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 .
DETAILED ACTION
Acknowledgement is made of applicant’s amendment which was received by the office on November 5, 2025. Claims 1,7-8,10-17,19,21-40 are currently pending and under examination.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1,7-8,10-17,19 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0348470 to D’Ambrosio et al. (Ambrosio) in view of JP 2010233883 to Takahiro (Takahiro) (all previously cited)
In reference to at least claim 1
Ambrosio discloses an optical sensor assembly (e.g. sensing assembly 1900, Fig. 9) for use in a blood pump assembly (e.g. blood pump assembly 101, Figs. 1-2, 8), the optical sensor assembly comprising: a visor having an inner surface and an outer surface (e.g. sensor visor 1922,2022,1222,1122 has an inner surface and an outer surface, Figs. 9-12); a support jacket (e.g. jacket 2027, 1127, 1227 and sensor head 1121, 2021, 1221 together form the claimed “support jacket” and include a “cavity”, Figs. 10-12), an optical sensor (e.g. optical sensing components within sensor 1020, 2020, Figs. 9-10, para. [0067]), positioned within the cavity (e.g. optical sensing components within sensor 1020, 2020, 1120, 1220 are positioned within the cavity defined by jacket 2027, 1127, 1227 and sensor head 1121, 2021, 1221, Figs. 9-12); and a silicone composition positioned within the cavity (e.g. layer 1120, 1202, Figs. 11-12; includes silicone, para. [0072]) , wherein the silicone composition coats the second surface of the optical sensor (e.g. layer 1120, 1202 coats a second surface of the sensor, Figs. 11-12, para. [0069], [0071]-[0073]).
However, Ambrosio does not explicitly the support jacket in contact with an inner surface of the visor along a length of the support jacket.
Takahiro, in the same field of endeavor, discloses a catheter used as an aortic balloon pump that includes on a distal end of the catheter a sensor assembly that includes a “support jacket” (e.g. short tube 37 “support jacket”, Figs. 5,7) defining a “cavity” (e.g. filling space 38 defines the “cavity” of the short tube 37 “support jacket”, Figs. 5,7, para. [0036]) that is in contact within an inner surface of the catheter “visor” along a length of the support jacket (e.g. short tube 37 is in contact with an inner surface of the catheter, Figs. 5,7, para. [0037]) and an optical sensor positioned within the cavity (e.g. sensor 40 positioned within the filling space 38, Figs. 5,7, para. [0036],[0040]-[0042]) so the sensor is not easily affected by deformation (e.g. para. [0041]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor assembly of Ambrosio to include a short tube on an inner surface of the visor that is part of the “support jacket” and defines a filling space “cavity” with the optical sensor positioned within the filing space as taught by Takahiro, to provide a sensor arrangement that is not easily affect by deformation ( ‘883, para. [0041]).
In reference to at least claims 7-8
Ambrosio modified by Takahiro renders obvious an assembly according to claim 1. Ambrosio further discloses the transmission fiber being coated with a protective coating including a polymer such as a polyimide (e.g. para. [0055]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the assembly of Ambrosio to have the support jacket include a polymer such as a polyimide tube to provide the support jacket with a material that will provide protection to the transmission fiber. Additionally, it would have been obvious to one having ordinary skill in the art at the time of the invention to make the support jacket out of polymer such as a polyimide tube, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 10
Ambrosio modified by Takahiro renders obvious an assembly according to claim 1. Ambrosio further discloses wherein the silicone composition is configured to be cured within the cavity (e.g. deposited…as a gel and cured, para. [0015], [0070], [0072], also include gel or other material proximal the sensor membrane..can partially or fully fill the cavity, para. [0074]).
In reference to at least claim 11
Ambrosio modified by Takahiro renders obvious an assembly according to claim 1. Ambrosio further discloses wherein the silicone composition is configured to protect the second surface of the optical sensor from damage due to forces exerted on the optical sensor when the blood pump assembly is used for percutaneous insertion into a patient (e.g. protect sensor from damage when pump assembly is inserted, abstract, para. [0069], [0070], [0072]-[0074]).
