DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
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Claims 2 and 9- 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of U.S. Patent No. 12,048,438. Although the claims at issue are not identical, they are not patentably distinct from each other because
Regarding application claim 2, claim 1 of U.S. Patent No. 12,048,438 claims
An occlusion device, comprising:
(An occlusion device, comprising)
a microcoil having a relaxed secondary configuration;
(a microcoil having a relaxed configuration)
the relaxed secondary configuration comprising four closed loops forming a tetrahedral shape (a plurality closed loop portions and a plurality of connecting portions that are each interposed between two different closed loop portions of the plurality of closed loop portions and that are free from closed loops; wherein the relaxed configuration is tetrahedral; it is noted that “a plurality of connecting portions that are each interposed between two different closed loop portions” indicates at least four different closed loop portions since “a plurality of connecting portions” signifies at least two connecting portions, each with two different closed loops) (See claim 1 of U.S. Patent No. 12,048,438).
Regarding application claim 9, claim 1 of U.S. Patent No. 12,048,438 claims
further comprising a plurality of open loops; and
wherein a single open loop of the plurality of open loops is connected to two of the four closed loops (a plurality of connecting portions that are each interposed between two different closed loop portions of the plurality of closed loop portions and that are free from closed loops; it is noted that a connecting portion free from closed loops is interpreted as an open loop) (See claim 1 of U.S. Patent No. 12,048,438).
Regarding application claim 10, claim 10 of U.S. Patent No. 12,048,438 claims
wherein each single open loop of the plurality of open loops is a "C", a "U", or a "V" shape (wherein each of the connecting portions comprise one or more of oppositely alternating “C,” “U,” or “V” shapes; it is noted that a connecting portion free from closed loops is interpreted as an open loop) (claim 10 of U.S. Patent No. 12,048,438).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 2- 8, 13- 18 and 20 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Monstadt et al. (US Pub. No. 2008/0319532 A1).
Regarding claim 2, Monstadt discloses an occlusion device, comprising:
a microcoil (9) (Figs. 2b- 7) (P. [0074] - - The helix 9 forming the tetrahedron 6 is a micro-helix) having a relaxed secondary configuration (Figs. 4a, 4b) (Ps. [0073], [0075] - - FIG. 4 shows two views 4a and 4b of a tetrahedron-shaped implant 1' according to the invention, said implant having assumed its three-dimensional tertiary structure; FIG. 5 by way of 4 radial sections 10 to 10''' represents the secondary structure of the tetrahedron shown in FIG. 4 in the form of the development of a ball; it is noted that Fig. 5 to Monstadt is similar to applicant’s Fig. 3 and is similarly not interpreted as a secondary configuration; it is further noted that the examiner is not limited to the terminology of a prior art reference);
the relaxed secondary configuration (Figs. 4a, 4b) comprising four closed loops (8) (Figs. 2a- 6) forming a tetrahedral shape (P. [0073] - - At the location where the projection of three adjoining large loops 7 each intersects there are the vertices 4' of the tetrahedron, with one smaller sized loop 8 each being arranged at said vertices).
Regarding claim 3, Monstadt further discloses wherein each of the four closed loops (8) approximately return to or contacts another portion of the microcoil (9) (See Figs. 4a, 4b) (P. [0021] - - In a closed loop the proximal and distal ends of the filament portion forming the closed loop intersect).
Regarding claim 4, Monstadt further discloses wherein each of the four closed loops (8) stack portions (S) (See Annotated Fig. 4b) of the microcoil (9) on top of one another.
Regarding claim 5, Monstadt further discloses wherein each of the four closed loops (8) define an area or boundary through which a plane may be approximately positioned (P. [0073] - - At the location where the projection of three adjoining large loops 7 each intersects there are the vertices 4' of the tetrahedron, with one smaller sized loop 8 each being arranged at said vertices; it is noted that each vertices 4’ define an area or boundary through which a plane may be approximately positioned).
Regarding claim 6, Monstadt further discloses wherein some of the four closed loops (8) are wound in a clockwise direction and some of the four closed loops (8)are wound in a counter clockwise direction (See Fig. 5 - - showing the top loops 8 being wound in opposite direction as bottom loops 8) (P. [0075] - - Along the longitudinal axis of helix 9 the large 7 and the small loops 8 are arranged alternately, with the small loops 8 being placed between the large loops 7).
Regarding claim 7, Monstadt further discloses wherein 1) each of the four closed loops (8) approximately return to or contacts another portion of the microcoil (P. [0021] - - In a closed loop the proximal and distal ends of the filament portion forming the closed loop intersect), 2) wherein each of the four closed loops stack portions (S) of the microcoil (9) on top of one another (See Annotated Fig. 4b), 3) wherein each of the four closed loops (8) are circular or oval (P. [0075] - - The loops 7/8 themselves are of roughly circular shape), 4) each of the four closed loops (8) define an area or boundary through which a plane may be approximately positioned (P. [0073] - - At the location where the projection of three adjoining large loops 7 each intersects there are the vertices 4' of the tetrahedron, with one smaller sized loop 8 each being arranged at said vertices; it is noted that each vertices 4’ define an area or boundary through which a plane may be approximately positioned), and 5) some of the four closed loops (8) are wound in a clockwise direction and some of the four closed loops (8) are wound in a counter clockwise direction (See Fig. 5 - - showing the top loops 8 being wound in opposite direction as bottom loops 8) (P. [0075] - - Along the longitudinal axis of helix 9 the large 7 and the small loops 8 are arranged alternately, with the small loops 8 being placed between the large loops 7).
