CTFR 18/170,798 CTFR 91454 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 This office action is responsive to the amendment filed on 02/13/2026. As directed by the amendment: claims 1, 4, 6-9, 11, 13-16, and 19-20 have been amended, claims 2, 3, 5, 12, 17, and 18 have been cancelled and claims 21-24 have been added. Thus, claims 1, 4, 6-11, 13-16, and 19-24 are presently pending in this application. Claim Objections 07-29-01 AIA Claim 11 is objected to because of the following informalities: line 18 recites “inflatable inflatable member” which should be “inflatable member” . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 11, 13-16, 19, 22, and 24 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 11 recites the limitation "the pressing portion" in line 22. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation is being interpreted as “the inflatable member”. Appropriate correction is required. Claim 24 recites “the plurality of hole portions include a pair of first hole portions facing each other with the inflatable member interposed between the pair of first hole portions and a pair of second hole portions facing each other with the pressing portion interposed between the pair of second hole portions at positions different from the first hole portions” which is already recited in claim 20 rendering the scope of the claim unclear. For examination purposes, this limitation is being interpreted as not present in claim 24. Appropriate correction is required. Claim 24 recites the limitation "the inflatable member " in lines 3, 7, 10-11. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation is being interpreted as “the pressing portion”. Appropriate correction is required. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. 07-04-03 AIA 07-04-01 Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claim s 1, 4, 6-11, 13-16, 19, 21, 22 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability , 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 1 and 11 recite “a first band body …disposed in an inter-finger portion located between a thumb and an index finger of the hand of the patient”. This is a positive recitation of a human organism. In order to avoid positively reciting human organisms, claim limitations referencing the human body should be worded as functional claim language (e.g. “a first band body …configured to be disposed in an inter-finger portion located between a thumb and an index finger of the hand of the patient”). Appropriate correction is required . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 11, 13, 14, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kiemeneij et al. (US 20190133602 A1) in view of Popp (US 20190290288 A1) and Clark (US 20100217202 A1) . Regarding claims 11 and 13 Kiemeneij discloses (fig. 1-3) a hemostatic device comprising: an inflatable member 145 configured to receive a fluid (see [0036]); a support member 144 connected to the inflatable member 145 (see [0035]), the support member 144 including a first region (center) where the inflatable member 145 is disposed (see fig. 1 and [0035]) and a second region (outer portion of 144, see fig. 1) positioned outside the first region (see fig. 1 and [0035]); a first band body 120 configured to be connectable to the support member 144 (see fig. 1 and [0027]) and disposed in an inter-finger portion located between a thumb and an index finger of the hand of the patient (see fig. 2); a second band body 110 configured to be connectable to the support member 144 (see fig. 1 and [0024]); a third band body 130 configured to be connectable to the support member 144 (see fig. 1 and [0030]); the first band body 120, the second band body 110, and the third band body 130 are configured to be respectively connectable to a plurality of hole portions/the two hole portions provided in the second region of the support member 144 (see fig. 1; and [0027], [0024], and [0030]); the plurality of hole portions include a first hole portion (hole connected to 120; see fig. 1) and a pair of second hole portions (holes connected to 110 and 130; see fig. 1) facing each other with the pressing portion 145 interposed between the pair of second hole portions (holes connected to 110 and 130; see fig. 1) at positions different from the first hole portion (see fig. 1); a second curved region convexly curved (curve of 144, see [0035] and fig. 2, the top surface, the surface opposite the pressing portion and not engaged with the hand, of the concave shape is convex) toward a side of the inflatable member 145 disposed on one surface of the support member 144 is formed at a part of the second region (outer portion) of the support member 144 where the pair of second hole portions (holes 110 and 130 are connected to) are disposed (see fig. 2). Kiemeneij is silent regarding one or more of the first band body, the second band body, and the third band body are configured to radially change in angle about the inflatable portion relative to the first region; a pair of first hole portions facing each other with the pressing portion interposed between the pair of first hole portions; the pair of first hole portions and the pair of second hole portions are disposed on a virtual circle along an outer shape of the support member. However Popp, in the same filed of endeavor, teaches (fig. 5) a hemostatic device comprising: a first band body, a second band body, a third band body 116 (there are 4 bands 116; see fig. 5 and [0047]); a support member 106 (see fig. 5) including a first region 107 and a second region (region surrounding 107) positioned outside the