In reference to at least claim 12
Ambrosio modified by Takahiro renders obvious an assembly according to claim 1. Ambrosio further discloses wherein the cavity is configured to be filled between about 30% to about 90% with the silicone composition selected to protect the optical sensor from damage due to forces exerted on the optical sensor during the percutaneous insertion of the blood pump assembly into a patient (e.g. protect sensor from damage when pump assembly is inserted, abstract; protects from damage due to flow of blood over the membrane, para. [0069], [0070], [0072]-[0074], [0076]; can partially or fully fill the cavity to ensure there is no blood ingress, para. [0074], therefore the cavity is filled “between about 30% to about 90%”).
In reference to at least claim 13
Ambrosio modified by Takahiro renders obvious an assembly according to claim 1. Ambrosio further discloses wherein the optical sensor is a silicone optical sensor (e.g. optical sensing components within sensor 1020, 2020,1120,1220 Figs. 9-12 contains layer 1120, 1202 coats a silicon composition on the optical sensor, Figs. 11-12, para. [0069], [0071]-[0073]).
In reference to at least claim 14
Ambrosio discloses a pump comprising a motor (e.g. blood pump motor 110, Figs. 1, 4-5, 8) and a rotor (e.g. impeller hub 113, Figs. 1,4-5,8, para. [0049]-[0050]) the rotor having at least one blade (e.g. impeller blade 140, Figs. 1,4-5,8, para. [0052], [0064],[0077]); a blood pump housing surrounding the at least one blade (e.g. blood pump housing component 103 surrounds the impeller blade, Figs. 1-2,5-6,8, impeller blade positioned at least in part in the blood pump housing component para. [0050], [0065], [0080]); a cannula extending distal of the pump housing (e.g. cannula assembly 102, Fig. 1, para. [0048], [0078]); an atraumatic extension extending distally from the cannula (e.g. atraumatic extension 108, Fig. 1, para. [0078]); and an optical sensor assembly (e.g. sensing assembly 1900, Fig. 9), wherein the optical sensor assembly comprises: a visor having an inner surface and an outer surface (e.g. sensor visor 1922,2022,1222,1122 has an inner surface and an outer surface, Figs. 9-12); a support jacket defining a cavity (e.g. jacket 2027, 1127, 1227 and sensor head 1121, 2021, 1221, Figs. 10-12), wherein the support jacket is in contact with the inner surface of the visor (e.g. jacket 2027, 1127, 1227 is in contact with the inner surface of the visor via contact made via glue, 1128, 2028, 1228, Figs. 10-12 and the sensor head 1920, 1121, 2021, 1221 which is part of the claimed “support jacket” is also in contact with an inner surface of the visor 1922,2022,1222,1122, Figs. 9-12); an optical sensor (e.g. optical sensing components within sensor 1020, 2020, Figs. 9-10, para. [0067]) positioned within the cavity (e.g. optical sensing components within sensor 1020, 2020, 1120, 1220 is positioned within the cavity defined by jacket 2027, 1127, 1227 and sensor head 1121, 2021, 1221, Figs. 9-12); and a silicone composition positioned within the cavity (e.g. layer 1120, 1202, Figs. 11-12; includes silicone, para. [0072]) , wherein the silicone composition coats the optical sensor (e.g. layer 1120, 1202 coats a second surface of the sensor, Figs. 11-12, para. [0069], [0071]-[0073]), wherein the optical sensor assembly is attached to the pump housing by the visor (e.g. visor attached to pump housing, Fig. 8, para. [0066]). However, Ambrosio does not explicitly the support jacket in contact with an inner surface of the visor along a length of the support jacket.
