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 § 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) 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vetter et al. (US 6,296,625 B1) in view of Steenhuisen et al. (US 4,801,012).
With regard to claim 11, Vetter discloses a volume limiter device (Fig. 1-4), comprising a top surface (4), a bottom surface (generally at 7.1 in Fig. 2. Noted as generally 7.1 pointing to the outer rim of the device but the bottom surface can also include element 1 as the device as a whole includes element 5 which has a bottom surface depicted as 1 shown below), an opening (5) capable of receiving a plunger of a syringe (use of the term capable implies functional language and therefore the plunger of a syringe is not positively recited and does not need to be taught by the art. The opening must only be able to receive a plunger. However, Vetter does teach that the opening 5 receives a plunger (15, Fig. 5d) of a syringe (1)); wherein the volume limiter is capable of operably connecting to a flange of the syringe (via element 8); wherein the bottom surface of the volume limiter is capable of restricting the longitudinal distance that the plunger can be drawn and limiting the amount of medication that can be drawn from a vial (via the tube 5, the rearward travel of the piston/plunger can be limited such that an exact amount of blood is drawn, Col. 3, lines 15-20; Col 1, lines 51-65).
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However, Vetter does not disclose a retention member that engages with a barrel of the syringe.
Steenhuisen teaches a similar device (Fig. 3, element 16) designed to be attached to a proximal end of a syringe and includes a retention member (18) which is in the form of a sleeve that engages with a barrel (11) of the syringe (Col 3, line 59 to Col 4, line 26).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the volume limiter of Vetter to include an additional retention sleeve as taught by Steenhuisen for the purpose of ensuring a firm locking of the volume limiter to the barrel (Col 3, line 59 to Col 4, line 26).
With regard to claim 12, Vetter discloses wherein the opening comprises a first surface (inner surface of tube 5 is considered the first surface) when the device is attached to the barrel the first surface of the opening engages the plunger (see Fig. 5d).
However, Vetter does not disclose the retention member.
Steenhuisen teaches a similar device (Fig. 3, element 16) designed to be attached to a proximal end of a syringe and includes a retention member (18) which is in the form of a sleeve that engages with a barrel (11) of the syringe (Col 3, line 59 to Col 4, line 26).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the volume limiter of Vetter to include an additional retention sleeve as taught by Steenhuisen for the purpose of ensuring a firm locking of the volume limiter to the barrel (Col 3, line 59 to Col 4, line 26).
With regard to claim 13, Vetter discloses wherein the volume limiter is capable of resiliently shifting on the flange (element 8 snaps on and resiliently slides over the flange, additionally the flange can rotate relative to the volume limiter and would also be considered to resiliently shift on the flange).
With regard to claim 14, Vetter discloses further comprising: a first bottom ledge (first of the two element 8) and a second bottom ledge (second of the two element 8) located on the bottom surface of the volume limiter, wherein the first bottom ledge and the second bottom ledge are capable of allowing the flange of the syringe to transition in between the first bottom ledge and the second bottom ledge (flange is considered to be able to transition between the first and second bottom ledge as the volume limiter is snapped onto each of the flanges of the syringe).
With regard to claim 15, Vetter discloses further comprising a frist flange housing element (see element 7.1 in Fig. 4) that is capable of receiving the flange (see Fig. 2).
With regard to claim 16, Vetter discloses when the volume limiter is attached the first surface of the opening automatically engages the plunger as shown between (Fig. 5a-d).
However, Vetter does not disclose the retention member.
Steenhuisen teaches a similar device (Fig. 3, element 16) designed to be attached to a proximal end of a syringe and includes a retention member (18) which is in the form of a sleeve that engages with a barrel (11) of the syringe (Col 3, line 59 to Col 4, line 26).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the volume limiter of Vetter to include an additional retention sleeve as taught by Steenhuisen for the purpose of ensuring a firm locking of the volume limiter to the barrel (Col 3, line 59 to Col 4, line 26).
With regard to claim 17, Vetter discloses the claimed invention except for the retention member.
Steenhuisen teaches the retention member (18) is capable of causing the volume limiter to resiliently transition on the flange (18 flexes outward to engaged with the barrel and then is snapped back into place into grooves on the barrel to retain the volume limiter on the syringe and therefore is considered to resiliently transition).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the volume limiter of Vetter to include an additional retention sleeve as taught by Steenhuisen for the purpose of ensuring a firm locking of the volume limiter to the barrel (Col 3, line 59 to Col 4, line 26).
With regard to claim 18, Vetter discloses the volume limiter, when connected, automatically limits the amount of medication that can be drawn from the vial (Col. 3, lines 15-20; Col 1, lines 51-65).
However, Vetter does not disclose the retention member.
Steenhuisen teaches the retention member (18) is capable of resiliently securing an operable connection between the volume limiter and the syringe (18 flexes outward to engaged with the barrel and then is snapped back into place into grooves on the barrel to retain the volume limiter on the syringe and therefore is considered to resiliently transition).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the volume limiter of Vetter to include an additional retention sleeve as taught by Steenhuisen for the purpose of ensuring a firm locking of the volume limiter to the barrel (Col 3, line 59 to Col 4, line 26).
With regard to claim 19, Vetter discloses further comprising a first flange housing element ((see at 7.1 in Fig. 4) capable of engaging with the flange (see Fig. 2).
With regard to claim 20, Vetter discloses further comprising a second flange housing element (7.1 opposite to the first 7.1 described in claim 19 above) capable of engaging the flange (see Fig. 2).
Response to Arguments
Applicant's arguments filed 11/14/25 have been fully considered but they are not persuasive. Applicant states the bottom surface does not restrict longitudinal movement of the plunger. Hwoever, element 5 is part of the volume limiter and includes a bottom surface depicted as element 1 in the annotated drawing above which directly contacts and limits the plunger. Further limitations regarding the structure of the bottom surface or the volume limiter itself would be needed to overcome the current rejection.
Applicant also argues the combination with Steenhuisen as the addition of the structures would render the Vetter device non-operable. As shown in Fig below the Steenhuisen reference teaches a flange cap covering over the proximal end of a syringe similar to Vetter and then further includes a portion that wraps around the syringe barrel.
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Below is a figure of how the Steenhuisen reference would be added to the Vetter reference. The lines depicting the barrel contact portions.
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Alternatively, several other references, including the one listed below, could be used in place of Steenhuisen if Applicant disagrees with the Examiner interpretation.
Tabata et al.(US 2012/0109072 A1): Fig. 1 and 2 shows a flange attachment that has a more clear wrap around configuration to attach to the flange as well as contact the barrel at 522. The inner ring of Vetter (5) could still be a part of the flange attachment of Matsumoto in order to provide the plunger limiter.
It does appear that Applicant’s structure differs slightly from the Vetter/Steenhuisen device and thus limitations regarding the retention member could be added to the and claims and could overcome the current rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783