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 .
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 39 and all dependents thereof 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.
Claim 39 recites “the plurality of fluid delivery systems in line 2. However, because the reference back to claim 35 has not yet been introduced, the fluid delivery systems have not yet been introduced and therefore the article “the” appears to need to be changed to “a”. It is suggested, for clarity that the claim language be changed to recite “A method comprising: providing the container of Claim 35; positioning a predetermined number of the plurality of fluid delivery systems in the container for a predetermined duration of treatment…” this would correct the issue and not present any additional 112 clarity issues.
Claim 39 recites “a substantially cylindrical recess” in line10. Because claim 35 has been incorporated in claim 39 the substantially cylindrical recess has already been introduced. Therefore it appears the claim should recite –the substantially cylindrical recess--.
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, 9-11, 15, 35, 36, 53, 54, 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claes et al. (US 5,566,828) in view of MacGregor (US 1,980,141).
With regard to claim 1, Claes discloses A container (Fig. 1-3) comprising: a first member (12) comprising an outer surface (see where 12 is pointing in Fig. 3) and a plurality of grooves (Fig. 1, elements 41, 42, 43) opposite the outer surface and configured to frictionally engage and releasably secure portions of any one of a plurality of fluid delivery systems (Fig. 2 shows a delivery system 48, claims only one of a plurality of delivery systems but does not required multiple delivery systems. Further the claims language does not positively recite a delivery system and therefore the prior art does not need to teach the actual delivery system but only grooves that are capable of releasably securing delivery systems), each of the plurality of fluid delivery systems being a pen injector (48, again the fluid dlivery system is not positively recited and therefore does not explicitly need to be taught by the prior art. However, for furthering compact prosecution if the prior art does teach any of the claimed elements, they will be referenced as well); a second member (13) comprising a substantially planar surface (see Fig. 3, where 13 is pointing) and hingedly connected to the first member (see between Fig. 3 and 5); and a third member (11) comprising an outer surface (where 11 is pointing in Fig. 3) and hingedly connected to the second member (see between Fig. 3 and 5), the third member comprising a substantially cylindrical recess (62) configured to releasably hold a proximal end of one of the plurality of fluid delivery systems so that a distal end of the fluid delivery system is oriented in an upright position during and/or after reconstitution (“configured to” language implies functional language and therefore the cylindrical recess must only be capable of holding a proximal end of a fluid delivery system. Thus the hollow cylindrical portion 62 would be capable to hold a proximal portion of a delivery system as it is simply a hollow tube structure for which any drug delivery device could be placed), wherein the fluid delivery system in the upright position is orthogonal to one or more of the plurality of fluid delivery systems releasably held in the grooves (if the fluid delivery system 48 is placed in the substantially cylindrical recess it would be in an orthogonal position); wherein the container is configured such that in a closed configuration, the outer surfaces of the first and third members are substantially parallel with each other with outer edges of the first and third members contacting or immediately adjacent thereto to form an enclosed housing (see Fig. 5); and wherein the container is configured such that in an open configuration (see Fig. 3), the outer surfaces of the first, second, and third members are substantially planar to one another and facing the same direction.
However, Claes does not explicitly disclose the grooves able to contain a plurality of fluid delivery systems.
MacGregor teaches a container (Fig. 1) having a first member (10), a second member (12) and a third member (11) in which the container also lays flat when in an open configuration (Fig. 1). The container further includes a plurality of grooves (3/6) configured to frictionally engage a plurality of fluid delivery systems (p. 2, col 2, lines 58-70, case can hold a plurality of syringe outfits (each considered fluid delivery systems) and the case includes grooves for at least 6 fluid delivery systems as shown in Fig. 1-5).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes to include more grooves in order to accommodate a plurality of delivery systems as taught by MacGregor for the purpose of allowing the container to safely carry multiple delivery systems for travel and emergency use without breaking (p.2, col 1, lines 6-22).
With regard to claim 2, Claes discloses the second member (13) being positioned between the first (12) and third members (11).
With regard to claim 9 and 10, Claes discloses the claimed invention except for the at least four separate delivery systems.
