DETAILED ACTION
This action is pursuant to claims filed on 6/11/2025. Claims 1 and 3-21 are pending, claim 2 has been cancelled. A final action on the merits of claims 1 and 3-21 is as follows.
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 .
Information Disclosure Statement
The information disclosure statement filed 6/13/2025 has been fully considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: component 150 in Fig. 4B. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 16-18 are 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 16 states, “the return delivery lumen” in line 4. This limitation lacks antecedent basis. It will be interpreted as the fluid return lumen.
Claims 17 and 18 are rejected due to their dependance on claim 16.
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.
Claim(s) 1 and 3-21 are rejected under 35 U.S.C. 103 as being unpatentable over Richardson (US 20110152982 A1) in view of Ellingboe et al. (hereinafter ‘Ellingboe’, US 20040030372 A1), in further view of Mathieu (GB 2118440 A).
Regarding independent claim 1, Richardson discloses a targeted temperature management (TTM) system (TTM system 100 shown in Fig. 2), comprising:
a TTM module (module 104 in Fig. 2) configured to provide a TTM fluid ([0022]: the heating/cooling unit 104 has a fluid container 106 for holding a fluid supply for circulating through pads);
a fluid delivery line (FDL) (fluid delivery line 108 terminating at hub 114 in Fig. 2) including a FDL hub (hub 114 in Fig. 2), a fluid delivery lumen (supply line 110 in Fig. 2) and a fluid return lumen (return line 112 in Fig. 2); and
a pad (pad 102 in Fig. 2) configured to facilitate thermal energy transfer between the TTM fluid and a patient ([0021]: system 100 circulates a fluid at a desired temperature through a series of pads 102 to maintain or alter the temperature of an object that is in direct contact with pads 102), the pad comprising:
a pad portion (pad portion 102 in Fig. 2) configured for placement on the patient ([0021]: object is in direct contact with the pads – the object would be the patient like in Fig. 6),
a fluid delivery conduit (supply line 120 in Fig. 2) extending away from the pad portion (line 120 extends away from the pad portion as seen in Fig. 2), the fluid delivery conduit including a delivery conduit connector ([0040]: tubing 151 connects to the primary supply line at a fist end 153 – while this paragraph is describing the first embodiment, the tubing 151 still connects to the secondary supply line 120 as shown in Fig. 2; [0024]: the supply line 120 provides fluid at the desired temperature to the pads 102 – the ability to connect to the pads discloses the presence of a connector) at a proximal end thereof (the connector is present at the proximal end as seen in Fig. 2 since the connection occurs closest to the pad),
a fluid return conduit (return conduit 130 in Fig. 2) extending away from the pad portion (conduit 130 extends away from the pad as shown in Fig. 2), the fluid return conduit including a return conduit connector ([0026]: the pad 102 is also connected in direct fluid communication with the return line 130 – the presence of a connection inherently discloses the presence of a connector that forms that connection) at a proximal end thereof (the connector is present at the proximal end as seen in Fig. 2 since the connection occurs closest to the pad), and
connectors coupled to a distal end of each of the fluid delivery conduit and the fluid return conduit (quick connect couplings 144 disposed on the distal end of the delivery and return conduits as shown in Fig. 3).
Richardson also states that while the quick connect couplings are present in the current embodiment, other couplings which produce the same or similar results may be used ([0037]).
However, Richardson does not disclose that the connectors can be connected to each other, forming a single connector.
Ellingboe teaches a system for the interconnection of a medical fluid processing system with at least one patient temperature control pad ([Abstract]). Ellingboe further teaches an intermediate connector system, similar to the connection system of Richardson, that comprises male and female connections ([0062]). Furthermore, the connection system connects to the hose in such a way that both conduits connect to a single connector as shown in Fig. 8a. The design and orientation of this connection device provides the advantage that the wrong channels through the male and female intermediate connectors will not be fluidly connected ([0062]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the connector of Ellingboe with the system of Richardson to avoid improper connections with the delivery and return lines.
Richardson further discloses that the quick connect couplings may comprise check valves to prevent fluid leakage upon removal ([0037]).
However, the Richardson/Ellingboe combination does not disclose the connector including a first membrane covering an opening of the fluid delivery conduit and a second membrane covering an opening of the fluid return conduit.
Mathieu teaches a self-sealing tubing connector for medical apparatuses that contains valve disks for sealing in the uncoupled condition ([Abstract]). Mathieu further teaches that the female part of the connector, which would correspond to the connector on the end of the conduits from Richardson, comprises a valve disk 34, which is synonymous with a membrane, that receives the tubing of the male connector, creating a fluid connection ([page 2 of specification]). The substitution of one known element (the check valves of Richardson) for another (the valve disks of Mathieu) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the valve disk of Mathieu would have yielded predictable and equivalent results to that of Richardson, namely, sealing the conduits in the uncoupled condition.
However, the Richardson/Ellingboe/Mathieu combination would create two membranes, one covering each conduit.
It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to utilize a single membrane, since applicant has not disclosed that utilizing a single membrane over separate membrane solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a single membrane as it would two separate membranes. The combination would result in the single membrane configured with a first piercing (Mathieu [page 2 of specification]: the valve disk has a star-like cut or slit) configured to receive a distal conduit tip of a fluid delivery lumen (Richardson [0024]: the output port 118 is in fluid connection with supply line 120; this fluid connection means the tip of the output 118 pierces the membrane of the combination as shown in Fig. 3) and a second piercing (Mathieu [page 2 of specification]: the valve disk has a star-like cut or slit) configured to receive a distal conduit tip of a fluid return lumen (Richardson [0025]: the input port 128 is in fluid connection with return line 130; this fluid connection means the tip of the input 128 pierces the membrane of the combination as shown in Fig. 3).
Regarding claim 3, the Richardson/Ellingboe/Matthieu combination discloses the system of claim 1 and described above. The combination further teaches wherein each of the first piercing and the second piercing is formed as one of a circular piercing, a linear slit or a star piercing (Mathieu [page 2 of specification]: the valve disk has a star-like cut or slit).
Regarding claim 4, The Richardson/Ellingboe/Matthieu combination discloses the system of claim 1, wherein the distal conduit tips of the fluid delivery lumen and the fluid return lumen are tapered from a proximal point to a distal point (the conduit tips 118 and 128 taper down from a wide base to a narrow tip as seen in Fig. 3, which is consistent with the definition of taper per Merriam-Webster: to become progressively smaller toward one end).
Regarding claim 5, the Richardson/Ellingboe/Matthieu combination discloses the system of claim 1. The combination further teaches wherein the connector includes a conduit partition that separates the fluid delivery conduit and fluid return conduit (the conduit partition is the block in the middle between the two conduits as seen in Ellingboe Fig. 8a).
Regarding claim 6, the Richardson/Ellingboe/Mathieu combination discloses the system of claim 1 and described above. The combination also teaches the male connector includes a top compression strip (top compression strip of Ellingboe highlighted below) connected to a top latch (latch portion of top compression strip of Ellingboe highlighted below) and a bottom compression strip (bottom compression strip of Ellingboe highlighted below) connected to a bottom latch (latch portion of bottom compression strip of Ellingboe highlighted below), wherein each of the top latch and bottom latch extends proximally from the connector (they both extend away from the ends of the conduits down the length of the hose).
However, the combination does not teach this configuration on the female side, which is the side of the pad conduits and the connector of claim 1. Instead, the female side of the connector of Ellingboe has grooves to receive the latches.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to reverse the latch and groove components such that the compression strips and latch are on the female connector and the receiving grooves are on the male connector, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
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Regarding claim 7, the Richardson/Ellingboe/Mathieu combination discloses the system of claim 6. The combination further teaches the top and bottom compression strips are configured to cause movement of the top and bottom latches in opposing directions upon application of pressure to the top and bottom compressions strips (Ellingboe [0060]: when a force is applied to the latch arms which moves them closer to the body portion, the latch ends move away from each other).
