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 .
Election/Restrictions
Claims 1-10 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Groups I and III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/02/2026.
Applicant's election with traverse of Group II in the reply filed on 06/02/2026 is acknowledged. The traversal is on the ground(s) that the withdrawn claims now recite subject matter in the same class as those of elected claims. Applicant’s amendment and arguments have been considered but are not persuasive. The lack of unity requirement set forth in the previous action is maintained because the fluid injector of Group I and the fluid manifold of Group II lack unity as their shared technical feature (a manifold comprising at least one fluid path section) does not make a contribution over the prior art as discussed below in view of Bae (U.S Patent Pub. No. 20200206490 A1). Examiner further notes that the claims do not recite subject matter in the same class since Group I recites a generic manifold for housing a fluid path in communication with sensor components and Group II recites a more narrow fluidic manifold having inlets, outlets, fill ports, etc. which would be searched in a different area than a generic manifold for sensor components.
The requirement is still deemed proper and is therefore made FINAL.
Response to Amendment
This office action is responsive to the amendment filed on 06/02/2026. As directed by the amendment: claims 1-2, 4, and 6-7 have been amended, claims 33-36, 46, 49, and 55 have been cancelled, and claims 56-58 have been added. Thus, claims 1-10, 18-20, 24-25, 27-28, 32, and 56-58 are presently pending in this application, with claims 1-10 and 18-20 being withdrawn from consideration.
Specification
The disclosure is objected to because of the following informalities:
Para. 00175, lines 20-21, the phrase “the manifold housing module 222” should read “the manifold housing module 220” for the proper reference number,
Appropriate correction is required.
Claim Objections
Claim 32 is objected to because of the following informalities:
Regarding claim 32, the phrase “the second fluid path within a second proximal sensor and a second distal sensor“ in lines 12-13 should read “the second fluid path with a second proximal sensor and a second distal sensor” for proper grammar,
Appropriate correction is required.
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 27 and 32 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “index” in line 3 of claim 27 is used by the claim to mean “to position in as orientation/location relative to another structure,” while the accepted meaning is “to inventory, to take stock, to measure by an associated value, to access a value by an index.” The term is indefinite because the specification does not clearly redefine the term. Examiner is interpreting this limitation in claim 27 as the at least one rib is configured to engage the manifold housing module to position the at least one fluid path section within said module in an orientation/location relative to said module.
Regarding claim 32, the phrase “a first manifold section” and “a second manifold section” in lines 3 and 4 render the claim indefinite because it is unclear. It is unclear whether these are manifold sections that are in addition to the at least one fluid path section in claim 24 or if the at least one fluid path section is comprised of the first manifold section and second manifold section. Spec. para. 00175 and Fig. 8 disclose the at least one fluid path section as comprising a first manifold section 502 and a second manifold section 504. Thus, examiner is interpreting this as the latter scenario and suggests applicant amend to state “The fluid manifold of claim 24, wherein the at least one fluid path section further comprising:”.
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) 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Bae (U.S Patent Pub. No. 20200206490 A1) in view of Smith (U.S Patent No. 4859864).
Regarding claim 24, Bae discloses the limitations of (Claim 24) a fluid manifold (T1, 501, T2, 502 in Fig. 1) for a fluid path component (see para. 0021-0023 – the fluid manifold is interpreted as the combined structure of the first connector T1, contrast-medium line 501, second connector T2, and saline line 502 which together form a fluid path), the fluid manifold (T1, 501, T2, 502) comprising:
at least one inlet port configured for fluid communication to at least one fluid reservoir (604, 605 in Fig. 1, see annotated Bae drawing 1 below and para. 0022 – the inlet side of connectors T1 and T2 in fluid communication with the syringes 604 and 605, respectively, are interpreted as the inlet ports);
at least one outlet port configured for fluid communication to at least one administration line (503 in Fig. 1, see annotated Bae drawing 1 below and para. 0021 and 0027 – the outlets of lines 501 and 502 that coupled to mixing device S are interpreted as the outlet ports which fluidly communicate with the subject line 503);
at least one fill port configured for fluid communication to at least one bulk fluid source (601, 602 in Fig. 1, see annotated Bae drawing 1 below and para. 0027 – the ports of connectors T1 and T2 coupled to valves V1 and V2 coupled to contrast chamber 601 and saline chamber 602, respectively, are interpreted as the fill ports); and
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at least one fluid path section in fluid communication with the at least one inlet port, the at least one outlet port, and the at least one fill port (see Fig. 1 and annotated Bae drawing 1 above – the interior fluid path defined by the connector T1 and line 501 is interpreted as a first fluid path section, the interior fluid path defined by connector T2 and line 502 is interpreted as a second fluid path section).
