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(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1–20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation of “such that the plurality of supports provide support to both the gas permeable tubing and the impermeable tubing shield” (emphasis added) in claims 1, 13 and 19 lacks written description. The published Spec. only discloses the plurality of supports 114 configured to support the gas permeable tubing 104, Spec. Fig. 3, [0042]. The published Spec. does not have written description as the plurality of supports 114 provides support the impermeable tubing shield 102.
Claims 2–12, 14–18 and 20 lacks written description because they depend on claim 1, 13 and 169, respectively.
Claim Rejections - 35 USC § 102(a)(1)
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The claims are rejected as follows:
Claims 1–4, 6–7, 12–14, 17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Varga et al., EP 3 838 312 A1 (“Varga”)1.
Regarding claim 1:
Varga discloses that an infusion line gas removal device (Varga’s gas elimination apparatus 600, Varga Fig. 6D, [0044]), comprising:
a gas permeable tubing (Varga’s membrane 610) coupled between first and second couplers (Varga’s fluid inlet 601 and outlet 603, Varga Fig. 6D, [0042]);
an impermeable tubing shield (Varga’s wall 615) encasing the gas permeable tubing 610 between the first and second couplers 601 and 603, Varga Fig. 6D, [0070],
the impermeable tubing shield 615 is larger in diameter than the gas permeable tubing 610 and comprises at least one vent (Varga’s vent is covered by valve 625) and a plurality of supports (Varga’s ribs forming support cage 613 and the end flange portion in direction contact with Varga’s wall 615, see annotated Figs. 6D below),
the plurality of supports of cage being positioned between the impermeable tubing shield 615 and the gas permeable tubing 610 such that the plurality of supports provide support to both the gas permeable tubing 610 and the impermeable tubing shield 615 (Varga’s support 613 provides support to its gas permeable tubing 610, Varga Fig. 7A, [0045], and Varga’s end flange portion as annotated in Fig. 6D provides support to the impermeable tubing shield 615 because it is shown in Vargas Fig. 6D being in contact with Varga’s wall 615 and therefore would bear some weight of the wall in the orientation shown in Fig. 6D of Varga) within the impermeable tubing shield 615 in a fixed position between the first and second couplers 601 and 603 and facilitate passage of gas from the gas permeable tubing 610 to the at least one vent 625, Varga Fig. 6D, [0040].
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Regarding claim 2:
Varga discloses that the infusion line gas removal device of Claim 1, wherein the plurality of supports of cage 613 is configured to support the gas permeable tubing 610 within the impermeable tubing shield 615 in a fixed position comprises the plurality of supports being positioned to provide support to an exterior of the gas permeable tubing 610 to prevent a pressure spike within the gas permeable tubing from causing an expansion of the gas permeable tubing (Varga’s support cage 613 is located at an outer peripheral of the membrane 610 and therefore capable of restraining expansion of the membrane caused by pressure spike, Varga Fig. 6D, [0044]).
Regarding claim 3:
Varga discloses that the infusion line gas removal device of Claim 2, wherein each of the plurality of supports of cage 613 comprises at least a portion of a disc (see annotated Fig. 7A, note the end flange as annotated in Fig. 6D in claim 1 is also disc shaped with a central opening and partially encasing and provides support to the gas permeable tubing, because the end flange is an integral structure of the support cage 613) with an aperture (see annotated Fig. 7A) at its center that at least partially encases and provides support to a portion of the gas permeable tubing 610 while facilitating passage of the gas from the gas permeable tubing to the at least one vent (Varga’s discs serve as an passage for gas to pass through, Varga Fig. 6D).
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Regarding claim 4:
Varga discloses that the infusion line gas removal device of Claim 3, wherein each of the plurality of supports of cage 613 comprises a gap in an outer edge between the impermeable tubing shield and the plurality of supports (Varga’s alternative embodiment of Fig. 12 shows a gap between disc of cage 1213 and wall, Varga Fig. 12, [0057], note that in this alternative embodiment, the end flange also comprise a gap in an outer edge between the impermeable tubing shield and the plurality of the supports, the examiner maps the cage 1213 and the end flange structure to the plurality of supports in this alternative embodiment).
