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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/8/2026 has been entered.
Response to Amendment
In light of Applicant’s amendment, claim(s) 1 and 9 is/are amended and claim(s) 4-5, 7, 10, and 13-21 were previously canceled. Claims 22-24 were previously added. Claims 1-3, 6, 8-9, 11-12, and 22-24 are now pending examination.
Response to Arguments
Applicant's arguments filed 5/8/2026 have been fully considered but they are not persuasive.
Applicant amended to include “a distal coil portion disposed on a first surface, a proximal coil portion disposed on a second surface, and an intermediate coil portion disposed on second surface, wherein said first surface and said second surface are non-coincident” in claim 1 and “a distal coil portion disposed on a first surface, a proximal coil portion disposed on a third surface, and an intermediate coil portion disposed on a second surface, wherein said first surface, second, and third surfaces are non-coincident” in claim 9 in an attempt to overcome the previous interpretation via product by process. However, the newly written claim renders the claim indefinite as it is unclear whether the claim is now reciting an intermediate product, as the coil portions are required to be disposed on surfaces, which according to the present specification, are surfaces of a mandrel, or if the mandrel surfaces are only functionally recited, wherein the claim is directed to the final product, which would be fully capable of being disposed on a mandrel while being formed. Since the preamble of the claim is directing the invention to “an embolic coil”, the invention is seen to be the final product, in which the coil portions would no longer be disposed on the mandrel surfaces. As such, Islak, previously relied upon, discloses the final product of the embolic coil and a rejection is made over U.S.C 102 in view of Islak.
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 1-3, 6, 8-9, 11-12, and 22-24 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 and 9 recite “a distal coil portion disposed on a first surface, a proximal coil portion disposed on a second surface, and an intermediate coil portion disposed on second surface”, reciting a surfaces of a mandrel. This claim is indefinite, as the preamble of the claim is directed to a final product of an embolic coil and the limitations requiring the coil portions to be disposed on a mandrel would indicate an intermediate product. Thus, it is unclear if the claims are truly directed to a final product, in which case, the limitations requiring the coil portions to be disposed on a mandrel would be obsolete, or if the claims are directed to an intermediate product, capturing the embolic coil in the process of forming while on a mandrel. For examination purposes, the claim will be seen as being directed to the final product, which would be fully capable of being disposed on a mandrel while being formed, but is not required to be expressly disclosed by the prior art.
Claims 2-3, 6, 8-9, 11-12, and 22-24 are rejected due to their dependence on claims 1 and 9.
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, 6, 9, and 11 is/are rejected under 35 U.S.C. as anticipated by Islak et al. (US 20160066920 A1) (previously of record).
Regarding claim 1, as best understood in view of the 112(b) issues above, Islak discloses an embolic coil (160) of a unitary strand of wire material (Figure 5), the embolic coil comprising:
a distal coil portion (which is fully capable of being disposed on a first surface while in the process of manufacturing) (labeled in Annotated Figure 5A), a proximal coil portion (labeled in Annotated Figure 5A) (which is fully capable of being disposed on a second surface while in the process of manufacturing), and an intermediate coil portion (labeled in Annotated Figure 5A) (which is fully capable of being disposed on said second surface while in the process of manufacturing) extending between said distal and proximal coil portions, wherein said first surface and said second surface are fully capable of being non-coincident,
said distal coil portion having an anchor loop (176, labeled in Annotated Figure 5A) (Figure 5; Paragraph 0031), operably connecting to a distal end transition loop unit (labeled in Annotated Figure 5A) formed between said distal coil portion and said intermediate coil portion (Annotated Figure 5A),
said intermediate coil portion comprising:
a primary coil portion (labeled in Annotated Figure 5A), said primary coil portion comprising a predetermined set of arcuate curves (labeled in Annotated Figure 5A) having a first radius and a second radius (each curve has a radius, thus having a first and second radius) (Annotated Figure 5A),
a secondary coil portion (labeled in Annotated Figure 5A) comprising a plurality of arcuate curves (labeled in Annotated Figure 5A) having radii smaller than said first radius and said second radius of said primary coil portion and that follow the trajectory of the primary coil portion (Annotated Figure 5A) (the curves of the secondary coil portion have visibly smaller radii than the curves labeled in the primary coil portion), and
said proximal coil portion having a delivery loop (labeled in Annotated Figure 5A) as an open-loop (the loop is G-shaped, thus is open) (labeled in Annotated Figure 5A) (Figure 5; Paragraph 0038), operably connecting to a proximal end transition loop (labeled in Annotated Figure 5A) disposed between said proximal coil portion and said intermediate coil portion (Annotated Figure 5A),
whereby said anchor loop is operable to secure to an inner surface of a vessel at a site of an embolization procedure (Paragraph 0032).
