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 .
Response to Arguments
Applicant's arguments filed 07/08/26 have been fully considered but they are not persuasive.
On page 15 regarding claim objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws claim objections.
On pages 15-17 Applicant argues amendments overcome the prior art of record, and argues that figure 19b of the instant application shows the stent assembly at an “intermediate state of expansion” as opposed to a fully radial expansion state. Applicant concludes figure 19b cannot be used to prove there is new matter and argues that one of ordinary skill would “understand” that in a fully expanded or unexpanded state, the bridges would be parallel to one another.
The Examiner respectfully points out that the disclosure actually does not indicate what sort of state of expansion figure 19b is. There is no mention of an “intermediate state of expansion” or a “full state of expansion”, making this unclear. The Examiner also disagrees that one of ordinary skill would “understand” anything regarding a fully expanded or fully unexpanded state from figure 19b or any other figure provided, since the disclosure does not actually identify a “fully expanded” or “fully unexpanded” state.
On page 19 regarding 112b rejections Applicant argues “elected Figures 19, 19A, 19B, and 22, taken as a whole” depict the bridges and apices and thus provide “sufficient support” for the claim language.
The Examiner respectfully withdraws 112b rejections based on amendments.
On page 19 regarding drawing objections Applicant argues amendments overcome the drawing objections.
The Examiner respectfully disagrees and notes the amendments have not addressed any of the drawing objections. These are accordingly maintained.
On pages 20-21 regarding prior art rejections Applicant argues amendments overcome the rejection of record since Gregorich does not teach each bridge is parallel to each other bridge since [0049] of Gregorich states that connector struts can typically be substantially straight, and they can be inclined relative to the longitudinal axis as is seen in figure 2.
The Examiner respectfully points out that a statement that connector struts may be inclined at an angle as is shown in one of the many embodiments is not sufficient to indicate that all struts are non-parallel in a specific fully-expanded or fully-unexpanded state as Applicant appears to be suggesting. Additionally, every other embodiment in the disclosure of Gregorich other than that of figure 2 describes and shows the bridges being parallel to one another, making this argument unpersuasive.
Further, the Examiner notes that Applicant’s own disclosure does not appear to disclose the amended claim features, leaving the Examiner unclear on whether Applicant is attempting to claim features that are drawn towards another, non-originally presented or non-elected species (in which case all claims would be considered withdrawn, and so the response non-responsive), or whether there is another explanation. The Examiner addresses the amended claims below as is best understood, but points out clarification/provision of support is greatly needed.
Drawings
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 pairs of circumferentially, consecutive adjacent bridges within a span between two stent components that has a single proximal or distal apex disposed radially therebetween, each bridge extending axially in a parallel manner relative to each other when in a fully radially unexpanded or fully radially expanded configuration, the fully radially unexpanded configuration, the fully radially expanded configuration, 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.
Claim Objections
Claims 1, 4, 6,8-9, 12, 14, 16, 18, 20, 146 are objected to because of the following informalities:
Claim 1 is objected to for referring to “an immediately-proximal radially-expandable stent component”, and “an immediately-distal radially-expandable stent component) with improper antecedent basis.
Further, the claim is unclear for referring to “two longitudinally, consecutive stent components” when it is unclear how, if at all, this relates to the previously identified “plurality of radially-expandable stent components”, “at least one of the stent components”, “immediately-proximally radially-expandable stent components”, and/or “immediately-distal radially-expandable stent component”.
The claim is further unclear for referring to “the radially-expandable stent components” when it is unclear how, if at all, these relate to the previously claimed “plurality of radially-expandable stent components”, “at least one of the stent components”, “immediately-proximally radially-expandable stent components”, “immediately-distal radially-expandable stent component”, and/or the “two longitudinally, consecutive stent components”.
The claim also is unclear for referring to “each bridge” when it is unclear how, if at all, this relates to the previously claimed “plurality of bridges” and “each pair of circumferentially, consecutive adjacent bridges”.
The claim is further objected to for referring to “a fully radially unexpanded or fully radially expanded configuration” when it is believed hyphens are required for these words to be grammatically correct.
