DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Amendments to the claims filed 09/22/2025 have been entered and overcome the previous claim 31 objection. As such, said objection is withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 11-24,27-31 regarding the prior art not teaching a bellows have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Further, the argument that the cited prior art fails to teach a system configured for gravity drainage is moot in view of the amendment regarding the bellows, as the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The argument regarding that the cited prior art fails to teach a method that includes inserting a flexible drainage tube in an ear, nose, or throat, of a patient is nonpersuasive. The examiner notes that per the previous office action, Goff is disclosed to be used for sinuses and nasal passages, thus in operation, Goff would include a step of inserting. Further, the examiner found obvious to modify Goff to have openings along the distal end, and thus Goff in view of Walz reads to the limitation. Regarding Walz only disclosing expelling fluid, as discussed during the interview, while Walz does disclose expelling fluid from the holes, Walz also discloses aspiration, where the catheter holes remain open, so it is interpreted that Walz teaches both expelling and withdrawal of fluid through the holes of the catheter.
Regarding the argument that the cited prior art fails to teach the openings having a length of 2-6mm and a width of 1-4mm, the examiner finds said argument nonpersuasive. Applicant argues that Morris specifically teaches that catheters having a large number of holes can cause problems such as blockages and that the amount of holes in the Goff, Walzman, and Felix rejection would therefore not be able to be modified in view of Morris. The examiner respectfully disagrees. The examiner is using the Morris reference to show that catheter hole sizes in art are known to be suitable when the sizing is between a length of 2-6mm and width of 1-4mm. As Goff teaches that the hole size is variable (per the previously provided rejection), it would therefore have been obvious to modify the size of the holes of Goff to be another suitable size (4.6mm length and 2.03mm width),as taught by Morris. As such the argument that the size of the Morris holes are inseparable from their number and arrangement is nonpersuasive.
The examiner notes that as claim 30 remains unamended, the rejection in view of Felix is upheld. The examiner notes that Felix teaches that the device has fluid flow through gravity and thus reads to the claimed invention, requiring gravity or gravity and suction. Felix further teaches that suction is used, and the examiner’s interpretation of suction flow being provided when the suction source is on, and gravity flow is provided when the suction source is off is maintained. See paragraph 0065 of Felix, in which fluid is taught to flow under gravity to the suction container.
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.
Claim1 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.
Regarding claim 11, the limitation of “wherein the container is formed as a bellows” is unclear. The examiner notes that as seen in figure 4, the device comprises a container (7) that consists of a bellows as the suction component, however the claim, as written reads that the entire container is the bellows, which is not supported by the figures. It is interpreted that the claim limitation reads as wherein the container comprises a bellows, as this is supported by the figures and is included in the claim language of claim 31.
Claims 12-24,29 depend from claim 11 and are thus rejected.
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) 11-13, 17-18,24,28,32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goff et al. US 2007/0060888, hereafter Goff, in view of Walzman, provided in previous office actions, and further in view of Hudspeth et al. US 2009/0292263, hereafter Hudspeth.
Regarding claim 11, Goff discloses
A drainage device configured to drain fluid and/or wound secretion from a cervical or neurological region of a patient (abstract, para. 0009, disclosing various locations the device can be used in including blood clots in arteries/veins, sinuses, nasal passages, and ear canal), the drainage device comprising: a flexible drainage tube (fig. 1, where device can be seen to be bent in various directions and is thus interpreted as flexible) with one or more drainage openings (figure 4, drainage side ports (52), see para. 0036, alternatively, slots (50) seen in figure 3)), insertable into the cervical or neurological region of the patient (para. 0009).
The examiner notes that while the device has to holes located at a distal end, Goff does not disclose wherein the one or more drainage openings are arranged over a length of 15 cm to 25 cm. Goff does disclose that the aspiration port may be modified in a variety of ways to avoid disruption (para. 0011)
Walzman discloses a catheter device for insertion and treatment of brain related issues, including thrombectomy (abstract), and is thus considered analogous to the claimed invention. Per column 27, lines 53-67, the catheter device of Walzman is taught to have holes for fluid travel in the catheter, where the holes may be placed along a length of the catheter ranging from .1 to 60cm, broadly, with various ranges claimed within said overlapping range, including 20-60cm. The examiner notes therefore that as Walzman teaches that various arrangements of holes are used known to be used to treat clot related conditions, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Goff to have the holes extend between 15 to 25cm the length of the catheter, as needed for treatment conditions.
