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 .
Response to Amendment
The amendment filed 11/18/2025 has been entered. Claims 1-25 are pending in the application. Applicant’s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 08/19/2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 7-9, 13-17, 21, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Gyrn (US 11,786,653) in view of Olivas (US 2019/0060562) and further in view of Gyrn (US 2012/0095406).
Regarding Claim 1, Gyrn discloses an injection port assembly (assembly of Fig 25B) for delivery of multiple injections to a patient comprising: a support body (101, Fig 21A) comprising: a main body (121, Fig 21C) with a sole passage (122, Fig 12A) extending through the main body; a receptacle including a receptacle wall (111, Fig 12E) extending from a first face (top surface of 121, Fig 12E) of the main body and surrounding the sole passage (122, Fig 21C) through the main body, the receptacle wall including at least one recess (notches or spaces between the attachment means 125, Fig 21E) into a face of the receptacle wall most distal to the main body and a plurality of retainer members (125, Fig 21E); a peripheral guard rim (110, Fig 21E) at the periphery of the main body; and an adhering body attached to a second face of the main body opposite the first (Col 17, lines 26-40); and a delivery assembly (108, Fig 24A) configured to be retained within the receptacle by the retainer members (Col 18, lines 28-31), the delivery assembly having a cannula (108a, Fig 24A) extending through the sole passage and a barrier (109, Fig 24A) forming a fluid tight seal against an injection receiving volume (volume within 129, Fig 24A) defined in an enlarged end region (enlarge proximal region of cannula 108a that defines at least part of the injection receiving volume) of the cannula (Col 21, lines 33-62), a sole externally accessible portion (top surface of barrier 109) of the barrier being aligned with an axis of the cannula (See Fig 24A).
Gyrn is silent regarding the plurality of retainer members being cantilever and the plurality of sections including a number of proud sections extending from the receptacle wall to the peripheral guard rim.
Olivas teaches an analogous receptacle including a receptacle wall (wall formed by the fingers 164 extending from the floor member; Para 0040) extending from a first face (160c, Fig 2) of the main body (160, Fig 2) and surrounding a passage (160b, Fig 2) through the main body, the receptacle wall including at least one notch (spaces between the fingers 164, Fig 2) recessed into a face of the receptacle wall most distal to the main body and a plurality of cantilevered retainer members (164, Fig 2) (Para 0046).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of barb retainer members disclosed by Gyrn to be a plurality of cantilevered retainer members as taught by Olivas as Olivas teaches that fingers and barbs could be used to achieve the same result (coupling the cannula and base as described in Para 0040) and thus were art-recognized equivalents at the time the invention was made. It has been held that substituting parts of an invention involves only routine skill in the art.
The modified invention of Gyrn and Olivas discloses all of the elements of the invention as discussed above, however, is silent regarding the plurality of sections including a number of proud sections extending from the receptacle wall to the peripheral guard rim.
Gyrn ‘406 teaches injection port assembly (assembly seen in 16B) comprising a support body comprising: a main body (191, Fig 16B) with a sole passage (121, Fig 16B) extending through the main body; a receptacle including a receptacle wall (wall surrounding opening 121, Fig 16B) extending from a first face of the main body and surrounding the sole passage; a plurality of sections proud of the first face, the plurality of sections including a number of proud sections (500, Fig 16D) extending from the receptacle wall to the peripheral rim (attachment means 400, Fig 16D) (Para 0133-0134).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main body to include a number of proud sections as taught by Gyrn ‘406 in order to have an injection port assembly that can provide distinct positioning means when the connector part is attached to the site allowing a user to choose the position of the connector part relative to the site (Para 0128, 0133-034).
Regarding Claim 2, the modified invention of Gyrn, Olivas, and Gyrn ‘406 discloses at least a portion of the receptacle wall most distal to the first face includes a taper (See Fig 21C of Gyrn wherein an interior portion of the receptacle wall is tapered).