Takahiro, in the same field of endeavor, discloses a catheter used as an aortic balloon pump that includes on a distal end of the catheter a sensor assembly that includes a “support jacket” (e.g. short tube 37 “support jacket”, Figs. 5,7) defining a “cavity” (e.g. filling space 38 defines the “cavity” of the short tube 37 “support jacket”, Figs. 5,7, para. [0036]) that is in contact within an inner surface of the catheter “visor” along a length of the support jacket (e.g. short tube 37 is in contact with an inner surface of the catheter, Figs. 5,7, para. [0037]) and an optical sensor positioned within the cavity (e.g. sensor 40 positioned within the filling space 38, Figs. 5,7, para. [0036],[0040]-[0042]) so the sensor is not easily affected by deformation (e.g. para. [0041]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor assembly of Ambrosio to include a short tube on an inner surface of the visor that is part of the “support jacket” and defines a filling space “cavity” with the optical sensor positioned within the filing space as taught by Takahiro, to provide a sensor arrangement that is not easily affect by deformation ( ‘883, para. [0041]).
In reference to at least claim 15
Ambrosio modified by Takahiro renders obvious an assembly according to claim 14. Ambrosio further discloses wherein the optical sensor is a silicone optical sensor (e.g. optical sensing components within sensor 1020, 2020,1120,1220 Figs. 9-12 contains layer 1120, 1202 coats a silicon composition on the optical sensor, Figs. 11-12, para. [0069], [0071]-[0073]).
In reference to at least claim 16
Ambrosio modified by Takahiro renders obvious an assembly according to claim 14. Ambrosio further discloses that the silicone composition can have a range of desired properties (e.g. silicone layer can have a desired thickness based on the desired properties of the layer(s), para. [0070]). It would have been an obvious matter of design choice to modify the Ambrosio reference, to have at least one of a viscosity of between about 2,000 cP and about 8,000 cP, a rigidity threshold value of between about 0.5N and about 1.5N, an adhesion strength threshold value of about between about 50N and about 150N, and a minimum tack energy per unit area of the silicone composition of between about 3,500 J/cm2 and about 7,500 J/cm2, since applicant has not disclosed that having viscosity of between about 2,000 cP and about 8,000 cP, a rigidity threshold value of between about 0.5N and about 1.5N, an adhesion strength threshold value of about between about 50N and about 150N, and a minimum tack energy per unit area of the silicone composition of between about 3,500 J/cm2 and about 7,500 J/cm2 solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of a viscosity of between about 2,000 cP and about 8,000 cP, a rigidity threshold value of between about 0.5N and about 1.5N, an adhesion strength threshold value of about between about 50N and about 150N, and a minimum tack energy per unit area of the silicone composition of between about 3,500 J/cm2 and about 7,500 J/cm2, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.05.
In reference to at least claim 17
Ambrosio modified by Takahiro renders obvious an assembly according to claim 14. Ambrosio further discloses wherein the silicone composition is configured to be cured within the cavity (e.g. deposited…as a gel and cured, para. [0015], [0070], [0072], also include gel or other material proximal the sensor membrane..can partially or fully fill the cavity, para. [0074]).
In reference to at least claim 19
Ambrosio modified by Takahiro renders obvious an assembly according to claim 14. Ambrosio further discloses wherein the silicone composition coats a measuring surface of the optical sensor (e.g. sensor membrane 2023, 1223, 1123 is coated with silicone thin layer 1102, 1202, Figs. 10-12, para. [0070], [0071]-[0073], [0076]).
