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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/15/2023 is being considered by the examiner.
Status of Claims
Claims 1-26 are currently pending and under examination.
Priority
The instant application (filed on 11/15/2023) is a non-provisional application filed under 35 USC 111(a). Acknowledgment is made of Applicant's claim for domestic priority as a continuation in part of parent applications 17/815,494 (filed 07/27/2022) and 17/815,482 (filed 07/27/2022), which also derive priority from provisional application 63/203,649 (filed 07/27/2021). The limitations “a first regular surface pattern formed in the bottom section; and whereby a surface area of the implantable pulse generator case is increased” from independent claim 1 and “forming an ellipsoidal bottom section having a first regular surface pattern” from independent claim 23 are not sufficiently described in any of 17/815,494, 17/815,482, and 63/203,649 to inherit priority for the instant claims. However, the instant application also claims domestic priority from provisional application 63/388,823 (11/15/2022). The regular surface pattern is described in provisional application 63/388,823. However, 63/388,823 lacks some of the specific features in the dependent claims, such as: (1) hexagon patterns in claims 4-5 and 12-13, (2) parallel striations in claims 6-7 and 14 -15 (claim 21 depends on claim 14), (3) the dimension ranges for the indentions and nodes in claims 9, 11, 17, and 19, and (4) striations as an option in method claims 25-26. Therefore, instant claims 1-3, 8, 10, 16, 18, 20, and 22-24 are disclosed from a combination of the priority documents to receive an effective priority date of 11/15/2022. However, instant claims 4-7, 9, 11-15, 17, 19, 21, and 25-26 are interpreted as receiving an effective filing date of 11/15/2023 (from the instant application filing date).
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 4 and 12 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.
Claims 4 and 12: There is insufficient written description of the limitation “surface pattern forms a series of hexagons, each hexagon of the series of hexagons, having a semi-spherical cross section.” The instant specification’s only reference to hexagons is Figure 7H and [0089] (“In one example, the pattern can assume a regular pattern of hexagons, such as pattern 780”). The instant specification also uses the term “semi-spherical cross section” only in reference to circular indentations ([0096] - “The following table illustrates the surprising results of including a pattern of circular indentions, having a semi-spherical cross section, arranged in a hexagonal packing pattern, on the bottom section of the IPG”; note this is both claims 5 and 13). The term “hemispherical cross section” is used to describe the indentions ([0087]) and raised nodes ([0088]), which can be in the shape of hexagons ([0089]). However, unlike the circles in [0090], the hexagons are not described as having a “hemispherical cross section.”
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 1-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1: The limitation “whereby a surface area of the implantable pulse generator case is increased” renders the claim indefinite because it is unclear to what the relative term “increased” surface area is being compared. By context the surface area could be increased when compared to a smooth surface (which would be understood as the minimum possible surface area).
Claims 4 and 12: The limitation “surface pattern forms a series of hexagons, each hexagon of the series of hexagons, having a semi-spherical cross section” renders claims 4 and 12 indefinite. The instant specification’s only reference to hexagons is Figure 7H and [0089] (“In one example, the
pattern can assume a regular pattern of hexagons, such as pattern 780”). The instant specification also uses the term “semi-spherical cross section” only in reference to circular indentations ([0096] - “The following table illustrates the surprising results of including a pattern of circular indentions, having a semi-spherical cross section, arranged in a hexagonal packing pattern, on the bottom section of the IPG”; note this is both claims 5 and 13). The term “hemispherical cross section” is used to describe the indentions ([0087]) and raised nodes ([0088]), which can be in the shape of hexagons ([0089]). However, unlike the circles in [0090], the hexagons are not described as having a “hemispherical cross section.” Given the description is unclear what is meant by a semi-spherical cross section on a hexagonal node or indentation, the claim language would benefit from a clarification of how this cross section relates to the hexagon patterns.
Claims 9 and 17: Claims 9 and 17 recite “each indention, of the plurality of indentions, is between about 2 mm and about 5 mm in a diameter and between about 0.1 mm and about 5 mm deep” which contains the descriptor “about.” This renders the claim indefinite because the bounds of “about” are not apparent in the claim language or description.
Claims 11 and 19: Claims 11 and 19 recite “each raised node, of the plurality of raised nodes, is between about 2 mm and about 5 mm in diameter and between about 0.1 mm and about 5 mm in height” which contains the descriptor “about.” This renders the claim indefinite because the bounds of “about” are not apparent in the claim language or description.
