DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 105, 147, and all claims depending therefrom are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Specifically, claims 105 and 147 recite “wherein the first inner radius at the proximal end is greater than or equal to 0.1 mm and less than or equal to 0.75 mm”. The specification does not reasonably provide enablement for any conduit within this range of values being able to perform the functional limitations of the remainder of the claims (such as allowing entry of some materials and/or resisting entry of other materials).
Further, claims 105 and 147 recite that “the sum of the advancing angle of the fourth material at the distal end and the distal angle is greater than 180 degrees.” The specification does not reasonably provide enablement for any conduit having these characteristics being able to perform the functional limitations of the remainder of the claims (such as allowing entry of some materials and/or resisting entry of other materials).
Claims 105-106, 108, 129, 134-136, 142, 143 and 147 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 105, the new matter is “…wherein at least one of the angle or the surface property of the inner surface vary to maintain a substantially constant or reducing Young-Laplace pressure of the fourth material from the proximal end to the distal end such that there is substantially no pinning of the fourth material from the proximal end to the distal end.” Applicant’s specification, as originally filed, makes no mention of this configuration as it relates to the fourth material. That is, Applicant’s specification makes no mention of preventing or eliminating pinning of a fourth material from the proximal end to the distal end.
Further, regarding claims 105 and 147, the new matter is “wherein the first inner radius at the proximal end is greater than or equal to 0.1 mm and less than or equal to 0.75 mm”. The original specification does not have support for the first inner radius being in this range. The original specification discusses embodiments of a tube having an inner radius at its proximal end of 0.107 mm (published specification at para [0265]), 0.058 mm (see published specification at para [0265]) and 0.275 mm (published specification at para [0263]). But the specification does not demonstrate to a skilled artisan that the Applicant was in possession of the full range of values recited in the art. MPEP 2163(II)(3)(a)(ii) instructs that the written description requirement for a claimed genus may be satisfied trough sufficient description of a representative number of species by actual reduction to practice. However, the description of a small number of embodiment within the claimed range, and no embodiments near the top end of the range, is not representative description of species for the claimed genus.
Further, regarding claims 105 and 147, the new matter is “the sum of the advancing angle of the fourth material at the distal end and the distal angle is greater than 180 degrees.” The original disclosure appears to mention a summation of angles, in para [0245] of the published application, stating “In certain embodiments, the summation of the advancing angle and the lumen flange angle at the distal end will be 180° such that the pressure has no discontinuities, hence avoiding any pinning of fluid.” However, the original disclosure does not have support for at least 1) the advancing angle is the advancing angle of the fourth fluid, 2) the claimed distal angle being the same as the lumen flange angle, 3) the sum of such angles being greater than 180 degrees (the specification states that the angle is 180 degrees, not greater than 180 degrees), and 4) sufficient disclosure that the Applicant was in possession of an embodiment having all of the features of the claimed invention including performing the claimed function.
Regarding claim 106, the new matter is “wherein the difference between the Young-Laplace pressure of the second material at the proximal end of the conduit and the Young- Laplace pressure of the fourth material at the proximal end of the conduit is in the range of 1 and 1,000 Pa.”. This limitation is not found in Applicant’s disclosure as originally filed. The disclosure does not mention the difference of the Young-Laplace pressures of the second and fourth materials at the proximal end of the conduit.
Regarding claim 108, the new matter is “wherein an advancing angle of the fourth material at the proximal end as the fourth material enters the proximal end is less than 90° and an advancing angle of the second material at the proximal end is as the second material enters the proximal end is greater than 90°” . There does not appear to be a disclosure that the conduit is sized or shaped to fulfill both of these conditions at the same time (i.e., the condition of the advancing angle of the fourth material and the advancing angle of the second material).
Claim 129 is rejected for reciting new matter of “the Young-Laplace pressure for the third material at the proximal end of the conduit is less than the Young-Laplace pressure for the second material at the proximal end of the conduit, but below a breakthrough pressure at the distal end.” The original disclosure makes no mention of the comparison of the Young-Laplace pressure for the third material and second material at the proximal end of the conduit.
Claim 134 is rejected for reciting new matter of “wherein the Young-Laplace pressure for the first material at the proximal end of the conduit is less than the Young-Laplace pressure for the second material at the proximal end of the conduit.” The original specification makes no mention of Young-Laplace pressure for the first material at the proximal end of the conduit. Instead, the specification mentions “breakthrough pressure” of the first material at the proximal end (see published specification at para [0077]).
Further, claim 134 is rejected for reciting the new matter that “the first inner radius, the second inner radius, the angle of the inner surface, the distal angle, the proximal angle, and the surface properties of the inner surface are selected such that the conduit is configured to allow entry of the first material in the manner described above (the original disclosure makes no mention of the aforementioned specific characteristics/properties of the inner surface being selected to carry out the intended use described above).
Claim 135 is rejected for reciting the new matter of “the difference between the Young-Laplace pressure of the first material at the proximal end of the conduit and the Young- Laplace pressure of the second material at the distal end of the conduit is in the range of 1 Pa to 1000 Pa.” The original disclosure makes no mention of the comparison of the Young-Laplace pressure for the first material and second material at the distal end of the conduit.
Claim 136 is rejected for reciting the new matter of “at least one of an angle or a surface property of the inner surface vary to maintain a substantially constant or reducing Young- Laplace pressure of the first material from the distal end to the proximal end or wherein at least one of an angle or a surface property of the inner surface varies such that there is substantially no pinning of the first material from the distal end to the proximal end. The original disclosure states “substantially no pinning of the first material from the proximal end to the distal end”.
