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 .
Response to Amendment
The amendments filed 03 April 2026 have been entered. Claims 1 – 11 are pending. Applicant’s amendments have overcome each and every rejection under 35 U.S.C. 112 previously applied in the office action dated 03 December 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 11 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 (lines 6 - 7), Claim 10 (line 7 – 8), and Claim 11 (line 7 – 8) each recite the term “the first interface portion and the second interface portion being defined by parts of the flexible sheet”. It is unclear if these recites “parts” are the first interface portion and second interface portion, such that they could be interchangeably referred to as a first and second part. Alternatively, the “parts” are another structure on the sheet beyond the interfaces, such that there is another structure there (like a pin, grommet, or indent). The metes and bounds of what constitutes each of the “parts” of the flexible sheet or what they could be are unclear. The “parts” are not clearly defined by the specification. For the purposes of examination for Claim 1, the term “the first interface portion and the second interface portion being defined by parts of the flexible sheet” is deemed to claim “the first interface portion and the second interface portion being defined by the overlapping portion.” Claims 2 – 9 are similarly rejected due to their dependence on Claim 1.
Claim 1 (lines 17 - 20), Claim 10 (lines 15 – 18), and Claim 11 (lines 15 – 18) each recite the terms “wherein the first material at the first interface portion extends through more than 20% of the thickness of the flexible sheet at the first interface portion” and “wherein the second material at the second interface portion extends through more than 20% of the thickness of the flexible sheet at the second interface portion”. In light of the amendment and discussion above regarding the unclear “parts” of the flexible sheet, and the additional recitation of “at the first interface portion” and “at the second interface portion”, it is additionally unclear whether the first (or second) interface portion is the entire latitudinal thickness of the “thickness at the interface portion”, but for only 20% of that interface (such as with a split-material at the interface), or if it supposed to be a longitudinal layering of at least 20% first (or second) material such that the first (or second) material is the entirety of the first (or second) interface.
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Figure A: Examiner-annotated drawing of possible interpretations of the limitations regarding the 20%, “thickness”, and what the interface portions.
Further, in light of the arguments submitted on 03 April 2026 ([Page 8, Bottom] – [Page 9, Top]), it becomes additionally unclear if the second interface can be 100% the second material, since it is argues that the embodiments in Figure 3A – 3B and Figure 4 are such that the entire flexible sheet includes the first material except for a “part of the sheet defining the second interface portion.” Looking to Figure 3B, the “second interface portion 30” appears to be extending outward from the material of “opposing second face 24.”, suggesting that the second material of the second interface portion adds to the thickness of the sheet rather than being inset into the sheet. For the purposes of examination, the term “wherein the first material at the first interface portion extends through more than 20% of the thickness of the flexible sheet at the first interface portion” is deemed to claim “wherein the first interface portion has a first material at the first face layered with a second material at the second face, with a first ratio of thickness between the first material and the second material of 2:5”, and “wherein the second material at the second interface portion extends through more than 20% of the thickness of the flexible sheet at the second interface portion” is deemed to claim “wherein the second interface portion has a second material at the second face layered with the first material at the first face, with a second ratio of thickness between the first material and the second material of 2:5.”, Claims 2 – 9 are similarly rejected due to their dependence on Claim 1.
Claim 2 (line 8) recites the term “a different material”. It is unclear if this is intended to be the same different material or another different material from that which is previously-recited. For the purposes of examination, the term “a different material” in line 8 is deemed to claim “a differing material”.
Claim 2 (line 4) recites the term “a first residual portion”. It is unclear if this is intended to be the same or different than the previously-recited first residual portion. For the purposes of examination, the term “a first residual portion” is deemed to claim “the first residual portion”.
Claim 2 (line 8) recites the term “a second residual portion”. It is unclear if this is intended to be the same or different than the previously-recited second residual portion. For the purposes of examination, the term “a second residual portion” is deemed to claim “the second residual portion”.
Claim 2 (lines 3 – 9) recites the term “wherein one of: (i) the first face is defined by a first residual portion and the first interface portion, and the first interface portion comprises a different material to the first residual portion and the second interface portion; or (ii) the second face is defined by a second residual portion and the second interface portion, and the second interface portion comprises a different material to the second residual portion and the first interface portion.” The term is unclear because there appears to be a condition in which both (i) and (ii) can be true. There is a first face and a second face, and it appears that they could both be defined by respective residual portions, and they could both comprise a different material to the first and second residual portion. Therefore, it is unclear if the metes and bounds require that only one condition be true, or if it is at least one. For the purposes of examination, the term “wherein one of…first interface portion” is deemed to claim “wherein at least one of…first interface portion”.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 4 and 8 – 9 are rejected under 35 U.S.C. 103 as being unpatentable over Nakanishi et al., (United States Patent Application Publication US 20100121205 A1), hereinafter Nakanishi. in view of Elliott et. al., (WO 2014125431 A1) hereinafter, Elliott.