While Bae discloses that an optical sensor (530 in Fig. 1) for detecting the presence of air bubbles may be provided at a position opposed to a tube of the contrast-medium line (501 in Fig. 1) and the saline line (502 in Fig.1, see para. 0079), wherein the sidewall of the tubes (501, 502) would be positioned for light to pass therethrough, Bae fails to disclose (Claim 24) the at least one fluid path section having a sidewall having a predetermined index of refraction such that light passes through the fluid path section at a known refraction.
Smith discloses an optical sensor (26, 28 in Fig. 1-5) for detecting the presence of air bubbles in a fluid conduit (15, see Col.3, lines 12-16, lines 4-27, and Col.4, lines 16-25), wherein the fluid conduit (15) comprises a sidewall that defines an interior fluid path section (see Fig. 1-5). Smith teaches (Claim 24) the at least one fluid path section having a sidewall having a predetermined index of refraction such that light passes through the fluid path section at a known refraction (see Fig. 5, Col.5, lines 1-17 – the conduit 15 and thus its sidewall has a predetermined refractive index of about 1.35 such that light rays 50a-50c pass through at a known refraction).
Since Bae discloses that an optical sensor for detecting the presence of air bubbles may be provided at the contrast line and saline line, and Smith discloses an optical sensor for detecting the presence of air bubbles in a fluid conduit, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the contrast line and saline line of Bae to have a sidewall with a predetermined index of refraction such that light from the optical sensors pass through at a known refraction as taught by Smith according to known methods to yield predicable results. The method of using optical sensors to determine the presence of air bubbles in a fluid conduit is a known method (see Col.1, lines 39-51), and the method of Smith using refractive indices is a substantial improvement over typical systems and provides results that are achievable without only the need for the use of clear liquids (see Col.6, lines 54-65).
Regarding claim 25, modified Bae discloses the fluid manifold of claim 24, as discussed above. In modified Bae, Smith discloses (Claim 25) wherein the index of refraction of the sidewall of the at least one fluid path section is closer to an index of refraction of water than to an index of refraction of air (see Col.5, lines 8-17 – the sidewall of the conduit 15 may have a refractive index of about 1.35 which is closer to the refractive index of water [1.333] than that of air [1.00]).
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Bae in view of Smith as applied to claim 24 above, and further in view of Lampropoulos et al. (U.S Patent No. 6170785 B1, “Lampropoulos”).
Regarding claim 27, modified Bae discloses the fluid manifold of claim 24, as discussed above.
While Bae discloses that the first connector (T1), contrast-medium line (501), second connector (T2), and saline line (502) are at least partially received in a groove formed in the base portion (606 in Fig. 1, see para. 0034), modified Bae fails to disclose (Claim 27) wherein the at least one fluid path section comprises at least one rib extending radially outward and configured to engage a manifold housing module to index the fluid path section in the manifold housing module.
