claim 16 as claims 16 limits the frustoconical portion positioned in the tapered segment and a cylindrical portion positioned in the distal segment. Therefore, claim 18 does not further limit claim 16. Examiner suggests cancelling the second part of claim 18 that reads “and the integrated helical filter is positioned in at least one of the proximal segment or the distal segment”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Walvekar (WO 2021236941 A1) in view of Stephenson (US 20120247477 A1) and Weaver (US 20160220777 A1).
Regarding claim 1, Walvekar teaches a tracheal tube inner cannula comprising: a proximal segment (Fig. 4 where head 216 is analogous to a proximal segment) comprising: a proximal opening; and a proximal inner lumen having a first diameter (Fig. 4 where 221 is an opening on the head 216; paragraph 0083 “In one embodiment, the head 216 comprise a cross-sectional diameter of about 15 mm”); a distal segment comprising: a distal opening (Fig. 4 where the body 210 is analogous to a distal segment with a bottom opening); and an inner distal lumen having a second diameter that is smaller than the first diameter (paragraph 0087 “In one embodiment, the cross sectional diameter of the body 210 of the internal cannula is about 6.5 mm”).
Walvekar is silent on a tapered segment attached to the proximal segment and the distal segment, the tapered segment comprising: a tapered lumen having a proximal diameter that is substantially the same as the first diameter and a distal diameter that is substantially the same as the second diameter.
However, Stephenson teaches a tapered segment attached to the proximal and distal segments with a tapered lumen having a proximal diameter that is substantially the same as the first diameter and a distal diameter that is substantially the same as the second diameter (Fig. 2; paragraph 0022 "The cannula itself has a proximal end 58 which forms a tapered upper section 60 configured to fit against the inner surface of the connector body as described below. A lower tapered section 62 also contacts and interfaces with the inner surface of the connector body to retain the cannula in place within the connector").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar to include a tapered segment with the tapered diameters. The tapered segment creates a more secure connection between the proximal and distal segments or other connections (paragraph 0022 “A lower tapered section 62 also contacts and interfaces with the inner surface of the connector body to retain the cannula in place within the connector”).
Walvekar is silent on an integrated filter having a proximal filter diameter and a distal filter diameter, wherein the proximal filter diameter is greater than the distal filter diameter and the second diameter.
However, Weaver teaches an integrated filter with a proximal diameter greater than the distal diameter (Fig. 12 where filter assembly 460 is integrated within the cannula and has a proximal filter diameter larger than the distal filter diameter and second diameter 454).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar to include an integrated filter with proximal and distal diameters in a tapered shape. The filter can remove unwanted particles within the cannula and improve the air quality within the cannula (paragraph 0083 “The hydrophobic filter element 462 is such that it prevents saliva and mucus from being drawn into the channel, such as channel 454, and/or otherwise blocking or impeding the desired flow of sample gas”).
Regarding claim 2, modified Walvekar teaches the cannula of claim 1.
Modified Walvekar is silent wherein the integrated filter is permanently affixed to a tube wall of the tapered lumen.
However, Weaver teaches an integrated filter permanently affixed to a tube wall of the tapered lumen (claim 6 “The oral cannula of claim 3 wherein the cap includes a body and a funnel that is housed within the body, and the filter housing is mounted to the funnel”; paragraph 0056 “Body 16 may be integrally formed with the tubing, or body 16 may be a unitary (that is, stand-alone) piece that has openings into which oxygen supply tubing 76 and ETCO2 sampling tubing 86 fit and are attached”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar to permanently affix the filter to the tube wall. The affixation of the filter allows the filter to remain stationary within the cannula and maintain its orientation.
Regarding claim 3, Walvekar teaches wherein the first diameter is at least 1.5 times greater than the second diameter (paragraph 0084 " In alternate embodiments, the head 216 comprise a diameter of less than about 5 mm. The head 216 can comprise a diameter of greater than 15 mm. In embodiments, the diameter of the head 216 ranges from about 5 mm to about 25 mm"; paragraph 0087 "In alternate embodiments, the body 210 comprise a diameter of less than about 1 mm. The body 210 can comprise a diameter of greater than 6.5 mm. In embodiments, the diameter of the body 210 ranges from about 1 mm to about 15 mm").
Claim 4-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Walvekar (WO 2021236941 A1) in view of Stephenson (US 20120247477 A1) and Weaver (US 20160220777 A1) as applied to claim 1 and in further view of Kilbride (WO 2017027754 A1).