Claim 142 is rejected for reciting the new matter of the fourth material being selected from the list in claim 142. Specifically, the original disclosure does not state that the list of materials complies with the requirement of amended independent claim 105, which now recites that “the Young-Laplace pressure for the fourth material at the proximal end of the conduit is less than the Young-Laplace pressure for the second material at the proximal end of the conduit.”
Regarding claim 143, the new matter is “…wherein at least one of the angle or the surface property of the inner surface vary to maintain a substantially constant or reducing Young-Laplace pressure of the first material from the proximal end to the distal end such that there is substantially no pinning of the first material from the proximal end to the distal end.” Applicant’s specification makes no mention of varying the angle or surface property of the inner surface to maintain a substantially constant or reducing Young-LaPlace pressure of the first material from the proximal end to the distal end (the specification only makes mention of “the at least one of an angle or a surface property of the inner surface vary to maintain a substantially constant or reducing Young-Laplace pressure of the first material from the distal end to the proximal end.”)
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 105, 136, 147 and all claims depending therefrom are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 105 recites a conduit “configured to allow entry of a fourth material… allow transport of the fourth material… and allow exit of the fourth material from the distal end of the conduit…and “resist entry of a second material into the proximal end the conduit”. But the claims do not recite a first material or third material. Therefore, it is not clear what is meant by a “fourth material”. Thus, the scope of the protection sought by Applicant is not clear.
Claim 105 recites “maintain a substantially constant or reducing Young-Laplace pressure of the fourth material from the proximal end to the distal end”. Claim 136 recites “maintain a substantially constant or reducing Young-Laplace pressure of the first material from the distal end to the proximal end.” Claim 147 recites “maintain a substantially constant or reducing Young-Laplace pressure of the first material from the distal end to the proximal end”. It is not clear what is meant by this limitation. It is not clear if the limitation is interpreted to mean that the pressure of the first material is substantially constant or reducing as the material travels from the distal end to the proximal end. For the purpose of examination, the limitation will be interpreted accordingly.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 105, 106, 111, 122, 126, and 129-142, 146 and 147 are rejected under 35 U.S.C. 103 as being unpatentable over Hageman (U.S. Pat. 5,389,088, hereinafter “Hageman”), in view of Berry (U.S. Pat. 4,775,370, hereinafter “Berry”).
Regarding claim 105, Hageman discloses a device comprising:
a conduit comprising:
a proximal end, in the region of flange 2 (see Fig. 1),
a distal end, in the region of the edge 5, opposite the proximal end (see Fig. 1),
wherein the conduit has a first inner radius at a proximal end 2 (see Fig. 1) and a second inner radius at a distal end (in the region of the edge 5), such that the second inner radius is greater than the first inner radius (see Fig. 1);
an inner surface that is continuously curved from the proximal end to the distal end, the inner surface having an angle that varies from the proximal end to the distal end such that the inner surface forms a proximal angle at the proximal end and distal angle at the distal end (see col. 3, lines 54-58, disclosing that the tube can be “trumpet-shaped” or monotonic), the inner surface comprising surface properties (every surface has “surface properties” per se),
an outer surface connecting the proximal end to the distal end (see Fig. 1), and
a proximal flange 2 (see Fig. 1) disposed on the proximal end of the conduit.
The following claim limitations in claim 105 are interpreted to cover the function, or intended use, of the device:
“… the conduit is configured to:
allow entry of a fourth material to the proximal end of the conduit, allow transport of the fourth material through the conduit along the inner surface toward the distal end, and allow exit of the first material from the distal end of the conduit, and resist entry of a second material into the proximal end of the conduit; and wherein the Young-Laplace pressure for the fourth material at the proximal end of the conduit is less than the Young-Laplace pressure for the second material at the proximal end of the conduit;
wherein at least one of the angle or the surface property of the inner surface vary to maintain a substantially constant or reducing Young-Laplace pressure of the fourth material from the proximal end to the distal end such that there is substantially no pinning of the fourth material from the proximal end to the distal end; […]
and wherein the sum of the advancing angle of the fourth material at the distal end and the distal angle is greater than 180 degrees.”
Although features of an apparatus may be recited functionally (see In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997)), apparatus claims cover what a device is, not what a device does. See Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.
In this case, Hageman teaches all the structural limitations of the claim. The manner in which a fourth material and a second material would be respectively allowed into, or resisted out of, the conduit appears to be based on “the Young-Laplace pressures for” the materials – which itself is a function of the effective surface tension of the material in the conduit as well as the contact angle, which in turn depends on the property of the materials in the conduit and the material of the tympanostomy tube. But these materials are not positively recited structural features of the claimed invention and the claims do not appear to contain any specific characteristics of the device, such as initial radii, initial flange angles, length of the lumen, surface functionalization, contact angles, etc., which appear to be necessary to optimizing the transport of materials into and out of the device according to Applicant’s disclosure (see, e.g., published specification at paras [0023], [0238], [0242]). Therefore, it appears that the prior art structure inherently possesses the functionally defined limitations.
It is noted Hageman does not appear to disclose that the first inner radius at the proximal end is greater than or equal to 0.1 mm and less than or equal to 0.75 mm.
Berry discloses an ear drum ventilation and drainage tube in the analogous art to Applicant’s invention, comprising a proximal end (at the flange 1’) which has a variable lumen diameter such that the lumen diameter at the proximal end is about 1.1 mm, i.e., a radius of about 0.55 mm (see col 2, lines 28-31).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Hageman so that the first inner radius at the proximal end is in the range of 0.1 mm and 0.75 mm, for example, about 0.55 mm, as a suitable dimension to accomplish the purposes of ventilation and drainage, with a reasonable expectation of success (see Berry at col. 2, lines 28-31).
