DETAILED ACTION
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Claim 7 recites that “in a first position, the first sharpened point of the cannula is within the cannula holder.” Applicant(s) describes Fig. 2B as depicting the first position, however, it is clear from the figure that the first sharpened point 355 of the cannula 350 protrudes from end of the cannula holder 300 in the same manner that the second sharpened point 360 protrudes from the opposite end of the cannula holder 300 and extends axially into the housing in the opposite direction. No other figure within the drawings depicts the first sharpened point as being in any way encompassed within the cannula holder. Therefore, the claimed configuration, wherein “in a first position, the first sharpened point of the cannula is within the cannula holder” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claim 16, the claim recites that “the volume [of buffering solution] transferred is between 0.9 and 1.1 ml.” However, the specification makes no mention of these values. Instead, the specification consistently describes the transferred volume as 0.1 ml, with a manufacturing tolerance of +/- 20%, which would result in a range of 0.08-0.12 ml (see, for example, [0026]). This is an order of magnitude different than the claimed range, and has no overlap with the claimed range. As such, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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.
Claims 1-19 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 claim recites “a housing about a center axis” and also recites within the same claim “a hollow body about a center axis.” Because the limitation “a center axis” is recited twice without any distinguishing context, it is unclear whether the hollow body’s axis is the same axis as the housing’s axis or is a second distinct axis. Further, the claim subsequently refers to “the center axis” within the phrases “closed distal end about the center axis” and “a cannula disposed about the center axis.” If the center axes are in fact distinct, it is then unclear which center axis is referenced by these limitations. For these reasons, the scope of the claim is unclear, rendering the claim and all claims dependent therefrom (claims 2-19) indefinite. Appropriate clarification is required. For examination purposes, it is presented that, in view of the specification, each “a/the center axis” is best understood to refer to the same center axis of the housing.
It should also be pointed out that the limitation “a cannula holder axially movable … in contact with the flexible piston” of claim 1 ends with a colon instead of a semicolon – a likely typographical error. Appropriate correction is required for grammatical clarity.
Claim 7 comprises the limitations “in a first position, the first sharpened point of the cannula is within the cannula holder” and “in a third position … the first sharpened point penetrates the flexible piston,” however, these limitations appear to conflict with the limitation “the cannula fixedly attached to the cannula holder” within claim 1, upon which claim 7 depends. This apparent conflict arises because it is unclear how the first sharpened point of the cannula (being part of the cannula) could penetrate the flexible piston while being contained within the cannula holder, thus the implication of the cited limitations of claim 7 is that the cannula must be capable of extending from (translating within) the cannula holder, however, such is prohibited by the fact that the cannula must be “fixedly attached” to the cannula holder, as established by claim 1. As a result of this conflict, the scope of the claim is rendered indefinite. Further, since no reasonable interpretation can be made of the claim’s scope for examination purposes, no rejections of claim 7 are presented in view of the prior art. This should not, however, be taken as any indication of allowability over the prior art.
In claim 16, the limitation “the volume transferred” lacks antecedent basis. No such term is introduced in claim 1, upon which claim 16 depends, nor is any process of volume transfer described therein. It is thus unclear whether “the volume transferred” refers to a volume of the buffering solution transferred into the anesthetic cartridge (as is suggested by the specification, although with numerical values that do not correspond to the claimed range – see above rejection over 35 U.S.C. 112(a)), or some other volume transferred. Claim 16 is thus rendered indefinite due to this uncertainty in scope. Appropriate clarification and/or correction is required. For examination purposes, the former interpretation, which is supported in part by the specification, is presented.
In claim 17, the limitation recites the limitation “the buffering solution sealed within a packaging”, but later appears to refer to the same “packaging” structure as “the package.” This inconsistency in terminology renders the meaning of the claim uncertain, since these terms could, based on the context of the claim alone, refer to separate structures. Appropriate clarification and/or correction is required. For examination purposes, it is presented that these terms refer to the same structure, as is supported within the specification.
