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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/20/2026 has been entered.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 05/08/2026 has/have been considered by the Examiner.
Status of the Claims
Claim 1 is currently amended. Claim 26 is newly added. Claims 7-8 are cancelled. Claims 1-6 and 9-26 are currently pending. Claims 1-6 and 9-26 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/20/2026, with respect to the rejection(s) of claim(s) 1 as amended under 103 have been fully considered and are somewhat persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of additional interpretation of Shue and Capes.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the overlap existing in a plane which extends radially from an axis situated at the center of the plunger/barrel/distal end plate) are not recited in the rejected claim(s). 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).
Examiner acknowledges the explanation of the “central lateral overlaps” provided by the Applicant, but notes that no special definition is present in the specification, and the term “central lateral” itself presents an issue in that it is indefinite, as described in the 112b rejection of claim 1 below.
Examiner further notes, regarding newly added claim 26, that the “axis” is not defined as centrally located with regards to any structure, and thus may be any line perpendicular to the proximal end.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that Shue does not disclose the contacting surfaces which “push against” each other as claimed, or any specific structure meant to withstand rotation. However, Examiner is not relying on Shue for these features. Applicant further argues that Capes, upon which Examiner does rely for the noted features, does not teach any mechanism meant to withstand rotation during assembly. However, as noted in the previous 103 rejection of claim 1, Capes [0036] notes that the arrangement of ribs/protuberances is preferred because it “is strong with respect to rotational movement or rotational forces”.
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.
Claims 1-6 and 9-25 are 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 1, in the second to last line, recites the limitation “a central lateral overlap forming an overlapping and crosswise connection”. It is unclear in the claim with reference to which structure the terms “central” and “lateral” refer (i.e. central with reference to the plunger rod, to the rib, to the contact area, or other structure). Furthermore, the combination of “central” and “lateral” renders the limitation indefinite since it is unclear in the claim how the overlap is both “central” and “lateral” simultaneously (do these terms reference the same structure? Different structures?). The term “lateral” seems to imply “off-center” or “at the side”, which directly contradicts the “central” modifier. Additionally, it is unclear which structures are meant to be “crosswise”, or what arrangement “crosswise” is meant to define in the claim, so any overlap is interpreted as “crosswise” since an overlap involves two structures which “cross” a plane which might otherwise separate them. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 2-6 and 9-25 are rejected for being dependent upon a claim rejected under 112b, since claims inherit the deficiencies of those claims from which they depend.
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.
Claim(s) 1-6, 10-13, 18, 22 and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shue et al (US-20070179442-A1; hereafter Shue) in view of Capes et al (US-20040064105-A1; hereafter Capes).
Regarding claim 1, Shue discloses a plunger rod (plunger 3, fig. 3, [0037]) for use in connection with a barrel (accommodation chamber 11, fig. 3, [0037]) of a syringe (single-use syringe noted in [0034] shown in fig. 3), the plunger rod (plunger 3) comprising:
a distal plunger top (second coupling member 7, fig. 3, [0040]) having a proximal bottom surface (see fig. 3, note that [0040] left and right bendable units 71 extend rearwardly from the second secured end 70 in the axial direction; Examiner notes that the surface from which these bendable units 71 extend is the proximal bottom surface); and
a proximal elongated shaft (plunger 3, noted in [0037] has an elongated shaft as shown in fig. 3) having a proximal end (rear end wall 32, fig. 3, [0037]) adapted to receive an applied force along an axis ([0037] rear end wall 32 allows for manual operation of the syringe; [0041] forward force is applied to rear end wall 32), and a distal end plate (front end wall 31, fig. 3, [0037]) adapted to transmit the applied force along the axis ([0040] plunger 3 is moved through syringe barrel/accommodation chamber 11 toward shoulder 14, see fig. 4 and fig. 5 which show the axial movement);
wherein the plunger rod (plunger 3, noted in [0037] has an elongated shaft as shown in fig. 3) is adapted to be inserted into the barrel of the syringe (accommodation chamber 11, note objection above) extending along the axis (see fig. 4 and 5 which show the elongated shaft of plunger 3 located inserted within syringe barrel 11);
wherein the distal plunger top (second coupling member 7, fig. 3) and the proximal elongated shaft (plunger 3, noted in [0037] has an elongated shaft as shown in fig. 3) are connected to each other by a releasable connection (first secured end 50 and second secured end 70, see fig. 3 for both 50 and 70 and see [0039] and [0040] respectively for description of each secured end), the releasable connection having
distal top rupture means (second secured end 70, fig. 3, [0040]) including at least one distal top rib (left and right bendable units 71, fig. 3) disposed eccentrically from the axis ([0040] left and right bendable units 71 are spaced apart from each other in the radial direction to define an axial clearance 74) on the proximal bottom surface (see fig. 3, note that left and right bendable units 71 extend rearwardly from proximal bottom surface), and
proximal shaft rupture means (first secured end 50, fig. 3, [0039]) including at least one proximal shaft rib (left and right sliding units 51, fig. 3) disposed eccentrically from the axis ([0039] left and right sliding units 51 are spaced apart from each other in a radial direction relative to the axis to confine an axial channel 54 therebetween) on the distal end plate (31, fig. 3);
wherein each of the at least one distal top rib (left and right bendable units 71) is connected to a corresponding at least one proximal shaft rib (left and right sliding units 51) ([0040] left and right bendable units 71 are attached to the left and right sliding units 51, respectively, at bonding regions 53),
the distal top and the proximal shaft ribs (71 and 51) being connected at a contact area (bond regions 53; [0040] left and right bendable units 71 are attached to the left and right sliding units 51 at bonding regions 53); and
wherein the distal top rupture means (70) is for detaching from the proximal shaft rupture means (50) due to compression failure when the distal plunger top (7) is pushed into a distal end (shoulder 14, fig. 3, [0043]) of the barrel ([0041] after injection, the plunger pushes against shoulder 14 and the bonding regions 53 break rendering the plunger unable to be reused; [0055] forward force applied to plunger 3 by user breaks the bonding region 53 when the syringe is pressed against the shoulder 14).
Shue is silent to wherein the releasable connection is configured such that when the plunger rod is rotated the distal top rib will be pushed against the proximal shaft rib at the contact area, or the proximal shaft rib will be pushed against the distal top rib at the contact area.
Capes, in the art of single-use syringes, teaches wherein the releasable connection is configured such that when the plunger rod is rotated the distal top rib (see fig. 10, protruding portions of distal portion 164 form the distal top rib, see [0035]) will be pushed against the proximal shaft rib (axial projection 169, see fig. 10 showing that axial projection 169 of proximal portion 163 forms the proximal shaft rib, see [0035]) at the contact area (breakable connection 168, fig. 9, [0035] proximal portion 163 and a distal portion 164 connected by a breakable connection 168), or the proximal shaft rib (axial projection 169, fig. 9) will be pushed against the distal top rib (portion of 164 shown in fig. 9) at the contact area (168, fig. 9) ([0036] diagonal positioning of the transverse protuberances is preferred because it creates a secure linkage between the proximal portion and the distal portion and it is strong with respect to rotational movement or rotational forces applied to the plunger and weaker with respect to axial forces applied to the plunger so that rotational forces should not break the breakable connection),
wherein the contact area between the distal top rib (protruding portions of distal portion 164, fig. 10) and the corresponding proximal shaft rib (axial projection 169, see fig. 10) includes a central lateral overlap forming an overlapping and crosswise connection (see 112b interpretation above) (see contact area between distal top rib and proximal shaft rib in fig. 10, note that the connection occurs at an overlap between the two ribs which is generally close to the central axis of the plunger, formed parallel to the axis but slightly toward a side of the plunger), configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to withstand rotation during threading of the plunger rod (see [0036]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to rearrange the distal top and proximal shaft ribs to have a diagonal positioning as taught by Capes since both deal with single use syringes. One would have been motivated to make the modification because, as taught by Capes [0036], the diagonal positioning of the transverse protuberances creates a rotationally strong linkage between the distal top rib and the proximal shaft rib, thus ensuring that rotational forces should not break the breakable connection during normal use of the syringe.
