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 .
This action is in response to the amendment filed on 10/08/2025. Claims 17-31 are pending. Claim 17 is independent. Claims 1-16 are canceled. Claims 26-31 have been newly added.
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.
Claim Rejections - 35 USC § 103
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.
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) 17-22, 24 and 26-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US Pub. No.: 2021/0045749) in view of Hui et al. (US Pub. No.: 2014/0128907).
Regarding claims 17-22, 24, and 26-31, Wang discloses [claim 17] an embolization device (10, Fig. 1) configured to be positioned within a body lumen of a patient, the embolization device comprising: an elongated primary structure formed of a coiled wire (at least Para. [0046], primary structure is a coiled wire), wherein the primary structure forms a secondary structure (secondary structure shown in Fig. 1 and Para. [0046]) when unconstrained in which the primary structure forms an anchor portion (14, Fig. 1) and a trailing portion (combination of all sections 16, Fig. 1), and wherein: the anchor portion comprises at least one loop configured to be in contact with and press radially outwardly against an inner surface of the body lumen at a treatment site such that the anchor portion is configured to anchor the embolization device at the treatment site (Para. [0060]), and the trailing portion is configured to fill space in the body lumen to reduce or block flow into and/or through the body lumen (Para. [0060]), wherein the wire comprises a first length (the length of the wire forming the anchor portion 14, Fig. 1) having a first cross-sectional dimension and a second length (the length of the wire forming the trailing portion 16, Fig. 1) comprising a second cross-sectional dimension greater than the first cross-sectional dimension, each of the first and second cross-sectional dimensions measured perpendicular to a longitudinal axis of the wire (Para. [0098], wire forming the device has greater diameter in the trailing section 16 than the anchor portion 14), and wherein the first length of the wire extends along at least a portion of a length of the primary structure that forms the anchor portion and the second length of the wire extends along a length of the primary structure that forms the trailing portion (Fig. 1). However, Wang does not specifically disclose that the trailing portion is more flexible than the anchor portion.
Hui teaches, in the same field of endeavor (embolization device), the trailing portion (52, Fig. 5) of an embolization device is more flexible than the anchor portion (54, Fig. 5) of the embolization device (Paras. [0023], [0025], and [0028]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the embolization device of Wang to include that the trailing portion is more flexible than the anchor portion, such that the anchor portion is stiffer than the trailing portion, as taught by Hui in order to facilitate anchoring the device to vessel/body lumen wall while allowing trailing portion to fill the vessel/lumen space to be more effective in occluding the vessel (Hui, Paras. [0028] –[0029]).
[claim 18] wherein the second length of the wire extends along the entire portion of the length of the primary structure that forms the anchor portion (Wang, Fig. 1 and interpretation above).
[claim 19] wherein the anchor portion comprises a first loop and a second loop contiguous with the first loop, and wherein the second length of the wire extends along one or both of the first loop and the second loop (Wang, Fig. 1, a first loop and a second loop contiguous with the first loop).
[claim 20] wherein the embolization device is configured to be positioned within a blood vessel (Wang, Para. [0045]);
[claim 21] wherein the primary structure defines a lumen extending therethrough (Wang, Paras. [0033]-[0036], the coil is formed by wrapping about an mandrel and thus a lumen is formed in the coiled primary structure);
[claim 22] wherein the embolization device is configured to be positioned within an aneurysm (Wang, Para. [0045]);
[Claim 24] wherein the primary structure defines a lumen extending therethrough (Wang, Paras. [0033]-[0036], the coil is formed by wrapping about an mandrel and thus a lumen is formed in the coiled primary structure). Hui further discloses the primary structure comprises a filler material (Hui, 34, Fig. 4 and Para. [0018]) disposed within the lumen along at least a portion of the second length. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the embolization device of Wang to include that the primary structure comprises a filler material disposed within the lumen along at least a portion of the second length as taught by Hui in order to prevent stretching and/or permanent plastic deformation of the coil (Hui, Para. [0019]).
