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 .
Receipt is acknowledged of applicant’s amendment filed August 22, 2025. Claims 2, 4-5, 16-22 and 24-25 have been canceled without prejudice. Claims 1, 3, 6-15, 23, 26-29 and new claims 30-31 are pending and an action on the merits is as follows.
Applicant’s arguments with respect to claims 1, 3, 6-15, 23, 26-29 have been considered but are moot in view of the new ground of rejection.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 14-15, 23, 26, 28, 30, 31 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Pancholy et al. (US 2019/0069905).
Regarding claim 1, Pancholy discloses a balloon assembly for a hemostasis device (Ref 120; Figures 10-11), the balloon assembly comprising: a first chamber (Figure 10, 11; Ref 125, 141); a second chamber (Figures 10-11; Ref 135, 142); at least one channel that extends between the first chamber and the second chamber and that is in fluid flow communication between the first chamber and the second chamber (Figures 10-11; Ref 143; see annotated Figure 10 below), wherein a single perimeter of attachment between a first layer of material and a second layer of material defines an entirety of a perimeter of the first chamber, an entirety of a perimeter of the second chamber, and at least a portion of a perimeter of the at least one channel (Para [0070], [0115]; where Figures 10-11 shows that there is a single perimeter around an entirety of the first chamber, an entirety of the second chamber and at least a portion of the channel; where Para [0070], [0115] show that the perimeter of attachment can be formed between first and second layers; see annotated Figure 10 below w to show first and second layers), the first layer of material possessing oppositely facing first and second surfaces (Figure 10-11; Para [0070], [0115]; see annotated Figure 10 below to show first and second layers; where each layer includes an inner surface and outer surface (i.e. first and second oppositely facing surfaces)), the second layer of material possessing oppositely facing first and second surfaces (Figure 10-11; Para [0070], [0115]; see annotated Figure 10 below to show first and second layers; where each layer includes an inner surface and outer surface (i.e. first and second oppositely facing surfaces)), the first surface of the first layer of material facing towards the first chamber, the second chamber and the at least one channel (Figure 10-11; Para [0070], [0115]; see annotated Figure 10 below to show first and second layers; where each layer includes an inner surface facing towards the chambers and channel (i.e. first inner surface)), the first surface of the second layer of material facing towards the first chamber, the second chamber and the at least one channel (Figure 10-11; Para [0070], [0115]; see annotated Figure 10 below to show first and second layers; where each layer includes an inner surface facing towards the chambers and channel (i.e. first inner surface)); and the first layer of material and the second layer of material being folded so that the balloon assembly includes a folded portion that is an exterior edge of the balloon assembly (Figure 10-11; Ref 135, 125, 141, 142; where Figures 10-11 show that the layers of material are folded to include a folded portion along an exterior edge, see annotated Figure 10 below For example), the at least one channel extending continuously from the first chamber, through the folded portion and to the second chamber so that the at least one channel provides the fluid flow communication between the first chamber and the second chamber (Figures 10-11; Ref 143; see annotated Figure10 below; where the channel extends from the first chamber through the folded portion to the second chamber to provide fluid flow communication); the first chamber including one part and the second chamber including one part (Figures 10-11; Ref 135, 142; 125, 141), the one part of the second chamber and the one part of the first chamber being positioned in overlying relation to one another such that the second surface of the first layer of material in the one part of the first chamber faces the second surface of the first layer of material in the one part of the second chamber (Figures 10-11; Ref 135, 142; 125, 141; see annotated Figure10 below for example; where when viewed from arrow A, the second chamber is shown on top of (i.e. overlying) with the first chamber such that a second surface of a first layer of material faces second surface of first layer of material in one part of 2nd chamber), the at least one channel including first and second channel portions (Figures 10-11; Ref 143; see annotated Figure *10 below), the first channel portion having a longitudinal extent extending from the folded portion to the first chamber (Figures 10-11; Ref 143; see annotated Figure 10 below), the second channel portion having a longitudinal extent extending from the folded portion to the one part of the second chamber (Figures 10-11; Ref 143; see annotated Figure 10 below), an entirety of the longitudinal extent of the first channel portion and at least a part of the longitudinal extent of the second channel portion being positioned in overlying relation to one another (see annotated Figure 10 below ; wherein when viewed from arrow A, the entirety of the longitudinal extend of the first channel portion and at least a part of the longitudinal extent of the second channel portion are positioned in overlying relation to one another), the first and second channel portions having a width in a direction perpendicular to the longitudinal extent that is less than the width of the first chamber and less than the width of the second chamber (see annotated Figure 10 below).
