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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/14/26 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, 3-7, 8-18, 20, 22, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothbauer et al. (US 2007/0175538 A1) in view of Okihara et al. (US 2015/0190578 A1) and in further view of LaRose (US 2017/0203046 A1).
With regard to claim 1, Rothbauer discloses A method (Fig. 6a-6c) comprising: providing a syringe (6) including and barrel flange (see top end of syringe 6 in Fig. 6b) and a non-lubricated barrel (no additional lubricants are mentioned in the prior art, thus suggesting a non-lubricated barrel); inserting a non-lubricated stopper (7) into a placement region (see where 7 is placed in Fig. 6a) located at a proximal end of hybrid insertion device (29), the hybrid insertion device including, sealing gasket (30), a conduit (hatched body of 29), and an insertion tube (35); lowering the hybrid insertion device until a distal end of a body of the insertion tube is located a desired distance above a liquid solution located within the syringe (see Fig. 6b); creating a seal between a sealing gasket of the hybrid insertion device and the barrel flange of the syringe (see Fig. 6b); applying a vacuum through a vacuum port (end of pipe 32that is connected to vacuum pump 33, [0052]) fluidly connected to a vacuum gap (formed between the insertion tube 35 and the inside wall of the barrel of the syringe as shown in Fig. 6b) and being located at a distal end of a vacuum chamber portion (pipe 32 forms a chamber) of the hybrid insertion device; translating the stopper through insertion tube and the non-lubricated barrel with an insertion rod (insertion rod 34, see between Fig. 6b and 6c, rod pushes the stopper into the syringe barrel, [0054]) until a desired headspace between a front edge of the sealing rib and a liquid solution located in the non-lubricated cartridge tube is achieved (fig. 6c); retracting the insertion rod away from the hybrid insertion device ([0057]); and retracting the hybrid insertion device away from the non-lubricated barrel ([0057]) wherein the insertion tube (35) has a diameter smaller than an inner diameter of the conduit (29) to form the vacuum gap therebetween (see Annotated Fig below indicating the gap. 31 which is considered the bypass is located between the outer surface of 35 and the inner surface of the conduit 29. The bypass 31 is formed of a tubing 32 that is connected to the vacuum. [0052] describes the bypass 31 as being inside the shaft 29 and the seal 30 and thus takes up a space between the shaft and the insertion tube 35. This space which 31 occupies is considered the vacuum gap and the insertion tube 35 must necessarily have a smaller diameter than the inner diameter of the conduit in order to accommodate for the bypass 31).
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However, Rothbauer does not disclose a sealing rib on the stopper or that the stopper has a polymer layer.
Okihara teaches a similar method for a stopper insertion device (shown in Fig. 4a-4d). Okihara teaches that the stopper has a sealing rib (120 and 122) and further wherein the non-lubricated stopper being at least partially covered by a polymer layer ([0047], PTFE is a polymer).
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 device of Rothbauer to has a stopper with a sealing rib and a polymer layer as taught by Okihara for the purpose of providing a liquid tight seal between the stopper and the barrel of the syringe and also to reduce sliding resistance ([0047]).
However, Rothbauer/Okihara do not teach the gap is circumferential.
LaRose teaches a method for insertion of a stopper similar to Rothbauer and further teaches the use of an insertion tube (Fig. 10a and 10b) where the stopper is placed within the diameter the insertion tube being smaller than the barrel of the syringe such is allowed to escaped as the stopper is placed inside the barrel and can be used with convention vacuum with an insertion pin insert ([0073]). Thus because Rothbauer already teaches the use of a gap to include vacuum for placing a stopper but the gap is not circumferential, the teaches of LaRose can be used to have a diameter smaller than the conduit such that the gap exists circumferentially and not just one side of the insertion tube.
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 device of Rothbauer/Okihara teaches the circumferential gap as taught by LaRose for the purpose of allowing air to escape as the stopper is placed inside the barrel ([0073]).
With regard to claim 3, Rothbauer discloses wherein the hybrid insertion device moves into the barrel without contacting an inner surface of the barrel (see Fig. 6b, insertion tube does not contact inner surface of barrel).
With regard to claim 4, Rothbauer discloses comprising adding the liquid solution (3) to the non-lubricated barrel prior to creating the vacuum seal between the sealing gasket and the barrel flange (see Fig. 6b , [0039]).
