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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 35-54 is/are pending. Claim(s) 1-34 is/are canceled.
Election/Restrictions
Applicant requested Examiner acknowledge claims 35, 46, and 54 are each generic to both species 1-1 and 1-2.
The Examiner agrees that claims 35, 46, and 54 are generic to species 1-1 and 1-2.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application will determine what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 35, 40-41, and 43-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7-8, 13, 15, 20, 24, and 27-28 of U.S. Patent No. 11,672,680. Although the claims at issue are not identical, they are not patentably distinct from each other because the following prior claims contain the limitations claimed by the current Application as indicated in the following table.
Current Application
Prior Patent ‘680
35
13
40
20
41
24
43
13
44
15
45
13
46
1
47
7
48
4
49
8
50
1
51
20
52
27
53
28
54
13
Claim Interpretation - 35 USC § 112, 6th paragraph
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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.
Claim limitation “see Table I below” has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “see Table I below” coupled with functional language “see Table I below” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) see Table I below has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: see Table I below.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Table I: Language Invoking 112(f)
Claims
Placeholder
Functional Language
Specification Location
35-36, 39, 43, 54
structures
restraining
Page 3, lines 5-9, has first and second ends, includes a restraining feature
Page 9-10, bridging paragraph, #155 – a longitudinal bar, e.g. Fig 1C
Page 3, lines 10-11, the retaining feature is a ring or nubbin
Page 13, lines 8-11, the retaining feature is “I” shape or other shapes
Page 10, lines 19-30, parallel to the longitudinal axis
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: see Table II below in claim see Table II below.
Table II: Language Not Invoking 112(f)
Claims
Placeholder
Functional Language
Claimed Structure
40
structures
restraining
Biocompatible material
44
structures
restraining
Nubbin (elected), suture ring (non-elected)
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 § 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.
Claim(s) 54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Univ Zuerich (Zuerich) (EP 1958597 A1.
Regarding Claim 54, Zuerich teaches a stent (e.g. [0033], translation), comprising:
a plurality of rings (e.g. Figures 4, 7B) coupled with a plurality of restraining structures (e.g. Zuerich, Figures 4, 7; (1) connections, #404; [0019], page 18, lines 740-741), the plurality of restraining structures extending about a longitudinal axis (e.g. Figures 4, 7B), the plurality of rings comprising a plurality of interconnected struts (e.g. Figures 4, 7B), at least a subset of the plurality of interconnected struts coupled with the plurality of restraining structures (e.g. Figures 4, 7B), the plurality of interconnected struts made of a material to apply a radial force against a site of a subject while the site grows and to expand while the site grows (e.g. [0033]).
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.
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.
Claim(s) 35-36, 39-47, and 51-53 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Univ Zuerich (Zuerich) (EP 1958597 A1), alone.
Regarding Claim 35, Zuerich teaches a stent (e.g. [0033], translation), comprising:
a plurality of rings along a longitudinal axis (e.g. Figures 4, 7B), each ring comprising a plurality of interconnected struts (e.g. Figures 4, 7B), the plurality of rings having a diameter in a first state of implantation at a site, the plurality of rings to expand in diameter to a second state of implantation as the site grows e.g. [0033], growth over time; [0023], the embodiment of nitinol is self-expandable; the stent has force to expand with growth of the vessel it’s implanted; thus, the first state is the initial implantation diameter and the second state is the diameter after the addition site growth occurs); and
a plurality of restraining structures coupled with the plurality of rings to extend between the plurality of rings (e.g. Zuerich, Figures 4, 7; (1) connections, #404; [0019], page 18, lines 740-741).
Zuerich teaches that the stent grows as the patient grows (e.g. [0033], long term growth).
Zuerich discloses the invention substantially as claimed but fails to teach the second state diameter is at least 1.5 times the first state diameter.
Zuerich are concerned with the same field of endeavor as the claimed invention, namely stents that grow with the patient as the patient grows.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zuerich such that the second state diameter is at least 1.5 times the first state diameter as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)) (see MPEP 2144.04(IV)(A)). The Examiner notes, Zuerich envisioned increasing the diameter of the stent after implantation as the patient grows (discussed supra), which includes patients that grow such that the blood vessel increases in size by at least 1.5 times.
Regarding Claim 36, the plurality of restraining structures have a constant length between the first state and the second state (e.g. Figures 4, 7; #s 405, 708 are linear bars/struts and thus do not change length on expansion).
Regarding Claim 39, at least one ring of the plurality of rings has a circumference around the longitudinal axis, the plurality of restraining structures extending proximally and distally from the circumference (e.g. Figures 4, 7).
