Prosecution Insights
Last updated: May 04, 2026
Application No. 18/561,627

Silicone Low Profile Port with Rigid Baseplate and Stem

Non-Final OA §103
Filed
Nov 16, 2023
Priority
May 20, 2021 — nonprovisional of PCTUS2021033375 +1 more
Examiner
VOKES, KATHLEEN PAIGE
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
BARD PERIPHERAL VASCULAR, INC.
OA Round
1 (Non-Final)
54%
Grant Probability
Moderate
1-2
OA Rounds
1y 6m
Est. Remaining
74%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allowance Rate
27 granted / 50 resolved
-16.0% vs TC avg
Strong +20% interview lift
Without
With
+20.0%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
39 currently pending
Career history
89
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
54.6%
+14.6% vs TC avg
§102
20.0%
-20.0% vs TC avg
§112
21.1%
-18.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 50 resolved cases

Office Action

§103
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. Information Disclosure Statement The information disclosure statements (IDSs) submitted on 02/29/24 and 09/03/24 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Response to Preliminary Amendment The preliminary amendment filed 11/16/23 has been entered. Claims 3-4, 6-7, 9- 10, 12-16, and 18-19 have been amended. Claims 1-2, 5, 8, 11, 17, and 20 are in the original/previously presented form. Claims 21-43 are cancelled. Thus, claims 1-20 remain pending in the application. Drawings The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “130” has been used to designate both the port stem and the base plate (see [0036]). Applicant could remedy this objection by correcting the numeral for the base plate from 130 to 140 in [0036]. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Objections Claim 1 is objected to because of the following informalities: Claim 1 lines 2-3 reads “ a port stem formed of a first material, being a rigid material and having a first durometer ; ” and should likely read “ a port stem formed of a first material [[ , ]] being a rigid material and having a first durometer ; ” for grammatical reasons and to make clear that the first material is the structure “being” a rigid material and having a first durometer Claim 1 lines 4-5 reads “ a body defining a reservoir in fluid communication with the port stem, and formed of a second material, being a flexible material and having a second durometer , ” and should likely read “ a body defining a reservoir in fluid communication with the port stem, [[ and ]] the body formed of a second material [[ , ]] being a flexible material and having a second durometer , ” for grammatical reasons and to make clear that the body is the structure formed of the second material and the second material is the structure “being” a flexible material and having a second durometer Appropriate correction is required. 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. 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 . Claims 1- 6, 10-11, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tal (U.S. PGPUB No. 2022/0313972) in view of Horgan (U.S. PGPUB No. 2013/0150811). Regarding claim 1, Tal discloses a subcutaneous access port (20, see FIG. 2A and [0161]) , comprising: a port stem (25) formed of a first material (port stem inherently formed of some kind of material to obtain structural element) , being a material and having a first durometer (a material inherently has a durometer) ; and a body (21 comprising port body extension 24, see [0163]) defining a reservoir (23, see [0003] & [0162]) in fluid communication (see [0166]: fluid communication to reservoir provided via catheter) with the port stem (see [0167]: catheter connected to port by the stem 25 and therefore stem is also in fluid communication with reservoir) , and formed of a second material (body inherently formed of some kind of material to obtain structural element) , being a flexible material (see [0172]: flexible polymer/ monolithic plastic. A plastic aligns with applicant disclosure of flexible material in [0009]) and having a second durometer (a material inherently has a durometer) , the body (21 comprising port body extension 24, see [0163]) transitionable between (see [0161-0172]) an expanded configuration (see FIG. 2C and the Figure provided below for immediate reference) and a collapsed configuration (see FIG. 2B and [0162-0163]) , the collapsed configuration (see FIG. 2B) defining a smaller outer profile (see [0162]: collapsed configuration has smaller length and [0163]: other dimensions such as length/width/height can be shorter) of the port (21) . Tal is silent to the first material being “ a rigid ” material . However, Horgan teaches a subcutaneous access port (see FIG. 1) comprising a port stem (18) formed of a first material being a rigid material (see [0021]: tubular stem formed of a metal and see [0027]: such as titanium. A metal aligns with applicant disclosure of rigid material in [0009]) and a body (11) formed of a second material being a flexible material (see [0021]: plastic. A plastic aligns with applicant disclosure of flexible material in [0009]) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the