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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 10, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on April 10, 2026. As directed by the amendment: claims 1, 3, and 5 have been amended, no claims have been added, claims 2 and 4 have been canceled. Thus claims 1, 3, and 5 are presently pending in this application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 13, 2026 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments, see Remarks, filed April 10, 2026, with respect to the rejection(s) of claim 1 under 35 U.S.C. 102 have been fully considered and are persuasive. Okuda does not disclose the maximum diameter part of the second annular protrusion being a vertex, the tilt angle of the upper surface side line of the second protrusion relative to the extended bottom surface being smaller than the tilt angle of the upper surface side line of the first protrusion relative to the extended bottom surface, and the tilt angle of the upper surface side line of the second protrusion relative to the extended bottom surface being smaller than the tilt angle of the lower surface side line of the second protrusion relative to the extended bottom surface. Additionally, Beedon does not disclose these limitations. Therefore, the rejection has been withdrawn, and the rejections of claims 3 and 5 are also withdrawn for similar reasons due to their dependency on claim 1. However, upon further consideration, in light of the amendments, a new ground(s) of rejection is made below.
Specification
The disclosure is objected to because of the following informalities: the replacement abstract filed February 9, 2023 recites “the syringe barre” in line 6, should read “the syringe barrel”.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1, line 6 recites “when the position is inserted into the syringe barrel”, should read “when the piston is inserted into the syringe barrel” for clarity. 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.
Claim 5 is 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 5 recites “a piston according to Claim 2” which renders the scope of the claim unclear as claim 2 is a cancelled claim. For examining purposes, claim 5 will be interpreted to depend from 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 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Okuda et al. (US 20160089499), hereinafter Okuda, in view Freeman (GB 594003),
Regarding claim 1, Okuda discloses a piston (Figs. 1-4, gasket 3) used by being inserted into a syringe barrel (Fig. 1-2, gasket 3 is inserted into syringe barrel 2) comprising an approximately cylindrical elastic body (Fig. 2-4 and [0010, 0057], gasket 3 is cylindrically-shaped and made of elastomer, thus an elastic body), the piston comprising an upper surface (Fig. 3-4, distal end with tapered surface 31) which is to be contacted with a liquid for internal use (Fig. 2, distal end contacts medicine 8 in barrel 2), a bottom surface (Fig. 3-4, proximal end with inner cavity 30) with which a plunger rod is to be contacted (Fig. 2, proximal end is in contact with plunger 4) and a side surface which is to be contacted with the inner surface of the syringe barrel, when the position is inserted into the syringe barrel (Fig. 2 and [0055-0056], gasket 3 has outer peripheral surface which contacts the inner surface of barrel 2), the side surface includes plural annular protrusions in an axial direction (Figs. 3-4, outer peripheral surface of gasket 3 comprises annular ribs 38 and 39), a maximum diameter part of each of the annular protrusions has an outer diameter which is to be contacted with the inner surface of the syringe barrel when the piston is inserted into the syringe barrel (Fig. 2 and [0056], annular ribs 38 and 39 have a maximum outer diameter larger than the inner diameter of the barrel 2, such that the ribs 38 and 39 are in sliding contact with the inner surface of the barrel 2 when inserted into the barrel), and a maximum diameter part of at least one annular protrusion is formed at a position which is shifted from the halfway of the axial length of the annular protrusion toward the bottom surface side (Annotated Fig. 3, annular rib 39 has its maximum diameter portion located in the bottom half of its axial length, adjacent the proximal end surface), wherein the side surface has a first annular protrusion (Fig. 3-4, annular rib 38), an annular recess (Fig. 3-4, annular recess between annular ribs 38 and 39) and a second annular protrusion (Fig. 3-4, annular rib 39) in this order from the upper surface side in the axial direction (Fig. 3-4, annular rib 38, annular recess, and annular rib 39 are in this order from the distal end in the axial direction), the at least one annular protrusion is the second annular protrusion (Annotated Fig. 3, the at least one annular protrusion is annular rib 39).
