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 .
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 5-12 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 5 recites “the second pyramidal portion” which lacks antecedent basis, noting a second pyramidal portion is first introduced in claim 4, from which claim 5 does not depend. For purposes of claim interpretation, claim 5 is being treated as though “the second pyramidal portion” reads “[[the]] a second pyramidal portion”. Claims 6-12 depend from claim 5 and are thus also indefinite for this reason.
Claim 10 recite “the first portion”, which lacks clear antecedent basis. As best understood, “the first portion” is meant to refer back to the previously recited “first pyramidal portion”. For purposes of claim interpretation, claim 10 is being treated as though it reads “the first pyramidal portion”.
Claim 12 recites “a second helical section” in line 2. However, “a second helical section” is already recited in claim 5, from which claim 12 depends and it is therefore unclear if two different helical sections are being claimed (in which case it is recommended that “second helical section” be changed to “third helical section” in claim 12), or if these two helical sections are one and the same (though not currently clearly claimed as such). As best understood, “a second helical section” in line 2 of claim 12 should read “[[a]] the helical section is” and is being thus treated for purposes of claim interpretation.
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) 1-9, 12-14, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2021/0045749) in view of Mondstadt (US 2008/0319532). Wang discloses a vaso-occlusive device comprising an elongated member having a primary configuration (delivery configuration shown in fig. 2) when the vaso-occlusive coil is in a constrained condition, wherein the elongated member forms a three-dimensional (“3D”) structure (fig. 1) having a secondary configuration when the vaso-occlusive coil device is in an unconstrained condition, the three-dimensional structure comprising a first tetrahedral portion (e.g., 14; [0066]) and a first helical section (e.g., 30) formed from the wire and extending proximally from the first pyramidal portion (leading end 15 may be the proximal end of the device as per [0052], [0071]). Wang does not expressly disclose the exact shape of the tetrahedral portion.
Mondstadt discloses another vaso-occlusive device comprising an elongate member having a primary configuration ([0006]) and a secondary configuration, the secondary configuration having a first tetrahedral portion (1’; figs. 2a, 2b), wherein the tetrahedral portion comprises a pyramidal portion having a first set of at least three first loops lying within at least three different respective first planes that are non-parallel and non-perpendicular with respect to each other (see loop 8 of each of the three lateral faces in figs. 2a, 2b). According to Mondstadt, the pyramidal tetrahedral shape having loops on each face allows for increased packing density which improves safety against rupturing dangers ([0069]), prevents subsequently inserted implants segments or additional implants from being forced out through the neck of the aneurysm ([0069]), and enables the implant to be particularly well secured in the aneurysm ([0070]).
Since Wang is silent on the exact tetrahedral shape of the tetrahedral portion and the location of loops forming the tetrahedral shape, it would have been obvious to one of ordinary skill to have used the pyramidal tetrahedron shape having at least three first loops lying within at least three different respective planes taught by Mondstadt in order to improve safety against rupturing dangers ([0069]) and to enable the implant to be particularly well secured in an aneurysm ([0070]).
Regarding claim 2, as taught by Mondstadt, the first pyramidal portion has three lateral faces forming a tetrahedral shape (see figs. 2a,2b).
Regarding claim 3, Wang in view of Mondstadt does not expressly that the first pyramidal portion may be a pentahedral shape, instead expressly disclosing a tetrahedral pyramidal shape as taught by Mondstadt. However, Wang discloses generally that the 3D structures (14/16) can comprise any solid with sides shaped as a regular polygon ([0066]). Additionally, applicant does not disclose any advantage gained, problem solved, or purpose served by the pentahedral pyramidal shape, as compared to the tetrahedral pyramidal shape. Therefore, it would have been considered obvious to one of ordinary skill in the art to further modify the prior art of Wang in view of Mondstadt to use a pentahedral pyramidal shape since such a modification appears to be a mere design choice, Wang contemplates configuring first polygonal portion (14) as any solid with sides shaped as a regular polygon, and one skilled in the art would have had a reasonable expectation of success.
Regarding claim 4, the 3D structure of Wang further comprises a second tetrahedral portion (any one of 16; [0066]). As discussed above, it would have been obvious in view of Mondstadt to construct this second tetrahedral portion as a pyramidal tetrahedral portion having a second set of at least three second loops lying within at least three different respective second planes that are non-parallel and non-perpendicular with respect to each other as taught by Mondstadt in order to improve safety against rupturing dangers ([0069]) and to enable the implant to be particularly well secured in the aneurysm ([0070]).
