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 .
Election/Restrictions
Claims 7-11 and 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, system, and plunger rod tip comprising a rotational locking detent as in Figure 4, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 31, 2026. It is noted that claim 11 is only supported for the embodiment of Figures 11A-11B wherein the recess 460 engages element 459 in the plunger tip. The elected embodiment of Figures 5A-5B does not contain the recess shaped complimentary to the plunger tip bore since the plunger tip of Figure 4 is intended to mate with the elected plunger tip. For this reason, claim 11 is also considered withdrawn as being directed to a non-elected species.
Applicant's election with traverse of the piston element of Figures 5A-5B and the plunger element comprising the single anti-rotation means of Figure 4 in the reply filed on August 31, 2026 is acknowledged. The traversal is on the ground(s) that the piston of Figures 6A-6B is intended to fit onto the plunger tip of Figures 5A-5B and that they are not different embodiments of the same feature. This is found persuasive and the piston of Figures 6A-6B will not be restricted from a separate feature. The restriction requirement between the plunger tip of Figures 5A-5B and that of Figures 11A-11B is maintained, and the election of the embodiment of Figures 5A-5B is noted. The restriction between these plunger tip embodiments is considered proper and the restriction is therefore made FINAL.
Claim Objections
Claim 14 is objected to because of the following informalities: the last line of claim 14 should be amended for clarity. The line “when is coupled to the plunger rod” doesn’t make grammatical sense. An example of clear language would be: “…relative to the plunger tip when it is coupled to the plunger rod.” Alternatively, another example could be: “…relative to the plunger tip when the plunger tip is coupled to the plunger rod.” Appropriate correction is required.
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 4-6 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. Regarding claim 4, the claim sets forth “…the proximal flange…” in line 4, however, it is unclear whether or not this is the proximal flange of the plunger tip or the plunger rod tip since no proximal flange has been previously set forth. It is assumed that the plunger tip comprises a proximal flange and is configured to engage with a detent disposed on a distal flange of the plunger rod. Claim 5 is rejected due to its dependence upon claim 4. Regarding claim 6, the claim sets forth “…into engagement with the detent when the internal thread…. However, the detent is set forth in claim 4 and not claim 3, from which claim 6 depends. It is assumed that claim 6 should depend from claim 4 to provide proper antecedent basis for the detent, and this is how it will be interpreted for the purposes of examination.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heinz et al. (US 2001/0004466).
Regarding claim 1, Heinz et al. (henceforth Heinz) discloses a syringe system, comprising: a barrel (e.g., body 1) comprising an interior surface (interior wall 2) defining a reservoir having a distal reservoir portion (at distal end of barrel) and a proximal reservoir portion (adjacent outlet end); a plunger member (5, 4) comprising: a plunger rod (5) defining a proximal end and a distal end; a plunger tip disposed at the distal end (the tip is engaged with piston 4); and a seal member (piston 4) coupled to the plunger tip (Figure 1); wherein the seal member is disposed within the barrel to define the distal reservoir portion disposed distal of the seal member (e.g., portion of barrel distal of piston when installed) and the proximal reservoir portion disposed proximal of the seal member; wherein a lubricant (lubricant layer 3) is disposed on the interior surface of the proximal reservoir portion; and wherein the interior surface of the distal reservoir portion is free of the lubricant (see lubricant free end “A”; Figure 1, ¶ [0049]).
Claim(s) 12, 13, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. (US 7,749,202).
Regarding claim 12, Miller et al. (henceforth Miller) teaches (Figures 10 and 33) a syringe plunger (440, 810, 830) comprising a plunger rod (440, it is useable will all disclosed embodiments having an internal threaded attachment for the plunger and plunger tip) defining a proximal end and a distal end (end with threaded tip comprising threads 422); a plunger tip (810, comprising core 820 which is the plunger tip) disposed at a distal end; and a seal member (sleeve 830) coupled to the plunger tip (Figure 33), wherein the plunger tip is configured to prevent movement of the plunger rod relative to the seal member (via threaded engagement of the plunger rod tip to the plunger tip, to which the seal is frictionally attached, there will be limited movement between the plunger rod and the seal as claimed).
