DETAILED ACTION
Response to Amendment
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koch et al. (US 4,929,243; hereafter Koch).
In regard to claim 1, Koch discloses a subcutaneous port assembly (see Fig. 1) comprising: a base (11); a connector (10) extending from a first end attached to the base to a distal end and including an inner surface (inner surface of 10) defining a socket (12) having an inside diameter and a first radial protrusion (10a) on the inner surface; a stem (27) extending from the base and into the socket, the stem including an outer surface having an outside diameter that is less than the inside diameter of the socket (shown in Fig. 1); a sealing element (21) disposed within the socket between the stem and the inner surface of the socket (shown in Fig. 1); and a locking member (18) having a plunger (forward portion of 18) received within the socket from the distal end and having (i) an outer surface including a second radial protrusion (17) configured to selectively engage the first radial protrusion (10a) to retain at least a portion of the plunger within the socket (see col. 2, lines 63-64) and (ii) a terminal end (19) facing the sealing element (19 faces head 22 of sealing element 21), the plunger axially movable between a first position and a second position to selectively compress the sealing element within the socket (see at least col. 3, lines 27-61).
In regard to claim 2, Koch discloses wherein the stem (27) is surrounded by the sealing element (21) (clearly shown in Fig. 1).
In regard to claim 3, Koch discloses wherein the sealing element (21) is spaced apart from the outside diameter of the outer surface of the stem (27) by a first distance in an uncompressed state (see Fig. 1 and col. 3, lines 27-61).
In regard to claim 4, Koch discloses wherein the plunger in the second position is configured to axially and radially compress the sealing element towards the outside diameter of the outer surface of the stem (see at least col. 3, lines 27-61).
In regard to claim 5, Koch discloses, wherein the locking member (18) further includes a cap (top surface of the plunger portion) attached to the plunger, the cap including a plurality of first threads (17) and the connector (10) includes a plurality of second threads (10a) engaged with the first threads (see col. 2, lines 63-64).
In regard to claim 11, Koch discloses wherein the sealing element (21) includes a tapered end (tapered face of 22) facing the terminal end (19) of the plunger (18), the terminal end of the plunger configured to axially and radially compress the tapered end of the sealing element when the plunger moves from the first position to the second position (see at least col. 3, lines 27-61).
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.
Claim(s) 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Koch in view of Burke (US 3,332,439).
In regard to claims 6-8, Koch fails to disclose wherein the cap includes a position indicator, wherein the position indicator is configured to communicate a rotational position of the cap, and wherein the cap includes a gripping member, the position indicator being provided on the gripping member.
In a similar art, Burke discloses a cap member (12) including a position indicator (60), wherein the position indicator (60) is configured to communicate a rotational position of the cap (see col. 4, lines 18-31), and wherein the cap includes a gripping member (56), the position indicator (60) being provided on the gripping member (see Figs. 1-2). The features allow for gripping the rotational cap member and providing a visual indicator to the user of the rotational position.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Koch with the features of Burke in order to provide gripping means and rotational position indication means.
In regard to claim 9, Koch discloses wherein the plunger (18) moves between the first position and the second position via the first threads (17) engaging with the second threads (10a) (see col. 2, lines 63-64; see at least col. 3, lines 27-61).
Response to Arguments
Applicant's arguments filed 6/1/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that the cited art of record fails to teach, suggest, or disclose a subcutaneous port assembly including a base, a connector including an inner surface defining a socket defining a socket having an inside diameter and a first radial protrusion on the inner surface, a sealing element disposed within the socket, and a locking member having a plunger received within the socket from the distal end and having (i) an outer surface including a second radial protrusion configured to selectively engage the first radial protrusion to retain at least a portion of the plunger within the socket and (ii) a terminal end facing the sealing element, in combination with the other elements of independent Claim 1, the examiner respectfully disagrees. The applicant argues (see first full paragraph of page 8) that Koch is silent to a locking member having a second radial protrusion that is configured to selectively engage a first radial protrusion of a socket to retain a plunger with the socket. The applicant argues that the threads (10a, 17) are continuous helical structures providing bidirectional engagement in contrast to the claimed protrusions which are first and second radial protrusions. This argument is not persuasive. Even if a thread is considered one continuous structure, the thread is still a protrusion extending at least partially in the radial direction. Furthermore, complimentary threads (10a, 17) and complementary threads, in general, are selectively engageable in the sense that they can be readily connected and disconnected from each other.
The applicant’s arguments (starting on the second paragraph) of page 8 are moot as the examiner has not used a design consideration rationale in the instant rejection.
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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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