MacGregor teaches a container with grooves (6) configured to hold at least four separate fluid delivery systems (there are at least six slots for holding delivery systems, and therefore are capable of holding at least four separate delivery systems (the delivery systems are not positively claimed and therefore not required to be explicitly taught in the claims). Further, MacGregor teaches that the grooves releasably hold the plurality of fluid delivery systems so that each is aligned with the other and oriented parallel with the outer surface of the second member (see Fig. 1 5 with the grooves 6 aligned and designed to hold a delivery system in parallel to one another).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes to include more grooves in order to accommodate a plurality of delivery systems as taught by MacGregor for the purpose of allowing the container to safely carry multiple delivery systems for travel and emergency use without breaking (p.2, col 1, lines 6-22).
With regard to claim 11, Claes discloses the claimed invention except for the grooves formed in a tray coextensive with the first member.
MacGregor teaches wherein the grooves are formed in a tray (1, Fig. 3) coextensive with the first member (10), the grooves (6) being configured to cradle at least one of the plurality of fluid delivery systems (as shown in Fig. 1 and 3) securely in a predetermined position during transport of the container.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes to include a tray as taught by MacGregor for the purpose of creating replaceable sets of drug delivery devices while being able to reuse the outer shell member (p.2, Col 2, lines 71-84).
With regard to claim 15, Claes discloses wherein each fluid delivery system comprises an ampoule (48) prepackaged with an active agent and a solvent whereby the ampoule is incapable of being removed from the fluid delivery system by an end user (the fluid delivery system and all elements pertaining to it are not positively claimed, only the container grooves configured to hold the delivery system is positively claimed and therefore required to be taught by the prior art. It is suggested that the fluid delivery system be positively claimed in order to require the prior art to also teach the components of the fluid delivery system).
With regard to claim 35, Claes discloses wherein the fluid delivery system comprises: a housing (Fig. 2, element 48); a cartridge holder fixedly coupled to the housing; a cartridge disposed within a cartridge holder internal cavity, the cartridge comprising; a distal tip (51); a first stopper (connected to plunger 49); a second stopper disposed between the distal tip and the first stopper; an active agent disposed between the distal tip and the second stopper; and a solvent disposed between the second stopper and the first stopper (the fluid delivery system is not positively claimed and there not required to be taught by the prior art however, citations are included wherever possible to help expedite prosecution. It is suggested that the fluid delivery system be positively claimed in order to require the prior art to also teach the components of the fluid delivery system.).
With regard to claim 36, Claes discloses wherein the active agent comprises lyophilized teduglutide (As stated above the fluid delivery system including limitations that are part of the fluid delivery system are not positively recited and therefore not required to be taught by the prior art).
With regard to claim 53, Claes in view of MacGregor teach a kit comprising one or more containers according to Claim 36 (see rejection above of 36).
With regard to claim 54, Claes discloses wherein each container comprises a predetermined supply of fluid delivery systems for a predetermined duration of treatment (container of Fig. 2, contains a supply of fluid delivery systems 48 for a predetermined duration of treatment. Without further definition as to how long the treatment is or how many fluid delivery systems are required, the system of Claes would be considered to be a supply used for a treatment and would necessarily have a predetermined duration).
With regard to claim 58, Claes discloses the claimed invention except for the tray.
MacGregor teaches wherein the tray (1) is detachable from the first member (shown in Fig. 3) and replaceable with a secondary tray with a second plurality of fluid delivery systems (p. 2, col 2, lines 72-84, the trays 1 are designed to be replaceable and therefore implies that a second tray would be placed in the container after the first tray is detached from the first member).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes to include a tray as taught by MacGregor for the purpose of creating replaceable sets of drug delivery devices while being able to reuse the outer shell member (p.2, Col 2, lines 71-84).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claes et al. (US 5,566,828) in view of MacGregor (US 1,980,141) in view of Lazarus (US 4,128,173).
With regard to claim 12, Claes discloses a third member (Fig. 2, element 11).
However Claes/MacGregor does not teach a plurality of recesses to hold needles.
