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 Status
Claims 1-8 and 11-19 are currently pending and under consideration. Claims 1, 5, 7-8, and 11-13 have been amended. Claims 9 and 10 are herein cancelled.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new ground of rejection relies upon Russo (U.S. Patent No. 10,058,481) as the primary reference in view of the teachings of Merhold (previously presented), and Fleischhaker (newly presented, U.S. Patent No. 5,114,408), which are seen to render the current claim limitations obvious to one of ordinary skill in the art. See below rejection.
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) 1-4, 6-8, 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Russo (U.S. Patent No. 10,058,481) in view of Merhold et al. (U.S. Publication 2016/0038374) and Fleischhaker et al. (U.S. Patent No. 5,114,408).
Regarding claim 1, Russo discloses an adapter (Fig. 11) for clinical, medical and laboratory equipment containers comprising (Abstract liquid medication bottle container):
(a) a cylindrical substrate 48 wherein the substrate comprises a plurality of ribs (49, 50, 51, 52) that extend outwardly from the substrate to orient and hold the adapter in an opening of the container (Col. 8 lines 8-22 describes the positioning of fins in opening of container) and
(b) an elastomeric insert 46 that is formed into (Col. 8 lines 23-41 describe forming of septum into housing) an opening (opening can be seen in Fig. 11 in which element 46 sits in element 48) in the substrate wherein the elastomeric insert comprises: (i) a transfer instrument passageway area (area of 54, 55, 56, 57, 58) that allows a tip of a transfer implement to pass through the elastomeric insert and allow a liquid contained in the container to be drawn into the transfer implement (Fig. 8 depicts process of inserting transfer implement such that transfer implement tip passes through insert and liquid can be drawn into the implement), the transfer instrument passageway area comprising a transfer passageway 56, an indented exterior area on a surface of the elastomeric insert (see illustrative diagram of Fig. 11 below) that is outside the container when the adapter is inserted into the container opening and allows a user to guide a tip of the transfer instrument consisting of a syringe (Abstract) into the transfer passageway, and an interior area on a surface of the elastomeric insert that is inside the container (see illustrative diagram of Fig. 11 below) when the adapter is inserted into the container opening (Fig. 8 illustrates placement of device in opening of container), the interior area being opposite the exterior area (see illustrative diagram of Fig. 11 below).
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Illustrative diagram of Fig. 11 of Russo.
Russo does not expressly disclose the elastomeric insert comprising an air passage structure to allow air to be drawn into the container when the liquid is being drawn into the transfer implement, or the exterior area and interior area being concave.
Regarding the insert comprising an air passage structure, Merhold, in the same field of endeavor of adapters for medical containers (¶0003 used for administrating doses of liquid medicine for example from a storage container into a dosing syringe) teaches an adapter 1 for medical containers 3 (¶0003 used for administrating doses of liquid medicine for example from a storage container into a dosing syringe) comprising:
An elastomeric (¶0023 silicone) insert 10 comprising: 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 (¶0006 ventilation channel creating an air connection between the inside of the container and the container surroundings) for the purpose of improving the handling and in particular improving the dosing procession when using the syringe adapter by reducing pulling force necessary when raising the dossing syringe because of the pressure equalization created by the ventilation channel (¶0007).
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 elastomeric insert of Russo to have included an air ventilation channel comprising a non-return valve as taught by Merhold for the purpose of improving the handling and in particular improving the dosing procession when using the syringe adapter by reducing pulling force necessary when raising the dossing syringe because of the pressure equalization created by the ventilation channel (¶0007 of Merhold).
Regarding the exterior and interior areas on the respective exterior and interior surfaces of the elastomeric insert being concave, Fleischhaker, in the same field of endeavor of elastomeric inserts (¶0005 elastic valve body with slits) that allow for insertion of instruments through a valved passageway (¶0005 slits placed into an open state when an elongated member is inserted into the sheath, teaches an elastomeric insert 5 comprising a concave exterior area 15 on a surface (surface on which 15 occurs can be seen in Fig. 3) of the elastomeric insert that is exterior to chamber (Fig. 1 shows external facing nature toward 15) when the adapter is inserted into a chamber opening (opening in which element 6 resides as seen in Fig. 1) and allows a user to guide (Col. 4 lines 46-50, if a catheter is attempted to be inserted slightly off-center, it will readily be guided into the pilot opening 13 and through the slit) a tip of an inserted instrument into a transfer passageway 14 and a concave interior area 4 on a surface of the elastomeric insert that is inside the container (Fig. 1 shows internal facing nature opposite 15) when the adapter is inserted into the chamber opening (opening in which element 6 resides as seen in Fig. 1) and the concave interior area is opposite the concave exterior area (Fig. 1 shows the concave areas on opposite faces) for the purpose of readily guiding the inserted device toward the transfer passageway (Col. 4 lines 46-50) and including a concave nature on the exit face 4 such that added pressure maintains the slit in the closed position with any backward pressure exhibited from the interior space serving to force the slit into closed position (Col. 4 lines 51-62).
