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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/9/2026 has been entered.
Response to Amendment
This action is in response to Applicant’s remarks, filed on 2/9/2026. The amendments to claim(s) 1, 12 and 20 filed on 2/9/2026 have been entered. No new claim(s) have been added, and no claims have been cancelled. Accordingly, claim(s) 1-20 remain pending for examination.
Response to Arguments
Applicant’s arguments, see p. 7-15, filed 2/9/2026, with respect to the rejections of claim(s) 1-20 have been fully considered.
After review of the Applicant’s arguments pertaining to the interpretation under 35 U.S.C. §112(f), Examiner respectfully agrees with the Applicant and the interpretation from the prior office action has been withdrawn.
After review of the amendment to the claim(s) and the Applicant’s remarks regarding the rejections under 35 U.S.C. §112(b), Examiner respectfully disagrees with the Applicant. The prior 35 USC §112(b) rejection is withdrawn in view of the amended language, and new rejections are issued.
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Rejections to dependent claims 2-11 and 13-19 are modified to address Applicant's amendments and the new rejection to independent claim(s) 1, 12 and 20 and are sustained. The rejections of claim(s) 1-20 under 35 U.S.C. §102 and 35 U.S.C. §103 are maintained.
Claim Rejections - 35 USC § 112
35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 2-11 and 13-19 are also rejected at least by virtue of dependency upon a rejected base claim.
Regarding claims 1 and 12, the limitation “a flexible retaining element physically separate from the flexible enclosure that is configured to be disposed on a second side of the portion of the subject to be imaged, wherein the flexible retaining element lacks any radio frequency coil” renders the claims indefinite. There is insufficient antecedent basis for this limitation in the claim. It is unclear what ‘any radio frequency coil’ is specifically pointing to; in an interpretation the limitation refers to the ‘radio frequency coil’ disposed in the ‘flexible enclosure’ recited earlier in the claims, and in another interpretation the limitation points to a new and distinct ‘radio frequency coil’. It is suggested to amend the claims to replace ‘any’ with ‘the’, if this is the Applicant’s preferred interpretation.
Claim Rejections - 35 USC § 102
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) 1-5, 7, 11-13, 15-17 and 19 is/are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by Li et al. (US20200093394A1, 2020-03-26; hereinafter “Li”).
Regarding claim 1, Li teaches a radio frequency receiving coil assembly for a magnetic resonance imaging system (“An RF coil assembly for a medical imaging device,” [clm 1]; “an RF coil assembly is provided for a magnetic resonance imaging (MRI) system (such as the MRI system shown by FIG. 1). The RF coil assembly […] is shaped to conform to a body of a patient and includes a plurality of RF coil arrays positioned in an adjustable, bra-like support structure.” [0018]; [0018-0051], [fig. 1-2B, 6]), comprising:
a flexible enclosure (“a first coil array housed in a first cup-shaped support structure; a second coil array housed in a second cup-shaped support structure;” [clm 1]; “the support structure 220 is a bra-like support structure including a first cup 222 and a second cup 224.” [0040]; “The RF coils included by the first coil array 202 may be mounted (e.g., coupled) to a flexible substrate (e.g., stretchable fabric, polymer, etc.). […] the flexible substrate may be a same material as the material of the first cup 222 and/or support structure 22” [0046]; The cup shaped support structures (i.e., flexible enclosure) form flexible cups with RF coils disposed within to support and image the breasts of a patient [0039-0051], [fig. 1-2B, 6]); and
a radio frequency coil disposed within the flexible enclosure (“a first coil array housed in a first cup-shaped support structure; a second coil array housed in a second cup-shaped support structure;” [clm 1]; “The first coil array 202 is coupled to the first cup 222 and the second coil array 204 is coupled to the second cup 224” [0041]; “First coil array 202 and second coil array 204 each include a plurality of RF coils […] coupled to their respective cup (e.g., first cup 222 and second cup 224) of the support structure 220. […] The first cup 222 and second cup 224 may each be formed of a stretchable or non-stretchable fabric (polyester, cotton, rayon, etc.), polymer (e.g., polyurethane), elastomer, foam, etc., or a combination thereof” [0042]; “The coils of the first coil array 202 and second coil array 204 may be sewn or otherwise secured to the respective exterior surface of the support structure 220 […] one or more layers of fabric or other material may be fastened to the interior surface of the first cup 222 and/or second cup 224 in order to contain the coils within their respective cups” [0043]; RF coils are disposed within the cup-shaped support structures [0039-0051], [fig. 1-2B, 6]),
wherein the radio frequency coil comprises a plurality of flexible loops having a malleable conductor, and the flexible enclosure is configured to be disposed on a first side of a portion of a subject to be imaged (“a first coil array housed in a first cup-shaped support structure; a second coil array housed in a second cup-shaped support structure;” [clm 1]; “First coil array 202 and second coil array 204 each include a plurality of RF coils (described in further detail below with reference to FIG. 4A) coupled to their respective cup (e.g., first cup 222 and second cup 224) of the support structure 220. […] The first cup 222 and second cup 224 may each be formed of a stretchable or non-stretchable fabric” [0042]; “The RF coils are local RF coils […] comprised of a generally flexible, flat, and electrically-conductive material (e.g., tin-plated copper).” [0047]; The RF coil arrays are a plurality of RF coils (i.e., flexible loops) comprised of flexible conductive material, wherein the RF coil arrays are disposed within the flexible cups and conform with the chest on the anterior surface (i.e., first side portion) of the patient [0039-0051], [fig. 1-2B, 6]); and