Regarding claim 4, modified Walvekar teaches the cannula of claim 1.
Modified Walvekar is silent wherein the integrated filter is a helical filter including a ramped filtering surface that wraps around a central axis.
However, Kilbride teaches a helical filter with a ramped filtering surface that wraps around a central axis (Fig. 20c; paragraph 0037 “FIGS.20A-20C illustrate solid cylindrical filtration devices having an opening at a distal planar end and another opening at the proximal planar end connected via a channel. The outer walls of the devices include a plurality of indentations that traverse from the distal planar end to the proximal planar end along a helical path”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar to include a helical filter with a ramped filtering surface that wraps around a central axis. The particular shape of the filter allows for defined channels for flow through the filter (paragraph 0052 “In certain embodiments, the outer wall of the filtration device may include indentations that allow for blood to traverse through an area between the outer wall of the filtration device and inner wall of the blood vessel. The indentations may be placed uniformly, for example, separated by a defined distance. The indentations may extend between the distal end and the proximal end of the filtration device in a straight line or a curved line”).
Regarding claim 5, modified Walvekar teaches the cannula of claim 4.
Kilbride further teaches wherein the helical filter included at least one spiral turn (Fig. 20c shows multiple spiral turns).
Regarding claim 8, modified Walvekar teaches the cannula of claim 1.
Modified Walvekar is silent wherein the integrated filter further comprises: a distal cylindrical portion that extends into the distal inner lumen, the distal cylindrical portion having a substantially constant diameter; and a frustoconical portion positioned proximally from the distal cylindrical portion.
However, Kilbride teaches a filter with a distal cylindrical portion that extends into the distal inner lumen with a substantially constant diameter and a frustoconical portion positioned proximally from the cylindrical portion (paragraph 0063 "Figs.1A-1B illustrate a filtration device that include a solid cylindrical member comprising a tapered edge (a frustoconical leading edge)"; Fig. 1A shows the cylindrical portion has a constant diameter).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar include a filter with a distal cylindrical portion that extends into the distal inner lumen with a substantially constant diameter and a frustoconical portion positioned proximally from the cylindrical portion. The frustoconical shape better facilitates flow both through and around the filter (paragraph 0063 “Figs. 1A-1B illustrate a filtration device that include a solid cylindrical member comprising a tapered edge (a frustoconical leading edge) opposite a planar edge; paragraph 0070 “As is evident from the various filtration devices described herein, the filtration devices have a configuration to facilitate blood flow through and/or around the filtration device maximizing the surface area which is exposed to blood while minimizing the amount of resistance to the flow of blood”).
Claim 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Walvekar (WO 2021236941 A1) in view of Stephenson (US 20120247477 A1), Weaver (US 20160220777 A1), and Kilbride (WO 2017027754 A1) as applied to claim 4 and in further view of Zhu (CN 110681017 A).
Regarding claim 6, modified Walvekar teaches the cannula of claim 4.
Modified Walvekar is silent on further comprising a membrane filter positioned distally from the helical filter.
However, Zhu teaches a membrane filter positioned distally from the helical filter (page 6 paragraph 6 “As shown in FIG. 5, preferably, the pipe 102 away from the base 101 of one end is provided with a first filter screen 107; one end of pipe 102 connected with the base 101 is provided with a second filter screen 108. a first filter screen 107 and the second screen 108”; The filters 107 and 108 could be membrane filters and they are each positioned distally and proximally from each other).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar include a membrane filter positioned distally from a helical filter. The additional filter allows for additional removal of foreign particles and reduce the harm of these particles to a patient’s health (page 6 paragraph 6 “it can achieve the function of filtrating the pipe, the pipe 102 in the passage to prevent foreign particles from the tube device 10 into the patient lumen, harm to patient health”).
Regarding claim 7, modified Walvekar teaches the cannula of claim 4.
Modified Walvekar is silent on further comprising a membrane filter positioned proximally from the helical filter.
However, Zhu teaches a membrane filter positioned proximally from the helical filter (page 6 paragraph 6 “As shown in FIG. 5, preferably, the pipe 102 away from the base 101 of one end is provided with a first filter screen 107; one end of pipe 102 connected with the base 101 is provided with a second filter screen 108. a first filter screen 107 and the second screen 108”; The filters 107 and 108 could be membrane filters and they are each positioned distally and proximally from each other).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar include a membrane filter positioned proximally from a helical filter. The additional filter allows for additional removal of foreign particles and reduce the harm of these particles to a patient’s health (page 6 paragraph 6 “it can achieve the function of filtrating the pipe, the pipe 102 in the passage to prevent foreign particles from the tube device 10 into the patient lumen, harm to patient health”).