In reference to at least claim 21
Ambrosio teaches a blood pump assembly having a sensor and a sensor shield which discloses a method of manufacturing an optical sensor assembly (e.g. sensing assembly 1900, Fig. 9) for use in a blood pump assembly (e.g. blood pump assembly 101, Figs. 1-2, 8), the method comprising: positioning an optical sensor within a support jacket (e.g. (e.g. optical sensing components within sensor 1020, 2020, 1120, 1220 are positioned within a cavity defined by jacket 2027, 1127, 1227 and sensor head 1121, 2021, 1221, Figs. 10-12), wherein the support jacket defines a cavity (e.g. jacket 2027, 1127, 1227 and sensor head 1121, 2021, 1221 define a cavity, Figs. 10-12); positioning a silicone composition within the cavity (e.g. layer 1120, 1202, Figs. 11-12; includes silicone, para. [0072]) such that the silicone composition coats a surface of the optical sensor (e.g. layer 1120, 1202 coats a surface of the sensor, Figs. 11-12, para. [0069], [0071]-[0073]); curing the silicone composition (e.g. deposited…as a gel and cured, para. [0015], [0070], [0072]); and attaching the visor to a pump housing of a blood pump (e.g. visor attached to pump housing using an adhesive, epoxy, weld or other structure or material, Fig. 8, para. [0060],[0066]).
However, Ambrosio does not explicitly disclose the support jacket in contacting an inner surface of the visor along a length of the support jacket or the.
Takahiro, in the same field of endeavor, discloses a catheter used as an aortic balloon pump that includes on a distal end of the catheter a sensor assembly that includes a “support jacket” (e.g. short tube 37 “support jacket”, Figs. 5,7) defining a “cavity” (e.g. filling space 38 defines the “cavity” of the short tube 37 “support jacket”, Figs. 5,7, para. [0036]) that is in contact within an inner surface of the catheter “visor” along a length of the support jacket (e.g. short tube 37 is in contact with an inner surface of the catheter, Figs. 5,7, para. [0037]) and an optical sensor positioned within the cavity (e.g. sensor 40 positioned within the filling space 38, Figs. 5,7, para. [0036],[0040]-[0042]) so the sensor is not easily affected by deformation (e.g. para. [0041]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ambrosio to include contacting a short tube on an inner surface of the visor that is part of the “support jacket” and defines a filling space “cavity” with the optical sensor positioned within the filing space as taught by Takahiro, to provide a sensor arrangement that is not easily affect by deformation ( ‘883, para. [0041]).
In reference to at least claim 22
Ambrosio modified by Takahiro renders obvious a method according to claim 21. Ambrosio further discloses wherein the silicone composition is configured to protect a measuring surface of the optical sensor (e.g. sensor membrane 2023, 1223, 1123 is coated with silicone thin layer 1102, 1202, Figs. 10-12, para. [0070], [0071]-[0073], [0076]) for use in a blood pump assembly from shear forces exerted on the optical sensor by blood during percutaneous insertion of the blood pump assembly into a patient (e.g. protect sensor from damage when pump assembly is inserted, abstract, para. [0069], [0070], [0072]-[0074]).
In reference to at least claim 23
Ambrosio modified by Takahiro renders obvious a method according to claim 22. Ambrosio further discloses wherein the measuring surface is a diaphragm (e.g. sensor membrane 2023, 1223, 1123 is coated with silicone thin layer 1102, 1202, Figs. 10-12, para. [0070], [0071]-[0073], [0076], sensor membrane is preferably thin, para. [0054]).
Claim(s) 24-26,30-32 and 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0348470 to D’Ambrosio et al. (Ambrosio) in view of JP 2010233883 to Takahiro (Takahiro) as applied to claims 1,14 and 21 further in view of US 2018/0118939 to Zou (Zou) (all references previously cited). ***Claims 38-40 are rejected first as they are the claims from which all other claims depend.
In reference to at least claim 38
Ambrosio modified by Takahiro renders obvious a method according to claim 1. Ambrosio further discloses one or more protective layers that include silicone “a first silicone component and a second silicone component” (e.g. para. [0007], [0007], [0070]) but does not explicitly teach the silicone layer(s) including a plasticizer.