Regarding claim 106, the following limitation recites intended use:
“wherein the difference between the Young-Laplace pressure of the second material” and “the Young-Laplace pressure of the fourth material”… “is in the range of 1 and 1,000 Pa”.
This limitation describes the first and the second materials, but since these materials are not positively recited structural elements of the claim, it is not clear how this claim limitation would meaningfully distinguish the instant invention from the device of Hageman (which would appear to function in the claimed manner if a first material, such as bodily fluids, were chosen having a lower Young-Laplace pressure than a Young-Laplace pressure for the second material, such as an emulsion, such that the difference in Young-Laplace pressure were in the range of 1 to 1000 Pa).
Regarding claim 111, Hageman does not appear to disclose that the conduit comprises a distal flange disposed on the distal end of the conduit.
Berry discloses a distal flange 1’’ located on the distal end of the conduit (see Figs. 1-3).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hageman to have a distal flange disposed on the distal end of the conduit, in order to resist dislodging of the tube (see Berry at col. 2, lines 5-10).
Regarding claim 122, Hageman discloses that the conduit comprise a stimulus-responsive portion, where the stimulus can be a lubricating liquid or chemical composition (e.g., the conduit would be lubricated by a lubricating liquid or respond to a chemical applied to it).
Regarding claim 126, Hageman discloses that the responsive portion is disposed on one or more of the inner surface and outer surface of the conduit (either the conduit would be lubricated by a lubricating liquid or respond to a chemical applied to it).
Regarding claim 129, the following limitation recites intended use:
“wherein the first inner radius, the second inner radius, the angle of the inner surface, the distal angle, the proximal angle, and the surface properties of the inner surface are selected such that the conduit is configured to allow entry of a third material to the proximal end of the conduit, allow transport of the third material through the conduit along the inner surface toward the distal end, and resist exit of the third material from the proximal end of the conduit; wherein the Young-Laplace pressure for the third material at the proximal end of the conduit is less than the Young-Laplace pressure for the second material at the proximal end of the conduit, but below a breakthrough pressure at the distal end”
This intended use of the device is based on the device’s structural characteristics when used with different materials. However, these materials are not positively recited structural elements of the claim; accordingly, it appears that the prior art structure inherently possesses the functionally defined limitations.
Regarding claim 130, Hageman discloses that at least a portion of the inner surface is configured to pin the third material thereon (it is understood that the inner surface could pin a variety of materials such as a liquid pharmaceutical, since the third material is not a positively recited structural claim element).
Regarding claim 131, the following limitation recites intended use:
“ wherein the difference between the Young-Laplace pressure of the second material and the Young-Laplace pressure of the third material is in the range of 1 and 1,000 Pa” .
This use describes the materials, but since these materials are not positively recited structural elements of the claim, it is not clear how this claim limitation would meaningfully distinguish the instant invention from the device of Labib, which would appear to function in the claimed manner if a material, such as a liquid pharmaceutical, were chosen having a lower Young-Laplace pressure than a Young-Laplace pressure for another material, such as an emulsion, such that the difference in Young-Laplace pressure were in the range of 1 to 1000 Pa. Moreover, Hageman does not appear to place any limits on what types of materials, or how many materials, can flow through the device. Since these materials are not positively recited structural elements of the claim, it appears that the prior art structure inherently possesses the functionally defined limitations.
Regarding claim 132, the following limitation recites intended use:
“wherein the distal end is configured to have the breakthrough pressure of at least 1 Pa higher than the Young-Laplace pressure of the third material at the location of the distal end to prevent exit of the third material from the distal end”
This limitation recites the breakthrough pressure of the distal end relative to an undisclosed material that has not been positively recited as a structural claim element. Therefore, it is not clear how this claim limitation would meaningfully distinguish the instant invention from the device of Hageman, which would appear to function in the claimed manner if a material, such as a liquid pharmaceutical, were chosen having a higher Young-Laplace pressure than a breakthrough pressure of the distal end. And if such material were chosen, then the device of Hageman would perform the claimed function of preventing exit of the material from the distal end. Moreover, Hageman does not appear to place any limits on what types of materials, or how many materials, can flow through the device. Since these materials are not positively recited structural elements of the claim, it appears that the prior art structure inherently possesses the functionally defined limitations.
Regarding claim 133, the following limitation recites intended use:
“wherein the advancing angle of the third material at the proximal end as the third material enters the proximal end is less than 90°”
This limitation recites an advancing angle of the undisclosed material that has not been positively recited as a structural claim element. Therefore, it is not clear how this claim limitation would meaningfully distinguish the instant invention from the device of Hageman, which would appear to function in the claimed manner if a material, such as a liquid pharmaceutical were chosen to have surface tension properties allowing it to enter the proximal end at an advancing angle of less than 90 degrees. Moreover, Hageman does not appear to place any limits on what types of materials, or how many materials, can flow through the device. Since these materials are not positively recited structural elements of the claim, it appears that the prior art structure inherently possesses the functionally defined limitations.
