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 without traverse of Group I, Species A in the reply filed on 6/16/2026 is acknowledged.
Claim(s) 48-59 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/ species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/16/2026.
Claim Objections
Claim(s) 35, 39, 43 is/are objected to because of the following informalities:
Within claim 35, line 1: “annuloplasty ring” should be replaced with –ring-- (in order to maintain consistent claim terminology).
Within claim 39, line 1: “the open-ended ring” should be replaced with –ring-- (in order to maintain consistent claim terminology).
Within claim 43, line 2: “that” should be replaced with --than--.
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(s) 1, 31-47 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the annulus" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim(s) 31-47, which depend from claim 1, inherit all the problems associated with claim 1.
Claim 1 recites the limitation "the perimeter" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation "the non-coronary segment" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation "the right-coronary […] segment" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation "the left-coronary segment" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Within claim 35, line 3: Applicant claims, “two, opposite ends”; it is unclear, and therefore indefinite, if these are the same as OR in addition to the two opposite open ends within claim 1, lines 3-4.
Within claim 35, line 4: Applicant claims, “a closed ring”; it is unclear, and therefore indefinite, if this is the same as OR in addition to the closed ring within claim 1, line 6.
Claim 36 recites the limitation "the elastic core member" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation "the first open end" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation "the core member" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation "the sheath" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation "the external sheath" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation "the elastic core member" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 recites the limitation "the second open end" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 recites the limitation "the core member" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 recites the limitation "the sheath" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 recites the limitation "the external sheath" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 recites the limitation "the elastic core member" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 40 recites the limitation "the core member" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 41 recites the limitation "the outer sheath layer" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 42 recites the limitation "the outer sheath layer" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 43 recites the limitation "the radial thickness" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim(s) 44-45, which depend from claim 43, inherit all the problems associated with claim 43.
Claim 43 recites the limitation "the core member" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 44 recites the limitation "the elastic core member" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim(s) 45, which depend from claim 44, inherit all the problems associated with claim 44.
Claim 46 recites the limitation "the core member" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Within claim 46, line 2: Applicant claims, “an aortic valve”; it is unclear, and therefore indefinite, if this is the same as OR different from the aortic valve within claim 1, line 2.
Claim 47 recites the limitation "the core member" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1, 31, 33-43, 46-47 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Nguyen et al. (US 2006/0282162 A1).
With respect to claim 1:
Nguyen et al. discloses an external aortic annuloplasty ring (annuloplasty ring 10), as can be seen in fig. 10, for positioning around the circumference of an aortic valve for external aortic root repair or stabilization of the annulus to support the aortic valve (paragraphs [0060, 0065]), wherein the ring (annuloplasty ring 10) is open-ended and thereby having two opposite open ends (free ends) (paragraph [0026]), wherein the ring (annuloplasty ring 10) comprises at least two sections with different elastic properties (variable flexibility/ stiffness) along the perimeter of the ring (annuloplasty ring 10) (paragraph [0062]), and wherein said opposite open ends (free ends) are suitable for being joined together so as to form a closed ring around the aortic root (paragraph [0026]).
With respect to claim 31:
Wherein the ring (annuloplasty ring 10) comprises a material configured to permit the ring (annuloplasty ring 10) to hold an elastic strain in the range of 1.25 - 20% strain (elastic strain between the diastolic and systolic phases of 5-20%) (paragraph [0064]).
With respect to claim 33:
Wherein the elastic properties (variable flexibility/ stiffness) are selected to accommodate the asymmetric dynamics of the aortic annulus of a subject (different flexibility at the nadirs VS the interleaflet triangles) (paragraph [0069]), wherein the non-coronary segment (NC) is less expansible than the right-coronary (RC) and the left-coronary (LC) segments (the one of the less flexible interleaflet triangle sections can be the “non-coronary segment” as claimed, and two of the more flexible nadir sections can the left and right coronary segments as claimed).
With respect to claim 34:
Wherein the sections having different elastic properties are provided with non-uniform cross-sections (cross-sectional area may be varied) (paragraph [0062]).
With respect to claim 35:
Wherein said ring (annuloplasty ring 10) comprises an elastic core member (either of core members 11, 12) (paragraph [0061]), and an outer sheath layer (sheath 16) (paragraph [0067]), wherein the elastic core member (either of core members 11, 12) and the outer sheath layer (sheath 16) are formed as a band comprising two, opposite open ends, suitable for joining together so as to form a closed ring around the aortic root (paragraph [0026]).
With respect to claim 36:
Wherein the elastic core member (either of core members 11, 12) comprises at least two sections having at least two different elastic properties (different cross sectional areas resulting in variable flexibility/ stiffness) (paragraph [0062]).
