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
Applicant’s election of 6, 8-19, 44, 45, 49 and 51-54 in the reply filed on 13 June 2026 is acknowledged. Because applicant 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 § 818.01(a)).
Claim Objections
Claims 11, 16 and 53 are objected to because of the following informalities:
Regarding claim 11, in line 2, “bowtie shaped” should be rewritten as “bowtie-shaped”.
Regarding claim 16, in line 4, --and-- should be added before “the angled elements taper”.
Regarding claim 53, in line 2, “has a thickness of about forty micrometers (40um) thickness”, does not need the second “thickness” and can be removed.
Appropriate correction is required.
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, 8-19, 44, 45, 49 and 51-54 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.
Regarding claims 6 and 51, it is unclear what the limitation “a plurality of elongate elements members” means, as “elements members” does not make sense grammatically and may be unintentionally redundant.
Regarding claim 8, it is unclear if “an enclosed lower end” is the same as or different than “a lower end” recited in line 2 of claim 6.
Regarding claim 9, it is unclear what constitutes “anisotropic properties configured to support a right ventricle” in line 2.
Regarding claim 12, it is unclear what constitutes “auxetic properties” in line 2.
Regarding claim 16, it is unclear regarding the structure of the “bowtie-shaped cells”, as well as the “first and second straight elements” and the “first and second angled elements” in the sentence; the “first and second straight elements opposite one another extending orthogonal to the axis and first and second angled elements extending between opposite ends, respectively, of the first and second straight elements the angled elements taper inwardly towards one another at intermediate regions between the opposite ends to define the bow-tie shape”.
Regarding claim 51, line 4 recites the limitation "their ends". There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 53, The term “of about” in “the coating has a thickness of about forty micrometers” is a relative term which renders the claim indefinite. The term “of about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 54, it is unclear what “the electrodes” are referring to since claim 45 recites “one or more electrodes”.
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.
Claims 6, 8, 10, 11, 17, 19, 44, 45, 49, 51 and 54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wildhirt (US 20140194678 A1).
Regarding claim 6, Wildhirt teaches a passive device for supporting a subject’s heart (“implantable heart support system”, paragraph [0006]), comprising:
A sleeve comprising an open upper end and a lower end defining an interior region sized to receive a portion of the heart (“sleeve having an inner surface arranged to contact the heart”, paragraph [0006]; open upper end and a lower end of sleeve 80 in Fig. 3), the sleeve comprising a plurality of elongate elements members coupled together to define a plurality of interconnected cells configured to provide epicardial support of the heart (“the sheath 2…consists of a mesh made of wires…wires form crossing points (intersections), which can be permanently interconnected”, paragraph [0056]).
Regarding claim 8, Wildhirt teaches the sleeve having an enclosed lower end (enclosed lower end shown in Fig. 3) sized to be positioned over an apex of the heart (“sleeve respectively extend along these angles up to the cardiac apex”, paragraph [0089]), wherein the upper end is sized to be received over the epicardium such that the sleeve overlies a right ventricle of the heart (“sleeve…positioned to assist a right ventricle”, paragraph [0095]).
Regarding claim 10, Wildhirt teaches the cells being configured to expand and contract to mimic and replicate normal motion of the heart (“located inside the expandable sheath 2 is at least one expandable unit, which can be used to apply pressure to the heart…expanded and a non-expanded state”, paragraph [0043]).
Regarding claim 11, Wildhirt teaches the cells comprising at least one of bowtie-shaped cells, diamond-shaped cells, and sinusoidal-shaped cells (“openings can be…diamond-shaped”, paragraph [0012]; diamond shape formed by lattice structure of sheath 2 shown in Fig. 3).
Regarding claim 17, Wildhirt teaches the cells having different mechanical properties in different regions of the sleeve (“the regions of the chamber wall between the folds are less stable than the folds”, paragraph [0099]).
Regarding claim 19, Wildhirt teaches the cells in a mid-region of the sleeve between the upper and lower ends being configured such that the mid-region has a higher stiffness relative to an upper region adjacent the upper end and a lower region adjacent the lower end (“areas requiring increased stability in the implanted state can be stabilized by connecting the wires at the crossing points…for expandable units 71, 72”, paragraph [0056]; 71 and 72 in mid-region of the sleeve shown in Fig. 3).
Regarding claim 44, Wildhirt teaches a strain sensor array (“sheath 2 can furthermore include at least one sensor…to detect…the contact force between the heart wall and the expandable unit…the pressure applied to a surface of the heart”, paragraph [0045]).