The claim is further unclear for claiming “at least one of the stent components including struts”, and then further defines proximal/distal apices of the struts of the one component. However, the claim then defines bridges as linking a portion of proximal (and distal) apices of an immediately-proximal radially-expandable stent component and proximal (and distal) apices of an immediately-distal radially-expandable stent component. However, if only one stent component has struts, it is unclear how there are bridges joining apices between two components, when only one of the components includes apices (defined by struts).
Claim 4 is objected to for referring to “a radially-collapsed position” when it is unclear how this relates, if at all, to the previously referred to “”fully radially unexpanded configuration”.
Claim 6 is objected to for referring to “the radially-expandable stent components” when it is unclear how this relates (if at all) to the previously claimed “plurality of radially-expandable stent components”, “at least one of the stent components”, “immediately-proximally radially-expandable stent components”, “immediately-distal radially-expandable stent component”, and/or the “two longitudinally, consecutive stent components”.
The claim is further unclear for referring to “a radially-expanded position” when it is unclear how this relates, if at all, to the previously claimed “fully radially expanded configuration”.
Claim 8 is objected to for referring to “the proximal apices” when it is unclear how this relates, if at all, to the previously claimed “proximal apices” and/or “at least a portion of the proximal apices”, and or “one of the proximal apices of the immediately-distal radially expandable stent component”.
The claim is further unclear for referring to “an immediate-radially expandable stent component” since it is unclear how this relates (if at all) to the previously claimed “plurality of radially-expandable stent components”, “at least one of the stent components”, “immediately-proximally radially-expandable stent components”, “immediately-distal radially-expandable stent component”, and/or the “two longitudinally, consecutive stent components”.
The claim is similarly unclear for referring to “proximal apices” when it is unclear how this relates, if at all, to the previously claimed “the proximal apices”, “proximal apices” and/or “at least a portion of the proximal apices”, and or “one of the proximal apices of the immediately-distal radially expandable stent component”.
The claim is similarly unclear for referring to “an immediately-distal radially-expandable stent component” when it is unclear how, if at all, this relates to the previously referred to “plurality of radially-expandable stent components”, “at least one of the stent components”, “immediately-proximally radially-expandable stent components”, “immediately-distal radially-expandable stent component”, and/or the “two longitudinally, consecutive stent components”.
Claim 9 is objected to for referring to “a plurality of the radially-expandable stent components” when it is unclear how, if at all, this relates to the previously claimed “plurality of radially-expandable stent components”, “at least one of the stent components”, “immediately-proximally radially-expandable stent components”, “immediately-distal radially-expandable stent component”, and/or the “two longitudinally, consecutive stent components”.
Claims 12 and 14 are objected to for referring to “an increase in the length of the struts” when it is unclear if this is the same increase in the length of struts that was referenced in claim 1, or whether this is a separate increase in length.
Claim 16 is objected to for referring to “the decrease in the axial stiffness of the luminal stent includes a plurality of incremental junctures” when the description appears to indicate that “junctures” are actually a part of the stent itself (e.g. item 64, 80, 205, etc.) and not a feature of stiffness as is currently claimed. The claim is further unclear for claiming “at each juncture the axial stiffness…decreases…” when it has just claimed that the decrease in axial stiffness includes junctures. It appears these two parts of the sentence do not agree with one another.
Claim 18 is objected to for claiming “the plurality of incremental junctures” when claim 17, from which this claim depends, only has one incremental juncture.
Further, the claim is unclear for referring to “each juncture” when it is unclear how this relates, if at all, to the previously claimed “incremental juncture” and/or the “plurality of incremental junctures”.
Claim 20 is objected to for claiming “the radiopaque marker is at least one of the incremental junctures” but this is unclear, since the specification [0084] (and [0098], [0100], [0103]) states that radial markers 82 can be fixed at…junctures 80”, making it appears that the markers might be located at a juncture, but not that the marker is the juncture as is claimed.
Claim 146 is objected to for referring to “a span” and “a distal apex” with improper antecedent basis.