Claims 2-3, 5-8,10, 13-16, 18, and 20-22 are rejected for being dependent on rejected claims.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 23 are rejected under U.S.C 102(a)(1) and U.S.C 102(a)(2) as being anticipated by Wolf II (US PG Pub 2021/0001114 A1, see 11/15/2023 IDS), to be referred to as Wolf.
Regarding Claim 1, Wolf discloses an implantable pulse generator ([0002] – implantable pulse generator (IPG)) case ([0087] – IPG case 507) comprising:
• a top section (Figure 6F, [0113] – casing divided into two opposing shell halves 622a and 622b, which could be considered either the top and bottom);
• a bottom section joined to the top section (Figure 6F, [0113] – casing divided into two opposing shell halves 622a and 622b, which could be considered either the top and bottom and “IPG casing 622 is formed by two opposing shell halves, 622a and 622b, hermetically sealed at junction 620”);
• a first regular surface pattern formed in the bottom section (Figure 6F, [0095], [0113] - the casing is displayed and described as being elliptical in shape with a curved surface, which is interpreted as a regular surface pattern (i.e. smooth surface pattern)).
Alternatively, the bottom and top section could be components 606 and 602 when joined together as IPG 600 (Figure 6F, [0113]). The limitation “whereby a surface area of the implantable pulse generator case is increased” is considered indefinite because it is unclear what the pattern surface area is being compared to when the surface area is increased.
Therefore, Claim 1 is anticipated by Wolf.
Regarding Claim 2, the implantable pulse generator case according to claim 1 is anticipated by Wolf, as indicated hereinabove. Wolf discloses a casing divided into two halves which could be considered the top and bottom ([0113]). Wolf further discloses a second regular surface pattern formed in the top section (Figure 6F, [0113] – casing divided into two opposing shell halves 622a and 622b, which could be considered either the top and bottom). The casing is displayed and described as being elliptical in shape with a curved surface (Figure 6F, [0095], [0113]), which is interpreted as a regular surface pattern (i.e. smooth surface pattern). Alternatively, the bottom and top section could be components 606 and 602 when joined together as IPG 600 (Figure 6F, [0113]).
Therefore, Claim 2 is anticipated by Wolf.
Regarding Claim 23, Wolf discloses a method (design of case detailed in [0096-0114]) of forming an implantable pulse generator ([0002] – implantable pulse generator (IPG)) case ([0087] – IPG case) comprising:
• forming an ellipsoidal top section (Figure 6B – shows the ellipse for each plane of the 3D figure, see [0096-0112] for written description of dimensions; [0113] – casing divided into two halves which could be considered the top and bottom);
• forming an ellipsoidal bottom section (Figure 6B – shows the ellipse for each plane of the 3D figure, see [0096-0112] for written description of dimensions; [0113] – casing divided into two halves which could be considered the top and bottom) having a first regular surface pattern ([0095], [0113] - the casing is displayed and described as being elliptical in shape with a curved surface, which is interpreted as a regular surface pattern (i.e. smooth surface pattern)); and
•joining the ellipsoidal top section to the ellipsoidal bottom section to form a hermetical seal (Figure 6F, [0113] – “IPG casing 622 is formed by two opposing shell halves, 622a and 622b, hermetically sealed at junction 620”).
Alternatively, the bottom and top section could be components 606 and 602 when joined together as IPG 600 (Figure 6F, [0113]).
Therefore, Claim 23 is anticipated by Wolf.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 4-5, 8, 10-13, 16, 18-20, 22, and 25 are rejected under U.S.C 103 as being unpatentable over Wolf II (US PG Pub 2021/0001114 A1, see 11/15/2023 IDS), to be referred to as Wolf, in view of Cola (US PG Pub 2021/0063099 A1, see “Notice of References Cited”).
Regarding Claim 4, the implantable pulse generator case according to claim 2 is anticipated by Wolf, as indicated hereinabove. Wolf discloses a casing divided into two halves which could be considered the top and bottom ([0113]). Wolf establishes excessive temperatures as unacceptable ([0019]) and includes changes in device usage ([0019]) and heat sinks ([0211]) to reduce or disperse heat. However, Wolf does not disclose wherein the second regular surface pattern forms a series of hexagons, each hexagon of the series of hexagons, having a semi-spherical cross section.