Regarding claim 5, noting 35 USC 112b rejection above, the 3D structure comprises a second helical section extending from a second pyramidal portion (16 next to 14 in fig. 1 of Wang considered the second pyramidal portion). In particular, Wang discloses that the sections (14, 15, 30) need not be connected directly, and may have some open length of the elongated structure between sections ([0085]). This length of the elongated member between adjacent tetrahedral sections (14 and 16 in fig. 1) is considered the claimed second helical section since it comprises a coil.
Regrading claim 6, the claimed “second helical section” can be considered the open length between sections (14) and (16) as discussed above with respect to claim 5 as well as the two right-most sections (16) in fig. 1 of Wang, noting that this entire section is formed of a coil and is thus helical. This second helical section (middle two 16s and “open length” between 16 and 14 as discussed above) has a longitudinal length which is longer than a cross-sectional width of the second pyramidal portion (left-most 16 in fig. 1, for claim 6 only) as understood in view of fig. 1. This interpretation is being used for claim 6 only.
Regarding claim 7, the elongated member is a primary coil (see fig. 2; delivery configuration is a coiled wire; [0046]).
Regarding claim 8, the first helical section (30) comprises a first secondary coil formed by a first segment of the primary coil (see fig. 1), the first pyramidal portion (14) is formed by a second segment of the primary coil, and the second pyramidal portion (16) is formed by a third segment of the primary coil (as understood in view of fig. 1 of Wang).
Regarding claim 9, the first pyramidal portion (14) has a cross-sectional dimension (20) larger than a cross-sectional dimension (22) of the second pyramidal portion (16) (see fig. 1 of Wang; [0061]).
Regarding claim 12, the 3D structure comprises a third tetrahedral section (e.g., middle 16 in fig. 1 of Wang) which takes the form of a third pyramidal portion having at least three third loops lying within at least three different respective third planes that are non-parallel and non-perpendicular with respect to each other as taught by Mondstadt. As noted above, Wang discloses that each section (16) need not be connected directly, and may have some open length of the elongated structure between sections ([0085]). This length of the elongated member between adjacent tetrahedral sections (16) forming the second and third pyramidal portions, which comprises a primary coil, forms the second helical section (noting 35 USC 112b).
Regarding claims 13 and 14, the 3D structure comprises a first anchor (e.g., left-most 16 in fig. 1, noting 30 is at the proximal end of the device) at a distal end of the vaso-occlusive device, the first anchor including a helical section. In particular, an end segment of the coil forming the first anchor (16) is helical since it comprises a coil.
Regarding claim 17, the first anchor (left-most 16 in fig. 1) comprises a second tetrahedral portion as disclosed by Wang. As discussed above in more detail, it would have been obvious to modify each tetrahedral portion of Wang to comprise a pyramidal tetrahedral portion comprising three loops lying in different respective planes that are non-parallel and non-perpendicular with respect to each other as taught by Mondstadt in order to provide a shape known to improve safety against rupturing dangers ([0069]) and to enable the implant to be particularly well secured in an aneurysm ([0070] of Mondstadt).
Regarding claim 18, the first helical section is now being considered loop (34) of Wang, which is helical as it is comprised of a coil, and Wang further discloses a second anchor (32) at a proximal end (15). Note that Wang discloses that leading end (labelled 15 in fig. 1) can be the proximal end of the device ([0052], [0071]).
Regarding claim 19, the secondary configuration comprises an elongated configuration (see fig. 3) configured to occlude a blood vessel.
Claim(s) 10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Mondstadt as applied to claims 5 and 13 above and further in view of Ken et al. (US 5,582,619). Wang in view of Mondstadt discloses the invention substantially as stated above including that the elongated member is a primary coil and a segment of the primary coil forms the first pyramidal portion (14) and the first anchor (30). Wang further discloses that the device body (12) may include stretch resistant elements ([0057]), but does not expressly disclose that the segment comprises a stretch-resistance member located within a lumen of the primary coil.