Regarding claim 13, Miller further discloses wherein the plunger tip (820) is selectively coupleable to the plunger rod (via internal threads 822 engaged with external threads e.g., 442 on plunger rod 440).
Regarding claim 15, Miller further discloses wherein the plunger tip (820) comprises a plurality of nubs (820a; Figure 33) configured to engage with an interior surface of the seal member (830; the nubs engage corresponding recesses in the distal end of the seal element) to prevent rotation of the seal member relative to the plunger tip (see Col. 8, lines 8-17 which disclose that this engagement results in less likelihood that the sleeve will move with respect to the plunger tip).
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) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heinz in view of Miller.
Regarding claim 2, Heinz discloses the claimed invention substantially as set forth above for claim 1 but fails to explicitly disclose the plunger tip as selectively coupleable to the plunger rod.
Miller teaches (e.g., Figure 33) a plunger tip (810) selectively coupleable to a plunger rod (e.g., 440, Figure 11, via threads 422 of the plunger rod tip engaged with internal threads 822 of the plunger tip; Col. 7, line 58-Col. 8, line 17).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the plunger rod assembly of Heinz to include the selectively coupleable plunger tip of Miller so as to prevent unwanted misalignment between the plunger and plunger tip which can result in uneven pressure on the plunger tip during use, as taught by Miller (e.g., Col. 1, lines 17-35).
Regarding claim 3, Miller further teaches wherein the plunger tip (810) comprises an internal thread (820; Figure 33), wherein the plunger rod comprises a plunger rod tip comprising an external thread (e.g., plunger rod 440 is an exemplary embodiment of a plunger rod useable with the plunger tip of embodiment 33, and which comprises external threads 442 on a tip thereof as depicted in Figure 10), and wherein the plunger tip is threadingly coupleable with the plunger rod tip (Figures 10 and 33, the plunger rod tip thread engages the internal thread of the plunger tip 810 to form the plunger assembly for use).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Gallagher (US 3,990,727).
Regarding claim 14, Miller discloses the claimed invention substantially as set forth above for claim 12, and further discloses wherein the plunger tip (820) comprises an internal thread (822; Figure 33) configured to threadingly engage with an external thread (442; Figure 10) on a distal end of the plunger rod (440) when the plunger tip is coupled to the plunger rod, and a proximal flange (820b). However, Miller fails to explicitly disclose the anti-rotation member on the flange to prevent relative rotation of the plunger rod relative to the plunger tip when coupled.
Gallagher teaches (Figure 6) two coupled elements wherein one element (wall member 60) provides a recess (keyway 78) which engages a detent (key 76) on another member (extension 56).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the plunger rod and plunger tip of Miller to comprise the key and keyway locking mechanism of Gallagher so as to provide a means of preventing relative rotation of the plunger rod and plunger tip after the plunger tip has been fully threaded onto the plunger rod tip as taught by Gallagher (Col. 4, lines 35-41).
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Heinz.
Regarding claim 1, Miller discloses a syringe system comprising: a barrel (e.g., 410, Figure 11) comprising an interior surface defining a reservoir (inside of barrel) having a distal reservoir portion (adjacent outlet) and a proximal reservoir portion (adjacent barrel flange); a plunger member (440, Figure 10) comprising: a plunger rod (shaft of 440) defining a proximal end and a distal end (Figure 10); a plunger tip (core 820, Figure 33) disposed at the distal end (the plunger tip is designed to be threadedly connected to the threaded tip portion of plunger rod 440); and a seal member (830) coupled to the plunger tip (Col. 7, line 58-Col. 8, line 17); wherein the seal member is disposed within the barrel to define the distal reservoir portion disposed distal of the seal member (portion of barrel distal of seal when installed into the barrel) and the proximal reservoir portion disposed proximal of the seal member (portion of barrel proximal of the seal when installed into the barrel). Miller fails to explicitly disclose lubrication within the barrel.
