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 .
Claims 17-32 are pending in the instant application and in light of the restriction requirement in which claims 19-20 and 27-29 were withdrawn, claims 17-18, 21-26, and 30-32 are examined on the merits herein.
Priority
The instant application is a 371 of PCT/IB2021/050484 filed 01/22/2021 which claims priority to IT/102020000002170 filed 02/04/2020 and IT/102020000001387 filed 01/24/2020.
Claims 17-32 receive priority to the prior-filed application, filed on 01/24/2020.
Response to Arguments
Rejections of the Claims under 35 U.S.C. 103
Applicant's arguments filed 04/27/2026 have been fully considered but they are not persuasive.
Regarding the independent claims, the applicant asserts on pg. 4-7 that the record fails to provide the required evidence of a motivation for a person of ordinary skill in the art to perform the modification of Gargione with Kopfer.
In response to the applicant’s arguments, the examiner respectfully disagrees.
The applicant asserts on pg. 4-5 that Kopfer is directed to a completely different problem such that one skilled in the art would not find any motivation to find any solution to the different technical problem that is solved by the claimed invention. It seems as though the applicant is arguing that Kopfer is not analogous art in view of Kopfer being directed to a different technical problem. The test for analogousness is a two-part test and only one part must be satisfied in the determination of analogousness: relevant field of endeavor and reasonably pertinent. See MPEP 2141.01(a). Kopfer as being a connector for a syringe to a vial adaptor (Fig. 5-6) is considered to be in a relevant field of endeavor to the instant invention in that the instant invention is directed to a connection mechanism for vial adaptors and syringes. One of ordinary skill in the art would not only look to syringes, but would look to anything that connects to a vial adaptor.
Further, the applicant asserts on pg. 5-6 that the Kopfer device never suggests, in order to solve the technical problem of the instant application, providing the prior art to Gargione with the structure that Gargione fails to disclose and that the rejection is based upon impermissible hindsight. The combination of Gargione with the teachings of Kopfer do not have to reflect the technical problem allegedly solved by the invention of the instant application to have a proper motivation to combine. See MPEP 2144(IV). As explained in the Office Action filed 01/27/2026, Kopfer is utilized for a teaching of a connector for a syringe that comprises a connection structure missing from Gargione. Kopfer is considered to be an attachment end of a syringe as it is connected to a syringe for connection to a vial adaptor and stays with the syringe after removal from the vial adaptor (col. 2:18-44), and therefore, Kopfer can be looked to for its structural teachings and motivations. Kopfer provides a motivation to modify a syringe or connector to a syringe that attaches to an adaptor to comprise a more secure connection as a releasable, locked engagement (col 3. ln. 64-67 and col. 4 ln. 1-12). Fisher, the evidentiary reference, further explains that luer slip adaptors, which rely on friction fit, could be improved upon as they can leak fluid if improperly seated (para. 0007). The missing structure from Gargione that is taught by Kopfer provides an improvement upon a connection that is not locked. This reasoning takes into account only the knowledge which was within the level of ordinary skill at the time of the invention as the rejection is based solely upon what Gargione discloses in view of Kopfer and Fisher; therefore the rejection is not based on impermissible hindsight. See MPEP 2145(X)(A).
Further still, the applicant asserts on pg. 6-7 that a person skilled in the art would have no reason to modify Gargione since it is already provided with coupling and sealing means between the insert and the syringe, i.e. the friction fit connection between the syringe and insert and the triangularly shaped leaves formed integrally with the insert opening. As explained in the Office Action filed 01/27/2026, Kopfer teaches that their structural arrangement provides for a locked connection (col. 3 ln. 64-67 and col. 4 ln. 1-12). As explained above, Fisher was brought in as an evidentiary reference to bolster the motivation of Kopfer. The rationale to modify or combine the prior art does not have to be expressly stated in the prior art. See MPEP 2144(I). One of ordinary skill in the art with the knowledge that luer slip adaptors can leak fluid as taught by Fisher would have been motivated to look for a more secure attachment such as that of Kopfer.
Although the form of the rejections have been modified for clarity, none of the citations or motivations have been modified such that there are no new grounds of rejection.