Regarding independent claim 8, Richardson discloses a targeted temperature management (TTM) system (TTM system 100 shown in Fig. 2), comprising:
a TTM module (module 104 in Fig. 2) configured to provide a TTM fluid ([0022]: the heating/cooling unit 104 has a fluid container 106 for holding a fluid supply for circulating through pads);
a fluid delivery line (FDL) including (fluid delivery line 108 terminating at hub 114 in Fig. 2) a FDL hub (hub 114 in Fig. 2), a fluid delivery lumen (supply line 110 in Fig. 2) and a fluid return lumen (return line 112 in Fig. 2); and
a pad (pad 102 in Fig. 2) configured to facilitate thermal energy transfer between the TTM fluid and a patient ([0021]: system 100 circulates a fluid at a desired temperature through a series of pads 102 to maintain or alter the temperature of an object that is in direct contact with pads 102), the pad comprising:
a pad portion (pad portion 102 in Fig. 2) configured for placement on the patient ([0021]: object is in direct contact with the pads – the object would be the patient like in Fig. 6),
a fluid delivery conduit (supply line 120 in Fig. 2) extending away from the pad portion, the fluid delivery conduit (line 120 extends away from the pad portion as seen in Fig. 2) including a delivery conduit connector ([0040]: tubing 151 connects to the primary supply line at a fist end 153 – while this paragraph is describing the first embodiment, the tubing 151 still connects to the secondary supply line 120 as shown in Fig. 2; [0024]: the supply line 120 provides fluid at the desired temperature to the pads 102 – the ability to connect to the pads discloses the presence of a connector) at a proximal end thereof (the connector is present at the proximal end as seen in Fig. 2 since the connection occurs closest to the pad),
a fluid return conduit (return conduit 130 in Fig. 2) extending away from the pad portion (conduit 130 extends away from the pad as shown in Fig. 2), the fluid return conduit including a return conduit connector ([0026]: the pad 102 is also connected in direct fluid communication with the return line 130 – the presence of a connection inherently discloses the presence of a connector that forms that connection) at a proximal end thereof (the connector is present at the proximal end as seen in Fig. 2 since the connection occurs closest to the pad), and
connectors coupled to a distal end of each of the fluid delivery conduit and the fluid return conduit (quick connect couplings 144 disposed on the distal end of the delivery and return conduits as shown in Fig. 3).
Richardson also states that while the quick connect couplings are present in the current embodiment, other couplings which produce the same or similar results may be used ([0037]).
However, Richardson does not disclose that the connectors can be connected to each other, forming a single connector.
Ellingboe teaches a system for the interconnection of a medical fluid processing system with at least one patient temperature control pad ([Abstract]). Ellingboe further teaches an intermediate connector system, similar to the connection system of Richardson, that comprises male and female connections ([0062]). Furthermore, the connection system connects to the hose in such a way that both conduits connect to a single connector as shown in Fig. 8a. The design and orientation of this connection device provides the advantage that the wrong channels through the male and female intermediate connectors will not be fluidly connected ([0062]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the connector of Ellingboe with the system of Richardson to avoid improper connections with the delivery and return lines.
Richardson further discloses that the quick connect couplings may comprise check valves to prevent fluid leakage upon removal ([0037]).
However, the Richardson/Ellingboe combination does not disclose the connector including a membrane configured to cover openings of each of the fluid delivery conduit and the fluid return conduit.
Mathieu teaches a self-sealing tubing connector for medical apparatuses that contains valve disks for sealing in the uncoupled condition ([Abstract]). Mathieu further teaches that the female part of the connector, which would correspond to the connector on the end of the conduits from Richardson, comprises a valve disk 34, which is synonymous with a membrane, that receives the tubing of the male connector, creating a fluid connection ([page 2 of specification]). The substitution of one known element (the check valves of Richardson) for another (the valve disks of Mathieu) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the valve disk of Mathieu would have yielded predictable and equivalent results to that of Richardson, namely, sealing the conduits in the uncoupled condition.