Regarding claim 6:
Varga discloses that the infusion line gas removal device of Claim 1, further comprising: a bubble diverter (Varga’s flow diversion member 605D) coupled to one of the first and second couplers 601 within the gas permeable tubing 610, the bubble diverter 605D is configured to direct bubbles within a fluid flowing inside the gas permeable tubing 610 toward a wall of the gas permeable tubing, Varga Fig. 6D, [0044].
Regarding claim 7:
Varga discloses that the infusion line gas removal device of Claim 1, wherein the gas permeable tubing 610 has a circular cross section, Varga Fig. 6D, [0041]. Varga also discloses that the infusion line gas removal device of Claim 1, wherein the impermeable tubing shield 615 has an ovoid cross section similar to that shown in Varga Fig. 2C, [0025].
Regarding claim 12:
Varga discloses that the infusion line gas removal device of Claim 1, wherein the gas permeable tubing has a circular cross section at the first and second couplers and an ovoid cross section between the first and second couplers (as clearly shown in Fig. 2C). Varga Fig. 2C, [0025].
Regarding claim 13:
Varga discloses that a process of providing an infusion line gas removal device (a process of using Varga’s gas elimination apparatus 600), comprising:
providing a gas permeable tubing (a process of providing Varga’s membrane 610) coupled between first and second couplers, Varga’s inlet 601 and outlet 603, Varga Fig. 6A, [0040],
encasing the gas permeable tubing 610 with an impermeable tubing shield 615 between the first and second couplers 601 and 603, Varga Fig. 6B, [0042],
wherein the impermeable tubing shield 615 is larger in diameter than the gas permeable tubing 610 and comprises at least one vent 625 and a plurality of supports (struts forming Varga’s support cage 613),
the plurality of supports of Varga’s support cage 613 being positioned between the impermeable tubing shield 615 and the gas permeable tubing 610 and such that the plurality of supports provide support to both the gas permeable tubing 610 and the impermeable tubing shield 615 (Varga’s support 613 provides support to its gas permeable tubing 610, Varga Fig. 7A, [0045], and Varga’s end flange portion as annotated in Fig. 6D shown in claim 1 provides support to the impermeable tubing shield 615 because it is shown in Vargas Fig. 6D being in contact with Varga’s wall 615 and therefore would bear some weight of the wall in the orientation shown in Fig. 6D of Varga) within the impermeable tubing shield 615 in a fixed position between the first and second couplers 601, 603 and facilitate passage of gas from the gas permeable tubing to the at least one vent, Varga Figs. 6D and 7A, [0044]–[0045].
Regarding claim 14:
Varga discloses that the process of Claim 13, further comprising forming the plurality of supports of Varga’s support cage 613 within the impermeable tubing shield 615 by positioning the plurality of supports in a manner to provide support to an exterior of the gas permeable tubing 610 to prevent a pressure spike within the gas permeable tubing from causing an expansion of the gas permeable tubing (Varga’s support cage 613 is capable of prevent a pressure spike within the gas permeable tubing from causing an expansion of the gas permeable tubing because the cage is locate at an exterior circumference of the membrane 610 and would restriction the membrane expansion from outside). Varga Figs. 6D and 7A, [0044]–[0045].
Regarding claim 17:
Varga discloses that the process of Claim 14, wherein each of the plurality of supports of cage 613 comprises at least a portion of a disc (where label 613 points in Fig. 7A would read on the term “disc” and the end portion as annotated in Varga’s Fig. 6D is in disc shape with an aperture that partially encasing and support the gas permeable tubing because it is part of the support structure) with an aperture at its center that at least partially encases and provides support to a portion of the gas permeable tubing 610 while facilitating passage of the gas from the gas permeable tubing to the at least one vent 625, where label 613 points in Fig. 6D, Varga Figs. 6D and 7A, [0044]–[0045]).
