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.
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 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.
Status of the Claims
Claim(s) 1-20 is/are pending. Claim(s) 5-7 and 15 is/are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Species 1-2 in the reply filed on 11/7/2025 is acknowledged.
Claims 5-7 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species 1-1, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/7/2025.
Claim Objections
Claims 8-9, 14, 16, and 20 are objected to because of the following informalities:
Claim 8, line 4 recites “the first and second”, which should be “the first and the second”.
Claim 9, line 1 recites “the proximal and distal”, which should be “the proximal and the distal”.
Claim 14, line 11 recites “and end”, which should be “an end”.
Claim 16, lines 4-5 recites “the first and second”, which should be “the first and the second”.
Claim 20, line 11 recites “and end”, which should be “an end”.
Appropriate correction is required.
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 1, 3-4, 10-14, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-8, 12, and 15 of U.S. Patent No. 11,559,412. 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 ‘412
1
1, 15
3, 17
1
10
5
11, 18
6
12, 19
7
13
8
4, 14
12, 15
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) 1-2, 8, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shank, et al (Shank) (US 2005/0110214 A1).
Regarding Claim 1, Shank teaches a stent (e.g. Figures 3-4, [0023]-[0024]), comprising:
an elongated tubular member having a first end, a second end, and a longitudinal axis extending therebetween (e.g. [0047], tubular bodies of stents inherently have these elements), the elongated tubular member formed from at least one filament (e.g. Figures 3-4, strand(s) seen in the Figure), the elongated tubular member including:
one or more first region (e.g. annotated Figure 3 below) in which the at least one filament defines a first knit stitch pattern including a plurality of twisted knit stitches each including a closed loop portion with a crossed base portion (e.g. annotated Figure 3 below) in which a portion of the at least one filament forming the closed loop portion crosses over itself (e.g. annotated Figure 3 below); and
one or more second region (e.g. annotated Figure 3 below) in which the at least one filament defines a second knit stitch pattern different from the first knit stitch pattern (e.g. annotated Figure 3 below), wherein an end of the first region is connected to an end of the second region (e.g. annotated Figure 3 below, since each region leads into the other region, they are directly connected to each other along the entire length of the stent, including at the ends of the regions).
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408
612
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Annotated Figure 3, Shank
Regarding Claim 2, the second knit stitch pattern includes a plurality of parallel knit stitches each defined by an incomplete loop having an open base (e.g. Figure 3).
Regarding Claim 8, the one or more first region includes a proximal first region defining the first end of the elongated tubular member and a distal first region defining the second end of the elongated tubular member (as the pattern extends from end to end the first region is at each ends, which are considered to be the proximal first region and the distal first region), and the one or more second region defines a middle portion of the elongated tubular member disposed between the first and second ends (as broadly claimed, the second region(s) define the portions of the wall where they are located).
Regarding Claim 10, the closed loop portion of at least some of the twisted knit stitches is wrapped around the crossed base portion of a longitudinally adjacent twisted knit stitch (e.g. Figure 3).
Claim(s) 1-4, 8, 11-14, and 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Su, et al (Su) (US 2008/0103584 A1).
Regarding Claim 1, Su teaches a stent (e.g. Figure 1, abstract), comprising:
an elongated tubular member having a first end, a second end, and a longitudinal axis extending therebetween (e.g. Figure 1), the elongated tubular member formed from at least one filament (e.g. Figure 1, [0079], the fiber(s) is the filament), the elongated tubular member including:
one or more first region (e.g. annotated Figure 1(1) below) in which the at least one filament defines a first knit stitch pattern including a plurality of twisted knit stitches each including a closed loop portion with a crossed base portion (e.g. annotated Figure 1(1) below) in which a portion of the at least one filament forming the closed loop portion crosses over itself (e.g. Figure 1); and
one or more second region (e.g. annotated Figure 1(1) below) in which the at least one filament defines a second knit stitch pattern different from the first knit stitch pattern (e.g. annotated Figure 1(1) below), wherein an end of the first region is connected to an end of the second region (e.g. Figure 1, since each region leads into the other region, they are directly connected to each other along the entire length of the stent, including at the ends of the regions).
