DETAILED ACTION
This office action is in response to the communication received June 10, 2025.
The amendments of claims 51, 54, 62, and 67 as well as the cancellations of claims 53, 66, and 71 are acknowledged.
The IDS filed June 10, 2025 is acknowledged.
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
The previous 35 USC 112(b) rejections are withdrawn in response to amendments to claim 51.
Response to Arguments
Applicant’s arguments that the drawings show each feature are persuasive and as agreed during the May 28th, 2025 telephone interview, the previous drawing objections are withdrawn.
Applicant’s arguments with respect to claim(s) 51, 62, and 68 as well as their dependents 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. New prior art Najafi et al. (US 2012/0022507) has been included in the rejections below to address the most recent amendments to the claims.
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) 51-52, 55-58, and 68-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan et al. (US 2011/0306916) in view of Keren (US 2018/0280667) and further in view of Najafi et al. (US 2012/0022507) and further in view of Reich et al. (US 2002/0183628).
Regarding claim 51, Nitzan discloses a system for shunting blood between a left atrium and a right atrium of a patient (see Fig. 6B, Abstract), the system comprising: a shunting element comprising one or more structural elements (see Figs. 5A-6A; par. 91-92), wherein, when the system is implanted across a septal wall of the patient, the structural elements are configured to extend across the septal wall of the patient and stabilize the shunting element relative to the septal wall (see par. 90, 92); a biocompatible membrane at least partially covering the one or more structural elements with the membrane having an outer portion layer and an inner portion layer (see Fig. 6B; par. 67, 70, tissue outer structure and inner polymer cover and par. 122-123), the biocompatible membrane defining a lumen through the shunting element that, when the system is implanted across the septal wall, fluidly connects the left atrium and the right atrium (see par. 57, 123).
Nitzan does not disclose a pressure sensor, wherein the pressure sensor is configured to measure at least one of left atrial pressure or right atrial pressure.
Keren discloses an interatrial shunt placed between two chambers of the heart within the interatrial septum, between the right atrium and left atrium (see Fig. 1), the shunt comprising one or more pressure sensors used to measure the pressure in the subject’s right atrium and/or left atrium used to monitor progression of the treatment and ascertain the point in time at which the shunt may be removed from the patient, with one pressure sensor disposed on the proximal portion of the shunt and pressure another on the distal portion, such that the pressure in both the left atrium and the right atrium is measured. Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add a sensor to the proximal portion of the shunt and the distal portion of the shunt, which would cause one to be in the right atrium and one in the left atrium such that pressure in both the left atrium and the right atrium is measured, as disclosed by Keren, to monitor progression of the treatment and ascertain the point in time at which the shunt may be removed from the patient.
Nitzan and Keren do not disclose the biocompatible membrane is configured to form an enclosed chamber between a portion of the biocompatible membrane and a portion of the septal wall with the pressure sensor positioned within the enclosed membrane.
Reich discloses an implantable apparatus providing a blood flow lumen across a vessel with a sensor for measuring blood pressure within the lumen, the sensor disposed between two layers 20, 22 of a biocompatible covering creating an enclosed chamber (see Figs. 2-4; par. 10). This positioning causes the sensor to be trapped in the device itself and therefore it cannot be liberated inside the patient during use (see par. 28). It would have been obvious to a person having ordinary skill in the art before an effective filing date of the claimed invention to have placed each left atrial and right atrial sensor of Nitzan and Keren between the two layers of biocompatible material making up the biocompatible membrane, therefore each being within an enclosed chamber, as Reich discloses such positioning and this would deter the sensors from being liberated inside the patient during use.
Nitzan, Keren, and Reich do not disclose the enclosed chamber between a portion of the biocompatible membrane and a portion of the septal wall.
Najafi discloses an implant placed at a septal wall between the left and right atrium, the implant having two pressure sensors for measuring pressure in the right and left atriums, one sensor placed at the end of the implant in the right atrium and one at the end of the implant in the left atrium (see par. 36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the pressure sensor measuring the pressure in the left atrium to be located at the end portion of the left side of the implant and the other sensor measuring the pressure in the right atrium to be located at the end portion of the right side of the implant, as disclosed by Najafi, in order to measure the left and right atrium pressures. Consequently, while Nitzan, Keren, and Reich disclose having an enclosed chamber with pressure sensor able to measure the left atrium pressure and an enclosed chamber with pressure sensor able to measure the right atrium pressure, they do not disclose the positioning of such chambers and teaches of Najafi provides such positioning. Furthermore, due to the diabolo shape of the shunting element of Nitzan, the ends of the implants with the enclosed chambers would cause the enclosed chambers to be between a portion of the biocompatible membrane that creates the chamber and portion of the septal wall (see Nitzan, Fig. 4A with half diabolo shape on right side of septum wall 18 for idea of configuration, as an enclosed chamber would be created near the end of frame 24 on the right side of the septum wall – embodiment of Fig. 6A-6B would have whole diabolo shape so outward cone on both sides of the septal wall when actually positioned within the body).
