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 .
Acknowledgments
In the reply, filed on March 22, 2026, Applicant amended claims 1-3, 6-7, 9, 14, 16-17, 27-28, 30, and 48.
Applicant cancelled claims 4-5, 8, 10, 32, and 56.
Applicant added new claims 64-72.
In the non-final rejection of December 23, 2025, Examiner objected to the Drawings under 37 CFR 1.83(a). Applicant amended Figures 1, 2A, 3A, and 3B. Objection is withdrawn.
Examiner objected to the Disclosure. Applicant amended the Specification. Objection is withdrawn.
Examiner objected to claims 1-4, 6-8, 14, 27-28, and 56. Applicant amended claims 1-3, 6-7, 14, and 27-28, and cancelled claims 4, 8, and 56. Objection is withdrawn.
Examiner rejected claims 1-14, 16-18, 25, 27-28, 30, 32, 36, 40-41, 48, and 56 under 35 U.S.C. 112(b). Applicant amended claims 1, 6, 28, 30, and 48, and cancelled claims 5 and 56. Rejection is withdrawn.
Currently, claims 1-3, 6-7, 9, 11-14, 16-18, 25, 27-28, 30, 36, 40-41, 48, and 64-72 are under examination.
Claim Objections
Claims 7, 25, 64, 67, and 70-72 are objected to because of the following informalities:
In regards to claim 7, lines 3-4, “the one or more deformable sealing element” should be changed to “the one or more deformable sealing elements”.
In regards to claim 7, lines 6-7, “the one or more deformable sealing element” should be changed to “the one or more deformable sealing elements”.
In regards to claim 25, line 3, “the open configuration” should be changed to “an open configuration”.
In regards to claim 64, line 5, “the first hinge knuckle” should be changed to “the first hinge knuckles”.
In regards to claim 64, line 6, “the second hinge knuckle” should be changed to “the second hinge knuckles”.
In regards to claim 67, line 5, “the first hinge knuckle” should be changed to “the first hinge knuckles”.
In regards to claim 67, line 6, “the second hinge knuckle” should be changed to “the second hinge knuckles”.
In regards to claim 70, line 1, “The device” should be changed to “The system”.
In regards to claim 70, line 5, “the first hinge knuckle” should be changed to “the first hinge knuckles”.
In regards to claim 70, line 6, “the second hinge knuckle” should be changed to “the second hinge knuckles”.
In regards to claim 71, line 1, “The device” should be changed to “The system”.
In regards to claim 72, line 1, “The device” should be changed to “The system”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-3, 6-7, 9, 11-14, 16-18, 25, 27-28, 30, 36, 40-41, 48, and 64-72 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.
In regards to claim 1, line 27 recites: a “deformable” sealing element; however, such is new matter not described in the Specification. Claims 2-3, 11-14, 16-18, 25, 27, and 64-66 are rejected by virtue of being dependent upon claim 1.
In regards to claim 3, lines 2-3 recite: the “deformable” sealing element; however, such is new matter not described in the Specification.
In regards to claim 6, line 15 recites: one or more “deformable” sealing elements; however, such is new matter not described in the Specification. Claims 7, 9, and 67-69 are rejected by virtue of being dependent upon claim 6.
In regards to claim 6, line 29 recites: the one or more “deformable” sealing elements; however, such is new matter not described in the Specification. Claims 7, 9, and 67-69 are rejected by virtue of being dependent upon claim 6.
In regards to claim 7, lines 3-4 recite: the one or more “deformable” sealing element; however, such is new matter not described in the Specification.
In regards to claim 7, lines 6-7 recite: the one or more “deformable” sealing element; however, such is new matter not described in the Specification.
In regards to claim 28, line 9 recites: a “deformable” sealing element; however, such is new matter not described in the Specification. Claims 30, 36, 40-41, 48, and 70-72 are rejected by virtue of being dependent upon claim 28.
In regards to claim 28, line 21 recites: the “deformable” sealing element; however, such is new matter not described in the Specification. Claims 30, 36, 40-41, 48, and 70-72 are rejected by virtue of being dependent upon claim 28.
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 1-3, 6-7, 9, 11-14, 16-18, 25, 27-28, 30, 36, 40-41, 48, and 64-72 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.