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Regarding claim 3, Pancholy discloses that the single perimeter of attachment defines the entirety of the perimeter of the at least one channel (Para [0070], [0115]; where Figures 10-11 shows that there is a single perimeter around an entirety of the first chamber, an entirety of the second chamber and an entirety of the channel).
Regarding claim 14-15, Pancholy discloses an inlet located along the perimeter through which a fluid can be introduced into an interior of the balloon assembly; where the inlet is in the form of a hollow cylindrical tubing (Where Para [0080], [0084] states that the chambers are inflated and Figures 5, 8, 14 show that the balloons of the invention include a tube for introducing fluid into the balloons Ref 521, 525, 821, 825, 235 and therefore Pancholy is interpreted as including an inlet along the perimeter through which fluid can be introduced similar to the inlets of Figures 5, 8 and 14).
Regarding claim 23, Pancholy discloses a balloon assembly for a hemostasis device (Ref 120; Figures 10-11), the balloon assembly comprising: a first chamber (Figure 10, 11; Ref 125, 141); a second chamber (Figures 10-11; Ref 135, 142); and at least one channel that is in fluid flow communication between the first chamber and the second chamber (Figures 10-11; Ref 143; see annotated Figure 10 above); wherein the first chamber, the second chamber, and the at least one channel are formed between a first layer of material and a second layer of material (Para [0070], [0114]; where para [0070], [0115] shows that the chambers can be formed by attaching first and second layers; where Figures 10-11 shows that the first chamber, second chamber and channel are formed between a first layer and a second layer of material), the first layer of material possessing oppositely facing first and second surfaces (Figure 10-11; Para [0070], [0115]; see annotated Figure 10 above to show first and second layers; where each layer includes an inner surface and outer surface (i.e. first and second oppositely facing surfaces)), the second layer of material possessing oppositely facing first and second surfaces (Figure 10-11; Para [0070], [0115]; see annotated Figure 10above to show first and second layers; where each layer includes an inner surface and outer surface (i.e. first and second oppositely facing surfaces)), the first surface of the first layer of material facing towards the first chamber, the second chamber and the at least one channel (Figure 10-11; Para [0070], [0115]; see annotated Figure 10above to show first and second layers; where each layer includes an inner surface facing towards the chambers and channel (i.e. first inner surface)), the first surface of the second layer of material facing towards the first chamber, the second chamber and the at least one channel (Figure 10-11; Para [0070], [0115]; see annotated Figure 10 above to show first and second layers; where each layer includes an inner surface facing towards the chambers and channel (i.e. first inner surface)), a single perimeter of attachment between the first layer of material and the second layer of material defining an entirety of a perimeter of the first chamber, an entirety of a perimeter of the second chamber, and at least a portion of a perimeter of the at least one channel (Para [0070], [0115]; where Figures 10-11 shows that there is a single perimeter around an entirety of the first chamber, an entirety of the second chamber and at least a portion of the channel; where Para [0070], [0115] show that the perimeter of attachment can be formed between first and second layers; see annotated Figure 10 above to show first and second layers); the first layer of material and the second layer of material being folded around a fold line so that i) the balloon assembly includes a folded portion that is an exterior edge of the balloon assembly (Figure 10-11; Ref 135, 125, 141, 142; where Figures 10-11 show that the layers of material are folded around a fold line to include a folded portion along an exterior edge, see annotated Figure 10 for example); and ii) one part of the second surface of the second layer overlies and faces away from another part of the second surface of the second laver (Figures 10-11; Ref 135, 142; 125, 141; see annotated Figure 10for example; where the first and second layers of material are folded such that a second surface of a second layer of material overlies and faces away from another part of the second surface of second layer); the at least one channel extending continuously from the first chamber, through the folded portion and to the second chamber so that the at least one channel provides the fluid flow communication between the first chamber and the second chamber (Figures 10-11; Ref 143; see annotated Figure 10 above; where the channel extends from the first chamber through the folded portion to the second chamber to provide fluid flow communication); the at least one channel including first and second channel portions (Figures 10-11; Ref 143; see annotated Figure 10 above), the first channel portion having a longitudinal extent extending in a longitudinal direction from the folded portion to the first chamber (Figures 10-11; Ref 143; see annotated Figure 10 above), the second channel portion having a longitudinal extent extending in the longitudinal direction from the folded portion to the one part of the second chamber (Figures 10-11; Ref 143; see annotated Figure 10 above), an entirety of the longitudinal extent of the first channel portion and at least a part of the longitudinal extent of the second channel portion being positioned in overlying relation to one another (see annotated Figure 10 above; wherein when viewed from arrow A, the entirety of the longitudinal extend of the first channel portion and at least a part of the longitudinal extent of the second channel portion are positioned in overlying relation to one another); and the first chamber having a longitudinal extent extending in the longitudinal direction from the first channel portion to the single perimeter of attachment (Figure 10, 11; Ref 125, 141; see annotated Figure 10 above) and the second chamber having a longitudinal extent extending in the longitudinal direction from the second channel portion to the single perimeter of attachment (Figures 10-11; Ref 135, 142; see annotated Figure 10 above), an entirety of the second chamber and at least a part of the first chamber being positioned in overlying relation to one another so that one portion of the second surface of the first layer of material and another portion of the second surface of the first layer of material face one another (see annotated Figure 10 above; wherein when viewed from arrow A, the entirety of the second chamber and at least a part of the first chamber are positioned in overlying relation to one another, where a portion of the second surface of the first and another portion of the second surface of the first layer face one another).
