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 .
Amendment Entered
In response to the amendment filed on February 17th, 2026, amended claims 21-23, 25-26, 28, 33, 38-40, 43, and 45 are entered. Claims 31-32 and 42 are canceled. Claims 21-30, 33-41, and 43-47 are currently pending and under examination.
Response to Arguments
Applicant's remarks and amendments with respect to the objections of the abstract have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 103 have been fully considered. The rejections are withdrawn in view of the amendment. However, upon reconsideration, a new grounds of rejection has been made below.
Claim Objections
Claim 33, 38, and 43 are objected to because they recite “one ” in line 7. Newly added claim limitations are entered with an underline, while eliminated language is indicated with either double brackets or strikethrough. In this case, the word “spaced” is both underlined and struck through; thus, it is unclear as to whether this word was meant to be a part of the claim limitations.
Appropriate correction is required. For examination purposes, the claim limitations will be interpreted as “one part”, honoring the strikethrough instead of the underline.
Claim Rejections - 35 USC § 112
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.
Claims 21-30, 33-41, and 43-47 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 21 recites “a film with a flat part for laying on the skin and at least one part spaced apart from the skin during use” in lines 3-4. Although this limitation itself is not unclear, the future recitations of “part”, which are recited in lines 7 and 11 of Claim 21, cause indefiniteness, as the “flat part” could still qualify as being “at least one part”, due to the broad language, even if the “at least one part” was meant to refer to the part that is “spaced apart from the skin”. In order to avoid this confusion, the Examiner suggests amending the claim to recite “a film comprising a flat part and at least one spaced part, wherein the flat part is configured to lay on the skin, and the at least one spaced part is configured to be spaced apart from the skin during use”. Furthermore, Claim 21 recites “wherein the at least one part” in line 7. Although the Examiner infers that this limitation is referencing the “part spaced apart from the skin” previously introduced in Claim 21, the “flat part” could still qualify as being “at least one part”, due to the broad language. In order to avoid this confusion, Examiner suggests amending the claim to recite “wherein the at least one spaced part”, similar to above. Similarly, Claim 21 recites “when the at least one part” in lines 10-11. Although the Examiner infers that this limitation is referencing the “part spaced apart from the skin” previously introduced in Claim 21, the “flat part” could still qualify as being “at least one part”, due to the broad language. In order to avoid this confusion, Examiner suggests amending the claim to recite “when the at least one spaced part”, similar to above. All further recitations of “the at least one part” in the dependent claims should be amended as well to match the language of the independent claim.
Claim 21 recites “a film” in line 3, and “a container” in line 5, but it is unclear as to how these two elements are connected to one another, as they are being recited to be components of a singular device. Examiner notes that the Applicant had previously recited “a container for receiving the liquid medium associated with the at least one spaced part” in line 5 of Claim 21, which was rejected under 112(b) in the previous Office Action due to indefinite language. Although the Applicant has amended the claims to remove the indefinite language, the amendment has now broadened the claims and possibly created new reasons for indefiniteness. In order to remedy the indefiniteness without sacrificing any clarity regarding the connection between the two elements, the Examiner suggests amending the claim language to read “wherein the at least one spaced part further comprises a container configured to receive the liquid medium”, or something of the like.
Claim 21 recites “wherein the at least one closable opening is sealed in a closed position of the valve and the valve is at least partly opened in a position deviating from the closed position when the at least one part is deformed” in lines 9-11. Although these limitations indicate that the opening is sealed when the valve is in the closed position, it is unclear as to whether the opening is sealed or not when the valve is in “a position deviating from the closed position”. Furthermore, Examiner requests clarification on whether “a position deviating from the closed position” would simply be equivalent to “an open position”, which would simply the claim language and enhance clarity. Furthermore, it is unclear as to whether “the at least one part is deformed” only during a position deviating from the closed position, or if “the at least one part is deformed” during both “a position deviating from the closed position” and the “closed position”. Clarification is requested.
Claim 21 recites “further comprising at least one pointed or sharp element” in line 12. It is unclear as to what limitation “further comprising” is modifying, as it could be referring to any of the previously referenced elements.
The term “sharp” in claims 21, 46, and 47 is a relative term which renders the claim indefinite. The term “sharp” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “local” in claim 21 is a relative term which renders the claim indefinite. The term “local” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “superficial” in claim 21 is a relative term which renders the claim indefinite. The term “superficial” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 23 recites “a filling opening for filling the container with the liquid medium” in lines 1-2. It is unclear as to whether this limitation is referring to the previously introduced “at least one closable opening” from Claim 21, or a separate element.
Claim 28 recites “so that during use a cavity is formed between the film and the skin” in lines 2-3. It is unclear as to whether this limitation is further limiting the independent claim, as Claim 21 had already recited wherein the at least one part is “spaced apart from the skin during use”. Therefore, although it was not referred to as a “cavity” specifically, there was already space present between the film and skin, as recited by the independent claim.