Zou teaches a dual temperature curable silicone compositions, methods of manufacture and articles prepared therefrom which discloses known components for use in the formulation of curable silicones including plasticizers (e.g. para. [0020]-[0021]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the assembly of Ambrosio modified by Takahiro to include plasticizers as such components within curable silicone mixtures is known, as taught by Zou, and would provide a curable silicone with properties tailored for the desired use (e.g. ‘939, para. [0002]). Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to make the silicone components and plasticizers each being different from each other since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 30
Ambrosio modified by Takahiro and Zou renders obvious an assembly according to claim 38. Zou further discloses the use of an activator as part of the silicone composition (e.g. platinum-containing catalyst, peroxide catalyst, abstract, para. [0003], [0015]-[0019], [0024]-[0029]; mixture that includes a silicon oxide, oxide, metal, metal oxide, polymer or any other coating commonly used in the processing of MEMS, para. [0070]).
In reference to at least claim 31
Ambrosio modified by Takahiro and Zou renders obvious an assembly according to claim 30. Zou further discloses the use of an activator as part of the silicone composition (e.g. platinum-containing catalyst, peroxide catalyst, abstract, para. [0003], [0015]-[0019], [0024]-[0029]; mixture that includes a silicon oxide, oxide, metal, metal oxide, polymer or any other coating commonly used in the processing of MEMS, para. [0070]). It would have been obvious to one having ordinary skill in the art at the time of the invention to make the activator comprise a fumed silica since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 32
Ambrosio modified by Takahiro and Zou renders obvious an assembly according to claim 38. Zou further discloses the use of a metallic catalyst (e.g. platinum-containing catalyst, peroxide catalyst, abstract, para. [0003], [0015]-[0019], [0024]-[0029]; mixture that includes a silicon oxide, oxide, metal, metal oxide, polymer or any other coating commonly used in the processing of MEMS, para. [0070]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the assembly of Ambrosio to include the silicone component including a platinum-based catalyst, as taught by Zou, and would provide a curable silicone with properties tailored for the desired use (e.g. ‘939, para. [0002]). Additionally, it would have been obvious to one having ordinary skill in the art at the time of the invention to make the second silicone component comprise a platinum-based catalyst, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 39
Ambrosio modified by Takahiro renders obvious a method according to claim 14. Ambrosio further discloses one or more protective layers that include silicone “a first silicone component and a second silicone component” (e.g. para. [0007], [0007], [0070]) but does not explicitly teach the silicone layer(s) including a plasticizer.
Zou teaches a dual temperature curable silicone compositions, methods of manufacture and articles prepared therefrom which discloses the use of components known for use in the formulation of curable silicones including plasticizers (e.g. para. [0020]-[0021]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the assembly of Ambrosio modified by Takahiro to include plasticizers as such components within curable silicone mixtures is known, as taught by Zou, and would provide a curable silicone with properties tailored for the desired use (e.g. ‘939, para. [0002]). Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to make the silicone components and plasticizers each being different from each other since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 40
Ambrosio modified by Takahiro renders obvious a method according to claim 21. Ambrosio further discloses one or more protective layers that include silicone “a first silicone component and a second silicone component” (e.g. para. [0007], [0007], [0070]) but does not explicitly teach the silicone layer(s) including a plasticizer.