first material forming the stem disclosed in Tal to be a metal, such as titanium, as taught by Horgan for the purpose of providing the stem with a higher structural integrity than a different material, such as a plastic (see [0027]), thus achieving the first material being “ a rigid ” material. Regarding claim 2, the modified system of Tal teaches the subcutaneous access port according to claim 1, but Tal is silent to “ wherein the first material includes one of a plastic, polymer, metal, alloy, or composite . ” However, Horgan teaches a subcutaneous access port (see FIG. 1) comprising a port stem (18) formed of a first material being a rigid material (see [0021]: tubular stem formed of a metal and see [0027]: such as titanium. A metal aligns with applicant disclosure of rigid material in [0009]) , wherein the first material includes one of a plastic, polymer, metal, alloy, or composite (see [0021] & [0027]). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the first material forming the stem disclosed in Tal to be a metal, such as titanium, as taught by Horgan for the purpose of providing the stem with a higher structural integrity than a different material, such as a plastic (see [0027]), thus achieving “ wherein the first material includes one of a plastic, polymer, metal, alloy, or composite . ” Regarding claim 3 , the modified system of Tal teaches the subcutaneous access port according to claim 1, and Tal further discloses wherein the second material includes one of a plastic, polymer, elastomer, synthetic rubber, organic rubber, silicone rubber, or composite (see [0172]: flexible polymer/monolithic plastic) . Regarding claim 4 , the modified system of Tal teaches the subcutaneous access port according to claim 1, and Tal further discloses wherein the port body ( 21 comprising port body extension 24, see [0163] ) in the expanded configuration (see FIG. 2C) defines one of a first port height (see [0163]: larger length/width/ height in deployed configuration of FIG. 2C compared to delivery configuration in FIG. 2B) , a first port width (see [0163]: larger length/width/ height in deployed configuration of FIG. 2C compared to delivery configuration in FIG. 2B) , or a first port length (see [0162]: first predetermined length of deployed/ expanded configuration in FIG. 2C is larger than the smaller second length of the delivery configuration in FIG. 2B) , and wherein the port body ( 21 comprising port body extension 24, see [0163] ) in the collapsed configuration (see FIG. 2B) defines one of a second port height (see [0163]: larger length/width/ height in deployed configuration of FIG. 2C compared to delivery configuration in FIG. 2B and thus delivery/ collapsed configuration has second height dimension) , a second port width (see [0163]: larger length/width/ height in deployed configuration of FIG. 2C compared to delivery configuration in FIG. 2B and thus delivery/ collapsed configuration has second width dimension) , or a second port length (see [0162]: first predetermined length of deployed/ expanded configuration in FIG. 2C is larger than the smaller second length of the delivery configuration in FIG. 2B) . Regarding claim 5 , the modified system of Tal teaches the subcutaneous access port according to claim 4 , and Tal further discloses wherein one of the second port height is less than the first port height (see [0163]: larger length/width/ height in deployed configuration of FIG. 2C compared to delivery configuration in FIG. 2B and thus delivery/ collapsed configuration has second height dimension less than the first) , the second port width is less than the first port width (see [0163]: larger length/width/ height in deployed configuration of FIG. 2C compared to delivery configuration in FIG. 2B and thus delivery/ collapsed configuration has second width dimension less than the first) , or the second port length is less than the first port length (see [0162]: first predetermined length of deployed/ expanded configuration in FIG. 2C is larger than the smaller second length of the delivery configuration in FIG. 2B, making the second port length less than the first) . Regarding claim 6 , the modified system of Tal teaches the subcutaneous access port according to claim 1 , and Tal further discloses wherein the port body ( 21 comprising port body extension 24, see [0163] ) in the expanded configuration (see FIG. 2C) defines a first port volume (see [0163]: the deployed/expanded configuration in FIG. 2C expands/increases in volume) , and the port body in the collapsed configuration (see FIG. 2B) defines a second port volume, the second port ( 21 comprising port body extension 24, see [0163] ) volume being less than the first port volume (see [0163]: the deployed/expanded configuration in FIG. 2C expands/increases in volume and therefore the delivery/collapsed configuration has a smaller/decreased/ second port volume) . Regarding claim 10 , the modified system of Tal teaches the subcutaneous access port according to claim 1 , and Tal discloses further including a needle penetrable septum (22, see FIG. 2A) disposed over (see [0162]) the