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 § 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.
Claim(s) 1-2, 5, 9, 11-12, 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Childs et al. (US Patent Pub. 20170120039 hereinafter “Childs”) in view of Kopperschmidt (US Patent 8177736), Fournie et al. (US Patent 7462170 hereinafter “Fournie”) and Osborne et al. (US Patent 5807333 hereinafter “Osborne”)
Regarding Claim 1, Childs teaches (Fig 1, 11-12) A disposable, molded tubing set configured for use in an enteral feeding system, comprising:
a first tube segment (122) having a first inlet and a first outlet and a second tube segment (124) having a second inlet and a second outlet, wherein the first tube segment and the second tube segment are configured to be parallel to each other and wherein the first inlet and the second inlet are connected to a first attachment component (128/502 in Fig 11, see [0049] teaching 500 can replace 128);
a Y connector (526) having a first Y connector inlet (inlet near 510), a second Y connector inlet (inlet near 512) and a Y connector outlet (outlet near 526), wherein the first outlet is connected to the first Y connector inlet and the second outlet is connected to the second Y connector inlet (see Figs 11-12, the tube portions outlets are connected to the y connector inlets); and
a third tube segment (126) having a third inlet (portion of 126 connected to y connector in Fig 1) and a third outlet (other side of 126); wherein the third inlet is connected to the Y connector outlet and wherein the third outlet is connected to a second attachment component (portion that holds 126 in place on 120).
Childs does not specify the first attachment component is attached to a most proximal entry point of the first inlet of the first tube segment and to a most proximal entry point of the second inlet of the second tube segment, and wherein the first attachment component is configured to be removably attached to a housing of the enteral feeding system;
Kopperschmidt teaches (Fig 2) an attachment component (26) that could be placed at any location of tubes to retain the tubes parallel to one another (Col 6 lines 39-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first attachment component of Childs such that it is an attachment component as seen in in Kopperschmidt. One of ordinary skill in the art would have been motivate to do so as it would be a similar design that would allow the user to attach the tubes at any location desired, while still running the tube segments parallel to each other (Kopperschmidt Col 6 lines 39-42).
The combination does not specify a second attachment component physically attached to the y-connector and configured to be removably attachable to the housing of the enteral feeding system; and
Fournie teaches (Fig 3b) a y connector (14) with a second attachment component (29) physically attached to the y-connector and configured to be removably attachable to the housing (See Col 5 lines 43-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the y-connector of Childs such that it includes a second attachment component physically attached to the y-connector and configured to be removably attachable to the housing of the enteral feeding system as taught by Fournie. One of ordinary skill in the art would have been motivated to do so in order to easily engage the y-connector to the apparatus (Fournie Col 5 lines 43-45).
The combination does not specify wherein the third outlet is connected to a third attachment component, and wherein the third attachment component is configured to be removably attachable to the housing of the enteral feeding system.
Osborne teaches (Fig 4) a third attachment component (56) that is configured to be removably attachable to the housing (Col 10 lines 24-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Childs such that it includes a third attachment component, and wherein the third attachment component is configured to be removably attachable to the housing of the enteral feeding system as taught by Osborne. One of ordinary skill in the art would have been motivated to do so in order to replaceably retain the tube segment to the housing (Osborne Col 10 lines 45-55).
Regarding Claim 2, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 1 as described above. Childs further teaches the disposable, molded tubing set wherein the first tube segment and the second tube segment comprise material having a first durometer value (necessarily true, any tube segment will comprise a material that has a durometer value).
Regarding Claim 5, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 1 as described above. Childs does not specify the disposable, molding tubing set wherein the third tubing segment is made of silicone.
Osborne teaches (Col 8 lines 61-64) a tubing set portion (49) made of an elastically flexible silicone rubber.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the third tubing segment of Childs such that it is made of silicone as taught by Osborne. One of ordinary skill in the art would have been motivated to do so as this is a known material used for enteral tubing sets. Additionally, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Regarding Claim 9, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 1 as described above. Kopperschmidt further teaches the disposable, molded tubing set wherein the first attachment component (26) comprises two channels (28, 29) connected to each other by a bridge member (Portion where 28 and 29 are attached).
