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
Applicant’s Amendments, filed 2/9/2026, to claims 1-2, 6, 11 acknowledged by Examiner. Additionally, applicant cancelled claims 3-5, 7-10, 12-14, and added claims 15-29.
Claims 1-2, 6, 11, 15-29 are now pending.
Previous drawing, specification, and claim objections withdrawn.
Previous 112b rejections withdrawn.
Previous 101 rejection withdrawn.
Response to Arguments
Applicant's arguments filed 2/9/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that Saatchi does not provide for an audible and/or tactile feedback when a circumferential wrap or band compresses the top portion of the device to indicate a specific applied pressure, Examiner disagrees.
Firstly, see updated rejection below.
Secondly, Saatchi provides that (see [0074]) the wrap/band 30 being the retention structure 30 may be inextensible such that as pressure increases in the bladder/balloon 40 the band 30 would compress the top portion 20 down against the user and indicates an applied compressive force at the patient contact area (see [0080, 0117] and Figures 1-8) wherein the dial 60 is used to adjust the pressure delivered to the patient, wherein an audible click noise may be provided when selecting a designated pressure level, thus an audible feedback being provided at the applied pressure, further more applied pressure itself is tactile feedback, so as the applied pressure occurs there is a tactile feeling of the pressure to the user therein from the bladder 40. As discussed in paragraph [0033] the device is selecting pressures when being used thus the clicking happening at a specific pressure being a selected pressure therein.
Examiner’s Notes
All references relied up on and not cited in the current Form 892 may be found in previous 892's or IDS'.
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:
“attachment mechanism” in claim 1. “Attachment mechanism” does not have any structural limitation, mechanism is generic, and attachment is functionally modifying a generic placeholder. The provided instant specification paragraph [0006] provides attachment mechanisms of: “hook and loop attachments (e.g., Velcro), a buckle, ziptie technology, adhesive dressing, cohesive dressings” and the hook/ring-shaped attachment mechanism shown in Figure 4.
“mechanical clicker mechanism” in claims 2, 22. “Mechanical clicker mechanism” does not have any structural limitation, mechanism is generic, and attachment is functionally modifying a generic placeholder. The instant specification provides for a “toy clicker mechanism” in [00032] being a lever clicker as shown in Fig. 1 and metal that clicks when bent or depressed (see further [00037]).
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 Objections
Claim 21 objected to because of the following informalities: “compresses” in line 6 should be -compress-. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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, 6, 11, 15-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saatchi (US 20150119926 A1) in view of Benz (US 20180028195 A1) and Du (US 20180193031 A1).
Regarding claim 1, Saatchi discloses a device (10) (Figures 1-8) for use with a circumferential wrap or band 30 (strap 30, Fig. 1-8) for applying compression over a bleeding wound (See [0076], wherein device 10 applies pressure over a puncture access site for hemostasis, thus applying compression over a bleeding wound),
wherein the device (10) is rigid or semi-rigid (device 10 comprises a dial 60 [0079], wherein a dial is implicitly rigid in order to function, thus the device is rigid or at least semi-rigid) and
has bottom portion comprising a patient contact area (42) ([0076] lower surface 42 of the bladder 42 of the device 10 contacts the patient, surface is an area, this being a bottom portion of the device), and
a top portion (20) (Figures 1-8 and [0073] base 20 which is above and thus a top portion of the contact area 42) comprising a wrap or band contact surface (26) (Fig. 2-3 and [0073], there is a slot 26 being a surface of the top portion 20 that contacts the wrap/band 30 being the strap 30) or a wrap or band attachment mechanism (26) (Figure 2-3 and [0073-0074] slot 26 is an attachment mechanism being a hook for the wrap/band 30),
wherein the device (10) is configured to provide an audible and/or tactile feedback when the circumferential wrap or band 30 compresses the top portion (20) of the device (10) (see [0074] the wrap/band 30 being the retention structure 30 may be inextensible such that as pressure increases in the bladder/balloon 40 the band 30 would compress the top portion 20 down against the user) and indicates an applied compressive force at the patient contact area (42) ([0080, 0117] and Figures 1-8, dial 60 is used to adjust the pressure delivered to the patient, wherein an audible click noise may be provided when selecting a designated pressure level, thus an audible feedback being provided at the applied pressure, further more applied pressure itself is tactile feedback, so as the applied pressure occurs there is a tactile feeling of the pressure to the user therein from the bladder 40).
