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 statement (IDS) submitted on 07/30/26 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 07/06/26 has been entered. Claims 1, 4, 6-7, 9, 14-15, and 20 have been amended. Claims 2-3, 5, 8, 10-13, and 16-19 are in the original/ previously presented form. Claims 21-43 are cancelled. Thus, claims 1-20 remain pending in the application. Applicant’s amendments to the Specification and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 04/06/26.
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, and 13- 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), the body (21 comprising port body extension 24) formed of a second material (body inherently formed of some kind of material to obtain structural element) being an elastically compliant material (see port body material being elastically compliant by changing from expanded/collapsed configurations as shown in FIGs. 2B-C and described in [0162-0163]: preloaded elastic member & [0165]. In the current Application, Applicant discloses the elastically compliant material being a material that can transition between an expanded configuration and a collapsed configuration/ a material that can elastically deform—see at least [0002], [0034], & [0050] of the current Application’s PGPUB. Thus, Tal’s disclosure of the port body aligns with elastically compliant material as disclosed by Applicant. See also [0172]: port body material may be a flexible polymer/ monolithic plastic, aligning with Applicant disclosure of listed elastically compliant materials in [0034]) and having a second durometer (the flexible polymer/monolithic plastic 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)
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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), the elastically compliant material (see FIGs. 2B-C, [0162-0163] & [0165], and [0172]) of the body (21 comprising port body extension 24, see [0163]) both defines the reservoir (23) and biases the body to one of the expanded configuration or the collapsed configuration (see [0162-0163]: body must be actively changed into expanded configuration and is therefore biased to the collapsed configuration).
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 body (21 comprising port body extension 24, see [0163]) in the expanded configuration (see FIG. 2C) defines one or more 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), and 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 body (21 comprising port body extension 24, see [0163]) in the collapsed configuration (see FIG. 2B) defines one or more 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), and 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 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 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 defining 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 14, the modified system of Tal teaches the subcutaneous access port according to claim 1, but in the embodiment of FIGs. 2A-C is silent to “wherein the body is biased towards the expanded configuration.”
However, Tal teaches that other embodiments include wherein the body is biased towards the expanded configuration (see [0011]).
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 biased to the collapsed configuration disclosed in Tal FIGs.2A-C to instead be biased toward the expanded configuration as taught by Tal for the purpose of allowing selective reverting from the expanded configuration to the delivery configuration (see [0011]), which would be advantageous during port removal, thus achieving “wherein the body is biased towards the expanded configuration.”
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 24, see FIG. 2B) is biased towards the collapsed configuration (see [0162-0163]: body must be actively changed into expanded configuration and is therefore biased to the collapsed configuration).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Tal in view of Horgan as applied to claim 1 above, and further in view of Olsen et al. (U.S. PGPUB No. 2007/0043335), hereinafter Olsen.
Regarding claim 7, the modified system of Tal teaches the subcutaneous access port according to claim 1, and Tal further discloses wherein the reservoir (23, see FIG.2A) in the collapsed configuration defines one or more of a first reservoir height (height of reservoir 23 shown in FIG.2A), a first reservoir width (width of reservoir shown in FIG. 2A), and a first reservoir length (23 inherently has length because is a 3D object), but Tal is silent to the first height, width, and length being in “the expanded configuration” and “wherein the reservoir in the collapsed configuration defines one or more of a second reservoir height, a second reservoir width, and a second reservoir length.”
However, Olsen teaches a subcutaneous access port with a reservoir (106, see Fig. 2 and [0038]: drug storage chamber 106) having an expanded configuration and a collapsed configuration (see [0038]: full vs empty), wherein the reservoir in the expanded configuration (full) defines one or more of a first reservoir height, a first reservoir width, and a first reservoir length (see [0038]), and wherein the reservoir in the collapsed configuration (empty) defines one or more of a second reservoir height, a second reservoir width, and a second reservoir length (see [0038]).
