DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see pg. 10, filed 07 Apr 2026, with respect to the claim objections have been fully considered and are persuasive. The claim objections of 12 Nov 2025 have been withdrawn in view of the amended claims.
Applicant’s arguments, see pg. 10, filed 07 Apr 2026, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive in part. The 35 U.S.C. 112(b) rejections of 12 Nov 2025, except for claim 5, have been withdrawn in view of the amended claims.
Regarding claim 5, Applicant argues, see pg. 10, that “Applicant accepts the Office’s interpretation of claim 5.” However, claim 5 was rejected under 35 U.S.C. 112(b) that requires a correction. See the 35 U.S.C. 112(b) rejection to claim 5 maintained below.
Applicant's arguments, see pg. 10-14, filed 07 Apr 2026, with respect to the 35 U.S.C. 102 and 103 rejections, have been fully considered but they are not persuasive.
Regarding at least independent claims 1 and 29, Applicant first argues, see pg. 11, that “Applicant’s invention requires a plasticizer”. However, the Examiner respectfully disagrees. A review of the original specification of the instant application explicitly discloses a list of plasticizers, including a xylene (see [00019]). Shikinami explicitly discloses in Col 15, lines 1-14, a xylylene diisocyanate. Applicant emphasizes Col 11, lines 21-23 of Shikinami explicitly stating “formed without the aid of a plasticizer, etc. deviates from the spirit of this invention”, but when considered in context, Shikinami actually emphasizes “a two-component system gel which cannot be formed without the aid of a plasticizer” deviates from the spirit of Shikinami’s invention, not the use of a plasticizer itself.
Applicant secondly argues, see pg. 12, that “the compositional materials used in Shikinami and the current invention are not the same and result in functionally not appreciated, disclosed, nor even suggested by Shikinami”. However, the Examiner respectfully disagrees. See the 35 U.S.C. 102 rejections to at least independent claims 1 and 29 below with respect to Shikinami’s Example 3 disclosed in Col 15, lines 1-14. Regarding independent claim 29 specifically, the original specification of the instant application explicitly discloses in [00051] that the term “about” includes “plus or minus 5 units (e.g., percentage) of the stated value”. Therefore, the limitation “the selected ratio producing an NCO:OH molar ratio between about 0.8 and about 2.0” in claim 29 actually includes an NCO:OH molar ratio ranging from 0.76 to 2.1, which is within 5% from 0.8 and 2.0, respectively. Thus, the limitation in claim 29 is anticipated by Shikinami’s NCO/OH molar ratio of 0.77, which is within the range of 0.76 and 2.1.
Applicant thirdly argues, see pg. 12-14, that “Shikinami directly emphasizes the absence of plasticizers, reinforcing that its materials are limited to non-plasticized gel systems, wholly unlike the currently amended claims herein”. However, the Examiner respectfully disagrees. First, as explained above, Shikinami actually emphasizes “a two-component system gel which cannot be formed without the aid of a plasticizer” deviates from the spirit of Shikinami’s invention, not the use of a plasticizer itself (See Col 11, lines 18-23). Second, as also explained above, see the 35 U.S.C. 102 rejections to at least independent claims 1 and 29 below with respect to Shikinami’s Example 3 disclosed in Col 15, lines 1-14. Furthermore, a review of the specification of the instant application discloses that the NCO/OH molar ratio between 0.5 and 2 and a % w/w of plasticizer between 12.73 and 48.94 results in the Shore Hardness between Shore A50 and Shore 000 0 and having an acoustic attenuation factor of 3.0 dB/MHz-cm or less (see [00015], [00020], [00031]-[00041] of the specification of the instant application). See the 35 U.S.C. 102 rejections to at least independent claims 1 and 29 below.
Regarding dependent claims 2-28, Applicant argues, see pg. 14, that the dependent claims are patentable at least for Applicant’s arguments presented for the amended independent claim 1. However, the Examiner respectfully disagrees at least for the reasons explained above for the independent claim 1. Also see the 35 U.S.C. 102 and 103 rejections to the dependent claims below.
Election/Restrictions
Amended claim 30 is now directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Amended claims 1-29, drawn to an acoustic coupling article (originally presented invention), classified in A61B8/4281.
Amended claim 30, drawn to a method of synthesizing an elastomeric material, classified in C08G18/08.
The inventions are distinct, each from the other because of the following reason(s):
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the process as claimed can be used to make a product different from that of invention I having a Shore hardness outside of the range of Shore A50 and Shore OOO 0 and acoustic attenuation factor greater than 3.0 dB/MHz-cm.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classifications;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
the inventions require a different field of search (for example, searching A61B8/4281 for the acoustic coupling article of invention I vs. C08G18/08 for the method of synthesizing an elastomeric material of invention II);
the prior art applicable to one invention would not likely be applicable to another invention; and
additional or different prior art needs to be considered to construe the claims of each invention and patentability considerations may be different due to different statutory classes of invention.
