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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 25, 2024 has been entered.
Claims 4, 10,1 5 have been cancelled without prejudice. Claims 1-3, 5-9, 11-14 and 16-23 are pending and will be prosecuted on the merits.
Applicant's arguments filed November 25, 2024 have been fully considered but they are not persuasive.
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, 5-6, 8-9, 11-14, 16-18, 20-23 is/are rejected under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Hakonson et al. (US 2007/0197943).
Regarding claim 1, Hakonson discloses a hemostasis device (Ref 17; Figures 1-2, 5B, 10; where the device is placed over a patient’s body part and inflated to apply pressure and is therefore capable of providing hemostasis and is thus being interpreted as a hemostasis device) comprising: a main body (Figures 1-2, 5B; Ref 17) comprising a band having a centerline (Figure 2 see below), the band being adapted to be wrapped and releasably secured around a body part of a patient that includes a site where bleeding is to be stopped (Para [0062]; Ref 240, 250, 17; Figures 8-12, 14; where the band is capable of being wrapped and releasably secured around a body part of a patient that includes a site where bleeding is to be stopped), the band comprising an interior side that is adapted to face a skin surface of the patient when releasably secured to the body part of the patient (Para [0062]; Ref 240, 250, 17; Figures 8-12, 14; where the side that faces the user is interpreted as the interior side that is capable of facing a skin surface when releasably secured to a body part), a first long edge, and a second long edge that opposes the first long edge (Figure 2 see below; Ref 17; Figures 1-2, 5B, 10), each of the first long edge and the second long edge forming portions of the perimeter of the band (Figure 2 see below; Ref 17; Figures 1-2, 5B, 10), each of the first long edge and the second long edge including an inflatable compartment located along a portion of a respective length thereof (Figure 2 see below; Ref 17; Figures 1-2, 5B, 10), wherein the main body has a centerline that is parallel with the inflatable compartments of each of the first long edge and the second long edge (Figure 2 see below; Ref 17; Figures 1-2, 5B, 10), the main body further comprising a plurality of additional inflatable compartments that are aligned along the centerline (Figure 2 see below; Ref 17; Figures 1-2, 5B, 10); and a compression element, the compression element comprising at least one balloon, the at least one balloon being inflatable and adapted to be placed atop the site on the body part of the patient (Figure 2 see below; Ref 17; Figures 1-2, 5B, 10; where the at least one balloon is inflatable and is capable of being placed atop a site of the body part); wherein the band is adapted to direct an applied force generated by the at least one balloon when it is inflated towards the site on the body part of the patient (Figures 1-2; Ref 17; Para [0002], [0008]-[0009]; where the band is wrapped around a body part, where the at least one balloon is inflated towards the body part and is therefore interpreted as being capable of directing an applied force generated by the at least one balloon to the body part).
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Regarding claim 2, Hakonson discloses that the compression element comprises at least two inflatable balloons that are adapted to press into each other when inflated to assist in the application of the applied force towards the site on the body part of the patient (Para [0066], [0079]; where two inflatable balloons next to each other are capable of pressing into each other when inflated to help reinforce each other and assist in the application of the applied force).
Regarding claim 3, Hakonson discloses that the at least two inflatable balloons are of different sizes (Figure 5B; Ref 17, see below).
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Regarding claim 5, Hakonson discloses that the inflatable compartments located along each of the first long edge and the second long edge are located along a majority of a respective length thereof (Ref 17; Figure 2 see above).
Regarding claim 6, Hakonson discloses that when at least one of the inflatable compartments is inflated, an orientation of the interior side of the band is adapted to adjust with respect to the skin surface of the patient (Figure 2 see above; Para [0062]; Ref, 17; Figures 8-12, 14; where the side that faces the user is interpreted as the interior side, where an orientation of the interior side is capable of adjusting with respect to the skin surface when the at least one inflatable compartment is inflated).
