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 .
This office action is in response to applicant’s communication of 6/25/2026. Currently claims 1-20 are pending and rejected below.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2019/173026 A1 (AMGEN INC).
Amgen discloses a syringe (10, 100) comprising: a barrel (14,114) having an interior, a dispensing opening (16) at a distal end, and an open proximal end (20); a stopper (38, 138) disposed within the interior of the barrel; a plunger rod (40, 140) having a first end (42) configured to be at least selectively operably coupled with the stopper and a second end extending through the open proximal end of the barrel, the second end including an outwardly extending flange (48); and a stop assembly including a plunger stop (54, 58, 150) coupled to the plunger rod at a location between the flange and the open proximal end of the barrel and a removable portion coupled to the plunger rod or barrel, the plunger stop being configured and dimensioned to engage a stop surface (24,122) adjacent to the open proximal end of the barrel to selectively limit displacement of the plunger and stopper along the interior of the barrel.
Concerning the language of “…wherein the plunger rod and stop assembly are configured to allow the plunger rod to move a predetermined length that corresponds with the plunger rod dispensing at least a specific volume of headspace within the syringe….”. Examiner is of the position that the prior art AMGEN does disclose this configuration and movement of the plunger rod and fluid from the syringe barrel. See figure 1 which shows space near 42 that the plunger rod may move to dispense a specific volume from the syringe barrel headspace. Also see para [0029] which states “[0029] Stated another way, by configuring the plunger rod 40 to have a predetermined length between the distal end 42 and the stop 54 that corresponds to a desired portion of the barrel 14, the syringe 10 can be preconfigured to dispense a specific volume of fluid. Advantageously, this can be utilized to avoid the problems associated with headspace within conventional prefilled syringes by limiting a dispensing operation to a volume that prevents the air 52 from being expelled…”.
Concerning the amended claim 1 language of “without dispensing more than 10% of the therapeutic product by having the plunger stop spaced from the proximal end of the barrel a distanc3e that corresponds to a predetermined length” Examiner is of the position that this is a functional type claim limitation. Examiner is of the position that the prior art Amgen would be “configured to” perform these functions as this is dose dependent of the amount of fluid in the syringe and the quantality of what is “10%” is a subjective amount dependent on the total liquid of the syringe. It is examiners position that the plunger rod and stop assembly as described in Amgen would be able to carry out the function of “10%” as Amgen plunger and stop move a controlled amount of fluid and this would be dependent on the total amount of initial fluid in the syringe.
Concerning claim 2 and the plunger stop and the removable portion of the stop assembly comprises first and second bodies pivotable with respect to one another to capture the plunger rod therebetween (see figure 1).
Concerning claim 3 and the plunger stop and the removable portion of the stop assembly comprises a clip including a hinge pivotably coupling first sides of the first and second bodies and a securing mechanism releasably connecting second sides of the first and second bodies.
Concerning claim 4 and the plunger stop (54/58) and the removable portion of the stop assembly comprises a clamp including a biasing mechanism, and the first and second bodies comprise jaws at first ends thereof and handles at second ends thereof, the biasing mechanism biasing the jaws of the first and second bodies together to capture the plunger rod therebetween (see figure 1 again).
Concerning claim 5 and the plunger stop and the removable portion of the stop assembly comprises a tab coupled to the plunger rod along a longitudinal length thereof by a breakaway feature (see 54/58 and figure 1).
Concerning claim 6 and the plunger stop and the removable portion of the stop assembly comprises: a body defining a cavity with an opening through an end wall thereof, the cavity configured to receive the plunger rod therein to restrict longitudinal movement of the plunger rod with respect to the body; and a securing mechanism coupled to the body to hold the plunger rod within the cavity (see 58 removable collar).
Concerning claim 7 and the securing mechanism comprises an adhesive member extending over cavity (examiner is of the position that the collar is secured and connected to the piston and would be considered a type of adhesive member over the cavity).
Concerning claim 8 the body comprises first and second clamshell components having inner faces configured to be brought together to define the cavity therebetween, and the securing mechanism holds the first and second clamshell components in a closed configuration with the plunger rod trapped within the cavity (as shown in figure 1).
Concerning claim 9 and the plunger stop (54) and the removable portion of the stop assembly (54) comprises a snap-fit member comprising first and second walls spaced from one another and connected by an end wall, the first and second walls defining channels on interior faces thereof and being configured to be flexed apart to dispose the plunger rod therebetween and returned towards an unflexed position to retain portions of the plunger rod within the channels (see collar 58).
Concerning claim 10 and the proximal end of the barrel comprises an outwardly projecting flange (48), and the removable portion of the stop assembly comprises a blocking member configured to removably engage the flange of the barrel; and wherein the plunger stop of the stop assembly comprises a stop flange extending outwardly from the plunger rod adjacent to the first end thereof, the stop flange having a perimeter sized to fit within the interior of the barrel and the blocking member having a portion disposed within a travel path of the stop flange to restrict longitudinal movement of the plunger rod (see figure 1 and previously identified structures).