PNG
media_image1.png
279
323
media_image1.png
Greyscale
Annotated Fig. 3 of Okuda
Okuda fails to disclose a maximum diameter part of the second annular protrusion is a vertex, a tilt angle of a line connecting an upper surface side end of the second annular protrusion on an extended bottom surface of the annular recess with the vertex of the second annular protrusion relative to the extended bottom surface is smaller than a tilt angle of a line connecting a vertex of the first annular protrusion with a bottom surface side end of the first annular protrusion on the extended bottom surface relative to the extended bottom surface, and the tilt angle of the line connecting the upper surface side end of the second annular protrusion with the vertex of the second annular protrusion relative to the extended bottom surface is smaller than a tilt angle of a line connecting the vertex of the second annular protrusion with a bottom surface side end of the second annular protrusion on the extended bottom surface relative to the extended bottom surface. However, Freeman discloses a maximum diameter part of the second annular protrusion is a vertex (Fig. 8, ribs 3, including the second annular rib of the piston 2, has a maximum diameter part which forms a vertex), a tilt angle of a line connecting an upper surface side end of the second annular protrusion on an extended bottom surface of the annular recess with the vertex of the second annular protrusion relative to the extended bottom surface (Annotated Fig. 8, theta 2 of second annular rib) is smaller than a tilt angle of a line connecting a vertex of the first annular protrusion with a bottom surface side end of the first annular protrusion on the extended bottom surface relative to the extended bottom surface (Annotated Fig. 8 and p. 3, ln. 1-9, theta 2 is at a smaller/shallower angle than the 90 deg angle of theta 1 of first annular rib), and the tilt angle of the line connecting the upper surface side end of the second annular protrusion with the vertex of the second annular protrusion relative to the extended bottom surface is smaller than a tilt angle of a line connecting the vertex of the second annular protrusion with a bottom surface side end of the second annular protrusion on the extended bottom surface relative to the extended bottom surface (Annotated Fig. 8 and p. 3, ln. 1-9, theta 2 is at a smaller/shallower angle than the 90 deg angle of theta 3 of second annular rib).
PNG
media_image2.png
310
477
media_image2.png
Greyscale
Annotated Fig. 8 of Freeman
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to have modified Okuda to incorporate the disclosures of Freeman and modify the maximum diameter part of the second annular protrusion to be a vertex, and modify the first and second annular protrusions such that a tilt angle of a line connecting an upper surface side end of the second annular protrusion on an extended bottom surface of the annular recess with the vertex of the second annular protrusion relative to the extended bottom surface is smaller than a tilt angle of a line connecting a vertex of the first annular protrusion with a bottom surface side end of the first annular protrusion on the extended bottom surface relative to the extended bottom surface, and the tilt angle of the line connecting the upper surface side end of the second annular protrusion with the vertex of the second annular protrusion relative to the extended bottom surface is smaller than a tilt angle of a line connecting the vertex of the second annular protrusion with a bottom surface side end of the second annular protrusion on the extended bottom surface relative to the extended bottom surface. Doing so would provide the piston with ribs shaped to effectively form a continuous peripheral seal when in sliding contact with the wall of the barrel during a working stroke of the piston (Freeman, p. 2, ln. 40-50; p. 3, ln. 1-9).
Regarding claim 5 and Okuda, in view of Freeman, Okuda further discloses a piston according to Claim 2, wherein a contact area in which the second annular protrusion is to be contacted with the inner surface of the syringe barrel (Figs. 3-4 and [0056], contact area of annular rib 39 is equivalent to the annular rib's axial length which is particularly 0.2-0.5 mm) is smaller than the contact area in which the first annular protrusion is to be contacted with the inner surface of the syringe barrel when the piston is inserted into the syringe barrel l (Figs. 3-4 and [0056], contact area of annular rib 38 is equivalent to the annular rib's axial length which is particularly 0.8-1.5 mm, which is thus larger than the contact area of rib 39).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Okuda (US 20160089499), in view Freeman (GB 594003), as applied to claim 1 above, and further in view of Beedon et al. (US 20050010175), hereinafter Beedon.
Regarding claim 3, Okuda, in view of Freeman, discloses a piston according to Claim 1.
Okuda, in view of Freeman, fails to disclose wherein a curvature radius of the second annular protrusion is smaller than a curvature radius of the first annular protrusion. However, Beedon discloses wherein a curvature radius of the second annular protrusion (Fig. 2-5, radius of curvature Rp of proximal lobe 34) is smaller than the curvature radius of the first annular protrusion (Fig. 2-5 and [0054, 0059], radius of curvature Rd of distal lobe 37, wherein the Rd is configured to be larger than the Rp).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Okuda, in view of Freeman, to incorporate the disclosures of Beedon and modify the first annular protrusion and second annular protrusion such that the curvature radius of the second annular protrusion is smaller than the curvature radius of the first annular protrusion. Doing so would result in a decreases surface contact between the piston and the syringe barrel and decreased breakaway forces of the piston, thus resulting in a piston which provides a sterile seal without generating excessive breakaway forces (Beedon, [0054]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm 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, 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.
/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights