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 § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 30-31 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Neftel et al. (US Patent 5827262 hereinafter “Neftel”).
Regarding Claim 30, Neftel teaches (Figs 11a-11c) a syringe assembly comprising:
a syringe barrel (12) having a proximal end (top of Fig 11a) and a distal end (end closest to 10), a needle (34) and needle hub (where needle 34 is attached to in Fig 11c) coupled to said distal end of the syringe barrel;
a sleeve (180) coupled to said distal end of said syringe barrel (See Fig 11a), and
a connecting member (14’’) for sliding on said sleeve (180) between a first position (See Fig 11b) where said needle (34) extends from a distal end of said connecting member (See Fig 11a-11b, where the needle extends distal of portions 158 and 154 of connecting member 14’’, it is interpreted that the 158 and 154 are the distal end of the connecting member 14’’, and in Fig 11a and Fig 11b the needle 34 is extending from the distal end 158/154 of 14’’) and a second position (Fig 11a, this potion will occur between 11B and 11C as syringe 12 is removed) covering said needle (34), and where said connecting member (14’’) is configured for connecting to a medication container (10) and supporting the medication container when said syringe barrel and the needle slide relative to said connecting member to pierce a septum (22) on the medication container (10),
wherein said connecting member (14’’) includes a collar (152), said collar having an open side with a dimension for receiving medication container (10) by sliding laterally into a cavity of said connecting member (see Figs 11a-11b, the container 10 fits within cavity of 152).
Regarding Claim 31, Neftel teaches (Figs 11a-11c) the syringe assembly of claim 30, and wherein said collar has an inwardly extending detent for engaging said medication container (see most distal portion of 152 which engages container 10).
Allowable Subject Matter
Claims 1-4, 6-8, 10, 15, 18-21, 27 and 32 are allowed.
Claims 12-14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 29 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding independent claim 1, the prior art fails to disclose singly or in combination before the effective filing date the claimed syringe assembly.
The closest prior art of record is Davidson et al. (US Patent 5279582 hereinafter “Davidson”). Davidson teaches (Figs 1-2, and Fig 7) a syringe assembly comprising:
a syringe barrel (12) having a proximal end (where 14 points to) and a distal end (where needle 16 is attached), a needle (16) and a needle hub (13, 22) coupled to said distal end of said syringe barrel (12); and
a connecting member (18) positioned on said syringe barrel (12) for sliding on said syringe barrel between a first position (Fig 7) where said needle (16) and said needle hub extend from a distal end (Fig 7; "D") of said connecting member (18) and a second position (Fig 1) covering said needle (16), and where said connecting member (18) is configured for connecting to a medication container See Fig 2, container "B") when said connecting member (18) is in said second position and supporting the container when said needle is advanced relative to said connecting member to pierce a septum on said container (See Fig 2, the needle extends into the bottle B, thus is in the second position as the needle is extending past the connecting member 18).
Davidson does not teach a sleeve positioned on said distal end of said syringe barrel, wherein said connecting member is slidably mounted on said sleeve. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify Davidson to satisfy these limitations.
Claims 2-4 and 6-8 are dependent on claim 1.
Regarding independent claim 10, the prior art fails to disclose singly or in combination before the effective filing date, the claimed syringe assembly.
The closest prior art of record is Thorne et al. (US Patent 6254575). Thorne teaches (Fig 27- 28) a syringe assembly comprising:
a syringe barrel (702) having a proximal end (end furthest away from 900) and distal end (end closest to where 540’ points to), a needle (40) and needle hub (540) coupled to said distal end of said syringe barrel (702); and
an adapter (708) having a body coupled to said distal end of said syringe barrel (see Fig 27) and a cap (600) hinged (602) to said body; said cap (600) having a first position to expose a first position of said needle have a first length extending from said body (Fig 12) and a second position (Figs 10-11) to cover the distal end of the syringe barrel to expose a second portion of said needle having a second length less than said first length (needle in Fig10 has an exposed length less than Fig 12).
Thorne does not teach the cap being pivotable between the first position to the second position. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify Thorne to satisfy these limitations.
