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 Arguments
The previous objection of claims 2, 9, 10, 14-16 and 18 due to minor informalities has been withdrawn in light of applicant’s amendments made 5/07/2026.
The previous rejection of claim(s) 16-20 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 16 on 5/07/2026.
The rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Hioki et al. (WO 2020/111184 A1) has been withdrawn in light of applicant’s amendment made 5/07/2026. Specifically, Hioki does not teach the constricted portion extending away from the other end of the curved region and toward the first band body and a width of the lower surface region in the constricted portion decreases from the side where the first band body is disposed to the side where the curved region is disposed.
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference O’Brien et al. (US 11,596,417 B2) teaches said limitation.
The rejection of claim 8 under 35 U.S.C. 102(a)(1) as being anticipated by Hioki et al. (WO 2020/111184 A1) has been withdrawn in light of applicant’s amendment made 5/07/2026. Specifically, Hioki does not teach a connecting region at which the interior surface of the upper surface region and the interior surface of the lower surface region are in contact with one another and are connected to one another on a proximal side of the proximal portion of the support member.
Applicant’s arguments with respect to claim 8 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference O’Brien et al. (US 11,596,417 B2) teaches said limitation.
Applicant's arguments filed 5/07/2026 with respect to claim 16 have been fully considered but they are not persuasive. Applicant argues that extending the pad portion 128 of Hioki ‘184 so that it extends to the first band body 150 as stated in the Office Action would eliminate the pad portion 128 and would therefore no longer prevent the end portion 180b of the first expansion portion 180 from coming into contact with the patient’s skin to reduce pain and discomfort to the patient. The examiner respectfully disagrees. It is noted that the modification of Hioki ‘184 in view of Hioki et al. (WO 2020/027122A1) is not intended to eliminate the pad portion 128 of Hioki ‘184, but instead extend the base end portion 126b of the support portion 126 of the pad portion 128 after the fold to further extend between the first expansion portion 180 and the cover member 125 to the one end 151, thereby enclosing the cover member 125. Such a modification would not destroy the pad portion 128 of Hioki ‘184.
Applicant argues that the rationale discussed in the Office Action for modifying the hemostatic device in Hioki ‘184 in view of Hioki ‘122 is not supported by the description of Hioki ‘122 because suppressing the gap between the surface of the back of the patient’s hand and the main body portion 120 is a result of the first region 121 being more flexible than the support member 125. However, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the addition of a layer between the cover member 125 and expanding member 170 of Hioki ‘184 would increase the force against the expansion of the expanding member 170, thereby helping to suppress a gap between the patient’s hand and the cover member 125.
Applicant argues the prior art fails to disclose the main body is comprised of a sheet, at least a portion of which is folded upon itself to define the inner side layer, the curved portion, and the outer side layer because in Hioki ‘122 there are simply two separate sheets of material that are positioned on either side of the support member. 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). Hioki ‘184 teaches a sheet that is folded over on itself to define an inner side layer, a curved portion, and an outer side layer. Hioki ‘184 fails to disclose the inner side layer extends distally and is connected to the outer side layer at a location on a distal side of the support member. However, Hioki ‘122 teaches an inner layer may extend distally to a distal location on a distal side of the support member and thus, surround the support member. Accordingly, the combination of Hioki ‘184 in view of Hioki ‘122 teaches the claimed limitation.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: pressing member in claims 1, 5-6, 8, 13, 16 and 20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4-10 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hioki et al. (WO 2020/111184 A1) in view of O’Brien et al. (US 11,596,417 B2).