Zou teaches a dual temperature curable silicone compositions, methods of manufacture and articles prepared therefrom which discloses the use of components known for use in the formulation of curable silicones including plasticizers (e.g. para. [0020]-[0021]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the assembly of Ambrosio modified by Takahiro to include plasticizers as such components within curable silicone mixtures is known, as taught by Zou, and would provide a curable silicone with properties tailored for the desired use (e.g. ‘939, para. [0002]). Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to make the silicone components and plasticizers each being different from each other since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 24
Ambrosio modified by Takahiro and Zou renders obvious a method according to claim 40. Ambrosio further discloses making the silicone composition , wherein the method of making the silicone composition comprises: mixing a first silicone component and a plasticizer to form a first silicone mixture (e.g. mixture that includes a silicon oxide, oxide, metal, metal oxide, polymer or any other coating commonly used in the processing of MEMS, para. [0070]); mixing a second silicone component and the plasticizer to form a second silicone mixture (e.g. mixture that includes a silicon oxide, oxide, metal, metal oxide, polymer or any other coating commonly used in the processing of MEMS, para. [0070]); combining the first silicone mixture and the second silicone mixture to make the silicone composition (e.g. mixture that includes a silicon oxide, oxide, metal, metal oxide, polymer or any other coating commonly used in the processing of MEMS, para. [0070]) but does not explicitly teach vacuum degassing the silicone composition. It was well known in the art before the effective filing date of the invention to use a vacuum degassing for removing air as evidence by Zou (e.g. para. [0022]). Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Ambrosio to include vacuum degassing the silicone composition to remove air bubbles from the composition and to cause the silicone composition to tightly adhere to the sensor surface.
In reference to at least claim 25
Ambrosio modified by Takahiro and Zou renders obvious a method according to claim 24. Zou further discloses the use of an activator as part of the silicone composition (e.g. platinum-containing catalyst, peroxide catalyst, abstract, para. [0003], [0015]-[0019], [0024]-[0029]) mixture that includes a silicon oxide, oxide, metal, metal oxide, polymer or any other coating commonly used in the processing of MEMS, para. [0070]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the assembly of Ambrosio to include the silicone component including an activator, as taught by Zou, and would provide a curable silicone with properties tailored for the desired use (e.g. ‘939, para. [0002]). Additionally, it would have been obvious to one having ordinary skill in the art at the time of the invention to make the first silicone component an activator, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 26
Ambrosio modified by Takahiro and Zou renders obvious a method according to claim 24. Zou further discloses the use of a platinum-based catalyst (e.g. platinum-containing catalyst, peroxide catalyst, abstract, para. [0003], [0015]-[0019], [0024]-[0029]) mixture that includes a silicon oxide, oxide, metal, metal oxide, polymer or any other coating commonly used in the processing of MEMS, para. [0070]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the assembly of Ambrosio to include the silicone component including a platinum-based catalyst, as taught by Zou, and would provide a curable silicone with properties tailored for the desired use (e.g. ‘939, para. [0002]). Additionally, it would have been obvious to one having ordinary skill in the art at the time of the invention to make the second silicone component comprise a platinum-based catalyst, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
Claim(s) 27-29 and 33-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0348470 to D’Ambrosio et al. (Ambrosio) in view of JP 2010233883 to Takahiro (Takahiro) and US 2018/0118939 to Zou (Zou) as applied to claims 24,38 and 39 further in view of US 2017/0369706 to Coenen et al. (Coenen) (all references previously cited).
In reference to at least claims 27 and 33
Ambrosio modified by Takahiro and Zou renders obvious an assembly and method according to claims 24 and 38 but does not explicitly teach the first or second plasticizer being a silicone oil plasticizer.
Coenen teaches a silicone elastomer, composition and optical coupling element which discloses an optical coupling element that is arranged between a sensor in which the optical coupling element contains a silicone elastomer “silicone component” with a plasticizer that can include an oil or oil blend such as a silicone oil (e.g. abstract, para. [0002], [0008], [0013], [0016]) which allows the sensor to maintain good optical properties (e.g. para. [0005]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the assembly or method of Ambrosio modified by Takahiro and Zou to include the first or second plasticizer being a silicone oil plasticizer as taught by Coenen to provide an optical sensor that maintains excellent optical properties over lifetime usage.
In reference to at least claims 28,34 and 36
Ambrosio modified by Takahiro and Zou renders obvious an assembly and method according to claims 24 and 38-39 but does not explicitly teach wherein a ratio of the first silicone component to the first plasticizer in the silicone composition is between about 1:4 and about 4:1 and a ratio of the second silicone component to the second plasticizer in the silicone composition is between about 1:4 and about 4:1.
