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 .
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.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-14, drawn to a system, classified in A61F2/2436.
II. Claims 15-20, drawn to a method of deploying a transcatheter aortic valve replacement implant, classified in A61F2/2436.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as products and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the process for using the product as claimed can be practiced with another materially different product. For example, the method of deploying a transcatheter aortic valve replacement implant can be practiced with a pig tail catheter without a tubular sheath slidably disposed over an elongate shaft.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions or processes have acquired a separate status in the art in view of their different classification, the inventions have acquired a separate status in the art due to their recognized divergent subject matter, and/or the inventions require a different field of search (for example, searching different classes/subclasses or electronic resourced, or employing different search queries).
During a telephone conversation with Glenn Seager on 7/20/2026 a provisional election was made without traverse to prosecute the invention of a system, claims 1-14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15-20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
Claim 4 is 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 4 recites the limitation "the tubular sheath" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 12-14 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 12 recites the surgical aortic valve implant “disposed within an ascending aorta” where is appears that an ascending aorta is being positively claimed.
Claim 13 recites the surgical aortic valve implant “disposed between the surgical aortic valve implant and a wall of the ascending aorta” where is appears that a wall of the ascending aorta is being positively claimed.
Claim 14 recites the surgical aortic valve implant “disposed between the surgical aortic valve implant and a wall of the ascending aorta” where is appears that a wall of the ascending aorta is being positively claimed.
The claims should be re-written with the term “configured to” prior to the limitations to overcome positively citing the human body.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Merhi (US PG Pub No. 2012/0179033 A1).
Regarding claim 1, Merhi discloses A pigtail catheter (Figs. 1A-1D, pigtail catheter 102), comprising: an elongate shaft (Figs. 1A-1D, proximal end 114) having a curled distal tip (Figs. 1A-1D, distal portion 104); a tubular sheath (Figs. 1A-1D, outer sheath 112) slidably disposed (Paragraph [0039], Figs. 1A-1D) over the elongate shaft (1114); and a compliant expandable member (Figs. 1A-1D, embolic filter 110) fixed (Paragraph [0039]) to the elongate shaft (102) and the tubular sheath (112).
Regarding claim 2, Merhi discloses wherein the elongate shaft (Figs. 1A-1D, proximal end 114) includes a guidewire (Paragraph [0039]) lumen (Figs. 1A-1D, lumen 118) extending therethrough.
Regarding claim 3, Merhi discloses wherein the compliant expandable member (Figs. 1A-1D, embolic filter 110) is configured to shift between a collapsed configuration (Figs. 1A and 1C) and an expanded configuration (Figs. 1B and 1D).
Regarding claim 4, Merhi discloses wherein axial translation (From Fig. 1A to 1B and 1C to 1D) of the tubular sheath (Figs. 1A-1D, outer sheath 112) relative to the elongate shaft (Figs. 1A-1D, proximal end 114) is configured to shift (Paragraph [0039]) the compliant expandable member (Figs. 1A-1D, embolic filter 110) between the collapsed configuration (Figs. 1A and 1C) and the expanded configuration (Figs. 1B and 1D).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5 and 8 rejected under 35 U.S.C. 103 as being unpatentable over Merhi (US PG Pub No. 2012/0179033 A1), as applied to claim 1 above.
Regarding claim 5, the primary embodiment of Merhi fails to disclose wherein the compliant expandable member is formed as a cage having a plurality of interstices. In a further embodiment, Merhi discloses wherein the compliant expandable member (Figs. 6A-6B, embolic protection filter 610) is formed as a cage (Paragraph [0068]), having a plurality of interstices (see annotated Fig. 6B below). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the primary embodiment of Merhi’s compliant expandable member wherein the compliant expandable member is formed as a cage having a plurality of interstices, as taught by the embodiment of Figs. 6A-6B, in order for the compliant expandable member to completely engage the catheter (Paragraph [0068]).
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Regarding claim 8, Merhi discloses wherein the cage (Figs. 6A-6B, embolic protection filter 610) is monolithically formed (Figs. 6A-6B, 610 is formed as one piece) from a plurality of interconnected struts (see annotated Fig. 6B above) defining the plurality of interstices therebetween (see annotated Fig. 6B above).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Merhi (US PG Pub No. 2012/0179033 A1), as applied to claim 5 above, and in view of Wang (US PG Pub No. 2013/0073032 A1).
