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 .
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 1-4 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.
As to Claim 1, the limitation “the large diameter part being in close contact with an entire area of an inner peripheral surface of the barrel in a circumferential direction when the syringe gasket is inserted into the barrel”, in Lines 4-7, is indefinite.
The preamble describes the claimed invention of just a syringe gasket, which is described as Element 3 in the instant application. Instant application Figure 2 shows gasket 3 as being separate from the inner peripheral surface 210 of barrel 21. As such, the scope of the claim is not clear, since the claim positively claims structure outside of the structure defined in the preamble, rendering the claim indefinite. Applicant may overcome this portion of the rejection by amending the first part of the limitation to state “the large diameter part is configured to be in close contact with…”.
Additionally, the bounds of the phrase “an entire area of an inner peripheral surface of the barrel in a circumferential direction” is not clear. One of ordinary skill in the art would interpret the phrase where the entirety of the inner peripheral surface of the barrel constitutes the claimed “entire area”. However, instant application Figure 7 shows the large diameter part 41 as only being in contact with a portion of the inner peripheral surface 210, not the entire inner peripheral surface. As such, there is a difference between what is claimed, and what is shown in the instant application figures. For the purpose of examination, the limitation will be interpreted where the large diameter part is in close contact with a portion of the inner peripheral surface.
The limitation “the recess having a bottom that is recessed to reach a boundary position between the large diameter part and the small diameter part in the axial direction or a certain position on the side of the second member relative to the boundary position”, in Lines 16-18, is indefinite. The limitation is written in a manner in which one of ordinary skill would conclude the bottom of the recess is also recessed from the recess. However, instant application Figure 3 just shows the bottom 4221 of the recess 422 as a boundary of recess 422. As such, it is not clear how the bottom is further recessed, rendering the limitation indefinite.
It is not clear how the recess can be located on the side of the second member, since the recess is part of the first member; or what structure is relative to the boundary position.
For the purpose of examination, the limitation will be interpreted as the recess having a bottom, the bottom is located between the large diameter part and the small diameter part in the axial direction, or the bottom is located adjacent to the side of the second member.
The limitation “a screw hole extending from an end surface of the second member on an opposite side to the first member toward the first member to reach an inside of the projection in the axial direction to allow a screw part provided at the distal end of the plunger rod to be screwed thereinto”, in Lines 19-24, is indefinite.
Lines 14-15 define an end surface on a side of the second member. As such, it is not clear if the end surface of the second member in Lines 14-15 is the same structure as the end surface of the second member in Lines 21-22, or if the respective structures are different. For the purpose of examination, the two respective structures will be interpreted as different structures.
It is not clear what structure is being referred to by the term “thereinto”. Based off of the limitation, either the inside of the projection or the screw hole may be the structure being referred to. For the purpose of examination, the limitation will be interpreted as “…to allow a screw part provided at the distal end of the plunger rod to be screwed into the screw hole”.
As to Claim 2, the limitation “the small diameter part has an annular projection that projects radially outward with a distance from the large diameter part in the axial direction, while extending through the entire area in the circumferential direction”, in Lines 2-4, is indefinite.
It is not clear what is meant by the phrase “with a distance from the large diameter part in the axial direction”, since the phrase is grammatically confusing. For the purpose of examination, the phrase will be interpreted as the annular projection is axially spaced from the large diameter portion.
The bounds of the phrase “the entire area in the circumferential direction” is not clear. One of ordinary skill in the art would interpret the phrase where the entirety of the inner peripheral surface of the barrel constitutes the claimed “entire area”. However, instant application Figure 7 shows the annular projection 423 as only being in contact with a portion of the inner peripheral surface 210, not the entire inner peripheral surface. As such, there is a difference between what is claimed, and what is shown in the instant application figures. Additionally, the entire area claimed in Claim 2 cannot be the entire area claimed in Claim 1, since the annular projection of Claim 2 and the large diameter part are separated by a distance from each other. Therefore, the respective circumferential areas are also separate from each other. For the purpose of examination, the limitation will be interpreted where the annular portion extends around a second portion of the inner peripheral surface in the circumferential direction.
The limitation “the annular projection is in close contact with an entire area of the inner peripheral surface of the barrel in the circumferential direction when the syringe gasket is inserted into the barrel”, in Lines 5-7, is indefinite.
