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
This office action is responsive to the amendment filed on December 24, 2025. As directed by the amendment: no claims have been amended, no claims have been added, no claims have been canceled. Thus claims 1-5 are presently pending in this application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 23, 2025 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 filed January 24, 2025, see Remarks, have been fully considered but they are not persuasive. On pgs. 4-5 of the Remarks, the applicant argues that Okuda fails to disclose the limitation “the 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” stating that the ribs 38 and 39 of Okuda have a uniform diameter and that the axial length of each rib is constant within said rib, therefore there is no localized peak, vertex, or maximum diameter part that is offset from a central axial position in the ribs of Okuda. The examiner respectfully disagrees, as the formation of proximal rib 39 of Okuda provides the rib with a profile which does not increase uniformly to a central “maximum diameter part”, but instead has a maximum diameter part that is shifted closer the bottom surface of the piston when considering the entire axial length of the rib, as shown in annotated Fig. 3 of Okuda:
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Annotated Fig. 3 of Okuda
While the examiner acknowledges that the annotated figure was accidentally omitted from the Non-Final Office Action mailed 09/24/2025, it is still clear from a non-annotated Fig. 3 of Okuda that the rib 39 begins as a gradual increase in diameter, relative to the constant diameter of the “non-rib” portion of the piston, therefore this portion of the piston may be considered a portion of the rib and contributes to its axial length. The rib then reaches a peak diameter region at its “back end”, which is a portion of the entire rib’s axial length that is closer to the bottom surface side of the piston than it is to upper surface. Therefore, the piston of Okuda does show that rib 39 has a maximum diameter part that is formed at a position which is shifted from the halfway of the axial length of the annular protrusion toward the bottom surface side. Thus, Okuda meets all the claim limitations of claim 1.
On pg. 5-6 of the remarks, the applicant argues that rejection of claim 3 under 35 U.S.C. 103 over Okuda, in view of Beedon, is improper since the smaller proximal radius of the piston in Beedon addresses a different technical problem and achieves a different operational effect than the smaller proximal radius of the instant application, therefore there is no motivation for the modification to the radius of the protrusions of Okuda. The examiner respectfully disagrees, as Okuda, in view of Beedon, teaches the structural limitations of the claim, and therefore meets the claimed limitations. While Beedon may disclose different benefits than the instant application to having the claimed radii of the protrusions, these different technical problems do not result in a structural difference between the claimed invention and the prior art, and thus do not patentably distinguish the claimed invention from the prior art. And Beedon’s disclosed beneficial reasonings for the radii of the protrusions provides motivation for modifying the piston of Okuda to have these features. Additionally, the examiner notes that the claim does not state that the smaller curvature radius is intended to “optimize sliding resistance during ongoing plunger movement after motion”. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the curvature radius need not be configured to perform this functionality to meet the scope of the claim. Thus, Okuda, in view of Beedon, meets all limitations of claim 3 and is provided with proper motivation.
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.
(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 1-2 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okuda et al. (US 20160089499), hereinafter Okuda.
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), wherein the piston comprises 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 the axial direction (Figs. 3-4, outer peripheral surface of gasket 3 comprises annular ribs 38 and 39), the maximum diameter part 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 the 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).
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Annotated Fig. 3 of Okuda
Regarding claim 2, Okuda discloses a piston according to Claim 1, 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 maximum diameter part of the first annular protrusion and the second annular protrusion 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 annular ribs 38 and 39 are in sliding contact with the inner surface of the barrel 2 when inserted into the barrel), and the maximum diameter part of the second annular protrusion is formed at a position which is shifted from the halfway of the axial length of the second 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).
Regarding claim 4, Okuda discloses a piston according to Claim 2, the tilt angle of the surface from the annular recess toward the maximum diameter part of the second annular protrusion relative to the annular recess (Annotated Fig. 3, distal tilt angle of annular rib 39, which forms an acute angle) is smaller than the tilt angle of the surface from the maximum diameter part toward the bottom surface side relative to the annular recess (Annotated Fig. 3, proximal tilt angle of annular rib 39, which forms a right angle, therefore the distal tilt angle is smaller than the proximal tilt angle).
Regarding claim 5, Okuda discloses a piston according to Claim 2, the 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, which is the maximum diameter region of the annular rib 39 and 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, which is the maximum diameter region of the annular rib 38 and is equivalent to the annular rib's axial length which is particularly 0.8-1.5 mm).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Okuda (US 20160089499), in view of Beedon et al. (US 20050010175), hereinafter Beedon.
Regarding claim 3, Okuda discloses a piston according to Claim 1, 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 maximum diameter part of the first annular protrusion and the second annular protrusion 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 annular ribs 38 and 39 are in sliding contact with the inner surface of the barrel 2 when inserted into the barrel),
Okuda fails to disclose the curvature radius of the second annular protrusion is smaller than the curvature radius of the first annular protrusion. However, Beedon discloses the 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 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
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 SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm 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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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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