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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 8/4/2026 is acknowledged. Accordingly, claims 18-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 7 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.
Claim 7 recites the phrase “the cap” on line 2. This phrase “the cap” lacks proper antecedent basis because a “cap” is not introduced in any claim upon which claim 7 depends. It is unclear if claim 7 meant to introduce “a cap” (instead of reciting “the cap”) or if claim 7 meant to depend on claim 3 (which introduces “a cap”). Since claim 7 needs to depend on both claims 3 and 4 in order to provide antecedent basis for both “the cap” (introduced claim 3) and “the plug” (introduced in claim 4), it is suggested to amend claim 4 to recite dependence on claim 3 (instead of on claim 1). For the sake of examination, this is the interpretation applied for the sake of examination.
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.
Claims 1-7 and 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Villain et al. (PG PUB 2020/0171243) in view of Okihara (PG PUB 2020/0009326) and Maillard (US Pat 2,826,339).
Re claim 1, Villain discloses a system 100 (Fig 7a-7g; if it noted that all reference characters cited below refer to Fig 7a-7g unless otherwise noted) for producing a mixture to deliver to a treatment site (Para 236), comprising: a needle hub 112; a multi-reservoir system 111+24+25+42+13, the multi-reservoir system comprising: a plunger assembly 42 including a first plunger 14 and a second plunger 14 (as seen in Fig 7d, the “first plunger 14” is on the left and the “second plunger 14” is on the right); a barrel portion 111+24+25+13 including a housing 111 including a first tubular wall 24A defining a first reservoir (formed by the interior of wall 24A) in fluid communication with a first port 24B and configured to contain a first constituent (it is noted that the italicized text constitutes functional language and, therefore, “a first constituent” is not a part of the claimed “system”; this limitation is met in view of Para 226) and a second tubular wall 25A defining a second reservoir (formed by the interior of wall 25A) in fluid communication with a second port 25B, the second reservoir configured to contain a second constituent (it is noted that the italicized text constitutes functional language and, therefore, “a second constituent’ is not a part of the claimed “system”; this limitation is met in view of Para 226); wherein actuating the plunger assembly relative to the barrel portion causes the contents of the first reservoir or the contents of the second reservoir to be delivered into the needle hub (Para 236).
Villain does not disclose that (a) the two plungers of the plunger assembly are tubular or that (b) the two tubular walls of the multi-reservoir system are arranged such that the first tubular wall is an inner wall and the second tubular wall is an outer wall surrounding the inner wall so that the second reservoir is defined by the two walls, is annular, and is disposed about the first reservoir; additionally, Villain does not disclose (c) a third plunger movably disposed relative to the plunger assembly and at least partially within the first reservoir or (d) a syringe defining a lumen configured to contain a third constituent, wherein a distal end of the syringe is configured to be releasably coupled to the first port or the second port such that actuation of the syringe causes the third constituent to be injected into the first reservoir or the second reservoir to mix with the first or second constituent and form a precursor.
Okihara teaches a system (Fig 8; it is noted that all reference characters cited below refer to Fig 8 unless otherwise noted) comprising a barrel portion 22 and a needle hub 24 – having a similar shape to the distal end of Villain’s needle hub – and a syringe 30 defining a lumen configured to contain a third constituent (it is noted that the italicized text constitutes functional language and, therefore, “a third constituent” is not a part of the claimed invention), wherein a distal end of the syringe is configured to be releasably coupled to the port such that actuation of the syringe causes the third constituent to be injected into the reservoir to mix with contents of the reservoir to form a precursor (it is noted that the italicized text constitutes functional language and, therefore, the art only has be structurally capable of performing this function; this limitation is met in view of Para 78,79). Okihara teaches that providing a syringe to inject a constituent to mix with the contents of the barrel portion allows for the system to be used for the preparation and delivery of medicine that comes in any form and not just liquid form (Para 50). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of Villain to include a syringe that is configured to be releasably coupled to a port of the multi-reservoir system, as taught by Okihara, for the purpose of allowing for the system to be used to deliver medicine that comes in any form, not just liquid (Para 50).
