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 .
Restriction/Election
Applicants’ election of claims 1, 3, 5-20, 55-56 drawn to Group I in the reply filed on 09/17/2026 is acknowledged. Because applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 31 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/17/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: figure 5B does not include the following reference sign(s) “140” mentioned in the description in page 11 lines 8-9.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "126" (see instant application specification page 11 line 4) and "124" (see instant application specification page 11 line 5) have both been used to designate “spring end”.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, claim 20, and claim 56 “interconnection locations” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“…Optionally, the microneedles 128 may be bioabsorbable, e.g., such that, when the device 120 is removed after treating a patient, the microneedles 128 may separate from the device 120 and remain in the tissue, which may be minimize damage to the heart 90 during removal.…” in page 11 lines 21-24 needs to be corrected. A suggested correction is --Optionally, the microneedles 128 may be bioabsorbable, e.g., such that, when the device 120 is removed after treating a patient, the microneedles 128 may separate from the device 120 and remain in the tissue, which may [[be]] minimize damage to the heart 90 during removal.--.
Appropriate correction is required.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 55 line 8 “ventricular growth” needs to be corrected. A suggested correction is – the ventricular growth – in light of its antecedent in claim 55 line 1 “ventricular growth”.
Claim 56 line 8 “ventricular growth” needs to be corrected. A suggested correction is – the ventricular growth – in light of its antecedent in claim 56 line 1 “ventricular growth”.
Claim 9 “wherein the loops of respective springs lie within a plane such that springs define an inner surface configured to enhance engagement with contacted tissue” needs to be corrected. A suggested correction is wherein the loops of respective springs lie within a plane [[such]] in a manner that springs define an inner surface configured to enhance engagement with contacted tissue —to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “such that” necessarily follows from preceding limitations and thus unclear as to whether this limitation is even required or not required.
Claim 15 “wherein the constraints are bioabsorbable such that, when the constraints dissolve, they release the constrained spring members to apply the stored potential energy to generate additional strain to the epicardium” needs ton be corrected. A suggested correction is --wherein the constraints are bioabsorbable [[such]] in a manner that, [[when]] upon the constraints [[dissolve]] dissolving, they release the constrained spring members to apply the stored potential energy to generate additional strain to the epicardium-- to [a] avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “such that” necessarily follows from preceding limitations and thus unclear as to whether this limitation is even required or not required; [b] to avoid conditional/contingent limitation recitation which would raise question as to whether the limitations resulting from the conditional clause is even required (see MPEP 2111.04) and also raises question as to what occurs when the condition is not met.
Appropriate correction is required.
Claim Rejections - 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.
Claims 1, 3, 5-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 in line 1 recites “other cardiac growth” which renders the claim unclear. More specifically, it is unclear as to what is encompassed by the term “other cardiac growth” which also renders the claim scope unclear.
Each of claim 9 and 18 recite “tissue” which renders each of these claim unclear in light of claim 1 which recites “a patient's heart” “epicardium” “ventricular growth” and/or “other cardiac growth”. More specifically, it is unclear as to claim 9 and 18 “tissue” is referencing which of the preceding tissue recited in claim 1 “a patient's heart” “epicardium” “ventricular growth” and/or “other cardiac growth”. Additionally, it is unclear as to what is encompassed by the term “other cardiac growth” which also renders the claim scope unclear.
Dependent claims 3, 5-20 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 3, 5-20 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed page 6 line 6 through page 7 line 8 and page 12 lines 9-24.
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5-12, 14, 16-18 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Lau et al. (Pub. No.: US 20090156892 A1, hereinafter referred to as “Hong”).