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876
1029
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Annotated Figure 1(1), Su
Regarding Claim 2, the second knit stitch pattern includes a plurality of parallel knit stitches each defined by an incomplete loop having an open base (e.g. Figure 1, rungs between closed loops).
Regarding Claim 3, the plurality of twisted knit stitches forms a series of linked stitches (e.g. Figure 1), wherein the elongated tubular member is configured to move between a radially collapsed configuration when constrained and a radially expanded configuration when unconstrained (e.g. [0078]), wherein when in the radially collapsed configuration the series of linked stitches form longitudinal columns of twisted knit stitches (e.g. annotated Figure 1(2) below, as broadly claimed there is no requirement that a column extend from terminal end to terminal end, thus two or more longitudinally aligned loops meets the required language) and in the radially expanded configuration the series of linked stitches extend helically around the elongated tubular member (e.g. Figure 1) such that each of the plurality of twisted knit stitches in each series of linked stitches is circumferentially offset from a longitudinally adjacent twisted knit stitch (e.g. Figure 1).
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1213
1149
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Annotated Figure 1(2), Su
Regarding Claim 11, the at least one filament forms rungs extending circumferentially between radially adjacent twisted knit stitches (e.g. Figure 1, linear portions between loops), wherein when in the radially expanded configuration the rungs define an outer surface of the elongated tubular member (e.g. Figure 1) and the crossed base portion of each twisted knit stitch extends radially outward from the outer surface (e.g. Figures 2, at the locations where the loops are in the shown cross section on the sides where labels #181 are located).
Regarding Claim 12, the crossed base portions form a raised ridge extending helically around the elongated tubular member in the radially expanded configuration (e.g. Figure 2).
Regarding Claim 13, the raised ridge has a longitudinal cross-sectional wave shape (e.g. annotated Figure 2(1) below, both overall and locally at each loop), with a first slope facing a proximal end of the elongated tubular member, a crest, and a pocket facing a distal end of the elongated tubular member (e.g. annotated Figure 2(1) below, as claimed only one instance of each element is required, which is the one shown), wherein when inserted within a body lumen, the raised ridge resists distal movement while allowing removal in a proximal direction (as the ridges project away from the main body, they are able to provide the function of anchoring the device into the tissue).
The Examiner notes the wave cross-section is also present in the orientation of e.g. annotated Figure 2(2) below and has the slope, crest, and pocket as shown, which is repeated along the longitudinal length of the device.
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802
1093
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Annotated Figure 2(1), Su
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1038
790
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Annotated Figure 2(2), Su
Regarding Claim 4, an entirety of the elongated tubular member is formed by a single filament (e.g. claim 19).
Regarding Claim 8, the one or more first region includes a proximal first region defining the first end of the elongated tubular member and a distal first region defining the second end of the elongated tubular member (as the pattern extends from end to end the first region is at each ends, which are considered to be the proximal first region and the distal first region), and the one or more second region defines a middle portion of the elongated tubular member disposed between the first and second ends (as broadly claimed, the second region(s) define the portions of the wall where they are located).
Regarding Claim 14, Su teaches a stent (discussed supra for claim 1), comprising:
an elongated tubular member having a first end, a second end, and a longitudinal axis extending therebetween (discussed supra for claim 1), an entirety of the elongated tubular member formed from a single filament (discussed supra for claim 4), the elongated tubular member including:
one or more first region (discussed supra for claim 1) in which the filament defines a first knit stitch pattern including a plurality of twisted knit stitches each including a closed loop portion with a crossed base portion (discussed supra for claim 1) in which the filament forming the closed loop portion crosses over itself (discussed supra for claim 1); and
one or more second region (discussed supra for claim 1) in which the filament defines a second knit stitch pattern (discussed supra for claim 1) including a plurality of parallel knit stitches (discussed supra for claim 11, rungs) each defined by an incomplete loop having an open base (e.g. Figure 1, they do not have a looped structure), wherein an end of the first region is directly connected to an end of the second region (discussed supra for claim 1).
