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 .
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 48-49, 51-53, 57-59, and 61-63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al., (US 20140249613; hereinafter Kaib) in view of Turk et al., (US 20130273809; hereinafter Turk).
Regarding claim 48, Kaib (Figure 1) discloses a support garment (100) configured to be worn by a patient, comprising: a defibrillation garment (110), which is configured to be worn by both male and female patients, configured to support a patient wearable defibrillator (defibrillation system comprising control unit 120 and therapy electrodes 114), comprising: a back portion (rear portion); a belt defined by side portions extending from the back portion around a front of the patient (belt portion carrying connection pod 130), wherein the back portion and/or the belt is configured to support at least one sensing electrode (112) and at least one therapeutic defibrillator electrode (114a/b) of the patient wearable defibrillator on an inside surface of the back portion or the belt; and a first shoulder strap (right strap) and a second shoulder strap (left strap) configured to be attached to the back portion and the belt and to be positioned over shoulders of the patient for supporting the defibrillation garment (110) on the patient's shoulders ([0046]-[0048]).
Kaib fails to disclose a modifying attachment configured to be detachably coupled to the shoulder straps of the defibrillation garment for modifying the defibrillation garment for use by a female patient, the modifying attachment comprising: a comfort support configured to support front upper torsal female anatomy of the female patient when the modifying attachment is coupled to the shoulder straps, the comfort support comprising first and second cups comprising inserts configured to contact and support breasts of the female patient; a first flap extending from a first lateral side of the comfort support configured to wrap around the first shoulder strap of the defibrillation garment to couple the first shoulder strap to the modifying attachment; and a second flap extending from a second lateral side of the comfort support configured to wrap around the second shoulder strap of the defibrillation garment to couple the second shoulder strap to the modifying attachment. However, Turk (Figures 1-5) teaches a modifying attachment (22) for a support garment (24), the modifying attachment (22) configured to be detachably coupled to the shoulder straps (44, 46) of the support garment (24) for modifying the support garment (24) for use by a female patient, the modifying attachment (22) comprising: a comfort support (26, 28) configured to support front upper torsal female anatomy of the female patient when the modifying attachment (22) is coupled to the shoulder straps (44, 46), the comfort support (26, 28) comprising first (26) and second (28) cups comprising inserts (37) configured to contact and support breasts of the female patient; a first flap (30) extending from a first lateral side of the comfort support (26, 28) configured to wrap around the first shoulder strap (44) of the support garment (24) to couple the first shoulder strap (44) to the modifying attachment (22); and a second flap (32) extending from a second lateral side of the comfort support (26, 28) configured to wrap around the second shoulder strap (46) of the support garment (24) to couple the second shoulder strap (46) to the modifying attachment (22), ([0018]-[0022]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kaib to include a modifying attachment, as taught by Turk, because the modification would enable the garment to support and better conform to the configuration of a female wearer's body (Turk; [0025]). Furthermore, in the modified device, the support garment would be the defibrillation garment.
Regarding claim 49, Kaib/Turk further teaches wherein the first flap (Turk; 30) and/or the second flap (Turk; 32) comprise a fastener (loop) for securing the first flap (Turk; 30) or the second flap (Turk; 32) around the respective shoulder strap (Turk; [0018]-[0022]).
Regarding claim 51, Kaib/Turk further teaches wherein the modifying attachment (Turk; 22) is configured to provide improved comfort for the female patient compared to use of the defibrillation garment alone for supporting the patient wearable defibrillator (Turk; [0018]-[0022]).
Regarding claim 52, Kaib/Turk further teaches wherein the defibrillation garment is configured to support the patient wearable defibrillator to provide cardiac monitoring and therapy for the male and female patients both when the modifying attachment is attached to the defibrillation garment and when the defibrillation garment is used without the modifying attachment. Specifically, the cardiac monitoring and therapy elements of the defibrillation garment in Kaib are located in the back and belt portions (Kaib; [0046]-[0048]). Therefore, the defibrillation garment would be configured to provide the cardiac monitoring and therapy whether the modifying attachment, taught by Turk, is attached or not.
Regarding claim 53, Kaib/Turk further teaches wherein the modifying attachment (Turk; 22) comprises a fastener (Turk; 42a-f) configured to detachably couple to a portion (Turk; 60a-f) of the belt (Turk; 58) configured to be positioned on a front of the patient (Turk; [0018]-[0022]).
Regarding claim 57, Kaib (Figures 6A-6C0 further discloses wherein the back portion of the defibrillation garment comprises at least one pocket (510) configured to receive the at least one therapeutic defibrillator electrode at a back of the patient ([0065]).