The preamble describes the claimed invention of just a syringe gasket, which is described as Element 3 in the instant application. Instant application Figure 2 shows gasket 3 as being separate from the inner peripheral surface 210 of barrel 21. As such, the scope of the claim is not clear, since the claim positively claims structure outside of the structure defined in the preamble, rendering the claim indefinite. Applicant may overcome this portion of the rejection by amending the first part of the limitation to state “the annular projection is configured to be in close contact with…”.
It is not clear if the phrase “an entire area of the inner peripheral surface of the barrel in the circumferential direction” is the same structure as defined in Claim 2, Lines 3-4, and in Claim 1, Lines 5-6, or if the respective structures are different structures. For the purpose of examination, the structure in Lines 5-6, will be interpreted as the same structure as in Claim 2, Lines 3-4. However, the structure in Lines 5-6 has the same indefinite issues as discussed for the structure in Lines 3-4 above.
As to Claim 3, the term “a cylindrical barrel”, in Line 2, is indefinite. Claim 3 incorporates all of the claimed structure of Claim 1 into Claim 3. As such, it is not clear if the cylindrical barrel of Claim 3 is the same cylindrical barrel of Claim 1, or if the respective barrels are different barrels. For the purpose of examination, the respective barrels will be interpreted as the same barrels.
The term “a plunger rod”, in Line 4, is indefinite. Claim 3 incorporates all of the claimed structure of Claim 1 into Claim 3. As such, it is not clear if the plunger rod of Claim 3 is the same plunger rod of Claim 1, or if the plunger rods are different barrels. For the purpose of examination, the respective plunger rods will be interpreted as the same plunger rods.
The term “a screw part”, in Line 4, is indefinite. Claim 3 incorporates all of the claimed structure of Claim 1 into Claim 3. As such, it is not clear if the screw part of Claim 3 is the same screw part of Claim 1, or if the screw parts are different screw parts. For the purpose of examination, the respective screw parts will be interpreted as the same screw parts.
The term “a distal end”, in Line 5, is indefinite. Claim 3 incorporates all of the claimed structure of Claim 1 into Claim 3. As such, it is not clear if the distal end of Claim 3 is the same distal end of Claim 1, or if the distal ends are different distal ends. For the purpose of examination, the respective distal ends will be interpreted as the same distal ends.
As to Claim 4, the term “a cylindrical barrel”, in Line 2, is indefinite. Claim 3 incorporates all of the claimed structure of Claims 1 & 2 into Claim 3. As such, it is not clear if the cylindrical barrel of Claim 3 is the same cylindrical barrel of Claims 1 & 2, or if the respective barrels are different barrels. For the purpose of examination, the respective barrels will be interpreted as the same barrels.
The term “a plunger rod”, in Line 4, is indefinite. Claim 3 incorporates all of the claimed structure of Claims 1 & 2 into Claim 3. As such, it is not clear if the plunger rod of Claim 3 is the same plunger rod of Claims 1 & 2, or if the plunger rods are different barrels. For the purpose of examination, the respective plunger rods will be interpreted as the same plunger rods.
The term “a screw part”, in Line 4, is indefinite. Claim 3 incorporates all of the claimed structure of Claims 1 & 2 into Claim 3. As such, it is not clear if the screw part of Claim 3 is the same screw part of Claims 1 & 2, or if the screw parts are different screw parts. For the purpose of examination, the respective screw parts will be interpreted as the same screw parts.
The term “a distal end”, in Line 5, is indefinite. Claim 3 incorporates all of the claimed structure of Claims 1 & 2 into Claim 3. As such, it is not clear if the distal end of Claim 3 is the same distal end of Claims 1 & 2, or if the distal ends are different distal ends. For the purpose of examination, the respective distal ends will be interpreted as the same distal ends.
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Fournier (U.S. PGPub 2017/0368264), in view of Schabbach (U.S. PGPub 2020/0114088).