Regarding claim 26, Pancholy discloses that the first chamber has a longitudinal extent extending from the first channel portion to the single perimeter of attachment (Figure 10, 11; Ref 125, 141; see annotated Figure 10 above) and the second chamber has a longitudinal extent extending from the second channel portion to the single perimeter of attachment (Figures 10-11; Ref 135, 142; see annotated Figure 10 above), an entirety of the second chamber and the one part of the first chamber being positioned in the overlying relation to one another (see annotated Figure 10 above; wherein when viewed from arrow A, the entirety of the second chamber and at least a part of the first chamber are positioned in overlying relation to one another).
Regarding claim 28, Pancholy discloses that the first and second channel portions each have a width in a direction perpendicular to the longitudinal direction (Figures 10-11; Ref 143, see annotated Figure 10 above), the first chamber having a width in the direction perpendicular to the longitudinal direction (Figures 10-11; Ref 125, 141; see annotated Figure 10 above), the second chamber having a width in the direction perpendicular to the longitudinal direction (Figures 10-11; Ref 135, 142; see annotated Figure 10 above), the width of the first and second channel portions along an entirety of the first and second channel portions being less than the width of an entirety of the first chamber and less than the width of the entirety of the second chamber (Figures 10-11; Ref 143, 125, 135, 141, 142; see annotated Figure 10 above).
Regarding claim 30, Pancholy discloses that i) the second surface of the second layer of material in the one part of the first chamber faces in a first direction away from the one part of the first chamber(Figures 10-11; Ref 125, 141; see annotated Figure 10 above); ii) the second surface of the second layer of material in the one part of the second chamber faces in a second direction away from the one part of the second chamber (Figures 10-11; Ref 135, 142; see annotated Figure 10 above); and iii) the first and second directions being opposite one another (Figures 10-11; Ref 125, 135, 141, 142; See annotated Figure 10 above).
Regarding claim 31, Pancholy discloses that the balloon assembly is attached to a band by (Ref 120, 123) at least one hinge (Ref 127; Figure 10; where Ref 127 allows for movement of the balloon and is therefore interpreted as a hinge), the band including rigid plate that extends over only a portion of the band (Ref 121; Figure 10; Para [0080]).