With respect to claim 37:
Wherein at the first open end (one of the ends of the ring 10’), as seen in figs. 19A, the core member (segments 11’, 12’, 203, 204) has a first length and the sheath (textile sheath 16’ in combination with one of cooperating flaps 211, 212) has a second length, wherein the second length of the external sheath (textile sheath 16’ in combination with one of cooperating flaps 211, 212) is longer than the first length of the elastic core member (segments 11’, 12’, 203, 204) (the sheath (textile sheath 16’ in combination with one of cooperating flaps 211, 212) extends beyond the end of the elastic core member (segments 11’, 12’, 203, 204) and thus is longer) (paragraphs [0121-0122]).
With respect to claim 38:
Wherein at the second open end (one of the ends of the ring 10’), as seen in figs. 18A-18B, the core member (segments 11’, 12’, 203, 204) has a first length and the sheath (textile sheath 16’) has a second length, where the second length of the external sheath (textile sheath 16’) is shorter than the first length of the elastic core member (segments 11’, 12’, 203, 204) (the sheath (textile sheath 16’) is extends between the first and second tacks (205, 206) and thus is shorter that the elastic core member (segments 11’, 12’, 203, 204) resulting in the open spaces through which joints (208) extend (paragraphs [0121, 1028]).
With respect to claim 39:
Wherein the open-ended ring (annuloplasty ring 10) is preformed within a predetermined diameter (below the maximum limiting ring diameter) (paragraphs [0064, 0068]).
With respect to claim 40:
Wherein the core member (either of core members 11, 12) is made from silicone (paragraph [0061]) or an elastic material having a low stress creep.
With respect to claim 41:
Wherein the outer sheath layer (either of core members 11, 12) is made from a medical grade polyester (paragraph [0069]).
With respect to claim 42:
Wherein the outer sheath layer (either of core members 11, 12) is made from a woven fabric of medical grade polyester (woven textile of polyester) (paragraph [0069]).
With respect to claim 43:
Wherein the radial thickness of the core member (either of core members 11, 12) is less that its axial extension (the core members 11, 12 maybe rectangular, and as can be seen in figs. 4C-4G, have an axial extension (spanning from the right to the left side of the page) that is greater than the radial thickness (spanning from the top to the bottom of the page) (paragraph [0062]).
With respect to claim 46:
Wherein the core member (either of core members 11, 12) is configured to accommodate an aortic valve of a patient (paragraph [0026]), based on a model thereof obtained by a scanning procedure or a measurement of said patient's aortic root (the claim requirement of “accommodating the based on a model thereof obtained by a scanning procedure or a measurement of said patient's aortic root” is considered by intended use; and either of core members (11, 12, as disclosed by Nguyen et al., is capable thereof).
With respect to claim 47:
Wherein the core member (either of core members 11, 12) is made from an additive manufacturing process (the aforementioned claim requirement is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a core member (either of core members 11, 12). Manufacturing steps such as additive manufacturing are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.).
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(s) 32, 44-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 2006/0282162 A1).
Nguyen et al. discloses the external aortic annuloplasty ring (annuloplasty ring 10) substantially as claimed as discussed above. However, Nguyen et al. does not explicitly recite: how the non-uniform cross-sections (different cross sectional areas resulting in variable flexibility/ stiffness) of the elastic core member (either of core members 11, 12) are altered, specifically by altering the radial thickness (as required by claim 44); nor how the ring (annuloplasty ring 10)/ non-uniform cross-sections (different cross sectional areas resulting in variable flexibility/ stiffness) of the elastic core member (either of core members 11, 12) to have at least three/ more than two section with different elastic properties (variable flexibility/ stiffness) (as required by claim(s) 32, 45).
With respect to claim 44:
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to alter the cross-section (different cross sectional areas resulting in variable flexibility/ stiffness) of the elastic core member (either of core members 11, 12) by varying the radial thickness thereof (as there are only two potential options – altering the thickness OR the length, and changes in size/ proportion/ shape are not found to be patentable distinct) (see MPEP 2144.04).
With respect to claim(s) 32, 45:
It would have additionally been obvious to one having ordinary skill in the art at the time the invention was made to alter the cross-section (different cross sectional areas resulting in variable flexibility/ stiffness) of the elastic core member (either of core members 11, 12) to have at least three/ more than two section with different elastic properties (variable flexibility/ stiffness) such that the cross-section (different cross sectional areas resulting in variable flexibility/ stiffness) has at least tapered regions (creating a third cross-section) between any two areas with different cross sections (different cross sectional areas resulting in variable flexibility/ stiffness) in order to prevent the formation of a stress/ strain concentration point (additionally, altering the thickness OR the length, and changes in size/ proportion/ shape are not found to be patentable distinct) (see MPEP 2144.04).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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REBECCA STRASZHEIM PRESTON
Primary Examiner
Art Unit 3774
/REBECCA S PRESTON/Primary Examiner, Art Unit 3774
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