an adaptive compression system (“one or more support straps supporting the first cup-shaped support structure, second cup-shaped support structure, […] and wherein a length of at least one of the one or more support straps is adjustable.” [clm 7]; “Additionally, the support structure 220 may include one or more straps (which may be referred to hereinafter as support straps), […] A length of one or more or each of the straps may be adjustable via hook and loop fasteners, buttons, or other fasteners in order to couple the support structure 220 to the patient.” [0041]; The back strap 212 and shoulder straps 208, 210 (i.e., adaptive compression system) are coupled to the cups [0039-0051], [fig. 1-2B, 6]), comprising:
a flexible retaining element physically separate from the flexible enclosure that is configured to be disposed on a second side of the portion of the subject to be imaged, wherein the flexible retaining element lacks any radio frequency coil (“front strap 214 may couple first cup 222 to second cup 224, first shoulder strap 208 may couple first cup 222 to back strap 212, and second shoulder strap 210 may couple second cup 224 to back strap 212.” [0040]; “one or both of the third coil array 206 and fourth coil array 216 may be coupled to back strap 212 via one or more additional straps.” [0041]; The back strap 212 (i.e., flexible retaining element) does not possess coil arrays and is positioned opposite the cup-shaped support structures [0039-0051], [fig. 1-2B, 6; see fig. 2A reproduced below]);
at least one band directly coupled to and extending between both the flexible enclosure and the flexible retaining element (“the support structure 220 may include one or more straps (which may be referred to herein as support straps), such as first shoulder strap 208, second shoulder strap 210, back strap 212, and front strap 214. […] In one example, front strap 214 may couple first cup 222 to second cup 224, first shoulder strap 208 may couple first cup 222 to back strap 212, and second shoulder strap 210 may couple second cup 224 to back strap 212.” [0040]; The shoulder straps 208, 210 (i.e., at least one band) couple the cup-shaped support structures to the back strap [0039-0051], [fig. 1-2B, 6; see fig. 2A reproduced below]); and
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RF coil arrays 202, 204 are disposed within cups 222, 224 to image the chest of the patient, wherein the back strap 212 and shoulder straps 208, 210 are adjustable to fit the patient (Li [fig. 2A])
a tension adjustment mechanism coupled to the at least one band and configured to adjust a tension of the at least one band to adjust how tight the flexible enclosure is disposed about the first side of the portion of the subject to be imaged (“one or more support straps supporting the first cup-shaped support structure, second cup-shaped support structure, third coil array, and fourth coil array, and wherein a length of at least one of the one or more support straps is adjustable” [clm 7]; “A length of one or more or each of the straps may be adjustable via hook and loop fasteners, buttons, or other fasteners in order to couple the support structure 220 to the patient.” [0040]; “The RF coil assemblies include adjustable straps in order to adapt to different body sizes.” [0076]; The straps (e.g., back strap, shoulder straps) may be adjustable using hook and loop fasteners or buttons (i.e., a tension adjustment mechanism) to secure the first and second cups (and RF coils) to the patient’s chest [0039-0051], [fig. 1-2B, 6]).
Regarding claim 2, Li teaches the radio frequency receiving coil assembly of claim 1,
Li further teaching wherein at least a portion of the at least one band is disposed within the flexible enclosure (“first shoulder strap 208 may couple first cup 222 to back strap 212, and second shoulder strap 210 may couple second cup 224 to back strap 212.” [0040]; “The first cup 222 and second cup 224 may each be formed of a stretchable or non-stretchable fabric (polyester, cotton, rayon, etc.), polymer (e.g., polyurethane), elastomer, foam, etc., or a combination thereof. The first cup 222 and second cup 224 may each include plastic or other polymer (non-metal) supports such as ribs, frames, etc.” [0042]; “one or more layers of fabric or other material may be fastened to the interior surface of the first cup 222 and/or second cup 224 in order to contain the coils within their respective cups.” [0043]; The shoulder straps 208, 210 may be secured to the circular frames 230, 232 (i.e., disposed within) of the cup-shaped support structures [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]).
Regarding claim 3, Li teaches the radio frequency receiving coil assembly of claim 1,
Li further teaching wherein the tension adjustment mechanism is coupled to the at least one band outside the flexible enclosure (“A length of one or more or each of the straps may be adjustable via hook and loop fasteners, buttons, or other fasteners in order to couple the support structure 220 to the patient.” [0040]; The fasteners (e.g., hook and loop, buttons) for the straps are disposed outside the cup-shaped support structures for access so that the patient or another technician may adjust the RF coil assembly [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]).
Regarding claim 4, Li teaches the radio frequency receiving coil assembly of claim 1,
Li further teaching wherein the tension adjustment mechanism is configured, via the at least one band, to pull the flexible enclosure and the flexible retaining element closer together about the portion of the subject to be imaged (“A length of one or more or each of the straps may be adjustable via hook and loop fasteners, buttons, or other fasteners in order to couple the support structure 220 to the patient.” [0040]; “The RF coil assemblies include adjustable straps in order to adapt to different body sizes.” [0076]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]).