Coenen teaches a silicone elastomer, composition and optical coupling element which discloses an optical coupling element that is arranged between a sensor in which the optical coupling element contains a silicone elastomer “silicone component” with a plasticizer that can include an oil or oil blend such as a silicone oil (e.g. abstract, para. [0002], [0008], [0013], [0016]) which allows the sensor to maintain good optical properties (e.g. para. [0005]). Coenen further discloses that a very high percentage by weight of the plasticizer component, e.g. at least 20% of the total weight, at least 30%, or at least 40% or at least 50% or at least 60%, further provides the advantage of maintaining good optical properties (e.g. para. [0017], [0020], [0027]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the assembly or method of Ambrosio modified by Takahiro and Zou to include a very high percentage by weight of the plasticizer component such as a ratio of 1:2 or above as taught by Coenen to provide an optical sensor that maintains excellent optical properties over lifetime usage.
In reference to at least claims 29 and 35
Ambrosio modified by Takahiro, Zou and Coenen renders obvious an assembly and method according to claims 28 and 34. Coenen further discloses wherein a ratio of the first silicone component to the second silicone component to a total of the first plasticizer and the second plasticizer in the silicone composition is between about 1:1:8 and about 2:2:1 (e.g. a very high percentage by weight of the plasticizer component, e.g. at least 20% of the total weight, at least 30%, or at least 40% or at least 50% or at least 60%, further provides the advantage of maintaining good optical properties, para. [0017], [0020], [0027]).
In reference to at least claim 37
Ambrosio modified by Takahiro and Zou renders obvious an assembly according to claim 39 but does not explicitly teach wherein a ratio of the first silicone component to the second silicone component to a total of the first plasticizer and the second plasticizer in the silicone composition is between about 1:1:8 and about 2:2:1
Coenen teaches a silicone elastomer, composition and optical coupling element which discloses an optical coupling element that is arranged between a sensor in which the optical coupling element contains a silicone elastomer “silicone component” with a plasticizer that can include an oil or oil blend such as a silicone oil (e.g. abstract, para. [0002], [0008], [0013], [0016]) which allows the sensor to maintain good optical properties (e.g. para. [0005]). Coenen further discloses that a very high percentage by weight of the plasticizer component, e.g. at least 20% of the total weight, at least 30%, or at least 40% or at least 50% or at least 60%, further provide the advantage of maintain the good optical properties (e.g. para. [0017], [0020], [0027]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the assembly or method of Ambrosio modified by Takahiro and Zou to include a very high percentage by weight of the plasticizer component such as a ratio 1:1:8 as taught by Coenen to provide an optical sensor that maintains excellent optical properties over lifetime usage.
Response to Arguments
Applicant's arguments filed 11/5/2025 have been fully considered but they are not persuasive. It is noted that the rejections have been updated in view of the claim amendment which removed the “optical fiber” language to clarify what is being interpreted as the “optical sensor”, see rejections above.
Applicant argues “D 'Ambrosio does not disclose or suggest all the above features of claim 1. For example, D 'Ambrosio does not disclose or suggest that the "optical sensor [is] positioned within the cavity" and the "silicone composition [is] positioned within the cavity", as recited in claim 1.”, see pg. 9 of response filed 11/5/2025, the examiner respectfully disagrees. It is the combined teachings of D’Ambrosio and Takahiro which discloses the claimed “support jacket” with the optical sensor and silicone composition within. Ambrosio discloses a support jacket defining a cavity (e.g. jacket 2027, 1127, 1227 and sensor head 1121, 2021, 1221 together form the claimed “support jacket” and include a “cavity”, Figs. 10-12). Takahiro discloses a “support jacket” (e.g. short tube 37 “support jacket”, Figs. 5,7) defining a “cavity” (e.g. filling space 38 defines the “cavity” of the short tube 37 “support jacket”, Figs. 5,7, para. [0036]) that is in contact within an inner surface of the catheter “visor” along a length of the support jacket (e.g. short tube 37 is in contact with an inner surface of the catheter, Figs. 5,7, para. [0037]) and an optical sensor positioned within the cavity (e.g. sensor 40 positioned within the filling space 38, Figs. 5,7, para. [0036],[0040]-[0042]) so the sensor is not easily affected by deformation (e.g. para. [0041]). Modifying Ambrosio with the teachings of Takahiro to include on an inner surface of the visor a short tube that is part of the “support jacket” and defines a filling space “cavity” with the optical sensor positioned within the filing space as taught by Takahiro provides the optical sensor and silicone composition within a cavity defined by a support jacket as claimed.