Regarding claim 2, Shue modified by Capes discloses the plunger rod according to claim 1, as described above. Shue further discloses wherein the distal top and the proximal shaft ribs (71 and 51, fig. 3) extend along the axis (see fig. 3, axis is established by plunger 3) from the distal end plate (31, fig. 3) and from the proximal bottom surface (see fig. 3, note that left and right bendable units 71 extend rearwardly from proximal bottom surface), respectively.
Regarding claim 3, Shue modified by Capes discloses the plunger rod according to claim 1, as described above. Shue further discloses wherein the plunger rod (plunger 3, fig. 3, [0037]) further comprises a cavity (see fig. 5 and fig. 6, fig. 6 shows that after the completion of injection as described in [0041], proximal shaft ribs 51 slide forward within the plunger rod into a cavity), formed between the proximal shaft ribs (51, fig. 3) of the distal end plate (front end wall 31, fig. 3) and the proximal bottom surface (see fig. 3, note that left and right bendable units 71 extend rearwardly from proximal bottom surface), configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to receive the proximal shaft ribs (51) when the force is transmitted along the axis (axis defined by plunger rod 3 in fig. 3) to the distal plunger top (7, fig. 3) and is causing the distal top ribs (71, fig. 3) and the proximal shaft ribs (51, fig. 3) to be released from each other ([0041] forward force applied to the rear end wall 32 of the plunger 3 shears the bonding regions 53).
Regarding claim 4, Shue modified by Capes discloses the plunger rod according to claim 1, as described above. Shue further discloses wherein the distal top ribs (71, fig. 3) are radially displaced (see fig. 3 which shows that the distal top ribs 71 and the proximal shaft ribs 51 are located at different radial positions) relative to the proximal shaft ribs (51, fig. 3).
Regarding claim 5, Shue modified by Capes discloses the plunger rod according to claim 1, as described above. Shue further discloses wherein when the distal top rib (71, fig. 3) and the proximal shaft rib (51, fig. 3) are disconnected from each other.
Shue is silent to distal rib fracture surfaces, although Examiner notes that the fracture surface could be implicitly present where the bonding region 53 breaks.
Capes teaches wherein when the distal top rib and the proximal shaft rib the distal top rib and the distal top rib are disconnected from each other, the distal top rib (see fig. 4, protruding portions of distal portion 64 form the distal top rib) has a distal rib fracture surface (see fig. 4, nubs shown on distal portion 64) and the proximal shaft rib (see fig. 4, protruding portion of proximal portion 63 forms the proximal shaft rib) has a proximal shaft rib fracture surface (see remainder of transvers protuberances 70 shown on proximal portion 63) pointing centrally and laterally, respectively, relative to the axis (see fig. 4).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Shue to have the fracture surface as taught by Capes since both deal with single use syringes. One would have been motivated to make the modification because the fracture surface on the proximal shaft ribs would help indicate to a user that the syringe has been broken after use, thus providing an additional signal that device reuse should not be attempted.
Regarding claim 6, Shue modified by Capes discloses the plunger rod according to claim 1, as described above. Shue further discloses wherein the distal top ribs (71, fig. 3) and the proximal shaft ribs (51, fig. 3) are aligned linearly along a diameter of the proximal bottom surface (see fig. 3, note that left and right bendable units 71 extend rearwardly from proximal bottom surface) and the distal end plate (31, fig. 3) (see fig. 3 and 4 which shows the ribs 71 and 51 arranged along a diameter of the proximal bottom surface and the distal end plate 31, respectively).
Regarding claim 10, Shue modified by Capes discloses the plunger rod according to claim 1, as described above. Shue further discloses wherein the distal top ribs (71, fig. 3) and the proximal shaft ribs (51, fig. 3) are in the shape of substantially a pyramid, a cube, a cuboid, a prism, a cone, a tetrahedron, a cylinder or any other geometrical three dimensional shape enabling the connection between the distal top ribs (71) and the proximal shaft ribs (51) (see fig. 3 and 4 which show that the left and right sliding units 51 [0039] and the left and right bendable units 71 [0040] are connected through bonding regions 53 as noted in [0040]).
Regarding claim 11, Shue modified by Capes discloses the plunger rod according to claim 1, as described above, and further discloses wherein the distal top rib (71, fig. 3) and the proximal shaft rib (51, fig. 3) comprise at least one distal rib protrusion and a proximal rib protrusion, respectively (see magnified fig. 4 below which shows a magnified portion of the ribs 51 and 71, with proximal rib protrusions shown on the distal end of the proximal shaft ribs 51).
Shue modified by Capes discloses the claimed invention except for the distal top ribs 71 also including a distal rib protrusion. It would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the proximal rib protrusions such that mirrored protrusions on the distal ribs formed the other portion of the connection between the distal top ribs 71 and the proximal shaft ribs 51, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP 2144.04 (VI-B).
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Regarding claim 12, Shue modified by Capes discloses the plunger rod according to claim 11, as described above. Shue further discloses wherein each distal rip protrusion (see magnified fig. 4 above) faces and is arranged opposite to a corresponding proximal rib protrusion (see magnified fig. 4 above); and
wherein the distal rib and the proximal rib protrusions (see fig. 3 which indicates that the bonding regions are located at the location of the proximal rib protrusions; [0040] left and right bendable units 71 are attached to the left and right sliding units 51 at bonding regions 53) form the connection between the distal top ribs (71, fig. 3) and the proximal shaft ribs (51, fig. 3).
Regarding claim 13, Shue modified by Capes teaches the plunger rod according to claim 12, as described above. Shue further discloses wherein the connection formed between each distal rib protrusion (see magnified fig. 4 above) and each corresponding proximal rib protrusion (see 103 duplication of parts rejection of claim 11 above) have a longitudinal cross-section along the axis with an hour-glass shape (Examiner notes that the protrusion shown in fig. 4 could be half of an hour-glass, thus the duplication of parts applied to claim 11 would arrive at the claimed limitation of having an hour-glass shape since the protrusions are the location of the bonding region 53 as noted in fig. 3).
Additionally, in the alternative, Shue modified by Capes as applied to claim 12 above discloses the claimed invention except for the protrusions having a longitudinal cross-section along the axis with an hour-glass shape. This limitation represents only a change in size/proportion (MPEP 2144.04(IV)(A)). Altering the shape of the protrusions would not adversely affect the device of Shue modified by Capes, since the frangible bonding region 53 could still separate when pushed into the shoulder 14. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Regarding claim 18, Shue modified by Capes discloses the plunger rod according to claim 11, as described above. Shue further discloses wherein the distal rib and the proximal rib protrusions (see 103 duplication of parts rejection of claim 11 above) are in the shape of substantially a pyramid, a cube, a cuboid, a prism, a cone, a tetrahedron, a cylinder or any other geometrical three dimensional shape enabling the connection between the distal rib protrusions and the proximal rib protrusions (see magnified fig. 4 above and fig. 3 which shows a three dimensional protrusion at bonding region 53 through which the connection is made as noted in [0040]).
Regarding claim 22, Shue discloses a syringe (single-use syringe shown in fig. 3-4, noted in [0034]) comprising:
a barrel (accommodation chamber 11, fig. 4, [0035]) having a syringe tip (passage 12, fig. 4, [0035]) arranged at a distal end (see fig. 4, passage 12 is located at the distal end of barrel 11) of the barrel, the barrel (11) being adapted to contain a drug (Examiner notes that the barrel would be able to contain a drug.), the barrel (11) having a tubular wall (large-diameter wall portion 133, fig. 3, [0035]) extending proximally from the distal end (see fig. 3), whereby the barrel (11) extends along an axis (see fig. 3);
wherein the barrel (11) includes an aperture (rear barrel end 132, fig. 3, [0035]) arranged at a proximal end of the barrel (see fig. 3) and;
wherein the syringe further comprises a plunger rod according to claim 1 (see above 103 rejection of claim 1 over Shue in view of Capes) extending along the axis (axis defined by the plunger 3, as shown in fig. 3).
Regarding claim 25, Shue modified by Capes discloses the syringe according to claim 22, as described above. Shue further discloses wherein the syringe tip (needle assembly 2, fig. 3, [0034]) comprises a needle (needle cannula 21, fig. 3, [0036]).
