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 .
Status of Claims
Claims 1-10 and 31-42 are pending and currently under consideration for patentability.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/10/2024, 08/12/2024, 10/03/2024, 01/30/2025, 07/31/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Castillejos (US 20090287136 A1).
Regarding Claim 1, Castillejos teaches an implantable shunt for treating a patient (Fig 5; para [0043]-[0046]), the implantable shunt comprising:
a first layer (bottom component of 39; Fig 5; para [0045]; two planar components 39 are taught to form the conduit, wherein the bottom planar component of 39 is considered to be the first layer);;
a second layer sealingly coupled to the first layer (top component of 39; Fig 5; para [0045]; two planar components 39 are taught to form the conduit, wherein the top planar component of 39 is considered to be the second layer - further, the two planar components 39 are taught to be joined and are reasonably considered to be sealed, since they are used to form a conduit, wherein if the two planar components 39 were not sealed in some manner, fluid would be able to move outside of the conduits formed); and
a network of fluid resistors (17; Fig 5; para [0043]-[0046]; passage 17 is considered a network of fluid resistors, such that passage 17 comprises multiple channels and is considered to resist the movement of fluid to be within the channels of passage 17) including at least a first channel having a first resistance (left channel of 17; Fig 5; para [0043]-[0046]; the passage 17 is shown to comprise a left channel that is shown to be a serpentine conduit, the first resistance being the resistance provided on the fluid within the left-most serpentine channel or passage 17) and a second channel in parallel with the first channel and having a second resistance (right channel of 17; Fig 5; para [0043]-[0046]; the passage 17 is shown to comprise a right channel that is shown to be a serpentine conduit, the second resistance being the resistance provided on the fluid within the right-most serpentine channel of passage 17 - further, the left and right serpentine channels of passage 17 are shown to be mirrored with one another and considered to be parallel to each other), wherein
the first channel is at least partially defined within the first layer (Fig 5; para [0045]; the conduit is taught to be half formed in the top planar component of 39 and half formed in the bottom planar component of 39, wherein the left-most serpentine channel is considered to be partially defined in the bottom planar component of 39),
the second channel is at least partially defined within the second layer (Fig 5; para [0045]; the conduit is taught to be half formed in the top planar component of 39 and half formed in the bottom planar component of 39, wherein the right-most serpentine channel is considered to be partially defined in the top planar component of 39), and
when the implantable shunt is implanted in the patient, the first channel and the second channel are each configured to drain fluid from a first body region toward a second body region in the patient (Fig 5; para [0043]-[0046]; para [0014] further teaches wherein the device is used to exit fluid from the anterior chamber and Fig 2-2a shows an end of the device being positioned within the anterior chamber of the eye).
Regarding Claim 2, Castillejos teaches the implantable shunt of claim 1. Castillejos further teaches the first layer defines a first plane (Fig 5; para [0045]; the bottom component of 39 is taught to be planar and is shown to define a first plane), the second layer defines a second plane (Fig 5; para [0045]; the top component of 39 is taught to be planar and is shown to define a second plane), and the first plane and the second plane are parallel (Fig 5; para [0045]; top and bottom components of 39 are shown to be parallel).
Regarding Claim 3, Castillejos teaches the implantable shunt of claim 2. Castillejos further teaches wherein the first plane and the second plane are parallel to a longitudinal axis of the implantable shunt (Fig 5; para [0043]-[0046]; the first and second planes taught by Castillejos have an axis that runs parallel to the longitudinal axis of the device extending longitudinally through neck portion 31).
Regarding Claim 4, Castillejos teaches the implantable shunt of claim 2. Castillejos further teaches wherein the first plane and the second plane are perpendicular to a longitudinal axis of the implantable shunt (Fig 5; para [0043]-[0046]; the first and second planes taught by Castillejos have an axis that runs perpendicular to the longitudinal axis of the device extending longitudinally through neck portion 31 ).
Regarding Claim 5, Castillejos teaches the implantable shunt of claim 1. Castillejos further teaches wherein the first channel is fluidically in parallel with the second channel such that the first channel defines a first flow path at least partially through the shunt and the second channel defines a second flow path at least partially through the shunt that is distinct from the first flow path (Fig 5; para [0043]-[0046]; the left and right serpentine channels are shown to be fluidically in parallel with one another, such that they diverge from a common point at neck portion 31 and are further shown to extend through the device and lo be distinct from one another).