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Regarding claim 3, Islak further discloses wherein said distal end transition loop unit and said proximal end transition loop each comprise at least one of said open-loop unit (Annotated Figure 5A).
Regarding claim 6, Islak further discloses wherein the arcuate curves of the secondary coil portion include one or more one loop unit selected from the group consisting of: (i) said open-loop unit, (ii) said single-loop unit (Annotated Figure 5A).
Regarding claim 9, as best understood in view of the 112(b) issues above, Islak discloses an embolic coil (160) of a strand of wire material, said embolic coil comprising:
a distal coil portion (which is fully capable of being disposed on a first surface while in the process of manufacturing) (labeled in Annotated Figure 5A), a proximal coil portion (which is fully capable of being disposed on a third surface while in the process of manufacturing) (labeled in Annotated Figure 5A), and an intermediate coil portion (which is fully capable of being disposed on a second surface while in the process of manufacturing) (labeled in Annotated Figure 5A) extending between said distal and proximate coil portions (Annotated Figure 5A),
said distal coil portion comprising:
an anchor loop (176, labeled in Annotated Figure 5A) with an open-loop unit, (Annotated Figure 5A; Paragraph 0032);
a distal end transition portion (labeled in Annotated Figure 5A) flexibly coupled to said distal coil portion and said intermediate coil portion(Annotated Figure 5A);
said intermediate coil portion comprising:
a primary coil portion (labeled in Annotated Figure 5A), said primary coil comprising a predetermined set of arcuate curves (labeled in Annotated Figure 5A) having a first radius and a second radius (each curve has a radius, thus having a first and second radius) (Annotated Figure 5A),
a secondary coil portion (labeled in Annotated Figure 5A) comprising a plurality of arcuate curves (labeled in Annotated Figure 5A) having radii smaller than said first radius and said second radius of said primary coil portion and that follow the trajectory of the primary coil (Annotated Figure 5A) (the curves of the secondary coil portion have visibly smaller radii than the curves labeled in the primary coil portion); and
a proximal end transition portion (labeled in Annotated Figure 5A) flexibly coupled to said intermediate coil portion and said proximal coil portion (Annotated Figure 5A);
said proximal coil portion comprises:
at least one delivery loop (labeled in Annotated Figure 5A) consisting of (i) said open-loop unit (Annotated Figure 5A),
whereby said anchor loop maintains a position on an inner surface of a vessel at a site of an embolization procedure and the embolic coil, in a relaxed state in the patient's body, substantially assumes the shape of the inner surface of the vessel at the site of an embolization procedure (Paragraph 0032-33).
Regarding claim 11, Islak further discloses wherein the arcuate curves of the secondary coil portion includes one or more one loop unit selected from the group consisting of: (i) said open-loop, (ii) said single-loop (Annotated Figure 5A).
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) 2 and 22-24 is/are rejected under 35 U.S.C. 102/103 as being unpatentable over Islak.
