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
Claims 1-4, 6-10, 13-14, and 16-22 are pending and currently under consideration for patentability.
Claims 1, 3, 14, 18, 20 and 22 are amended and
Claim 11 is canceled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/19/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 6-10, 13-14, and 16-22 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.
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1-4, 6, 13-14, 16-19, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Degen (USPGPUB 2018/0056050 A1) in view of Ogle (USPGPUB 2019/0183517 A1) in view of Manouchehr (US 20170021127 A1) in view of Keaney (US 20180043084 A1) in view of Keaney (US 20180043084 A1).
Regarding Claim 1, Degen teaches a hydrocephalus inflow shunt system (abstract), comprising:
an inlet portion having length extending between a first end (proximal region, 113) and a second end (distal region, 112), wherein the inlet portion includes a wall (tube 111) (figure 6) defining a cannula (lumen of 110), the wall having an external wall surface and an internal wall surface, (internal or external wall of 111), and a plurality of first through bores (holes, 115) extending from the external wall surface to the internal wall surface and into the cannula (lumen of 110) (figure 6), wherein each first through bore (115) defines a first internal dimension (figure 6);
an outlet portion extending away from the second end (figure 6);
a filter member (mesh sleeve, 116) configured to extend over at least a portion of the inlet portion and cover the plurality of first through bores (115) (figure 6);
wherein the filter member (116) includes a plurality of second through bores (mesh sleeve) formed through the filter member (paragraph [0049]), wherein the each second through bore (mesh sleeve) defines a second internal dimension less than the first internal dimension (paragraph [0049]) (figure 6).
wherein the plurality of first and second through bores are sized and configured to enable a flow of fluid to flow into the inlet portion in through the plurality of second through bores along the external wall surface and in through the plurality of first through bores to the outlet portion and inhibit solids to pass through the plurality of the second through bores (paragraph 0049).
Degen fails to teach wherein the filter member is formed of polytetrafluoroethylene. Ogle teaches a suction catheter system for fluid removal (abstract) comprising: a tube lines made of polytetrafluorethylene (paragraph 0085). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the filter of Degen to include polytetrafluoroethylene similar to that disclosed by Ogle so that the filter is both lubricious (Ogle, paragraph 0085) and biocompatible (Ogle, paragraph 0106).
Degen and Ogle fail to teach wherein a filter member configured to extend over at least a portion of the inlet portion and cover only some of the plurality of first through bores to provide uncovered first through bores. Manouchehr teaches a cannula having one or more bores (218) in the sidewall to allow passage of a fluid through the sidewall wherein a filter member (213) (Paragraph [0057]: the sheath may have additional holes, and when rotated can filter the fluid through the holes in the coils so that the holes are closed, opened, or partly closed limiting fluid flow (fig. 5))configured to extend over at least a portion of the inlet portion and cover only some of the plurality of first through bores to provide uncovered first through bores (paragraph [0057]) (figure 7). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the filter of Degen to include a filter than can be moved and only cover some holes similar to that disclosed by Manouchehr so that depending on application, some holes would be beneficial to be uncovered so larger items may enter (paragraph [0046]).
Degen and Ogle also fail to teach wherein the plurality of first through bores formed in a plurality of rows spaced apart axially along the inlet portion and wherein the bores are aligned in rows.
Manouchehr teaches the plurality of first through bores formed in a plurality of rows spaced apart axially along the inlet portion and wherein the bores are aligned in rows (paragraph [0039]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the plurality of through bores of Degen so the bores are aligned in rows and spaced apart axially, similar to Manouchehr so the flow of the fluid is easily predicted and controlled (as motivated by Manouchehr, paragraph [0036]).
Degen in view of Ogle and Manouchehr fail to teach wherein the separate filter member includes an elongated member wrapped over the external surface of the wall of the cannula. Keaney teaches a filtering system teach wherein the separate filter member includes an elongated member wrapped over the external surface of the wall of the cannula (paragraph [0070]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the filter member of Degen so that it wraps over the external surface of the wall of the cannula, similar to Keaney, allowing the filter member to be replaced and cleaned.
Regarding Claim 2, Degen in view of Ogle and Manouchehr teaches the system of Claim 1. Degen further teaches a flow regulating portion (duckbill valve) between the inlet (inlet, 162) portion and the outlet portion (outlet, 163) (paragraph 0055) (figure 9).