Regarding claim 19:
Varga discloses that a method for removal of gas from an infusion line, comprising
providing a gas permeable tubing coupled between first and second couplers (providing Varga’s membrane 610 between Varga’s inlet 601 and outlet 603, Varga Fig. 6D, [0044]),
providing an impermeable tubing shield 615 encasing the gas permeable tubing 610 between the first and second couplers 601 and 603, Varga Fig. 6D, [0044],
the impermeable tubing shield 615 is larger in diameter than the gas permeable tubing 610 and comprises at least one vent 625 and a plurality of supports (struts forming Vargo’s support cage 613),
the plurality of supports of support cage 615 being positioned between the impermeable tubing shield 615 and the gas permeable tubing 610 and such that the plurality of supports provide support to both the gas permeable tubing 610 and the impermeable tubing shield 615 (Varga’s support 613 provides support to its gas permeable tubing 610, Varga Fig. 7A, [0045], and Varga’s end flange portion as annotated in Fig. 6D shown in claim 1 provides support to the impermeable tubing shield 615 because it is shown in Vargas Fig. 6D being in contact with Varga’s wall 615 and therefore would bear some weight of the wall in the orientation shown in Fig. 6D of Varga) within the impermeable tubing shield 615 in a fixed position between the first and second couplers 601, 603 and facilitate passage of gas from the gas permeable tubing to the at least one vent 625, Vargo Figs. 6D and 7A, [0044]–[0045].
Claim Rejections - 35 USC § 103
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.
The claims are rejected as follows:
Claim 8 is rejected under 35 U.S.C. 103 as being obvious over Varga in view of Hooven et al., WO 2018/218082 A1 (“Hooven”).
Regarding claim 8:
Varga does not disclose that the infusion line gas removal device of Claim 1, wherein one of the first and second couplers comprises an anti-siphon valve configured to facilitate fluid moving in only one direction and to facilitate positive pressure within the gas permeable tubing.
In the analogous art of medical fluid transfer and injection apparatus, Hooven discloses a check valve that are located at an injection syringe to prevent backflow. Hooven Fig. 90, [000264]. It would therefore have been obvious for one ordinary skill in the art at the time of filing to include Hooven’s check valve at the second coupler (outlet 103) to facilitate fluid moving in only one direction and facilitate positive pressure within the gas permeable tubing, i.e, a positive pressure would prevent backflow. A person of ordinary skill in the would be motived to include such check valve/siphon valve to avoid blood backflow.
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being obvious over Varga in view of Hayakawa et al., WO 2006/103951 A1 (“Hayakawa”).
Regarding claim 9:
Varga does not disclose that the infusion line gas removal device of Claim 1, further comprising a vacuum source fluidically sealed to the at least one vent, wherein the vacuum source creates a vacuum within the impermeable tubing shield, facilitating removal of the gas from a fluid flowing inside the gas permeable tubing.
In the analogous art of liquid supplying tube for medical use, Hayakawa discloses a vacuum source (Hayakawa’s decompressor 20, which could be vacuum pump) connected to the at least one vent (Hayakawa’s suction pipe 19a), wherein the vacuum source 20 creates a vacuum within the deaeration module 13 facilitating removal of the gas from a fluid flowing inside the deaeration module 13. Hayakawa Fig. 1, [0045]. It would therefore have been obvious for one ordinary skill in the art at the time of filing to include Hayakawa’s decompressor 20 in Varga to facilitate gas venting.
Regarding claim 18:
Varga does not disclose that the process of Claim 13, further comprising fluidically sealing a vacuum source to the at least one vent, wherein the vacuum source creates a vacuum within the impermeable tubing shield, facilitating removal of the gas from a fluid flowing inside the gas permeable tubing.
In the analogous art of liquid supplying tube for medical use, Hayakawa discloses a vacuum source (Hayakawa’s decompressor 20, which could be vacuum pump) connected to the at least one vent (Hayakawa’s suction pipe 19a), wherein the vacuum source 20 creates a vacuum within the deaeration module 13 facilitating removal of the gas from a fluid flowing inside the deaeration module 13. Hayakawa Fig. 1, [0045]. It would therefore have been obvious for one ordinary skill in the art at the time of filing to include Hayakawa’s decompressor 20 in Varga to facilitate gas venting.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being obvious over Varga in view of Hayakawa and in further view of Schlienger et al., US 2021/0121614 A1 (“Schlienger”).