Regarding claim 1, Hioki ‘184 discloses a hemostatic device (hemostatic instrument 100; Fig. 1) for stopping bleeding at a puncture site on a patient’s hand (Fig. 8), the hemostatic device comprising: a cover member (covering member 110) configured to cover the puncture site on the patient (Figs. 1, 8); a pressing member (interpreted under 112(f) as an inflatable member that can be inflated by injection of a fluid ([0049]) and equivalents thereof and Hioki ‘184 discloses an expanding member 170 inflatable by injecting fluid; Figs. 6-7; page 5, lines 1-2 of the attached English translation) disposed on the cover member (Fig. 4) and configured to compress the puncture site (Figs. 13-14); a support member (cover member 125) disposed on the cover member to cover the pressing member (170; Figs. 1-4, 6-7); the cover member (110) including a main body (at least a portion of body part 120) in which the pressing member (170) is located (Figs. 6-7), a first band body (third arm part 150) configured to be disposed between fingers (f1 and f2) of the patient and extending in a first direction (to the top of the page in Fig. 1) from the main body (Figs. 1, 8), a second band body (first arm part 130) extending from the main body in a second direction (to the left of the page in Fig. 1) different from the first direction (Fig. 1), and a third band body (second arm part 140) extending from the main body in a third direction (to the right of the page in Fig. 1) different from the first direction and the second direction (Fig. 1), the third band body (140) facing the second band body (130; as 130 and 140 face each other around body part 120; Fig. 1); the main body (120) including a retaining portion that has a two-layer structure (including at least support portion 126 and pad portion 128; Fig. 7) and retains the support member (as 125 is retained within 126; Fig. 7); the retaining portion including an upper surface region (support portion 126 located above 125; Fig. 7) located on an upper surface side (side above 125) of the support member (125; Fig. 7), a lower surface region (pad portion 128) located on a lower surface side (side below 125) of the support member and facing the upper surface region across the support member (as a line may be drawn intersecting the upper portion of 126, 125, and 128; Fig. 7), and a curved region (curved portion between the upper surface proximal end of 126 and 126b when viewing Figs. 6-7) having one end connected to the upper surface region (Figs. 6-7) and an other end connected to the lower surface region so that the curved region connects the upper surface region and the lower surface region, the curved region being on a proximal side of the support member (125; Figs. 6-7); the curved region is formed by folding a part of the main body (120) toward a side where the first band body is disposed so that the lower surface region extends from the other end of the curved region to an end of the part of the main body (as 126 is folded towards 150 then back to an end of 120; Fig. 7); the lower surface region including a constricted portion (lateral sides of 126b of Figs. 4-5) on a side where the curved region is disposed (Figs. 4, 7), the constricted portion extending away from the other end of the curved region and toward the first band body (Fig. 4).
Hioki ‘184 discloses the width of 126b at the proximal end of 120 of the upper surface region is less that the width of 126 towards arm 150 (Figs. 3-4), but fails to disclose a width of the lower surface region in the constricted portion decreases from the side where the first band body is disposed to the side where the curved region is disposed. Instead, the width of the lower surface region is uniform.
However, O’Brien teaches a hemostasis band (30; Fig. 1) with regions (attachment straps 62, 80) that are folded over each other around a patient’s wrist (Fig. 1), the regions curve at the sides forming cutouts (70, 71, 74, 75, 88, 89, 92, 93) i.e., lateral sides of the curved regions. Because of the cutouts, a width of a lower surface region (near 68) at the cutouts (70, 74) decreases from the side where a first band body (80) is disposed to a side where the curved region is disposed (as 68 will be folded back towards the user’s wrist i.e. toward 80). O’Brien teaches the cutouts reduce tension as compared to linear edges (columns 7-8, lines 63-67, 1-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the constricted portion of the lower surface region of Hioki ‘184 to have a width which decreases from the side where the first band body is disposed to the side where the curved region is disposed, as taught by the upper surface region of Hioki ‘184 and the cutouts of O’Brien in order to reduce tension on the cover when it is folded back on itself.
Regarding claim 2, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the support member (125) includes an upper end (towards 151 of Fig. 3), which is located on the side where the first band body (150) is disposed and forms an end of the support member (Fig. 3), and a lower end (curved end towards 126b of Fig. 3) forming an end opposite to the upper end, a width of the lower end is smaller than a width of the upper end (due to the curvature of 125 at its proximal end; Fig. 3), and the support member having a lower surface that is curved in a shape projecting in a direction away from the pressing member (170; as the lower curved end of 125 is a convex curve pointing in a direction proximal direction, away from 170; Fig. 3).
Regarding claim 4, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein a width of the curved region (width of 126b) is smaller than a width of a proximal portion of the support member (curved proximal portion of 125) in a plan view (Fig. 4).
