DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claim 18 is 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.
Claim 18 recites “the first and second valves” however, there is no antecedent basis for this earlier in the claim nor in the claim from which this claim depends. It is unclear what “first and second valves” are being referred to. For the above reasons the claim does not clearly define the metes and bounds and the claim is indefinite. Examiner notes that Applicants may have meant to have claim 18 depend from claim 15 which is not currently in claim 18s claim tree but does mention first and second valves.
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) 1, 4-6, 8-9, 11-14, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200215245 to Haddadi et al. (hereinafter Haddadi) in view of US 20150306291 to Bonde et al. (hereinafter Bonde). Examiner notes that Bonde also incorporates by reference “U.S. patent application Ser. Nos. 13/843,884 and 14/213,256, each of which are incorporated by reference in their entirety” in [0052]; 13/843,884 and 14/213,256 which have published as US 20130310630 to Smith et al. (hereinafter Smith) and US 20140275727 to Asgari et al. (hereinafter Asgari), respectively.
Regarding Claim 1, an interpretation of Haddadi discloses an intracardiac device comprising:
a pump ([0082]-[0084], [0095], Figs. 1-6), the pump comprising a rotatable housing having first and second open ends and an internal passage therebetween ([0082] including “In the example, described non-limitatively, this is a body 2 in the shape of a slender hollow cylinder the inner wall 3 of which comprises several blades 4, 5, 6 and 7”, [0083]-[0084], [0095], Figs. 1-6), and a rotor positioned within the housing, wherein the rotor comprises one or more blades coupled to an inner surface of the housing extending into the internal passage ([0082] including “In the example, described non-limitatively, this is a body 2 in the shape of a slender hollow cylinder the inner wall 3 of which comprises several blades 4, 5, 6 and 7”, [0083], Figs. 1-6); and
an actuator coupled to the housing and configured to rotate the housing ([0019], [0088], [0095], [0121]).
An interpretation of an elongate tubular body configured with first and second ends and an internal lumen therebetween, the tubular body is movable between a collapsed configuration for advancement through a vessel in a patient, and an expanded configuration.
However, in the same field of endeavor (medical devices), Bonde teaches an elongate tubular body configured with first and second ends and an internal lumen therebetween ([0030], [0054] including “the device is deliverable in a compressed configuration, where the shell is compressed to the pump housing . . . the shell 905 may also be a stent or stent-like body as shown in FIG. 14, wherein the stent includes the pump within the lumen of the stent”, Figs. 13-14 see also [0027]-[0028], Fig. 8a-9d), the tubular body is movable between a collapsed configuration for advancement through a vessel in a patient, and an expanded configuration ([0030], [0054] including “the device is deliverable in a compressed configuration, where the shell is compressed to the pump housing . . . the shell 905 may also be a stent or stent-like body as shown in FIG. 14, wherein the stent includes the pump within the lumen of the stent”, Figs. 13-14 see also [0027]-[0028], Fig. 8a-9d); the pump is substantially centered within the internal lumen of the tubular body in the collapsed and expanded configurations ([0030] including “a first compressed configuration, where the shell is compressed to the pump surface, and transformed into a second expanded configuration, where the shell expands to create a fluid filled space between the pump surface and shell (see for example FIG. 13-14)”, [0054]-[0055], Figs. 13-14 see also [0027]-[0028], Fig. 8a-9d; Examiner notes, currently for clarity of the record, that the pump “substantially centered” in the lumen has limited support and is broadly being interpreted as being encompassed by the disclosure. Examiner further notes that, while not currently interpreted as such, in an alternative interpretation this does not have support in priority documents which would mean this Application is a CIP and change the priority date to the date of this application for this claim and its dependent claims).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet as recited by Had to include a tubular body surrounding the pump as recited by Bonde because it provides a flow multiplier as well as an anchoring the pump at a desired location ([0054]).
Regarding Claim 4, an interpretation of Haddadi further comprises wherein the actuator comprises one or more magnets coupled to the housing ([0039], [0088], Figs. 1, 3a-7).
Regarding Claim 5, an interpretation of Haddadi further comprises wherein the rotor comprises a plurality of helical blades extending from the inner surface of the housing ([0037]-[0039], [0085]-[0086], Figs. 1, 2b, 6).