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 exterior facing and interior facing surfaces of the elastomeric insert of Russo to have included concave interior and exterior areas as taught by Fleischhaker, for the purpose of readily guiding the inserted device toward the transfer passageway (Col. 4 lines 46-50) and including a concave nature on the exit face 4 such that added pressure maintains the slit in the closed position with any backward pressure exhibited from the interior space serving to force the slit into closed position (Col. 4 lines 51-62).
Regarding claim 2, Russo in view of Merhold and Fleischhaker suggests the adapter of claim 1. Russo further discloses a diameter of a first rib 49 which is positioned near a base (end of 48 opposite element 53) of the cylindrical substrate that is inserted into the opening of the container has a diameter that is smaller than a diameter of the remaining ribs that extend outwardly from the cylindrical substrate (Col. 8 lines 3-7 first fin is dimensionally undersized to 18 mm).
Regarding claim 3, Russo in view of Merhold and Fleischhaker suggests the adapter of claim 2. Russo further discloses the diameter of the first rib is about 95% to about 99.9% of the inner diameter of the opening of the container (Col. 8 lines 3-7 first fin 18 mm, neck opening 18.3 mm, 18 98 percent of 18.3).
Regarding claim 4, Russo in view of Merhold and Fleischhaker suggests the adapter of claim 2. Russo further discloses the plurality of ribs comprises at least a second rib 50 (second fin) and a third rib 51 (third fin) wherein the diameter of the second rib is equal to the inner diameter of the opening of the container (Col. 8 lines 8-13 second fin dimensioned at 0.720 to form a kiss match dimension with the bottle opening), the diameter of third rib is about 10% greater than the inner diameter of the opening the container (Col. 8 lines 14-17, 20.3 mm to 18.3 mm about 10%) and the second rib is located between a first rib 49 and third rib (Fig. 11 shows second rib 50 located between 51 and 49) and the third rib is located further from the base (element most distal from flange 53 in relation to insertion direction of bottle) of the cylindrical substrate than the first and second ribs (Fig. 11 shows third rib 51 further from base than 50 or 49).
Russo does not expressly disclose the diameter of the second rib being about 0.5% to about 5% greater than the inner diameter of the opening of the container, or the range of the diameter of third rib of 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 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 Russo 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, Russo in view of Merhold and Fleischhaker suggests the adapter of claim 2. Russo further discloses the cylindrical substrate further comprise a top cover portion 53 opposite the base wherein the top cover portion has a diameter that is larger than the inner diameter of the opening of container (Fig. 4 depicts the top flange element having a diameter larger than the inner diameter of the bottle neck, Col. 8 lines 21-22 top flange equivalent to what is shown in Fig. 4).
Regarding claim 7, Russo in view of Merhold and Fleischhaker suggests the adapter of claim 1. Russo further discloses wherein the transfer instrument passageway 56 is a single linear cut that extends through the elastomeric insert (valve slit 56, Fig. 3 shows single cut nature of slits).
Regarding claim 8, Russo in view of Merhold and Fleischhaker suggests the adapter of claim 1. Russo does not expressly disclose the transfer instrument passageway comprising a plurality of cuts that extend through the elastomeric insert wherein the plurality of cuts intersect forming a cross patter, a star pattern, a Z shaped pattern or an N shaped pattern.