The examiner further notes that as the combination of Goff and Walzman teaches that the device may be varied to ensure proper treatment, and per MPEP Section 2144 IV A In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), 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, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the device with a size of the distal end to be 2:1 with regard to the size of the wound. The examiner notes that as the device is configured to treat various areas of the body (Goff para. 0009) and is disclosed to be modifiable as detailed above, the mere recitation of a size ratio between the device and the wound does not distinguish the instant application from the prior art. Therefore as modifying the device of Goff and Walzman to be within the claimed ratio to wound size, would have no effect on the function, as understood by the examiner, it is interpreted that the prior art reads to the claimed limitation.
The examiner further notes that while Goff discloses a connector (fig. 1, (18)) at the end of the tube, the examiner notes however, that the prior art fails to teach that the connector connects to a container, where the container is configured to gravity drainage, or both vacuum and gravity drainage.
In view of the amendments filed 09/22/2025, the device also fails to teach a bellows.
Hudspeth teaches a wound drainage system (Hudspeth para. 0035), and is thus considered analogous to the claimed invention. Hudspeth teaches that the collection bag may comprises a bellows (abstract), and further teaches that suction through the device can be provided in many forms, including a diaphragm, peristaltic, or bellows type pump (Hudspeth para. 0031). As seen in figure 3, the container comprises outlet port (206b) for connecting to said vacuum source (para. 0036). Therefore, as Hudspeth teaches that a bellows type pump is a suitable suction source for drainage of fluids connected to a container, it would have been obvious to one having ordinary skill in the art to provide a bellows and the suction source of the device of Goff and Walzman. The examiner notes that the combination of art therefore teaches that the container is configured for both suction and gravity drainage, in that, when the bellows is compressed, suction is present, and when the bellows is expanded, no suction and thus gravity drainage is present.
Regarding claim 12, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 11, wherein the drainage device is configured to drain the fluid and/or wound secretion after a surgical procedure in an ear, nose or throat region of the patient (Goff para. 0009), wherein the drainage tube comprises a single drainage opening arranged over a length of 19 cm to 21 cm at the distal end thereof. The examiner notes that as seen in figures 3-6, the distal end of the lumen may be provided with slits or slots to allow fluid to be aspirated when the end of the lumen has been plugged (para. 0036). Per paragraph 0014 of Goff these modifications are disclosed in that “the port modification may comprise modifications of the geometries, shapes, profiles, or other geometrical characteristics of the port. For example, the periphery or lip of the port may have one or more axial slots formed therein. Such slots allow the bypass of infused materials should a larger clot…lodged in the main region. Further per paragraph 0015, the port modification could include one or more side apertures. Therefore as Goff teaches that the drainage device may have a single axial (one or more) slot along the side of the device to aid in drainage, and therefore teaches that the geometry including one slit/aperture is an effective configuration for drainage, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention modify the multi-slit/multi-aperture distal end of Goff (seen in figure 3) to include only a single slot or aperture for aiding in draining fluid. As detailed under the rejection of claim 11, various ranges for the length coverage of the distal holes were found to be obvious based on treatment, including 20 to 60cm. 20cm is within the claimed range. Therefore, the opening would be arranged along a length of 20cm.
Regarding claim 13, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 11, wherein the one or more drainage openings are arranged over a length of 19 cm to 21 cm at the distal end of the drainage tube. As detailed under the rejection of claim 11, various ranges for the length coverage of the distal holes were found to be obvious based on treatment, including 20 to 60cm. 20cm is within the claimed range.
Regarding claim 17, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 11, wherein the drainage tube has multiple drainage openings spaced from each other (Goff fig. 4, where holes (52) or slots (50) are spaced apart).
Regarding claim 18, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 17, wherein a spacing between the respective drainage openings along the length of the drainage tube is constant (Goff Fig. 4).
Regarding claim 24, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 17, wherein the multiple drainage openings are arranged at opposite sides of the drainage tube (per para. 0036, Goff discloses that the slots may be formed around all or a portion of the distal end).