reservoir (23) and configured to provide percutaneous access thereto by a needle (see [0003] & [0153]) . Regarding claim 11 , the modified system of Tal teaches the subcutaneous access port according to claim 10 , and Tal further discloses the needle penetrable septum (22, see FIG. 2A). Tal ( FIGs. 2A-C) is silent to “ wherein the needle penetrable septum is formed of either the second material or a silicone rubber ” . However, in an alternate embodiment (see FIG. 17A ), Tal teaches a subcutaneous access port (see [0227]) with a needle penetrable septum (502, see [0227]), wherein the needle penetrable septum (502) is formed of either the second material or a silicone rubber (see [0227]: silicon septum) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle penetrable septum disclosed in Tal (FIGS. 2A-C) to be formed of silicone rubber as taught by Tal (FIG. 17A) for the purpose of ensuring the septum can withstand 2,000 needle punctures or more (see [0227]) , thus achieving “ wherein the needle penetrable septum is formed of either the second material or a silicone rubber ” . Regarding claim 13, the modified system of Tal teaches the subcutaneous access port according to claim 1, and Tal further discloses wherein the second material (see [0172]: flexible polymer/monolithic plastic) is an elastically deformable material ( port body material allows device to move from collapsed configuration in FIG.2B to expanded in FIG.2C, aligning with Applicant disclosure defin ing elastically deformable material as one that changes from expanded to compressed shape, see [ 0050 ]) . Tal is silent to “ wherein the first material is a rigid material and is substantially resistant to flexible deformation ”. However, Horgan teaches a subcutaneous access port (see FIG. 1) comprising a port stem (18) formed of a first material , wherein the first material is a rigid material ( see [0021]: tubular stem formed of a metal and see [0027]: such as titanium. A metal aligns with applicant disclosure of rigid material in [0009] ) and is substantially resistant to flexible deformation ( Applicant’s only disclosure of flexible deformation is in [0006] that the first material is substantially resistant to flexible deformation. Thus, because Horgan teaches the rigid material aligning with that as disclosed by Applicant, Horgan’s material must also be substantially resistant to flexible deformation in as much as is disclosed by Applicant ) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the first material forming the stem disclosed in Tal to be a rigid material substantially resistant to flexible deformation, such as a metal like titanium, as taught by Horgan for the purpose of providing the stem with a higher structural integrity than a different material, such as a plastic (see [0027]), thus achieving “ wherein the first material is a rigid material and is substantially resistant to flexible deformation ”. Regarding claim 15, the modified system of Tal teaches the subcutaneous access port according to claim 1, and Tal further discloses wherein the body ( 21 comprising port body extension 24, see [0163] ) is elastically deformable (see [0162]: device selectively changeable to a deployed configuration ) from the collapsed configuration (see FIG.2B) to the expanded configuration (see FIG.2C) . Claims 1 , 7-9, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bansal ( FOR patent GB2489518 provided in IDS dated 02/29/24 ) in view of Horgan (U.S. PGPUB No. 2013/0150811). Regarding claim 1, Bansal discloses a subcutaneous access port, comprising: a port stem (19, see FIG. 4A and page 9 lines 6-9) formed of a first material (port stem inherently formed of some kind of material to obtain structural element) and having a first durometer (a material inherently has a durometer) ; and a body (12) formed of a second material (see page 8 line 26- page 9 line 18: port comprises resilient expansion member 16) , being a flexible material (see page 7 lines 23-29: 16 may be an elastic material such as a polymer. A polymer aligns with applicant disclosure of flexible material in [0009]) and having a second durometer (a material inherently has a durometer) , the body (12) transitionable between an expanded configuration (see FIG. 4A provided for immediate reference below) and a collapsed configuration (see FIG. 5 provided for immediate reference below) , the collapsed configuration (see FIG. 5) defining a smaller outer profile (see smaller profile in Fig. 5 compared to FIG. 4A, see also page 8 lines 26-29 and page 9 lines 4-26) of the port (12) . Bansal is silent to the first material of the port stem “ being a rigid material ” and the body “ defining a reservoir in fluid communication with the port stem ”. However, Horgan teaches a subcutaneous access port (see FIG. 1) comprising a port stem (18) formed of a first material being a rigid material (see [0021]: tubular stem formed of a metal and see [0027]: such as titanium. A metal aligns with applicant disclosure of rigid material in [0009]) and a body (11) defining a reservoir (12) in fluid communication (see [0021]: reservoir 12 and port stem 18 fluidly communicating) with the port stem (18) , the body (11) formed of a second material being a flexible material (see [0021]: plastic. A plastic aligns with applicant disclosure of flexible material in [0009]) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the first material forming the stem disclosed in Bansal to be a metal, such as titanium, as taught by Horgan for the purpose of providing the stem with a higher structural integrity than a different material, such as a plastic (see [0027]), thus achieving the port stem “ being a rigid material ”. Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the port body disclosed in Bansal to include a reservoir in fluid communication with the port stem as taught by Horgan for the purpose of providing a needle-accessible reservoir that provides fluid communication to a delivery site by way of the stem (see [0021]) , which would be advantageous to Bansal ( FIGs. 4A-5) that seems to require a constant catheter connection for providing fluid supply, or to allow the stem to extend from different locations of the port/reservoir (see [0021]), thus achieving the body “ defining a reservoir in fluid communication with the port stem ”. Regarding claim 7, the modified system of Bansal teaches the subcutaneous port according to claim 1, but Modified Bansal (Bansal FIGs. 4A-5 in view of Horgan) is silent to “ wherein the reservoir in the expanded configuration defines one of a first reservoir height, a first reservoir width, or a first reservoir length, and wherein the reservoir in the collapsed configuration defines one of a second reservoir height, a second reservoir width, or a second reservoir length . ” However, in an alternate embodiment (see FIGs. 7A -7B) , Bansal teaches a subcutaneous port with an expanded configuration (see FIG. 7B provided for reference below) and a collapsed configuration (see FIG. 7A provided for reference below and page 14 lines 1-10 ) and a body (12, see FIG. 6 for numeral) defining a reservoir (32) , wherein the reservoir (32) in the expanded configuration (see FIG. 7B) defines one of a first reservoir height, a first reservoir width, or a first reservoir length (see modified figure provided above) , and wherein the reservoir (32) in the collapsed configuration (see FIG. 7A) defines one of a second reservoir height, a second reservoir width, or a second reservoir length (see modified figure provided above) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir taught by Modified Bansal to have a first length in the expanded configuration and a second length in the collapsed configuration as taught by Bansal ( FIGs. 7A-B) for the purpose of allowing the reservoir to collapse and expand while being contained within the collapsing/expanding resilient body of the port (see page 14 lines 1-10) , which would likely ease the transition between the expanded and collapsed positions and ensure that the reservoir element is not damaged during the collapsing stage, thus achieving “ wherein the reservoir in the expanded configuration defines one of a first reservoir height, a first reservoir width, or a first reservoir length, and wherein the reservoir in the collapsed configuration defines one of a second reservoir height, a second reservoir width, or a second reservoir length . ” Regarding claim 8 , the modified system of Bansal teaches the subcutaneous port according to claim 7, but Bansal FIGs. 4A-5 in view of Horgan is silent to “ wherein one of the second reservoir height is less than the first reservoir height, the second reservoir width is less than the first reservoir width, or the second reservoir length is less than the first reservoir length . ” However, in an alternate embodiment (see FIGs. 7A -7B) , Bansal teaches a subcutaneous port with an expanded configuration (see FIG. 7B provided for reference below) and a collapsed configuration (see FIG. 7A provided for reference below and page 14 lines 1-10) and a body (12, see FIG. 6 for numeral) defining a reservoir (32) , wherein the reservoir (32) in the expanded configuration (see FIG. 7B) defines one of a first reservoir height, a first reservoir width, or a first reservoir length (see modified figure provided above) , and wherein the reservoir (32) in the collapsed configuration (see FIG. 7A) defines one of a second reservoir height, a second reservoir width, or a second reservoir length (see modified figure provided above) , wherein one of the second reservoir height is less than the first reservoir height, the second reservoir width is less than the first reservoir width, or the second reservoir length (see modified figure provided above) is less than (see length comparison in modified figure above and page 14 lines 1-10) the first reservoir length (see modified figure above). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir taught by Modified Bansal to have a first length in the expanded configuration and a second length in the collapsed configuration that is smaller than the first length as taught by Bansal ( FIGs. 7A-B) for the purpose of allowing the reservoir to collapse and expand while being contained within the collapsing/expanding resilient body of the port (see page 14 lines 1-10) , which would likely ease the transition between the expanded and collapsed positions and ensure that the reservoir element is not damaged during the collapsing stage, thus achieving “ wherein one of the second reservoir height is less than the first reservoir height, the second reservoir width is less than the first reservoir width, or the second reservoir length is less than the first reservoir length . ” Regarding claim 9 , the modified system of Bansal teaches the subcutaneous port according to claim 7, but Bansal FIGs. 4A-5 in view of Horgan is silent to “ wherein the reservoir in the expanded configuration defines a first reservoir volume, and the reservoir in the collapsed configuration defines a second reservoir volume, the second volume being less than the first volume . ” However, in an alternate embodiment (see FIGs. 7A-7B) , Bansal teaches a subcutaneous port with an expanded configuration (see FIG. 7B) and a collapsed configuration (see FIG. 7A and page 14 lines 1-10) , and a body (12, see FIG. 6 for numeral) defining a reservoir (32) , wherein the reservoir (32) in the expanded configuration (see FIG. 7B) defines a first reservoir volume (reservoir inherently has a volume in the expanded configuration) , and the reservoir (32) in the collapsed configuration (see FIG. 7A) defines a second reservoir volume (reservoir inherently has a volume in the collapsed configurations) , the second volume (collapsed volume as in FIG. 7A) being less than (see page 14 lines 1-10: uncompressed state in FIG. 7B and therefore has the larger volume by definition of uncompressed) the first volume (expanded volume in FIG. 7B). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir taught by Modified Bansal to have a second volume in the collapsed configuration that is less than a first volume of the expanded configuration as taught by Bansal ( FIGs. 7A-B) for the purpose of allowing the reservoir to collapse and expand while being contained within the collapsing/expanding resilient body of the port (see page 14 lines 1-10) , which would likely ease the transition between the expanded and collapsed positions and ensure that the reservoir element is not damaged during the collapsing stage, thus achieving “ wherein the reservoir in the expanded configuration defines a first reservoir volume, and the reservoir in the collapsed configuration defines a second reservoir volume, the second volume being less than the first volume . ” Regarding claim 14, the modified system of Bansal teaches the subcutaneous port according to claim 1, and Bansal ( FIGs. 4A-5) further discloses wherein the body (12, see FIG. 4A) is elastically deformable (see page 9 lines 4-18: shape allows body to switch between both expanded and compressed state and body described as being “squeezed” into the compressed configuration) from the expanded configuration (see FIG. 4A) to the collapsed configuration (see FIG. 5) . Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Bansal in view of Horgan as applied to claim 1 above, and further in view of Goode et al. (U.S. PGPUB No. 2010/0121313), hereinafter Goode , and Davey (U.S. PGPUB No. 2016/0213909) . Regarding claim 12, the modified system of Bansal teaches the subcutaneous access port according to claim 1, and Bansal discloses a first durometer (material inherently has a durometer) of a first materi al (material forming stem 19, see FIG. 4A) and a second durometer (material inherently has a durometer) of the second material (see page 7 lines 23-29: 16 may be an elastic material such as a polymer. A polymer aligns with applicant disclosure of flexible material in [0009]). Bansal is silent to wherein the first durometer of the first material “ is larger than ” the second durometer of the second material. However, Horgan teaches a subcutaneous access port (see FIG. 1) comprising a port stem (18) formed of a first material being a rigid material (see [0021]: tubular stem formed of a metal and see [0027]: such as titanium. A metal aligns with applicant disclosure of rigid material in [0009]) and a body (11) formed of a second material being a flexible material (see [0021]: plastic. A plastic aligns with applicant disclosure of flexible material in [0009]) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the first material forming the stem disclosed in Tal to be a metal, such as titanium, as taught by Horgan for the purpose of providing the stem with a higher structural integrity than a different material, such as a plastic (see [0027]) , thus achieving the first material being formed of the rigid material as claimed by Applicant in claim 1. Goode teaches a subcutaneous access port (see FIG. 1) with a stem (member 20, see FIG. 3) formed of a titanium metal (see [0031]) having a high durometer (see [0031]: such as between 65 and 80). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the titanium metal of the port stem taught by Bansal in view of Horgan to have a high durometer such as between 65 and 80 as taught by Goode. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element ( a titanium metal ) for another known element ( a titanium metal having the specific durometer between 65 and 80 ) in the art to obtain the predictable result of forming the port stem by a titanium metal (see MPEP § 2143.I.B) , thus achieving a titanium metal of the port stem with a durometer between 65 and 80. Davey teaches a subcutaneous access port (see FIG. 2) having a body (110) formed of a polymer (see [0084]) , the polymer having a low durometer (see [0084]: such as 40) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the polymer material of the port body disclosed in Bansal to be formed of a polymer having a low durometer such as 40 as taught by Davey. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element ( a polymer ) for another known element ( a polymer having the specific durometer of 40 ) in the art to obtain the predictable result of forming the port body by a polymer material (see MPEP § 2143.I.B), thus achieving the polymer having a durometer of 40 and subsequently achieving wherein the first durometer of the first material (titanium metal between 65 to 80) “ is larger than ” the second durometer of the second material (polymer material of 40) . Claim s 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bansal in view of Horgan as applied to claim 1 above, and further in view of Fedor et al. (U.S. PGPUB No. 2019 / 0232035 ), hereinafter Fedor , Goode (U.S. PGPUB No. 2010/0121313 ), and Davey (U.S. PGPUB No. 2016/0213909 ). Regarding claim 16, the modified system of Bansal teaches the subcutaneous access port according to claim 1, but Bansal is silent to “ further including a third material, being elastically deformable and including a third durometer greater than the second durometer and less than the first durometer . ” However, Fedor teaches a subcutaneous access port (see FIG. 25A) comprising a port stem (824) formed of a first material (stem inherently has a material to form the structural body) , a port body (810) formed of a second material (body inherently has a material to form the structural component) , and further including a third material (836, see [0110] & [0116]: an overmold provided to the port) , being elastically deformable (see [0116]: 836 formed of silicone rubber and therefore aligns with Applicant disclosure of the third material being elastically deformable in [0038] of Applicant disclosure) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the port body disclosed in Bansal to include a third material being elastically deformable (such as by providing a silicone overmolded portion onto the port) as taught by Fedor for the purpose of providing the body of the port with a relatively soft outside surface to reduce patient discomfort after implantation (See [0116]) , thus achieving “ further including a third material, being elastically deformable and including a third durometer greater than the second durometer and less than the first durometer ”. Bansal in view of Horgan and Fedor remain silent to further including a third material, being elastically deformable “ and including a third durometer greater than the second durometer and less than the first durometer . ” However, Goode teaches a subcutaneous access port (see FIG. 1) with a stem (member 20, see FIG. 3) formed of a titanium metal (see [0031]) having a high durometer (see [0031]: such as between 65 and 80). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the titanium metal of the port stem taught by Bansal in view of Horgan to have a high durometer such as between 65 and 80 as taught by Goode. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element ( a titanium metal ) for another known element ( a titanium metal having the specific durometer between 65 and 80 ) in the art to obtain the predictable result of forming the port stem by a titanium metal (see MPEP § 2143.I.B) , thus achieving a titanium metal/a first material of the port stem with a durometer between 65 and 80. Davey teaches a subcutaneous access port (see FIG. 2) having a body (110) formed of a polymer (see [0084]) , the polymer having a low durometer (see [0084]: such as 40) . Davey further discloses that silicone may have a durometer of 70 (see [0084]). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the polymer material of the port body disclosed in Bansal to be formed of a polymer having a low durometer such as 40 as taught by Davey. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element ( a polymer ) for another known element ( a polymer having the specific durometer of 40 ) in the art to obtain the predictable result of forming the port body by a polymer material (see MPEP § 2143.I.B), thus achieving the port body being formed of a polymer/ a second material having a durometer of 40. Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the silicone third material taught by Bansal in view of Horgan and Fedor to be formed of a silicone having a durometer of 70 as taught by Davey. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element ( a silicone ) for another known element ( a silicone having the specific durometer of 7 0 ) in the art to obtain the predictable result of forming a third material of the device body with silicone (see MPEP § 2143.I.B), thus achieving a third material, being elastically deformable “ and including a third durometer greater than the second durometer and less than the first durometer . ” Regarding claim 1 7 , the modified system of Bansal teaches the subcutaneous access port according to claim 16, but Bansal in view of Horgan is silent to “ wherein the third material is disposed on an outer surface of the body . ” However, Fedor teaches a subcutaneous access port (see FIG. 25A) comprising a port stem (824) formed of a first material (stem inherently has a material to form the structural body) , a port body (810) formed of a second material (body inherently has a material to form the structural component) , and further including a third material (836, see [0110] & [0116]: an overmold provided to the port) , being elastically deformable (see [0116]: 836 formed of silicone rubber and therefore aligns with Applicant disclosure of the third material being elastically deformable in [0038] of Applicant disclosure) , wherein the third material (836) is disposed on an outer surface ( see [0110] & [0116] ) of the body (810). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the port body disclosed in Bansal to include a third material being elastically deformable and disposed on an outside surface of the body (such as by providing a silicone overmolded portion onto the port) as taught by Fedor for the purpose of providing the body of the port with a relatively soft outside surface to reduce patient discomfort after implantation (See [0116]), thus achieving “ wherein the third material is disposed on an outer surface of the body . ” Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Bansal in view of Horgan as applied to claim 1 above, and further in view of Sansone et al. (U.S. PGPUB No. 2015 / 0360012 ), hereinafter Sansone, Goode (U.S. PGPUB No. 2010/0121313 ), and Davey (U.S. PGPUB No. 2016/0213909 ). Regarding claim 16, the modified system of Bansal teaches the subcutaneous access port according to claim 1, but Bansal is silent to “ further including a third material, being elastically deformable and including a third durometer greater than the second durometer and less than the first durometer . ” However, Sansone teaches an implantable drug delivery device ( see FIG. 1 ) comprising a delivery end (120) formed of a first material (see [0056-0058]) , a body (102) formed of a second material (see [0041] & [0048]) , and a reservoir (102, see FIG.3 and [0034]) include a wall (104 with frame 114, see FIG. 3 and [0034]) further including a third material (see [0096]: wall 124 forming 104 housing 114, see FIG. 3, formed of silicone) , being elastically deformable (see [0040] and [0098-0100]) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir taught by Bansal in view of Horgan to include a third material forming a wall of the reservoir as taught by Sansone for the purpose of permitting the device to return to an expanded shape once implanted in the body (See [0040]) , thus achieving “ further including a third material, being elastically deformable ”. Bansal in view of Horgan and Sansone remain silent to further including a third material, being elastically deformable “ and including a third durometer greater than the second durometer and less than the first durometer . ” However, Goode teaches a subcutaneous access port (see FIG. 1) with a stem (member 20, see FIG. 3) formed of a titanium metal (see [0031]) having a high durometer (see [0031]: such as between 65 and 80). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the titanium metal of the port stem taught by Bansal in view of Horgan to have a high durometer such as between 65 and 80 as taught by Goode. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element ( a titanium metal ) for another known element ( a titanium metal having the specific durometer between 65 and 80 ) in the art to obtain the predictable result of forming the port stem by a titanium metal (see MPEP § 2143.I.B) , thus achieving a titanium metal/a first material of the port stem with a durometer between 65 and 80. Davey teaches a subcutaneous access port (see FIG. 2) having a body (110) formed of a polymer (see [0084]) , the polymer having a low durometer (see [0084]: such as 40) . Davey further discloses that silicone may have a durometer of 70 (see [0084]). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the polymer material of the port body disclosed in Bansal to be formed of a polymer having a low durometer such as 40 as taught by Davey. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element ( a polymer ) for another known element ( a polymer having the specific durometer of 40 ) in the art to obtain the predictable result of forming the port body by a polymer material (see MPEP § 2143.I.B), thus achieving the port body being formed of a polymer/ a second material having a durometer of 40. Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the silicone third material taught by Bansal in view of Horgan and Sansone to be formed of a silicone having a durometer of 70 as taught by Davey. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element ( a silicone ) for another known element ( a silicone having the specific durometer of 70 ) in the art to obtain the predictable result of forming a third material of the device body with silicone (see MPEP § 2143.I.B), thus achieving a third material, being elastically deformable “ and including a third durometer greater than the second durometer and less than the first durometer . ” Regarding claim 18, the modified system of Bansal teaches the subcutaneous access port according to claim 16, but Bansal in view of Horgan is silent to “ wherein the third material is disposed on a wall of the reservoir . ” However, Sansone teaches an implantable drug delivery device ( see FIG. 1 ) comprising a delivery end (120) formed of a first material (see [0056-0058]) , a body (102) formed of a second material (see [0041] & [0048]) , and a reservoir (102, see FIG.3 and [0034]) include a wall (104 with frame 114, see FIG. 3 and [0034]) further including a third material (see [0096]: wall 124 forming 104 housing 114, see FIG. 3, formed of silicone) , being elastically deformable (see [0040] and [0098-0100]) , wherein the third material (see [0096]) is disposed on a wall (see [0096]: wall 124 forming 104 housing 114, see FIG. 3) of the reservoir (102 ) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir taught by Bansal in view of Horgan to include a third material forming a wall of the reservoir as taught by Sansone for the purpose of permitting the device to return to an expanded shape once implanted in the body (See [0040]), thus achieving “ wherein the third material is disposed on a wall of the reservoir . ” Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bansal in view of Horgan as applied to claim 1 above, and further in view of Woo et al. ( U.S. PGPUB No. 2021 / 0290923 ), hereinafter Woo. Regarding claim 19, the modified system of Bansal teaches the subcutaneous access port according to claim 1, but Modified Bansal is silent to “ further including a base plate formed of one of the first material or a flexible needle impenetrable material . ” However, Woo teaches a subcutaneous access port (see FIG. 1 D and [0049]) further including a base plate (128) formed of one of the first material (see [0052]: housing, including 128 as seen in FIG. 1D, formed of titanium aligning with applicant disclosure of rigid/ first material in [0009] and stem of Bansal in view of Horgan formed of titanium) or a flexible needle impenetrable material . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the access port disclosed by Bansal to include a base plate formed of the first material as taught by Woo for the purpose of providing the device with a desired shaped footprint providing a rigid material for the base (see [0052]) , thus achieving “ further including a base plate formed of one of the first material or a flexible needle impenetrable material . ” Regarding claim 20, the modified system of Bansal teaches the subcutaneous access port according to claim 19, but Bansal is silent to “ wherein the base plate and the stem are formed integrally as a single unitary piece . ” Woo teaches a subcutaneous access port (see FIG. 1 D and [0049]) further including a base plate (128) formed of one of the first material ((see [0052]: housing, including 128 as seen in FIG. 1D, formed of titanium aligning with applicant disclosure of rigid/ first material in [0009] and stem of Bansal in view of Horgan formed of titanium) or a flexible needle impenetrable material , wherein the base plate (128) and a stem (130, see [0049]) are formed integrally (see FIG.1D with stem and plate showing same cross-sectional wall) as a single unitary piece (see FIG. 1D). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the access port disclosed by Bansal to include a base plate formed of the first material and formed integrally with the stem as taught by Woo for the purpose of defining a stem side and a tunneling side of the device (see [0049]) or providing the device with a desired shaped footprint providing a rigid material for the base (see [0052]) , thus achieving “ wherein the base plate and the stem are formed integrally as a single unitary piece . ” Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KATHLEEN PAIGE FARRELL whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0198 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F: 730AM-330PM Eastern Time . 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, FILLIN "SPE Name?" \* MERGEFORMAT Michael Tsai can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-5246 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KATHLEEN PAIGE FARRELL/ Examiner, Art Unit 3783 /Lauren P Farrar/ Primary Examiner, Art Unit 3783
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Prosecution Timeline

Nov 16, 2023
Application Filed
Mar 27, 2026
Non-Final Rejection — §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
54%
Grant Probability
74%
With Interview (+20.0%)
4y 0m (~1y 6m remaining)
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Low
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