Saatchi does not disclose the patient contact area being 0.5 to 10 square inches
However, Benz teaches an analogous compression device for hemostasis of a wound (see [0018]) utilizing an analogous bladder (see balloons [0063]) with analogous patient contact area ([0063] footprint), wherein a contact area of 1.5 to 2.5 square inches is provided for sufficient size when targeting a puncture site (see [0063]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the patient contact area 42 of Saatchi to be in the range of 1.5 to 2.5 square inches as taught by Benz in order to provide sufficient coverage for a puncture site (Benz [0063]), thus the range of 0.5 to 10 square inches has been found obvious since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. See MPEP § 2144.05.
Saatchi in view of Benz does not disclose the applied compression force being in the range of 50 to 300mmHg.
However, Du teaches an analogous hemostatic compression device (Abstract) provides that a pressure of 100 mmHg should be provided as enough pressure to stop bleeding while not being too high of a pressure for injuries (see [0058]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided one of the selectable compressions of the dial 60 of Saatchi, thus an applied compression force, to be 100 mmHg as taught by Du in order to provide a pressure that stops bleeding while being not too high to cause injuries (Du [0058]), finding the range of 50 to 300 mmHg obvious since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. See MPEP § 2144.05.
Regarding claim 2, Saatchi in view of Benz and Du discloses the device of claim 1 above.
Saatchi further discloses wherein the device comprises a mechanical clicker mechanism 70 (Fig. 7-8 and [0117] the indicated ring indicator 70 is a mechanical mechanism that provides a click when bent/depressed by the dial into convex and concave configurations).
Regarding claim 6, Saatchi in view of Benz and Du discloses the device of claim 1 above.
Saatchi further discloses wherein the device (10) is configured to provide a second audible and/or tactile feedback when the circumferential wrap or band decompresses the top portion of the device and indicates a lower compression force (see [0117] and Fig. 7-8, wherein Fig. 7 shows the device in a state of the applied compression force created from the bladder 40, wherein switching into this configuration creates the click from indicator 70 this being the first feedback therein, and Fig. 8 shows the device in a configuration of less pressure within the bladder 40 and going into this state is a lower compression and also forms a click or a pop therein as discussed in [0117-0119]) (see [0063] wherein the further selecting of other compression levels will cause further clicking noises thus there would be multiple audible feedbacks for varying compressions).
Regarding claim 11, Saatchi in view of Benz and Du discloses the device of claim 1 above.
Saatchi further discloses wherein the device (10) comprises a balloon (40) (Fig. 1-8 and see [0076] inflation of the bladder 40 creates the pressure/compression, wherein a bladder is a synonym for a balloon), and wherein inflation of the balloon (40) causes the circumferential wrap or band (30) to compress the top portion (20) of the device (10) (see [0074] wherein the band 30 is inextensible such that as the bladder 40 is inflated the band 30 applies pressure therein to the top portion 20) to provide the audible and/or tactile feedback (see [0117-0119] wherein the audible feedback is caused by the ring indicator 70 which is altered by the dial therein and as further seen in Fig. 7-8 the inflation of the bladder 40 and audible click are directly connected in function).
Regarding claim 15, Saatchi in view of Benz and Du discloses the device of claim 1 above.
Saatchi further discloses wherein the device (10) is configured for use with a circumferential wrap 30 (Fig. 1-8, the strap 30 is a circumferential wrap 30).
Regarding claim 16, Saatchi in view of Benz and Du discloses the device of claim 1 above.