However, Fleischhaker, in the same field of endeavor of elastomeric inserts (¶0005 elastic valve body with slits) that allow for insertion of instruments through a valved passageway (¶0005 slits placed into an open state when an elongated member is inserted into the sheath, further teaches a transfer instrument passageway 14 comprising a plurality of cuts that extend through the elastomeric insert wherein the plurality of cuts intersect forming a cross pattern (Col. 4 lines 37-45 slit may be in the form of a cross or a single 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 single slit passageway of Russo that performs the function of allowing an instrument to be inserted therethrough in a sealed fashion for the cross-patterned passageway of Fleischhaker, since these elements perform the same function of allowing insertion of an instrument in a sealed manner. Simply substituting one sealed valving passageway means for insertion of a member means for another would yield the predictable result of allowing a(n) instrument to be inserted in a sealed manner through the valve. See MPEP 2143. Furthermore, one of ordinary skill would have been considered to have been successful in performing this substitution as Fleischhaker discloses the ability of the slits in passageways to be provided in either a cross format or a slit format suggesting that these formats were known to be interchangeable with one another (Col. 4 lines 37-45 cross or a single slit).
Regarding claim 11, Russo in view of Merhold and Fleischhaker suggests the adapter of claim 1. Merhold further suggests 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 (surface up to valve 16,17) 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 (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).
As such the modification of Russo with the teachings of Merhold as stated above in claim 1 would have rendered these features obvious to one of ordinary skill in the art before the effective filing date for the reasons detailed above in claim 1.
Regarding claim 12, Russo in view of Merhold and Fleischhaker suggests the adapter of claim 11. Merhold further teaches the valve being a duckbill shape (see Fig. 1 elements 16 and 17).
As such the modification of Russo with the teachings of Merhold as stated above in claim 1 would have rendered these features obvious to one of ordinary skill in the art before the effective filing date for the reasons detailed above in claim 1.
Claim(s) 5 and 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Russo (U.S. Patent No. 10,058,481) in view of Merhold et al. (U.S. Publication 2016/0038374), Fleischhaker et al. (U.S. Patent No. 5,114,408), and Rumpler (U.S. Patent No. 4,193,402).
Regarding claim 5, Russo in view of Merhold and Fleischhaker suggests the adapter of claim 4. Russo does not expressly disclose or suggest the cylindrical substrate further comprising a return passageway that extends through the cylindrical substrate and 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, Rumpler, in the same field of endeavor of inserted bottle closures (Abstract), teaches a cylindrical substrate (Fig. 4 element 2) comprising a return passageway 8 that extends through the cylindrical substrate and from a base (Col. 2 lines 67-68 – Col. 3 lines 1-11 The stopper further comprises a lateral opening or slit extending from the lower or free end of the skirt to a point along the skirt between the collar or flange and the cap; see illustrative diagram of Fig. 4 below) to an area below (Fig. 4 element 8 can be seen to extend from the base to an area below the second rib 5) a second rib 5 for the purpose of allowing free flow of medicinal product towards the central cavity through the slots and only retaining a very small quantity of product by the lower edge of the skirt (Col. 4 lines 3-9 the medicinal product is thus free to flow towards the central cavity through slots 7 and 8. It is to be noted that only a very small quantity of product is retained by means of the lower edge of the skirt).
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Illustrative diagram of Fig. 4 of Rumpler.
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 cylindrical substrate of Russo to have included the return passageway taught by Rumpler, for the purpose of allowing free flow of medicinal product towards the central cavity through the slots and only retaining a very small quantity of product by the lower edge of the skirt (Col. 4 lines 3-9 of Rumpler the medicinal product is thus free to flow towards the central cavity through slots 7 and 8. It is to be noted that only a very small quantity of product is retained by means of the lower edge of the skirt).
While Rumpler does not expressly teach the return passageway allowing 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, this limitation is considered functional language (described ability of passageway to allow fluid flow such that fluid returns to interior of the container from a position past the first rib). 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 return passageway of Russo as modified by Rumpler discloses all the structure as claimed, and is further capable of allowing free flow of fluids through the passageway (Rumpler Col. 4 lines 3-9). As such, it is capable of performing the functions as claimed (i.e. it is capable of allowing fluid to flow back into the container space).
