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
This action is entered in response to Applicant's amendment and reply of 3/19/26. The claims 1-19 are pending. The claims 1, 11, 15 are amended.
Response to Arguments
Applicant’s arguments, filed 3/19/26 with respect to the rejections of claims 1-6 under 35 U.S.C. 103 as being unpatentable over Henderson (US1473041) in view of Altobelli (US2012/0232578) and Riebman (US2018/0193010) have been fully considered and the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of over Johnson (US2007/0260166) in view of Altobelli (US2012/0232578) and Askem (US2015/0174304). Applicant argues, the reference Altobelli has an inflatable bladder 36 that is used against the compressible mass 22. Examiner notes as stated in paragraph [0027] of Altobelli “an inflatable bladder 36, which may itself be optionally secured within a fabric pocket 28”. Furthermoe, Altobelli is relied upon for a teaching of the body within a cap, not for the force on the components. Where this force is already taught in Johnson by the wrapping around the body.
Applicants arguments, filed 3/19/26 with respect to the rejections of claims 15, 18, and 19 under 35 U.S.C. 103 as being unpatentable over Steinbaugh (US2014/0228732) the arguments have been considered but are not persuasive. Applicant argues Steinbaugh is unsuitable for junctional injuries and cites to paragraph [0060] which states the bandage is wrapped around “an arm, leg, torso, etc”. Examiner disagrees, where the limitation is functional, and the device of Steinbaugh need only be capable of performing the claimed function. The bandage of Steinbaugh is capable of being wrapped around a junctional injury, since it is wrapped around the body.
Terminal Disclaimer
The terminal disclaimer filed on 7/22/25 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11903590 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 of this title, 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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US2007/0260166) in view of Altobelli (US2012/0232578) and Askem (US2015/0174304).
Regarding claim 1, Johnson discloses trauma dressing article (see Abstract) for junctional injuries, comprising:
a body (protrusion 620), wherein the body has a height (height of the protrusion 620) having an outer surface (see Fig. 6C);
a wrap strip (bandage 610) having a first end that is attached to the body (bandage 610 is attached to the body/bar 620 by the flaps 640, [0047]) and a second end that is free (see Fig. 6A), and wherein, when the body is placed directly against a wound site at a junctional location of a person (the bandage is used in military/battlefield wounds for amputations, stumps, extremities; see Abstract), the wrap strip is configured to wrap around the person and over the body ([0046]), and be in contact with the body, wherein the height of the body causes the wrap strip, when so wrapped around the person, to compress the body and the cap directly against the wound site ([0046]).
Johnson does not explicitly disclose the body having a natural uncompressed shape, and that is made of elastic foam, the body deforms from the natural uncompressed shape under compression and returns to the natural uncompressed shape when not being compressed; a cap formed over at least a portion of the outer surface of the body and attached to the body. Henderson teaches the pressure bar is interior to the band (Page 2, lines 81-83). Altobelli teaches a cap (fabric pocket 34) formed over at least a portion of the outer surface of the body (compressing mass 32) and attached to the body (see Fig. 4). Altobelli according to embodiments teaches the compressing mass includes microbeads of Styrofoam material that are compressible and return to an uncompressed shape when not being compressed, by the beads being pliable expanded polymer that are compressed ([0025]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the body of Johnson with the body and cap of Altobelli in Fig. 4, since the substitution would have the same predictable result of providing a means for applying pressure to the body.
Johnson further discloses using gauze applied to the outer surface of the body ([0007]); yet, is silent regarding a gauze cap. Henderson teaches the use of cotton to strengthen the band (Page 2, line 34). Askem teaches a dressing for pressure wound therapy (see Abstract). The dressing is applicable to a broad range of wounds that would include junctional locations on the body ([0017]). The dressing can include gauze positioned above the cover layer ([0274]). It would have been obvious to one having ordinary skill in the art to modify the fabric material interpreted as the claimed cap of Johnson/Altobelli to be made of gauze, as taught by Askem, as the modification merely involves a substitution of known equivalent materials with a predictable result of providing a known suitable material in a device for applying pressure to the body.
Where the modified invention discloses wherein the height of the body causes the wrap strip, when so wrapped around the person, to compress the body directly against the wound site (the wrapping is taught by Johnson to compress the body, [0046]; where the body as modified by Altobelli would be compressed against the wound site in the same manner).
Regarding the requirement that the cap is attached to the body: the term “attached” is not construed to require any particular means of attachment. Altobelli teaches the body is within a pocket ([0027]), which meets the broad requirement of “attach.”
Regarding claim 2, Johnson/Altobelli/Askem makes obvious the trauma dressing article of claim 1, Altobelli further teaches wherein the body has a diameter of one and a half to three inches (Altobelli discloses the mass 32 being the size of a tennis ball (2.7 inches), [0023]).