Regarding Claim 3, Degen in view of Manouchehr, and Ogle teaches the system of Claim 1. Degen teaches a filter member (116). Degen further teaches wherein the separate filter member includes an external wall (116) having an external surface (surface facing away from 111) and an internal surface (surface facing 111)(figure 6) wherein the plurality of second through bores (mesh) extends from the external surface to the internal surface through the filter member (116)- and the fluid flows into the external surface of the internal surface of the filter member (catheter is inflow, paragraph [0042]).
Regarding Claim 4, Degen in view of Ogle, Manouchehr teaches the system of Claim 3. Degen further teaches wherein the plurality of second through bores (mesh) are formed along a length of the filter member (116) (figure 6) (mesh sleeve implies that the bores extend the length).
Regarding Claim 6, Degen in view of Ogle, and Manouchehr teaches the system of Claim 4. However, Degen fails to teach the plurality of second through bores are formed into and through the filter member. Manouchehr teaches a device wherein the plurality of second through bores (8) are formed separately from formation of the filter member (11) (paragraph 0053). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify filter of Degen so bores are produced separate from the filter so that the filter may be placed over the cannula and is a separate element to ease in adjustment.
Regarding Claim 13, Degen in view of Manouchehr, and Ogle teaches the system of Claim 1. Further, Degen discloses a method of limiting ingrowth of material into the hydrocephalus shunt system (paragraph 0001 and paragraph 0017), comprising: assembling the separate filter member (116) onto the inlet portion (figure 6); and preparing the assembly of the filter member (116) and the inlet portion at least partially for implantation into a subject (paragraph 0029).
Regarding Claim 14, Degen teaches a method of limiting ingrowth of material into a hydrocephalus inflow shunt system (paragraph 0042), comprising: configuring a catheter (110) to have:
an inlet portion having length extending between a first end (proximal region, 113) and a second end (distal region, 112), wherein the inlet portion includes a wall (tube 111) (figure 6) defining a cannula (lumen of 110), the wall having an external wall surface and an internal wall surface, (internal or external wall of 111), and a plurality of first through bores (holes, 115) extending from the external wall surface to the internal wall surface and into the cannula (lumen of 110) (figure 6), wherein each first through bore (115) defines a first internal dimension (figure 6); and
an outlet portion (outlet end, 94)(figure 4),
wherein a fluid is operable to flow into the inlet portion through the plurality of first through bores (paragraph 0049) to the outlet portion (paragraph 0045); and
an elongated filter member to cover the plurality of through bores (115) (figure 6),
comprising an elongated filter member (116) includes a plurality of second through bores (mesh sleeve) formed through the elongated filter member, wherein the each second through bore defines a second internal dimension less than the first internal dimension (paragraph 0049).
wherein the plurality of through bores are sized to enable a flow of fluid to flow into the inlet portion through the plurality of second through bores along the external wall surface and through the plurality of first through bores to the outlet portion and inhibit solids to pass through the plurality of the second through bores (paragraph 0049).
comprising a elongated filter member (116) includes a plurality of through bores (115) formed through the elongated filter member, wherein the each second through bore defines a second internal dimension less than the first internal dimension (paragraph 0049).
Degen fails to teach wherein the elongated filter member is formed of a polytetrafluoroethylene. Ogle teaches a suction catheter system for fluid removal (abstract) comprising: a tube lines made of polytetrafluorethylene (paragraph 0085). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the filter of Degen to include polytetrafluoroethylene similar to that disclosed by Ogle so that the filter is both lubricious (Ogle, paragraph 0085) and biocompatible (Ogle, paragraph 0106).
Degen and Ogle fail to teach wherein an elongated filter member configured to extend over at least a portion of the inlet portion and cover only some of the plurality of first through bores to provide uncovered first through bores. Manouchehr teaches a cannula having one or more bores (218) in the sidewall to allow passage of a fluid through the sidewall wherein a filter member (213) (Paragraph [0057]: the sheath may have additional holes, and when rotated can filter the fluid through the holes in the coils so that the holes are closed, opened, or partly closed limiting fluid flow (fig. 5))configured to extend over at least a portion of the inlet portion and cover only some of the plurality of first through bores to provide uncovered first through bores (paragraph [0057]) (figure 7). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the filter of Degen to include a filter than can be moved and only cover some holes similar to that disclosed by Manouchehr so that depending on application, some holes would be beneficial to be uncovered so larger items may enter (paragraph [0046]).
Degen and Ogle also fail to teach wherein the plurality of first through bores formed in a plurality of rows spaced apart axially along the inlet portion and wherein the bores are aligned in rows. Manouchehr the plurality of first through bores formed in a plurality of rows spaced apart axially along the inlet portion and wherein the bores are aligned in rows (paragraph [0039]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the plurality of through bores of Degen so the bores are aligned in rows and spaced apart axially, similar to Manouchehr so the flow of the fluid is easily predicted and controlled (as motivated by Manouchehr, paragraph [0036]).
