CTNF 18/646,387 CTNF 97631 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 08-08 AIA Restriction to one of the following inventions is required under 35 U.S.C. 121: I. Claim s 1-12 , drawn to a system for producing a mixture to deliver to a treatment site , classified in A61M5/19 . II. Claim s 13-17 , drawn to a kit for producing a mixture for delivery to a treatment site , classified in A61M5/32 . 08-09 AIA III. Claim s 18-20 , drawn to a method for producing a mixture with a mixing system to deliver to a treatment site , classified in A61M5/284 . 08-13 AIA The inventions are independent or distinct, each from the other because: 08-14-01 AIA Inventions I and II are directed to related products . The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed can have a materially different design because the system of invention I does not require the “at least one channel” to be “formed in an inner wall” of the barrel, which is required by invention II. Further, the kit of invention II does not require the contents of the first and second reservoir to be mixed, which is require by invention I, and therefore could have a materially different operation. Secondly, the inventions do not overlap in scope because invention II does not require that the contents of the reservoirs be mixed, which is required in invention I. Thirdly, the inventions are not obvious variants because the kit could be used for individually injecting three separate reservoir contents while the system requires that at least the first and second reservoir contents be mixed . Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants. 08-20 AIA Inventions I a nd I II a re 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, t he process for using the product as claimed can be practiced with another materially different product (the method of invention III does not require the reservoir contents to be mixed via the “at least one channel” that is required by the system invention I. therefore, the process could be practiced with another product that mixes reservoir contents via other means—for example, breakable seals) . 08-20 AIA Inventions II and III 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, the product as claimed can be used in a materially different process of using that product (the kit does not require mixing of any of the reservoir contents and therefore could be used in a process of delivering the contents of the reservoirs without mixing the contents) . 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: The inventions have acquired a separate status in the art in view of their different classification. The inventions have acquired a separate status in the art due to their recognized divergent subject matter. The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries) . 18-22 AIA 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. 08-23-02 AIA 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). 08-21-04 AIA 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. 08-23 AIA During a telephone conversation with David Bonham on 06/03/26 a provisional election was made without traverse to prosecute the invention of the system for producing a mixture to deliver to a treatment site , claim s 1-12 . Affirmation of this election must be made by applicant in replying to this Office action. Claim 13- 20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Information Disclosure Statement 06-52 The information disclosure statements (IDSs) submitted on 07/08/24 and 08/07/24 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Claim Objections 07-29-01 AIA Claim 8 is objected to because of the following informalities: Claim 8 line 1 reads “ wherein the cap includes at least one cavity ” and should likely read “ wherein the cap includes at least one [[cavity]] chamber ” to align with the language as set forth for the structure in the specification (see at least [0086] of the current Application: “The cap 128 may include a first portion 158 and a second portion 160…the second portion 160 may include one or more chambers 164 a , 164 b configured to receive fluid from the second and third reservoirs”. a “cavity” does not appear to be described in the specification) Appropriate correction is required. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claims 1-4, 7, and 10-12 are r ejected under 35 U.S.C. 103 as being unpatentable over K eller (U.S. PGPUB No. 2011/0021982) in view of Schwab et al. (U.S. PGPUB No. 2014/0257179), hereinafter Schwab. R egarding claim 1, Keller discloses a system for producing a mixture to deliver to a treatment site (see [0001-0003]) , comprising: A mixing hub (14 comprising connector 21, see FIG. 1 for numeral or ‘Modified FIG. 3’ below for immediate reference. See also [0015]) ; and PNG media_image1.png 666 392 media_image1.png Greyscale a multi-reservoir system (see FIG. 3 and [0017]) , the multi-reservoir system comprising: a plunger assembly (7, see [0015]: double plunger 7) including a first plunger and a second plunger (plungers in respective barrels, see ‘Modified FIG. 3’ above) ; a barrel portion (see ‘Modified FIG. 3’ above) including a housing (15) extending from a proximal end (downward end of housing 15 in FIG. 3) to a distal end (syringe housing 15 terminates at flange 19 as shown in FIG. 1/ top end in FIG. 3) , the housing (15) including a first barrel (16, see numeral in FIG. 1 and [0015]) defining a first lumen extending from the proximal end to the distal (see [0015-0016]: first barrel 16 forms reservoir chambers 8/9 as seen in FIG. 1) , the first barrel (16) including at least one channel (18, specifically the bypass 18 of FIG. 5. See FIG. 5/6 and [0020]: bypass 18 may be recesses/channels 25 in the barrel wall) configured to communicate between different positions (see ‘Modified FIG. 5’ below, fluid flow from proximal end of recess/ first position to distal end of recess/second position as in [0018-0019] and [0020-0021]) PNG media_image2.png 393 373 media_image2.png Greyscale along a length of an inside of the first barrel (see FIG. 5&6 and [0020]: elongated recesses along length of inside wall of barrel) and a second barrel (17) defining a second lumen extending from the proximal end to the distal end (see [0015-0016]) ; a first movable gasket (2) disposed within the first lumen of the barrel portion (first lumen of 16) , the first movable gasket (2) dividing the first lumen of the barrel portion into a first reservoir (9, numeral seen in FIG. 1) configured to contain a first constituent (23, see [0017]: reservoir 9 has constituent 23) and a second reservoir (8, numeral seen in FIG. 1) configured to contain a second constituent (22, see [0017]: reservoir 8 has constituent 22) ; and a second gasket (4) disposed within the second lumen of the barrel portion (lumen of barrel 17) , the second gasket (4) bounding a third reservoir (12) configured to contain a third constituent (24, see [0017]: reservoir 12 has constituent 24) ; wherein actuating (see [0017-0018] and progression from FIG. 2 to FIG. 3) the plunger assembly (7) relative to the barrel portion (see ‘Modified FIG. 3’ above) causes the first constituent (23) to be injected from the first reservoir (9) , through the at least one channel (channels 25 forming bypass 18) , and into the second reservoir (8) to mix with the second constituent (22) to form a precursor (22/23 as seen in FIG.4 and described in [0019]) and further actuation (see [0019]) of the plunger assembly (7) causes the precursor (22/23) and the third constituent (24) to be delivered from the second (8) and third (12) reservoirs, respectively, into the mixing hub (see [0019]: both media mixed via mixer 14 at distal end of hub) . Although Keller discloses the mixing hub (14 with connector 21) attached to (see [0015]) the system via a removable coupling (21) and that the system may be used to inject medicines (see [0003]), Keller is silent to the hub being specifically a “ needle ” hub. However, Schwab teaches a system for producing a mixture to deliver to a treatment site (see FIG. 3, [0008], and [0041-0044]) comprising a needle hub (38 disposed on mixing hub 30’ removably connected to the multi-reservoir system, see [0041-0044]) ; and a multi-reservoir system (system has at least two reservoirs 12 & 18 as shown in FIG. 3) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mixing hub disclosed in Keller to include a needle as taught by Schwab for the purpose of moving the contents out of the mixing tip and into a target region of a patient via a needle (see [0008]) such as a target region of soft tissue (see [0032]) , thus achieving the hub being specifically a “ needle ” hub. Regarding claim 2, the modified system of Keller teaches the system of claim 1, and Keller further discloses wherein the at least one channel (25, see FIG. 5 and [0020]) extends less than an entire length of the first lumen (as shown in FIG. 5—channels 25 only extend along a portion of the first lumen of the first barrel 16) . Regarding claim 3, the modified system of Keller teaches the system of claim 1, and