Regarding claim 5, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the retaining portion (including at least support portion 126 and pad portion 128; Fig. 7) is located on a proximal side of the main body (Figs. 3-4), and the pressing member (170) is connected to the lower surface region in such a manner that a part of the pressing member is located in the constricted portion (lateral sides of 126b; Fig. 4).
Regarding claim 6, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the pressing member (170) has an edge portion (proximal edge of 180) located on a proximal side of the pressing member (Fig. 4), the edge portion being located in the curved region (at 180b; Fig. 7).
Regarding claim 7, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the curved region has curved portions located at both ends in a width direction of the curved region (as lateral sides of 126b on the top surface of 110 are curved; Fig. 3).
Regarding claim 8, Hioki ‘184 discloses a hemostatic device (hemostatic instrument 100; Fig. 1) for stopping bleeding at a puncture site on a patient’s hand (Fig. 8), the hemostatic device comprising: a cover member (covering member 110) configured to cover the puncture site on the patient (Figs. 1, 8); a pressing member (interpreted under 112(f) as an inflatable member that can be inflated by injection of a fluid ([0049]) and equivalents thereof and Hioki ‘184 discloses an expanding member 170 inflatable by injecting fluid; Figs. 6-7; page 5, lines 1-2 of the attached English translation) connected to the cover member (Fig. 4) and configured to compress the puncture site (Figs. 13-14); a support member (cover member 125) disposed on the cover member (Fig. 3) to cover the pressing member (170; Figs. 6-7); the cover member (125) including a main body (at least a portion of body part 120) in which the pressing member (170) is located (Figs. 6-7), a first band body (third arm part 150) configured to be disposed between fingers (f1, f2) of the patient (Fig. 8) and extending in a first direction (towards the top of the page in Fig. 1) from the main body, a second band body (first arm 130) extending from the main body in a second direction (towards the left of the page in Fig. 1) different from the first direction, and a third band body (second arm 140) extending from the main body in a third direction (towards the right of the page in Fig. 1) different from the first direction and the second direction (Fig. 1), the third band body (140) facing the second band body (130; as 130 and 140 face each other around body part 120; Fig. 1); the main body (120) including a retaining portion that has a two-layer structure (including at least support portion 126 and pad portion 128; Fig. 7) and retains the support member (125; Figs. 6-7); the retaining portion including an upper surface region (upper surface region of 126 above 125) located on an upper surface side (side above 125) of the support member (Figs. 6-7), a lower surface region (pad portion 128) located on a lower surface side (side below 125) of the support member and having an interior surface facing an interior surface of the upper surface region across the support member (as a line may be drawn intersecting the upper portion of 126, 125, and 128; Figs. 6-7), and a curved region (curved portion between the upper surface proximal end of 126 and 126b when viewing Figs. 6-7) connecting the upper surface region and the lower surface region on the proximal side of the connection region (Figs. 6-7) and forming a space portion (space 129) between the interior surface of the upper surface region and the interior surface of the lower surface region (Figs. 6-7), and the curved region being formed by folding a part of the main body toward a side where the first band body is disposed (as 126 is folded towards 150; Fig. 7).
Hioki ‘184 fails to disclose a connection region at which the interior surface of the upper surface region and the interior surface of the lower region are in contact with one another and are connected to one another on a proximal side of a proximal portion of the support member.
However, O’Brien teaches a hemostasis band (straps 110, 210) that may be folded over on itself forming upper and lower surface regions with interior surfaces (Figs. 3-4), wherein the folds may not be surface-bonded (Fig. 3; column 9, lines 5-8), similar to the fold of Hioki ‘184, or alternatively, wherein the fold may be surface bonded (Fig. 4, column 9, lines 9-16) so that the interior surface of the upper surface region and the interior surface of the lower surface region are in contact with one another rand are connected to one another (Fig. 4). The folds of O’Brien are used for improved patient comfort (column 8, lines 45-50), similar to the fold of Hioki ‘184.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the interior surface of the lower surface region of Hioki ‘184 to be in contact with the interior surface of the upper surface region as taught by O’Brien, thereby forming a connection region. All of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of providing a folded region for improved patient comfort. It is noted that the fold of Hioki ‘184 is positioned on a proximal side of a proximal portion of the support member; therefore, the connection region of modified Hioki ‘184 would also be positioned proximal the support member.