Degen in view of Ogle and Manouchehr fail to teach wherein the separate filter member includes an elongated member wrapped over the external surface of the wall of the cannula. Keaney teaches a filtering system teach wherein the separate filter member includes an elongated member wrapped over the external surface of the wall of the cannula (paragraph [0070]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the filter member of Degen so that it wraps over the external surface of the wall of the cannula, similar to Keaney, allowing the filter member to be replaced and cleaned.
Regarding Claim 16, Degen in view of Ogle and Manouchehr teaches the system and method of Claim 14. Degen teaches selecting the second internal dimension to allow passage of a fluid into the shunt system and inhibit ingrowth of a tissue (paragraph 0042).
Regarding Claim 17, Degen in view of Manouchehr and Ogle teaches the system and method of Claim 16. Degen teaches, wherein the selected second internal dimension is selected to extend a useful life of the inlet portion (paragraph 0049, reduces clogging).
Regarding Claim 18, Degen in view of Manouchehr, and Ogle teaches the system and method of Claim 14. Degen teaches configuring the assembly of the filter member and the inlet portion for implantation into a subject (paragraph 0029) implanting the shunt system; and allowing the fluid to flow into the shunt system through the first and second through bores. Degen fails to teach allowing the fluid to flow into the shunt system through the first and second through bores
comprising an elongated filter member (116) includes a plurality of through bores (115) formed through the filter member, wherein the each second through bore defines a second internal dimension less than the first internal dimension (paragraph 0049).
wherein the plurality of through bores are sized to enable a flow of fluid to flow into the inlet portion through the plurality of second through bores along the external wall surface and through the plurality of first through bores to the outlet portion and inhibit solids to pass through the plurality of the second through bores (paragraph 0049).
Regarding Claim 19, Degen in view of and Ogle and Manouchehr teaches the method of Claim 18. Degen teaches configuring the catheter to be connected to a flow control system (duckbill valve) (paragraph 055) (figure 9).
Regarding Claim 21, Degen in view of Ogle and Manouchehr teaches the system of Claim 1. The combination further teaches wherein the plurality of first through bores are formed in the plurality of rows spaced along the inlet portion (Degen, figure 8) and at least one of row of the plurality of first through bored is not covered by the filter member to provide the uncovered first through bores (Manouchehr, figures 7-8)(Manouchehr, paragraph [0046]).
Regarding Claim 22, Degen in view of and Ogle and Manouchehr teaches the method of claim 14. The combination further teaches wherein a row of first through bores is not covered by the elongate filter member (51) (figures 7-8)(paragraph [0012][0051].
Claim 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Degen (USPGPUB 2018/0056050 A1) in view of Ogle (USPGPUB 2019/0183517 A1)in view of Manouchehr ( US 20170021127 A1) in view of Keaney (US 20180043084 A1) as applied to claim 1 above, and further view of Olsen (USPGPUB 2005/0245867 A1)
Regarding Claim 7, Degen in view of Ogle and Manouchehr teaches the system of claim 1. Degen teaches wherein the plurality of through bores are sized and configured to enable a flow of fluid to flow into the inlet portion in through the plurality of second through bores along the external wall surface and in through the plurality of first through bores to the outlet portion and inhibit solids to pass through the plurality of the second through bores (paragraph 0049).
Degen fails to teach a fixation portion to fix the filter member to the inlet portion. Olsen teaches catheter system for fluid removal to provide pressure relief (abstract) comprising: a fixation portion (Inlet port, 202) configured to fix the filter member (filter, 220) relative to the inlet portion (Inlet fitting, 212) (figure 3A) (paragraph 0058). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the filter of Degen to include a fixation portion similar to that disclosed by Olsen so that the filter cannot be separated (Olsen, paragraph 0058).
Regarding Claim 9, Degen in view of Manouchehr, Ogle and Olsen teaches the system of claim 7.
Degen fails to teach a fixation portion to fix the filter member to the inlet portion. Olsen teaches a device wherein the fixation portion (202) is a weld formed between the filter member (220) and the inlet portion (212) (paragraph 0058) (Figure 3A). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the filter of Degen to include a fixation portion similar to that disclosed by Olsen so that the filter cannot be separated (Olsen, paragraph 0058).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Degen (USPGPUB 2018/0056050 A1) in view of Manouchehr ( US 20170021127 A1) in view of Olsen (USPGPUB 2005/0245867 A1) in view of Keaney (US 20180043084 A1) in view of Ogle (USPGPUB 2019/0183517 A1), as applied to claim 7 above, in further view of Yang (USPGPUB 2004/0236309 A1).