Regarding Claim 16, the one or more first region includes a proximal first region defining the first end of the elongated tubular member and a distal first region defining the second end of the elongated tubular member (discussed supra for claim 8), and the one or more second region defines a middle portion of the elongated tubular member disposed between the first and second ends (discussed supra for claim 8).
Regarding Claim 17, the plurality of twisted knit stitches forms a series of linked stitches (discussed supra for claim 3), wherein the elongated tubular member is configured to move between a radially collapsed configuration when constrained and a radially expanded configuration when unconstrained (discussed supra for claim 3), wherein when in the radially collapsed configuration the series of linked stitches form longitudinal columns of twisted knit stitches (discussed supra for claim 3) and in the radially expanded configuration the series of linked stitches extend helically around the elongated tubular member (discussed supra for claim 3) such that each of the plurality of twisted knit stitches in each series of linked stitches is circumferentially offset from a longitudinally adjacent twisted knit stitch (discussed supra for claim 1).
Regarding Claim 18, the at least one filament forms rungs extending circumferentially between radially adjacent twisted knit stitches (discussed supra for claim 11), wherein when in the radially expanded configuration the rungs define an outer surface of the elongated tubular member (discussed supra for claim 11) and the crossed base portion of each twisted knit stitch extends radially outward from the outer surface (discussed supra for claim 11).
Regarding Claim 19, the crossed base portions form a raised ridge extending helically around the elongated tubular member in the radially expanded configuration (discussed supra for claim 12).
Regarding Claim 20, Su teaches a stent (discussed supra for claim 1), comprising:
an elongated tubular member having a first end, a second end, and a longitudinal axis extending therebetween (discussed supra for claim 1), the elongated tubular member formed from at least one filament (discussed supra for claim 1), the elongated tubular member including:
one or more first region (discussed supra for claim 1) in which the at least one filament defines a first knit stitch pattern including a plurality of twisted knit stitches each including a closed loop portion with a crossed base portion (discussed supra for claim 1) in which a portion of the at least one filament forming the closed loop portion crosses over itself (discussed supra for claim 1); and
one or more second region (discussed supra for claim 1) in which the at least one filament defines a second knit stitch pattern (discussed supra for claim 1) including a plurality of parallel knit stitches (discussed supra for claim 14) each defined by an incomplete loop having an open base (discussed supra for claim 14), wherein and end of the first region is connected to an end of the second region (discussed supra for claim 1);
wherein the plurality of twisted knit stitches forms a series of linked stitches (discussed supra for claim 3), wherein the elongated tubular member is configured to move between a radially collapsed configuration when constrained and a radially expanded configuration when unconstrained (discussed supra for claim 3), wherein when in the radially collapsed configuration the series of linked stitches form longitudinal columns of twisted knit stitches (discussed supra for claim 3) and in the radially expanded configuration the series of linked stitches extend helically around the elongated tubular member (discussed supra for claim 3) such that each of the plurality of twisted knit stitches in each series of linked stitches is circumferentially offset from a longitudinally adjacent twisted knit stitch (discussed supra for claim 3).
Claim(s) 1-2, 4, 8, 10, 14, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson, et al (Anderson) (US 5,876,445).
Regarding Claim 1, Anderson teaches a stent (e.g. abstract, Figures 1-1c), comprising:
an elongated tubular member having a first end, a second end, and a longitudinal axis extending therebetween (e.g. Figures 1, 1c), the elongated tubular member formed from at least one filament (e.g. column 1, lines 55-63), the elongated tubular member including:
one or more first region (e.g. column 16, lines 44-54, colon stent with flared portions on both ends; the first region being the flared portion) in which the at least one filament defines a first knit stitch pattern including a plurality of twisted knit stitches each including a closed loop portion with a crossed base portion (e.g. Figures 1, 1c show the general knit stitch pattern; column 15, line 57 to column 16, line 17 and column 16, lines 27-43 indicate the closed configuration in Figure 11g is applicable to the colon device noted supra; the pattern shown in Figures 11g is in the flared portions) in which a portion of the at least one filament forming the closed loop portion crosses over itself (e.g. Figure 11g, column 15, line 57 to column 16, line 17, there is overlap as shown); and
one or more second region (the region between the flared ends) in which the at least one filament defines a second knit stitch pattern different from the first knit stitch pattern (e.g. column 15, line 57 to column 16, line 17; as the distance between the filament parts depends on the degree of expansion, the flared ends pattern changes as the diameter increases from a baseline diameter that remains in the middle portion), wherein an end of the first region is connected to an end of the second region (e.g. Figures 1, 1c, the sections are continuous with one another).