Regarding Claim 1, Nakanishi discloses
A shell cuff (Fig 1, [Abstract]) for use with an actuator cuff (Fig 1, [Abstract]; [0065]) and sensor pad (Fig 1; [0004]) in hemodynamic monitoring ([Abstract]), the shell cuff comprising:
a flexible sheet (Fig 1, Fig 2, [0054] “core 2…a substantially rectangular sheet…” with “inner cover 21” and “cushion member 6”) comprising
a first face (Fig 1, “ONE END”’s inner wall facing to the right in the figure) and an opposing second face (Fig 1, “OTHER END’s outer wall, facing to the left in the figure), the flexible sheet being curved such that a first end of the flexible sheet and an opposing second end of the flexible sheet overlap to form an overlapping portion (Fig 1, “ONE END” and “OTHER END” curved to an overlap; [0001] “…overlapping parts of a cuff”; [0050] ”This cuff 1 is used in a rolled condition where one end of the cuff is wound within the other end thereof.”) in which a first interface portion of the first face (Fig 1, overlapping portion of “ONE END”’s inner wall facing to the right in the figure, [0079] “an inner cover 21”) (Fig 1, “ONE END’s outer wall, facing to the right in the figure, the portion that is overlapping, including “rod member 43”; [0070] “an inner cover 21”), interfaces with a second interface portion of the second face (Fig 1, overlapping portion of “OTHER END”’s inner wall facing to the left in the figure, [0098] “raised fabric 61”; [005] “outer cover 22”), the first interface portion (Fig 1, overlapping portion of “ONE END”’s inner wall facing to the right in the figure, [0079] “an inner cover 21”) and the second interface portion being defined by parts of the flexible sheet (Fig 1, overlapping portion of “OTHER END”’s inner wall facing to the left in the figure, [0098] “raised fabric 61”; [0005] “outer cover 22”)(Examiner notes that both the first interface portion and the second interface portion are on the rectangular sheet, “core 2” with the “inner cover 21” and “cushion member 6”, such that the interfaces are broadly defined by overlapping parts of the flexible sheet.)
wherein the second face (Fig 1, “OTHER END’s outer wall, facing to the left in the figure) is defined by a second residual portion (Fig 1, “OTHER END’s outer wall, facing to the left in the figure, the portion that is not overlapping), and the second interface portion (Fig 1, “OTHER END’s outer wall, facing to the left in the figure, the portion that is overlapping including “raised fabric 61”), and wherein the second interface portion is flush with the second residual portion (Fig 1, “OTHER END’s outer wall, facing to the left in the figure, overall outward-facing portion)(Examiner notes that the residual portion and interface portion are both colinear along the outer face, or “outer cover 22”, so they are flush on at least one side.):
wherein the flexible sheet is configured to be tightened on application of force so as to increase the size of the overlapping portion between the first face and the second face (Fig 1, [0065] “fastening means 5 tightens the core 2…onto the upper arm and maintains the tightened state…tightening belt 51”);
wherein the first interface portion is made from a first material (Fig 1, [0079] “an inner cover 21”; [0054] “resin cloth”) and the second interface portion is made from a second material (Fig 1, [0098] “raised fabric 61”) which is different to the first material (Fig 1, [0098] “raised fabric”; [0055] “a raised fabric 61 like the loop surface of a hook-and-loop fastener, for example, is used.” is different than [0079] “an inner cover 21”; [0054] “ Resin cloth is generally used for the inner cover 21 and the outer cover 22.”),
wherein the sensor pad ([0004] “a pressure sensor 113”)…measure a hemodynamic parameter ([0001] “a blood pressure monitor”; [0070] “pressures sensor 113…detects a pressure signal containing a pulse wave”).
Nakanishi does not specifically disclose and wherein the first material at the first interface portion extends through more than 20% of the thickness of the flexible sheet at the first interface portion (Fig 1, overlapping portion of “ONE END”’s inner wall facing to the right in the figure, [0079] “an inner cover 21”)(See 112(b) interpretation above), and the second material at the second interface portion extends through more than 20% of the thickness of the flexible sheet at the second interface portion (Fig 1, overlapping portion of “OTHER END”’s inner wall facing to the left in the figure, [0098] “raised fabric 61”; [0005] “outer cover 22”)(Examiner notes that the dimensions may be chosen through routine experimentation such that they each extend through more than 20% of the thickness of the flexible sheet at the first interface portion for manufacturability for the application of the cuff shell sheet, where [0057] teaches that this can be a design choice.), and wherein the sensor pad is filled with liquid to measure a hemodynamic parameter. However, Nakanishi does disclose at [0057] “the kind, thickness, size, number and attachment place of the raised fabrics 61 can be freely selected”. Therefore, the claimed features of “wherein the first material at the first interface portion extends through more than 20% of the thickness of the flexible sheet at the first interface portion, and the second material at the second interface portion extends through more than 20% of the thickness of the flexible sheet at the second interface portion” are considered a design choice. As such, person having ordinary skill in the art before the effective filing data of the claimed invention could have modified the thicknesses of “inner cover 2” and “cushion member 6” (and “core 2”) disclosed in Nakanishi to have the claimed thickness relative to the thickness of the overall sheet (“core 2” and “inner cover 21” and “cushion member 6”), through routine experimentation for their desired application of the blood pressure cuff shell sheet.