Lampropoulos discloses a manifold (130 in Fig. 6-7) for coupling to a medical device (20 in Fig. 6-7), wherein the manifold (130) which comprises a plurality of inlets, outlets, valves, and connectors defines a fluid path section (see Abstract and Col.5, lines 20-31). Lampropoulos teaches (Claim 27) wherein the at least one fluid path section comprises at least one rib (148 in Fig. 8) extending radially outward and configured to engage a manifold housing module (100 in Fig. 6-8) to index the fluid path section in the manifold housing module (100, examiner notes this limitation is being interpreted in light of the 112(b) rejection above as the at least one rib is configured to engage the manifold housing module to position the at least one fluid path section within said module in an orientation/location relative to said module, see Fig. 7-8 and Col.5, line 56 - Col.6, line 4 – rib 148 extends radially outwardly from the flange 144 of manifold 130 and engages the groove 112 of bracket 100 to position the manifold 130 in a desired positioned).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the manifold taught by modified Bae to incorporate the at least one rib for engaging in a groove of the manifold housing module as taught by Lampropoulos such that the first connector (T1) and contrast-medium line (501) would have a connecting flange to the second connector (T2) and saline line (502) therebetween and said connecting flange would comprise a rib for engaging in a corresponding groove provided on the base portion (606). Lampropoulos teaches a variety of different coupling mechanisms between the manifold and the medical device, with the embodiment of Fig. 6-8 disclosing one such mechanism that provides convenient orientation of the manifold to be able to manipulate the valves and the ports of said valves are readily accessible for connection to tubing (see Col.5, lines 45-55).
Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Bae in view of Smith as applied to claim 24 above, and further in view of Cobb, Jr. (U.S Patent No. 4805984, “Cobb”).
Regarding claim 28, modified Bae discloses the fluid manifold of claim 24, as discussed above.
However, modified Bae fails to disclose (Claim 28) wherein the at least one fluid path section has a surface finish configured to concentrate or disperse light passing through the fluid path section.
Cobb discloses a hollow, tubular light conduit (10 in Fig. 1) comprising a sidewall (11 in Fig. 1) that has a surface finish (16 in Fig. 2-3) that is configured to disperse light striking the surface (14, see Col. 3, line 60 – Col.4, lines 25).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sidewall of the at least one fluid path section as taught by modified Bae to have a surface finish configured to disperse light passing therethrough as taught by Cobb. Cobb teaches that the conduit through which light is passed for optical sensing may be manipulated using a surface finish in order to tailor light distribution in a desired fashion (see Col.7, line 65 – Col.8, line 3). Thus, the optical sensor of modified Bae would beneficially be used with a fluid conduit having the surface finish of Cobb to control the distribution of light passed therethrough and thus improve the distinguishment between air and liquid within the fluid conduit.
Claim(s) 32 is rejected under 35 U.S.C. 103 as being unpatentable over Bae in view of Smith as applied to claim 24 above, and further in view of Stokes, JR. et al. (U.S Patent Pub. No. 20120123257 A1, “Stokes”) in view of Meijer (U.S Patent No. 4658244) in view of Lampropoulos.
Regarding claim 32, modified Bae discloses the fluid manifold of claim 24, as discussed above. In modified Bae, Bae discloses the limitations of (Claim 32) further comprising:
a first manifold section (T1, 501 in Fig. 1) defining a first fluid path for a first medical fluid (see para. 0021-002);
a second manifold section (T2, 502) defining a second fluid path for a second medical fluid (see para. 0021 and 0023); and
wherein the first fluid path is isolated from the second fluid path (see Fig. 1 and para. 0021-0023 – the contrast fluid in connector T1 and line 501 is isolated from the saline fluid in connector T2 and line 502 before they reach the mixing device S).
However, modified Bae fails to disclose (Claim 32) at least one connecting beam connecting the first manifold section to the second manifold section, wherein the at least one connecting beam orients the first manifold section and the second manifold section in a position to fit within the manifold housing module and correctly interface the first fluid path with a first proximal sensor and a first distal sensor and interface the second fluid path within a second proximal sensor and a second distal sensor.
Stokes discloses a similar contrast-saline injector (10 in Fig. 1-17) which comprising a first manifold section comprising a first connector (1150 in Fig. 3) and contrast line (1504 in Fig. 3) and a second manifold section comprising a second connector (1150 in Fig. 3) and saline line (1502 in Fig. 3, see para. 0146), wherein Stokes teaches that the first manifold section (1150, 1504) and the second manifold section (1150, 1502) are positioned to fit within the manifold housing module (200, 300 in Fig. 17) and correctly interface with a first air detector (320 in Fig. 17) and second air detector (320 in Fig. 17), respectively, (see para. 0114 and 0121).