Regarding Claim 6, Castillejos teaches the implantable shunt of claim 1. Castillejos further teaches wherein the first resistance is different than the second resistance (Fig 5; para [0043]-[0045]; the length of the bottom portion of the left serpentine channel that is perpendicular to 31 is longer than the portion of 17 connecting the serpentine channels - since the diameter of the channels is shown to be substantially the same, the increased length of the bottom portion of the left serpentine channel that is perpendicular to 31 compared to the portion of 17 connecting the serpentine channels provides for greater resistance within the bottom portion of the left serpentine channel that is perpendicular to 31 ).
Regarding Claim 7, Castillejos teaches the implantable shunt of claim 1. Castillejos further teaches wherein the second channel is longer than the first channel, and wherein the second resistance is greater than the first resistance ((Fig 5; para [0043]-(0045]; the length of the bottom portion of the left serpentine channel that is perpendicular to 31 is longer than the portion of 17 connecting the serpentine channels - since the diameter of the channels is shown to be substantially the same, the increased length of the bottom portion of the left serpentine channel that is perpendicular to 31 compared to the portion of 17 connecting the serpentine channels provides for greater resistance within the bottom portion of the left serpentine channel that is perpendicular to 31 ).
Regarding Claim 8, Castillejos teaches the implantable shunt of claim 1. Castillejos further teaches wherein at least one of the first channel or the second channel is spiral and/or serpentine shaped (Fig 5; para [0045]; the left and right channels are shown to be serpentine shaped).
Regarding Claim 9, Castillejos teaches the implantable shunt of claim 8. Castillejos further teaches wherein both the first channel and the second channel are spiral and/or serpentine shaped (Fig 5; para [0045]; the left and right channels are shown to be serpentine shaped).
Regarding Claim 10, Castillejos teaches the implantable shunt of claim 1. Castillejos further teaches wherein the implantable shunt is an intraocular shunt, and wherein the first body region is an anterior chamber of an eye of the patient (Fig 5; para [0043)-(0046]; para [0014) further teaches wherein the device is used to exit fluid from the anterior chamber and Fig 2-2a shows an end of the device being positioned within the anterior chamber of the eye).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 31-38 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Castillejos (US 20090287136 A1) in view of Olsen et al. "Human sclera: thickness and surface area" American Journal of Ophthalmology, A Vol. 125, lss. 2, https://pubmed.ncbi.nlm.nih.gov/9467451, 01 February 1998 (01.02.1998).
Regarding Claim 31, Castillejos in view of Olsen teaches implantable shunt for treating a patient (Fig 5; para [0043]-[0046]), the implantable shunt comprising:
a first flat layer (bottom component of 39; Fig 5; para [0045]; two planar components 39 are taught to form the conduit, wherein the bottom planar component of 39 is considered to be the first layer) having a first thickness of between 10 microns and 500 microns;
a second layer sealingly coupled to the first layer (top component of 39; Fig 5; para [0045]; two planar components 39 are taught to form the conduit, wherein the top planar component of 39 is considered to be the second layer - further, the two planar components 39 are taught to be joined and are reasonably considered to be sealed, since they are used to form a conduit, wherein if the two planar components 39 were not sealed in some manner, fluid would be able to move outside of the conduits formed)
a network of fluid resistors (17; Fig 5; para [0043]-[0046]; passage 17 is considered a network of fluid resistors, such that passage 17 comprises multiple channels and is considered to resist the movement of fluid to be within the channels of passage 17) including at least a first channel having a first resistance (left channel of 17; Fig 5; para [0043]-[0046]; the passage 17 is shown to comprise a left channel that is shown to be a serpentine conduit, the first resistance being the resistance provided on the fluid within the left-most serpentine channel or passage 17) and a second channel in parallel with the first channel and having a second resistance (right channel of 17; Fig 5; para [0043]-[0046]; the passage 17 is shown to comprise a right channel that is shown to be a serpentine conduit, the second resistance being the resistance provided on the fluid within the right-most serpentine channel of passage 17 - further, the left and right serpentine channels of passage 17 are shown to be mirrored with one another and considered to be parallel to each other), wherein
the first channel is at least partially defined within the first layer (Fig 5; para [0045]; the conduit is taught to be half formed in the top planar component of 39 and half formed in the bottom planar component of 39, wherein the left-most serpentine channel is considered to be partially defined in the bottom planar component of 39),
the second channel is at least partially defined within the second layer (Fig 5; para [0045]; the conduit is taught to be half formed in the top planar component of 39 and half formed in the bottom planar component of 39, wherein the right-most serpentine channel is considered to be partially defined in the top planar component of 39), and
the first channel and the second channel are each configured to drain fluid from a first body region toward a second body region in the patient when the implantable shunt is implanted in the patient (Fig 5; para [0043]-[0046]; para [0014] further teaches wherein the device is used to exit fluid from the anterior chamber and Fig 2-2a shows an end of the device being positioned within the anterior chamber of the eye).