Elliott teaches a personal monitor for acquiring blood pressure measurement signals, including a fluid-filled occlusion means and pressure sensor. Specifically for Claim 1, Elliott teaches wherein the sensor pad is filled with liquid to measure a hemodynamic parameter ([Page 23, Line 32] – [Page 24, line 5],”signal acquisition device…blood flow occlusion means…sealed vessel containing an essentially incompressible fluid in which is immersed a pressure sensor…fluid may be a quasi-solid gel or…a liquid”)
Both Nakanishi and Elliott disclose and teach blood pressure cuffs with pressure sensors that sense blood pressure with a cuff that inflated using a fluid: Nakanishi with “pressure sensor 113” measuring pressure associated with “air bag 3” using air as the fluid, and Elliott with a pressure sensor in an enclosed pad with a liquid as fluid associated with a “blood flow occlusion” means. Elliott provides a motivation to combine at [Page 23, Line 32] – [Page 24, line5] with “”PHHM includes a blood flow occlusion means that is a sealed vessel…immersed a pressure sensor which is adapted to provide electrical signals to the processor…” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using an incompressible liquid-filled pack with a pressure sensor would be useful for obtaining consistent pressure measurement values in a blood pressure cuff device as an alternative to air as the fluid for a flow-occluding cuff means.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the pressure sensor with an airbladder blood pressure measurement system disclosed in Nakanishi with the liquid bladder pressure sensor for blood pressure measurement taught by Elliott, creating a single blood pressure measurement with a shell and liquid-filled pressure sensing means for acquiring signals.
Regarding Claim 2, Nakanishi in view of Elliott discloses as described above, The shell cuff according to claim 1. For the remainder of Claim 2, Nakanishi discloses wherein the first face (Fig 1, “ONE END’s outer wall, facing to the right in the figure) is defined by a first residual portion (Fig 1, “ONE END’s outer wall, facing to the right in the figure, the portion that is not overlapping) and the first interface portion (Fig 1, “ONE END’s outer wall, facing to the right in the figure, the portion that is overlapping, including “rod member 43”), and wherein one of
the first face is defined by a first residual portion (Fig 1, “ONE END’s outer wall, facing to the right in the figure, the portion that is not overlapping) and the first interface portion (Fig 1, “ONE END’s outer wall, facing to the right in the figure, the portion that is overlapping, including “rod member 43”), and the first interface portion (Fig 1, “ONE END’s outer wall, facing to the right in the figure, the portion that is overlapping, including “rod member 43”; [0064]) comprises a different material to the first residual portion (Fig 1, “ONE END’s outer wall, facing to the right in the figure, the portion that is not overlapping—including the “rod member”, which is [0064] “the rod member 43…metal in terms of strength, but may be made of a resin.” versus Fig 1, “OTHER END’s outer wall, facing to the left in the figure, the portion that is not overlapping; [0005] “outer cover 22”; [0054] “Resin cloth…used for...outer cover 22.”)(Examiner notes that the rod can be a solid resin material and the residual portion a resin cloth, which is broadly different) and the second interface portion (Fig 1, “OTHER END’s outer wall, facing to the left in the figure, the portion that is overlapping including “raised fabric 61”, versus Fig 1, “OTHER END’s outer wall, facing to the left in the figure, the portion that is not overlapping; [0005] “outer cover 22”; [0054] “Resin cloth…used for…outer cover 22.”), or
the second face is defined by a second residual portion and the second interface portion, and the second interface portion comprises a different material to the second residual portion and the first interface portion
Regarding Claim 3, Nakanishi in view of Elliott discloses as described above, The shell cuff according to claim 1. For the remainder of Claim 3, Nakanishi discloses wherein the flexible sheet (Fig 1, [0054] “core 2…a substantially rectangular sheet…” with “inner cover 21” and “cushion member 6”) comprises:
a first layer comprising the first material which forms the first face (Fig 1, [0079] “an inner cover 21”; [0054] “…resin cloth…”) and
a second layer comprising the second material which forms the second face (Fig 1, [0050] “cushion member 6”; [0055] “cushion member 6…a raised fabric 61 like the loop surface of a hook-and-loop fastener…”).
Regarding Claim 4, Nakanishi in view of Elliott discloses as described above, The shell cuff according to claim 1. For the remainder of Claim 4, Nakanishi discloses wherein at least one of the first face or the second face (Fig 1, [0055] “…raised fabric 61…”) comprises a textured surface (Fig 1, [0050] “cushion member 6”; [0055] “cushion member 6…a raised fabric 61 like the loop surface of a hook-and-loop fastener…”). on at least the respective first interface portion or the second interface portion (Fig 1, [0050] “cushion member 6”; [0055] “cushion member 6…a raised fabric 61 like the loop surface of a hook-and-loop fastener…” on “OTHER END”’s outer wall, the portion that is overlapping).
Regarding Claim 8, Nakanishi in view of Elliott discloses as described above, The shell cuff according to claim 1. For the remainder of Claim 8, Nakanishi discloses wherein the first face (Fig 1, “ONE END’s outer wall, facing to the right in the figure) is defined by a first residual portion (Fig 1, “ONE END’s outer wall, facing to the right in the figure, the portion that is not overlapping) and the first interface portion (Fig 1, “ONE END’s outer wall, facing to the right in the figure, the portion that is overlapping, including “rod member 43”), and wherein the first interface portion is flush with the first residual portion. (Fig 1, “ONE END’s inner wall, facing to right in the figure, overall inward-facing portion)( Examiner notes that the residual portion and interface portion are both colinear along the inner face, or “inner cover 21”, so they are flush on at least one side.).