Concerning claim 11 and the blocking member comprises a clip having first and second walls spaced from one another and connected by an end wall, the clip configured to engage the flange of the barrel between the first and second walls (see collar 58).
Concerning claim 12 and the blocking member comprises a tab having a distal end with a configuration complementary to a portion of a horizontal cross- section of the plunger rod, and the flange of the barrel comprises a channel sized to receive the tab therein, the channel configured to guide the tab into engagement with the plunger rod (see collar 58 and note how it fits into and against 54/55).
Concerning claim 13 and the stop assembly comprises a wall portion having a face with information displayed thereon regarding the operation of the stop assembly (see paragraphs [0025-27]).
Concerning claim 14 and the method of dispensing headspace from a syringe containing a liquid therapeutic product, the method comprising: providing a syringe comprising: a barrel having an interior, a dispensing opening at a distal end, and an open proximal end; a stopper disposed within the interior of the barrel; a plunger rod having a first end configured to be at least selectively operably coupled with the stopper and a second end extending through the open proximal end of the barrel, wherein the second end includes an outwardly extending flange; a fluid therapeutic product and a headspace disposed in the interior of the barrel between the stopper and the dispensing opening; and a stop assembly including a plunger stop coupled to the plunger rod and a removable portion coupled to the plunger rod or barrel; driving the plunger rod toward the open proximal end of the barrel of the syringe to drive the stopper along the interior of the barrel toward the dispensing opening to dispense the headspace through the dispensing opening; abutting the plunger stop against a stop surface adjacent to the open proximal end of the barrel, thereby stopping movement of the stopper and preventing the fluid therapeutic product from being expelled; and removing the removable portion of the stop assembly from the plunger rod or barrel (see previously identified structures, figure 1 and paragraphs [0025-33]).
Concerning the language of “…wherein the plunger rod and stop assembly are configured to allow the plunger rod to move a predetermined length that corresponds with the plunger rod dispensing at least a specific volume of headspace within the syringe….”. Examiner is of the position that the prior art AMGEN does disclose this configuration and movement of the plunger rod and fluid from the syringe barrel. See figure 1 which shows space near 42 that the plunger rod may move to dispense a specific volume from the syringe barrel headspace. Also see para [0029] which states “[0029] Stated another way, by configuring the plunger rod 40 to have a predetermined length between the distal end 42 and the stop 54 that corresponds to a desired portion of the barrel 14, the syringe 10 can be preconfigured to dispense a specific volume of fluid. Advantageously, this can be utilized to avoid the problems associated with headspace within conventional prefilled syringes by limiting a dispensing operation to a volume that prevents the air 52 from being expelled…”.
Concerning the amended claim 14 language of “without dispensing more than 10% of the therapeutic product by having the plunger stop spaced from the proximal end of the barrel a distanc3e that corresponds to a predetermined length” Examiner is of the position that this is a functional type claim limitation. Examiner is of the position that the prior art Amgen would be “configured to” perform these functions as this is dose dependent of the amount of fluid in the syringe and the quantality of what is “10%” is a subjective amount dependent on the total liquid of the syringe. It is examiners position that the plunger rod and stop assembly as described in Amgen would be able to carry out the function of “10%” as Amgen plunger and stop move a controlled amount of fluid and this would be dependent on the total amount of initial fluid in the syringe.
Concerning claim 15 and the plunger stop and the removable portion of the stop assembly comprises first and second bodies having the plunger rod captured therebetween, and removing the removable portion of the stop assembly from the plunger rod or barrel comprises pivoting first and second bodies of the stop with respect to one another (see figure 1 and previously identified structures).
Concerning claim 16 and the removable portion of the stop assembly from the plunger rod or barrel comprises breaking a tab off of the plunger rod (see collar 58).
Concerning claim 17 and the plunger stop and the removable portion of the stop assembly comprises: a body defining a cavity with an opening through an end wall thereof, the plunger rod received within the cavity, and a securing mechanism coupled to the body to hold the plunger rod within the cavity, and removing the removable portion of the stop assembly from the plunger rod or barrel comprises manipulating the body and securing mechanism to free the plunger rod from the cavity (see previously identified structures, figure 1 and paragraphs [0025-33]).
Concerning claim 18 and removing the removable portion of the stop assembly from the plunger rod or barrel comprises flexing first and second walls of the stop assembly away from one another to release the plunger rod from being captured therebetween (see removable collar 58 that examiner is of the position that could be removed that way).
Concerning claim 19 and the proximal end of the barrel comprises an outwardly projecting flange, the plunger stop comprises a stop flange extending outwardly from the plunger rod, wherein the stop flange has a perimeter sized to fit within the interior of the barrel, and removing the removable portion of the stop assembly from the plunger rod or barrel comprises uncoupling a blocking member having a portion disposed within a travel path of the stop flange to restrict longitudinal movement of the plunger rod from the flange of the barrel (see previously identified structures, figure 1 and paragraphs [0025-33]).