Claim 30 recites “a vent hole is arranged in the protuberance” in lines 1-2. It is unclear as to whether the “vent hole” is referring to the previously introduced “valve” and/or “closeable opening from independent Claim 21, as both are located in the at least one part spaced apart from the skin of the film.
Claim 33 recites “a film with a flat part for laying on the skin and at least one part spaced apart from the skin during use” in lines 3-4. Although this limitation itself is not unclear, the future recitations of “part”, which are recited in lines 7 and 11 of Claim 33, cause indefiniteness, as the “flat part” could still qualify as being “at least one part”, due to the broad language, even if the “at least one part” was meant to refer to the part that is “spaced apart from the skin”. In order to avoid this confusion, the Examiner suggests amending the claim to recite “a film comprising a flat part and at least one spaced part, wherein the flat part is configured to lay on the skin, and the at least one spaced part is configured to be spaced apart from the skin during use”. Furthermore, Claim 33 recites “wherein the at least one part” in line 7. Although the Examiner infers that this limitation is referencing the “part spaced apart from the skin” previously introduced in Claim 33, the “flat part” could still qualify as being “at least one part”, due to the broad language. In order to avoid this confusion, Examiner suggests amending the claim to recite “wherein the at least one spaced part”, similar to above. Similarly, Claim 33 recites “when the at least one part” in lines 10-11. Although the Examiner infers that this limitation is referencing the “part spaced apart from the skin” previously introduced in Claim 33, the “flat part” could still qualify as being “at least one part”, due to the broad language. In order to avoid this confusion, Examiner suggests amending the claim to recite “when the at least one spaced part”, similar to above. All further recitations of “the at least one part” in the dependent claims should be amended as well to match the language of the independent claim.
Claim 33 recites “a film” in line 3, and “a container” in line 5, but it is unclear as to how these two elements are connected to one another, as they are being recited to be components of a singular device. Similar to independent Claim 21, the Examiner suggests amending the claim language to read “wherein the at least one spaced part further comprises a container configured to receive the liquid medium”, or something of the like.
Claim 33 recites “wherein the at least one closable opening is sealed in a closed position of the valve and the valve is at least partly opened in a position deviating from the closed position when the at least one part is deformed” in lines 9-11. Although these limitations indicate that the opening is sealed when the valve is in the closed position, it is unclear as to whether the opening is sealed or not when the valve is in “a position deviating from the closed position”. Furthermore, Examiner requests clarification on whether “a position deviating from the closed position” would simply be equivalent to “an open position”, which would simply the claim language and enhance clarity. Furthermore, it is unclear as to whether “the at least one part is deformed” only during a position deviating from the closed position, or if “the at least one part is deformed” during both “a position deviating from the closed position” and the “closed position”. Clarification is requested.
Claim 38 recites “a film with a flat part for laying on the skin and at least one part spaced apart from the skin during use” in lines 3-4. Although this limitation itself is not unclear, the future recitations of “part”, which are recited in lines 7 and 11 of Claim 38, cause indefiniteness, as the “flat part” could still qualify as being “at least one part”, due to the broad language, even if the “at least one part” was meant to refer to the part that is “spaced apart from the skin”. In order to avoid this confusion, the Examiner suggests amending the claim to recite “a film comprising a flat part and at least one spaced part, wherein the flat part is configured to lay on the skin, and the at least one spaced part is configured to be spaced apart from the skin during use”. Furthermore, Claim 38 recites “wherein the at least one part” in line 7. Although the Examiner infers that this limitation is referencing the “part spaced apart from the skin” previously introduced in Claim 38, the “flat part” could still qualify as being “at least one part”, due to the broad language. In order to avoid this confusion, Examiner suggests amending the claim to recite “wherein the at least one spaced part”, similar to above. Similarly, Claim 38 recites “when the at least one part” in lines 10-11. Although the Examiner infers that this limitation is referencing the “part spaced apart from the skin” previously introduced in Claim 38, the “flat part” could still qualify as being “at least one part”, due to the broad language. In order to avoid this confusion, Examiner suggests amending the claim to recite “when the at least one spaced part”, similar to above. All further recitations of “the at least one part” in the dependent claims should be amended as well to match the language of the independent claim.
Claim 38 recites “a film” in line 3, and “a container” in line 5, but it is unclear as to how these two elements are connected to one another, as they are being recited to be components of a singular device. Similar to independent Claim 21, the Examiner suggests amending the claim language to read “wherein the at least one spaced part further comprises a container configured to receive the liquid medium”, or something of the like.
Claim 38 recites “wherein the at least one closable opening is sealed in a closed position of the valve and the valve is at least partly opened in a position deviating from the closed position when the at least one part is deformed” in lines 9-11. Although these limitations indicate that the opening is sealed when the valve is in the closed position, it is unclear as to whether the opening is sealed or not when the valve is in “a position deviating from the closed position”. Furthermore, Examiner requests clarification on whether “a position deviating from the closed position” would simply be equivalent to “an open position”, which would simply the claim language and enhance clarity. Furthermore, it is unclear as to whether “the at least one part is deformed” only during a position deviating from the closed position, or if “the at least one part is deformed” during both “a position deviating from the closed position” and the “closed position”. Clarification is requested.
