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 .
Drawings
The replacement drawing of Fig 5 filed 5/18/2026 is acknowledged and entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “304” has been used to designate different features in Figures 3 and 5. Paragraph [0103] of the Specification defines reference character “304” as being a “securing apparatus” and, therefore, the reference characters is applied correctly in Fig 3 but not in Fig 5. 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.
Specification
The amendment to Paragraph [0001] of the Specification has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities: The term “mechanism” should be inserted after the term “valve” on line 15 to match the language used on line 11 to ensure consistency of claim language. Appropriate correction is required.
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 1-11 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 has been amended to require the subject matter of now-cancelled dependent claim 5, resulting in claim 1 requiring a port device that comprises (1) a “tapered seat” that is “configured to create a mismatch fit with a diameter of the tip of the access tube when in use”, (2) “an interface surface” that is “configured to engage (i) the blood vessel of the patient or (ii) a vascular access device” and that has “an aperture in fluid communication with the distal portion of the tapered seal” and (3) “a valve mechanism having a spherical element that is configured to be displaced by introduction of the tip of the access tube through the skin of the patient into the tapered seat”. Such a port device does not appear to be described in the Specification or shown in the Drawings. Because of this, it is unclear how to interpret claim 1 in light of the Specification and it is unclear how such a port device could operate as claimed.
The embodiments described in the Specification and shown in the Drawings that include a “tapered seat” that “is configured to create a mismatch fit with a diameter of a tip of an access tube when in use” do not appear to allow the tip of the access tube to pass distally out of the tapered seat (as seen in Fig 4B). However, the embodiments described in the Specification and shown in the Drawings that include a “valve mechanism” having a “spherical element” require the tip of the access tube to pass distally out of the tapered seat and engage with the spherical element (as seen in Fig 14A-15). Because the “mismatch” feature of the claim prevents the tip of the access tube from passing out of the tapered seat and the “valve mechanism” feature of the claim requires the tip of the access tube to pass out of the tapered seat, it is unclear how both limitations can be met. Therefore, it is unclear how to interpret the claim for the sake of examination. For the sake of examination, claim 1 is interpreted as the mismatch allowing the tip of the access tube to pass into the tapered seat so that the valve mechanism of the claim can be operable.
Additionally, the embodiments described in the Specification and shown in the Drawings that include an “interface surface […] having an aperture in fluid communication with the distal portion of the tapered seal” have the “interface surface” being directly in contact with the outside of the blood vessel or vascular access device (like in the embodiment of Fig 3,5). However, the embodiments described in the Specification and shown in the Drawings that include the “valve mechanism” of claim 5 have an “interface surface” that is the exterior surface of a nozzle (like 1463 in Fig 14A for example); such an “interface surface” does not have “an aperture in fluid communication with the distal portion of the tapered seal” because it is the outer surface of a tubular member. Because the “interface surface” is claimed as having an aperture in fluid communication with the distal portion and being configured to engage with a blood vessel or a vascular access catheter, but the embodiments described in the Specification and shown in the Drawings that include a “valve mechanism” have an interface surface that does not possess an “aperture in fluid communication with the distal portion of the tapered seat”, it is unclear a port device meeting both limitations can be met. For the sake of examination, claim 1 is interpreted as referring to “an interface component” instead of “an interface surface”; this interpretation does not require that the “aperture” be possessed by a “surface” that engages the blood vessel or the vascular access catheter, but simply requires that the “aperture” be possessed by the component that also possesses the “surface”.
Claims 2-11 are rejected due to their dependence on claim 1.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Burbank et al. (WO 01/32141) in view of McIntyre et al. (PG PUB 2009/0105688) and Ellefson et al. (US Pat 3,892,974).