Regarding claim 9, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the support member (125) includes one end (upper end of 125 towards 151) and an opposite end (lower end of 125 towards 126b), the one end of the support member being closer to the first band body (150) than the opposite end of the support member (Fig. 4), the opposite end of the support member being positioned between the second band body (130) and the third band body (140; Figs. 3-4) as seen in a plan view of the hemostatic device, the first band body (150) having a center line (center line through 150 from the top to bottom of the page of Fig. 1) extending along a length of the first band body (Fig. 1), the support member (125) possessing a width measured perpendicular to the center line of the first band body, the width of the support member varying between the one end of the support member and the opposite end of the support member (as the width of 125 is larger at the end towards 150 that at its curved proximal end towards 126a; Fig. 3).
Regarding claim 10, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the support member (125) includes one end (upper end of 125 towards 151) and an opposite end (lower end of 125 towards 126b), the one end of the support member being closer to the first band body (150) than the opposite end of the support member (Fig. 1), the opposite end of the support member being positioned between the second band body (130) and the third band body (140; Fig. 1) as seen in a plan view of the hemostatic device, the first band body (150) having a center line (center line through 150 from the top to bottom of the page of Fig. 1) extending along a length of the first band body (Fig. 1), the support member (125) possessing a width measured perpendicular to the center line of the first band body, the width of the support member decreasing in a direction from the one end of the support member toward the opposite end of the support member (as the width of 125 is larger at the end towards 150 that at its curved proximal end towards 126a; Fig. 3).
Regarding claim 13, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the support member (125) includes one surface (lower surface of 125) facing towards the pressing member (170) and an opposite surface (upper surface) facing away from the pressing member (170; Figs. 6-7, 13-14), the support member (125) being a curved support member (at least when 170 is expanded; Figs. 7, 14) in which the one surface (lower) is a concave-shaped surface and the opposite surface (upper) is a convex-shaped surface (when 170 is expanded and viewed from Fig. 14).
Regarding claim 14, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the support member (125) includes one end (upper end of 125 towards 151) and an opposite end (lower end of 125 towards 126b), the one end of the support member being closer to the first band body (150) than the opposite end of the support member (Fig. 1), the first band body (150) having a center line extending along a length of the first band body (Fig. 1), the support member (125) having a width measured perpendicular to the center line of the first band body (Fig. 3), the curved region having a width measured perpendicular to the center line of the first band body (width of 126b of Fig. 3), the width of the curved region being less than the width of the one end of the support member (Fig. 3).
Regarding claim 15, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the main body (120) includes one edge portion (top edge of 120 when viewing Fig. 3) connected to the first band body (150; Fig. 3) and an opposite edge portion (bottom edge of 120 when viewing Fig. 3), the first band body (150) having a center line extending along a length of the first band body and intersecting both the one edge portion of the main body and the opposite edge portion of the main body in a plan view (Fig. 3), the support member (125) including one end (upper end of 125 towards 151) and an opposite end (lower end of 125 towards 126b), the one end of the support member being closer to the first band body (150) than the opposite end of the support member (Figs. 1, 3), the center line of the first band body intersecting the one end of the support member and the opposite end of the support member as seen in the plan view (Fig. 3), a straight line distance between the one end (upper end of 125 towards 151) of the support member and the one edge potion (top edge of 120 when viewing Fig. 3) of the main body along the center line being greater than the straight line distance between the opposite end (lower end of 125 towards 126b) of the support member and the opposite edge portion (bottom edge of 120 when viewing Fig. 3) of the main body along the center line (see annotated Fig. 3 below).
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Claim(s) 16-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hioki et al. (WO 2020/111184 A1) in view of Hioki et al. (WO 2020/027122 A1).