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 disclosed in Tal to have a second height in the collapsed configuration compared to the expanded configuration (such as by forming the reservoir with a shape-memory material membrane within the body) as taught by Olsen for the purpose of ensuring that the reservoir does not fracture during the elastic deformation between collapsed and expanded configurations (see [0038]) and to allow the reservoir to tolerate the large strains of being repeatedly filled and emptied (see [0038]), thus achieving the first height, width, and length being in “the expanded configuration” and “wherein the reservoir in the collapsed configuration defines one or more of a second reservoir height, a second reservoir width, and a second reservoir length.”
Regarding claim 8, the modified system of Tal teaches the subcutaneous access port according to claim 7, but Tal 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, Olsen teaches a subcutaneous access port with a reservoir (106, see Fig. 2 and [0038]: drug storage chamber 106) having an expanded configuration and a collapsed configuration (see [0038]: full vs empty), wherein the reservoir in the expanded configuration (full) defines one or more of a first reservoir height, a first reservoir width, and a first reservoir length (see [0038]), and wherein the reservoir in the collapsed configuration (empty) defines one or more of a second reservoir height, a second reservoir width, and a second reservoir length (see [0038]), 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 (see [0038]: at LEAST the empty/collapsed/second height is less than the full/expanded/first height).
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 disclosed in Tal to have a second height in the collapsed configuration that is less than a first height of the expanded configuration (such as by forming the reservoir with a shape-memory material membrane within the body) as taught by Olsen for the purpose of ensuring that the reservoir does not fracture during the elastic deformation between collapsed and expanded configurations (see [0038]) and to allow the reservoir to tolerate the large strains of being repeatedly filled and emptied (see [0038]), 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 Tal teaches the subcutaneous access port according to claim 1, and Tal further discloses wherein the reservoir (23, see [0003]) in the expanded configuration (see FIG. 2C) defines a first reservoir volume (3d space of cavity 23 inherently has a volume in the expanded configuration), and the reservoir in the collapsed configuration (see FIG. 2A) defines a second reservoir volume (3d space of cavity 23 inherently has a volume in the collapsed configuration ).
Tal is silent to “the second reservoir volume being less than the first reservoir volume”.
However, Olsen teaches a subcutaneous access port with a reservoir (106, see Fig. 2 and [0038]: drug storage chamber 106) having an expanded configuration and a collapsed configuration (see [0038]: full vs empty), wherein the reservoir (106) in the expanded configuration (full) defines a first reservoir volume (see [0038]), and the reservoir in the collapsed configuration (empty) defines a second reservoir volume (see [0038]), the second reservoir volume being less than the first reservoir volume (empty is a less volume than full, see [0038]).
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 second reservoir volume disclosed in Tal to be less than the first reservoir volume of the expanded configuration as taught by Olsen for the purpose of ensuring that the reservoir does not fracture during the elastic deformation between collapsed and expanded configurations (see [0038]) and to allow the reservoir to tolerate the large strains of being repeatedly filled and emptied (see [0038]), thus achieving “the second reservoir volume being less than the first reservoir volume”.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Tal 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 Tal teaches the subcutaneous access port according to claim 1, and Tal discloses a first durometer (material inherently has a durometer) of a first material (material forming stem 25, see FIG. 2A) and a second durometer (a material inherently has a durometer) of the second material (see [0172]: flexible polymer).
Tal 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 Tal 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 Tal 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).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tal 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 Tal teaches the subcutaneous access port according to claim 1, but Tal 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 Tal 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”.
Tal 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 Tal 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 Tal 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 Tal 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 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 17, the modified system of Tal teaches the subcutaneous access port according to claim 16, but Tal 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 Tal 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 Tal 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 Tal teaches the subcutaneous access port according to claim 1, but Tal 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 Tal 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”.