Claim Rejections - 35 USC § 103
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 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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Ex. Fig. 1 of Gargione Fig. 5A-5B
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Ex. Fig. 2 of Kopfer Fig. 4-5
Claims 17-18, 21-26, and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over WO/02085429 A2 to Gargione in view of U.S. Patent no. 5,584,819 A to Kopfer as evidenced by US/2004/0049162 A1 to Fisher.
Regarding claims 17-18, 21, 23, 24, and 31, Gargione discloses
(Claim 17) a dosing syringe (Fig. 2B, syringe assembly 10) comprising: a hollow cylindrical body (Fig. 1, hollow cylindrical body 12) and a plunger configured to slide within the hollow cylindrical body (Fig. 1, elongated plunger 22; pg. 7 ln. 12-22), the hollow cylindrical body comprising a main body and a proximal end provided with an aperture (Ex. Fig. 1 showing main body and proximal end provided with aperture 20);
wherein the proximal end is removable and blocked between a side surface of the adapter and a bottom wall provided with an aperture of the adapter (pg. 7 ln. 2-11 and 19-22 and pg. 8 ln. 1-3; Ex. Fig. 1 showing proximal end snugly seated in interior wall 44 of adaptor 30 and triangular shaped leaves 60 sealed about central aperture 56 of adaptor 30), the aperture of the proximal end and the aperture of the bottom wall being in direct fluid communication therebetween (Ex. Fig. 1 showing aperture 20 of the proximal end in direct fluid communication with central aperture 56 comprising leaves 60);
(Claim 18) wherein said proximal end is hemispherical (Ex. Fig. 1 showing proximal end as generally hemispherical); and
(Claim 23) an adapter for use with the dosing syringe according to claim 17 (Fig. 4A, vial insert 30 as an adaptor; Fig. 5A-B showing syringe assembly 10 in use with adaptor 30), comprising a hollow cylindrical body (Fig. 5B, cylindrical body 32 of adaptor 30) and a flange extending from the hollow cylindrical body (Fig. 5B, flange 34 extending from cylindrical body 32); wherein the hollow cylindrical body comprises a bottom wall including an aperture configured to abut against the hemispherical proximal end of the dosing syringe (Fig. 5B, cylindrical body 32 comprising bottom wall 54 including aperture 56 comprising leaves 60 configured to abut against proximal end of syringe assembly 10), and the proximal end of the hollow cylindrical body contacting adaptor above the bottom wall (Fig. 5A-B showing proximal end of hollow cylindrical body in contact with adaptor 30 above bottom wall 54).
Gargione differs from the instantly claimed invention in that Gargione fails to disclose
(Claim 17) wherein the main body that has at least one portion having a cross-section smaller than that of the proximal end, wherein a surface is delimited between the main body and the proximal end, which is configured to abut against a corresponding surface of an adaptor;
(Claim 18) wherein said main body comprises at least one groove formed on an external surface of the main body that extends along a perimeter length of the main body immediately above said abutment surface and at an end of the major axis of the cross-section of the main body;
(Claim 21) wherein said surface between the main body and the proximal end, for abutment against the adapter, is orthogonal or inclined with respect to a longitudinal axis of main body;
(Claim 23) an annular tooth extending internally to an adaptor body which delimits an annular surface configured to abut against the abutment surface of the main body;
(Claim 24) wherein said annular tooth is complementary to that of at least one groove formed in the hollow cylindrical body of the dosing syringe;
(Claim 31) wherein the annular surface of the annular tooth is orthogonal or inclined with respect to a longitudinal axis of the adapter.