Keller further discloses wherein prior to actuating (see FIG. 2) the plunger assembly (7) a distal end (see top end of gasket 2 in FIG. 2) of the first movable gasket (2) is proximal to (downward in FIG. 2 and [0017]: gasket 2 located behind bypass in FIG. 2) a proximal end (bottom end of channel 25 seen in FIG. 5) of the at least one channel (25 forming bypass 18 as in FIG. 5 and [0020]) . Regarding claim 4, the modified system of Keller teaches the system of claim 1, and Keller further discloses wherein actuating (see progression from FIG. 2 to FIG. 3 and [0017-0018]) the plunger assembly (7) relative to the barrel portion to cause the first constituent (23) to be injected into (as shown in FIG. 3) the second reservoir (8) actuates the first movable gasket (2, see gasket movement from FIG. 2 to 3 and see [0018]) such that the first movable gasket (2) is adjacent to (see [0018]: 2 located at height of bypass) the at least one channel (25 forming bypass 18 as shown in FIG. 5) . Regarding claim 7, the modified system of Keller teaches the system of claim 1, and Keller discloses further comprising a cap (13, see FIG. 2) removably coupled (cap replaced with mixing hub as shown from FIG. 2 to FIG. 3) with a distal end region (19) of the barrel portion (see [0015-0016]) . Regarding claim 10, the modified system of Keller teaches the system of claim 1, and Keller discloses the mixing hub (14 with connector 21) attached to (see [0015]) the system via a removable coupling (21) and that the system may be used to inject medicines (see [0003]). Keller is silent to “ further comprising a needle that is configured to be coupled to the needle hub .” However, Schwab teaches a system for producing a mixture to deliver to a treatment site (see FIG. 3, [0008], and [0041-0044]) comprising a needle hub (needle 38 disposed on mixing hub 30’ removably connected to the multi-reservoir system, see [0041-0044]) ; and a multi-reservoir system (system has at least two reservoirs 12 & 18 as shown in FIG. 3) and further comprising a needle (38) that is configured to be coupled to (see [0041-0044]) the needle hub (30’). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mixing hub disclosed in Keller to include a needle as taught by Schwab for the purpose of moving the contents out of the mixing tip and into a target region of a patient via a needle (see [0008]) such as a target region of soft tissue (see [0032]), thus achieving “ further comprising a needle that is configured to be coupled to the needle hub .” Regarding claim 11, the modified system of Keller teaches the system of claim 1, and Keller discloses wherein the hub (14, see FIG. 3) comprises a first lumen (see ‘Modified FIG. 3i’ below) PNG media_image3.png 577 477 media_image3.png Greyscale in fluid communication with the second reservoir (8) of the barrel portion (see [0019]: fluid conveyed out reservoirs and into mixer 14) , the first lumen in fluid communication with the third reservoir (12) of the barrel portion (see [0019]) , a central lumen (see ‘Modified FIG. 3i’ above) configured to be in fluid communication with a needle (14 conveys fluid out and is therefore “configured to be in fluid communication” with any structure, such as a needle. See [0019]) , and a mixing region (portion of central lumen shown in ‘Modified FIG. 3i’ above having helical mixer) connecting the first lumen with the central lumen (see [0019]) . Keller discloses the mixing hub (14 with connector 21) attached to (see [0015]) the system via a removable coupling (21) and that the system may be used to inject medicines (see [0003]). Keller is silent to the hub being a “ needle ” hub and the hub having a first and second lumen separately coupled to the second and third reservoirs such that “ a second lumen ” in fluid communication with the third reservoir of the barrel portion and the mixing region connecting the first “ and second lumens ” with the central lumen. However, Schwab teaches a system for producing a mixture to deliver to a treatment site (see FIG. 3, [0008], and [0041-0044]) comprising a needle hub (38 disposed on mixing hub 30’ removably connected to the multi-reservoir system, see [0041-0044]) ; and a multi-reservoir system (system has at least two reservoirs 12 & 18 as shown in FIG. 3) ; the needle hub (30’) having a first lumen (see ‘Modified FIG. 4’ below) in fluid communication with a reservoir (12) PNG media_image4.png 516 676 media_image4.png Greyscale and second lumen (see ‘Modified FIG. 4’ above) in fluid communication with a separate reservoir (18) of a barrel portion (60) and a mixing region (see ‘Modified FIG. 4’ above) connecting the first and second lumens with a central lumen (lumen out needle 38) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mixing hub disclosed in Keller to include a needle as taught by Schwab for the purpose of moving the contents out of the mixing tip and into a target region of a patient via a needle (see [0008]) such as a target region of soft tissue (see [0032]) , thus achieving the hub being specifically a “ needle ” hub. Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mixing hub disclosed in Keller to include two separate lumens, such as a first and second lumen, as taught by Schwab for the purpose of coupling the hub to each reservoir separately via corresponding coupling structures that form an enhanced sealed coupling (see [0042-0043]) , thus achieving the hub having a first and second lumen separately coupled to the second and third reservoirs such that “ a second lumen ” in fluid communication with the third reservoir of the barrel portion and the mixing region connecting the first “ and second lumens ” with the central lumen. Regarding claim 12, the modified system of Keller teaches the system of claim 1, and Keller discloses wherein the hub (14, see FIG. 1) is removably coupled to a distal end region (19) of the barrel portion of the multi-reservoir system (see [0015]: bayonet coupling is inherently removable) . Keller is silent to the hub being specifically a “ needle ” hub. However, Schwab teaches a system for producing a mixture to deliver to a treatment site (see FIG. 3, [0008], and [0041-0044]) comprising a needle hub (38 disposed on mixing hub 30’ removably connected to the multi-reservoir system, see [0041-0044]) ; and a multi-reservoir system (system has at least two reservoirs 12 & 18 as shown in FIG. 3) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mixing hub disclosed in Keller to include a needle as taught by Schwab for the purpose of moving the contents out of the mixing tip and into a target region of a patient via a needle (see [0008]) such as a target region of soft tissue (see [0032]) , thus achieving the hub being specifically a “ needle ” hub . 07-22-aia AIA Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Keller in view of Schwab as applied to claim 1 above, and further in view of Rissman et al. (U.S. PGPUB No. 2010/0249829), hereinafter Rissman . Regarding claim 5, the modified system of Keller teaches the system of claim 1, but Modified Keller is silent to “ further comprising a first removable retainer positioned between a proximal end of the plunger assembly and a proximal end of the barrel portion, the first removable retainer limiting movement of the plunger assembly relative to the barrel portion to a first length configured to inject the first constituent into the second reservoir .” However, Rissman teaches a system for producing a mixture to deliver to a treatment site (see [0008]) , comprising a multi-reservoir system (see FIG. 12 and ‘Modified FIG. 12’ provided for immediate reference below) , PNG media_image5.png 687 484 media_image5.png Greyscale the multi-reservoir system (see FIG. 12) comprising: a plunger assembly (930) ; a first movable gasket (932a, see [0066]) disposed within a first lumen of a barrel portion (lumen of left-side barrel as seen in FIG. 12) , the first movable gasket (932a) dividing the first lumen into a first reservoir (312) configured to contain a first constituent (S 1 , see [0066]) and a second reservoir (314) configured to contain a second constituent (S 2 , see [0066]) ; the system further comprising a first removable retainer (901, see removing in FIG. 15 and [0067]: 901 removed after plunger reaches desired location) positioned between a proximal end of the plunger assembly and a proximal end of the barrel portion (as seen in ‘Modified FIG. 12’ above) , the first removable retainer (901) limiting movement of the plunger assembly (930) relative to the barrel portion to a first length configured to inject the first constituent into the second reservoir (see [0066]: 901 allows only a predetermined length/ distal movement of plunger 932 such that a predetermined volume of S 1 is advanced from first reservoir 312 and into second reservoir 314) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Modified Keller to include a first removable retained positioned between the proximal end of the barrel portion and the proximal end of the plunger assembly such that movement of the plunger assembly is limited to a first length configured to inject the first constituent into the second reservoir as taught by Rissman for the purpose of preventing distal advancement of the plunger beyond a predetermined location (see [0066-0067]) , thus achieving “ further comprising a first removable retainer positioned between a proximal end of the plunger assembly and a proximal end of the barrel portion, the first removable retainer limiting movement of the plunger assembly relative to the barrel portion to a first length configured to inject the first constituent into the second reservoir .” 