Saatchi further discloses wherein the device (10) is configured for use with a band 30 (Fig. 1-8, strap 30 is a band).
Regarding claim 17, Saatchi in view of Benz and Du discloses the device of claim 1 above.
Saatchi further discloses wherein the device (10) comprises a wrap or band attachment mechanism 26 (Fig. 1 and [0073], slot 26 receives and attaches the wrap/band 30).
Regarding claim 18, Saatchi in view of Benz and Du discloses the device of claim 2 above.
Saatchi further discloses wherein the mechanical clicker mechanism 70 comprises a depressible lever 70 (Fig. 7-8 and [0117] the indicated ring indicator 70 is shown in its cross-section to be a lever that is able to depress into concave and convex configurations of Fig. 7-8).
Regarding claim 19, Saatchi in view of Benz and Du discloses the device of claim 2 above.
Saatchi further discloses wherein the mechanical clicker mechanism 70 clicks when a portion is bent or depressed (Fig. 7-8 and [0117], a click sound is formed the ring indicator 70 is bent/depressed into concave and convex configurations).
Regarding claim 20, Saatchi in view of Benz and Du discloses the device of claim 1 above.
Saatchi discloses wherein the device (10) provides an audible feedback (see [0117] audible click).
Regarding claim 21, Saatchi discloses a device (10) (Figures 1-8) for use with a circumferential wrap or band 30 (strap 30, Fig. 1-8) for applying compression over a bleeding wound (See [0076], wherein device 10 applies pressure over a puncture access site for hemostasis, thus applying compression over a bleeding wound),
wherein the device (10) is rigid or semi-rigid (device 10 comprises a dial 60 [0079], wherein a dial is implicitly rigid in order to function, thus the device is rigid or at least semi-rigid) and
has bottom portion comprising a patient contact area (42) ([0076] lower surface 42 of the bladder 42 of the device 10 contacts the patient, surface is an area, this being a bottom portion of the device), and
a top portion (20) (Figures 1-8 and [0073] base 20 which is above and thus a top portion of the contact area 42) comprising a wrap or band contact surface (26) (Fig. 2-3 and [0073], there is a slot 26 being a surface of the top portion 20 that contacts the wrap/band 30 being the strap 30) or a wrap or band attachment mechanism (26) (Figure 2-3 and [0073-0074] slot 26 is an attachment mechanism being a hook for the wrap/band 30),
wherein the wrap or band 30 comprises a balloon (40) (Fig. 1-8 and see [0076] inflation of the bladder 40 creates the pressure/compression, wherein a bladder is a synonym for a balloon; wherein as seen in Fig. 1-8 and [0073] the top portion 20 and the band 30 are attached with each other, thus as the bladder 40 is in the top portion which is connected to the wrap/band 30, the wrap/band 30 comprises a balloon),
wherein the device (10) is configured to provide an audible and/or tactile feedback upon inflation of the balloon (40) causing the wrap or band 30 to compress the top portion (20) of the device (10) (see [0074] wherein the band 30 is inextensible such that as the bladder 40 is inflated the band 30 applies pressure therein to the top portion 20) (see [0117-0119] wherein the audible feedback is caused by the ring indicator 70 which is altered by the dial therein and as further seen in Fig. 7-8 the inflation of the bladder 40 and audible click are directly connected in function) (see [0074] the wrap/band 30 being the retention structure 30 may be inextensible such that as pressure increases in the bladder/balloon 40 the band 30 would compress the top portion 20 down against the user) and indicates an applied compressive force at the patient contact area (42) ([0080, 0117] and Figures 1-8, dial 60 is used to adjust the pressure delivered to the patient, wherein an audible click noise may be provided when selecting a designated pressure level, thus an audible feedback being provided at the applied pressure, further more applied pressure itself is tactile feedback, so as the applied pressure occurs there is a tactile feeling of the pressure to the user therein from the bladder 40).