Kopfer teaches a connector for a syringe
(Claim 17) that has at least one portion having a cross-section smaller than that of the proximal end (Ex. Fig. 2 showing main body of needle hub 11 having groove 14 smaller than some sections of the proximal end of needle hub 11), wherein a surface is delimited between the main body and the proximal end, which is configured to abut against a corresponding surface of an adaptor (Ex. Fig. 2 showing abutment surface configured to abut against annular rim 24/24’ on adaptor 20), so that the proximal end is removable (col. 4 ln. 8-12);
(Claim 18) wherein said main body comprises at least one groove formed on an external surface of the main body that extends along a perimeter length of the main body immediately above said abutment surface and at an end of the major axis of the cross-section of the main body (col. 3 ln. 64-67 and col. 4 ln. 1-12; Ex. Fig. 2 showing main body of needle hub 11 having groove 14 extending along perimeter of main body immediately above abutment surface and around the cross-section of the main body);
(Claim 21) wherein said surface between the main body and the proximal end, for abutment against the adapter, is orthogonal or inclined with respect to a longitudinal axis of main body (Ex. Fig. 2 showing abutment surface inclined to a longitudinal axis of the main body of needle hub 11);
(Claim 23) an annular tooth extending internally to an adaptor body which delimits an annular surface configured to abut against the abutment surface of the main body (Ex. Fig. 2 showing annular tooth 24/24’ extending internally delimiting an annular surface that abuts against abutment surface);
(Claim 24) wherein said annular tooth is complementary to that of at least one groove formed in the hollow cylindrical body of the dosing syringe (Ex. Fig. 2 showing annular tooth 24/24’ has shape complementary to groove 14);
(Claim 31) wherein the annular surface of the annular tooth is orthogonal or inclined with respect to a longitudinal axis of the adapter (Ex. Fig. 2 showing annular surface of annular tooth 24/24’ inclined to longitudinal axis of the main body of needle hub 11); and
wherein the connection means of provides for a releasable, locked engagement (col. 3 ln. 64-67 and col. 4 ln. 1-12).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the main body and adaptor of Gargione to comprise the connection means as taught by Kopfer, because Kopfer teaches that this provides for a releasable, locked engagement (col. 3 ln. 64-67 and col. 4 ln. 1-12), which would provide further security to the friction-fit connection of Gargione’s syringe and adaptor when filling the syringe.
Fisher provides evidence that a luer slip adaptor, such as that of Gargione, could be improved upon as it allows for motion and loosening between the syringe and the device (para. 0004) and can leak fluid if improperly seated (para. 0007).
In the modification of Gargione with Kopfer, the dosing syringe of Gargione would comprise all of the connection mechanisms of the body of the connector of the syringe as taught by Kopfer and the adaptor of Gargione would comprise all of the connection mechanisms of the adaptor as taught by Kopfer; therefore, the groove (14) of Kopfer would be considered the portion of the main body of Gargione that has a smaller cross-section than the proximal end, the abutment surface (Ex. Fig. 2) of Kopfer would be considered the surface of Gargione that is delimited between the main body and proximal end, and the annular tooth (24/24’) of Kopfer would be considered the corresponding surface of the adaptor of Gargione.
The prior art differ from the instantly claimed invention in that they fail to disclose (Claim 18) wherein the main body has an elliptical cross-section.
It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main body to define an elliptical cross-section, since a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04(IV)(B). In the device as modified, the main body of the syringe would have an elliptical cross-section.
Regarding claim 22, the combination of Gargione and Kopfer suggests the invention of claim 18; however, the prior art differ from the instantly claimed invention in that they fail to disclose wherein said at least one groove comprises two grooves, each of the grooves extending at a respective end of the major axis of the elliptical cross-section of the main body.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to have duplicated the groove to comprise two grooves since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See MPEP 2144.
Regarding claim 25, the cited prior art suggests the invention of claim 23. Gargione further discloses: wherein said aperture has a diameter different from the diameter of the aperture of the proximal end of the dosing syringe (Fig. 5B showing central aperture 56 having a different size than that of discharge opening 20; Fig. 5B showing triangular shaped leaves 60 covering central aperture 56 allowing for different sized opening based on pressure put on triangular shaped leaves 60) and is coaxial and in direct fluid communication with the aperture of the proximal end of the dosing syringe (Fig. 5B showing central aperture 56 coaxial with and in direct fluid communication with discharge opening 20), and wherein the dosing syringe is coupled to the adapter (Fig. 5A showing coupled engagement between 10 syringe assembly and 30 adaptor).
Regarding claim 26, the cited prior art suggests the invention of claim 23. The combination of the art further suggests wherein the distance between the aperture of the bottom wall and the annular surface of the annular tooth is smaller than the distance between the aperture of the proximal end and the abutment surface of the dosing syringe as the aperture of the proximal end of the syringe (20) passes through the central aperture (56) of the bottom wall of the adaptor of Gargione such that the proximal end aperture is below the central aperture and the abutment surface (Ex. Fig. 2) and annular surface of the annular tooth (Ex. Fig. 2) of Kopfer are in direct overlapping connection.