As per independent Claim 1, Hong discloses a device for mechanically induced ventricular and/or other cardiac growth in a patient (Hong in at least abstract, fig. 1-6, 11-13, 15-18, 21-23, 28, [0003], [0011-0013], [0015], [0017-0019], [0054-0065], [0067], [0069-0070], [0082], [0089-0092], [0098-0102], [0105], [0109-0112], [0122], [0127], [0151] for example discloses relevant subject-matter. More pertinently, Hong in at least fig. 1, 5-6, [0055-0057], [0060] for example discloses device/cardiac harness shaped with structural and functional features to perform recited function of inducing ventricular and/or other cardiac growth in a patient. See at least Hong [0055] “a mammalian heart 30 having a cardiac wall stress reduction device in the form of a harness 32 applied to it. The cardiac harness 32 comprises a series of hinges or spring elements 34 that circumscribe the heart 30 and, collectively, apply a mild compressive force on the heart”; [0060] “cardiac harnesses 32, 50 comprise a base portion 52, which is sized and configured to generally engage and fit onto a base region of a patient's heart; an apex portion 56, which is sized and shaped so as to generally engage and fit on an apex region of a patient's heart; and a medial portion 58 between the base and apex portions”. Also, see fig. 18.), comprising:
a body (Hong in at least fig. 1, 5-6 disclose harness having a body), comprising a plurality of spring members coupled together to define an open upper end and a lower end (Hong, in at least fig. 1, 5-6, [0063] “harness 62 disposed upon a simulated heart 30… harness fits circumferentially about the heart”; [0065] “each row or strand 36 of spring hinges 34 is attached to an adjacent row or strand of spring hinges by one or more longitudinally-extending spring hinges 64” ), wherein the spring members surround an interior region of the body sized to receive a portion of a patient's heart (Hong in at least fig. 1, fig. 5, [0060] “cardiac harnesses 32, 50 comprise a base portion 52, which is sized and configured to generally engage and fit onto a base region of a patient's heart; an apex portion 56, which is sized and shaped so as to generally engage and fit on an apex region of a patient's heart; and a medial portion 58 between the base and apex portions”;) and are configured to apply strain to the epicardium of the heart to induce ventricular growth (Hong in at least [0062] “undulating spring elements 34 exert a force … Collectively, the force exerted by the spring elements tends toward compressing the heart… several arrangements and configurations of spring members can be used to create a mildly compressive force on the heart … spring members can be disposed over only a portion of the circumference of the heart or harness.”).
As per dependent Claim 3, Hong further discloses device wherein the spring members are coupled together at their opposite ends in an array to define open regions between the spring members through the body(Hong, fig. 5, fig. 21-22, [0058] “strands 36 of spring elements 34 …adjacent strands 36 interwoven one with another…adjacent strands 36 may not overlay or touch one another”; [0044] “a connective junction where opposing ends of a strand of spring hinges are connected”; [0127] “Each elongate strand is comprised of a series 204 … spring members 34…opposite ends of the elongate strand are bonded together…opposite ends 206 of each circumferentially extending ring 200 are attached to one another by a connective junction 208” Also, see fig. 18), and
wherein the array comprises first and second sets of spring members extending orthogonally relative to one another and interconnected at their opposite ends to define the open regions (Hong in at least fig. 5-6, [0065]. see at least Hong [0065] “each row or strand 36 of spring hinges 34 is attached to an adjacent row or strand of spring hinges by one or more longitudinally-extending spring hinges 64”. Also, see fig. 18).
As per dependent Claim 5, Hong further discloses device wherein the spring members are integrally formed in the body (Hong in at least [0059] “harness 50 is first formed from a relatively thin, flat sheet of material. Any method can be used to form the harness from the flat sheet… etched from a thin sheet of Nitinol, which is a superelastic material that also exhibits shape memory properties.”; [0092] “Each of the spring hinge panels 92 … have been etched from a flat piece of material”).