Cola, in the same field of endeavor of casing materials and designs for electronic devices ([0018]), teaches a heat sink to be placed around an electronic device to disperse heat ([0024]). Cola teaches polymeric protrusions on the surface which increase the surface area of the heat sink to improve heat transfer ([0059]). The heat sink design in Cola is interpreted as being applied to surround the electronic device (e.g. top or bottom surface of the device in Wolf). The polymeric protrusions are described as being placed regularly and able to have hexagonal and circular (semi-spherical) cross sections ([0057] – “The polymeric protrusions may be arranged in a regular or an irregular array on the base. In another instance, any desired three-dimensional shape can be used for the polymeric protrusions, such as cylinder, cone, truncated cone, pyramid, truncated pyramid, hemisphere, truncated hemisphere, rectangle, square, hexagon, octagon, other polygonal shape, additional suitable shapes, and combinations of the aforementioned shapes resulting in hybrid shapes. One or more shapes can be present in the plurality of polymeric protrusions of the heat sink”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case by incorporating the surface heat sink protrusion design in Cola. This would have been obvious because both Wolf and Cola are concerned with temperature regulation to prevent excessive device temperatures and Cola provides a solution/improvement which provides a heat sink with protrusions on the case to improve heat dispersion rate and prevent overheating. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the heat sink protrusion design in Cola.
Therefore, Claim 4 is obvious over Wolf in view of Cola.
Regarding Claim 5, the implantable pulse generator case according to claim 2 is anticipated by Wolf, as indicated hereinabove. Wolf discloses a casing divided into two halves which could be considered the top and bottom ([0113]). Wolf establishes excessive temperatures as unacceptable ([0019]) and includes changes in device usage ([0019]) and heat sinks ([0211]) to reduce or disperse heat. However, Wolf does not disclose wherein the second regular surface pattern forms a series of circles in a hexagonal packing arrangement, each having a semi-spherical cross section.
Cola, in the same field of endeavor of casing materials and designs for electronic devices ([0018]), teaches a heat sink to be placed around an electronic device to disperse heat ([0024]). Cola teaches polymeric protrusions on the surface which increase the surface area of the heat sink to improve heat transfer ([0059]). The heat sink design in Cola is interpreted as being applied to surround the electronic device (e.g. top or bottom surface of the device in Wolf). The polymeric protrusions are described as being placed regularly and have circular (semi-spherical) cross sections ([0057]). The arrangement of the polymeric protrusions can be arranged in a hexagonal configuration such as that displayed in Figure 2D ([0065]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case by incorporating the surface heat sink protrusion design in Cola. This would have been obvious because both Wolf and Cola are concerned with temperature regulation to prevent excessive device temperatures and Cola provides a solution/improvement which provides a heat sink with protrusions on the case to improve heat dispersion rate and prevent overheating. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the heat sink protrusion design in Cola.
Therefore, Claim 5 is obvious over Wolf in view of Cola.
Regarding Claim 8, the implantable pulse generator case according to claim 2 is anticipated by Wolf, as indicated hereinabove. Wolf further discloses a casing divided into two halves which could be considered the top and bottom ([0113]). Wolf establishes excessive temperatures as unacceptable ([0019]) and includes changes in device usage ([0019]) and heat sinks ([0211]) to reduce or disperse heat. However, Wolf does not disclose wherein the second regular surface pattern is a plurality of indentions.
Cola, in the same field of endeavor of casing materials and designs for electronic devices ([0018]), teaches a heat sink to be placed around an electronic device to disperse heat ([0024]). Cola teaches polymeric protrusions on the surface which increase the surface area of the heat sink to improve heat transfer ([0059]). The heat sink design in Cola is interpreted as being applied to surround the electronic device (e.g. top or bottom surface of the device in Wolf). The polymeric protrusions are described as being placed regularly and able to have circular cross sections ([0057]). The protrusions can be dimpled to create an interior section or recessed into the surface to further increase the surface area of the heat sink and improve heart dispersal ([0059] – “In some instances, the polymeric protrusions can include additional features such as being fluted, dimpled, recessed, and/or ribbed. These features can be designed to modify cooling medium flow around the protrusions which can also increase the heat transfer surface area for a given polymeric protrusion type present in the heat sink”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case by incorporating the surface heat sink protrusion design in Cola. This would have been obvious because both Wolf and Cola are concerned with temperature regulation to prevent excessive device temperatures and Cola provides a solution/improvement which provides a heat sink with protrusions on the case to improve heat dispersion rate and prevent overheating. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the heat sink protrusion design in Cola.