Regarding claim 45, Wildhirt teaches the strain sensor array comprising a nanoparticle coating on an outer surface of the sleeve (“inside the expandable sheath 2, is at least one expandable unit…chamber include…nanoparticle mixtures”, paragraph [0044]) and one or more electrodes on each of the upper end and the lower end of the sleeve (“upper rim of the sheath…for a sleeve with at least one sensor 81 or one electrode…positioned at the lower end of the cup-shaped sheath…through which one…electrode…can be passed”, paragraph [0058]).
Regarding claim 49, Wildhirt teaches a processor coupled to the strain sensor array configured to process signals from the array related to deformation of the heart (“microprocessor configured to receive and process data from the at least one sensor”, paragraph [0046]).
Regarding claim 51, Wildhirt teaches a passive device for supporting a subject’s heart (“implantable heart support system”, paragraph [0006]), comprising:
A sleeve comprising an open upper end and a lower end defining an interior region sized to receive a portion of the heart (“sleeve having an inner surface arranged to contact the heart”, paragraph [0006]; open upper end and a lower end of sleeve 80 in Fig. 3), the sleeve comprising a plurality of elongate elements members coupled together at their ends to define a plurality of interconnected cells surrounding open regions configured to provide epicardial support of the heart (“the sheath 2…consists of a mesh made of wires…wires form crossing points (intersections), which can be permanently interconnected”, paragraph [0056]).
Regarding claim 54, Wildhirt teaches the coating being configured to provide a resistive strain sensor between the electrodes on the upper and lower ends (sensor 81 in middle of sleeve in Fig. 3, “upper rim of the sheath…for a sleeve with at least one sensor 81 or one electrode…positioned at the lower end of the cup-shaped sheath…through which one…electrode…can be passed”, paragraph [0057]).
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 9 is rejected under 35 U.S.C. 103 as being obvious over Wildhirt in view of Whayne (WO 0219917 A1).
Regarding claim 9, Wildhirt teaches all the limitations of claim 6, but does not teach the cells being shaped such that the sleeve has anisotropic properties configured to support a right ventricle of the hear under varying loading conditions during a cardiac cycle of the heart.
However, Whayne teaches a device for supporting a subject’s heart comprising a sleeve (“support structure maintains…heart functionality”, abstract) where the cells are shaped such that the sleeve has anisotropic properties (“support structure embodiments…anisotropic structural properties”, page 11, paragraph 3) configured to support a right ventricle of the heart under varying loading conditions during a cardiac cycle of the heart (“support structure…may be secured to the endocardial surface…and the right ventricle”, page 10, paragraph 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Wildhirt with the device of Whayne and configure the sleeve to have anisotropic properties to better provide structure and support for the heart, such as the right ventricle.
Claims 12-15 are rejected under 35 U.S.C. 103 as being obvious over Wildhirt in view of Nappi (WO 2016071823 A1).
Regarding claim 12, Wildhirt teaches all the limitations of claim 6, but does not teach the cells being shaped such that the sleeve has auxetic properties configured to support a right ventricle of the heart under varying loading conditions during a cardiac cycle of the heart.
However, Nappi teaches a device supporting a subject’s heart comprising a sleeve (“prosthesis 1…to a heart”, page 8, paragraph 7), wherein the cells of the sleeve are shaped such that the sleeve has auxetic properties (“the layer of auxetic material 3 is used to realize the longitudinal strips 31 as a deformable matrix (composite crosslinked prosthesis)”, page 7, paragraph 6) configured to support a right ventricle of the heart under varying loading conditions during a cardiac cycle of the heart (sleeve can be configured to support a right ventricle of the heart).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Wildhirt with the device of Nappi and configure the sleeve to have auxetic properties to better provide structure and support for the heart, such as the right ventricle.
Regarding claims 13, 14 and 15, Wildhirt in view of Nappi teaches all the limitations of claim 12.
Furthermore, Nappi teaches the sleeve having auxetic properties (“the layer of auxetic material 3 is used to realize the longitudinal strips 31 as a deformable matrix (composite crosslinked prosthesis)”, page 7, paragraph 6). Nappi does not teach the sleeve comprising a longitudinal axis extending between the upper and lower ends, and wherein the cells are configured to be auxetic orthogonal and auxetic laterally relative to the axis, as well as the cells being figured to be auxetic circumferentially around the sleeve.
