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
Applicant's election with traverse of Group I in the reply filed on 12/19/2025 is acknowledged. The traversal is on the ground(s) that the examiner erred in finding that the technical feature common to Groups I and II is not a special technical feature because it is known in the art. This is not found persuasive because the prior art of Jayaraman (US 2005/0187564) discloses all of the common technical features of Group I and Group II, as discussed in detail in the requirement for unity of invention dated 10/21/2025 and the rejection of claims 1 and 14 below. With respect to applicant’s argument that Jayaraman fails to disclose angled bends that expand when the vascular occlusion device moves from the unexpanded state to the expanded state, the examiner respectfully disagrees. The cited paragraph ([0020]) indicates that the vascular occlusion device is substantially linear in the unexpanded state. See also [0028], wherein the occlusion device is delivered in a first substantially straight configuration and thereafter expands once it warms above a transition temperature. After being advanced out of the catheter, the vascular occlusion device expands into its secondary shape. In order for the occlusion device to expand from its linear configuration to the expanded shape that includes a cross/star shape (see fig. 15f or 28) having a diameter matching that of the vessel, the angled bends have expanded outwardly as compared to when the bends are held in a substantially linear configuration within the catheter.
The requirement is still deemed proper and is therefore made FINAL.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “detachment mechanism” in claim 12. It is noted that the detachment mechanism is defined with sufficient structure in claim 13 such that claim 13 does not invoke 35 USC 112f. (See 35 USC 112b, wherein it appears that detachment element in claim 13 should read detachment mechanism.)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1 and 14 are objected to because of the following informalities: in lines 9-10 of claim 1 and lines 10-11 of claim 14, “the contact points contact the vessel wall” should read “the contact points are configured to contact the vessel wall” in order to avoid any possible 35 USC 101 issues with respect to positively reciting a part of the human body. 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 6-8, 11, 13, 17-19 and 21 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.
Claims 6, 8, 11, 17, 19, and 21 each recite “the radially-extending segments”. It is unclear whether “the radially-extending segments” refers back to the previously recited “two or more radially-extending segments” or the previously recited “plurality of radially-extending segments”. As best understood, “the radially-extending segments” should read “the plurality of radially-extending segments” each time it appears in claims 6, 8, 11, 17, 19, and 21, and is being thus treated for purposes of claim interpretation. Claims 7 and 18 depend from claims 6 and 17, respectively, and are therefore also indefinite.
Claim 13 recites “the detachment element” which lacks clear antecedent basis. As best understood, “the detachment element” should read “the detachment mechanism” (noting claim 12 introduces a detachment mechanism) and is being thus treated for purposes of claim interpretation.
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) 1-4 and 14-16 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Jayaraman (US 2005/0187564). Regarding claims 1 and 14, Jayaraman discloses a vascular occlusion device configurable between an unexpanded state (substantially straight configuration, which fits snugly in catheter; [0020], [0095]-[0096]) and an expanded state (fig. 15f or 28), the vascular occlusion device comprising: a plurality of radially-extending segments and a plurality of bending portions that, in the expanded state, define angled bends connecting ends of two or more radially-extending segments of the plurality of radially-extending segments. See the examiner-annotated reproduction of fig. 15(f) below, on which two radially extending segments and one angled bend have been labelled.
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Each angled bend defines a contact point configured to anchor to a vessel wall ([0077]) when the vascular occlusion device moves from the unexpanded state (substantially straight configuration in catheter) to the expanded state (shown in fig. 15f or 28), the plurality of angled bends expand such that the contact points contact the vessel wall ([0077], [0135]), the contact points define a width of the vascular occlusion device (at least at that location) in a direction perpendicular to a length of the vascular occlusion device ([0085]), and the width is configured to correspond to a diameter of a blood vessel (noting “configured to correspond to a diameter of a blood vessel” is a recitation of intended use; because the device of Jayaraman is capable of being placed in a blood vessel having a diameter corresponding to the width of the occlusion device, it meets this limitation; note also that the angled bends are meant to contact the vessel wall as per [0077]). Further regarding claim 14, the device of Jayaraman is for occluding a vessel via contact with the vessel wall (which serves to anchor the occlusion device in place to occlude flow; [0077]). The plurality of radially-extending segments extend radially between successive contact points to occlude blood flow in the vessel (see figs. 15f or 28).
Regarding claims 2 and 15, the vascular occlusion device comprises a single piece of shape memory material (see abstract; fig. 15f and 28), and the vascular occlusion device self-transitions from the unexpanded state to the expanded state upon reaching a threshold temperature (see [0028], [0095]; see also [0102]).
Regarding claims 3 and 16, the shape memory material comprises nitinol ([0022]).
