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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 01/09/2025 and 08/27/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Examiner notes, a minor typographical error was found in the title of the 1st NPL reference listed on the IDS filed on 01/09/2025. Therefore, the IDS was annotated to fix that mistake.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Figure 2A, reference number (216).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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 as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “320” has been used to designate both, Paragraph [0095], line 3, flanged end (320); line 10, terminal cell (320).
Reference character “320” has been used to designate both, Paragraph [0097], line 2, flanged end (420); line 5, terminal cell (420).
Reference character “320” has been used to designate both, Paragraph [0098], line 2, flanged end (520); line 9, terminal cell (520).
Reference character “620” has been used to designate both, Paragraph [0099], line 2, flanged end (620); line 4, terminal cell (620).
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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because:
It includes the following phrases which can be implied, “Described herein are...” and “The methods described herein may be used to...”. The abstract should avoid using phrases which can be implied.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
Paragraph [0005], missing a period at the end.
Paragraph [0095], line 3, remove the “s” from “FIGs. 2B”.
Paragraph [0103], line 25, “patency in maintained” should be “patency is maintained”.
Paragraph [0127], line 16, “It is also understood that the throughout the…” should be “It is also understood that throughout the…”.
Appropriate correction is required.
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 should be amended to the following, “A method of maintaining a patent ductus arteriosus in a pediatric patient, comprising:
deploying a first end of a self-expanding stent at a first end of a lumen defined by a ductus arteriosus, wherein a stent body of the self-expanding stent has three or fewer connections between adjacent rings; (period should be a semicolon)
anchoring at least a portion of a first flange of the first end of the self-expanding stent such that the first flange at least partially circumferentially covers one of: a pulmonary artery ostium or an aortic ostium;
deploying a second end of the self-expanding stent, such that the stent body covers an entire length of the lumen defined by the ductus arteriosus; and
anchoring at least a portion of a second flange of the second end of the self-expanding stent such that the second flange at least partially circumferentially covers the other of the pulmonary artery ostium or the aortic ostium.” This will help maintain consistency and avoid ambiguity in the claim.
Appropriate correction is required.
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 14-16, 18, and 22 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 14 recites the limitation "adjacent rings" in the 5th line of the claim. There is insufficient antecedent basis for this limitation in the claim. The claim refers to "adjacent rings," but the claim has not previously introduced "rings" or "a plurality of rings" as part of the stent body. It is therefore unclear which rings the claim is referring to, or if the "adjacent rings" are a new element altogether rather than a component of the previously recited "stent body". Because the structural relationship between the stent body and the rings is not clearly established, the metes and bounds of the claimed invention are not reasonably ascertainable to one of ordinary skill in the art. Examiner will interpret the limitation as follows, “wherein a stent body of the self-expanding stent comprises a plurality of rings, and has three or fewer connections between adjacent rings of the plurality of rings”.
Claims 15-16, 18, and 22 are rejected by virtue of their dependency on claim 14. Examiner notes that should applicant choose to amend claim 14 to include the limitation “plurality of rings” it should also be reflected in the dependent claims as seen in the prior art rejections below.
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) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sudhir (US Patent No. 9408952), in view of Harrison (US PGPUB No. 20190060052), and further in view of Passman (US PGPUB No. 20200391016).
Regarding claim 14, Sudhir discloses methods of treating congenital heart defects in infants and children with bioabsorbable polymer stents. Sudhir teaches, a method of maintaining a patent ductus arteriosus in a pediatric patient (Col. 3, line 20-30 and Col. 13, line 5-36), comprising:
deploying a first end of a self-expanding stent (Figure 1, stent (100); Col. 6, line 47-62) at a first end of a lumen defined by a ductus arteriosus (Col. 13, line 13-19; Where it is clear that deploying stent (100) in the ductus arteriosus will lead to the distal end of stent (100) deploying at a first end of the lumen of the ductus arteriosus), wherein a stent body (Figure 1, body having a pattern or network of interconnecting structural elements (105); Col. 6, line 47-50) of the self-expanding stent comprises a plurality of rings (Figure 1, rings (107); Col. 6, line 50-53), and has connections (Figure 1, linking elements (110); Col. 6, line 50-53) between adjacent rings of the plurality of rings (Figure 1); and
deploying a second end of the self-expanding stent (stent (100)), such that the stent body covers an entire length of the lumen defined by the ductus arteriosus (Col. 13, line 13-19; Where it is clear that deploying stent (100) in the ductus arteriosus will lead to the eventual deployment of the second end of the stent (100) which will allow the stent (100) to cover the entirety of the length of the lumen defined by the ductus arteriosus, given that it must provide support to the ductus arteriosus at an increased diameter to allow increased blood flow into the heart and body of the patient as disclosed in Col. 13, line 18-20).