Therefore, Claim 8 is obvious over Wolf in view of Cola.
Regarding Claim 10, the implantable pulse generator case according to claim 2 is anticipated by Wolf, as indicated hereinabove. Wolf further discloses a casing divided into two halves which could be considered the top and bottom ([0113]). Wolf establishes excessive temperatures as unacceptable ([0019]) and includes changes in device usage ([0019]) and heat sinks ([0211]) to reduce or disperse heat. However, Wolf does not disclose wherein the second regular surface pattern comprises a plurality of raised nodes.
Cola, in the same field of endeavor of casing materials and designs for electronic devices ([0018]), teaches a heat sink to be placed around an electronic device to disperse heat ([0024]). Cola teaches polymeric protrusions on the surface which increase the surface area of the heat sink to improve heat transfer ([0059]). The heat sink design in Cola is interpreted as being applied to surround the electronic device (e.g. top or bottom surface of the device in Wolf). The polymeric protrusions are described as being placed regularly and able to have circular cross sections ([0057]). Nodes are described in the instant specification as “Referring then to Figure 71, another preferred pattern of indentions or raised nodes is shown. In this example, the shape of each of the indentions or raised nodes is circular with a generally hemispherical cross section, such as pattern 782” ([0090]), which is interpreted as matching with the polymeric protrusions in Cola.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case by incorporating the surface heat sink protrusion design in Cola. This would have been obvious because both Wolf and Cola are concerned with temperature regulation to prevent excessive device temperatures and Cola provides a solution/improvement which provides a heat sink with protrusions on the case to improve heat dispersion rate and prevent overheating. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the heat sink protrusion design in Cola.
Therefore, Claim 10 is obvious over Wolf in view of Cola.
Regarding Claim 11, the implantable pulse generator case according to claim 10 is obvious over Wolf in view of Cola, as indicated hereinabove. Wolf further discloses a casing divided into two halves which could be considered the top and bottom ([0113]). Wolf establishes excessive temperatures as unacceptable ([0019]) and includes changes in device usage ([0019]) and heat sinks ([0211]) to reduce or disperse heat. However, Wolf does not disclose wherein each raised node, of the plurality of raised nodes, is between about 2 mm and about 5 mm in diameter and between about 0.1 mm and about 5 mm in height.
Cola, in the same field of endeavor of casing materials and designs for electronic devices ([0018]), teaches a heat sink to be placed around an electronic device to disperse heat ([0024]). Cola teaches polymeric protrusions on the surface which increase the surface area of the heat sink to improve heat transfer ([0059]). The heat sink design in Cola is interpreted as being applied to surround the electronic device (e.g. top or bottom surface of the device in Wolf). The polymeric protrusions are described as being placed regularly and able to have circular cross sections ([0057]). Nodes are described in the instant specification as “Referring then to Figure 71, another preferred pattern of indentions or raised nodes is shown. In this example, the shape of each of the indentions or raised nodes is circular with a generally hemispherical cross section, such as pattern 782” ([0090]), which is interpreted as matching with the polymeric protrusions in Cola.
Cola teaches the polymeric protrusion dimensions for height and diameter as falling between 1-15 mm as the maximum range presented ([0061]). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case by incorporating the surface heat sink protrusion design in Cola. This would have been obvious because both Wolf and Cola are concerned with temperature regulation to prevent excessive device temperatures and Cola provides a solution/improvement which provides a heat sink with protrusions on the case to improve heat dispersion rate and prevent overheating. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the heat sink protrusion design in Cola.
Therefore, Claim 11 is obvious over Wolf in view of Cola.
Regarding Claim 12, the implantable pulse generator case according to claim 1 is anticipated by Wolf, as indicated hereinabove. Wolf discloses a casing divided into two halves which could be considered the top and bottom ([0113]). Wolf establishes excessive temperatures as unacceptable ([0019]) and includes changes in device usage ([0019]) and heat sinks ([0211]) to reduce or disperse heat. However, Wolf does not disclose wherein the first regular surface pattern forms a series of hexagons, each hexagon of the series of hexagons, having a semi-spherical cross section.