See MPEP §808.02.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 30 is withdrawn from consideration as being
directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of Claims
Claims 1-29 are currently under examination. Claim 30 is withdrawn from consideration as being directed to a non-elected invention. See Election/Restriction above for the restriction by original presentation.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the new limitation “wherein a ratio of the first polymerizable material, the second polymerizable material, and/or the at least one plasticizer, modulates a Shore Hardness between a range of about Shore A50 and about Shore OOO 0 while maintaining an acoustic attenuation factor of about 3.0 dB/MHz-cm or less”. A review of the original specification, however, discloses working examples of a molar ratio of NCO to OH ranging from 1 to 1.7 and a % w/w, or a weight concentration, of plasticizer ranging from 12.3 to 48.9 that result in a Shore Hardness ranging from Shore OOO 5 to Shore A20 and an acoustic attenuation factor ranging from -0.74 to -0.67 dB/MHz/cm (see Tables 1-3 and [00031]-[00041] of the original specification). Thus, the original specification does not disclose, for examples, 1) only one or even two of first polymerizable material, second polymerizable material, and at least one plasticizer modulating the claimed ranges of Shore Hardness and acoustic attenuation factor (note “and/or” in the new limitation); 2) a single ratio unit of first polymerizable material, second polymerizable material, and at least one plasticizer modulating the claimed ranges of Shore Hardness and acoustic attenuation factor (note mere “ratio” in the new limitation); and 3) the claimed Shore Hardness and acoustic attenuation factor that are less than or greater than the range of Shore OOO 5 and Shore A20 and the range of -0.74 and -0.67 dB/MHz/cm, respectively. In particular, [00051] of the specification discloses that the term “about” includes “plus or minus 5 units (e.g., percentage) of the stated value” that the claimed ranges are even wider than the recited numerical values. Therefore, the new limitation recites new matter that are beyond the original specification of the instant application to reasonably convey to one skilled in the relevant art that the inventors had possession of the claimed invention of claim 1. Claims 2-28 inherit the deficiency by the nature of their dependency on claim 1.
Claim 2 recites the new limitation “wherein the ratio of the first polymerizable material, the second polymerizable material, and/or the at least one plasticizer is adjustable, and wherein adjusting the ratio allows for a longitudinal speed of sound of the acoustic coupling to be adjusted between a range of about 1000 m/s to about 1850 m/s at 25 degrees C”. A review of the original specification, however, discloses working examples of the combination of first polymerizable material, second polymerizable material, and at least one plasticizer allowing a longitudinal speed of sound between 1326 m/s and 1530 m/s at 25 degrees C (see Tables 1-3 of the instant application). Thus, the original specification does not disclose only one or even two of first polymerizable material, second polymerizable material, and at least plasticizer allowing a longitudinal speed of sound that is less than or greater than the range of 1326 m/s and 1530 m/s. Additionally, [00051] of the specification discloses that the term “about” includes “plus or minus 5 units (e.g., percentage) of the stated value” that the claimed ranges are even wider than the recited numerical values. Therefore, the new limitation recites new matter that is beyond the original specification of the instant application to reasonably convey to one skilled in the relevant art that the inventors had possession of the claimed invention of claim 2.
Claim 3 recites the new limitation “wherein the ratio of the first polymerizable material, the second polymerizable material, and/or the at least one plasticizer is adjustable, and wherein adjusting the ratio allows for an adjustable acoustic impedance range of the elastomeric material of between about 1.0 to about 3.0 MRayl”. A review of the original specification, however, discloses working examples of the combination of first polymerizable material, second polymerizable material, and at least one plasticizer allowing an acoustic impedance of 1.5 MRayl (see Tables 1-3 and [00031]-[00041] of the original specification). Thus, the original specification does not disclose only one or even two of first polymerizable material, second polymerizable material, and at least plasticizer allowing an acoustic impedance that is less than or greater than 1.5 MRayl. Additionally, [00051] of the specification discloses that the term “about” includes “plus or minus 5 units (e.g., percentage) of the stated value” that the claimed ranges are even wider than the recited numerical values. Therefore, the new limitation recites new matter that is beyond the original specification of the instant application to reasonably convey to one skilled in the relevant art that the inventors had possession of the claimed invention of claim 3.
Claim 6 recites the new limitation “wherein the at least one plasticizer, alone or in combination with one or both of the first polymerizable material and/or the second polymerizable material, is capable of directly or indirectly modulating an ability to self-heal following tearing, wherein the at least one plasticizer includes at least one of: Di-n-hepytl phthalate (DHP), Di-2-ethylhexyl phthalate (DOP), Diisoctyl phthalate (DIOP), Diisononyl phthalate (DINP), Diisodecyl phthalate (DIDP), Diundecyl phthalate (DUP), Diisodecyl glutarate (DIDG), Di-n-butyl sebacate (DBS), Diisodecyl adipate (DIDA), Dibutoxyethyl adipate (DBEA), Dibutoxyethoxyethyl sebacate (DBEES), tri octyl trimellitate (TOTM), Dioctyl terephthalate (DOTP), phenyl, biphenyl, terphenyl, toluene, xylene, alkylbenzenes, or combinations and mixtures thereof.”. A review of the original specification, however, discloses in [00019] “Optionally, phenyl, biphenyl, terphenyl, toluene, xylene, and other alkylbenzenes may be incorporated to provide a high mobility external plasticizer within the elastomer to impart additional flexibility and the ability for the elastomer to self-heal following being torn or damaged”. Thus, only “phenyl, biphenyl, terphenyl, toluene, xylene, and other alkylbenzenes” as a plasticizer modulates the ability to self-heal, not any of “Di-n-hepytl phthalate (DHP), Di-2-ethylhexyl phthalate (DOP), Diisoctyl phthalate (DIOP), Diisononyl phthalate (DINP), Diisodecyl phthalate (DIDP), Diundecyl phthalate (DUP), Diisodecyl glutarate (DIDG), Di-n-butyl sebacate (DBS), Diisodecyl adipate (DIDA), Dibutoxyethyl adipate (DBEA), Dibutoxyethoxyethyl sebacate (DBEES), tri octyl trimellitate (TOTM), Dioctyl terephthalate (DOTP)” listed in the claim, according to the original specification. Furthermore, the original specification does not disclose in sufficient detail the at least one plasticizer “directly or indirectly modulating an ability to self-heal following tearing”. Therefore, the new limitation introduces new matter that is beyond the original specification of the instant application to reasonably convey to one skilled in the relevant art that the inventors had possession of the claimed invention of claim 6.