Regarding claim 8, Hakonson discloses that the main body further comprising a plate (Ref 15A or Ref 20A), wherein the at least one balloon (Ref 17) is adapted to be located at least partially between the plate (Ref 15A or Ref 20A depending on which is the exterior side) and the skin surface of the patient, when the least one balloon is placed atop the site on the body part of the patient (Figure 1; where one of Ref 15A or Ref 20A is closes to the skin surface of the patient; where Ref 17 is between Ref 15A and Ref 20A and is therefore capable of being located at least partially between the plate and the skin surface of the patient), the plate being made of a material that is more rigid than the band (Ref 15A or 20A; Ref 85, whichever is the exterior side; Para [0070], [0078], [0108]; where top layer includes Ref 85, which may reinforce or strengthen the material and is therefore interpreted as being a plate made of a material that is more rigid than the band).
Regarding claim 9, Hakonson discloses that the plate being located at a first end of the band (Ref 15A or 20A; where the plate is located at a first end of the band) and comprising a means for connecting to a second end of the band (Ref 240, 250; Figure 8; Para [0088]-[0089], [0100]), the first end and second ends being spaced apart along a length of the band (Ref 240, 250; where first and second ends are on opposite ends of the band and are therefore spaced apart along the length of the band).
Regarding claim 11, Hakonson discloses that the plurality of additional inflatable compartments are connected in fluid flow communication with the inflatable compartments located along the first and second long edge via a channel (Ref 17; Figure 2 see above; Para [0059], [0095]).
Regarding claim 12, Hakonson discloses a clamp, valve, or stopcock located along the channel, the clamp, valve, or stopcock permitting the plurality of additional inflatable compartments to be opened to or closed from fluid flow communication with the inflatable compartments located along the first and second long edge (Ref 55, 290; Para [0093]).
Regarding claim 13, Hakonson discloses that at least one of the inflatable compartments located along the first long edge and second long edge is in fluid flow communication with the compression element (Ref 17; Figure 2 see above).
Regarding claim 14, Hakonson discloses a hemostasis device (Figures 1-2, 5B, Ref 17; where the device is placed over a patient’s body part and inflated to apply pressure and is therefore capable of providing hemostasis and is thus being interpreted as a hemostasis device) comprising: a band (Ref 17), the band being adapted to be wrapped and releasably secured around a body part of a patient that includes a site where bleeding is to be stopped (Para [0062]; Ref 240, 250, 17; Figures 8-12, 14; where the band is capable of being wrapped and releasably secured around a body part of a patient that includes a site where bleeding is to be stopped), the band comprising an interior side that is adapted to face a skin surface of the patient when releasably secured to the body part of the patient (Para [0062]; Ref 240, 250, 17; Figures 8-12, 14; where the side that faces the user is interpreted as the interior side that is capable of facing a skin surface when releasably secured to a body part), a first long edge, and a second long edge that opposes the first long edge (Figure 2 see above; Ref 17; Figures 1-2, 5B, 10), each of the first long edge and the second long edge forming portions of the perimeter of the band (Figure 2 see above; Ref 17; Figures 1-2, 5B, 10), the interior side of the band comprising a contiguous inflatable chamber (Figure 2 see above; where the contiguous inflatable chamber is formed of the inflatable chamber along the first edge, the inflatable chamber along the second edge and the inflatable chamber along the short edge; Ref 17; Figures 1-2, 5B, 10), the contiguous inflatable chamber comprising a first edge portion located along the first long edge and a second edge portion located along the second long edge (Figure 2 see above; Ref 17; Figures 1-2, 5B, 10), wherein the first edge portion and the second edge portion are each located along at least a portion of a perimeter of the band (Figure 2 see above, Ref 17; Figures 1-2, 5B, 10), wherein the band has a centerline that is parallel with the first edge portion and the second edge portion of the contiguous inflatable chamber(Figure 2 see above), the main body further comprising a plurality of additional inflatable compartments that are aligned along the centerline (Figure 2 see above; Ref 17; Figures 1-2, 5B, 10); and a compression element comprising at least one balloon, the at least one balloon being inflatable and adapted to be placed atop the site on the body part of the patient (Figure 2 see above; Ref 17; Figures 1-2, 5B, 10; where the at least one balloon is inflatable and is capable of being placed atop a site of the body part); wherein the band is adapted to direct an applied force generated by the at least one balloon when it is inflated towards the site on the body part of the patient (Figures 1-2; Ref 17; Para [0002], [0008]-[0009]; where the band is wrapped around a body part, where the at least one balloon is inflated towards the body part and is therefore interpreted as being capable of directing an applied force generated by the at least one balloon to the body part).