Regarding claim 26, Shue discloses a plunger rod (plunger 3, fig. 3, [0037]) for use in connection with a barrel (accommodation chamber 11, fig. 3, [0037]) of a syringe (single-use syringe noted in [0034] shown in fig. 3), the plunger rod (plunger 3) comprising:
a distal plunger top (second coupling member 7, fig. 3, [0040]) having a proximal bottom surface (see fig. 3, note that [0040] left and right bendable units 71 extend rearwardly from the second secured end 70 in the axial direction; Examiner notes that the surface from which these bendable units 71 extend is the proximal bottom surface); and
a proximal elongated shaft (plunger 3, noted in [0037] has an elongated shaft as shown in fig. 3) having a proximal end (rear end wall 32, fig. 3, [0037]) adapted to receive an applied force along an axis ([0037] rear end wall 32 allows for manual operation of the syringe; [0041] forward force is applied to rear end wall 32; Examiner notes that any line perpendicular to the rear end wall 32 may define “an axis”), and a distal end plate (front end wall 31, fig. 3, [0037]) adapted to transmit the applied force along the axis ([0040] plunger 3 is moved through syringe barrel/accommodation chamber 11 toward shoulder 14, see fig. 4 and fig. 5 which show the axial movement);
wherein the plunger rod (plunger 3, noted in [0037] has an elongated shaft as shown in fig. 3) is adapted to be inserted into the barrel of the syringe (accommodation chamber 11) extending along the axis (see fig. 4 and 5 which show the elongated shaft of plunger 3 located inserted within syringe barrel 11);
wherein the distal plunger top (second coupling member 7, fig. 3) and the proximal elongated shaft (plunger 3, noted in [0037] has an elongated shaft as shown in fig. 3) are connected to each other by a releasable connection (first secured end 50 and second secured end 70, see fig. 3 for both 50 and 70 and see [0039] and [0040] respectively for description of each secured end), the releasable connection having
a distal top rib (left and right bendable units 71, fig. 3) disposed eccentrically from the axis ([0040] left and right bendable units 71 are spaced apart from each other in the radial direction to define an axial clearance 74) on the proximal bottom surface (see fig. 3, note that left and right bendable units 71 extend rearwardly from proximal bottom surface), and
a proximal shaft rib (left and right sliding units 51, fig. 3) disposed eccentrically from the axis ([0039] left and right sliding units 51 are spaced apart from each other in a radial direction relative to the axis to confine an axial channel 54 therebetween) on the distal end plate (31, fig. 3);
wherein the distal top rib is connected to the proximal shaft rib (71 and 51) at a contact area (bond regions 53; [0040] left and right bendable units 71 are attached to the left and right sliding units 51 at bonding regions 53);
wherein the distal top rib is (71) detachable from the corresponding proximal shaft rib due to compression failure when the distal plunger top (7) is pushed into a distal end (shoulder 14, fig. 3, [0043]) of the barrel ([0041] after injection, the plunger pushes against shoulder 14 and the bonding regions 53 break rendering the plunger unable to be reused; [0055] forward force applied to plunger 3 by user breaks the bonding region 53 when the syringe is pressed against the shoulder 14);
wherein the contact area (bond regions 53) is located in a bonding plane that extends along and through the axis (note interpretation of “axis” above, the point which defines the axis may exist in a plane formed by the bond region 53, which is spaced apart from each rib since it exists between the ribs).
Shue is silent to wherein the releasable connection is configured such that when the plunger rod is rotated the distal top rib will be pushed against the proximal shaft rib at the contact area, or the proximal shaft rib will be pushed against the distal top rib at the contact area.
