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 Amendment
This office action is responsive to the amendment filed on 05/27/2026. As directed by the amendment: claims 1, 7, 9, and 14-16 been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-20 are presently pending in this application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection set forth in the Non-Final Office Action mailed on 03/03/2026.
The examiner notes that the amended claims contain language which is unmarked but was not presented in the previously filed claims. For example, in claim 7, the limitation “said barrel extending along a longitudinal axis” in lines 2-3 should be underlined to indicate amended language. The examiner respectfully notes that all claims being currently amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version (MPEP 714). The changes in any amended claim must be shown by strike-through (for deleted matter) or underlining (for added matter).
Response to Arguments
Applicant's arguments in “Remarks”, filed 05/27/2026, have been fully considered but they are not persuasive.
A. In response to applicant’s argument, on p.3-4 of “Remarks”, that there is no teaching, suggestion, or motivation to combine the references Benarous in view of Ballet, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, applicant’s arguments that Benarous and Ballet address fundamentally different technical problems in fundamentally different device architectures are not persuasive. Benarous discloses a syringe having pistons slidably disposed within a syringe barrel would thus introduce the problems of friction, gliding forces, and break loose forces between the pistons and the syringe barrel. Ballet discloses a syringe also having pistons slidably disposed within a syringe barrel and teaching a solution to these above problems by placing lubricating coatings on the inner surface of the syringe barrel, and one of ordinary skill in the art would recognize that there is explicit motivation in Ballet to modify the syringe of Benarous to have the lubricous coatings on the inner surface of the syringe barrel to provide enhanced gliding for said pistons (see Ballet, para. 0090-0091). Further, Ballet is explicit in the fact that the lubricous coating is only partially disposed on the inner surface of the syringe barrel, and that the drug containing chamber (3D2 in Fig. 13) does not have said lubricious coating to prevent unwanted drug interactions. Thus, one of ordinary skill would further have recognized that the inner surface of the drug containing chamber (chamber defined between 122 and 124 in Fig. 4C) of Benarous would not be treated with the lubricious coating as taught by Ballet to prevent unwanted drug interactions. Therefore, the rejection of record is maintained.
B. In response to the applicant’s argument, on p.5-6 of “Remarks”, that “the resulting combination would not arrive at the specific limitation of Amended claim 7 requiring the annular portion of the inner surface containing the bypass protrusion and the adjacent area is not treated with friction reducing agent”, the examiner respectfully disagrees. The applicant argues that “Ballet’s chamber-boundary coating strategy, mechanically applied to Benarous, would not specifically identify or target the bypass protrusion zone as a distinct lubricant-free annular region requiring independent surface treatment consideration” and “the functional rationale for specifically excluding the bypass protrusion zone from surface treatment is entirely absent from the cited combination”. In Ballet, Fig. 13 and para. 0089 disclose that the “surface of the second drug compartment 3D2 is designed for drug stability”, and para. 0090 discloses “the second distal portion 3D2 will be, for example, made of raw glass with no coating at all, as raw glass is known for interacting with very few drugs.” Thus, Ballet clearly teaches that the drug compartment (3D2 in Fig. 13) identified as the intermediate drug compartment between the two pistons (10 and 25 in Fig. 13) would not have a lubricious coating to preserve drug stability and reduce drug interactions. Benarous discloses an analogous, intermediate drug compartment between the two pistons (122 and 124 in Fig. 4C). Thus, one of ordinary skill in the art would have recognized that when applying the lubricious coatings taught by Ballet to Benarous to enhance gliding properties, as discussed above, that the intermediate drug compartment should remain uncoated to preserve drug stability and reduce drug interactions. Being that the bypass protrusion (128 in Fig. 4C) of Benarous is positioned within said intermediate drug compartment and contacts the drug preparation (440 in Fig. 4C), one of ordinary skill would recognize that this bypass protrusion (128) would thus not have the lubricious coating as well. Therefore, the rejection of record is maintained.
C. In response to the applicant’s argument, on p.6-7 of “Remarks”, that the plunger rod assembly limitation of amended claim 7 performs an important and non-trivial function in the context of the claim as a whole that neither Benarous nor Ballet contemplates in combination with the annular bypass protrusion untreated zone limitation, the examiner respectfully disagrees. Examiner points to the above discussions on the combination of Benarous in view of Ballet to teach the untreated bypass protrusion and drug compartment, and thus the plunger rod assembly of Benarous would perform said function as claimed. Therefore, the rejection of record is maintained.
