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 Objections
Claims 9 and 14-15 are objected to because of the following informalities:
Regarding claim 9, the phrase “wherein at least one bypass protrusion arranged“ in lines 1-2 should read “wherein at least one bypass protrusion is arranged” for proper grammar,
Regarding claim 9, the phrase “said syringe barrel” in line 2 should read “said barrel” for consistency,
Regarding claim 14, the phrase “between a drug preparation and between the friction reducing agent in storage” in lines 3-4 should read “between a drug preparation and the friction reducing agent in storage” to remove the second between for proper grammar,
Regarding claim 15, the phrase “are configured to contact the areas of the inner surface that is treated” in lines 2-3 should read “are configured to contact the areas of the inner surface that are treated” for proper grammar.
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.
Claim 16 is 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.
The term “substantially” in claim 16 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the limitation “substantially the entire circumference of the second piston” in lines 1-2 of claim 16 is rendered indefinite because one cannot ascertain the scope of the limitation. Examiner is interpreting this limitation as the entire circumference of the second piston contacts one of the areas of the inner surface that is treated with friction reducing agent.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ballet et al. (W.O Patent Pub. No. 2011092536 A1, “Ballet”).
Regarding claim 1, Ballet discloses (Claim 1) a medical container (1 in Fig. 1-5), comprising:
a barrel (2 in Fig. 5) having an inner surface (inner surface of 2) partially treated with a friction reducing agent (see Fig. 5 and para. 0075 and 0076 – the inner surface of the proximal portion 3F of the barrel is coated with friction reducing agent wherein the inner surface of distal portion 2D is not coated with said friction reducing agent);
the barrel (2) having at least one substance chamber (D, F in Fig. 5, see para. 0072); and
wherein said at least one substance chamber (D, F) defines a portion (3D) of said inner surface (inner surface of 2), which is not treated with said friction reducing agent (see Fig. 5 and para. 0075 – the inner surface of portion 3D of substance chamber D is not treated with said friction reducing agent).
Regarding claim 2, Ballet discloses (Claim 2) the medical container (1 in Fig. 1-5) according to claim 1, and wherein said at least one substance chamber (D, F) defines two substance chambers and at least one of said two substance chambers defines said portion (3D) of said inner surface (inner surface of 2), which is not treated with said friction reducing agent (see Fig. 5 and para. 0075 – the inner surface of portion 3D of substance chamber D is not treated with said friction reducing agent).
Regarding claim 3, Ballet discloses (Claim 3) the medical container (1 of Fig. 1-5) according to claim 1, and wherein a drug preparation is configured to be contained within said at least one substance chamber (D in Fig. 5) confined by a piston (10 in Fig. 5, see para. 0069), and the inner surface (inner surface of 2) defined by said at least one substance chamber (D in Fig. 5) is not treated with friction reducing agent to avoid contact between the drug preparation and the friction reducing agent (see para. 0073-0075 – the friction reducing agent is not applied to the substance chamber D which avoids contact with the drug preparation in substance D), and wherein the remainder of the inner surface (inner surface of 2) of the barrel (2) is treated with friction reducing agent (see Fig. 5 and para. 0075-0076 – the remaining inner surface is portion 3F which is treated with a friction reducing agent).
Regarding claim 4, Ballet discloses (Claim 4) the medical container (1 of Fig. 1-5) according to claim 1, wherein said friction reducing agent is a lubricant (see para. 0077-0078 – the friction reducing agent may be silicone oil, baked silicone, or other forms of lubricants).
Regarding claim 5, Ballet discloses (Claim 5) the medical container (1 of Fig. 1-5) according to claim 1, wherein said friction reducing agent is a coating substance (see para. 0075-0077 – the substance applied to the portion 3F is a coating).