Sudhir does not explicitly teach, three or fewer connections (Though Figure 1 clearly shows at least two connections between adjacent rings (107)); anchoring at least a portion of a first flange of the first end of the self-expanding stent such that the first flange at least partially circumferentially covers one of: a pulmonary artery ostium or an aortic ostium; and anchoring at least a portion of a second flange of the second end of the stent such that the second flange at least partially circumferentially covers the other of the pulmonary artery ostium or the aortic ostium.
Harrison discloses, self-expending stents that include circumferential rings of alternating interconnected struts connected by flexible connectors. Harrison teaches, a self-expanding stent (Figures 4-5, stent (10); Paragraph [0046]) comprising a stent body (Figures 4-5) with a plurality of rings (Figure 5, rings (12); Paragraph [0046]) having connectors between them (Figure 5, connectors (14); Paragraph [0046]) (Paragraph [0055], discloses, “For the embodiment of FIGS. 4-6, the connectors 14 connect alternate peaks, but the frequency of such connections can be varied depending on desired flexibility of the stent 10 with recognition that too few connectors 14 could result in fish scaling or other bending anomalies that would interfere with effective function. In any case, other examples of connector shape and frequency and connection location are described hereinbelow to illustrate that such variations are possible and still within the scope of the present invention.” This indicates that while connectors can connect alternate peaks, the frequency can be varied, and specifically mentions that "too few connectors... could result in fish scaling". This provides a direct structural disclosure of a stent body with a specific, limited number of connections (e.g., one or two) to maximize flexibility for tortuous anatomy like the ductus arteriosus).
Passman discloses methods and techniques for performing transcatheter procedure on a patient that results in blood flow changes, that are meant to be performed shortly after the birth of a patient (within about a month of birth), followed by another procedure when the patient is about 4-12 months, and a third procedure that is performed on the patient when they are 18-36 months old (Paragraph [0021]), the first procedure being disclosed as placing a shunt scaffold between the aorta and pulmonary artery to create a passage (Paragraph [0017]), which is what the ductus arteriosus does. Passman teaches, anchoring at least a portion of a first flange (Figures 10B-11, end portions (130A); Paragraph [0069]) of the first end of the self-expanding stent (Figures 6-11, shunt scaffold (130); Paragraph [0060]) such that the first flange (end portions (130A)) at least partially circumferentially covers one of: a pulmonary artery ostium or an aortic ostium (Figures 6-9; Paragraphs [0064]-[0065]; Figures 8-9, clearly illustrate the anchoring of one of the end portions (130A) to an ostium of the pulmonary artery (20), thus covering the ostium circumferentially given the geometry of shunt scaffold (130) shown in Figures 10B and 11); and
anchoring at least a portion of a second flange (Figures 10B-11, end portions (130A); Paragraph [0069]) of the second end of the self-expanding stent (shunt scaffold (130)) such that the second flange (end portions (130A)) at least partially circumferentially covers the other of the pulmonary artery ostium or the aortic ostium (Figures 6-9; Paragraphs [0064]-[0065]; Figures 8-9, clearly illustrate the anchoring of one of the end portions (130A) to an ostium of the aorta (14), thus covering the ostium circumferentially given the geometry of shunt scaffold (130) shown in Figures 10B and 11).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the method and stent of Sudhir with the teachings of Passman and Harrison, specifically, utilize the flanged anchoring technique of Passman to ensure that the stent of Sudhir at least partially circumferentially covers the pulmonary and aortic ostia, while further configuring the stent body with three or fewer connections between adjacent rings, as taught by Harrison, as all the references and the claimed invention are directed to devices/methods used to directing the flow of blood. 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 method and stent of Sudhir with the teachings of Passman and Harrison, specifically, utilize the flanged anchoring technique of Passman to ensure that the stent of Sudhir at least partially circumferentially covers the pulmonary and aortic ostia, while further configuring the stent body with three or fewer connections between adjacent rings, as taught by Harrison, as such a modification would have been predictable, namely, aid in securing the stent against migration while preventing perivalvular leakage in the high-pressure environment between the aorta and pulmonary artery. Furthermore, varying the frequency of connectors allows the stent to be tailored for the desired flexibility.