As per dependent Claim 6, Hong further discloses device wherein the spring members are configured to apply strain in multiple directions along the surface of the heart (Hong in at least [0062] “undulating spring elements 34 exert a force … Collectively, the force exerted by the spring elements tends toward compressing the heart… several arrangements and configurations of spring members can be used to create a mildly compressive force on the heart … spring members can be disposed over only a portion of the circumference of the heart or harness”;[0065] “the arms 42a of the longitudinal hinges 64 are generally longer than those of the circumferential spring hinges 34 and thus are more relaxed and compliant… resistance of the harness 62 to expansion in a longitudinal direction of the heart is considerably less than resistance of the harness to circumferential expansion of the heart.”; [0067] “he apex portion 69 of the harness 62 comprises a plurality of longitudinal spring hinges 64. When the device is installed on a heart 30, as shown in FIG. 7, adjacent spring hinges 64 may overlap one another. However, the spring hinges remain very compliant”;[0076] “spring hinge panel 72 comprises several interconnected rows of spring hinge strands 36. Each strand comprises a series of spring hinges 34 that are configured to expand and contract generally in a transverse direction relative to a longitudinal axis of the harness 70”. Also, see fig. 18).
As per dependent Claim 7, Hong further discloses device wherein the spring members comprise a plurality of sinuous springs (Hong fig. 5-6. Also see fig. 17-18, fig. 28).
As per dependent Claim 8, Hong further discloses device wherein the sinuous springs comprise a plurality of loops extending along an axis between opposite ends of the respective springs (Hong fig. 2, fig. 6. Also see fig. 17-18, fig. 28).
As per dependent Claim 9, Hong further discloses device wherein the loops of respective springs lie within a plane such that springs define an inner surface configured to enhance engagement with contacted tissue (Hong fig. 5-6. Also see fig. 18) .
As per dependent Claim 10, Hong further discloses device wherein each spring is configured to provide an elongation force between ends of the spring to apply the strain to the contacted epicardium (Hong in at least fig. 2, [0062] “undulating spring elements 34 exert a force … Collectively, the force exerted by the spring elements tends toward compressing the heart… several arrangements and configurations of spring members can be used to create a mildly compressive force on the heart … spring members can be disposed over only a portion of the circumference of the heart or harness.”; [0065] “the arms 42a of the longitudinal hinges 64 are generally longer than those of the circumferential spring hinges 34 and thus are more relaxed and compliant… resistance of the harness 62 to expansion in a longitudinal direction of the heart is considerably less than resistance of the harness to circumferential expansion of the heart.”; [0067] “he apex portion 69 of the harness 62 comprises a plurality of longitudinal spring hinges 64. When the device is installed on a heart 30, as shown in FIG. 7, adjacent spring hinges 64 may overlap one another. However, the spring hinges remain very compliant”;[0076] “spring hinge panel 72 comprises several interconnected rows of spring hinge strands 36. Each strand comprises a series of spring hinges 34 that are configured to expand and contract generally in a transverse direction relative to a longitudinal axis of the harness 70”).
As per dependent Claim 11, Hong further discloses device further comprising constraints limiting elongation of at least some of the springs (Hong, fig. 11-13, “a line 98 of suture material”).
As per dependent Claim 12, Hong further discloses device wherein the constraints comprise sutures (Hong, fig. 11-13, “a line 98 of suture material”).
As per dependent Claim 14, Hong further discloses device wherein at least some of the spring members comprise constraints that store potential energy in the spring members (Hong, fig. 2, 11-13, [0023] “a spring hinge in a relaxed position and under tension”; [0057] “cardiac harness 32 … comprises at least one undulating strand 36 comprising a series of spring elements 34 referred to as hinges or spring hinges …Each hinge 34 provides substantially unidirectional elasticity, in that it acts in one direction and does not provide much elasticity in the direction perpendicular to that direction”; [0069] “cardiac harnesses can be constructed and that such embodiments may have varying configurations, sizes, flexibilities, etc. … cardiac harnesses can be constructed from many suitable materials including various metals, fabrics, plastics and braided filaments. Suitable materials also include superelastic materials and materials that exhibit shape memory… constructed of Nitinol. Shape memory polymers can also be employed.”; [0070] “bending stresses are absorbed by the spring members 34 … and are stored in the members as bending energy… bending energy stored within the spring members 34 is at least partially released”; [0089-0090] “a method and apparatus for connecting adjacent panels 92 of a cardiac harness…each of the adjacent spring hinge panels 92 has several strands 36 of spring hinges 34. An eyelet 94 is disposed at an end of each strand, at the side edges 96 of each panel 92…a line 98 of suture material… is threaded through the eyelets 94 in order to connect the adjacent panels 92 to one another… method of holding the suture line 98 together at the crossover points wherein a block 104 of polymer material is heat-molded to the suture 98 line at each crossover point”).