Regarding claim 6, Ballet discloses (Claim 6) the medical container (1 of Fig. 1-5) according to claim 3, wherein partial treatment of the inner surface (inner surface of 2) of the barrel (2) with friction reducing agent provides both for reduced friction forces between the barrel (2) and the piston (10) and for avoiding damage of the drug preparation during storage, due to lack of contact between the treated area of the barrel (2) and the drug preparation (see para. 0073-0075 – only treating portion 3F with friction reducing agent reduces friction forces for the piston 10 and avoids contamination of the drug).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 7-20 are rejected under 35 U.S.C. 103 as being unpatentable over Benarous et al. (U.S Patent Pub. No. 20210100953 A1, “Benarous”) in view Ballet.
Regarding claim 7, Benarous discloses (Claim 7) a dual chamber syringe (100 in Fig. 1 and 8), comprising:
a barrel (104 in Fig. 1B) having a forward end (106 in Fig. 1B) and a rearward end (108 in Fig. 1B), said barrel (104) has an inner surface (see Fig. 8C and para. 0041);
a forward stopper (122 in Fig. 8C), a first piston (124 in Fig. 8C) and a second piston (126 in Fig. 8C) rearwardly spaced from said first piston (124 in Fig. 8C, see para. 0042); the first piston (124) and the second piston (126) are configured to be slidably displaceable relative to said barrel (104, see para. 0042);
a first chamber is defined between said forward stopper (122) and said first piston (124, see annotated Benarous drawing 1 below for chambers, Fig. 8C, and para. 0095); a second chamber is defined between said first piston (124) and said second piston (126, see annotate Benarous drawing 1 below for chambers, Fig. 8C, and para.
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0099).
However, Benarous fails to disclose the Limitations of (Claim 7) wherein said inner surface is partially treated with a friction reducing agent, such that in storage the inner surface defined by at least one of said first chamber and said second chamber is not treated with said friction reducing agent.
Ballet discloses a syringe barrel for sequential delivery of two drugs; however, the coating configuration of the syringe barrel having three separate chambers would have been reasonably pertinent to one of ordinary skill in the art for solving the problem of coatings on a syringe barrel having three separate chambers. Ballet further discloses a syringe barrel (2) comprising a forward stopper (25 in Fig. 13), a first piston (10 in Fig. 13), and a second piston (15 in Fig. 13) which define a first chamber (3D2) and a second chamber (3F, see para. 0087). Ballet teaches (Claim 7) wherein said inner surface is partially treated with a friction reducing agent, such that in storage the inner surface defined by said first chamber (3D2) is not treated with said friction reducing agent (see Fig. 13 and para. 0088 and 0090 – before use as shown in Fig. 13 which would also be the storage condition, the inner surface of the first chamber 3D2 is not treated with any coating while the inner surface of the second chamber 3F is treated with a friction reducing coating).
Since Benarous discloses the first chamber and second chamber (see annotated Benarous drawing 1 above), and Ballet similarly discloses the first chamber (3D2) and the second chamber (3F), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner surfaces of the first and second chambers as taught by Benarous such that the first chamber is not treated with a friction reducing agent and the second chamber is treated with the friction reducing agent as taught by Ballet. Ballet teaches that coating the inner surface of the first chamber allows for enhanced gliding for the piston while leaving other portions of the inner surface of the barrel uncoated to reduce interaction risks with the drug (see para. 0090-0091).
Regarding claim 8, modified Benarous discloses the dual chamber syringe of claim 7, as discussed above. In modified Benarous, Ballet discloses wherein said friction reducing agent is selected from a group of: a lubricant or a coating substance (see para. 0090 – the second chamber 3F is treated with a silicone oil coating which is both a lubricant and a coating substance).
Regarding claim 9, modified Benarous discloses the dual chamber syringe of claim 7, as discussed above. In modified Benarous, Benarous discloses (Claim 9) wherein at least one bypass protrusion (128 in Fig. 1A) arranged along the longitudinal extent of said syringe barrel (104, see Fig. 1A and para. 0044).
Regarding claim 10, modified Benarous discloses the dual chamber syringe of claim 7, as discussed above. In modified Benarous, Benarous discloses (Claim 10) wherein a plunger rod (120 in Fig. 1A and 8C) is configured to be partially inserted into said barrel (104) and slidably displace at least one of said first (124) and second pistons (126) relative to said barrel (104, see para. 0101 and 0108).
