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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/19/2025 has been entered.
Claim Objections
Claims 2 and 14 are objected to because of the following informalities:
Claim 2 line 4 should read “syringe barrel, and [[a]] the distal end having a retaining member for coupling with the container”
Claim 14 line 2 should read “second position exposes [[a]] the first length of said needle extending from said needle hub”
Claim 14 line 4 should read “to expose [[a]] the second length of said needle when said cap is in the closed position, and where said”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-14 and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites the limitation “the closed position" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 13-14 are rejected due to their dependence on claim 12.
Claim 14 recites the limitation "the closed position" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "the second portion" in line 8. There is insufficient antecedent basis for this limitation in the claim.
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”) or, in the alternative, under 35 U.S.C. 103 as obvious over Neftel et al. (US Patent 5827262 hereinafter “Neftel”) in view of Nelson et al. (US Patent Pub. 20080306439 hereinafter “Nelson”).
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 10c, 10d where the needle extends distal of 14’’, it is interpreted that the needle is capable of extending from a distal end of the connecting member 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).
The examiner believes that the syringe assembly of Neftel would be capable of having a needle extending distal of 14’’ as seen in Figs 10c and 10d of Neftel. However, if it is found that the embodiment of Neftel does not teach the limitation where said needle extends from a distal end of said connecting member, then the examiner believes the combination of Neftel and Nelson would teach the limitation.
Nelson teaches (Fig 10) a connecting member (80) and a needle (88) that extends from a distal end of said connecting member (80).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the needle of Neftel such that it extends from a distal end of said connecting member as taught by Nelson. One of ordinary skill in the art would recognize this as another design that would allow for fluid passage from the container to the adapter/connecting member (Nelson [0064]).
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).
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) 15, 18 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neftel et al. (US Patent 5827262 hereinafter “Neftel”) in view of Foshee et al. (US 20110264037 hereinafter “Foshee”).
Regarding Claim 15, 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.
Foshee (Fig 8) teaches an adapter body (501) comprising a longitudinal opening (540a,b) used to align the syringe barrel in the adapter when in use ([0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the adapter body of Neftel such that it includes a longitudinal opening as taught by Foshee. One of ordinary skill in the art would have been motivated to do so in order to help align the syringe within the adapter (Foshee [0083]).
Regarding Claim 18, the combination of Neftel and Foshee teaches the syringe assembly of claim 15, wherein said body has opposite side walls (side walls forming the longitudinal opening) extending from said body (14”), said side walls (side walls forming the longitudinal opening) having a free end (proximal end forming opening) forming an opening (proximal opening of 15”) with a dimension to slide laterally over the distal end of said syringe barrel (See Figs 11A-11B; proximal part of 14” slides over barrel 12).
Regarding Claim 32, 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.
Foshee (Fig 8) teaches an adapter body (501) comprising a longitudinal opening (540a,b) used to align the syringe barrel in the adapter when in use ([0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the adapter body of Neftel such that it includes a longitudinal opening as taught by Foshee. One of ordinary skill in the art would have been motivated to do so in order to help align the syringe within the adapter (Foshee [0083]).
Allowable Subject Matter
Claims 1-4, 6-8, 10, 19-21 and 27 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 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.
Response to Arguments
Applicant's arguments filed 10/3/2025 have been fully considered but some are not persuasive.
As to the remarks on Pg. 10 line 19 – Pg. 11 line 10, the applicant argues that Neftel does not teach a side opening where the medicament container is inserted within the dimension of the side opening. The examiner does not find this to be persuasive. The recitation of “side opening” is broad, and a distal side opening is considered to read on this recitation. The distal opening of 152 would necessarily have a dimension (the diameter of the opening) and Neftel Figures 11A-11C show how a medicament container is retained within the “side opening”. For these reasons the rejection is maintained.
Applicant’s arguments with respect to claim(s) 15 have been considered but are moot because the new ground of rejection does not rely on any reference 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 NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783