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 .
Election/Restrictions
Claims 22-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention of Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/30/2026.
Applicant’s election without traverse of invention of Group I (claims 1-21) in the reply filed on 04/30/2026 is acknowledged.
Claim Rejections - 35 USC § 112
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.
Claims 6-9, 12-14, 16, and 21 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 6 recites the limitation "wherein the conductive composite is arranged on a network fiber layer comprising a fiber of the self-healing polymer" in lines 1-2. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner how the network fiber layer can comprise the same fiber of the self-healing polymer which comprises the conductive composite. It is unclear to Examiner if Applicant intended to recite that the conductive composite is arranged on a distinct layer, the claimed network fiber layer. If so, the scope of the claim limitation is indefinite because the self-healing polymer and any of its constituents that form the self-healing polymer such as the claimed fiber is already part of the conductive composite (see claim 1: “a conductive composite comprising a self-healing polymer and liquid metal”). Therefore, it is unclear whether the network fiber layer is part of the self-healing polymer or a distinct network fiber layer other than the self-healing polymer. For Examination purposes, Examiner will interpret the claim as the conductive composite comprises a self-healing polymer, wherein the conductive component is arranged on a separate/ distinct network fiber layer, wherein where the network fiber layer is formed from the same/different material which forms the self-healing polymer. Claims 10-14 are also rejected because they are dependent on claim 6.
Claim 7 recites the limitation "the network fiber layer" in line 1. There is insufficient antecedent basis for this limitation in the claim. For Examination purposes, Examiner will interpret claim 7 as being dependent on claim 6.
Claim 8 recites the limitation "the network fiber layer" in line 2. There is insufficient antecedent basis for this limitation in the claim. For Examination purposes, Examiner will interpret claim 7 as being dependent on claim 6.
Claim 9 recites the limitation "the fiber layer" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret the fiber layer as the network fiber layer described in claim 8.
Claim 12 recites the limitation "the hydrogel" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the hydrogel" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the hydrogel" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the polymer main chain" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "cardiac tissue of human or animal" in lines 1-2. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this human or animal is different from the human or animal already cited in the dependent claim 20, or if they are the same. For examination purposes, Examiner will treat both human/animal as the same human/animal on recited in claim 20.
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.
Claims 1-3, 5, 15-16, 18, and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bao (U.S. Application No. 20190110363 A1).
Regarding independent claim 1, Bao discloses a device (140) for measuring biosignals and electrical stimulation (pa. 0005-0006), the device comprising a conductive composite comprising a self-healing polymer (lower layer of self-healing and flexible polymer film) and liquid metal (conductive lines layer) (pa. 0046, 0055 & Fig. 1D).
Regarding claim 2, Bao discloses wherein the liquid metal is a eutectic alloy (pa. 0046).
Regarding claim 3, Bao discloses wherein the liquid metal comprises one or more selected from the group consisting of eutectic gallium-indium alloy, eutectic gallium-tin alloy, eutectic gallium-indium-tin alloy, and gallium (pa. 0046).
Regarding claim 5, Bao discloses wherein the liquid metal is dispersed within the conductive composite (pa. 0009, 0100).
Examiner is interpreting the term “dispersed” as the ability of the liquid metal to contact/bond with the self-healing polymer of the conductive composite in order to create an end product that is able to effectively deliver electrical stimulation within the desired range of biological tissues and receive corresponding biological electrical signals.
Regarding claim 15, Bao discloses wherein the self-healing polymer comprises a polymer main chain, a first structural unit containing -HN-C(=O)-NH- capable of forming a strong hydrogen bond, and a second structural unit containing -HN-C(=O)-NH- capable of forming a weak hydrogen bond (pa. 0006 & Fig. 4G).
Regarding claim 16, Bao discloses wherein the polymer main chain comprises at least one selected from polysiloxane and polydialkylsiloxane (where alkyl is C1 to C6), such as polydimethylsiloxane, polyethylene oxide (PEO), polypropylene oxide (PPO), polybutylene oxide (PBO), perfluoropolyether (PFPE), polyolefin, poly(ethylene-co-1-butylene), polybutadiene, hydrogenated polybutadiene, poly(ethylene oxide)-poly(propylene oxide) copolymer, poly(hydroxyalkanoate), styrene-butadiene copolymer (SB), styrene-butadiene-styrene copolymer (SBS), styrene-ethylene-butylene-styrene copolymer (SEBS), ethylene propylene diene rubber (EPDR), acrylic rubber, polychloroprene rubber, polyurethane, fluoro-rubber, butyl rubber, or silicone rubber (pa. 0006).