Appropriate correction is required.
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.
Claims 1,4-9,12-14,16-20 and 146 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is rejected for having new matter, since the originally filed specification fails to have support for “each pair of circumferentially, consecutive adjacent bridges of the plurality of bridges within a span between two longitudinally, consecutive stent segments, has a single proximal or distal apex of the proximal or distal apices radially disposed therebetween, and wherein each bridge extends axially in a parallel manner relative to each other, when in a fully radially unexpanded or fully radially expanded configuration”. Notably, there is no mention of the level of expansion of the stent in any of the figures throughout the disclosure, let alone the number of apices between adjacent bridges in such state, or the axial configuration of the bridges in such a state. Further, it appears many bridges do not extend parallel to one another, at least in figure 19b, which is part of the elected embodiment.
PNG
media_image1.png
347
544
media_image1.png
Greyscale
Further, the claim is rejected for having new matter since there is no support in the originally filed disclosure for each pair of the circumferentially adjacent bridges between two longitudinally consecutive stent components to extend parallel relative to each other when in the fully radially expanded/unexpanded configuration, and also have a decrease in the number of bridges and an increase in the length of the struts of the stent components from the proximal end of the stent to the distal end of the stent. Notably, for example, while figure 22 shows a stent with a left half of the stent having three connectors and a right half of the stent having two connectors, this is not the same thing as having an axial stiffness decrease from the proximal end to the distal end. It appears there are two stepped values of stiffness, as opposed to a decreasing value from one end to the other as the claim requires. This figure also does not teach the number of connectors decreasing and the length of the stent components increasing at the same time, let alone the length of the stent components increasing from one end to the other. This figure also does not teach each pair of circumferentially adjacent bridges having a single proximal or distal apex positioned therebetween. At least half the stent includes only two connectors, so there are at least two distal apices and one proximal apex positioned therebetween. Figure 19-19b all have similar problems, none of which support all the amended language of the claim.
Claim 146 is rejected for having new matter for claiming “at least one of the single apices between each pair of circumferentially, consecutive adjacent bridges of the plurality of bridges within a span between two longitudinally, consecutive stent components is a distal apex”. Claim 1 states that each pair of circumferentially consecutive adjacent bridges with a span between two longitudinally consecutive stent components has a single (now distal) apex therebetween, but every single pair of circumferentially consecutive adjacent bridges within a span between two stent components is not a distal apex. At least every other row of the stent components includes apices which appear to be proximal apices located therebetween, indicating that it is new matter for EACH PAIR of adjacent bridges to have a distal apex as the claim requires.
Remaining claims are rejected for depending on a claim with new matter.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4-14, 16-20, 146 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gregorich (US 20040243216 A1) in view of Moriuchi et al. (US 20020095207 A1) hereinafter known as Moriuchi, further in view of Dakin et al. (US 20080065194 A1) hereinafter known as Dakin.