Regarding Claim 6, an interpretation of Haddadi further comprises wherein each of the helical blades has a length less than half an inner diameter of the housing (Figs. 2a, 2c, 3a-3c see also [0037], [0039], [0082], [0085]-[0086]).
Regarding Claim 8, an interpretation of Haddadi further comprises wherein the pump further comprises a diffusor ([0100], [0101]).
Regarding Claim 9, an interpretation of Haddadi further comprises wherein the rotatable housing has a central bore within the internal passage, the one or more blades being positioned radially outward from the central bore ([0082] including “including “In the example, described non-limitatively, this is a body 2 in the shape of a slender hollow cylinder the inner wall 3 of which comprises several blades 4, 5, 6 and 7”, [0083]-[0084], [0095], Figs. 1-6).
Regarding claim 11, an interpretation of Haddadi may not explicitly disclose a transmitting coil and an implantable receiving coil coupled to the pump, the transmitting coil being configured to wirelessly transmit energy to the receiving coil.
However, in the same field of endeavor (medical devices), Bonde teaches a transmitting coil and an implantable receiving coil coupled to the pump, the transmitting coil being configured to wirelessly transmit energy to the receiving coil (Bonde [0052]; Smith [0043], Figs. 1, 3).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet as recited by Haddadi to include a wireless power system for receiving power to provide the electricity for actuating the pump as recited by Bonde because transcutaneous transmission of power is one of two enumerated (the other being a power cable through the skin) and predictable solutions which have a reasonable expectation of success. The two forms are recited as being known in the art with a reasonable expectation of success thus using one would be obvious to try.
Regarding claim 12, an interpretation of Haddadi may not explicitly disclose a wireless receiver and a controller coupled to the wireless receiver and configured to modulate a speed of the pump.
However, in the same field of endeavor (medical devices), Bonde teaches a wireless receiver and a controller coupled to the wireless receiver and configured to modulate a speed of the pump (Asgari [0038], [0041]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet as recited by Haddadi to include a wireless data transmission for receiving control data to provide the control data for actuating the pump as recited by Bonde because reduces the risk of infection from using a transcutaneous data line (Asgari [0003]). Furthermore, transcutaneous transmission of data is one of two enumerated (the other being a data cable through the skin) and predictable solutions which have a reasonable expectation of success. The two forms are recited as being known in the art with a reasonable expectation of success thus using one would be obvious to try.
Regarding Claim 13, an interpretation of Haddadi discloses an intracardiac device comprising:
a pump ([0082]-[0084], [0095], Figs. 1-6), the pump comprising a rotatable housing having first and second open ends and an internal passage therebetween ([0082] including “In the example, described non-limitatively, this is a body 2 in the shape of a slender hollow cylinder the inner wall 3 of which comprises several blades 4, 5, 6 and 7”, [0083]-[0084], [0095], Figs. 1-6), and a rotor with one or more blades positioned within the housing ([0082] including “In the example, described non-limitatively, this is a body 2 in the shape of a slender hollow cylinder the inner wall 3 of which comprises several blades 4, 5, 6 and 7”, [0083], Figs. 1-6), wherein the rotatable housing has a central bore within the internal passage ([0082]-[0084], [0095], Figs. 1-6), the one or more blades being positioned radially outward from the central bore ([0082]-[0084], [0095], Figs. 1-6); and
an actuator coupled to the housing and configured to rotate the housing ([0019], [0088], [0095], [0121]).
An interpretation of Haddadi may not explicitly disclose an elongate tubular body with first and second ends and an internal lumen therebetween, the elongate tubular body being configured for implanting within a right atrium of a patient's heart to form a fluid pathway between a left atrium and an aorta of the patient; the pump positioned within the internal lumen between the first and second ends of the elongate tubular body.