Regarding Claim 9, Nakanishi in view of Elliott discloses as described above, The shell cuff according to claim 1. For the remainder of Claim 9, Nakanishi discloses A hemodynamic monitoring kit ([Abstract]) comprising: a pressure sensor pad ([0004] “a pressure sensor 113”); and
the actuator cuff (Fig 1, “air bag 3” with “fastening means 5” with “tightening belt 51”) configured to surround the shell cuff (Fig 1 and 2, “air bag 3” on one side on “cuff 2” and “fastening means 5” with “tightening belt” 51 around the other side of the shell of “sheet 2”, “inner cover 21” and “cushion member 6”))(Examiner notes that the sheet is surrounded by the means that actuate and tighten the cuff, applying pressure.) and to inflate to apply pressure to the shell cuff ([0070] “when air is sent into the air bag 3….the air bag 3 compresses the arm…”; [0071] “air is further sent into the air bag 3…one end and the other end of the cuff 1 move a slight distance away from each other”)
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nakanishi in view of Elliott, further in view of Cong et. al., “Wireless Less-Invasive Blood Pressure Sensing Microsystem for Small Laboratory Animal In Vivo Real-Time Monitoring”, hereinafter Cong, further in view NuSil “Options for Reducing Friction When Using Silicone Elastomers”, hereinafter NuSil.
Regarding Claim 5, Nakanishi in view of Elliott discloses as described above, The shell cuff according to claim 1. For the remainder of Claim 5, Nakanishi discloses wherein at least one of the first interface portion and the second interface portion comprises a compressible material impregnated with silicone oil which is configured to be released on application of pressure to the compressible material.
Nakanishi does not disclose wherein at least one of the first interface portion and the second interface portion comprises a compressible material impregnated with silicone oil which is configured to be released on application of pressure to the compressible material.
Cong teaches an instrumented circular blood pressure measurement cuff made of soft biocompatible silicone material with components immersed in silicone oil. Specifically for Claim 5, Cong teaches wherein at least one of the first interface portion and the second interface portion comprises a compressible material ([Page 3, Left Column] “…silicone cuff…pre-curved internal cuff structure with a circular profile…attaching a silicone base with a pre-defined geometry to a pre-stretched thin silicone membrane…”, “biomedical-grade silicone…”) with silicone oil ([Page 2, Left Column, “2. Wireless Less-Invasive Long-Term Implantable Blood Pressure Monitoring” section] “…elastic circular cuff is made of bio-compatible elastomer and is filled with low viscosity bio-compatible insulating fluid…silicone oil”).
Cong provides a motivation to combine at [Page 2, Right Column, 1st full paragraph] with “…since the cuff is made of soft elastic material, the restrictive effect on the vessel is substantially minimized, thus suitable for long-term monitoring”. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using silicone material for a blood pressure cuff on a body part would be useful for a biocompatible material that that is comfortable, gentle, and not-restrictive on the skin (or blood vessel) when the additional constriction is not desired. It would have been predictable to use the silicone cuff material choice and associated low viscosity silicone oil interface in any similar apparatus that wraps around a human body part for blood pressure measurement, as it would continue to operate with the function of wrapping around a body part to bring blood pressure measurement instrumentation in proximity to the body.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the flexible elastomer blood pressure cuff system disclosed in Nakanishi with the bio-compatible silicone elastomer cuff with silicone oil interface taught by taught by Cong, creating a single blood pressure cuff assembly with an advantageously bio-compatible and comfortable interface for user wear.
Cong does not teach that the compressible material is impregnated with silicone oil which is configured to be released on application of pressure to the compressible material.
NuSil teaches methods to reduce friction when using silicone elastomers in medical devices, such as using liquid silicone rubber in self-lubricating elastomer setting to reduce friction. Specifically for Claim 5, NuSil teaches at least one of the first interface potion and the second interface portion ([Page 2, “Self-Lubricating LSRS” Section] “minimizing friction at the interfaces between various components…”) comprises a compressible material ([Page 2, “Self-Lubricating LSRS” Section] “silicone devices…”; [Page 1, Figure]) impregnated with silicone oil ([Page 1, Bottom] “lubricating liquid silicone rubber (LSR)”; [Page 2, “Self-Lubricating LSRS” Section]) which is configured to be released on application of pressure to the compressible material ([Page 2, “Self-Lubricating LSRS” Section] “medical device manufacturers…silicone elastomer system…lubricity is built in…formulated…elutes…minimizing friction at the interfaces between various components…silicone devices with moving or sliding parts”)
NuSil provides a motivation to combine at [Page 2, “Self-Lubricating LSRS” Section] “The performance of many medical devices depends upon minimizing friction at the interfaces between various components, and self-lubricating LSRs provide the basis on which to produce effective results.“ A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that incorporating a self-lubricating elastomer system with an LSR additive that elutes out over time would be useful for minimizing friction at the interfaces between components, such as at the interface between blood pressure cuff shell interface surfaces. This material is a biomedical-grade silicone, as is the “biomedical-grade silicone” taught by Cong for the combination of Nakanishi in view of Elliott, with Cong above.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the silicone cuff material blood pressure cuff system with overlapping interface surfaces disclosed in Nakanishi in view of Elliott, further in view of Cong, with NuSil’s taught silicone elastomer system self-lubricating LSR that elutes the lubricant, creating a single blood pressure cuff assembly with an advantageously low-friction interface between its shell surfaces.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nakanishi in view of Elliott, further in view of Mizukoshi, et. al., (United States Patent US 7,070,567 B2), further in view of Nishida et. al., (United States Patent Application Publication US 2020/0323445 A1).