Regarding claim 4, when the vascular occlusion device is in the unexpanded state, the vascular occlusion device comprises a wire or ribbon of the shape memory material ([0093] – nitinol wire).
Claim(s) 1, 5, 11, 14 and 21 is/are rejected under 35 U.S.C. 102a1 as being anticipated by White, Jr. et al. (US 9,301,764). Regarding claims 1 and 14, White discloses a vascular occlusion device (fig. 6a-c) configurable between an unexpanded state (unfolded, straight configuration within catheter; col. 5, ll. 35-42; col. 8, ll. 49-55) and an expanded state (“folded state”; figs. 6a-c), the vascular occlusion device comprising: a plurality of radially-extending segments and a plurality of bending portions (see fig. 6c and annotated drawing below) that, in the expanded state, define angled bends connecting ends of two or more radially-extending segments of the plurality of radially-extending segments. Each angled bend defines a contact point configured to anchor to a vessel wall (fig. 6c) when the vascular occlusion device moves from the unexpanded state to the expanded state, the plurality of angled bends expand such that the contact points contact the vessel wall (folding from straight configuration housed in catheter to expanded state shown in figs. 6a-6c represents a radial expansion), the contact points define a width of the vascular occlusion device (at least at that location) in a direction perpendicular to a length of the vascular occlusion device, and the width is configured to correspond to a diameter of a blood vessel (see fig. 6c). Further regarding claim 14, the device of White is for occluding a vessel via contact with the vessel wall (see abstract and fig. 6c). The plurality of radially-extending segments extend radially between successive contact points to occlude blood flow in the vessel (figs. 6b, 6c).
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Regarding claim 5, in the expanded state, one or more radially-extending segments of the plurality of radially-extending segments are configured to extend radially through a geometric center of the vascular occlusion device. See the examiner-annotated reproduction of fig. 6c below, showing the geometric center (where the two lines intersect) of the vascular occlusion device of White.
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Regarding claims 11 and 21, White discloses thrombogenic fibers (dacron fibers 228) extending from at least one of the radially-extending segments and/or the angled bends (see fig. 2b, 6a-6c; col. 4, ll. 50-55).
Claim(s) 1-4, 9, and 14-16 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kobayashi et al. (US 6,375,671). Regarding claims 1 and 14, Kobayashi discloses a vascular occlusion device (fig. 2) configurable between an unexpanded state (see fig. 6; when in catheter) and an expanded state (fig. 7), the vascular occlusion device comprising: a plurality of radially-extending segments and a plurality of bending portions (formed by zigzag; fig. 2) that, in the expanded state, define angled bends connecting ends of two or more radially-extending segments of the plurality of radially-extending segments (fig. 2). Each angled bend defines a contact point configured to anchor to a vessel wall (if placed into a vessel with a narrowing matching that of the occlusion device; similar to figs. 6, 7), when the vascular occlusion device moves from the unexpanded state (noting portion in catheter in fig. 6) to the expanded state (fig. 7), the plurality of angled bends expand such that the contact points contact the vessel wall (see figs. 6, 7), the contact points define a width of the vascular occlusion device (at least at that location) in a direction perpendicular to a length of the vascular occlusion device, and the width is configured to correspond to a diameter of a blood vessel (noting “configured to correspond to a diameter of a blood vessel is a recitation of intended use and the prior art must only be capable of being placed in a blood vessel having a diameter corresponding to the width of the occlusion device; see also fig. 7). Further regarding claim 14, the device of Kobayashi is for occluding a vessel via contact with the vessel wall (see figs. 6,7; occluding patent ductus arteriosus) . The plurality of radially-extending segments extend radially between successive contact points to occlude blood flow in the vessel (similar to fig. 7).
Regarding claims 2 and 15, the vascular occlusion device comprises a single piece of shape memory material (1), and the vascular occlusion device self-transitions from the unexpanded state to the expanded state upon reaching a threshold temperature (col. 3, ll. 43-53; col. 5, ll. 8-29).
Regarding claims 3 and 16, the shape memory material comprises nitinol (col. 3, ll. 43-53)
Regarding claim 4, when the vascular occlusion device is in the unexpanded state, the vascular occlusion device comprises a wire or ribbon of the shape memory material (see fig. 5, noting Kobayashi discloses that the fixing member 1 is a made of a shape memory wire).
Regarding claim 9, when in the expanded state, two angled bends disposed at opposite ends of a linear segment of the plurality of radially-extending segments (noting zigzag shape) are configured to contact different radial positions of a wall of the blood vessel as understood in fig. 7 (see patent ductus arteriosus D in figs. 6 and 7).
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.
Claim(s) 6, 8, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jayaraman in view of Lefebvre (US 4,990,156). Jayaraman discloses the invention substantially as stated above except for the angled bends comprising an increased coefficient of friction as compared to the plurality of radially extending segments, or the angled bends having a surface roughness that is greater than that of the plurality of radially extending segments.