07-22-aia AIA Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Keller in view of Schwab and Rissman as applied to claim 5 above, and further in view of Bowman et al. (U.S. PGPUB No. 2018/0126085), hereinafter Bowman . Regarding claim 6, the modified system of Keller teaches the system of claim 5, but Keller in view of Schwab is silent to “ further comprising a second removable retainer positioned between the proximal end of the plunger assembly and the proximal end of the barrel portion and proximal to a distal end of the first retainer, the second removable retainer limiting movement of the plunger assembly relative to the barrel portion to a second length configured to purge any air that may be present from the second and third reservoirs .” However, Rissman teaches a system for producing a mixture to deliver to a treatment site (see [0008]) , comprising a multi-reservoir system (see FIG. 12 and ‘Modified FIG. 12’ provided for immediate reference below) , the multi-reservoir system (see FIG. 12) comprising: a plunger assembly (930) ; and the system comprising a first removable retainer (901, see removing in FIG. 15 and [0067]: 901 removed after plunger reaches desired location). Rissman further teaches that one or more removable retainers may be removably coupled to the plunger which prevent the plunger from being advanced distally beyond a predetermined location (see [0010]) . Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Keller in view of Schwab to include a first and second removable retainer as taught by Rissman for the purpose of preventing the plunger from being advanced distally beyond one or more predetermined locations (see [0010]) , thus achieving “ further comprising a second removable retainer ”. Modified Keller remains silent to further comprising a second removable retainer “ positioned between the proximal end of the plunger assembly and the proximal end of the barrel portion and proximal to a distal end of the first retainer, the second removable retainer limiting movement of the plunger assembly relative to the barrel portion to a second length configured to purge any air that may be present from the second and third reservoirs .” However, Bowman teaches a system with a plunger assembly (2180, see FIG. 21A and [0005]) , the system comprising a first removable retainer (2130) and a second retainer (2125) , the second retainer (2125) positioned between the proximal end of the plunger assembly (see ‘Modified FIG. 21A-B’ below) PNG media_image6.png 505 669 media_image6.png Greyscale and the proximal end of the barrel portion (see ‘Modified Fig. 21A-B’ above) and proximal to a distal end of the first retainer (as shown in ‘Modified Fig. 21A-B’ above) , the second retainer (2125) limiting movement of the plunger assembly (2180) relative to the barrel portion to a second length (see [0102]: first and second retainers stop plunger at two different positions) configured to purge any air that may be present (movement of plunger actuates plunger and therefore is ‘configured to purge’ air). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second removable retainer taught by Modified Keller to be positioned between the proximal end of the plunger assembly and the proximal end of the barrel portion and proximal to a distal end of the first retainer, the second retainer limiting movement of the plunger assembly relative to the barrel portion to a second length configured to purge any air that may be present from the second and third reservoirs as taught by Bowman for the purpose of limiting the plunger using different nested bearing surfaces (see [0102]) , thus achieving further comprising a second removable retainer “ positioned between the proximal end of the plunger assembly and the proximal end of the barrel portion and proximal to a distal end of the first retainer, the second removable retainer limiting movement of the plunger assembly relative to the barrel portion to a second length configured to purge any air that may be present from the second and third reservoirs .” 