However, in the same field of endeavor (medical devices), Bonde teaches an elongate tubular body configured with first and second ends and an internal lumen therebetween ([0030], [0054] including “the device is deliverable in a compressed configuration, where the shell is compressed to the pump housing . . . the shell 905 may also be a stent or stent-like body as shown in FIG. 14, wherein the stent includes the pump within the lumen of the stent”, Figs. 13-14 see also [0027]-[0028], Fig. 8a-9d), the elongate tubular body being configured for implanting within a right atrium of a patient's heart to form a fluid pathway between a left atrium and an aorta of the patient ([0027], [0030], [0054] including “the device is deliverable in a compressed configuration, where the shell is compressed to the pump housing . . . the shell 905 may also be a stent or stent-like body as shown in FIG. 14, wherein the stent includes the pump within the lumen of the stent”, Figs. 13-14 see also [0027]-[0028], Fig. 8a-9d; to the extent this is an intended use the device recited by the prior art is functionally capable of performing the intended use); the pump positioned within the internal lumen between the first and second ends of the elongate tubular body ([0030] including “a first compressed configuration, where the shell is compressed to the pump surface, and transformed into a second expanded configuration, where the shell expands to create a fluid filled space between the pump surface and shell (see for example FIG. 13-14)”, [0054]-[0055], Figs. 13-14 see also [0027]-[0028], Fig. 8a-9d)
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet as recited by Had to include a tubular body surrounding the pump as recited by Bonde because it provides a flow multiplier as well as an anchoring the pump at a desired location ([0054]).
Regarding claim 14, an interpretation of Haddadi discloses a pump device sized to be placed within the heart due to its small dimensions ([0134]).
An interpretation of Haddadi may not explicitly disclose an elongate tubular body with an internal lumen therebetween and a pump positioned within the internal lumen.
However, in the same field of endeavor (medical devices), Bonde teaches an elongate tubular body wherein the tubular body includes anchors on the first and second ends configured for implanting to form a fluid pathway ([0030], [0054] including “the shell 905 may also be a stent or stent-like body as shown in FIG. 14, wherein the stent includes the pump within the lumen of the stent”, Figs. 13-14 see also [0027]-[0028], Fig. 8a-9d) the anchors configured for securing the first end to a fossa ovalis of the patient and the second end configured for securing to sinotubular junction of the patient (While the anchors are structural elements and disclosure is provided for the structure above. The “for securing . . .” are intended uses of the device which the disclosed device is functionally capable of performing. The structures (i.e., pumps, stents etc.) of Haddadi and Bonde are designed with the dimensions for being anchored in the fossa ovalis between the right and left atriums of the heart such as and the sinotubular junction of the aorta).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet as recited by Haddadi to include a tubular body surrounding the pump as recited by Bonde because it provides a flow multiplier as well as an anchoring the pump at a desired location ([0054]).
Regarding Claim 19, an interpretation of Haddadi may not explicitly disclose wherein the tubular body is movable between a collapsed configuration for advancement through a vessel in a patient, and an expanded configuration
However, in the same field of endeavor (medical devices), Bonde teaches the tubular body is movable between a collapsed configuration for advancement through a vessel in a patient, and an expanded configuration ([0030], [0054] including “the device is deliverable in a compressed configuration, where the shell is compressed to the pump housing . . . the shell 905 may also be a stent or stent-like body as shown in FIG. 14, wherein the stent includes the pump within the lumen of the stent”, Figs. 13-14 see also [0027]-[0028], Fig. 8a-9d).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet as recited by Haddadi to include a collapsible tubular body surrounding the pump as recited by Bonde because it provides a flow multiplier as well as an anchoring the pump at a desired location ([0054]).
Regarding claim 20, an interpretation of Haddadi may not explicitly disclose a transmitting coil and an implantable receiving coil coupled to the pump, the transmitting coil being configured to wirelessly transmit energy to the receiving coil.
However, in the same field of endeavor (medical devices), Bonde teaches a transmitting coil and an implantable receiving coil coupled to the pump, the transmitting coil being configured to wirelessly transmit energy to the receiving coil (Bonde [0052]; Smith [0043], Figs. 1, 3).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet as recited by Haddadi to include a wireless power system for receiving power to provide the electricity for actuating the pump as recited by Bonde because transcutaneous transmission of power is one of two enumerated (the other being a power cable through the skin) and predictable solutions which have a reasonable expectation of success. The two forms are recited as being known in the art with a reasonable expectation of success thus using one would be obvious to try.