Capes, in the art of single-use syringes, teaches wherein the releasable connection is configured such that when the plunger rod is rotated the distal top rib (see fig. 10, protruding portions of distal portion 164 form the distal top rib, see [0035]) will be pushed against the proximal shaft rib (axial projection 169, see fig. 10 showing that axial projection 169 of proximal portion 163 forms the proximal shaft rib, see [0035]) at the contact area (breakable connection 168, fig. 9, [0035] proximal portion 163 and a distal portion 164 connected by a breakable connection 168), or the proximal shaft rib (axial projection 169, fig. 9) will be pushed against the distal top rib (portion of 164 shown in fig. 9) at the contact area (168, fig. 9) ([0036] diagonal positioning of the transverse protuberances is preferred because it creates a secure linkage between the proximal portion and the distal portion and it is strong with respect to rotational movement or rotational forces applied to the plunger and weaker with respect to axial forces applied to the plunger so that rotational forces should not break the breakable connection).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to rearrange the distal top and proximal shaft ribs to have a diagonal positioning as taught by Capes since both deal with single use syringes. One would have been motivated to make the modification because, as taught by Capes [0036], the diagonal positioning of the transverse protuberances creates a rotationally strong linkage between the distal top rib and the proximal shaft rib, thus ensuring that rotational forces should not break the breakable connection during normal use of the syringe.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shue modified by Capes or alternatively Shue modified by Capes and further in view of Hsu (US-6773416-B1; hereafter Hsu).
Regarding claim 9, Shue modified by Capes discloses the plunger rod according to claim 1, as described above. Shue further discloses wherein the distal top (71, fig. 3) and the proximal shaft ribs (51, fig. 3) are arranged such that a side edge of the distal top rib (see fig. 3), perpendicular to a side of the distal top rib facing away from the axis (note rearrangement of parts rationale below), is connected to a side edge of a proximal shaft rib (see fig. 3), perpendicular to a side of the proximal shaft rib facing away from the axis (note rearrangement of parts rationale below).
Shue modified by Capes teaches all elements of the claim except for the connected side edges being perpendicular to side edges which face away from the axis. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the connected edges to be perpendicular to the side edges facing away from the axis since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function providing a connection which would fail under too much forward pushing after completion of injection.
Alternatively, regarding claim 9, Shue modified by Capes discloses the plunger rod according to claim 1.
Shue modified by Capes is silent to the arrangement of the side edges.
Hsu, directed to a safety syringe, teaches wherein the distal top (locating blocks 42a, 42b, 42c, and 42d; fig. 5, col. 3 ln. 15-30) and the proximal shaft ribs (front wings 41a, 41b, 41c, and 41d; fig. 5, col. 3 ln. 15-30) are arranged such that a side edge of the distal top rib (protruded engagement portion 422a, fig. 5), perpendicular to a side of the distal top rib facing away from the axis (see fig. 5), is connected to a side edge of a proximal shaft rib (retaining block 412a, fig. 5), perpendicular to a side of the proximal shaft rib facing away from the axis (see fig. 5) (col. 3 ln. 15-30 protruded engagement portions engage the retaining blocks).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Shue modified by Capes with the teachings of Hsu since all deal with syringes that detach from their stopper portions. One would have been motivated to make the modification because the engagement of the protruded engagement portions and the retaining blocks, since it includes contact areas which are arranged off center, allows for greater stability of the plunger rod during insertion. Capes further supports explicitly modifying the ribs in this way because, as noted by Capes [0036], it is preferable to have a strong rotational linkage ensuring that rotational forces do not prematurely fracture the breakable connection.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shue modified by Capes and further in view of Hawasheen (US-20140316336-A1; hereafter Hawasheen).
Regarding claim 14, Shue modified by Capes discloses the plunger rod according to claim 1, as described above. Shue further discloses wherein the distal plunger top (7, fig. 3) comprises a sealing member (deformable sealing member 4, fig. 3, [0038]); and
wherein the sealing member (4) is adapted to be in fluid-tight engagement with a tubular wall (133, fig. 3, [0038] deformable sealing member 4 is in a fluid-tight and slidable engagement with the large-diameter wall portion 133) of the barrel (11), the sealing member being displaceable along the axis ([0038] engagement is slidable) within the barrel (fig. 4 and 5 show slidable movement along the axis).
Shue modified by Capes is silent to the sealing member being a washer.