Regarding claim 5, Li teaches the radio frequency receiving coil assembly of claim 1,
Li further teaching wherein the at least one band comprises a first band and a second band directly coupled to and extending between both the flexible enclosure and the flexible retaining element (“the support structure 220 may include one or more straps (which may be referred to herein as support straps), such as first shoulder strap 208, second shoulder strap 210, back strap 212, […] first shoulder strap 208 may couple first cup 222 to back strap 212, and second shoulder strap 210 may couple second cup 224 to back strap 212.” [0040]; The first and second shoulder strap (i.e., first and second bands) couple the cup-shaped support structure to the back strap [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]).
Regarding claim 7, Li teaches the radio frequency receiving coil assembly of claim 1,
Li further teaching wherein the at least one band is configured to be removed and to be replaced (“By coupling the RF coils to the flexible substrate and forming the flexible substrate as a separate piece relative to the support structure 220, the RF coils may be removed from the support structure 220 for cleaning, replacement, etc.” [0046]; The support structure (including straps) and the RF coils (disposed on flexible substrate) are separable and may be replaced [0039-0051], [fig. 1-2B, 6]).
Regarding claim 11, Li teaches the radio frequency receiving coil assembly of claim 1,
Li further teaching wherein the adaptive compression system is configured to enable positioning of the flexible enclosure about curved surfaces of different parts of an anatomy of the subject to be imaged (“one or more support straps supporting the first cup-shaped support structure, second cup-shaped support structure, third coil array, and fourth coil array, and wherein a length of at least one of the one or more support straps is adjustable” [clm 7]; “The cups may be made of stretchable, flexible, and/or soft material, and the RF coils within the RF coil arrays may be moveable relative to each other […] during expansion and/or contraction of the cups, thereby enabling a diameter of the cups to expand or contract to conform to the body of the patient.” [0019]; “The RF coil assemblies include adjustable straps in order to adapt to different body sizes.” [0076]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]).
Regarding claim 12, Li teaches a radio frequency receiving coil assembly for a magnetic resonance imaging system (“An RF coil assembly for a medical imaging device,” [clm 1]; “an RF coil assembly is provided for a magnetic resonance imaging (MRI) system (such as the MRI system shown by FIG. 1). The RF coil assembly […] is shaped to conform to a body of a patient and includes a plurality of RF coil arrays positioned in an adjustable, bra-like support structure.” [0018]; [0018-0051], [fig. 1-2B, 6]), comprising:
a flexible enclosure (“a first coil array housed in a first cup-shaped support structure; a second coil array housed in a second cup-shaped support structure;” [clm 1]; “the support structure 220 is a bra-like support structure including a first cup 222 and a second cup 224.” [0040]; “The RF coils included by the first coil array 202 may be mounted (e.g., coupled) to a flexible substrate (e.g., stretchable fabric, polymer, etc.). […] the flexible substrate may be a same material as the material of the first cup 222 and/or support structure 22” [0046]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]); and
a radio frequency coil disposed within the flexible enclosure (“a first coil array housed in a first cup-shaped support structure; a second coil array housed in a second cup-shaped support structure;” [clm 1]; “The first coil array 202 is coupled to the first cup 222 and the second coil array 204 is coupled to the second cup 224” [0041]; “First coil array 202 and second coil array 204 each include a plurality of RF coils […] coupled to their respective cup (e.g., first cup 222 and second cup 224) of the support structure 220. […] The first cup 222 and second cup 224 may each be formed of a stretchable or non-stretchable fabric (polyester, cotton, rayon, etc.), polymer (e.g., polyurethane), elastomer, foam, etc., or a combination thereof” [0042]; “The coils of the first coil array 202 and second coil array 204 may be sewn or otherwise secured to the respective exterior surface of the support structure 220 […] one or more layers of fabric or other material may be fastened to the interior surface of the first cup 222 and/or second cup 224 in order to contain the coils within their respective cups” [0043]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]),
wherein the radio frequency coil comprises a plurality of flexible loops having a malleable conductor, and the flexible enclosure is configured to be disposed on a first side of a portion of a subject to be imaged (“a first coil array housed in a first cup-shaped support structure; a second coil array housed in a second cup-shaped support structure;” [clm 1]; “First coil array 202 and second coil array 204 each include a plurality of RF coils (described in further detail below with reference to FIG. 4A) coupled to their respective cup (e.g., first cup 222 and second cup 224) of the support structure 220. […] The first cup 222 and second cup 224 may each be formed of a stretchable or non-stretchable fabric” [0042]; “The RF coils are local RF coils […] comprised of a generally flexible, flat, and electrically-conductive material (e.g., tin-plated copper).” [0047]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]), and
an integral adaptive compression system (“one or more support straps supporting the first cup-shaped support structure, second cup-shaped support structure, […] and wherein a length of at least one of the one or more support straps is adjustable.” [clm 7]; “Additionally, the support structure 220 may include one or more straps (which may be referred to hereinafter as support straps), […] A length of one or more or each of the straps may be adjustable via hook and loop fasteners, buttons, or other fasteners in order to couple the support structure 220 to the patient.” [0041]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]), comprising:
a flexible retaining element physically separate from the flexible enclosure that is configured to be disposed on a second side of the portion of the subject to be imaged, wherein the flexible retaining element lacks any radio frequency coil (“front strap 214 may couple first cup 222 to second cup 224, first shoulder strap 208 may couple first cup 222 to back strap 212, and second shoulder strap 210 may couple second cup 224 to back strap 212.” [0040]; “one or both of the third coil array 206 and fourth coil array 216 may be coupled to back strap 212 via one or more additional straps.” [0041]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]);
cordage directly coupled to and extending between both the flexible enclosure and the flexible retaining element, wherein at least a portion of the cordage is disposed within the flexible enclosure (“the support structure 220 may include one or more straps (which may be referred to herein as support straps), such as first shoulder strap 208, second shoulder strap 210, back strap 212, and front strap 214. […] In one example, front strap 214 may couple first cup 222 to second cup 224, first shoulder strap 208 may couple first cup 222 to back strap 212, and second shoulder strap 210 may couple second cup 224 to back strap 212.” [0040]; The shoulder straps 208, 210 (i.e., cordage) couple to circular frames within the fabric of cup-shaped support structures and the back strap [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]); and
a tension adjustment mechanism coupled to the cordage and configured to adjust a tension of the cordage to adjust how tight the flexible enclosure is disposed about the first side of the portion of the subject to be imaged (“one or more support straps supporting the first cup-shaped support structure, second cup-shaped support structure, third coil array, and fourth coil array, and wherein a length of at least one of the one or more support straps is adjustable” [clm 7]; “A length of one or more or each of the straps may be adjustable via hook and loop fasteners, buttons, or other fasteners in order to couple the support structure 220 to the patient.” [0040]; “The RF coil assemblies include adjustable straps in order to adapt to different body sizes.” [0076]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]).
