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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 10, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on June 25, 2024 contains a typographical error. The Written Opinion application number as printed on the IDS (“PCT/050409”) does not include all of the necessary characters. However, since there is only one attached written opinion which has the complete PCT number (“PCT/IB2024/050409”), this reference has been considered. The IDS is annotated with the updated PCT application number.
The IDS is otherwise in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 30, 2025.
Applicant's election with traverse of Invention I, claims 1-11 drawn to a stent in the reply filed on December 30, 2025 is acknowledged. The traversal is on the ground(s) that art applicable to Group I is likely not applicable to Groups II and III. This is not found persuasive because applicant has not “distinctly and specifically point[ed] out the supposed errors upon which the applicant relies for his or her conclusion that the requirement is in error” (See MPEP 817). Applicant has not presented arguments with respect to examiner’s showing distinctness between inventions. Furthermore, the inventions as presented have separate status in the art and different classifications (See Restriction Requirement mailed October 30, 2025).
The requirement is still deemed proper and is therefore made FINAL.
Response to Amendment
Claims 1-20 are pending in the application. Claims 12-20 are withdrawn. Claim 8 has been amended. Claims 1-3, 7-11 are rejected.
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.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “structural extension member”; “growth promoting structural elements” in claims 1-11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 8-10 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 8 recites the limitation "the interface" in line 3 and “the free edge” in line 4. There is insufficient antecedent basis for this limitation in the claim. It is noted that claim 8 depends from claim 7 which in turn depends from claim 1. Neither claim 1 nor claim 7 recite “an interface” or “a free edge”. It is further noted that claim 4 does recite both these limitations. Examiner suggests either amending claim 8 to read “an interface” and “a free edge” or to amend the dependency of claim 8 to depend on claim 4. Appropriate action is required.
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.
Claim(s) 1-3, 7, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vonderwalde et al (US PG Pub 2004/0215324).
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Regarding claim 1, Vonderwalde teaches an implantable stent (50) (See Fig. 11) comprising:
a tubular scaffolding (50) having a proximal end, an opposite distal end and a lumen extending therethrough (See Fig. 11; paragraphs [0040] and [0048]);
the tubular scaffolding including a plurality of individual struts (55) arranged in a pattern defining open spaces therebetween (See Fig. 11); wherein the tubular scaffolding has a lumen facing surface (internal surface) that faces radially inward toward the lumen and an opposite tissue facing surface1 (external surface) that faces radially outward away from the lumen (See annotated Fig. 13); wherein each of the individual struts has a longitudinal axis and a lateral cross-section with opposing sides extending between the lumen facing surface and the tissue facing surface; and
at least one structural extension member (52) associated with one of the individual struts (See Fig. 11), wherein the at least one structural extension member has a lumen facing surface (internal surface) that faces radially inward toward the lumen and an opposite tissue facing surface (external surface) that faces radially outward away from the lumen; the at least one structural extension member extending in a direction perpendicular to the longitudinal axis outward from one of the opposing sides of the associated individual strut (See Figs. 11 and 13); wherein the at least one structural extension member has a plurality of growth promoting structural elements2 (holes/openings 53 – note each extension member 52 has two holes 53).
Regarding claim 2, Vonderwalde teaches the stent as required by claim 1 as set forth above and further teaches the at least one structural extension member (52) is integral with as a single unit or attached as a separate component to the associated one of the individual struts. (See paragraphs [0044] and [0051] which state the connector elements (such as 52) may be manufactured separately and later joined to the stent or may be manufactured with the stent “as a one piece unit”)
Regarding claim 3, Vonderwalde teaches the stent as required by claim 1 as set forth above and further teaches the at least one structural extension member (52) is disposed on each of the opposing sides of the associated individual strut (See Fig. 11); and wherein the at least one structural extension member disposed on each of the opposing sides of the associated individual strut are fully aligned in a direction of the longitudinal axis from one another (See Fig. 11, note extension member 52 has two aligned halves one on each side of the strut).
