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 .
Response to Arguments
Applicant's arguments filed 10/21/2025 have been fully considered.
Regarding the 112 rejection, Applicant’s arguments are convincing. The amendment to the claim overcomes the rejection and the rejection is therefore withdrawn.
Regarding the rejection of claim 22 over Odell, Applicant argues that the method of manufacturing the syringe includes the steps of providing or obtaining a specification of standard syringe dimensions according to ISO-11040-4. The examiner agrees that Odell fails to disclose this specific standard. Therefore, the rejection is withdrawn. However, upon further consideration, a new rejection is made in view of Skufca (US 10,576,208) which teaches the steps of obtaining standards according to ISO-11040-4 in order to determine the desired syringe volume and then adjusting the length of the syringe barrel to achieve the desired volume (col. 6, lines 1-43).
Regarding the rejection of claims over Odell, Reinhard, Elias, and/or Sugo, Applicant argues that Odell fails to disclose a syringe having a reservoir having a nominal volume of 3mL and an inner diameter equal to the standard inner diameter of a 5mL syringe wherein ISO 11040-4 indicates the standard inner diameter of the 5mL syringe. The examiner agrees that this is not explicitly disclosed by Odell as Odell discloses a 3 mL syringe having a diameter of a standard 10 mL syringe. As discussed in the prior Office action, Applicant has not provided criticality to specifically a 10 mL syringe, rather describing that any standard size other than the nominal size is contemplated. With regard to the ISO 11040-4 standard, Reinhard teaches this standard as discussed in the prior Office action, and further, in light of the amendment, Skufca is now cited to teach this standard specifically for use in providing a syringe having a standard diameter and a different nominal volume.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3, 5, , 6, 10, 12, 22, , 29, 32, , 40, 41, 43, 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Odell et al (US 7,682,342) in view of Skufca (US 10,576,208).
Regarding claim 1, Odell discloses a syringe 55 comprising a reservoir having a nominal volume of 3 mL (fig. 8; col. 6, lines 6-8), and a wall comprising a cylindrical portion (fig. 8). Claim 1 calls for the cylindrical portion to have an inner diameter and an outer diameter equal to or approximately equal to those of a standard 5 mL syringe. Odell discloses that the inner diameter and outer diameter of the 3 mL syringe are approximately equal to those of a standard 10 mL syringe (col. 7, lines 53-58; fig. 8), thereby making the diameter of the 3 mL syringe larger which has a variety of benefits such as providing a similar injection force across all syringe sizes (col. 6, lines 33-38) and providing a smaller volume syringe that has a larger surface area for printed instruction or description of syringe contents (col. 6, lines 11-15). Claim 1 differs from Odell in calling for the inner and outer diameters of the 3 mL syringe to be equal to or approximately equal to those of a 5 mL syringe. Applicant has not provided criticality to specifically the 5 mL syringe. The disclosure describes that the 3 mL syringe may have diameters equal to or approximately equal to a standard 5 mL syringe or a standard inner and outer diameter of “any other syringe volume not equal to the preselected volume or 3mL” (spec. page 1, para. 0005). Therefore, it is understood that the specific volume of the syringe is not critical, but rather that the 3 mL syringe conforms to the diameters of another standard syringe of a different volume. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the 3 mL syringe of Odell to have an inner diameter and outer diameter equal to or approximately equal to those of a standard 5 mL syringe because Odell teaches that a 3 mL syringe can have inner and outer diameters equal to or approximately equal to a standard larger volume syringe to provide consistent injection pressures across a variety of syringe volumes and to provide more surface area on the 3 mL syringe for printed material, and Applicant has not provided criticality to specifically the 5 mL syringe. Further, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A). In this case, the difference between syringe of Odell and the claimed invention is the diameter of the syringe corresponding to a standard 5 mL syringe rather than a standard 10 mL syringe as taught by Odell. Changing the diameter would not result in a syringe that performs differently than the prior art device. therefore, in light of this and the teachings of Odell and Skufca, the claimed invention is not patentably distinct from the prior art.
Claim 1 calls for ISO 11040-4 to indicate the standard diameter of the 5 mL syringe. Skufca teaches that ISO 11040-4 is a standard used to standardize the inner diameter, outer diameter, and length of syringes having a nominal volume such that the syringes are sized for use with other elements (col. 5, line 23 – col. 5, line 43). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe of Odell to be sized based on standards defined by ISO 11040-4, as taught by Skufca so that the syringes can be readily used with other elements of the system as each element is sized according to the same standard.