Regarding claim 3, Johnson/Altobelli/Askem makes obvious the trauma dressing article of claim 1; yet, does not disclose wherein the body includes a first portion having a first radius and a second portion having a second radius that is smaller than the first radius, and wherein the gauze cap covers the second portion.
Johnson further teaches the pressure bar can have various shapes ([0045]). Therefore, Johnson sets forth that the shape of the body is a matter of design choice, wherein the shape of the body can be altered to any shape to apply a wound ([0045]). It would have been an obvious matter of design choice to one having ordinary skill in the art at the effective filing date of the application to have the spherical body have two different radius at two different portions, for the purpose of application to a specific type of wound or area of the body. One of ordinary skill in the art would have expected the shape of the modified body and Applicant’s invention to perform equally well with either design because both designs would perform the same function of applying localized pressure to the body to stop blood flow and/or bleeding. Where the cap of Altobelli would cover the entire surface of the body and therefore cover the first semispherical portion of the body.
Regarding claim 4, Johnson/Altobelli/Askem makes obvious the trauma dressing article of claim 1, Johnson further discloses wherein the wrap strip is self-adhering (the wrap strip includes Velcro to self-adhere to itself, [0044]).
Regarding claim 5, Johnson/Altobelli/Askem makes obvious the trauma dressing article of claim 1, Johnson further discloses wherein the wrap strip is elastic ([0005], [0029]).
Regarding claim 6, Johnson/Altobelli/Askem makes obvious the trauma dressing article of claim 1; Johnson further discloses wherein the wrap strip is provided in a rolled configuration ([0005], [0044]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US2007/0260166) in view of Altobelli (US2012/0232578) and Askem (US2015/0174304) as applied to claim 1; and further in view of Parssinen (US9226846).
Regarding claim 7, Johnson/Altobelli/Askem makes obvious the trauma dressing article of claim 1; yet, does not explicitly disclose wherein the wrap strip is at least four feet long. Parssinen teaches the dimensions of a rolled bandage (C15:L10). Where the length can range from 0.5 to 10 meters (1.64 to 32 feet) (C15:L11). As bandages are used to wrap the body, it would have been obvious to one of ordinary skill in the art to change the length of the wrap strip based on the portion of the body or body part of either an animal or human for usage of the wrap. Furthermore, the use of a known bandage length, including 1.64-32 feet as taught by Parssinen would have been particularly obvious. Therefore, the claimed limitation is considered at least obvious to one of ordinary skill in the art. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US2007/0260166) in view of Altobelli (US2012/0232578) and Askem (US2015/0174304) as applied claim 1; and further in view of Steinbaugh (US2014/0228732).
Regarding claim 8, Johnson/Altobelli/Askem makes obvious the trauma dressing article of claim 1; yet, does not disclose wherein the first end of the wrap strip is glued to the body. Steinbaugh teaches a trauma dressing where the wrap strip is glued to the body ([0032]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have modified the first end of the wrap strip of Johnson/Altobelli/Askem to be glued to the body, as taught by Steinbaugh, in order to secure the body to the wrap strip ([0032]).
Regarding claim 9, Johnson/Altobelli/Askem makes obvious the trauma dressing article of claim 1; yet does not disclose wherein the gauze cap contains a clotting agent that is at least one of kaolin, chitosan, or recombinant activated human clotting factors. Steinbaugh teaches a trauma dressing having an absorbent layer (like the gauze cap) that contains chitosan ([0040]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have modified the gauze cap of Johnson/Altobelli/Askem to contain chitosan, as taught by Steinbaugh, in order provide absorbent material to the cap for more absorption of fluid ([0040]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US2007/0260166) in view of Altobelli (US2012/0232578) and Askem (US2015/0174304) applied to claim 1; and further in view of Delmore (US5939339)
Regarding claim 10, Johnson/Altobelli/Askem makes obvious the trauma dressing article of claim 1; yet do not disclose wherein the gauze cap includes a dressing tail comprising a free section of dressing material that extends freely from the gauze cap. Delmore teaches a wound dressing 10 to treat or dress different wounds and apply force to the wound (Abstract). The wound dressing an absorbent layer 12 that covers all but a small portion of the elastic bandage width along a major portion of the bandage’s length (C3:L46-51). Delmore teaches the area the absorbent layer extends along the bandage can be altered (C3:L54-56). As it would be desirable to alter the area to maximize the amount of the absorbent layer that contacts the wound site, it would have been obvious to one of ordinary skill in the art to change the area of the absorbent layer based on the size of the wound site. Furthermore, the absorbent layer extending along the majority of the bandage is known as taught by Delmore, it would have been particularly obvious.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US2007/0260166) in view of Altobelli (US2012/0232578), Askem (US2015/0174304), and Johnson-2 (US2007/0260165).