Tal 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 Tal 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 Tal 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 Tal 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 Tal teaches the subcutaneous access port according to claim 16, but Tal 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 Tal 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 Tal 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 Tal teaches the subcutaneous access port according to claim 1, but Modified Tal 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. 1D 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 Tal 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 Tal teaches the subcutaneous access port according to claim 19, but Tal is silent to “wherein the base plate and the port stem are formed integrally as a single unitary piece.”
Woo teaches a subcutaneous access port (see FIG. 1D 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 port 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 Tal to include a base plate formed of the first material and formed integrally with the port 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.”
Response to Arguments
Applicant's arguments filed 07/06/26 have been fully considered but they are not persuasive.
Arguing 35 U.S.C. § 103 claim rejection of claim 1 under Tal in view of Horgan
On pages 7-8, Applicant submits that Tal fails to disclose the port body “defining” the reservoir and therefore the 35 U.S.C. § 103 claim rejection of claim 1 under Tal in view of Horgan should be withdrawn. The examiner disagrees and has maintained the rejection.
The definition of “define” is to mark out the boundaries/ form an outline (see Merriam-Webster dictionary definition 2b). Tal’s port body (21 comprising 24, see FIG. 2A) outlines the boundaries of the reservoir (23) and therefore “defines” the reservoir as required by the claim limitation. Further, Tal’s port body “defines” the reservoir in the same manner as disclosed by Applicant (see Modified Figure below).
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Therefore, the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 claim rejection of claim 1.
On page 8, Applicant argues that Tal fails to disclose a reservoir and only discloses a “cavity”. Applicant asserts that Tal’s port body has “no fluid delivery functionality” and thus Tal’s port body cannot define a reservoir. The definition of reservoir is “a part of an apparatus in which liquid is held” (see Merriam-webster dictionary definition 1b). Therefore, Tal’s cavity alone (see at least [0003] & [0162]) meets the definition of a reservoir, regardless of whether or not the reservoir has “fluid delivery functionality” as argued by Applicant. Further, the examiner maintains that Tal discloses fluid delivery functionality. Applicant cites Tal’s [0172] for supporting the assertion that Tal has “no fluid delivery functionality”. However, this argument mischaracterizes Tal’s disclosure. Tal [0172] merely describes that in SOME embodiments, the port body is implanted first with the reservoir and fluid delivery capabilities being fully assembled later. Tal [0166] (as cited by the examiner in the NFOA and the rejection of claim 1 above) states that the fluid communication between cavity 23 can be a “distinct step”. Therefore, regardless of the assembling process of the port (i.e.: reservoir and port body to establish fluid communication provided in one step or in distinct steps), the port in final form will include a reservoir with fluid delivery capabilities. Thus, the entirety of Tal (see at least [0166] and [0172]) would have reasonably suggested to one of ordinary skill in the art that the cavity 23 is a reservoir for delivering fluid from the cavity/ having fluid delivery functionality (see MPEP § 2123.I). Therefore, the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 claim rejection of claim 1.
On page 8, Applicant asserts that Tal’s port body maintains size and shape when moved between the collapsed and expanded configurations. Applicant cites Tal [0033], [0177], and [0201] for support of this assertion. However, this argument is considered moot by the examiner because Tal’s [0033], [0177], and [0201] describe embodiments that were NOT relied upon in the rejection of claim 1 (FIGs. 3A-C and 6A-C). The examiner uses the embodiment of Tal FIGs. 2A-C in the rejection, rendering Applicant arguments against the embodiments of Figs. 3A-C and 6A-C as in [0033], [0177], and [0201] moot.
Arguing 35 U.S.C. § 103 claim rejection of claim 1 under Bansal in view of Horgan
Applicant’s arguments with respect to claim 1 under Bansal in view of Horgan (see pages 8-10) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The examiner has maintained the rejection of claim 1 under Tal in view of Horgan and has provided new rejections for claims 7-9 further in view of Olsen due to the amended limitations.
No further arguments were presented. Therefore, all depending claim rejections were subsequently maintained by the examiner.
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 KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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