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
Claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/28/2026.
Applicant’s election without traverse of Group I, drawn to an access and delivery device system and species A (Figs 1-3D) an anchor member that extends on two sides of the tissue-penetrating element through a window in the reply filed on 07/28/2026 is acknowledged.
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 1-7 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 the limitation "proximal portion of said flexible elongate element" in line 8. There is insufficient antecedent basis for this limitation in the claim. It is not clear if “said flexible elongate element” refers to “an access and delivery device having a proximal portion” or another element, as “flexible elongate element” is not positively claimed. For the purpose of prior art examination “proximal portion of said flexible elongate element” will be interpreted as “proximal portion of said access and delivery device”. Appropriate correction is required.
Claim 4 recites the limitation "said distal tip of said flexible elongate element" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of prior art examination “said distal tip of said flexible elongate element” will be interpreted as “said distal tip of said access and delivery device”. Appropriate correction is required.
Claim 6 recites the limitation "said anchor member of said flexible elongate element" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of prior art examination “said anchor member of said flexible elongate element” will be interpreted as “said anchor member of said access and delivery device”. Appropriate correction is required.
Claim 7 recites the limitation "said distal tip of said flexible elongate element" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of prior art examination “said distal tip of said flexible elongate element” will be interpreted as “said distal tip of said access and delivery device”. Appropriate correction is required.
Claims 2-3 are rejected as being dependent on claim 1. Claim 5 is rejected as being dependent on claim 4.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim #
Line #
Current
Suggested change
4
2
Said distal end of said distal end
Said distal end
4
3
and soft to engage
and is soft to engage
Appropriate correction is required.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lepulu et al (US 20120130417 A1), herein referenced to as “Lepulu”.
Claim 1
Lepulu discloses: An access and delivery device and system 10 (see Figs. 1-9E, [0035]) configured to access a deployment site L2 (see Figs. 9A-9E, [0035] and [0040]) beyond a proximal tissue wall T1 (see Figs. 9A-9E, [0040]) of an anatomical structure T1 + T2 (see Figs. 9A-9E), said access and delivery device and system 10 comprising: a tissue-penetrating element 20 (see Figs. 1-9E, [0035], penetration and dilation assembly) having a distal end 24 (see Figs. 1-9E, [0036], can dilate and advance through the tissue layers without the blade 34) configured to penetrate through tissue walls (see [0034]); and an access and delivery device 30 (see Figs. 1-9E, [0036]) having a proximal portion proximal portion of 30, proximal of 42, an anchor member 42 (see Figs. 1-9E, [0037]-[0038], 42 are wings that expand to anchor onto tissue and can be used to pull tissue), and a distal tip 33 (see Figs. 1-9E, [0036]); wherein: said anchor member 42 is formed of a flexible material (see [0037], preformed memory metal, which in the art is known to be a flexible material that can expand, such as nitinol) different from the material (see [0037], attached on the surface of 30, hence formed of a different material) of at least said proximal portion proximal portion of 30, proximal of 42 of said flexible elongate element 30 (see 112b rejection above, interpreted as “the access and delivery device”), said flexible material (see [0037]) configured to flex transversely (see Figs. 3-9E, [0037]-[0038], deploying radially) with respect to said tissue-penetrating element 20 to form an anchor feature 40 (see Figs. 1-9E, [0037]) of said system 10.
Claim 2
Lepulu discloses: The system of claim 1, see 102 rejection above. Lepulu further discloses: wherein said anchor member 42 is formed of a shape memory material (see [0037], preformed memory metal, which in the art is known to be a shape memory material that can expand, such as nitinol).
Claim 3
Lepulu discloses: The system of claim 1, see 102 rejection above. Lepulu further discloses: wherein the flexible material (see [0037]) of said anchor member 42 is sufficiently strong to maintain a flexed configuration transverse to said tissue-penetrating element 20 when pulled proximally (see [0011]-[0012], tissue of luminal walls is held together) with respect to the proximal tissue wall T1 through which said system is extended (see Figs. 9A-9E).
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.
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) 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lepulu in view of Phan et al (US 20100268029 A1), herein referenced to as “Phan”.
Claim 4
Lepulu discloses: The system of claim 1, see 102 rejection above. Lepulu further discloses: wherein said distal end 24 of said tissue-penetrating element 20 is sharp to puncture tissue (see Figs. 1-9E, [0036], can dilate and advance through the tissue layers without the blade 34); and said distal tip 33 of said flexible elongate element 30 (see 112b rejection above, interpreted as “an access and delivery device”) is extendable distal to said distal end 24 of said distal end 24 of said tissue-penetrating element 20 (see Figs. 1-9E, 33 can extend distally to 24).