Claim Rejections - 35 USC § 103
Claim(s) 2-3, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haddadi in view of Bonde in further view of US 20160045654 to Connor (hereinafter Connor).
Regarding claim 2, an interpretation of the Haddadi may not explicitly disclose wherein the actuator comprises a motor coupled to the one of the first and second open ends of the housing.
However, in the same field of endeavor (medical devices), Connor teaches wherein the actuator comprises a motor coupled to the rotatable housing ([0095] including “this control unit can be located locally in direct mechanical communication with the blood flow increasing mechanism. In an example, such a local control unit can further comprise an actuation mechanism (such as a motor) which moves or otherwise actuates the blood flow increasing mechanism.”, [0243] including “rotating cylinder 9001 can be rotated by a direct mechanical drive mechanism which operated by control units 9003 and 9004.”, [0289]) and
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet as recited by Haddadi to include a motor coupled to the housing for actuating the rotatable turbine as recited by Connor as a motor connected to the turbine for actuating it is one of a limited number of enumerated (the other being actuated by external magnets reacting with magnets attached to the “housing”/turbine) and predictable solutions which have a reasonable expectation of success. The two forms are recited as being known in the art as alternatives with a reasonable expectation of success thus using a separate motor which is attached would be obvious to try.
An interpretation of the first embodiment of Haddadi may not explicitly disclose wherein the motor coupled to the one of the first and second open ends of the housing.
However, in the same field of endeavor (medical devices), a second embodiment of Haddadi teaches a motor on one end of the device attached to the turbine ([0024], [0123], [0125], Fig. 17).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet with a motor mechanically connected to actuate the rotatable turbine as recited by Haddadi in view of Connor to further include placing the motor on an end of the device as shown by the second embodiment of Haddadi because it is merely the simple substitution of one known element for another to obtain predictable results. It is substituting the placement of the motor or actuator as shown from the side when using magnets/a separate motor to placing the motor on an end and driving the device through a mechanical connection.
Regarding claim 3, an interpretation of Haddadi may not explicitly disclose wherein the motor is coupled to an internal or external surface of the housing.
However, in the same field of endeavor (medical devices), Connor teaches wherein the motor is coupled to an internal or external surface of the housing ([0095], [0243], [0289]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet as recited by Had to include a motor coupled to the housing for actuating the rotatable turbine as recited by Connor as a motor connected to the turbine for actuating it is one of a limited number of enumerated (the other being actuated by external magnets reacting with magnets attached to the “housing”/turbine) and predictable solutions which have a reasonable expectation of success. The two forms are recited as being known in the art as alternatives with a reasonable expectation of success thus using a separate motor which is attached would be obvious to try.
Regarding claim 7, an interpretation of Haddadi may not explicitly disclose wherein each of the helical blades has an adjustable pitch.
However, in the same field of endeavor (medical devices), Connor teaches wherein each of the helical blades has an adjustable pitch ([0245]-[0247]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet as recited by Haddadi to include a helical blades/vanes which have an adjustable pitch as recited by Connor because adjusting the pitch provides the capability of increasing blood flow when the pump is in use and removing blades/fins from the blood flow and thus not hindering the flow when the device is not in use ([0245], [0247]).
Claim Rejections - 35 USC § 103
Claim(s) 10, 15-16, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haddadi in view of Bonde in further view of WO 2016100600 to Bonde (hereinafter Bond).
Regarding claim 10, an interpretation of Haddadi may not explicitly disclose first and second valves positioned at, or near, the first and second ends of the tubular body, respectively, wherein the first and second valves are movable between an open position, wherein the first and second ends allow fluid passage therethrough, to a closed position, wherein the first and second ends are substantially sealed.
However, in the same field of endeavor (medical devices), Bond teaches first and second valves positioned at, or near, the first and second ends of the tubular body, respectively, wherein the first and second valves are movable between an open position, wherein the first and second ends allow fluid passage therethrough, to a closed position, wherein the first and second ends are substantially sealed ([0022], [0025]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet with a tubular body surrounding the pump as recited by Haddadi in view of Bonde to further include valves for sealing the inlet and outlet when the device is not in use as recited by Bond because the seals provide the ability to seal the device off from the blood stream when the device is not required such as when the person has hemodynamic stability ([0022]).