Regarding claim 3, the Odell in view of Skufca teaches syringes conforming to the standards provided in ISO 11040-4 as noted above with regard to claim 1. ISO 11040-4 describes a 5 mL syringe having an inner diameter of 11.85 mm and an outer diameter of 14.45 mm (see BS ISO 11040-4:2015 Table 1 – Syringe barrel dimensions as provided by Applicant). As discussed above, it would have been obvious to modify the 3 mL syringe of Odell to have the dimensions of a standard 5 mL syringe. Therefore, the modified 3 mL syringe has the dimensions as claimed as these are the standard 5 mL syringe dimensions.
Regarding claim 5, the syringe of Odell necessarily has a first length measured between a proximally facing inner surface of the wall and a proximally facing outer surface of the wall.
Regarding claim 6, Odell teaches that the 3 mL syringe has a larger diameter than a standard 3 mL syringe as discussed above with regard to claim 1. The result is that the syringe has a length less than a standard 3 mL syringe as is required for a container with the same volume and a larger diameter per the rules of geometry. Additionally, applicant has not provided criticality to the claimed length and it is understood that the length is the result of the desired volume of the syringe and the desire diameter, as the volume of a cylinder is dependent upon the length and the diameter.
Regarding claim 10, the 3 mL syringe of Odell necessarily has a second length measured between a distally facing outer surface of the wall and a proximally facing outer surface of the wall (fig. 5). Odell fails to disclose the specific length. Applicant has not provided criticality to this length. It is noted that the second length is equal to the claimed first length plus the length of the syringe tip. As shown in the ISO 11040-4 standard provided by Applicant, the standard tip has a length of about 8 mm. Therefore, the syringe taught by Odell above with regard to claim 6 and having a standard syringe tip would result in the second length being as claimed. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the 3 mL syringe of Odell to have a second length as claimed because doing so would conform with the accepted standard lengths of the syringe tip so that that syringe can engage with other standard components.
Regarding claim 12, Odell discloses that the syringe has a needle (fig. 6), and the syringe necessarily has a third length measured between the distal end of the needle and a proximal facing outer surface of the wall (fig. 6), but fails to specifically disclose the distance. Applicant has not provided criticality to this distance. It is well known in the art to provide needles having different lengths to meet the needs of a particular use. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the needle of Odell such that the third length is as claimed because Applicant has not provided criticality to this particular needle length and a wide range of needle lengths are known in the art to achieve the desired purpose of the syringe.
Regarding claim 22, Odell discloses a syringe having a nominal volume of 3 mL (fig. 8), the syringe is necessarily manufactured, the syringe has dimensions according to typical commercially available syringes (col.1, 60-65), wherein the syringe volume indicated by the specification for the selected standard does not equal the nominal volume (col. 7, lines 53-58; fig. 9: 3 mL, 5 mL, 10 mL volume syringes all having the diameter of a standard 10 mL syringe).
Claim 22 calls for the step of providing or obtaining a specification of standard syringe dimensions, the specification comprising ISO 11040-4, wherein ISO 11040-4 indicates for each of a plurality of syringe volumes at least one of a plurality of standard diameters and a plurality of standard lengths, and selecting a standard diameter of a 5 mL syringe where ISO 11040-4 indicates the standard diameter of the 5 mL syringe. Skufca teaches that ISO 11040-4 obtained as a standard used to standardize the inner diameter, outer diameter, and length of syringes having a nominal volume such that the syringes are sized for use with other elements (col. 5, line 23 – col. 5, line 43). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Odell to include obtaining standards defined by ISO 11040-4, and choosing the diameter of the syringe according to those standards as taught by Skufca so that the syringes can be readily used with other elements of the system as each element is sized according to the same standard.
Claim 22 calls for the inner diameter of the syringe to be approximately equal to a standard diameter of a 5 mL syringe. Odell teaches that syringes with nominal volumes of 3 mL, 5 mL, and 10 mL all have a diameter according to a typical 10 mL syringe (col. 7, lines 53-58; fig. 8). This allows the syringes to have the same pressure characteristics regardless of the volume. Skufca teaches that the length of a syringe barrel can be adjusted so that the syringe provides the desired filling volume while maintaining the diameter as defined by ISO 11040-4 (col. 6, lines 14-43). Therefore, it is known in the art to provide a syringe having a nominal volume wherein the diameter of the syringe corresponds to a standard size for a different nominal volume, and the nominal volume is achieved by adjusting the length of the barrel and not the diameter. However, the prior art does not specifically teach the nominal volume being 3 mL and the diameter corresponding to the standard diameter of a 5 mL syringe. However, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A). In this case, the difference between the device defined by the method of Odell in view of Skufca discussed above and the claimed invention is the diameter of the syringe corresponding to a standard 5 mL syringe rather than a standard 10 mL syringe as taught by Odell. Changing the diameter would not result in a syringe that performs differently than the prior art device. therefore, in light of this and the teachings of Odell and Skufca, the claimed invention is not patentably distinct from the prior art.