Regarding claim 10:
Modified Varga discloses that the infusion line gas removal device of Claim 9, wherein the vacuum source 20 comprises a vacutainer (box of decompressor 20) connected to the at least one vent 19a. Hayakawa Fig. 1, [0043].
Modified Varga does not disclose a flexible membrane, within the vacutainer, configured to flex and become concave within the flexible membrane in response to the vacuum.
Similar to modified Varga, Schlienger discloses a vacuum source (breast pump). Schlienger Fig. 1, [0116]. Schlienger discloses a vacutainer (Schlienger’s pump housing 8). Schlienger Fig. 1, [0116]. Schlienger discloses that the breast pump discloses a flexible pump membrane for producing a vacuum. Schlienger Fig. 1, claim 1. It would therefore have been obvious for one ordinary skill in the art at the time of filing for modified Varga’s vacuum source to have a similar structure as disclosed by Schlienger because a vacuum source comprising a pump membrane that changes shape (concave or convex) to produce a vacuum is known in the art.
Regarding claim 20:
Vargo does not disclose that the method of Claim 19, further comprising providing a vacuum source configured to be fluidically sealed to the at least one vent, wherein the vacuum source creates a vacuum within the impermeable tubing shield, facilitating removal of the gas from a fluid flowing inside the gas permeable tubing, and includes a flexible membrane configured to flex and become concave within the flexible membrane in response to the vacuum.
In the analogous art of liquid supplying tube for medical use, Hayakawa discloses a vacuum source (Hayakawa’s decompressor 20, which could be vacuum pump) connected to the at least one vent (Hayakawa’s suction pipe 19a), wherein the vacuum source 20 creates a vacuum within the deaeration module 13 facilitating removal of the gas from a fluid flowing inside the deaeration module 13. Hayakawa Fig. 1, [0045]. It would therefore have been obvious for one ordinary skill in the art at the time of filing to include Hayakawa’s decompressor 20 in Varga to facilitate gas venting.
Additionally, as discussed in claim 10, Schlienger discloses a vacuum source (breast pump). Schlienger Fig. 1, [0116]. Schlienger discloses that the breast pump discloses a flexible pump membrane for producing a vacuum. Schlienger Fig. 1, claim 1. It would therefore have been obvious for one ordinary skill in the art at the time of filing for modified Varga’s vacuum source to have a similar structure as disclosed by Schlienger because a vacuum source comprising a pump membrane that changes shape (concave or convex) to produce a vacuum is known in the art.
Claim 11 is rejected under 35 U.S.C. 103 as being obvious over Varga in view of Luceyk et al., US 4,038,194 A (“Luceyk”).
Regarding claim 11:
Varga does not disclose that the infusion line gas removal device of Claim 1, wherein the gas permeable tubing comprises a pleated interior surface with a plurality of ridges formed along a length of the gas permeable tubing and having a larger surface area than a tubing of a same diameter as the gas permeable tubing.
Similar to Varga, Luceyk discloses a medical degassing device comprising a gas filtering membrane structure 12. Luceyk Fig. 1, col. 2, ll. 38–44. Luceyk discloses its membrane comprises a pleated structure. Luceyk Fig. 1. Luceyk also discloses its pleated interior surface with a plurality of ridges formed along a gas of a gas permeable tubing and necessarily would have a larger surface area than a tubing of a same diameter as the gas permeable tubing. Luceyk Fig. 2. It would therefore have been obvious for one ordinary skill in the art at the time of filing to modify Varga’s 610 to be pleated structure as disclosed by Luceyk for the benefits of a larger surface area.
Claims 15–16 are rejected under 35 U.S.C. 103 as being obvious over Varga in view of Guala, US 2021/0046243 A1 (“Guala”).