Regarding claim 52, Nitzan, Keren, Reich, and Najafi disclose the system of claim 51 and Nitzan discloses the biocompatible membrane includes an outer membrane portion and an inner membrane portion (see Fig. 6B; par. 67, 70, tissue outer structure and inner polymer cover and par. 122-123), and the resulting system of Nitzan, Keren, Najafi, and Reich has the pressure sensor positioned between the outer membrane portion and the inner membrane portion (see rejection of claim 51 above).
Regarding claim 55, Nitzan, Keren, Najafi, and Reich discloses the system of claim 51, and Nitzan discloses the biocompatible membrane is at least partially flexible (see Fig. 6B; par. 36, 70, 123, pericardium or PTFE/ePTFE shown would be flexible, and would have to be flexible to allow for opening of valve).
Regarding claim 56, Nitzan, Keren, Najafi, and Reich discloses the system of claim 51, and Nitzan discloses the biocompatible membrane is impermeable (see Fig. 6B and par. 36, PTFE is well known to be impermeable to fluids).
Regarding claim 57, Nitzan, Keren, Najafi, and Reich discloses the system of claim 51, and Nitzan discloses the biocompatible membrane is composed of ePTFE, polyester, polyurethane, and/or silicone (see par. 67, see par. 122).
Regarding claim 58, Nitzan, Keren, Najafi, and Reich discloses the system of claim 51, and the resulting system of Nitzan, Keren, Najafi, and Reich includes the pressure sensor is a first pressure sensor configured to measure a left atrial pressure, and wherein the system further comprises a second pressure sensor configured to measure a right atrial pressure, and further wherein the second pressure sensor is positioned within the biocompatible membrane (see rejection of claim 51 with left atrial pressure sensor and right atrial pressure sensor).
Regarding claim 68, Nitzan discloses implantable system for shunting blood between a left atrium and a right atrium of a patient (see Fig. 6B, Abstract), the system comprising: a frame configured to extend between the left atrium and the right atrium of the patient when the system is implanted across a septal wall of the patient (see Figs. 5A-5D; par. 91-92); a biocompatible membrane coupled to the frame with the membrane having an outer portion layer and an inner portion layer (see Fig. 6B; par. 67, 70, tissue outer structure and inner polymer cover and par. 122-123), wherein the biocompatible membrane at least partially defines a lumen through frame that, when the system is implanted across the septal wall, fluidly connects the left atrium and the right atrium (see par. 57, 123).
Nitzan does not disclose a pressure sensor, wherein the pressure sensor is configured to measure at least one of left atrial pressure or right atrial pressure.
Keren discloses an interatrial shunt placed between two chambers of the heart within the interatrial septum, between the right atrium and left atrium (see Fig. 1), the shunt comprising one or more pressure sensors used to measure the pressure in the subject’s right atrium and/or left atrium used to monitor progression of the treatment and ascertain the point in time at which the shunt may be removed from the patient, with one pressure sensor disposed on the proximal portion of the shunt and pressure another on the distal portion, such that the pressure in both the left atrium and the right atrium is measured. Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add a sensor to the proximal portion of the shunt and the distal portion of the shunt, which would cause one to be in the right atrium and one in the left atrium such that pressure in both the left atrium and the right atrium is measured, as disclosed by Keren, to monitor progression of the treatment and ascertain the point in time at which the shunt may be removed from the patient.
Nitzan and Keren do not disclose the biocompatible membrane is configured to form an enclosed chamber between a portion of the biocompatible membrane and a portion of the septal wall with the pressure sensor positioned within the enclosed membrane.
Reich discloses an implantable apparatus providing a blood flow lumen across a vessel with a sensor for measuring blood pressure within the lumen, the sensor disposed between two layers 20, 22 of a biocompatible covering, therefore forming an enclosed chamber (see Figs. 2-4; par. 10). This positioning causes the sensor to be trapped in the device itself and therefore it cannot be liberated inside the patient during use (see par. 28). It would have been obvious to a person having ordinary skill in the art before an effective filing date of the claimed invention to have placed each left atrial and right atrial sensor of Nitzan and Keren between the two layers of biocompatible material making up the biocompatible membrane and therefore creating an enclosed chamber for each pressure sensor, as Reich discloses such positioning and this would deter the sensors from being liberated inside the patient during use.