Regarding Claim 3, the modified invention of Gyrn, Olivas, and Gyrn ‘406 discloses each of the at least one recesses includes a taper at least at a portion of each of the at least one recess which is most distal to the first face (See Fig 21C of Gyrn wherein an interior portion of the receptacle wall is tapered, thus the notched portions between the attachment means 125 are also tapered).
Regarding Claim 4, the modified invention of Gyrn, Olivas, and Gyrn ‘406 discloses each of the retainer members (164, Fig 2 -Olivas) include a ramped latching protuberance (164a, Fig 2 -Olivas) at an unsupported end of each of the retainer members.
Regarding Claim 5, the modified invention of Gyrn, Olivas, and Gyrn ‘406 discloses the delivery assembly (108, Fig 24A -Gyrn) includes a set of notches (130, 131, Fig 24A -Gyrn) each configured to engage with a respective retainer member of the plurality of retainer members (Col 22, lines 10-21 -Gyrn; Para 0046 -Olivas).
Regarding Claim 7, the modified invention of Gyrn, Olivas, and Gyrn ‘406 discloses the barrier (109, Fig 24A -Gyrn) is constructed of a self-sealing material which self-seals after removal of a deliver sharp that has pierced the barrier (Col 21, lines 38-49 -Gyrn).
Regarding Claim 8, the modified invention of Gyrn, Olivas, and Gyrn ‘406 discloses the injection port assembly further comprises a medicament injecting implement adapter (52, Fig 12 -Gyrn), the adapter configured to couple to the support body (Col 8, lines 17-37 -Gyrn).
Regarding Claim 9, the modified invention of Gyrn, Olivas, and Gyrn ‘406 discloses the medicament injecting implement adapter (52, Fig 12 -Gyrn) includes an adapter receptacle for accepting a medicament injecting implement, the medicament injecting implement adapter receptacle disposed over the sole externally accessible portion of the barrier when coupled to the support body (See Fig 6 -Gyrn; the adapter 52 receives the introducer needle 47 and the associated insertion parts. Examiner is interpreting the introducer needle 47 and associated parts as the medicament injecting implement as it aids in the delivery of the cannula (which delivers a medicament) into the patient skin. The claim still does not provide any specific structure for the medicament injecting implement).
Regarding Claim 13, Gyrn discloses an injection port assembly (assembly of Fig 25B) for delivery of multiple injections to a patient comprising: a support body (121, Fig 21A) with a sole passage (122, Fig 12A) extending through the support body; a receptacle including a receptacle wall (111, Fig 12E) surrounding the sole passage (122, Fig 12E), the receptacle wall including at least recess (spaces between the attachment means 125, Fig 21E) extending from an end surface of the receptacle wall toward the support body, the receptacle wall including a plurality of retainer members (125, Fig 21E); a guard rim rib (110, Fig 21E) around the periphery of the support body; an adhering body attached to the support body (Col 17, lines 26-40); and a delivery assembly (108, Fig 24A) configured to couple within the receptacle by engagement with the retainer members (Col 18, lines 28-31), the delivery assembly having a cannula (108a, Fig 24A) extending through the sole passage and including an enlarged end region (enlarge proximal region of cannula 108a that defines at least part of the injection receiving volume) which forms an injection receiving volume, the delivery assembly having a barrier (109, 127, Fig 24A) sealing against a portion of the enlarged region (Col 21, lines 33-62; the septum 109 and bushing 127 seals against a top portion of the enlarged region of cannula 108a) and having a sole externally accessible portion (top surface of barrier 109) aligned with an axis of the cannula (See Fig 24A).
Gyrn is silent regarding the plurality of retainer members being cantilever and the plurality of ribs including a number of additional ribs extending from the receptacle wall to the guard rim rib.