Castillejos fails to teach a first flat layer having a first thickness of between 10 microns and 500 microns and a second flat layer having a second thickness of between 10 microns and 500 microns
While Castillejos teaches an the implantable shunt having small dimensions (Fig 5; para [0043]-[0046); Fig 2-2a show the device positioned in the sclera 49 of the patient, at the corneoscleral limbus, wherein the thickness of the average corneal scleral limbus is 530 um, as reference by the article entitled "Human sclera: thickness and surface area" by Olsen et al. (hereinafter "Olsen"), wherein the length of the device 12 was measured to be approximately 1060 um accordingly, the thickness of the two planar components was determined to be approximately 8.22 um), Castillejos does not specifically
teach wherein the first layer and the second layer each have a thickness of 10 microns and 500 microns. However, it is well known that routine experimentation and various engineering design choices could have been made to have arrived at wherein the first layer and the second layer each have a thickness of 10 microns to 500 microns (Note: using the calculations and measurements mentioned above, it would have been obvious to have arrived at the limitations as claimed). Accordingly, it would have been obvious to one of ordinary skill in the art to have arrived at wherein the first layer and the second layer each have a thickness of less than about 50 microns, in order to improve placement of the implantable shunt.)
Regarding Claim 32, Castillejos in view of Olsen teaches the implantable shunt of claim 31. Castillejos further teaches wherein the first channel is fluidically in parallel with the second channel such that the first channel defines a first flow path at least partially through the shunt and the second channel defines a second flow path at least partially through the shunt that is distinct from the first flow path (Fig 5; para [0043]-[0046]; the left and right serpentine channels are shown to be fluidically in parallel with one another, such that they diverge from a common point at neck portion 31 and are further shown to extend through the device and lo be distinct from one another).
Regarding Claim 33, Castillejos in view of Olsen teaches the implantable shunt of claim 31. Castillejos further teaches wherein the first resistance is different than the second resistance (Fig 5; para [0043]-[0045]; the length of the bottom portion of the left serpentine channel that is perpendicular to 31 is longer than the portion of 17 connecting the serpentine channels - since the diameter of the channels is shown to be substantially the same, the increased length of the bottom portion of the left serpentine channel that is perpendicular to 31 compared to the portion of 17 connecting the serpentine channels provides for greater resistance within the bottom portion of the left serpentine channel that is perpendicular to 31 ).
Regarding Claim 34, Castillejos in view of Olsen teaches the implantable shunt of claim 31. Castillejos further teaches the first layer defines a first plane (Fig 5; para [0045]; the bottom component of 39 is taught to be planar and is shown to define a first plane), the second layer defines a second plane (Fig 5; para [0045]; the top component of 39 is taught to be planar and is shown to define a second plane), and the first plane and the second plane are parallel to a longitudinal axis of the implantable shunt. (Fig 5; para [0045]; top and bottom components of 39 are shown to be parallel).
Regarding Claim 35, Castillejos in view of Olsen teaches the implantable shunt of claim 31. Castillejos fails to teach wherein the first thickness is between 10 microns and 100 microns, and wherein the second thickness is between 10 microns and 100 microns. While Castillejos teaches an the implantable shunt having small dimensions (Fig 5; para [0043]-[0046); Fig 2-2a show the device positioned in the sclera 49 of the patient, at the corneoscleral limbus, wherein the thickness of the average corneal scleral limbus is 530 um, as reference by the article entitled "Human sclera: thickness and surface area" by Olsen et al. (hereinafter "Olsen"), wherein the length of the device 12 was measured to be approximately 1060 um accordingly, the thickness of the two planar components was determined to be approximately 8.22 um), Castillejos does not specifically teach wherein the first layer and the second layer each have a thickness of 10 microns and 500 microns. However, it is well known that routine experimentation and various engineering design choices could have been made to have arrived at wherein the first layer and the second layer each have a thickness between 10 microns and 100 microns (Note: using the calculations and measurements mentioned above, it would have been obvious to have arrived at the limitations as claimed). Accordingly, it would have been obvious to one of ordinary skill in the art to have arrived at wherein the first layer and the second layer each have a thickness of between 10 microns and 100 microns, in order to improve placement of the implantable shunt.)
