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 04/16/2026. Claims 1-8, 10, and 12-34 are pending. Claims 1, 18, and 30 are independent. Claims 18-32 have been withdrawn.
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) 1, 3-7, 10, 12, 14-16, 33, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trans et al. (US Pub. No.: 6,524,299) in view of Rafiee (US Pub. No.: 2006/0074403) and Le et al. (US Pat. No. 6,355,027).
Regarding claims 1, 3-6, 10, 12, 14-16, 33, and 34, Trans discloses [claim 1] an embolic material delivery device (100, Figs. 1 and 2B and see Abstract) comprising: a conduit body (conduit body of 100, Fig. 1 and 2B) extending between a proximal end portion and a distal end portion (proximal portion and distal portion of 100, Fig. 1), wherein the conduit body defines an axial lumen (Figs. 1 and 2B, lumen of 100) extending between the proximal end portion and the distal end portion, and wherein the axial lumen is configured to transport the embolic material (Abstract and Col. 3, lines 3-5), wherein the conduit body comprises a first flexibility zone (the zone along the portion of 108, Fig. 1, Col. 3, lines 41-60 and claim 1), a transition zone (114, Fig. 1), and a second flexibility zone (the zone along the portion of 110, Fig. 1), the transition zone comprising overlapping portions (Col. 4, lines 18-41) of a first tube (108, Fig. 1) and a second tube (110, Fig. 1); wherein the first flexibility zone is positioned between the proximal end portion and the transition zone (Fig. 1), and wherein the second flexibility zone is positioned between the transition zone and the distal end portion (Fig. 1), and wherein the first flexibility zone is configured to transfer pushing force toward the second flexibility zone and defines a first kink radius (Col. 3, lines 41-60 and claim 1, the first flexibility zone defines a first kink radius with less flexibility) and a first bending stiffness (Col. 3, lines 41-60 and claim 1, the first flexibility zone defines first bending stiffness with less flexibility), and wherein the second flexibility zone is fully capable to be navigable through tortuous neurovascular anatomy and defines a second kink radius smaller than the first kink radius (the second flexibility zone is fully capable to be navigable through tortuous neurovascular anatomy since it is more flexible. The second flexibility zone defines a second kink radius smaller than the first kink radius because the second flexibility zone at 110 is more flexible than the first flexibility zone at 108) and a second bending stiffness smaller than the first bending stiffness (second flexibility zone defines a second bending stiffness smaller than the first bending stiffness because it is more flexible than the first flexibility zone); [claim 3] wherein the first tube (108, Fig. 1) defines a first outer diameter at the first flexibility zone; and the second tube (110, Fig. 1) defines a second outer diameter at the second flexibility zone, wherein the second outer diameter is less than the first outer diameter (Fig. 1), and wherein the first tube and the second tube are coupled to one another at the transition zone (Fig. 1 and 2B and Col. 4, lines 35-53); [claim 4] a welded joint (the welded joint at 114, Figs. 1 and 2B and Col. 4, line 35 – Col. 5, line 3) coupling the first tube and the second tube to one another at the transition zone; [claim 5] wherein the second tube is positioned within the first tube at the transition zone (Fig. 2B); [claim 6] wherein the first tube and the second tube are formed from the same material (Col. 3, lines 41-43); [claim 10] wherein the first flexibility zone defines a first outer diameter; and the second flexibility zone defines a second outer diameter less than the first outer diameter (Fig. 1); [claim 12] wherein the transition zone defines a tapering outer diameter transitioning from the first outer diameter to the second outer diameter (Figs. 1 and 2B); [claim 14] wherein each of the first tube and the second tube has a respective constant inner diameter (Figs. 2A and 2B); [claim 15] the transition zone is a first transition zone (Fig. 1); and the conduit body comprises: a third flexibility zone (112, Fig. 1), and a second transition zone (116, Fig. 1) between the second flexibility zone and the third flexibility zone; [claim 16] wherein the first transition zone comprises overlapping tubes and a welded coupling (Fig. 1, 2A and Col. 4, line 35 – Col. 5, line 3), and the second transition zone comprises a taper (taper at 116, Figs. 1 and 2A) between two monolithic flexibility zones (between monolithic flexibility zones at 110 and 112, Fig. 1); [claim 33] wherein the first transition zone includes a step down between a first outer diameter of the conduit body at the first flexibility zone and a second outer diameter of the conduit body at the second flexibility zone (Fig. 1 and 2B and Col. 4, lines 29-31 and 35-53, a step down is formed between a first outer diameter of the conduit body at the first flexibility zone and a second outer diameter of the conduit body at the second flexibility zone when the ends of the tubes at the first transition zone are chamfered); and [claim 34] wherein the heat treatment is annealing (Col. 4, line 35 – Col. 5, line 3). However, Trans does not disclose that the first flexibility zone is heat treated such that the first flexibility zone has a first ductility and the second flexibility zone is heat treated such that the second flexibility zone has a second ductility different than the first ductility; and the second bending stiffness is within a range of 3% to 50% of the first bending stiffness.