Regarding claim 28, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 11, wherein the container is a vacuum container. The examiner notes that as detailed under the rejection of claim 11, it was found obvious to use a suction container as a collection container, per Hudspeth.
Regarding claim 32, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 11, wherein the container is configured for both vacuum and gravity drainage. The examiner notes that as detailed under the rejection of claim 11, Hudspeth, found obvious to combine with Goff teaches the use of both gravity and vacuum drainage within the container, where the vacuum is provided when the bellows in compressed and no vacuum is provided when the bellows is expanded.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goff in view of Walzman and Felix, previously provided.
Regarding claim 30, Goff discloses
A method of treating a patient, comprising: inserting a flexible drainage tube (para. 0018) with one or more drainage openings (figure 4, drainage side ports (52), see para. 0036, alternatively, slots (50) seen in figure 3)) into an ear, nose, or throat of the patient (para. 0009). The examiner notes that while paragraph 0018 details a method of using the device to aspirating a clot, the examiner notes that per paragraph 0009, Goff teaches that the device can be used in various locations including blood clots in arteries/veins, sinuses, nasal passages, and ear canal. As such it is interpreted that the same method step of inserting the device for treatment would apply to the other areas as well. Goff further discloses wherein the flexible drainage tube (fig. 1, where device can be seen to be bent in various directions and is thus interpreted as flexible is of a drainage device configured to drain fluid and/or wound secretion (para. 0009)
The examiner notes that while the device has to holes located at a distal end, Goff does not disclose wherein the one or more drainage openings are arranged over a length of 15 cm to 25 cm. Goff does disclose that the aspiration port may be modified in a variety of ways to avoid disruption (para. 0011)
Walzman discloses a catheter device for insertion and treatment of brain related issues, including thrombectomy (abstract), and is thus considered analogous to the claimed invention. Per column 27, lines 53-67, the catheter device of Walzman is taught to have holes for fluid travel in the catheter, where the holes may be placed along a length of the catheter ranging from .1 to 60cm, broadly, with various ranges claimed within said overlapping range, including 20-60cm. The examiner notes therefore that as Walzman teaches that various arrangements of holes are used known to be used to treat clot related conditions, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Goff to have the holes extend between 15 to 25cm the length of the catheter, as needed for treatment conditions.
The examiner further notes that as the combination of Goff and Walzman teaches that the device may be varied to ensure proper treatment, and per MPEP Section 2144 IV A In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), 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, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the device with a size of the distal end to be 2:1 with regard to the size of the wound. The examiner notes that as the device is configured to treat various areas of the body (Goff para. 0009) and is disclosed to be modifiable as detailed above, the mere recitation of a size ratio between the device and the wound does not distinguish the instant application from the prior art. Therefore as modifying the device of Goff and Walzman to be within the claimed ratio to wound size, would have no effect on the function, as understood by the examiner, it is interpreted that the prior art reads to the claimed limitation
The examiner further notes that while Goff discloses a connector (fig. 1, (18)) at the end of the tube, the examiner notes however, that the prior art fails to teach that the connector connects to a container, where the container is configured to gravity drainage, or both vacuum and gravity drainage.
Felix teaches a fluid management system for negative pressure treatment and is thus considered analogous to the claimed invention. Felix teaches that the device, uses suction to remove fluid from a treatment site (para. 0008). Felix teaches that said fluid is removed through the conduit (fig. 7-10) through outlet tube (214) to a suction source (para. 0065) where the suction source is a suitable suction container (para. 0065). Per para. 0065, the fluid flow may exist under both gravity and suction through the suction source. Therefore, as Felix teaches that suction sources in the form of suction cannisters that may provide either gravitational drainage (suction not activated), or suction (actuated suction source) are common in the art (see para. 0040, where commercial products are described, and therefore interpreted to be known in the art), it would have been obvious to one having ordinary skill in the art to provide a suction cannister as the suction source of Goff as a means to collect aspirated fluid as well as allow for the switching between gravitational and actuated suction to aid in treatment. Therefore as the method includes draining fluid from the patient, and the fluid, upon obviousness combination with Felix is drained into a container, it is interpreted that the method further includes the fluid/wound secretion being drained via gravity and vacuum to the container.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goff in view of Walzman and Felix, previously provided, and further in view of Hudspeth.