Claims 9-10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Walvekar (WO 2021236941 A1) in view of Stephenson (US 20120247477 A1), Weaver (US 20160220777 A1), Kilbride (WO 2017027754 A1), and Anukhin (WO 2010077966 A1).
Regarding claim 9, Walvekar teaches a tracheal tube inner cannula comprising: a proximal segment (Fig. 4 where head 216 is analogous to a proximal segment); a distal segment (Fig. 4 where the body 210 is analogous to a distal segment).
Walvekar is silent on a tapered segment attached to the proximal segment and the distal segment, the tapered segment comprising: a tapered lumen.
However, Stephenson teaches a tapered segment attached to the proximal and distal segments with a tapered lumen (Fig. 2; paragraph 0022 "The cannula itself has a proximal end 58 which forms a tapered upper section 60 configured to fit against the inner surface of the connector body as described below. A lower tapered section 62 also contacts and interfaces with the inner surface of the connector body to retain the cannula in place within the connector").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar to include a tapered segment. The tapered segment creates a more secure connection between the proximal and distal segments or other connections (paragraph 0022 “A lower tapered section 62 also contacts and interfaces with the inner surface of the connector body to retain the cannula in place within the connector”).
Walvekar is silent on an integrated filter having a proximal filter diameter and a distal filter diameter, wherein the proximal filter diameter is greater than the distal filter diameter.
However, Weaver teaches an integrated filter with a proximal diameter greater than the distal diameter (Fig. 12 where filter assembly 460 is integrated within the cannula and has a proximal diameter at the top that is larger than the distal diameter at the bottom and larger than a distal segment diameter 454; claim 6 “The oral cannula of claim 3 wherein the cap includes a body and a funnel that is housed within the body, and the filter housing is mounted to the funnel” where the filter being mounted to the funnel is analogous to being integrated).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar to include an integrated filter with proximal and distal diameters in a tapered shape. The filter can remove unwanted particles within the cannula and improve the air quality within the cannula (paragraph 0083 “The hydrophobic filter element 462 is such that it prevents saliva and mucus from being drawn into the channel, such as channel 454, and/or otherwise blocking or impeding the desired flow of sample gas”).
Walvekar is silent on the integrated filter being a helical filter and the integrated helical filter having a ramped surface that wraps around a central axis at an angle such that the ramped surface extends distally through the integrated helical filter.
However, Kilbride teaches a helical filter with a ramped filtering surface that wraps around a central axis such that the ramped surface extended distally throughout the filter (Fig. 20c; paragraph 0037 “FIGS.20A-20C illustrate solid cylindrical filtration devices having an opening at a distal planar end and another opening at the proximal planar end connected via a channel. The outer walls of the devices include a plurality of indentations that traverse from the distal planar end to the proximal planar end along a helical path”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar to include a helical filter with a ramped filtering surface that wraps around a central axis that extends distally. The particular shape of the filter allows for defined channels for flow through the filter (paragraph 0052 “In certain embodiments, the outer wall of the filtration device may include indentations that allow for blood to traverse through an area between the outer wall of the filtration device and inner wall of the blood vessel. The indentations may be placed uniformly, for example, separated by a defined distance. The indentations may extend between the distal end and the proximal end of the filtration device in a straight line or a curved line”).
Walvekar is silent on the ramped surface including a coating to trap particulates as air flows through the integrated helical filter.
However, Anukhin teaches a coating to help trap particulates through the filter (page 9 paragraph 1 "Various beneficial agents may be applied to the filter material or the body 111 of the filter 100 to facilitate lysing of particulates and/or to facilitate a reduction in body lumen growth around the filter 100 while in place for long periods of time").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar to include a coating on the ramped surface to trap particulates. The coating promotes further removal of particulates, especially if the tube is in use for an extended period of time (page 9 paragraph 1 "Various beneficial agents may be applied to the filter material or the body 111 of the filter 100 to facilitate lysing of particulates and/or to facilitate a reduction in body lumen growth around the filter 100 while in place for long periods of time").
Regarding claim 10, modified Walvekar teaches the cannula of claim 9.