Regarding claim 13, Russo discloses an adapter (Fig. 11) for a bottle comprising multiple doses of a liquid medication (Abstract liquid medication bottle container; Col. 7 lines 5-30 statement the syringe tip removed automatically closes the valve…normally biased closed valve continues to preserve and protect liquid medication suggests multiple doses) wherein the adapter comprises:
(a) a cylindrical substrate 48 with a base region (end of 48 opposite element 53) for inserting the adapter into an opening of the bottle or vial (Col. 8 lines 8-22 describes the positioning of fins in opening of container) and a top region 53 that is opposite the base region and the cylindrical substrate further comprises
(i) at least three ribs (49-52) that extend outwardly from the cylindrical substrate to engage an inner surface of the opening of the bottle (Col. 8 lines 8-22 describes the positioning of fins in opening of container) wherein the first rib has a diameter that is about 95% to about 99.9% of the inner diameter of the bottle or vial opening (Col. 8 lines 3-7 first fin 18 mm, neck opening 18.3 mm, 18 98 percent of 18.3);
the diameter of the second rib is equal to the inner diameter of the opening of the container (Col. 8 lines 8-13 second fin dimensioned at 0.720 to form a kiss match dimension with the bottle opening), the diameter of third rib is about 10% greater than the inner diameter of the opening the container (Col. 8 lines 14-17, 20.3 mm to 18.3 mm about 10%) and the second rib is located between a first rib 49 and third rib (Fig. 11 shows second rib 50 located between 51 and 49) and the third rib is located further from the base (element most distal from flange 53 in relation to insertion direction of bottle) of the cylindrical substrate than the first and second ribs (Fig. 11 shows third rib 51 further from base than 50 or 49)
(b) an elastomeric insert 46 comprising
(i) an indented exterior area on a surface of the elastomeric insert (see illustrative diagram of Fig. 11 below) that is outside the container when the adapter is inserted into the container opening, an interior area on a surface of the elastomeric insert that is inside the container (see illustrative diagram of Fig. 11 below) when the adapter is inserted into the container opening (Fig. 8 illustrates placement of device in opening of container), the interior area being opposite the exterior area (see illustrative diagram of Fig. 11 below); and a transfer instrument passageway 56 that allows a tip of an oral syringe (Abstract oral syringe) to pass through the elastomeric insert and contact the liquid contained in the bottle or vial and be drawn into the oral syringe (Fig. 8 depicts process of inserting transfer implement such that transfer implement tip passes through insert and liquid can be drawn into the implement).
Russo does not expressly disclose the elastomeric insert comprising an air passage structure to allow air to be drawn into the container when the liquid is being drawn into the transfer implement, or the exterior area and interior area being concave, or a return passageway that extends through the cylindrical substrate and 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..
Regarding the insert comprising an air passage structure, Merhold, in the same field of endeavor of adapters for medical containers (¶0003 used for administrating doses of liquid medicine for example from a storage container into a dosing syringe) teaches an adapter 1 for medical containers 3 (¶0003 used for administrating doses of liquid medicine for example from a storage container into a dosing syringe) comprising:
An elastomeric (¶0023 silicone) insert 10 comprising: 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 (¶0006 ventilation channel creating an air connection between the inside of the container and the container surroundings) for the purpose of improving the handling and in particular improving the dosing procession when using the syringe adapter by reducing pulling force necessary when raising the dossing syringe because of the pressure equalization created by the ventilation channel (¶0007).
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 elastomeric insert of Russo to have included an air ventilation channel comprising a non-return valve as taught by Merhold for the purpose of improving the handling and in particular improving the dosing procession when using the syringe adapter by reducing pulling force necessary when raising the dossing syringe because of the pressure equalization created by the ventilation channel (¶0007 of Merhold).
Regarding the exterior and interior areas on the respective exterior and interior surfaces of the elastomeric insert being concave, Fleischhaker, in the same field of endeavor of elastomeric inserts (¶0005 elastic valve body with slits) that allow for insertion of instruments through a valved passageway (¶0005 slits placed into an open state when an elongated member is inserted into the sheath, teaches an elastomeric insert 5 comprising a concave exterior area 15 on a surface (surface on which 15 occurs can be seen in Fig. 3) of the elastomeric insert that is exterior to chamber (Fig. 1 shows external facing nature toward 15) when the adapter is inserted into a chamber opening (opening in which element 6 resides as seen in Fig. 1) and allows a user to guide (Col. 4 lines 46-50, if a catheter is attempted to be inserted slightly off-center, it will readily be guided into the pilot opening 13 and through the slit) a tip of an inserted instrument into a transfer passageway 14 and a concave interior area 4 on a surface of the elastomeric insert that is inside the container (Fig. 1 shows internal facing nature opposite 15) when the adapter is inserted into the chamber opening (opening in which element 6 resides as seen in Fig. 1) and the concave interior area is opposite the concave exterior area (Fig. 1 shows the concave areas on opposite faces) for the purpose of readily guiding the inserted device toward the transfer passageway (Col. 4 lines 46-50) and including a concave nature on the exit face 4 such that added pressure maintains the slit in the closed position with any backward pressure exhibited from the interior space serving to force the slit into closed position (Col. 4 lines 51-62).