Lefebvre discloses another self-expanding vascular implant that includes a portion (12) meant to contact the vessel wall to anchor the implant at a location within the vessel. The portion (12) meant to contact the vessel wall includes a surface roughness (caused by “rough portions” 13) greater than that of other sections of the device not meant to contact the wall in order to better anchor the implant to the vessel wall (col. 5, ll. 18-22; noting other sections are free of “rough portions” 13). As understood in view of the surface roughness enhancing anchoring of portion (12) to the wall, the roughness results in an increased coefficient of friction at portion (12) as compared to the other sections of the device that do not have the surface roughness. According to Lefebvre, the rough portions procure for the implant a very good stability in position and will avoid long-term migration of the implant (col. 5, ll. 17-22). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Jayaraman in view of Lefebvre to provide the angled bends, which are meant to contact the vessel wall to anchor the device in place according to Jayaraman, with increased surface roughness resulting in increased coefficient of friction as compared to the radially extending segments in order to procure for the implant very good stability and to prevent migration of the implant.
Claim(s) 7 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jayaraman in view of Lefebvre as applied to claims 6 and 17 above and further in view of Duncan (US 2013/0184658). Jayaraman in view of Lefebvre disclose the invention substantially as stated above including a greater surface roughness (and therefore coefficient of friction as it is meant to better anchor the implant to the wall) on the angled bends in order to facilitate better anchoring of the device. Jayaraman in view of Lefebvre do not expressly disclose using a layer of polymeric material on the angled bends.
Duncan discloses another occlusion device and further discloses that a coating including granules of polymeric material are known in the art and can be used to impart a textured surface to impart increased frictional properties to prevent movement of the device ([0122]). Thus, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Jayaraman in view of Lefebvre to provide the surface roughness on the angled bends via a layer of polymeric material in the form of a coating with granules of polymeric material as taught by Duncan in view of Duncan’s teaching that such coatings are known in the art as an alternative means of providing increased surface roughness and coefficient of friction on a portion of a vascular implant, the results are predictable, and one skilled in the art would have had a reasonable expectation of success.
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jayaraman in view of Buiser et al. (US 2007/0142859). Jayaraman discloses the invention substantially as stated above except for a hydrogel coating disposed on at least the angled bends.
Buiser discloses another vascular occlusion device comprising a coil (20) having a collapsed, linear configuration (fig. 1b, 2c) and an expanded configuration (figs. 2d, 2e). Buiser discloses a hydrogel (20; [0076]-[0077]) over the entire length of the occlusion device that enhances the deliverability of the coil and can be used to deliver one or more therapeutic agents to a target site ([0066]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Jayaraman in view of Buiser to include a hydrogel coating over the entire length of the occlusion device, which includes the angled bends, in order to enhance deliverability of the coil and allow delivery of therapeutic agents to a target site.
Claim(s) 11 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jayaraman in view of White, Jr. et al. (US 9,301,764). Jayaraman discloses the invention substantially as stated above including that thrombogenic fibers extending “along the length of the coil” ([0107]), but does not expressly disclose the exact location of the fibers along the length.
White, Jr. discloses another vascular occlusion device configurable between an unexpanded shape and an expanded shape. White discloses providing thrombogenic fibers along the entire length of the vascular occlusion device in order to help occlude fluid flow through the lumen of the blood vessel (see fig. 2b, 6a-6c; col. 4, ll. 50-55). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Jayaraman to include thrombogenic fibers along the entire length of the vascular occlusion device (which includes the radially-extending segments and angled bends) in view of White for the predictable result of encouraging quicker occlusion of fluid flow through the vessel lumen.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jayaraman in view of Marks (US 5,217,484). Jayaraman discloses the invention substantially as stated above including a vascular occlusion device that is deployed from a catheter, but fails to expressly disclose a detachment mechanism extending from an end radially-extending segment of the device as claimed.
Marks discloses another vascular occlusion device comprising a wire that is configurable between an unexpanded shape and an expanded shape. The occlusion device includes a detachment mechanism (42,32; fig. 2) extending from its proximal end, the detachment mechanism being configured to engage with a removable tool (22,30) for removing the occlusion device from the blood vessel (col. 8, ll. 43-62). The detachment mechanism comprises a clamp hold (32; considered a clamp hold as it provides a projection for clamp 30 to hold). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Jayaraman to include a detachment mechanism as claimed extending from an end radially extending segment (noting “clip” that forms angular bends of the device of Jayaraman is disclosed as being at the proximal end of the device as it is released last from the catheter; [0095])) in view of Marks in order to facilitate removal of the device when desired.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 2/5/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771