Re claim 1, Burbank discloses a fully implantable port device 10 (Fig 2,3; it is noted that all reference characters cited below refer to Fig 2,3 unless otherwise noted) for establishing access to a blood vessel of a patient that is configured to be implanted entirely underneath the skin of the patient (the italicized text constitutes functional language; this limitation is met in view of page 7, lines 17-19), the port device comprising: a tapered seat 36 configured to receive a tip of an access tube (the italicized text constitutes functional language and, therefore, “an access tube” and its “tip” are not a part of the claimed invention; this limitation is met in view of Fig 3), the tapered seat having a proximal portion (facing upward in Fig 2), a distal portion (facing downward in Fig 2), and a conical section extending between the proximal portion and the distal portion (as seen in Fig 2; Page 9, Lines 8-9), wherein the proximal portion of the tapered seat is configured to receive the tip of the access tube therethrough (as set forth above, the “access tube” and its “tip” are not a part of the claimed invention; this limitation is met in view of Fig 3); a port guide 24; a valve mechanism 40+40 having a spherical element 40 that is configured to be displaced by introduction of the tip of the access tube through the skin of the patient into the tapered seat (as seen in Fig 3; page 9, lines 12-15), wherein the spherical element is configured to return to its original position in response to the removal of the tip of the access tube from the tapered seat (page 9, lines 15-17, lines 21-23); and an interface surface (belonging to conduit 14 – page 8, lines 23-25 – or belonging to the portion of plunger 23 that lies within tube 32 which forms the proximal end of the conduit 14 – page 9, lines 1-3) configured to engage (i) the blood vessel of the patient or (ii) a vascular access catheter (the italicized text constitutes functional language; this limitation is met in view of page 8, lines 23-25 – which disclose engagement of conduit 14 with a blood vessel – or page 9, lines 1-3 – which disclose engagement of plunger 23 with a vascular access catheter), the interface surface having an aperture (the lumen within conduit 14 or the opening at the distal end of bore 34) in fluid communication with the distal portion of the tapered seat (as seen in Fig 3); wherein the tapered seat is configured to create a mismatch fit with a diameter of the tip of the access tube when in use, wherein the mismatch fit is adapted to cause an increase in flow during treatment (the italicized text constitutes functional language and, again, it is noted that the “access tube” is not a part of the claimed invention; this limitation is met since the port device can be used with an access tube having a tip that is cylindrical in a distal portion thereof that is sized to move through the valve mechanism 40,40 but is wider in a proximal portion thereof that is sized to be smaller than the proximal end of the tapered seat and larger than the distal end of the tapered seat). Burbank does not disclose that the port guide includes one more light sources that are configured to illuminate a location of the tapered seat so that the tapered seat is visible to a user to guide introduction of the tip of the access tube through the skin of the patient and to illuminate the valve for percutaneous access.
McIntyre, however, teaches a fully implantable port device 100 (Fig 1; Para 3) comprising a seat 104 (Fig 1; comparable to seat 36 of Burbank), a chamber 114 (Fig 1; comparable to chamber 34 of Burbank) below the seat, and one or more light sources 110 (Fig 1; “one or more light emitting diodes”, Para 14) below the chamber (as seen in Fig 1), wherein the light sources are configured to illuminate upward to illuminate a location of the seat so that the seat is visible to a user to guide introduction of a tip of an access tube through the skin of a patient (Para 12) for the purpose of providing means for a practitioner to locate the seat (Para 4). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Burbank to include the port guide (which is below the chamber 34) with one or more light sources, as taught by McIntyre, for the purpose of providing means for a practitioner to locate the seat (Para 4). Although McIntyre does not disclose a valve mechanism, Burbank’s valve mechanism resides below the tapered seat and above the chamber formed by the bottom surface of the port guide; therefore, since the McIntyre’s light source is located below the chamber, and illuminates upward, the light would shine on the valve mechanism; however, since Burbank is silent as to the material of the spherical elements of the valve mechanism and, therefore, the combination of Burbank and McIntyre does not explicitly disclose that the one or more light sources would illuminate the valve for percutaneous access.
Ellefson, however, teaches a spherical element 14 (Fig 1) made of synthetic sapphire (Col 1, Lines 24-28; Col 2, Line 27) that, when shown upon by a light emitting diode 22 (Fig 1), illuminates and focuses the light emitted by the diode (Col 3, Lines 63-65). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Burbank/McIntyre to include the spherical element (which would be shown upon by McIntyre’s light emitting diodes and which is located underneath the tapered seat as explained above) such that it is made of synthetic sapphire, as taught by Ellefson, for the purpose of illuminating the spherical element to focus the light emitted by the diode (Col 3, Lines 63-65). One of ordinary skill in the art would recognize that focusing the light would provide the physician with a more precise location of the tapered seat to better guide the user in percutaneous access
Re claim 2, Burbank as modified by McIntyre and Ellefson in the rejection of claim 1 above discloses all the claimed features with McIntyre teaching that the one or more light sources comprise light emitting diodes (“one or more light emitting diodes”, Para 14). The motivation set forth in claim 1 above also applies to this claim.