Additionally, Maillard teaches a multi-reservoir system (as seen in Fig 6; it is noted that all reference characters cited below refer to Fig 6 unless otherwise noted) comprising a plunger assembly 15+30+32 including a first tubular plunger 15 and a second tubular plunger 30; a barrel portion (formed by the “inner wall”, the “outer wall” and the “third wall” labeled in Fig A below and the pipes 5,6 and 22 of Fig 6) including a housing including an inner tubular wall (labeled as “inner wall” in Fig A below) defining a first reservoir 3 in fluid communication with a first port 5 and configured to contain a first constituent and an outer tubular wall (labeled as “outer wall” in Fig A below) defining a second annular reservoir 21 together with the first wall in fluid communication with a second port 22, the second annular reservoir being disposed about the first reservoir (as seen in Fig 6) and configured to contain a second constituent; and a third plunger 16 (within a third wall, labeled as “third wall” in Fig A below) movably disposed relative to the plunger assembly and at least partially within the first reservoir (as seen in Fig 6). Maillard teaches that providing the multi-reservoir system with three concentric reservoirs and three concentric plungers allows for a 3-component mixture to be delivered (Col 1, Lines 16-26 and Col 2, Lines 43-59). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Villain to include the multi-reservoir system as a concentric system with three concentric reservoirs each having its own plunger, as taught by Maillard, for the purpose of allowing for a three-component mixture to be delivered (Col 1, Lines 16-26 and Col 2, Lines 43-59).
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Re claim 2, Villain discloses a removable retainer 16 (Fig 7b) positioned between a proximal end of the barrel portion and a proximal end of the plunger assembly (as seen in Fig 7b), the removable retainer preventing actuation of the plunger assembly relative to the barrel portion (Para 238).
Re claim 3, Villain discloses a cap 35 (Fig 9d) removably coupled with the first port of the barrel portion (as seen in Fig 9d).
Re claim 4, Villain discloses a cap 36 (Fig 9d) removably coupled with the second port of the barrel portion (as seen in Fig 9d), but does not disclose that this cap includes a plug or is a plug. Okihara, however, teaches a cap 58 (Fig 7) that includes a plug 58b (Fig 7) that is received within a port when attached to a barrel portion (as seen in Fig 4) for the purpose of ensuring better liquid tightness than with a cap alone (Para 9). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Villain to include the cap coupled to the second port of the barrel portion with a plug, as taught by Okihara, for the purpose of ensuring better liquid tightness than with a cap alone (Para 9).
Re claim 5, Villain as modified in the rejection of claim 1 discloses all the claimed features with Maillard teaching that the first plunger and the second plunger are concentrically arranged (as seen in Fig 6; “arranged coaxially” – Col 2, Lines 50-53). The motivation cited in the rejection of claim 1 also applies here.
Re claim 6, Villain as modified in the rejection of claim 1 discloses all the claimed features with Maillard teaching that the first reservoir and the second annular reservoir are concentrically arranged (as seen in Fig 6; “coaxial cylindrical compartments” – Col 2, Lines 44-50).
Re claim 7, Villain as modified in the rejection of claim 4 (to include the cap 36 with the plug 58b of Okihara) discloses that the plunger assembly is configured to be actuated with the first port of the barrel portion free from the cap and the second port of the barrel portion free from the plug (Para 267)
Re claim 9, Villain discloses a needle 247 (Fig 12a) that is configured to be coupled to the needle hub (as seen in Fig 12a, Para 220,273).
Re claim 10, Villain discloses that the needle hub comprises a first lumen 27A (Fig 8d) in fluid communication with the first reservoir of the barrel portion via the first port (as seen in Fig 8d), a second lumen 28A (Fig 8d) in fluid communication with the second reservoir of the barrel portion via the second port (as seen in Fig 8d), a central lumen 26 (Fig 8d) configured to be in fluid communication with a needle (it is noted that the italicized text constitutes functional language and, therefore, “a needle” is not a part of the claimed system)(as seen in Fig 8d), and a mixing region 29 (Fig 8d) connecting the first and second lumens with the central lumen (as seen in Fig 8d) (Para 220,221).
Re claim 11, Villain discloses that the needle hub is removably coupled to a distal end region of the barrel portion of the multi-reservoir system (via protrusions 41, Fig 8d; Para 263).