Olivas teaches an analogous receptacle including a receptacle wall (wall formed by the fingers 164 extending from the floor member; Para 0040) extending from a first face (160c, Fig 2) of the main body (160, Fig 2) and surrounding a passage (160b, Fig 2) through the main body, the receptacle wall including at least one notch (spaces between the fingers 164, Fig 2) recessed into a face of the receptacle wall most distal to the main body and a plurality of cantilevered retainer members (164, Fig 2) (Para 0046).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of barb retainer members disclosed by Gyrn to be a plurality of cantilevered retainer members as taught by Olivas as Olivas teaches that fingers and barbs could be used to achieve the same result (coupling the cannula and base as described in Para 0040) and thus were art-recognized equivalents at the time the invention was made. It has been held that substituting parts of an invention involves only routine skill in the art.
The modified invention of Gyrn and Olivas discloses all of the elements of the invention as discussed above, however, is silent regarding the plurality of ribs including a number of additional ribs extending from the receptacle wall to the guard rim rib.
Gyrn ‘406 teaches injection port assembly (assembly seen in 16B) comprising a support body comprising: a main body (191, Fig 16B) with a sole passage (121, Fig 16B) extending through the main body; a receptacle including a receptacle wall (wall surrounding opening 121, Fig 16B) extending from a first face of the main body and surrounding the sole passage; a plurality of ribs, the plurality of ribs including a number of additional ribs (500, Fig 16D) extending from the receptacle wall to the peripheral rim (attachment means 400, Fig 16D) (Para 0133-0134).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main body to include a number of additional ribs as taught by Gyrn ‘406 in order to have an injection port assembly that can provide distinct positioning means when the connector part is attached to the site allowing a user to choose the position of the connector part relative to the site (Para 0128, 0133-034).
Regarding Claim 14, the modified invention of Gyrn, Olivas, Gyrn ‘406 discloses the receptacle wall includes a tapered portion (See Fig 21C of Gyrn wherein an interior portion of the receptacle wall is tapered).
Regarding Claim 15, the modified invention of Gyrn, Olivas, Gyrn ‘406 discloses each of the at least one recess includes a tapered portion (See Fig 21C of Gyrn wherein an interior portion of the receptacle wall is tapered, thus the notched portions between the attachment means 125 are also tapered).
Regarding Claim 16, the modified invention of Gyrn, Olivas, Gyrn ‘406 discloses each of the retainer members (164, Fig 2 -Olivas) include a ramped latching protuberance (164a, Fig 2 -Olivas) at an unsupported end of each of the retainer members.
Regarding Claim 17, the modified invention of Gyrn, Olivas, Gyrn ‘406 discloses the delivery assembly (108, Fig 24A -Gyrn) includes a set of retention recesses (130, 131, Fig 24A -Gyrn) each configured to engage with a respective retainer member of the plurality of retainer members (Col 22, lines 10-21 -Gyrn; Para 0046 -Olivas).
Regarding Claim 21, the modified invention of Gyrn, Olivas, Gyrn ‘406 discloses the adapter (52, Fig 12 -Gyrn) includes an adapter receptacle for accepting a delivery implement, the adapter receptacle disposed over the sole externally accessible portion of the barrier when coupled to the support body (See Fig 6 -Gyrn; the adapter 52 receives the introducer needle 47 and the associated insertion parts. Examiner is interpreting the introducer needle 47 and associated parts as the medicament injecting implement as it aids in the delivery of the cannula (which delivers a medicament) into the patient skin. The claim still does not provide any specific structure for the medicament injecting implement).