Re claim 3, Burbank as modified by McIntyre and Ellefson in the rejection of claim 1 above discloses all the claimed features with McIntyre teaching that the light emitting diodes include a radiant material (Para 12 discloses that the light sources emit light and, therefore, the material of the light source is a radiant material). The motivation set forth in claim 1 above also applies to this claim.
Re claim 4, Burbank as modified by McIntyre and Ellefson in the rejection of claim 1 above discloses all the claimed features except that the light emitting diodes include ruby or sapphire. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify McIntyre to include the LEDs with ruby or sapphire since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Claim 4 has additionally been rejected with art below.
Re claim 5, Burbank as modified by McIntyre and Ellefson in the rejection of claim 1 above discloses all the claimed features with Ellefson teaching that the spherical element comprises synthetic sapphire (Col 1, Lines 24-28; Col 2, Line 27). The motivation set forth in claim 1 above also applies to this claim.
Re claim 6, Burbank discloses that the port guide is configured to engage a proximal portion of the tip of the access tube (via the surface forming aperture 42, Fig 3) and assist in directing the tip of the access tube toward the tapered seat (as set forth in the rejection of claim 1 above, the “access tube” is not a part of the claimed invention; therefore, the port guide of Burbank only has to be structurally capable of engaging a proximal portion of a tip of an access tube and assist in directing the tip toward the tapered seat; this limitation is met because the surface forming aperture 42 is structurally capable of engaging a proximal portion of a tip of an access tube that has a diameter substantially similar to that of aperture 42 as the tip moved distally through the tapered seat).
Re claim 7, Burbank as modified by McIntyre and Ellefson in the rejection of claim 1 above discloses all the claimed features with McIntyre teaching that the port guide further comprises a receiver coil 254 (Fig 3; “coil”, Para 17) for receiving an electrical current (Para 17), wherein the one or more light sources are configured to be illuminated when an electromagnetic inducer is positioned in proximity to the receiver coil (Para 17) for the purpose of providing non-contact control of when the light sources are illuminated (Para 17). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Burbank to include the receiver coil of McIntyre for the purpose of providing non-contact control of when the light sources are illuminated (Para 17).
Re claim 8, Burbank discloses that the mismatch fit is further configured to decrease a cross-sectional sealing area (as set forth in the rejection of claim 1 above, the “access tube” is not a part of the claimed invention; therefore, the port device of Burbank only has to be structurally capable of creating a mismatch fit with a hypothetical tip of a hypothetical access tube that is configured to decrease a cross-sectional sealing area; this limitation is met because the conical section of the tapered seal would create a mismatch fit that decreases a cross-sectional sealing area with a proximal portion of the tip of the access tube that has a cylindrical shape with a diameter that is equal to a diameter along the conical section).
Re claim 9, Burbank discloses that the proximal portion of the tapered seat is distanced from the distal portion of the tapered seat (as seen in Fig 2) but Burbank/McIntyre/Ellefson do not explicitly disclose that the distance between these two portions is between about 1.0 mm and 5.0 mm. However, it would have been an obvious matter of design choice to include the tapered seat with a distance between about 1.0 mm and 5.0 mm between the proximal portion and the distal portion since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Re claim 10, Burbank discloses that the tip of the access tube is cylindrical and creates the mismatch fit along the conical section of the tapered seat (as set forth in the rejection of claim 1 above, the “access tube” is not a part of the claimed invention; therefore, the conical section of the tapered seat of Burbank only has to be structurally capable of creating a mismatch fit with a hypothetical cylindrical tip of a hypothetical access tube; this limitation is met because the conical section of the tapered seal would create a mismatch fit with a proximal portion of the tip of the access tube that has a cylindrical shape having a diameter that is equal to a diameter along the conical section).