Regarding Claim 11, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 1 as described above. Childs further teaches the disposable, molded tubing set further comprising a pinch wall (505, 506) positioned between the first tube segment and the second tube segment (See Figs 11-13).
Regarding Claim 12, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 11 as described above. Childs further teaches the disposable, molded tubing set wherein the pinch wall is moved closer to the first tube segment for stopping fluid flow in the first tube segment, and wherein the pinch wall is moved closer to the second tube segment for stopping fluid flow in the second tube segment (See Figs 11-13; [0049-0051]).
Regarding Claim 14, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 1 as described above. Childs further teaches the disposable, molded tubing set wherein each of the first tube segment, the second tube segment, the Y connector, and the third tube segment constitute a single molded, monolithic component (this is considered a product by process claim. Since Childs teaches all structural elements of the claim Childs meets the limitations of the claim).
Regarding Claim 15, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 1 as described above. Childs does not teach the disposable, molded tubing set further comprises a pair of protrusions extending outwards from the Y connector for attaching the first Y connector inlet with the first outlet of the first tube segment and the second Y connector inlet with the second outlet of the second tube segment.
Osborne teaches (Figs 35-38) a connector (56) with protrusions (65g-65j) extending outwards from the connector.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the y connector of Childs such that it includes a pair of protrusions extending outwards from the connector as taught by Osborne. One of ordinary skill in the art would have been motivated to do so in order to help retain the connector element in the pump element and provide additional stability to the user during insertion and removable of the connector element (Osborne Col 11 lines 30-49).
Regarding Claim 16, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches the disposable, molded tubing set of claim 15, wherein the pair of protrusions provide structural integrity to the first and the second tube segments when connected to the Y connector (with the modification done in claim 15, the protrusions 65 would provide additional structural integrity by securing the first and second tube elements to the pump system).
Regarding Claim 17, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches the disposable, molded tubing set of claim 15, wherein the pair of protrusions are positioned at a center of a length of the Y connector (See annotated Fig 11, where the protrusions will be added).
PNG
media_image1.png
279
456
media_image1.png
Greyscale
Annotated Fig 11 (Childs)
Regarding Claim 18, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches the disposable, molded tubing set of claim 15, wherein the pair of protrusions are positioned on an outer surface of the Y connector (See Osborne Figs 35-38, protrusions 65 are on an outer surface).
Regarding Claim 19, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches the disposable, molded tubing set of claim 15, wherein the pair of protrusions are positioned within an outer surface of the Y connector (See Osborne Figs 35-38, protrusions 65 are on an outer surface).
Regarding Claim 20, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 1 as described above. Childs further teaches the disposable, molded tubing set being configured for use in a dual-use enteral feeding or flushing system (this is considered an intended use limitation, the device of Childs could be used for enteral feeding or for flushing as it comprises all the structural limitations required of the claim).
Claim(s) 3-4, 8 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Childs (US Patent Pub. 2017012003) in view of Kopperschmidt (US Patent 8177736), Fournie (US Patent 7462170) and Osborne (US Patent 5807333) as applied to claim 1 above, and further in view of Dimalanta et al. (US Patent Pub. 20100056991 hereinafter “Dimalanta”).
Regarding Claim 3, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 2 as described above. Childs does not specify the disposable, molded tubing set wherein the third tube segment comprise material having a second durometer value, wherein the first durometer value is less than the second durometer value.
Dimalanta teaches tubing with sections comprising different materials [0033] and different durometers [0028].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the materials of the tubing segments of Childs such that the third tube segment comprise material having a second durometer value, wherein the first durometer value is less than the second durometer value as taught by Dimalanta. One of ordinary skill in the art would have been motivated to do so in order to have differing levels of compliance for the various sections of tubing (see Dimalanta [0033]). Additionally, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Regarding Claim 4, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 2 as described above. Childs does not specify the disposable, molded tubing set wherein the third tube segment comprise material having a second durometer value, and wherein the first durometer value is substantially equal to the second durometer value.
