DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The specification objections have been withdrawn in light of amendments.
The drawing objections have been withdrawn in light of amendments.
The claim objections have been withdrawn in light of amendments.
Response to Arguments
Applicant's arguments filed on August 5th, 2026, have been fully considered.
With regards to applicant’s argument under “Claim Rejections - 35 U.S.C. §§ 102, 103” on pages 10-12 of Remarks, “Applicant submits Tallarida fails to teach at least 1) upper/lower housings that co-operate to define a reservoir, and 2) a septum disposed in a reservoir opening” for claim 1, have been fully considered but they are not persuasive. The examiner’s identification of element 602 is not intended to limit the claimed reservoir only to the portion of the structure labeled as the “chamber”. Rather, the examiner intended the numeral 602 to identify the chamber/reservoir region of the access port body, including the volume/area defined by the cooperating portions of the body/housing. Thus, the upper 640 and lower 642 housing co-operate to define a reservoir with septum 622 disposed in an opening of the reservoir (See Fig.6a below).
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Applicant’s arguments, see Remarks, page 12-13, filed 08/05/2026, with respect to claim 4, have been fully considered and are persuasive. The 35 U.S.C. § 103 of claim 4 has been withdrawn.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7-8, and 11 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Tallarida et al. (US Pub No. 20170000995 A1, herein, Tallarida).
Regarding claim 1, A subcutaneous access port, comprising:
a body (600 – Fig.6a) including a lower housing (642 – Fig.6a) and an upper housing (640 – Fig.6a) slidably engaged therewith (“sliding manner” – Para [0042]) and co-operating to define a reservoir (602 – Fig.6a), the body transitionable between an expanded configuration (Fig.6a) and a collapsed configuration (Fig.6b), the collapsed configuration defining a smaller overall profile (Fig.6b);
a needle penetrable septum (622 – Fig.6a) disposed in a reservoir opening (Shown at 622 – Fig.6a) disposed in a top surface of the upper housing (646 – Fig.6a) and configured to provide percutaneous access thereto (“the needle may pass through the septum ” – Para [0042]); and
a port stem defining a stem lumen (See Annotated Fig.6a below, the port stem in Fig.6a is similar to the port stem, 330, shown in Fig.3a) in fluid communication with the reservoir (“fluids to pass out of the bore from the chamber and into the connector and/or catheter” – Para [0036]).
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Regarding claim 2, Tallarida discloses the subcutaneous access port set forth above, wherein the body in the expanded configuration defines a first port height, and wherein the body in the collapsed configuration defines a second port height, the second port height being less than the first port height (See annotated Fig.6a and Fig.6b below).
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Regarding claim 3, Tallarida discloses the subcutaneous access port set forth above, wherein the body in the expanded configuration defines a first port volume, and the body in the collapsed configuration defines a second port volume, the second port volume being less than the first port volume (See annotated Fig.6a and Fig.6b above).
Regarding claim 7, Tallarida discloses the subcutaneous access port set forth above, wherein the lower housing is telescopically engaged with the upper housing and slidably (“sliding manner” – Para [0042]) engaged to transition between the expanded configuration and the collapsed configuration (Para [0041], Para [0042]).
Regarding claim 8, Tallarida discloses the subcutaneous access port set forth above, wherein an outer surface of the upper housing (644 – Fig.6a) is slidably engaged with an inner surface of the lower housing (648 – Fig.6b, Para [0042]).
Regarding claim 11, Tallarida discloses the subcutaneous access port set forth above, further including a biasing member (609, 660 – Fig.6b) configured to bias the body towards the expanded configuration (“moving the housing halves relative to each other” – Para [0041], Para [0042]).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tallarida in view of Bansal (GB 2489518 A). For ease of discussion, the examiner will be referencing the foreign reference document (Bansal), submitted by the applicant on 05/24/2024.
Regarding claim 5, Tallarida discloses the subcutaneous access port set forth above, but Tallarida does not expressly disclose wherein the reservoir in the expanded configuration defines a first reservoir volume, and the reservoir in the collapsed configuration defines a second reservoir volume, the second reservoir volume being less than the first reservoir volume.