Regarding claim 13, Li teaches the radio frequency receiving coil assembly of claim 12,
Li further teaching wherein the portion of the subject to be imaged is a chest having breasts, and wherein the integral adaptive compression system is configured to enable positioning of the flexible enclosure about breasts of different sizes (“systems are provided for a flexible, comfortable breast radio frequency (RF) coil assembly for a magnetic resonance imaging system” [abst]; “the coils may be allowed to move relative to one another (e.g., to accommodate different breast sizes).” [0047]; “the RF coils of the first coil array 202 may be coupled to the first cup 222 such that as the size of the first cup 222 increases in order to conform to the shape of the body of the patient […] the RF coil assembly 200 may be utilized by patients having different body sizes, breast sizes, etc.” [0058]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]).
Regarding claim 15, Li teaches the radio frequency receiving coil assembly of claim 12,
Li further teaching wherein the tension adjustment mechanism is coupled to the cordage outside the flexible enclosure (“A length of one or more or each of the straps may be adjustable via hook and loop fasteners, buttons, or other fasteners in order to couple the support structure 220 to the patient.” [0040]; [0039-0051], [fig. 1-2B, 6], [see claim 3 rejection]).
Regarding claim 16, Li teaches the radio frequency receiving coil assembly of claim 12,
Li further teaching wherein the tension adjustment mechanism is configured, via the cordage, to pull the flexible enclosure and the flexible retaining element closer together about the portion of the subject to be imaged (“A length of one or more or each of the straps may be adjustable via hook and loop fasteners, buttons, or other fasteners in order to couple the support structure 220 to the patient.” [0040]; “The RF coil assemblies include adjustable straps in order to adapt to different body sizes.” [0076]; [0039-0051], [fig. 1-2B, 6], [see claim 4 rejection]).
Regarding claim 17, Li teaches the radio frequency receiving coil assembly of claim 12,
Li further teaching wherein the cordage comprises a first band and a second band directly coupled to and extending between both the flexible enclosure and the flexible retaining element (“the support structure 220 may include one or more straps (which may be referred to herein as support straps), such as first shoulder strap 208, second shoulder strap 210, back strap 212, […] first shoulder strap 208 may couple first cup 222 to back strap 212, and second shoulder strap 210 may couple second cup 224 to back strap 212.” [0040]; [0039-0051], [fig. 1-2B, 6], [see claim 5 rejection]).
Regarding claim 19, Li teaches the radio frequency receiving coil assembly of claim 12,
Li further teaching wherein the integral adaptive compression system is configured to enable positioning of the flexible enclosure about curved surfaces of different parts of an anatomy of the subject to be imaged (“one or more support straps supporting the first cup-shaped support structure, second cup-shaped support structure, third coil array, and fourth coil array, and wherein a length of at least one of the one or more support straps is adjustable” [clm 7]; “The cups may be made of stretchable, flexible, and/or soft material, and the RF coils within the RF coil arrays may be moveable relative to each other […] during expansion and/or contraction of the cups, thereby enabling a diameter of the cups to expand or contract to conform to the body of the patient.” [0019]; “The RF coil assemblies include adjustable straps in order to adapt to different body sizes.” [0076]; [0039-0051], [fig. 1-2B, 6], [see claim 11 rejection]).
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) 6, 8 and 18 is/are rejected under 35 U.S.C. 103 as being obvious over Li, as applied to claims 1, 5 and 17 above.
Regarding claim 6, Li teaches the radio frequency receiving coil assembly of claim 5,
Li further teaching wherein the flexible enclosure comprises a first end and a second end opposite the first end, the first band is disposed closer to the first end than the second band, the second band is disposed closer to the second end than the first band, and the tension adjustment mechanism is coupled to both the first band and the second band and is configured to adjust the tension of both the first band and the second band (“During conditions in which the RF coil assembly 200 is worn by a patient, the first side 250 of the support structure 220 and the second side 252 of the support structure 220 each surround the upper sides of the torso of the patient […] the support structure 220 may include one or more straps (which may be referred to herein as support straps), such as first shoulder strap 208, second shoulder strap 210, back strap 212, and front strap 214. A length of one or more or each of the straps may be adjustable via hook and loop fasteners, buttons, or other fasteners” [0040]; The shoulder straps 208, 210 may be adjustable using fasteners or buttons attached to the straps to adjust the RF coil assembly and fit the patient [0039-0051], [fig. 1-2B, 6; see fig. 2A reproduced below], [see claim 1 rejection]).