In claim 18, the limitation “the anesthetic cartridge” lacks antecedent basis. Claim 18 depends on claim 1, which does not introduce a cartridge structure, thereby rendering the meaning of “the anesthetic cartridge” unclear, and the claim indefinite. A cartridge structure is introduced in claim 4, thus it is likely that claim 18 was intended to depend therefrom, rather than from claim 1. Appropriate correction is required. For examination purposes, it is presented that “the anesthetic cartridge” refers to a cartridge containing an anesthetic liquid, as is supported by the specification and the plain meaning of the claim language.
In claim 19, the limitations “the device” and “the solution” do not correspond to introduced structures/features, and thus lack antecedent basis. It is therefore unclear to which introduced or non-introduced structures/features these limitations refer, thereby rendering the claim indefinite. Appropriate clarification/correction is required. For examination purposes, it is presented that “the device” likely refers to the “a buffering capsule” and “the solution” likely refers to the “a buffering solution”, as is suggested within the specification.
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.
Claim(s) 1-2, 4-5, 8-9, 11-16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (U.S. Pat. Pub. No. 2023/0131145 A1) in view of Uchida (U.S. Pat. No. 5,445,631) and Ogle (U.S. Pat. No. 4,191,225).
Regarding claim 1, Jensen discloses a buffering capsule (medicament compounding vial 100) for buffering an anesthetic cartridge ([0001], [0014], [0023], and [0026-0028]) comprising: a housing (housing 110) about a center axis and having a housing length (see Fig. 1-3B), the housing including: a hollow body (first/proximal portion 114) about a center axis, the hollow body having a first inner circumferential surface, a hollow body length, and a hollow body diameter, and a closed distal end (distal/closed end 112) about the center axis including a receptacle (distal portion 115), the receptacle having a second inner circumferential surface, a receptacle length, and a receptacle diameter (see Fig. 1-3B, [0020-0021], and [0035], wherein the distal portion 115 is a camber defined within the closed distal end which holds first medicament/buffering solution 119); and an opening (open end 111) opposite the closed distal end (see Fig. 1-3B and [0020]); a buffering solution (first medicament 119) disposed within the receptacle (see Fig. 2-3B, [0021], [0023], and [0028]); and a flexible piston (stopper 116) disposed within the receptacle in sealing contact with the second inner circumferential surface and the buffering solution, wherein the flexible piston is axially movable within the housing toward the closed distal end (see Fig. 2-3B, [0021], [0027], and [0035]). Jensen also teaches a cannula (needle 117) provided within the flexible piston (see Fig. 2-3B and [0022]) and teaches that a cartridge (ampoule/carpule 150) comprising a septum (septum 153) and filled with anesthetic liquid (second medicament 155) may be provided within the housing (see Fig. 3A-3B and [0026]). When the user applies an axial force directed to bringing the cartridge closer to the receptacle the cartridge is pressed against the cannula such that the septum is pierced by the cannula, establishing fluid communication between the cartridge and receptacle (see Fig. 3A and [0026]) and such that, upon sustained application of the axial force, the flexible piston is driven by contact with the distal end of the cartridge towards the distal end of the receptacle, thereby emptying it of buffer solution (see Fig. 3B and [0027]).
Jensen thus fails to teach a cannula holder axially movable within the housing and in contact with the flexible piston; a cannula disposed about the center axis, the cannula fixedly attached to the cannula holder, the cannula having a cannula length less than the housing length, a first sharpened point, and a second sharpened point opposite the first sharpened point; wherein the flexible piston is capable of receiving the first sharpened point. Such cannula holders are, however, well known within the art of fluid transfer devices in medical applications.
