DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the preliminary amendment filed on July 19, 2026. As directed by the amendment: claims 3-5, 8-13, 16-17 and 20-21 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-21 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 line 2 recites “…a base defining reservoir and having a nose portion extending longitudinally…”. It is not clear what the nose portion is extending longitudinally relative to. For purposes of examination, this is interpreted as “…a base defining reservoir and having a nose portion extending longitudinally relative to a longitudinal axis…”. Claims 2-13 are rejected at least because they depend from claim 1. Independent claim 14 lines 2-3 is similarly rejected and interpreted. Claims 15-21 are rejected at least because they depend from claim 14.
Claim 6 recites the limitation "the bottom surface of the base" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “[[the]] a bottom surface of the base”.
Claim 7 recites the limitation "the bottom surface of the base" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “[[the]] a bottom surface of the base”.
Claim 9 recites the limitation "the marker" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the radiopaque marker”.
Claim 11 line 2 recites “…wherein the marker symbol includes one or more of the letters “C,” “T,” or a…”. It is not clear if the comma is part of the symbol, as well as whether or not just one letter “C” or “T” is sufficient. For purposes of examination, this is interpreted as “…wherein the marker symbol includes one or more of the letters [[[“C,” “T,”]] “C”, “T” or a…”. Claim 21 is similarly rejected and interpreted.
Claim 12 recites the limitation "the longitudinal axis" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “[[the]] a longitudinal axis”.
Claim 14 recites the limitation "the recess" in lines 8 and 11. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the first recess”. Claims 15-21 are rejected at least because they depend from claim 14.
Claim 14 recites the limitation "the marker" in line 5. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the radiopaque marker”. Claim 20 line 3 is similarly rejected and interpreted. Claims 15-21 are rejected at least because they depend from claim 14.
Claim 19 recites the limitation "the bottom surface of the base" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “[[the]] a bottom surface of the base”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5-8, 10-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (Smith) US 2019/0054284 A1 in view of Finberg et al. (Finberg) US 2015/0100032 A1.
Regarding claim 1, Smith discloses a subcutaneous access port (access port 25, P0066-0071 and shown in Figs. 3-6), comprising: a base (base 27, P0066) defining a reservoir (reservoir 29, P0066) and having a nose portion (nose portion, see annotated Figs. 5-6 below) extending longitudinally relative to a longitudinal axis (longitudinal axis, see annotated Fig. 5 below); a stem (outlet passageway 31, P0068-0069) in fluid communication with the reservoir opposite the nose portion.
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The Figs. 3-6 embodiment of Smith does not teach a first recess disposed in a bottom surface of the base; and a cover plate disposed over the first recess and coupled to the base to secure the radiopaque marker within the first recess.
However, Smith teaches that further aspects of the access port may include an identifiable feature for identifying the access port after the access port is implanted within a patient, see P0092. P0098-0103 and Figs. 39-41 of Smith teach a first recess disposed in a bottom surface of the base (first recessed portion P0099, wherein “CT” letters may be etched out of the bottom surface of the port using a process similar to the machine engraving process of P0098); and a cover plate (plastic plate 367, P0101) disposed over the first recess and coupled to the base to secure the radiopaque marker within the first recess.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the embodiment of Figs. 3-6 to include identifiable features as claimed for the purpose of identifying the access port after the access port has been implanted into a patient, such as a CT port that is suitable for power injection, P0096.
Smith P0098 teaches the engraving could be filled with a tungsten filled RTV silicon (radiopaque silicon), but does not explicitly teach a radiopaque marker, an outer perimeter thereof defining a marker symbol and matching a shape of the first recess such that the radiopaque marker is configured to fit within the first recess in a first orientation.
However, Finberg teaches an access port having a radiopaque marker (radiopaque insert 16, P0032 and shown in Fig. 5), an outer perimeter thereof defining a marker symbol (“CT”) and matching a shape of a recess (cavity, P0032) such that the radiopaque marker is configured to fit within the recess in a first orientation (Fig. 5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the engraved first recess of Smith to accept a shape matching the radiopaque marker of Finberg for the purpose of improving manufacturing efficiency by providing a one-piece solid radiopaque insert, P0032 Finberg.
Smith does not explicitly teach the stem extending from the base.
However, Finberg teaches the stem (outlet 10d, P0025) extending from the base (Fig. 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the stem of Smith to extend from the base as taught by Finberg for the purpose of connecting a conduit or catheter to the access port, Finberg P0025.
Regarding claim 2, Smith in view of Finberg teaches the subcutaneous access port according to claim 1, wherein the radiopaque marker defines a transverse height, the first recess defines a transverse depth that is equal to the transverse height of the radiopaque marker (Finberg, teaches that the cavity and insert form a flush mount to the surrounding surface, P0032).