Regarding Claim 6, Nakanishi in view of Elliott discloses as described above, The shell cuff according to claim 1. For the remainder of Claim 6, Nakanishi does not disclose wherein the first material comprises HDPE, and the second material comprises a polyamide, and wherein the first material and the second material are bonded together with an adhesive layer.
Mizukoshi teaches a blood pressure device with a shield plate to support the cuff to be a cylinder shape, the plate being made of high-density polyethylene. Specifically for Claim 6, Mizukoshi teaches wherein the first material comprises HDPE ([Column 4, Lines 15 – 16] “The shield plate 40 is made of high-density polyethylene…”), and the second material comprises a polyamide ([Column 4, Lines 53 – 64] “…separating cloth 38…separating cloth 38 is in contact with the shield plate 40…low friction of the separating cloth 38 reduces noises produced in blood pressure measurement by friction between the separating cloth 38 and the shield plate 40…”; [Column 4, Lines 10 - 14] “…separating cloth 38 has a surface of raised nylon cloth”).
Nakanishi and Mizukoshi both disclose and teach multi-material blood pressure cuff assemblies with structural “shell” sheet members, with one of the materials for use in noise-reduction purposes: Nakanishi with the overlapping “shell” sheet a tightening belt and raised fabric 61 [Nakanishi: 0055] “at a place where one end and the other end of the cuff 1 rub against each other, and absorbs, with its raised fibers, vibrations caused by the friction…effectively prevent noise”, and Mizukoshi with the HDPE shield plate and nylon “raised” surface that reduces noises produced by friction. Mizukoshi provides a motivation to combine at ([Col 1, Lines 54 – 59] with “…a shield play is adhered so as to prevent oscillation of the outer bag from propagating to the inner bag” and polyamide [Column 4, Lines 53 – 64] “…separating cloth 38…separating cloth 38 is in contact with the shield plate 40…low friction of the separating cloth 38 reduces noises produced in blood pressure measurement by friction between the separating cloth 38 and the shield plate 40…” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that including a shield material made of HDPE with a nylon raised fiber cloth would be useful for reducing noise in a blood pressure cuff assembly due to friction.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the blood pressure cuff and shell device made of elastomer and broadly “raised fabric” parts disclosed by Nakanishi with Mizukoshi’s taught HDPE and nylon raised fabric shell-associated parts, creating a single blood pressure apparatus with a suitable shell for reducing noise with its raised nylon interface.
Mizukoshi does not teach wherein the first material and the second material are bonded together with an adhesive layer.
Nishida teaches a wrist-worn blood pressure measurement device with a sheet that forms a shell on the wrist within a wristwatch form factor, and the sheet is produced option manufacturing methods including injection molding, thermoforming, and extrusion ([Abstract]; [0120] - [0122]). Specifically for Claim 6, Nishida teaches wherein the first material and the second material are bonded together with an adhesive layer ([0101] “The back plate 72 is adhered to the outer surface 86a1 of the first sheet member 86a of the pressing cuff 71 with an adhesive layer or double-sided tape…back plate 72 may be formed of a resin material into a plate…shape-conforming capability”).
Nishida provides a motivation to combine at [0101] “The back plate is adhered to the outer surface…back plate has a shape-conforming capability” and [0102] “…can conform to the shape of the contact portion of the wrist”. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that adhering layers of material would be useful for connecting materials that are intended to have a conforming shell shape around a limp, such as for a blood pressure cuff shell.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the multiple materials for blood pressure cuff shell sheet materials disclosed in Nakanishi in view of Mizukoshi with adhering layers of material with adhesive or double-sided tape taught by Nishida, creating a single multi-material blood pressure cuff assembly with a shell that can conform to a cylindrical shape while its layers stay suitably connected.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nakanishi in view of Elliott, further in view of Pfeiffer, et. al., (United States Patent Application Publication US 2015/0359446 A1), hereinafter Pfeiffer.
Regarding Claim 7, Nakanishi in view of Elliott discloses as described above, The shell cuff according to claim 1. For the remainder of Claim 7, Nakanishi discloses wherein the first material comprises a first plastic (Fig 1, [0079] “an inner cover 21”; [0054] “…resin cloth…”).
Nakanishi does not disclose and the second material comprises the first plastic modified with PTFE particles or silicone oil.