Uchida, for example, exhibits a fluid transfer device (Fig. 1-7) for fluidly connecting two sealed containers – a first sealed container (solution container 1) and a second sealed container (vial 2) – each containing medicament in a sealed, sterile manner, the fluid transfer device including a housing (capsule 4) into which the first sealed container is fixedly (threadedly) installed and the second sealed container is slidably provided (see Fig. 1-3 and Col. 4, ln 1-65). Uchida teaches that such a fluid transfer device may include, in between the two sealed containers and within the housing, a cannula holder (assembly of sliding member hub 3 and slide arms 32) that is slidably connected to (via slide arms 32) and axially movable within the housing (see Fig. 1-7 and Col. 4, ln 66 – Col. 5, ln 7) and which is configured to come into contact with each of the sealed containers (via upper needle 33 and lower needle 34) in to establish fluid communication between them (see Fig. 1-3 and Col. 5, ln 36-59); a cannula (assembly of upper needle 33 and lower needle 34) disposed about the center axis, the cannula fixedly attached to the cannula holder (sliding member 3), the cannula having a cannula length less than the housing length (see Fig. 1-3), a first sharpened point (pointed tip of upper needle 33), and a second sharpened point (pointed tip of lower needle 34) opposite the first sharpened point (see Fig. 1-3); and wherein the septum of a first container is capable of receiving the first sharpened point and the septum of a second container is capable of receiving the second sharpened point (Col. 5, ln 36-59).
Ogle exhibits another fluid transfer device (assembly of Fig. 7-9) similar to that of Jensen and Uchida for fluidly connecting a sealed container (bottle comprising intravenous solution 36) to a receptacle (chamber formed within the distal end of the vial comprising liquid alimentary component 16, sealed therein by flexible piston 22) formed within a housing (vial comprising liquid alimentary component 16) into which the sealed container is slidably provided (see Fig. 7-9, Col. 1, ln 45 – Col. 2, ln 14, and Col. 2, ln 53-61). Ogle also teaches a cannula holder (transfer device 42) similar to that of Uchida, axially movable within the housing (see Fig. 7-9) and which is configured to be driven into piercing contact with a flexible piston (flexible piston 22) of the receptacle container by an axial force directed to bringing the sealed container and the receptacle closer together (see Fig. 7-8 and Col. 2 , ln 67 – Col. 3, ln 8, and Col. 3, ln 25 – Col. 3, ln 32). Ogle teaches that upon further application of that axial force, which is now transferred through the cannula holder, the flexible piston is driven axially distally within the housing, thereby driving fluid from the receptacle container through the cannula and to the other container (see Fig. 7-9, Col. 3, ln 25 – Col. 3, ln 3, and claim 1b). This mode of operation closely corresponds to that in Jensen, wherein such an axial force applied to the cartridge in Jensen drives axial translation of the flexible piston and thereby empties the receptacle of buffer solution, however Ogle teaches that such an axial force may be transferred through an axially movable cannula holder provided within the housing between the sealed container and receptacle, thereby achieving the same effect.
Based on the teachings and example of Uchida and Ogle, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the cannula configuration of Jensen with a slidable cannula holder of the type taught by Uchida, which can be axially movable within the housing, as taught by Uchida, and which is also capable of contacting and driving the flexible piston, as shown in Ogle, which may comprise a cannula disposed about the center axis, the cannula fixedly attached to the cannula holder, the cannula having a cannula length less than the housing length, a first sharpened point, and a second sharpened point opposite the first sharpened point, all as taught by Uchida, and to modify the flexible piston of Jensen such that the flexible piston is capable of receiving the first sharpened point, in the manner taught by Ogle, since such a configuration is well known within the art (see Uchida and Ogle), and since such a configuration provides advantages in sterility and leak-prevention over that of Jensen. In the configuration of Jensen, the cannula is in fluid communication with the buffer solution at all times prior to use, thus the potential for leakage or bacterial contamination is greater than a configuration in which the buffer solution is maintained in a sealed receptacle until use. Ogle and Uchida both teach the principle of keeping the source container/receptable’s stopper unpierced until use, and piercing the receiving container’s closure first in order to preserve sterility and avoid leakage (see Ogle, Fig. 7-9 and Col. 3, ln 25-32, and Uchida, Col. 5, ln 36-59, and Col. 5, ln 66 – Col. 6, ln 7).
