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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/10/2025 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/313,077, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The cited provisional application does not disclose the claimed embodiment where an injection port is integrally connected with a spherical shaped body, and thus all claims get the priority date of the filing date of PCT/US2017/024035, which is 03/24/2017.
Response to Amendment
Applicant has amended claims 1, 2, 4, 11, and 21. No new matter has been entered. Claims 1-19 and 21 remain pending.
No new rejections under 35 USC 112 or claim objections are found in the amended claims.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 and 4-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Leuthardt et al. (US 20180243546, henceforth Leuthardt).
Regarding claim 1, Leuthardt discloses a shielded injection port (see fig. 4) for use in an intravenous (IV) medication delivery system (see fig. 4 and [0003]), the shielded injection port comprising: a single piece spherical shaped body (housing 106, fig. 4) having a hollow interior (see annotated fig. 4, the hollow interior is considered to be the space which is continuous and spans between distal port 116 and proximal port 118 and includes conduit segments 112 and chamber 110), the spherical shaped body being truncated (see the distal end of conduit segment 112 which is directly adjacent to proximal port 118 as called out in annotated fig. 4; this constitutes a truncation because the spherical chamber 110 is shortened at the point where the material for housing 106 is missing and a truncation is a shortening by cutting off a piece of material as is defined by Merriam-Webster – this conduit segment will subsequently be referred to as the proximal segment 112), at a location above a plane that passes through a center of the spherical shaped body and defines a diameter of the spherical shaped body (see annotated fig. 4 which calls out the plane and orients the assembly as arranged with the top and bottom; if housing 106 was arranged such that proximal segment 112 was at the top, then the truncation is above the plane which splits the sphere into equal top and bottom halves), so as to define a first opening (see the called out first opening in annotated fig. 4 located at the truncation at the distal end of proximal segment 112) formed at a first end of the spherical shaped body (the first end is the top end keeping with the orientation previously described, see annotated fig. 4) for receiving a fluid delivery member into the hollow interior (the hole of the valve is capable of receiving a needle which is a fluid delivery member as it is an opening which can have things moving through where it can allow fluid to move through it), the first opening having a diameter that is less than the diameter of the spherical shaped body (see annotated fig. 4, the diameter of the first opening is called out and is smaller than the diameter at the center of the housing 106); and an injection port body (see annotated fig. 4, the injection port body is conduit segment 112 which is adjacent to distal port 116 which is considered to be extending from distal end 116 called out in fig. 4 into the proximal opening at chamber 110 as demonstrated by the provided solid gray outline in the annotated figure which is meant to be the full outline of the injection port body as claimed – it will subsequently be referred to as distal segment 112) that is integrally formed with the spherical shaped body (see fig. 4, distal segment 112 and housing 106 are integrally formed as shown by the material cross section being continuous), the injection port body having a first end (see annotated fig. 4, the first end of the injection port body is called out) that is contained within a bottom half of the hollow interior of the spherical shaped body (see annotated fig. 4, the called out first end exists in the space which is distal to, or below, the plane that passes through the center of the spherical shape body as shown and thus the first end is contained in the bottom half of the hollow interior since it is fully within the hollow interior and below the plane) such that the spherical shaped body is configured to surround and extend above the first end of the injection port body (see annotated fig. 4, housing 106 surrounds the first end as it wraps radially around the exterior of the projection of the first end of the injection port body as called out in the figure, and it extends above the first end of the injection port body where it extends proximally, or towards the top of the spherical body as called out in the image, relative to the first end of the injection port body), the first end of the injection port body having a second opening (see annotated fig. 4, the called out second opening is provided in the first end of the injection port body as claimed) that opens into a center lumen of the injection port body (see annotated fig. 4, the center lumen of the injection port body is the hollow interior of the injection port body and is directly connected to the called out second opening and thus the second opening is considered to open into the center lumen as claimed), the injection port body extending outward from a second end of the spherical shaped body (see annotated fig. 4, the portion of the injection port body which is not the first end is shown as extending outward in the distal, or downward, direction from the second end, or bottom half, of housing 106 as called out in the provided figure) in a direction that is opposite the first end (see the provided dashed arrow in annotated fig. 4, the protrusion direction of the injection port body from housing 106 is in the distal, or downward, direction, while the first end of housing 106 points upward, or proximally, relative to the plane that passes through the center of the housing 106 as called out); wherein a width of the first opening (see the dashed line in annotated fig. 4 which calls out a width of the first opening) is greater than a width of the second opening at the first end of the injection port body (see annotated fig. 4, the dashed line calling out the width of the first opening is longer than the diameter of the dotted circle calling out the width which the second opening is meant to be measured about, and thus the width of the first opening is greater than the width of the second opening as claimed; Examiner notes that the claim does not tie the claimed widths to any particular structures, and thus the width of the second opening could be chosen to be a width that is smaller than the maximum width of the opening as shown in the annotated figure).