Regarding claim 16, Hakonson discloses that the plurality of additional inflatable compartments are connected in fluid flow communication with the first long edge portion and the second long edge portion
Regarding claim 17, Hakonson discloses a clamp, valve, or stopcock located along the channel, the clamp, valve, or stopcock permitting the plurality of additional inflatable compartments to be opened to or closed from fluid flow communication with a remainder of the contiguous inflatable chamber (Ref 55, 290; Para [0093]).
Regarding claim 18, Hakonson discloses that the contiguous inflatable chamber is in fluid flow communication with the compression element (Ref 17; Figure 2 see above).
Regarding claim 20, Hakonson discloses that when the contiguous inflatable chamber is inflated, an orientation of the interior side of the band is adapted to adjust with respect to the skin surface of the patient (Figure 2 see above; Para [0062]; Ref, 17; Figures 8-12, 14; where the side that faces the user is interpreted as the interior side, where an orientation of the interior side is capable of adjusting with respect to the skin surface when the contiguous inflatable channel is inflated).
Regarding claim 21, Hakonson discloses that each of the plurality of additional inflatable compartments is bisected by the centerline (Figure 2 see above; Figures 1-2, 5B, 10).
Regarding claim 22, Hakonson discloses that the band further comprising a short edge located between the first long edge and the second long edge (Figure 2 see above; Figures 1-2, 5B, 10), the short edge also comprising a portion of the perimeter of the band, wherein the short edge includes an inflatable compartment located along the length thereof that is continuous with the inflatable compartments located along the first long edge and the second long edge (Figure 2 see above; Figures 1-2, 5B, 10).
Regarding claim 23, Hakonson discloses that each of the plurality of additional inflatable compartments is bisected by the centerline (Figure 2 see above; Figures 1-2, 5B, 10).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hakonson et al. (US 2007/0197943) in view of Hoskins (US 2018/0263634).
Regarding claim 7, Hakonson discloses all of the claimed limitations above but fails to explicitly discloses that portions of the band can be transparent.
However, Hoskins teaches a similar device and additionally teaches that it is well known for portions of an inflatable device to be transparent to allow a user to monitor a status of the user (Para [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify portions of the band and balloon that are adapted to be placed in the vicinity of the site on the body part to be transparent as suggested by Hoskins, since such a modification allows a user to monitor a status of the user.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hakonson et al. (US 2007/0197943) in view of Billotti (US 5,588,956).
Regarding claim 19, Hakonson discloses all of the claimed limitations above including a contiguous inflatable chamber, a compression element (Ref 17; Figure 2 see above) and a first inflator attached in fluid communication with the contiguous inflatable chamber and the compression element (Ref 260) but discloses that the inflatable elements are placed in fluid flow communication instead of inflatable elements (i.e. the contiguous inflatable chamber and the compression element) that are not in fluid flow communication and include two separate inflators.
However, Billotti teaches a similar inflatable band wrapped around a body part and additionally teaches that it is well known for two different inflatable elements to either be placed in fluid flow communication with one another and include a single inflator attached in fluid flow communication with the inflatable elements (Figure 21; Ref 336A, 334A, 338A, 336B, 334B, 338B; where Figure 21 shows that the contiguous inflatable chamber can be in fluid flow communication with the compression element Ref 336B, 334B, 338B) and additionally teaches that is well known for two different inflatable elements to not be placed in fluid flow communication with one another (Figure 20; Ref 336A, 334A, 338A, 336B, 334B, 338B; where Figure 20 shows that the contiguous inflatable chamber is not in fluid flow communication with the compression element Ref 336B, 334B, 338B) and therefore includes a first inflator attached in fluid flow communication with one inflatable element and being adapted to allow inflation of the one inflatable element (Ref 342B) and a second inflator attached in fluid flow communication with a second inflatable element and being adapted to allow for inflation of the second inflatable element (Ref 342A).