Heinz teaches (Figure 1) a syringe system, comprising: a barrel (e.g., body 1) comprising an interior surface (interior wall 2) defining a reservoir having a distal reservoir portion (at distal end of barrel) and a proximal reservoir portion (adjacent outlet end); a plunger member (5, 4) comprising: a plunger rod (5) defining a proximal end and a distal end; a plunger tip disposed at the distal end (the tip is engaged with piston 4); and a seal member (piston 4) coupled to the plunger tip (Figure 1); wherein the seal member is disposed within the barrel to define the distal reservoir portion disposed distal of the seal member (e.g., portion of barrel distal of piston when installed) and the proximal reservoir portion disposed proximal of the seal member; wherein a lubricant (lubricant layer 3) is disposed on the interior surface of the proximal reservoir portion; and wherein the interior surface of the distal reservoir portion is free of the lubricant (see lubricant free end “A”; Figure 1, ¶ [0049]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the syringe barrel of Miller to comprise the lubricant along a length of the barrel to provide for smooth motion during operation while providing an uncoated distal section of the barrel to prevent the piston from being moved back into the injector body to prevent reuse of the device as taught by Heinz (¶ [0049]).
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Heinz, and further in view of Miceli et al. (US 2004/0195197).
Regarding claim 4, Miller/Heinz teach the claimed invention substantially as set forth above for claim 1 but fail to explicitly disclose the anti-rotation feature.
Miceli et al. (henceforth Miceli) teaches (Figures 1F and 2D) two elements connected via an anti-rotation mechanism (elements 20 and 44; ¶ [0044]) embodied as a plurality of detents and recesses (between the detents) on each element; wherein a proximal flange portion (top of flange on 32, Figure 1F) engage with a slot (between detents 44 on inner cap 40) to prevent relative rotation between the two elements in one direction.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the proximal flange (flange on plunger rod tip just proximal to the threaded shaft in Figure 10) of Miller to comprise at least one pawl or detent which engages a slot on a proximal flange portion of the plunger tip to provide a stop surface or end-of-travel abutment between the plunger tip and the plunger rod tip to substantially limit the connecting rotation of the two elements to a specific point. In this manner, the two elements can be rotated together until the slot on the plunger tip engages the detent on the plunger rod tip, whereby the detent, embodied as a ratchet tooth element, will prevent further rotation in such a direction, while the tapered side of the ratchet tooth will allow reverse rotation to provide a means of maintaining the separability of the two elements relative to one another after use. In this embodiment only a single pawl is required and would need only engage with a slot or opening rather than with corresponding ratchet teeth. One of ordinary skill in the art would realize the versatility of such a configuration without requiring the full circumference of the flanges to comprise the ratcheting mechanism in order to provide the desired function.
Regarding claim 5, Miceli further teaches wherein the detent (e.g., 20) comprises a first face (tapered face; Figure 1F) and a second face (flat or perpendicular face), wherein the first face comprises an acute angle relative to a distal surface of the distal flange (Figure 1F, it can be seen that the angle for the tapered side is acute as claimed), wherein the second face comprise a perpendicular angle relative to the distal surface (Figure 1F, it can be seen that the flat face is substantially perpendicular or at a right angle to the surface), and wherein the first face is configured to allow rotation of the plunger rod relative to the plunger tip in a first direction and the second face is configured to prevent rotation of the plunger rod in a second direction when the detent is engaged with the slot (e.g., ¶ [0040]).
Regarding claim 6, Miller further teaches wherein the internal and external threads are single start threads (see Figures 10 and 33, it is clear from the depiction that the threads provide a lead equal to the pitch), and wherein a single start of the internal thread and the external thread are configured to position the slot into engagement with the detent when the internal thread and the external thread are fully engaged (in the cited modification, the intent is that the detent on the flange of the plunger rod engages with the ratchet tooth on the plunger tip to prevent excess rotation of the plunger tip relative to the plunger rod when installed thereon; for this reason, it would have been obvious to one of ordinary skill in the art, when making this modification, to orient the thread start so that the detent entered the slot at the desired end of travel of the plunger tip relative to the plunger rod).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