Claim 43 recites “a film with a flat part for laying on the skin and at least one part spaced apart from the skin during use” in lines 3-4. Although this limitation itself is not unclear, the future recitations of “part”, which are recited in lines 7 and 11 of Claim 43, cause indefiniteness, as the “flat part” could still qualify as being “at least one part”, due to the broad language, even if the “at least one part” was meant to refer to the part that is “spaced apart from the skin”. In order to avoid this confusion, the Examiner suggests amending the claim to recite “a film comprising a flat part and at least one spaced part, wherein the flat part is configured to lay on the skin, and the at least one spaced part is configured to be spaced apart from the skin during use”. Furthermore, Claim 43 recites “wherein the at least one part” in line 7. Although the Examiner infers that this limitation is referencing the “part spaced apart from the skin” previously introduced in Claim 43, the “flat part” could still qualify as being “at least one part”, due to the broad language. In order to avoid this confusion, Examiner suggests amending the claim to recite “wherein the at least one spaced part”, similar to above. Similarly, Claim 43 recites “when the at least one part” in lines 10-11. Although the Examiner infers that this limitation is referencing the “part spaced apart from the skin” previously introduced in Claim 43, the “flat part” could still qualify as being “at least one part”, due to the broad language. In order to avoid this confusion, Examiner suggests amending the claim to recite “when the at least one spaced part”, similar to above. All further recitations of “the at least one part” in the dependent claims should be amended as well to match the language of the independent claim.
Claim 43 recites “a film” in line 3, and “a container” in line 5, but it is unclear as to how these two elements are connected to one another, as they are being recited to be components of a singular device. Similar to independent Claim 21, the Examiner suggests amending the claim language to read “wherein the at least one spaced part further comprises a container configured to receive the liquid medium”, or something of the like.
Claim 43 recites “wherein the at least one closable opening is sealed in a closed position of the valve and the valve is at least partly opened in a position deviating from the closed position when the at least one part is deformed” in lines 9-11. Although these limitations indicate that the opening is sealed when the valve is in the closed position, it is unclear as to whether the opening is sealed or not when the valve is in “a position deviating from the closed position”. Furthermore, Examiner requests clarification on whether “a position deviating from the closed position” would simply be equivalent to “an open position”, which would simply the claim language and enhance clarity. Furthermore, it is unclear as to whether “the at least one part is deformed” only during a position deviating from the closed position, or if “the at least one part is deformed” during both “a position deviating from the closed position” and the “closed position”. Clarification is requested.
Claim 43 recites “a transport lock having cylindrical elements, the transport lock being arranged on an underside of the film for enclosing the container and the valve in the at least one part” in lines 12-14. It is unclear as to how the “cylindrical elements” would be arranged to enclose the container and the valve, and exactly where on the “cylindrical elements” the ruler would be arranged. Clarification is requested.
Claim 47 recites “[t]he allergy test device according to claim 46, wherein at least one of the film, the container, the valve, and the at least one pointed or sharp element” in lines 1-2. It is unclear as to whether the limitation “at least one of the film, the container, the valve, and the at least one pointed or sharp element” is referring to the same element from “at least one of the film, the container, the valve, and the at least one pointed or sharp element” of Claim 46, or a separate element. Examiner notes that if Claim 47 was meant to refer to a separate element, Applicant may want to re-consider whether Claim 47 should be dependent on Claim 46, or another claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 33 is rejected under 35 U.S.C. 103 as being unpatentable over Svedman (U.S. Patent No. 6,436,078; previously cited) in view of Weigum et al (U.S. Publication No. 2008/0038738; previously cited).
Regarding Claim 33, Svedman discloses an allergy test device for applying a liquid medium onto or into skin (An apparatus for use in transdermal perfusion of fluids; Abstract), comprising:
a film (disc-shaped base 602; contact surface 603; “a transparent housing 601 with a disc-shaped base 602. A contact surface 603 is adhesively coated so as to adhere to a skin surface”; Column 17 Lines 51-53) with a flat part for laying on the skin (bottom part of contact surface 603; Figure 14 shows that 602 and 603 are flat) and at least one part spaced apart from the skin during use (additional suction cup 623; expanding device 627; “The injection device 621 comprises an additional suction cup 623 defining a suction chamber 624 to which suction is applied to immediately draw skin into the chamber as shown in FIG. 16”; Column 18 Lines 29-32; “Drug within the reservoir 625 is pressurised by means of an expanding device 627 placed in contact with the reservoir 625 which is formed of a deformable material so as to be collapsible”; Column 18 Lines 35-39; Figures 15-16); and
a container for receiving the liquid medium (“Drug within the reservoir 625”; Column 18 Lines 35-36; Figures 15-16);
wherein the container has at least one closable opening (“Drug is then injected through the cannula from a reservoir 625 on release of a valve 626”; Column 18 Lines 34-35);
wherein the at least one part is deformable in a direction of the flat part of the film (“Drug within the reservoir 625 is pressurised by means of an expanding device 627 placed in contact with the reservoir 625 which is formed of a deformable material so as to be collapsible”; Column 18 Lines 35-39; Examiner’s Note: Expanding device 627 deforms horizontally which is the direction of the film) and a valve is arranged in the at least one closable opening (“Drug is then injected through the cannula from a reservoir 625 on release of a valve 626”; Column 18 Lines 34-35; See Figures 15-16);
further comprising at least one pointed or sharp element for local and superficial injury to the skin on at least one of a side of the container and the valve facing the skin during use (“an injection device 621 which is operable to inject via a cannula 622 an initial dose of drug prior to de-epithelialisation and transdermal delivery by means of the transdermal apparatus using an adjacent patch of skin…the cannula 622 is located within the chamber in a position such that skin drawn into the chamber by suction is penetrated. Drug is then injected through the cannula from a reservoir 625 on release of a valve 626”; Column 18 Lines 21-35).