Nitzan, Keren, and Reich do not disclose the enclosed chamber between a portion of the biocompatible membrane and a portion of the septal wall.
Najafi discloses an implant placed at a septal wall between the left and right atrium, the implant having two pressure sensors for measuring pressure in the right and left atriums, one sensor placed at the end of the implant in the right atrium and one at the end of the implant in the left atrium (see par. 36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the pressure sensor measuring the pressure in the left atrium to be located at the end portion of the left side of the implant and the other sensor measuring the pressure in the right atrium to be located at the end portion of the right side of the implant, as disclosed by Najafi, in order to measure the left and right atrium pressures. Consequently, while Nitzan, Keren, and Reich disclose having an enclosed chamber with pressure sensor able to measure the left atrium pressure and an enclosed chamber with pressure sensor able to measure the right atrium pressure, they do not disclose the positioning of such chambers and teaches of Najafi provides such positioning. Furthermore, due to the diabolo shape of the shunting element of Nitzan, the ends of the implants with the enclosed chambers would cause the enclosed chambers to be between a portion of the biocompatible membrane that creates the chamber and portion of the septal wall (see Nitzan, Fig. 4A with half diabolo shape on right side of septum wall 18 for idea of configuration, as an enclosed chamber would be created near the end of frame 24 on the right side of the septum wall – embodiment of Fig. 6A-6B would have whole diabolo shape so outward cone on both sides of the septal wall when actually positioned within the body).
Regarding claim 69, Nitzan, Keren, Najafi, and Reich discloses the system of claim 68 and Nitzan discloses the biocompatible membrane includes an outer membrane portion (second layer) and an inner membrane portion (first layer) (see Fig. 6B; par. 67, 70, tissue outer structure and inner polymer cover and par. 122-123), and the resulting system of Nitzan, Keren, Najafi, and Reich has the pressure sensor positioned between the outer membrane portion and the inner membrane portion (see rejection of claim 68 above).
Regarding claim 70, Nitzan, Keren, Najafi, and Reich discloses the system of claim 69 and Nitzan discloses the first layer is an inner layer that at least partially defines the lumen (see Fig. 6B).
Claim(s) 54 and 62-65 are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan in view of Keren and further in view of Reich and further in view of Najafi and further in view of Boedecker et al. (EP 1312302). Citations of paragraphs for Boedecker are to English Translation provided with this office action.
Regarding claim 54, Nitzan, Keren, Najafi, and Reich discloses the system of claim 51 but do not specifically teach the enclosed chamber is configured to hold a fluid other than blood.
Boedecker discloses a pressure sensor for detecting pressure within a body, the pressure sensor formed from a pressure transducer and pressure responsive membrane along with an enclosed cavity containing a fluid other than blood (see par. 16-17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the pressure sensor of Nitzan, Keren, Najafi, and Reich with that of Boedecker as the substitution of one known element for another would have yielded predictable results, mainly, the detection of pressure. Consequently, the chamber, due to containing the pressure sensor, would hold a fluid other than blood.
Regarding claim 62, Nitzan discloses a system for shunting blood between a left atrium and a right atrium of a patient (see Fig. 6B, Abstract), the system comprising: a shunting element comprising one or more structural elements that (see Figs. 5A-6A; par. 91-92), when the system is implanted across a septal wall of the patient, are configured to extend across the septal wall of the patient and stabilize the shunting element to the septal wall (see par. 90, 92); a biocompatible membrane at least partially covering the one or more structural elements with the membrane having an outer portion layer and an inner portion layer (see Fig. 6B; par. 67, 70, tissue outer structure and inner polymer cover and par. 122-123), the biocompatible membrane defining a lumen through the shunting element that, when the system is implanted across the septal wall, fluidly connects the left atrium and the right atrium (see par. 57, 123).
Nitzan does not disclose a pressure sensing system configured to measure at least one of left atrial pressure or right atrial pressure, the pressure sensing system comprising a pressure responsive membrane and a pressure sensor and wherein, when the system is implanted across the septal wall, the pressure responsive membrane is exposed to at least one of the left atrium or the right atrium of the patient.
