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 .
Correction of Election/Restriction
Note: previously, Examiner issued the Requirement for Election/Restriction 10/16/25 as a patentably distinct species. At this point, the Examiner realizes that the claims 1-20 are more suitable to make the Restriction/Election Requirement under a different format, such as a different Invention(s) and various species. Therefore, Examiner would like to correct the Election/Restriction as below.
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-11, (Figs. 1-3B), drawn to a system for producing a mixture, classified in A61M5/31596.
II. Claims 12-20, (Figs. 4A, 6A-7C), drawn to a method for producing a mixture, classified in A61J1/2058.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, instead of performing a step of moving the first chamber and/or the second chamber relative to the other causing the partition to open so that the second constituent moves form the outer cavity through the partition and mixes with the first constituent in the inner cavity to form a first mixture, as recited in the method claim 12,
In this case, the product as claimed can be used in a materially different process of using that product such as moving the first chamber relative to the second chamber cause the partition to open so that the first constituent of the inner/first cavity enters into the second cavity to mix with the second constituent of the second cavity to form a first mixture.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(b) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(c) the prior art applicable to one invention would not likely be applicable to another invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
This application contains claims directed to the following patentably distinct species:
If the Invention I elected, this application contains claims directed to the following patentably distinct species:
Ia) Figs. 1A-3B Ib) Fig. 5
If the Invention II elected, this application contains claims directed to the following patentably distinct species:
IIa) Figs. 4A-4B IIb) Figs. 6A-6C IIc) Fig. 7
The species are independent or distinct because structure and different method of using device of these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, no claim is generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(b) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(c) the prior art applicable to one invention would not likely be applicable to another invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Response to Election/Restriction
Applicant's election with traverse of species I (Figs. 2A-3B, see page 2 of the Remarks 12/16/25) in the reply filed on 12/16/25 is acknowledged.
Note: the elected species I (Figs. 2A-2B) is equivalent to the election of Invention I, Species Ia (Figs. 1-3B) under new format as the Examiner addressed the above.
The traversal is on the ground(s) that the Figs. 2A-4B & 7 features that are combinable and should be examined together. This is not found persuasive because:
The claim 12 requires a method of moving the first chamber and/or the second chamber relative to the other causing the partition to open so that the second constituent moves form the outer cavity through the partition and mixes with the first constituent in the inner cavity to form a first mixture. Meanwhile, the product claim 1 simply requires that: wherein moving the first chamber and/or the second chamber relative to the other causes the partition to open so that the first constituent and the second constituent mixt with each other to form a first mixture. It is noted that product claim 1 does not requires that the second constituent moves form the outer cavity through the partition and mixes with the first constituent in the inner cavity to form a first mixture. In this case, the product as claimed can be used in a materially different process of using that product such as moving the first chamber relative to the second chamber cause the partition to open so that the first constituent of the inner/first cavity enters into the second cavity to mix with the second constituent of the second cavity to form a first mixture.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Therefore, the claims 1-11 are being examined in this office action.
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 1-11 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.
In claim 1, the limitation “the first cavity” are vague. It is unclear to Examiner that which element is being referred to the claimed “the first cavity”. Is the claimed “the first cavity” same or different with the limitation “an inner cavity”?
The limitation “the first and second cavities” is vague. It is unclear to Examiner that which element is being referred to the claimed “the … second cavities”. Is the second cavity same or different with the limitation “an outer cavity”?
For examining purpose, examiner interprets that the first cavity is equivalent to “an inner cavity” and the second cavity is equivalent to “an outer cavity”.
The limitation “… to the other…” is vague. It is unclear to Examiner that the limitation “to the other” is being referred to which element? In addition, the limitation "the other" in line 7 in claim 1 lack antecedent basis for this limitation in the claims.
The limitation “… mix together to form the mixture…” in last line of claim 1 is vague. It is unclear to Examiner that “the mixture” in last line is being referred to the first mixture or a second mixture that is different with the first mixture.
The claims 2-11 are being rejected due to their dependency.
Claim 1 recites the limitation "the first cavity" in line 3; the limitation “the … second cavities” in line 4. There is insufficient antecedent basis for these limitations in the claim.