Since Bae discloses that an optical sensor (530 in Fig. 1) for detecting the presence of air bubbles may be provided at a position opposed to a tube of the contrast-medium line (501 in Fig. 1) and the saline line (502 in Fig.1, see para. 0079), and Stoke explicitly discloses a manifold (1150, 1502, 1504 in Fig. 1-17) positioned to fit within a manifold housing module (200, 300) to correctly interface the contrast line (1504) with a first air detector (320) and the saline line (1502) with a second air detector (320, see para. 0114 and 0121), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the manifold taught by modified Bae to have a first and second optical sensor such that the manifold sections are positioned to fit within the manifold housing module to correctly interface the manifold sections with said sensors as taught by Stokes according to known methods to yield predictable results. Stoke teaches that air detectors (32) are positioned on both the contrast and saline lines such that fluid drawn into and dispense from the syringes during their operation are subject to air detection when out-going from the syringes (see para. 0121), and thus the snap-fit engagement between the manifold and manifold housing module positions the contrast and saline lines for air detection (see para. 0114 and 0121). One of ordinary skill in the art could have recognized that fluid conduits intended for air detection are interfaced in such a way to correctly position said conduits with said sensors.
Meijer discloses a fluid line (22 in Fig. 1-2) positioned within a channel (56 in Fig. 2) of a fluid detector (12 in Fig. 1) comprising a plurality of optical sensors (see Fig. 3-4, see Abstract and Col.4, lines 30-31 and lines 46-67 – the plurality of light emitters 30, 32, 34, 36, and 38 optically communicate with a plurality of light detectors 40, 42, 44, 46, 48 to form a plurality of optical sensors for detecting the presence of air bubbles within the fluid line 22). Meijer teaches wherein the fluid detector (12) comprises a first proximal sensor and a first distal sensor (see Fig. 8a-8b and see Col.5, line 62 – Col.6, line 12 – Fig. 8a-8b shows the embodiment of Fig. 1-4 in operation with a first optical sensor 90 in series with a second optical sensor 92 for detecting presence of air bolus in fluid line 22).
Since Stoke discloses an air detector (320) positioned on each the contrast line (1504) and saline line (1502), and Meijer discloses an air detector (12) comprising a plurality of optical sensors positioned on a fluid line (22, see Fig. 8a-8b), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the each air detector of Stokes in modified Bae to comprise a distal sensor and a proximal sensor as taught by Meijer such that modified Bae would comprise a first distal sensor and a first proximal sensor on the contrast line and a second distal sensor and a second proximal sensor on the saline line. Meijer teaches that an air detector comprising at least two optical sensors can be used in an ON-OFF mechanism which provides redundancy in the air detection system (see Col.3, lines 1-36).
Lampropoulos discloses a manifold (130 in Fig. 6-7) for coupling to a medical device (20 in Fig. 6-7), wherein the manifold (130) which comprises a plurality of inlets, outlets, valves, and connectors defining a fluid path section (see Abstract and Col.5, lines 20-31). Lampropoulos teaches at least one connecting beam (142 in Fig. 8) connecting the plurality of manifold sections (134, 136, 138 in Fig. 6-7, see Col.5, lines 33-45), wherein the at least one connecting beam (142) orients the plurality of manifold sections (134, 136, 138) in a position to fit within the manifold housing module (100 in Fig. 6-7) and correctly interface with other components (see Col.5, lines 45-63 – connecting beam 142 comprises a flange 144 with a rib 148 to fit within a groove 112 of manifold housing module 100 which positions and correctly interfaces the ports of valves 134, 136, 138 for connection to other components).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the manifold taught by modified Bae to incorporate the at least one connecting beam as taught by Lampropoulos such that the manifold would have a connecting beam between the first connector (T1) and the second connector (T2) and said connecting beam would comprise a rib for engaging in a corresponding groove provided on the base portion (606). Lampropoulos teaches a variety of different coupling mechanisms between the manifold and the medical device, with the embodiment of Fig. 6-8 disclosing one such mechanism that provides convenient orientation of the manifold to be able to manipulate the valves and the ports of said valves are readily accessible for connection to tubing (see Col.5, lines 45-55).
