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.
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10, line 5 states “at an oblique angle in the first shape which is at least 30° different than the approximate right angle shape” and line 7 states “wherein the oblique angle in the first shape which is at least 45° different than the approximate right angle shape”. The limitations on line 5 should be deleted because it is made redundant by the narrower limitation on line 7.
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.
Claim 7 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 pre-AIA the applicant regards as the invention.
The preamble indicates the anchoring element needs to comprise “one or more” of a base, an elastic member or a base. However, lines 4 and 7 recite a connection between the elastic member and the base, so it’s unclear if that limitation needs to be met if only one of those elements is in the prior art.
Claim 7 introduces “a base” on line 3 and again on line 5 so it is unclear if the base on line 5 is intended to refer to the same base on line 3 or a second base. Figures 1 and 6 show two bases – structure surrounding each of recesses 604 and 606. Line 7 refers to “one of the base regions” and line 9 refers to “another of the base regions” indicating there are two bases. The claim should make it this clear – for example, by introducing “a second base” in line 3.
The terms “the base regions” lacks antecedent basis.
Line 9 recites “an elongated member connected to another of the base regions bypassing the elastic member”. This is unclear because lines 3-6 appear to only require one of a base, elastic member and a base (i.e. a second base? -see above) while line 9 recites a connection between an elongated member and a base.
Ultimately, it is unclear if Applicant intends to claim: (a) a base and an elastic member; or (b) a first base, a second base and an elastic member; or (c) one of a base or an elastic member. Further, if Applicant only intends to claim one of a base or an elastic member, it is unclear how to interpret lines 7-10 because they recite a relationship between the elastic member and the base region.
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, 7, 9, 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dolan et al. (US patent Publication 2006/0106420).
Claim 1: Dolan’420 discloses a self-expanding tissue anchoring mechanism (100) configured to deploy from an arm of an implantable device, the anchoring mechanism comprising:
an arm (114), including an anchor-mounting portion (distal end of arm 114);
an anchoring element (116) having a sharp distal end (Figure 1), and a proximal end engaged with the anchor-mounting portion (Figure 1 shows the arm and anchoring element are a unitary piece);
wherein, together, the proximal end and anchor-mounting portion form an assembly (Figure 1 shows the arm and anchoring element are a unitary piece), the assembly having an elastic member which relaxes to interconvert the assembly between a first shape and a second shape (paragraph [0023] discloses the arm & anchoring element are formed of a shape memory material – which is known to be superelastic; the assembly moves between a first shape shown in Figure 2 and a second shape shown in Figure 4); and
the first shape is collapsed to position a distal portion of the sharp distal end of the anchoring element relatively close to a longitudinal axis of the arm (Figure 2), compared to the second shape (Figure 4).
Claim 2: Dolan’420 discloses the elastic member is tensioned in the first shape, and relaxed in the second shape (Figures 2 and 4 and paragraph [0024]).
Claim 3: Dolan’420 discloses interconversion between the first shape and the second shape moves the distal portion of the sharp distal end of the anchoring element longitudinally along the longitudinal axis, and further away from the longitudinal axis (see the movement of the sharp distal tip along the longitudinal axis of the arm in Figures 2 through 4).
Claim 4: Dolan’420 discloses the elastic member (i.e. middle of arm 114) comprises a spring formed into the anchoring element (the superelastic material described in paragraph [0023] is a spring);
wherein the anchoring element comprises a piece cut from sheet stock, and the elastic member is a part of the piece (the limitation “the anchoring element comprises a piece cut from sheet stock” is considered a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. In this case, the elastic member (i.e. middle of arm 114) and the anchoring element are a single unitary element, so the structure is the same regardless of whether this single unitary element was cut from sheet stock or formed in another way.).
Claim 7, as best understood: Dolan’420 discloses the anchoring element comprises an elastic member (paragraph [0023]) extending between the sharp distal end and a base (112).
Claim 9: Dolan’420 discloses the implantable device is a suturing clip (100) comprising a plurality of arms extending from a core (112), each provided with a corresponding anchor element (Figure 1).
Claim 10: Dolan’420 discloses the sharp distal end is held away from the anchor mounting portion of the arm by an elongated member (210), wherein a longitudinal axis of the elongated member extends away from a longitudinal axis of the arm at an approximate right angle in the second shape (Figure 4; paragraph [0024]), and at an oblique angle in the first shape (Figure 2) which is at least 45 degrees different from the right angle shape (Figure 2).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 6, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Dolan’420, as applied to claim 1, further in view of Keren et al. (WO 2019/207585).