Regarding claim 3, Smith in view of Finberg teaches the subcutaneous access port according to claim 1, wherein the first recess is disposed on a bottom surface of the nose portion base (as shown in Smith Fig. 41, the first recess is centered on the bottom surface of the base, and annotated Figs. 5-6 of Smith above show the nose portion extending distally along the longitudinal axis from the center of the port such that the first recess is disposed on at least a portion of the bottom surface of the nose portion).
Regarding claim 5, Smith in view of Finberg teaches the subcutaneous access port according to claim 1, wherein the base further includes a lip (Smith, lip, see annotated Fig. 41 below) extending circumferentially about the first recess and configured to engage the cover plate in a press fit (Smith, plastic cap 367 is inserted, P0101).
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Regarding claim 6, Smith in view of Finberg teaches the subcutaneous access port according to claim 5, wherein the lip extends transversely downwards from a bottom surface of the base to secure the cover plate over the first recess (Smith, see annotated Fig. 41 above and P0101).
Regarding claim 7, Smith in view of Finberg teaches the subcutaneous access port according to claim 5, wherein the lip extends from a bottom surface of the base transversely upwards into the base to define a second recess (Smith, second recess, see annotated Fig. 41 above), the first recess disposed within the second recess, and the cover plate configured to fit within second recess (Smith, P0101).
Regarding claim 8, Smith in view of Finberg teaches the subcutaneous access port according to claim 5, wherein a shape of a perimeter of the lip (Smith, circular shape, see Fig. 41) matches a shape of a perimeter of the cover plate (Smith, circular shape, see Fig. 41), and a transverse depth of the lip is equal to a transverse height of the cover plate (Smith, the plastic cap 367 becomes flush with the bottom surface of the port P0101, and rests the ledge between the first and second recess).
Regarding claim 10, Smith in view of Finberg teaches the subcutaneous access port according to claim 1, wherein the marker symbol indicates a property of the port (Smith, “CT” is suitable for power injection, P0096).
Regarding claim 11, Smith in view of Finberg teaches the subcutaneous access port according to claim 1, wherein the marker symbol includes one or more of the letters “C”, “T” or a conjoined symbol indicating the letters "CT" (Finberg, conjoined symbol, see Fig. 5).
Regarding claim 13, Smith in view of Finberg teaches the subcutaneous access port according to claim 1, wherein the port further includes a septum (Smith, septum, see annotated Fig. 6 below) positioned over the reservoir and a cap (Smith, retainer ring 34, P0070) configured to engage the base and secure the septum to the base.
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Claims 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view Finberg as applied to claim 1 above, and further in view of Gray et al. (Gray) US 8,075,536 A1.
Regarding claim 4, Smith in view of Finberg teaches the subcutaneous access port according to claim 1, wherein the cover plate extends under a portion of the base disposed transversely below the reservoir (Smith, Fig. 41).
Smith is silent regarding the cover plate being coupled to the base using one of adhesive, bonding, or welding.
However, Gray teaches the cover plate 32 of Fig. 4 joined by any standard plastic joining process, such ultrasonic welding, snap fit and solvent bond, c 3 ln 19-35.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the coupling of the cover plate to the base in Smith with welding as taught by Gray for the purpose of securely holding the radiopaque insert in place.
Regarding claim 12, Smith in view of Finberg teaches the subcutaneous access port according to claim 1.
Smith does not teach wherein the reservoir is disposed between the stem and the radiopaque marker along the longitudinal axis.
However, Gray teaches a power injectable port identification wherein the identification is positioned in an expanded nose portion, see Fig. 4, such that the reservoir is between the stem and radiopaque marker along the longitudinal axis.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the access port of Smith by expanding the nose portion and repositioning the identifiable feature of Smith to the bottom surface of the expanded nose portion, such that the reservoir is disposed between the stem and the radiopaque marker along the longitudinal axis as claimed, for the purpose of increasing the space available on the port to allow for adequate size and visibility of the “CT” lettering, as taught by Gray c 1 ln 29-41.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Finberg as applied to claim 1 above, and further in view of Wiley et al. (Wiley) US 2013/0338494 A1.
Regarding claim 9, Smith in view of Finberg teaches the subcutaneous access port according to claim 1.
Smith does not teach wherein the cover plate includes a cover plate symbol disposed thereon, the cover plate symbol matching that of the radiopaque marker symbol.
However, Wiley teaches that with an identification feature visible from the exterior of the access port as shown in Fig. 77, a clinician can view and ascertain the predetermined attribute of the port before implantation, P0169.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cover plate of Smith to include a cover plate symbol matching that of the radiopaque symbol as claimed, for the purpose determining the attributes of the port before implantation, as taught by Wiley, P0169, since the user would be able to see the symbol on an outer surface of the cover plate of the modified access port.
Claims 14-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Finberg in view of Gray.