Since Hakonson a contiguous inflatable chamber, a compression element and a first inflator attached in fluid communication with the contiguous inflatable chamber and the compression element and Billotti teaches a similar inflatable band and teaches that it is known for inflatable elements to be in fluid flow communication with one another or alternatively not in fluid flow communication with one another, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute two inflatable elements not in fluid flow communication with one another and including two separate inflators as suggested in Billotti for the configuration where two separate inflators are in fluid flow communication with one another and include a single inflator as in Hakonson because both configurations were known equivalents for allowing first and second inflatable elements to inflate, where the substitution would have resulted in the predictable results of allowing the contiguous inflatable chamber and the compression element to both inflate.
Where one of ordinary skill in the art would recognize that modifying the contiguous inflatable chamber and the compression element of Hakonson as suggested above would results in the contiguous inflatable chamber (i.e. one inflatable element) to not be placed in fluid flow communication with the compression element (i.e. a second inflatable element); where the device further would include a first inflator attached in fluid flow communication with the compression element and being adapted to allow for inflation of the at least one balloon, and a second inflator attached in fluid flow communication with the contiguous inflatable chamber and being adapted to allow for inflation of the contiguous inflatable chamber as suggested by Figure 20, Ref 342A, 342B of Billotti.
Response to Arguments
Applicant’s arguments, see pages 6-7 of the remarks, filed November 25, 2024, with respect to the as failing to comply with the written description requirement and the objection to the drawings and specification have been fully considered and are persuasive. The rejection of claims 1-3, 5-9, 11-14 and 16-23 under 35 U.S.C. Section 112(a) and the objection to the drawings and specification has been withdrawn.
Applicant's arguments filed November 25, 2024 have been fully considered but they are not persuasive.
Applicant argues that Hakonson fails to teach an inflatable “balloon” for force application that is separate and apart from the inflatable chamber integral to the band itself (bladder 17) since Ref 85 is labeled as asymmetry features, where the spec refers to the as guide seams and elastic features which do not include any inflatable parts. Applicant continues on to argue that Para [0072]-[0075] of Hakonson clearly explain that there is not a separate inflatable “balloon” being used in this device. Applicant additionally continues on to argue that Hakonson does not teach one balloon separate from the inflatable compartments, let alone two balloons as claimed in claim 2-3; where the compression element balloons of the office action cannot be both the “inflatable compartments” and the claimed “balloons” at the same time
The Examiner respectfully disagrees and notes that the Examiner did not call the same portion both the “inflatable compartments” and the “balloons” at the same time. Instead the office action referred to separate portions (i.e. separate compartments formed) as the “inflatable compartments” and the “balloons”. The Examiner notes there is nothing in the claims that precludes the “inflatable compartments” and the “balloons” to be interconnected, in fact Applicant’s specification similarly notes that the “inflatable compartments” and the “balloons” are in fluid communication. Where annotated Figure 2 shows different portions formed between the different seams labeled as the “inflatable compartments”, the “compression element” (i.e. balloon of the compression element), where a “first balloon of compression element” is labeled and a second line from the “compression element” can be seen going to what can be interpreted as a second “balloon of the compression element”. Since as shown in the annotated Figure 2 provided in the office action, separate portions were noted to be the “inflatable compartments” and the “balloons”, where the same separate portion was never cited to be both the “inflatable compartment” and the “balloons” at the same time and since the instant application even describes that the “inflatable compartment” and the “balloons” can be in fluid communication (i.e. connected), Hakonson does in fact disclose all of the claimed limitations and the arguments are not persuasive.
