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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/23/2026 has been entered.
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) 1, 5, 6, 9, 12, 21, 22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freed et al (US 2012/0059347) in view of Sullivan (US 2,735,427).
Regarding claim 1, Freed discloses a syringe plunger, comprising: a plunger rod 60; a base 65 formed at a proximal end of the plunger rod, wherein at least a portion of the plunger rod is configured to extend from the base into a syringe barrel (fig 3); and a plunger arm 210 including a projection 250 formed at a second end of the plunger arm, the projection comprising a surface configured to receive an applied force that causes an entirety of the syringe plunger to move towards a distal end of the syringe barrel, wherein moving the syringe plunger towards the distal end of the syringe barrel causes a reduction in a volume of the syringe barrel defined by the syringe barrel and the end of the plunger (figs 2 and 3).
While Freed substantially discloses the invention as claimed, it does not disclose a first interference fit connector extending laterally from the plunger rod below the base of the plunger, a second interference fit connector extending laterally from a first end of the plunger arm, the second interference fit connector configured to be coupled to the first interference fit connector, nor the first and second interference fit connectors are couplable via a movement of the second interference fit connector relative to the first interreference fit connector.
Sullivan discloses a syringe which is operated via an actuator parallel to the barrel, similar to Freed. Sullivan discloses a first interference fit connector 62 extending laterally from the plunger rod below the base 61 of the plunger (fig 7), a second interference fit connector 14 extending laterally from a first end of the plunger arm 31/41, the second interference fit connector configured to be coupled to the first interference fit connector (fig 7), wherein the first and second interference fit connectors are couplable via a movement of the second interference fit connector relative to the first interreference fit connector (threaded attachment).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Freed such that it comprises a first interference fit connector extending laterally from the plunger rod below the base of the plunger, a second interference fit connector extending laterally from a first end of the plunger arm, the second interference fit connector configured to be coupled to the first interference fit connector, and the first and second interference fit connectors are couplable via a movement of the second interference fit connector relative to the first interreference fit connector as taught by Sullivan as they are known, alternative connection means for a plunger and plunger arm with every expectation of success. Further, the threaded connection is less easily overcome compared to the snap and/or friction connections of Sullivan (if say the device is dropped on accident).
Regarding claim 5, wherein the second interference fit connector is partially curved to conform to a shape of the plunger rod (see combination in claim 1 and fig 7 of Sullivan).
Regarding claim 6, wherein the first interference fit connector is configured to be disposed within the second interference fit connector to form an irreversible coupling directly below the base of the plunger rod, such that the base of the plunger rod and the irreversible coupling form a base structure for the entirety of the syringe plunger (fig 7).
Regarding claim 9, wherein the projection comprises a circular sector or segment with an arc measure in the range of 90 to 180 degrees, the circular sector or segment configured to be pushed by a finger of a user to cause the entirety of the syringe plunger to move relative to the syringe barrel (fig 2).
Regarding claim 12, wherein a lower portion of the plunger arm is configured to contact the syringe barrel (capable of such; also see fig 12), and an upper portion of the plunger arm is outdented from the lower portion of the plunger arm (fig 1) to prevent or reduce contact between the upper portion of the plunger arm and the syringe barrel for reduced friction between the plunger arm and the syringe barrel when the entirety of the syringe plunger to moves relative to the syringe barrel (fig 1, see gap).
Regarding claim 21, wherein the first and second interference fit connectors are couplable via lateral movement (twisting, see combination in claim 1) of the second interference fit connector relative to the first interference fit connector (fig 7, due to threads from combination with Sullivan)
Regarding claim 22, wherein the first and second interference fit connectors comprise cooperatively shaped structures that couple together irreversibly once the first and second interference fit connectors are translated relative to one another in a single direction (see combination in claim 1; twisting motion toward each other of Sullivan).
Regarding claim 24, wherein upon coupling the first interference fit connector to the second interference fit connector, the base of the plunger rod is positioned on top of the second interference fit connector (see combination with Sullivan in claim 1, and fig 7 of Sullivan, when rotated 180 degrees).
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freed et al (US 2012/0059347) in view of Sullivan (US 2,735,427) and Wagner et al (US 2008/0167621).
Regarding claim 7, while Freed substantially discloses the invention as claimed, it does not disclose the first and second interference fit connectors are further irreversibly coupled by an application of heat or radiation after the first and second interference fit connectors are forced together.
Wagner discloses a plunger bonded to a linking element via a heat treatment (¶99).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Freed such that the first and second interference fit connectors are further irreversibly coupled by an application of heat or radiation after the first and second interference fit connectors are forced together as taught by Wagner to better join the arm and plunger together.
Claim(s) 8 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freed et al (US 2012/0059347) in view of Sullivan (US 2,735,427) and Nerney (US 6,368,308).
Regarding claim 8, while Freed substantially discloses the invention as claimed, it does not disclose the first and second interference fit connectors are further irreversibly coupled by an adhesive disposed between the first and second interference fit connectors before the first and second interference fit connectors are forced together.
Nerney discloses a variety of syringe plunger/arm configurations including one where they are joined via an adhesive (Col.4 ll 28-31).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Freed such that the first and second interference fit connectors are further irreversibly coupled by an adhesive disposed between the first and second interference fit connectors before the first and second interference fit connectors are forced together as taught by Nerney to further secure the two together.
Regarding claim 13, while Freed substantially discloses the invention as claimed, it does not disclose the lower portion of the plunger arm further includes a smooth bump configured to contact the syringe barrel and configured to prevent or reduce contact between a remainder of the lower portion of the plunger arm and the syringe barrel for reduced friction between the plunger arm and the syringe barrel when the entirety of the syringe plunger to moves relative to the syringe barrel.
Nerney discloses the lower portion of the plunger arm further includes a smooth bump (concave surface of 25) configured to contact the syringe barrel (fig 3) and configured to prevent or reduce contact between a remainder of the lower portion of the plunger arm and the syringe barrel for reduced friction between the plunger arm and the syringe barrel when the entirety of the syringe plunger to moves relative to the syringe barrel (due to preventing the arm from being pressed against the syringe when the arm is being moved along the syringe).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Freed such that the lower portion of the plunger arm further includes a smooth bump configured to contact the syringe barrel and configured to prevent or reduce contact between a remainder of the lower portion of the plunger arm and the syringe barrel for reduced friction between the plunger arm and the syringe barrel when the entirety of the syringe plunger to moves relative to the syringe barrel as taught by Nerney to further steady the arm as it moves along the syringe.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-13 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,167,091 in view of Freed et al (and others cited above). The claims are generally broader with a few obvious differences rendered obvious in view of Freed and other art cited above.
Response to Arguments
While, the examiner does not find Applicant’s arguments persuasive, a new rejection is issued as it is considered a better rejection (since the rejection of Sullivan requires reliance on an atypical interpretation of a use of the device). Should Sullivan be the only rejection left, the rejection will be reintroduced and Applicant’s arguments addressed at that time.
Freed is reintroduced as a primary reference, so Applicant’s arguments from 10/17/2025 are once again considered, but Sullivan cures the argued deficiencies of Freed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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