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.
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.
Claims 1-9, 11 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Weaver et al. (WO 2016/049501, cited from IDS 02/13/23).
Regarding claim 1, Weaver discloses a system, in Figs. 1-6, for producing a mixture to deliver to a treatment site, comprising:
a first chamber 520 comprising an inner cavity 514 comprising a first constituent (solid substance) and an outer cavity 526 concentric with the first/inner cavity 514 and comprising a second constituent (liquid substance);
a partition 524 being openable and separating the first and second cavities;
a second chamber (another similar chamber 514 or 526, see note below) comprising a third constituent, the second chamber being concentric with the first chamber;
Note: Weaver discloses that: outer chamber 526 is a compartmentalized that comprising a plurality of compartments… with each compartment containing different fluid or solid substance, whereby depression of mixing piston 800 facilitates mixing of each different fluid or solid substance. Additionally, or alternatively, inner chamber 514 maybe similarly compartmentalized, each compartment comprising: different fluid or solid substance. Accordingly, drug container 500 includes two or more substances for mixing and injection, see page 25, lines 5-9. The drug container having two or more mutable chambers, page 25, line 16. In other words, the system 500 is inherently/obviously including: a second chamber comprising a third constituent (either fluid or solid substance that is different with the first and second constituent).
wherein moving the first chamber 526 (by a movement of a proximal seal 522 distally in the chamber 526 forces liquid contained in the chamber 526 to displace distal seal 524 towards vent cap 530, page 19, lines 25-33 & Figs. 2B-2C) and/or the second chamber relative to the other causes the partition to open so that the first constituent and the second constituent mix with each other to form a first mixture; and
wherein applying a force to the system causes the first mixture and the third constituent to egress through distal portions of the first and second chambers and mix together to form another mixture (formed by the first mixture and the third constituent) for delivery to the treatment site.
Regarding claim 2, wherein distal ends of the second cavity (at a distal seal 550) and a delivery lumen 320 for the first mixture in fluid communication with the inner cavity are aligned with each other.
Regarding claim 3, wherein a pathway 518 of the partition is opened by applying a torque to a cap of the outer cavity to compensate for a restoring force of a spring 122 coupled to the outer cavity.
Regarding claim 4, wherein when the restoring force or a pressure of the outer cavity is higher on an outlet side of the partition or an inlet side of the partition has insufficient pressure, the partition remains closed.
Regarding claim 5, wherein a distal portion 520/530 & 550 of the first and second chambers being joined in a central lumen 321, and wherein the first mixture and the third constituent mix in the central lumen to form the mixture.
Regarding claim 6, further comprising: one or more arms 2816 positioned on an external surface of at least one of the first and second chambers, the one or more arms configured to facilitate the applying of the force to the system to cause the first mixture and the third constituent to egress through distally positioned ports and mix together within the central lumen to form the mixture.
Regarding claims 7-8, Weaver discloses the claimed invention as required. Weaver further discloses that the first/inner cavity 514 and outer cavity 526 contain one or more mixing substances, i.e., power, crystal, solid, fluid, liquid, suspension, gas, or other substances suitable for mixing, or pharmaceutically active or a pharmaceutically inactive such as a diluent, see lines 10-33 on page 17. Weaver also discloses that the powered drug is often lyophilized with polyols, mannitol or lactose, lines 32-33 on page 17 (Note: polyols, mannitol or lactose are generally considered hydrophilic). Therefore, a person skilled in the art would recognize that the first constituent is a hydrophilic polymer and the second constituent is a diluent to form a first mixture of a precursor solution. Alternatively, the first constituent is a diluent, the second constituent is hydrophilic polymer to form a first mixture of a precursor solution and that is considered rearrangement parts.
Regarding claim 9, wherein moving the first chamber and/or the second chamber relative to the other causes the first chamber to telescope away from the second chamber while remaining at least partially concentric with each other and in fluid communication.
Regarding claim 11, wherein a distal portion (at seal 550) of the first cavity comprises a delivery lumen 514 in fluid communication with the inner cavity and extended within and concentric to the second cavity.