With regard to claim 5, Rothbauer discloses wherein the liquid solution is a therapeutic substance ([0010]).
With regard to claim 6, Rothbauer discloses wherein the therapeutic substance contains therein a biologic, a therapeutic compound, or a combination thereof ([0010]).
With regard to claim 8, Rothbauer discloses wherein at least the stopper, the sealing gasket, the conduit, the insertion tube, the syringe barrel, the barrel flange, and the insertion pin are free or substantially free of lubricants (lubricants are not part of the invention disclosed by the prior art and therefore is considered to be lubricant free).
With regard to claim 9, Rothbauer/Okihara teach the claimed invention except for a tapered introduction tube.
LaRose teaches a similar introduction tube (which a part of the hybrid insertion device) (Fig. 10b) wherein a transition zone (1040) in the hybrid insertion device tapers from a placement region ((region above 1042) to the tube body (1010) at a taper angle for transitioning the non-lubricated stopper from the placement region to a proximal end of the barrel (see fig. 10b).
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 device of Rothbauer/Okihara to have a transition zone as taught by LaRose for the purpose of compressing the stopper in order to be able to placed into the syringe barrel ([0080]).
With regard to claim 10, Rothbauer/Okihara disclose the claimed invention except for the taper angle.
LaRose teaches a taper angle is between about 0.1 degree and about 20 degrees ([0080]).
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 device of Rothbauer/Okihara to have a transition zone as taught by LaRose for the purpose of compressing the stopper in order to be able to placed into the syringe barrel ([0080]).
With regard to claim 11, Rothbauer discloses the claimed invention except for a headspace.
Okihara teaches a similar method where a headspace is left between the stopper (112) and the surface of the liquid (110s, see Fig. 4d). While Okihara does not disclose a specific desired range, it would be prima facie obvious to optimize the range of the desired headspace ranges from about 0.1 mm to about 25 mm as doing so would not affect the overall function of the device ([0046]) and is used to equalize the pressure in the syringe barrel ([0046]).
With regard to claim 12, Rothbauer discloses wherein the insertion rod includes a pin tip end (see distal end of rod 34 that has a narrowed pin tip that contacts the stopper) and the non-lubricated stopper contains therein a cavity to receive the pin tip end (see Fig. 6a, where element 7 is pointing).
With regard to claim 13 and 14, Rothbauer/Okihara teach the claimed invention except for an expanded fluoropolymer.
LaRose teaches a stopper having an expanded fluoropolymer layer comprising an expanded polytetrafluoroethylene layer ([0057]-[0058]).
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 device of Rothbauer/Okihara to use an ePTFE as taught by LaRose for the purpose of reducing friction as the stopper slides within the syringe barrel ([0057]).
With regard to claim 15, Rothbauer discloses wherein the hybrid insertion device is positioned above and is aligned with the non-lubricated barrel (see Fig. 6b).
With regard to claim 18, Rothbauer discloses A method (Fig. 6a-6c) comprising: providing a syringe (6) including and barrel flange (see at top end of barrel 6) and a non-lubricated barrel (barrel is considered non-lubricated as the prior art does not teach coating the barrel); inserting an insertion tube (35) into a conduit (hatched portion of 29) of a vacuum chamber (chamber formed by the space within the hatched portion of 29 that holds the insertion tube and the vacuum pipe) to form a hybrid insertion device (Fig. 6a), the insertion tube including a body (inherent), an insertion body and a distal end (inherent); inserting a non-lubricated stopper (7) into a placement region (see where element 7 is located in Fig. 6a) located at a proximal end of the vacuum chamber; lowering the hybrid insertion device until the insertion body of the insertion tube is located a desired distance above a liquid solution located within the non-lubricated barrel (Fig. 6b); creating a seal between a sealing gasket (30) of the vacuum chamber and the barrel flange of the syringe; applying a vacuum through a vacuum port fluidly connected to a vacuum gap and being located at a distal end of the vacuum chamber ([0052]); translating the stopper through insertion tube and the non-lubricated barrel with an insertion rod (3$) until a desired headspace between a front edge of the sealing rib and a liquid solution located in the non-lubricated barrel is achieved ([0055]); retracting the insertion rod away from the hybrid insertion device; and retracting the hybrid insertion device away from the non-lubricated barrel ([0057]) wherein the insertion tube (35) has a diameter smaller than an inner diameter of the conduit (29) to form the vacuum gap therebetween (see Annotated Fig below indicating the gap. 31 which is considered the bypass is located between the outer surface of 35 and the inner surface of the conduit 29. The bypass 31 is formed of a tubing 32 that is connected to the vacuum. [0052] describes the bypass 31 as being inside the shaft 29 and the seal 30 and thus takes up a space between the shaft and the insertion tube 35. This space which 31 occupies is considered the vacuum gap and the insertion tube 35 must necessarily have a smaller diameter than the inner diameter of the conduit in order to accommodate for the bypass 31).