Regarding claim 6, Merhi discloses the compliant expandable member, but fails to disclose wherein the compliant expandable member is formed from a radiopaque material. Wang also discloses a compliant expandible member (Figs. 1A and 2A-2B, marker cage 30) formed as a cage (Figs. 1A and 2A-2B, marker cage 30) on a catheter (Fig. 1A, catheter assembly 16). Wang teaches wherein the compliant expandable member (30) is formed from a radiopaque material (Paragraph [0040]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the primary embodiment of Merhi’s compliant expandable member is formed from a radiopaque material, as taught by Wang, in order to increase visibility for fluoroscopy (Paragraph [0040]). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the cage of Wang for the cage of Merhi. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Merhi (US PG Pub No. 2012/0179033 A1), as applied to claim 5 above, and in view of Korngold (US PG Pub No. 2023/0241370 A1).
Regarding claim 7, Merhi discloses the cage (Figs. 6A-6B, embolic protection filter 610), but fails to disclose wherein the cage is formed from one or more interwoven filaments defining the plurality of interstices therebetween. Korngold also discloses a compliant expandible member (Paragraph [0047]) formed as a cage (interwoven metallic wires 10) on a catheter (Figs. 14A-14B, catheter 80). Korngold teaches wherein the cage (10) is formed from one or more interwoven filaments (Paragraph [0047]) defining the plurality of interstices therebetween (see annotated Fig. 14A below). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the primary embodiment of Merhi’s compliant expandable member wherein the cage is formed from one or more interwoven filaments defining the plurality of interstices therebetween, as taught by Korngold, in order to expand in the aorta (Paragraph [0047]). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the cage of Korngold for the cage of Merhi. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
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Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Merhi (US PG Pub No. 2012/0179033 A1), as applied to claim 1 above, and further in view of Pedersen et al. (US PG Pub No. 2016/0287270 A1).
Regarding claim 9, Merhi fails to disclose wherein the compliant expandable member is formed as an inflatable balloon. Pedersen also discloses a pigtail catheter (Figs. 5A-5C, balloon valvuloplasty catheter 200) comprising an elongate shaft (Figs. 5A-5C, catheter body 204), a curled distal tip (Figs. 5A-5C, pigtail shape 206), a tubular sheath (Figs. 5A-5C, sheath 124), and a compliant expandable member (Figs. 5A-5C, catheter balloon 202). Pedersen teaches wherein the compliant expandable member (202) is formed as an inflatable balloon (Paragraph [0080]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Merhi’s pigtail catheter wherein the compliant expandable member is formed as an inflatable balloon, as taught by Pedersen, in order for the compliant expandable member to have progressive inflation (Paragraph [0080]).
Regarding claim 10, Merhi as modified by Pedersen further discloses wherein the inflatable balloon (Figs. 5A-5C, catheter balloon 202) includes a radiopaque material (Figs. 5A-5C, radiopaque markers 203). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Merhi’s compliant expandable member wherein the inflatable balloon includes a radiopaque material, as taught by Pedersen, in order to use fluoroscopy (Paragraph [0099]).
Regarding claim 11, Merhi as modified by Pedersen further discloses wherein the inflatable balloon (Figs. 5A-5C, catheter balloon 202) is configured to be selectively filled (Figs. 5A-5C, media port 201) with an inflation fluid that is radiopaque (Paragraphs [0080 and 0099], inflation media, contrast media).
Claims 12-14 rejected under 35 U.S.C. 103 as being unpatentable over Spence (US PG Pub No. 2018/0153690 A1) in view of Merhi (US PG Pub No. 2012/0179033 A1) and Azadani (US PG Pub No. 2023/0397954 A1).
Regarding claim 12, Spence discloses a transcatheter aortic valve replacement (TAVR) system (Fig. 28C), comprising: a pigtail catheter (Fig. 28C, pigtail catheter 370), a TAVR delivery device (Fig. 28C, catheter 62, Paragraph [0276]) comprising an elongate shaft (see annotated Fig. 28C below) having an implant holding portion (see annotated Fig. 28C below) proximate a distal end thereof (see annotated Fig. 28C below); and a TAVR implant (Figs. 28C-28D, aortic valve prosthesis 380) disposed within the holding portion (see annotated Fig. 28C below) in a collapsed configuration (Paragraph [0276], Fig. 28C), the TAVR implant (380) comprising an expandable framework including a lower crown (see annotated Fig. 28D below) disposed at an upstream end (see annotated Fig. 28D below) and an upper crown (see annotated Fig. 28D below) disposed downstream (see annotated Fig. 28D below) of the lower crown (see annotated Fig. 28D below).