Claim 29 recites the new limitation “wherein the selected ratio of polymerizable materials, and/or a selected ratio of the polymerizable materials relative to one another and/or to the pre-mixture plasticizer, provide for modulating a Shore Hardness at or under about Shore A50 while maintaining an acoustic attenuation factor of about 3.0 dB/MHz-cm or less”. A review of the original specification, however, discloses working examples of a molar ratio of NCO to OH ranging from 1 to 1.7 and a % w/w, or a weight concentration, of plasticizer ranging from 12.3 to 48.9 that result in a Shore Hardness ranging from Shore OOO 5 to Shore A20 and an acoustic attenuation factor ranging from -0.74 to -0.67 dB/MHz/cm (see Tables 1-3 of the instant application). Thus, the original specification does not disclose, for examples, 1) only one or even two of polymerizable materials and a pre-mixture plasticizer modulating the claimed ranges of Shore Hardness and acoustic attenuation factor (note “and/or” in the new limitation); 2) a single ratio unit of polymerizable materials and a pre-mixture plasticizer modulating the claimed ranges of Shore Hardness and acoustic attenuation factor (note mere “ratio” in the new limitation); and 3) the claimed Shore Hardness and acoustic attenuation factor that are less than or greater than the range of Shore OOO 5 and Shore A20 and the range of -0.74 and -0.67 dB/MHz/cm, respectively. Therefore, the new limitation recites new matter that are beyond the original specification of the instant application to reasonably convey to one skilled in the relevant art that the inventors had possession of the claimed invention of claim 29.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-29 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.
Claim 1 recites the new limitation “wherein the acoustic coupling article transmits the acoustic signal produced by the at least one acoustic signal transducer through the elastomeric material of the acoustic coupling article and into the one or more receiving bodies”. First, claim 1 is directed to a product. It is unclear whether the limitation attempts to recite the process (“the acoustic coupling article transmits the acoustic signal”) by which the product of claim 1 performs, thus mixing patentable statutory categories. See MPEP 2173.05(p). Therefore, the metes and bounds of the claim are unclear. Second, the antecedent basis for “the acoustic signal” is unclear. Claims 2-28 inherit the deficiency by the nature of their dependency on claim 1. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the acoustic coupling article is configured to transmit an acoustic signal produced by the at least one acoustic signal transducer through the elastomeric material of the acoustic coupling article and into the one or more receiving bodies”.
Claim 1 recites the limitation “wherein a ratio of the first polymerizable material, the second polymerizable material, and/or the at least one plasticizer, modulates a Shore Hardness between a range of about Shore A50 and about Shore OOO 0 while maintaining an acoustic attenuation factor of about 3.0 dB/MHz-cm or less”. The metes and bounds of “a ratio of the first polymerizable material, the second polymerizable material, and/or the at least one plasticizer” are unclear. In particular, it is unclear whether the ratio is based on molecular weight, mole, or otherwise. Further, a review of the original specification of the instant application does not disclose a single unit ratio of, for example, all of the first polymerizable material, the second polymerizable material, and the at least one plasticizer. Claims 2-28 inherit the deficiency by the nature of their dependency on claim 1. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the first polymerizable material, the second polymerizable material, and the at least one plasticizer together modulate a Shore Hardness between a range of about Shore A50 and about Shore OOO 0 while maintaining an acoustic attenuation factor of about 3.0 dB/MHz-cm or less”.
Claim 2 recites the limitation “wherein the ratio of the first polymerizable material, the second polymerizable material, and/or the at least one plasticizer is adjustable, and wherein adjusting the ratio allows for a longitudinal speed of sound of the acoustic coupling to be adjusted between a range of about 1000 m/s to about 1850 m/s at 25 degrees C”. Claim 2 is directed to a product. It is unclear whether the limitation attempts to recite the process (“the ratio of the first polymerizable material, the second polymerizable material, and/or the at least one plasticizer is adjustable”) by which the product of claim 2 (“The acoustic coupling article of claim 1 …”) is made or is directed to the process of adjusting the ratio, thus mixing patentable statutory categories. See MPEP 2173.05(p). Therefore, the metes and bounds of the claim are unclear. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the first polymerizable material, the second polymerizable material, and the at least one plasticizer together provide an acoustic coupling at a longitudinal speed of sound of about 1000 m/s to about 1850 m/s at 25 degrees C”.