Regarding claim 16, Hioki ‘184 discloses a hemostatic device (hemostatic instrument 100; Fig. 1) configured to be applied to a hand of a patient to stop bleeding at a puncture site on the patient’s hand (Fig. 8), the hemostatic device comprising: a cover member (covering member 110) configured to cover the puncture site on the patient (Figs. 8, 13-15); a pressing member (interpreted under 112(f) as an inflatable member that can be inflated by injection of a fluid ([0049]) and equivalents thereof and Hioki ‘184 discloses an expanding member 170 inflatable by injecting fluid; Figs. 6-7; page 5, lines 1-2 of the attached English translation) connected to the cover member (Fig. 4) and configured to compress the puncture site (Figs. 13-14); a support member (cover member 125) disposed on the over member to cover the pressing member (Figs. 6-7); the cover member (110) including a main body (at least a portion of body part 120), a first band body (third arm 150) configured to be positioned between fingers (f1, f2) of the patient’s hand when the hemostatic device is applied to the patient’s hand (Fig. 8) and extending in a first direction (towards the top of the page of Fig. 1) away from the main body (Fig. 1), a second band body (first arm 130) extending away from the main body in a second direction (towards the left of the page in Fig. 1) different from the first direction (Fig. 1), and a third band body (second arm 140) extending away from the main body in a third direction (towards the right of the page in Fig. 1) different from the first direction and the second direction (Fig. 1); the main body (120) being comprised of a sheet (support part 126), at least a portion of the sheet (126) being folded upon itself to define an inner side layer (inner layer at 128; Figs. 6-7), a curved portion (curved portion between the upper surface proximal end of 126 and 126b when viewing Figs. 6-7) and an outer side layer (outer side layer of 126), the portion of the sheet that is folded upon itself including an end that is also an end of the inner side layer (Figs. 6-7); the inner side layer, the curved portion and the outer side layer all being a part of the sheet (Figs. 6-7) and surrounding a space (space 129) constituting a retaining portion in which is positioned the support member (cover member 125); the first band body (150) having a center line (center line through 150 from the top to bottom of the page of Fig. 1) extending along a length of the first band body; the curved portion of the main body being on a proximal side of the support member as seen in the cross-section along the center line of the first band body (Figs. 6-7); and the center line of the first band body (150) intersecting the support member (125) and the curved portion (curved portion between the upper surface proximal end of 126 and 126b when viewing Figs. 6-7) of the main body in a plan view (Fig. 1), the center line of the first band body (150) being located between the second band body (130) and the third band body (140; Fig. 1).
Hioki ‘184 fails to disclose the inner side layer being located between the pressing member and the support member as seen in a cross-section along the center line of the first band body, the end of the inner side layer being connected to the outer side layer at a location on a distal side of the support member, and the support member being positioned between the curved portion and the location at which the end of the inner side layer is connected to the outer side layer as seen in the cross-section along the center line of the first band body.
However, Hioki ‘122 teaches a hemostatic device (hemostasis apparatus 100; Fig. 1) configured to be applied to a hand of a patient to stop bleeding at a puncture site on the patient’s hand (Figs. 4-9), the hemostatic device comprising: a cover member (covering member 110) configured to cover the puncture site on the patient (Figs. 1, 4-9); a pressing member (expansion member 160 including first expansion portion 170 and second expansion portion 180) connected to the cover member and configured to compress the puncture site (Figs. 1-9); the cover member (110) including a main body (at least a portion of main body 120), a first band body (first arm 130) configured to be positioned between fingers of the patient’s hand when the hemostatic device is applied to the patient’s hand and extending in a first direction away from the main body (Figs. 4-5), a second band body (second arm 140) extending away from the main body in a second direction different from the first direction (Fig. 1); the main body (120) being comprised of a sheet (first region 121 and second region 122) defining an inner side layer (121), and an outer side layer (122; Fig. 3); the inner side layer (121) and the outer side layer (122) all being a part of the sheet and surrounding a space (insertion section space 128a) constituting a retaining portion in which is positioned a support member (support member 125); the first band body (130) having a center line (c1) extending along a length of the first band body (Fig. 2); the inner side layer (121) being located between the pressing member (170, 180) and the support member (125) as seen in a cross-section along the center line of the first band body (Fig. 3) because the inner side layer (121) extends distally to cover the entirety of the support member and connect to the first band body (Fig. 3), an end of the inner side layer being connected to the outer side layer at a location on a distal side of the support member (at reference number 121 when viewing Fig. 3), and the support member (125) being positioned between the proximal end of the retaining portion and the location at which the end of the inner side layer is connected to the outer side layer as seen in the cross-section along the center line of the first band body because the inner side layer (121) extends distally to cover the entirety of the support member and connect to the first band body (Fig. 3). Hioki ‘122 teaches the inner side layer (121), the outer side layer (122) and the support member (125) help to suppress the formation of a gap between the surface of the back of the hand and the main body (120) at the peripheral edge of the main body (page 6 lines 4-6 of the attached English translation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the folded inner side layer of Hioki ‘184 to further extend distally to the first band body such that the inner side layer is located between the pressing member and the support member as seen in a cross-section along the center line of the first band body as taught by Hioki ‘122 in order to provide a smooth fully encapsulated retaining portion for the support member which may help to suppress the formation of a gap between the surface of the back of the hand and the main body at the peripheral edge of the main body.