In regards to claim 1, line 31 recites “tubing”. Claim 1, line 15 previously recites “tubing”. It is unclear whether the two recitations are the same or different. Claims 2-3, 11-14, 16-18, 25, 27, and 64-66 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 32 recites “tubing”. Claim 1, line 15 previously recites “tubing” and line 31 previously recites “tubing”. It is unclear whether the three recitations are the same or different. Claims 2-3, 11-14, 16-18, 25, 27, and 64-66 are rejected by virtue of being dependent upon claim 1.
In regards to claim 6, line 28 recites “tubing”. Claim 6, line 24 previously recites “tubing”. It is unclear whether the two recitations are the same or different. Claims 7, 9, and 67-69 are rejected by virtue of being dependent upon claim 6.
In regards to claim 6, line 32 recites “tubing”. Claim 6, line 24 previously recites “tubing” and line 28 previously recites “tubing”. It is unclear whether the three recitations are the same or different. Claims 7, 9, and 67-69 are rejected by virtue of being dependent upon claim 6.
In regards to claim 6, line 34 recites “tubing”. Claim 6, line 24 previously recites “tubing”, and line 28 previously recites “tubing”, and line 32 previously recites “tubing”. It is unclear whether the four recitations are the same or different. Claims 7, 9, and 67-69 are rejected by virtue of being dependent upon claim 6.
In regards to claim 7, lines 3-4 recite “one of the one or more deformable sealing element”. Claim 7 depends upon claim 6. Claim 6, line 29 recites “one of the one or more deformable sealing elements”. It is unclear whether the two recitations are the same or different.
In regards to claim 9, line 3 recites “tubing”. Claim 9 depends upon claim 6. Claim 6, line 24 previously recites “tubing”, line 28 previously recites “tubing”, line 32 previously recites “tubing”, and line 34 previously recites “tubing”. It is unclear whether the five recitations are the same or different.
In regards to claim 28, line 24 recites “tubing”. Claim 28, line 8 previously recites “a fluid outlet tube” and line 14 previously recites “a fluid inlet tube”. It is unclear whether “tubing” is the same or different from “a fluid outlet tube” and “a fluid inlet tube”. Claims 30, 36, 40-41, 48, and 70-72 are rejected by virtue of being dependent upon claim 28.
In regards to claim 28, line 25 recites “tubing”. Claim 28, line 8 previously recites “a fluid outlet tube”, line 14 previously recites “a fluid inlet tube”, and line 24 previously recites “tubing”. It is unclear whether “tubing” of line 25 is the same or different from “a fluid outlet tube”, “a fluid inlet tube”, and “tubing” of line 24. Claims 30, 36, 40-41, 48, and 70-72 are rejected by virtue of being dependent upon claim 28.
In regards to claim 64, line 5 recites “the hinge pin”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 67, line 5 recites “the hinge pin”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 70, line 5 recites “the hinge pin”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 6-7, 9, 12-13, 25, 28, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bentley et al (US 2017/0333680).
In regards to claim 1, Bentley et al teaches a tubing connector protection device (Figures 1-4) comprising:
body sections (102/104) comprising:
a first body section (102) defining a first internal cavity (Figures 1-3)
a second body section (104) defining a second internal cavity (Figures 1-3), the second body section being hingeably connected to the first body section (paragraph [0021]: hinge)
wherein, in a closed configuration, the first internal cavity and the second internal cavity are adjacent to create a connector cavity configured to contain a first connector (Figure 4)
tubing notches (108A/108B) comprising:
a first tubing notch (108A)
a second tubing notch (108B)
wherein the first tubing notch and the second tubing notch are positioned to align when the device is in the closed configuration, thereby forming a first hole (106A) in the device, the first hole configured to accommodate tubing passing therethrough (Figure 4)
c. a deformable sealing element (paragraph [0027]: gasket):
i. disposed in proximity to the first hole (paragraph [0027]: Each port can have a gasket)
ii. configured to prevent contamination from entering the connector cavity when the device is in the closed configuration (paragraph [0027]: The seal acts as a dust and dirt barrier, and generally protects the interior of the catheter protection device from contamination when the port is not being used) and:
the first hole accommodates tubing passing therethrough (paragraph [0027]: Each port can have a gasket disposed at the port to… cushion the tubing when inserted through the port)
in an absence of tubing passing through the first hole (paragraph [0027]: Each port can have a gasket disposed at the port… to effectively seal off the port when the port is not in use)
In regards to claim 2, Bentley et al teaches wherein the first hole is located at a first end of the device (Figure 1)
In regards to claim 3, Bentley et al teaches wherein at least one of the first tubing notch or the second tubing notch comprises the deformable sealing element (paragraph [0027]).