Claim Objections
Claims 9 and 16-17 are objected to because of the following informalities:
Regarding claim 9, the phrase “wherein at least one bypass protrusion” in lines 1-2 should read “wherein the at least one bypass protrusion” for clarity,
Regarding claim 16, the phrase “one of the areas of the inner surface that are treated” in lines 2-3 should read “one of the areas of the inner surface that is treated” for proper grammar,
Regarding claim 17, the phrase “the plunger rod and the pistons” in line 3 should read “the plunger rod assembly and the first and second pistons” for clarity and proper antecedent basis,
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 10-11, 14, and 17-18 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.
Regarding claim 10, the phrase “wherein a plunger rod is configured to be partially inserted into said barrel” in lines 1-2 renders the claim indefinite because it is unclear. It is unclear whether this is a different plunger rod or the aforementioned plunger rod assembly in claim 7. Examiner is interpreting this as the same as the plunger rod assembly in claim 7.
Regarding claim 11, the phrase “a drug preparation” in lines 1-2 renders the claim indefinite because it is unclear. It is unclear whether this is a different drug preparation or the aforementioned drug preparation in claim 7. Examiner is interpreting it as the same.
Regarding claim 14, the phrase “a drug preparation” in line 3 renders the claim indefinite because it is unclear. It is unclear whether this is a different drug preparation or the aforementioned drug preparation in claim 7. Examiner is interpreting it as the same.
Regarding claims 17-18, these claims are rejected due to their dependency upon a rejected base claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 12, the claim discloses “wherein the inner surface that contains the bypass protrusion and adjacent to the bypass protrusion is not treated with friction reducing agent” in lines 1-3. It’s base claim, claim 7, states “wherein an annular portion of said inner surface that contains the at least one bypass protrusion, and an area adjacent to said at least one bypass protrusion, are not treated with said friction reducing agent.” Thus, claim 12 fails to further limit the subject matter upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-20 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 et al. (W.O 2011092536 A1, “Ballet”).
Regarding claim 1, Benarous discloses the limitations of (Claim 1) a medical container (100 in Fig. 1A-1B and 8), comprising:
a barrel (104 in Fig. 1B) having an inner surface (see Fig. 8C and para. 0041); the barrel (104) having at least one substance chamber (see annotated Benarous drawing 1 below for first and second substance chambers, see 0095 and 0099);
and at least one bypass protrusion (128 in Fig. 8C) disposed on said barrel (104) at an intermediate location along a longitudinal axis (103 in Fig. 1A) of said barrel (104, see para. 0044);
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and wherein said at least one substance chamber defines a portion of said inner surface (see annotated Benarous drawing 1 below);
However, Benarous fails to disclose the limitations of (Claim 1) an inner surface is partially treated with a friction reducing agent, wherein said at least one substance chamber defines a portion of said inner surface, which is not treated with said friction reducing agent; and wherein an annular portion of said inner surface that contains said at least one bypass protrusion, and an area adjacent to said at least one bypass protrusion, are 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 1) an inner surface is partially treated with a friction reducing agent, wherein said at least one substance chamber (3D2, 3F) defines a portion of said inner surface, which is not treated with said friction reducing agent (see para. 0090 – the inner surface of barrel 2 is partially treating with lubricous coatings where the first substance chamber 3D2 defines a portion of said inner surface not treating with said lubricious coating).
Since Benarous discloses a distal portion distally of the stopper (122), a first chamber delimited between stopper (122) and first piston (124), and a second chamber delimited between first piston (124) and second piston (126, see annotated Benarous drawing 1 above), and Ballet similarly discloses a distal portion (3D1) distally of the stopper (25), the first chamber (3D2) delimited between the stopper (25) and first piston (10), and the second chamber (3F) delimited between the first piston (10) and the second piston (15), 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 distal portion, first chamber, and second chamber as taught by Benarous such that the distal portion and the second chamber are treated with the friction reducing agent and the first chamber is not treated with a friction reducing agent as taught by Ballet. Ballet teaches that coating the inner surface of the distal portion and second chamber allows for enhanced gliding for the piston while leaving the inner surface of the first chamber uncoated to reduce interaction risks with the drug and provide drug stability (see para. 0089-0091).
Thus, in combination modified Benarous discloses (Claim 1) 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 2, modified Benarous discloses the medical container of claim 1, as discussed above. In modified Benarous, Benarous discloses (Claim 2) wherein said at least one substance chamber defines two substance chambers (see annotated Benarous drawing 1 above).
In modified Benarous, Ballet discloses (Claim 2) wherein said at least one substance chamber (3D2, 3F in Fig. 13) defines two substance chambers and at least one of said two substance chambers defines said portion of said inner surface, which is not treated with said friction reducing agent (see Fig. 13, and para. 0090 – substance chamber 3D2 defines said portion of said inner surface not treated with the lubricious coating).