Regarding claim 17, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the inner side layer has a width (width of 126b) and the outer side layer has a width (width of 126), the width of the inner side layer immediately adjacent the curved portion being less than the width of the outer side layer immediately adjacent the curved portion (as the width of 126b is less than 126; Figs. 3-4).
Regarding claim 18, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the support member (125) includes one end (upper end of 125 towards 151) and an opposite end (lower end of 125 towards 126b), the one end of the support member being closer to the first band body (150) than the opposite end of the support member (Fig. 1), the center line (C1; Fig. 5) of the first band body intersecting the one end of the support member and the opposite end of the support member in the plan view (Fig. 5), the support member (125) possessing a width measured perpendicular to the center line of the first body band, the width of the support member decreasing from the one end of the support member toward the opposite end of the support member (as the width of 125 is larger at the end towards 150 that at its curved proximal end towards 126a; Fig. 3).
Regarding claim 20, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the support member (125) includes one surface facing towards the pressing member (170) and an opposite surface facing away from the pressing member (Figs. 6-7), the support member (125) being a curved support member in which the one surface is a concave-shaped surface and the opposite surface is a convex-shaped surface (when 170 is expanded and viewed from Fig. 14).
Claim(s) 3 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hioki et al. (WO 2020/111184 A1) in view of O’Brien et al. (US 11,596,417 B2), as applied to claims 2 and 8 above, and further in view of Kawaura et al. (US 2021/0059686 A1)
Regarding claim 3, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the support member (125) has a side surface portion (side of 125 shown in Fig. 7) connecting the upper end and the lower end (Fig. 7) but fails to disclose a thickness of the side surface portion decreases from the upper end to the lower end.
However, Kawaura teaches a compression device (251; Fig. 38) comprising a support member (holder 272) and a pressing member (expander 271), wherein the support member (272) has a side surface portion (surface of holder 272 shown in Fig. 38) connecting an upper end (end of 272 towards the right of the page of Fig. 38) and a lower end (end of 272 towards the left of the page of Fig. 38), and a thickness of the side surface portion decreases from the upper end to the lower end (via surface 272b) for the purpose of protruding the pressing member toward an inclined direction rather than a perpendicular direction to efficiently narrow the perforation by a smaller pressing force ([0328]-]0329]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support member of Hioki ‘184 such that a thickness of the side surface portion decreases from the upper end to the lower end as taught by Kawaura in order to better support an inclined pressing member to efficiently narrow the puncture by a smaller pressing force.
Regarding claim 11, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the support member (125) includes one end (upper end of 125 towards 151) and an opposite end (lower end of 125 towards 126b), the one end of the support member being closer to the first band body (150) than the opposite end of the support member (Fig. 1), the support member (125) having two spaced-apart side surface portions that are on opposite sides of the support member and that extend between the one end of the support member and the opposite end of the support member (Figs. 3-4, 6-7), the side surface portions have a thickness (Figs. 6-7).
Hioki ‘184 fails to disclose the thickness of each side surface portion at the one end of the support member being greater than the thickness at the opposite end of the support member.
