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 .
Election/Restrictions
Newly submitted claims 11-13 and 15-21 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
With regard to claims 11-13, the claims are directed to a distinct species as seen in Fig. 8. This species is distinct since it requires a plurality of inclined strips placed at an incline and overlapping to form the covering. This is materially different than the covering disclosed in the species as seen in Figs. 1 and 2 and required by previously presented claims 4 and 7 requiring a plurality of axial sizes of the cover layer gradually decrease in the circumferential direction. There would be a serious search burden due to the separate status in the art, and field of search. Additionally, there is a serious examination burden as evidenced by issues relevant to one invention that are not relevant to the other invention.
With regard to claims 15-21, the claims are directed to a distinct invention, namely a stent system featuring a double layer lumen stent and an aortic stent. The newly submitted claims are drawn to a combination while the previously examined claims are drawn to a subcombination. The combination as claimed does not require all the particulars of the sub-combination. For example, the combination does not require the plurality of corrugated metal bars (of the support structure of the outer layer skirt) are distributed in an axial direction to form a barrel shaped structure. Additionally, the subcombination, the dual layer lumen stent has separate utility in that it can be used independently in a materially different place within the body such as in the stomach as a gastric bypass sleeve. There would be a serious search burden due to the separate status in the art, and field of search. Additionally, there is a serious examination burden as evidenced by issues relevant to one invention that are not relevant to the other invention.
Since applicant has received an action on the merits for the originally presented invention and species, this invention and species has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 11-13 and 15-21 are withdrawn from consideration as being directed to a non-elected species and invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
Claims 1, 2, 7, 11-21 are pending in the application. Claims 4, 8, and 9 have been cancelled. Claims 3, 5, 6 and 10 were previously cancelled. Claims 1, 2, and 7 have been amended. Claims 11-13 and 15-21 are withdrawn as being directed to a non-elected species and invention as set forth above. Claims 1, 2, 7, and 14 are rejected.
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 openings at the two ends of the main body lumen stent have a cut-shaped structure as recited in claim 14 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 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 1, 2, 7, and 14 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 1 recites “…wherein the cover layer has a first axial length S on one side of the opening structure, and a second axial length L on an other side of the opening structure, with the first axial length S being 1/2 to 2/3 of the second axial length L…” in lines 12-14. It is unclear what is meant by “on one side of the opening structure” and “on an other side of the opening structure”. Since the skirt is a circle, it has no “sides”. For the purposes of examination, this limitation is being interpreted as “axial lengths” at various points along the circumference.
Claim 7 recites “the cover layer extends from a wave trough of the waveform structure of one side to a wave crest of the waveform structure of the other side”. It is unclear if this limitation is attempting to refer back to the similarly recited limitation which has been added to claim 1 at lines 22-24 or if applicant is attempting to claim a separate distinct extension of the cover layer from a different wave trough to wave crest. For the purposes of examination, this limitation is being interpreted as referring back to the similar limitation of claim 1. It is noted that this limitation is redundant and unnecessary.
Claim 14 recites “…the main body lumen stent has two ends, and an opening at each of the two ends, wherein the openings at the two ends of the main body lumen stent have a cut-shaped structure.”. It is unclear what is meant by “cut-shaped structure” The only recitation in the specification of “cut-shaped structure” is paragraph [0030] which states “Openings at two ends of the main body lumen stent 10 may also have a cut-shaped structure, which is conducive to smoothly assembling the double-layer lumen stent 100 into the delivery sheath.” It is unclear is this recitation is attempting to claim “an oblique cut shape” or some other configuration. It is noted that neither the written description nor the drawings provides support for the two ends of the main body lumen stent to also have oblique cut-shapes.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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(s) 1, 2, 7, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over previously cited Elliot (US PG Pub 2003/0236567) in view of applicant cited Zigelboim et al (US PG Pub 2018/0333251) and previously cited Fogarty et al (US Pat. No 6,491,719).