Note: For Applicant’s convenience, Examiner notes that Keren’585 is published as US Patent Publication 2021/0137507. However, the rejection relies solely on the WIPO document.
Claim 6: Dolan’420 does not teach the anchoring element and anchor-mounting portion are separate interlocking pieces. However, the courts have held that making two pieces separable is an obvious modification. See MPEP 2144.04 Section V(C).
Additionally, Keren’507 teaches a similar device including an arm (104) with an anchoring element (106) on the end of the arm (Figure 2o) such that the arm and anchoring element are a unitary structure. In an alternate embodiment (Figure 10a-10c), Keren’507 shows the arm (1004) can be a separate interlocking element from the anchoring element (1008).
In light of this teaching, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Dolan’420 such that the anchoring element and anchor-mounting portion are separate interlocking pieces, as taught by Keren’507, in order to allow the surgeon to select a different type of anchor depending on the intended target tissue such that it is best suited for its intended purpose.
Claim 12: Dolan’420 does not teach the elastic member terminates in a recess shaped to engage with the anchor-mounting portion.
Keren’507 teaches a similar device including an arm (104) with an anchoring element (106) on the end of the arm (Figure 2o) such that the arm and anchoring element are a unitary structure and include an elastic element (page 10, lines 1-2). In an alternate embodiment (Figure 10a-10c), Keren’507 shows the arm (1004) can terminate in a recess (1009) shaped to engage with the anchor mounting portion (proximal portion of anchor 1008 that fits into opening 1009) (Figure 10c).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Dolan’420 such that the anchoring element and anchor-mounting portion are separate interlocking pieces, as taught by Keren’507, in order to allow the surgeon to select a different type of anchor depending on the intended target tissue such that it is best suited for its intended purpose.
Claim 14: Dolan’420 does not teach the elastic member terminates in a recess shaped to engage with the anchoring element.
Keren’507 teaches a similar device including an arm (104) with an anchoring element (106) on the end of the arm (Figure 2o) such that the arm and anchoring element are a unitary structure and include an elastic element (page 10, lines 1-2). In an alternate embodiment (Figure 10a-10c), Keren’507 shows the arm (1004) can terminate in a recess (1009) shaped to engage with the anchoring element (anchor 1008) (Figure 10c).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Dolan’420 such that the anchoring element and anchor-mounting portion are separate interlocking pieces, as taught by Keren’507, in order to allow the surgeon to select a different type of anchor depending on the intended target tissue such that it is best suited for its intended purpose.
Claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alon (US Patent Publication 2016/0120645).
Claim 16: Alon’645 discloses a self-expanding tissue anchoring mechanism configured to deploy from an arm (24) of an implantable device (Figure 2; this device is configured for implantation because it is inserted in the body and could be left there), the anchoring mechanism comprising:
an anchoring element (16) terminating in a sharp distal end (46) and attached, through a plurality of base regions (shoulders 44; paragraph [0097]) on its proximal side, to an anchor-mounting portion (42) of the arm;
wherein the sharp distal end is joined to a first of the plurality of base regions (shoulder 44) through an elastic member and separately to a second of the plurality of base regions (second shoulder 44; paragraph [0097]) through a separate elongated member (see annotated copy of Figure 7 below).
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Claims 16, 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGuckin et al. (US Patent Publication 2005/0165441).
Claim 16: McGuckin’441 discloses a self-expanding tissue anchoring mechanism configured to deploy from an arm of an implantable device (Figure 11g), the anchoring mechanism comprising:
an anchoring element terminating in a sharp distal end (356a; Figure 11g) and attached, through a plurality of base regions (see annotated copy of Figure 11g) on its proximal side, to an anchor-mounting portion of the arm (see annotated copy of Figure 11g); wherein the sharp distal end is joined to a first of the plurality of base regions through an elastic member (paragraph [0078] teaches the filter is made of nickel-titanium shape memory alloy, which is a superelastic material), and separately to a second of the plurality of base regions through a separate elongated member (annotated copy of Figure 11g below).
Claim 17: McGuckin’441 discloses the elastic member (base) bends, moving the sharp distal end from a collapsed position nearer to a longitudinal axis of the anchor-mounting portion of the arm, to an expanded position further from the longitudinal axis (Figure 11e, 11f shows the collapsed position; Figure 11g shows the expanded position).
Allowable Subject Matter
Claims 26, 27, 30 and 31 are allowed.
Claims 18-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Friday 9am-5pm and alternating Fridays.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 22 October 2025
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771