Regarding claim 134, the following limitation recites intended use:
“wherein the first inner radius, the second inner radius, the angle of the inner surface, the distal angle, the proximal angle, and the surface properties of the inner surface are selected such that the conduit is configured to allow entry of a first material to the distal end of the conduit, allow transport of the first material through the conduit along the inner surface toward the
This limitation recites an intended use of the device based on the device’s structural characteristics with two types of materials. However, these materials are not positively recited structural elements of the claim; accordingly, it appears that the device of Hageman would function in the claimed manner if a material (such as a liquid pharmaceutical compound) were chosen having a lower Young-Laplace pressure than a Young-Laplace pressure for another material (such as an emulsion). Moreover, Hageman does not appear to place any limits on what types of materials, or how many materials, can flow through the device. Since these materials are not positively recited structural elements of the claim, it appears that the prior art structure inherently possesses the functionally defined limitations.
Regarding claim 135, the following limitation recites intended use:
“wherein the difference between the Young-Laplace pressure of the first material at the proximal end of the conduit and the Young-Laplace pressure of the second material at the distal end of the conduit is in the range of 1 and 1000 Pa”
This limitation describes the materials, but since these materials are not positively recited structural elements of the claim, it is not clear how this claim limitation would meaningfully distinguish the instant invention from the device of Hageman, which would appear to function in the claimed manner if a material, such as a liquid pharmaceutical, were chosen having a lower Young-Laplace pressure than a Young-Laplace pressure for another material, such as an emulsion, such that the difference in Young-Laplace pressure were in the range of 1 to 1000 Pa. Moreover, Hageman does not appear to place any limits on what types of materials, or how many materials, can flow through the device. Since these materials are not positively recited structural elements of the claim, it appears that the prior art structure inherently possesses the functionally defined limitations.
Regarding claim 136, the limitation regarding:
an angle or a surface property of the inner surface varies to maintain a substantially constant or reducing Young-Laplace pressure of the first material from the distal end to the proximal end or wherein at least one of an angle or a surface property of the inner surface varies such that there is substantially no pinning of the first material from the distal end to the proximal end …
recites intended use.
The materials are not positively recited structural elements of the claim; accordingly, it appears that the device of Hageman would function in the claimed manner if a material (such as a liquid pharmaceutical compound) were chosen having a lower Young-Laplace pressure than a Young-Laplace pressure for another material (such as an emulsion). Moreover, Hagman does not appear to place any limits on what types of materials, or how many materials, can flow through the device. Since these materials are not positively recited structural elements of the claim, it appears that the prior art structure inherently possesses the functionally defined limitations.
Regarding claim 137, the following limitation recites intended use:
“wherein the advancing angle of the first material at the distal end as the first material enters the distal end is less than 90°”
This limitation recites an advancing angle of the undisclosed material that has not been positively recited as a structural claim element. Therefore, it is not clear how this claim limitation would meaningfully distinguish the instant invention from the device of Hageman, which would appear to function in the claimed manner if a material, such as a liquid pharmaceutical were chosen to have surface tension properties allowing it to enter the proximal end at an advancing angle of less than 90 degrees. Moreover, Hageman does not appear to place any limits on what types of materials, or how many materials, can flow through the device. Since these materials are not positively recited structural elements of the claim, it appears that the prior art structure inherently possesses the functionally defined limitations.
Regarding claim 138, the following limitation recites intended use:
“wherein the distal end is configured to have breakthrough pressure for the fourth liquid of at least 1 Pa lower than the Young-Laplace pressure of the fourth material at the location of the distal end to enable its exit”
This limitation recites the breakthrough pressure of an end relative to an undisclosed material that has not been positively recited as a structural claim element. Therefore, it is not clear how this claim limitation would meaningfully distinguish the instant invention from the device of Hageman, which would appear to function in the claimed manner if a material, such as a liquid pharmaceutical, were chosen having a higher Young-Laplace pressure than a breakthrough pressure of said end. And if such material were chosen, then the device of Hageman would perform the claimed function. Moreover, Hageman does not appear to place any limits on what types of materials, or how many materials, can flow through the device. Since these materials are not positively recited structural elements of the claim, it appears that the prior art structure inherently possesses the functionally defined limitations.
Regarding claims 139-142, the claims recite a wide variety of materials from which the first, second, third and fourth materials can be chosen. However, these materials are not positively recited structural claim elements, and it appears that the selection of these materials to allow the claimed device to function properly is dependent on the material chosen. Since these materials are not positively recited structural elements of the claim, it appears that the prior art structure inherently possesses the functionally defined limitations.
Regarding claim 146, Hageman, in view of Berry, discloses a tympanostomy or ventilation device (as disclosed in Hageman at Abstract) comprising: the conduit of claim 105, configured to be positioned in an ear (see Fig. 5), the conduit comprising:
an input port at the distal end configured to be received in an ear canal (see Fig. 5), the input port configured to receive a first liquid; an output port at the proximal end configured to be received in a middle ear (see Fig. 5), the output port configured to output the first liquid received in the input port (the inlet and outlet ports are openings in either side of the conduit through which fluid can flow); and
the inner surface extending from the input port to the output port (see Figs. 1-3 showing the conduit extending from between the ends of the device).
The limitation “the first inner radius, the second inner radius, the angle of the inner surface, the distal angle, the proximal angle, and the surface properties of the inner surface are selected such that the conduit is configured to allow the transport of the first liquid between the ports” is functional in nature because allowing the transport of the first liquid between the ports depends on the material properties of the liquid. Since these materials are not positively recited structural elements of the claim, it appears that the prior art structure inherently possesses the functionally defined limitations.