Claim(s) 15-16, 18, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sudhir, in view of Harrison , further in view of Passman, and even further in view of Chew (US PGPUB No. 20030135266).
Regarding claim 15, Sudhir teaches, deploying the stent body ensuring coverage of the entire length of the lumen defined by the ductus arteriosus (Col. 13, line 13-20; Where it is disclosed that the bioabsorbable polymer scaffold is deployed in the ductus arteriosus of the patient to maintain patency of the ductus arteriosus and to allow blood flow to the lungs and the body, by providing support to the ductus arteriosus at an increased diameter to allow increased blood flow into the heart and body of the patient, which is a clear indication that the tissue along the length of the ductus arteriosus is being supported by covering the entire length with the scaffold). Sudhir further teaches the stent (stent (100)) as segmented where a segment is a ring of the plurality of rings or a ring of the plurality of rings and a connector (Figure 1, rings (107) & linking elements (110)).
Sudhir does not explicitly teach, deploying the stent body segment by segment to control a spacing between adjacent segments to ensure coverage of the entire length of the lumen defined by the ductus arteriosus.
Harrison teaches, aspects of the method according to claim 14 (See above rejection of claim 14).
Passman teaches, other aspects of the method according to claim 14 (See above rejection of claim 14).
Chew discloses, to apparatus and methods for independently delivering a plurality of luminal prostheses within a body lumen, such as a blood vessel. Chew teaches, deploying the stent body segment by segment to control a spacing between adjacent segments to ensure coverage of the entire length of the lumen defined by the blood vessel (Figures 8A-9C along with Paragraphs [0066]-[0069], describe deploying the stent body segment by segment which will enable for the control of the spacing between adjacent segments ensuring coverage of the entire length of the lumen defined by the blood vessel).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the method and stent of Sudhir with the teachings of Chew, specifically, utilize the segment by segment deployment of the stent body enabling for the control of the spacing between adjacent segments ensuring coverage of the entire length of the lumen defined by the blood vessel/ductus arteriosus, as taught by Chew, as all the references and the claimed invention are directed to devices/methods used to directing the flow of blood. 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 method and stent of Sudhir with the teachings of Chew, specifically, utilize the segment by segment deployment of the stent body enabling for the control of the spacing between adjacent segments ensuring coverage of the entire length of the lumen defined by the blood vessel/ductus arteriosus, as taught by Chew, as such a modification would have been predictable, namely, provide stents, delivery systems, and methods for the treatment of disseminated and variable length stenotic regions within the vasculature (Paragraph [0007] of Chew).
Regarding claim 16, modified Sudhir teaches, wherein the stent body has two or fewer connections between the adjacent rings of the plurality of rings (Paragraph [0055] of Harrison, discloses, “For the embodiment of FIGS. 4-6, the connectors 14 connect alternate peaks, but the frequency of such connections can be varied depending on desired flexibility of the stent 10 with recognition that too few connectors 14 could result in fish scaling or other bending anomalies that would interfere with effective function. In any case, other examples of connector shape and frequency and connection location are described hereinbelow to illustrate that such variations are possible and still within the scope of the present invention.” This indicates that while connectors can connect alternate peaks, the frequency can be varied, and specifically mentions that "too few connectors... could result in fish scaling". This provides a direct structural disclosure of a stent body with a specific, limited number of connections (e.g., one or two) to maximize flexibility for tortuous anatomy like the ductus arteriosus).
Regarding claim 18, modified Sudhir teaches, wherein the stent body has zero or one connection between the adjacent rings of the plurality of rings (Paragraph [0055] of Harrison, discloses, “For the embodiment of FIGS. 4-6, the connectors 14 connect alternate peaks, but the frequency of such connections can be varied depending on desired flexibility of the stent 10 with recognition that too few connectors 14 could result in fish scaling or other bending anomalies that would interfere with effective function. In any case, other examples of connector shape and frequency and connection location are described hereinbelow to illustrate that such variations are possible and still within the scope of the present invention.” This indicates that while connectors can connect alternate peaks, the frequency can be varied, and specifically mentions that "too few connectors... could result in fish scaling". This provides a direct structural disclosure of a stent body with a specific, limited number of connections (e.g., one or two) to maximize flexibility for tortuous anatomy like the ductus arteriosus).
Regarding claim 22, Sudhir further teaches, wherein a segment comprises one of: a ring of the plurality of rings or a ring of the plurality of rings and a connector (Figure 1, rings (107) & linking elements (110); Col. 6, line 47-57).
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771