Regarding claim 14, Smith discloses a method of manufacturing a subcutaneous access port (access port 25, P0066-0071 and shown in Figs. 3-6), comprising: providing a base (base 27, P0066) defining a reservoir (reservoir 29, P0066) and including nose portion (nose portion, see annotated Figs. 5-6 below) extending longitudinally relative to a longitudinal axis (longitudinal axis, see annotated Fig. 5 below), the base including a stem (outlet passageway 31, P0068-0069) opposite the nose portion.
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Smith teaches that further aspects of the access port may include an identifiable feature for identifying the access port after the access port is implanted within a patient, see P0092. Smith teaches forming a first recess (base engraved with “CT” lettering, P0098) that is then filled with a radiopaque silicone to form a radiopaque marker, and securing the radiopaque marker within the recess with a plastic plate 367, P0101.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the embodiment of Figs. 3-6 to include identifiable features as claimed for the purpose of identifying the access port after the access port has been implanted into a patient, such as a CT port that is suitable for power injection, P0096.
Smith does not teach forming a radiopaque marker, the perimeter of the radiopaque marker defining a marker symbol; placing the radiopaque marker within the first recess disposed in a first orientation, a shape of the first recess configured to prevent the radiopaque marker from engaging the first recess in a second orientation different from the first orientation.
However, Finberg teaches an access port having a radiopaque marker formed into letters (radiopaque insert 16 formed into the letters “CT”, P0032 and shown in Fig. 5), the perimeter of the radiopaque marker defining a marker symbol (“CT”, see Fig. 5); placing the radiopaque marker within a recess (cavity, P0032) disposed in a first orientation, a shape of the first recess configured to prevent the radiopaque marker from engaging the first recess in a second orientation different from the first orientation (Fig. 5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the first recess of Smith to accept a shape matching the radiopaque insert of Finberg for the purpose of improving manufacturing efficiency by providing a one-piece solid radiopaque insert, P0032 Finberg.
Smith does not teach the stem extending from the base.
However, Finberg teaches the stem (outlet 10d, P0025) extending from the base (Fig. 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the stem of Smith to extend from the base as taught by Finberg for the purpose of connecting a conduit or catheter to the access port, Finberg P0025.
Smith does not teach the first recess disposed in a bottom surface of the nose portion.
However, Gray teaches a power injectable port identification wherein the identification feature is positioned in an expanded nose portion, see Fig. 4.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the access port of Smith by expanding the nose portion and repositioning the identifiable feature of Smith to the bottom surface of the expanded nose portion for the purpose of increasing the space available on the port to allow for adequate size and visibility of the “CT” lettering, as taught by Gray c 1 ln 29-41.
Regarding claim 15, Smith in view of Finberg in view of Gray teaches the method according to claim to 14, wherein the radiopaque marker defines a first transverse height and the first recess defines a first transverse depth equal to the first transverse height of the radiopaque marker (Finberg, teaches that the cavity and insert form a flush mount to the surrounding surface, P0032).
Regarding claim 16, Smith in view of Finberg in view of Gray teaches the method according to claim 14, wherein securing the radiopaque marker within the first recess includes one or more of a press-fit (Finberg, mounted, P0032), .
Regarding claim 17, Smith in view of Finberg in view of Gray teaches the method according to claim 14, wherein securing the radiopaque marker within the first recess includes coupling a cover plate (Smith, plastic cap 367, P0101) to the base using a press-fit (Smith, plastic cap 367 is inserted, P0101).
Regarding claim 18, Smith in view of Finberg in view of Gray teaches the method according to claim 17, wherein a portion of the cover plate extends underneath a portion of the base, below the reservoir (Smith, Fig. 41).
Regarding claim 19, Smith in view of Finberg in view of Gray teaches the method according to claim 14, wherein the first recess is disposed within a second recess (Smith, second recess, see annotated Fig. 41 below) disposed in a bottom surface of the base, the cover plate configured to fit within the second recess (Smith, P0101).
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Regarding claim 21, Smith in view of Finberg in view of Gray teaches the method according to claim 14, wherein the marker symbol includes the letters "C", "T" or a conjoined symbol indicating the letters "CT" (Finberg, conjoined, see Fig. 5) and indicates a property of the port (Smith, “CT” suitable for power injection, P0096).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Finberg in view of Gray as applied to claim 14 above, and further in view of Wiley.
Regarding claim 20, Smith in view of Finberg in view of Gray teaches the method according to claim 14.
Smith in view of Finberg in view of Gray does not teach wherein the cover plate includes a cover plate symbol disposed thereon, the cover plate symbol matching that of the radiopaque marker symbol.
However, Wiley teaches that with an identification feature visible from the exterior of the access port as shown in Fig. 77, a clinician can view and ascertain the predetermined attribute of the port before implantation, P0169.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cover plate of Smith to include a cover plate symbol matching that of the radiopaque symbol for the purpose determining the attributes of the port before implantation, as taught by Wiley, P0169, since the user would be able to see the symbol on an outer surface of the cover plate of the modified access port.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