Regarding claim 7, Vonderwalde teaches the stent as required by claim 1 as set forth above and further teaches the plurality of growth promoting structural elements (holes 53) of the associated structural extension member (52) are: (i) through holes (See Fig. 11; paragraphs [0040]; [0048]).
Regarding claim 11, Vonderwalde teaches the stent as required by claim 1 as set forth above and further teaches the tubular scaffolding is transitionable between a radially compressed state and a radially expanded state (See paragraphs [0040] and [0054]); and irrespective of the state of the tubular scaffolding, positioning of the at least one structural extension member relative to the associated individual strut remains unchanged. (See Fig. 11, note that since the extension 52 is permanently attached to a specific portion of the strut it will remain in that location in both the expanded and compressed states.)
Citation of Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Euteneuer (US Pat. No 5,681,345) teaches a stent made of struts with extensions (32) extending perpendicularly from the struts.
Chuter (US Pat. No. 5,993,482) teaches a stent with struts and extensions (20)
Shank et al (US Pat. No. 6,231,581) teaches an implantable device with anchoring extensions (See Figs. 9 & 10)
Allen et al (US PG Pub 2001/0016770) teaches a stent made of struts with a variety of extensions/connectors (See Figs. 7A-7L and 9).
Owens (US Pat. No 6,494,906) teaches a stent made of struts with perpendicular extensions (28) extending from a strut.
Gomez et al (US PG Pub 2002/0198693) teaches a stent made of struts with extensions (56) extending from the strut.
Lombardi (US PG Pub 2003/0144725) teaches a stent made of struts with extensions (41) extending from the strut
Sohier (US PG Pub 2004/0006382) teaches a stent with openings (perforations) in the struts. (See Fig. 3).
Lowe et al (US PG Pub 2004/0093073) teaches a stent with foot shaped extensions (40) in the struts.
Riccotta et al (US PG Pub 2005/0102024) teaches a stent graft where the struts have a variety of extension member for retaining the stent (See Figs. 3; 5A-5L)
Pacetti et al (US PG Pub 2013/0172982) teaches a stent made of struts with extensions (80) between the struts (See Figs. 4A-5C)
Melanson et al (US Pat. No. 8,834,553) teaches a stent with extension members (110) which have openings (112) therein.
Allowable Subject Matter
Claims 4-6 and 8-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Implantable stents with retention and/or growth promoting features are well known in the art. This is supported by the references cited during prosecution as well as other reference in the general area that could be located with minimal effort.
With specific regard to claims 4-6, the prior art of record fails to specifically teach or render obvious a stent made of multiple struts where at least one strut has at least one structural extension member with a plurality of growth promoting structural elements and where the structural extension member has a free edge and the extension member is tapered in thickness such that the maximum thickness is located where the extension member meets the strut and the minimum thickness is at the free edge of the extension in combination with the other elements as claimed. Additionally, no other references, or reasonable combination thereof, could be found which disclose or suggest these features in combination with other limitations in the claims.
With specific regard to claims 8-10, the prior art of record fails to specifically teach or render obvious a stent made of multiple struts where at least one strut has at least one structural extension member with a plurality of growth promoting structural elements where the growth promoting structural elements located closest to the juncture of the stent strut and extension member (interface) are largest in size while the growth promoting structural elements located closest to the free edge are smallest in size in combination with the other elements as claimed. Additionally, no other references, or reasonable combination thereof, could be found which disclose or suggest these features in combination with other limitations in the claims.
The closest prior art is deemed to be Vonderwalde (see rejection set forth above). Vonderwalde does not teach the extension members (52) taper in thickness nor does it teach the growth promoting elements (holes 53) have multiple sizes where the larger sized holes are closer to the strut and the smaller holes are closer to the free end. Additionally, it would not be obvious to make such modifications without the use of hindsight.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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 call the examiner at the number listed above. Applicant may 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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.S.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
1 It is noted that the external surface of the stent faces radially outward from the lumen and faces towards the tissue into which the stent is deployed.
2 It is noted that applicant’s specification specifically lists “through holes” as examples of “growth promoting structural elements” (See paragraphs [0037], [0038], [0041], etc.)