Regarding independent claim 15, the prior art fails to disclose singly or in combination before the effective filing date, the claimed syringe assembly.
The closest prior art of record is Neftel et al. (US Patent 5827262 hereinafter “Neftel”). Neftel teaches (Figs 10a-11c) A syringe assembly comprising:
a syringe barrel (12) having a proximal end (top end of Fig 11A) and a distal end (end closest to 10),
a needle (34) and needle hub (where needle 34 is attached to in Fig 11c) coupled to said distal end of said syringe barrel (12);
an adapter (14”) having a body (outer surface of 14”) coupled to said distal end of said syringe barrel (12), said body having a first cavity (162, 160) having an open proximal end (open end of 180 where needle 34 enters) and a closed distal end (distal end of 160 where needle 34 pierces 166), and defining a needle shield (180) where said first cavity (160, 162) longitudinally fits over said needle (34) to completely cover said needle (See Fig 11A-11B), and where said body has an end wall (166) and an opening (proximal opening of 150) defining a second cavity (cavity within 150 where barrel 12 enters), for sliding laterally over the distal end of the syringe barrel (12) and receiving said syringe barrel (12) and the needle (34), where said end wall (166) has a slot (slot created by needle piercing 166) to slide laterally over said needle (34; necessarily slides “over” needle since slot surrounds needle) whereby said needle projects from the end wall (166) of said body of said adapter (14”; see Fig 11B, needle 34 extends/projects from 166).
Neftel does not specify a longitudinal opening for sliding over the distal end of the syringe barrel. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify Neftel to satisfy these limitations.
Claim 18 is dependent on claim 15.
Regarding independent claim 19, the prior art fails to disclose singly or in combination before the effective filing date, the claimed syringe assembly.
The closest prior art of record is Wesson et al. (US Patent 4994046 hereinafter “Wesson”). Wesson teaches (Figs 7-15) A syringe assembly comprising:
a syringe barrel (40) having a proximal end and a distal end, a needle (44) and needle hub (42) coupled to said distal end of said syringe barrel (40);
and adapter (30) having a body coupled to said distal end of said syringe barrel, said body having a first cavity (annotated Fig 7) having an open proximal end and a closed distal end (See annotated Fig 7.2 which is compared to instant Fig 47), and defining a needle shield where said first cavity longitudinally fits over said needle to cover said needle (See Fig 15), and where said body has an end wall and a longitudinal an opening defining a second cavity for sliding laterally over the distal end of the syringe barrel and receiving said syringe barrel and the needle (Annotated Fig 7 and Figs 14-15 show how 30 slides on distal end of syringe barrel 40) where said end wall has a slot (50; Fig 11) to slide laterally over said needle whereby said needle projects from the end wall of said body of said adapter (See Fig 14, needle projects from 30).
Wesson does not teach or make obvious the syringe assembly wherein said end wall is coupled to said side walls to close said longitudinal opening in combination with the elements of claim 19. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify Wesson to satisfy these limitations.
Claims 20-21 depend on claim 19.
Regarding independent claim 27, the prior art fails to disclose singly or in combination before the effective filing date, the claimed method for aspirating and filling a syringe.
The closest prior art of record is Vedrine et al. (US Patent Pub. 20070060904 hereinafter “Vedrine”). Vedrine teaches (Figs 16-20) A method for aspirating and filling a syringe comprising
providing a syringe barrel (16) having a proximal end and distal end, a needle (4,6) and needle hub (2) coupled to said distal end of said syringe barrel; and an adapter (30) coupled to said distal end of said syringe barrel, said adapter being movable between a first position to expose a first portion of said needle having a first length, and a second position to expose a second portion of said needle having second length (See [0053] teaching 30 slides along 16 , as 30 retracts there will be different positions with different lengths of the needle exposed); piercing a septum on a container (50) by the needle, aspirating the syringe, and removing the needle from the container (See [0040] and [0051]).
Vedrine does not teach and an adapter having a collar coupled to said distal end of said syringe barrel, said adapter having a cover hinged to said collar and being movable between a first position to expose a first portion of said needle having a first length; pivoting said cap of said adapter to the first position to expose the needle; pivoting the cap of the adapter to the second position to expose the second portion of the needle. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify Vedrine to satisfy these limitations.