Regarding claim 2, Islak discloses the embolic coil of claim 1 and further discloses said anchor loop is formed on a plane of a mandrel (180) (Figure 6; Paragraph 0039) with an open-loop unit (Figure 5; Paragraph 0032). The claimed phrase “said anchor loop being formed on a plane on a spherical tip of a mandrel with at least one loop unit selected from the group consisting of (i) an open-loop unit, (ii) a single-loop unit, and (iii) a multi-turn loop unit” is being treated as a product by process limitation; that is, the phrase will be examined as “said anchor loop being formed with at least one loop unit selected from the group consisting of (i) an open-loop unit, (ii) a single-loop unit, and (iii) a multi-turn loop unit”. 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.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 22, the claimed phrase “wherein said first and said second surfaces are selected from the group consisting of: a plane, a cone, a cylinder and a sphere” is being treated as a product by process limitation. As indicated in the rejection of claim 1, since the method of forming the apparatus is not considered in an apparatus claim, the features of the first and second surfaces are not required to be disclosed by the prior art as claimed. 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.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 23, the claimed phrase “wherein said first, said second and said third surfaces are selected from the group consisting of: a plane, a cone, a cylinder and a sphere” is being treated as a product by process limitation. As indicated in the rejection of claim 9, since the method of forming the apparatus is not considered in an apparatus claim, the features of the first and second surfaces are not required to be disclosed by the prior art as claimed. 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.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 24, Islak further discloses said anchor loop subtends an arc of between about 180° and about 520° and said delivery loop comprises an open loop (Annotated Figure 5). However, the claimed phrase “wherein said first surface is spherical, said second surface is cylindrical” is being treated as a product by process limitation. As indicated in the rejection of claim 1, since the method of forming the apparatus is not considered in an apparatus claim, the features of the first and second surfaces are not required to be disclosed by the prior art as claimed. 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.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Claim(s) 8 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Islak in view of Aguilar et al. (US 20190307546 A1) (previously of record).
Regarding claim 8, Islak discloses the embolic coil of claim 1 but fails to explicitly disclose wherein the strand of wire material comprises a Heat Set Shapable Wire, Shape Memory Wire and/or other composite materials, metals, and metal alloys selected from the group of consisting of: Gold and/or Gold composites, Platinum and/or Platinum composites including Pt, Pt/Ir, Pt/W, Titanium and/or Titanium composites platinum including Ni/Ti, and other precious metals.
However, Aguilar is directed to an embolic coil and teaches a coil comprising a strand of Shape Memory Wire, Platinum, or Ni/Ti (Paragraph 0039).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Islak such that a coil comprising a strand of Shape Memory Wire or Ni/Ti, as taught by Aguilar, as both references and the claimed invention are directed to embolic coils. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Islak with the teachings of Aguilar by incorporating a coil comprising a strand of Shape Memory Wire or Ni/Ti in order to allow the device to be deployed and reform into its desired shape (Paragraph 0051). Further, Islak is silent to the material of the coil, but does teach a coil with a predetermined shape (Islak Paragraph 0039).
Regarding claim 12, Islak discloses the embolic coil of claim 9 but fails to explicitly disclose wherein the strand of wire material comprises a Heat Set Shapable Wire, Shape Memory Wire and/or other composite materials, metals, and metal alloys selected from the group of consisting of: Gold and/or Gold composites, Platinum and/or Platinum composites including Pt, Pt/Ir, Pt/W, Titanium and/or Titanium composites platinum including Ni/Ti, and other precious metals.
However, Aguilar is directed to an embolic coil and teaches a coil comprising a strand of Shape Memory Wire, Platinum, or Ni/Ti (Paragraph 0039).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Islak with the teachings of Aguilar by incorporating a coil comprising a strand of Shape Memory Wire or Ni/Ti in order to allow the device to be deployed and reform into its desired shape ( Paragraph 0051). Further, Islak is silent to the material of the coil, but does teach a coil with a predetermined shape (Islak Paragraph 0039).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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