DETAILED ACTION
Response to Amendment
Acknowledgements
The amendments filed on 7/13/2026 have obviated the 112 rejections. The 112 rejections are withdrawn.
Election/Restrictions
Newly submitted claim 15 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The apparatus as claimed can be used in a materially different manner.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 15 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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) 1-2 and 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bidensya CO., LTD (WO 2019/231099; hereafter Bidensya) in view of Mandaroux et al. (US 2017/0290987; hereafter Mandaroux) in view of Heim et al. (US 2020/0078528; hereafter Heim).
In regard to claim 1, Bidensya discloses a syringe (see at least Fig. 1) for injection and aspiration (plunger rod is movable in either direction), comprising: a tube (40) arranged to hold a liquid material; a plunger rod (20) having a plunger (50) movably arranged within the tube, and a plunger rod head (21) attached to the plunger rod opposite from the plunger (see Fig. 1), the plunger rod head having a first surface (top of 21) and a second surface (bottom of 21) opposite to the first surface, and a finger grip component (10), comprising a first portion (11) extending away from a longitudinal axis of the syringe and a second portion (12) extending away from the longitudinal axis of the syringe; wherein the finger grip component is a one-piece body attached to the tube (see Figs. 6-7 showing the one-piece nature of 10), comprising an injection finger support (110) surface with a third surface part positioned in the first portion and arched in a direction perpendicular to the longitudinal axis (see Figure 1), wherein the third surface part faces away from the first surface of the plunger rod head, and a pair of aspiration finger support surfaces (interior surface of 12) extending in opposite directions from the longitudinal axis, at least one aspiration finger support surface having a fourth surface part positioned in the second portion and arched in a direction perpendicular to the longitudinal axis with a second curvature (see Figure 1), wherein the fourth surface part faces toward the second surface of the plunger rod head (see Figure 1), wherein the second surface faces the finger grip component (see Figure 1).
Bidensya fails to disclose wherein a first non-slip surface part is provided on at least a part of the first surface and a second non-slip surface part is provided on at least a part of the second surface of the plunger rod head and fails to disclose a third non-slip surface positioned in the first portion, and fails to disclose a fourth non-slip portion in the second portion. Bidensya also fails to expressly disclose wherein the injection finger support surface having a first curvature of a substantially smooth and convex configuration extending from a center of the injection support surface.
In a similar art, Mandaroux discloses a plunger rod head (204) attached to the plunger rod opposite from the plunger (see Fig. 3), the plunger rod head (204) having a first surface (top surface of 204) and a second surface (bottom surface of 204) opposite to the first surface (see Fig. 4), wherein a first non-slip surface part (216) is provided on at least a part of the first surface and a second non-slip surface part (216) is provided on at least a part of the second surface (see par. [0069]-[0070]; 216 is a soft polymer that enhances friction and can extend along both the upper and lower surfaces of 204) and a finger grip component is a one-piece body attached to the tube (see Fig. 2 and par. [0036]), comprising an injection finger support surface (portion under flange extender wings) with a third non-slip surface part (342; see par. [0105]; material 342 provides enhanced friction) positioned in the first portion and arched in a direction perpendicular to the longitudinal axis with a first curvature (note that 342 can extend around the entirety of 108; see par. [0105]-[0107]; the portion under flange extender wings is arched in a direction perpendicular to the longitudinal axis with a first curvature), wherein the third non-slip surface part faces away from the first surface of the plunger rod head (see at least Fig. 3), and an aspiration finger support surface (portion at unnumbered ring portion at bottom area of 108) with a fourth non-slip surface part (342; again notes par. [0105]-[0107]) positioned in the second portion and arched in a direction perpendicular to the longitudinal axis with a second curvature (the ring portion has a slight curve away from the longitudinal axis with a second curvature), wherein the fourth non-slip surface part faces toward the second surface of the plunger rod head (see Figure 3), wherein the second surface faces the finger grip component (see Figure 3). In short, Mandaroux teaches covering the plunger rod head and the finger grip component (see cited portions above) with non-slip surfaces to improve grip.