Regarding claim 58, Kaib (Figures 6A-6C) further discloses wherein the at least one therapeutic defibrillator electrode comprises two therapeutic defibrillator electrodes (500), and wherein the back portion of the defibrillation garment (110) comprises two pockets (510) disposed on the back portion of the defibrillation garment (110) configured to support the two therapeutic defibrillator electrodes (500) on the inside surface of the defibrillation garment (110) at a back of the patient ([0065]-[0067]).
Regarding claim 59, Kaib/further discloses wherein the pockets (510) comprise a non-elastic, conductive mesh fabric configured to isolate the two therapeutic defibrillator electrodes (500) from skin of the patient while allowing a conductive gel extruded from the two therapeutic defibrillator electrodes (500) to pass through the mesh fabric ([0061], [0063]-[0067]).
Regarding claim 61, Kaib (Figure 1) discloses a patient wearable defibrillator, comprising: a plurality of sensing electrodes (112) configured to monitor a cardiac function of a patient; at least one therapeutic defibrillator electrode (114a/b); and a support garment (100) configured to be worn by the patient comprising: a defibrillation garment (110), which is configured to be worn by both male and female patients, comprising: a back portion (rear portion); a belt defined by side portions extending from the back portion around a front of the patient (belt portion carrying connection pod 130), wherein the back portion and/or the belt is configured to support the plurality of sensing electrodes (112) and the at least one therapeutic defibrillator electrode (114a/b) on an inside surface of the back portion or the belt; and a first shoulder strap (right strap) and a second shoulder strap (left strap) configured to be attached to the back portion and the belt and to be positioned over shoulders of the patient for supporting the defibrillation garment (110) on the patient's shoulders ([0046]-[0048]).
Kaib fails to disclose a modifying attachment configured to be detachably coupled to the shoulder straps of the defibrillation garment for modifying the defibrillation garment for use by a female patient, the modifying attachment comprising: a comfort support configured to support front upper torsal female anatomy of the female patient when the modifying attachment is coupled to the shoulder straps, the comfort support comprising first and second cups comprising inserts configured to contact and support breasts of the female patient; a first flap extending from a first lateral side of the comfort support configured to wrap around the first shoulder strap of the defibrillation garment to couple the first shoulder strap to the modifying attachment; and a second flap extending from a second lateral side of the comfort support configured to wrap around the second shoulder strap of the defibrillation garment to couple the second shoulder strap to the modifying attachment. However, Turk (Figures 1-5) teaches a modifying attachment (22) for a support garment (24), the modifying attachment (22) configured to be detachably coupled to the shoulder straps (44, 46) of the support garment (24) for modifying the support garment (24) for use by a female patient, the modifying attachment (22) comprising: a comfort support (26, 28) configured to support front upper torsal female anatomy of the female patient when the modifying attachment (22) is coupled to the shoulder straps (44, 46), the comfort support (26, 28) comprising first (26) and second (28) cups comprising inserts (37) configured to contact and support breasts of the female patient; a first flap (30) extending from a first lateral side of the comfort support (26, 28) configured to wrap around the first shoulder strap (44) of the support garment (24) to couple the first shoulder strap (44) to the modifying attachment (22); and a second flap (32) extending from a second lateral side of the comfort support (26, 28) configured to wrap around the second shoulder strap (46) of the support garment (24) to couple the second shoulder strap (46) to the modifying attachment (22), ([0018]-[0022]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kaib to include a modifying attachment, as taught by Turk, because the modification would enable the garment to support and better conform to the configuration of a female wearer's body (Turk; [0025]). Furthermore, in the modified device, the support garment would be the defibrillation garment.
Regarding claim 62, Kaib/Turk further teaches wherein the modifying attachment (Turk; 22) is configured to provide improved comfort for the female patient compared to use of the defibrillation garment alone for supporting the plurality of sensing electrodes and the at least one therapeutic defibrillator electrode of the patient wearable defibrillator (Turk; [0018]-[0022]).
Regarding claim 63, Kaib/Turk further teaches wherein the defibrillation garment is configured to support the plurality of sensing electrodes and the at least one therapeutic defibrillator electrode of the patient wearable defibrillator to provide cardiac monitoring and therapy for the male and female patients both when the modifying attachment is attached to the defibrillation garment and when the defibrillation garment is used without the modifying attachment. Specifically, the cardiac monitoring and therapy elements of the defibrillation garment in Kaib are located in the back and belt portions (Kaib; [0046]-[0048]). Therefore, the defibrillation garment would be configured to provide the cardiac monitoring and therapy whether the modifying attachment, taught by Turk, is attached or not.