Regarding Claim 25, Gyrn discloses an injection port assembly (assembly of Fig 25B) for delivery of multiple injections to a patient comprising: a support body (121, Fig 21A) having a sole passage (122, Fig 12E) therethrough and a receptacle (111, 122, Fig 12E) associated with the sole passage, the receptacle having at least one notched recess (notches or spaced between the attachment means 125, Fig 21E) in an end surface of the receptacle opposite the support body, the receptacle having a plurality of retainer members (125, Fig 21E); a plurality of ribs (110, 121, 123, Fig 24E) including a guard rim rib (110, Fig 21E) about a periphery of the support body; and a delivery assembly (108, Fig 24A) latched within the receptacle via the retainer members (Col 18, lines 28-31), the delivery assembly having a cannula (108a, Fig 24A) extending through the sole passage, the delivery assembly having an injection receiving volume (volume within 129, Fig 24A) within the delivery assembly in fluid communication with a lumen of the cannula and otherwise sealed from the surrounding environment by a self-sealing barrier (109, Fig 24A) (Col 21, lines 38-49), a sole externally accessible portion (top surface of barrier 109) of the barrier being aligned with an axis of the lumen (See Fig 24A).
Gyrn is silent regarding the plurality of retainer members being cantilever and the plurality of ribs including a number of additional ribs extending from the receptacle wall to the guard rim rib.
Olivas teaches an analogous receptacle including a receptacle wall (wall formed by the fingers 164 extending from the floor member; Para 0040) extending from a first face 160c, Fig 2) of the main body (160, Fig 2) and surrounding a passage (160b, Fig 2) through the main body, the receptacle wall including at least one notch (spaces between the fingers 164, Fig 2) recessed into a face of the receptacle wall most distal to the main body and a plurality of cantilevered retainer members (164, Fig 2) (Para 0046).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of barb retainer members disclosed by Gyrn to be a plurality of cantilevered retainer members as taught by Olivas as Olivas teaches that fingers and barbs could be used to achieve the same result (coupling the cannula and base as described in Para 0040) and thus were art-recognized equivalents at the time the invention was made. It has been held that substituting parts of an invention involves only routine skill in the art.
The modified invention of Gyrn and Olivas discloses all of the elements of the invention as discussed above, however, is silent regarding the plurality of ribs including a number of additional ribs extending from the receptacle wall to the guard rim rib.
Gyrn ‘406 teaches injection port assembly (assembly seen in 16B) comprising a support body comprising: a main body (191, Fig 16B) with a sole passage (121, Fig 16B) extending through the main body; a receptacle including a receptacle wall (wall surrounding opening 121, Fig 16B) extending from a first face of the main body and surrounding the sole passage; a plurality of ribs, the plurality of ribs including a number of additional ribs (500, Fig 16D) extending from the receptacle wall to the peripheral rim (attachment means 400, Fig 16D) (Para 0133-0134).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main body to include a number of additional ribs as taught by Gyrn ‘406 in order to have an injection port assembly that can provide distinct positioning means when the connector part is attached to the site allowing a user to choose the position of the connector part relative to the site (Para 0128, 0133-034).
Claims 6, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gyrn (US 11,786,653) in view of Olivas (US 2019/0060562) and further in view of Gyrn (US 2012/0095406) and further in view of Sonderegger (US 2014/0074028).
Regarding Claim 6, the modified invention of Gyrn, Olivas, and Gyrn ‘406 discloses all of the elements of the invention as discussed above, however, is silent regarding the delivery assembly includes a number of ear projections equal to the number of the at least one recess in the receptacle wall, each ear projection being disposed in one of the at least one recess in the receptacle wall.
Sonderegger teaches a delivery assembly (30, Fig 5) includes a number of ear projections (313, Fig 5) equal to the number of at least one recess (601, Fig 9A) in the receptacle wall, each ear projection being disposed in one of the at least one recess in the receptacle wall (Para 0029-0030).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery assembly to include a number of ear projections with corresponding recesses as taught by Sonderegger in order to guide the delivery assembly to the appropriate position in the base (Para 0029-0030).
Regarding Claim 18, the modified invention of Gyrn, Olivas, and Gyrn ‘406 discloses all of the elements of the invention as discussed above, however, is silent regarding the delivery assembly includes a number of ear projections equal to the number of the at least one recess in the receptacle wall, each ear projection being disposed in one of the at least one recess in the receptacle wall.