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Shoulder strap 208 disposed near second side 252, and shoulder strap 210 disposed near first side 250, wherein the straps may be adjusted to fit the patient (Li [fig. 2A])
Li discloses the claimed invention except for explicitly disclosing a single ‘tension adjustment mechanism’ coupling the first and second bands together. Li presently teaches adjusting the length of any of the ‘straps’ using fasteners or buttons (Li [0040]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the radio frequency receiving coil assembly taught by Li to couple the tension adjustment mechanism to both the first band and second band, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art [Howard v. Detroit Stove Works, 150 U.S. 164 (1893)]. In addition, Applicant has not disclosed that coupling the first and second band together with the ‘tension adjustment mechanism’ solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the fasteners and buttons provided by Li.
Regarding claim 8, Li teaches the radio frequency receiving coil assembly of claim 1,
Li further teaching wherein the at least one band comprises twine, an elastic cord, or an elastic band (“The first cup 222 and second cup 224 may each be formed of a stretchable or non-stretchable fabric (polyester, cotton, rayon, etc.), polymer (e.g., polyurethane), elastomer, foam, etc., or a combination thereof.” [0042]; “with the pluralities of RF coils secured to panels of fabric or other material forming the support structure 220.” [0044]; “The RF coils included by the first coil array 202 may be mounted (e.g., coupled) to a flexible substrate (e.g., stretchable fabric, polymer, etc.).” [0046]; The support structure may be formed of stretchable fabric or elastomer [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]).
Li discloses the claimed invention except for explicitly disclosing the straps are composed of elastic. However, Li does teach that the support structure and cups may be formed of elastomer fabric (Li [0042-0046]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the straps with elastic, 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 [In re Leshin, 125 USPQ 416].
Regarding claim 18, Li teaches the radio frequency receiving coil assembly of claim 17,
Li further teaching wherein the flexible enclosure comprises a first end and a second end opposite the first end, the first band is disposed closer to the first end than the second band, the second band is disposed closer to the second end than the first band, and the tension adjustment mechanism is coupled to both the first band and the second band and is configured to adjust the tension of both the first band and the second band (“During conditions in which the RF coil assembly 200 is worn by a patient, the first side 250 of the support structure 220 and the second side 252 of the support structure 220 each surround the upper sides of the torso of the patient […] the support structure 220 may include one or more straps (which may be referred to herein as support straps), such as first shoulder strap 208, second shoulder strap 210, back strap 212, and front strap 214. A length of one or more or each of the straps may be adjustable via hook and loop fasteners, buttons, or other fasteners” [0040]; [0039-0051], [fig. 1-2B, 6], [see claim 6 rejection]).
Li discloses the claimed invention except for explicitly disclosing a single ‘tension adjustment mechanism’ coupling the first and second bands together. Li presently teaches adjusting the length of any of the ‘straps’ using fasteners or buttons (Li [0040]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the radio frequency receiving coil assembly taught by Li to couple the tension adjustment mechanism to both the first band and second band, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art [Howard v. Detroit Stove Works, 150 U.S. 164 (1893)]. In addition, Applicant has not disclosed that coupling the first and second band together with the ‘tension adjustment mechanism’ solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the fasteners and buttons provided by Li.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claim 1 above, and further in view of Hammerslag et al. (US2016/0206047 A1, 2016-07-21; hereinafter “Hammerslag”) as provided by Applicant.
Regarding claim 9, Li teaches the radio frequency receiving coil assembly of claim 1,
Li further teaching the tension adjustment mechanism configured to tighten the flexible enclosure about the portion of the subject to be imaged ([0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]);
but Li fails to explicitly teach the tension adjustment mechanism comprises a dial coupled to a spool.
However, in the same field of endeavor, Hammerslag teaches closure systems used in combination in any of a variety of applications including clothing ([clm 10], [0004-0017]);
Hammerslag further teaching wherein the tension adjustment mechanism comprises a dial coupled to a spool, wherein the dial is configured to be turned to wind the at least one band on to the spool to tighten the flexible enclosure about the portion of the subject to be imaged (“A reel based closure system, comprising: a housing, […] a spool rotatably disposed within the housing, the spool being coupled with a tension member such that as the spool rotates in a first direction, the tension member winds about the spool and as the spool rotates in a second direction, the tension member unwinds from about the spool;” [clm 10]; “The closure system includes a rotatable spool for receiving a lace. The spool is rotatable in a first direction to take up lace and a second direction to release lace. A knob is connected to the spool such that the spool can be rotated in the first direction to take up lace only in response to rotation of the knob.” [0157]; The winder is a tightening mechanism comprising a spool coupled to a knob, wherein rotating the knob winds the lace onto the spool [0160-0182], [fig. 21-23]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the RF coil assembly taught by Li with the closure system having clothing applications as taught by Hammerslag. These two closure systems were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute the straps as taught by Li for the dial and spool closure system taught by Hammerslag. It is desirable to provide an RF coil assembly shaped to comfortably support breasts of a patient and configured to enable bilateral scanning of the patient with an increased number of coils (Li [0004]). The combined RF coil assemblies may result in bra-like coil assemblies that increase patient comfort while increasing spatial resolution and reducing scan time during a breast MRI examination (Li [0074]).
