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) 30-44 is/are pending. Claim(s) 1-29 is/are canceled.
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.
Claim 30 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 15 of U.S. Patent No. 11,963,894. 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
US 11,963,894
30
5, 15
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 31-37 and 43-44 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.
The term "lowest" in claim 31 is a relative term which renders the claim indefinite. The term "lowest" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure provides no metric for determining the bounds of “lowest” (such as what direction relative to the device is considered “low”). Therefore, this term is indefinite.
Claim 31 recites the limitation "the distal end face". 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 face of the distal end of the inner branch”.
The term "highest" in claims 31 and 44 each is a relative term which renders the claim indefinite. The term "highest" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure provides no metric for determining the bounds of “highest” (such as what direction relative to the device is considered “high”). Therefore, this term is indefinite.
Claim 31 recites the limitation "the proximal end face". 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 face of the proximal end of the outer branch”.
Claims 32-33 each recites the limitation "the outer branch window". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an outer branch window”.
Likewise, claim 34 also recites “the outer branch window”, which also lacks antecedent basis. However, this instance becomes moot when that for claim 32, from which claim 34 depends, is addressed as noted supra.
The term "below" in claim 32 is a relative term which renders the claim indefinite. The term "below" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure provides no metric for determining the bounds of “below” (such as what direction relative to the device is considered “below”). Therefore, this term is indefinite.
The term "above" in claim 32 is a relative term which renders the claim indefinite. The term "above" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure provides no metric for determining the bounds of “above” (such as what direction relative to the device is considered “above”). Therefore, this term is indefinite.
Claims 33-34 each recites the limitation "the inner branch window". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an inner branch window”.
Claims 35-37 each recites the limitation "the number". 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 number”.
Claim 35 recites the limitation "the inner branch windows". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “inner branch windows”.
Claim 35 recites the limitation "the two inner branch windows". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “the inner branch windows comprising two inner branch windows”.
Claims 36-37 each recites the limitation "the inner branches". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “the inner branch is a first inner branch and there is a second inner branch” or similar language to clarify there is an additional inner branch beyond the single inner branch introduced in claim 30.
Claim 36 recites the limitation "the outer walls". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “outer walls”.
Claim 36 recites the limitation "the distal ends". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “distal ends”. The Examiner notes only one distal end of the (single) inner branch is introduced in claim 30.
Claims 36-37 recites the limitation "the two inner branches". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “the inner branch is a first inner branch and there is a second inner branch” or similar language to clarify there is an additional inner branch beyond the single inner branch introduced in claim 30.
Claim 37 recites the limitation "the waveform rings". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “waveform rings”.
Claim 43 recites the limitation "the outer wall". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an outer wall”.
Claim 43 recites the limitation "the proximal end of the inner branch". 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 proximal end of the inner branch”.
Claim 43 recites the limitation "the proximal end of the first segment". 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 proximal end of the first segment”.
Claim 44 recites the limitation "the proximal end surface of the inner branch". 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 proximal end surface of the inner branch”.
Claim 44 recites the limitation "the proximal end of the first body segment". 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 proximal end of the first body segment”.
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 30-42 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivancev (US 2012/0323303 A1) in view of Khoury (US 2014/0094902 A1).
Regarding Claim 30, Ivancev teaches a lumen stent (e.g. Figure 1, abstract), comprising a tubular body (e.g. Figure 1), an outer branch (#26) which are respectively communicated with the tubular body (e.g. [0032]), the tubular body comprising a first body segment (#14), a tapered segment (#18) and a second body segment (#16) which are connected in sequence (e.g. Figure 1), and a proximal end of the outer branch is connected to the tapered segment (e.g. Figure 1).
Ivancev discloses the invention substantially as claimed but fails to teach:
an inner branch communicated with the tubular body and
a distal end of the inner branch is connected to the tapered segment and the distal end of the inner branch is located proximal to the proximal end of the outer branch.
Khoury teaches a branched stent graft having first and second inner branches each communicated with the tubular body and with respective inner branch windows in a tapered portion that is only on the tapered segment such that a distal end of each inner branch is connected to the inner branch window on the tapered portion (e.g. Figure 6, branch #214, window #220).
Khoury and Ivancev are concerned with the same field of endeavor as the claimed invention, namely branched stent grafts having branches on a tapered portion of the tubular body.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ivancev such that there is an inner branch having a window in the tapered portion that is only on the tapered segment as taught by Khoury in order to insure the branch does not kink during placement or under the strong pulsatile flow dynamics in the vasculature (e.g. Khoury, [0016]) and in order to provide branches for a given patient (e.g. Khoury, [0019]).
The combination of Ivancev and Khoury discloses the invention substantially as claimed but fails to teach:
the distal end of the inner branch is located proximal to the proximal end of the outer branch.
Khoury further teaches placement of the branches such that flow to anatomical vessels is facilitated (e.g. [0023]).
Khoury and Ivancev are concerned with the same field of endeavor as the claimed invention, namely branched stent grafts having branches on a tapered portion of the tubular body.
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 Ivancev and Khoury such that the distal end of the inner branch is located proximal to the proximal end of the outer branch as taught by Khoury in order to facilitate placement of the branches for flow to anatomical vessels (e.g. Khoury, [0023]).
Regarding Claim 31, the combination of Ivancev and Khoury discloses the invention substantially as claimed but fails to teach:
a vertical distance between the lowest point on the distal end face of the inner branch and the highest point on the proximal end face of the outer branch is 0 to 10 mm.
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 Ivancev and Khoury such that a vertical distance between the lowest point on the distal end face of the inner branch and the highest point on the proximal end face of the outer branch is 0 to 10 mm as such a modification would have been an obvious matter of design choice involving a change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art and 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 (see MPEP 2144.04 IV).