However, the Richardson/Ellingboe/Mathieu combination would create two membranes, one covering each conduit.
It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to utilize a single membrane, since applicant has not disclosed that utilizing a single membrane over separate membrane solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a single membrane as it would two separate membranes.
Regarding claim 9, the Richardson/Ellingboe/Mathieu combination discloses the system of claim 8. The combination further teaches the single membrane is configured with a first piercing (Mathieu [page 2 of specification]: the valve disk has a star-like cut or slit) corresponding to an opening of the fluid delivery conduit (Richardson [0024]: the output port 118 is in fluid connection with supply line 120; this fluid connection means the tip of the output 118 pierces the membrane of the combination as shown in Fig. 3) and a second piercing (Mathieu [page 2 of specification]: the valve disk has a star-like cut or slit) corresponding to an opening of the fluid return conduit (Richardson [0025]: the input port 128 is in fluid connection with return line 130; this fluid connection means the tip of the input 128 pierces the membrane of the combination as shown in Fig. 3).
Regarding claim 10, the Richardson/Ellingboe/Mathieu combination discloses the system of claim 9. The combination further teaches each of the first and second piercings are formed as one of a circular piercing, a linear slit or a star piercing (Mathieu [page 2 of specification]: the valve disk has a star-like cut or slit).
Regarding claim 11, the Richardson/Ellingboe/Mathieu combination discloses the system of claim 9. The combination further teaches the first piercing is configured to receive (Richardson [0024]: the output port 118 is in fluid connection with supply line 120; this fluid connection means the tip of the output 118 pierces the membrane of the combination as shown in Fig. 3) a distal conduit tip of the fluid delivery lumen (the fluid delivery conduit tip 118 in Fig. 3) and the second piercing is configured to receive (Richardson [0025]: the input port 128 is in fluid connection with return line 130; this fluid connection means the tip of the input 128 pierces the membrane of the combination as shown in Fig. 3) a distal conduit tip of the fluid return lumen (the fluid return conduit tip 128 in Fig. 3) thereby establishing fluid communication between the FDL hub and the connector (Richardson [0024] and [0026]: fluid connection is established between the delivery lines and the return lines).
Regarding claim 12, the Richardson/Ellingboe/Mathieu combination discloses the system of claim 11, wherein the distal conduit tips of the fluid delivery lumen and the fluid return lumen are tapered from a proximal point to a distal point (the conduit tips 118 and 128 taper down from a wide base to a narrow tip as seen in Fig. 3, which is consistent with the definition of taper per Merriam-Webster: to become progressively smaller toward one end).
Regarding claim 13, The system of claim 8, wherein the connector includes a conduit partition that separates the fluid delivery conduit and fluid return conduit (the conduit partition is the block in the middle between the two conduits as seen in Ellingboe Fig. 8a).
Regarding independent claim 14, Richardson discloses a targeted temperature management (TTM) pad (pad 102 in Fig. 2) to receive and circulate TTM fluid to facilitate thermal energy transfer between the TTM fluid and a patient ([0021]: system 100 circulates a fluid at a desired temperature through a series of pads 102 to maintain or alter the temperature of an object that is in direct contact with pads 102), the TTM pad comprising:
a pad portion (pad portion 102 in Fig. 2) configured for placement on the patient ([0021]: object is in direct contact with the pads – the object would be the patient like in Fig. 6),
a fluid delivery conduit (supply line 120 in Fig. 2) extending away from the pad portion (line 120 extends away from the pad portion as seen in Fig. 2), the fluid delivery conduit including a delivery conduit connector ([0040]: tubing 151 connects to the primary supply line at a fist end 153 – while this paragraph is describing the first embodiment, the tubing 151 still connects to the secondary supply line 120 as shown in Fig. 2; [0024]: the supply line 120 provides fluid at the desired temperature to the pads 102 – the ability to connect to the pads discloses the presence of a connector) at a proximal end thereof (the connector is present at the proximal end as seen in Fig. 2 since the connection occurs closest to the pad),
a fluid return conduit (return conduit 130 in Fig. 2) extending away from the pad portion (conduit 130 extends away from the pad as shown in Fig. 2), the fluid return conduit including a return conduit connector ([0026]: the pad 102 is also connected in direct fluid communication with the return line 130 – the presence of a connection inherently discloses the presence of a connector that forms that connection) at a proximal end thereof (the connector is present at the proximal end as seen in Fig. 2 since the connection occurs closest to the pad), and
connectors coupled to a distal end of each of the fluid delivery conduit and the fluid return conduit (quick connect couplings 144 disposed on the distal end of the delivery and return conduits as shown in Fig. 3).
