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 Arguments
Applicant's arguments filed 9/24/2026 have been fully considered.
Regarding the 112(b) rejections, Applicant’s arguments are convincing. The amendment to claim 10 overcomes the rejection and the rejection is therefore withdrawn. In light of the amendment to the claim, a new rejection is made over Kern.
Regarding the prior art rejections, Applicant’s arguments have been considered and are not persuasive. Applicant argues that Jo fails to teach or disclose the plurality of protrusions are arranged in at least one circle on the outer surface of the tail and/or the head of the stopper. This argument is not convincing. As can be seen in Fig. 9 of Jo, the protrusions intersect the outer circular perimeter of the piston head and therefore are arranged in a circle. Further, due to the arrangement of the protrusions, a circle superimposed on the piston head would contact contiguous protrusions and therefore the protrusions are considered to be arranged in a circle.
Applicant further argues that Jo fails to teach or suggest the angular distance between two adjacent protrusions in the circle is less than the angular distance occupied by one of the protrusions and is greater than zero. The examiner agrees that the embodiment of Jo shown in fig. 9 and previously relied upon teaches the protrusions abutting each other and therefore does not teach the distance being greater than 0. However, in a different embodiment shown in fig. 11, Jo teaches the claimed separation of the adjacent protrusions as can be seen in the cutaway drawing.
Applicant argues that Jo teaches that the protrusions serve a different purpose than the claimed invention. This argument is not convincing as the prior art need not recognize the same benefit to the protrusions. A prior art structure having the claimed configuration would operate in the same manner to perform the same function.
Regarding Kern, Applicant argues that Kern fails to disclose a plurality of grooves between the ribs. This argument is not convincing as Kern shows a plurality of grooves between ribs.
PNG
media_image1.png
676
937
media_image1.png
Greyscale
Applicant argues that the sealing elements 30 of Kern would not be understood to be annular ribs. This argument is not convincing. The sealing elements 30 of Kern are individual annular elements extending around the body and providing support thereto and therefore would be understood to be ribs. Kern shows the protrusions 28 extending from within the grooves as shown above.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3, 7, 8, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jo et al (KR 2016-0006635 A). Machine translation was previously provided.
Regarding claim 1, Jo discloses a stopper for a syringe (pages 18, 20) comprising a body having a proximal tail for attachment to a plunger rod 120 of the syringe and a distal head (fig. 11, page 20), and a plurality of protrusions 143 extending from an outer surface of the head (page 20), the protrusions are arranged in at least one circle on the outer surface of the head of the stopper (fig. 11, page 20: a number of protrusions lie in a circle located near the outer perimeter of the head) and an angular distance between two adjacent protrusions in the circle is less than the angular distance occupied by the protrusions and greater than 0 (see fig. 11 annotated below).
PNG
media_image2.png
548
718
media_image2.png
Greyscale
Regarding claim 3, Jo discloses that the protrusions are arranged in an outer circle around an outer perimeter of the outer surface of the head of the stopper (page 20) and further in at least one additional concentric circle within the outer circle (fig. 11 annotated below: protrusions lie at least partially on the circles illustrated), and an angular distance between two adjacent protrusions in each circle is less than the angular distance occupied by one of the protrusion (fig. 11 annotated below: distance between circles protrusions is less than width of a protrusion).
PNG
media_image3.png
674
936
media_image3.png
Greyscale
Regarding claim 7, Jo discloses that the protrusions are arranged in an outer circle around an outer perimeter of the outer surface of the head of the stopper (see figure from page 20 annotated above), and a protrusion in the center of the circle.
Regarding claim 8, Jo discloses that the outer surface of the head of the stopper is flat (page 20).
Regarding claim 15, Jo discloses a syringe (page 18) comprising a syringe body defining a chamber (page 18), a plunger rod 120 in the chamber, and a stopper according to claim 1 (fig. 11; see claim 1 above).
Claim(s) 1, 10, 11, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kern et al (US 9,238,543).