Regarding claim 29, Odell discloses that the length of the syringe is selected such that it is less than a standard length indicated by the specification of the nominal volume (fig. 9: volume of a cylinder is defined by the length and the diameter, therefore when Odell discloses that the nominal 3 mL syringe has a diameter that is greater than the specification for a 3 mL syringe, the length must necessarily be shorter than the specification to achieve the desired volume). Further, Skufca teaches that the barrel length may be adjusted to provide the desired filling volume (col. 6, lines 41-43). Such a calculation would be well understood by a person of ordinary skill in the art based on basic geometric principles.
Regarding claim 32, Odell discloses that the plurality of standard diameters correspond to a plurality of standard outer and/or inner diameters (fig. 9).
Regarding claim 40, Odell discloses a syringe 55 comprising a reservoir configured to be filled with a 3 mL volume of fluid (fig. 8; col. 6, lines 6-8; “configured to be filled with a … dose of drug” is interpreted to be a functional limitation – the syringe of Odell is capable of being filled with any fluid including a dose of medication), and a wall comprising a cylindrical portion and a flange 56 (fig. 8). Claim 40 calls for the cylindrical portion to have at least one of an inner diameter or an outer diameter equal to or approximately equal to those of a standard 5 mL syringe or a flange having an outer diameter of 18 mm. Odell discloses that the inner diameter and outer diameter of the 3 mL syringe are approximately equal to those of a standard 10 mL syringe (col. 7, lines 53-58; fig. 8), thereby making the diameter of the 3 mL syringe larger which has a variety of benefits such as providing a similar injection force across all syringe sizes (col. 6, lines 33-38) and providing a smaller volume syringe that has a larger surface area for printed instruction or description of syringe contents (col. 6, lines 11-15). Claim 1 differs from Odell in calling for the inner and outer diameters of the 3 mL syringe to be equal to or approximately equal to those of a 5 mL syringe. Applicant has not provided criticality to specifically the 5 mL syringe. The disclosure describes that the 3 mL syringe may have diameters equal to or approximately equal to a standard 5 mL syringe or a standard inner and outer diameter of “any other syringe volume not equal to the preselected volume or 3mL” (spec. page 1, para. 0005). Therefore, it is understood that the specific volume of the syringe is not critical, but rather that the 3 mL syringe conforms to the diameters of another standard syringe of a different volume. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the 3 mL syringe of Odell to have an inner diameter and outer diameter equal to or approximately equal to those of a standard 5 mL syringe because Odell teaches that a 3 mL syringe can have inner and outer diameters equal to or approximately equal to a standard larger volume syringe to provide consistent injection pressures across a variety of syringe volumes and to provide more surface area on the 3 mL syringe for printed material, and Applicant has not provided criticality to specifically the 5 mL syringe. Further, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A). In this case, the difference between syringe of Odell and the claimed invention is the diameter of the syringe corresponding to a standard 5 mL syringe rather than a standard 10 mL syringe as taught by Odell. Changing the diameter would not result in a syringe that performs differently than the prior art device. therefore, in light of this and the teachings of Odell and Skufca, the claimed invention is not patentably distinct from the prior art.
Regarding claim 41, Odell discloses that the distal end of the syringe includes a needle (fig. 6).
Regarding claim 43, the syringes of Odell appear to conform to the standards provided in ISO 11040-4 as noted above with regard to claim 40. ISO 11040-4 describes a 5 mL syringe having an inner diameter of 11.85 mm and an outer diameter of 14.45 mm (see BS ISO 11040-4:2015 Table 1 – Syringe barrel dimensions as provided by Applicant). As discussed above, it would have been obvious to modify the 3 mL syringe of Odell to have the dimensions of a standard 5 mL syringe. Therefore, the modified 3 mL syringe has the dimensions as claimed as these are the standard 5 mL syringe dimensions.