[claim 26] wherein the trailing portion has a first portion (Wang, see Figure below, a portion of 16 extending from 14) configured to deploy to a maximum cross-sectional dimension (see Figure below) and a second portion (see Figure below) configured to deploy to a maximum cross-sectional dimension (see Figure below) different than the maximum cross-sectional dimension of the first portion (see Figure below);
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[claim 27] wherein the first portion of the trailing portion is continuous with the anchor portion (Wang, see Figure above);
[claim 28] wherein the maximum cross-sectional dimension of the first portion is greater than the maximum cross-sectional dimension of the second portion (Wang, see Figure above);
[claim 29] wherein the trailing portion forms at least one loop when the embolization device is implanted at the treatment site (Wang, Fig. 1);
[claim 30] wherein the anchor portion is configured to define a conical spiral (Wang, Fig. 1 at 34 and 32 and Para. [0069]) in a deployed state;
[claim 31] wherein the anchor portion is configured to exert a larger radial force against the vessel wall compared to the trailing portion when embolization device is implanted at the treatment site (Wang, Para. [0060], the anchor portion is configured to exert a larger radial force against the vessel wall compared to the trailing portion when embolization device is implanted at the treatment site).
Claim(s) 23 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US Pub. No.: 2021/0045749) in view of Hui et al. (US Pub. No.: 2014/0128907) as applied to claim 17 above, and further in view of Monstadt et al. (US Pub. No.: 2004/0034378).
Regarding claim 23, Wang in view of Hui discloses all the limitations of claims claim 17 as taught above but fails to disclose a sidewall of the primary structure comprises a first number of coil layers along the first length and a second number of coil layers along at least a portion of the second length, the second number greater than the first number.
Monstadt teaches, in the same field of endeavor (embolization device), a sidewall of the primary structure comprises a first number of coil layers (Fig. 1) along a first length (the length at the distal portion of 5, Fig. 1) and a second number of coil layers (three layers of coils at the proximal portion of 5, Fig. 1) along at least a portion of a second length at the proximal end (Fig. 1), the second number greater than the first number (Fig. 1, three layers at the proximal end portion is greater than one or two layers at the distal portion).
Before the effectively filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the embolization device of Wang in view of Hui to include that a sidewall of the primary structure comprises a first number of coil layers along the first length and a second number of coil layers along at least a portion of the second length, the second number greater than the first number as taught by Monstadt in order to obtain the advantage of increasing the pushability of the device with more coil layers at the proximal portion of the device.
Regarding claim 25, Wang in view of Hui discloses all the limitations of claims claim 17 as taught above. Wang further discloses that the primary structure defines a lumen extending therethrough (Wang, Paras. [0033]-[0036], the coil is formed by wrapping about an mandrel and thus a lumen is formed in the coiled primary structure).
Hui further discloses the primary structure comprises a filler material (Hui, 34, Fig. 4 and Para. [0018]) disposed within the lumen along at least a portion of the second length. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the embolization device of Wang to include that the primary structure comprises a filler material disposed within the lumen along at least a portion of the second length as taught by Hui in order to prevent stretching and/or permanent plastic deformation of the coil (Hui, Para. [0019]).
However, neither Wang nor Hui discloses a sidewall of the primary structure comprises a first number of coil layers along the first length and a second number of coil layers along at least a portion of the second length, the second number greater than the first number.
Monstadt teaches, in the same field of endeavor (embolization device), a sidewall of the primary structure comprises a first number of coil layers (Fig. 1) along a first length (the length at the distal portion of 5, Fig. 1) and a second number of coil layers (three layers of coils at the proximal portion of 5, Fig. 1) along at least a portion of a second length at the proximal end (Fig. 1), the second number greater than the first number (Fig. 1, three layers at the proximal end portion is greater than one or two layers at the distal portion).
Before the effectively filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the embolization device of Wang in view of Hui to include that a sidewall of the primary structure comprises a first number of coil layers along the first length and a second number of coil layers along at least a portion of the second length, the second number greater than the first number as taught by Monstadt in order to obtain the advantage of increasing the pushability of the device with more coil layers at the proximal portion of the device.
Response to Arguments
Applicant’s arguments with respect to claim(s) 17-31 have been considered but are moot in view of new ground(s) of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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/JING RUI OU/ Primary Examiner, Art Unit 3771