Cola, in the same field of endeavor of casing materials and designs for electronic devices ([0018]), teaches a heat sink to be placed around an electronic device to disperse heat ([0024]). Cola teaches polymeric protrusions on the surface which increase the surface area of the heat sink to improve heat transfer ([0059]). The heat sink design in Cola is interpreted as being applied to surround the electronic device (e.g. top or bottom surface of the device in Wolf). The polymeric protrusions are described as being placed regularly and able to have hexagonal and circular (semi-spherical) cross sections ([0057] – “The polymeric protrusions may be arranged in a regular or an irregular array on the base. In another instance, any desired three-dimensional shape can be used for the polymeric protrusions, such as cylinder, cone, truncated cone, pyramid, truncated pyramid, hemisphere, truncated hemisphere, rectangle, square, hexagon, octagon, other polygonal shape, additional suitable shapes, and combinations of the aforementioned shapes resulting in hybrid shapes. One or more shapes can be present in the plurality of polymeric protrusions of the heat sink”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case by incorporating the surface heat sink protrusion design in Cola. This would have been obvious because both Wolf and Cola are concerned with temperature regulation to prevent excessive device temperatures and Cola provides a solution/improvement which provides a heat sink with protrusions on the case to improve heat dispersion rate and prevent overheating. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the heat sink protrusion design in Cola.
Therefore, Claim 12 is obvious over Wolf in view of Cola.
Regarding Claim 13, the implantable pulse generator case according to claim 1 is anticipated by Wolf, as indicated hereinabove. Wolf establishes excessive temperatures as unacceptable ([0019]) and includes changes in device usage ([0019]) and heat sinks ([0211]) to reduce or disperse heat. Wolf discloses a casing divided into two halves which could be considered the top and bottom ([0113]). However, Wolf does not disclose wherein the first regular surface pattern forms a series of circles in a hexagonal packing arrangement, each having a semi-spherical cross section.
Cola, in the same field of endeavor of casing materials and designs for electronic devices ([0018]), teaches a heat sink to be placed around an electronic device to disperse heat ([0024]). Cola teaches polymeric protrusions on the surface which increase the surface area of the heat sink to improve heat transfer ([0059]). The heat sink design in Cola is interpreted as being applied to surround the electronic device (e.g. top or bottom surface of the device in Wolf). The polymeric protrusions are described as being placed regularly and able to have circular (semi-spherical) cross sections ([0057]). The arrangement of the polymeric protrusions can be arranged in a hexagonal configuration such as that displayed in Figure 2D ([0065]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case by incorporating the surface heat sink protrusion design in Cola. This would have been obvious because both Wolf and Cola are concerned with temperature regulation to prevent excessive device temperatures and Cola provides a solution/improvement which provides a heat sink with protrusions on the case to improve heat dispersion rate and prevent overheating. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the heat sink protrusion design in Cola.
Therefore, Claim 13 is obvious over Wolf in view of Cola.
Regarding Claim 16, the implantable pulse generator case according to claim 1 is anticipated by Wolf, as indicated hereinabove. Wolf further discloses a casing divided into two halves which could be considered the top and bottom ([0113]). Wolf establishes excessive temperatures as unacceptable ([0019]) and includes changes in device usage ([0019]) and heat sinks ([0211]) to reduce or disperse heat. However, Wolf does not disclose wherein the first regular surface pattern is a plurality of indentions.
Cola, in the same field of endeavor of casing materials and designs for electronic devices ([0018]), teaches a heat sink to be placed around an electronic device to disperse heat ([0024]). Cola teaches polymeric protrusions on the surface which increase the surface area of the heat sink to improve heat transfer ([0059]). The heat sink design in Cola is interpreted as being applied to surround the electronic device (e.g. top or bottom of the device in Wolf). The polymeric protrusions are described as being placed regularly and able to have circular cross sections ([0057]). The protrusions can be dimpled to create an interior section or recessed into the surface to further increase the surface area of the heat sink and improve heart dispersal ([0059] – “In some instances, the polymeric protrusions can include additional features such as being fluted, dimpled, recessed, and/or ribbed. These features can be designed to modify cooling medium flow around the protrusions which can also increase the heat transfer surface area for a given polymeric protrusion type present in the heat sink”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case by incorporating the surface heat sink protrusion design in Cola. This would have been obvious because both Wolf and Cola are concerned with temperature regulation to prevent excessive device temperatures and Cola provides a solution/improvement which provides a heat sink with protrusions on the case to improve heat dispersion rate and prevent overheating. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the heat sink protrusion design in Cola.
Therefore, Claim 16 is obvious over Wolf in view of Cola.