Regarding claim 35, Goff, Walzman, and Felix teach
The method of claim 30, but fails to teach wherein the fluid and/or wound secretion drain from the wound to a container, wherein the container comprises a bellows that creates a vacuum in a folded state and creates no vacuum in an unfolded state.
Hudspeth teaches a wound drainage system (Hudspeth para. 0035), and is thus considered analogous to the claimed invention. Hudspeth teaches that the collection bag may comprises a bellows (abstract), and further teaches that suction through the device can be provided in many forms, including a diaphragm, peristaltic, or bellows type pump (Hudspeth para. 0031). As seen in figure 3, the container comprises outlet port (206b) for connecting to said vacuum source (para. 0036). Therefore, as Hudspeth teaches that a bellows type pump is a suitable suction source for drainage of fluids connected to a container, it would have been obvious to one having ordinary skill in the art to provide a bellows and the suction source of the device of Goff and Walzman. The examiner notes that the combination of art therefore teaches that the container is configured for both suction and gravity drainage, in that, when the bellows is compressed, suction is present, and when the bellows is expanded, no suction and thus gravity drainage is present.
Claim(s) 14-15, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of Walzman and Hudspeth, and further in view of Kersten, provided in previous office actions.
Regarding claim 14 and 15, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 11, but fails to specifically disclose wherein the drainage tube has an outer diameter of 3 mm to 8 mm (per claim 14) and an inner diameter of 1mm to 6mm (per claim 15).
Kersten teaches an aspiration device and is thus considered analogous to the claimed invention. Kersten teaches that for aspiration device, suitable dimensions can be readily selected based on anatomical dimensions (para. 0079), wherein such dimensions include the length of the body and the inner and outer diameter (Kersten para. 0080, where the outer diameter is disclosed to be 6mm or less and the inner diameter is disclosed to be 2mm or more). Further, per MPEP Section 2144 IV A In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), 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, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the device with a size of the distal end to be 2:1 with regard to the size of the wound. Therefore, as Kersten teaches that aspiration devices may require dimensional changes depending on anatomical dimensions of treatment sites, Goff teaches (para. 0009) that the device can be used in various anatomical locations, and relative dimensions of a device would not have the device of Goff perform differently (changing the diameter of Goff would not have an inherent functional change so long as the device still allows fluid to flow through) it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the outer diameter of the aspiration device of Goff to be 6mm or less and the inner diameter of Goff to be 2mm or more.
Regarding claim 29, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 11, wherein the distal end of the drainage tube is at least one of atraumatic and rounded (Goff figs 3-6, where the end can be seen to be rounded). However, should applicant disagree with this interpretation, the examiner provides a rejection in view of Kersten.
Kersten teaches an aspiration device and is thus considered analogous to the claimed invention. Kersten teaches that the aspiration device comprises a rounded end, (fig. 1b,3, where the end is rounded). Therefore, as Kersten teaches that such aspiration catheters are known in the art to have a rounded end, it would have been obvious to one having ordinary skill in the art to modify the end of Goff to be rounded, as such shapes are common in the art.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goff in view of Walzman and Hudspeth, and further in view of Janardhan et al CN 105228688, hereafter Janardhan, provided in the previous office action.
Regarding claim 16, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 11, however fails to disclose wherein the drainage tube has a length of 30 cm to 100 cm.
Janardhan teaches a method of vasculature treatment using catheters and is thus considered analogous to the claimed invention. Janardhan teaches that depending on the type of treatment used for treating a thrombus or other vascular condition, catheters may come in different sizes, ranging from 40-150cm. Wherein specifically, neural vascular catheters may range from 80-150cm (para. 0254). Therefore it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the device of Goff with a catheter having a length of 45-150cm as catheters in vascular treatment require variations in sizes due to their uses. Said range overlaps with the claimed range and thus reads to the claimed limitation.
Claim(s) 19,21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goff in view of Walzman and Hudspeth, and further in view of Burkett US 2016/0067456, hereafter Burkett, provided in the previous office action.
Regarding claim 19, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 17, but fails to teach wherein a spacing between the respective drainage openings along the length of the drainage tube is irregular.