Regarding Claim 40, the plurality of rings and the plurality of restraining structures comprise a biocompatible material (e.g. [0023], at least nitinol).
Regarding Claim 41, further comprising a sheath on an outer surface of the plurality of rings (e.g. [0033], catheter/endoscope combination; at least the endoscope is radially outward of the catheter; however, in the case of a self-expandable stent, nitinol, the catheter has a radially outer sleeve to hold the stent in the crimped position, so that it does not expand until it reaches the implantation site).
Regarding Claim 42, further comprising an annular cuff coupled with the plurality of rings (e.g. [0029], coating).
Regarding Claim 43, at least one restraining structure of the plurality of restraining structures is parallel with the longitudinal axis (e.g. Figures 4, 7).
Regarding Claim 44, at least one restraining structure of the plurality of retraining structures comprises one or more retaining elements along the at least one restraining structure (e.g. Figures 4, 7; here, the restraining structure is considered all of the frame except the terminal end rings; thus the elements are the straight portions #s 405, 708 are the restraining elements), the one or more retaining elements comprising a nubbin (e.g. Figures 4, 7; #s 405, 708 are considered nubbins).
Regarding Claim 45, the plurality of rings are configured to apply an outward force against a vessel of a subject at the site in the first state of implantation and the second state of implantation (e.g. [0033]).
Regarding Claim 46, Zuerich teaches a growth adaptive stent (discussed supra for claim 35), comprising:
at least one structure extending parallel with a longitudinal axis (discussed supra for claim 35; restraining structure); and
at least one ring coupled with the at least one structure and extending around the longitudinal axis (discussed supra for claim 35), the at least one ring comprising a plurality of struts (discussed supra for claim 35), the plurality of struts configured to deform to expand the at least one ring, responsive to growth of a site in which the growth adaptive stent is implanted (discussed supra for claims 35, 45), from a first state to a second state having a diameter at least fifty percent greater than a diameter of the first state (discussed supra for claim 35), the plurality of struts configured to apply an outward force against the site in the first state and the second state (discussed supra for claims 35, 45).
Regarding Claim 47, the limitations of claim 47 are discussed supra for claim 36.
Regarding Claim 50, the limitations of claim 50 are discussed supra for claim 39.
Regarding Claim 51, the limitations of claim 51 are discussed supra for claim 40.
Regarding Claim 52, the limitations of claim 52 are discussed supra for claim 41.
Regarding Claim 53, the limitations of claim 53 are discussed supra for claim 42.
Claim(s) 37-38 and 48-49 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Univ Zuerich (Zuerich) (EP 1958597 A1) as discussed supra and further in view of Lashinski, et al (Lashinski) (US 2006/0020334 A1).
Regarding Claims 37 and 48, Zuerich discloses the invention substantially as claimed but fails to teach the diameter in the first state is greater than or equal to 4 millimeters (mm) and less than or equal to 20 mm.
Lashinski teaches an outer diameter of 16 mm to 30 mm (e.g. [0151]).
Lashinski and Zuerich are concerned with the same field of endeavor as the claimed invention, namely aortic stented heart valves.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zuerich such that the diameter is 16 mm to 30 mm as taught by Lashinski as it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Regarding Claims 38 and 49, one or more struts of the plurality of struts have a width and a depth (these elements are inherently present).
Zuerich discloses the invention substantially as claimed but fails to teach a ratio of the width to the depth is greater than 1:1.
Lashinski teaches an aortic heart valve having a wall thickness of 0.01" to 0.1" (0.254 mm to 2.54 mm or 254 microns to 2540 microns), [0162], and a strut thickness of 0.06" to 0.09" (1.524 mm to 2.286 mm), [0150]. The ratio of strut depth to strut width (wall thickness to strut thickness) results in a range of 0.17 to 1.67.
Lashinski and Zuerich are concerned with the same field of endeavor as the claimed invention, namely aortic stented heart valves.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zuerich such that the strut depth and thickness are those as taught by Lashinski and therefore, ratio of the depth of the strut to the localized width of the strut is greater than one as taught by Lashinski as it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Relevant Prior Art
US 2002/0128706 A1 to Osypka teaches a growth adaptive stent (e.g. abstract, Figures 1-2).
US 2010/0249918 A1 to Zhang teaches a stent having nubbins (e.g. Figures 2A, 2B, 5A).
US 2009/0216314 A1 to Quadri teaches a stent having nubbins (e.g. Figure 1).
US 2009/0234429 A1 to Lau teaches a stent having nubbins (e.g. Figures 1, 19).
US 2009/0270972 A1 to Lane teaches a stent having nubbins (e.g. Figure 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 3/18/2026
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