Regarding claim 147, Hageman discloses a device comprising:
a conduit comprising:
a proximal end, in the region of flange 2 (see Fig. 1),
a distal end, in the region of the edge 5, opposite the proximal end (see Fig. 1),
wherein the conduit has a first inner radius at a proximal end 2 (see Fig. 1) and a second inner radius at a distal end (in the region of the edge 5), such that the second inner radius is greater than the first inner radius (see Fig. 1);
an inner surface that is continuously curved from the proximal end to the distal end, the inner surface having an angle that varies from the proximal end to the distal end such that the inner surface forms a proximal angle at the proximal end and distal angle at the distal end (see col. 3, lines 54-58, disclosing that the tube can be “trumpet-shaped” or monotonic), the inner surface comprising surface properties (every surface has “surface properties” per se),
an outer surface connecting the proximal end to the distal end (see Fig. 1), and
a proximal flange 2 (see Fig. 1) disposed on the proximal end of the conduit.
The following limitations The following claim limitations are interpreted to cover the function, or intended use, of the device:
wherein the first inner radius, the second inner radius, the angle of the inner surface, the distal angle, the proximal angle, and the surface properties of the inner surface are selected such that the conduit is configured to:
allow entry of a first material to the distal end of the conduit, allow transport of the first material through the conduit along the inner surface toward the proximal end, and allow exit of the first material from the proximal end of the conduit, and
resist entry of a second material into the proximal end of the conduit;
wherein the Young-Laplace pressure for the first material at the distal end of the conduit is less than the Young-Laplace pressure for the second material at the proximal end of the conduit;
wherein at least one of the angle or the surface property of the inner surface vary to maintain a substantially constant or reducing Young-Laplace pressure of the first material from the distal end to the proximal end such that there is substantially no pinning of the first material from the distal end to the proximal end; […]
and wherein the sum of the advancing angle of the fourth material at the distal end and the distal angle is greater than 180 degrees.”
Although features of an apparatus may be recited functionally (see In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997)), apparatus claims cover what a device is, not what a device does. See Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.
In this case, Hageman teaches all the structural limitations of the claim. The manner in which multiple materials would be allowed into, or resisted out of, the conduit appears to be based on “the Young-Laplace pressures for” the materials – which itself is a function of the effective surface tension of the material in the conduit as well as the contact angle, which in turn depends on the property of the materials chosen in the conduit and the material of the tympanostomy tube. But these materials are not positively recited structural features of the claimed invention and the claims do not appear to contain any specific characteristics of the device, such as initial radii, initial flange angles, length of the lumen, surface functionalization, contact angles, etc., which appear to be necessary to optimizing the transport of materials into and out of the device according to Applicant’s disclosure (see, e.g., published specification at paras [0023], [0238], [0242]). Therefore, it appears that the prior art structure inherently possesses the functionally defined limitations.
It is noted Hageman does not appear to disclose that the first inner radius at the proximal end is greater than or equal to 0.1 mm and less than or equal to 0.75 mm.
Berry discloses an ear drum ventilation and drainage tube in the analogous art to Applicant’s invention, comprising a proximal end (at the flange 1’) which has a variable lumen diameter such that the lumen diameter at the proximal end is about 1.1 mm, i.e., a radius of about 0.55 mm (see col 2, lines 28-31).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Hageman so that the first inner radius at the proximal end is in the range of 0.1 mm and 0.75 mm, for example, about 0.55 mm, as a suitable dimension to accomplish the purposes of ventilation and drainage, with a reasonable expectation of success (see Berry at col. 2, lines 28-31).
Claims 108 and 112-116 are rejected under 35 U.S.C. 103 as being unpatentable over Hageman, in view of Berry, further in view of Aizenberg et al (U.S. Pub. 2015/012270 A1, hereinafter “Aizenberg”).
Regarding claims 108, 112-116, it is noted that Hageman, in view of Berry, does not appear to disclose that an advancing angle of the fourth material at the proximal end as the fourth material enters the proximal end is less than 90 degrees, and an advancing angle of the second material at the proximal end is as the second material enters the proximal end is greater than 90 degrees. And further, Hageman does not appear to disclose a portion of the conduit provided with a slippery surface comprising a partially or fully stabilized lubricating layer.
Aizenberg discloses that it was known at the time of the invention to provide a lubricating layer on a polymer to render a surface slippery (see para [0004], which results in a surface with substantially no pinning (see para [0234], disclosing that no pinning occurs due to the diffusion of the excess lubricant to the site and the formation of a lubricant bridge formed over the lubricated part). Aizenberg discloses that the lubricating liquid can be mineral oil (see para [0069]).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to provide a lubricating layer on the conduit, the layer being, for example, mineral oil, in order to maintain a desired lubrication even in the presence of water or other damage to the device (see Aizenberg at para [0243]). Further, it would have been obvious to place the lubricating layer in any area desired to the lubricated, such as the inner surface or the outer surface of the conduit, with a reasonable expectation of success. And further, a skilled artisan would have expected that such a lubricating layer would perform the function recited in claims 113 and 114, i.e., the lubricating liquid would decrease an advancing angle of the first material and increases an advancing angle of the second material, and would decrease an effective surface tension of the first material and increases an effective surface tension of the second material.
Claims 117, 118, 120, 121 and 143-145 are rejected under 35 U.S.C. 103 as being unpatentable over Hageman, in view of Berry (U.S. Pat. 4,775,370), further in view of Labib et al (U.S .Pub. 2016/0022497 A1, hereinafter “Labib”).
Regarding claims 117, 118, 120 and 121, it is noted that Hageman, in view of Berry, does not disclose the claimed surface properties.