Claims 1-2, 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hofstetter et al. (US 5,569,193) in view of Weaver et al. (WO 2016/049501, cited from IDS 02/13/23).
Regarding claim 1, Hofstetter discloses a system in Figs. 1-4 for producing a mixture to deliver to a treatment site, comprising:
Hofstetter discloses a system in Figs. 1-4 for producing a mixture to deliver to a treatment site, comprising:
a first chamber 22 comprising an inner cavity 50 comprising a first constituent 46 and an outer cavity 24 concentric with the first/inner cavity and comprising a second constituent 40;
a partition 42 being openable and separating the first and second cavities;
wherein moving the first chamber (moving the chamber 50 is a part of the first chamber) relative to the other (i.e., the second chamber, as modified by Weaver below) causes the partition 42 to open (by a needle 60) so that the first constituent 46 and the second constituent 40 mix with each other to form a first mixture, see Figs. 3-4; and
Hofstetter does not disclose a second chamber comprising a third constituent, the second chamber being concentric with the first chamber; wherein applying a force to the system causes the first mixture and the third constituent to egress through distal portions of the first and second chambers a mix together to form the mixture for delivery to the treatment site.
Weaver discloses a system in n Figs. 2A-2D for producing a mixture. Weaver states that: outer chamber 526 is a compartmentalized that comprising a plurality of compartments… with each compartment containing different fluid or solid substance, whereby depression of mixing piston 800 facilitates mixing of each different fluid or solid substance. Additionally, or alternatively, inner chamber 514 maybe similarly compartmentalized, each compartment comprising: different fluid or solid substance. Accordingly, drug container 500 includes two or more substances for mixing and injection, see page 25, lines 5-9. The drug container having two or more mutable chambers, page 25, line 16.
In other words, the system 500 is inherently/obviously including: a second chamber comprising a third constituent (either fluid or solid substance that is different with the first and second constituent).
Since Hofstetter and Weaver are both from the same field of endeavor, the purpose disclosed by Weaver would have been recognized in the pertinent art of Hofstetter.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Hofstetter with providing a second chamber including a third constituent, as taught by Weaver, in order to mix more than two substances before injection.
In addition, giving teaching from Hofstetter, it would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain additional chamber, i.e., second chamber with a third constituent, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. For example: the device is able to mixture more than two substances before an injection.
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As seen in the marked-up figure -Hofstetter in view of Weaver above, the Hofstetter in view of Weaver disclose that a first chamber comprising an inner cavity comprising a first constituent and an outer cavity concentric with the first cavity and comprising a second constituent; wherein moving the first chamber and/or the second chamber relative to the other causes the partition to open so that the first constituent and the second constituent mix with each other to form a first mixture; and wherein applying a force to the system causes the first mixture and the third constituent to egress through distal portions of the first and second chambers and mix together to form the mixture for delivery to the treatment site.
Regarding claim 2, Hofstetter in view of Weaver discloses all the claimed subject matter as required. Hofstetter in view of Weaver further discloses that: wherein distal ends of the second cavity and a delivery lumen (via a needle) for the first mixture in fluid communication with the inner cavity are aligned with each other.
Regarding claim 5, Hofstetter in view of Weaver discloses all the claimed subject matter as required. Hofstetter in view of Weaver further discloses that wherein a distal portion of the first and second chambers being joined in a central lumen, and wherein the first mixture and the third constituent mix in the central lumen to form the mixture.
Regarding claim 6, Hofstetter in view of Weaver discloses all the claimed subject matter as required. Hofstetter in view of Weaver further discloses that one or more arms (flange provided at proximal end of each chamber) positioned on an external surface of at least one of the first and second chambers, the one or more arms configured to facilitate the applying of the force to the system to cause the first mixture and the third constituent to egress through distally positioned ports and mix together within the central lumen to form the mixture.