07-22-aia AIA Claim s 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Keller in view of Schwab as applied to claim 7 above, and further in view of Thorne, JR. et al. (U.S. PGPUB No. 2018/0093040), hereinafter Thorne . Regarding claim 8, the modified system of Keller teaches the system of claim 7, but Modified Keller is silent to “ wherein the cap includes at least one cavity configured to receive fluid from the second and/or third reservoirs .” However, Thorne teaches a system with a barrel portion (150’, see Figure 13) , and multiple reservoirs (154’ & 152’, see [0160-0165]) , the system further comprising a cap (40, see [0160]) removably coupled (see [0165]) with a distal end region (leftward end of barrel) of the barrel portion (150’) , wherein the cap (40) includes at least one cavity (see ‘Modified Figure 13’ below) PNG media_image7.png 354 697 media_image7.png Greyscale configured to receive fluid (cap has a cavity and therefore is capable of receiving any fluid permitted to flow therein) from the multiple reservoirs (154’ and 152’). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cap taught by Modified Keller to include a cavity configured to receive fluid from the reservoirs as taught by Thorne for the purpose of allowing mixing of the reservoir contents prior to removal of the cap (see [0160-0165]) , thus achieving “ wherein the cap includes at least one cavity configured to receive fluid from the second and/or third reservoirs .” Regarding claim 9, the modified system of Keller teaches the system of claim 7, but Modified Keller is silent to “ wherein the plunger assembly is configured to be at least partially actuated with the cap coupled to the distal end region of the barrel portion .” However, Thorne teaches a system with a barrel portion (150’, see Figure 13) , a plunger assembly (50, see [0164]) , and multiple reservoirs (154’ & 152’, see [0160-0165]) , the system further comprising a cap (40, see [0160]) removably coupled (see [0165]) with a distal end region (leftward end of barrel) of the barrel portion (150’) , wherein the plunger assembly (50, see [0164]) is configured to be at least partially actuated with the cap coupled to the distal end region of the barrel portion (see plunger actuation with cap 40 attached in progression of Figures17-19 and described in [0160-0165]). Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger assembly taught by Modified Keller to be configured to be partially actuated with the cap attached as taught by Thorne for the purpose of allowing mixing of the reservoir contents prior to removal of the cap (see [0160-0165]) , thus achieving “ wherein the plunger assembly is configured to be at least partially actuated with the cap coupled to the distal end region of the barrel portion .” Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure : Akbari et al. (U.S. PGPUB No. 2023/0355895) teaches a number of removable retainers positioned along a plunger that delimit the plunger to a length sufficient for removing a headspace/ air from the dispensing syringe Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783 Application/Control Number: 18/646,387 Page 2 Art Unit: 3783 Application/Control Number: 18/646,387 Page 3 Art Unit: 3783 Application/Control Number: 18/646,387 Page 4 Art Unit: 3783 Application/Control Number: 18/646,387 Page 5 Art Unit: 3783 Application/Control Number: 18/646,387 Page 6 Art Unit: 3783 Application/Control Number: 18/646,387 Page 7 Art Unit: 3783 Application/Control Number: 18/646,387 Page 8 Art Unit: 3783 Application/Control Number: 18/646,387 Page 9 Art Unit: 3783 Application/Control Number: 18/646,387 Page 10 Art Unit: 3783 Application/Control Number: 18/646,387 Page 11 Art Unit: 3783 Application/Control Number: 18/646,387 Page 12 Art Unit: 3783 Application/Control Number: 18/646,387 Page 13 Art Unit: 3783 Application/Control Number: 18/646,387 Page 14 Art Unit: 3783 Application/Control Number: 18/646,387 Page 15 Art Unit: 3783 Application/Control Number: 18/646,387 Page 16 Art Unit: 3783 Application/Control Number: 18/646,387 Page 17 Art Unit: 3783 Application/Control Number: 18/646,387 Page 18 Art Unit: 3783 Application/Control Number: 18/646,387 Page 19 Art Unit: 3783 Application/Control Number: 18/646,387 Page 20 Art Unit: 3783 Application/Control Number: 18/646,387 Page 21 Art Unit: 3783 Application/Control Number: 18/646,387 Page 22 Art Unit: 3783
Prosecution Insights