In regards to claim 6, Bentley et al teaches a tubing connector protection device (Figures 1-4) comprising:
a first body section (102):
extending from a first end to a second end (Figures 1-4)
defining a first internal cavity (Figures 1-3)
having a first section first tubing notch (108A) positioned at the first end of the first body section and a first section second tubing notch (108C) positioned at the second end of the first body section
a second body section (104):
extending from a first end to a second end (Figures 1-4)
defining a second internal cavity (Figures 1-3)
having a second section first tubing notch (108B) positioned at the first end of the second body section and a second section second tubing notch (108D) positioned at the second end of the second body section
c. one or more deformable sealing elements (paragraph [0027]: gasket)
d. wherein:
i. the device has an open configuration (Figures 1-3) and a closed configuration (Figure 4)
ii. the first body section and the second body section are hingeably connected (paragraph [0021]: hinge)
iii. in the closed configuration of the device:
the first internal cavity and the second internal cavity are adjacent to create a connector cavity configured to contain a first connector (Figure 4)
the first section first tubing notch and the second section first tubing notch are positioned to align, thereby forming a first hole (106A) in the device, the first hole configured to accommodate tubing passing therethrough (Figures 3-4)
the first section second tubing notch and the second section second tubing notch are positioned to align, thereby forming a second hole (106B) in the device, the second hole configured to accommodate tubing passing therethrough (Figures 3-4)
one of the one or more deformable sealing elements is configured to prevent contamination from entering the connector cavity through one of the first hole or the second hole (paragraph [0027]: The seal acts as a dust and dirt barrier, and generally protects the interior of the catheter protection device from contamination when the port is not being used) when:
the one of the first hole or the second hole accommodates tubing passing therethrough (paragraph [0027]: Each port can have a gasket disposed at the port to… cushion the tubing when inserted through the port)
in an absence of tubing passing through the one of the first hole or the second hole (paragraph [0027]: Each port can have a gasket disposed at the port… to effectively seal off the port when the port is not in use)
In regards to claim 7, Bentley et al teaches wherein at least one of the first section first tubing notch or the second section first tubing notch comprises one of the one or more deformable sealing element (paragraph [0027]); and at least one of the first section second tubing notch or the second section second tubing notch comprises another one of the one or more deformable sealing element (paragraph [0027]).
In regards to claim 9, Bentley et al teaches a plug configured to close the other one of the first hole or the second hole in an absence of tubing passing therethrough (paragraph [0027]: Each port can have a gasket disposed at the port… to effectively seal off the port when the port is not in use).
In regards to claim 12, Bentley et al teaches wherein: the first body section comprises a flexible latch (paragraph [0020]: bar); the second body section comprises a latch peg (paragraph [0020]: hook); and the flexible latch is configured to detachably connect with the latch peg when the device is in the closed configuration (paragraph [0020]).
In regards to claim 13, Bentley et al teaches wherein the first body section comprises a latch finger (paragraph [0020]: bar) configured to engage with a latch tab () disposed on the second body section when the device is in the closed configuration (paragraph [0020]).
In regards to claim 25, Bentley et al teaches wherein the first body section and the second body section form a single component that are connected via a flexible portion bendable to transition the device from the open configuration (Figures 1-3)and the closed configuration (Figure 4).