Regarding claims 7-8, Hofstetter in view of Weaver discloses all the claimed subject matter. Weaver discloses the claimed invention as required. Weaver further discloses that the first/inner cavity 514 and outer cavity 526 contain one or more mixing substances, i.e., power, crystal, solid, fluid, liquid, suspension, gas, or other substances suitable for mixing, or pharmaceutically active or a pharmaceutically inactive such as a diluent, see lines 10-33 on page 17. Weaver also discloses that the powered drug is often lyophilized with polyols, mannitol or lactose, lines 32-33 on page 17 (Note: polyols, mannitol or lactose are generally considered hydrophilic).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Hofstetter in view of Weaver with providing a hydrophilic polymer being as a first constituent and a diluent being a second constituent, as taught by Weaver, in order to mix more than two substances before injection in need of certain treatment.
Alternatively, Hofstetter in view of Weaver discloses that the first and second constituent can be swapped positions in the first and second cavities. Thus, first constituent is a diluent, the second constituent is hydrophilic polymer to form a first mixture of a precursor solution and that is considered rearrangement parts.
In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain these material as listed in claims 7-8, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 9, Hofstetter in view of Weaver discloses all the claimed subject matter as required. Hofstetter in view of Weaver further discloses that wherein moving the first chamber and/or the second chamber relative to the other causes the first chamber to telescope away from the second chamber while remaining at least partially concentric with each other and in fluid communication.
Regarding claim 10, Hofstetter in view of Weaver discloses all the claimed subject matter as required. Hofstetter in view of Weaver further discloses that wherein a distal end of the inner cavity is connected to a plunger 42 in the second chamber 24.
Regarding claim 11, Hofstetter in view of Weaver discloses all the claimed subject matter as required. Hofstetter in view of Weaver further discloses that wherein a distal portion of the first cavity comprises a delivery lumen (needle) in fluid communication with the inner cavity and extended within and concentric to the second/outer cavity 50.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gueret (US 5,692,644) in view of Weaver et al. (WO 2016/049501, cited from IDS 02/13/23) & Gettig (US 4,581,016).
Regarding claim 1, Gueret discloses a system for producing a mixture to deliver to a treatment site, comprising:
a first chamber 1 comprising an inner cavity 6 comprising a first constituent 17 and an outer cavity 1 & 4 concentric with the first/inner cavity 7 and comprising a second constituent 16;
a partition 8 being openable and separating the first and second cavities;
wherein moving the first chamber and/or the second chamber (as modified in Geting as below) relative to the other causes the partition 8 to open so that the first constituent 17 and the second constituent 16 mix with each other to form a first mixture, see Fig. 5;
Note: with aspect to the limitation, i.e. and/or the second chamber…, the “and/or” conjunction is interpreted as an optional and does not include in the claimed invention. In this case, examiner interprets that: wherein moving the first chamber relative to the other causes the partition…
Gueret does not disclose a second chamber comprising a third constituent, the second chamber being concentric with the first chamber; wherein applying a force to the system causes the first mixture and the third constituent to egress through distal portions of the first and second chambers and mix together to form the mixture for delivery to the treatment site.
Note: Gueret states that the system for separately storing at least two products, see abstract. Therefore, a person skilled in the art would recognize that the system in Gueret can be stored more than two products, or three products in three different chambers.
Weaver discloses a system in n Figs. 2A-2D for producing a mixture. Weaver states that: outer chamber 526 is a compartmentalized that comprising a plurality of compartments… with each compartment containing different fluid or solid substance, whereby depression of mixing piston 800 facilitates mixing of each different fluid or solid substance. Additionally, or alternatively, inner chamber 514 maybe similarly compartmentalized, each compartment comprising: different fluid or solid substance. Accordingly, drug container 500 includes two or more substances for mixing and injection, see page 25, lines 5-9. The drug container having two or more mutable chambers, page 25, line 16. In other words, the system 500 is inherently/obviously including: a second chamber comprising a third constituent (either fluid or solid substance that is different with the first and second constituent).
Giving such a teaching by Weaver, a person having ordinary skill in the art would have easily recognizes that modifying the device of Gueret with obtaining a second chamber including a third constituent, as taught by Weaver, would provide the benefit of mixing more than two constituents.
Weaver in view of Gueret does not disclose that the second chamber being concentric with the first chamber.