Regarding claim 18, Bao discloses wherein the second structural unit is represented by Formula 2-1:
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where a is an integer from 5 to 20. See Fig. 4G of Bao which shows 5 carbons between the HN bonds.
Regarding claim 20, Bao discloses wherein the biosignal is a biosignal of human or animal tissue (pa. 0009).
Regarding claim 21, Bao discloses wherein the biosignal is a biosignal of cardiac tissue of human or animal.
It is noted that the recitation of “wherein the biosignal is a biosignal of cardiac tissue” is regarded as a functional recitation of the intended use of the conductive composite. It has been held that a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the conductive composite of Bao readily provides for such functionality of sensing a biosignal (i.e., temperature) of any tissue including cardiac tissue (pa. 0009).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bao as applied to claim 1 above, and further in view of Chu (E.P. Application No. 3330327 A1).
Regarding claim 4, Bao discloses the self-healing polymer can be a polydimethylsiloxane (PDMS) material (pa. 0006).
However, Bao does not disclose wherein the liquid metal is 82 to 88 wt% in content based on a total weight of the conductive composite as 100 wt%.
Chu, in the same field of endeavor, teaches a paste (100) which includes a plurality of liquid metal particles LM10 and a polymer binder PB 10 that is mixed with the plurality of liquid metal particles LM10 (pa. 0051), wherein the liquid metal particles ML10 are an eutectic gallium-indium alloy (pa. 0053) and the polymer binder PB 10 is a polydimethylsiloxane (PDMS) (pa. 0056).
The content (weight percent (wt%)) of the plurality of liquid metal particles LM10 in the paste is greater than the content (wt%) of the polymer binder PB10. For example, the content of the plurality of liquid metal particles LM10 with respect to a total weight of the plurality of liquid metal particles LM10 and the polymer binder PB10 is in the range from about 80 wt% to about 90 wt% (pa. 0052).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the weight percent of the liquid metal and the self-healing polymer of the conductive composite of Bao to be in the range taught by Chu for the purpose of creating a proper balance between the conductivity and flexibility of the composite.
Claims 6-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bao as applied to claim 1 above, and further in view of Martin (E.P. Application No. 4091639 A1).
Regarding claims 6-7, as best understood, Bao discloses a upper layer of self-healing and flexible polymer film arranged on/coupled to the conductive composite (see Fig. 1D)
However, Bao does not disclose wherein the upper layer of self-healing and flexible polymer film comprises a network fiber layer comprising a fiber of the self-healing polymer.
As discussed in the pending 112(b) rejection above, Examiner will be interpreting the claim language as the conductive composite comprises a self-healing polymer, wherein the conductive component is arranged on a separate/ distinct network fiber layer, wherein where the network fiber layer is formed from the same/different material which forms the self-healing polymer.
Martin, in the same field of endeavor, teaches a nanostructure component comprising any suitable form including fibers, filaments, mesh sections, branched filaments or networks, sheets, or shaped particles (pa. 0124). The nanostructure has self-healing polymers (pa. 0071) and is fabricated via electrospinning technique, wherein the process of electrospinning involves the introduction of a liquid into an electric field, so that the liquid is caused to produce fibers. These fibers are generally drawn to a conductor at an attractive electrical potential for collection. During the conversion of the liquid into fibers, the fibers harden and/or dry (pa. 0128). The process of electrostatic spinning is directed toward the use of the fibers to create a mat or other non-woven material for biomedical applications (pa. 0129).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the manufacturing method of the upper layer of self-healing and flexible polymer film of Bao to be fabricated using the electrospinning technique, thereby creating a network fiber layer, as taught by Martin, for the purpose of creating a mat or other non-woven material well-suited for biomedical applications (Martin, pa. 0129).