Regarding claim 15, an interpretation of Haddadi may not explicitly disclose first and second valves positioned at, or near, the first and second ends of the tubular body, respectively, wherein the first and second valves are movable between an open position, wherein the first and second ends allow fluid passage therethrough, to a closed position, wherein the first and second ends are substantially sealed.
However, in the same field of endeavor (medical devices), Bond teaches first and second valves positioned at, or near, the first and second ends of the tubular body, respectively, wherein the first and second valves are movable between an open position, wherein the first and second ends allow fluid passage therethrough, to a closed position, wherein the first and second ends are substantially sealed ([0022], [0025]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet with a tubular body surrounding the pump as recited by Haddadi in view of Bonde to further include valves for sealing the inlet and outlet when the device is not in use as recited by Bond because the seals provide the ability to seal the device off from the blood stream when the device is not required such as when the person has hemodynamic stability ([0022]).
Regarding Claim 16, an interpretation of Haddadi may not explicitly disclose wherein the first and second valves are movable into one or more partially closed positions, wherein the first and seconds ends of the tubular body have a smaller inner diameter in the partially closed positions than in the open position and a larger inner diameter in the partially closed positions than in the closed position.
However, in the same field of endeavor (medical devices), Bond teaches wherein the first and second valves are movable into one or more partially closed positions, wherein the first and seconds ends of the tubular body have a smaller inner diameter in the partially closed positions than in the open position and a larger inner diameter in the partially closed positions than in the closed position ([0022], [0025]; the valves are actuated to move between an open and closed position thus are “movable” and during the transition between open and closed meet the claim elements).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet with a tubular body surrounding the pump as recited by Haddadi in view of Bonde to further include valves for sealing the inlet and outlet when the device is not in use as recited by Bond because the seals provide the ability to seal the device off from the blood stream when the device is not required such as when the person has hemodynamic stability ([0022]).
Regarding Claim 18, an interpretation of Haddadi may not explicitly disclose a second actuator for moving the first and second valves between the open and closed positions.
However, in the same field of endeavor (medical devices), Bond teaches a second actuator for moving the first and second valves between the open and closed positions ([0022] including “will be actuated by a small motor”, [0025]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet with a tubular body surrounding the pump as recited by Haddadi in view of Bonde to further include valves for sealing the inlet and outlet when the device is not in use as recited by Bond because the seals provide the ability to seal the device off from the blood stream when the device is not required such as when the person has hemodynamic stability ([0022]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-22 of U.S. Patent No. 12364855 in view of Bonde.
Regarding Claim 1, ‘855 claim 18 discloses claim 1 except for the compressible and expandable tubular element with the centered pump. However, this is disclosed by Bonde, see the rejection of claim 1 above. It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet as recited by ‘855 to include a compressible/expandable tubular body surrounding the pump as recited by Bonde because it provides for a safe delivery of the pump at a desired location ([0054], [0057]).
The dependent claims either are either commensurate in scope with those of the depend claims of ‘855 or are rejected over ‘855 in view of the elements recited above in their rejections.
Claim 13-16, 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-22 of U.S. Patent No. 12364855 in view of Haddadi.
Regarding Claim 13, ‘855 claim 1 discloses claim 13 except ‘855 may not explicitly disclose “wherein the rotatable housing has a central bore within the internal passage, the one or more blades being positioned radially outward from the central bore”. However, this is disclosed by Haddadi, see the rejection of claim 13 above. It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified implantable pump with rotatable turbine with inward facing blades/vanes to drive blood from the inlet to the outlet as recited by ‘855 to combine the specifics of the central bore and blades as recited by Haddadi because it is merely combining prior art elements according to known methods to yield predictable results.
The dependent claims (excluding 17) either are either commensurate in scope with those of the depend claims of ‘855 or are rejected over ‘855 in view of the elements recited above in their rejections.
Allowable Subject Matter
Claim 17 is allowable over the prior art. However, claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/James Moss/Examiner, Art Unit 3792
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