Regarding claim 11, modified Benarous discloses the dual chamber syringe of claim 7, as discussed above. In modified Benarous, Benarous discloses (Claim 11) wherein a drug preparation (440 in Fig. 8C) is confined within the first chamber and a solvent (450 in Fig. 8C) is confined within the second chamber and upon longitudinal displacement of the first (124) and second pistons (126) relative to the barrel (104), the drug preparation (440) and the solvent (450) are configured for reconstitution and subsequent ejection from the barrel (104, see annotated Benarous drawing 1 above for chambers, Fig. 8C, para. 0095, 0099, and 0110).
Regarding claim 12, modified Benarous discloses the dual chamber syringe of claim 7, as discussed above. In modified Benarous, Benarous discloses the bypass protrusion (128 in Fig. 8C) positioned within the first chamber in the syringe’s initial state (see annotated Benarous drawing 1 above for chambers, Fig. 8C, para. 0044 and 0094).
In modified Benarous, Ballet discloses wherein the inner surface of the first chamber (3D2) is not treated with friction reducing agent (see para. 0090 – inner surface of 3D2 is not coated).
Thus, in combination modified Benarous discloses (Claim 12) wherein the first chamber of Benarous (see annotated Benarous drawing 1 above) would not be treated with friction reducing agent and thus the bypass protrusion (128) and the adjacent inner surface still defining the first chamber would not be treated with friction reducing agent.
Regarding claim 13, modified Benarous discloses the dual chamber syringe of claim 7, as discussed above. In modified Benarous, Ballet discloses (Claim 13) wherein the inner surface of the barrel (2) is treated with friction reducing agent in the region (3F in Fig. 13) where the first piston (10 in Fig. 13) is configured to be seated in storage and axially rearwardly therefrom (see Fig. 13 and para. 0090 – Fig. 13 illustrated the syringe in its pre-use condition and thus would be the condition in storage).
However, modified Benarous fails to disclose (Claim 13) wherein the inner surface of the barrel is only treated with friction reducing agent in the region where the forward stopper is configured to be seated in storage and axially forwardly therefrom.
Ballet discloses (Claim 13) wherein the inner surface of the barrel (2) is treated with friction reducing agent in the region (3D1 in Fig. 13) where the forward stopper (25 in Fig. 13) is configured to be seated in storage and axially forwardly therefrom (see Fig. 13 and para. 0090 – the portion 3D1 axially forward from stopper 25 in the pre-use condition and thus the storage condition is treated with a friction reducing agent, see para. 0079 – the transition regions between the chambers may have a smooth transition between treated and untreated areas indicating that the inner surface at the forward stopper 25 is at least partially treated with friction reducing agent).
Since Benarous discloses a portion of the barrel (104 in Fig. 8C) axially forward from the forward stopper (122 in Fig. 8C), and Ballet similarly discloses a portion (3D1) of the barrel (2 in Fig. 13) axially forward from the forward stopper (25 in Fig. 13), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner surface of said forward stopper and axially forwardly of Benarous to be treated with friction reducing agent as taught by Ballet. Ballet teaches that coating the inner surface of this forward portion allows for enhanced gliding for the forward stopper while leaving other portions of the inner surface of the barrel uncoated to reduce interaction risks with the drug (see para. 0090-0091).
Regarding claim 14, modified Benarous discloses the dual chamber syringe of claim 7, as discussed above. In modified Benarous, Ballet discloses (Claim 14) wherein the inner surface of the barrel (2 in Fig. 13) defined between the forward stopper (25 in Fig. 13) and the first piston (10 in Fig. 13) is not treated with friction reducing agent (see para. 0090 – portion 3D2 is not treated with a coating), thereby preventing contact between a drug preparation and between the friction reducing agent in storage (see para. 0073 – the partial treatment of the inner surface of the barrel 2 is to prevent contamination of the drug in the pre-use state seen in Fig. 13).