Labib discloses a tube in the analogous art to Applicant’s invention, comprising a tube conduit having surface properties comprising a gradient or pattern on at least a portion of the conduit, which can be applied to the inner surface of the conduit, the outer surface of the conduit, the inner surface of the proximal flange, and the inner surface of the distal flange (see para [0147] disclosing that the conduit can have a patterning of the surface that liquid is exposed to, which is interpreted to include the inner surface of the conduit; and see also para [0098] disclosing that the surface may be provided with grooves, ridges, roughness, protrusions, recesses, holes, texturing, or any other form of irregularity).
Further, regarding claim 120, the grooves, ridges, roughness, protrusions, recesses, holes, texturing, or any other form of irregularity would appear to perform the claimed function of decreasing the effective surface tension of the first material when the first material is disposed on the gradient or pattern and increasing the effective surface tension of the second material when the second material is disposed on the gradient or pattern (it was previously noted that the first and second materials are not positively recited structural features of the claimed invention).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hageman, in order to have the claimed surface properties, in order to enhance the surface of the device when it is desired to dissolve drug from the tube (see Labib at para [0098], [0147].
Regarding claims 143-145, Hageman, in view of Berry, does not disclose the specific material of the conduit.
Labib discloses the device as described above, comprising the conduit having one or more of a porous material (see para [0023]) or grooves and ridges (see para [0098]); the conduit comprises one or more of biostable or bioabsorbable polymers (see para [0066]), silicone (see para [0064]), polyamides (see para [0064]), ethylene vinyl-acetate (see para [0064]), polyesters (see para [0227]), polytetrafluoroethylene (see para [0227]), polycaprolactone (see para [0066]), and polyglycolic acid (see para [0227]); and the conduit comprises Si (i.e., silicon; see silicone in para [0064], which is a polymer composed of repeating units of siloxane, which itself contains silicon).
A skilled artisan would have found it obvious at the time of the invention to modify the device Hageman to have the specific material properties described above, in order to enhance the device’s biostability, bioabsorbability, porosity and biocompatibility in the body with a reasonable expectation of success.
Claim 123 is rejected under 35 U.S.C. 103 as being unpatentable over Hageman, in view of Berry, further in view of Clopp et al (U.S. Pub. 2014/0094733 A1, hereinafter “Clopp”).
Regarding claim 123, it is noted that Hageman, in view of Berry, does not appear to disclose that the conduit comprises a flange disposed at or near the proximal end or the distal end of the conduit, and stimulus-responsive portion comprises the flange disposed at or near the proximal end or the distal end of the conduit; and wherein the flange is capable of transitioning between a first configuration and a second configuration in response to the stimulus, wherein the flange changes at least one of a size of the flange or a shape of the flange when transitioning between the first configuration and the second configuration.
Clopp discloses a tube for insertion into a patient’s ear, comprising a flange capable of transitioning between a first configuration and a second configuration in response to a stimulus, wherein the flange changes at least one of a size of the flange or a shape of the flange when transitioning between the first configuration and the second configuration (see Figs. 17-18 showing a flange that changes shape; and see para [0074] describing the tube being a taper shape in one configuration and having a flange 704 that expands into a self-anchoring shape when pushed into place in the ear).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Hageman to incorporate a stimulus-responsive portion comprising a flange disposed at or near the proximal end or the distal end of the conduit; and wherein the flange is capable of transitioning between a first configuration and a second configuration in response to the stimulus, wherein the flange changes at least one of a size of the flange or a shape of the flange when transitioning between the first configuration and the second configuration, in order to allow for safe insertion and self-anchoring of the tube device when placed into the ear (see para [0074] of Clopp), with a reasonable expectation of success.
Claims 124, 125 and 127 are rejected under 35 U.S.C. 103 as being unpatentable over Hageman, in view of Berry, further in view of Avior (U.S. Pat. 8,579,973 B2, hereinafter “Avior”).
Regarding claims 124, 125 and 127, it is noted that Hageman does not appear to disclose a stimuli responsive portion being a valve disposed within the conduit, the valve being capable of closing in response to the stimulus; such that the conduit has a first diameter in the first configuration, and the conduit has a second diameter in the second configuration; and the conduit is capable of transitioning between a first configuration and a second configuration in response to the stimulus, and the stimuli-responsive portion is disposed in a lumen defined by the inner surface and extending from the distal end to the proximal end, wherein the lumen is open to the fourth material in the first configuration and closed to the fourth material in the second configuration.
Avior discloses a tube device for placement in the ear canal, comprising an inner surface of a conduit of the tube device having a stimuli responsive portion in the form of a valve 6 (see Fig. 1) disposed within the conduit, the valve being capable of closing in response to the stimulus (such as pressure; see col. 15, line 49 referring to the valve 6 as a “pressure actuated valve”); such that when the valve is open, the conduit has a first diameter in the first configuration, and when the valve is closed, the conduit has a second diameter in the second configuration; and the stimuli-responsive portion is disposed in a lumen defined by the inner surface and extending from the distal end to the proximal end, wherein the lumen is open to a material in the first configuration (when the valve is open) and closed to the material in the second configuration (when the valve is closed).
A skilled artisan would have found it obvious at the time of the invention to modify the inner surface of the conduit to comprise a stimuli responsive portion, in the form of a valve disposed within the conduit, the valve being capable of closing in response to the stimulus; such that the conduit has a first diameter in the first configuration, and the conduit has a second diameter in the second configuration; and the stimuli-responsive portion is disposed in a lumen defined by the inner surface and extending from the distal end to the proximal end, wherein the lumen is open to the fourth material in the first configuration and closed to the fourth material in the second configuration, thus providing enhanced drainage and controlled ventilation (see Avior at col. 5, lines 2-4) with a reasonable expectation of success.