Svedman fails to specifically teach wherein the valve is slidably arranged in the at least one closable opening; and wherein the at least one closable opening is sealed in a closed position of the valve and the valve is at least partly opened in a position deviating from the closed position when the at least one part is deformed; and wherein: the valve comprises a cylindrical body with at least one channel; the cylindrical body in the closed position of the valve seals the at least one closable opening of the container; and the cylindrical body in the position deviating from the closed position opens at least one channel to the container.
In a similar technical field, Weigum teaches a cartridge device fluid delivery system ([0016-0017]), comprising a valve slidably arranged in the at least one closable opening (“valves are used to control fluid flow through the cartridge. Valves may be positioned on or in the cartridge. Valves may direct, control, and/or restrict fluid flow. Active or passive valves may be positioned in channels…pinch valve 158 may include one or more layers 160, 162, 164 and channel 166. Layers 160, 162, 164 may be positioned over a surface of cartridge 100. In some embodiments, the layers are incorporated into the cartridge. Channel 166 may be an opening in cartridge 100”; [0171-0175]); and wherein the at least one closable opening is sealed in a closed position of the valve and the valve is at least partly opened in a position deviating from the closed position when the at least one part is deformed (“Pinch valve 158 may include one or more layers 160, 162, 164, and channel 166…layer 162 may be designed so that pressure applied to a surface of layer 162 causes the layer to deform (e.g., layer 162 flexes). Deformation of at least a portion of layer 162 may at least partially obstruct channel 166 as layer 162 is forced into channel 166 by the applied pressure. Layer 162 may be formed of any material that exhibits flexibility when pressure is applied to the layer (e.g., formed of an elastomer material)”; [0175-0176]); and wherein: the valve comprises a cylindrical body with at least one channel (FIG. 5 depicts cartridge 100 depicted in FIG. 4 with valves 156; [0174]; Examiner’s Note: Figure 5 shows wherein valve 156 comprises a cylindrical body with at least one channel); the cylindrical body in the closed position of the valve seals the at least one closable opening of the container; and the cylindrical body in the position deviating from the closed position opens at least one channel to the container (valves are used to control fluid flow through the cartridge. Valves may be positioned on or in the cartridge. Valves may direct, control, and/or restrict fluid flow. Active or passive valves may be positioned in channels…FIG. 5 depicts cartridge 100 depicted in FIG. 4 with valves 156. Valves 156 are positioned after collection region 102 and after metered volume portion 138. Valves 156 may be used to direct fluid flow from collection region 102 to detection region 108. Valves 156 may be positioned at various other locations in or on cartridge 100… Valves may be activated manually or automatically. In some embodiments, an analyzer system automatically opens or closes the valves. Actuators may be coupled to the analyte-detection system to open and/or close the valves. In some embodiments, an actuator is positioned above the cartridge to apply pressure to a valve through an opening in the cartridge. In some embodiments, an actuator is positioned below the cartridge to apply pressure to a valve through an opening in the cartridge; [0171-0177]; Examiner notes that these limitations merely recite the standard functions of opening/closing a valve).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the valve teachings of Weigum into the invention of Svedman in order to direct, control, and/or restrict fluid flow through applied pressure and deformation (Weigum [0171-0176]).
Claims 21-30, 37-41, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Svedman in view of Weigum et al and Maganias (U.S. Patent No. 4,802,493).