In regards to claim 28, Bentley et al teaches a system (Figures 1-4) comprising:
a connector protection device (100) comprising:
a first body section (102) defining a first internal cavity (Figures 1-3)
a second body section (104) defining a second internal cavity (Figures 1-3), the second body section being hingeably connected to the first body section (paragraph [0021]: hinge)
a first tubing notch (108A) positioned at a first end of the connector protection device
a second tubing notch (108C) positioned at a second end of the connector protection device and sized to retain at least a portion of a fluid outlet tube
a deformable sealing element (paragraph [0027]: gasket) disposed at or in one of the first tubing notch or the second tubing notch (paragraph [0027]: Each port can have a gasket)
a plug (paragraph [0027]: gasket) configured to close the other one of the first tubing notch or the second tubing notch (paragraph [0027]: Each port can have a gasket disposed at the port… to effectively seal off the port when the port is not in use)
a first connector (of 305) having a fluid inlet tube (305) extending therefrom
wherein:
when the connector protection device is in a closed configuration, the first internal cavity and the second internal cavity are adjacent to create a connector cavity configured to contain the first connector (Figure 4)
when the connector protection device is in the closed configuration, the fluid inlet tube extends through the first tubing notch (Figure 4)
the deformable sealing element is configured to prevent contamination from entering the connector cavity when the device is in the closed configuration (paragraph [0027]: The seal acts as a dust and dirt barrier, and generally protects the interior of the catheter protection device from contamination when the port is not being used) and:
the one of the first tubing notch or the second tubing notch accommodates tubing passing therethrough (paragraph [0027]: Each port can have a gasket disposed at the port to… cushion the tubing when inserted through the port)
in an absence of tubing passing through the one of the first tubing notch or the second tubing notch (paragraph [0027]: Each port can have a gasket disposed at the port… to effectively seal off the port when the port is not in use)
In regards to claim 30, Bentley et al teaches a second connector (301) having the fluid outlet tube (303) extending therefrom; wherein: the connector cavity is configured to contain the second connector; and a distance between the first tubing notch and the second tubing notch is substantially the same as a length from a first end of the second connector to a second end of the first connector (Figure 4).
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.
Claims 11 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Bentley et al, as applied to claims 1 and 28 above, and further in view of Peters et al (US 5,830,195).
In regards to claim 11, Bentley et al does not teach wherein the first body section and the second body section form a capsular shape when the device is in the closed configuration, as Bentley et al instead teaches wherein the first body section and the second body section form a rectangular shape when the device is in the closed configuration (Figure 4). Peters et al teaches a tubing connector protection device (Figure 26) wherein a first body section (top half of 110) and a second body section (bottom half of 110) form a capsular shape when the device is in a closed configuration (Figure 26). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first body section and the second body section, of the device of Bentley et al, to form a capsular shape when the device is in the closed configuration, as taught by Peters et al, as such will define a substantially sealed enclosure around engaged connectors for excluding bacteria from contact therewith (column 2, lines 56-61), to further assist in maintaining sterility and/or prevent unintentional disconnection (column 6, lines 55-58).
In regards to claim 36, Bentley et al does not teach wherein the first body section and the second body section form a capsular shape when the device is in the closed configuration, as Bentley et al instead teaches wherein the first body section and the second body section form a rectangular shape when the device is in the closed configuration (Figure 4). Peters et al teaches a system (Figure 26) wherein a first body section (top half of 110) and a second body section (bottom half of 110) form a capsular shape when a device (Figure 26) is in a closed configuration (Figure 26). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first body section and the second body section, of the system of Bentley et al, to form a capsular shape when the device is in the closed configuration, as taught by Peters et al, as such will define a substantially sealed enclosure around engaged connectors for excluding bacteria from contact therewith (column 2, lines 56-61), to further assist in maintaining sterility and/or prevent unintentional disconnection (column 6, lines 55-58).
Claims 14, 65, 68, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Bentley et al, as applied to claims 1, 6, and 28 above, and further in view of Clark et al (US 2011/0208132).
In regards to claim 14, Bentley et al does not teach wherein the first body section comprises a plurality of latch fingers, each latch finger of the plurality of latch fingers configured to engage with one of a plurality of latch tabs disposed on the second body section, as Bentley et al instead teaches wherein the first body section comprises a latch finger (paragraph [0020]: bar) configured to engage with a latch tab (paragraph [0020]: hook) disposed on the second body section. Clark et al teaches a tubing connector protection device (Figures 1-10) wherein a first body section (6) comprises a plurality of latch fingers (40b, 40c), each latch finger of the plurality of latch fingers configured to engage with one of a plurality of latch tabs (34a, 34b) disposed on a second body section (4). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first body section, of the device of Bentley et al, to comprise a plurality of latch fingers, each latch finger of the plurality of latch fingers configured to engage with one of a plurality of latch tabs disposed on the second body section, as taught by Clark et al, as such will couple the first body section and the second body section to each other to prevent inadvertent uncoupling of the first body section and the second body section (Abstract).