Claim 128 is rejected under 35 U.S.C. 103 as being unpatentable over Hageman, in view of Berry, further in view of Johnson et al (U.S. Pat. 8,122,892 B2, hereinafter “Johnson”).
Regarding claim 128, it is noted that Hageman discloses that the conduit comprises a tube, but does not appear to disclose that the device further comprises a second conduit, the second conduit comprising a tube having a proximal end and a distal end, the second conduit proximal end disposed near the proximal end of the conduit and the second conduit distal end disposed near the distal end of the conduit.
Johnson discloses a device for insertion into the ear, the device having a first conduit and a second conduit (see conduits 28 in Fig. 7) through which fluids can flow from a distal end 23 of the device to a proximal end 22, such that the second conduit has a distal end and a proximal end corresponding to the distal end 23 and proximal end 22 (see Fig. 7 and col. 9, lines 8-23).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Hageman to incorporate a second conduit, the second conduit comprising a tube having a proximal end and a distal end, the second conduit proximal end disposed near the proximal end of the conduit and the second conduit distal end disposed near the distal end of the conduit, in order to provide an additional means for draining fluid from the ear with ease and simplicity (see Johnson at col.9, lines 20-23), with a reasonable expectation of success.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered. Where persuasive, the rejections have been withdrawn.
Applicant’s arguments regarding the rejections under 35 U.S.C. 112(a), for lacking enablement, have been considered but are not persuasive. Regarding claims 105 and 147, the rejections have been maintained because the specification does not reasonably provide enablement for any conduit within the claimed range performing the functional limitations of the claims (such as allowing entry of some materials and/or resisting entry of other materials). Applicant pointed to Fig. 12A for alleged support (see Remarks, pg. 13), but this figure is disclosed by Applicant to show “optimized conduits of various radii compared to cylindrical and conical conduits” (see published specification at para [0024]). But the specification makes no mention of the characteristics of these so-called “optimized conduits”, much less that one of them is the claimed conduit. Moreover, the specification does not explain that an embodiment within this range of values would necessarily have the claimed fluid flow characteristics.
Further, Applicant cited a teaching of an embodiment having a first inner radius of 0.144 mm (see Remarks, pg. 13), but the claimed invention recites a range of radii, not a single value. Moreover, the specification does not explain that any embodiment within this range of values would have the claimed fluid flow characteristics.
Further, claims 105 and 147 recite that “the sum of the advancing angle of the fourth material at the distal end and the distal angle is greater than 180 degrees.” The specification does not reasonably provide enablement for any conduit having these characteristics being able to perform the functional limitations recited in the claims (such as allowing entry of some materials and/or resisting entry of other materials).
Applicant’s arguments regarding the rejections under 35 U.S.C. 112(a) as lacking written description have been considered, but are not persuasive.
Regarding claims 105 and 147, Applicant’s specification makes no mention of this configuration as it relates to the fourth material, i.e., it makes no mention of preventing or eliminating pinning of a fourth material from the proximal end to the distal end. Applicant cited Fig. 8E as allegedly providing support (see Remarks, pg. 15). But Fig. 8E does not show a conduit having the curved inner surface as claimed. The published specification at para [0228] refers to Fig.8E as showing “an exemplary embodiment”, but no other detail is provided as to the structural characteristics of this embodiment, much less that this embodiment is the one claimed.
Regarding claim 106, Applicant’s specification, as originally filed, does not disclose the difference of the Young-Laplace pressures of the second and fourth materials at the proximal end of the conduit. Applicant’s arguments cite paras [0139], [0276], [0270] and Fig. 13 (see Remarks, pg. 17), but none of these paragraphs or figures mention the proximal end of the conduit specifically having the claimed function.
Regarding claim 108, Examiner reiterates that the specification lacks mention of the conduit is sized or shaped to fulfill both of the recited conditions at the same time (i.e., the condition of the advancing angle of the fourth material and the advancing angle of the second material). Various paragraphs were alleged by Applicant to disclose the claimed invention (see Remarks, pg. 18), but none of these paragraphs do so with the specificity of the claimed invention.
Regarding claim 129, Examiner reiterates that the original disclosure makes no mention of the comparison of the Young-Laplace pressure for the third material and second material at the proximal end of the conduit.
Regarding claim 134, Examiner reiterates that the original specification makes no mention of Young-Laplace pressure for the first material at the proximal end of the conduit. Instead, the specification mentions “breakthrough pressure” of the first material at the proximal end (see published specification at para [0077]).
Further, claim 134 was rejected for reciting new matter of “the first inner radius, the second inner radius, the angle of the inner surface, the distal angle, the proximal angle, and the surface properties of the inner surface are selected such that the conduit is configured to allow entry of the first material” in the manner claimed (the original disclosure makes no mention of the aforementioned specific characteristics/properties of the inner surface being selected to carry out the claimed function).
Regarding claim 135, Examiner reiterates that the original disclosure makes no mention of the comparison of the Young-Laplace pressure for the first material and second material at the distal end of the conduit.
Regarding claim 136, Examiner reiterates that the original disclosure states “substantially no pinning of the first material from the proximal end to the distal end”, which is much broader than the claimed recitation of “at least one of an angle or a surface property of the inner surface vary to maintain a substantially constant or reducing Young- Laplace pressure of the first material from the distal end to the proximal end or wherein at least one of an angle or a surface property of the inner surface varies such that there is substantially no pinning of the first material from the distal end to the proximal end”.