Burkett teaches a intravascular catheter device (abstract, para. 0007) and is thus considered analogous to the claimed invention. Burkett teaches that the catheter device comprises a plurality of openings that are configured in a pattern (para. 0038) to ensure proper function of the device. Said pattern may have the holes equally spaced apart, or a pattern wherein the openings are irregularly spaced may be used (para. 0039). Burkett teaches that the pattern may be any pattern choice so long as the device comes to an adequate resolution. Therefore as Burkett teaches that various patterns are used for openings on intravascular catheters, so long as desired treatment occurs, where said patterns included both regularly and irregularly spaced holes, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the holes of Goff in an irregularly shaped pattern, as taught by Burkett. The examiner also notes that per MPEP section 2144.04 Section IV. B, changes in shape rationale can be used to support an obviousness rationale per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The examiner notes that as Burkett teaches both regular and irregular spacing are known to be used in the art, and the claimed invention lacks criticality to the spacing (as the spacing may be either regular or irregular), the claim is found to be obvious, as detailed above under the same rejection.
Regarding claim 21, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 17, but fail to specifically teach wherein a spacing between the drainage openings decreases in a direction of the distal end of the drainage tube.
Burkett teaches a intravascular catheter device (abstract, para. 0007) and is thus considered analogous to the claimed invention. Burkett teaches that the catheter device comprises a plurality of openings that are configured in a pattern (para. 0038) to ensure proper function of the device. Said pattern may have the holes equally spaced apart in various patterns, or a pattern wherein the openings are irregularly spaced may be used (para. 0039). Burkett teaches that the pattern may be any pattern choice so long as the device comes to an adequate resolution. Therefore as Burkett teaches that various patterns are used for openings on intravascular catheters, so long as desired treatment occurs, where said patterns included both regularly and irregularly spaced holes, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the holes of Goff in a decreasing distance pattern. The examiner also notes that per MPEP section 2144.04 Section IV. B, changes in shape rationale can be used to support an obviousness rationale per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The examiner notes that as Burkett teaches both regular and irregular spacing are known to be used in the art, and the claimed invention lacks criticality to the spacing (as the spacing may be either regular or irregular), the claim is found to be obvious, as detailed above under the same rejection.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goff in view of Walzman and Hudspeth, and further in view of Hurt US 2011/0282264, hereafter Hurt, provided in the IDS, and in the previous office action.
Regarding claim 20, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 17, but fail to specifically teach wherein a size of the drainage openings increases in a direction of the distal end of the drainage tube. Goff does teach that the shape may be variable (see Goff figures 3-5).
Hurt teaches a drainage catheter and is thus considered analogous to the claimed invention. Hurt teaches that as a means to control fluid flow (para. 0050) inlet holes have a smaller cross sectional area than the ones preceding it (para. 0047-0050, see also figure 3). It is therefore interpreted that the size of the drainage openings increases toward a distal end as seen in figure 3 of Hurt. Therefore as a means to control fluid flow into the catheter, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the holes of Goff to increase in size distally.
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goff in view of Walzman and Hudspeth, and further in view of Morris et. al US 2010/0152706, hereafter Morris, provided in the previous office action.
Regarding claim 22, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 17. As seen in figure 3 and 4, the holes of Goff may be provided in configurations comprising shapes and lengths and may be modified (para. 0011). However, the prior art fails to teach wherein the multiple drainage openings each have a length of 2 mm to 6 mm.
Morris teaches a suction catheter and is thus considered analogous to the claimed invention. Morris teaches that the catheter comprises openings (24) for drainage (para. 0039), where said openings are oval in shape (para.0039) and comprise variable width and lengths. Per paragraph 0042, the opening may desirably have a length of .18 inches, or 4.6mm. Therefore as Morris teaches that openings for drainage on catheters may be oval in shape and have variable lengths, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the holes of Goff with a length of .18inches as Morris teaches said length as desirable within a greater range of lengths. The examiner also notes that per MPEP section 2144.04 Section IV. B, changes in shape rationale can be used to support an obviousness rationale per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The examiner notes that as Morris teaches various ranges for lengths known to be used in the art, the claim is found to be obvious, as detailed above under the same rejection.
