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 on 12/02/2025 have been fully considered.
Applicant’s arguments, see “Differences w.r.t D1 (Jakob)” on pages 7-11 of Remarks/Arguments, filed on 12/02/2025, with respect to the rejection(s) of claim 1 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art reference that rejects the new amendments made when combined with prior art, Yamane.
With regards to applicant’s argument under “Differences w.r.t D2 (Yamane)” on pages 11-13 of Remarks/Arguments for claim 1, have been fully considered but they are not persuasive. In response to applicants’ argument that “the structural prerequisites of Yamane's mechanism, including the vent hole, vent passage, vent-controlled airflow, and spring arrangement between a flange and the pressing portion, are not present in Jakob and cannot be incorporated without reconstructing Jakob's piston assembly in its entirely”, Jakob does not require the structural prerequisites of Yamane’s mechanism, since that is not necessary when combining only the biasing member of Yamane to couple with the plunger of Jakob.
With regards to applicant’s argument under “Judd, Helliwell and Goisis” and “Legal arguments” on pages 14-15 and 18 of Remarks/Arguments for the claims rejected under the prior art of Judd, Helliwell and Goisis, have been fully considered but they are not persuasive. The arguments are directed to the prior Non-Final rejection, which is no longer operative. The present office action sets forth new grounds of rejection in view of newly applied prior art and addresses claim 1 as amended. Therefore, Applicant’s arguments are not persuasive.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 4-5, 8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hoyle (US Pub No. US 20130090603 A1) in view of Yamane (US Pub No. 20090209823 A1).
Regarding claim 1, Hoyle discloses a syringe comprising:
a barrel (12 – Fig.1) including an orifice (See annotated Fig.1 below) and an internal cavity (16 – Fig.1);
a plunger (14 – Fig.1) including an actuating end (Shown at 14 – Fig.1) and an operating end (Shown at 20 – Fig.1), wherein the plunger is at least partially disposed in the internal cavity of the barrel (Fig.1) and is slidable in a first direction and a second direction opposite to the first direction in the internal cavity (See annotated Fig.1 below), and wherein the operating end of the plunger and the orifice of the barrel defines a chamber (Shown at 16 – Fig.1);
an actuating member (24, 26 – Fig.1) coupled with the plunger (Fig.1), wherein the actuating member, upon application of an actuating force thereon, is to cause a movement of the plunger in the first direction (“the thumb positioned above the plunger flange, for example, and squeezed to urge the plunger downwardly relative to barrel” – Para [0036]); and
characterized in that,
a movement control mechanism (30 – Fig.1) including a pin (34 – Fig.1) and a set of pin-receiving members (28, 32 – Fig.1), wherein the pin is insertable in any of the pin-receiving members, from the set of pin-receiving members (“tooth-engaging projection lockably engages one or more of teeth along track” – Para [0032]), to provide a variable limit for the movement of the plunger within the barrel, in the first direction (“limits or prevents further downward movement of plunger” – Para [0036]), wherein the first direction is a direction towards a needle (See annotated Fig.1 below).
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However, Hoyle does not expressly disclose wherein the syringe comprises a biasing member coupled with the plunger, wherein the biasing member is to bias upon movement of the plunger in the first direction and is to apply a restoring force on the plunger towards the second direction.
Yamane teaches a biasing member (17 – Fig.2) coupled with the plunger (12 – Fig.2), wherein the biasing member is to bias upon movement of the plunger in the first direction (Fig.3) and is to apply a restoring force on the plunger towards the second direction (Fig.4)(“a spring 17 urging the pressed pressing portion 12c in a direction to its original position is provided” – Para [0028]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the actuating member disclosed by Hoyle to comprise a biasing member coupled to the plunger as taught by Yamane since Yamane teaches that the bias member acts as a stopper mechanism for ensuring a reliable and stable stop operation to be provided (Yamane, Para [0028]).
Regarding claim 2, Hoyle, as modified, discloses the syringe as described above, wherein the set of pin-receiving members (28, 32 – Fig.1) are on an outer surface of the barrel (“Disposed along outer surface of barrel” – Para [0031]).
Regarding claim 4, Hoyle, as modified, discloses the syringe as described above, wherein the set of pin-receiving members are aligned along a straight line inclined with respect to a longitudinal axis of the semi-automatically controllable syringe (Fig.1).
Regarding claim 5, Hoyle, as modified, discloses the syringe as described above, wherein the set of pin-receiving members are aligned along a straight line but fails to expressly disclose wherein the set of pin-receiving members are aligned on a zig-zag line.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the alignment line for the set of pin-receiving members since it has been held that mere changes in shape are obvious, MPEP 2144.04 IV B: In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant). In the instant case, the device of Hoyle would not operate differently with the claimed shape of the alignment line for the set of pin-receiving members considering Hoyle discloses a straight-line alignment. Further, applicant places no criticality on the shape claimed, indicating simply “The set of pin-receiving members 120B are aligned on a zig-zag line” (Para [0047]).
Regarding claim 8, Hoyle, as modified, discloses the syringe as described above, further comprising a biasing member being a spring (Yamane, 17 – Fig.1A).
Regarding claim 10, Hoyle, as modified, discloses the syringe as described above, wherein the actuating member is one of a linear actuating member (“the thumb positioned above the plunger flange, for example, and squeezed to urge the plunger downwardly relative to barrel” – Para [0036]).