Regarding claim 10, Li teaches the radio frequency receiving coil assembly of claim 1,
but Li fails to explicitly teach the tension adjustment mechanism comprises a cord lock stopper.
However, in the same field of endeavor, Hammerslag teaches wherein the tension adjustment mechanism comprises a cord lock stopper (“Tongue guide 1308 preferably includes mounting flange 1382, sliding surfaces 1384 a and 1384 b and central cap 1388. Central cap 1388 is preferably disposed in a raised manner above sliding surface 1384 by one or more support legs 1390. […] Support legs 1390 are preferably angled to accommodate the different ingress and egress directions of lace 23 as it enters the central cap portion 1388.” [0262]; “the tightening mechanism 1200, the tongue guides, and the other lace guides described above in connection with tightening mechanism 1200 can be made of any suitable material, […] lace 23 comprises a stranded cable, such as a 7 strand by 7 strand cable manufactured of stainless steel.” [0263]; The tightening mechanism may comprise tongue guides (i.e., cord lock stopper) to securely tighten cord [fig. 51]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the RF coil assembly taught by Li with the closure system having clothing applications as taught by Hammerslag. These two closure systems were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute the straps as taught by Li for the cord lock stopper closure system taught by Hammerslag. It is desirable to provide an RF coil assembly shaped to comfortably support breasts of a patient and configured to enable bilateral scanning of the patient with an increased number of coils (Li [0004]). The combined RF coil assemblies may result in bra-like coil assemblies that increase patient comfort while increasing spatial resolution and reducing scan time during a breast MRI examination (Li [0074]).
Claim(s) 14 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claim 13 above, and further in view of Harter (US20070250047A1, 2007-10-25; hereinafter “Harter”).
Regarding claim 14, Li teaches the radio frequency receiving coil assembly of claim 13,
Li further teaching wherein the cordage comprises a first region of cordage within the flexible enclosure and a second region of cordage within the flexible enclosure that are configured to be respectively disposed about a respective breast of the breasts (“The first cup 222 and second cup 224 are positioned at a front side of the support structure 220 and are each shaped to support breasts of a patient.” [0040]; “The first cup 222 and second cup 224 may each be formed of a stretchable or non-stretchable fabric (polyester, cotton, rayon, etc.), polymer (e.g., polyurethane), elastomer, foam, etc., or a combination thereof. The first cup 222 and second cup 224 may each include plastic or other polymer (non-metal) supports such as ribs, frames, etc.” [0042]; “the RF coils of the first coil array 202 may be coupled to the first cup 222 such that as the size of the first cup 222 increases […] a distance between opposing RF coils of the first coil array 202 increases (e.g., first diameter 500 between fourth RF coil 406 and eighth RF coil 414 increases to second diameter 502).” [0058]; The first and second cup flexibly support respective breasts of the patient and may be enable RF coils to displace and conform to the different breast sizes [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]);
but Li may fail to explicitly teach “net-like” geometry.
However, in the same field of endeavor, Harter teaches a radio frequency receiving coil assembly (“Interventional immobilization devices used to immobilize a body part and then, during a medical procedure, orient a medical device to treat located tissue within the body part are provided. […] The device enables real time (RT) imaging-guided interventional (IGI) capabilities when the devices are coupled with medical imaging systems, such as magnetic resonance imaging (MRI) systems.” [0003]; “when an embodiment of the interventional immobilization device is used in a MRI scan, a radiofrequency (RF) coil may be directly attached to the at least one curved compression grid plate.” [0011]; [fig. 12-19]);
Harter further teaching wherein the cordage comprises a first net-like region and a second net-like region that are configured to be respectively disposed about a respective breast of the breasts (“an interventional immobilization device, which demonstrates three curved compression grid plates […] the curved compression grid plates (202) comprise sections of a compound curved, or cup-shaped body, having radii of curvature in two orthogonal axes. A breast may be received between the curved compression grid plates (202).” [0062]; “the interventional immobilization device may be designed as an integral part of a customized RF receiver coil and platform structure, […] the lower coil rings (216) house the lower coil loops (217) of the RF circuitry while the upper coil rings (233) house the upper coil loops (219) of the RF circuitry of a Helmholtz pair RF receiver coil for high resolution bilateral breast MR imaging.” [0074]; [0062-0075], [fig. 12-19; see fig. 19 reproduced below]).
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Two net-like regions disposed to receive respective breasts for MRI imaging (Harter [fig. 19])
It would have been an obvious matter of design choice to combine the flexible RF coil assembly taught by Li with the first and second net-like regions as taught by Harter. Applicant has not disclosed that the net-like regions of cordage solve any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the configuration as taught by Li. Li teaches an adjustable RF coil assembly for breast MR imaging, disclosing “The cups may be made of stretchable, flexible, and/or soft material, and the RF coils within the RF coil arrays may be moveable relative to each other […] during expansion and/or contraction of the cups, thereby enabling a diameter of the cups to expand or contract to conform to the body of the patient” (Li [0019]). Due to the wide range of breast and chest anatomies (size and shape) and located tissue positions inside the breast, optimal planning of a medical procedure requires both appropriate preparation of the breast, i.e. immobilization, and choice of the trajectory of the intervention of the medical device, i.e. path of insertion (Harter [0005]). Increasing the number of RF coils per each breast (e.g., from 4 channels to 8 channels) enables the RF coils to be positioned more closely to each other and to anatomical structures that are to be imaged. Additionally, the RF coils of each RF coil array may move relative to each other during conditions in which the material forming the cups is expanded or contracted, thereby enabling the RF coil assemblies to be utilized with an increased amount of body sizes (Li [0076]).