first region 107 (see fig. 5); the first band body, the second band body, and the third band body 116 are configured to be respectively connectable to a plurality of hole portions 115 provided in the second region of the support member (see fig. 5 and [0047]); one or more of the first band body, the second band body, and the third band body 116 are configured to radially change in angle about a pressing portion (at 107) relative to the first region (see fig. 5 and [0047]); ) the plurality of hole portions 115 include a pair of first hole portions facing each other with the pressing portion ( at 107) interposed between the pair of first hole portions (see annotated fig. 5 below) and a pair of second hole portions facing each other with the pressing portion (at 107) interposed between the pair of second hole portions at positions different from the first hole portions (see annotated fig. 4 below); the pair of first hole portions and the pair of second hole portions are disposed on a virtual circle along an outer shape of the support member 106 (circle that is formed by the four holes 115; see fig. 1). PNG media_image1.png 716 742 media_image1.png Greyscale Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kiemeneij to have the first band body, the second band body, and the third band body are configured to radially change in angle about the pressing portion relative to the first region; to have the first hole portion be a pair of first hole portions facing each other with the pressing portion interposed between the pair of first hole portions as taught by Popp, for the purpose of the user being able adjust the angle of one or more of the bands and have an additional band to securely attach the device to a variety of locations on the patient’s body (see Popp [0047]). Kiemeneij as modified is silent regarding a first curved region convexly curved toward a side away from the pressing portion disposed on one surface of the support member is formed at a part of the second region of the support member where the pair of first hole portions are disposed. However Clark, in the same field of endeavor, teaches (fig. 1-3) a first curved region 5 convexly curved toward a side away from a pressing portion 10 disposed on one surface of a support member 2 (see fig. 1-3) is formed at a part of a second region (outer region) of the support member 2 where a pair of first hole portions 14 are disposed (see fig. 1-3 and [0022]). Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kiemeneij as modified to have a first curved region convexly curved toward a side away from the pressing portion disposed on one surface of the support member is formed at a part of the second region of the support member where the pair of first hole portions are disposed as taught by Clark, for the purpose of the user being able to engage the curved arms to adjust the device and/or apply additional pressure (see Clark [0034]). Regarding claim 14, Kiemeneij as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Kiemeneij as modified further teaches the pair of first hole portions include one first hole portion (hole 120 of Kiemeneij is in, see fig. 1 of Kiemeneij) and an other first hole portion (hole opposite of 120 Kiemeneij is modified to have) configured to be disposed at positions on a proximal side of the hand of the patient (see fig. 2 of Kiemeneij) with the pressing portion (145 of Kiemeneij) interposed between the one first hole portion and the other first hole portion (see fig. 1 and 2 of Kiemeneij); the pair of second hole portions (holes connected to 110 and 130; see fig. 1) include one second hole portion (hole 110 of Kiemeneij is connected to) and an other second hole portion (hole 130 of Kiemeneij is connected to) disposed with the pressing portion (145 of Kiemeneij) interposed between the one second hole portion (hole 110 of Kiemeneij is connected to) and the other second hole portion (hole 130 of Kiemeneij is connected to) in a direction intersecting a straight line connecting the one first hole portion (hole 120 of Kiemeneij is connected to) and the other first hole portion (hole opposite of 120 Kiemeneij is modified to have; see fig. 1-2 of Kiemeneij mand fig. 5 of Popp); the first band body (120 of Kiemeneij) is configured to be connected to the one first hole portion (hole connected to 120 of Kiemeneij); the second band body (110 of Kiemeneij) is configured to be connected to the one second hole portion (hole 110 of Kiemeneij is connected to) in a slidable state (see claims 1 and 11 above); and the third band body (130 of Kiemeneij) is configured to be connected to the other second hole portion (hole 130 of Kiemeneij is connected to) in a slidable state (see claims 1 and 11 above). Regarding claim 16, Kiemeneij as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Kiemeneij as modified is silent regarding each of the pair of second hole portions is longer in hole length than each of the pair of first hole portions. Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have each of the pair of second hole portions is longer in hole length than each of the pair of first hole portions because Applicant has not disclosed that such a configuration is critical simply indicating that it is so. One of ordinary skill in the art, furthermore, would have expected Kiemeneij as modified’s device, and applicant’s invention, to perform equally well with either the sizes by Kiemeneij as modified or the claimed unequal sizes because both sizes dimensions would perform the same function of allowing the angle of the bands to be adjusted. Therefore, it would have been prima facie obvious to modify Kiemeneij as modified to obtain the invention as specified in claims 5 and 16 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Kiemeneij as modified. Regarding claim 19, Kiemeneij as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Kiemeneij further discloses (fig. 1-3) a plurality of fasteners (hook and loop, see [0023]), the plurality of fasteners including a first fastener (top surface of 110 can have the hook/loop fasteners; see [0023]), a second fastener (top surface of 130 can have the hook/loop fasteners; see [0023]), a third fastener (bottom surface of 130 can have the hook/loop fasteners; see [0023]), and a fourth fastener (bottom surface of 120 can have the hook/loop fasteners; see [0023]), the first fastener being disposed on an outer surface of the second body band 110 (top and bottom surface of 110 can have the hook/loop fasteners; see [0023]), the second fastener being disposed on an outer surface of the third band body 130 (top and bottom surface of 130 can have the hook/loop fasteners; see [0023]), the third fastener being disposed on an inner surface of the third band body 130 (top and bottom surface of 110 can have the hook/loop fasteners; see [0023]) and configured to come into contact with the first fastener disposed on the outer surface of the second band body (see note below), and the fourth fastener being disposed on an inner surface of the first band body 120 (top and bottom surface of 120 can have the hook/loop fasteners; see [0023]) and configured to come into contact with the second fastener disposed on the outer surface of the third band body (see note below). Note: The language “the third fastener configured to come into contact with the first fastener , and the fourth fastener configured to come into contact with the second fastener ” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Kiemeneij as modified meets the structural limitations of the claim, and the third fastener is capable of coming into contact with the first fastener , and the fourth fastener is capable of coming into contact with the second fastener . Fig. 3 shows the 3 bands with the fastener overlapping to secure the device. The bands can be overlapped such that the claimed contact occurs . 07-22-aia AIA Claim 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kiemeneij in view of Popp and Clark as applied to claim 11 above, and further in view of Hioki et al. (WO 2020111184 A1) . Note that all references to Hioki herein refer to the copy and translation provided by applicant. Regarding claim 15, Kiemeneij as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Kiemeneij as modified is silent regarding inflatable member has a shape in which a width of the inflatable member decreases from one first hole portion side toward an other first hole portion side between the pair of first hole portions. However Hioki, in the same filed of endeavor, teaches (fig. 12 and 19) an inflatable member has a shape that decreases in width (see fig. 19 and pg. labeled 17/18 second to last paragraph) from the fingertip side of the hand back (see pg. labeled 17/18 second to last paragraph). Therefore, the substitution of one known inflatable shape (triangle as taught in Hioki ) for another (circle as taught in Kiemeneij ) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since Hioki teaches that a triangle pressing member is an alternative to a circle and the substitution of the triangle shape as taught in Hioki would have yielded predictable results, namely, a pressing member of Kiemeneij that would compress a puncture to achieve hemostasis. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Kiemeneij as modified teaches the width of the inflatable member decreases in width from one first hole portion side (hole connected to 120; see fig. 1) toward an other first hole portion side (hole opposite 120 in Kiemeneij as modified) between the pair of first hole portions (hole connected to 110, 130; see fig. 1). Kiemeneij is modified to have the wide side of the triangle be adjacent the finger tip side (side of 120) and tapering backward . 07-22-aia AIA Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Kiemeneij in view of Popp and Clark as applied to claim 11 above, and further in view of Hafemann (US 6,752,820 B1) . Regarding claim 22, Kiemeneij as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Kiemeneij as modified is silent regarding the support member has a circular shape. However Hafemann, in the same filed of endeavor, teaches (fig. 1) a support member 4 has a circular shape (see fig. 1 and col. 2 ln. 56-63). Hafemann further teaches the support member can be circular or rectangular (see fig. 4-6 and col. 3 ln. 50-55). Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kiemeneij as modified to have the support member have a circular shape as taught by Hafemann, as Hafemann teaches support member can be circular or rectangular and it has been held that shape is a matter of choice which a person of ordinary skill in the art would have found obvious. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) . Response to Arguments 07-38-01 AIA Applicant’s arguments, see pg. 13-14 , filed 02/13/2026 , with respect to the objection of claims 11 and 20 have been fully considered and are persuasive. The objection of claims 11 and 20 has been withdrawn. 07-38-01 AIA Applicant’s arguments, see pg. 14 , filed 02/13/2026 , with respect to the interpretation of claims 8 and 19 under 35 U.S.C. 112(f) have been fully considered and are persuasive. The interpretation of claims 8 and 19 under 35 U.S.C. 112(f) has been withdrawn. 