Dimalanta teaches tubing with sections comprising different materials [0033] and different durometers [0028].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the materials of the tubing segments of Childs such that the third tube segment comprise material having a second durometer value, and wherein the first durometer value is substantially equal to the second durometer value as taught by Dimalanta. One of ordinary skill in the art would have been motivated to do so in order to have substantially similar levels of compliance for the various sections of tubing (see Dimalanta [0033]). Additionally, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Regarding Claim 8, the combination of Childs, Kopperschmidt , Fournie, Osborne and Dimalanta teaches all elements of claim 3 as described above. The combination does not specify the disposable, molded tubing set wherein the first attachment component, the second attachment component, and the third attachment component comprise material having a durometer value that is greater than the first durometer value or second durometer value.
Dimalanta further teaches [0027] that transition sections may include connectors.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first, second and third attachment components of Childs such that the first attachment component, the second attachment component, and the third attachment component comprise material having a durometer value that is greater than the first durometer value or second durometer value. It has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Regarding Claim 13, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 1 as described above. Childs does not specify the disposable, molded tubing set of claim 1, wherein each of the first tube segment and the second tube segment have a greater degree of compliance compared to silicone and a lower degree of compliance compared to PVC tubing.
Dimalanta teaches [0033] known materials and possible durometer and compliance characteristics for medical tubing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first tube segment and second tube segment of Childs such that each of the first tube segment and the second tube segment have a greater degree of compliance compared to silicone and a lower degree of compliance compared to PVC tubing as taught by Dimalanta. It has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Childs (US Patent Pub. 2017012003) in view of Kopperschmidt (US Patent 8177736), Fournie (US Patent 7462170) and Osborne (US Patent 5807333) as applied to claim 1 above, and further in view of Brader (US Patent 4869718).
Regarding Claim 6, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 1 as described above. Childs does not specify the disposable, molded tubing set wherein the third tube segment is made of polyorganosiloxane and amorphous silica having a specific gravity in a range of 1.05 g/cm3 to 1.3 g/cm3.
Brader teaches (Col 4 lines 42-50) medical grade silicon rubber (polyorganosiloxane) is a known material in the medical art.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the third tube segment of Childs such that it is made of polyorganosiloxane and amorphous silica. It has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
The combination of Childs and Brader does not specify a specific gravity in a range of 1.05 g/cm3 to 1.3 g/cm3. The instant disclosure [0088] describes the parameter of a specific gravity in a range of 1.05 g/cm3 to 1.3 g/cm3 as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as a specific gravity in a range of 1.05 g/cm3 to 1.3 g/cm3 are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of a specific gravity in a range of 1.05 g/cm3 to 1.3 g/cm3 would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 7, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 1 as described above. Childs does not specify the disposable, molded tubing set wherein the third tube segment is made of polyorganosiloxane and amorphous silica having a specific gravity in a range of 1.11 g/cm3 to 1.18 g/cm3.
Brader teaches (Col 4 lines 42-50) medical grade silicon rubber (polyorganosiloxane) is a known material in the medical art.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the third tube segment of Childs such that it is made of polyorganosiloxane and amorphous silica. It has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
The combination of Childs and Brader does not specify a specific gravity in a range of 1.11 g/cm3 to 1.18 g/cm3. The instant disclosure [0088] describes the parameter of a specific gravity in a range of 1.11 g/cm3 to 1.18 g/cm3 as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as a specific gravity in a range of 1.11 g/cm3 to 1.18 g/cm3 are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of a specific gravity in a range of 1.11 g/cm3 to 1.18 g/cm3 would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Childs (US Patent Pub. 2017012003) in view of Kopperschmidt (US Patent 8177736), Fournie (US Patent 7462170) and Osborne (US Patent 5807333) as applied to claim 1 above, and further in view of Heyns et al. (US Patent Pub. 20140163528 hereinafter “Heyns”).
Regarding Claim 10, the combination of Childs, Kopperschmidt , Fournie and Osborne teaches all elements of claim 1 as described above. Childs does not specify the disposable, molding tubing set wherein each of the first tube segment, the second tube segment , the y connector, and the third tube segment comprise one or more plastic portions.
Heyns teaches [0044] that plastic is a common material for disposable medical equipment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first tube segment, the second tube segment, the y connector, and the third tube segment of Childs such that it includes one or more plastic portions as taught by Heyns. One of ordinary skill in the art would have been motivated to do so as this is a known material for disposable medical equipment (Heyns [0040]). Additionally, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection takes into consideration the amendments filed 8/7/2025.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783