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 Objections
Claims 11 and 13 are objected to because of the following informalities:
Claim 11 Line 3 states “formed value” should read –formed valve--.
Claim 13 line 25 states “opening, the through” should read –opening, through--.
Claim 13 line 28 states “does no extended” should read –does not extend—
Appropriate correction is required.
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, 8, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merhold et al. (U.S. Publication 2016/0038374).
Regarding claim 1, Merhold discloses an adapter 19 for medical containers 3 (¶0003 used for administrating doses of liquid medicine for example from a storage container into a dosing syringe) comprising:
A cylindrical substrate (see below illustrative diagram of Fig. 2) wherein the substrate comprises a plurality of ribs 11 that extend outwardly from the substrate to orient and hold the adapter 19 in an opening 4 of the container 3 and
An elastomeric (¶0023 silicone) insert 10 (see below illustrative diagram of Fig. 2) that is inserted (¶0023 soft component 10 injected onto hard component, injected defined as “to introduce into something forcefully” by Merriam-Webster, and as such covers insertion) into an opening (space of hard component in which 10 resides as seen in Fig. 2) in the substrate wherein the elastomeric insert comprises: a transfer instrument passageway 15 that allows a tip 22 of a transfer implement 2 to interact with the elastomeric insert (¶0040 introduced through the opening 6) and allow a liquid contained in the container to be drawn into the transfer implement (¶0040 dosing syringe drawn up and a desired amount of fluid flows out of the container through the valve inside the dosing syringe) and an air passage structure (12 and 13) to allow air to be drawn into the container when the liquid is being drawn into the transfer implement (¶0039 in the presence of a container-side negative pressure the respective valve mount lifts from the valve body and thus enables pressure between the inside of the container and the container surroundings to be equalized, this occurs through channels 12 and 13 as seen in Fig. 2).
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Illustrative diagram of Fig. 2 of Merhold.
Merhold does not expressly disclose the transfer implement passing through the elastomeric insert.
Regarding the transfer implement passing through the elastomeric insert, Merhold in a separate embodiment detailed in Figure 1, teaches an elastomeric insert in which the transfer implement passes through slit valve 15 (¶0034 suction syringe 18 passes through the slit valve whereby it completely opens the slit).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the valve 15 of Merhold that performs the function of allowing the transfer implement to draw fluid from the medical container through it for the slit valve of Fig. 1 of Merhold since these elements perform the same function of a valve for the control of fluid removal from the container. Simply substituting one valve means for another would yield the predictable result of allowing a(n) transfer implement to draw fluid from the medical container while closing of the container when fluid is not being transferred. See MPEP 2143.
Regarding claim 8, Merhold suggests the adapter of claim 1. Merhold further suggests the transfer instrument passageway 15 comprising a plurality of cuts (Fig. 1 shows cross pattern on slit valve 15 showing two cuts) that extend through the elastomeric insert (¶0010 continuous slit, ¶0034 describes opening of slit when syringe inserted) wherein the plurality of cuts intersect forming a cross pattern (Fig. 1 shows cross pattern on slit valve 15).
Regarding claim 11, Merhold suggests the adapter of claim 1. Merhold further discloses the air passage structure 12,13 comprising a passageway (portion of 12 and 13 formed by element 10) that extends from the surface of the elastomeric insert that is outside the container (see below illustrative diagram of Fig. 2) when the adapter is inserted into the container opening, through the elastomeric insert and forms a resilient and deformable valve (16 and 17) on the surface of the elastomeric insert that is inside the container (see illustrative diagram of Fig. 2 below; valve itself creates the inside and outside surfaces through closing of passageway) when the adapter is inserted into the container and the formed valve extends from the inside surface (extends from inside surface to outside surface) of the elastomeric insert but does not extend beyond the length of the cylindrical substrate (valve fully surrounded by cylindrical substrate and thus maintained within and does not extend past it on any side).
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Illustrative diagram of Fig. 2 of Merhold.
Regarding claim 12, Merhold suggests the adapter of claim 11. Merhold does not expressly suggest the valve being in a conical shape or a duck bill shape, however, Merhold teaches in the embodiment of Fig. 1 the valve being a duckbill shape (see Fig. 1 elements 16 and 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted air passage valve of Fig. 2 that performs the function of providing valved control of inflowing air through air passage for the valve of Fig. 1 since these elements perform the same function of providing valved control of air flow through the air passage into the bottle. Simply substituting one valve means for another would yield the predictable result of allowing a(n) air flow through an air passage to be controlled. See MPEP 2143.