Regarding claim 2, Uchida further teaches that the cannula holder may be slidably connected to the housing (via slide arms 32, see Col, 4, ln 66 – Col. 5, ln 7). Because a cannula holder of the type taught by Uchida is incorporated into the buffering capsule of Jensen in the above modification in re claim 1, it follows that the proposed combination also may exhibit this claimed feature.
Regarding claim 4, Jensen discloses a cartridge having a septum, wherein the cartridge contains an anesthetic liquid (see in re claim 1).
Regarding claim 5, Jensen as modified by Ogle and Uchida exhibits that the buffering solution disposed within the receptacle is fluidly connected to the anesthetic liquid via the cannula (see [0026-0027] of Jensen and see above modification, wherein the fluid connection is made in the manner of Ogle Fig. 7-9 by a cannula formed as part of a cannula holder, rather than in the manner of Jensen).
Regarding claim 8, Jensen further discloses that the buffering capsule may be made of plastic materials and may be injection molded ([0020]), and therefore may be free of glass.
Regarding claim 9, Jensen further discloses that the buffering capsule may be single-use ([0015] and claim 10).
Regarding claim 11, Jensen further discloses that the housing may comprise injection molded plastic ([0020]). Further, in accordance to MPEP 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight. Please note that even though product- by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e. the housing, does not depend on its method of production, i.e. injection molding. In re Thompson, 227 USPQ 964, 966 (Federal Circuit 1985).
Regarding claim 12, Jensen further discloses that the housing may comprise polypropylene ([0020]).
Regarding claim 13, Uchida further teaches that the cannula holder (sliding member 3) may be made of plastic material (Col. 5, ln 7-9). In regards to the cannula holder being injection molded, in accordance to MPEP 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight. Please note that even though product- by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e. the cannula holder, does not depend on its method of production, i.e. injection molding. In re Thompson, 227 USPQ 964, 966 (Federal Circuit 1985).
Regarding claim 14, Uchida teaches that the cannula holder (assembly of hub 31 and slide arms 32) may be formed of any suitable synthetic resin (Col. 5, ln 7-9) and both Uchida and Jensen suggest the use of polypropylene for other components of the capsule, such as the housing (Uchida, Col. 4, ln 13-14, and Jensen, [0020]). Thus, while Uchida does not explicitly teach that the cannula holder comprises polypropylene, it would have been obvious in view of these teachings and suggestions for one of ordinary skill in the art to select polypropylene as a known suitable synthetic resin for use in such an application as a matter of routine design choice in which the designer must select from a list of known and functionally equivalent materials. Further, the selection of the same material (polypropylene) for constructing both the cannula holder and the other components of the capsule would simplify manufacturing.
Regarding claim 15, while Jensen does not teach that the cannula is 28 gauge, the relationship between cannula gauge and flow rate through the cannula is well understood within the art (Poiseuille’s Law – flow rate through a narrow tube depends upon pressure, tube diameter (gauge), fluid viscosity, and tube length), therefore, one of ordinary skill in the art would have found it obvious, as a matter of routine design optimization to select a cannula gauge (result effective variable), including 28 gauge, that would be suitable for producing a desired flow rate of buffer solution according to the predictable relationship governed by Poiseuille’s law. See MPEP 2144.05.
Regarding claim 16, Jensen further discloses that the volume transferred may be between 0.03 to about 1 ml ([0023], [0028], and claim 4) and the buffering solution is a sterile 8.4% sodium bicarbonate solution ([0023], [0028], and [0040]). This range overlaps the claimed range, therefore, one of ordinary skill in the art, based upon this teaching, may select a transfer volume of 1 ml corresponding to the claimed range.