Rafiee teaches, in the same field of endeavor (catheter/delivery device), a catheter/delivery device comprising a first flexibility zone heat treated such that the first flexibility zone has a first ductility and a second flexibility zone heat treated such that the second flexibility zone has a second ductility different than the first ductility (Paras. [0007], [0009] and [0019]-[0022], different heat-treatment is applied to the distal region of the catheter/delivery device to make the distal region more flexible/ductile than the proximal region).
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 delivery device of Trans to include that the first flexibility zone has a first ductility and the second flexibility zone is heat treated such that the second flexibility zone has a second ductility different than the first ductility as taught by Rafiee in order to obtain a desired stiffness at the proximal region and a desired flexibility at the distal region of the catheter / delivery device to facilitate the catheter to be pushed through the patient’s vasculature (Rafiee, at least Paras. [0003], [0006], [0007], and [0009]).
Regarding claim 7, Rafiee teaches catheter/delivery device comprising a first flexibility zone heat treated such that the first proximal flexibility zone and the second distal flexibility zone heat treated to have different material properties (Paras. [0007], [0009] and [0019]-[0022].) 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 first proximal tube and the second distal tube of the delivery device of Trans in view of Rafiee to be treated with different extents of a heat treatment such that the first tube and the second tube have different material properties in order to in order to obtain a desired stiffness at the proximal region and a desired flexibility at the distal region of the catheter / delivery device to facilitate the catheter to be pushed through the patient’s vasculature (Rafiee, at least Paras. [0003], [0006], [0007], and [0009]).
Le teaches, in the same field of endeavor (delivery device/catheter), a delivery device / catheter comprising a first flexibility zone (24, Fig. 1 and Col. 3, lines 28-33) defining a first bending stiffness (Col. 3, lines 28-33, such that zone 24 has the hardness of 50D) and a second flexibility zone (22, Fig. 1 and Col. 3, lines 20-24) defining a second bending stiffness (Col. 3, lines 20-24, such zone 22 has the hardness of 25D); wherein the second bending stiffness is within a range of 3% to 50% of the first bending stiffness (Col. 3, lines 28-33 and lines 20-24, zone 22 has the hardness of 25D which is 50% of the hardness of zone 24 which is 50D).
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 second bending stiffness of Trans is within a range of 3% to 50% (such as 50%) of the first bending stiffness by as taught by Le, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable range involves only routine skill in the art.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trans et al. (US Pub. No.: 6,524,299) in view of Rafiee (US Pub. No.: 2006/0074403) and Le et al. (US Pat. No. 6,355,027) as applied to claim 6 above, and further in view of Jaroch et al. (US Pub. No.: 2018/0193591).
Regarding claim 2, Trans in view of Rafiee and Le discloses substantially all the limitation of the claim as taught above but fails to disclose that the second kink radius is within a range of 10% to 80% of the first kink radius.