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However, Rothbauer does not disclose a sealing rib on the stopper or that the stopper has a polymer layer.
Okihara teaches a similar method for a stopper insertion device (shown in Fig. 4a-4d). Okihara teaches that the stopper has a sealing rib (120 and 122) and further wherein the non-lubricated stopper being at least partially covered by a polymer layer ([0047], PTFE is a polymer).
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 device of Rothbauer to has a stopper with a sealing rib and a polymer layer as taught by Okihara for the purpose of providing a liquid tight seal between the stopper and the barrel of the syringe and also to reduce sliding resistance ([0047]).
However, Rothbauer/Okihara do not teach the gap is circumferential.
LaRose teaches a method for insertion of a stopper similar to Rothbauer and further teaches the use of an insertion tube (Fig. 10a and 10b) where the stopper is placed within the diameter the insertion tube being smaller than the barrel of the syringe such is allowed to escaped as the stopper is placed inside the barrel and can be used with convention vacuum with an insertion pin insert ([0073]). Thus because Rothbauer already teaches the use of a gap to include vacuum for placing a stopper but the gap is not circumferential, the teaches of LaRose can be used to have a diameter smaller than the conduit such that the gap exists circumferentially and not just one side of the insertion tube.
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 device of Rothbauer/Okihara teaches the circumferential gap as taught by LaRose for the purpose of allowing air to escape as the stopper is placed inside the barrel ([0073]).
With regard to claim 20 and 22, Rothbauer/Okihara teach the claimed invention except for the insertion tube having a specific kutosis. However, it would be prima facie obvious to optimize the kutosis to be less than 8 because the purpose of the insertion to provide low friction to allow for the stopper to slide through easily and thus a lower kutosis would be beneficial to providing the lowered friction.
With regard to claim 23, Rothbauer discloses wherein the vacuum gap (at 31) extends from the seal (30) to the distal end of the vacuum chamber portion (located generally at 33).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothbauer et al. (US 2007/0175538 A1) in view of Okihara et al. (US 2015/0190578 A1) and in further view of LaRose (US 2017/0203046 A1) and Golba (US 5,919,172).
With regard claim 7, Rothbauer/Okihara/LaRose teach the claimed invention except for the vacuum chamber being electropolished, extrude honed, or a combination thereof.
Golba teaches electropolishing as a means to decrease the coefficient of sliding friction (Col 5, lines 38-42). This technique could be used on the vacuum chamber as the purpose is make it easier to move the stopper through the chamber and into the syringe barrel.
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 device of Rothbauer/Okihara/LaRose to be electorpolished as taught by Golba for the purpose of making the sliding of the stopper easier through the insertion tube (Col 5, lines 38-42).
Claim(s) 19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothbauer et al. (US 2007/0175538 A1) in view of Okihara et al. (US 2015/0190578 A1) and in further view of (LaRose (US 2017/0203046 A1) and Minezaki et al. (US 2020/0164147 A1).
With regard to claim 19 and 21, Rothbauer/Okihara/LaRose teach the claimed invention except for the specific surface roughness.
Minezaki teaches average surface roughness of a barrel having a range between 4nm to 25nm ([0041]). Minezaki further teaches that a surface roughness above 25nm causes reduced sealing ability and less than 4nm causes inferior slidability ([0041]). Thus the surface of roughness of the insertion could be optimized to also be in the range taught by Minezaki because the purpose of the insertion tube is to reduce friction in order for a stopper to slide through the insertion tube.
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 device of Rothbauer/Okihara/LaRose to have a surface roughness from about 20nm to about 400nm as taught by Minezaki for the purpose providing optimal slidabiltiy within the insertion tube ([0041]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-23 have been considered but are moot because the new ground of rejection does not rely on the same grounds of rejection applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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
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