Gettig discloses a system for producing a mixture to deliver to treatment site comprising: a fist chamber 3; a second chamber 2 comprising a constituent, the second chamber being concentric with the first chamber.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Weaver in view of Gueret with providing a second chamber being concentric with a first chamber, as taught by Gettig, in order to allow to mix a first mixture and a third constituent to form new mixture substance.
Thus, Gueret in view of Weaver and Gettig discloses that a second chamber comprising a third constituent, the second chamber being concentric with the first chamber; wherein applying a force to the system causes the first mixture and the third constituent to egress through distal portions of the first and second chambers and mix together to form the mixture for delivery to the treatment site.
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Regarding claim 2, Gueret in view of Weaver and Gettig discloses all claimed subject matter; wherein distal ends of the second/outer cavity 1 (in Gueret) a delivery lumen (a needle 26 as modified by Getig) for the first mixture in fluid communication with the inner cavity are aligned with each other.
Regarding claim 3, Gueret in view of Weaver and Gettig discloses all claimed subject matter. Gueret discloses that a pathway of the partition 8 is opened by applying a torque to a cap 11 of the outer cavity 1 & 4 to compensate for a restoring force of a spring 21 coupled to the outer cavity.
Regarding claim 4, Gueret in view of Weaver and Gettig discloses all claimed subject matter. Gueret discloses that wherein when the restoring force or a pressure of the outer cavity is higher on an outlet side of the partition or an inlet side of the partition has insufficient pressure, the partition remains closed, see Fig. 4.
Regarding claim 5, Gueret in view of Weaver and Gettig discloses all claimed subject matter. Gueret in view of Weaver and Gettig discloses that wherein a distal portion of the first and second chambers being joined in a central lumen 5 & 6 (as modified by Gettig), and wherein the first mixture and the third constituent mix in the central lumen 5 & 6 to form the mixture.
Regarding claim 6, Gueret in view of Weaver and Gettig discloses all claimed subject matter. Gueret in view of Weaver and Gettig discloses that one or more arms (arm 11 in the first chamber, as shown in Guerett and a flange 4, as modified by Gettig) positioned on an external surface of at least one of the first and second chambers, the one or more arms configured to facilitate the applying of the force to the system to cause the first mixture and the third constituent to egress through distally positioned ports and mix together within the central lumen to form the mixture.
Regarding claims 7-8, Gueret in view of Weaver and Gettig discloses all claimed subject matter. as required. Weaver discloses the claimed invention as required. Weaver further discloses that the first/inner cavity 514 and outer cavity 526 contain one or more mixing substances, i.e., power, crystal, solid, fluid, liquid, suspension, gas, or other substances suitable for mixing, or pharmaceutically active or a pharmaceutically inactive such as a diluent, see lines 10-33 on page 17. Weaver also discloses that the powered drug is often lyophilized with polyols, mannitol or lactose, lines 32-33 on page 17 (Note: polyols, mannitol or lactose are generally considered hydrophilic).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Gueret in view of Weaver and Gettig with providing a hydrophilic polymer being as a first constituent and a diluent being a second constituent, as taught by Weaver, in order to mix more than two substances before injection in need of certain treatment.
Alternatively, Gueret in view of Weaver and Gettig discloses that the first and second constituent can be swapped positions in the first and second cavities. Thus, first constituent is a diluent, the second constituent is hydrophilic polymer to form a first mixture of a precursor solution and that is considered rearrangement parts.
In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain these material as listed in claims 7-8, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 9, Gueret in view of Weaver and Gettig discloses all claimed subject matter. Gueret in view of Weaver and Gettig discloses that wherein moving the first chamber and/or the second chamber relative to the other causes the first chamber to telescope away from the second chamber while remaining at least partially concentric with each other and in fluid communication, see the marked-up figure in the rejection 1 above.
Regarding claim 10, Gueret in view of Weaver and Gettig discloses all claimed subject matter. Gueret in view of Weaver and Gettig discloses that wherein a distal end of the inner cavity is connected to a plunger in the second chamber.
Regarding claim 11, Gueret discloses that a distal portion of the first cavity at 7 comprises a delivery lumen 7/17 in fluid communication with the inner/first cavity and extended within concentric to the second cavity 1.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783