Claim(s) 64-65, and 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib in view of Turk and Yau et al., (US 20160106159; hereinafter Yau).
Regarding claim 64, Kaib (Figure 1) discloses a support garment kit for assembling a support garment (100) configured to be worn by a patient, the support garment kit comprising: a defibrillation garment (110), which is configured to be worn by both male and female patients, configured to support a patient wearable defibrillator (defibrillation system comprising control unit 120 and therapy electrodes 114) comprising: a back portion (rear portion); a belt defined by side portions extending from the back portion around a front of the patient belt portion carrying connection pod 130), wherein the back portion and/or the belt is configured to support at least one sensing electrode (112) and at least one therapeutic defibrillator electrode (114a/b) of the patient wearable defibrillator on an inside surface of the back portion or the belt; and a first shoulder strap (right strap) and a second shoulder strap (left strap) configured to be attached to the back portion and the belt and to be positioned over shoulders of the patient for supporting the defibrillation garment (110) on the patient's shoulders ([0046]-[0048]).
Kaib fails to disclose a modifying attachment configured to be detachably coupled to the shoulder straps of the defibrillation garment for modifying the defibrillation garment for use by a female patient, the modifying attachment comprising: a comfort support configured to support front upper torsal female anatomy of the female patient when the modifying attachment is coupled to the shoulder straps, the comfort support comprising first and second cups comprising inserts configured to contact and support breasts of the female patient; a first flap extending from a first lateral side of the comfort support configured to wrap around the first shoulder strap of the defibrillation garment to couple the first shoulder strap to the modifying attachment; and a second flap extending from a second lateral side of the comfort support configured to wrap around the second shoulder strap of the defibrillation garment to couple the second shoulder strap to the modifying attachment. However, Turk (Figures 1-5) teaches a modifying attachment (22) for a support garment (24), the modifying attachment (22) configured to be detachably coupled to the shoulder straps (44, 46) of the support garment (24) for modifying the support garment (24) for use by a female patient, the modifying attachment (22) comprising: a comfort support (26, 28) configured to support front upper torsal female anatomy of the female patient when the modifying attachment (22) is coupled to the shoulder straps (44, 46), the comfort support (26, 28) comprising first (26) and second (28) cups comprising inserts (37) configured to contact and support breasts of the female patient; a first flap (30) extending from a first lateral side of the comfort support (26, 28) configured to wrap around the first shoulder strap (44) of the support garment (24) to couple the first shoulder strap (44) to the modifying attachment (22); and a second flap (32) extending from a second lateral side of the comfort support (26, 28) configured to wrap around the second shoulder strap (46) of the support garment (24) to couple the second shoulder strap (46) to the modifying attachment (22), ([0018]-[0022]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kaib to include a modifying attachment, as taught by Turk, because the modification would enable the garment to support and better conform to the configuration of a female wearer's body (Turk; [0025]). Furthermore, in the modified device, the support garment would be the defibrillation garment.
Kaib/Turk fails to teach wherein the modifying attachment is a plurality of modifying attachments of different sizes, wherein the plurality of modifying attachments comprises comfort supports of different sizes and cups of different sizes. However, Yau (Figure 1) teaches a support garment kit (100) wherein a modifying attachment (110) can provided as a plurality if modifying attachments (110) of different sizes, wherein the plurality of modifying attachments (110) comprises comfort supports (114) of different sizes and cups (122/124) of different sizes ([0044], [0068]-[0069]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kaib/Turk to include the modifying attachment as a plurality of modifying attachments of different sizes, wherein the plurality of modifying attachments comprises comfort supports of different sizes and cups of different sizes, as taught by Yau, because the modification would accommodate a variety of bust sizes (Yau; [0068]-[0069]) to provide a comfortable fit for a female user.
Regarding claim 65, Kaib/Turk/Yau further teaches wherein the comfort supports (Yau; 114) and the cups (Yau; 122/124) of the plurality of modifying attachments (Yau; 110) are sized at least small, medium, and large (Yau; [0068]-[0069]).
Regarding claim 67, Kaib/Turk/Yau further teaches wherein the defibrillation garment is configured to support the patient wearable defibrillator to provide cardiac monitoring and therapy for the male and female patients both when one of the plurality of the modifying attachments is attached to the defibrillation garment and when the defibrillation garment is used without the plurality of modifying attachments. Specifically, the cardiac monitoring and therapy elements of the defibrillation garment in Kaib are located in the back and belt portions (Kaib; [0046]-[0048]). Therefore, the defibrillation garment would be configured to provide the cardiac monitoring and therapy whether a modifying attachment of the modified device is attached or not.