Regarding claim 11, Johnson discloses a trauma dressing article (see Abstract), comprising:
a body (protrusion 620) having a height (defined by protrusion 620);
a wrap strip (bandage 610) including a sheet strip of dressing wrap having a first end attached to the body (attached to the body/bar 620 by the flaps 640, [0047]) and a second end that is a free end (see Fig. 6A), the wrap strip having a length that allows the wrap strip to be wrapped around a junctional location of a person (the bandage is used in military/battlefield wounds for amputations, stumps, extremities; see Abstract), and further around the person and over the body of the trauma dressing article to make contact with, and compress the body of the trauma dressing article ([0046]) in the junctional location and directly against a wound site in the junctional location.
Johnson is silent regarding the body having a semispherical portion, and that is made of elastic foam, wherein the body is compressible and deforms from the natural uncompressed shape under compression and returns to the natural uncompressed shape when not being compressed, and the semispherical portion presents a rounded outer surface; a cap disposed on and covering the rounded outer surface of the semispherical portion. Altobelli teaches a cap (fabric pocket 34) formed over at least a portion of the outer surface of the body (compressing mass 32) and attached to the body (see Fig. 4). Altobelli further teaches embodiments of the compressing mass includes microbeads of Styrofoam material that are compressible and return to an uncompressed shape when not being compressed, by the beads being pliable expanded polymer that are compressed ([0025]). Where the shape of the compressing mass 32 is semispherical (see Fig. 4, mass is a semi-spheroid, [0023]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the body of Johnson with the body and cap of Altobelli in Fig. 4, since the substitution would have the same predictable result of providing a means for applying pressure to the body.
Johnson further discloses using gauze applied to the outer surface of the body ([0007]); yet, is silent regarding a gauze cap. Henderson teaches the use of cotton to strengthen the band (Page 2, line 34). Askem teaches a dressing for pressure wound therapy (see Abstract). The dressing is applicable to a broad range of wounds that would include junctional locations on the body ([0017]). The dressing can include gauze positioned above the cover layer ([0274]). It would have been obvious to one having ordinary skill in the art to modify the fabric material interpreted as the claimed cap of Johnson/Altobelli to be made of gauze, as taught by Askem, as the modification merely involves a substitution of known equivalent materials with a predictable result of providing a known suitable material in a device for applying pressure to the body.
Johnson/Altobelli/Askem is silent regarding a packaging in which the body, gauze cap, and wrap strip are disposed and sealed. Johnson-2 teaches vacuuming a rolled trauma dressing wrap in a vacuumed storage pouch ([0031]). It would have been obvious to one having ordinary skill in the art to have provided the vacuum packaging for the body, gauze cap and wrap strip as taught by Johnson in order to have the structures stored in safe conditions prior to use (see [0031] of Johnson).
The modified invention of Johnson/Altobelli/Askem/Johnson-2 discloses compressing the body of the trauma dressing article (the wrapping is taught by Johnson to compress the body, [0046]; where the body as modified by Altobelli would be compressed against the wound site in the same manner) in the junctional location and directly against a wound site in the junctional location thereby pressing the gauze cap against the wound site in the junctional location (where the modified invention would have the gauze cap over the body and therefore pressed against the junctional location).
Regarding claim 12, Johnson/Altobelli/Askem/Johnson-2 makes obvious the packaged trauma dressing article of claim 11, Johnson-2 further teaches wherein the packaging is vacuum sealed ([0031] of Johnson).
Regarding claim 13, Johnson/Altobelli/Askem/Johnson-2 makes obvious the packaged trauma dressing article of claim 11, yet, does not explicitly disclose wherein the semispherical portion is a first semispherical portion having a first radius, the body further comprises a second semispherical portion having a second radius that is larger than the first radius, and wherein the gauze cap covers the first semispherical portion.
Johnson further teaches the pressure bar can have various shapes ([0045]). Therefore, Johnson sets forth that the shape of the body is a matter of design choice, wherein the shape of the body can be altered to any shape to apply a wound ([0045]). It would have been an obvious matter of design choice to one having ordinary skill in the art at the effective filing date of the application to have the spherical body have two different radius at two different portions, for the purpose of application to a specific type of wound or area of the body. One of ordinary skill in the art would have expected the shape of the modified body and Applicant’s invention to perform equally well with either design because both designs would perform the same function of applying localized pressure to the body to stop blood flow and/or bleeding. Where the cap of Altobelli would cover the entire surface of the body and therefore cover the first semispherical portion of the body.