Ken discloses a vaso-occlusive coil comprising a primary coil (fig. 1) that transitions to a secondary three-dimensional shape (figs. 6, 7, 10b-D) wherein the coil includes a stretch-resistant element (108) located within a lumen of the primary coil, the stretch-resistant member stretching the entire length of the primary coil (fig. 1) in order to prevent stretching of the coil during movement of the coil by retrieval or positioning after deployment (see abstract). It would have been obvious to have modified the prior art of Wang to include a stretch resistant member within the lumen of the primary coil and extending the entire length of the primary coil (and thus within the first anchor and first pyramidal portion formed from the primary coil) of Wang as taught by Ken in order to prevent stretching of the coil during movement of the coil.
Claim(s) 11 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Mondstadt as applied to claims 5 and 13 above and further in view of Divino et al. (US 2013/0190801). Wang in view of Mondstadt discloses the invention substantially as stated above including that the elongate coil is a primary coil, wherein a first segment of the primary coil forms the first pyramidal portion (14) and a second segment of the primary coil forms the second pyramidal portion (16 adjacent 14).
Regarding claim 11, Wang in view of Mondstadt fails to disclose that the first segment has a first coil wire diameter and the second segment has a second coil wire diameter less than the first coil wire diameter.
Divino discloses another vaso-occlusive device comprising an elongate member formed of a primary coil (see fig. 1D), wherein the elongate member forms a 3D structure having a secondary configuration when the vaso-occlusive device is in an unconstrained condition (fig. 1B). Divino discloses that the primary coil is formed of a coil wire having a first coil wire diameter at the proximal end (1602a may be proximal portion; fig. 16 and [0179]) and a second coil wire diameter at the distal end (1602b may be distal portion in fig. 16), the second coil wire diameter being less than the first coil wire diameter (see fig. 16). Divino teaches that using a finer coil wire at the distal end of the vaso-occlusive coil provides atraumatic end for the coil that is designed to prevent injury to the vasculature as it is moved within the vasculature ([0179]).
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Wang to construct the primary coil of a wire having a diameter that is larger at the proximal end of the wire than at the distal end of the wire as taught by Divino in order to provide an atraumatic distal end for the coil that is designed to prevent injury. With such a modification, the first segment forming the first pyramidal portion (14) will have a first coil-wire diameter larger than the second coil-wire diameter of the second segment that forms the second pyramidal portion since the first segment (first pyramidal portion 14) is proximal of the second pyramidal portion (16; noting 30 is located at proximal end of device of Wang).
Regarding claim 16, Wang in view of Mondstadt discloses the invention substantially as stated above including that the elongate coil is a primary coil, wherein a first segment of the primary coil forms the first pyramidal portion (14) and a second segment of the primary coil forms the first anchor (left-most 16 in fig. 1). Wang fails to disclose that the first segment has a first coil wire diameter and the second segment has a second coil wire diameter larger than the first coil wire diameter.
Divino further teaches, as an alternative to the configuration discussed above with respect to claim 14, that the diameter of the coil-wire forming the vaso-occlusive device may be larger at the distal end (noting [0179] discloses that 1602b, formed of the final wire, may form the proximal end of the coil instead of the distal end of the coil) in order to provide an atraumatic proximal end that is easily packed into remaining open interstices within of the deployed coil ([0179]).
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Wang to construct the primary coil of a wire having a diameter that is larger at the distal end of the wire than at the proximal end of the wire as taught by Divino in order to provide an atraumatic proximal end that is easily packed into remaining open interstices within the deployed coil. With such a modification, the second coil-wire diameter of the second segment that forms the first anchor (left-most 16) will have a second coil-wire diameter larger than the first coil-wire diameter of the first segment forming the first pyramidal portion (14) since the second segment (forming 1st anchor 16) is distal of the first segment (forming first pyramidal portion 14) of Wang.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2, respectively of copending Application No. 18/667,790 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1 and 2 are merely broader than claims 1 and 2 of ‘790 and are thus “anticipated” by claims 1 and 2 of ‘790. With respect to claim 1 of ‘790, the faces of a tetrahedral pyramid form planes that are non-parallel and non-perpendicular with respect to each other and thus it is understood that the faces of the tetrahedral pyramidal shape of claim 1 of ’790 in which each coil (and its loops) lie are non-parallel and non-perpendicular with respect to each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented (though it is noted that a notice of allowability has been issued in co-pending application 18/667,790).
Conclusion
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9/17/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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