Regarding claims 1, 4, 6 Gregorich discloses a luminal stent ([0001]) comprising:
a plurality of radially-expandable stent components (Figures 1-3 item 112), each component having a proximal and distal end, wherein at least one component includes struts (Figures 1-3 item 1 shows zigzag strut elements making up the ring-shaped components) with opposite ends, the struts being joined to each other at the respective opposite ends to form proximal apices and distal apices (Figure 1 items 136 and 132), wherein the components are arranged in relative proximal and distal relationship to each other (Figure 1-3); and
a plurality of bridges linking immediately proximal and distal components to each other (Figures 1-3 item 124),
wherein at least a portion of the proximal apices of an immediately proximal component are each joined to one of the distal apices of an immediately distal component by the bridges to thereby form the stent (Figures 1-3), and
and wherein each bridge extends axially in a parallel manner relative to each other when in a fully radially-unexpanded or fully radially-expanded configuration (Figures 1 and 3 show the bridges 134 extending parallel to one another. While not the disclosure does not indicate whether the stent in these figures show a fully expanded or a fully unexpanded configuration, the disclosure of Gregorich only refers to an unexpanded state and an expanded state ([0001]), which the Examiner understands as “fully” unexpanded or expanded, respectively. Since the disclosure of Gregorich does not describe or suggest any other state the stent can be in, the person of ordinary skill would find it obvious to assume the stent of Figures 1-12 of Gregorich is in either of the two disclosed states. ),
wherein the stent has a continuous lumen (Figures 1-3) and a proximal and distal end (Figures 1-3 items 104, 108),
wherein the axial stiffness of the stent decreases from the proximal to distal end ([0045]; it is considered inherent that if the number of bridges decrease, the axial stiffness decreases (increase in flexibility) with the decrease in connectors) as a consequence of a decrease in the number of the plurality of bridges spanning the components (Figure 1 shows less bridges at the distal end and more bridges at the proximal end),
and the radial stiffness (which includes resistance to radial expansion from a radially collapsed position and resistance to radial collapse from a radially expanded position) (claims 4 and 6) of the stent decreases from the proximal to distal end (it is considered inherent that if the strut length increases and/or the strut thickness decreases, the radial stiffness (towards collapse or expansion) decreases (increase in flexibility) with the increase in length/strut thickness),
but is silent with regards to a portion of the proximal apices being joined to immediately proximal adjacent apices and a portion of the distal apices being joined to immediately distal apices through a connector,
and the number of bridges decreasing and the strut length increasing at the same time, and
each pair of circumferentially, consecutive adjacent bridges of the plurality of bridges within a span between two longitudinally consecutive stent components, has a single proximal or distal apex of the proximal of distal apices radially disposed therebetween.
However, regarding claims 1, 4, and 6 Moriuchi teaches a stent wherein at least a portion of proximal apices of an immediately proximal stent component are each joined to one of the proximal apices of an immediately distal stent component by connector, and at least a portion of the distal apices of an immediately proximal stent component are each joined to one of the distal apices of an immediately distal stent component by connector (Figure 3). Gregorich and Moriuchi are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the location of the connectors of Gregorich so they connect proximal apex to proximal apex, as well as distal apex to distal apex, as is taught by Moriuchi since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the connections of peak to peak, trough to trough, or peak to trough are all well-understood and utilized connections within the art and considered obvious to try.
PNG
media_image2.png
368
720
media_image2.png
Greyscale
Further, regarding claims 1, 4, and 6, Gregorich teaches that the specific embodiments disclosed therein can be used in combination ([0101]-[0103]), and further discloses that within one of the embodiments, any of the listed mechanisms for changing the flexibility off the stent could be used as additional mechanisms to change the flexibility (see [0078] in which the embodiment of figure 12 is discussed as being able to have more connection struts and increased length connection struts). The person of ordinary skill in the art, in reading Gregorich’s disclosure, would have accordingly found it obvious to modify the specific embodiments of any of the figures of Gregorich (decreased number of bridges as in figure 1 as well as increased strut length as in figure 1), since Gregorich teaches that both these methods modify the flexibility of the stent so the proximal end is stiffer than the distal end. Any combination of elements that creates the gradient in flexibility would be obvious to the person of ordinary skill, since combining prior art elements according to known methods to yield predictable results is held as a prima facie case of obviousness (see MPEP 2143(I)(A)).
Further, regarding claim 1 Dakin teaches a stent where each pair of circumferentially, consecutive adjacent bridges (Figure 5 item 22) within a span between two longitudinally consecutive stent components (Figure 5 item 18a,b), has a single proximal or distal apex of the proximal of distal apices radially disposed therebetween (see Figure 5 where at least one single proximal or distal apex is positioned between the connectors 22 within one row). Gregorich and Dakin are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the Combination so that there is a single apex between adjacent bridges as is taught by Dakin since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by the Gregorich Moriuchi Combination.
Regarding claim 5 the Gregorich Moriuchi Dakin Combination teaches the stent of claim 4 substantially as is claimed,
wherein Gregorich further discloses a portion of the components are stainless steel/Nitinol ([0085]).