Claim(s) 2, 3, 4, and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merhold et al. (U.S. Publication 2016/0038374) in view of Krystopik (U.S. Patent No. 6,742,678).
Regarding claim 2, Merhold suggests the adapter of claim 1. Merhold further discloses a first rib (rib 11 furthest from element 5) positioned near the base of the cylindrical substrate (positioned near lower portion that is inserted into container first which is being defined as the base) and the base being inserted into the opening of the container.
Merhold does not expressly disclose or suggest the first rib having a diameter that is smaller than a diameter of the remaining ribs that extend outwardly from the cylindrical substrate.
However, Kyrstopik, in the same field of endeavor of adapters to be placed into an opening of a fluid container, teaches providing a first rib having a diameter that is smaller than a diameter of the remaining ribs, with each adjacent rib as one moves away from the insertion direction of the adapter increasing in diameter (see Fig. 5 elements 24 increase in diameter from 21 toward 23) for the purpose of providing a frictionally engagement with the interior surface of the container (Col. 2 lines 52-58).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the ribs of Merhold that performs the function of frictionally engaging an interior surface of the container for the ribs of Kyrstopik since these elements perform the same function of frictionally engaging an interior surface of a container. Simply substituting one rib extending engagement means for another would yield the predictable result of allowing a(n) adaptor to frictionally engage the mouth of a container. See MPEP 2143.
Moreover, it would have been obvious to one of ordinary skill in the art to include a first rib that has a smaller diameter than the remaining ribs, as taught by Krystopik, since such a modification would have involved a mere change in the size of a component, i.e. the change in size of the diameter of the ribs. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claims 3 and 4, Merhold in view of Kyrstopik suggest the adapter of claim 2. Kyrstopik further discloses a second and third rib (see Fig. 5 ribs adjacent to and sequentially toward the proximal end 23 from the distal end 21) and the second rib being located between the first rib and third rib and the third rib being located further from the base of the cylindrical substrate than the first and second ribs (see Fig. 5, distal most 24 first rib, second rib proximally adjacent to first rib, third rib proximally adjacent second rib). While Kyrstopik does teach the distal most rib 24 having an inner diameter smaller than the opening of the container (see Fig. 5 rib 24 closest to element 21) and a second rib that is greater than the inner diameter of the opening of the container (see third and fourth rib 24 above distalmost rib 24), neither Merhold or Kyrstopik suggest or disclose the first rib being about 95% to about 99.9 of the inner diameter of the opening of the container, wherein the diameter of the second rib is about 0.5% to about 5% greater than the inner diameter of the opening of the container, the diameter of third rib is about 0.75% to about 10% greater than the inner diameter of the opening of the container.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the first rib about 95% to about 99.9% of the inner diameter, the second about 0.5% to about 5% greater than the inner diameter, and the third rib about .75% to about 10% greater in order to fit the particular application since this claimed dimension of the ribs does not change the ability of ribs to frictionally engage the container in a tapering dimensional manner. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see Page 6 Paragraphs 1-3 of applicant specification) simply stating that the relative dimension of the container to the stopper should be within the respective range, the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777. The ribs of Krystopik disclose the first rib being smaller than the inner diameter of the container, with the second rib approximately the same diameter as the inner diameter, and the third greater than the inner diameter, as such these ribs are seen to provide the function as detailed by the applicant.
Regarding claim 6, Merhold in view of Kyrstopik suggest the adapter of claim 2. Merhold further discloses the cylindrical substrate further comprising a top cover portion 5 opposite the base wherein the top cover portion has a diameter that is larger than the inner diameter of the opening of the container (¶0021 bears on the edge on an end wall of the container neck, see Fig. 1 for relation of bearing ring to endwall 7).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merhold et al. (U.S. Publication 2016/0038374) in view of Krystopik (U.S. Patent No. 6,742,678) and Ross et al. (U.S. Publication 2015/0225107).