Regarding claim 1, Kern discloses a stopper for a syringe (fig. 1) comprising a body having a proximal tail for attachment to a plunger rod 50 of the syringe (fig. 3) and a distal head (fig. 2), and a plurality of protrusions 42/44 extending from an outer surface of the head (fig. 2), the protrusions are arranged in at least one circle on the outer surface of the head of the stopper (fig. 2) and an angular distance between two adjacent protrusions in the circle is less than the angular distance occupied by the protrusions and greater than 0 (fig. 2).
Regarding claim 10, Kern discloses that the head of the stopper is conical (fig. 2) and a circle of protrusions having substantially triangular shape, with a vertex corresponding to a vertex angle of the triangular shape of the protrusion (fig. 2: inner point of the protrusion), a base corresponding to the base of the triangular shape of the protrusion (fig. 2: outer perimeter of the protrusion), and two sides extending between the vertex and the base extend from the outer surface of the head of the stopper (fig. 2: radially extending sides).
Regarding claim 11, Kern discloses a stopper for a syringe comprising a body 24 having a proximal tail adapted for attachment to a plunger rod of the syringe – note “adapted for attachment” is interpreted to be an intended use limitation wherein the plunger rod is not positively recited. The proximal end of the body of Kern is capable of being connected to a syringe plunger. Kern discloses that the body has a distal head (fig. 2), a plurality of annular ribs 30 around a circumference of an outer sidewall of the body and a plurality of grooves 26 between the ribs (fig. 2), wherein the ribs are spaced from one another by the grooves (fig. 2), and a plurality of protrusions 28 extending outwardly from eh outer side wall of the body in a radial direction from within the grooves (fig. 2).
Regarding claim 12, Kern shows six protrusions spaced equally around the body and therefore the protrusions are spaced within the claimed range, i.e. roughly 60 degrees separated.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jo in view of Ma et al (CN 202933324 U). Machine translation previously provided.
Claim 2 differs from Jo in calling for a cavity adapted to receive and engage at least a portion of the plunger rod of the syringe is defined within the body of the stopper and an opening to the cavity is provided in the tail of the stopper, and protrusions are provided on the tail of the stopper and are arranged in at least one circle on the outer surface of the tail of the stopper extending from an annular ring on the outer surface of the tail of the stopper defined between an outer perimeter of the end face and an outer perimeter of the cavity. Ma teaches a stopper for a syringe including a cavity for receiving a portion of the plunger rod of the syringe and an opening to the cavity being provided in the tail of the stopper (fig. 1). 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 stopper of Jo to include a cavity to receive the plunger rod as taught by Ma to provide a two part piston plunger as is well known in the art and which allows the plunger rod and the stopper to be formed from different materials and separately sterilized as needed.
Ma further teaches that protrusions are provided on the tail of the stopper and arranged in a circle on the outer surface of the tail between an outer perimeter of the rear end face and the perimeter of the cavity (fig. 1). 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 outer surface of the tail of Jo to include protrusions as taught by Ma to provide a surface that prevents sticking.
Claim(s) 4, 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jo.
Claim 4 differs from Jo in calling for the protrusions to be substantially cylindrical. Applicant has not provided criticality to the shape of the protrusions. The specification page 3, para. 0010 discloses that the protrusions may have any shape. Jo also shows the protrusions having a variety of shapes in various drawings. Therefore, a person of ordinary skill in the art would expect the protrusions of Jo to perform equally well having any shape. Therefore, it would have been a matter of obvious design choice to modify the shape of the protrusions of Jo to be substantially cylindrical.
Regarding the number of protrusions providing in the first circle, at least the parameter γ is not specific and can be chosen such that arrangement of protrusions shown by Jo meets the claimed equation.
Regarding claim 5, Jo shows the number of protrusions in the inner circle meeting the equation for the same reasons as those described above with regard to claim 4.
Allowable Subject Matter
Claims 6, 9, 13, 14 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.
The following is a statement of reasons for the indication of allowable subject matter: see prior office action.
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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