Sonderegger teaches a delivery assembly (30, Fig 5) includes a number of ear projections (313, Fig 5) equal to the number of at least one recess (601, Fig 9A) in the receptacle wall, each ear projection being disposed in one of the at least one recess in the receptacle wall (Para 0029-0030).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery assembly to include a number of ear projections with corresponding recesses as taught by Sonderegger in order to guide the delivery assembly to the appropriate position in the base (Para 0029-0030).
Claims 8-10, 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gyrn (US 11,786,653) in view of Olivas (US 2019/0060562) and further in view of Gyrn (US 2012/0095406) and further in view of Yodfat (US 2010/0137695).
Regarding Claim 8, the modified invention of Gyrn, Olivas, and Gyrn ‘406 discloses all of the elements of the invention as discussed above, however, is silent regarding the injection port assembly further comprises a medicament injecting adapter, the adapter configured to couple to the support body.
Yodfat teaches an analogous injection port assembly (30, Fig 2b) further comprises a delivery implement adapter (62, Fig 12e), the adapter configured to couple to the support body (Para 0124).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection port assembly to include a delivery implement adapter as taught by Yodfat in order to enable connection and alignment of a syringe to the injection port assembly (Para 0124, 0128)
Regarding Claim 9, the modified invention of Gyrn, Olivas, Gyrn ‘406 and Yodfat discloses the medicament injecting implement adapter (62, Fig 12e -Yodfat) includes an adapter receptacle for accepting a medicament injecting implement (60, Fig 12e -Yodfat), the medicament injecting implement adapter receptacle disposed over the sole externally accessible portion of the barrier when coupled to the support body (Para 0129).
Regarding Claim 10, the modified invention of Gyrn, Olivas, Gyrn ‘406 and Yodfat discloses the receptacle wall includes a number of ledges (32, 34, Fig 12e -Yodfat) and the adapter (62, Fig 12e -Yodfat) includes a number of latching arms (See annotated Fig 12e below), each latch arm configured to engage with a ledge of the number of ledges (Para 0129 -Yodfat).
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Regarding Claim 20, the modified invention of Gyrn, Olivas, and Gyrn ‘406 discloses all of the elements of the invention as discussed above, however, is silent regarding the injection port assembly further comprises a medicament injecting implement adapter configured to couple to the receptacle wall.
Yodfat teaches an analogous injection port assembly (30, Fig 2b) further comprises a medicament injecting implement adapter (62, Fig 12e), the adapter configured to couple to the receptacle wall (Para 0124).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection port assembly to include a delivery implement adapter as taught by Yodfat in order to enable connection and alignment of a syringe to the injection port assembly (Para 0124, 0128)
Regarding Claim 21, the modified invention of Gyrn, Olivas, Gyrn ‘406 and Yodfat discloses the medicament injecting implement adapter (62, Fig 12e -Yodfat) includes an adapter receptacle for accepting a medicament injecting implement (60, Fig 12e -Yodfat), the medicament injecting implement adapter receptacle disposed over the sole externally accessible portion of the barrier when coupled to the support body (Para 0129).
Regarding Claim 22, the modified invention of Gyrn, Olivas, Gyrn ‘406 and Yodfat discloses the receptacle wall includes a number of ledges (32, 34, Fig 12e -Yodfat) and the adapter (62, Fig 12e -Yodfat) includes a number of latching arms (See annotated Fig 12e below), each latch arm configured to engage with a ledge of the number of ledges (Para 0129 -Yodfat).
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Claims 11, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Gyrn (US 11,786,653) in view of Olivas (US 2019/0060562) and further in view of Gyrn (US 2012/0095406) and further in view of and further in view of Yodfat (US 2010/0137695) and further in view of Kornerup (US 2008/0215003).