Regarding claim 5, Merhold in view of Kyrstopik suggest the adapter of claim 4. Merhold in view of Kyrstopik do not expressly disclose or suggest a return passageway that extends from the base of the cylindrical substrate to an area below the second rib to allow any liquid that is contained within the container and that passes over the first rib when the container with the adapter in place is inverted to return to the interior of the container when the container is returned from an inverted orientation to a normal upright orientation.
However, Ross, in the same field of endeavor of adapters to be placed in the opening of a container, teaches a return passageway 96 that extends from a base (see below illustrative diagram of Fig. 3) of a cylindrical substrate 60 to an area below a sealing rib 72 for the purpose of forming a path for any liquid that enters a space between projections during tilting of the container to flow downward back into the container (¶0121).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first rib of Merhold in view of Krystopik which does not fully contact the neck of the container and therefore would allow liquid to flow into it when inverted, to have had a channel through it as taught by Ross for the purpose of forming a path for any liquid that enters a space between projections during tilting of the container to flow downward back into the container (¶0121). While this combination does not expressly disclose the channel extending to an area below the second rib, the subsequent ribs of Merhold in view of Krystopik are designed to contact the walls of the container in a sealed fashion and therefore it would have been obvious to one of ordinary skill in the art to have stopped the channel prior to the second rib as to not interfere with the sealing nature of the rib. As the first rib is shown not to contact the wall of the container and therefore would allow fluid to enter the space between the first rib and the second rib during inversion, one of ordinary skill in the art would have found it obvious to have the channel only extend through this rib and thus extend from the base to below the second rib.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merhold et al. (U.S. Publication 2016/0038374) in view Russo (U.S. Patent No. 10,058,481).
Regarding claim 7, Merhold suggests the adapter of claim 1. Merhold does not expressly disclose or suggest the transfer instrument passageway being a single linear cut that extends through the elastomeric insert.
However, Russo, in the same field of endeavor of adapters to be placed in an opening of a container, discloses a transfer instrument passageway 14 being a single linear cut (14 of Fig. 1 linear slit)that extends through an elastomeric insert 10.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the slit of Merhold that performs the function of allowing a dosing syringe to enter through it and seal the device when the dosing syringe is not inserted for the linear slit of Russo since these elements perform the same function of allowing a dosing syringe to enter through it and seal the device when the dosing syringe is not inserted. Simply substituting one slit providing means for another would yield the predictable result of allowing a(n) slit valve to open and seal the container with regard to dosing syringe insertion. See MPEP 2143.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merhold et al. (U.S. Publication 2016/0038374) in view of Levy (U.S. Publication 2012/0103462).
Regarding claims 9 and 10, Merhold suggests the adapter of claim 1. Merhold further suggests the elastomeric insert comprising a concave interior area that is opposite the concave exterior area (see below illustrative diagram of Fig. 1).
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Illustrative diagram of Fig. 1 of Merhold.
Merhold does not expressly the transfer instrument passageway being located in a concave exterior area of the elastomeric insert and the concave exterior area allowing a user to guide a tip of a transfer instrument selected from the group of a pipette or syringe, into the transfer instrument passageway (Claim 9).
However, Levy, in the same field of endeavor of adapters to be placed in an opening of a container for dosing control, teaches a transfer instrument passageway 120 being located in a concave exterior area 36 that allows a user to guide a tip of a transfer instrument syringe (S in Fig. 7), into the transfer instrument passageway (¶0033 helps guide the neck of the syringe and to hold it in general alignment with the center of the area of minimum thickness of the dished septum as the syringe neck is advanced into the depression).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the slit valve 15 of Merhold to have had a concave exterior area for the purpose of helping to guide the neck of the syringe and to hold I in general alignment with the center of the area of minimum thickness of the dished septum as the syringe neck is advanced into the depression (¶0033 of Levy), as taught by Levy.
Claim(s) 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merhold et al. (U.S. Publication 2016/0038374) in view of Krystopik (U.S. Patent No. 6,742,678), Ross et al. (U.S. Publication 2015/0225107), and Levy (U.S. Publication 2012/0103462).