Richardson also states that while the quick connect couplings are present in the current embodiment, other couplings which produce the same or similar results may be used ([0037]).
However, Richardson does not disclose that the connectors can be connected to each other, forming a single connector.
Ellingboe teaches a system for the interconnection of a medical fluid processing system with at least one patient temperature control pad ([Abstract]). Ellingboe further teaches an intermediate connector system, similar to the connection system of Richardson, that comprises male and female connections ([0062]). Furthermore, the connection system connects to the hose in such a way that both conduits connect to a single connector as shown in Fig. 8a. The design and orientation of this connection device provides the advantage that the wrong channels through the male and female intermediate connectors will not be fluidly connected ([0062]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the connector of Ellingboe with the system of Richardson to avoid improper connections with the delivery and return lines.
Richardson further discloses that the quick connect couplings may comprise check valves to prevent fluid leakage upon removal ([0037]).
However, Richardson does not disclose the connector including a membrane configured to cover at least an opening of one of the fluid delivery conduit or the fluid return conduit.
Mathieu teaches a self-sealing tubing connector for medical apparatuses that contains valve disks for sealing in the uncoupled condition ([Abstract]). Mathieu further teaches that the female part of the connector, which would correspond to the connector on the end of the conduits from Richardson, comprises a valve disk 34, which is synonymous with a membrane, that receives the tubing of the male connector, creating a fluid connection ([page 2 of specification]). The substitution of one known element (the check valves of Richardson) for another (the valve disks of Mathieu) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the valve disk of Mathieu would have yielded predictable and equivalent results to that of Richardson, namely, sealing the conduits in the uncoupled condition.
However, the Richardson/Ellingboe/Mathieu combination would create two membranes, one covering each conduit.
It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to utilize a single membrane, since applicant has not disclosed that utilizing a single membrane over separate membrane solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a single membrane as it would two separate membranes.
Regarding claim 16, the Richardson/Ellingboe/Mathieu combination discloses the TTM pad of claim 15. The combination further teaches the single membrane is configured with a set of piercings (Mathieu [page 2 of specification]: the valve disk has a star-like cut or slit; the combination creates a single membrane that would therefore have two piercings), wherein the set of piercings of the single membrane is configured to receive (Richardson [0024]: the output port 118 is in fluid connection with supply line 120; this fluid connection means the tip of the output 118 pierces the membrane of the combination as shown in Fig. 3) a distal conduit tip of the fluid delivery lumen (the fluid delivery conduit tip 118 in Fig. 3) and a distal conduit tip of the return delivery lumen (Richardson [0025]: the input port 128 is in fluid connection with return line 130; this fluid connection means the tip of the input 128 pierces the membrane of the combination as shown in Fig. 3) thereby establishing fluid communication between the FDL hub and the connector(Richardson [0024] and [0026]: fluid connection is established between the delivery lines and the return lines).
Regarding claim 17, the Richardson/Ellingboe/Mathieu combination discloses the TTM pad of claim 16. The combination further teaches each piercing in the set of piercings is formed as one of a circular piercing, a linear slit or a star piercing (Mathieu [page 2 of specification]: the valve disk has a star-like cut or slit).