Walvekar further teaches the proximal segment includes a proximal inner lumen having a first diameter (paragraph 0083 “In one embodiment, the head 216 comprise a cross-sectional diameter of about 15 mm”); the distal segment includes an inner distal lumen having a second diameter that is smaller than the first diameter (paragraph 0087 “In one embodiment, the cross sectional diameter of the body 210 of the internal cannula is about 6.5 mm”).
Stephenson further teaches wherein the tapered segment has a proximal diameter that is substantially the same as the first diameter and a distal diameter that is substantially the same as the second diameter (paragraph 0022 "The cannula itself has a proximal end 58 which forms a tapered upper section 60 configured to fit against the inner surface of the connector body as described below. A lower tapered section 62 also contacts and interfaces with the inner surface of the connector body to retain the cannula in place within the connector”).
Regarding claim 15, modified Walvekar teaches the cannula of claim 9.
Weaver further teaches wherein an outer surface of the filter contacts an interior surface (paragraph 0086 “filter assembly 460 is located on cap insert 440 such that circular flange 466 is in contact with a proximal rim of cap insert distal body 442, an outboard surface of filter skirt 468 is in contact with or within the inboard surface of distal portion 442 of insert body 440, and an outboard surface of insert channel 454 is in contact with or within an inboard surface of filter skirt 468”).
Modified Walvekar is silent wherein the surface is conical of the helical filter and the filter contacts the interior surface of the tapered segment.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar so that the outer conical surface of the helical filter contacts an interior surface of the tapered segment. It would have been obvious to have placed the helical filter of modified Walvekar in the tapered segment as they have a similar shape and would therefore fit together in a way that spans the entire cross section of the tube while still filtering in a position preceding the distal inner lumen. The filter can still achieve its intended purpose to remove unwanted particles within the cannula and improve the air quality within the cannula.
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Walvekar (WO 2021236941 A1) in view of Stephenson (US 20120247477 A1), Weaver (US 20160220777 A1), Kilbride (WO 2017027754 A1), and Anukhin (WO 2010077966 A1) as applied to claim 9 and in further view of Zhu (CN 110681017 A).
Regarding claim 11, modified Walvekar teaches the cannula of claim 9.
Modified Walvekar is silent on further comprising a membrane filter positioned in the proximal segment.
However, Zhu teaches a membrane filter positioned proximally (page 6 paragraph 6 “As shown in FIG. 5, preferably, the pipe 102 away from the base 101 of one end is provided with a first filter screen 107; one end of pipe 102 connected with the base 101 is provided with a second filter screen 108. a first filter screen 107 and the second screen 108”; The filters 107 and 108 could be membrane filters and they are each positioned distally and proximally from each other).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar include a membrane filter positioned proximally. The additional filter allows for additional removal of foreign particles and reduce the harm of these particles to a patient’s health (page 6 paragraph 6 “it can achieve the function of filtrating the pipe, the pipe 102 in the passage to prevent foreign particles from the tube device 10 into the patient lumen, harm to patient health”).
Regarding claim 13, modified Walvekar teaches the cannula of claim 9.
Modified Walvekar is silent on further comprising a membrane filter positioned in the distal segment.
However, Zhu teaches a membrane filter positioned distally (page 6 paragraph 6 “As shown in FIG. 5, preferably, the pipe 102 away from the base 101 of one end is provided with a first filter screen 107; one end of pipe 102 connected with the base 101 is provided with a second filter screen 108. a first filter screen 107 and the second screen 108”; The filters 107 and 108 could be membrane filters and they are each positioned distally and proximally from each other).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar include a membrane filter positioned distally. The additional filter allows for additional removal of foreign particles and reduce the harm of these particles to a patient’s health (page 6 paragraph 6 “it can achieve the function of filtrating the pipe, the pipe 102 in the passage to prevent foreign particles from the tube device 10 into the patient lumen, harm to patient health”).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Walvekar (WO 2021236941 A1) in view of Stephenson (US 20120247477 A1), Tupper (US 20240216637 A1), and Kilbride (WO 2017027754 A1).