Applicant argues that all obviousness grounds of rejection based on Hakonson should be withdrawn because Hakonson is non-analogous art to a hemostasis device- which is designed to apply targeted pressure to a wound/access site- neither being in the field of hemostasis devices or reasonably pertinent to this specific challenge. Instead Hakonson device is in the field of orthotics for back pain.
The Examiner respectfully disagrees and notes almost all of the rejection using Hakonson were 35 U.S.C. rejections and therefore the arguments against Hakonson as being non-analogous art is moot. Additionally, it is noted in response to applicant's argument that Hakonson is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Hakonson is directed to a bladder that is inflated to direct the bladder to expand in a selected direction and therefore is reasonably pertinent to the problems associated with a hemostasis device, which is formed of a bladder that is inflated to direct the bladder to expand in a selected direction, to apply targeted pressure to a site. Since Hakonson is directed to art that would be reasonably pertinent to problems associated with an inflatable bladder that expands to direct the bladder to apply pressure to a targeted site, Hakonson is considered analogous art and therefore the arguments are not persuasive..
Applicant argues with respect to claim 8, that Hakonson fails to teach anything that can reasonably referred to as a “plate” that is “made of a material that is more rigid than” the band.
The Examiner respectfully disagrees and notes that given the broadest reasonable interpretation of the term “plate”, the guide Ref 15A/117 is a thin, flat sheet of material used to join or strengthen something and is therefore capable of being interpreted as a plate. Additionally, it is noted that the guide Ref 15A/117 can be made out of different materials or different thickness of material (Para [0107], where if two parts are made out of the same material, the thicker part will be more rigid); where the guide can additionally have materials embedded to reinforce/strengthen the material (Para [0078]) and where the guide constrains the bladder to expand preferentially in a selected direction upon inflation (Abstract, Para [0009]); and the encircling members/band do not need to be particularly stiff (Para [0109]); Ref 15A/117 can therefore be interpreted as being a plate made of a material that is more rigid than the band. Since the guide Ref 15A/117 of Hakonson can be interpreted as being a plate made of a material that is more rigid than the band, the arguments are not persuasive.
Applicant argues with respect to claims 12 and 17 that the cited paragraphs fail to teach a clam, valve, or stopcock that permits the plurality of additional compartments to be opened to or closed from fluid flow communication with the inflatable compartments located along the first and second long edge since there are no such divisions between compartments within its device or any device capable of sectioning off airflow between various compartments. Applicant continues on to argue that part Ref 290 of Hakonson is a pressure relief vent
The Examiner respectfully disagrees and notes 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., divisions between compartments or that the device is capable of sectioning off airflow between various compartments) 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). In the instant case, the claims merely require a clamp, valve, or stopcock to be located along the channel; where the clamp, valve, or stopcock permit the plurality of additional inflatable compartments to be opened or closed from fluid flow communication and requires the inflatable compartments to be located along the first and second long edge. Where the Examiner notes that Hakonson does in fact disclose a valve Ref 55, 290 located along the channel (see Figures 2, 10 ); where the valve allows the plurality of additional inflatable compartments and the inflatable compartments to be opened and allows fluid flow communication through all of the inflatable compartments to be released if necessary, which permits the plurality of additional inflatable compartments to be opened in fluid flow communication (Ref 55, 290; Para [0093]); where Figure 2 additionally shows that inflatable compartments are located along the first and second long edge and that the additional inflatable compartments are in fluid flow communication with the inflatable compartments along a channel. Since the claim language does not require the clamp/valve/stopcock to be located at specific locations nor does the claim language require multiple clamps/valves/stopcocks nor does the claim language require divisions between compartments nor that the device is capable of sectioning off airflow between various compartments and Hakonson does teach a valve that allows the channel in fluid flow communication between all of the inflatable compartments to be opened to fluid flow, the claimed limitations are met and the arguments are not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN L COLELLO whose telephone number is (571)270-3212. The examiner can normally be reached Mondays 8-5pm, Tuesday-Thursdays 10-2pm.
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/ERIN L COLELLO/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771