Claim 3 recites the limitation “wherein the ratio of the first polymerizable material, the second polymerizable material, and/or the at least one plasticizer is adjustable, and wherein adjusting the ratio allows for an adjustable acoustic impedance range of the elastomeric material of between about 1.0 to about 3.0 MRayl”. Claim 3 is directed to a product. It is unclear whether the limitation attempts to recite the process (“the ratio of the first polymerizable material, the second polymerizable material, and/or the at least one plasticizer is adjustable”) by which the product of claim 3 (“The acoustic coupling article of claim 1 …”) is made or is directed to the process of adjusting the ratio, thus mixing patentable statutory categories. See MPEP 2173.05(p). Therefore, the metes and bounds of the claim are unclear. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the first polymerizable material, the second polymerizable material, and the at least one plasticizer together provide an acoustic impedance range of the elastomeric material of between about 1.0 to about 3.0 MRayl”.
Claim 5 recites the limitation “at least one of the following isocyanates or composition including one or more isocyanate: methylene diphenyl diisocyanate, hexamethylene diisocyanate, toluene diisocyanate, isophorone diisocyanate, optionally modified polymeric compositions, and combinations or mixtures thereof”. First, it is unclear whether “one or more isocyanate” recited in the limitation is the same or different from any of diisocyanates that are listed after “one or more isocyanate”. Second, it is unclear that the limitation recites “at least one of the following isocyanates or composition” yet also recites “optionally modified polymeric compositions”. Therefore, it is unclear whether “optionally modified polymeric compositions” is required or not. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “at least one of an isocyanate or the following isocyanates: methylene diphenyl diisocyanate, hexamethylene diisocyanate, toluene diisocyanate, isophorone diisocyanate, and combinations or mixtures thereof”.
Claim 29 recites the limitation “wherein the selected ratio of polymerizable materials, and/or a selected ratio of the polymerizable materials relative to one another and/or to the pre-mixture plasticizer, provide for modulating a Shore Hardness at or under about Shore A50 while maintaining an acoustic attenuation factor of about 3.0 dB/MHz-cm or less”. The metes and bounds of “the selected ratio of polymerizable materials, and/or a selected ratio of the polymerizable materials relative to one another and/or to the pre-mixture plasticizer” are unclear. In particular, it is unclear whether the ratio is based on molecular weight, mole, or otherwise. Further, a review of the original specification of the instant application does not disclose a single unit ratio of, for example, all of the polymerizable materials the pre-mixture plasticizer. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the polymerizable materials and the pre-mixture plasticizer together modulate a Shore Hardness at or under Shore A50 while maintaining an acoustic attenuation factor of about 3.0 dB/MHz-cm or less”.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-14, 20, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shikinami et al. (US Patent No. 5037994) – hereinafter referred to as Shikinami.
Regarding claim 1, Shikinami discloses an acoustic coupling article for acoustic signal transmission (Fig. 1-9) comprising:
an elastomeric material capable of conforming to a surface of one or more receiving bodies (Col 6, lines 9-15: elastic gel comprising liquid segmented polyurethane; Col 12, line 67 - Col 13, line 59: coupler made of polyurethane gel to be coupled to a probe for ultrasonic diagnosis and a skin);
wherein the acoustic coupling article comprising the elastomeric material is configured to be acoustically coupled to at least one acoustic signal transducer, wherein the acoustic coupling article transmits the acoustic energy produced by the at least one acoustic signal transducer through the elastomeric material of the acoustic coupling article and into the one or more receiving bodies (Col 13, lines 32-59: coupler fixed to a probe for ultrasonic diagnosis by inserting the probe into socket 2 and shows a rate of ultrasonic wave transmission which is very close to that of the human body tissues);
wherein the elastomeric material comprises a mixture of first polymerizable material, a second polymerizable material, and at least one plasticizer (Col 15, lines 1-14: polyether polyol (first polymerizable material) and mixture of propylene glycol and glycerin (second polymerizable material) reacted with XDI (xylylene diisocyanate, plasticizer)),
wherein a molar ratio of the first polymerizable material and the second polymerizable material is 0.77 (Col 15, lines 1-14: OH/NCO ratio is 1.3, or NCO/OH molar ratio is 1/1.3 ≈ 0.77) and a % w/w of the at least one plasticizer is about 15% (Col 15, lines 1-14: the (AO, or alkylene oxide)/XDI weight ratio is 6.5, or % w/w of XDI is (1/6.5)*100% ≈ 15%).
It is noted that Shikinami does not explicitly disclose that the combination of polyether polyol, triisocyante, and XDI provides for modulating the Shore Hardness between Shore A50 and Shore OOO 0 while maintaining an acoustic attenuation factor of 3.0 dB/MHz-cm or less. However, a review of the specification of the instant application discloses that the NCO/OH molar ratio between 0.5 and 2 and a % w/w of plasticizer between 12.73 and 48.94 results in the Shore Hardness between Shore A50 and Shore 000 0 and having an acoustic attenuation factor of 3.0 dB/MHz-cm or less (see [00015], [00020], [00031]-[00041] of the specification of the instant application). Thus, Shikinami’s molar ratio of NCO/OH being 0.77 and % w/w of XDI being 15%, which are within the disclosed respective range of the original specification of the instant application, would inherently have the Shore Hardness between Shore A50 and Shore 000 0 while maintaining an acoustic attenuation factor of 3.0 dB/MHz-cm or less.