Regarding claim 3, modified Benarous discloses the medical container of claim 1, as discussed above. In modified Benarous, Benarous discloses (Claim 3) wherein a drug preparation (440 in Fig. 8C) is configured to be contained within said at least one substance chamber confined by a piston (124 in Fig. 8C, see annotated Benarous drawing 1 above and para. 0095).
In modified Benarous, Ballet discloses (Claim 3) wherein a drug preparation is configured to be contained within said at least one substance chamber (3D2) confined by a piston (10 in Fig. 13, see para. 0087), and the inner surface defined by said at least one substance chamber (3D2) is not treated with friction reducing agent to avoid contact between the drug preparation and the friction reducing agent (see para. 0090), and wherein the remainder of the inner surface of the barrel (2) is treated with friction reducing agent (see para. 0090 – the remaining inner surfaces of the distal portion 3D1 and the second chamber 3F are both treated with friction reducing agent).
Regarding claim 4, modified Benarous discloses the medical container of claim 1, as discussed above. In modified Benarous, Ballet discloses (Claim 4) wherein said friction reducing agent is a lubricant (see para. 0077-0078 and 0090 – both the silicone oil and fluoric coating are lubricants as they minimize friction to enhance sliding conditions).
Regarding claim 5, modified Benarous discloses the medical container of claim 1, as discussed above. In modified Benarous, Ballet discloses (Claim 5) wherein said friction reducing agent is a coating substance (see para. 0077-0078 and 0090).
Regarding claim 6, modified Benarous discloses the medical container of claim 3, as discussed above. In modified Benarous, Ballet discloses (Claim 6) wherein partial treatment of the inner surface 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. 0089 and 0090 – treating portions 3F and 3D1 with friction reducing agent reduces friction forces for the piston 10 and piston 25 while avoiding contamination of the drug within chamber 3D2).
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), said barrel (104) extending along a longitudinal axis (103 in Fig. 1A);
at least one bypass protrusion (128 in Fig. 8C) disposed on said barrel (104) at an intermediate location along said longitudinal axis (103 in Fig. 1A) of said barrel (104, see para. 0044);
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);
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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. 0099).
and a plunger rod assembly (130 in Fig. 3C-3D) configured to be at least partially inserted into said barrel (104 in Fig. 8C) and operatively coupled to said second piston (126, see Fig. 8C and para. 0096 and 0101), said plunger rod assembly (130) comprising a plunger rod outer portion (134 in Fig. 3C-3D) having an outer surface (195 in Fig. 3C-3D) with a guiding track (200 in Fig. 3C) formed thereon (see para. 0056), said guiding track (200) comprising a helical track portion (204 in Fig. 3C) and a longitudinal track portion (202 in Fig. 3C) connected to said helical track portion (204, see para. 0056), wherein said helical track portion (204) is configured to convert rotational displacement of said plunger rod assembly (130) into axial forward displacement for driving said first piston (124 in Fig. 8C) toward said at least one bypass protrusion (128 in Fig. 8C) during reconstitution of a drug preparation (see Fig. 10B-10C and para. 0117-0118).
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; wherein an annular portion of said inner surface that contains said at least one bypass protrusion, and an area adjacent to said at least one bypass protrusion, are 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 a distal portion distally of the stopper (122), a first chamber delimited between stopper (122) and first piston (124), and a second chamber delimited between first piston (124) and second piston (126, see annotated Benarous drawing 1 above), and Ballet similarly discloses a distal portion (3D1) distally of the stopper (25), the first chamber (3D2) delimited between the stopper (25) and first piston (10), and the second chamber (3F) delimited between the first piston (10) and the second piston (15), 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 chamber and the second chamber as taught by Benarous such that the second chamber is treated with the friction reducing agent and the first chamber is not treated with a friction reducing agent as taught by Ballet. Ballet teaches that coating the inner surface of the second chamber allows for enhanced gliding for the piston while leaving the inner surface of the first chamber uncoated to reduce interaction risks with the drug and provide drug stability (see para. 0089-0091).
Thus, in combination modified Benarous discloses (Claim 7) 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 8, modified Benarous discloses the dual chamber syringe of claim 7, as discussed above. In modified Benarous, Ballet discloses (Claim 8) wherein said friction reducing agent is selected from a group of: a lubricant or a coating substance (see para. 0090).
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) is arranged along the longitudinal extent of said 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 (130 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 9, 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 teaches (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 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 are 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 are 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 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
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 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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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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