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Regarding claim 2, Leuthardt discloses the port wherein the spherical shaped body and the injection port body are formed of a molded plastic material ([0019] teaches the use of polycarbonate or ABS, two types of plastic which are known to be manufactured by molding); and wherein the first opening comprises the only opening formed in the spherical shaped body in that an outer wall of the spherical shaped body is completely solid from the second opening to the first opening (if a small slice of the first housing 106 of the first valve 102 is taken along the flow axis 114 as shown in second annotated fig. 4, there is a cut which can be taken which has the outer wall of first housing 106 as completely and continuously solid as the spherical shaped body extends from the first opening to the second opening).
{The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.}
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Second annotated fig. 4 as required for the rejection of claim 3
Regarding claim 4, Leuthardt discloses the port wherein the injection port body comprises an elongated main body section (see annotated fig. 4, the span of the elongated main body section is called out as the portion of the injection port body which extends outwards from housing 106) with a flange at the first end (see annotated fig. 4, the called out flange spans the length of the first end and thus is at the first end as claimed) that has a diameter (see the called out diameter of the flange in annotated fig. 4 which extends from one radial exterior edge of the flange to the opposite radial exterior edge of the flange and is marked by a solid arrow) greater than a diameter of the main body section (see the called out diameter of the main body section in annotated fig. 4 which extends from one radial interior edge of the main body section to the opposite radial interior edge of the main body section and is marked by a solid arrow; the diameter of the flange is greater than the diameter of the main body section by twice the thickness of the wall of the main body thickness; Examiner notes that the claim does not describe how the diameter is to be measured, only that it exists in the claimed sections), wherein the flange is located within the hollow interior of the spherical shaped body (see fig. 4, the hollow interior as previously called out is considered to be the space which is continuous and spans between distal port 116 and proximal port 118 and includes conduit segments 112 and chamber 110, and since the called out flange is in the middle of that continuous space, it is located within the hollow interior as claimed) and is raised relative to a bottom wall of the spherical shaped body (see annotated fig. 4 which calls out a bottom wall of the spherical shaped body, the top edge of the flange, or the edge of the flange which is closest to he called out top of the spherical body, is raised relative to the called out bottom wall along the direction of the flow path 114 since it is between the bottom wall and the top wall) through which the injection port body passes (see annotated fig. 4, the injection port body as called out passes through the called out bottom wall since it passes below and above the bottom wall as it extends along flow path 114).
Regarding claim 5, Leuthardt discloses the port wherein the flange seats against the second end of the spherical shaped body (see annotated fig. 4, the called out flange is considered to be seated against the bottom half of housing 106 which is called out as the second end where it is in direct abutment and contact with the second end of housing 106 where they are integrally formed with each other) at a location that is internal to the spherical shaped body (see annotated fig. 4, the interface between the flange and the wall of housing 106 is within the boundaries of the radial exterior edge of housing 106 and thus is considered to be internal to housing 106) within the hollow interior (see annotated fig. 4, where the flange terminates at its proximal end into chamber 110 and is integrally formed with housing 106, it is within the hollow interior as it this interface is radially between the distal most end of the hollow interior at distal port 116 and chamber 110 and thus it is within it).
Regarding claim 6, Leuthardt discloses the port wherein the injection port body is configured to attach to a first tubing (since the first end of distal segment 112 is a rounded opening and tubes are known to be rounded, the first end of distal segment 112 is configured to attach to a tube where the tube can be press fit into the first end of distal segment 112) along a side of the injection port body (the first end of distal segment 112 is a side as it is the proximal-most side of the segment) and is also configured to attach to a second tubing at a second end of the injection port body that is opposite the first end of the injection port body (the distal end of distal segment 112, called out as distal port 116 is a rounded opening and tubes are known to be rounded, this distal end of distal segment 112, which is a second end, is configured to attach to a tube where the tube can be press fit into the second end of distal segment 112; further, the first and second ends of distal segment 112 are opposite each other as they point in antiparallel directions as shown in fig. 4).