However, the sleeve of Wildhirt is meant to cover a longitudinal axis extending between the upper and lower ends (shown in Fig. 3 of Wildhirt), as well as circumferentially around the heart. The auxetic sleeve of Nappi would then be orthogonal and laterally relative to the axis, and circumferentially around the sleeve.
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 auxetic sleeve of Nappi with the positioning of the sleeve of Wildhirt to be able to provide better structure and support for the heart. Additionally, since such a modification would simply involve merely extending the shape of the auxetic sleeve of Nappi to fit over the longitudinal axis extending between the upper and lower ends and circumferentially around the heart without changing the operation of the device, a rearrangement of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Claims 16 and 53 is rejected under 35 U.S.C. 103 as being obvious over Wildhirt.
Regarding claim 16, Wildhirt teaches all the limitations of claim 12, but does not teach the cells comprising bowtie-shaped cells, each bowtie-shaped cell comprising first and second straight elements opposite one another extending orthogonal to the axis and first and second angled elements extending between opposite ends, respectively, of the first and second straight elements, the angled elements taper inwardly towards one another at intermediate regions between the opposite ends to define the bowtie-shape.
Wildhirt teaches a first and second straight/angled elements opposite one another (“sheath can be made of a wire mesh…the crossing points may also be separable which increases the flexibility of the sheath…some of the crossing points may be permanently interconnected while other crossing points are not permanently interconnected”, paragraph [0008]) that can extend orthogonal to the axis and first and second angled elements extending between opposite ends, respectively, of the first and second straight elements, the angled elements taper inwardly towards one another at intermediate regions between the opposite ends to define a bowtie-shape.
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 first and second straight/angled elements of Wildhirt to be arranged in a way that can provide better structure for supporting the heart. Additionally, since such a modification would simply involve merely rearranging the orientation of the straight/angled elements of Wildhirt- to which is capable of, a rearrangement of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Regarding claim 53, Wildhirt teaches all the limitations of claim 45, but does not teach the coating having a thickness of about forty micrometers.
Wildhirt does teach the coating having a thickness of 0.1 mm to 1 mm (paragraph [0104]).
It would have been obvious to one of ordinary skill in the art to have recognized that the range of about 40 micrometers would be subject to optimization within the claimed range by routine experimentation with a reasonable expectation of success, in order to obtain a thickness that provides durability and resistance to support the heart. Moreover, it would have been obvious to one of ordinary skill in the art at the time of the invention to choose the instantly claimed ranges through process optimization, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 II and in re Boesch, 205 USPQ 215 (1980).
Claim 18 is rejected under 35 U.S.C. 103 as being obvious over Wildhirt in view of Bonhoeffer (WO 2008100599 A1).
Regarding claim 18, Wildhirt teaches all the limitations of claim 17, but does not teach the cells in a mid-region of the sleeve between the upper and lower ends being configured such that the mid-region has a lower Poisson ratio relative to an upper region adjacent the upper end and a lower region adjacent the lower end.
Wildhirt does teach the mid-region having a higher stiffness than the upper end and lower region (“areas requiring increased stability in the implanted state can be stabilized by connecting the wires at the crossing points…for expandable units 71, 72”, paragraph [0055]; 71 and 72 in mid-region of the sleeve shown in Fig. 3).
However, Bonhoeffer teaches using the Poisson ratio to test the stress and strain on a device to support the heart (“engineering stress-strain data for axial tension tests includes…a Poisson ratio”, page 10, paragraph 5), where a region with a lower Poisson ratio would be stiffer.
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 mid-region of the sleeve of Wildhirt to have a lower Poisson ratio as taught by Bonhoeffer, as the mid-region of the sleeve of Wildhirt is stiffer than the upper and lower ends of the sleeve.
Claim 52 is rejected under 35 U.S.C. 103 as being obvious over Wildhirt in view of Ameer (US 20070071790 A1).
Regarding claim 52, Wildhirt teaches all the limitations of claim 45, but does not teach the coating comprising silicone rubber and carbon black nanoparticles.
However, Ameer teaches a device for supporting a subject’s heart (“patches…to an external portion (surface) of a body passageway or cavity…examples of body passageways…the heart”, paragraph [0054]), with a coating comprising silicone rubber and carbon black nanoparticles (“rubber materials which are often doped with silica or carbon black nanoparticles”, paragraph [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Wildhirt with the device of Ameer and configure the coating to be comprised of silicone rubber and carbon black nanoparticles in order to provide better durability and resistance for the material of the sleeve.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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/L.L.T./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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