Regarding claim 15, modified Benarous discloses the dual chamber syringe of claim 7, as discussed above. In modified Benarous, Ballet discloses (Claim 15) a rearward portion (proximal surface of 10) of the first piston (10 in Fig. 13) is configured to contact the area of the inner surface that is treated with friction reducing agent in storage (see Fig. 13 and para. 0090 – the distal surface of the first piston 10 contacts the inner surface of portion 3F treated with friction reducing agent in the ready to use state and thus the storage condition as seen by the distal surface of piston 10 overlapping with the “plus-signs” representing the coating).
However, modified Benarous fails to disclose (Claim 15) wherein a forward portion of the forward stopper is configured to contact the area of the inner surface that is treated with friction reducing agent in storage.
Ballet discloses wherein the inner surface of the barrel (2) is treated with friction reducing agent in the region (3D1 in Fig. 13) where the forward stopper (25 in Fig. 13) is configured to be seated in storage and axially forwardly therefrom (see Fig. 13 and para. 0090 – the portion 3D1 axially forward from stopper 25 in the pre-use condition and thus the storage condition is treated with a friction reducing agent, see para. 0079 – the transition regions between the chambers may have a smooth transition between treated and untreated areas indicating that the inner surface at the forward stopper 25 is at least partially treated with friction reducing agent).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner surface of said forward stopper and axially forwardly of Benarous to be treated with friction reducing agent as taught by Ballet. Ballet teaches that coating the inner surface of this forward portion allows for enhanced gliding for the forward stopper while leaving other portions of the inner surface of the barrel uncoated to reduce interaction risks with the drug (see para. 0090-0091). Thus, in combination, modified Benarous discloses (Claim 15) wherein a forward portion (distal surface of 25 of Ballet in Fig. 13) of the forward stopper (25 of Ballet in Fig. 13) is configured to contact the area of the inner surface that is treated with friction reducing agent in storage (see Fig. 13 and para. 0090 – the distal surface of forward stopper 25 of Ballet overlaps with the dashed lines representing the coating in the region 3D1).
Regarding claim 16, modified Benarous discloses the dual chamber syringe of claim 7, as discussed above. In modified Benarous, Ballet discloses (Claim 16) wherein substantially the entire circumference of the second piston (15) contacts one of the areas of the inner surface that are treated with friction reducing agent (see Fig. 13 and para. 0090 – as seen in Fig. 13, the second piston 15 overlaps with the friction reducing agent illustrated with the “plus-signs” in region 3F which is disposed around the entire circumference of the inner surface of the barrel 2, and thus the entire circumference of the second piston 15 contacts the area of 3F treated with the friction reducing agent).
Regarding claim 17, modified Benarous discloses the dual chamber syringe of claim 10, as discussed above. In modified Benarous, Ballet discloses (Claim 17) wherein partial treatment of the inner surface of the barrel (2 in Fig. 13) with friction reducing agent is configured to reduce friction forces that are created during displacement of the plunger rod (18 in Fig. 13) and the pistons (10, 15 in Fig. 13) relative to the barrel (2, see para. 0090).
Regarding claim 18, modified Benarous discloses the dual chamber syringe of claim 11, as discussed above. In modified Benarous, Ballet discloses (Claim 18) wherein partial treatment of the inner surface of the barrel (2 in Fig. 13) with friction reducing agent provides both for reduced friction forces and avoiding damage of the drug preparation during storage, due to lack of contact between the treated area and the drug preparation (see para. 0073 and 0090).
Regarding claim 19, modified Benarous discloses the dual chamber syringe of claim 7, as discussed above. In modified Benarous, Benarous discloses (Claim 19) wherein the forward stopper (122 in Fig. 8C) is configured to be slidably displaceable relative to said barrel (104, see Fig. 8C and 12C and para. 0094).
Regarding claim 20, modified Benarous discloses the dual chamber syringe of claim 7, as discussed above. In modified Benarous, Benarous discloses (Claim 20) wherein the forward stopper (122 in Fig. 8C) is configured to be releasable from said barrel (104, see Fig. 12C and para. 0133-0134 – the forward stopper 122 is releasable from the barrel 104 such that when it reaches the distal end of barrel 104 it is released into the luer lock portion 322 as seen in Fig. 12C).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
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/K.M.T./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783