Regarding claim 23, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 17. As seen in figure 3 and 4, the holes of Goff may be provided in configurations comprising various shapes and lengths and may be modified (para. 0011). However the prior art fails to teach wherein the multiple drainage openings each have a width of 1 mm to 4 mm.
Morris teaches a suction catheter and is thus considered analogous to the claimed invention. Morris teaches that the catheter comprises openings (24) for drainage (para. 0039), where said openings are oval in shape (para.0039) and comprise variable width and lengths. Per paragraph 0041, the opening may desirably have a width of .08 inches, or 2.03mm. Therefore as Morris teaches that openings for drainage on catheters may be oval in shape and have variable widths, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the holes of Goff with a width of .08 inches as Morris teaches said length as desirable within a greater range of widths. The examiner also notes that per MPEP section 2144.04 Section IV. B, changes in shape rationale can be used to support an obviousness rationale per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The examiner notes that as Morris teaches various ranges for lengths known to be used in the art, the claim is found to be obvious, as detailed above under the same rejection.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goff in view of Walzman and Hudspeth, and further in view of Yoo US 2008/0183156.
Regarding claim 27, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 11, but fail to specifically disclose wherein the container is a bag.
Yoo teaches a suction drainage apparatus and is thus considered analogous to the claimed invention. Yoo teaches that the device uses suction to drain blood or other fluids (para. 0008), where said drained matter is collected in a drainage collection container, such as a suction bag (para. 0028). Additionally, Yoo teaches that the container is not limited to a bag and may any suitable structure so long as it can create negative pressure. Therefore as the combination of art previously applied teaches a suction container configured to drain fluids through the device, and Yoo teaches that suction bags are suitable containers for drainage fluids through suction, it would have been obvious to one having ordinary skill in the art to use a bag as the suction container of Goff, Walzman and Hudspeth, as it is known in the art the suction bags may serve as suitable suction containers as long as they can create a negative pressure, as taught by Yoo.
Claim(s) 31,33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goff in view of Walzman and Hudspeth, and further in view of Morris.
Regarding claim 31, Goff discloses
A drainage device configured to drain fluid and/or wound secretion from a patient (abstract, para. 0009, disclosing various locations the device can be used in including blood clots in arteries/veins, sinuses, nasal passages, and ear canal) , the drainage device comprising: a flexible drainage tube (fig. 1, where device can be seen to be bent in various directions and is thus interpreted as flexible) configured for insertion into an ear, nose, or throat of the patient (para. 0009) with one or more drainage openings with one or more drainage openings (figure 4, drainage side ports (52), see para. 0036, alternatively, slots (50) seen in figure 3)), and wherein the one or more drainage openings are arranged over a length of 15 cm to 25 cm at a distal end of the drainage tube (column 27, lines 53-67, where the holes may be placed along a length of the catheter ranging from .1 to 60cm, thus overlapping the claimed range).
The examiner notes that while the device has to holes located at a distal end, Goff does not disclose wherein the one or more drainage openings are arranged over a length of 15 cm to 25 cm. Goff does disclose that the aspiration port may be modified in a variety of ways to avoid disruption (para. 0011)
Walzman discloses a catheter device for insertion and treatment of brain related issues, including thrombectomy (abstract), and is thus considered analogous to the claimed invention. Per column 27, lines 53-67, the catheter device of Walzman is taught to have holes for fluid travel in the catheter, where the holes may be placed along a length of the catheter ranging from .1 to 60cm, broadly, with various ranges claimed within said overlapping range, including 20-60cm. The examiner notes therefore that as Walzman teaches that various arrangements of holes are used known to be used to treat clot related conditions, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Goff to have the holes extend between 15 to 25cm the length of the catheter, as needed for treatment conditions.
The examiner further notes that while Goff discloses a connector (fig. 1, (18)) at the end of the tube, the examiner notes however, that the prior art fails to teach that the connector connects to a container, where the container is configured to gravity drainage, or both vacuum and gravity drainage.
In view of the amendments filed 09/22/2025, the device also fails to teach a bellows.