Regarding claim 20, Li teaches a radio frequency receiving coil assembly for a magnetic resonance imaging system (“An RF coil assembly for a medical imaging device,” [clm 1]; “an RF coil assembly is provided for a magnetic resonance imaging (MRI) system (such as the MRI system shown by FIG. 1). The RF coil assembly […] is shaped to conform to a body of a patient and includes a plurality of RF coil arrays positioned in an adjustable, bra-like support structure.” [0018]; [0018-0051], [fig. 1-2B, 6]), comprising:
a flexible enclosure (“a first coil array housed in a first cup-shaped support structure; a second coil array housed in a second cup-shaped support structure;” [clm 1]; “the support structure 220 is a bra-like support structure including a first cup 222 and a second cup 224.” [0040]; “The RF coils included by the first coil array 202 may be mounted (e.g., coupled) to a flexible substrate (e.g., stretchable fabric, polymer, etc.). […] the flexible substrate may be a same material as the material of the first cup 222 and/or support structure 22” [0046]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]); and
a radio frequency coil disposed within the flexible enclosure (“a first coil array housed in a first cup-shaped support structure; a second coil array housed in a second cup-shaped support structure;” [clm 1]; “The first coil array 202 is coupled to the first cup 222 and the second coil array 204 is coupled to the second cup 224” [0041]; “First coil array 202 and second coil array 204 each include a plurality of RF coils […] coupled to their respective cup (e.g., first cup 222 and second cup 224) of the support structure 220. […] The first cup 222 and second cup 224 may each be formed of a stretchable or non-stretchable fabric (polyester, cotton, rayon, etc.), polymer (e.g., polyurethane), elastomer, foam, etc., or a combination thereof” [0042]; “The coils of the first coil array 202 and second coil array 204 may be sewn or otherwise secured to the respective exterior surface of the support structure 220 […] one or more layers of fabric or other material may be fastened to the interior surface of the first cup 222 and/or second cup 224 in order to contain the coils within their respective cups” [0043]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]),
wherein the radio frequency coil comprises a plurality of flexible loops having a malleable conductor (“a first coil array housed in a first cup-shaped support structure; a second coil array housed in a second cup-shaped support structure;” [clm 1]; “First coil array 202 and second coil array 204 each include a plurality of RF coils (described in further detail below with reference to FIG. 4A) coupled to their respective cup (e.g., first cup 222 and second cup 224) of the support structure 220. […] The first cup 222 and second cup 224 may each be formed of a stretchable or non-stretchable fabric” [0042]; “The RF coils are local RF coils […] comprised of a generally flexible, flat, and electrically-conductive material (e.g., tin-plated copper).” [0047]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]),
the flexible enclosure is configured to be disposed on a chest having breasts of a subject to be imaged, and the flexible enclosure comprises a first cup region and a second cup region (“systems are provided for a flexible, comfortable breast radio frequency (RF) coil assembly for a magnetic resonance imaging system” [abst]; “the coils may be allowed to move relative to one another (e.g., to accommodate different breast sizes).” [0047]; “the RF coils of the first coil array 202 may be coupled to the first cup 222 such that as the size of the first cup 222 increases in order to conform to the shape of the body of the patient […] the RF coil assembly 200 may be utilized by patients having different body sizes, breast sizes, etc.” [0058]; [0039-0051], [fig. 1-2B, 6], [see claim 13 rejection]); and
an integral adaptive compression system (“one or more support straps supporting the first cup-shaped support structure, second cup-shaped support structure, […] and wherein a length of at least one of the one or more support straps is adjustable.” [clm 7]; “Additionally, the support structure 220 may include one or more straps (which may be referred to hereinafter as support straps), […] A length of one or more or each of the straps may be adjustable via hook and loop fasteners, buttons, or other fasteners in order to couple the support structure 220 to the patient.” [0041]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]),
wherein the integral adaptive compression system is configured to enable positioning of the flexible enclosure about breasts of different sizes (“the RF coils of the first coil array 202 may be coupled to the first cup 222 such that as the size of the first cup 222 increases in order to conform to the shape of the body of the patient […] the RF coil assembly 200 may be utilized by patients having different body sizes, breast sizes, etc.” [0058]; [0039-0051], [fig. 1-2B, 6], [see claim 13 rejection]), wherein the integral adaptive compression system comprises:
a flexible retaining element separate from the flexible enclosure that is configured to be disposed on a back of the subject to be imaged (“front strap 214 may couple first cup 222 to second cup 224, first shoulder strap 208 may couple first cup 222 to back strap 212, and second shoulder strap 210 may couple second cup 224 to back strap 212.” [0040]; “one or both of the third coil array 206 and fourth coil array 216 may be coupled to back strap 212 via one or more additional straps.” [0041]; [0039-0051], [fig. 1-2B, 6], [see claim 1 rejection]);