Regarding claim 44, Odell discloses a syringe 55 comprising a reservoir configured to be filled with a 3 mL volume of fluid (fig. 8; col. 6, lines 6-8; “configured to be filled with a … dose of drug” is interpreted to be a functional limitation – the syringe of Odell is capable of being filled with any fluid including a dose of medication), and a wall comprising a cylindrical portion (fig. 8). Claim 40 calls for the cylindrical portion to have at least one of an inner diameter or an outer diameter equal to or approximately equal to those of a standard 5 mL syringe. Odell discloses that the inner diameter and outer diameter of the 3 mL syringe are approximately equal to those of a standard 10 mL syringe (col. 7, lines 53-58; fig. 8), thereby making the diameter of the 3 mL syringe larger which has a variety of benefits such as providing a similar injection force across all syringe sizes (col. 6, lines 33-38) and providing a smaller volume syringe that has a larger surface area for printed instruction or description of syringe contents (col. 6, lines 11-15). Claim 1 differs from Odell in calling for the inner and outer diameters of the 3 mL syringe to be equal to or approximately equal to those of a 5 mL syringe. Applicant has not provided criticality to specifically the 5 mL syringe. The disclosure describes that the 3 mL syringe may have diameters equal to or approximately equal to a standard 5 mL syringe or a standard inner and outer diameter of “any other syringe volume not equal to the preselected volume or 3mL” (spec. page 1, para. 0005). Therefore, it is understood that the specific volume of the syringe is not critical, but rather that the 3 mL syringe conforms to the diameters of another standard syringe of a different volume. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the 3 mL syringe of Odell to have an inner diameter and outer diameter equal to or approximately equal to those of a standard 5 mL syringe because Odell teaches that a 3 mL syringe can have inner and outer diameters equal to or approximately equal to a standard larger volume syringe to provide consistent injection pressures across a variety of syringe volumes and to provide more surface area on the 3 mL syringe for printed material, and Applicant has not provided criticality to specifically the 5 mL syringe. Further, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A). In this case, the difference between syringe of Odell and the claimed invention is the diameter of the syringe corresponding to a standard 5 mL syringe rather than a standard 10 mL syringe as taught by Odell. Changing the diameter would not result in a syringe that performs differently than the prior art device. therefore, in light of this and the teachings of Odell and Skufca, the claimed invention is not patentably distinct from the prior art.
Claim(s) 15, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Odell in view of Skufca as applied to claim 12 above, and further in view of Elias (US 3,380,452).
Claim 15 calls for a removable sterile barrier covering the needle, wherein the syringe has a fourth length measure between the distally facing outer surface of the removable sterile barrier and a proximally facing outer surface of the wall, the length being equal to or approximately equal to 80 mm. Odell fails to disclose the sterile barrier. Elias teaches a syringe having a needle covered with a sterile barrier 40 to ensure that the needle remains sterile before use and to prevent accidental sticks (col. 5, lines 36-40; fig. 5). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Odell to include a sterile barrier as taught by Elias so that the needle remains sterile prior to use and to prevent accidental sticks. As discussed above, claim 12 is obvious over Odell. The fourth length recited in claim 15 includes the third length recited in claim 12 plus the length that the cap extends beyond the needle (see fig. 4 of the instant invention). Applicant has not provided criticality to this distance nor the fourth length. Elias shows that the cap extends a small distance beyond the distal tip of the needle (fig. 5). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle cap of Odell in view of Elias so that the cap extends approximately 5 mm beyond the tip of the needle, thereby resulting in the fourth length as claimed because Applicant has not provided criticality to this dimension and this cap configuration allows the sharp tip of the needle to be protected without adding unnecessary bulk to the needle and cap.
Regarding claim 16, the modified Odell in view of Elias described above with regard to claim 15 includes a sterile barrier and necessarily has a fifth length measured between a distally facing outer surface of the removable sterile barrier and a proximally facing outer surface of the removable sterile barrier, but fails to teach that the length is equal to or approximately equal to 25.1 mm. Applicant has not provided criticality to this length. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the removable sterile barrier to have a length as claimed because Applicant has not provided criticality to this length and the length of the cap is the result of the length of the underlying needle, and needles of various lengths are well known in the art to achieve the desired function of the needle, and it follows that the cap could similarly have any known length.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Odell in view of Skufca as applied to claim 1 above, and further in view of Sudo (US 2013/0030382).
Regarding claim 21, Odell discloses a stopper 70 disposed at least partially within the cylindrical portion of the wall (fig. 5), but fails to disclose that the stopper has a sixth length being equal to or approximately equal to 10 mm. Sudo teaches a syringe having a stopper wherein the stopper has a length of 10 mm (page 8, para. 0059). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stopper of Odell to have a length of 10 mm as taught by Sudo as this is a suitable length for a stopper to provide a secure sliding seal between the stopper and the syringe barrel. Additionally, it is noted that Applicant has not provided criticality to this particular dimension.
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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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