Regarding Claim 11, the modified invention of Gyrn, Olivas, Gyrn ‘406, and Yodfat discloses the sole exposed portion of the barrier is spaced from the injection receiving volume by a barrier distance (See annotated Fig 24A below), however, is silent regarding the adapter includes a stop which limits a delivery sharp of a delivery implement from advancing into the injection port assembly to a depth greater than the barrier distance plus a partial percentage of a height of the injection receiving volume.
Kornerup teaches an analogous adapter (30, Fig 23) that includes a stop (22, Fig 23) which limits a delivery sharp (21, Fig 23) of a delivery implement from advancing into the injection port assembly to a depth greater than the barrier distance plus a partial percentage of a height of the injection receiving volume (Para 0076, Para 0094).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adapter to have a stop as taught by Kornerup in order to assure easy and secure injection because it is only possible to place the needle in the correct position (Para 0094).
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Regarding Claim 23, the modified invention of Gyrn, Olivas, Gyrn ‘406, and Yodfat discloses the sole exposed portion of the barrier is spaced from the injection receiving volume by a barrier distance (See annotated Fig 24A above), however, is silent regarding the adapter includes a stop which limits a delivery sharp of a delivery implement from advancing into the injection port assembly to a depth greater than the barrier distance plus a partial percentage of a height of the injection receiving volume.
Kornerup teaches an analogous adapter (30, Fig 23) that includes a stop (22, Fig 23) which limits a delivery sharp (21, Fig 23) of a delivery implement from advancing into the injection port assembly to a depth greater than the barrier distance (thickness of barrier 4, Fig 23) plus a partial percentage of a height of the injection receiving volume (See Fig 23; Para 0076, Para 0094).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adapter to have a stop as taught by Kornerup in order to assure easy and secure injection because it is only possible to place the needle in the correct position (Para 0094).
Claims 12, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Gyrn (US 11,786,653) in view of Olivas (US 2019/0060562) and further in view of Gyrn (US 2012/0095406) and further in view of Kamen (US 2017/0281863).
Regarding Claim 12, the modified invention of Gyrn, Olivas, and Gyrn ‘406 discloses all of the elements of the invention as discussed above, however, is silent regarding the barrier includes a cavity into which the enlarged end region extends, an outwardly facing sealing surface of the enlarged end region forming a fluid tight seal against the barrier, a portion of the cavity most distal the outlet of the cannula being disposed adjacent open space within the injection receiving volume.
Kamen teaches an analogous injection port assembly comprising a barrier (208, Fig 50C) includes a cavity (cavity comprising septum retainer and cannula) into which the enlarged end region extends (See Fig 52D wherein the enlarge end region of the cannula is at an inner distalmost surface; Para 0062 indicates that the septum retainer and cannula can be a single part), an outwardly facing sealing surface of the enlarged end region forming a fluid tight seal against the barrier (See Fig 50C), a portion of the cavity most distal the outlet of the cannula being disposed adjacent open space within the injection receiving volume (See Fig 50C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barrier and cannula to be shaped and arranged as taught by Kamen in order to allow the cannula to move with respect to the base when the base moves while keeping costs of the device low (Para 0005, Para 0063).
Regarding Claim 24, the modified invention of Gyrn, Olivas, and Gyrn ‘406 discloses the delivery assembly devoid of open volumes in communication with the cannula other than the injection receiving volume (Col 21, lines 33-62 -Gyrn), however, is silent regarding the enlarged end region extends into a receptacle of the barrier, the end region having an outwardly facing sealing surface which forms a fluid tight seal against barrier.
Kamen teaches an analogous injection port assembly comprising a barrier (208, Fig 50C) includes a receptacle (cavity comprising septum retainer and cannula) into which the enlarged end region extends (See Fig 52D wherein the enlarge end region of the cannula is at an inner distalmost surface; Para 0062 indicates that the septum retainer and cannula can be a single part), an outwardly facing sealing surface of the enlarged region forming a fluid tight seal against the barrier (See Fig 50C), the delivery assembly devoid of open volumes in communication with the cannula other than the injection receiving volume (Para 0052).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barrier and cannula to be shaped and arranged as taught by Kamen in order to allow the cannula to move with respect to the base when the base moves while keeping costs of the device low (Para 0005, Para 0063).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gyrn (US 11,786,653) in view of Olivas (US 2019/0060562) and further in view of Schraga (US 2009/0069750).