As to Claim 1, Fournier teaches a syringe gasket (510) configured to be connected to a distal end (the leading end of the piston rod, described in Paragraph 0003) of a plunger rod (the piston rod described in Paragraph 0002), while being disposed in (Paragraph 0055) a cylindrical (Paragraph 0050 describes the gasket as cylindrical, and Paragraph 0054 describes a cylindrical sealing zone between the barrel and the gasket; as such one of ordinary skill in the art would conclude the syringe body must be cylindrical) barrel (the syringe body described in Paragraph 0055), the syringe gasket (510) comprising:
a first member (513) having a large diameter part (630) and a small diameter part (the portion of 513 below 630, as viewed in Figure 2), the large diameter part (630) being in close contact with an entire area (the cylindrical sealing zone of the syringe body cylindrical wall and the large diameter part 630 discussed in Paragraph 0054) of an inner peripheral surface (the syringe body cylindrical wall discussed in Paragraph 0054) of the barrel (the syringe body described in Paragraph 0055) in a circumferential direction (one of ordinary skill in the art would conclude a cylindrical zone is inherently circumferential) when the syringe gasket (510) is inserted into (as described in Paragraph 0055) the barrel (the syringe body described in Paragraph 0055), the small diameter part (the portion of 513 below 630, as viewed in Figure 2) being located adjacent to (as shown in Figure 2) the large diameter part (630) and having a smaller diameter (see Figure 2 below) than the large diameter part (630);
a second member (511) configured to be connected to (as shown in Figure 2) the first member (513) from a side (the bottom side, as viewed in Figure 2) of the small diameter part (the portion of 513 below 630, as viewed in Figure 2) in an axial direction (up and down, as viewed in Figure 2) that is a direction (up and down, as viewed in Figure 2) in which the large diameter part (630) and the small diameter part (the portion of 513 below 630, as viewed in Figure 2) are aligned with each other (as shown in Figure 2)…
the first member (513) and the second member (511) having elasticity (one of the elastic material described in Paragraph 0060),
the first member (513) having a recess (see Figure 2 below) that is recessed from (as shown in Figure 2) an end surface (see Figure 2 below) on a side (the top side of 511, as viewed in Figure 2) of the second member (511) toward (as shown in Figure 2) the large diameter part (630) in the axial direction (up and down, as viewed in Figure 2),
the recess (see Figure 2 below) having a bottom (see Figure 2 below), the bottom (see Figure 2 below) is located (as shown in Figure 2) between (as shown in Figure 2) the large diameter part (630) and the small diameter part (the portion of 513 below 630, as viewed in Figure 2) in the axial direction (up and down, as viewed in Figure 2), or the bottom (see Figure 2 below) is located adjacent to (as shown in Figure 2) the side (the top side of 511, as viewed in Figure 2) of the second member (511).
the second member (511) having a projection (see Figure 2 below) that projects toward (as shown in Figure 2) the first member (513) and is configured to fit into (as shown in Figure 2) the recess (see Figure 2 below)…and having a screw (via threads 615) hole (515) extending from (as shown in Figure 2) an end surface (see Figure 2 below) of the second member (511) on an opposite side to (as shown in Figure 2) the first member (513) toward (as shown in Figure 2) the first member (513) to reach (as shown in Figure 2) an inside (the volume of the projection shown in Figure 2 below) of the projection (see Figure 2 below) in the axial direction (up and down, as viewed in Figure 2) to allow a screw part (the corresponding thread of the leading end of the piston rod, described in Paragraph 0003) provided at the distal end (the leading end of the piston rod, described in Paragraph 0003) of the plunger rod (the piston rod described in Paragraph 0002) to be screwed thereinto (as described in Paragraph 0003).
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Fournier Figure 2, Modified by Examiner
Fournier does not teach an element disposed between the first member and the second member…the element disposed between the recess and the projection.
Schabbach describes a similar two part gasket (1300) in (as shown in Figures 13A/13B) a syringe (1308), and teaches an element (1307) disposed between (as shown in Figures 13A/13B) the first member (1302) and the second member (1318).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the sensor, as taught by Schabbach, in the second member, as taught by Fournier, to be responsive to the position of the gasket in the barrel (Paragraph 0013).
Modifying Schabbach into Fournier results in the element (Schabbach 1307) disposed between the recess (see Fournier Figure 2 above) and the projection (see Fournier Figure 2 above). Since Schabbach Figures 13A/13B show Schabbach element 1307 within a recess at the bottom of second member 1318, one of ordinary skill in the art would be motivated to place the Schabbach element at the top –Schabbach Figures 13A/13B are rotated 180 degrees with respect to Fournier Figure 2-- of Fournier second member 511, which would place Schabbach element 1307 between the Fournier recess and the Fournier projection, shown in Fournier Figure 2 above.