{Examiner notes that Leuthardt [0029] also refers to tubing being attached to at least distal segment 112, and since no specific structure is added or mentioned, it is understood that this is done by a press fit.}
Regarding claim 7, Leuthardt discloses the port wherein the injection port body and the second tubing are configured to be coaxial (see [0029] where a second tube is added to distal segment 112; this is understood to be a press fit since no threaded structures are present, and since distal segment 112 extends along a longitudinal axis and a tube which is connected via press fit would also extend along that same longitudinal axis, the structures are considered to be configured to be coaxial as they extend along the same longitudinal axis where they are press fitted together).
Regarding claim 8, Leuthardt discloses the port wherein a length of the injection port body that is contained within the hollow interior is less than a length of the injection port body that lies outside the spherical shaped body (see fig. 4).
Regarding claim 9, Leuthardt discloses the port wherein the first opening of the spherical shaped body is located at a top edge of the spherical shaped body (see fig. 4) and is opposite and coaxial with the injection port body (see fig. 4).
Regarding claim 10, Leuthardt discloses the port wherein a side wall of the spherical shaped body is curved inwardly (the side wall of the upper half of housing 106 is curved inwardly such as to create a sphere) for positioning above the first end of the injection port body (see fig. 4) and the first opening is positioned for placement directly above the first end of the injection port body (see fig. 4).
Regarding claim 11, Leuthardt discloses the port wherein the plane that passes through the center of the spherical shaped body is a parallel to a plane that contains the entire first end of the spherical shaped body (the plane referred to in claim 1 and called out in annotated fig. 4 is parallel to a plane which is created by the truncation at the top edge of housing 106 which contains the entire top half of housing 106), wherein the plane that passes through the center of the spherical shaped body (see annotated fig. 4) intersects the spherical shaped body at locations at which the spherical shaped body has a solid form (see annotated fig. 4, if a cut was made along the called out plane of fig. 4 perpendicular to flow path 114, the plane would intersect with housing 106 at portions where housing 106 has a solid form between opposed sleeve segments 120).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Leuthardt et al. (US 20180243546, henceforth Leuthardt) as applied to claim 1, and further in view of Cannon (US Pat. No. 5,423,775).
Regarding claim 3, Leuthardt does not disclose that the first end of the injection port body comprises a septum that is configured to allow the fluid from the fluid delivery device to be injected into the injection port body. Cannon teaches an injection port body (Y-site 26, fig. 3) comprising a septum (pierceable septum 42, fig. 3) at a first end which is an inlet end (inlet mouth 40, fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the septum of Cannon to first end of the injection port body of Leuthardt as Cannon teaches that septums are used in medical tubing ports to further provide a barrier to contaminants and to further reduce risk of fluid loss (Col. 1 lines 42-51).
Thus, the modified device of Leuthardt in view of Cannon discloses the port wherein the septum is located inside of the hollow interior (since in the modified device, the added septum is placed in the free end of the injection port body, and since the hollow interior as called out in annotated fig. 4 extends both distally and proximally relative to the first end of the injection port body, it is the Examiner’s position that the added septum of Cannon would be located inside of the hollow interior as claimed) at a location spaced from a bottom of the spherical shaped body (see the called out bottom of the spherical shaped body in annotated fig. 4; the free end of the injection port body where the septum of Cannon is added is spaced from this circled area by a distance, meeting the claim limitation; Examiner notes that no structure is placed specifically on the claimed bottom of the spherical body, and thus since the circled area in annotated fig. 4 is in the bottom half of housing 106, it is considered to be a bottom of housing 106).
Claims 12-15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kornberg (US Pat. No. 5,084,032, henceforth Kornberg) in view of Leuthardt et al. (US 20180243546, henceforth Leuthardt).
Regarding claim 12, Kornberg discloses an intravenous (IV) medication delivery system (system shown in fig. 8) comprising: a main line (main line 20 and mixed fluid line 36, figs. 8 and 13) that is configured to be placed in fluid communication with a source of fluid (fluid source 16, fig. 13) for delivery to a patient (see fig. 13) and terminates in a distal end that is configured for insertion into the patient (cannula 38 is the distal end of main line 20 and mixed fluid line 36, see fig. 13 where it is inserted into a patient).