Jaroch teaches, in the same field of endeavor (medical catheter/delivery device), a delivery device comprising a second kink radius (kink radius at segment 504, Figs. 24 and 26) is within a range from 10% to 85% (Para. [0086], such as one half to two third) of a first kink radius (kink radius at segment 502, Figs. 25 and 26).
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 delivery device of Trans in view of Rafiee and Le to include that the second kink radius is within a range of 10% to 80%, such as one half to two third, of the first kink radius as taught by Jaroch, since it has been held that where the general conditions of a claim are discovered in the prior art, discovering the optimum or workable range involves only routine skill in the art. See MPEP 2144.05
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trans et al. (US Pub. No.: 6,524,299) in view of Rafiee (US Pub. No.: 2006/0074403) and Le et al. (US Pat. No. 6,355,027) as applied to claim 6 above, and further in view of Euteneuer et al. (US Pub. No.: 2007/0167877).
Regarding claim 8, Trans in view of Rafiee and Le discloses substantially all the limitation of the claim as taught above but fails to disclose that the first tube and second tube are nitinol.
Euteneuer teaches, in the same field of endeavor (medical catheter/delivery device), a first tube and second tube (proximal tube and distal tube, Para. [0011] and [0043] and Fig. 1) of a delivery device (10, Fig. 1) are nitinol (Para. [0011] and [0043] and Fig. 1).
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 first tube and second tube of the delivery device of Trans in view of Rafiee and Le to be nitinol as taught by Euteneuer, since it has been held within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. See MPEP 2144.07
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trans et al. (US Pub. No.: 6,524,299) in view of Rafiee (US Pub. No.: 2006/0074403) and Le et al. (US Pat. No. 6,355,027) as applied to claim 12 above, and further in view of Pepin et al. (US Pat. No.: 5,614,136).
Regarding claim 13, Trans in view of Rafiee and Le discloses all the limitations of claim 12 as taught above. Furthermore, Trans discloses that taper can be any convenient length (Col. 4, lines 25-28). However, neither Trans nor Rafiee specifically discloses that the taper extends at least 2 cm in order for the conduit body to define a variable kink radius transitioning from the first kink radius to the second kink radius.
Pepin teaches, in the same field of endeavor (catheter / delivery device), a taper defined by a transition zone extends at least 2 cm in order for the conduit body to define a variable kink radius transitioning from the first kink radius to the second kink radius (Col. 8, lines 3-5).
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 taper of Trans in view of Rafiee and Le to extends at least 2 cm in order for the conduit body to define a variable kink radius transitioning from the first kink radius to the second kink radius as taught by Pepin in order to allow the transition zone / taper to curve at a desired degree.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trans et al. (US Pub. No.: 6,524,299) in view of Rafiee (US Pub. No.: 2006/0074403) and Le et al. (US Pat. No. 6,355,027) as applied to claim 1 above, and further in view of Samson et al. (US Pat. No.: 6,090,099)
Regarding claim 17, Trans in view of Rafiee and Le discloses substantially all the limitation of the claim as taught above but fails to disclose a heat shrink positioned around the first flexibility zone, transition zone, and the second flexible zone.
Samson teaches, in the same field of endeavor (medical catheter/delivery device), a heat shrink (208, Fig. 2) positioned around the first flexibility zone (204, Fig. 2), transition zone (the tapered zone shown in Fig. 2 or the zone between 202 and 204, Fig. 2), and the second flexible zone (202, Fig. 2 and Col. 8, lines 36-43).
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 delivery device of Trans in view of Rafiee and Le to include a heat shrink positioned around the first flexibility zone, transition zone, and the second flexible zone as taught by Samson in order to obtain the advantage of creating a unitary structure having high kink resistance in additional to the variable flexibility and pushability (Samson, Col. 8, lines 35-43).
Response to Arguments
All the ground(s) of rejection made in the most recent office action have been withdrawn in light of the amendment. Applicant’s arguments with respect to claim(s) 1-8, 10, 12-17, 33, and 34 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JING RUI OU/Primary Examiner, Art Unit 3771
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