Pfeiffer teaches a blood pressure measurement system with an overlapping portion made of PTFE. Specifically for Claim 7, Pfeiffer teaches wherein the first material comprises a first plastic ([0046] “…kinking-proof shell might be made from…polytetrafluorethylene (PTFE)”), and the second material comprises the first plastic modified with PTFE particles ([0046] “…kinking-proof shell might be…coated with polytetrafluorethylene (PTFE)”) or silicone oil.
Pfeiffer provides a motivation to combine at [0046] with “The material…is stiff enough not to buckles when pressure is applied by the pressurization means, and that the kinking-proof shell, on the other hand, is flexible enough so as to allow a reduction of its inner diameter when pressure is applied by the pressurization means”. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using a material and thickness for the shell that includes PTFE would be useful for a supportive shell that does not kink and has low friction qualities.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the blood pressure cuff overlapping-sheet shell disclosed in Nakanishi with the PTFE shell material and PTFE shell coating taught by Pfeiffer, creating a single blood pressure assembly with a shell that is flexible enough to form the shell without kinking and low friction enough to slide along itself during inflation and deflation pressure changes in blood pressure measurement.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Nakanishi in view of Elliott, further in view of Nishida et. al., (United States Patent Application Publication US 2020/0323445 A1), hereinafter Nishida.
Regarding Claim 10, Nakanishi in view of Elliott discloses as described above in claim 1, the shell cuff comprises the sheet comprising a first face and an opposing second face, the sheet being curved such that a first end of the sheet and an opposing second end of the sheet overlap to form an overlapping portion in which a first interface portion of the first face interfaces with a second interface portion of the second face, the first interface portion and the second interface portion being defined by parts of the sheet, and wherein the second face is defined by a second residual portion, and the second interface portion, and wherein the second interface portion is flush with the second residual portion, wherein the sheet is configured to be tightened on application of force so as to increase the size of the overlapping portion between the first face and the second face, wherein the first interface portion is made from the first material and the second interface portion is made from second material which is different to the first material, and wherein the first material at the first interface portion extends through more than 20% of the thickness of the sheet at the first interface portion, and the second material at the second interface portion extends through more than 20% of the thickness of the sheet at the second interface portion, and wherein the sensor pad is filled with liquid to measure a hemodynamic parameter (See Rejection of Claim 1 above).
The motivation for Claim 10 to combine Nakanishi and Elliott for the limitations above is the same as that of Claim 1. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the pressure sensor with an airbladder blood pressure measurement system disclosed in Nakanishi with the liquid bladder pressure sensor for blood pressure measurement taught by Elliott, creating a single blood pressure measurement with a shell and liquid-filled pressure sensing means for acquiring signals.
For the remainder of Claim 10, Nakanishi does not specifically also does not specifically disclose A method of manufacturing a shell cuff, the method comprising injection moulding the first material and the second material to form a sheet and thermoforming the sheet to form a shell cuff, wherein the shell cuff comprises the sheet
Nishida teaches a wrist-worn blood pressure measurement device with a sheet that forms a shell on the wrist within a wristwatch form factor, and the sheet is produced option manufacturing methods including injection molding, thermoforming, and extrusion. Specifically for Claim 10, Nishida teaches A method of manufacturing a shell cuff ([0122]), the method comprising injection moulding the first material and the second material to form a sheet ([0122] “sheet members 86b, 86c, and 86d…and the sheet member 96b…are shaped with a forming technique such as…injection”; Fig 1, Fig 9, Fig 13;) and thermoforming the sheet to form a shell cuff ([0122] “…a forming technique such as…thermal pressing…may be used for producing a concave/convex pattern…”; Fig 1, Fig 9, Fig 13), wherein the shell cuff comprises the sheet ([0122])
Nishida provides a motivation to combine at [0122] with multiple interchangeable manufacturing methods presented including “When a thermoplastic elastomer is adopted, the sheet members…are shaped with a forming technique such as T-die extrusion, injection, blow molding, and calendaring” and [0123] “…a forming technique such as embossing, thermal pressing, vacuum forming, or pressure forming may be used for producing a concave/convex pattern…” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that injection molding and thermoforming are common manufacturing methods that can be chosen for making sheets of thermoplastic medical device parts into particular profiles and geometries.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the blood pressure cuff and shell device made of elastomer parts disclosed by Nakanishi with the injection molding and thermoforming manufacturing processes for a thermoplastic elastomer blood pressure cuff shell parts taught by Nishida, creating a single blood pressure cuff assembly with a shell precisely manufactured using well-known thermoplastic manufacturing methods of injection molding and thermoforming.
Regarding Claim 11, Nakanishi in view of Elliott discloses as described above in Claims 1 and 10, A method of manufacturing a shell cuff, thermoforming the sheet to form the shell cuff, wherein the shell cuff comprises the sheet (See Claim 10 citation and combination);
wherein the shell cuff comprises the sheet comprising a first face and an opposing second face, the sheet being curved such that a first end of the sheet and an opposing second end of the sheet overlap to form an overlapping portion in which a first interface portion of the first face interfaces with a second interface portion of the second face, the first interface portion and the second interface portion being defined by parts of the sheet, and wherein the second face is defined by a second residual portion, and the second interface portion, wherein the second interface portion is flush with the second residual portion, the sheet is configured to be tightened on application of force so as to increase the size of the overlapping portion between the first face and the second face, the first interface portion is made from the first material and the second interface portion is made from the second material which is different to the first material, the first material at the first interface portion extends through more than 20% of the thickness of the sheet at the first interface portion, the second material at the second interface portion extends through more than 20% of the thickness of the sheet at the second interface portion, the sensor pad is filled with liquid to measure a hemodynamic parameter, and the sheet comprises a first layer comprising the first material which forms the first face; and a second layer comprising the second material which forms the second face (See Rejection of Claims 1 and 10 above).