Regarding claim 8, Monstadt further discloses wherein portions of the microcoil (9) between each of the four closed loops (8) do not contact itself (See Annotated Fig. 4b - - showing portions adjacent to encircled stacked portions).
Regarding claim 13, Monstadt further discloses wherein each of the closed loops (4) are wound from one to 2.25 rotations (See Fig. 5 - - showing slightly over one rotation forming each of the closed loops (4)).
Regarding claim 14, Monstadt discloses an occlusion device, comprising:
a microcoil (9) (Figs. 2b- 7) (P. [0074] - - The helix 9 forming the tetrahedron 6 is a micro-helix) having a relaxed secondary configuration (Figs. 4a, 4b) (Ps. [0073], [0075] - - FIG. 4 shows two views 4a and 4b of a tetrahedron-shaped implant 1' according to the invention, said implant having assumed its three-dimensional tertiary structure; FIG. 5 by way of 4 radial sections 10 to 10''' represents the secondary structure of the tetrahedron shown in FIG. 4 in the form of the development of a ball; it is noted that Fig. 5 to Monstadt is similar to applicant’s Fig. 3 and is similarly not interpreted as a secondary configuration; it is further noted that the examiner is not limited to the terminology of a prior art reference);
the relaxed secondary configuration (Figs. 4a, 4b) forming a plurality of closed loops (8) (Figs. 2a- 6) that are each defined by a region of the microcoil (9) that approximately returns to or contacts itself (See Figs. 4a, 4b) (P. [0021] - - In a closed loop the proximal and distal ends of the filament portion forming the closed loop intersect);
wherein the closed loops (8) are arranged in a tetrahedral shape (P. [0073] - - At the location where the projection of three adjoining large loops 7 each intersects there are the vertices 4' of the tetrahedron, with one smaller sized loop 8 each being arranged at said vertices).
Regarding claim 15, Monstadt further discloses wherein each of the plurality of closed loops (8) stack portions (S) (See Annotated Fig. 4b) of the microcoil (9) on top of one another.
Regarding claim 16, Monstadt further discloses wherein each of the plurality of closed loops (8) define an area or boundary through which a plane may be approximately positioned (P. [0073] - - At the location where the projection of three adjoining large loops 7 each intersects there are the vertices 4' of the tetrahedron, with one smaller sized loop 8 each being arranged at said vertices; it is noted that each vertices 4’ define an area or boundary through which a plane may be approximately positioned).
Regarding claim 17, Monstadt further discloses wherein some of the plurality of closed loops (8) are wound in a clockwise direction and some of the closed loops (8)are wound in a counter clockwise direction (See Fig. 5 - - showing the top loops 8 being wound in opposite direction as bottom loops 8) (P. [0075] - - Along the longitudinal axis of helix 9 the large 7 and the small loops 8 are arranged alternately, with the small loops 8 being placed between the large loops 7).
Regarding claim 18, Monstadt further discloses wherein portions of the microcoil (9) between each of the closed loops (8) do not contact itself (See Annotated Fig. 4b - - showing portions adjacent to encircled stacked portions).
Regarding claim 20, Monstadt further discloses wherein each of the closed loops (4) are wound from one to 2.25 rotations (See Fig. 5 - - showing slightly over one rotation forming each of the closed loops (4)).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 12 and is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Monstadt et al. (US Pub. No. 2008/0319532 A1) in view of Monetti et al. (US Pub. No. 2007/0175536 A1). Monetti is cited in the IDS filed 6/26/24.
Regarding claim 12, Monstadt discloses the apparatus of claim 2, but Monstadt does not disclose
(claim 12) wherein the four closed loops each have a diameter ranging from approximately 2 to 20 millimeters.
However, Monetti teaches a three-dimensional coil configured to be deployed in an aneurysm in the same field of endeavor (Abstract, P. [0024])
(claim 12) wherein the four closed loops each have a diameter ranging from approximately 2 to 20 millimeters (P. [0029] - - The loops may be of any dimension and are typically scaled to the approximate size of the treatment site. In the previous example, the loops may range from 0.5 mm diameter to 50 mm diameter; it is noted that the claimed range of approximately 2 to 20 millimeters falls within the disclosed range of 0.5 mm diameter to 50 mm diameter).
It is further noted that Monetti sets forth that loop size is a result effective variable, wherein the loop diameter is scaled to the approximate size of the treatment site (P. [0029]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to dimension the loops associated with Monstadt ranging from 0.5 mm diameter to 50 mm diameter for the purpose of scaling the implant to the approximate size of the treatment site, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Allowable Subject Matter
Claims 11 and 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 11, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein each of the plurality of open loops occur between locations on adjacent closed loops of the four closed loops, and wherein the locations on adjacent closed loops are where portions of each of the four closed loops approximately return to or contact another portion of the microcoil.
Regarding claim 21, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, 6) wherein portions of the microcoil between each of the four closed loops do not contact itself and are each connected to two of the four closed loops.
The closest cited prior art reference, Monstadt et al. (US Pub. No. 2008/0319532 A1) discloses a microcoil (9) (Figs. 2b- 7) (P. [0074]) having a relaxed secondary configuration (Figs. 4a, 4b) (Ps. [0073], [0075]), the relaxed secondary configuration (Figs. 4a, 4b) comprising four closed loops (8) (Figs. 2a- 6) forming a tetrahedral shape (P. [0073]), however, Monstadt does not teach or suggest, alone or in combination open loops or wherein portions of the microcoil between each of the four closed loops do not contact itself and are each connected to two of the four closed loops.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771