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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kosinski (US 8,007,475).
Regarding claim 1, Kosinski discloses (Figure 12) a syringe plunger rod (338) comprising: a rod body having a proximal rod end and a distal rod end (comprising threaded distal tip 355), the distal rod end having a distal rod end circumference; a threaded extension (comprising thread 365) extending distally from the distal rod end (Figure 12), the threaded extension including at least one male thread (thread 365; Col. 9, lines 17-59) extending from a thread shank, the thread shank having a proximal thread shank end and a distal thread shank end (it extends along the distal shank portion from a proximal end to a distal end as claimed), the proximal thread shank end having a diameter less than the diameter of the distal rod end circumference (it can be seen in Figure 12, that the distal end circumference of the rod end is of a greater diameter than the threaded extension which is formed as a reduced diameter portion extending from the distal end of the rod end as claimed); and an annular distal rod surface extending between the distal rod end circumference and the proximal male thread shank end, the annular distal rod surface including at least one auxiliary passage (384), the auxiliary passage defining a channel positioned between the distal rod end circumference and the proximal thread shank end (Col. 9, lines 17-59).
Regarding claim 2, Kosinski further discloses wherein the channel (384) extends at least radially outwardly to the distal rod end circumference (the channel is formed through the thread body and extends proximally to the distal rod end circumference; it also extends radially along the distal rod end circumference to form the opening therein which is considered to meet the claim limitation as currently set forth).
Regarding claim 3, Kosinski further discloses wherein the channel extends at least radially inwardly to the proximal thread shank end (see Figure 12, the channel 384 extends in a radial direction adjacent the proximal thread shank end; the claim does not require the channel to be formed in an outer surface of the proximal thread shank end).
Regarding claim 4, Kosinski further discloses wherein the channel (384) extends at least radially inwardly terminating before the proximal thread shank end (the channel is formed within the threaded extension of the rod and does not extend all of the way to the threaded portion of the shank as it’s formed in a central area of the extension; the channel therefore is considered to extend toward the threaded exterior surface while terminating before reaching the threads as claimed).
Regarding claim 5, Kosinski further discloses wherein the channel (384) does not extend distally beyond the at least one male thread (Figure 12, it can be seen that the channel ends at the terminal surface of the plunger rod distal extension and therefore does not extend distally beyond the threaded end section as claimed).
Regarding claim 6, Kosinski further discloses wherein the plunger rod is comprised of a polymeric material (various polymers for forming the rod are disclosed in Col. 6, lines 14-18).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kosinski (US 8,007,475) in view of Cleveland et al. (US 2013/0325011).
Regarding claim 7, Kosinski discloses a syringe plunger rod (337) comprising: a rod body (338) having a proximal rod end and a distal rod end (end of 338 adjacent plunger; Figure 12), the distal rod end having a distal rod end circumference (circumference of portion just proximal of distal end 340; i.e., the larger distal diameter of 338 before narrowed portion 340); a threaded extension (forming thread shank 355 comprising thread 365) extending distally from the distal rod end (Figure 12), the threaded extension including at least one male thread (365) extending from a thread shank (body of 355), the thread shank having a proximal thread shank end and a distal thread shank end, the proximal thread shank end (adjacent distal end 340) having a diameter less than the diameter of the distal rod end circumference (it can be seen in Figure 12 that the threaded shank extension is of a smaller diameter than the distal end 340 of the rod); and an annular distal rod surface (distal end of 340) extending between the distal rod end circumference and the proximal thread shank end (the surface is formed at the distal end of portion 340). Kosinski fails to explicitly disclose the protrusions extending distally from the surface.
Cleveland et al. (henceforth Cleveland) teaches (Figure 1) an element (protrusion 118) extending from a surface (from cap means 106a and 106b) for engaging another element (distal surface of 102) during connection (¶ [0093]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the distal surface of the plunger rod of Kosinski to provide a plurality of protrusions extending therefrom so as to engage the proximal surface of the piston during connection to ensure alignment of the rod and plunger as taught by Cleveland (¶ [0093]; such a means would provide a way of registering the plunger with the rod during insertion even with the use of threads for the connection to ensure the two elements are fixed in a desired position after connection.
Regarding claim 8, Kosinski/Cleveland further teach wherein the plurality of protrusions does not extend distally beyond the at least one male thread (in the cited combination, the protrusions would extend from distal feature 340 of Kosinski to engage the proximal surface of the plunger after threading the piston onto the rod; it is clear from the combination that the threaded extension would extend further distally than the protrusions as claimed).
Regarding claim 9, Kosinski further discloses wherein the plunger rod is comprised of a polymeric material (Col. 6, lines 14-18).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