Regarding claim 11, Hoyle, as modified, discloses the syringe as described above, wherein the actuating member is one of a mechanical actuating member (“the thumb positioned above the plunger flange, for example, and squeezed to urge the plunger downwardly relative to barrel” – Para [0036]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hoyle, in view of Yamane as applied to claim 1 above, and further in view of Hoyle.
Regarding claim 3, Hoyle, as modified, discloses the syringe as described above, comprising a movement control mechanism (30 – Fig.1) but Hoyle does not expressly disclose wherein the movement control mechanism comprises a sleeve mountable on the barrel, and wherein the set of pin-receiving members are on the sleeve.
An alternative embodiment of Hoyle teaches wherein the movement control mechanism comprises a sleeve mountable on the barrel, and wherein the set of pin-receiving members are on the sleeve (215’ – Fig.8, Para [0041]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the movement control mechanism as disclosed by Hoyle to comprise a sleeve mountable on the barrel, and wherein the set of pin-receiving members are on the sleeve as disclosed by the alternative embodiment Hoyle since Hoyle teaches that it may provide the benefit of increased size, compared to the surfaces of inner wall and it may also provide improved visual reference to the position of an adjustable lock member (Para [0037]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hoyle, in view of Yamane as applied to claim 1 above, and further in view of Jakob et al. (US Pub No. 20150119810 A1, herein, Jakob).
Regarding claim 6, Hoyle, as modified, discloses the syringe as described above, comprising a set of pin-receiving members (28, 32 – Fig.1) but Hoyle does not disclose wherein the set of pin-receiving members is a set of holes.
Jakob teaches wherein a set of pin-receiving members (20 – Fig.4) is a set of holes (“The first positive fit means are each configured as orifices or windows” – Para [0053]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the set of pin-receiving members as disclosed by Hoyle to be a set of holes as taught by Jakob since Jakob teaches that using holes is an alternative well-known engagement mechanism for receiving a pin.
Regarding claim 7, Hoyle, as modified, discloses the syringe as described above, comprising a set of pin-receiving members (28, 32 – Fig.1) but Hoyle does not disclose wherein the set of pin-receiving members is a set of cavities.
Jakob teaches wherein a set of pin-receiving members (20 – Fig.4) is a set of cavities (“The first positive fit means are each configured as orifices or windows” – Para [0053]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the set of pin-receiving members as disclosed by Hoyle to be a set of cavities as taught by Jakob since Jakob teaches that using cavities is an alternative well-known engagement mechanism for receiving a pin.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hoyle in view of Yamane as applied to claim 1 above, and further in view of Judd et al. (US Pub No. 20090093759 A1, herein, Judd).
Regarding claim 9, Hoyle, as modified, discloses the syringe as described above, but Hoyle, as modified, does not expressly disclose wherein the biasing member is a pneumatically controlled drive unit.
Judd teaches a biasing member that is a pneumatically controlled drive unit (Para [0098], 3100 – Fig.16-18).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the biasing member disclosed by Hoyle, as modified, to be a pneumatically controlled drive unit as taught by Judd because Judd teaches that pneumatic controlling means facilitates control of the rate of retraction of the plunger (Judd, Para [0098]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Helliwell et al.(US Pub No. 20150112248 A1) in view of Hoyle, as modified and applied to the claims above, and further in view of Goisis (US Pub No. 20180303983).
Regarding claim 12, Helliwell discloses a syringe assembly comprising:
a manually controllable syringe (See Annotated Fig.2 Below) including a barrel (14 – Fig.2), an actuating member (63 – Fig.2), a piston (62 – Fig.2), and an orifice (See Annotated Fig.2 Below);
a coupler (16 – Fig.1) connected to the orifice of the at least one semi-automatically controllable syringes and the orifice of the manually controllable syringe;
a tube (49 – Fig.1) having a first end coupled with the coupler and a second end coupled with a needle (50,51 – Fig.1);
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However, Helliwell does not expressly disclose a syringe assembly comprising at least one semi-automatically controllable syringe as claimed in claim 1 and a pressure sensor coupled with the coupler, wherein the pressure sensor is to measure a value of pressure being applied from at least one of the at least one semi-automatically controllable syringes and the manually controllable syringe.
Hoyle, as modified above, teaches at least one semi-automatically controllable syringe as claimed in claim 1 (Fig.1);
Goisis teaches a pressure sensor coupled with a coupler (“associated with a pressure sensor” – Para [0039]), wherein the pressure sensor is to measure a value of pressure being applied from at least one of at least one semi-automatically controllable syringes and a manually controllable syringe (Para [0039]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the syringe assembly as disclosed by Helliwell to comprise a semi-automatically controllable syringe as claimed in claim 1, as taught by Hoyle since Hoyle teaches a syringe with a lock member that can be locked in a fixed location corresponding to a desired dosage to be set in an extremely precise and individually adjustable manner to limit or prevent administering an overdose of the fluid (Hoyle, Para [0004]) and to comprise a pressure sensor coupled with the coupler as taught by Goisis since it allows a user to reduce the pressure exerted on the plunger of a syringe in case the predetermined pressure threshold is exceeded (Goisis, Para [0039]).
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 Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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/MARISSA TAYLOR/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783