The motivation for Claim 11 to combine Nakanishi and Elliott for the limitations above is the same as that of Claim 1. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the pressure sensor with an airbladder blood pressure measurement system disclosed in Nakanishi with the liquid bladder pressure sensor for blood pressure measurement taught by Elliott, creating a single blood pressure measurement with a shell and liquid-filled pressure sensing means for acquiring signals.
Nakanishi does not specifically disclose extruding a first material and a second material to form a sheet having at least two extruded layers.
Nishida teaches extruding a first material and a second material to form a sheet having at least two extruded layers ([0122] “sheet members 86b, 86c, and 86d…and the sheet member 96b…are shaped with a forming technique such as T-die extrusion.”)
The motivation for Claim 11 to combine Nakanishi and Nishida is similar to that described in more detail in Claim 10. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the blood pressure cuff and shell device made of elastomer parts disclosed by Nakanishi with the injection molding and thermoforming manufacturing processes for a thermoplastic elastomer blood pressure cuff shell parts taught by Nishida, creating a single blood pressure cuff assembly with a shell precisely manufactured using well-known thermoplastic manufacturing methods of extrusion and thermoforming.
Response to Arguments
Applicant's arguments filed 03 April 2026 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 103 Rejections:
Applicant argues at [Page 7, ”Rejections under 35 U.S.C. 103”Section] – [Page 8, Top] that hindsight substitution of fundamentally different analytical approaches is improper when the prior art does not suggest doing so in the manner claimed. There is no specific citation in the argument of where such hindsight was employed. The argument is not persuasive.
Applicant argues at [Page 8, 1st Full Paragraph] that a “design choice” rationale is only proper when the claimed difference is merely a change in form, size, shape, proportion, or arrangement of the same prior-art structure, without a demonstrated different in function or operation, and that a “recognized result-effective variable” must be identified. Based on the 35 U.S.C. 103 rejection citations above, the difference is a change in the size/proportion, thickness, of the same layered cuff structure. Regarding the claimed “second material…extends through more than 20% of the thickness of the flexible sheet”, it is an element of routine experimentation in manufacturing to tune the thickness of the material to the chosen manufacturing process in order to ensure that it can, for example, properly de-mold from the machine, maintain a uniform wall thickness, avoid tears, still be flexible, etc. Further, depending on material choice, there are well-known requirements for manufacturing thickness, such that a person with ordinary skill in the art would make thickness choices within the design for manufacturability requirements for the material. A person with ordinary skill in the art given the broad design requirement for there to be a first and second material together relative to an interface would potentially begin with a ratio of 1:1 for the material thicknesses and decrease or increase the ratio in order to achieve results that are still manufacturable with the necessary equipment, are collectively still within the broad claimed requirement of “flexible”, and that dimensionally fit within any slots or other hardware associated with the materials. The specification provides no clear rationale for where the 20% value specifically originates, other than at [Page 5, Lines 4 - 15] in which the specification describes that for the example in Fig. 3A “In this example, the second material extends through at least one third of the thickness of the sheet”, and that other examples may have the second material “extend through more than 20% of the thickness of the sheet, up to 50% of the thickness or up to the whole thickness of the sheet at the second interface portion.” The reasoning for picking these particular percentages does not appear to be given. There is a relationship of (from [Page 5, Lines 13 – 15]) “a minimum thickness of the first material and the second material of 1.5 mm. This minimum ratio of thicknesses also enables the layers of the sheet to be extruded or injected moulded more easily”, which appears to apply to the minimum thickness of 50%, not 20%. With exemplar minimum sizing in consideration for ease of extrusion or injection molding, this seems to allude to routine experimentation of design for manufacturability. The argument is not persuasive.
Applicant argues at [Page 8, 2rd Full Paragraph] – [Page 9, Top] that the amended claims are not taught or suggest by Nakanishi, because Nakanishi described raised fabric 61 as a separately attached component. Applicant argues that the claimed arrangement is defined by parts of the flexible sheet itself, with the recited materials extending through the thickness of the sheet at those interface portions, as described by the specification with the whole sheet comprising the first material “except for a part of the sheet defining the second interface portion”. As claimed, there is nothing in particular that requires all of the components to be manufactured as a single piece, nor that elements cannot be attached to become part of the flexible sheet. Also, in light of these arguments, it is additionally unclear that if the whole sheet does comprise the first material, then it appears that there cannot truly be a claimed condition in which “the second material at the second interface portion extends through more than 20% of the thickness of the flexible sheet at the second interface portion” (wherein the second interface portion is also “part” of the sheet) with the second material being 100% of the thickness (which is greater than 20%). The second material cannot simultaneously be 100% of the sheet’s thickness in a sections of the sheet, while the first material is the whole sheet. Importantly, once a material has been attached to surface, such as fabric that has be sewn onto a surface, it can be said to be broadly part of that surface (as they can now be moved together as a unit). In this case, attaching layers to the sheet would broadly encompass being part of the sheet. The argument is not persuasive.