Regarding Claim 18, the implantable pulse generator case according to claim 1 is anticipated by Wolf, as indicated hereinabove. Wolf further discloses a casing divided into two halves which could be considered the top and bottom ([0113]). Wolf establishes excessive temperatures as unacceptable ([0019]) and includes changes in device usage ([0019]) and heat sinks ([0211]) to reduce or disperse heat. However, Wolf does not disclose wherein the first regular surface pattern comprises a plurality of raised nodes.
Cola, in the same field of endeavor of casing materials and designs for electronic devices ([0018]), teaches a heat sink to be placed around an electronic device to disperse heat ([0024]). Cola teaches polymeric protrusions on the surface which increase the surface area of the heat sink to improve heat transfer ([0059]). The heat sink design in Cola is interpreted as being applied to surround the electronic device (e.g. top or bottom surface of the device in Wolf). The polymeric protrusions are described as being placed regularly and able to have circular cross sections ([0057]). Nodes are described in the instant specification as “Referring then to Figure 7I, another preferred pattern of indentions or raised nodes is shown. In this example, the shape of each of the indentions or raised nodes is circular with a generally hemispherical cross section, such as pattern 782” ([0090]), which is interpreted as matching with the polymeric protrusions in Cola.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case by incorporating the surface heat sink protrusion design in Cola. This would have been obvious because both Wolf and Cola are concerned with temperature regulation to prevent excessive device temperatures and Cola provides a solution/improvement which provides a heat sink with protrusions on the case to improve heat dispersion rate and prevent overheating. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the heat sink protrusion design in Cola.
Therefore, Claim 18 is obvious over Wolf in view of Cola.
Regarding Claim 19, the implantable pulse generator case according to claim 18 is obvious over Wolf in view of Cola, as indicated hereinabove. Wolf further discloses a casing divided into two halves which could be considered the top and bottom ([0113]). Wolf establishes excessive temperatures as unacceptable ([0019]) and includes changes in device usage ([0019]) and heat sinks ([0211]) to reduce or disperse heat. However, Wolf does not disclose wherein each raised node, of the plurality of raised nodes, is between about 2 mm and about 5 mm in diameter and between about 0.1 mm and about 5 mm in height.
Cola, in the same field of endeavor of casing materials and designs for electronic devices ([0018]), teaches a heat sink to be placed around an electronic device to disperse heat ([0024]). Cola teaches polymeric protrusions on the surface which increase the surface area of the heat sink to improve heat transfer ([0059]). The heat sink design in Cola is interpreted as being applied to surround the electronic device (e.g. top or bottom surface of the device in Wolf). The polymeric protrusions are described as being placed regularly and able to have circular cross sections ([0057]). Nodes are described in the instant specification as “Referring then to Figure 7I, another preferred pattern of indentions or raised nodes is shown. In this example, the shape of each of the indentions or raised nodes is circular with a generally hemispherical cross section, such as pattern 782” ([0090]), which is interpreted as matching with the polymeric protrusions in Cola.
Cola teaches the polymeric protrusion dimensions for height and diameter as falling between 1-15 mm as the maximum range presented ([0061]). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case by incorporating the surface heat sink protrusion design in Cola. This would have been obvious because both Wolf and Cola are concerned with temperature regulation to prevent excessive device temperatures and Cola provides a solution/improvement which provides a heat sink with protrusions on the case to improve heat dispersion rate and prevent overheating. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the heat sink protrusion design in Cola.
Therefore, Claim 19 is obvious over Wolf in view of Cola.
Regarding Claim 20, the implantable pulse generator case according to claim 1 is anticipated by Wolf, as indicated hereinabove. Wolf further discloses wherein the bottom section is formed of one of a group of aluminum oxide, silicon oxide and zirconium ([0113] – “IPG device 600 is comprised of header 602 and IPG body 606. IPG body 606 is further comprised of IPG casing 622, optical window 618 and electrical feedthrough plate 616. IPG casing 622 is formed by two opposing shell halves, 622a and 622b, hermetically sealed at junction 620. In a preferred embodiment, IPG casing 802 is a ceramic material, such as alumina, sapphire or zirconia” where alumina and sapphire are types of aluminum oxide). Note this passage is interpreted as either casing shell half being able to have the alumina or sapphire material construction. Only one of aluminum oxide, silicon oxide and zirconium was interpreted as being required in the claim language.
Therefore, Claim 20 is obvious over Wolf in view of Cola.