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Haidukewych (US 2013/0125903)
Regarding claim 1, Haidukewych discloses a balloon assembly for a hemostasis device (Figure 1; Ref 10; where the balloon assembly is positioned around a body part, inflated to engage the body part and can apply pressure to the body part; where the balloon assembly Ref 10 includes all of the structure below defined as a hemostasis device, where the device is capable of being applied to provide pressure to the body part, where enough pressure applied can temporarily stop bleeding and can therefore be interpreted as a balloon assembly for a hemostasis device), the balloon assembly comprising: a first chamber (see annotated Figure 1 below); a second chamber (see annotated Figure 1 below); at least one channel that extends between the first chamber and the second chamber and that is in fluid flow communication between the first chamber and the second chamber (see annotated Figure 1 below), wherein a single perimeter of attachment between a first layer of material and a second layer of material defines an entirety of a perimeter of the first chamber, an entirety of a perimeter of the second chamber, and at least a portion of a perimeter of the at least one channel (see annotated Figure 1 below; Para [0047]; Figures 1, 4; Ref 28, 30), the first layer of material possessing oppositely facing first and second surfaces ( Figures 1, 4; Ref 28, 30), the second layer of material possessing oppositely facing first and second surfaces (Figure 1; 4; Ref 28, 30), the first surface of the first layer of material facing towards the first chamber, the second chamber and the at least one channel (Figure 4; Ref 28,3 0; where the inner surface of Ref 28 and 30 are the first surfaces of the first and second layers facing towards the chambers/channel), the first surface of the second layer of material facing towards the first chamber, the second chamber and the at least one channel (Figure 4; Ref 28,3 0; where the inner surface of Ref 28 and 30 are the first surfaces of the first and second layers facing towards the chambers/channel); and the first layer of material and the second layer of material being folded so that the balloon assembly includes a folded portion that is an exterior edge of the balloon assembly (Ref 28, 30; where Figure 2 shows that the first and second layers of material are folded so that the balloon assembly includes a folded portion that is an exterior edge), the at least one channel extending continuously from the first chamber, through the folded portion and to the second chamber so that the at least one channel provides the fluid flow communication between the first chamber and the second chamber (see annotated Figure 1 below); the first chamber including one part and the second chamber including one part (see annotated Figure 1 below), the one part of the second chamber and the one part of the first chamber being positioned in overlying relation to one another such that the second surface of the first layer of material in the one part of the first chamber faces the second surface of the first layer of material in the one part of the second chamber (Figure 2; where Figure 2 shows that when folded one part of the second chamber and one part of the first chamber are positioned in overlying relation; where the second surface of the first layer of material is the surface that is contacting the patient and therefore the second surface of the first layer of material int eh one part of the first chamber faces the second surface of the first layer of material in the one part of the second chamber), the at least one channel including first and second channel portions (See annotated Figure 1 below), the first channel portion having a longitudinal extent extending from the folded portion to the first chamber (See annotated Figure 1 below), the second channel portion having a longitudinal extent extending from the folded portion to the one part of the second chamber (See annotated Figure 1 below), an entirety of the longitudinal extent of the first channel portion and at least a part of the longitudinal extent of the second channel portion being positioned in overlying relation to one another (See annotated Figure 1 below; where Figure 2 shows that when the balloon is folded, the longitudinal extent of the first channel portion and a portion of the longitudinal extent of the second channel portion are positioned in overlying relation to one another), the first and second channel portions having a width in a direction perpendicular to the longitudinal extent that is less than the width of the first chamber and less than the width of the second chamber (See annotated Figure 1 below).
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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.
Claim(s) 6-10, 27, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pancholy et al. (US 2019/0069905) as applied to claims 1 and 23 above, and further in view of Billotti (US 5,588,956).
Regarding claims 6-10, Pancholy discloses all of the claimed limitations above but fails to explicitly disclose at least one piece of secondary material located within the at least one channel.
However, Billotti in the same field of endeavor (i.e. balloon assemblies), teaches a balloon assembly and additionally teaches that it is well known to include at least one piece of secondary material (i.e. a third layer of material) located within the at least one channel to reinforce at least a portion of the channel between the first and second layers of material (Ref 35, 37; C3, L46-53; where the secondary material can be a mesh webbing and therefore can be gas-permeable; where the secondary material can be metal and therefore formed of a gas-impermeable material; where the secondary material can line the channel and therefore as suggested by Figure 2; Ref 35 can include a cross-section shape similar to the shape of the channel, where the cross-sectional shape is circle-like and is therefore being interpreted as a circular cross-sectional shape; where the secondary material (i.e. third layer of material) can be located within the at least one channel and is therefore at least partially located between and attached to the first and second layers of material that make up the at least one channel).
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 at least one channel of Pancholy to include at least one piece of secondary material as suggested by Billotti, since such a modification helps reinforce at least a portion of the channel.
Regarding claim 27, Pancholy discloses all of the claimed limitations above but fails to explicitly disclose a breather strip located in the at least one channel to help prevent material adhesion between the first layer of material and the second layer of material.