Regarding Claim 21, Svedman discloses an allergy test device for applying a liquid medium onto or into skin (An apparatus for use in transdermal perfusion of fluids; Abstract), comprising:
a film (disc-shaped base 602; contact surface 603; “a transparent housing 601 with a disc-shaped base 602. A contact surface 603 is adhesively coated so as to adhere to a skin surface”; Column 17 Lines 51-53) with a flat part for laying on the skin (bottom part of contact surface 603; Figure 14 shows that 602 and 603 are flat) and at least one part spaced apart from the skin during use (additional suction cup 623; expanding device 627; “The injection device 621 comprises an additional suction cup 623 defining a suction chamber 624 to which suction is applied to immediately draw skin into the chamber as shown in FIG. 16”; Column 18 Lines 29-32; “Drug within the reservoir 625 is pressurised by means of an expanding device 627 placed in contact with the reservoir 625 which is formed of a deformable material so as to be collapsible”; Column 18 Lines 35-39; Figures 15-16); and
a container for receiving the liquid medium (“Drug within the reservoir 625”; Column 18 Lines 35-36; Figures 15-16);
wherein the container has at least one closable opening (“Drug is then injected through the cannula from a reservoir 625 on release of a valve 626”; Column 18 Lines 34-35);
wherein the at least one part is deformable in a direction of the flat part of the film (“Drug within the reservoir 625 is pressurised by means of an expanding device 627 placed in contact with the reservoir 625 which is formed of a deformable material so as to be collapsible”; Column 18 Lines 35-39; Examiner’s Note: Expanding device 627 deforms horizontally which is the direction of the film) and a valve is arranged in the at least one closable opening (“Drug is then injected through the cannula from a reservoir 625 on release of a valve 626”; Column 18 Lines 34-35; See Figures 15-16);
further comprising at least one pointed or sharp element for local and superficial injury to the skin on at least one of a side of the container and the valve facing the skin during use (“an injection device 621 which is operable to inject via a cannula 622 an initial dose of drug prior to de-epithelialisation and transdermal delivery by means of the transdermal apparatus using an adjacent patch of skin…the cannula 622 is located within the chamber in a position such that skin drawn into the chamber by suction is penetrated. Drug is then injected through the cannula from a reservoir 625 on release of a valve 626”; Column 18 Lines 21-35).
Svedman fails to specifically teach wherein the valve is slidably arranged in the at least one closable opening; and wherein the at least one closable opening is sealed in a closed position of the valve and the valve is at least partly opened in a position deviating from the closed position when the at least one part is deformed.
In a similar technical field, Weigum teaches a cartridge device fluid delivery system ([0016-0017]), comprising a valve slidably arranged in the at least one closable opening (“valves are used to control fluid flow through the cartridge. Valves may be positioned on or in the cartridge. Valves may direct, control, and/or restrict fluid flow. Active or passive valves may be positioned in channels…pinch valve 158 may include one or more layers 160, 162, 164 and channel 166. Layers 160, 162, 164 may be positioned over a surface of cartridge 100. In some embodiments, the layers are incorporated into the cartridge. Channel 166 may be an opening in cartridge 100”; [0171-0175]); and wherein the at least one closable opening is sealed in a closed position of the valve and the valve is at least partly opened in a position deviating from the closed position when the at least one part is deformed (“Pinch valve 158 may include one or more layers 160, 162, 164, and channel 166…layer 162 may be designed so that pressure applied to a surface of layer 162 causes the layer to deform (e.g., layer 162 flexes). Deformation of at least a portion of layer 162 may at least partially obstruct channel 166 as layer 162 is forced into channel 166 by the applied pressure. Layer 162 may be formed of any material that exhibits flexibility when pressure is applied to the layer (e.g., formed of an elastomer material)”; [0175-0176]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the valve teachings of Weigum into the invention of Svedman in order to direct, control, and/or restrict fluid flow through applied pressure and deformation (Weigum [0171-0176]).
Svedman and Weigum fail to wherein the at least one pointed or sharp element is made in one piece with at least one of the container and the valve.
In a similar technical field, Maganias teaches a device and method for allergy testing (Abstract), comprising at least one pointed or sharp element for local and superficial injury to the skin on at least one of a side of the container and the valve facing the skin during use (lance 32); and wherein the at least one pointed or sharp element is made in one piece with at least one of the container and the valve (FIG. 4 illustrates a test strip 30 which includes only a single lance 32 or a plurality of such lances spaced apart sufficiently that a skin reaction caused by one lance is independent of a skin reaction caused by another lance. In the illustrated construction the lance 32 is molded from plastics material integrally with a substrate 34 which forms a concave recess 36 around the base of the lance 32. The substrate 34 is circular in plan view and is dome-shaped with a peripheral flange 38 which surrounds the generally semi-spherical recess 36. The lance 32 projects through the center of the recess 36 and is conical in shape with a sharp point 40. Suitable dimensions for the substrate 34 are an overall diameter of about 0.3 inches, an overall height of about 0.125 inches and a flange and wall thickness of about 0.03 inches. The conical lance 32 may have a taper of 16°. As with the embodiments of FIGS. 2 and 3 the test strip 30 of FIG. 4 includes a plastic strip 42, preferably essentially colorless and transparent, coated on its lower surface with a layer of pressure-sensitive adhesive 44. While not shown in FIG. 4 the test strip 30 can be provided with a protective film (as shown at 22 in FIG. 2 and at 22' in FIG. 3), and the lance 32 can be provided with a cover (as shown at 20 in FIG. 2). The concave substrate in FIG. 3 and recess 36 in FIG. 4 serve to standardize the amount of allergen applied to the skin; Column 4 Lines 32-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the lance teachings of Maganias into those of Svedman and Weigum in order to cause the lance or lances to penetrate the skin to a depth less than the subcutaneous tissue thereby carrying some of the allergen into the skin and maintaining constant contact between the allergen and the traumatized skin cells (Maganias Column 1 Line 63 – Column 2 Line 29).