Regarding Claim 8, Degen in view of Manouchehr, Ogle and Olsen teaches the system of claim 7. Degen, Manouchehr, and Ogle fail to teach wherein the fixation portion is an adhesive applied at a first end and a second end of the separate filter member and the inlet portion-, wherein the adhesive is applied as a band around the inlet portion of the first and second ends.
Yang teaches A catheter is provided for use within the cerebral ventricle (abstract) wherein the fixation portion is an adhesive applied at a first end and a second end of the filter member (mesh filer element, 20) (figure 2) and the inlet portion (paragraph 0020) wherein the adhesive is applied as a band around the inlet portion of the first and second ends (paragraph 0020).Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the filter of Degen to include a fixation portion similar to that disclosed by Yang so that the filter cannot be separated.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Degen (USPGPUB 2018/0056050 A1) in view of Manouchehr ( US 20170021127 A1) in view of Keaney (US 20180043084 A1) in view of Ogle (USPGPUB 2019/0183517 A1) in view of Olsen (USPGPUB 2005/0245867) in view of Yang (USPGPUB 2004/0236309 A1) , as applied to claim 8 above, and further view of Adams (USPGPUB 2009/0277850 A1)
Regarding Claim 10, Degen in view of Manouchehr, Ogle, Olsen and Yang teaches the system of Claim 8. However, Degen and Manouchehr fail to teach wherein the separate filter member is an elongated tube and configured to be slid over the inlet portion, wherein the adhesive is applied to only the first and second ends of the elongated tube to substantially surround the inlet portion at the first and second ends.
Adams teaches a filter (filter, 224) (figure 11) that is configured to slide (paragraph 0074). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the filter of Degen in view of Manouchehr, Olsen and Yang such that filter is slidable similar to that disclosed by Adam so that the filter can be adjusted to the ideal position for use (Adams , paragraph 0074). Degen in view of Manouchehr, Olsen and Yang and Adams discloses the claimed invention except for wherein the adhesive is applied to only the first and second ends of the elongated tube to substantially surround the inlet portion at the first and second ends. It would have been obvious to one having ordinary skill in the art at the time the invention was made to apply the adhesive first and second ends of the elongated tube since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In addition, it would be obvious to add the adhesive only at the two ends so that it is not impacting the exterior filter.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Degen (USPGPUB 2018/0056050 A1) in view of Manouchehr ( US 20170021127 A1) in view of Keaney (US 20180043084 A1) in view of Ogle (USPGPUB 2019/0183517 A1) as applied to claim 1 above, and further view of Qian (CN 113144394 A)
Regarding Claim 11, Degen in view of Manouchehr, and Ogle teaches the system of Claim 1. Both
The combination fails to teach wherein the filter portion includes an elongated member wrapped around the inlet portion. Qian teaches an intracranial parameter detection device (abstract) including a drainage tube wherein the filter portion (shell, 72) (figure 7 and 8) includes an elongated member wrapped around the inlet portion (page 5, paragraph 2). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the filter of Degen in view of Manouchehr such that filter is wrapped around the inlet portion similar to that disclosed by Qian so that the filter can be used to protect the inlet of elongated member (page 5, paragraph 2).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Degen (USPGPUB 2018/0056050 A1) in view of Ogle (USPGPUB 2019/0183517 A1) in view of Manouchehr ( US 20170021127 A1) in view of Keaney (US 20180043084 A1), as applied to claim 14 above, and further view of Mao (WO 2018120873 A1).
Regarding Claim 20, Degen in view of Ogle and Manouchehr teaches the method of Claim 14. However fails to teach forming the plurality of second through bores through the elongated filter member prior to assembling the elongated filter member over the inlet portion. Mao teaches a device and method of a positive- pressure connector comprising: wherein said air pressure balance hole is formed on a side wall of the outer casing (filter membrane, 2), and said filter membrane comprises a head filter membrane disposed on the platform and a filter membrane and a connection port disposed at the head layer a second layer of filter membrane is disposed (second layer is added to the filter member after forming through bores), and the connecting port is provided with an internal thread adapted to the external thread of the positive pressure joint (page 9, paragraph 3) (figures 1-6). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the filter of Degen to include forming second through bores through the filter member prior to assembling the filter member over the inlet portion similar to that disclosed by Mao so that the filter may be aligned based on the hole formation (as motivated by Mao page 9, paragraph 3).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/
Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781