In regards to claim 65, Bentley et al is silent about protective padding surrounding the first body section and the second body section on an external face of each of the first body section and the second body section when the device is in the closed configuration. Clark et al teaches a tubing connector protection device (Figures 1-10) comprising protective padding (54) surrounding a second body section (4) on an external face of the second body section when the device is in a closed configuration. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device, of Bentley et al, with protective padding surrounding the second body section, as taught by Clark et al, as such will possibly have some indicia for example the name of the assignee embossed thereon and will provide the user with a touch responsive elastomeric pad for better grasping the device (paragraph [0041]). However, Clark et al does not teach protective padding surrounding the first body section on an external face of the first body section when the device is in the closed configuration. But as the first body section and the second body section are similar, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device, of Bentley et al and Clark et al, with protective padding surrounding the first body section on an external face of the first body section when the device is in the closed configuration, as such will possibly have some indicia for example the name of the assignee embossed thereon and will provide the user with a touch responsive elastomeric pad for better grasping the device (paragraph [0041]).
In regards to claim 68, Bentley et al is silent about protective padding surrounding the first body section and the second body section on an external face of each of the first body section and the second body section when the device is in the closed configuration. Clark et al teaches a tubing connector protection device (Figures 1-10) comprising protective padding (54) surrounding a second body section (4) on an external face of the second body section when the device is in a closed configuration. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device, of Bentley et al, with protective padding surrounding the second body section, as taught by Clark et al, as such will possibly have some indicia for example the name of the assignee embossed thereon and will provide the user with a touch responsive elastomeric pad for better grasping the device (paragraph [0041]). However, Clark et al does not teach protective padding surrounding the first body section on an external face of the first body section when the device is in the closed configuration. But as the first body section and the second body section are similar, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device, of Bentley et al and Clark et al, with protective padding surrounding the first body section on an external face of the first body section when the device is in the closed configuration, as such will possibly have some indicia for example the name of the assignee embossed thereon and will provide the user with a touch responsive elastomeric pad for better grasping the device (paragraph [0041]).
In regards to claim 71, Bentley et al is silent about protective padding surrounding the first body section and the second body section on an external face of each of the first body section and the second body section when the device is in the closed configuration. Clark et al teaches a system (Figures 1-10) comprising protective padding (54) surrounding a second body section (4) on an external face of the second body section when a device is in a closed configuration. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the system, of Bentley et al, with protective padding surrounding the second body section, as taught by Clark et al, as such will possibly have some indicia for example the name of the assignee embossed thereon and will provide the user with a touch responsive elastomeric pad for better grasping the device (paragraph [0041]). However, Clark et al does not teach protective padding surrounding the first body section on an external face of the first body section when the device is in the closed configuration. But as the first body section and the second body section are similar, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system, of Bentley et al and Clark et al, with protective padding surrounding the first body section on an external face of the first body section when the device is in the closed configuration, as such will possibly have some indicia for example the name of the assignee embossed thereon and will provide the user with a touch responsive elastomeric pad for better grasping the device (paragraph [0041]).
Claims 16-18, 40-41, 66, 69, and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Bentley et al, as applied to claims 1, 6, and 28 above, and further in view of Gross et al (US 4,405,312).
In regards to claim 16, Bentley et al teaches wherein: the first body section comprises a first padding (112) and the second body section comprises a second padding (112); however, Bentley does not teach the first body section comprises first padding tabs disposed within the first internal cavity and configured to hold the first padding, and the second body section comprises second padding tabs disposed within the second internal cavity and configured to hold the second padding. Gross et al teaches a tubing connector protection device (Figures 1-3) wherein: a first body section (38) comprises adhesive disposed within a first internal cavity and configured to hold a first padding (66), and a second body section (40) comprises adhesive disposed within a second internal cavity and configured to hold a second padding (68) (column 5, lines 40-42). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first body section and the second body section, of the device of Bentley et al, to comprise adhesive disposed within the first internal cavity and configured to hold the first padding, and adhesive disposed within the second internal cavity and configured to hold the second padding, as taught by Gross et al, as such will allow for positioning of antiseptic sponge padding therewithin (column 5, lines 37-44) for asepticizing connectors (column 2, lines 51-55). However, Gross et al does not teach wherein the first body section comprises first padding tabs disposed within the first internal cavity and configured to hold the first padding, and the second body section comprises second padding tabs disposed within the second internal cavity and configured to hold the second padding, as Gross et al instead teaches wherein the first body section comprises adhesive disposed within the first internal cavity and configured to hold the first padding, and the second body section comprises adhesive disposed within the second internal cavity and configured to hold the second padding. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first body section and the second body section comprising adhesive, of the modified device of Bentley et al and Gross et al, to instead comprise first padding tabs and second padding tabs, as an obvious matter of design choice, as either adhesive, as taught by Gross et al, or first padding tabs and second padding tabs, as taught by Applicant, as obvious alternatives will arrive at the same end result of holding the first padding within the first body section and the second padding within the second body section.