Lepulu does not explicitly disclose: soft to engage a tissue wall atraumatically and to protect the tissue wall from said distal end of said tissue-penetrating element.
However, Phan in a similar field of invention teaches an access and delivery device and system 100 (see Figs. 6-7B) with a tissue-penetrating element 110 (see Figs. 6-7B) and an access and delivery device 120 (see Figs. 7A-7B) with a distal tip 132 (see Figs. 7A-7B) and an anchor member 126 (see Figs. 7A-7B). Phan further teaches: said distal tip 132 is soft (see Figs. 7A-7B, [0042], steerable tip instead of a tissue-penetrating tip, which engages a tissue wall atraumatically) to engage a tissue wall atraumatically.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal tip of the flexible elongate element of Lepulu to incorporate the teachings of Phan and teach an access and delivery device and system with the distal tip is soft to engage a tissue wall atraumatically. Motivation for such can be found in Phan as this allows for a steerable to advance the device through a body lumen (see [0036] and [0042]). Furthermore, in regard to the combination, the distal tip of the flexible elongate element of Lepulu would retain its ability to penetrate tissue as necessary (but not always) through the blade 34, preserving its functionality (see [0036]).
The language, " and to protect the tissue wall from said distal end of said tissue-penetrating element," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lepulu and Phan meets the structural limitations of the claim, and is capable of a steerable distal tip that can advance distally from the tissue-penetrating element to prevent the tissue-penetrating element from contacting a distal tissue wall.
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Claim 5
The combination of Lepulu and Phan teaches: The system of claim 4, see 103 rejection above. Lepulu further discloses: wherein said tissue-penetrating element 20 has a window 28 (see Figs. 5-6, [0038]) formed therethrough, said anchor member 42 extendable through the window 28 to form said anchor feature 40 (see Fig. 6, [0038]).
Claim 6
The combination of Lepulu and Phan teaches: The system of claim 5, see 103 rejection above. Lepulu further discloses: wherein said distal end 24 and window 28 of said tissue-penetrating element are spaced from each other (see Figs. 2-6, the distal end 24, the tip/end of which is distally spaced from the window 28) and said distal tip 33 and said anchor member 42 of said flexible elongate element 30 (see 112b rejection above, interpreted as the access and delivery device) are spaced from each other (see Figs. 5-6, 33 is spaced from 42) such that said distal tip 33 extends distally beyond said tissue-penetrating distal end 24 (see Fig. 6, 33 extend distally past 24 while 42 is extending from 28) when said anchor member 42 extends from the window 28.
Claim 7
Lepulu discloses: The system of claim 1, see 102 rejection above. Lepulu does not explicitly disclose: wherein said distal tip of said flexible elongate element is soft to engage and push a tissue wall atraumatically.
However, Phan in a similar field of invention teaches an access and delivery device and system 100 (see Figs. 6-7B) with a tissue-penetrating element 110 (see Figs. 6-7B) and an access and delivery device 120 (see Figs. 7A-7B) with a distal tip 132 (see Figs. 7A-7B) and an anchor member 126 (see Figs. 7A-7B). Phan further teaches: wherein said distal tip 132 of said flexible elongate element 120 (see 112b rejection above, interpreted as “an access and delivery device”) is soft (see Figs. 7A-7B, [0042], steerable tip instead of a tissue-penetrating tip, which engages a tissue wall atraumatically) to engage and push a tissue wall atraumatically.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal tip of the flexible elongate element of Lepulu to incorporate the teachings of Phan and teach an access and delivery device and system with the distal tip is soft to engage a tissue wall atraumatically. Motivation for such can be found in Phan as this allows for a steerable to advance the device through a body lumen (see [0036] and [0042]). Furthermore, in regard to the combination, the distal tip of the flexible elongate element of Lepulu would retain its ability to penetrate tissue as necessary (but not always) through the blade 34, preserving its functionality (see [0036]).
The language, "push a tissue wall," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lepulu and Phan meets the structural limitations of the claim, and is capable of a steerable distal tip that can advance distally from the tissue-penetrating element to apply force distally to push instead of puncture bodily tissue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Freitas (US 5217451 A), teaches an access and delivery device and system with an anchor member that expands transversely
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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