Saatchi does not disclose the patient contact area being 0.5 to 10 square inches
However, Benz teaches an analogous compression device for hemostasis of a wound (see [0018]) utilizing an analogous bladder (see balloons [0063]) with analogous patient contact area ([0063] footprint), wherein a contact area of 1.5 to 2.5 square inches is provided for sufficient size when targeting a puncture site (see [0063]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the patient contact area 42 of Saatchi to be in the range of 1.5 to 2.5 square inches as taught by Benz in order to provide sufficient coverage for a puncture site (Benz [0063]), thus the range of 0.5 to 10 square inches has been found obvious since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. See MPEP § 2144.05.
Saatchi in view of Benz does not disclose the applied compression force being in the range of 50 to 300mmHg.
However, Du teaches an analogous hemostatic compression device (Abstract) provides that a pressure of 100 mmHg should be provided as enough pressure to stop bleeding while not being too high of a pressure for injuries (see [0058]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided one of the selectable compressions of the dial 60 of Saatchi, thus an applied compression force, to be 100 mmHg as taught by Du in order to provide a pressure that stops bleeding while being not too high to cause injuries (Du [0058]), finding the range of 50 to 300 mmHg obvious since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. See MPEP § 2144.05.
Regarding claim 22, Saatchi in view of Benz and Du discloses the device of claim 21 above.
Saatchi further discloses wherein the device comprises a mechanical clicker mechanism 70 (Fig. 7-8 and [0117] the indicated ring indicator 70 is a mechanical mechanism that provides a click when bent/depressed by the dial into convex and concave configurations).
Regarding claim 23, Saatchi in view of Benz and Du discloses the device of claim 22 above.
Saatchi further discloses wherein the mechanical clicker mechanism 70 comprises a depressible lever 70 (Fig. 7-8 and [0117] the indicated ring indicator 70 is shown in its cross-section to be a lever that is able to depress into concave and convex configurations of Fig. 7-8).
Regarding claim 24, Saatchi in view of Benz and Du discloses the device of claim 22 above.
Saatchi further discloses wherein the mechanical clicker mechanism 70 clicks when a portion is bent or depressed (Fig. 7-8 and [0117], a click sound is formed the ring indicator 70 is bent/depressed into concave and convex configurations).
Regarding claim 25, Saatchi in view of Benz and Du discloses the device of claim 21 above.
Saatchi further discloses wherein the device (10) is configured to provide a second audible and/or tactile feedback when the circumferential wrap or band decompresses the top portion of the device and indicates a lower compression force (see [0117] and Fig. 7-8, wherein Fig. 7 shows the device in a state of the applied compression force created from the bladder 40, wherein switching into this configuration creates the click from indicator 70 this being the first feedback therein, and Fig. 8 shows the device in a configuration of less pressure within the bladder 40 and going into this state is a lower compression and also forms a click or a pop therein as discussed in [0117-0119]) (see [0063] wherein the further selecting of other compression levels will cause further clicking noises thus there would be multiple audible feedbacks for varying compressions).
Regarding claim 26, Saatchi in view of Benz and Du discloses the device of claim 21 above.
Saatchi further discloses wherein the device (10) is configured for use with a circumferential wrap 30 (Fig. 1-8, the strap 30 is a circumferential wrap 30).
Regarding claim 27, Saatchi in view of Benz and Du discloses the device of claim 21 above.
Saatchi further discloses wherein the device (10) is configured for use with a band 30 (Fig. 1-8, strap 30 is a band).
Regarding claim 28, Saatchi in view of Benz and Du discloses the device of claim 21 above.
Saatchi further discloses wherein the device (10) comprises a wrap or band attachment mechanism 26 (Fig. 1 and [0073], slot 26 receives and attaches the wrap/band 30).
Regarding claim 29, Saatchi in view of Benz and Du discloses the device of claim 1 above.
Saatchi discloses wherein the device (10) provides an audible feedback (see [0117] audible click).
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 KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786