Regarding Claim 2, Regarding Claim 2, the second knit stitch pattern includes a plurality of parallel knit stitches each defined by an incomplete loop having an open base (e.g. Figure 11g, at #612).
Regarding Claim 4, an entirety of the elongated tubular member is formed by a single filament (e.g. column 8, lines 15-29; column 8, lines 30-67, applicable to the colon stent).
Regarding Claim 8, the one or more first region includes a proximal first region defining the first end of the elongated tubular member (one of the flared ends) and a distal first region defining the second end of the elongated tubular member (the other of the flared ends), and the one or more second region defines a middle portion of the elongated tubular member disposed between the first and second ends (portion between the flared ends).
Regarding Claim 10, the closed loop portion of at least some of the twisted knit stitches is wrapped around the crossed base portion of a longitudinally adjacent twisted knit stitch (e.g. Figure 11g).
Regarding Claim 14, Anderson teaches a stent (discussed supra for claim 1), comprising:
an elongated tubular member having a first end, a second end, and a longitudinal axis extending therebetween (discussed supra for claim 1), an entirety of the elongated tubular member formed from a single filament (discussed supra for claim 4), the elongated tubular member including:
one or more first region (discussed supra for claim 1) in which the filament defines a first knit stitch pattern including a plurality of twisted knit stitches each including a closed loop portion with a crossed base portion (discussed supra for claim 1) in which the filament forming the closed loop portion crosses over itself (discussed supra for claim 1); and
one or more second region (discussed supra for claim 1) in which the filament defines a second knit stitch pattern including a plurality of parallel knit stitches (discussed supra for claim 2) each defined by an incomplete loop having an open base (e.g. Figure 11g, at #612), wherein an end of the first region is directly connected to an end of the second region (discussed supra for claim 1).
Regarding Claim 16, the one or more first region includes a proximal first region defining the first end of the elongated tubular member and a distal first region defining the second end of the elongated tubular member (discussed supra for claim 8), and the one or more second region defines a middle portion of the elongated tubular member disposed between the first and second ends (discussed supra for claim 8).
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 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson, et al (Anderson) (US 5,876,445) as discussed supra, alone.
Regarding Claim 9, the proximal and distal first regions make up to 25% of an overall length of the elongated tubular member (e.g. column 16, lines 44-54, flared portions have an axial length of 1.5 cm, while the colon stent is 4 to 10 cm in length overall; thus (1.5 cm*2)/10cm*100% = 30%).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson such that the proximal and distal first regions make up to 25% of an overall length of the elongated tubular member as it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (MPEP 2144.05(I)).
Relevant Prior Art
US 2009/0005855 A1 to Goto, et al teaches a stent having open loop knit stitches and rungs (e.g. Figure 28), but lacks the knit stitches being in a closed loop crossing itself.
US 5,662,713 to Anderson, et al teaches a stent having open loop knit stitches (e.g. Figures 1, 1b).
US 6,161,399 to Jayaraman teaches a stent having twisted knit stitches and first and second knit stitch patterns (e.g. Figure 13).
US 2004/0167606 A1 to Chouinard teaches a stent having different patterns at different longitudinal positions (e.g. Figures 1-6, 9).
US 2009/0138070 A1 to Holzer, et al teaches a stent having multiple patterns including one having an open knit stitch pattern (e.g. Figures 5-6).
US 2010/0256735 A1 to Morales teaches a stent having a closed loop pattern (e.g. Figures 1, 1A).
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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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 11/19/2025