Regarding claim 14, Johnson/Altobelli/Askem/Johnson-2 makes obvious the packaged trauma dressing article of claim 11, Johnson further discloses wherein the wrap strip is provided in a rolled configuration ([0005], [0044]).
Claims 15, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Steinbaugh (US2014/0228732).
Regarding claim 15, Steinbaugh embodiment of Fig. 4 discloses a trauma dressing article for use in junctional injuries to prevent exsanguination (see Abstract), comprising:
a body (404) having a sealed gas volume (bladder 404 is inflated to a desired pressure and therefore has a sealed gas volume, [0045], the bladder is forms an airtight seal, [0021]) and a flexible exterior wall having an outer surface (bladder may be made from materials that are flexible, see [0024], bladder has a surface 404, see Figs. 4A, 4B), wherein the body is compressible and deforms from the natural uncompressed shape under compression and returns to the natural uncompressed shape when not being compressed (bladder can be compressed and deform by the bladder being adapted to permit sufficient pressure where needed, [0018], and then be inflated again to return to a natural uncompressed shape);
an absorbent (absorbent pad 416) covering disposed over and attached to the outer surface (the pad 416 is attached to the outer surface of 404, [0036], see Fig. 4B); and
a wrap strip (bandage 402) having a first end that is attached to the absorbent covering (end where the air bladder 404 is bonded to bandage 402, [0032]; the wrap strip and absorbent covering being attached by the bond), wherein, when the body is placed directly against a wound site at a junctional location of a person, the wrap strip is configured to wrap around the person and the junctional location (the bandage 402 is intended to wrap around the wound site, [0018]), and the height of the body is such that, when the wrap strip is so wrapped around the person and the junctional location, the wrap strip acts against the body to compress the body directly against the wound site (see Abstract, [0032]; where the bandage 402 is capable of being wrapped at a junctional location).
Steinbaugh does not explicitly disclose the wrap strip has a portion that extends from the first end to a free end of the wrap strip. Steinbaugh teaches embodiments with a section of bandage on both sides of the body/bladder that extends to a free end (see Fig. 2, [0023]). It would have been obvious to one having ordinary skill in the art to have used the rolled bandage that extends to a free end as shown in the embodiment of Fig. 2, in order to roll the bandage for easy storage ([0018]).
Regarding claim 18, Steinbaugh makes obvious the trauma dressing article of claim 15, wherein the absorbent covering contains a clotting agent that is at least one of kaolin, chitosan, or recombinant activated human clotting factors ([0040]).
Regarding claim 19, Steinbaugh makes obvious the trauma dressing article of claim 15, wherein the wrap strip is elastic, self-adhering, and configured in a roll (Steinbaugh teaches the bandage is a rolled state, [0023]; where the bandage 102 is elastic and self-adhering, see [0020]).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Steinbaugh (US2014/0228732) in view of Riebman (US2018/0193010).
Regarding claim 16, Steinbaugh makes obvious the trauma dressing article of claim 15; yet, is silent regarding wherein the body is spherical and includes a first portion having a first radius and a second portion having a second radius that is smaller than the first radius. Riebman further teaches a scaffold 10 that can be any shape to apply to a wound ([0036]). Where the shape can be spherical, elliptical, etc. ([0036]). Therefore, Riebman sets forth that the shape of the body is a matter of design choice, wherein the shape of the body can be altered to any shape to apply a wound ([0036] of Riebman). It would have been an obvious matter of design choice to one having ordinary skill in the art at the effective filing date of the application to have the spherical body have two different radius at two different portions, for the purpose of application to a specific type of wound or area of the body. One of ordinary skill in the art would have expected the shape of the modified body and Applicant’s invention to perform equally well with either design because both designs would perform the same function of applying localized pressure to the body to stop blood flow and/or bleeding.
The modified invention teaches wherein the absorbent covering covers the second portion (the absorbent layer 416 covers the entirety of the surface of the bandage, see Fig. 4A, [0034] and would therefore cover the second portion).
Regarding claim 17, Steinbaugh makes obvious the trauma dressing article of claim 15; yet, is silent regarding wherein the wrap strip and the absorbent covering are formed of a continuous portion of gauze. Steinbaugh is silent regarding the wrap strip and absorbent covering being made of gauze. Riebman teaches wound sealing pads or patches that are supported on application scaffolds ([0035]). The scaffold having a fabric sack that is a made of gauze ([0036]). It would have been obvious to one having ordinary skill in the art to modify the wrap strip and absorbent covering of Steinbaugh to be made of gauze, as taught by Riebman, as the modification merely involves a combination of known wound dressings that obtains a predictable result of providing known biocompatible material to promote healing (see [0035]-[0036] of Riebman).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/ /THOMAS C BARRETT/Examiner, Art Unit 3774 SPE, Art Unit 3799
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