Kornberg does not disclose the shielded injection port of claim 1, wherein the injection port body is in fluid communication with the main line and the first end of the injection port body has an interface that is configured to allow a fluid from a fluid delivery device to be injected into the main line through the injection port body. Leuthardt teaches the shielded injection port of claim 1 (see rejection of claim 1 above), wherein the injection port body is in fluid communication with tubing (see Leuthardt [0029] and Abstract) and the first end of the injection port body has an interface (the first end of distal segment 112 is an interface as it is a junction between distal segment 112 and housing 106, see fig. 4) that is configured to allow a fluid from a fluid delivery device to be injected into tubing through the injection port body (the opening is configured to allow fluid which comes from a fluid delivery device to travel through it as this is the purpose of the invention, see Abstract; when the injection port of Leuthardt is fully assembled as shown in fig. 7, fluid can flow through in either direction through the first end of distal segment 112).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the injection port of Leuthardt into the main line of Kornberg for preventing the main line from being damaged and/or removed from the patient which can cause discomfort to the patient, loss of fluid or sterility in the infusion system, and replacement of the tube (Leuthardt [0003]). {The connector would be added in fluid communication with mixed fluid line 36 of Kornberg downstream from Y-junction 22 as shown in Kornberg fig. 13.}
Regarding claim 13, Kornberg as modified by Leuthardt (henceforth Kornberg as modified) discloses the system wherein the fluid delivery device comprises a syringe (see Kornberg col. 1 lines 56-61 which call out that an auxiliary fluid source can be a syringe, which is the chosen embodiment; the auxiliary fluid source is shown as 18 in fig. 13 but can be replaced with a syringe; fluid from this syringe can be injected through Y-junction 22 and then travel through the added port of Leuthardt in the modified device).
Regarding claim 14, Kornberg as modified discloses the system wherein a side wall of the spherical shaped body is curved inwardly above the first end of the injection port body (from Leuthardt: the side wall of the upper half of housing 106 is curved inwardly such as to create a sphere) and the first opening is positioned directly above the first end of the injection port body (see annotated fig. 4, the openings are coaxial and thus the first opening is positioned directly above the first end of the injection port body when proximal segment 112 is held vertically above distal segment 112).
Regarding claim 15, Kornberg as modified discloses the system wherein the spherical shaped body and the injection port body are formed of a molded plastic material (from Leuthardt: [0019] teaches the use of polycarbonate or ABS, two types of plastic which are known to be manufactured by molding).
{The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.}
Regarding claim 17, Kornberg as modified discloses the system wherein the injection port body comprises an elongated main body section (from Leuthardt: see annotated fig. 4, the span of the elongated main body section is called out as the portion of the injection port body which extends outwards from housing 106) with a flange at the first end (see annotated fig. 4, the called out flange spans the length of the first end and thus is at the first end as claimed) that has a diameter (see the called out diameter of the flange in annotated fig. 4 which extends from one radial exterior edge of the flange to the opposite radial exterior edge of the flange and is marked by a solid arrow) greater than a diameter of the main body section (see the called out diameter of the main body section in annotated fig. 4 which extends from one radial interior edge of the main body section to the opposite radial interior edge of the main body section and is marked by a solid arrow; the diameter of the flange is greater than the diameter of the main body section by twice the thickness of the wall of the main body thickness; Examiner notes that the claim does not describe how the diameter is to be measured, only that it exists in the claimed sections).
Regarding claim 18, Kornberg as modified discloses the system wherein a length of the injection port body that is contained within the hollow interior is less than a length of the injection port body that lies outside the spherical shaped body (from Leuthardt: see fig. 4).
Regarding claim 19, Kornberg as modified discloses the system wherein the first opening of the spherical shaped body is located at a top edge of the spherical shaped body and is opposite and coaxial with the injection port body (from Leuthardt: see fig. 4; when proximal segment 112 is held vertically above distal segment 112 the first opening which is proximal segment 112 is at the top edge of housing 106 and is coaxial with downward-facing distal segment 112).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kornberg (US Pat. No. 5,084,032, henceforth Kornberg) in view of Leuthardt et al. (US 20180243546, henceforth Leuthardt) as applied to claim 12, and further in view of Cannon (US Pat. No. 5,423,775).