In regards to claim 17, in the modified device of Bentley et al and Gross et al, Bentley et al does not teach wherein the first padding is a sponge, as Bentley et al instead teaches wherein the first padding is non-woven fabric, woven fabric, a semi-solid gel, foam, or any other suitable material (paragraph [0028]). Gross et al teaches wherein the first padding is a sponge (66). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first padding, of the modified device of Bentley et al and Gross et al, to be a sponge, as taught by Gross et al, as such will allow for asepticizing connectors (column 2, lines 51-55).
In regards to claim 18, in the modified device of Bentley et al and Gross et al, Bentley et al does not teach wherein the sponge comprises an antiseptic, as Bentley et al instead teaches wherein the non-woven fabric, woven fabric, semi-solid gel, foam, or any other suitable material comprises an antimicrobial (paragraph [0028]). Gross et al teaches wherein the sponge comprises an antiseptic (column 5, lines 42-44). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the sponge, of the modified device of Bentley et al and Gross et al, to comprise an antiseptic, as taught by Gross et al, as such will allow for asepticizing connectors (column 2, lines 51-55).
In regards to claim 40, Bentley et al teaches wherein the first body section comprises a first padding (112); however, Bentley et al does not teach the first body section comprises a first plurality of padding tabs disposed within the first internal cavity and configured to hold the first padding. Gross et al teaches a system (Figures 1-3) wherein a first body section (38) comprises adhesive disposed within a first internal cavity and configured to hold a first padding (66) (column 5, lines 40-42). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first body section, of the system of Bentley et al, to comprise adhesive disposed within the first internal cavity and configured to hold the first padding, as taught by Gross et al, as such will allow for positioning of antiseptic sponge padding therewithin (column 5, lines 37-44) for asepticizing connectors (column 2, lines 51-55). However, Gross et al does not teach wherein the first body section comprises a first plurality of padding tabs disposed within the first internal cavity and configured to hold the first padding, as Gross et al instead teaches wherein the first body section comprises adhesive disposed within the first internal cavity and configured to hold the first padding. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first body section comprising adhesive, of the modified system of Bentley et al and Gross et al, to instead comprise a first plurality of padding tabs, as an obvious matter of design choice, as either adhesive, as taught by Gross et al, or a first plurality of padding tabs, as taught by Applicant, as obvious alternatives will arrive at the same end result of holding the first padding within the first body section.
In regards to claim 41, in the modified system of Bentley et al and Gross et al, Bentley et al teaches wherein the second body section comprises a second padding (112); however, Bentley et al does not teach the second body section comprises a second plurality of padding tabs disposed within the second internal cavity and configured to hold the second padding. Gross et al teaches wherein a second body section (40) comprises adhesive disposed within a second internal cavity and configured to hold a second padding (68) (column 5, lines 40-42). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second body section, of the modified system of Bentley et al and Gross et al, to comprise adhesive disposed within the second internal cavity and configured to hold the second padding, as taught by Gross et al, as such will allow for positioning of antiseptic sponge padding therewithin (column 5, lines 37-44) for asepticizing connectors (column 2, lines 51-55). However, Gross et al does not teach wherein the second body section comprises a second plurality of padding tabs disposed within the second internal cavity and configured to hold the second padding, as Gross et al instead teaches wherein the second body section comprises adhesive disposed within the second internal cavity and configured to hold the second padding. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second body section comprising adhesive, of the modified system of Bentley et al and Gross et al, to instead comprise a second plurality of padding tabs, as an obvious matter of design choice, as either adhesive, as taught by Gross et al, or a second plurality of padding tabs, as taught by Applicant, as obvious alternatives will arrive at the same end result of holding the second padding within the second body section.