Bansal teaches a port (12 – Fig.6) with a reservoir (32 – Fig.6) in an expanded configuration defining a first reservoir volume, and the reservoir in a collapsed configuration defines a second reservoir volume, the second reservoir volume being less than the first reservoir volume (Fig.7A, Fig.7B, Page. 14, lines 1-10).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the reservoir of Tallarida wherein the reservoir in the expanded configuration defines a first reservoir volume, and the reservoir in the collapsed configuration defines a second reservoir volume, the second reservoir volume being less than the first reservoir volume as taught by Bansal since Bansal teaches a port that is switchable between a compressed state for insertion through the skin and an uncompressed state, therefore minimizing tissue damage during implantation (Bansal, Page.3, lines 10-13).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tallarida in view of Bansal as applied to claim 5 above, and further in view of Moorehead (US Patent No. 6478783 B1).
Regarding claim 6, Tallarida discloses the subcutaneous access port, as modified above, but Tallarida, as modified, does not disclose wherein the second reservoir volume defines a zero volume or a de minimis volume.
Moorehead teaches a reservoir volume that defines a zero volume or a de minimis volume (“dispensed or discharged from the reservoir by reducing its volumetric size to essentially zero.” – Col.7, lines 46-48).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the second reservoir volume disclosed by Tallarida, as modified, to define a zero volume or a de minimis volume as taught by Moorehead since Moorehead teaches that a volumetric size of zero is a well-known reservoir volume after fluids have been discharged from a port.
Claim 9, 12-13, and 15 is rejected under 35 U.S.C. 103 as being unpatentable over Tallarida.
Regarding claim 9, Tallarida discloses the subcutaneous access port, as modified above, wherein an outer surface of the upper housing is slidably engaged with an inner surface of the lower housing but Tallarida does not expressly disclose wherein an inner surface of the upper housing is slidably engaged with an outer surface of the lower housing.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify wherein an inner surface of the upper housing is slidably engaged with an outer surface of the lower housing since rearrangement of parts has been held to be an obvious matter of design choice, MPEP 2144.04 VI. C. In the instant case, the device of Tallarida would not operate differently with the rearrangement of parts of the upper housing and the lower housing. Further, applicant places no criticality on the arrangement of parts, indicating simply, “In some embodiments, an inner surface of the upper housing is slidably engaged with an outer surface of the lower housing” (Para [0010]).
Regarding claim 12, Tallarida discloses the subcutaneous access port, as modified above, but Tallarida does not expressly disclose a latching mechanism transitionable between a locked position and an unlocked position, and configured to retain the upper housing in one of the expanded configuration or the collapsed configuration.
However, Tallarida discloses a second embodiment of the subcutaneous access port further including a latching mechanism (552 – Fig.5b) transitionable between a locked position (Fig.5a, “The tabbed latch may be received in a recess” – Para [0038]) and an unlocked position (Fig.5b), and configured to retain the upper housing in one of the expanded configuration or the collapsed configuration (“hold the body in a first expanded position” – Para [0038]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the port of Tallarida to comprise the latching mechanism as taught by the second embodiment of Tallarida since Tallarida teaches that when the port body is held by the latching mechanism in the expanded position, the needle may be completely or substantially contained within the access port body, therefore covering the needle, enhancing patient/user safety (Para [0038]).
Regarding claim 13, Tallarida discloses the subcutaneous access port, as modified above, wherein the latching mechanism is configured to lock the upper housing in the expanded configuration when a needle accesses the reservoir (Para [0038]).
Regarding claim 15, Tallarida discloses the subcutaneous access port, as modified above, but Tallarida does not expressly disclose an actuator coupled to the latching mechanism and configured to transition the latching mechanism between the locked position and the unlocked position.
However, Tallarida discloses a second embodiment of the subcutaneous access port further including an actuator (524 – Fig.5a) coupled to the latching mechanism (Fig.5a) and configured to transition the latching mechanism between a locked position and an unlocked position (Para [0039]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the port of Tallarida to comprise an actuator coupled to the latching mechanism as taught by the second embodiment of Tallarida since Tallarida teaches that a spring is a well-known actuator used when a port transitions between an expanded and collapsed configuration.
Allowable Subject Matter
Claims 4, 10, 14, and 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARISSA TAYLOR/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