Hawasheen, in the field of safety syringes, teaches a sealing member which is a washer (O-ring 68, fig. 2, [0023] An O-ring 68 on the piston 31 forms a fluid seal against the inner surface of the barrel wall 23).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the sealing member of Shue modified by Capes to be an O-ring as taught by Hawasheen because all deal with sealing syringes. One would have been motivated to make the modification because O-rings are commonly used in fluid seals and thus may be more easily sourced/produced than a more custom seal.
Regarding claim 15, Shue modified by Capes and Hawasheen discloses the plunger rod according to claim 14, as described above, including wherein the washer is an O-ring seal (Hawasheen: O-ring 68, fig. 2, [0023] An O-ring 68 on the piston 31 forms a fluid seal against the inner surface of the barrel wall 23).
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shue modified by Capes and further in view of Chao (US-20040230159-A1; hereafter Chao).
Regarding claim 16, Shue modified by Capes discloses the plunger rod according to claim 1, as described above.
Shue modified by Capes is silent to an end protrusion.
Chao, in the art of single-use syringes, teaches wherein the distal plunger top (rod head 71, fig. 7, [0031]) further comprises an end protrusion (buckling head 75, fig. 7, [0031]) distally arranged on the distal plunger top (see fig. 7) and including a retaining portion (buckling lip 77, fig. 7, [0031]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to engage an internal retaining recess (recess formed by buckling lip 68, see fig. 7, [0031]) of the syringe (syringe 50 and seat 60, fig. 7, [0029]) ([0031] inner wall of the unidirectional buckling chamber 65 has a second unidirectional buckling lip 68).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the plunger rod of Shue modified by Capes to have an end protrusion as taught by Chao since all deal with safety/prevention features for syringes. One would have been motivated to make the modification because the inclusion of the buckling head helps to reduce the residue of the liquid to match the international standard, as noted in Chao [0032].
Regarding claim 17, Shue modified by Capes and Chao discloses the plunger rod according to claim 16, as described above.
Chao further teaches wherein the distal plunger top (rod head 71, fig. 7, [0031]) comprises an elevated socket (axial strip 79, fig. 7, [0032]) having a distal end surface (see annotated fig. 7 below) arranged at a proximal end of the end protrusion (75, fig. 7), such that the distal end surface (see annotated fig. 7 below) is brought into direct contact with a distal end (buckling chamber 65 of the seat 60, fig. 7, [0031]) of the barrel (seat 60 and inner wall of the syringe 50 noted in [0027] and shown in fig. 7 and 8) when the distal plunger top (rod head 71, fig. 7) is pushed in the distal end ([0029] the buckling head 75 at the front end of the rod head 71 can be pressed into the unidirectional buckling chamber 65 at a rear end of the seat 60, see fig. 8).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the plunger rod of Shue modified by Capes and Chao to further have the direct contact as taught by Chao since both deal with safety/prevention features for syringes. One would have been motivated to make the modification because the inclusion of the buckling head 75 and axial strip 79 contacting the seat 60 as shown in fig. 8 helps to reduce the residue of the liquid to match the international standard, as noted in Chao [0032].
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shue modified by Capes and further in view of Greenwood et al (US-4923443-A; hereafter Greenwood).
Regarding claim 19, Shue modified by Capes discloses the plunger rod according to claim 1, as described above, including the contact area (Shue: bonding regions 53, fig. 3, [0040]).
Shue modified by Capes is silent to the contact area comprising a weakening.
Greenwood, directed to a single use syringe, teaches wherein the contact area (col. 5 ln. 3-11 force applied to beam members 50 and 51 close to fulcrums 52 and 53; col. 7 ln. 58-61 fig. 5 is generally identical to the embodiment in fig. 1 which has beam members 50 and 51) comprises a weakening (col. 7 ln. 52-58 angled surfaces 75 and 76 are defined by beam members 70 and 71 at fulcrums 72 and 73) arranged on a distally facing side of the contact area (see fig. 5 which shows the weakening, formed by the angled surfaces, on the proximally facing side).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the plunger rod of Shue modified by Capes with the teachings of Greenwood because all deal with single use syringes. One would have been motivated to make the modification because the weakening taught by Greenwood would facilitate a more predictable failure point for the connection, reducing the possibility of failure in an unexpected part of the device prior to failure at the weak point designed to fail.