Re claim 12, Villain as modified in the rejection of claim 1 discloses all the claimed features with Maillard teaching that the plunger assembly and the barrel portion are assembled in a telescoping arrangement (Col 2, Lines 50-53). The motivation cited in the rejection of claim 1 also applies to this claim.
Re claim 13, Villain discloses a kit 100 (Fig 7a-7g; it is noted that all reference characters cited below refer to Fig 7a-7g unless otherwise noted) for producing a mixture for delivery to a treatment site (Para 236), the kit comprising: a multi-reservoir system 111+24+25+42+13, the multi-reservoir system comprising: a plunger assembly 42 including a first plunger 14 and a second plunger 14 (as seen in Fig 7d, the “first plunger 14” is on the left and the “second plunger 14” is on the right); a barrel portion 111+24+25+13 including a housing 111 including a first tubular wall 24A defining a first reservoir (formed by the inner surface of wall 24A) in fluid communication with a first port 24B and configured to contain a first constituent (it is noted that the italicized text constitutes functional language and, therefore, “a first constituent” is not a part of the claimed “system”; this limitation is met in view of Para 226) and a second tubular wall 25A defining a second reservoir (formed by the inner surface of wall 25A) in fluid communication with a second port 25B and configured to contain a second constituent (it is noted that the italicized text constitutes functional language and, therefore, “a second constituent” is not a part of the claimed “system”; this limitation is met in view of Para 226); and an injection system 112+247 (Fig 12b), the injection system comprising: a needle hub 112; and a needle 247 (Fig 12b) coupled to the needle hub (as seen in Fig 12b, Para 220,273)
Villain does not disclose that (a) the two plungers of the plunger assembly are tubular or that (b) the two tubular walls of the multi-reservoir system are arranged such that the first tubular wall is an inner wall and the second tubular wall is an outer wall surrounding the inner wall so that the second reservoir is defined by the two walls, is annular, and is disposed about the first reservoir; additionally, Villain does not disclose (c) a third plunger movably disposed relative to the plunger assembly and at least partially within the first reservoir or (d) a syringe defining a lumen configured to contain a third constituent.
Okihara teaches a kit (Fig 8; it is noted that all reference characters cited below refer to Fig 8 unless otherwise noted) comprising a barrel portion 22 and a needle hub 24 – having a similar shape to the distal end of Villain’s needle hub – and a syringe 30 defining a lumen configured to contain a third constituent (it is noted that the italicized text constitutes functional language and, therefore, “a third constituent” is not a part of the claimed invention; this limitation is met in view of Para 50). Okihara teaches that providing a syringe allows for the system to be used for the preparation and delivery of medicine that comes in any form and not just liquid form (Para 50). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of Villain to include a syringe, as taught by Okihara, for the purpose of allowing for the system to be used to deliver medicine that comes in any form, not just liquid (Para 50).
Additionally, Maillard teaches a multi-reservoir system (as seen in Fig 6; it is noted that all reference characters cited below refer to Fig 6 unless otherwise noted) comprising a plunger assembly 15+30+32 including a first tubular plunger 15 and a second tubular plunger 30; a barrel portion (formed by the “inner wall”, the “outer wall” and the “third wall” labeled in Fig A below and the pipes 5,6 and 22 of Fig 6) including a housing including an inner tubular wall (labeled as “inner wall” in Fig A below) defining a first reservoir 3 in fluid communication with a first port 5 and configured to contain a first constituent and an outer tubular wall (labeled as “outer wall” in Fig A below) defining a second annular reservoir 21 together with the first wall in fluid communication with a second port 22, the second annular reservoir being disposed about the first reservoir (as seen in Fig 6) and configured to contain a second constituent; and a third plunger 16 (within a third wall, labeled as “third wall” in Fig A below) movably disposed relative to the plunger assembly and at least partially within the first reservoir (as seen in Fig 6). Maillard teaches that providing the multi-reservoir system with three concentric reservoirs and three concentric plungers allows for a 3-component mixture to be delivered (Col 1, Lines 16-26 and Col 2, Lines 43-59). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Villain to include the multi-reservoir system as a concentric system with three concentric reservoirs each having its own plunger, as taught by Maillard, for the purpose of allowing for a three-component mixture to be delivered (Col 1, Lines 16-26 and Col 2, Lines 43-59).