Regarding Claim 36, Castillejos in view of Olsen teaches the implantable shunt of claim 31. Castillejos fails to teach wherein the first thickness is between 10 microns and 50 microns, and wherein the second thickness is between 10 microns and 50 microns. While Castillejos teaches an the implantable shunt having small dimensions (Fig 5; para [0043]-[0046); Fig 2-2a show the device positioned in the sclera 49 of the patient, at the corneoscleral limbus, wherein the thickness of the average corneal scleral limbus is 530 um, as reference by the article entitled "Human sclera: thickness and surface area" by Olsen et al. (hereinafter "Olsen"), wherein the length of the device 12 was measured to be approximately 1060 um accordingly, the thickness of the two planar components was determined to be approximately 8.22 um), Castillejos does not specifically teach wherein the first layer and the second layer each have a thickness of 10 microns and 500 microns. However, it is well known that routine experimentation and various engineering design choices could have been made to have arrived at wherein the first layer and the second layer each have a thickness between 10 microns and 50 microns (Note: using the calculations and measurements mentioned above, it would have been obvious to have arrived at the limitations as claimed). Accordingly, it would have been obvious to one of ordinary skill in the art to have arrived at wherein the first layer and the second layer each have a thickness of between 10 microns and 50 microns, in order to improve placement of the implantable shunt.)
Regarding Claim 37, Castillejos in view of Olsen teaches the implantable shunt of claim 31. Castillejos fails to explicitly teach wherein the first thickness and the second thickness are about the same. It would have been an obvious matter of design choice to make the different portions of the first and second thickness about the same, since such a modification would have involved a mere change in the proportions of components. A change in proportion is generally recognized as being within the level of ordinary skill in the art. In re Reese, 129 USPQ 402.
Regarding Claim 38, Castillejos in view of Olsen teaches the implantable shunt of claim 31. Castillejos fails to explicitly teach wherein the first thickness and the second thickness are different. It would have been an obvious matter of design choice to make the different portions of the first and second thickness are different, since such a modification would have involved a mere change in the proportions of components. A change in proportion is generally recognized as being within the level of ordinary skill in the art. In re Reese, 129 USPQ 402.
Regarding Claim 42, Castillejos in view of Olsen teaches the implantable shunt of claim 31. Castillejos further teaches wherein the implantable shunt is an intraocular shunt, and wherein the first body region is an anterior chamber of an eye of the patient (paragraph 0037).
Claims 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Castillejos (US 20090287136 A1) in view of Olsen et al. "Human sclera: thickness and surface area" American Journal of Ophthalmology, A Vol. 125, lss. 2, https://pubmed.ncbi.nlm.nih.gov/9467451, 01 February 1998 (01.02.1998) in view of Shadduck (US 2004/0193095 A1)
Regarding Claim 39, Castillejos in view of Olsen teaches the implantable shunt of claim 31. Castillejos fails to teach further comprising a third layer. Shadduck teaches a similar implantable shunt (Fig 4A-4B; para [0034]; the device is taught to be used similarly to the shunt taught by Castillejos, such that it is implanted into the eye of the patient, as shown in Fig 5, para [0035]) wherein the implantable shunt comprises a third layer (layer of 139; Fig 4A-4B; para [0034]; the device is shown to have a material 138, similar to the first and second layer taught by Castillejos, such that it defines channels - the device of Shadduck further teaches a material 139 that is positioned within the channels of material 138 to define further channels 122' within - further see how material 139 comprises ports 135', similar to the apertures 14 taught by Castillejos). Accordingly, it would have been obvious to one of ordinary skill in the art to have employed the third layer taught by Shadduck with the implantable shunt taught by Castillejos, in order to further prevent unwanted fluid leaks within the implantable shunt.
Regarding Claim 40, Castillejos in view of Olsen and Shadduck teaches the implantable shunt of claim 39. The combination further teaches wherein the third layer is composed of a different material than the first layer and/or the second layer (Fig 5; para [0043]-[0046]; the modification as combined allows for the third layer, taught by Shadduck to be a shape memory polymer, para [0034], to be different than the first and second layer taught by Castillejos, which are taught to be made of silicone, para [0018]-[0019]).
Regarding Claim 41, Castillejos in view of Olsen and Shadduck teaches the implantable shunt of claim 39. The combination further teaches wherein the third layer includes an actuator housing (portion of 139 proximal to the branches of 139; Fig 4A-4B; para [0034]) configured to house an actuator operable to selectively control the flow of fluid through the first channel and/or the second channel (Fig 4A-4B; para [0034]; Note: "configured to house an actuator operable to selectively control the now of fluid through the first channel and/or the second channel" is considered an intended use and carries no patentable weight. Shadduck's actuator housing is considered "configured to house an actuator operable to selectively control the now of fluid through the first channel and/or the second channel" since it comprises a channel capable of receiving a valve or other actuator).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20140098663 A1, US 8337393 B2, US 20110282453 A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781