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 exterior facing and interior facing surfaces of the elastomeric insert of Russo to have included concave interior and exterior areas as taught by Fleischhaker, for the purpose of readily guiding the inserted device toward the transfer passageway (Col. 4 lines 46-50) and including a concave nature on the exit face 4 such that added pressure maintains the slit in the closed position with any backward pressure exhibited from the interior space serving to force the slit into closed position (Col. 4 lines 51-62).
Regarding the return passageway, however, Rumpler, in the same field of endeavor of inserted bottle closures (Abstract), teaches a cylindrical substrate (Fig. 4 element 2) comprising a return passageway 8 that extends through the cylindrical substrate and from a base (Col. 2 lines 67-68 – Col. 3 lines 1-11 The stopper further comprises a lateral opening or slit extending from the lower or free end of the skirt to a point along the skirt between the collar or flange and the cap; see illustrative diagram of Fig. 4 below) to an area below (Fig. 4 element 8 can be seen to extend from the base to an area below the second rib 5) a second rib 5 for the purpose of allowing free flow of medicinal product towards the central cavity through the slots and only retaining a very small quantity of product by the lower edge of the skirt (Col. 4 lines 3-9 the medicinal product is thus free to flow towards the central cavity through slots 7 and 8. It is to be noted that only a very small quantity of product is retained by means of the lower edge of the skirt).
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Illustrative diagram of Fig. 4 of Rumpler.
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 cylindrical substrate of Russo to have included the return passageway taught by Rumpler, for the purpose of allowing free flow of medicinal product towards the central cavity through the slots and only retaining a very small quantity of product by the lower edge of the skirt (Col. 4 lines 3-9 of Rumpler the medicinal product is thus free to flow towards the central cavity through slots 7 and 8. It is to be noted that only a very small quantity of product is retained by means of the lower edge of the skirt).
While Rumpler does not expressly teach the return passageway allowing 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, this limitation is considered functional language (described ability of passageway to allow fluid flow such that fluid returns to interior of the container from a position past the first rib). 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 return passageway of Russo as modified by Rumpler discloses all the structure as claimed, and is further capable of allowing free flow of fluids through the passageway (Rumpler Col. 4 lines 3-9). As such, it is capable of performing the functions as claimed (i.e. it is capable of allowing fluid to flow back into the container space).
Regarding claims 14-17, Russo in view of Merhold, Fleischhaker, and Rumpler suggest the adapter of claim 13. Russo further discloses the liquid medication being an oral liquid medication (Abstract oral syringe) (Claim 14).
Russo in view of Merhold, Fleischhaker, and Rumpler do not expressly disclose or suggest 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 Russo in view of Merhold, Fleischhaker, and Rumpler suggests all the structure as claimed, and is further used for bottles intended to contain oral 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 Russo in view of Merhold, Fleischhaker, and Rumpler as applied above in the rejection of claim 13 and further in view of Folger et al. (U.S. Publication 2014/0224680).
Regarding claims 18 and 19, Russo in view of Merhold, Fleischhaker, and Rumpler suggest the adapter as described in claim 13. Russo further discloses a bottle comprising multiple doses of a medication that is sealed with a child resistant cap (31; Col. 5 lines 45-67 caps are of the child safety type) and an oral syringe (Abstract).
Russo in view of Merhold, Fleischhaker, and Rumpler do not expressly disclose the components being a kit, the oral syringe comprising calibrated markings indicating appropriate single does amounts or volumes, 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, 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, cap, and oral syringe of Russo in view of Merhold, Fleischhaker, and Rumpler as suggested in claim 13, in a kit comprising 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, cap, and oral syringe of Russo in view of Merhold, Fleischhaker, and Rumpler to be in a kit with the components taught by Folger.
Folger further teaches providing calibrated markings indicating appropriate single dose amounts or volumes (¶0101 in order to achieve a simplified dose adjustment the front surface of the dispenser is preferably provided with a scale reading which facilitates to determine and adjust the amount of pharmaceutically active ingredient to be administered to the patient) for the purpose of being able to determine and adjust the amount of pharmaceutically active ingredient to be administered to the patient (¶0101).
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 syringe of Russo to have included calibrated markings as taught by Folger for the purpose of being able to determine and adjust the amount of pharmaceutically active ingredient to be administered to the patient (¶0101 of Folger).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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