Regarding claim 1, Elliot teaches a double-layer1 lumen2 stent comprising:
a main body lumen stent (12) and an outer-layer skirt stent (16 in combination with scaffold 22) surrounding an outer wall of the main body lumen stent (See Figs. 3-7; paragraphs [0024] and [0030]),
the outer-layer skirt stent (16) comprising a support structure (22) and a cover layer (16) arranged on the support structure (See paragraphs [0030] and [0032]), characterized in that one end of the outer-layer skirt stent is connected to the outer wall of the main body lumen stent (See Figs. 3-7; paragraph [0030]); the other end of the outer-layer skirt stent is an opening structure (note the skirt has an open end which extends away from the main stent body) composed of the support structure (22).
Elliot further teaches the support structure (22) comprises corrugated3 metal bars (22) distributed in a circumferential direction (See paragraph [0030]). Elliot does not explicitly teach the corrugated metal bar at the edge of the opening structure has a plurality of waveform structures distributed in a circumferential direction, the plurality of waveform structures having a plurality of wave crests and wave troughs. Elliot does teach that the scaffold 22 may be “wavy, S-shaped, bent, and so forth” and “the skirt 16 may be more fully supported wherein the scaffold 22 includes a plexus of elements (e.g., wire members) arranged in a typical stent configuration.” (See paragraph [0030]).
Zigelboim teaches an analogous endovascular prosthesis having a stent graft (110) and an outer skirt (42) where the outer skirt (42) has a support structure which is corrugated metal bars (strut members 30) distributed in a circumferential direction, the plurality of waveform structures having a plurality of wave crests and wave troughs (See Figs. 5A & 5B).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stent as taught by Elliot to include the teachings of Zigelboim such that the support structure of the outer skirt was made of a plurality of sinusoidal metal bars distributed in an axial direction to form a barrel-shaped structure since Elliot explicitly teaches the scaffold of the skirt may have multiple wire members arranged in a typical stent configuration and Zigelboim teaches this configuration helps to prevent leakage after implantation.
Modified Elliot does not explicitly teach the cover layer is formed into an oblique cut shape at an edge of the opening structure; the cover layer has a first axial length S on one side of the opening structure and a second axial length L on an other side of the opening structure with the first axial length S being ½ to 2/3 of the second axial length L; and the cover layer is covered on the plurality of waveform structures gradually decreasing in a circumferential direction wherein the cover layer extends from a wave trough of the waveform structure of the one side to a wave crest of the waveform structure of the other side. Eliot does teach the skirt “may be formed in various geometric configurations” (See paragraph [0024])
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Fogarty teaches an analogous intraluminal prosthesis (Stent) where at least one open end has an oblique cut shape at an edge of the opening where the cover layer has a first axial length S on one side4 of the opening structure and a second axial length L on an other side of the opening structure with the first axial length S being 1/2 to 2/3 of the second axial length L (See annotated Fig. 11 above); and the cover layer is covered on the plurality of waveform structures gradually decreasing in a circumferential direction wherein the cover layer extends from a wave trough of the waveform structure of the one side to a wave crest of the waveform structure of the other side. (See annotated Fig. 11 above). Fogarty teaches having the opening at the end be at an oblique angle is advantageous because it avoids occlusion of the opening from cell proliferation which occurs at the end of an implanted stent (See Col. 1, lines 37-42).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stent as taught by Elliot so that the cover layer of the outer skirt had an oblique cut shape at an edge of the opening structure and the cover layer has a first axial length S on one side of the opening structure and a second axial length L on an other side of the opening structure with the first axial length S being ½ to 2/3 of the second axial length L; and the cover layer is covered on the plurality of waveform structures gradually decreasing in a circumferential direction wherein the cover layer extends from a wave trough of the waveform structure of the one side to a wave crest of the waveform structure of the other side as taught by Fogarty since Elliot explicitly contemplates a variety of skirt geometries depending upon the desired criteria for a particular placement and since Fogarty teaches that an oblique end opening is desirable so as to avoid excessive cellular proliferation at the opening of the stent which can result in restenosis thus making a safer device for the patient.