cordage coupled to both the flexible enclosure and the flexible retaining element, wherein the cordage comprises a first region of cordage within the first cup region of the flexible enclosure and a second region of cordage within the second cup region of the flexible enclosure that are configured to be respectively disposed about a respective breast of the breasts (“the support structure 220 may include one or more straps (which may be referred to herein as support straps), such as first shoulder strap 208, second shoulder strap 210, back strap 212, and front strap 214. […] In one example, front strap 214 may couple first cup 222 to second cup 224, first shoulder strap 208 may couple first cup 222 to back strap 212, and second shoulder strap 210 may couple second cup 224 to back strap 212.” [0040]; “The first cup 222 and second cup 224 may each be formed of a stretchable or non-stretchable fabric (polyester, cotton, rayon, etc.), polymer (e.g., polyurethane), elastomer, foam, etc., or a combination thereof. The first cup 222 and second cup 224 may each include plastic or other polymer (non-metal) supports such as ribs, frames, etc.” [0042]; “the RF coils of the first coil array 202 may be coupled to the first cup 222 such that as the size of the first cup 222 increases […] a distance between opposing RF coils of the first coil array 202 increases (e.g., first diameter 500 between fourth RF coil 406 and eighth RF coil 414 increases to second diameter 502).” [0058]; [0039-0051], [fig. 1-2B, 6], [see claim 14 rejection]); and
a tension adjustment mechanism coupled to the cordage and configured to adjust a tension of the cordage to adjust how tight the flexible enclosure is disposed about the chest of the subject to be imaged, wherein the tension adjustment mechanism is disposed outside of the flexible enclosure between the first cup region and the second cup region (“one or more support straps supporting the first cup-shaped support structure, second cup-shaped support structure, third coil array, and fourth coil array, and wherein a length of at least one of the one or more support straps is adjustable” [clm 7]; “A length of one or more or each of the straps may be adjustable via hook and loop fasteners, buttons, or other fasteners in order to couple the support structure 220 to the patient.” [0040]; “The RF coil assemblies include adjustable straps in order to adapt to different body sizes.” [0076]; [0039-0051], [fig. 1-2B, 6], [see claim 1, 15 rejection]);
but Li may fail to explicitly teach “net-like” geometry.
However, in the same field of endeavor, Harter teaches a radio frequency receiving coil assembly (“Interventional immobilization devices used to immobilize a body part and then, during a medical procedure, orient a medical device to treat located tissue within the body part are provided. […] The device enables real time (RT) imaging-guided interventional (IGI) capabilities when the devices are coupled with medical imaging systems, such as magnetic resonance imaging (MRI) systems.” [0003]; “when an embodiment of the interventional immobilization device is used in a MRI scan, a radiofrequency (RF) coil may be directly attached to the at least one curved compression grid plate.” [0011]; [fig. 12-19]);
Harter further teaching the cordage comprises a first net-like region of cordage within the first cup region of the flexible enclosure and a second net-like region of cordage within the second cup region of the flexible enclosure that are configured to be respectively disposed about a respective breast of the breasts (“an interventional immobilization device, which demonstrates three curved compression grid plates […] the curved compression grid plates (202) comprise sections of a compound curved, or cup-shaped body, having radii of curvature in two orthogonal axes. A breast may be received between the curved compression grid plates (202).” [0062]; “the interventional immobilization device may be designed as an integral part of a customized RF receiver coil and platform structure, […] the lower coil rings (216) house the lower coil loops (217) of the RF circuitry while the upper coil rings (233) house the upper coil loops (219) of the RF circuitry of a Helmholtz pair RF receiver coil for high resolution bilateral breast MR imaging.” [0074]; [0062-0075], [fig. 12-19], [see claim 14 rejection]).
It would have been an obvious matter of design choice to combine the flexible RF coil assembly taught by Li with the first and second net-like regions as taught by Harter. Applicant has not disclosed that the net-like regions of cordage solve any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the configuration as taught by Li. Li teaches an adjustable RF coil assembly for breast MR imaging, disclosing “The cups may be made of stretchable, flexible, and/or soft material, and the RF coils within the RF coil arrays may be moveable relative to each other […] during expansion and/or contraction of the cups, thereby enabling a diameter of the cups to expand or contract to conform to the body of the patient” (Li [0019]). Due to the wide range of breast and chest anatomies (size and shape) and located tissue positions inside the breast, optimal planning of a medical procedure requires both appropriate preparation of the breast, i.e. immobilization, and choice of the trajectory of the intervention of the medical device, i.e. path of insertion (Harter [0005]). Increasing the number of RF coils per each breast (e.g., from 4 channels to 8 channels) enables the RF coils to be positioned more closely to each other and to anatomical structures that are to be imaged. Additionally, the RF coils of each RF coil array may move relative to each other during conditions in which the material forming the cups is expanded or contracted, thereby enabling the RF coil assemblies to be utilized with an increased amount of body sizes (Li [0076]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Leussler et al. (US20080204021A1, 2008-08-28) teaches a radio frequency apparatus for at least one of (i) receiving and (ii) exciting a magnetic resonance signal includes an item of clothing. The item of clothing includes one or more layers that are stretchable to comport with differently sized and shaped imaging subjects [abst].
Harms et al. (US20090143672A1, 2009-06-04) teaches magnetic resonance imaging (MRI), particularly for imaging and mapping tissue structures within the breast, and more particularly to facilitating accurate collection of biopsy tissue samples [0002].
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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
Prosecution Insights