Regarding claims 2-4, Shikinami discloses all limitations of claim 1, as discussed above, and Shikinami does not explicitly disclose:
wherein the ratio of the first polymerizable material, the second polymerizable material, and/or the at least one plasticizer is adjustable, and wherein adjusting the ratio allows for a longitudinal speed of sound of the acoustic coupling to be adjusted between a range of about 1000 m/s to about 1850 m/s at 25 degrees C (claim 2);
wherein the ratio of the first polymerizable material, the second polymerizable material, and/or the at least one plasticizer is adjustable, and wherein adjusting the ratio allows for an adjustable acoustic impedance range of the elastomeric material of between about 1.0 to about 3.0 MRayl (claim 3); and
wherein the elastomeric material exhibits a density ranging from 0.5 g/cm3 - 1.5 g/cm3 (claim 4).
However, as noted above for claim 1, Shikinami discloses molar ratio of NCO/OH being 0.77 and % w/w of XDI being 15%, which are within the disclosed respective range of the original specification of the instant application for 1) allowing a longitudinal speed of sound between 1000 m/s and 1850 m/s at 25 deg C, 2) allowing an acoustic impedance of between 1.0 MRayl and 3.0 MRayl, and 3) exhibiting a density ranging from 0.5 g/cm3 - 1.5 g/cm3 (see [00015], [00020], [00031]-[00041] of the specification of the instant application). Therefore, Shikinami’s molar ratio of NCO/OH being 0.77 and % w/w of XDI being 15%, molar ratio of NCO/OH being 0.77 and % w/w of XDI being 15%, would inherently 1) allow a longitudinal speed of sound between 1000 m/s and 1850 m/s at 25 deg C, 2) allow an acoustic impedance of between 1.0 MRayl and 3.0 MRayl, and 3) exhibit a density ranging from 0.5 g/cm3 - 1.5 g/cm3.
Regarding claim 5, Shikinami discloses all limitations of claim 1, as discussed above, and Shikinami further discloses:
wherein the first polymerizable material, the second polymerizable material, or both, are a polyurethane (Col 6, lines 9-15: elastic gel comprising liquid segmented polyurethane obtained by reacting at least one polyol and at least one polyisocyanate) comprising:
at least one of the following polyols: polyhydroxyl-polyethers, polyhydroxyl-polyesters, polyhydroxyl-polyacetals, polyhydroxyl-polyesteramides, polyhydroxyl-polyamides, polyhydroxyl-polybutadienes, and combinations or mixtures thereof (Col 15, lines 1-14: polyether polyol); and
at least one of the following isocyanates or composition including one or more isocyanate: methylene diphenyl diisocyanate, hexamethylene diisocyanate, toluene diisocyanate, isophorone diisocyanate, optionally modified polymeric compositions, and combinations or mixtures thereof (Col 15, lines 1-14: triisocyante obtained from reacting propylene glycol and glycerin mixture with xylylene diisocyanate (XDI)).
Regarding claim 6, Shikinami discloses all limitations of claim 5, as discussed above, and Shikinami further discloses:
wherein the at least one plasticizer includes at least one of: Di-n-hepytl phthalate (DHP), Di-2-ethylhexyl phthalate (DOP), Diisoctyl phthalate (DIOP), Diisononyl phthalate (DINP), Diisodecyl phthalate (DIDP), Diundecyl phthalate (DUP), Diisodecyl glutarate (DIDG), Di-n-butyl sebacate (DBS), Diisodecyl adipate (DIDA), Dibutoxyethyl adipate (DBEA), Dibutoxyethoxyethyl sebacate (DBEES), tri octyl trimellitate (TOTM), Dioctyl terephthalate (DOTP), phenyl, biphenyl, terphenyl, toluene, xylene, alkylbenzenes, and combinations and mixtures thereof (Col 15, lines 1-14: xylylene diisocyanate (XDI)).
It is noted that while Shikinami does not explicitly disclose the limitation “wherein the at least one plasticizer, alone or in combination with one or both of the first polymerizable material and/or the second polymerizable material, is capable of directly or indirectly modulating an ability to self-heal following tearing” recited in claim 6, the claim recites examples of the one or more plasticizers (also see [00019] of the specification of the instant application). Shikinami’s plasticizer includes 2,4-toluylene (or xylene) diisocyanate, which the claim and the specification identify as a plasticizer, thus Shikinami inherently discloses the limitation “wherein the at least one plasticizer, alone or in combination with one or both of the first polymerizable material and/or the second polymerizable material, is capable of directly or indirectly modulating an ability to self-heal following tearing” recited in claim 6.
Regarding claim 7, Shikinami discloses all limitations of claim 1, as discussed above, and Shikinami further discloses:
wherein the elastomeric material is capable of being molded into a three-dimensional shape, and wherein the molded elastomeric material substantially or mostly retains the three-dimensional shape during use or handling (Fig. 1-9 and Col 12, line 67 - Col 13, line 68: coupler produced in any desired shape in a prescribed casting mold, is excellent in preservation stability, and is abrasion resistant).
Regarding claims 8-9, Shikinami discloses all limitations of claim 1, as discussed above, and Shikinami does not explicitly disclose:
wherein the elastomeric material is capable of retaining its mechanical and acoustic properties for five years or more (claim 8);
wherein the elastomeric material does not substantially degrade via dehydration or require maintenance to retain its mechanical and acoustic properties for five years or more (claim 9).