Regarding claim 7 the Gregorich Moriuchi Dakin Combination teaches the stent of claim 6 substantially as is claimed,
wherein Gregorich further discloses a portion of the components are stainless steel/Nitinol ([0085]).
Regarding claim 8 the Gregorich Moriuchi Dakin Combination teaches the stent of claim 1 substantially as is claimed,
wherein Gregorich further discloses a portion of the components are self-expanding and include a shape memory elastic metal ([0085]-[0086]),
the proximal apices of an immediate-radially expandable stent component spaced from proximal apices of an immediately-distal radially expandable stent component (see Gregorich Figure 1; see also Moriuchi figure 3).
Regarding claim 9 the Gregorich Moriuchi Dakin Combination teaches the stent of claim 8 substantially as is claimed,
wherein Gregorich further discloses a portion of the components are balloon-expandable and include a member made of stainless steel/Nitinol ([0085]-[0086]).
Regarding claim 12 the Gregorich Moriuchi Dakin Combination teaches the stent of claim 1 substantially as is claimed,
wherein Gregorich further discloses the decrease in radial stiffness is a consequence of an increase in the length of struts of the components (Figure 11; [0074]). Please see the explanation in the rejection to claim 1 above regarding the obviousness of utilizing more than one method disclosed by Gregorich for adjusting the flexibility of the stent.
Regarding claim 13 the Gregorich Moriuchi Dakin Combination teaches the stent of claim 1 substantially as is claimed,
wherein Gregorich further discloses the decrease in radial stiffness is a consequence of a decrease in thickness of at least a portion of the struts of the components (Figure 4a; [0054]).
Regarding claim 14 the Gregorich Moriuchi Dakin Combination teaches the stent of claim 1 substantially as is claimed,
wherein the Combination further teaches the decrease in radial stiffness is a consequence of an increase in length and a decrease in thickness (see the explanation in the rejection of claim 1 above regarding the obviousness of combining of multiple embodiments of Gregorich to achieve the flexibility gradient).
Regarding claim 16 the Gregorich Moriuchi Dakin Combination teaches the stent of claim 1 substantially as is claimed,
wherein Gregorich further discloses the decrease in axial stiffness of the stent includes a plurality of incremental junctures, wherein at least juncture the axial stiffness decreases (this is considered inherent, based on the separation of the stent into bridges and components: each segment represented by a component or bridge represents an incremental juncture of change).
Regarding claim 17 the Gregorich Moriuchi Dakin Combination teaches the stent of claim 1 substantially as is claimed,
wherein Gregorich further discloses the radial stiffness of the stent is stepped, wherein the stent includes an incremental juncture where the radial stiffness changes in at least one increment (this is considered inherent, based on the separation of the stent into bridges and components: each segment represented by a component or bridge represents an increment of change).
Regarding claim 18 the Gregorich Moriuchi Dakin Combination teaches the stent of claim 17 substantially as is claimed,
wherein Gregorich further discloses the stent includes a plurality of incremental junctures, wherein each juncture has the radial stiffness decreasing with increasing distance from the proximal end (this is considered inherent, based on the separation of the stent into bridges and components: each segment represented by a component or bridge represents an increment of change).
Regarding claim 19 the Gregorich Moriuchi Dakin Combination teaches the stent of claim 18 substantially as is claimed,
wherein Gregorich further discloses at least one radiopaque marker ([0090] radiopaque coating).
Regarding claim 20 the Gregorich Moriuchi Dakin Combination teaches the stent of claim 19 substantially as is claimed,
wherein Gregorich further discloses the marker is located at at least one of the incremental junctures ([0090] a generally applied radiopaque coating is understood to cover at least one juncture).
Regarding claim 146 the Gregorich Moriuchi Dakin Combination teaches the stent of claim 1 substantially as is claimed,
wherein Dakin further teaches at least one of the single apices between each pair of circumferentially, consecutive adjacent bridges of the plurality of bridges within a span between two longitudinally, consecutive stent components is a distal apex (Figure 5 at least one of the apices between the connectors 22 in one row is considered to be a distal apex).
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 07/21/26
Prosecution Insights