Regarding claim 142, Examiner reiterates that the specification makes no mention that the list of materials complies with the requirement of amended independent claim 105, which recites that “the Young-Laplace pressure for the fourth material at the proximal end of the conduit is less than the Young-Laplace pressure for the second material at the proximal end of the conduit.” Applicant alleged that the list of materials disclosed in para [0148] satisfied the written description requirement (see Remarks, pg. 20), but this list does not include, let alone compare, the Young-Laplace pressures of any of these materials.
Regarding claim 143, Examiner reiterates that Applicant’s specification makes no mention of varying the angle or surface property of the inner surface to maintain a substantially constant or reducing Young-LaPlace pressure of the first material from the proximal end to the distal end (the specification only makes mention of “the at least one of an angle or a surface property of the inner surface vary to maintain a substantially constant or reducing Young-Laplace pressure of the first material from the distal end to the proximal end.”)
Applicant’s arguments regarding the rejections under 35 U.S.C. 112(b) have been considered, but are not persuasive.
Claim 105 recites a conduit “configured to allow entry of a fourth material… allow transport of the fourth material… and allow exit of the fourth material from the distal end of the conduit…and “resist entry of a second material into the proximal end the conduit”. But the claims do not recite a first material or third material., and so it is not clear what is meant by a “fourth material”. Thus, the scope of the protection sought by Applicant is not clear. In the Remarks, Applicant did not explain what was meant by these claim terms.
Claims 105, 106, 129, 132, 134, 135, 138 and 147 recite a “Young-Laplace pressure of” the first, second, third or fourth materials. These claims were previously rejected under 35 U.S.C. 112(b) for lacking definiteness. Applicant specified in the Remarks that the “Young-Laplace pressure of a [first, second, third or fourth] material” means the pressure difference across the meniscus of the fluid (see Remarks, pgs. 22-23).
Regarding claim 105, 136 and 147, Examiner reiterates that the claims are not definite for the reasons cited above. Applicant responded to this rejection by stating that a person of ordinary skill in the art would understand the meaning of the limitations exactly as they are written (see Remarks, pg. 23), but did not otherwise address the rejection.
Applicant’s arguments regarding the rejections under 35 U.S.C. 103 were considered, but are not persuasive.
Applicant argued that Hageman does not disclose a continuously curved shape from the proximal end to the distal end (see Remarks, pg. 27). Applicant argued that a person of ordinary skill in the art would conclude that Hageman’s disclosure of a “trumpet-shaped [curve], in other words it widens out in a regular monotonically curved shape from the flange” does not necessarily mean a continuously curved shape. Applicant further argued that Hageman does not disclose that the other side of the grommet is continuously curved and that the shape of the external surface of the grommet does not necessarily correspond to its internal surface (see Remarks, pg. 28).
First, Hageman’s figures show the continuously curved shape, along with a three-dimensional view showing the interior of the grommet—one that a person of ordinary skill in the art would clearly understand matches its exterior shape.
Moreover, the plain meaning of “monotonically” is consistently increasing or decreasing (in this context, it refers to consistent widening). Further, a skilled artisan would envision a “trumpet-shape” to be a continuously flaring shape, not a shape that discontinuously tapers.
Finally, the claims do not require that the device have a continuously curved shape on the other side of the flange; rather, the claims require that the continuously curved shape extend “from the proximal end to the distal end”. In Hageman, the flange is at the proximal end, and an edge 5 is at the distal end, with the shape of the grommet being continuously curved from the proximal end to the distal end.
Applicant argued that Examiner has not explained how the shape of Hageman inherently possesses the claimed function, citing MPEP 2114 (see Remarks, pg. 28). In this case, the prior art inherently possesses the claimed functional limitations because the prior art has the same structural characteristics as the claimed invention, and a skilled artisan would not expect the claimed invention to function any differently than the prior art. As noted in the above rejection, the manner in which a fourth material and a second material would be respectively allowed into, or resisted out of, the conduit appears to be based on “the Young-Laplace pressures for” the materials – which itself is a function of the effective surface tension of the material in the conduit as well as the contact angle, which in turn depends on the property of the materials in the conduit and the material of the tympanostomy tube. But these materials are not positively recited structural features of the claimed invention and the claims do not appear to contain any specific characteristics of the device, such as initial radii, initial flange angles, length of the lumen, surface functionalization, contact angles, etc., which appear to be necessary to optimizing the transport of materials into and out of the device according to Applicant’s disclosure (see, e.g., published specification at paras [0023], [0238], [0242]).
The declaration under 37 CFR 1.132, filed 07/25/2025 (hereinafter “Declaration”) has been considered.
The Declaration states that the co-inventor1 of the instant application has “performed numerical modeling and experiments to discover that, as described in the instant application, “tubes with a curved, optimized design based on tuning the interplay of Young-Laplace equation parameters provide an exceptional selectivity for a desired fluid”2. The Declaration describes non-limiting examples of embodiments described in the instant specification3. The Declaration does not consider Hageman to disclose the claimed invention non-limiting examples of embodiments described in the instant specification4, relying on simulations5 cited in a previous declaration (dated 11/27/2024) that does not appear to have bearing on the present rejection. The Declaration appeared to make numerous and varied conclusions about how fluid would, or could, flow through the tube of Hageman based on assumptions of the properties of the Hageman device that were not actually described in the Hageman disclosure.
For at least these reasons, the rejections are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
11/03/2025
1 Declaration item 1
2 Declaration item 8
3 Declaration items 9-11
4 Declaration items 12-13
5 Declaration item 14