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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: reference number 112c disclosed in paragraphs 159 and 160 is not disclosed in the drawings. 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. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The 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 “retention shoulder” 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 1-13 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.
Regarding claim 1, line 7, the Examiner believes that the use of the word “gate” is improper because the gate is part of the first leg and is not the only part that defines one of the two flow channels. The Examiner believes that the first leg defines one of the two channels, therefore, the Applicant’s representative should say: “the first leg”. Correction or clarification is required.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-6, 14 and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Perkins et al US Patent Pub. 2020/0375724A1.
Perkins et al discloses a bifurcated endoprosthesis (200) extending for a length between a proximal end (202) and a distal end (204). The bifurcated endoprosthesis bifurcating from a primary flow channel into two flow channels (214 and 212). The bifurcated endoprosthesis comprising a trunk (210) defining the primary flow channel at the proximal end; a first leg (212) extending from the trunk and defining a gate for receiving a branch endoprosthesis; and a second leg (214) extending from the trunk to the distal end. The first leg (212) and the second leg (214) defining the two flow channels. The first leg and the second leg bifurcating from the trunk at a bifurcation region (See figure below) having a diameter that is greater than a diameter of the trunk (See figure below).
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Regarding claim 2, as disclosed by the claim, the diameter of 16mm is optional, therefore, the Examiner is only looking for a trunk having a substantially uniform diameter (see figure above).
Regarding claim 3, the bifurcated trunk is capable of being inserted in a different main body endoprosthesis.
Regarding claim 4, see paragraph 88 disclosing that the proximal body (210) length ranges from 3-6cm.
Regarding claim 5, as disclosed by the claim, the diameter of 8mm and the length of 2.5cm are optional, therefore, the Examiner is only looking for the first leg shorter than the second leg.
Regarding claim 6, see figure above showing the second leg transitioning distally to a larger diameter portion proximate to a position along a length of the second leg corresponding to an end of the first leg.
Regarding claim 14, see Figures 4 and 5 disclosing the step of deploying an iliac bifurcated endoprosthesis (100) into a contralateral gate of a bifurcated main body endoprosthesis (302).
Regarding claim 15, see Figures 3B-3C disclosing the step of deploying an iliac bifurcated endoprosthesis (100) into an ipsilateral leg of a bifurcated main body endoprosthesis (302).
Claims 16-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by King et al US Patent 11,471,264B2.
King et al discloses a bifurcated endoprosthesis extending for a length between a proximal end and a distal end. The bifurcated endoprosthesis bifurcating from a primary flow channel into two flow channels. The endoprosthesis comprising a trunk defining the primary flow channel at the proximal end. A first leg extending from the trunk and defining a gate for receiving a branch endoprosthesis; and a second leg extending from the trunk to the distal end, the first leg and the second leg defining the two flow channels extending from the primary flow channel. The first leg and the second leg bifurcating from the trunk at a bifurcation region, the first leg having a first section extending from the bifurcation region, a second section, and an intermediate section between the first section and the second section. The first section having a first diameter that is substantially constant along the first section (see figure below). The second section having a second diameter that is substantially constant along the second section and having a diameter that is smaller than the first diameter (see figure below), and the intermediate section tapering in diameter between the first section and the second section. See figure below for all the structural limitations.
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Regarding claims 17 and 18, see figure above and figure 1 showing the branch endoprosthesis (300) received in the gate (See Fig. 2) having complementary fit in parts of the 1st leg, the whole intermediate and 2nd sections. See also col. 3, lines 38-46 disclosing that the leg (216) of the bifurcated stent-graft (1500) in Fig. 15 can have the stent-graft (200) configuration of Fig. 1. Therefore, the top section of element (300) have the complementary fit to the 1st , 2nd and intermediate sections.
Regarding claims 19 and 20, see col. 3, line 38-42 and col. 8, lines 1-7 disclosing self-expandable stent and balloon expandable or a combination of both expandable configurations.
Regarding claim 21, the Applicant’s representative has not defined in the written specification the full meaning of “retention shoulder”, therefore, the Examiner is interpreting the retention shoulder as the angle created by the leg (216) with the intermediate section (220), see below.
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Regarding claims 22 and 23, the branch endoprosthesis is capable of being an internal iliac btanch endoprosthesis and the bifurcated implant (1500) shown in Fig. 15 is capable of being used as an iliac bifurcated endoprosthesis.
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.
Claims 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Perkins et al US Patent Pub. 2020/0375724A1 in view of King et al US Patent 11,471,264B2.
Regarding claim 8, Perkins et al discloses the invention substantially as claimed. However, Perkins et al does not disclose the first leg having a first section having a first diameter that is substantially constant along the first section, a second section having a second diameter that is substantially constant along the second section and having a diameter that is smaller than the first diameter, and the intermediate section tapering in diameter between the first section and the second section.
King et al teaches (as disclosed in the 102 rejection above) all the missing limitations of the Perkins et al reference. Additionally, the tapering of the distal end of the first leg is created for the purpose of generating a transitional configuration to gradually narrow the cross-section of the lumen to thereby reduce disruptions to the blood flow.
It would have been obvious to one ordinary skill in the art to modify the 1st leg of the Perkins et al reference by adding three different sections, wherein the second section has a diameter smaller than the first section and an intermediate section tapering between the first and the second sections in order to create a transitional configuration to gradually narrow the cross-section of the lumen to thereby reduce disruptions to the blood flow.
Regarding claims 9 and 10, see Perkins figure above and figure 1 showing the branch endoprosthesis (300) received in the gate (See Fig. 2) having complementary fit in parts of the 1st leg, the whole intermediate and 2nd sections. See also col. 3, lines 38-46 disclosing that the leg (216) of the bifurcated stent-graft (1500) in Fig. 15 can have the stent-graft (200) configuration of Fig. 1. Therefore, the top section of element (300) have the complementary fit to the 1st , 2nd and intermediate sections.
Regarding claims 11 and 12, see col. 3, line 38-42 and col. 8, lines 1-7 disclosing self-expandable stent and balloon expandable or a combination of both expandable configurations.
Regarding claim 13, the Applicant’s representative has not defined in the written specification the full meaning of “retention shoulder”, therefore, the Examiner is interpreting the retention shoulder as the angle created by the leg (216) with the intermediate section (220), see Kings et al figure above.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Perkins et al US Patent Pub. 2020/0375724A1 in view of Chung et al US Patent Pub. 2020/0170777A1.
Perkins et al discloses all the structural limitations in addition to a trunk having more than one stent, a 1st leg having one stent at the proximal end and a second stent at the distal end and a second leg having more than one stent. However, Perkins et al does not disclose a first leg with a lower density than the volume of the trunk and second leg.
Chung et al discloses a volume of the first leg with lower density than the volume of the second leg. See figure below.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the density of one leg compare to the other, since it has been held that finding an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Pub. 2024/0407908A1 disclosing wider bifurcated region compared to trunk.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-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, 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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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 10/7/26