Claim(s) 50 and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib/Turk, as applied to claims 49 and 53, and further in view of Miller et al., (US 6165045; hereinafter Miller).
Regarding claim 50, Kaib/Turk teaches the support garment of claim 49, but fails to teach wherein the fastener comprises at least one strip of hook and pile fasteners on the modifying attachment for securing the first flap or the second flap of the modifying attachment around the respective shoulder strap of the defibrillation garment. However, Miller (Figures 1-3) teaches a support garment (30) comprising at least one strip of hook and pile fasteners (23) on a modifying attachment (31+32) for securing a first flap (24) or a second flap (25) of the modifying attachment (31+32) around a respective shoulder strap (1/2) of the support garment (30), (Col. 3, lines 34-42; Col. 4, line 63 – Col. 5, line 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the fastener of Kaib/Turk with the at least one strip of hook and pile fasteners, as taught by Miller, since both fasteners perform the same function of securing the modifying attachment to the support garment and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Regarding claim 54, Kaib/Turk teaches the support garment of claim 53, but fails to teach wherein the fastener comprises at least one strip of hook and pile fasteners along a bottom of the modifying attachment for securing the modifying attachment to the belt. However, Miller (Figures 1-3) teaches a support garment (30) comprising at least one strip of hook and pile fasteners (23) on a modifying attachment (31+32) for securing the modifying attachment (31+32) to the support garment (30), (Col. 3, lines 34-42; Col. 4, line 63 – Col. 5, line 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the fastener of Kaib/Turk with the at least one strip of hook and pile fasteners, as taught by Miller, since both fasteners perform the same function of securing the modifying attachment to the support garment and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib/Turk, as applied to claim 48, and further in view of Volker (US 20130053674).
Regarding claim 55, Kaib/Turk teaches the support garment of claim 48, but fails to teach wherein at least the back portion and belt of the defibrillation garment and modifying attachment comprise an elastic, low spring rate material; wherein the elastic, low spring rate material comprises a spandex material with nylon and/or polyester materials. However, Volker teaches a support garment which may be constructed from a mixture of spandex with nylon and/or polyester ([0039]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kaib/Turk to include at least the back portion and belt of the defibrillation garment and modifying attachment constructed from an elastic, low spring rate material comprising a spandex material with nylon and/or polyester materials, as taught by Volker, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
Claim(s) 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib/Turk, as applied to claim 48, and further in view of Corrado et al., (US 20160278461; hereinafter Corrado).
Regarding claim 60, Kaib/Turk teaches the support garment of claim 48, but fails to teach wherein the modifying attachment further comprises a halter strap connected to a top of the modifying attachment proximate to the lateral sides of the first flap and the second flap, the halter strap being configured to extend around a neck of the patient. However, Corrado teaches a support garment comprising a halter strap (38) attached to cups of the support garment, the halter strap (38) being configured to extend around a neck of the patient ([0026]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kaib/Turk to include the modifying attachment comprising a halter strap connected to a top of the modifying attachment, the halter strap being configured to extend around a neck of the patient, as taught by Corrado, because the modification would aid in accommodating extremely large or full cups (Corrado; [0026]). Furthermore, since the halter strap would extend around a neck of the patient, the halter strap of the modified device would be proximate to the lateral sides of the first flap and the second flap.
Claim(s) 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib/Turk/Yau, as applied to claim 64, and further in view of Miller.
Regarding claim 66, Kaib/Turk teaches the support garment kit of claim 64, but fails to teach wherein the first flap and/or the second flap of the plurality of modifying attachments comprise a fastener comprising at least one strip of hook and pile fasteners for securing the first flap or the second flap of the plurality of modifying attachments around the respective shoulder strap of the defibrillation garment. However, Miller (Figures 1-3) teaches a support garment (30) comprising at least one strip of hook and pile fasteners (23) on a modifying attachment (31+32) for securing a first flap (24) or a second flap (25) of the modifying attachment (31+32) around a respective shoulder strap (1/2) of the support garment (30), (Col. 3, lines 34-42; Col. 4, line 63 – Col. 5, line 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the fastener of Kaib/Turk with the at least one strip of hook and pile fasteners, as taught by Miller, since both fasteners perform the same function of securing the modifying attachment to the support garment and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Conclusion
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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