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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. SG10202110444X, filed on 09/21/2021.
Claim Objections
Claim 17 objected to because of the following informalities:” Error! Reference sources not found.” Examiner recommends removing this error message. 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.
Claim 29 is 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 29 recites the limitation "The tricuspid valve prosthesis of any one of claim 18" in claim 18. Per applicant’s amendment claim 18 was canceled.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function.
Such claim limitation(s) is/are:
“a connector element connected to the tips of the two or more leaflets” in claim 1.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 6-7, 9-8, 11, 16, 19, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tabata et al. US 20190358034 A1, herein referred to as Tabata.
Regarding claim 1, Tabata discloses a tricuspid valve prosthesis (Fig 5a-b, 1) to be transplanted into a heart ([0059]), the tricuspid valve prosthesis comprising: two or more leaflets (Fig 5a, 5 and 7, also see Fig 10a-c, 4) each comprising an annular length (Fig 5a) and two free edges forming a tip (Fig 5a), the two or more leaflets joined together at commissures to create a ring (Fig 2, 3), and configured to coapt with each other ([0058]); and a connector element (Fig 10, junction 71; this element is interpreted under 112(f) as a “connector element 132, see [0080] and Figs 3A-C of the instant application, and equivalents thereof) connected to the tips of the two or more leaflets (Fig 1 and 2): surrounded by the connector element (Fig 10a).
But does not disclose wherein two or more leaflets include two or more sets of cords, each set of cords attached to the tip of one of the two or more leaflets at a first end.
However, in another embodiment Tabata teaches each set of cords attached to the tip of one of the two or more leaflets at a first end (Fig 10a), and two or more sets of cords (Fig 10a-c, 75, 73), each set of cords attached to the tip of one of the two or more leaflets at a first end (Fig 10b-c).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify the base invention of Tabata to incorporate two or more sets of cords, each set of cords attached to the tip of one of the two or more leaflets at a first end, as taught and suggested by Tabata in order to stabilize an implant (Tabata [0081-0082]).
Regarding claim 2, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the two or more leaflets coapt with each other edge-to-edge (Fig 1 and 2).
Regarding claim 3, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the two or more leaflets coapt with each other surface-to-surface (Fig 1 and 2).
Regarding claim 4, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the connector element is configured to be attached to a papillary muscle of the heart and wherein the papillary muscle is an anterior papillary muscle (Fully capable of functional limitations stated, see Fig 1-2).
Regarding claim 6, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the connector element is configured to be attached to a free wall of a right ventricle (Capable of functioning as claimed).
Regarding claim 7, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches further comprising two or more sets of cords (Fig 10b), each set of cords attached to the connector element at a first end (Fig 10b).
Regarding claim 9, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the connector element surrounds a first end of the two or more sets of cords (Fig 5a, combination with Fig 10b leaflets and cords).
Regarding claim 11, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the two or more sets of cords are configured to be attached to one or more papillary muscles of the heart at a second end (fully capable of claimed limitation).
Regarding claim 16, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches a tricuspid valve prosthesis (Fig 5a-b, 1) to be transplanted into a heart ([0059]), the tricuspid valve prosthesis comprising: two or more leaflets (Fig 5a, 5 and 7, also see Fig 10a-c, 4) each comprising an annular length Fig 5a) and two free edges forming a tip (Fig 5a), the two or more leaflets joined together at commissures to create a ring (Fig 2, 3, and configured to coapt with each other; [0058]) and two or more sets of cords (Fig 10a-c: and two or more sets of cords (Fig 10a-c, 71, 73), each set of cords attached to the two or more leaflets at a first end (Fig 10a-c, 71).
Regarding claim 19, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 16 teaches wherein the two or more sets of cords are sutured together to form a cap (Fig 1 and 2), the cap configured to be attached to a free wall of the right ventricle ([0030]).
Regarding claim 22, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 16 teaches wherein the two or more leaflets further comprise a slot that splits a tip of the two or more leaflets ([0053] and [0081-0082]; Fig 10b), the slot comprising two circular arcs, the two circular arcs are configured to coapt with each other (Fig 10b).
Claim(s) 10 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tabata in view of Myers et al. EP 1251804 B1, herein referred to as Myers.
Regarding claim 10, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose explicitly disclose wherein the connector element spans the length of the two or more sets of cords.
Myers teaches wherein the connector element spans (Fig 28, 370) length of the two or more sets of cords (Fig 28, 370).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Tabata to incorporate wherein the connector element spans the length of the two or more sets of cords, as taught and suggested by Myers in order secure tab and maintain low profile (Myers [0080-0081]).
Regarding claim 17, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 10 teaches wherein the two or more sets of cords are sutured together to form a cap (Myers Fig 28, 372), the cap configured to be attached to a papillary muscle of the heart and wherein the papillary muscle is an anterior papillary muscle (Myers teaches adhering commissure cap include element 372 to papillary muscle, see [0073]).
Claim(s) 12, 20-21, 24, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tabata in view of Navia et al. WO 2004032724 A2, herein referred to as Navia.
Regarding claim 12, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not explicitly disclose wherein the ring is bean-shaped or saddle-shaped and the free edges are shaped along a concave arc of a circle.
But Navia teaches wherein the ring is bean-shaped (Fig 1, 12) or saddle-shaped and the free edges are shaped along a concave arc of a circle (Fig 1).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Tabata to incorporate wherein the ring is bean-shaped or saddle-shaped and the free edges are shaped along a concave arc of a circle, as taught and suggested by Navia in order to allow sphincter-like function (Navia pg 2 lines 17- pg 3 lines 3).
Regarding claim 20, Tabata/Navia discloses the invention substantially as claimed and as discussed above with respect to claim 12 teaches wherein the free edges are shaped along a concave arc of a circle (Navia Fig 1).
Regarding claim 21, Tabata/Navia discloses the invention substantially as claimed and as discussed above with respect to claim 20 teaches wherein the free edges are shaped along a concave arc of a circle (Navia Fig 1).
Regarding claim 24, Tabata/Navia discloses the invention substantially as claimed and as discussed above with respect to claim 12 teaches further comprising a stent frame (Navia Fig 3, conduit 20), wherein two or more leaflets are positioned within the stent frame (Navia Fig 3); and wherein the ring is dimensioned to match perimeter of the stent frame (Navia Fig 3).
Regarding claim 25, Tabata/Navia discloses the invention substantially as claimed and as discussed above with respect to claim 20 teaches wherein said stent frame (Navia Fig 3, conduit 20) comprising one or more slots for inserting the two or more leaflets to the stent frame and a plurality of holes for stitching of the two or more leaflets (Fig 10b; [0053]; [0081-0082]).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tabata in view of Rajamannan et al. US 20170304497 A1, herein referred to as Rajamannan.
Regarding claim 29, Tabata discloses the invention substantially as claimed and as discussed above with respect to claim 18, but does not explicitly disclose further comprising a cuff coated with one or more drugs and attached to the stent frame.
But Rajamannan further comprising a cuff coated with one or more drugs and attached to the stent frame (Rajamannan [0009]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify Tabata to incorporate further comprising a cuff coated with one or more drugs and attached to the stent frame, as taught and suggested by Rajamannan in order to stop calcification of implant in body over time (Rajamannan [0009]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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