Regarding claim 16, Kornberg as modified does not disclose that the first end of the injection port body comprises a septum that is configured to allow the fluid from the fluid delivery device to be injected into the main line. Cannon teaches an injection port body (Y-site 26, fig. 3) comprising a septum (pierceable septum 42, fig. 3) at a first end which is an inlet end (inlet mouth 40, fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the septum of Cannon to first end of the injection port body of Leuthardt as Cannon teaches that septums are used in medical tubing ports to further provide a barrier to contaminants and to further reduce risk of fluid loss (Col. 1 lines 42-51).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leuthardt et al. (US 20180243546, henceforth Leuthardt) in view of Cannon (US Pat. No. 5,423,775)
Regarding claim 21, Leuthardt discloses a shielded injection port (see fig. 4) for use in an intravenous (IV) medication delivery system ([0003]), the shielded injection port comprising: a single piece spherical shaped body (housing 106, fig. 4) having a hollow interior (see annotated fig. 4, the hollow interior is considered to be the space which is continuous and spans between distal port 116 and proximal port 118 and includes conduit segments 112 and chamber 110), the spherical shaped body being truncated (see the distal end of conduit segment 112 which is directly adjacent to proximal port 118 as called out in annotated fig. 4; this constitutes a truncation because the spherical chamber 110 is shortened at the point where the material for housing 106 is missing and a truncation is a shortening by cutting off a piece of material as is defined by Merriam-Webster – this conduit segment will subsequently be referred to as the proximal segment 112), at a location above a plane that passes through a center of the spherical shaped body and defines a diameter of the spherical shaped body (see annotated fig. 4 which calls out the plane and orients the assembly as arranged with the top and bottom; if housing 106 was arranged such that proximal segment 112 was at the top, then the truncation is above the plane which splits the sphere into equal top and bottom halves), so as to define a first opening (see the called out first opening in annotated fig. 4 located at the truncation at the distal end of proximal segment 112) formed at a first end of the spherical shaped body (the first end is the top end keeping with the orientation previously described, see annotated fig. 4) for receiving a fluid delivery member into the hollow interior (the hole of the valve is capable of receiving a needle which is a fluid delivery member), the first opening having a diameter that is less than the diameter of the spherical shaped body (see annotated fig. 4, the diameter of the first opening is called out and is smaller than the diameter at the center of the housing 106); and an injection port body (see annotated fig. 4, the injection port body is conduit segment 112 which is adjacent to distal port 116 which is considered to be extending from distal end 116 called out in fig. 4 into the proximal opening at chamber 110 as demonstrated by the provided solid gray outline in the annotated figure which is meant to be the full outline of the injection port body as claimed – it will subsequently be referred to as distal segment 112) that is integrally formed with the spherical shaped body (see fig. 4, distal segment 112 and housing 106 are integrally formed as shown by the material cross section being continuous) the injection port body having a first end (see annotated fig. 4, the first end of the injection port body is called out) that is contained internally within a bottom half of the hollow interior of the spherical shaped body (see annotated fig. 4, the called out first end exists in the space which is distal to, or below, the plane that passes through the center of the spherical shape body as shown and thus the first end is contained in the bottom half of the hollow interior since it is fully within the hollow interior and below the plane) such that the spherical shaped body is configured to surround and extend above the first end of the injection port body (see annotated fig. 4, housing 106 surrounds the first end as it wraps radially around the exterior of the projection of the first end of the injection port body as called out in the figure, and it extends above the first end of the injection port body where it extends proximally, or towards the top of the spherical body as called out in the image, relative to the first end of the injection port body), the first end of the injection port body having a second opening (see annotated fig. 4, the called out second opening is provided in the first end of the injection port body as claimed) that opens into a center lumen of the injection port body (see annotated fig. 4, the center lumen of the injection port body is the hollow interior of the injection port body and is directly connected to the called out second opening and thus the second opening is considered to open into the center lumen as claimed), the injection port body extending outward from a second end of the spherical shaped body (see annotated fig. 4, the portion of the injection port body which is not the first end is shown as extending outward in the distal, or downward, direction from the second end, or bottom half, of housing 106 as called out in the provided figure) in a direction that is opposite the first end (see the provided dashed arrow in annotated fig. 4, the protrusion direction of the injection port body from housing 106 is in the distal, or downward, direction, while the first end of housing 106 points upward, or proximally, relative to the plane that passes through the center of the housing 106 as called out); wherein the first end of the injection port body includes a flange (see annotated fig. 4, the called out flange spans the length of the first end and thus is at the first end as claimed) that has a diameter (see the called out diameter of the flange in annotated fig. 4 which extends from one radial exterior edge of the flange to the opposite radial exterior edge of the flange and is marked by a solid