Hudspeth teaches a wound drainage system (Hudspeth para. 0035), and is thus considered analogous to the claimed invention. Hudspeth teaches that the collection bag may comprises a bellows (abstract), and further teaches that suction through the device can be provided in many forms, including a diaphragm, peristaltic, or bellows type pump (Hudspeth para. 0031). As seen in figure 3, the container comprises outlet port (206b) for connecting to said vacuum source (para. 0036). Therefore, as Hudspeth teaches that a bellows type pump is a suitable suction source for drainage of fluids connected to a container, it would have been obvious to one having ordinary skill in the art to provide a bellows and the suction source of the device of Goff and Walzman. The examiner notes that the combination of art therefore teaches that the container is configured for both suction and gravity drainage, in that, when the bellows is compressed, suction is present, and when the bellows is expanded, no suction and thus gravity drainage is present.
Goff further fails to teach where in the drainage openings have a length of 2-6mm and a width of 1-4mm. As seen in figure 3 and 4, the holes of Goff may be provided in configurations comprising various shapes and lengths and may be modified (para. 0011).
Morris teaches a suction catheter and is thus considered analogous to the claimed invention. Morris teaches that the catheter comprises openings (24) for drainage (para. 0039), where said openings are oval in shape (para.0039) and comprise variable width and lengths. Per paragraph 0042, the opening may desirably have a length of .18 inches, or 4.6mm. Therefore as Morris teaches that openings for drainage on catheters may be oval in shape and have variable lengths, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the holes of Goff with a length of .18inches as Morris teaches said length as desirable within a greater range of lengths. The examiner also notes that per MPEP section 2144.04 Section IV. B, changes in shape rationale can be used to support an obviousness rationale per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The examiner notes that as Morris teaches various ranges for lengths known to be used in the art, the claim is found to be obvious, as detailed above under the same rejection.
The examiner notes that while Goff is disclosed to be able to be positioned in various locations, it is not expressly disclosed that the device is configured to be positioned adjacent a wound from a surgical invention. However, the examiner notes that per the MPEP section 2114 section II “[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Goff teaches the same structural limitations (See claim 31 rejection) and is insertable into various areas on a patient’s body including blood vessels, ear, nose, bowel, colon, urethra, etc. (para. 0009) the device would also reasonably be able to be inserted adjacent a wound from surgical intervention to drain fluid.
Regarding claim 33, Goff, Walzman, Hudspeth and Morris teach
The drainage device according to claim 31, wherein the container is configured for both vacuum and gravity drainage. The examiner notes that as detailed under the rejection of claim 31, Hudspeth, found obvious to combine with Goff teaches the use of both gravity and vacuum drainage within the container, where the vacuum is provided when the bellows in compressed and no vacuum is provided when the bellows is expanded.
Regarding claim 34, Goff, Walzman, and Hudspeth teach
The drainage device according to claim 31, wherein the drainage tube comprises a single drainage opening arranged over a length of 19 cm to 21 cm at the distal end thereof. The drainage device according to claim 11, wherein the drainage device is configured to drain the fluid and/or wound secretion after a surgical procedure in an ear, nose or throat region of the patient (Goff para. 0009), wherein the drainage tube comprises a single drainage opening arranged over a length of 19 cm to 21 cm at the distal end thereof. The examiner notes that as seen in figures 3-6, the distal end of the lumen may be provided with slits or slots to allow fluid to be aspirated when the end of the lumen has been plugged (para. 0036). Per paragraph 0014 of Goff these modifications are disclosed in that “the port modification may comprise modifications of the geometries, shapes, profiles, or other geometrical characteristics of the port. For example, the periphery or lip of the port may have one or more axial slots formed therein. Such slots allow the bypass of infused materials should a larger clot…lodged in the main region. Further per paragraph 0015, the port modification could include one or more side apertures. Therefore as Goff teaches that the drainage device may have a single axial (one or more) slot along the side of the device to aid in drainage, and therefore teaches that the geometry including one slit/aperture is an effective configuration for drainage, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention modify the multi-slit/multi-aperture distal end of Goff (seen in figure 3) to include only a single slot or aperture for aiding in draining fluid. As detailed under the rejection of claim 11, various ranges for the length coverage of the distal holes were found to be obvious based on treatment, including 20 to 60cm. 20cm is within the claimed range. Therefore, the opening would be arranged along a length of 20cm.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wilson et al. US 2012/0078159, disclosing a drainage device with an elongated slit.
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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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781 /ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781