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) 9-16 and 38-45 is/are pending. Claim(s) 9-16, 38-40, and 42-45 is/are withdrawn. Claim(s) 1-8 and 17-37 is/are canceled.
Election/Restrictions
Newly submitted amendment to claim 9 (and thus, claims 10-16, 38-40, and 42-45) are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons.
Species of link pattern
Species 1-1: 2-2-3-2-2-3 (previously presented in claim 9, currently in claim 41)
Species 1-2: 2-2-3-2-2-3-3 (amended into claim 9 at the 12/10/2025 response)
Applicant’s original specification at [0045] discloses both of these patterns and clearly indicates that they are separate embodiments. Likewise, [0044] discloses an alternative link pattern and also a separate embodiment as the first pattern plus an additional 3 links at the end, which mirrors that of [0045]. Thus, Applicant has consistently disclosed species 1-1 and 1-2 as different embodiments and the same kind of different embodiments for at least the pattern in [0044]. It is clear from [0044]-[0045] that each link pattern has been created for a particular reason associated with the given pattern. Therefore, each pattern is a distinct embodiment.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 9-16, 38-40, and 42-45 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Therefore, claims 9-16, 38-40, and 42-45 are withdrawn as drawn to a non-elected species.
Response to Arguments
Applicant’s arguments, filed 12/10/2025, with respect to the claim objection have been fully considered and are persuasive. The objection of claim 15 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments, filed 12/10/2025, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 9-15 has/have been withdrawn due to the Applicant’s amendments.
Applicant's arguments with respect to the drawing objections and filed 12/10/2025 have been fully considered but they are not persuasive.
Applicant argues the 2-2-3-2-2-3 link pattern is seen in Figures 5A-B, which shows the 2-2-3-2-2-3-3 pattern.
As noted supra in the election/restriction section, Applicant’s original specification at [0045] discloses both of these patterns and clearly indicates that they are separate embodiments. Likewise, [0044] discloses an alternative link pattern and also a separate embodiment as the first pattern plus an additional 3 links at the end, which mirrors that of [0045]. Thus, Applicant has consistently disclosed species 1-1 and 1-2 as different embodiments and the same kind of different embodiments for at least the pattern in [0044]. It is clear from [0044]-[0045] that each link pattern has been created for a particular reason associated with the given pattern. Therefore, each pattern is a distinct embodiment.
Therefore, the drawing objection for the elected 2-2-3-2-2-3 pattern remains.
Applicant’s arguments with respect to the prior art and claims 9-16, 38-40, and 42-45 are moot because Applicant has amended independent claim 9 to be drawn to a non-elected species as noted supra.
Applicant’s arguments with respect to the prior art and claims 41 and 46-50 have been considered but are moot in view of the new grounds of rejection. The Examiner notes the change in prior art was necessitated by the Applicants amendments.
Although the Ta prior art is re-used herein, it is not used for the argued features.
Drawing Objection
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the 2-2-3-2-2-3 link pattern must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The Examiner notes Applicant’s Figure 5A has a 2-2-3-2-2-3-3 pattern. The last “3” prevents Figure 5A from representing a 2-2-3-2-2-3, since the next repeat of the claimed pattern would require the next connection be a “2” rather than a “3”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 48 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 48 recites “each of the rings has six peaks and the links in the 3-link pattern are separated by three peaks”. In all of Applicant’s Figures having 3-links (Figures 4A, 5A, 6A, 7A, 8A, 9A, 10A) 3-links are separated by two peaks. Further, to have six total links and 3 evenly spaced links, there must be two peaks between each pair of links. Thus, the requirement of three peaks between each pair of links is new matter. Since it is not possible to have three peaks each link in a 3-link pattern, for purposes of examination the Examiner considers this language to be two peaks between each pair of links in a 3-link pattern.
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 46 and 48-50 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 46, line 1 and claim 49, line 2 and claim 50, line 2 each recites the limitation "the 2-link pattern". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a 2-link pattern” between the pair(s) of rings that the pattern is associated with.
Claim 46, line 2 and claim 48, line 2 each recites the limitation "the 3-link pattern". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a 3-link pattern” between the pair(s) of rings that the pattern is associated with.
Claim 48 recites “each of the rings has six peaks and the links in the 3-link pattern are separated by three peaks”. To have six total links and three evenly spaced links, there must be two peaks between each pair of links. It is unclear how three links can have three peaks between pairs when there are also six total links
Claim 48, line 2 and claim 50, lines 2-3 each recites “three peaks”. It is unclear if these three peaks are part of the six peaks introduced earlier in the claim or a separate three peaks or some combination of these two options. For purposes of examination the Examiner considers this language to be “three peaks of the six peaks”.
Claim 49, line 2 recites “two peaks”. It is unclear if these two peaks are part of the six peaks introduced earlier in the claim or a separate two peaks or some combination of these two options. For purposes of examination the Examiner considers this language to be “two peaks of the six peaks”.
Claim 49, line 3 recites “four peaks”. It is unclear if these four peaks are part of the six peaks introduced earlier in the claim or a separate four peaks or some combination of these two options. For purposes of examination the Examiner considers this language to be “four peaks of the six peaks”.
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.
Claims 41 and 47-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ta, et al (Ta) (US 2011/0208286 A1) in view of Lau, et al (Lau) (US 2001/0037146 A1).
Regarding Claim 41, Ta teaches a stent (e.g. Figure 6A), comprising:
a tubular body having a distal end ring and a plurality of body rings including a first body ring, a second body ring, a third body ring, a fourth body ring, a fifth body ring and a sixth body ring (e.g. Figure 6A, where distal is to the bottom as shown on the page (which is also to left with “Fig. 6A” at the bottom)), the tubular body having a compressed diameter and an expanded implanted diameter (e.g. [0018]);
the distal end ring and the body rings being positioned in an in-phase relationship (e.g. Figure 6A);
the distal end ring and the body rings being connected by a pattern of links (e.g. Figure 6A).