Regarding claim 16, Walvekar teaches a tracheal tube assembly having an outer cannula and an inner cannula configured to be inserted into the outer cannula (paragraph 0070 “The outer cannula further comprises a lumen [more clearly seen at 321 of Figure 5], which is configured to receive and hold at least a portion of the inner cannula body 210”), the inner cannula comprising: a proximal segment (Fig. 4 where head 216 is analogous to a proximal segment) comprising: a proximal opening; and a proximal inner lumen having a first diameter (Fig. 4 where 221 is an opening on the head 216; paragraph 0083 “In one embodiment, the head 216 comprise a cross-sectional diameter of about 15 mm”); a distal segment comprising: a distal opening (Fig. 4 where the body 210 is analogous to a distal segment with a bottom opening); and an inner distal lumen having a second diameter that is smaller than the first diameter (paragraph 0087 “In one embodiment, the cross sectional diameter of the body 210 of the internal cannula is about 6.5 mm”).
Walvekar is silent on a tapered segment attached to the proximal segment and the distal segment, the tapered segment comprising: a tapered lumen having a proximal diameter that is substantially the same as the first diameter and a distal diameter that is substantially the same as the second diameter.
However, Stephenson teaches a tapered segment attached to the proximal and distal segments with a tapered lumen having a proximal diameter that is substantially the same as the first diameter and a distal diameter that is substantially the same as the second diameter (Fig. 2; paragraph 0022 "The cannula itself has a proximal end 58 which forms a tapered upper section 60 configured to fit against the inner surface of the connector body as described below. A lower tapered section 62 also contacts and interfaces with the inner surface of the connector body to retain the cannula in place within the connector").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar to include a tapered segment with the tapered diameters. The tapered segment creates a more secure connection between the proximal and distal segments or other connections (paragraph 0022 “A lower tapered section 62 also contacts and interfaces with the inner surface of the connector body to retain the cannula in place within the connector”).
Walvekar is silent on an integrated filter.
However, Tupper teaches an analogous tracheal tube assembly with (Fig. 2) an integrated filter (Fig. 2; paragraph 0019 “The HME element 23 could include a filter, such as in the enlarged machine end portion 34”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar to include an integrated filter. The filter allows for improved quality of the inspired air before reaching a user (paragraph 0020 “When the patient inhales air is drawn in through the HME element 23, through the HME device 2 and connector 13 and into the bore of the tracheostomy tube 1”).
Walvekar is silent on the integrated filter being a helical filter positioned at least partially in the distal segment and the tapered segment, and the integrated helical filter having a ramped surface that wraps around a central axis at an angle such that the ramped surface extends distally through the integrated helical filter, wherein the integrated helical filter includes a frustoconical portion, positioned in the tapered segment, and a distal cylindrical portion positioned in the distal segment.
However, Kilbride teaches a helical filter with a ramped filtering surface that wraps around a central axis such that the ramped surface extended distally throughout the filter (Fig. 20c; paragraph 0037 “FIGS.20A-20C illustrate solid cylindrical filtration devices having an opening at a distal planar end and another opening at the proximal planar end connected via a channel. The outer walls of the devices include a plurality of indentations that traverse from the distal planar end to the proximal planar end along a helical path”) and a filter with a frustoconical portion and distal cylindrical portion (paragraph 0063 "Figs.1A-1B illustrate a filtration device that include a solid cylindrical member comprising a tapered edge (a frustoconical leading edge)"; Fig. 1A shows the cylindrical and frustoconical portions). Kilbride further suggests combining aspects of different filters to have a combination of aspects within a single device (paragraph 0053 “It is understood that certain aspects from the different embodiments of the filtration devices may be combined to provide a device that includes a combination of the aspects in a single device”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar to include a helical filter with a ramped filtering surface that wraps around a central axis that extends distally. The particular shape of the filter allows for defined channels for flow through the filter (paragraph 0052 “In certain embodiments, the outer wall of the filtration device may include indentations that allow for blood to traverse through an area between the outer wall of the filtration device and inner wall of the blood vessel. The indentations may be placed uniformly, for example, separated by a defined distance. The indentations may extend between the distal end and the proximal end of the filtration device in a straight line or a curved line”). It would have also been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar include a filter with a frustoconical portion and distal cylindrical portion. The frustoconical shape better facilitates flow both through and around the filter (paragraph 0063 “Figs. 1A-1B illustrate a filtration device that include a solid cylindrical member comprising a tapered edge (a frustoconical leading edge) opposite a planar edge; paragraph 0070 “As is evident from the various filtration devices described herein, the filtration devices have a configuration to facilitate blood flow through and/or around the filtration device maximizing the surface area which is exposed to blood while minimizing the amount of resistance to the flow of blood”). Therefore, it would be reasonable for one skilled in the art to combine both of these aspects into one filter, as suggested by Kilbride, to incorporate both of the advantages of the filter aspects. It would have been obvious to position the frustoconical portion in the tapered segment and cylindrical portion in the distal segment as the frustoconical shape is designed to fit in a similarly shaped segment and the cylindrical portion must therefore be positioned distally from frustoconical portion based on the shape of the filter. The filter would only fit in the cannula if the frustoconical portion is positioned in the tapered segment and the cylindrical portion is positioned in the distal segment, which also reasonably means the filter is positioned at least partially in the distal segment and the tapered segment.