In the alternative, with specific regard to the limitation “the first axial length S being ½ to 2/3 of the second axial length L”, the ratio of the first axial length “S” and second axial length “L” is disclosed to be a result effective variable which assists with self-expansion of the skirt element. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in further modifying Elliott to have the first axial length S being ½ to 2/3 of the second axial length L, as it only involves adjusting the dimension of a component already disclosed to be adjustable. Therefore, 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 first axial length S being ½ to 2/3 of the second axial length L as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05
Regarding claim 2, modified Elliot teaches the stent according to claim 1 as set forth above and further teaches the plurality of corrugated metal bars are distributed in an axial direction to form a barrel-shaped structure. (See Figs. 3, 6, and 7 of Elliot and Figs. 5A & 5B of Zigelboim).
Regarding claim 7, modified Elliot teaches the stent according to claim 1 as set forth above and further teaches the cover layer extends from a wave trough of the waveform structure of one side to a wave crest of the waveform structure of the other side (See annotated Fig. 11 and rejection of claim 1 above), so that the cover layer at the edge of the opening structure can be formed into the oblique cut shape according to a linear change. (See also rejection of claim 1 above. It is noted that the limitations of this claim are incredibly similar to the recitations of claim 1.
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Regarding claim 14, modified Elliot teaches the stent according to claim 1 as set forth above and further teaches the main body lumen stent (12) has two ends, and an opening at each of the two ends (See Figs. 3-7; paragraphs [0024]-[0030]), wherein the openings at the two ends of the main body lumen stent have a cut-shaped5 structure6.
Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as a matter of design choice to further modify the stent as taught by Elliot to have the openings at each of the ends of the main body lumen stent to have “a cut-shaped structure” or whatever other shape was desired or expedient. A change in shape or form is generally recognized as a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant (produced unexpected results). In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). See also MPEP §2144.04(IV)(B).
Response to Arguments
Applicant's arguments filed June 14, 2025 have been fully considered but they are not persuasive.
Applicant argues that the combination of Elliot (US PG Pub 2003/0236567) in view of Fogarty et al (US Pat. No 6,491,719) does not teach the skirt has the arrangement as claimed. This is unpersuasive. As set forth above Elliot teaches a double layer stent with a main stent and a skirt. Elliot has been modified to incorporate the teachings of Fogarty such that the skirt has an oblique shape at the opening.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary reference. For the reasons set forth above, this is unpersuasive.
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 RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm eastern time zone .
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.S.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
1 Note the skirt 16 is a separate layer from the stent wall 12 (See paragraphs [0021] and [0024])
2 Note tubular body 12 has a lumen running therethrough. (See Fig. 2b)
3 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. “Corrugated” is defined by the Cambridge English Dictionary as “having parallel rows of folds that look like a series of waves when seen from the edge” It is the examiner’s position that Elliot’s disclosure that the support members 22 may be “wavy, S-shaped, bent, and so forth” (Paragraph [0030]) is sufficient to meet the claimed limitation of “corrugated”.
4 As noted in the 35 U.S.C. §112(b) section above, since the skirt is circular it does not have “sides”. MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, the term “side” is being interpreted as an axial length along any given point of the circumference of the skirt since such a location would be on an outside of the skirt. Additionally, it is noted that the claim does not require any specific relationship between “one side” and “an other side”. It is the examiner’s position that the lengths as indicated on annotated Fig. 11 meets the claimed limitation since it shows two separate axial lengths on two separate circumferential locations.
5 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. It is noted that there is only one recitation of “cut shaped structure” in the specification at paragraph [0030] and it does not give a special definition. The Cambridge English Dictionary defines “cut” as “to divide or make something smaller, using a sharp tool, especially a knife”. As seen in Figs. 3-7, the ends of the main body lumen stent have openings and are the terminus of the stent.
6 As can best be understood from the instant claims and applicant’s disclosure, this is a product-by-process limitation since “cut-shape” is defining how the ends of the stent are formed. Only the product will be examined. As noted by the court in Thorpe. “[e]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe. 777 F.2d 695, 698 (Fed. Cir. 1985) (citations omitted). The court further stated in Brown. “[w]e are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product by process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 173 USPQ 685, 688 (CCPA 1972)