Claim(s) 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2008/281274 A1 (ROLLA JOSE SANTIAGO)
Concerning claim 20 Rolla teaches a syringe comprising: a barrel (1) having an interior, a dispensing opening at a distal end (3), and an open proximal end (3) having an end surface; a stopper (4) disposed within the interior of the barrel; a plunger rod (5) having a first end (51) configured to be at least selectively operably coupled with the stopper and a second end (50) extending through the open proximal end of the barrel;and either (a) or (b):(a) an outwardly projecting stop (6) adjacent the second end of the plunger rod; an engagement portion (61) at the second end of the plunger rod spaced from the stop; and at least one wall portion (63) extending longitudinally between the stop and the engagement portion and laterally outward from the plunger rod, the at least one wall portion being integrally formed with the plunger rod (5 and figures 12-14) and having a face with information displayed thereon regarding the operation of the stop (para [0052] and 63), or(b) an engagement portion at the second end of the plunger rod; a flange adjacent to the second end of the plunger rod and spaced from the engagement portion; and a snap-fit member releasably coupled to the plunger rod, the snap-fit member comprising a first and second walls spaced from one another and connected by an end wall, the first and second walls be in a configured to be flexed apart to dispose the plunger rod therebetween and returned towards an unflexed position to retain the snap-fit member on the plunger rod between the engagement portion and the flange.
Concerning the language of “…wherein the plunger rod and stop assembly are configured to allow the plunger rod to move a predetermined length that corresponds with the plunger rod dispensing at least a specific volume of headspace within the syringe….”. Examiner is of the position that the prior art Rolla does disclose this configuration and movement of the plunger rod and fluid from the syringe barrel. See Rolla figure 1 which shows space near 51 that the plunger rod may move to dispense a specific volume from the syringe barrel headspace.
Concerning the amended claim 20 language of “without dispensing excess amounts of the fluid therapeutic product.” Examiner is of the position that this is a functional type claim limitation. Examiner is of the position that the prior art Rolla would be “configured to” perform these functions as this is dose dependent of the amount of fluid in the syringe and the quantality of what is “excess amounts” is a subjective amount. It is examiners position that the plunger rod and stop assembly as described in Rolla would be able to carry out the function of “without dispensing an excess amount of the fluid” as Rolla plunger and stop move a controlled amount of fluid.
Concerning the amended claim 20 and language of “without dispensing more than 10% of the therapeutic product by having the plunger stop spaced from the proximal end of the barrel a distanc3e that corresponds to a predetermined length” Examiner is of the position that this is a functional type claim limitation. Examiner is of the position that the prior art Amgen would be “configured to” perform these functions as this is dose dependent of the amount of fluid in the syringe and the quantality of what is “10%” is a subjective amount dependent on the total liquid of the syringe. It is examiners position that the plunger rod and stop assembly as described in Amgen would be able to carry out the function of “10%” as Amgen plunger and stop move a controlled amount of fluid and this would be dependent on the total amount of initial fluid in the syringe.
Response to Arguments
Applicant's arguments filed 6/25/2026 have been fully considered but they are not persuasive. Applicant’s argue that the amendments to the claims overcome the prior art rejections above. Examiner disagrees.
Concerning the amended claim language of “without dispensing more than 10% of the therapeutic product by having the plunger stop spaced from the proximal end of the barrel a distanc3e that corresponds to a predetermined length” Examiner is of the position that this is a functional type claim limitation. Examiner is of the position that the prior art Amgen would be “configured to” perform these functions as this is dose dependent of the amount of fluid in the syringe and the quantality of what is “10%” is a subjective amount dependent on the total liquid of the syringe. It is examiners position that the plunger rod and stop assembly as described in Amgen would be able to carry out the function of “10%” as Amgen plunger and stop move a controlled amount of fluid and this would be dependent on the total amount of initial fluid in the syringe.
Examiner is of the position that the prior art Amgen would be “configured to” perform these functions as this is dose dependent of the amount of fluid in the syringe and the quantality of what is “10%” is a subjective amount dependent on the total amount chosen as a dosage in the device. It is examiners position that the plunger rod and stop assembly as described in Amgen would be able to carry out the function Amgen plunger and stop move a controlled amount of fluid.
Again, Examiner is of the position that the prior art AMGEN (and Rollo) does disclose this configuration and movement of the plunger rod and fluid from the syringe barrel. See figure 1 which shows space near 42 that the plunger rod may move to dispense a specific volume from the syringe barrel headspace. Also see para [0029] which states “[0029] Stated another way, by configuring the plunger rod 40 to have a predetermined length between the distal end 42 and the stop 54 that corresponds to a desired portion of the barrel 14, the syringe 10 can be preconfigured to dispense a specific volume of fluid. Advantageously, this can be utilized to avoid the problems associated with headspace within conventional prefilled syringes by limiting a dispensing operation to a volume that prevents the air 52 from being expelled…”. Alternatively see Rolla figure 1 which shows space near 51 that the plunger rod may move to dispense a specific volume from the syringe barrel headspace.
Again, It is recommended that applicant greater amend the claims to overcome the prior art of record and any obvious modifications thereof.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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