Regarding claim 13, Merhold discloses an adapter 19 for a bottle 3 comprising doses of a liquid medication (¶0003 used for administrating doses of liquid medicine for example from a storage container into a dosing syringe) wherein the adapter comprises:
A cylindrical substrate (see above illustrative diagram of Fig. 2 in the rejection of claim 1) with a base region (see above illustrative diagram of Fig. 2 in the rejection of claim 1) for inserting the adapter into an opening (opening formed by neck 4) of the bottle (Fig. 1 shows adapter inserted into opening of neck of bottle 4) and a top region (region of element 5) that is opposite the base region and the cylindrical substrate further comprising at least three ribs (elements 11) that extend outwardly from the cylindrical substrate to engage an inner surface of the opening of the bottle (see Fig. 1 elements 11 engage neck 4) including a first rib (most adjacent to base), a second rib (second most adjacent to base), and a third rib (third most adjacent to base), wherein the second rib is located between the first rib and third rib and the third rib is located further from the base region (third most adjacent) of the cylindrical substrate than the first and second ribs;
and an elastomeric (¶0023 silicone) insert 10 (see above illustrative diagram of Fig. 2 in rejection of claim 1) comprising a concave interior region that is opposite an exterior region (see above illustrative diagram of Fig. 1 in the rejection of claims 9 and 10) wherein the regions comprise a transfer instrument passageway 15 that allows a tip 22 of a syringe 2 to remove liquid through the elastomeric insert and contact the liquid contained in the bottle and be drawn into the syringe (¶0040 dosing syringe drawn up and a desired amount of fluid flows out of the container through the valve inside the dosing syringe) and an air passage structure (12 and 13) to allow air to be drawn into the bottle when the liquid in the bottle is being drawn into the syringe (¶0039 in the presence of a container-side negative pressure the respective valve mount lifts from the valve body and thus enables pressure between the inside of the container and the container surroundings to be equalized, this occurs through channels 12 and 13 as seen in Fig. 2) wherein the air passage structure comprises a passageway (portion of 12 and 13 formed by element 10) that extends from the surface of the elastomeric insert that is outside the bottle (see below illustrative diagram of Fig. 2) when the adapter is inserted into the bottle opening, through the elastomeric insert and forms a resilient and deformable valve (16 and 17) on the surface of the elastomeric insert that is inside the container (see illustrative diagram of Fig. 2 below; valve itself creates the inside and outside surfaces through closing of passageway) when the adapter is inserted into the bottle and the formed valve extends from the inside surface (extends from inside surface to outside surface) of the elastomeric insert but does not extend beyond the length of the cylindrical substrate (valve fully surrounded by cylindrical substrate and thus maintained within and does not extend past it on any side).
Merhold does not expressly disclose the first rib having a diameter that is about 95% to about 99.9% of the inner diameter of the bottle opening; the second rib having a diameter that is about 0.5% to about 5% greater than the inner diameter of the bottle opening, the third rib having a diameter that is about 0.75% to about 10% greater than the inner diameter of the bottle, a return passageway that extends from the base region of the cylindrical substrate to an area below the second rib to allow any liquid that is contained within the bottle and that passes over the first rib when the bottle with the adapter inserted into the bottle is inverted to return to the interior of the bottle when the bottle is returned from an inverted orientation to a normal upright orientation; the exterior region being concave; the syringe being an oral syringe; or the tip of the syringe passing through the elastomeric insert,
Regarding the diameters of the first through third ribs, Kyrstopik, in the same field of endeavor of adapters to be placed into an opening of a fluid container, teaches providing a first rib having a diameter that is smaller than a diameter of the remaining ribs, with each adjacent rib as one moves away from the insertion direction of the adapter increasing in diameter (see Fig. 5 elements 24 increase in diameter from 21 toward 23) for the purpose of providing a frictionally engagement with the interior surface of the container (Col. 2 lines 52-58), the second and third rib (see Fig. 5 ribs adjacent to and sequentially toward the proximal end 23 from the distal end 21) and the second rib being located between the first rib and third rib and the third rib being located further from the base of the cylindrical substrate than the first and second ribs (see Fig. 5, distal most 24 first rib, second rib proximally adjacent to first rib, third rib proximally adjacent second rib), the distal most rib 24 having an inner diameter smaller than the opening of the container (see Fig. 5 rib 24 closest to element 21) the second rib being approximately the inner diameter of the opening of the container (see Fig. 5 rib 24 second closest to element 21) and the third rib diameter being greater than the inner diameter of the opening of the container (see third rib 24 third closest to element 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the ribs of Merhold that performs the function of frictionally engaging an interior surface of the container for the ribs of Kyrstopik since these elements perform the same function of frictionally engaging an interior surface of a container. Simply substituting one rib extending engagement means for another would yield the predictable result of allowing a(n) adaptor to frictionally engage the mouth of a container. See MPEP 2143.