Regarding Claim 22, Svedman discloses wherein the container is integral with the at least one part of the film (Examiner’s Note: The container (reservoir) is not disclosed as being detachable and therefore is integral with the additional suction cup 623 and expanding device 627, as the container (reservoir) is essential to the functioning of the device and its components).
Regarding Claim 23, Svedman, in a separate embodiment, discloses a filling opening for filling the container with the liquid medium (“the insertion port 675 is located so as to provide a means of injecting liquid drug through the housing into the reservoir 660”; Column 20 Lines 40-41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the filling opening teachings of Svedman into the other embodiment of Svedman in order to provide a means of injecting liquid drug through the housing into the reservoir (Svedman Column 20 Lines 40-41).
Regarding Claim 24, Svedman, in a separate embodiment, discloses wherein the filling opening is configured to be closed with a lid (“The drug insertion port 675 comprises a duct 676 communicating with the reservoir 660 and closed by a self-healing rubber bung 677 through which a syringe needle is insertable…the drug insertion port 675 may be replaced by a drug filling port 685 of the type shown in FIG. 29 in which a duct 686 is normally closed by a hinged snap fitting closure 687. Drug is therefore introduced into the reservoir 660 by opening the closure 687, pouring the drug in and replacing the closure”; Column 20 Line 46 – Column 21 Line 26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the closure teachings of Svedman into the other embodiment of Svedman in order to provide a means for closing and/or replacing the closure the port (Svedman Column 20 Line 46 – Column 21 Line 26).
Regarding Claim 25, Svedman discloses wherein the container is formed by a cup connected to the at least one part of the film (Examiner’s Note: The reservoir 625 is depicted as a cup-like structure connected to the additional suction cup 623 and expanding device 627, as seen in Figures 15-16).
Regarding Claim 26, Svedman discloses wherein the at least one part of the film or the entire film is elastically deformable (“Drug within the reservoir 625 is pressurised by means of an expanding device 627 placed in contact with the reservoir 625 which is formed of a deformable material so as to be collapsible”; Column 18 Lines 35-39; Examiner’s Note: Expanding device 627 deforms horizontally which is the direction of the film).
Regarding Claim 27, Svedman discloses wherein the film is made of one of thermoplastic synthetic material and silicone (“In the above embodiments the adhesive used in contact with the skin may be of a hydrocolloidal type composed of pectin and gelatine or may alternatively be composed of acrylic or silicon”; Column 21 Lines 55-58).
Regarding Claim 28, Svedman discloses wherein the at least one part is formed by a protuberance of the film, so that during use a cavity is formed between the film and the skin (“The injection device 621 comprises an additional suction cup 623 defining a suction chamber 624 to which suction is applied to immediately draw skin into the chamber as shown in FIG. 16”; Column 18 Lines 29-32).
Regarding Claim 29, Svedman discloses wherein the cavity formed during use is a closed cavity (Figures 15-16 show that the cavity is closed).
Regarding Claim 30, Svedman discloses wherein a vent hole is arranged in the protuberance (“The cannula 622 is located within the chamber in a position such that skin drawn into the chamber by suction is penetrated”; Column 18 Lines 32-34).
Regarding Claim 37, Svedman, in a separate embodiment, discloses an adhesive film with a peel-off film on a side of the flat part of the film facing the skin during use (“The disc 503 is formed of a rigid transparent plastics material and has a lower surface 506 which is coated with adhesive and prior to use is protected by a peel-off paper film 507”; Column 14 Lines 51-54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the peel-off film teachings of Svedman into the other embodiment of Svedman in order to offer protection prior to use (Svedman Column 14 Lines 51-54).
Regarding Claim 38, Svedman discloses an allergy test device for applying a liquid medium onto or into skin (An apparatus for use in transdermal perfusion of fluids; Abstract), comprising:
a film (disc-shaped base 602; contact surface 603; “a transparent housing 601 with a disc-shaped base 602. A contact surface 603 is adhesively coated so as to adhere to a skin surface”; Column 17 Lines 51-53) with a flat part for laying on the skin (bottom part of contact surface 603; Figure 14 shows that 602 and 603 are flat) and at least one part spaced apart from the skin during use (additional suction cup 623; expanding device 627; “The injection device 621 comprises an additional suction cup 623 defining a suction chamber 624 to which suction is applied to immediately draw skin into the chamber as shown in FIG. 16”; Column 18 Lines 29-32; “Drug within the reservoir 625 is pressurised by means of an expanding device 627 placed in contact with the reservoir 625 which is formed of a deformable material so as to be collapsible”; Column 18 Lines 35-39; Figures 15-16); and
a container for receiving the liquid medium (“Drug within the reservoir 625”; Column 18 Lines 35-36; Figures 15-16);
wherein the container has at least one closable opening (“Drug is then injected through the cannula from a reservoir 625 on release of a valve 626”; Column 18 Lines 34-35);
wherein the at least one part is deformable in a direction of the flat part of the film (“Drug within the reservoir 625 is pressurised by means of an expanding device 627 placed in contact with the reservoir 625 which is formed of a deformable material so as to be collapsible”; Column 18 Lines 35-39; Examiner’s Note: Expanding device 627 deforms horizontally which is the direction of the film) and a valve is arranged in the at least one closable opening (“Drug is then injected through the cannula from a reservoir 625 on release of a valve 626”; Column 18 Lines 34-35; See Figures 15-16).