As per dependent Claim 16, Hong further discloses device wherein the constraints comprise sutures (Hong, fig. 11-13, “a line 98 of suture material”).
As per dependent Claim 17, Hong further discloses device wherein each of the spring members comprise a plurality of loops extending along an axis between opposite ends of the respective spring members (Hong fig. 1-2, 5-6, fig. 22, fig. 11-13. Also see fig. 17-18, 28 ), and
wherein the constraints compress at least some of the loops together along the axis to generate the stored potential energy (Here, recited constraints are represented by prior art memory shape material/nitinol harness with panels coupled by suture lines. Hong in at least fig. 11-13, [0069] “cardiac harnesses can be constructed and that such embodiments may have varying configurations, sizes, flexibilities, etc. … cardiac harnesses can be constructed from many suitable materials including various metals, fabrics, plastics and braided filaments. Suitable materials also include superelastic materials and materials that exhibit shape memory… constructed of Nitinol. Shape memory polymers can also be employed.”; [0089-0090] “a method and apparatus for connecting adjacent panels 92 of a cardiac harness…each of the adjacent spring hinge panels 92 has several strands 36 of spring hinges 34. An eyelet 94 is disposed at an end of each strand, at the side edges 96 of each panel 92…a line 98 of suture material… is threaded through the eyelets 94 in order to connect the adjacent panels 92 to one another… method of holding the suture line 98 together at the crossover points wherein a block 104 of polymer material is heat-molded to the suture 98 line at each crossover point”).
As per dependent Claim 18, Hong further discloses device further comprising one or more engagement features (Hong [0069] “cardiac harnesses can be constructed and that such embodiments may have varying configurations, sizes, flexibilities, etc. … cardiac harnesses can be constructed from many suitable materials including various metals, fabrics, plastics and braided filaments. Suitable materials also include superelastic materials and materials that exhibit shape memory… constructed of Nitinol. Shape memory polymers can also be employed.”; [0128] “lengths of the strands, as well as the sizes of the spring members, may be selected according to the intended size of the cardiac harness 220”) extending from the body inwardly to contact tissue received within the interior region (Hong fig. 6, fig. 18, [0128]).
Claims 55-56 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Lau et al. (Pub. No.: US 20050054892 A1, hereinafter referred to as “Lau”).
As per independent Claim 55, Lau discloses a device for mechanically induced ventricular growth in a single ventricle patient (Lau in at least abstract, [0007], [0009-0012], fig. 3-7, 10, 12, 20, 22, [0049], [0051], [0054-0065], [0077], [0087], [0093-0095], [0099-0100] for example discloses relevant subject-matter. More pertinently, Lau in at least fig. 3, [0054] for example discloses a device/cardiac harness 50 shaped with structural and functional features to perform recited function of inducing ventricular growth in a single ventricle patient), comprising:
a body (Lau in at least fig. 3, [0054], cardiac harness 50 has body) comprising an open upper end and a closed lower end (Lau in at least fig. 3, [0054], “harness is configured to circumferentially surround at least a portion of the heart between an apex portion 58 and a base portion 60”), the body formed by a plurality of spring members coupled together at their opposite ends in an array to define open regions between the spring members through the body (Lau in at least fig. 3-4, fig. 7 [0054] “a cardiac harness 50 has several adjacent elastic rows 52 of spring members 54 …adjacent rows preferably are connected to one another by one or more connectors 56…connectors have a length oriented longitudinally relative to the elastic rows so as to create a space between adjacent rows”),
wherein the spring members surround an interior region of the body sized to receive a portion of a patient's heart (Lau in at least fig. 3, [0054] “a cardiac harness 50 has several adjacent elastic rows 52 of spring members 54…harness is configured to circumferentially surround at least a portion of the heart between an apex portion 58 and a base portion 60”) and are configured to apply strain to the epicardium of the heart to induce ventricular growth ( Lau in at least fig. 3, [0056] “elastic rows 52 exert a force…Collectively, the force exerted by the elastic rows tends toward compressing the heart…several arrangements and configurations of elastic rows can be used to create a mildly compressive force on the heart…elastic members 54 can be disposed over only a portion of the circumference of the heart or harness”).