Lazarus teaches a container (fig. 1, having a first member (10b) containing grooves for holding a fluid delivery system (36) and a third member (10a), wherein the third member comprises: a plurality of needle recesses (100, 90) configured to releasably hold sealed disposable needles (where 12 and 16 are pointing) for use with a distal end of the fluid delivery system (36). (NOTE: the needles are not positively recited and not required to be taught by the prior art). The recesses could be added to the third member of Claes as the third member of Claes has space and room to include further recesses that would allow needles to be attached.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes/MacGregor with the recesses for holding needles as taught by Lazarus for the purpose of providing all necessary equipement to perform a specific procedure (Col 2, lines 58-61; Col 3, lines 6-10).
With regard to claim 13, Claes discloses whereby, during and/or after reconstitution, an active agent and a solvent comprised in a distal ampoule portion of the fluid delivery system in the upright position mixes for a predetermined period of time (As stated above the fluid delivery system including limitations that are part of the fluid delivery system are not positively recited and therefore not required to be taught by the prior art).
With regard to claim 14, Claes discloses the cylindrical recess (62) in the center of the third member, however it would be prima facie obvious to move the location of the cylindrical recess to be adjacent a corner as doing so would be considered a simple design choice and no significance has been provided in the claims.
Claim(s) 39, 55, 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claes et al. (US 5,566,828) in view of MacGregor (US 1,980,141) in view of Drake et al. (WO 2008/093063 A1).
With regard to claim 39, Claes discloses A method, comprising: positioning a predetermined number of the plurality of fluid delivery systems in the container of Claim 35 (see rejection above) for a predetermined duration of treatment (the term “predetermined” has not been defined to impart any particular restraints or time conditions, therefore the use of the fluid delivery system in Claes (48) is considered to be enough for the predetermined injection that it is intended for. The delivery system 48 is positioned in the container as shown in Fig. 2);selecting, by a user, one of the plurality of fluid delivery systems (48), where each of the plurality of fluid delivery systems comprises medication (within 48 and also in vial 54) corresponding to one or more days of treatment (the injection from 48 would be considered treatment for a day as it would be used on at least one day); delivering medication, by the selected one of the fluid delivery, to the patient (Col 4, lines 15-32),
However, Claes does not explicitly disclose the grooves able to contain a plurality of fluid delivery systems and detaching the first and second member from the container.
MacGregor teaches a container (Fig. 1) having a first member (1), in which the container also lays flat when in an open configuration (Fig. 1). The container further includes a plurality of grooves (3/6) configured to frictionally engage a plurality of fluid delivery systems (p. 2, col 2, lines 58-70, case can hold a plurality of syringe outfits (each considered fluid delivery systems) and the case includes grooves for at least 6 fluid delivery systems as shown in Fig. 1-5). MacGregor further teaches then upon use of each of the plurality of fluid delivery systems of the container, detaching the first (1) or third member previously comprising the plurality of fluid delivery systems; and then attaching another first or third member to the container (p. 2, col 2, lines 72-84, the trays 1 are designed to be replaceable and therefore implies that a second tray would be placed in the container after the first tray is detached from the first member).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes to include more grooves in order to accommodate a plurality of delivery systems as well as a detachable first member as taught by MacGregor for the purpose of allowing the container to safely carry multiple delivery systems for travel and emergency use without breaking (p.2, col 1, lines 6-22) and for creating replaceable sets of drug delivery devices while being able to reuse the outer shell member (p.2, Col 2, lines 71-84)..
However, Claes/MacGregor do not teach positioning a proximal end of the fluid delivery system in the cylindrical recess and reconstituting the solvent.
Drake teaches a container (Fig. 22b/23) having a hinged third member (184) connected to a first member (182) and having grooves to contain a fluid delivery system (202/212/222). Drake further teaches a recess (192) such that causing an active agent of a fluid delivery system in the container to mix with a solvent disposed in the fluid delivery system thereby creating a reconstituted liquid (p. 36, lines 14-27); positioning a proximal end of the fluid delivery system in a substantially cylindrical recess of the container for a predetermined period of time during and/or after reconstitution (see Fig. 26, where proximal end of 202b is placed in recess 192; p. 36, lines 14-27). Thus the device of Claes (48) could be placed in the cylindrical recess 62 in a similar fashion in order to reconstitute the solvent.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes/MacGregor to be used such that a solvent is reconstituted by placed the proximal end of a fluid delivery system in the recess as taught by Drake for the purpose of forming the required medicament and assist in mixing (p. 36, lines 23-27).