However, as noted above for claim 1, Shikinami discloses molar ratio of NCO/OH being 0.77 and % w/w of XDI being 15%, which are within the disclosed respective range of the original specification of the instant application for 1) the elastomeric material being capable of retaining its mechanical and acoustic properties for five years or more, and 2) the elastomeric material does not substantially degrade via dehydration or require maintenance to retain its mechanical and acoustic properties for five years or more (see [00015], [00020], [00031]-[00041] of the specification of the instant application). Therefore, Shikinami’s molar ratio of NCO/OH being 0.77 and % w/w of XDI being 15%, which are within the disclosed respective range of the original specification of the instant application, would inherently allow 1) Shikinami’s elastomeric material being capable of retaining its mechanical and acoustic properties for five years or more, and 2) Shikinami’s elastomeric material does not substantially degrade via dehydration or require maintenance to retain its mechanical and acoustic properties for five years or more.
Regarding claim 10, Shikinami discloses all limitations of claim 1, as discussed above, and Shikinami further discloses:
wherein the surface of the one or more receiving bodies is a surface or a structural material undergoing non-destructive testing (Col 13, lines 18-31: coupler for inspection of thyroid gland or carotid artery (neck)).
Regarding claims 11-12, Shikinami discloses all limitations of claim 1, as discussed above, and Shikinami further discloses:
wherein the surface of the one or more receiving bodies is a surface of an anatomical region of a human body, including at least one of an arm, a leg, a torso, a pelvis, a back, a shoulder, a neck, a head, an abdomen, a chest, a knee, an elbow, a foot, an ankle, a hand, a wrist, a finger, or a toe (Col 13, lines 18-31: coupler for inspection of thyroid gland or carotid artery (neck)).
Regarding claim 13, Shikinami discloses all limitations of claim 1, as discussed above, and Shikinami further discloses:
wherein the elastomeric material is capable of being temporarily affixed to the surface of the one or more receiving bodies, a surface of the at least one acoustic signal transducer, or both the surface of the one or more receiving bodies and the surface of the at least one acoustic signal transducer, using a mechanical joining mechanism (Col 13, lines 32-39: coupler is easily fixed to a probe by inserting the probe into socket 2 of coupler of polyurethane) or an adhesive material (Col 14, lines 31-33: elastic gel coupler exhibits adhesive properties on its surface and comes into intimate contact with skin surface).
Regarding claim 14, Shikinami discloses all limitations of claim 1, as discussed above, and Shikinami further discloses:
wherein the elastomeric material of the acoustic coupling article is capable of being permanently affixed to a surface of the at least one acoustic signal transducer using a mechanical joining mechanism (Col 13, lines 32-39: coupler is easily fixed to a probe by inserting the probe into socket 2 of coupler of polyurethane) or an adhesive material (Col 14, lines 31-33: elastic gel coupler exhibits adhesive properties on its surface and comes into intimate contact with skin surface).
Regarding claim 20, Shikinami discloses all limitations of claim 1, as discussed above, and Shikinami does not explicitly disclose:
wherein the elastomeric material is optically transparent or semi-transparent.
However, as noted above for claim 1, Shikinami discloses molar ratio of NCO/OH being 0.77 and % w/w of XDI being 15%, which are within the disclosed respective range of the original specification of the instant application for the elastomeric material to be optically transparent or semi-transparent (see [00015], [00020], [00031]-[00041] of the specification of the instant application). Therefore, Shikinami’s molar ratio of NCO/OH being 0.77 and % w/w of XDI being 15%, which are within the disclosed respective range of the original specification of the instant application, would inherently be optically transparent or semi-transparent.
Regarding claim 29, Shikinami discloses a composition for acoustically transmitting signals, the composition comprising:
a selected ratio of polymerizable materials including isocynate prepolymers and polyols (Col 15, lines 1-14: polyether polyol and a mixture of propylene glycol and glycerin), the selected ratio producing an NCO:OH molar ratio between about 0.8 and about 2.0 (Col 15, lines 1-14: OH/NCO ratio is 1.3, or NCO/OH molar ratio is 1/1.3 ≈ 0.77); and
a pre-mixture plasticizer having a % w/w relative to the composition of between about 10% and about 60% (Col 15, lines 1-14: mixture of propylene glycol and glycerin reacted with XDI (xylylene diisocyanate, plasticizer), the (AO, or alkylene oxide)/XDI weight ratio is 6.5, or % w/w of XDI is (1/6.5)*100% ≈ 15%).
First, the original specification of the instant application explicitly discloses in [00051] that the term “about” includes “plus or minus 5 units (e.g., percentage) of the stated value”. Therefore, the limitation “the selected ratio producing an NCO:OH molar ratio between about 0.8 and about 2.0” actually includes an NCO:OH molar ratio ranging from 0.76 to 2.1, which is within 5% from 0.8 and 2.0, respectively. Thus, the limitation is anticipated by Shikinami’s NCO/OH molar ratio of 0.77, which is within the range of 0.76 and 2.1.
Second, the original specification of the instant application also discloses in [00019] (“phenyl, biphenyl, terphenyl, toluene, xylene, and other alkylbenzenes may be incorporated to provide a high mobility external plasticizer within the elastomer”) that the claimed plasticizer includes xylene. Thus, the claimed plasticizer is anticipated by Shikinami’s 2,4-toluylene (or xylene) diisocyanate.