Regarding claim 18, Jensen does not teach, in the embodiment of Fig. 2-3B, that the receptacle diameter is smaller than the inner diameter of the anesthetic cartridge, however, Jensen does exhibits such a configuration in the embodiment of Fig. 5 (see Fig. 5 and [0033-0034], wherein the buffering solution is contained within a narrowed receptacle in order to allow for an annual vent chamber 323 surrounding the receptacle, and compare against Fig. 3A-3B, wherein it is apparent that the receptacle of Fig. 5 has a smaller diameter than that of the cartridge). It would have been obvious to one of ordinary art prior to the filing date of the claimed invention to modify the embodiment of Fig. 5 of Jensen in the same manner and for the same reasons as identified above in re claim 1, whereupon, the proposed combination would exhibit the claimed configurations of claims 1 and 18.
Regarding claim 20, Jensen teaches a process for buffering an anesthetic cartridge comprising: advancing a buffering capsule onto an anesthetic cartridge having a septum and containing an anesthetic liquid ([0016], [0026], [0042], and [0045]), the buffering capsule having a housing (housing 110), a flexible piston (stopper 116), and a cannula (injection needle 117) embedded within the flexible piston (Fig. 2 and [0020-0022]), advancing the buffering capsule onto the anesthetic cartridge until the sharpened point of the cannula has penetrated the septum to fluidly connect the cannula to the anesthetic cartridge (Fig. 3A and [0026]), and further advancing the buffering capsule onto the anesthetic cartridge until the flexible piston is in contact with a closed distal end of the housing (Fig. 3B and [0027])), and intermixing the buffering solution and the anesthetic liquid within the anesthetic cartridge ([0027] and [0043]). Jensen may be modified as described above in re claim 1 such that the stationary cannula is replaced with a cannula that is axially moveable within the housing (via a cannula holder of the type taught by Uchida), the cannula having a first sharpened point and a second sharpened point opposite the first sharpened point (as taught by Uchida – see in re claim 1). As result of the above modification, and in line with Uchida’s and Ogle’s teachings of keeping the source container/receptable’s stopper unpierced until use, and piercing the receiving container’s closure first in order to preserve sterility and avoid leakage (see Ogle, Fig. 7-9 and Col. 3, ln 25-32, and Uchida, Col. 5, ln 36-59, and Col. 5, ln 66 – Col. 6, ln 7), it would have been obvious to one of ordinary skill in the art to correspondingly modify the method of operation of the buffering capsule of Jensen, such that upon advancing the buffering capsule onto the anesthetic cartridge, the next steps would entail penetrating the first sharpened point of the cannula into the septum to fluidly connect the cannula to the anesthetic cartridge, as taught by Ogle (Fig. 6 and Col. 3, ln 25-28) and Uchida (Col. 5, ln 41 – Col. 6, ln 24); penetrating the second sharpened point through the flexible piston and into the receptacle containing a buffering solution to fluidly connect the cannula to the buffering solution, as also taught by Ogle (Fig. 7-8 and Col. 3, ln 28-34); and advancing the buffering capsule onto the anesthetic cartridge further until the flexible piston is in contact with a closed distal end of the housing, and intermixing the buffering solution and the anesthetic liquid within the anesthetic cartridge, as taught by Jensen (see above) and Ogle (Fig. 9 and Col. 3, ln 28-34).
Claim(s) 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen as modified by Uchida and Ogle according to claim 2, and in further view of Wu (U.S. Pat. Pub. No. 2015/0020919 A1).
Regarding claim 3, Jensen as modified by Uchida and Ogle according to claim 2 exhibits the buffering capsule of claim 2. Uchida further teaches that the cannula holder may include first and second extensions (slide arms 32) at a cannula holder base (see Fig. 2-3 and Col. 5, ln 1-9), where the first and second extensions are slidably movable within the hollow body of the housing, and may engage a recess (recess 47) within the interior surface of the hollow body of the housing (Col. 6, ln 25-41). Neither Jensen nor Uchida, however, teach first and second extensions that are slidably movable in first and second apertures in the hollow body of the housing.