Shue modified by Capes and Greenwood teaches all elements of the claim except for the weakening arranged on a distally facing side of the contact area. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the weakening on the distally facing side since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of providing a more predictable failure point.
Regarding claim 20, Shue modified by Capes discloses the plunger rod according to claim 1, as described above, including the contact area (Shue: bonding regions 53, fig. 3, [0040]).
Shue modified by Capes is silent to the contact area comprising a reinforcement.
Greenwood teaches wherein the contact area (col. 5 ln. 3-11 force applied to beam members 50 and 51 close to fulcrums 52 and 53) comprises a reinforcement (end flange 36, fig. 2 and 4) arranged on a proximally facing side of the contact area (see fig. 4).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the plunger rod of Shue modified by Capes with the teachings of Greenwood because all deal with single use syringes. One would have been motivated to make the modification because the reinforcement taught by Greenwood would facilitate a more predictable failure point for the connection, since it supports one side of the contact area during fracture, thus reducing the possibility of failure in an unexpected part of the device prior to failure at the weak point designed to fail.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shue modified by Capes in view of Schottli (US-20010041867-A1; hereafter Schottli).
Regarding claim 21, Shue modified by Capes discloses the plunger rod according to claim 1, as described above, including wherein the proximal bottom surface (Shue: see fig. 3, note that left and right bendable units 71 extend rearwardly from proximal bottom surface) has a diameter smaller than a diameter formed on an inner wall of the barrel (Shue: see fig. 4), and this diameter is smaller than the stopper (Shue: deformable sealing member 4, [0038], see fig. 4).
Shue modified by Capes is silent to a circumferential flange formed on the inner wall of the barrel.
Schottli, in the art of single-use syringes, teaches wherein a proximal bottom surface (plunger 11a, [0060], fig. 4 and 5) has a diameter smaller than a diameter (see fig. 4 and fig. 5, as well as fig. 6 and 7 which show similar embodiments with a clear difference in diameter of plunger 11a/11c and sealing element 19) of a circumferential flange (internal constriction 33, fig. 4 and fig. 5, [0059]) formed on an inner wall of the barrel ([0059] barrel 3A is provided with at least one internal constriction 33, see fig. 4 and 5).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to add the circumferential flange as taught by Schottli to the barrel of Shue modified by Capes because all deal with single-use syringes. One would have been motivated to make the modification because as noted in Schottli [0059], the addition of the constriction 33 further ensures that the spokes break at the appropriate position in the barrel.
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shue modified by Capes in view of Caizza et al (US-20130110044-A1; hereafter Caizza
Regarding claim 23, Shue modified by Capes discloses the syringe according to claim 22, as described above.
Shue modified by Capes is silent to the syringe specifically containing a drug.
Caizza, in the art syringes with frangible connections between a plunger rod and a stopper, teaches wherein the syringe (syringe assembly 100, fig. 2, [0075] syringe assembly includes a barrel 120) contains the drug ([0076] barrel 120 shown in fig. 3 defines a chamber 128 which may include fluid medication).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the barrel of Shue modified by Capes to contain a drug as taught by Caizza since all deal with single-use syringes. One would have been motivated to make the modification because as noted in Caizza [0003] reuse of hypodermic syringe products without sterilization or sufficient sterilization is believed to perpetuate drug abuse and facilitate the transfer of contagious diseases. Thus, using the single-use syringe of Shue with a drug would help prevent drug abuse.
Regarding claim 24, Shue modified by Capes discloses the syringe according to claim 22, as described above.
Shue modified by Capes is silent to the material of the barrel.
Caizza in the art syringes with frangible connections between a plunger rod and a stopper, teaches wherein the barrel (barrel 120, fig. 3, [0076]) is made of plastic or glass ([00080] barrel may be made of plastic or glass).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to have the barrel of Shue modified by Capes be plastic or glass as taught by Caizza since all deal with single-use syringes. One would have been motivated to make the modification because plastic and glass would effectively contain the liquid medicament and help maintain sterility of the drug.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lloyd et al (US 20080082055 A1) - fig. 19 shows two abutments occurring along a plane which radially extends through a central axis
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 06/12/2026
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