However, Billotti in the same field of endeavor (i.e. balloon assemblies), teaches a balloon assembly and additionally teaches that it is well known to include a breather strip located within the at least one channel to reinforce at least a portion of the channel and help prevent material adhesion between the first and second layers of material (Ref 35, 37; C3, L46-53; where the breather strip can be located within the at least one channel and is therefore at least partially located between the first and second layers of material that make up the at least one channel and can help prevent material adhesion); where the breather strip extends from a first channel portion to a second channel portion (Ref 37, 35; C3, L46-53).
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 at least one channel of Pancholy to include a breather strip as suggested by Billotti, since such a modification helps reinforce at least a portion of the channel.
Where one of ordinary skill in the art before the effective filing date of the claimed invention would recognize that modifying the at least one channel of Pancholy to include a breather strip as suggested by Billotti, would result in the breather strip extending from a first channel portion, though the folded portion and to the second channel portion.
Regarding claim 29, Pancholy discloses all of the claimed limitations above but fails to explicitly disclose a breather strip located in the at least one channel to help prevent material adhesion between the first layer of material and the second layer of material.
However, Billotti in the same field of endeavor (i.e. balloon assemblies), teaches a balloon assembly and additionally teaches that it is well known to include a breather strip located within the at least one channel to reinforce at least a portion of the channel and help prevent material adhesion between the first and second layers of material (Ref 35, 37; C3, L46-53; where the breather strip can be located within the at least one channel and is therefore at least partially located between the first and second layers of material that make up the at least one channel and can help prevent material adhesion); where the breather strip extends from a first channel portion to a second channel portion (Ref 37, 35; C3, L46-53).
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 at least one channel of Pancholy to include a breather strip as suggested by Billotti, since such a modification helps reinforce at least a portion of the channel.
Where one of ordinary skill in the art before the effective filing date of the claimed invention would recognize that modifying the at least one channel of Pancholy to include a breather strip as suggested by Billotti, would result in the breather strip extending from a first channel portion, though the folded portion and to the second channel portion.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haidukewych (US 2013/0125903) as applied to claim 1 above, and further in view of Jacobs et al. (US 5,489,259).
Regarding claim 11, Haidukewych discloses all of the claimed limitations above including an outer perimeter attachment but fails to explicitly disclose an inner perimeter of attachment between the first and second layers.
However, Jacobs, in a similar field of endeavor (i.e. balloon assemblies), teaches a similar device including a balloon placed around a body part that comprises an outer perimeter of attachment between first and second layers (Ref 17, 19, C4, L55-62) and additionally teaches an inner perimeter of attachment between the first layer and the second layer (Ref 24, 25 C4, L63-C5, L20; where first and second layers Ref 17, 19 are joined together about the circumference of each opening Ref 24, 25 and therefore include an inner perimeter of attachment between the first and second layers), the inner perimeter being located interior to the outer perimeter (Figure 1, 3, where Figures 1, 3 show that the inner perimeter around Ref 24, 25 is located interior to outer perimeter); where the assembly incudes at least one channel that includes a first channel and a second channel, where the outer perimeter and the inner perimeter form the first channel and the second channel portion (Figure 3; Ref 12; where the first and second channels are formed between the outer and inner perimeter and can be seen between Ref 24’ and 25 in Figure 3’; where the section to the left of the center of the space between Ref 24’ and 25’ is the 2nd chamber and the section to the right of the center of the space between Ref 24’ and 25’ is the 1st chamber); where the balloon assembly additionally includes a cutout region interior to the inner perimeter from which portions of the first layer of material and second layer of material are absent (Ref 24, 25; C4, L63-C5, L20; where Figure 3 shows that cutout regions are formed at Ref 24, 25 interior to the inner perimeter formed around the cutouts; where there is no first layer or second layer of material present at Ref 24, 25).
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 balloon assembly of Haidukewych to include an inner perimeter of attachment between the first and second layers interior to the outer perimeter such that the first and second channel portions are formed between the inner and outer perimeters and a cutout region is formed interior to the inner perimeter as suggested by Jacobs, since such a modification dissipates heat and moisture and provides air flow to improve comfort of the balloon assembly on a user.
Response to Arguments
Applicant’s arguments with respect to claims 1, 3, 6-15, 23 and 26-29 have been considered but are moot in view of the new ground of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10,888,334- Figure 11 shows a folded balloon assembly with first and second compartments and at least one channel
US2018/0263634- Figure 17e shows a balloon assembly hingedly connected to a band; where the band includes a rigid plate over a portion.
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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/E.L.C/Examiner, Art Unit 3771
/KATHERINE M SHI/Primary Examiner, Art Unit 3771