Re claim 11, Burbank discloses that the diameter of the tip of the access tube is greater than a diameter of the distal portion of the tapered seat (as set forth in the rejection of claim 1 above, the “access tube” is not a part of the claimed invention; therefore, the distal portion of the tapered seat of Burbank only has to be structurally capable of having a diameter that is less than a hypothetical diameter of a hypothetical distal end of a hypothetical access tube; this limitation is met since the port device can be used with an access tube having a tip that is cylindrical in a distal portion thereof that is sized to move through the valve mechanism 40,40 but is wider in a proximal portion thereof that is sized to be smaller than the proximal end of the tapered seat and larger than the distal end of the tapered seat).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Burbank et al. (WO 01/32141)/McIntyre et al. (PG PUB 2009/0105688)/Ellefson et al. (US Pat 3,892,974) in view of Hughes (PG PUB 2006/0092626).
Re claim 4, Burbank/McIntyre/Ellefson disclose all the claimed features except explicitly disclosing that the light emitting diodes include ruby or sapphire. Hughes, however, teaches using sapphire in light emitting diodes to achieve a generally blue light (Para 7). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Burbank/McIntyre/Ellefson to include the LEDs with sapphire, as taught by Hughes, for the purpose of emitting generally blue light (Para 7).
Response to Arguments
Applicant's arguments filed 5/18/2026 have been fully considered but they are not persuasive.
Regarding the 112(b) rejection that was previously made on claim 5 and now made on claim 1 (due to the incorporation of the subject matter of now-cancelled claim 5 into claim 1), the Applicant states that “previously pending claim 5 and its subject matter are sufficiently definite as written as one having ordinary skill in the art would appreciate that the ball valve system as shown and described in Applicant’s Specification at least with respect to FIGS. 14A-15 may be implemented in any of the port devices described in Applicant’s Specification” and “the ball valve system as shown and described in Applicant’s Specification at least with respect to FIGS. 14A-15 may be implemented as the valve 510 of FIG. 5 as would be appreciated by one having ordinary skill in the art upon reading the present disclosure”. The Examiner respectfully disagrees for the reasons set forth in the 112(b) rejection above; most notably that claim 1 requires the tapered seat to “create a mismatch fit” which prevents the tip of the access tube from moving through the distal end of the tapered seat while the “spherical element” of the valve mechanism requires the tip of the access tube to move through the distal end of the tapered seat and contact the spherical element. One of ordinary skill in the art would recognize that two conditions that contradict each other cannot both be met. Applicant has not shown or explained how both conditions can be met. Therefore, the 112(b) rejection is maintained.
Regarding the McIntyre reference previously applied and maintained herein, the Applicant argues that McIntyre does not teach the “port guide including one or more light sources” as claim. Regarding the argument that “McIntyre’s illumination is directed at the septum for port identification, not for guiding access tube tip placement”, the Examiner respectfully disagrees; since McIntyre’s illumination is directed “through the septum 104 toward a surface of the skin”, this light does indeed “guide introduction of the tip of the access tube through the skin of the patient” as claimed because the light indicates the location which the tip of the access tube should be inserted (Para 12). Regarding the argument that “McIntyre’s light source 110 is integral with the housing 102 […] and the light source 110 does not form any part of a guide element for inserting an access tube”, the Examiner respectfully disagrees in view of the rejection set forth above wherein the newly-cited Burbank reference teaches a port guide and it is explained how one of ordinary skill in the art would have been motivated to add McIntyre’s light source(s) into the Burbank’s port guide. Regarding the argument that “illuminating the housing of a port is not equivalent to illuminating the particular tapered seat access site for introduction of an access tube”, the Examiner respectfully disagrees; it is noted that the claim does not require the tapered seat to be the only portion of the port device that is illuminated and, since, McIntyre’s illumination is directed “through the septum 104 toward a surface of the skin”, this light does indeed “guide introduction of the tip of the access tube through the skin of the patient” as claimed because the light indicates the location which the tip of the access tube should be inserted (Para 12).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. US Pat 4,534,759 to Trawoger (Fig 1,2), US Pat 5,226,879 to Ensminger et al. (Fig 8,9), and US Pat 5,281,199 to Ensminger et al. (Fig 31-33) each disclose port devices having a tapered seat and a valve mechanism comprising a spherical element that is configured to be displaced by introduction of a tube into the tapered seat and configured to return to its original position in response to removal of a tube from the tapered seat.
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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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