Regarding Claim 22, the implantable pulse generator case according to claim 1 is anticipated by Wolf, as indicated hereinabove. Wolf further discloses wherein the bottom section is ellipsoidal (Figures 6E-6F – show an ellipsoidal profile for the outer casing (which includes the bottom section), Figures 6B – shows the ellipse for each plane of the 3D figure, see [0096-0112] for written description of dimensions).
Therefore, Claim 22 is obvious over Wolf in view of Cola.
Regarding Claim 25, the method of forming an implantable pulse generator case according to claim 23 is anticipated by Wolf, as indicated hereinabove. Wolf further discloses the step of forming the ellipsoidal bottom section (Figures 6B – show the ellipse for each plane of the 3D figure, see [0096-0112] for written description of dimensions; [0113] – casing divided into two halves which could be considered the top and bottom). However, Wolf does not disclose wherein the step of forming the ellipsoidal bottom section further comprises: providing the first regular surface pattern as one of indentions, protruding nodes and striations.
Cola, in the same field of endeavor of casing materials and designs for electronic devices ([0018]), teaches a heat sink to be placed around an electronic device to disperse heat ([0024]). Cola teaches polymeric protrusions on the surface which increase the surface area of the heat sink to improve heat transfer ([0059]). The heat sink design in Cola is interpreted as being applied to surround the electronic device (e.g. top or bottom surface of the device in Wolf). The polymeric protrusions are described as being placed regularly and able to have circular cross sections ([0057]).
Nodes are described in the instant specification as “Referring then to Figure 7I, another preferred pattern of indentions or raised nodes is shown. In this example, the shape of each of the indentions or raised nodes is circular with a generally hemispherical cross section, such as pattern 782” ([0090]), which is interpreted as matching with the polymeric protrusions in Cola. Only protruding nodes are interpreted as necessary based on the claim language, but the same rationale for the indentions in claims 8-9 and 16-17 and striations in claims 6-7 and 14-15 could be incorporated into the argument for this claim as well.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case by incorporating the surface heat sink protrusion design in Cola. This would have been obvious because both Wolf and Cola are concerned with temperature regulation to prevent excessive device temperatures and Cola provides a solution/improvement which provides a heat sink with protrusions on the case to improve heat dispersion rate and prevent overheating. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the heat sink protrusion design in Cola.
Therefore, Claim 25 is obvious over Wolf in view of Cola.
Claims 3, 24, and 26 are rejected under U.S.C 103 as being unpatentable over Wolf II (US PG Pub 2021/0001114 A1, see 11/15/2023 IDS), to be referred to as Wolf, in view of Single (US PG Pub 2021/0268293 A1, see “Notice of References Cited”).
Regarding Claim 3, the implantable pulse generator case according to claim 2 is anticipated by Wolf, as indicated hereinabove. Wolf further discloses wherein the top section is a partial ellipsoid (Figure 6B – shows the ellipse for each plane of the 3D figure, see [0096-0112] for written description of dimensions; [0113] – casing divided into two halves which could be considered the top and bottom). Wolf discloses a single optical bay 602 and a non-optical bay section 622 situated across both the top and bottom halves 622A and 622B of the case’s shell (Figure 6F, [0113]). The casing is displayed and described as being elliptical in shape with a curved surface (Figure 6F, [0095], [0113]), which is interpreted as a regular surface pattern (i.e. smooth surface pattern). However, Wolf does not disclose forming two opposing optical bays and a central section, the central section including the second regular surface pattern.
Single, in the same field of endeavor of an implantable stimulator ([0009]), teaches a first header ([0059] – with a specified function) attached on one side of the device and a second header ([0060] – with a specified function) attached on the opposite side of the device ([0074]) with body section 103 positioned in between the headers (Figure 8, [0062]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case with a single optical bay by incorporating the two header design for a stimulator in Single. This would have been obvious because both Wolf and Single relate to implantable stimulators with header compartments and Single provides a solution/improvement which allows a second header compartment to be added on the opposite side of the device to increase the connection points (add functions) and reduce interference between device components (e.g. adding an opposing optical bay to match the existing optical bay in Wolf). Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the two header design for a stimulator in Single.
Therefore, Claim 3 is obvious over Wolf in view of Single.
Regarding Claim 24, the method of forming an implantable pulse generator case according to claim 23 is anticipated by Wolf, as indicated hereinabove. Wolf further discloses the step of forming the ellipsoidal top section (Figures6B – shows the ellipse for each plane of the 3D figure, see [0096-0112] for written description of dimensions; [0113] – casing divided into two halves which could be considered the top and bottom). The casing is displayed and described as being elliptical in shape with a curved surface (Figure 6F, [0095], [0113]), which is interpreted as a regular surface pattern (i.e. smooth surface pattern). However, Wolf does not disclose wherein the step of forming the ellipsoidal top section further comprises: forming a second regular surface pattern, in a central region of the ellipsoidal top section, between a pair of optical header bays.