Moreover, it would have been obvious to one of ordinary skill in the art to include a first rib that has a smaller diameter than the remaining ribs, as taught by Krystopik, since such a modification would have involved a mere change in the size of a component, i.e. the change in size of the diameter of the ribs. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Neither Merhold or Kyrstopik suggest or disclose the first rib being about 95% to about 99.9 of the inner diameter of the opening of the container, wherein the diameter of the second rib is about 0.5% to about 5% greater than the inner diameter of the opening of the container, the diameter of third rib is about 0.75% to about 10% greater than the inner diameter of the opening of the container.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the first rib about 95% to about 99.9% of the inner diameter, the second about 0.5% to about 5% greater than the inner diameter, and the third rib about .75% to about 10% greater in order to fit the particular application since this claimed dimension of the ribs does not change the ability of ribs to frictionally engage the container in a tapering dimensional manner. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see Page 6 Paragraphs 1-3 of applicant specification) simply stating that the relative dimension of the container to the stopper should be within the respective range, the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777. The ribs of Krystopik disclose the first rib being smaller than the inner diameter of the container, with the second rib approximately the same diameter as the inner diameter, and the third greater than the inner diameter, as such these ribs are seen to provide the function as detailed by the applicant.
Regarding the return passageway, Ross, in the same field of endeavor of adapters to be placed in the opening of a container, teaches a return passageway 96 that extends from a base (see above illustrative diagram of Fig. 3 in the rejection of claim 5) of a cylindrical substrate 60 to an area below a sealing rib 72 for the purpose of forming a path for any liquid that enters a space between projections during tilting of the container to flow downward back into the container (¶0121).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first rib of Merhold in view of Krystopik which does not fully contact the neck of the container and therefore would allow liquid to flow into it when inverted, to have had a channel through it as taught by Ross for the purpose of forming a path for any liquid that enters a space between projections during tilting of the container to flow downward back into the container (¶0121). While this combination does not expressly disclose the channel extending to an area below the second rib, the subsequent ribs of Merhold in view of Krystopik are designed to contact the walls of the container in a sealed fashion and therefore it would have been obvious to one of ordinary skill in the art to have stopped the channel prior to the second rib as to not interfere with the sealing nature of the rib. As the first rib is shown not to contact the wall of the container and therefore would allow fluid to enter the space between the first rib and the second rib during inversion, one of ordinary skill in the art would have found it obvious to have the channel only extend through this rib and thus extend from the base to below the second rib.
Regarding the exterior region being concave, Levy, in the same field of endeavor of adapters to be placed in an opening of a container for dosing control, teaches a transfer instrument passageway 120 being located in a concave exterior area 36 that allows a user to guide a tip of a transfer instrument syringe (S in Fig. 7), into the transfer instrument passageway (¶0033 helps guide the neck of the syringe and to hold it in general alignment with the center of the area of minimum thickness of the dished septum as the syringe neck is advanced into the depression).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the slit valve 15 of Merhold to have had a concave exterior area for the purpose of helping to guide the neck of the syringe and to hold I in general alignment with the center of the area of minimum thickness of the dished septum as the syringe neck is advanced into the depression (¶0033 of Levy), as taught by Levy.
Regarding the syringe being an oral syringe, the limitation of “oral” is considered functional claim language as it describes the intended use of the syringe as being to place the contents drawn into the syringe into a mouth of the intended user. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Merhold discloses all the structure as claimed of the syringe, and is further used to draw in a liquid medication to be dispensed. As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning as an oral syringe).
Regarding the transfer implement passing through the elastomeric insert, Merhold in a separate embodiment detailed in Figure 1, teaches an elastomeric insert in which the transfer implement passes through slit valve 15 (¶0034 suction syringe 18 passes through the slit valve whereby it completely opens the slit).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the valve 15 of Merhold that performs the function of allowing the transfer implement to draw fluid from the medical container through it for the slit valve of Fig. 1 of Merhold since these elements perform the same function of a valve for the control of fluid removal from the container. Simply substituting one valve means for another would yield the predictable result of allowing a(n) transfer implement to draw fluid from the medical container while closing of the container when fluid is not being transferred. See MPEP 2143.