In regards to claim 66, in the modified device of Bentley et al and Gross et al, Bentley et al teaches wherein the first padding and the second padding are configured to one or more of: secure the first connector within the connector cavity (Figure 4), or provide a medium to include an antiseptic (paragraph [0028]).
In regards to claim 69, Bentley et al teaches wherein: the first body section comprises a first padding (112) and the second body section comprises a second padding (112); and wherein the first padding and the second padding are configured to one or more of: secure the first connector within the connector cavity (Figure 4), or provide a medium to include an antiseptic (paragraph [0028]); however, Bentley does not teach the first body section comprises first padding tabs disposed within the first internal cavity and configured to hold the first padding, and the second body section comprises second padding tabs disposed within the second internal cavity and configured to hold the second padding. Gross et al teaches a tubing connector protection device (Figures 1-3) wherein: a first body section (38) comprises adhesive disposed within a first internal cavity and configured to hold a first padding (66), and a second body section (40) comprises adhesive disposed within a second internal cavity and configured to hold a second padding (68) (column 5, lines 40-42). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first body section and the second body section, of the device of Bentley et al, to comprise adhesive disposed within the first internal cavity and configured to hold the first padding, and adhesive disposed within the second internal cavity and configured to hold the second padding, as taught by Gross et al, as such will allow for positioning of antiseptic sponge padding therewithin (column 5, lines 37-44) for asepticizing connectors (column 2, lines 51-55). However, Gross et al does not teach wherein the first body section comprises first padding tabs disposed within the first internal cavity and configured to hold the first padding, and the second body section comprises second padding tabs disposed within the second internal cavity and configured to hold the second padding, as Gross et al instead teaches wherein the first body section comprises adhesive disposed within the first internal cavity and configured to hold the first padding, and the second body section comprises adhesive disposed within the second internal cavity and configured to hold the second padding. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first body section and the second body section comprising adhesive, of the modified device of Bentley et al and Gross et al, to instead comprise first padding tabs and second padding tabs, as an obvious matter of design choice, as either adhesive, as taught by Gross et al, or first padding tabs and second padding tabs, as taught by Applicant, as obvious alternatives will arrive at the same end result of holding the first padding within the first body section and the second padding within the second body section.
In regards to claim 72, in the modified system of Bentley et al and Gross et al, Bentley et al teaches wherein the first padding and the second padding are configured to one or more of: secure the first connector within the connector cavity (Figure 4), or provide a medium to include an antiseptic (paragraph [0028]).
Claims 27, 64, 67, and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Bentley et al, as applied to claims 1, 6, and 28 above, and further in view of Christie et al (US 2017/0157384).
In regards to claim 27, Bentley et al is silent about wherein at least one of the first body section or the second body section comprises a periphery seal along an outer periphery of the at least one of the first body section or the second body section, the periphery seal configured to protect the connector cavity when the device is in the closed configuration. Christie et al teaches a tubing connector protection device (Figures 1A-7D) wherein at least one of a first body section (12a) or a second body section (12b) comprises a periphery seal (paragraph [0071]: sealant) along an outer periphery of the at least one of the first body section or the second body section, the periphery seal configured to protect a connector cavity when the device is in a closed configuration (paragraph [0071]: the fluid line locking device 10 shown in FIGS. 1A-1F can comprise a sealant attached to the first closure surface 16a, the second closure surface 16b, or any combination thereof)(paragraph [0072] The attached sealant may comprise, for example, a silicone layer deposited on the surfaces. Alternatively, the attached sealant may comprise, for example, a gasket structure such as an O-ring. The attachment of a sealant to closure surfaces and/or bearing surfaces may further prevent liquid from infiltrating into or out of the interior volume of the closed fluid line locking device, which may further decrease the likelihood of bacterial contamination and infection, for example, in medical applications where the fluid line locking device comprising the attached sealant is used to enclose and secure a Luer lock connection). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify at least one of the first body section or the second body section, of the device of Bentley et al, to comprise a periphery seal, as taught by Christie et al, as such will further prevent liquid from infiltrating into or out of the interior volume of the closed device, which may further decrease the likelihood of bacterial contamination and infection, for example, in medical applications where the device comprising the attached seal is used to enclose and secure a Luer lock connection (paragraph [0072]).
In regards to claim 64, Bentley et al does not teach wherein: the first body section comprises first hinge knuckles, the second body section comprises second hinge knuckles positioned to engage with the first hinge knuckles in an alternating manner, and the hinge pin is configured to engage hinge holes disposed within the first hinge knuckle and the second hinge knuckle, as Bentley et al instead teaches the first body section and the second body section are connected via a flexible portion (Figures 1-4). Christie et al teaches a tubing connector protection device (Figures 1A-7D) wherein: a first body section (12a) comprises first hinge knuckles (22a), a second body section (12b) comprises second hinge knuckles (22b) positioned to engage with the first hinge knuckles in an alternating manner (Figures 1A-1B), and wherein the hinge pin is configured to engage hinge holes disposed within the first hinge knuckle and the second hinge knuckle (Figures 1A-1B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first body section and the second body section, of the device of Bentley et al, to comprise first hinge knuckles, second hinge knuckles, and the hinge pin, as taught by Christie et al, as such will provide a butt-mortise hinge for connecting the first body section and the second body section to be rotatable from a closed configuration to an open configuration (Abstract)(paragraph [0027]).
In regards to claim 67, Bentley et al does not teach wherein: the first body section comprises first hinge knuckles, the second body section comprises second hinge knuckles positioned to engage with the first hinge knuckles in an alternating manner, and the hinge pin is configured to engage hinge holes disposed within the first hinge knuckle and the second hinge knuckle, as Bentley et al instead teaches the first body section and the second body section are connected via a flexible portion (Figures 1-4). Christie et al teaches a tubing connector protection device (Figures 1A-7D) wherein: a first body section (12a) comprises first hinge knuckles (22a), a second body section (12b) comprises second hinge knuckles (22b) positioned to engage with the first hinge knuckles in an alternating manner (Figures 1A-1B), and wherein the hinge pin is configured to engage hinge holes disposed within the first hinge knuckle and the second hinge knuckle (Figures 1A-1B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first body section and the second body section, of the device of Bentley et al, to comprise first hinge knuckles, second hinge knuckles, and the hinge pin, as taught by Christie et al, as such will provide a butt-mortise hinge for connecting the first body section and the second body section to be rotatable from a closed configuration to an open configuration (Abstract)(paragraph [0027]).
In regards to claim 70, Bentley et al does not teach wherein: the first body section comprises first hinge knuckles, the second body section comprises second hinge knuckles positioned to engage with the first hinge knuckles in an alternating manner, and the hinge pin is configured to engage hinge holes disposed within the first hinge knuckle and the second hinge knuckle, as Bentley et al instead teaches the first body section and the second body section are connected via a flexible portion (Figures 1-4). Christie et al teaches a system (Figures 1A-7D) wherein: a first body section (12a) comprises first hinge knuckles (22a), a second body section (12b) comprises second hinge knuckles (22b) positioned to engage with the first hinge knuckles in an alternating manner (Figures 1A-1B), and the hinge pin is configured to engage hinge holes disposed within the first hinge knuckle and the second hinge knuckle (Figures 1A-1B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first body section and the second body section, of the system of Bentley et al, to comprise first hinge knuckles, second hinge knuckles, and the hinge pin, as taught by Christie et al, as such will provide a butt-mortise hinge for connecting the first body section and the second body section to be rotatable from a closed configuration to an open configuration (Abstract)(paragraph [0027]).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Bentley et al, as applied to claim 28 above, and further in view of Graham et al (US 2018/0328841).
In regards to claim 48, Bentley et al does not teach wherein the connector protection device further comprises a contamination sensor being a colorimetric sensor. Graham et al teaches a system (Figures 15A-16) wherein a connector protection device (1500) further comprises a contamination sensor being a colorimetric sensor (1506). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector protection device, of the system Bentley et al, to comprise a contamination sensor being a colorimetric sensor, as taught by Graham et al, as such will allow for a subject to perform a breathing therapy (paragraph [0072]).
Response to Arguments
Applicant’s arguments with respect to claims 1-3, 6-7, 9, 11-14, 16-18, 25, 27-28, 30, 36, 40-41, 48, and 64-72 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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