Svedman fails to specifically teach wherein the valve is slidably arranged in the at least one closable opening; and wherein the at least one closable opening is sealed in a closed position of the valve and the valve is at least partly opened in a position deviating from the closed position when the at least one part is deformed.
In a similar technical field, Weigum teaches a cartridge device fluid delivery system ([0016-0017]), comprising a valve slidably arranged in the at least one closable opening (“valves are used to control fluid flow through the cartridge. Valves may be positioned on or in the cartridge. Valves may direct, control, and/or restrict fluid flow. Active or passive valves may be positioned in channels…pinch valve 158 may include one or more layers 160, 162, 164 and channel 166. Layers 160, 162, 164 may be positioned over a surface of cartridge 100. In some embodiments, the layers are incorporated into the cartridge. Channel 166 may be an opening in cartridge 100”; [0171-0175]); and wherein the at least one closable opening is sealed in a closed position of the valve and the valve is at least partly opened in a position deviating from the closed position when the at least one part is deformed (“Pinch valve 158 may include one or more layers 160, 162, 164, and channel 166…layer 162 may be designed so that pressure applied to a surface of layer 162 causes the layer to deform (e.g., layer 162 flexes). Deformation of at least a portion of layer 162 may at least partially obstruct channel 166 as layer 162 is forced into channel 166 by the applied pressure. Layer 162 may be formed of any material that exhibits flexibility when pressure is applied to the layer (e.g., formed of an elastomer material)”; [0175-0176]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the valve teachings of Weigum into the invention of Svedman in order to direct, control, and/or restrict fluid flow through applied pressure and deformation (Weigum [0171-0176]).
Svedman and Weigum fail to wherein several spaced parts of a film are arranged in at least two rows.
In a similar technical field, Maganias teaches a device and method for allergy testing (Abstract), several spaced parts of a film (FIG. 4 illustrates a test strip 30 which includes only a single lance 32 or a plurality of such lances spaced apart sufficiently that a skin reaction caused by one lance is independent of a skin reaction caused by another lance. In the illustrated construction the lance 32 is molded from plastics material integrally with a substrate 34 which forms a concave recess 36 around the base of the lance 32. The substrate 34 is circular in plan view and is dome-shaped with a peripheral flange 38 which surrounds the generally semi-spherical recess 36. The lance 32 projects through the center of the recess 36 and is conical in shape with a sharp point 40. Suitable dimensions for the substrate 34 are an overall diameter of about 0.3 inches, an overall height of about 0.125 inches and a flange and wall thickness of about 0.03 inches. The conical lance 32 may have a taper of 16°. As with the embodiments of FIGS. 2 and 3 the test strip 30 of FIG. 4 includes a plastic strip 42, preferably essentially colorless and transparent, coated on its lower surface with a layer of pressure-sensitive adhesive 44. While not shown in FIG. 4 the test strip 30 can be provided with a protective film (as shown at 22 in FIG. 2 and at 22' in FIG. 3), and the lance 32 can be provided with a cover (as shown at 20 in FIG. 2). The concave substrate in FIG. 3 and recess 36 in FIG. 4 serve to standardize the amount of allergen applied to the skin; Column 4 Lines 32-57) are arranged in at least two rows (a single tape can carry a plurality of lances or groups of lances, each lance or group carrying a different allergen. The appearance of the skin area may be compared to one or more control skin areas which have been similarly punctured by similar test strips having a lance or lances free of allergen. The lance or lances, which may be made of plastics material or metal, may be needle-like with sharp points, conical with sharp points or blade-like with both edges sharpened and a pointed end or rounded knife-edge end. In one embodiment there is at least one group of closely-spaced short needle-like lances, the group being for example circular and having a diameter less than the smallest dimension of the adhesive surface of the strip. A suitable arrangement is 5 to 10 lances disposed in a circular group of approximately 0.125 inch diameter. The length of the lances may be in the range 0.06 inch to 0.03 inch; Column 2 Lines 11-29; Examiner’s Note: In the given example of 5 to 10 lances disposed in a circular group, there would exist at least two rows of lances, which would qualify under the current claim limitations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the lance arrangement teachings of Maganias into those of Svedman and Weigum in order appl different allergens to the skin simultaneously or essentially simultaneously. The appearance of the skin area may be compared to one or more control skin areas which have been similarly punctured by similar test strips having a lance or lances free of allergen (Maganias Column 2 Lines 4-17).