Regarding claim 30, the cited prior art suggests the invention of claim 23. Gargione further discloses: wherein said bottom wall is arched upwards, so that when the dosing syringe is coupled to the adapter, an interspace is delimited between the proximal end and the bottom wall (Ex. Fig. 1 showing 54 bottom wall flared upwards to delimit a space between the proximal end and 54 bottom wall when 10 syringe assembly and 30 adaptor are in coupling arrangement).
Regarding claim 32, Gargione discloses a kit for administering a product in liquid or semi-liquid form (pg. 3; Fig. 5A showing syringe assembly 10 and adaptor 30) comprising a dosing syringe (Fig. 2B, syringe assembly 10) comprising: a hollow cylindrical body (Fig. 1, hollow cylindrical body 12) and a plunger sliding within the hollow cylindrical body (Fig. 1, elongated plunger 22; pg. 7 ln. 12-22), the hollow cylindrical body comprising a main body and a proximal end provided with an aperture (Ex. Fig. 1 showing main body and proximal end provided with aperture 20);
wherein the proximal end is removable and blocked between a side surface of the adapter and a bottom wall provided with an aperture of the adapter (pg. 7 ln. 2-11 and 19-22 and pg. 8 ln. 1-3; Ex. Fig. 1 showing proximal end snugly seated in interior wall 44 of adaptor 30 and triangular shaped leaves 60 sealed about central aperture 56 of adaptor 30), the aperture of the proximal end and the aperture of the bottom wall being in direct fluid communication therebetween (Ex. Fig. 1 showing aperture 20 of the proximal end in direct fluid communication with central aperture 56 comprising leaves 60) and
the adaptor comprises a hollow cylindrical body (Fig. 5B, cylindrical body 32 of adaptor 30) and a flange extending from the hollow cylindrical body (Fig. 5B, flange 34 extending from cylindrical body 32);
wherein the hollow cylindrical body comprises a bottom wall including an aperture configured to abut against the hemispherical proximal end of the dosing syringe (Fig. 5B, cylindrical body 32 comprising bottom wall 54 including aperture 56 comprising leaves 60 configured to abut against proximal end of syringe assembly 10)
Gargione differs from the instantly claimed invention in that Gargione fails to disclose the main body that has at least one portion having a cross-section smaller than that of the proximal end, wherein a surface is delimited between the main body and the proximal end, which is configured to abut against a corresponding surface of an adaptor, and the adaptor comprising an annular tooth extending internally to the hollow cylindrical body, and which delimits an annular surface configured to abut against the abutment surface.
Kopfer teaches a connector for a syringe that has at least one portion having a cross-section smaller than that of the proximal end (Ex. Fig. 2 showing main body of needle hub 11 having groove 14 smaller than some sections of the proximal end of needle hub 11), wherein a surface is delimited between the main body and the proximal end, which is configured to abut against a corresponding surface of an adaptor (Ex. Fig. 2 showing abutment surface configured to abut against annular rim 24/24’ on adaptor 20), and an adaptor comprises an annular tooth extending internally to the hollow cylindrical body and above the bottom wall, and which delimits an annular surface configured to abut against the abutment surface of the hollow cylindrical body of the dosing syringe (Ex. Fig. 2 showing annular tooth 24/24’ extending internally delimiting an annular surface that abuts against abutment surface).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the main body and adaptor of Gargione to comprise the connection means as taught by Kopfer, because Kopfer teaches that this provides for a releasable, locked engagement (col. 3 ln. 64-67 and col. 4 ln. 1-12), which would provide further security to the friction-fit connection of Gargione’s syringe and adaptor when filling the syringe.
Fisher provides evidence that a luer slip adaptor could be improved upon as it allows for motion and loosening between the syringe and the device (para. 0004) and can leak fluid if improperly seated (para. 0007).
In the modification of Gargione with Kopfer, the dosing syringe of Gargione would comprise all of the connection mechanisms of the body of the connector of the syringe as taught by Kopfer and the adaptor of Gargione would comprise all of the connection mechanisms of the adaptor as taught by Kopfer; therefore, the groove (14) of Kopfer would be considered the portion of the main body of Gargione that has a smaller cross-section than the proximal end, the abutment surface (Ex. Fig. 2) of Kopfer would be considered the surface of Gargione that is delimited between the main body and proximal end, and the annular tooth (24/24’) of Kopfer would be considered the corresponding surface of the adaptor of Gargione.
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 Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
23 July 2026
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