Regarding Claim 32, the tapered segment is provided with a waveform ring comprising a plurality of peaks, a plurality of valleys and a plurality of connecting rods respectively connecting adjacent peaks and valleys (e.g. Ivancev, Figure 1), wherein the outer branch window is located below the peaks (e.g. Ivancev, Figure 1), and the inner branch window being located above the valleys (e.g. Khoury, Figures 1 and 6, respectively; the inner branches are toward the top, as shown, of the tapered portion and the outer branches extend down relative to these top branches; therefore, in the combination inner branch windows is above the valleys which are shown as away from the top in Ivancev, e.g. Figure 1).
Regarding Claim 33, the tapered segment is provided with a waveform ring comprising a plurality of peaks, a plurality of valleys and a plurality of connecting rods respectively connecting adjacent peaks and valleys (discussed supra for claim 32), wherein the outer branch window is located distal to the peaks, or the inner branch window being located proximal to the valleys (discussed supra for claim 32, where above is proximal and below is distal).
Regarding Claim 34, at least one of the peaks and at least one of the valleys is disposed between the inner branch window and the outer branch window (e.g. Ivancev, Figure 1).
Regarding Claim 35, the number of the inner branch windows is two (e.g. Khoury, Figure 6), a peak is disposed between the two inner branch windows (e.g. Khoury, Figure 6; Ivancev, Figure 1; to achieve Khoury’s spacing with Ivancev’s rings, there is at least one peak between the two inner branch windows), and wherein a waveform angle of the peak is between 0o-10o (as broadly claimed, there is no reference point for the angle (between what to locations), therefore there is a feature of the stent that is relative to the peak in the claimed range).
Regarding Claim 36, the number of the inner branches is two (discussed supra for claim 35), and the outer walls of the distal ends of the two inner branches are in a closed connection with an inner wall of the tubular body (e.g. Khoury, Figure 6).
Regarding Claim 37, the number of the inner branches is two (discussed supra for claim 35), and the waveform rings on the two inner branches are distributed in a staggered manner (the inner branch from Khoury has waveforms, #32, as seen in e.g. Figure 3 of Khoury).
Regarding Claim 38, a proximal end surface of the inner branch is inclined with respect to a longitudinal center axis of the inner branch (e.g. Khoury, the end surface is perpendicular to the longitudinal axis), and a distal end surface of the outer branch is inclined with respect to a longitudinal center axis of the outer branch (e.g. Ivancev, Figure 1).
Regarding Claim 39, a proximal end surface of the inner branch is inclined with respect to a longitudinal center axis of the inner branch (discussed supra for claim 38), or a distal end surface of the outer branch is inclined with respect to a longitudinal center axis of the outer branch (discussed supra for claim 38).
Regarding Claim 40, the combination of Ivancev and Khoury discloses the invention substantially as claimed but fails to teach:
an angle between the proximal end surface of the inner branch and the longitudinal center axis of the inner branch is between 30°-60° and an angle between the distal end surface of the outer branch and the longitudinal center axis of the outer branch is between 30°-60°.
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 Ivancev and Khoury such that the inner and/or outer branch has the relative angle as claimed as such a modification would have been an obvious matter of design choice involving a change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04 IV).
Regarding Claim 41, the combination of Ivancev and Khoury discloses the invention substantially as claimed but fails to teach:
an angle between the proximal end surface of the inner branch and the longitudinal center axis of the inner branch is between 30°-60° or an angle between the distal end surface of the outer branch and the longitudinal center axis of the outer branch is between 30°-60°.
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 Ivancev and Khoury such that the inner and/or outer branch has the relative angle as claimed as such a modification would have been an obvious matter of design choice involving a change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04 IV).
Regarding Claim 42, an outer surface of the lumen stent is provided with a partial-release device (e.g. Ivancev, [0042], the stents other than those in the tapered segment are self-expanding and therefore act to partially expand the body at the portions that are attached to).
Regarding Claim 44, the combination of Ivancev and Khoury discloses the invention substantially as claimed but fails to teach:
a vertical distance between the highest point of the proximal end surface of the inner branch and the proximal end of the first body segment is not less than 20 mm.
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 Ivancev and Khoury such that a vertical distance between the highest point of the proximal end surface of the inner branch and the proximal end of the first body segment is not less than 20 mm as such a modification would have been an obvious matter of design choice involving a change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art and 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 (see MPEP 2144.04 IV).
Claim 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivancev (US 2012/0323303 A1) in view of Khoury (US 2014/0094902 A1) as discussed supra and further in view of Iancea, et al (Iancea) (US 2003/0176911).
Regarding Claim 43, the combination of Ivancev and Khoury teaches the inner branch has a proximal end (there is inherently such a proximal end), the first body segment has a proximal end (there is inherently such a proximal end).
The combination of Ivancev and Khoury discloses the invention substantially as claimed but fails to teach:
an outer wall of the first body segment is provided with a barbed structure located between the proximal end of the inner branch and the proximal end of the first body segment.
Iancea teaches barbs on the end ring stents (e.g. Figure 1).
Iancea and the combination of Ivancev and Khoury are concerned with the same field of endeavor as the claimed invention, namely stent grafts.
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 Ivancev and Khoury such that there is a barb structure on the end rings as taught by Iancea in order to provide secure attachment at the implantation site (e.g. Iancea, [0055]).
The combination of Ivancev and Khoury teaches an outer wall of the first segment has a barbed structure between the proximal end of the inner branch and the proximal end of the first body segment (e.g. Ivancev, Figure 6, shows the location of the end rings to which the barbs are added).
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.
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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 6/9/2026
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