Regarding claim 8, as best understood, Bao discloses the invention substantially as claimed in claims 1 and 6 discussed above.
However, Bao does not disclose further comprising a hydrogel coating layer formed by coating hydrogel on the network fiber layer and the conductive composite.
Examiner will be interpreting “coating” as a layer or film of material applied to the surface of an object/another material via chemical or mechanical methods.
In this case, the Martin reference teaches a composite material comprising a hydrogel and a nanostructure for use in methods for reconstruction of soft tissue (pa. 0051), wherein the hydrogel/nanostructure composite can be coated on non-biological structures or devices to be used in surgery or otherwise for in vivo implantation, such as surgical instruments (pa. 0118, 0161).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added to the composite material comprising the hydrogel material, as taught by Martin to be coated on the conductive composite, including the network fiber layer of Bao for the purpose of providing a non-allergenic barrier between the conductive composite and living tissue, and aid in mechanical sensing and bio-detection (Martin, pa. 0161-0162).
Regarding claim 9, as best understood, Bao discloses the invention substantially as claimed in claims 1 and 8 discussed above.
However, Bao does not disclose wherein the hydrogel is infiltrated into the fiber layer.
Examiner will be interpreting “infiltrated” as physically/chemically penetrating/contacting a material via a physical or chemical bonding process.
In this case, the Martin reference teaches the composite material comprising a hydrogel and a nanostructure for use in methods for reconstruction of soft tissue (pa. 0051). It is advantageous to render the hydrogel composition to be electrically conductive for use in biomedical electrodes and other electrotherapy contexts, i.e., to attach an electrode or other electrically conductive member to the body surface. These applications involve modification of the hydrogel composition so as to contain a conductive species, such as ionically conductive electrolytes, particularly those that are normally used in the manufacture of conductive adhesives used for application to the skin or other body surface (pa. 0118).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added to the composite material comprising the hydrogel material, as taught by Martin to be coated/bonded/infiltrated into the network fiber layer of Bao for the purpose of providing a non-allergenic barrier between the conductive composite and living tissue, and aid in mechanical sensing and bio-detection (Martin, pa. 0161-0162).
Examiner is interpreting the physical bond of the hydrogel composition when it is coated on the upper layer of the self-healing and flexible polymer film of Bao, previously modified to be a network fiber layer, as an infiltration due to the conductive adhesives reacting/bonding with the network fiber layer.
Regarding claim 10, Bao discloses the invention substantially as claimed in claims 1 and 6 discussed above.
However, Bao does not disclose wherein the network fiber layer is porous.
Martin, in the same field of endeavor, teaches a biodegradable composite (100) which includes a nanofiber (101) reinforced gel (103). The gel includes any suitable material, such as hydrogel, and the nanofibers is made of any suitable nanomaterial. The composite includes high porosity (e.g., to mediate cell adhesion and migration) while maintaining sufficient mechanical properties (pa. 0167 & Figs. 1A-1D).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the network fiber layer of Bao to be porous as taught by Martin for the purpose of aiding in cell adhesion and migration (Martin, pa. 0167).
Regarding claim 11, Bao discloses the invention substantially as claimed in claims 1 and 6 discussed above.
However, Bao does not disclose wherein the network fiber layer comprises a fiber with a diameter of 4.5 to 6.5 μm and a pore with a diameter of 50 to 70 μm.
Martin, in the same field of endeavor, teaches a polymeric fiber, generally having a diameter of 100nm (0.1 μm) to 8,000nm (8 μm) and a pore size of 1 μm to 100 μm (pa. 0065).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the network fiber layer to have a specific fiber diameter and pore size, as taught by Martin for the purpose of aiding in cell adhesion and migration (Martin, pa. 0167).
Regarding claim 12, Bao discloses the invention substantially as claimed in claims 1 and 6 discussed above.
However, Bao does not disclose wherein the hydrogel penetrate less than 60% of the thickness of the network fiber layer from a contact surface with the network fiber layer.