As to Claim 2, Fournier, as modified, teaches all the limitations of Claim 1, and continues to teach the small diameter part (the portion of Fournier 513 below Fournier 630, as viewed in Fournier Figure 2) has an annular projection (Fournier 610) that projects radially outward (as shown in Fournier Figure 2) with a distance (the distance between Fournier 610 and the Fournier large diameter portion, shown in Fournier Figure 2 in the Claim 1 rejection above) from the large diameter part (Fournier 630) in the axial direction (up and down, as viewed in Fournier Figure 2), while extending through the entire area (the cylindrical area of the Fournier syringe body cylindrical wall in contact with Fournier annular projection 610, as described in Fournier Paragraph 0056) in the circumferential direction,
the annular projection (Fournier 610) is in close contact with an entire area of the inner peripheral surface of the barrel in the circumferential direction (the cylindrical area of the Fournier syringe body cylindrical wall in contact with Fournier annular projection 610, as described in Fournier Paragraph 0056) when the syringe gasket (Fournier 510) is inserted into (as described in Fournier Paragraph 0055) the barrel (the Fournier syringe body described in Fournier Paragraph 0055),
the element (Schabbach 1307) is disposed between (since Schabbach Figures 13A/13B show Schabbach element 1307 within a recess at the bottom of second member 1318, one of ordinary skill in the art would be motivated to place the Schabbach element at the top –Schabbach Figures 13A/13B are rotated 180 degrees with respect to Fournier Figure 2-- of the Fournier second member 511 projection, which would place Schabbach element 1307 between the Fournier large diameter part 630 and the Fournier annular projection 610, shown in Fournier Figure 2 above.) the large diameter part (Fournier 630) and the annular projection (Fournier 610) in the axial direction (up and down, as viewed in Fournier Figure 2), and
the screw hole (515) extends (as shown in Fournier Figure 2) at least to a position (as shown in Fournier Figure 2) of the annular projection (Fournier 610) in the axial direction (up and down, as viewed in Fournier Figure 2).
As to Claim 3, Fournier, as modified, teaches a syringe comprising: a syringe body having a cylindrical barrel (the Fournier syringe body described in Fournier Paragraph 0055):
the syringe gasket (Fournier 510, as modified) according to claim 1 (as described in the Claim 1 rejection above) being disposed in (Fournier Paragraph 0055) the barrel (the Fournier syringe body described in Fournier Paragraph 0055); and
a plunger rod (the Fournier piston rod described in Fournier Paragraph 0002) extending (one of ordinary skill in the art would conclude the Fournier plunger rod described in Paragraph 0002 must extend along the Fournier syringe body axis in order to actuate the Fournier stopper/gasket, as described in Fournier Paragraph 0002) along a central axis (the longitudinal axis of the Fournier barrel described in Fournier Paragraph 0055) of the barrel (the Fournier syringe body described in Fournier Paragraph 0055) and having a screw part (the Fournier thread on the Fournier leading end of the Fournier piston rod, described in Fournier Paragraph 0003) that is provided in (as described in Fournier Paragraph 0003) a distal end (the Fournier leading end of the Fournier piston rod, described in Fournier Paragraph 0003) of the plunger rod (the Fournier piston rod described in Fournier Paragraph 0002) and configured to be threaded into (as described in Fournier Paragraph 0003) the screw hole (Fournier 515) of the syringe gasket (Fournier 510, as modified).
As to Claim 4, Fournier, as modified, teaches a syringe comprising: a syringe body having a cylindrical barrel (the Fournier syringe body described in Fournier Paragraph 0055):
the syringe gasket (Fournier 510, as modified) according to claim 2 (as described in the Claims 1 & 2 rejections above) being disposed in (Fournier Paragraph 0055) the barrel (the Fournier syringe body described in Fournier Paragraph 0055); and
a plunger rod (the Fournier piston rod described in Fournier Paragraph 0002) extending (one of ordinary skill in the art would conclude the Fournier plunger rod described in Paragraph 0002 must extend along the Fournier syringe body axis in order to actuate the Fournier stopper/gasket, as described in Fournier Paragraph 0002) along a central axis (the longitudinal axis of the Fournier barrel described in Fournier Paragraph 0055) of the barrel (the Fournier syringe body described in Fournier Paragraph 0055) and having a screw part (the Fournier thread on the Fournier leading end of the Fournier piston rod, described in Fournier Paragraph 0003) that is provided in (as described in Fournier Paragraph 0003) a distal end (the Fournier leading end of the Fournier piston rod, described in Fournier Paragraph 0003) of the plunger rod (the Fournier piston rod described in Fournier Paragraph 0002) and configured to be threaded into (as described in Fournier Paragraph 0003) the screw hole (Fournier 515) of the syringe gasket (Fournier 510, as modified).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kawamura (2012/0109076) describes a similar two part syringe gasket as claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783