As per independent Claim 56, Lau discloses a device for mechanically induced ventricular growth in a single ventricle patient (Lau in at least abstract, [0007], [0009-0012], fig. 3-7, 10, 12, 20, 22, [0049], [0051], [0054-0065], [0077], [0087], [0093-0095], [0099-0100] for example discloses relevant subject-matter. More pertinently, Lau in at least fig. 3, [0054], [0056] for example discloses a device/cardiac harness 50 shaped with structural and functional features to perform recited function of mechanically inducing ventricular growth in a single ventricle patient), comprising:
a body (Lau in at least fig. 3, [0054], cardiac harness 50 has body) comprising an open upper end and a closed lower end (Lau in at least fig. 3, [0054], “harness is configured to circumferentially surround at least a portion of the heart between an apex portion 58 and a base portion 60”), the body formed by a plurality of spring members coupled together at interconnection locations in an array to define open regions between the spring members through the body(Lau in at least fig. 3-4, fig. 7 [0054] “a cardiac harness 50 has several adjacent elastic rows 52 of spring members 54 …adjacent rows preferably are connected to one another by one or more connectors 56…connectors have a length oriented longitudinally relative to the elastic rows so as to create a space between adjacent rows”);
wherein the spring members surround an interior region of the body sized to receive a portion of a patient's heart (Lau in at least fig. 3, [0054] “a cardiac harness 50 has several adjacent elastic rows 52 of spring members 54…harness is configured to circumferentially surround at least a portion of the heart between an apex portion 58 and a base portion 60”) and are configured to apply strain to the epicardium of the heart to induce ventricular growth (Lau in at least fig. 3, [0056] “elastic rows 52 exert a force…Collectively, the force exerted by the elastic rows tends toward compressing the heart…several arrangements and configurations of elastic rows can be used to create a mildly compressive force on the heart…elastic members 54 can be disposed over only a portion of the circumference of the heart or harness”); and
a plurality of engagement features (Lau, fig. 3, fig. 22, [0054] “adjacent rows preferably are connected to one another by one or more connectors 56”; [0072] “cardiac harness has a plurality of tissue engaging elements 78. Each tissue engaging element includes a surface relief made up of a plurality of protuberances.”; [0077] “a tissue engaging element 78 has surface relief protuberances 80 … tissue-engaging element is located on a connector 56 disposed between adjacent elastic rows 52 … tissue-engaging element 78 is disposed on a connective junction 62 of a harness… tissue-engaging element 78 is disposed on a tube segment 82 at a basal-most ring 72 and at an upper-most portion of a harness…different arrangements of tissue-engaging elements that can be used for a harness … tissue-engaging elements can be used with any cardiac harness having any type of structure.”; [0090] “a tissue engaging element 78 … has several rows of protuberances 130”) extending from an inner surface of the body at the interconnection locations (Lau, fig. 3, fig. 22, [0077] “a tissue engaging element 78 has surface relief protuberances 80 … tissue-engaging element is located on a connector 56 disposed between adjacent elastic rows 52 … tissue-engaging element 78 is disposed on a connective junction 62 of a harness…different arrangements of tissue-engaging elements that can be used …with any cardiac harness having any type of structure”; [0090] “tissue engaging element … has several rows of protuberances 130 having conical surfaces. The conical surface of each protuberance extends from a base 132 at a substrate 134 and terminates in a generally pointed peak 136.”).