07-38-01 AIA Applicant’s arguments, see pg. 14-15 , filed 02/13/2026 , with respect to the rejection of claims 2-7, 9, and 11-19 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 2-7, 9, and 11-19 under 35 U.S.C. 112(b) has been withdrawn. 07-38-01 AIA Applicant’s arguments, see pg. 15-17 , filed 02/13/2026 , with respect to the rejection of claims 1 and 20 under 35 U.S.C. 103 have been fully considered and are persuasive. The rejection of claims 1 and 20 under 35 U.S.C. 103 has been withdrawn. 07-37 AIA Applicant's arguments filed 02/13/2026 have been fully considered but they are not persuasive. Regarding claim 11, Applicant argues that “[n]one of the applied references disclose or suggest wherein a first curved region convexly curved toward a side away from the inflatable member disposed on one surface of the support member is formed at a part of the second region of the support member where the pair of first hole portions are disposed; and wherein a second curved region convexly curved toward a side of the inflatable member disposed on one surface of the support member is formed at a part of the second region of the support member where the pair of second hole portions are disposed as recited in claim 11 as amended” specifically because “in Clark, the footplate 2 merely includes a pair of curved arms 5” and “Kiemeneij discloses ‘[t]he housing 144 may be formed in a concave shape relative to a top surface such that the housing 144 conforms to an anatomical shape of the snuffbox area of the hand’”. The Office agrees with applicant’s characterization of Clark and Kiemeneij but respectfully disagrees that they do not teach the claim language. Kiemeneij shows 144 in use conforming to the hand of a user. In this position the outward facing surface of 144 is convex meeting the limitation of “a second curved region convexly curved toward a side of the inflatable member disposed on one surface of the support member is formed at a part of the second region of the support member where the pair of second hole portions are disposed”. Clark teaches convex arms 5 that are convexly curved toward a side away from the inflatable member (see fig. 1-3 of Clark) disposed on one surface of the support member (disposed on the top surface) is formed at a part of the second region (forms part of the outer region of the support member) of the support member where the pair of first hole portions are disposed (the pair of first hole portions are also disposed in the second (outer) region of the support member. The Office notes that the claim language does not require the hole portions to be formed in the convexly curved portion but instead just requires both to be on the second (outer) portion of the support member. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the hole portions to be formed in the convexly curved portion) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns , 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) . Allowable Subject Matter 12-151-07 AIA 07-97 12-51-07 Claim s 20 and 23 are allowed. 07-43-01 Claims 1, 4, 6-10, 21, and 24 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, and 35 U.S.C. 101 set forth in this Office action. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: the prior art, alone or in combination, sails to teach or render obvious a hemostatic device with a support member comprising two pairs of hole where at least two of the plurality of hole portions having widths that are larger than a width of the first band body, a width of the second band body, and a width of the third band body, the at least two of the plurality of hole portions being configured in a non- linear shape, and wherein one or more of the first band body, the second band body, and the third band body are configured to be connected to the at least two hole portions and configured to radially change in angle about the pressing portion relative to the first regions in combination with each of the pair of second hole portions is longer in hole length than each of the pair of first hole portions, and a width of an end portion of the first band body connected to the one first hole portion or to the other first hole portion is substantially the same as a hole length of the one first hole portion and the other first hole portion. Each of these limitations are taught in the prior art (see Kiemeneij and Popp) but there is no teaching of combining two of the holes having widths larger than the band bodies and one of the hole portions have a substantially equal length to a band body . Conclusion 07-40 AIA 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 KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771 Application/Control Number: 18/170,798 Page 2 Art Unit: 3771 Application/Control Number: 18/170,798 Page 3 Art Unit: 3771 Application/Control Number: 18/170,798 Page 4 Art Unit: 3771 Application/Control Number: 18/170,798 Page 5 Art Unit: 3771 Application/Control Number: 18/170,798 Page 6 Art Unit: 3771 Application/Control Number: 18/170,798 Page 7 Art Unit: 3771 Application/Control Number: 18/170,798 Page 8 Art Unit: 3771 Application/Control Number: 18/170,798 Page 9 Art Unit: 3771 Application/Control Number: 18/170,798 Page 10 Art Unit: 3771 Application/Control Number: 18/170,798 Page 11 Art Unit: 3771 Application/Control Number: 18/170,798 Page 12 Art Unit: 3771 Application/Control Number: 18/170,798 Page 13 Art Unit: 3771 Application/Control Number: 18/170,798 Page 14 Art Unit: 3771 Application/Control Number: 18/170,798 Page 15 Art Unit: 3771
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