Third, Shikinami does not explicitly disclose the limitation “wherein the selected ratio of polymerizable materials, and/or a selected ratio of the polymerizable materials relative to one another and/or to the pre-mixture plasticizer, provide for modulating a Shore Hardness at or under about Shore A50 while maintaining an acoustic attenuation factor of about 3.0 dB/MHz-cm or less”. However, a review of the specification of the instant application discloses that the NCO/OH molar ratio between 0.5 and 2 and a % w/w of plasticizer between 12.73 and 48.94 results in a Shore Hardness at or under about Shore A50 and providing an acoustic attenuation factor of about 3.0 dB/MHz-cm or less (see [00015], [00020], [00031]-[00041] of the specification of the instant application). Thus, Shikinami’s molar ratio of NCO/OH being 0.77 and % w/w of XDI being 15%, which are within the disclosed respective range of the original specification of the instant application, would inherently have a Shore Hardness at or under about Shore A50 while maintaining an acoustic attenuation factor of 3.0 dB/MHz-cm or less.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 15-19 and 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Shikinami, as applied to claim 1 above, and further in view of Wagner et al. (US PG Pub No. 2019/0099157) – hereinafter referred to as Wagner.
Regarding claims 15-17, Shikinami discloses all limitations of claim 1, as discussed above, and Shikinami does not disclose:
wherein the elastomeric material of the acoustic coupling article is capable of being acoustically coupled to the surface of the one or more receiving bodies, a surface of the at least one acoustic signal transducer, or both the surface of the one or more receiving bodies and the surface of the at least one acoustic signal transducer, using a couplant (claims 15-17);
wherein the couplant is an aqueous couplant (claims 16-17); and
wherein the aqueous couplant comprises one or more of an acoustic gel, water, saline solution, or a hydrogel (claim 17).
In the same field of acoustic coupling using polyurethane, Wagner, however, teaches:
an elastomeric material that is acoustically coupled to the surface of the one or more receiving bodies, a surface of the at least one acoustic signal transducer, or both the surface of the one or more receiving bodies and the surface of the at least one acoustic signal transducer, using a couplant (Fig. 2C: substrate layer 120 of polyurethane coupled to hydrophilic layer 130; [0028]: hydrophilic layer 130 activated using water for coupling with ultrasound transducer);
wherein the couplant is an aqueous couplant (Fig. 2C: hydrophilic layer 130; [0029]: hydrophilic layer 130 activated by water); and
wherein the aqueous couplant comprises one or more of an acoustic gel, water, saline solution, or a hydrogel (Fig. 2C: hydrophilic layer 130; [0029]: hydrophilic layer 130 activated by water).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shikinami’s elastomeric material to include Wagner’s aqueous couplant. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., addition of a couplant to a layer of polyurethane, as disclosed by Wagner), and the combination would have yielded a reasonable expectation of success since both Shikinami and Wagner are directed to acoustic coupling using polyurethane. The motivation for the combination would have been “to provide the requisite acoustic coupling interface between transducer 110 and patient 105”, as taught by Wagner ([0012]), only at the time of ultrasound imaging to preserve the shelf life of the elastomeric material.
Regarding claims 18-19, Shikinami discloses all limitations of claim 1, as discussed above, and Shikinami does not disclose:
wherein the elastomeric material of the acoustic coupling article is capable of being acoustically coupled to the surface of the one or more receiving bodies, a surface of the at least one acoustic signal transducer, or both the surface of the one or more receiving bodies and the surface of the at least one acoustic signal transducer, using a non-aqueous couplant (claims 18-19); and
wherein the non-aqueous couplant comprises one or more of a synthetic lubricant, a silicone-based lubricant, a mineral oil, or a petroleum-based lubricant (claim 19).
In the same field of acoustic coupling using polyurethane, Wagner, however, teaches:
an elastomeric material that is acoustically coupled to the surface of the one or more receiving bodies, a surface of the at least one acoustic signal transducer, or both the surface of the one or more receiving bodies and the surface of the at least one acoustic signal transducer, using a non-aqueous couplant (Fig. 2C: substrate layer 120 of polyurethane coupled to adhesive layer 125; [0028]: adhesive layer 125 to be applied to transducer or patient); and
wherein the non-aqueous couplant comprises one or more of a synthetic lubricant, a silicone-based lubricant, a mineral oil, or a petroleum-based lubricant ([0016]-[0017]: adhesive layer 125 of silicone-based or synthetic rubber-based adhesive).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shikinami’s elastomeric material to include Wagner’s non-aqueous couplant. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., addition of a couplant to a layer of polyurethane, as disclosed by Wagner), and the combination would have yielded a reasonable expectation of success since both Shikinami and Wagner are directed to acoustic coupling using polyurethane. The motivation for the combination would have been to provide “An adhesive (between the ultrasound transducer and the elastomeric material) having a higher removal force may be desirable in some circumstances, such as where slippage of the pad during use is a concern”, as taught by Wagner ([0017]).
Regarding claim 21, Shikinami discloses all limitations of claim 1, as discussed above, and Shikinami does not disclose:
wherein a surface of the elastomeric material is adhesively bonded to at least one of a silicone rubber, a polyurethane rubber, or a semi-rigid thermoplastic, and
wherein the at least one of the silicon rubber, the polyurethane rubber, or the semi-rigid thermoplastic are optionally applied to a silane-based surface primer on the surface of the elastomeric material, thereby forming a multi-layered acoustic coupling article.