However, Kawaura teaches a compression device (251; Fig. 38) comprising a support member (holder 272) and a pressing member (expander 271), wherein the support member (272) has a side surface portion (surface of holder 272 shown in Fig. 38) connecting an upper end (end of 272 towards the right of the page of Fig. 38) and a lower end (end of 272 towards the left of the page of Fig. 38), and a thickness of the side surface portion decreases from the upper end to the lower end (via surface 272b) for the purpose of protruding the pressing member toward an inclined direction rather than a perpendicular direction to efficiently narrow the perforation by a smaller pressing force ([0328]-]0329]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support member of Hioki ‘184 such that the thickness of each side surface portion at the one end of the support member is greater than the thickness at the opposite end of the support member as taught by Kawaura in order to better support an inclined pressing member to efficiently narrow the puncture by a smaller pressing force.
Regarding claim 12, Hioki ‘184 modified discloses the invention as claimed above, and Hioki ‘184 further discloses wherein the support member (125) includes one end (upper end of 125 towards 151) and an opposite end (lower end of 125 towards 126b), the one end of the support member being closer to the first band body (150) than the opposite end of the support member (Fig. 1), the support member (125) having two spaced-apart side surface portions that are on opposite sides of the support member and that extend between the one end of the support member and the opposite end of the support member (Figs. 3-4, 6-7), the side surface portions have a thickness (Figs. 6-7).
Hioki ‘184 fails to disclose the thickness of each side surface portion decreasing from the one end of the support member to the opposite end of the support member.
However, Kawaura teaches a compression device (251; Fig. 38) comprising a support member (holder 272) and a pressing member (expander 271), wherein the support member (272) has a side surface portion (surface of holder 272 shown in Fig. 38) connecting an upper end (end of 272 towards the right of the page of Fig. 38) and a lower end (end of 272 towards the left of the page of Fig. 38), and a thickness of the side surface portion decreases from the upper end to the lower end (via surface 272b) for the purpose of protruding the pressing member toward an inclined direction rather than a perpendicular direction to efficiently narrow the perforation by a smaller pressing force ([0328]-]0329]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support member of Hioki ‘184 such that the thickness of each side surface portion decreases from the one end of the support member to the opposite end of the support member as taught by Kawaura in order to better support an inclined pressing member to efficiently narrow the puncture by a smaller pressing force.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hioki et al. (WO 2020/111184 A1) in view of Hioki et al. (WO 2020/027122 A1), as applied to claim 16 above, and further in view of Kawaura et al. (US 2021/0059686 A1).
Regarding claim 19, Hioki ‘184 modified discloses the invention as discussed above, and Hioki ‘184 further discloses wherein the support member (125) includes one end (upper end of 125 towards 151) and an opposite end (lower end of 125 towards 126b), the one end of the support member being closer to the first band body (150) than the opposite end of the support member (Fig. 1), the centerline (C1) of the first band body intersecting the one end of the support member and the opposite end of the support member in the plan view (Fig. 5), the support member (125) having two spaced-apart side surface portions that are on opposite sides of the support member and that extend between the one end of the support member and the opposite end of the support member (Figs. 3-4, 6-7), the side surface portions have a thickness (Figs. 6-7).
Hioki ‘184 fails to disclose the thickness of each side surface portion decreasing from the one end of the support member to the opposite end of the support member.
However, Kawaura teaches a compression device (251; Fig. 38) comprising a support member (holder 272) and a pressing member (expander 271), wherein the support member (272) has a side surface portion (surface of holder 272 shown in Fig. 38) connecting an upper end (end of 272 towards the right of the page of Fig. 38) and a lower end (end of 272 towards the left of the page of Fig. 38), and a thickness of the side surface portion decreases from the upper end to the lower end (via surface 272b) for the purpose of protruding the pressing member toward an inclined direction rather than a perpendicular direction to efficiently narrow the perforation by a smaller pressing force ([0328]-]0329]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support member of Hioki ‘184 such that the thickness of each side surface portion decreases from the one end of the support member to the opposite end of the support member as taught by Kawaura in order to better support an inclined pressing member to efficiently narrow the puncture by a smaller pressing force.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hioki et al. (WO 2020/111184 A1) in view of O’Brien et al. (US 11,596,417 B2), as applied to claim 1, and further in view of Hioki et al. (WO 2020/027122 A1).
Regarding claim 22, Hioki ‘184 fails to disclose wherein: the lower surface region has an interior surface facing towards an interior surface of the upper surface region and an opposite exterior surface facing away from the interior surface of the upper surface region; and the support member is positioned between the interior surface of the lower surface region and the interior surface of the upper surface region so that the interior surface of the lower surface region faces one surface of the support member and the interior surface of the upper surface region faces an opposite surface of the support member.