Applicant argues “However, according to the above paragraph [0069] of )'Ambrosio, its "sensor 1120 includes a sensor head 1121", which in turn "includes a cavity 1140" (emphasis added). That is, the cavity of 'Ambrosio is part of its sensor and its sensor cannot be received within a component of itself. Hence, its optical sensor is not "positioned within the cavity", as recited in claim 1”, see pg. 10-11 of response filed 11/5/2025, the examiner respectfully disagrees. As stated above, it is the combined teachings of D’Ambrosio and Takahiro which discloses the claimed “support jacket” with the optical sensor and silicone composition within. Ambrosio discloses a support jacket defining a cavity (e.g. jacket 2027, 1127, 1227 and sensor head 1121, 2021, 1221 together form the claimed “support jacket” and include a “cavity”, Figs. 10-12). Takahiro discloses a “support jacket” (e.g. short tube 37 “support jacket”, Figs. 5,7) defining a “cavity” (e.g. filling space 38 defines the “cavity” of the short tube 37 “support jacket”, Figs. 5,7, para. [0036]) that is in contact within an inner surface of the catheter “visor” along a length of the support jacket (e.g. short tube 37 is in contact with an inner surface of the catheter, Figs. 5,7, para. [0037]) and an optical sensor positioned within the cavity (e.g. sensor 40 positioned within the filling space 38, Figs. 5,7, para. [0036],[0040]-[0042]) so the sensor is not easily affected by deformation (e.g. para. [0041]). Modifying Ambrosio with the teachings of Takahiro to include on an inner surface of the visor a short tube that is part of the “support jacket” and defines a filling space “cavity” with the optical sensor positioned within the filing space as taught by Takahiro provides the optical sensor and silicone composition within a cavity defined by a support jacket as claimed.
Applicant argues “D'Ambrosio states that "cavity 1140 in combination with the sensor membrane 1123 forms a Fabry-Perot resonator" (emphasis added). According to paragraph [0067] of 'Ambrosio, "[a]s pressure is applied to the sensor the sensor membrane 1923 deflects, causing a change/modulation of the membrane 1923, reflected light which is sent back to the sensor head 1921." In order for there to be a change in the reflected light, the sensor membrane must be able to deflect, which in turn requires the cavity to be empty…As noted above, modifying D'Ambrosio in view of Takahiro to include a silicone composition within the cavity of D 'Ambrosio would render its cavity unfit for its intended purposes. "If a proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, then there is no suggestion or motivation to make the proposed modification. In re Gordon, 733 F.2d 900, 221 USPQ 1125 (Fed.Cir. 1984)". MPEP § 2143.01(V).” see pg. 11 of response filed 11/5/2025, the examiner respectfully disagrees. Applicant states that the cavity disclosed by Ambrosio must remain empty, however Ambrosio discloses the cavity and sensor membrane forming a Fabry-Perot resonator, see para. [0071], in which the a gel or other material can partially or fully fill the cavity, see para. [0074], therefore the cavity does not have to remain empty. The combination of Ambrosio in view of Takahiro which provides a cavity with the optical sensor and silicone composition within the cavity would not render the prior art invention unsatisfactory for its intended purpose.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JG/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796