Claim 32 is taught with Bae disclosing the first manifold section and second manifold section which are modified to have the connecting beam of Lampropoulos therebetween such that they are positioned to fit within the manifold housing. Bae is further modified in view of Stokes in view of Meijer to comprise air detectors on each the contrast line and the saline line, wherein each air detector comprises two optical sensors. Thus, the connecting beam of Lampropoulos would correctly interface the first manifold section with the first air detector and the second manifold section with the second air detector.
Claim(s) 56 is rejected under 35 U.S.C. 103 as being unpatentable over Bae in view of Smith as applied to claim 24 above, and further in view of Rosenberg (U.S Patent No. 3710942).
Regarding claim 56, modified Bae discloses the fluid manifold of claim 24, as discussed above. However, modified Bae fails to disclose (Claim 56) wherein the at least one fluid path section is rigid.
Rosenberg discloses a T-connector (see Fig. 3) which can be used to couple a syringe to an additional reserve container (see Col.1, lines 20-25 and Col.2, lines 12-15), wherein the T-connector defines a portion of a fluid path section and is rigid (see Col.2, lines 39-42).
Since Bae discloses that a portion of the fluid path section is formed by T-connectors (T1, T2 in Fig. 1), and Rosenberg discloses features of a similarly used T-connector (see Fig. 3), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the T-connectors of modified Bae to be rigid as taught by Rosenberg. Rosenberg provides that having the T-connectors be formed of a rigid, non-pressure-deformable material ensures that none of the fluid available fluid pressure delivered via the syringe is lost in distending the connector (see Col.2, lines 39-42).
Claim(s) 57 is rejected under 35 U.S.C. 103 as being unpatentable over Bae in view of Smith as applied to claim 24 above, and further in view of Trocki et al. (U.S Patent Pub. No. 20070272311 A1, “Trocki”).
Regarding claim 57, modified Bae discloses the fluid manifold of claim 24, as discussed above.
However, modified Bae fails to disclose (Claim 57) wherein each of the at least one outlet ports comprises a check valve.
Trocki discloses an injection system (see Fig. 4A-4B) comprising two syringes (410a, 410b) containing contrast medium and saline, respectively, (see para. 0062), and a manifold (400 in Fig. 4A-4B) wherein each syringe (410a, 410b) has an inlet port at the exit of each syringe (410a, 410b), a fill port for refilling (see para. 0071), and an outlet port comprising the check valves (430a, 430b in Fig. 4a-4b, see para. 0071).
Since Bae discloses a manifold comprising an outlet port on each the contrast medium line and the saline line before they reach a mixing point, and Trocki discloses an outlet port on each the contrast line and the saline line before they reach a mixing point, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outlet ports of modified Bae to each have a check valve as taught by Trocki. Trocki teaches that the one way check valves prevent reverse mixing or backflow of fluids into the reservoirs (410a, 410b, see para. 0071).
Claim(s) 58 is rejected under 35 U.S.C. 103 as being unpatentable over Bae in view of Smith as applied to claim 24 above, and further in view of Riphagen et al. (U.S Patent Pub. No. 20180036480 A1, “Riphagen”).
Regarding claim 58, modified Bae discloses the fluid manifold of claim 24, as discussed above.
However, modified Bae fails to disclose (Claim 58) wherein the at least one fluid path section is transparent to at least one of ultraviolet light, visible light, and infrared light.
Riphagen discloses a manifold (2 in Fig. 1-2) for an infusion system (1) wherein the housing (3) of the manifold (2) which forms a section of the fluid path may be transparent to visible light (see para. 0014 and 0045).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the manifold of modified Bae to have at least a portion of the fluid path section be transparent to visible light as taught by Riphagen. Riphagen provides that by being transparent to visible light, it allows for simple detection of whether the fluid path section is filled with fluid by means of a human eye (see para. 0014).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783