However, Hioki ‘122 teaches a hemostatic device (hemostasis apparatus 100; Fig. 1) configured to be applied to a hand of a patient to stop bleeding at a puncture site on the patient’s hand (Figs. 4-9), the hemostatic device comprising: a cover member (covering member 110) configured to cover the puncture site on the patient (Figs. 1, 4-9); a pressing member (expansion member 160 including first expansion portion 170 and second expansion portion 180) connected to the cover member and configured to compress the puncture site (Figs. 1-9); the cover member (110) including a main body (at least a portion of main body 120), a first band body (first arm 130) configured to be positioned between fingers of the patient’s hand when the hemostatic device is applied to the patient’s hand and extending in a first direction away from the main body (Figs. 4-5), a second band body (second arm 140) extending away from the main body in a second direction different from the first direction (Fig. 1); the main body (120) being comprised of a sheet (first region 121 and second region 122) defining an inner side layer (121), and an outer side layer (122; Fig. 3); the inner side layer (121) and the outer side layer (122) all being a part of the sheet and surrounding a space (insertion section space 128a) constituting a retaining portion in which is positioned a support member (support member 125); the first band body (130) having a center line (c1) extending along a length of the first band body (Fig. 2); the inner side layer (121) being located between the pressing member (170, 180) and the support member (125) as seen in a cross-section along the center line of the first band body (Fig. 3) because the inner side layer (121) extends distally to cover the entirety of the support member and connect to the first band body (Fig. 3), an end of the inner side layer being connected to the outer side layer at a location on a distal side of the support member (at reference number 121 when viewing Fig. 3), and the support member (125) being positioned between the proximal end of the retaining portion and the location at which the end of the inner side layer is connected to the outer side layer as seen in the cross-section along the center line of the first band body because the inner side layer (121) extends distally to cover the entirety of the support member and connect to the first band body (Fig. 3). Hioki ‘122 teaches the lower surface region (121) has an interior surface facing towards an interior surface of the upper surface region (122) and an opposite exterior surface facing away from the interior surface of the upper surface region (Fig. 3); and the support member (125) is positioned between the interior surface of the lower surface region and the interior surface of the upper surface region so that the interior surface of the lower surface region faces one surface of the support member and the interior surface of the upper surface region faces an opposite surface of the support member (Fig. 3). Hioki ‘122 teaches the inner side layer (121), the outer side layer (122) and the support member (125) help to suppress the formation of a gap between the surface of the back of the hand and the main body (120) at the peripheral edge of the main body (page 6 lines 4-6 of the attached English translation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the folded inner side layer of Hioki ‘184 to further extend distally to the first band body such that the inner side layer is located between the pressing member and the support member as seen in a cross-section along the center line of the first band body as taught by Hioki ‘122 in order to provide a smooth fully encapsulated retaining portion for the support member which may help to suppress the formation of a gap between the surface of the back of the hand and the main body at the peripheral edge of the main body. Such a modification would result in the interior surfaces of the upper and lower surface regions facing one another as claimed.
Allowable Subject Matter
Claims 21 and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Hioki ‘184 and Kawamura (US 2024/0000462 A1), does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, the claimed invention of dependent claims 21-23. While Kawamura teaches an inflatable pressing member (180) being comprised of a film-shaped member having an outer peripheral edge that is connected to an exterior surface of a lower surface region (190) so that the interior of the inflatable pressing member is bounded by the exterior surface of the lower surface region and the film-shaped member (Fig. 6), it would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hioki ‘184 as such because Hioki ‘184 includes two inflatable pressing members (180, 190). Thus, substantial reconstruction and redesign of Hioki ‘184 would be required. Alternatively, it would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lower surface region (190) of Kawamura to have the curved region of Hioki ‘184 because the balloon edge of Kawamura is attached to the exterior surface of the lower surface region of Kawamura.
Nichtnennung (DE 102012013153 A1) teaches a support member (22) enclosed in a bag (19), but the bag is moveable with respect to the pressing member and the bag is stitched rather than folded along its sides (Figs. 1, 7).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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