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 of this title, 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.
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.
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hong view of Kovalsky et al. (Pub. No.: US 20140222142 A1, hereinafter referred to as “Kovalsky”).
As per dependent Claim 13, Hong discloses device of claim 11 (see claim 11 analysis)
Hong does not explicitly disclose constraints are bioabsorbable.
However, in an analogous cardiac assist device field of endeavor, Kovalsky discloses a cardiac assist device (Kovalsky in at least fig. 52, [0213] for example discloses a cardiac device/prosthetic) wherein the constraints are bioabsorbable (Kovalsky in at least [0213] “In order to provide the first, acute or short-term deployed configuration upon initial deployment … for a period of time thereafter… prosthesis 5200 may include one or more resorbable or biodegradable sutures 5293 attached at … frame 5210 to radially constrain or hold … prosthesis 5200 in the acute configuration temporarily constrains support arms 5206 from fully expanding with resorbable or biodegradable sutures 5293… to prevent damage to the anatomy upon initial deployment and for a short-term thereafter… prosthesis 5200 evolves over time as one or more of the resorbable or biodegradable sutures 5293 are absorbed or degraded…any support arm and/or frame disclosed herein may have an acute configuration and a chronic configuration”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the constraints used in the device for mechanically induced ventricular and/or other cardiac growth in a patient as taught by Hong, such that the constraints are bioabsorbable, as taught by Kovalsky. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of preventing damage to the anatomy upon initial deployment and for a short-term thereafter (Kovalsky, [0213]).
As per dependent Claim 15, Hong discloses device of claim 14 (see claim 14 analysis above).
Hong does not explicitly disclose constraints are bioabsorbable features i.e. constraints are bioabsorbable such that, when the constraints dissolve, they release the constrained spring members to apply the stored potential energy to generate additional strain to the epicardium.
However, in an analogous cardiac assist device field of endeavor, Kovalsky discloses a cardiac assist device (Kovalsky in at least fig. 52, [0213] for example discloses a cardiac device/prosthetic),
wherein the constraints are bioabsorbable such that, when the constraints dissolve, they release the constrained spring members to apply the stored potential energy to generate additional strain to the epicardium (Kovalsky in [0213] for example discloses string constraints 5293 are bioabsorbable such that, when the constraints dissolve, they release the constrained spring members to apply the stored potential energy to generate additional strain to the heart tissue which concept can be extended to recited epicardium. Kovalsky in at least [0213] “In order to provide the first, acute or short-term deployed configuration upon initial deployment… for a period of time thereafter …prosthesis 5200 may include one or more resorbable or biodegradable sutures 5293 … to radially constrain or hold … support arms 5206 and/or frame 5210 to a reduced diameter or a narrower dimension than its fully expanded state. … prosthesis 5200 in the acute configuration temporarily constrains support arms 5206 from fully expanding with resorbable or biodegradable sutures 5293… to prevent damage to the anatomy upon initial deployment and for a short-term thereafter… prosthesis 5200 may include first and second resorbable or biodegradable sutures 5293A, 5293B that radially constrain inner and outer support arms 5288, 5286, respectively, … in order to constrain support arms 5206 to a reduced diameter or dimension when the …prosthesis is in the acute deployed configuration…first and second resorbable or biodegradable sutures 5293A, 5293B may have different dissolution rates in order to provide a more gradual transition to the chronic configuration, or stated another way to permit a more gradual expansion of support arms 5206 and/or frame 5210… … any support arm and/or frame disclosed herein may have an acute configuration and a chronic configuration”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the constraints used in the device for mechanically induced ventricular and/or other cardiac growth in a patient as taught by Hong, such that the constraints are bioabsorbable such that, when the constraints dissolve, they release the constrained spring members to apply the stored potential energy to generate additional strain to the cardiac tissue, as taught by Kovalsky. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of optimizing treatment via modification of prosthetic tension/potential energy by providing a more gradual transition from first acute deployed configuration to the chronic configuration using the resorbable or biodegradable sutures/constraints (Kovalsky, [0213]).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hong view of Lau
As per dependent Claim 19, Hong discloses device of claim 18 (see claim 18 analysis).