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 Bidensya with non-slip surface on the plunger rod head and finger grip component as disclosed by Mandaroux in order to provide enhanced gripping surfaces for the areas intended to be handled by the operator.
The combination still fails to disclose or suggest wherein the injection finger support surface having a first curvature of a substantially smooth and convex configuration extending from a center of the injection support surface. The instant disclosure describes the recited convex surface as being merely preferable, and does not describe the recited convex surface as contributing any unexpected results to the system. As such, parameters such as the shape of the flange including the recited convex surface are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the limitation of the recited convex surface would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
In a similar art, Heim discloses gripping wings (4) arranged at the proximal end of a syringe body (2), wherein the wings include an injection finger support surface (41) having a first curvature of a substantially smooth and convex configuration extending from a center of the injection support surface (see Fig. 6 and par. [0073]).
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 combination with the shape taught by Heim because Heim teaches that such a shape is suitable for finger gripping. Since the specification does not attribute any criticality or unexpected results to the recited flange shape, selecting Heim’s known shape would have been nothing more than use of a known design alternative to achieve the expected function of the flange, yielding predictable results.
In regard to claim 2, see par. [0069], [0105]-[0111] of Mandaroux.
In regard to claim 5, these limitations are design considerations which fail to distinguish over the cited art.
In regard to claim 6, Mandaroux teaches wherein the injection finger support extends farther in a direction perpendicular to the longitudinal axis than at least one of the aspiration finger support surfaces (see Fig. 4 of Mandaroux). Furthermore, changing the size is only a design consideration.
In regard to claim 7, Madaroux teaches wherein the third non-slip surface part and the fourth non-slip surface part are connected by an intermediate non-slip surface (see par. [0105]-[0111]- the friction surface can extend along any surface creating intermediate non-slip surfaces).
In regard to claim 8, Mandaroux teaches wherein the third non-slip surface part and the fourth non-slip surface part extend on one or more side surfaces of the finger grip component (the defined surfaces can include the enhanced friction material; see cited sections above).
In regard to claim 9, Bidensya discloses wherein the second surface of the plunger rod head is arched in a direction perpendicular to the longitudinal axis with a third curvature (see Fig. 1).
In regard to claim 10, Mandaroux teaches wherein the first non-slip surface parts and the second non-slip surface parts are connected by an intermediate non-slip surface part (see par. [0105]-[0111]- the friction surface can extend along any surface creating intermediate non-slip surfaces).
In regard to claim 11, Mandaroux teaches wherein the first non-slip surface parts and the second non-slip surface parts extend on one or more side surfaces of the plunger rod head (the defined surfaces can include the enhanced friction material; see cited sections above).
In regard to claim 12, Bidensya discloses wherein the finger grip component (10) comprises an opening (see Figs. 6-7, side opening where syringe is inserted) aligned with the longitudinal axis.
In regard to claim 13, Bidensya teaches wherein the finger grip component has a partial circumferential aperture parallel to the longitudinal axis (see Figs. 6-7, side opening where syringe is inserted).
In regard to claim 14, Mandaroux teaches wherein an aperture of the finger grip component and the intermediate non-slip surface part are on opposite circumferential sides (see at least Fig. 4 and 8).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bidensya and Mandaroux and Heim in view of Barbour (US 2012/220948).
The combination fails to disclose the specific material set forth in claim 3. Barbour teaches at paragraph [0079] that it is known in the art of friction enhancing materials to use the claimed material (thermoplastic elastomers) to manufacture the grip material. In view of the teaching of Barbour, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select thermoplastic elastomer as the specific type of material from which to manufacture the grip material of Mandaroux, because it amounts to selection of a known material based on its known suitability for the purpose.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bidensya and Mandaroux and Heim in view of Dowds (US 2011/0276026).
The combination fails to disclose the specific material set forth in claim 4. Dowds teaches at paragraph [0021] that it is known in the art of syringe parts to use the claimed material (polypropylene) to manufacture the syringe part. In view of the teaching of Dowds, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select polypropylene as the specific type of material from which to manufacture the syringe part of the combination, because it amounts to selection of a known material based on its known suitability for the purpose.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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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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