Regarding Claim 19, the modified invention of Gyrn and Olivas discloses the barrier (109, Fig 24A -Gyrn) is constructed of a self-sealing material (Col 21, lines 38-49), however, is silent regarding it being constructed of an elastomer.
Shraga teaches a self-sealing barrier constructed of an elastomer (Para 0151).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barrier to be made of an elastomer as taught by Schraga in order to have a barrier made of a biocompatible material (Para 0151).
Response to Arguments
Applicant’s arguments filed 11/18/2025, On page 10, regarding Gyrn’s bottom surface not being a first face as it is planar have been fully considered but are moot in view of the current rejection that now characterizes the top surface of portion 21 (See Gyrn) as the first face having the receptacle wall extending from it.
Applicant’s arguments filed 11/18/2025, On page 11, regarding Gyrn failing to teach the plurality of sections have been fully considered but are moot in view of the current rejection that relies on Gyrn ‘406 to teach the plurality of sections.
Applicant’s arguments filed 11/18/2025, On pages 11-12, regarding Gyrn’s barrier not contacting the enlarged end of the cannula have been fully considered but are not persuasive. The language in claim 1 recites “a barrier forming a fluid tight seal against an injection receiving volume defined in an enlarged end region of the cannula”. This requires the barrier to form a fluid tight seal against an injection receiving volume, that injection receiving volume being defined by an enlarged region of the cannula. The language does not require the seal to be formed against the enlarged region of the cannula as Applicant states. Therefore, Gyrn’s barrier meets the limitation of the claim as detailed in Col 21, lines 33-62.
Applicant’s arguments filed 11/18/2025, On page 12, regarding Gyrn teaches away from removing the items 123 have been fully considered but are not persuasive. It is unclear what Applicant is referring to here as none of the rejections or modifications detail removing this feature. In the current rejection, the main body is being interpreted as portion 121 as it has only one passage, opening 122 (Best seen in Fig 21A).
Applicant’s arguments filed 11/18/2025, On page 12, regarding the rejections of claim 8 and 9 in view of Gyrn and Olivas should be withdrawn due to the alternative rejection in view of Yodfat have been fully considered but are not persuasive. As claims 8 and 9 do not provide any specific structure regarding what the delivery implement must comprise, it is being interpreted broadly and thus Gyrn and Olivas. Examiner has provided an alternative rejection in view of Yodfat to teach an adapter more in line with the disclosed adaptor in the name of compact prosecution. Examiner recommends further specifying the delivery implement that the adaptor is compatible with to prevent the broader interpretation.
Applicant’s arguments filed 11/18/2025, On page 13, regarding Gyrn and Olivas failing to teach the additional ribs have been fully considered but are moot in view of the current rejection that relies on Gyrn ‘406 to teach the additional ribs.
Applicant’s arguments filed 11/18/2025, On pages 13-14, regarding Gyrn failing to teach the amended barrier of claim 13 have been fully considered but is not persuasive. As detailed in the rejection of claim 13 above, the barrier is not being interpreted as the septum 109 and bushing 127 of Gyrn. As described in Col 21, lines 33-62, the septum and bushing seal the injection receiving volume against the enlarged end of the cannula. Nothing in the claim requires the barrier to a specific structure and therefore, Gyrn still reads on the is limitations.
Applicant’s arguments filed 11/18/2025, On page 14, regarding claim 25 have been fully considered but are moot in view of the current rejection that relies on Gyrn, Olivas, and Gyrn ‘406 to teach all of the elements of the claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783