Ta discloses the invention substantially as claimed but fails to teach:
the distal end ring and the body rings being connected by a pattern of 2 links - 2 links - 3 links - 2 links - 2 links - 3 links;
the distal end ring being connected to the first body ring by only two links, the first body ring being connected to the second body ring by only two links, the second body ring being connected to the third body ring by only three links, the third body ring being connected to the fourth body ring by only two links, the fourth body ring being connected to the fifth body ring by only two links, and the fifth body ring being connected to the sixth body ring by only three links.
Lau teaches stents having rings interconnected by links (e.g. Figures 7-10) where “[t]he number and location of elements interconnecting adjacent cylindrical elements can be varied in order to develop the desired longitudinal flexibility in the stent structure” (e.g. [0014]).
Lau and Ta are concerned with the same field of endeavor as the claimed invention, namely stents having multiple rings interconnected by links.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ta such that the distal end ring and the body rings being connected by a pattern of only 2 links – only 2 links – only 3 links – only 2 links – only 2 links – only 3 links ...since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (MPEP 2144.05, B; "In reBoesch, 617 F.2d 272,205 USPQ 215 (CCPA 1980))". In this case, Lau teaches varying the number of links between rings in order to “minimize alteration of the natural physiology of the body lumen into which the stent is implanted and to maintain the compliance of the body lumen which is internally supported by the stent.” (e.g. Lau, [0014]).
Therefore, the combination of Ta and Lau teaches:
the distal end ring being connected to the first body ring by only two links, the first body ring being connected to the second body ring by only two links, the second body ring being connected to the third body ring by only three links, the third body ring being connected to the fourth body ring by only two links, the fourth body ring being connected to the fifth body ring by only two links, and the fifth body ring being connected to the sixth body ring by only three links
Regarding Claim 47, the stent is formed from a metal alloy taken from the group of metal alloys consisting of stainless steel, nickel-titanium, titanium, tantalum, and cobalt-chromium (e.g. Ta, [0037]).
Regarding Claim 48, each of the rings has six peaks (e.g. Ta, Figure 6A) and the links in the 3-link pattern are separated by three peaks (see 35 USC 112(a) and 35 USC 112(b) sections supra; e.g. Ta, Figure 6A).
Claims 46 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ta, et al (Ta) (US 2011/0208286 A1) in view of Lau, et al (Lau) (US 2001/0037146 A1) as discussed supra and further in view of Pienknaguyra (US 2007/0265698 A1).
Regarding Claim 46, the combination of Ta and Lau discloses the invention substantially as claimed but fails to teach the links in the 2-link pattern are linear and the links in the 3-link pattern are non-linear.
Pienknaguyra teaches a stent the end rings are connected by straight links and the remaining rings are connected by non-linear links (e.g. Figure 9A).
Pienknaguyra and the combination of Ta and Lau are concerned with the same field of endeavor as the claimed invention, namely stents having rings connected by links.
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 combination of Ta and Lau such that the links in the 2-link pattern at each end of the stent are linear and the links in the 3-link pattern are non-linear as taught by Pienknaguyra to increase stent stability by having the straight struts at the stent ends (e.g. Pienknaguyra, [0069]).
The Examiner notes as broadly claimed, the claim requires the 2-link pattern and the 3-link pattern meet the claimed requirements, which is one pattern of each kind of linkages. In this combination, there is at least one set of links between a pair of rings meeting the requirement for each “pattern”.
Regarding Claim 50, each of the rings has six peaks (e.g. Ta, Figure 6A).
The combination of Ta and Lau discloses the invention substantially as claimed but fails to teach the links in the 2-link pattern between the distal end ring and the first body ring are separated by three peaks.
Pienknaguyra teaches a stent end ring having six peaks and connected to the immediately adjacent ring by 2 links that are evenly spaced and thus have three rings between the pair of links (e.g. Figure 11).
Pienknaguyra and the combination of Ta and Lau are concerned with the same field of endeavor as the claimed invention, namely stents having rings connected by links.
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 combination of Ta and Lau such that the links in the 2-link pattern between the distal end ring and the first body ring are separated by three peaks as taught by Pienknaguyra to increase stent stability by having the straight struts at the stent ends (e.g. Pienknaguyra, [0069]).
Claim 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ta, et al (Ta) (US 2011/0208286 A1) in view of Lau, et al (Lau) (US 2001/0037146 A1) as discussed supra and further in view of Santos, et al (Santos) (US 7,169,178 B1).
Regarding Claim 49, each of the rings has six peaks (e.g. Ta, Figure 6A).
The combination of Ta and Lau discloses the invention substantially as claimed but fails to teach the links is the 2-link pattern between the body rings are separated by two peaks in one circumferential direction and four peaks in the opposite circumferential direction.
Santos teaches a stent having rings connected by links (e.g. Figure 1) where two body rings are connected by 2 links such that the 2-link pattern between the body rings are separated by an unequal number of peaks one circumferential direction versus the opposite circumferential direction (e.g. Figure 1).
Santos and the combination of Ta and Lau are concerned with the same field of endeavor as the claimed invention, namely stents having rings connected by links.
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 combination of Tau and Lau such that the 2-link pattern between the body rings are separated by two peaks in one circumferential direction and four peaks in the opposite circumferential direction as taught by Santos as it is a simple substitution of one known element (link pattern) for another to obtain predictable results (MPEP 2143(I)) of stent rings connected to each other having circumferential cells of differing circumferential size, which allows side branches to be placed through the bigger opening (e.g. Ta, [0016]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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 3/11/2026