Regarding claim 17, modified Walvekar teaches the assembly of claim 16.
Modified Walvekar does not specifically teach wherein the integrated helical filter is positioned in the tapered segment.
However, It would have been obvious to position the frustoconical portion in the tapered segment and cylindrical portion in the distal segment as the frustoconical shape is designed to fit in a similarly shaped segment and the cylindrical portion must therefore be positioned distally from frustoconical portion based on the shape of the filter, as described above. The filter would only fit in the cannula if the frustoconical portion is positioned in the tapered segment and the cylindrical portion is positioned in the distal segment, which also reasonably means the integrated helical filter is positioned in the tapered segment.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Walvekar (WO 2021236941 A1) in view of Stephenson (US 20120247477 A1), Tupper (US 20240216637 A1), and Kilbride (WO 2017027754 A1) as applied to claim 16 and in further view of Weaver (US 20160220777 A1).
Regarding claim 18, modified Walvekar teaches the assembly of claim 16.
Tupper further teaches wherein the filter is positioned in at least one of the proximal segment or the distal segment (Fig. 2 shows where 34 is positioned in an area analogous to a proximal segment; paragraph 0019 “The HME element 23 could include a filter, such as in the enlarged machine end portion 34”).
Modified Walvekar is silent on wherein the integrated helical filter has a diameter that is greater than the second diameter, and the integrated helical filter is positioned in at least one of the proximal segment or the distal segment.
However, Weaver teaches an integrated filter with a diameter greater than a distal diameter (Fig. 12 where filter assembly 460 is integrated within the cannula and has a distal diameter at the bottom and larger than a distal segment diameter 454).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar to include an integrated filter with a diameter greater than a second diameter in a distal segment. The larger diameter in the filter can occupy more airflow and thereby filter more air before narrowing the flow into a smaller diameter, creating an efficient airflow path.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Walvekar (WO 2021236941 A1) in view of Stephenson (US 20120247477 A1), Tupper (US 20240216637 A1), and Kilbride (WO 2017027754 A1) as applied to claim 16 and in further view of Anukhin (WO 2010077966 A1).
Regarding claim 20, modified Walvekar teaches the assembly of claim 16.
Modified Walvekar is silent wherein the ramped surface of the integrated helical filter includes a coating that traps particulates of air flowing through the integrated helical filter.
However, Anukhin teaches a coating to help trap particulates through the filter (page 9 paragraph 1 "Various beneficial agents may be applied to the filter material or the body 111 of the filter 100 to facilitate lysing of particulates and/or to facilitate a reduction in body lumen growth around the filter 100 while in place for long periods of time").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Walvekar to include a coating on the ramped surface to trap particulates. The coating promotes further removal of particulates, especially if the tube is in use for an extended period of time (page 9 paragraph 1 "Various beneficial agents may be applied to the filter material or the body 111 of the filter 100 to facilitate lysing of particulates and/or to facilitate a reduction in body lumen growth around the filter 100 while in place for long periods of time").
Allowable Subject Matter
Claims 12, 14, and 21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 12 and 14, the closest prior art of record is Zhu (CN 110681017 A) and Haley (US 20100152765 A1).
The prior art does not specifically teach where a membrane filter is configured to filter a size of particulates greater than or less than a second size of particulates filtered by the helical filter. While the prior art does show these filters being positioned appropriately from each other as mentioned above, there is no mention about these filters configured for different sized particulates relative to each other.
Regarding claim 21, the closest prior art of record is Kilbride (WO 2017027754 A1) which teaches a helical filter in Fig. 20A-20C.
The prior art does not specifically teach a band of adhesive bonded to interior walls of the inner distal lumen of a cannula. It would not be obvious for one skilled in the art to make this modification, and the prior does not suggest any combinations to render such a modification reasonable. Therefore, the subject matter of claim 21 is considered allowable.
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.
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/AKHIL A JAYAN/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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