With regard to claim 55 and 56, Claes/MacGregor teach the claimed invention except for the size of the fluid delivery system.
Drake teaches the fluid delivery system can be 3ml or 4ml of medication comprising the active agent and solvent (p. 14, lines20-21). Further it would be prima facie obvious to optimize the size of the fluid delivery system as doing so would not alter the overall function of the device.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes/MacGregor to have a specific size for the fluid delivery system as taught by Drake for the purpose of using standard sized equipment (p. 14, line 20-21). Further it would be prima facie obvious to optimize the size of the fluid delivery system as doing so would not alter the overall function of the device.
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claes et al. (US 5,566,828) in view of MacGregor (US 1,980,141) in view of Drake et al. (WO 2008/093063 A1) and Godfrey et al. (US 2017/0224435 A1).
With regard to claim 40, Claes/MacGregor teach the claimed invention except for a lyophilized teduglutide.
Drake teaches the uses of a lyophilized active agent (p. 1, lines 13-16).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes/MacGregor to use a lyophilized active agent as taught by Drake for the purpose of keeping the active agent in storage (p. 1, lines 13-16).
However, Claes/MacGregor/Drake do not specifically teach teduglutide.
Godfrey teaches delivery of teduglutide ([0146]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes/MacGregor/Drake with Teduglutide as taught by Godfrey because the substitution of one known substance for another is well-known in the art and does not alter the function of the device ([0146]).
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claes et al. (US 5,566,828) in view of MacGregor (US 1,980,141) in view of Drake et al. (WO 2008/093063 A1) and Helmer (US 2020/0164160 A1).
With regard to claim 47, Claes discloses the claimed invention except for four delivery systems.
MacGregor teaches a container (Fig. 1) having a first member (1), in which the container also lays flat when in an open configuration (Fig. 1). The container further includes a plurality of grooves (3/6) configured to frictionally engage a plurality of fluid delivery systems (p. 2, col 2, lines 58-70, case can hold a plurality of syringe outfits, at least 6 (each considered fluid delivery systems) and the case includes grooves for at least 6 fluid delivery systems as shown in Fig. 1-5).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes to include more grooves in order to accommodate a plurality of delivery systems as well as a detachable first member as taught by MacGregor for the purpose of allowing the container to safely carry multiple delivery systems for travel and emergency use without breaking (p.2, col 1, lines 6-22).
However, Claes/MacGregor/Drake do not teach a treatment duration of approximately a week.
Helmer teaches a hinged container (Fig. 2) containing a plurality of drug delivery systems enough for a predetermined duration of treatment being approximately a week ([0003], [0005], [0122]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes/MacGregor/Drake to include enough for a duration of a week as taught by Helmer for the purpose of allowing a user to carry enough medication if travelling for a longer period of time ([0003]).
Claim(s) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claes et al. (US 5,566,828) in view of MacGregor (US 1,980,141) in view of Helmer (US 2020/0164160 A1).
With regard to claim 57, Claes discloses the claimed invention except for four delivery systems.
MacGregor teaches a container (Fig. 1) having a first member (1), in which the container also lays flat when in an open configuration (Fig. 1). The container further includes a plurality of grooves (3/6) configured to frictionally engage a plurality of fluid delivery systems (p. 2, col 2, lines 58-70, case can hold a plurality of syringe outfits, at least 6 (each considered fluid delivery systems) and the case includes grooves for at least 6 fluid delivery systems as shown in Fig. 1-5).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes to include more grooves in order to accommodate a plurality of delivery systems as well as a detachable first member as taught by MacGregor for the purpose of allowing the container to safely carry multiple delivery systems for travel and emergency use without breaking (p.2, col 1, lines 6-22).
However, Claes/MacGregor do not teach a treatment duration of approximately a week.
Helmer teaches a hinged container (Fig. 2) containing a plurality of drug delivery systems wherein the predetermined duration of treatment is approximately a month ([0005], [0122], [0137]), the kit comprising at least four containers and each container comprised by the kit comprises approximately supply to last a week enough for a predetermined duration of treatment being approximately a week ([0005], [0122], [0137]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Claes/MacGregor to include enough for a duration of a week up to a month as taught by Helmer for the purpose of allowing a user to carry enough medication if travelling for a longer period of time ([0003]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783