Martin, in the same field of endeavor, teaches the composite material comprising a hydrogel and a nanostructure for use in methods for reconstruction of soft tissue (pa. 0051), wherein the hydrogel/nanostructure composite can be coated on non-biological structures or devices to be used in surgery or otherwise for in vivo implantation, such as surgical instruments (pa. 0118, 0161).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added to the composite material comprising the hydrogel material, as taught by Martin to be coated on the conductive composite, including the network fiber layer of Bao for the purpose of providing a non-allergenic barrier between the conductive composite and living tissue, and aid in mechanical sensing and bio-detection (Martin, pa. 0161-0162).
Examiner is interpreting the hydrogel as penetrating less than 60% of the thickness given that it is only coated on the network fiber layer and it is not explicitly described as penetrating too deeply from a top surface layer of the network fiber layer.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bao and Martin as applied to claims 1 and 6 above, and further in view of Bettinger (U.S. Application No. 20170156621 A).
Regarding claim 13, Bao/Martin combination disclose the invention substantially as claimed in claims 1 and 6 discussed above.
However, they do not teach wherein the hydrogel is a catechol conjugated polymer.
Bettinger, in the same field of endeavor, teaches a hydrogel having adhesion-promoting features, such as moieties comprising one or more catechol groups (pa. 0005, 0035). The hydrogel includes a dopamine methacrylamide monomer, wherein the dopamine methacrylate (DMA) monomers are copolymerized with poly(2-hydroxyethyl methacrylate) (HEMA) hydrogels and poly(ethyl glycol) dimethacrylate crosslinker to form P(HEMA-co-DMA) hydrogels (pa. 0006, 0036).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the hydrogel with the hydrogel that contains a catechol conjugated polymer, as taught by Bettinger, for the purpose of providing a conformable substrate with excellent adhesion-promoting features.
Regarding claim 14, Bao/Martin combination disclose the invention substantially as claimed in claims 1 and 6 discussed above.
However, they do not teach wherein the hydrogel undergoes hydrogen bonding or hydrophobic interactions with tissue.
Bettinger, in the same field of endeavor, teaches catechols bond to inorganic/organic materials in hydrated environments through polarizable aromatic groups, hydrogen bonds, and coordination bonds (pa. 0035).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the hydrogel with the hydrogel that contains a catechol conjugated polymer, as taught by Bettinger, for the purpose of providing a conformable substrate with excellent adhesion-promoting features.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Bao as applied to claim 1 above, and further in view of Seo (K.R Application No. 102118200 B1).
Regarding claim 17, Bao discloses the invention substantially as claimed in claims 1 and 15 discussed above.
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However, Bao does not disclose wherein the first structural unit is represented by Formula 1:
where Ar is a substituted or unsubstituted arylene group of C6 to C30 or a planar heteroarylene group of C3 to C30.
Seo, in the same field of endeavor, teaches a polymer of a self-recovering monomer having a first polymerizable functional group and a plurality of side chains having a main chain and at least one urethane group, urea group, or amide group suspended from the main chain. The polymer is a self-healing polymer network having a repeating unit represented by the following formula (3):
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where R b is a substituted or unsubstituted C1 to C10 arylene group (see abstract and claims under pages 1-2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the substituted or unsubstituted C1 to C10 arylene group to the first structural unit of Bao for the purpose of providing a self-healing polymer with superior mechanical strength, enable reversible pi to pie stacking to drive dynamic healing, and improve overall thermal stability and environmental resistance.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Bao as applied to claim 1 above, and further in view of Xiamen (C.N Application No. 111171365 A).
Regarding claim 19, Bao discloses the invention substantially as claimed in claims 1 and 15 discussed above.
However, Bao does not disclose wherein the second structural unit is represented by Formula 2-2:
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where Cy is a substituted or unsubstituted cyclic alkylene group of C5 to C30, and b is an integer of 1 or 3.
Xiamen, in the same field of endeavor, teaches a polymer molecular chain/supramolecular chain topology which includes, but are not limited to, linear, cyclic, branched, clustered, cross-linked, and combinations thereof (page 5, lines 36-37), wherein in one embodiment, a compound raw material may be selected from a compound containing no more preferably a dynamic alkylene (page 399, second to last paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the cyclic alkylene group to C5 to C30 to the second structural unit of Bao for the purpose of providing a self-healing polymer with dynamic hydrogen bonds that quickly disassociate, migrate, and reform.
Conclusion
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/A.V.G./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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