Regarding independent claim 29, the prior art fails to disclose singly or in combination before the effective filing date, the claimed method for aspirating and filling a syringe.
The closest prior art of record is Vedrine et al. (US Patent Pub. 20070060904 hereinafter “Vedrine”). Vedrine teaches (Figs 16-20) a method for aspirating and filing a syringe subject, comprising
providing a syringe barrel (16) having a proximal end (end closest to where 22 points to in Fig 16) and distal end (end closest to where 21 points to in Fig 16), a needle bearing hub (2) coupled to said distal end of said syringe barrel (16); and an adapter (30) coupled to said distal end of said syringe barrel (16), said adapter being movable between a first position to expose a first portion of said needle having a first length, and a second position to expose a second portion of said needle having second length (see [0053] teaching that 30 slides along 16, as 30 retracts there will be different positions with different lengths of the needle exposed);
moving said adapter to the first position to expose the needle (See Fig 19);
piercing a septum on a container (50) by the needle, aspirating the syringe, and removing the needle from the container (see [0040] and [0051]); and moving the adapter to the second position to expose the second portion of the needle (see [0053] teaching that 30 may retract from an extending position, any position that is more retracted after the syringe has been connected and removed from the container is considered the second position).
Vedrine does not teach or make obvious the method further comprising removing said adapter from said syringe to expose the needle, and replacing the adapter to a position to expose the second portion of the needle. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify Vedrine to satisfy these limitations.
Regarding independent claim 32, the prior art fails to disclose singly or in combination before the effective filing date, the claimed syringe assembly.
The closest prior art of record is Neftel et al. (US Patent 5827262 hereinafter “Neftel”). Neftel teaches (Figs 10a-11c) A syringe assembly comprising:
a syringe barrel (12) having a proximal end (top end of Fig 11A) and a distal end (end closest to 10),
a needle (34) and needle hub (where needle 34 is attached to in Fig 11c) coupled to said distal end of said syringe barrel (12);
an adapter (14”) having a body (outer surface of 14”) coupled to said distal end of said syringe barrel (12), said body having a first cavity (162, 160) having an open proximal end (open end of 180 where needle 34 enters) and a closed distal end (distal end of 160 where needle 34 pierces 166), and defining a needle shield (180) where said first cavity (160, 162) longitudinally fits over said needle (34) to cover said needle (See Fig 11A-11B), and where said body has an end wall (166) and a opening (proximal opening of 150) defining a second cavity (cavity within 150 where barrel 12 enters), separate from said first cavity (160, 162), for sliding laterally over the distal end of the syringe barrel (12) and receiving said syringe barrel (12) and the needle (34), where said end wall (166) has a slot (slot created by needle piercing 166) to slide laterally over said needle (34; necessarily slides “over” needle since slot surrounds needle) whereby said needle projects from the end wall (166) of said body of said adapter (14”; see Fig 11B, needle 34 extends/projects from 166).
Neftel does not specify a longitudinal opening for sliding over the distal end of the syringe barrel. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify Neftel to satisfy these limitations.
Response to Arguments
Applicant's arguments filed 6/24/2026 have been fully considered but some are not persuasive.
As to the remarks on Pg. 10-11, the applicant argues that Neftel does not teach a needle that extends from the distal end of the connecting member. The applicant’s arguments are presuming that the distal end of the connecting member 14’’ of Neftel is at the bottom most portion of 152, however due to the broad nature of the claims (the distal end is not defined to any particular structure of the connecting member), the examiner is taking the interpretation that the distal end of the connecting member is the area of 158 to 154 of connecting member 14’’. The needle extends from the distal end (158, 154) if the connecting member (14’’) in Figures 11a-11b as described in the rejection above. For these reasons the rejection is maintained.
Applicant’s arguments, see Pgs. 12-13, filed 6/24/2026, with respect to claims 15 and 32 have been fully considered and are persuasive. The 35 USC 103 rejections of 3/24/2026 have been withdrawn.
The 112 rejections and claim objections of 3/24/2026 are withdrawn.
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.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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