In the same field of acoustic coupling using polyurethane, Wagner, however, teaches:
a surface of an elastomeric material that is adhesively bonded to at least one of a silicone rubber, a polyurethane rubber, or a semi-rigid thermoplastic (Fig. 2C: substrate layer 120 of polyurethane coupled to adhesive layer 125; [0016]-[0017]: adhesive layer 125 of silicone-based or synthetic rubber-based adhesive).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shikinami’s elastomeric material to include Wagner’s adhesive. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., addition of an adhesive to a layer of polyurethane, as disclosed by Wagner), and the combination would have yielded a reasonable expectation of success since both Shikinami and Wagner are directed to acoustic coupling using polyurethane. The motivation for the combination would have been to provide “An adhesive (between the ultrasound transducer and the elastomeric material) having a higher removal force may be desirable in some circumstances, such as where slippage of the pad during use is a concern”, as taught by Wagner ([0017]).
Regarding claim 22, Shikinami in view of Wagner discloses all limitations of claim 21, as discussed above, and Wagner further teaches (also see claim 21 above):
wherein the multi-layered acoustic coupling article (Fig. 2C) is capable of being temporarily affixed to the surface of the one or more receiving bodies, a surface of the at least one acoustic signal transducer, or both the surface of the one or more receiving bodies and the surface of the at least one acoustic signal transducer, using a mechanical joining mechanism or an adhesive material (Fig. 1C, 2C and [0028]: adhesive layer 125 to be applied to transducer or patient).
Regarding claim 23, Shikinami in view of Wagner discloses all limitations of claim 21, as discussed above, and Wagner further teaches (also see claim 21 above):
wherein the multi-layered acoustic coupling article (Fig. 2C) is capable of being permanently affixed to a surface of the at least one acoustic signal transducer using a mechanical joining mechanism or an adhesive material (Fig. 1C, 2C and [0028]: adhesive layer 125 to be applied to transducer).
Regarding claim 24, Shikinami in view of Wagner discloses all limitations of claim 21, as discussed above, and Shikinami does not disclose:
wherein the multi-layered acoustic coupling article is capable of being acoustically coupled to the surface of the one or more receiving bodies, a surface of the at least one acoustic signal transducer, or both the surface of the one or more receiving bodies and the surface of the at least one acoustic signal transducer, using an aqueous couplant.
In the same field of acoustic coupling using polyurethane, Wagner, however, teaches:
a multi-layered acoustic coupling article that is acoustically coupled to the surface of the one or more receiving bodies, a surface of the at least one acoustic signal transducer, or both the surface of the one or more receiving bodies and the surface of the at least one acoustic signal transducer, using an aqueous couplant (Fig. 2C: substrate layer 120 of polyurethane coupled to hydrophilic layer 130; [0028]: hydrophilic layer 130 activated using water for coupling with ultrasound transducer).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shikinami’s elastomeric material to include Wagner’s aqueous couplant. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., addition of a couplant to a layer of polyurethane, as disclosed by Wagner), and the combination would have yielded a reasonable expectation of success since both Shikinami and Wagner are directed to acoustic coupling using polyurethane. The motivation for the combination would have been “to provide the requisite acoustic coupling interface between transducer 110 and patient 105”, as taught by Wagner ([0012]), only at the time of ultrasound imaging to preserve the shelf life of the elastomeric material.
Regarding claim 25, Shikinami in view of Wagner discloses all limitations of claim 21, as discussed above, and Wagner further teaches (also see claim 21 above):
wherein the multi-layered acoustic coupling article is capable of being acoustically coupled to the surface of the one or more receiving bodies, a surface of the at least one acoustic signal transducer, or both the surface of the one or more receiving bodies and the surface of the at least one acoustic signal transducer, using a non-aqueous couplant (Fig. 2C: substrate layer 120 of polyurethane coupled to adhesive layer 125; [0016]-[0017]: adhesive layer 125 of silicone-based or synthetic rubber-based adhesive; [0028]: adhesive layer 125 to be applied to transducer or patient).
Regarding claim 26, Shikinami in view of Wagner discloses all limitations of claim 21, as discussed above, and Shikinami further discloses:
wherein the surface of the one or more receiving bodies is a surface of an anatomical region of a human body (Col 13, lines 18-31: coupler for inspection of thyroid gland or carotid artery (neck)).
Regarding claim 27, Shikinami in view of Wagner discloses all limitations of claim 21, as discussed above, and Shikinami further discloses:
wherein the surface of the one or more receiving bodies is a surface or a structural material undergoing non-destructive testing (Col 13, lines 18-31: coupler for inspection of thyroid gland or carotid artery (neck)).
Regarding claim 28, Shikinami in view of Wagner discloses all limitations of claim 21, as discussed above, and Shikinami does not explicitly disclose:
wherein the elastomeric material of the acoustic coupling article is optically transparent or semi-transparent.
However, as noted above for claim 1, Shikinami discloses a molar ratio of NCO/OH being 0.77 and % w/w of XDI being 15%, which are within the disclosed respective range of the original specification of the instant application, for the elastomeric material to be optically transparent or semi-transparent (see [00015], [00020], [00031]-[00041] of the specification of the instant application). Therefore, Shikinami’s molar ratio of NCO/OH being 0.77 and % w/w of XDI being 15%, which are within the disclosed respective range of the original specification of the instant application, would inherently, would inherently be optically transparent or semi-transparent.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Y.C./Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
6/25/26
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