Keren discloses an interatrial shunt placed between two chambers of the heart within the interatrial septum, between the right atrium and left atrium (see Fig. 1), the shunt comprising one or more pressure sensors used to measure the pressure in the subject’s right atrium and/or left atrium used to monitor progression of the treatment and ascertain the point in time at which the shunt may be removed from the patient, with one pressure sensor disposed on the proximal portion of the shunt and pressure another on the distal portion, such that the pressure in both the left atrium and the right atrium is measured. Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add a sensor to the proximal portion of the shunt and the distal portion of the shunt, which would cause one to be in the right atrium and one in the left atrium such that pressure in both the left atrium and the right atrium is measured, as disclosed by Keren, to monitor progression of the treatment and ascertain the point in time at which the shunt may be removed from the patient.
Nitzan and Keren do not disclose the biocompatible membrane is configured to form an enclosed chamber between a portion of the biocompatible membrane and a portion of the septal wall with the pressure sensor positioned within the enclosed membrane.
Reich discloses an implantable apparatus providing a blood flow lumen across a vessel with a sensor for measuring blood pressure within the lumen, the sensor disposed between two layers 20, 22 of a biocompatible covering, therefore forming an enclosed chamber for the sensor (see Figs. 2-4; par. 10). This positioning causes the sensor to be trapped in the device itself and therefore it cannot be liberated inside the patient during use (see par. 28). It would have been obvious to a person having ordinary skill in the art before an effective filing date of the claimed invention to have placed each left atrial and right atrial sensor of Nitzan and Keren between the two layers of biocompatible material making up the biocompatible membrane, therefore creating an enclosed chamber for each sensor, as Reich discloses such positioning and this would deter the sensors from being liberated inside the patient during use.
Nitzan, Keren, and Reich do not disclose the enclosed chamber between a portion of the biocompatible membrane and a portion of the septal wall.
Najafi discloses an implant placed at a septal wall between the left and right atrium, the implant having two pressure sensors for measuring pressure in the right and left atriums, one sensor placed at the end of the implant in the right atrium and one at the end of the implant in the left atrium (see par. 36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the pressure sensor measuring the pressure in the left atrium to be located at the end portion of the left side of the implant and the other sensor measuring the pressure in the right atrium to be located at the end portion of the right side of the implant, as disclosed by Najafi, in order to measure the left and right atrium pressures. Consequently, while Nitzan, Keren, and Reich disclose having an enclosed chamber with pressure sensor able to measure the left atrium pressure and an enclosed chamber with pressure sensor able to measure the right atrium pressure, they do not disclose the positioning of such chambers and teaches of Najafi provides such positioning. Furthermore, due to the diabolo shape of the shunting element of Nitzan, the ends of the implants with the enclosed chambers would cause the enclosed chambers to be between a portion of the biocompatible membrane that creates the chamber and portion of the septal wall (see Nitzan, Fig. 4A with half diabolo shape on right side of septum wall 18 for idea of configuration, as an enclosed chamber would be created near the end of frame 24 on the right side of the septum wall – embodiment of Fig. 6A-6B would have whole diabolo shape so outward cone on both sides of the septal wall when actually positioned within the body).
Neither Nitzan, Keren, Najafi, or Reich disclose the required pressure responsive membrane.
Boedecker discloses a pressure sensor for detecting pressure within a body, the pressure sensor formed from a pressure transducer and pressure responsive membrane (see par. 16-17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the pressure sensor of Nitzan, Keren, Najafi, and Reich with that of Boedecker as the substitution of one known element for another would have yielded predictable results, mainly, the detection of pressure.
Regarding claim 63, Nitzan, Keren, Reich, Najafi, and Boedecker disclose the system of claim 62, and Boedecker further discloses the pressure sensing system further comprises an enclosed cavity containing a pressure transmission medium, and wherein: the pressure responsive membrane at least partially covers the enclosed cavity; and the pressure sensor is in communication with the pressure transmission medium (see Figs. 1-3; par. 16-17).
Regarding claim 64, Nitzan, Keren, Reich, Najafi, and Boedecker disclose the system of claim 63, and Boedecker further discloses the pressure transmission medium is a liquid (see par. 17).
Regarding claim 65, Nitzan, Keren, Reich, Najafi, and Boedecker disclose the system of claim 62 and Nitzan discloses the biocompatible membrane includes an outer membrane portion and an inner membrane portion (see Fig. 6B; par. 67, 70, tissue outer structure and inner polymer cover and par. 122-123), and the resulting system of Nitzan, Keren, Reich, and Boedecker has the pressure sensor positioned between the outer membrane portion and the inner membrane portion (see rejection of claim 62 above).
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan in view of Keren and further in view of Reich and further in view of Najafi as applied to claim 58 above, and further in view of Fayram et al. (US 2006/0116590).