Re claim 14, Villain discloses a removable retainer 16 (Fig 7b) positioned between a proximal end of the barrel portion and a proximal end of the plunger assembly (as seen in Fig 7b), the removable retainer preventing actuation of the plunger assembly relative to the barrel portion (Para 238).
Re claim 15, Villain discloses a cap 35 (Fig 9d) removably coupled with the first port of the barrel portion (as seen in Fig 9d).
Re claim 16, Villain discloses a cap 36 (Fig 9d) removably coupled with the second port of the barrel portion (as seen in Fig 9d), but does not disclose that this cap includes a plug or is a plug. Okihara, however, teaches a cap 58 (Fig 7) that includes a plug 58b (Fig 7) that is received within a port when attached to a barrel portion (as seen in Fig 4) for the purpose of ensuring better liquid tightness than with a cap alone (Para 9). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Villain to include the cap coupled to the second port of the barrel portion with a plug, as taught by Okihara, for the purpose of ensuring better liquid tightness than with a cap alone (Para 9).
Re claim 17, Villain discloses all the claimed features except a connector configured to couple the needle hub to a saline syringe. Okihara, however, teaches providing a connector 56 (Fig 6A,8) configured to couple a needle hub of one syringe to another syringe (as seen in Fig 8; Para 6) for the purpose of ensuring a liquid-tight seal between the needle hub and the adjoining syringe (Para 6). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Villain to include a connector configured to couple the needle hub to a saline syringe, as taught by Okihara, for the purpose of ensuring a liquid-tight seal between the needle hub an a connected syringe (Para 6).
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of dependent claim 8 could not be found nor was suggested in the prior art of record in combination with the subject matter of claim 1 (upon which it depends). Dependent claim 8 requires the third plunger to be “unsecured to both the plunger assembly and the barrel portion”.
The third plunger 16 of Maillard (cited above) is disclosed as being secured to the plunger assembly (Col 2, Lines 58-67) and Maillard explicitly sets forth that all plungers must move together since the purpose of the invention is “for the mixture in predetermined proportions of different materials” and that the “material expelling means [i.e. the ‘plungers’] act simultaneously on all compartments so as to make them feed each [of the exhaust pipes] amounts of material proportional to their contents” (Col 1, Lines 15-25). Because Maillard requires the third plunger to move with the other two plungers, it would not have been obvious to one of ordinary skill in the art at the time the invention was made to modify Maillard to include the third plunger so that it “is unsecured to both the plunger assembly and the barrel portion” as claimed” since Maillard teaches away from doing so.
Although Cucchiara (US Pat 3,749,084) teaches a system (Fig 6) comprising a needle hub 71 and a multi-reservoir system 16 including all of the features of claim 1 – including a first tubular plunger 73 for a first chamber formed by an inner tubular wall 84, a second tubular plunger 21 for a second annular chamber formed between the inner tubular wall and an outer tubular wall 17, and a third plunger 23 movably disposed relative to the plunger assembly and at least partially within the first reservoir (as seen in Fig 6) – wherein the third plunger 23 is unsecured to both the plunger assembly 73+21 and the barrel portion 84+17, Cucchiara does not disclose a syringe having a distal end configured to releasably coupled to one of the first and second ports (the ports of 71 to which needle members 76 and 78 are directly attached, respectively) as required by claim 1. As seen in Fig 6, the ports are coaxially arranged with the first port being recessed proximally within the second port. A syringe structured so that it is configured to be releasably coupled to either of these ports could not be found nor was suggested in the prior art of record. Therefore, although Cucchiara may disclose the “third plunger being unsecured to both the plunger assembly and the barrel portion” as recited in claim 8, it cannot be modified to read on claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Liberson (US Pat 1,948,388), Muller (PG PUB 2007/0083155), Kazuhiro et al. (PG PUB 2010/0228121), Brugner (US Pat 7,306,126) each disclose a multi-reservoir system comprising concentrically arranged barrel portions, plungers and ports similar to that of the claimed invention.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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