arrow) greater than a diameter of the main body section (see the called out diameter of the main body section in annotated fig. 4 which extends from one radial interior edge of the main body section to the opposite radial interior edge of the main body section and is marked by a solid arrow; the diameter of the flange is greater than the diameter of the main body section by twice the thickness of the wall of the main body thickness; Examiner notes that the claim does not describe how the diameter is to be measured, only that it exists in the claimed sections), wherein the flange is located within the hollow interior of the spherical shaped body (see fig. 4, the hollow interior as previously called out is considered to be the space which is continuous and spans between distal port 116 and proximal port 118 and includes conduit segments 112 and chamber 110, and since the called out flange is in the middle of that continuous space, it is located within the hollow interior as claimed) and is raised relative to a bottom wall of the spherical shaped body (see annotated fig. 4 which calls out a bottom wall of the spherical shaped body, the top edge of the flange, or the edge of the flange which is closest to he called out top of the spherical body, is raised relative to the called out bottom wall along the direction of the flow path 114 since it is between the bottom wall and the top wall) through which the injection port body passes (see annotated fig. 4, the injection port body as called out passes through the called out bottom wall since it passes below and above the bottom wall as it extends along flow path 114); wherein a width of the first opening (see the dashed line in annotated fig. 4 which calls out a width of the first opening) is greater than a width of the second opening at the first end of the injection port body (see annotated fig. 4, the dashed line calling out the width of the first opening is longer than the diameter of the dotted circle calling out the width which the second opening is meant to be measured about, and thus the width of the first opening is greater than the width of the second opening as claimed; Examiner notes that the claim does not tie the claimed widths to any particular structures, and thus the width of the second opening could be chosen to be a width that is smaller than the maximum width of the opening as shown in the annotated figure).
Leuthardt does not disclose that the first end of the injection port body comprises a septum that is configured to allow the fluid from the fluid delivery device to be injected into the injection port body and that covers the second opening. Cannon teaches an injection port body (Y-site 26, fig. 3) comprising a septum (pierceable septum 42, fig. 3) at a first end which is an inlet end (inlet mouth 40, fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the septum of Cannon to first end of the injection port body of Leuthardt as Cannon teaches that septums are used in medical tubing ports to further provide a barrier to contaminants and to further reduce risk of fluid loss (Col. 1 lines 42-51).
Thus, the modified device of Leuthardt in view of Cannon discloses the port wherein the septum covers the second opening (this is where the septum is added in the modified device since it is in line with the teachings of Cannon), is located inside of the hollow interior (since in the modified device, the added septum is placed in the first end of the injection port body, and since the hollow interior as called out in annotated fig. 4 extends both distally and proximally relative to the first end of the injection port body, it is the Examiner’s position that the added septum of Cannon would be located inside of the hollow interior as claimed) at a location spaced from a bottom inner surface of the spherical shaped body (see the called out inner bottom of the spherical shaped body in annotated fig. 4,; the free end of the injection port body where the septum of Cannon is added is spaced from this dashed circled area by a distance, meeting the claim limitation; Examiner notes that no structure is placed specifically on the claimed bottom inner surface of the spherical body, and thus since the circled area in annotated fig. 4 is in the bottom half of housing 106, it is considered to be a bottom of housing 106).
Terminal Disclaimer
The terminal disclaimer filed on 04/23/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Pat. No. 11207515 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
Applicant has argued that Leuthardt does not disclose the new claim limitations required in the amended claims. Examiner respectfully disagrees.
Regarding claim 1, the claim does not require that the width of the second opening is tied to any specific measurement points of the opening or that the width is a maximum width, that the opening is at an end most point of the injection port body, or tie specific structures to constitute the opening which overcome the provided interpretation.
Regarding claim 2, the claim does not require that the entire wall of the spherical shaped body is non-hollow about the entire circumference of the spherical shaped body from the second opening to the first opening; the claim only requires that an outer wall is completely solid, and thus the interpretation provided above applies. Examiner further notes that solid could also mean that the wall is not a liquid or a gas at any point in a non-relied-upon interpretation.
Regarding claim 4, further structural specificity would need to be added to the claim requirements to overcome the provided interpretation regarding the differences between the flange and the bottom wall of the spherical shaped body.
Regarding claim 11, the plane as called out in the provided interpretation does intersect with non-liquid and non-gaseous portions of the spherical shaped body as claimed.
Regarding claim 21, please see above for the explanations regarding the other claims and the reasoning in the rejection provided above.
For these reasons, Examiner respectfully finds Applicant’s arguments unpersuasive and rejects all pending claims as indicated in the body of the rejection above.
Conclusion
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783