Hong does not explicitly disclose engagement features comprise microneedles feature i.e. the one or more engagement features comprise microneedles extending from an inner surface of the body.
However, in an analogous device for mechanically induced cardiac treatment in a patient field of endeavor, Lau discloses a device for mechanically induced ventricular and/or other cardiac growth in a patient (Lau in at least abstract, [0007], [0009-0012], fig. 3-7, 10, 12, 20, 22, [0049], [0051], [0054-0065], [0077], [0087], [0093-0095], [0099-0100] for example discloses relevant subject-matter. More pertinently, Lau in at least fig. 3, [0054], [0056] for example discloses a device/cardiac harness 50 shaped with structural and functional features to perform recited function of mechanically induced ventricular and/or other cardiac growth in a patient)
wherein the one or more engagement features comprise microneedles extending from an inner surface of the body (Lau, fig. 3, fig. 22, [0054] “adjacent rows preferably are connected to one another by one or more connectors 56”; [0072] “cardiac harness has a plurality of tissue engaging elements 78. Each tissue engaging element includes a surface relief made up of a plurality of protuberances.”; [0077] “a tissue engaging element 78 has surface relief protuberances 80 … tissue-engaging element is located on a connector 56 disposed between adjacent elastic rows 52 … tissue-engaging element 78 is disposed on a connective junction 62 of a harness… tissue-engaging element 78 is disposed on a tube segment 82 at a basal-most ring 72 and at an upper-most portion of a harness…different arrangements of tissue-engaging elements that can be used for a harness … tissue-engaging elements can be used with any cardiac harness having any type of structure.”; [0090] “tissue engaging element … has several rows of protuberances 130 having conical surfaces. The conical surface of each protuberance extends from a base 132 at a substrate 134 and terminates in a generally pointed peak 136.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more engagement features device used in the mechanically induced ventricular and/or other cardiac growth in a patient as taught by Hong, in a manner that one or more engagement features comprise microneedles extending from an inner surface of the body, as taught by Lau. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of self-anchoring and holding the harness on the heart in a manner as to resist migration of the harness relative to the heart without the need to substantially penetrate the surface of the heart (Lau, [0002], [0006]).
As per dependent Claim 20, the combination of Hong and Lau as a whole further discloses device wherein the microneedles are provided at interconnection locations where ends of adjacent spring members are attached together (Lau, fig. 3, fig. 22, [0077] “a tissue engaging element 78 has surface relief protuberances 80 … tissue-engaging element is located on a connector 56 disposed between adjacent elastic rows 52 … tissue-engaging element 78 is disposed on a connective junction 62 of a harness…different arrangements of tissue-engaging elements that can be used …with any cardiac harness having any type of structure”; [0090] “tissue engaging element … has several rows of protuberances 130 having conical surfaces. The conical surface of each protuberance extends from a base 132 at a substrate 134 and terminates in a generally pointed peak 136.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
US 3464322 A (at least fig. 9-10).
US 20070213582 A1 (at least [0050] “tensioning element can take various forms. It may be a common suture. For applications where the tension was desired to be temporary, or where body tissue was expected to grow and take over the role of applying the tension, the tensioning line and/or adjustable support pad could be formed from material that is absorbed over time.”).
US 20110257461 A1 (at least fig. 4A, fig. 5-8 ).
US 20030199955 A1 (at least fig. 1-2, 5).
US 20080081944 A1 (at least fig. 1-11, 14-16)
US 20020045799 A1 (at least fig. 1-11, 14-16)
US 20030229265 A1 (at least fig. 4-8)
US 20050102012 A1 (at least fig. 5, 9-15, 17, 35)
US 20210401579 A1 (at least fig. 1-2, 4-5)
US 20060009675 A1 (see at least fig. 3-29)
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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