Single, in the same field of endeavor of an implantable stimulator ([0009]), teaches a first header ([0059] – with a specified function) attached on one side of the device and a second header ([0060] – with a specified function) attached on the opposite side of the device ([0074]) with body section 103 positioned in between the headers (Figure 8, [0062]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case with a single optical bay by incorporating the two header design for a stimulator in Single. This would have been obvious because both Wolf and Single relate to implantable stimulators with header compartments and Single provides a solution/improvement which allows a second header compartment to be added on the opposite side of the device to increase the connection points (add functions) and reduce interference between device components (e.g. adding an opposing optical bay to match the existing optical bay in Wolf). Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the two header design for a stimulator in Single.
Therefore, Claim 24 is obvious over Wolf in view of Single.
Claim 26 is rejected under U.S.C 103 as being unpatentable over Wolf II (US PG Pub 2021/0001114 A1, see 11/15/2023 IDS), to be referred to as Wolf, in view of Cola (US PG Pub 2021/0063099 A1, see “Notice of References Cited”) and Single (US PG Pub 2021/0268293 A1, see “Notice of References Cited”).
Regarding Claim 26, the method of forming an implantable pulse generator case according to claim 24 is obvious over Wolf in view of Single, as indicated hereinabove. Wolf further discloses the step of forming the ellipsoidal top section (Figure 6B – shows the ellipse for each plane of the 3D figure, see [0096-0112] for written description of dimensions; [0113] – casing divided into two halves which could be considered the top and bottom). However, Wolf does not disclose wherein the step of forming the ellipsoidal top section further comprises: providing the second regular surface pattern as one of indentions, protruding nodes and striations.
Cola, in the same field of endeavor of casing materials and designs for electronic devices ([0018]), teaches a heat sink to be placed around an electronic device to disperse heat ([0024]). Cola teaches polymeric protrusions on the surface which increase the surface area of the heat sink to improve heat transfer ([0059]). The heat sink design in Cola is interpreted as being applied to surround the electronic device (e.g. top or bottom surface of the device in Wolf). The polymeric protrusions are described as being placed regularly and able to have circular cross sections ([0057]).
Nodes are described in the instant specification as “Referring then to Figure 7I, another preferred pattern of indentions or raised nodes is shown. In this example, the shape of each of the indentions or raised nodes is circular with a generally hemispherical cross section, such as pattern 782” ([0090]), which is interpreted as matching with the polymeric protrusions in Cola. Only protruding nodes are interpreted as necessary based on the claim language, but the same rationale for the indentions in claims 8-9 and 16-17 and striations in claims 6-7 and 14-15 could be incorporated into the argument for this claim as well.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wolf’s implantable pulse generator case by incorporating the surface heat sink protrusion design in Cola. This would have been obvious because both Wolf and Cola are concerned with temperature regulation to prevent excessive device temperatures and Cola provides a solution/improvement which provides a heat sink with protrusions on the case to improve heat dispersion rate and prevent overheating. Therefore, a person of ordinary skill in the art would be motivated to improve the device in Wolf by incorporating the heat sink protrusion design in Cola.
Therefore, Claim 26 is obvious over Wolf in view of Cola and Single.
Claims 6-7, 14-15, and 21 are rejected under U.S.C 103 as being unpatentable over Wolf II (US PG Pub 2021/0001114 A1, see 11/15/2023 IDS), to be referred to as Wolf, in view of Mira (US 5,709,263, see “Notice of References Cited”).
Regarding Claim 6, the implantable pulse generator case according to claim 2 is anticipated by Wolf, as indicated hereinabove. Wolf discloses a casing divided into two halves which could be considered the top and bottom ([0113]). Wolf establishes excessive temperatures as unacceptable ([0019]) and includes changes in device usage ([0019]) and heat sinks ([0211]) to reduce or disperse heat. However, Wolf does not disclose wherein the second regular surface pattern is a set of striations arranged in a generally parallel pattern.
Mira, in the same field of endeavor of surface designs for electronic devices (Col 3, Lines 19-29), teaches a heat sink to be placed around an electronic device to disperse he