Applicant argues at [Page 9, 1st Full Paragraph] that Nakanishi does not disclose as a “result-effective variable the extent to which different materials extend through the thickness of a sheet-defined interface region”. Applicant further argues that Nakanishi does not teach or suggest interface portions defined by parts of the sheet itself, nor the extent to which different materials extend through the thickness of a sheet-defined interface region. Nakanishi specifically discloses that [0057] “the kind, thickness, size, number and attachment place of the raised fabrics 61 can be freely selected”. With the raised fabrics being located at an interface region, as shown in Fig. 1, choosing the “kind, thickness, size, number and attachment place of the raised fabrics 61” with the aim of ensuring manufacturability and geometric fitment in the device mechanisms are all result-effective variables, which could through routine experimentation yield the claimed thickness of at least 20%. There is nothing particularly recited in the claim that indicates that the 20%+ thickness of the second material is also positively requiring inset into the first material/inset into the overall sheet. As recited, the second interface is “defined by parts of the flexible sheet” (see 112(b) rejection above), and those parts could broadly be a section on top of the flexible sheet. Laying second material fabric on top of a first material (and connecting it so that it is now collectively part of the sheet), measuring the thickness, and ensuring that the fabric is at least 20% of that thickness satisfies the scope of the claim as recited.
The argument is not persuasive.
Applicant argues at [Page 9, 2nd Full Paragraph] that the specification associates the claimed thickness relationship with manufacturability for extrusion or injection moulding and permits reduced friction without requiring a coating. Looking to the specification, at [Page 6, Lines 8 – 13] discusses that it is the use of “Both extruding and injection moulding the materials to form a shell cuff having two different materials at an overlap of the shell cuff means that the effect of reduced friction is achieved without requiring a coating for the sheet”. There does not appear to be disclosure in the specification that the thickness relationship itself is what reduces friction without requiring coating. Rather, it is the overall manufacturing processes being chosen that are described to achieve this end. The thickness appears to be chosen for the manufacturing process of choice through routine experimentation. The argument is not persuasive.
Applicant argues at [Page 9, 3rd Full Paragraph] that Elliott does not remedy the deficiencies of Nakanishi. Based on the 35 U.S.C. 103 rejection and discussion above, Elliott is used to teach the fluid-filled sensor pad to measure a hemodynamic parameter, and Nakanishi is used to disclose the remaining elements of Claim 1. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The argument is not persuasive.
Applicant argues at [Page 10, Paragraph 1] – [Page 11, 1st Full Paragraph] that neither Nakanishi nor Elliott teaches interface portions defined by parts of the sheet itself with the claimed through-thickness material arrangement, and Nishida is not cited for curing that structural deficiency. Based on the 112(b) rejection above, it is unclear what the “parts” of the sheet are. Further, as discussed above, Nakanishi specifically discloses that [0057] “the kind, thickness, size, number and attachment place of the raised fabrics 61 can be freely selected”. With the raised fabrics being located at an interface region, as shown in Fig. 1, choosing the “kind, thickness, size, number and attachment place of the raised fabrics 61” with the aim of ensuring manufacturability and geometric fitment in the device mechanisms are all result-effective variables, which could through routine experimentation yield the claimed thickness of at least 20%. There is nothing particularly recited in the claim that indicates that the 20%+ thickness of the second material is also positively requiring inset into the first material/inset into the overall sheet. As recited, the second interface is “defined by parts of the flexible sheet” (see 112(b) rejection above), and those parts could broadly be a section on top of the flexible sheet. Laying second material fabric on top of a first material (and connecting it so that it is now collectively part of the sheet), measuring the thickness, and ensuring that the fabric is at least 20% of that thickness satisfies the scope of the claim as recited. The argument is not persuasive.
Applicant argues at [Page 10, Paragraph 2] that Claims 10 and 11 are directed to the manufacturing embodiments for which the claimed proportions are a “result—effective variable associated with an in-sheet interface region”. As claimed, the first interface portion and the second interface portion are “defined by parts of the flexible sheet”. As discussed above, what the “parts” are is unclear. Whether the interface region is actually residing into the sheet our out from the sheet is also not recited plainly in the claim (see discussion above). The flexible sheet is not precisely claimed as a unibody element with multiple materials embedded a certain distance therein. The argument is not persuasive.
Applicant summarily argues at [Page 11, 4th Full Paragraph] - [Page 12 Top] that Claims 5 – 6 rely on Nakanishi in view of Elliott for the underlying shell cuff, and the additional references applied do not remedy the deficiencies of Nakanishi and Elliott, such that the claims are allowable. Based on the 35 U.S.C. 103 rejection and discussion above, Nakanishi in view of Elliot discloses the elements of Claim 1 for the underlying shell cuff. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The argument is not persuasive.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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/MELISSA JO MONTGOMERY/ Examiner, Art Unit 3791
/PATRICK FERNANDES/ Primary Examiner, Art Unit 3791
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