Regarding claim 18, the Richardson/Ellingboe/Mathieu combination discloses the TTM pad of claim 16. The combination further discloses the distal conduit tips of the fluid delivery lumen and the fluid return lumen are tapered from a proximal point to a distal point (the conduit tips 118 and 128 taper down from a wide base to a narrow tip as seen in Fig. 3, which is consistent with the definition of taper per Merriam-Webster: to become progressively smaller toward one end).
Regarding claim 19, the Richardson/Ellingboe/Mathieu combination discloses the TTM pad of claim 14. The combination further teaches the single membrane is configured to cover openings of each of the fluid delivery conduit (the membrane of the combination would cover the fluid delivery conduit 120 in Fig. 3 of Richardson based on the combination described above) and the fluid return conduit (the single membrane of the combination would cover the fluid delivery conduit 130 in Fig. 3 of Richardson based on the combination described above), and wherein the single membrane is configured with a first piercing corresponding to an opening of the fluid delivery conduit (Mathieu [page 2 of specification]: the valve disk has a star-like cut or slit; the first piercing would be located in to the fluid delivery conduit 120 side of the membrane of the combination) and a second piercing corresponding to an opening of the fluid return conduit (Mathieu [page 2 of specification]: the valve disk has a star-like cut or slit; the second piercing would be located on the fluid return conduit 130 side of the membrane of the combination).
Regarding claim 20, the Richardson/Ellingboe/Mathieu combination discloses the TTM pad of claim 19. The combination further teaches wherein the first and second piercings are formed as one of a circular piercing, a linear slit or a star piercing (Mathieu [page 2 of specification]: the valve disk has a star-like cut or slit).
Regarding claim 21, the Richardson/Ellingboe/Matthieu combination discloses the TTM pad of claim 19. The combination further teaches the first piercing is configured to receive (Richardson [0024]: the output port 118 is in fluid connection with supply line 120; this fluid connection means the tip of the output 118 pierces the membrane of the combination as shown in Fig. 3) a distal conduit tip of a fluid delivery lumen (the fluid delivery conduit tip 118 in Fig. 3) and the second piercing is configured to receive (Richardson [0025]: the input port 128 is in fluid connection with return line 130; this fluid connection means the tip of the input 128 pierces the membrane of the combination as shown in Fig. 3) a distal conduit tip of a fluid return lumen (the fluid return conduit tip 128 in Fig. 3) thereby establishing fluid communication between the FDL hub and the connector (Richardson [0024] and [0026]: fluid connection is established between the delivery lines and the return lines).
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.
Claims 1 and 5-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, and 8-9 of copending Application No. 17/849419.
Regarding claim 1 of the instant application, claim 1 of the copending applications recites all of the limitations of the instant application except for the single membrane. The copending application instead claims a flapper valve configured to alternate between an open and closed position. Based on Figs. 7A-7C of the copending application, the flapper valve covers both the fluid delivery conduit and the fluid return conduit, similar to that of the instant application. Based on [00056] of the copending application, the flapper valve is meant to block the openings of the conduits in the closed state. Based on [00072] of the instant application, the membrane serves the same purpose of sealing the openings of the conduits when decoupled. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that these are obvious variants of each other and it would be a simple substitution to substitute one for the other without creating an unexpected result.
Regarding claims 5-7, although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the claims of the instant claimed invention.
Instant Application
Copending Application
Claim 5: The system of claim 1, wherein the connector includes a conduit partition separates the fluid delivery conduit and fluid return conduit.
Claim 2: The system of claim 1, wherein the connector includes a connector housing having disposed therein proximal ends of the fluid delivery conduit and the fluid return conduit, a conduit partition separates the fluid delivery conduit and fluid return conduit and the flapper valve.
Claim 6: The system of claim 1, wherein the connector includes a top compression strip connected to a top latch and a bottom compression strip connected to a bottom latch, wherein each of the top latch and bottom latch extends proximally from the connector.