Wu exhibits an adapter assembly (transfer set 310, embodiment of Fig. 17-23) for establishing fluid connection between a cartridge (cartridge 318) and a vial (vial 316) in a manner similar to the buffering capsule of Jensen and the fluid transfer device of Uchida (see Fig. 17-23 and [0069-0071]). Wu teaches that such a device may comprise a cannula (transfer needle 382) provided between the cartridge and the vial within a housing (cylindrical body 340) of the device and mounted on a cannula holder (assembly of ring slider 360 and float hub 380, these features moving cooperatively and interlocking during axial movement within the housing) that is slidably connected to the housing (via locking tabs 362, which are biased against the inner wall surface of the housing prior to insertion of the cartridge 318, thereby holding the cannula holder in slidable connection, and which are subsequently engaged within expansion windows 356 to slidably connect the cannula holder to the housing), such that the cannula and cannula holder are axially moveable within the housing of the device (see Fig. 17 and 19-21, and [0069-0071]). Wu also teaches that such a cannula holder may include first and second extensions (locking tabs 362) at a cannula holder base (see Fig. 17 and 19-22, and [0069]), where the first and second extensions are slidably movable within first and second apertures (expansion windows 356 corresponding to first/second locking tabs 362) in the hollow body of the housing (see Fig. 17-23). Wu teaches that this configuration assists in guiding the cannula holder in its motion through the housing ([0069], ln 15-18). Wu further teaches that upon the cannula holder reaching its final position (wherein fluid connection between the cartridge and vial are securely established), the first and second extensions (locking tabs 362) expand into another window (expansion window 358) in order to thereby lock the cannula holder in its final position so that the cannula cannot be re-exposed (see Fig. 21 and [0071]), thereby reducing the danger of accidental needle exposure or re-use of the device.
Based on the teachings of Wu, and because both Jensen and Wu describe single-use capsules/adapters with concern for preventing needle exposure after use (see Jensen, [0014] and cl. 6, and Wu, [0008-0010], [0069], and [0071]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second extensions and housing of the buffering capsule of Jensen as modified by Uchida according to the guiding/locking configuration taught by Wu, such that the first and second extensions are slidably movable in first and second apertures formed in the hollow body of the housing, as taught by Wu, since this configuration assists in guiding the cannula holder in its motion through the housing and allows the cannula holder to be locked in its final position so that the cannula cannot be re-exposed, as described by Wu (see Fig. 21, [0069], ln 15-18, and [0071]), thereby reducing the danger of accidental needle exposure or re-use of the device.
Regarding claim 6, Wu further teaches that the cannula holder is axially moveable from an initial position, where the first and second extensions are at first ends of the first and second apertures (see Fig. 17 and 19, and [0069-0071], wherein it is clear that at a stage between these figures, the locking tabs 362 are disposed within the expansion windows 356 at their proximal end), to another position advanced axially in a direction toward the distal end of the housing, where the first and second extensions are at second ends of the first and second apertures and the vial and cartridge are fluidly connected via the cannula (see Fig. 20 and 21 and [0069-0071], wherein it is clear that at a stage between these figures, the locking tabs 362 are disposed within the expansion windows 356 at their distal end, and at this position, both the septa/plugs of the vial and cartridge will have been pierced, establishing fluid communication between the vial and cartridge). Because the buffering capsule of Jensen as modified by Uchida and Ogle is further modified in the above modification to include the guiding/locking configuration taught by Wu, it follows that, as part of this modification and for the same reasons, it would have been obvious to one of ordinary skill in the art to configure the first and second extensions and corresponding first and second apertures of the proposed combination such the first and second extensions are at first ends of the first and second apertures in an initiation position of the cannula holder, and such that the first and second extensions are at second ends of the first and second apertures when the buffering solution is fluidly connected via the cannula in an advanced position of the cannula holder.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jensen as modified by Uchida and Ogle according to claim 1, and in further view of FDA (NPL, “Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP 8.4%, 50 mEq/50 mL Vial, 20-Count Carton Due to Vial Breakage”).