Regarding claim 15:
Varga does not disclose that the process of Claim 14, wherein forming the plurality of supports within the impermeable tubing shield comprises forming the impermeable tubing shield in two molded cross sections, each cross section traversing a length of a gas permeable tubing and comprising a plurality of partial supports that, when the two molded cross sections are coupled together around the gas permeable tubing, come together to form the plurality of supports and support the gas permeable tubing within the impermeable tubing shield in the fixed position; and coupling the two molded cross sections around the gas permeable tubing.
In the analogous art of Infusion medical lines, Guala discloses an impermeable tubing shield 2, which is formed by two molded cross sections 5 and 6, and each cross section 5, 6 traversing a length of a gas permeable tubing 13 and comprising a plurality of partial supports (see annotated Fig. 8). Guala annotated Figs. 3 and 8, [0023]. Guala also discloses that when the two molded cross sections are coupled together around the gas permeable tubing 13, come together to form the a plurality of supports and support the gas permeable tubing within the impermeable tubing shield 2 in the fixed position and coupling the two molded cross sections around the gas permeable tubing 13. Guala Fig. 4, [0025]. It would have been obvious for Varga’s plurality of supports of its support cage to be formed in the same way as disclosed by Guala because such forming method is known in the art.
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Regarding claim 16:
Modified Varga discloses that the process of Claim 15, wherein the impermeable tubing shield 615, when formed, has a circular cross section (as shown in Fig. 6D), and the plurality of supports of cage 613, when formed, each comprise a disc (where label 613 points would read on the term “disc”, the end flange annotated as supports in Varga’s Fig. 6D in claim 1 also comprises a disc with an aperture in the center that constrain an end portion of the gas permeable tubing, Varga annotated Fig. 6D in Claim 1) with an aperture at its center that constrains a portion of the gas permeable tubing 610, Varga Figs. 6D and 7A, [0072] and [0051].
Allowable Subject Matter
Claim 5 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 5:
Varga does not disclose that the infusion line gas removal device of Claim 4, wherein each gap of the plurality of supports is aligned with the at least one vent, because the gap in Varga’s end flange is part of a seal structure, which is not aligned with the at least one vent. It would not have been obvious for one ordinary skill in the art at the time of filing to further modify Varga’s end flange for such limitation because there is a lack motivation to modify a seal structure to be communicating with a vent.
Response to Arguments
Claim Rejections - 35 USC § 112(b)
The examiner drops the current rejection because the applicant has amended the claims to overcome the current rejection.
Claim Rejections - 35 USC §§ 102 and 103
The examiner amends the independent claims 1, 13 and 19 to include a further limitation to require the plurality of supports to provide support to both the gas permeable tugging and the impermeable tubing shield, Applicant Rem. dated Dec. 05, 2025 (hereinafter “Applicant Rem.”) p. 8. The applicant then argues that Varga generally discloses a support cage supporting the membrane 610, but Varga does not disclose the support supports the impermeable tubing shield, Id.
In response, the examiner first points out the published Spec. only discloses the plurality of supports 114 configured to support the gas permeable tubing 104, Spec. Fig. 3, [0042]. The published Spec. does not have written description as the plurality of supports 114 provides support the impermeable tubing shield 102.
Additionally, Varga would still read on the amended claim. As shown in annotated Figs. 6D and 7A of Varga, the examiner now includes the end flange of Varga’s support cage to the mapping of the claimed “the plurality of supports” structure, and the end portion of the flange (shown in annotated Fig. 6D in claim 1 above) is in direct contact with Varga’s wall 615, and in the orientation shown in Varga’s Fig. 6D, such structure would bear a partial weight of the wall 615 and therefore read on the claimed limitation.
Applicant’s arguments are therefore not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIANPING HE whose telephone number is (571)272-8385. The examiner can normally be reached on 7:30-5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dieterle can be reached on (571) 270-7872. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Qianping He/Examiner, Art Unit 1776
1 Varga is the 40-page FOR dated Jul. 24, 2023.