Regarding claims 14-17, Merhold in view of Krystopik, Ross, and Levy suggest the adapter of claim 13. Merhold in view of Krystopik, Ross, and Levy do not expressly disclose or suggest the liquid medication being an oral liquid medication or the oral liquid medication comprising levothyroxine, liothyronine, gliptin, or sitagliptin.
However, the limitation of “for a bottle or vial comprising multiple doses of a liquid medication” further modified by “wherein the liquid medication is an oral liquid medication”, “wherein the oral liquid medication comprises levothyroxine or liothyronine”, “wherein the oral liquid medication comprises a gliptin”, and “wherein the oral liquid medication comprises a sitagliptin” is considered functional language as it is drawn toward the intended use of the adapter in a bottle containing a particular oral liquid medication. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Merhold in view of Krystopik, Ross, and Levy suggests all the structure as claimed, and is further used for bottles intended to contain liquid medications. As such, it is capable of performing the functions as claimed (i.e. it is capable of being “for a bottle or vial comprising multiple does of a liquid medication” wherein the medication is for oral use and comprises levothyroxine or liothyronine or gliptin or sitagliptin, as all of these drugs only require the adapter to capable of maintaining a fluid within the bottle and being made of an inert material i.e. silicon and plastic).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merhold et al. (U.S. Publication 2016/0038374) in view of Krystopik (U.S. Patent No. 6,742,678), Ross et al. (U.S. Publication 2015/0225107), and Levy (U.S. Publication 2012/0103462) and further in view of Folger et al. (U.S. Publication 2014/0224680).
Regarding claims 18 and 19, Merhold in view of Krystopik, Ross, and Levy suggest the adapter as described in claim 13. Merhold further discloses a bottle comprising multiple doses of a medication and a syringe with calibrated markings indicating appropriate volumes.
Merhold in view of Krystopik, Ross, and Levy do not expressly disclose a kit comprising the bottle, a child proof cap, adapter, oral syringe, and instructions for inserting the adapter into the bottle or vial and/or withdrawing an appropriate single dose of the liquid medication into the oral syringe or Luer syringe for administration to a patient after the adapter has been inserted into the bottle or vial, the bottle being sealed with the child resistant cap, or the child resistant cap being replaced on the bottle with the adapter in place to allow the bottle or vial comprising the multiple doses of liquid medication to be stored until the next single dose of the liquid medication needs to be removed from the bottle or vial and administered to the patient.
However, Folger, in the same field of endeavor of administering oral medication to a patient (¶0066 orally administered), teaches a kit (abstract) comprising a bottle 10 comprising liquid medication (abstract liquid composition) sealed with a child proof cap 15 (¶0073 child-proof lock used), an adapter 50, an oral syringe 20 (¶0097 oral dispenser, syringe like), and instructions (Abstract) for inserting the adapter into the bottle (¶0122 applying adapter) and withdrawing an appropriate single dose of the liquid medication into the oral syringe (¶0151 instruction step i. the desired amount of liquid dosage form is removed from the container using the dispenser) after the adapter has been inserted into the bottle () and the child resistant cap being replaced on the bottle with the adapter in place to allow the bottle comprising the liquid medication to be stored until the next single dose of the liquid medication needs to be removed from the bottle and administered to the patient (¶0153 container closed again in step l) preferably directly after withdrawal of the liquid in order to protect liquid dosage form against contamination; ¶0155 dispenser may be used several times in order to uptake the desired amount of liquid dosage form for several treatments) for the purpose of improving the convenience of the treatment and/or prevention of diseases.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the adapter of Merhold in view of Krystopik, Ross, and Levy as suggested in claim 13, in a kit comprising the bottle, cap, oral syringe, and instructions, as taught by Folger for the purpose of improving the convenience of the treatment and/or prevention of diseases. By providing all of the components as well as instructions of use in a kit to the user, the user treatment experience would be greatly streamlined which would provide sufficient motivation for one of ordinary skill in the art to modify the adapter of Merhold in view of Krystopik, Ross, and Levy to be in a kit with the components taught by Folger.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Manera et al. (U.S. Patent NO. 8,459,312) discloses a valved adapter having flanges with different diameters (see Fig. 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781