Regarding claim 10, Jensen as modified by Uchida and Ogle according to claim 1 exhibits the buffering capsule of claim 1. Jensen fails to explicitly teach that the buffering capsule has a shelf life of 180 days or more (Jensen making no comment regarding shelf life), it is well known within the art that a properly sterilized and sealed capsule of sodium bicarbonate solution of the type disclosed by Jensen may have a shelf life of more than a year. For example, such is apparent from FDA, a recall notice for just the same type of buffering capsule (sealed injection vial of sodium bicarbonate, USP 8.4% - see pg. 2, ln 1-10) as is claimed and as is disclosed in the present application, wherein buffering capsules distributed to customers between December 16, 2021 and August 10, 2022 are listed as having expiration dates varying from October 2023 to May 2024 (see Table, and see pg. 4, ln 13-14). This corresponds to a best-case shelf life of 29 months, and a worst-case shelf life of 14 months. Thus, in light of the example of FDA, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as a matter of conventional practice within the art and in order to extend the useful life of the product (thereby improving its ability to be transported and stockpiled for future need) to provide the buffer capsule of Jensen in a properly sterilized and sealed state which may support a shelf life of more than 180 days, as is commonly done within the art.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Jensen as modified by Uchida and Ogle according to claim 1, and in further view of Iguchi (U.S. Pat. No. 6,232,128 B1).
Regarding claim 17, Jensen as modified by Uchida and Ogle according to claim 1 exhibits the buffering capsule of claim 1. Jensen does not teach that the buffering capsule may be sealed within a packaging, wherein the carbon dioxide concentration within the package is higher than atmospheric conditions, however, it is well known within the art to provide such packaging (modified atmosphere packaging) in order to improve the sterility and shelf-life of medical/pharmaceutical products and perishable foods. Iguchi specifically exhibits a packaging configuration for extending the shelf-life of medical bicarbonate-containing solutions (such as the present buffering solution of Jensen) and allowing for detection of product aging or package leakage (see Fig. 1, Abstract, and Col. 2, ln 43 – Col. 3, ln 25). Iguchi teaches that capsules of such solutions may be sealed within a packaging (gas impermeable packaging member 3), wherein the carbon dioxide concentration within the package is higher than atmospheric conditions (about 40% CO2 – see Col. 5, ln 12-27 and Examples 1-6) in order to thereby extending the shelf-life of medical bicarbonate-containing solutions and allowing for detection of product aging or package leakage (via a pH monitor 5 – see Fig. 1, Abstract, Col. 1, ln 15-48, Col. 2, ln 43 – Col. 3, ln 25, and Examples 1-6). Based on the teachings and example of Iguchi, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to package the buffering capsule of Jensen as sealed within a packaging, wherein the carbon dioxide concentration within the package is higher than atmospheric conditions, such as in the manner taught by Iguchi, in order to thereby extend the shelf-life of the bicarbonate-containing buffering solution contained therein and allow for detection of product aging or package leakage, as described by Iguchi.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Jensen as modified by Uchida and Ogle according to claim 1, and in further view of Patel (U.S. Pat. Pub. No. 2020/0246533 A1).
Regarding claim 19, Jensen as modified by Uchida and Ogle according to claim 1 exhibits the buffering capsule of claim 1. While Jensen does teach that the buffering capsule may be sterilized ([0040]), Jensen does not teach that the device and solution are sterilized with ionizing radiation. However, use of ionizing radiation is well known in the art as one of a number of known ways to sterilize such a device. Patel, for example, exhibits a medical capsule (pre-filled syringe – see [0043]) which may be sterilized by ionizing gamma radiation in order to provide a preliminary sterilization (see [0043-0046]) and teaches that ionizing gamma radiation is one among several known methods of sterilization known to those skilled in the art which does not result in significant damage or inactivation of the target medical capsule ([0038]). It would thus have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, based on the teachings of Patel, to sterilize the buffering capsule and buffering solution of Jensen (as a pre-filled container) using ionizing gamma radiation in order to provide a preliminary sterilization which may not result in significant damage or inactivation of the target medical capsule, as described by Patel.
Conclusion
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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