Regarding Claim 39, Maganias discloses wherein a first number of the spaced parts of the film in a first row of the at least two rows is different from a second number of the spaced parts of the film in a second row of the at least two rows (a single tape can carry a plurality of lances or groups of lances, each lance or group carrying a different allergen. The appearance of the skin area may be compared to one or more control skin areas which have been similarly punctured by similar test strips having a lance or lances free of allergen. The lance or lances, which may be made of plastics material or metal, may be needle-like with sharp points, conical with sharp points or blade-like with both edges sharpened and a pointed end or rounded knife-edge end. In one embodiment there is at least one group of closely-spaced short needle-like lances, the group being for example circular and having a diameter less than the smallest dimension of the adhesive surface of the strip. A suitable arrangement is 5 to 10 lances disposed in a circular group of approximately 0.125 inch diameter. The length of the lances may be in the range 0.06 inch to 0.03 inch; Column 2 Lines 11-29; Examiner’s Note: In the given example of 5 to 10 lances disposed in a circular group, there would exist at least two rows of lances wherein the number of lances would differ from one another, which would qualify under the current claim limitations).
Regarding Claim 40, Maganias discloses wherein an identification is arranged on an outside of at least one of the at least one spaced part (For the convenience of the medical practitioner the allergy testing strips can be supplied in kit form, with each strip being marked to identify its respective allergen or allergens; Column 3 Lines 24-27).
Regarding Claim 41, Svedman, in a separate embodiment, discloses wherein the film is formed at least partly from transparent material (“The disc 503 is formed of a rigid transparent plastics material”; Column 14 Lines 51-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the transparent teachings of Svedman into the other embodiment of Svedman in order to enable the observation of the functioning of the device through the transparent housing (Svedman Column 15 Lines 57-61).
Regarding Claim 45, Svedman discloses wherein sterile packaging is provided (“In each case the apparatus may be supplied with the adhesive covered in a protective sheet which also seals the aperture formed in the contact surface and the entire assembly can be sterilised in readiness for use”; Column 21 Lines 58-61).
Claims 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over Svedman, Weigum, and Maganias as applied to claim 28 above, and further in view of Drzala et al (U.S. Publication No. 2019/0307389; previously cited).
Regarding Claim 46, Svedman, Weigum, and Maganias fail to specifically disclose wherein at least one of the film, the container, the valve and the at least one pointed or sharp element is one of at least partly formed from a biocompatible material and at least partly coated with a biocompatible coating.
In a similar technical field, Drzala teaches an apparatus including a wearable holder and a test material unit and a method for assessing skin reactivity to a test material (Abstract), wherein at least one of the film, the container, the valve and the at least one pointed or sharp element is one of at least partly formed from a biocompatible material and at least partly coated with a biocompatible coating (“The test material unit can include any test materials subjected to a skin hypersensitivity test. The test materials may include implant materials commonly used in medicine and dentistry or implant materials that are specific to the needs of certain patient populations. For example, the test materials can include metals commonly used in orthopedic fracture fixation and joint replacement procedures including, without limitation, aluminum, chromium, cobalt, molybdenum, nickel, and titanium, or other identified implant materials. In another example, the test materials can include non-metallic materials frequently used in orthopedic surgery including, without limitation, polymethyl methacrylate (PMMA or bone cement), polyethylene (joint replacement liners), polyaryl ether ketone (e.g., PEEK), and carbon fiber”; [0028-0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the material teachings of Drzala into those of Svedman, Weigum, and Maganias in order to incorporate materials commonly used in medicine, dentistry or implant materials that are specific to the needs of certain patient populations, materials commonly used in orthopedic fracture fixation and joint replacement procedures, and/or materials frequently used in orthopedic surgery in order to ensure biocompatibility with the patient (Drzala [0028-0029]).
Regarding Claim 47, Svedman, Weigum, and Maganias fail to specifically disclose wherein at least one of the film, the container, the valve, and the at least one pointed or sharp element is one of: at least partly formed from polyether ether ketone (PEEK), and at least partly coated with a parylene coating.
In a similar technical field, Drzala teaches an apparatus including a wearable holder and a test material unit and a method for assessing skin reactivity to a test material (Abstract), wherein at least one of the film, the container, the valve, and the at least one pointed or sharp element is one of: at least partly formed from polyether ether ketone (PEEK), and at least partly coated with a parylene coating (“The test material unit can include any test materials subjected to a skin hypersensitivity test. The test materials may include implant materials commonly used in medicine and dentistry or implant materials that are specific to the needs of certain patient populations. For example, the test materials can include metals commonly used in orthopedic fracture fixation and joint replacement procedures including, without limitation, aluminum, chromium, cobalt, molybdenum, nickel, and titanium, or other identified implant materials. In another example, the test materials can include non-metallic materials frequently used in orthopedic surgery including, without limitation, polymethyl methacrylate (PMMA or bone cement), polyethylene (joint replacement liners), polyaryl ether ketone (e.g., PEEK), and carbon fiber”; [0028-0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the polyether ether ketone (PEEK) teachings of Drzala into those of Svedman, Weigum, and Maganias, as PEEK is well-known to be a high-performance material for its high strength, heat and chemical resistance, and biocompatibility (Drzala [0028-0029]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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