Claim 8: The system of claim 1, wherein the connector includes a top compression strip connected to a top latch and a bottom compression strip connected to a bottom latch, wherein each of the top latch and bottom latch extends proximally from the connector.
Claim 7: The system of claim 6, wherein the top and bottom compression strips are configured to cause movement of the top and bottom latches in opposing directions upon application of pressure to the top and bottom compressions strips.
Claim 9: The system of claim 8, wherein the top and bottom compression strips are configured to cause movement of the top and bottom latches in opposing directions upon application of pressure to the top and bottom compressions strips
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 6/11/2025 regarding the Drawing Objection to Fig. 4B have been fully considered but they are not persuasive. It appears that the replacement sheet was not attached to the submission. The examiner understands the argument and once the replacement sheet is submitted, the objection can be withdrawn. However, because the replacement sheet is not filed, the drawing objection to Fig. 4B is maintained.
Applicant’s arguments, see page 9, filed 6/11/2025, with respect to the drawing objections for failing to show the “connector housing” have been fully considered and are persuasive in light of the amendments. The objection to the drawings under 37 CPR 1.83(a) has been withdrawn.
Applicant’s arguments, see page 9, filed 6/11/2025, with respect to the specification objections have been fully considered and are persuasive in light of the amendments. The objections of the specification have been withdrawn.
Applicant’s arguments, see page 9-10, filed 6/11/2025, with respect to the 112b rejections regarding the use of “proximal” and “distal” have been fully considered and are persuasive. The 112b rejections regarding the use of “proximal” and “distal” of the claims 2-5, 11-13, 16-18, and 21 have been withdrawn.
Applicant’s arguments, see page 10, filed 6/11/2025, with respect to the 112b rejections regarding the antecedent issues of claims 2, 11, 19, and 21 have been fully considered and are persuasive in light of the amendments. The 112b rejections regarding antecedent issues of claims 2, 11, 19, and 21 have been withdrawn.
Applicant's arguments filed 6/11/2025 regarding the 112b rejection of claim 16 of lack of antecedent bases have been fully considered but they are not persuasive. Claim 16 was not amended to overcome the 112b rejection for lack of antecedent basis as the claim still recites “the return delivery lumen” in line 4. Therefore, the rejection is maintained.
Applicant's arguments filed 6/11/2025 regarding the 103 rejection of claim 1 have been fully considered but they are not persuasive. As explained in the rejection above, it would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to utilize a single membrane over two separate membranes, since applicant has not disclosed that utilizing a single membrane over separate membrane solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a single membrane as it would two separate membranes. The combination would result in the claimed single membrane configured with a first piercing (Mathieu [page 2 of specification]: the valve disk has a star-like cut or slit) configured to receive a distal conduit tip of a fluid delivery lumen (Richardson [0024]: the output port 118 is in fluid connection with supply line 120; this fluid connection means the tip of the output 118 pierces the membrane of the combination as shown in Fig. 3) and a second piercing (Mathieu [page 2 of specification]: the valve disk has a star-like cut or slit) configured to receive a distal conduit tip of a fluid return lumen (Richardson [0025]: the input port 128 is in fluid connection with return line 130; this fluid connection means the tip of the input 128 pierces the membrane of the combination as shown in Fig. 3). The design choice rejection is maintained because it was placed on the record for independent claim 8 for a very similar limitation and was not argued. Therefore, the rejection to claim 1 is maintained.
The rejections of claims 8 and 14 are maintained for the reasons above.
The rejections of the dependent claims are maintained because the rejections of the independent claims are maintained.
The provisional nonstatutory double patenting rejection of claims 1 and 5-7 being unpatentable over claims 1-3 and 8-9 of copending application number 17/849419 are maintained.
The provisional nonstatutory double patenting rejection of claim 1 being unpatentable over claims 1 and 2 of copending application number 17/848039 in view of Mathieu have been withdrawn in light of the amendments.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/W.M./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794