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Spence fails to disclose the pigtail catheter comprising an elongate shaft having a curled distal tip, a tubular sheath slidably disposed over the elongate shaft, and a compliant expandable member fixed to the elongate shaft and the tubular sheath. Merhi also discloses a pigtail catheter (Figs. 1A-1D, pigtail catheter 102). Merhi teaches the pigtail catheter (102) comprising: an elongate shaft (Figs. 1A-1D, proximal end 114) having a curled distal tip (Figs. 1A-1D, distal portion 104); a tubular sheath (Figs. 1A-1D, outer sheath 112) slidably disposed (Paragraph [0039], Figs. 1A-1D) over the elongate shaft (1114); and a compliant expandable member (Figs. 1A-1D, embolic filter 110) fixed (Paragraph [0039]) to the elongate shaft (102) and the tubular sheath (112). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Spence’s pigtail catheter comprising an elongate shaft having a curled distal tip, a tubular sheath slidably disposed over the elongate shaft, and a compliant expandable member fixed to the elongate shaft and the tubular sheath, as taught by Merhi, in order to include a radiopaque marker to visualize and position the catheter and implant (Paragraph [0008]).
Spence as modified by Merhi fails to disclose wherein the compliant expandable member is configured to identify a downstream extent of a surgical aortic valve implant disposed within an ascending aorta prior to deploying the TAVR implant.
Azadani also discloses a transcatheter aortic valve replacement system (Fig. 5, valve-in-valve prosthetics 500). Azadani teaches a surgical aortic valve implant (Fig. 5, primary valve prosthetic 510) and a TAVR implant (Fig. 5, second valve prosthetic 520). It would have been obvious to one of ordinary skill in the art before effective filing date of the invention to include the valve-in-valve replacement as taught by Azadani, the pigtail catheter as modified by Merhi in the transcatheter aortic valve replacement system of Spence, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Regarding claim 13, Spence as modified by Merhi and Azadani discloses wherein the compliant expandable member (Merhi Figs. 1A-1D, embolic filter 110) is disposable radially outward (Merhi Fig. 1B) of at least a portion of the surgical aortic valve implant (Azadani Fig. 5, primary aortic valve 510) such that a portion of the compliant expandable member (110) is disposed between the surgical aortic valve implant (510) and a wall of the ascending aorta (Spence Fig. 28C, native aortic valve 14). It would have been obvious to one of ordinary skill in the art before effective filing date of the invention to include the valve-in-valve replacement as taught by Azadani, the pigtail catheter as modified by Merhi in the transcatheter aortic valve replacement system of Spence, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Regarding claim 14, Spence as modified by Merhi and Azadani discloses wherein the portion of the compliant expandable member (Merhi Figs. 1A-1D, embolic filter 110) disposed between the surgical aortic valve implant (Azadani Fig. 5, primary aortic valve 510) and the wall of the ascending aorta (Spence Fig. 28C, native aortic valve 14) is configured to remain in place (Spence Fig. 28C) between the surgical aortic valve implant and the wall of the ascending aorta as the upper crown (see annotated Spence Fig. 28D above) is deployed downstream of the downstream extent of the surgical aortic valve implant (Azadani Fig. 5, primary aortic valve 510). It would have been obvious to one of ordinary skill in the art before effective filing date of the invention to include the valve-in-valve replacement as taught by Azadani, the pigtail catheter as modified by Merhi in the transcatheter aortic valve replacement system of Spence, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hou (US 2022/0160997 A1) also discloses a pigtail catheter (Fig. 2, pigtail catheter 104) comprising an elongate shaft (Fig. 2, elongate shaft 114), a curled distal tip (Fig. 2, distal end region 110), a tubular sheath (Fig. 1, outer sheath 102), and radiopaque markers for transcatheter aortic valve replacement (Paragraph [0061]).
Al-Jilaihawi (US Patent No. 10,507,301 B2) also discloses a pigtail catheter (Fig. 1) and a transcatheter aortic valve replacement system (Col. 5, lines 16-25).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.L.C./ Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/ Primary Examiner, Art Unit 3700
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