Regarding claim 59, Nitzan, Keren, Najafi, and Reich disclose the system of claim 58 but do not disclose a processor configured to calculate a pressure differential between the left atrium and the right atrium.
Fayram discloses adding a processor for data calculations (see par. 57-58) as well as calculating a pressure differential between the left atrium and the right atrium via a sensor in each left and right atrium in order to monitor the heart (see Fig. 3, par. 81). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include a processor configured to calculate a pressure differential between the left atrium and the right atrium, as disclosed by Fayram, in order to monitor the heart.
Claim(s) 60-61 and 72-75 are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan in view of Keren and further in view of Reich and further in view of Najafi as applied to claims 51 and 68 above, and further in view of Whitehurst et al. (US 6,733,485).
Regarding claim 60, Nitzan, Keren, Najafi and Reich disclose the system of claim 51 and while Nitzan discloses a valve in the shunt to adjust flow through the shunt, the valve coupled to the frame (see Figs. 5A-5D; par. 59, 61, 65) but Nitzan does not disclose the shunting element further includes a flow control mechanism is configured to be selectively actuated to adjust a geometry of the lumen.
Whitehurst discloses an adjustable valve/flow control mechanism made from shape-memory material that is actuated such that the size of the lumen is adjusted, therefore adjusting a geometry of the lumen (see col. 14, lines 34-49) and can be done externally (see col. 14, lines 34-49). As the valve would be configured to be selectively actuated to adjust a geometry of the lumen, it is considered the actuation mechanism. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the valve of Nitzan replaced with that of Whitehurst in order to better regulate the flow and change conditions as desired externally.
Regarding claim 61, Nitzan, Keren, Reich, Najafi, and Whitehurst disclose the system of claim 60, and Whitehurst further discloses the flow control mechanism comprises a shape memory material (see col. 14, lines 34-49).
Regarding claim 72, Nitzan, Keren, Najafi, and Reich disclose the system of claim 68 and while Nitzan discloses a valve to adjust flow through the shunt, the valve coupled to the frame (see Figs. 5A-5D; par. 59, 61, 65) but Nitzan does not disclose an actuation mechanism coupled to the frame, wherein the actuation mechanism is configured to be selectively actuated to adjust a geometry of the lumen.
Whitehurst discloses an adjustable valve made from shape-memory material that is actuated such that the size of the lumen is adjusted, therefore adjusting a geometry of the lumen (see col. 14, lines 34-49) and can be done externally (see col. 14, lines 34-49). As the valve would be configured to be selectively actuated to adjust a geometry of the lumen, it is considered the actuation mechanism. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the valve of Nitzan replaced with that of Whitehurst in order to better regulate the flow and change conditions as desired externally.
Regarding claim 73, Nitzan, Keren, Reich, Najafi, and Whitehurst disclose the system of claim 72, and Nitzan further discloses the biocompatible membrane at least partially covers the actuation mechanism (see par. 67).
Regarding claim 74, Nitzan, Keren, Reich, Najafi, and Whitehurst disclose the system of claim 72, and due to the actuation mechanism affecting the size of lumen, the actuation mechanism would at least partially define the lumen (see rejection of claim 72 above).
Regarding claim 75, Nitzan, Keren, Reich, Najafi, and Whitehurst disclose the system of claim 72, and Whitehurst further discloses the actuation mechanism is at least partially composed of a shape memory material (see col. 14, lines 34-49).
Claim(s) 67 is rejected under 35 U.S.C. 103 as being unpatentable over Nitzan in view of Keren and further in view of Reich and further in view of Najafi, and further in view of Boedecker as applied to claim 62 above, and further in view of Whitehurst.
Regarding claim 67, Nitzan, Keren, Reich, Najafi, and Boedecker disclose the system of claim 62 and while Nitzan discloses a valve in the shunt to adjust flow through the shunt, the valve coupled to the frame (see Figs. 5A-5D; par. 59, 61, 65) but Nitzan does not disclose the shunting element further includes a flow control mechanism is configured to be selectively actuated to adjust a geometry of the lumen.
Whitehurst discloses an adjustable valve/flow control mechanism made from shape-memory material that is actuated such that the size of the lumen is adjusted, therefore adjusting a geometry of the lumen (see col. 14, lines 34-49) and can be done externally (see col. 14, lines 34-49). As the valve would be configured to be selectively actuated to adjust a geometry of the lumen, it is considered the actuation mechanism. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the valve of Nitzan replaced with that of Whitehurst in order to better regulate the flow and change conditions as desired externally.
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 ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781