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 .
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.
Response to Arguments
Applicant's arguments filed September 30, 2025 have been fully considered but they are not persuasive.
Regarding the 112b: The total for a plurality of wires can be 16. The max total for each subset combined as recited in claim 2 is 17. How can there be more in the subset than in the original total for the plurality? That’s impossible, rendering the scope of the claim indefinite. The claims do not make any distinction that the subsets are subsets of each other but they are claimed as merely subsets of the overall total plurality of wires. Thus, the arguments are not persuasive.
Regarding the prior art rejection:
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
“The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981). See also In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. 1983) (“[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.”); and In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”). However, the claimed combination cannot change the principle of operation of the primary reference or render the reference inoperable for its intended purpose. See MPEP § 2143.01. (See MPEP 2145 III).
Examiner notes multiple factors can affect flexibility. Reynolds does not disclose that they must have every single factor combined to alter flexibility. Reynolds literally states that varying pitch can alter flexibility. Reynolds does teach that the coil can have various different segments with different coil angles along the length of the coil (Paragraph 0092; ‘The pitch...can vary, depending upon the desired characteristics, for example flexibility’). Feller teaches being able to have a coil that can be altered to desired system performance based on the number of wires as well as varying pitch (Paragraph 0055; coils can be similar to the braid thus braid wires would be considered coil wires; ‘The configuration of braid layer can be changed to change system performance. This is achieved by changing the pitch of the braid, the shape of the individual braid wires, the number of braid wires, and the braid wire diameter’). As noted in the rejection braid wires are substantially the same as coil wires.
Applicant’s claims are directed to subject matter that is all considered a design choice in the art as evidenced by the art explicitly stating so. Applicant’s specification provides no specifical or technical reasoning for any of the choices beyond effects that would be predictable to those of ordinary skill in the art as evidenced by the prior art applied stating so. Applicant has not provided any evidence that the claimed design choices can be considered unexpected results. Therefore, Applicant’s arguments are not persuasive.
Response to Amendment
Claim 7 objected to because of the following informalities:
-Claim 7 recites “of wire of wires” which should read “of wires”
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-“movement restrictor” in claim 19 interpreted to be “The movement restrictor 1846 may include a polymer (e.g., PEEK), an adhesive, a weld, and/or any other suitable material.” per the specification
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-8 and 12-22 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 recites the limitation "the first and second subsets of wires" in Lines 28-29. There is insufficient antecedent basis for this limitation in the claim. Examiner notes this should read ‘the first subset of the plurality of wires and the second subset of the plurality of wires’.
Claim 1 recites the limitation "the first, second, third, and fourth coil segments" in Line 34. There is insufficient antecedent basis for this limitation in the claim. Examiner notes this should read ‘the first coil segment, the second coil segment, the third coil segment, and the fourth coil segment’. Similarly this applies to claim 20.
Claim 2 recites ‘the plurality of wires comprises between six wires and 16 wires’ but then later has a max total of 17 wires (8 in the first subset, 2 in the second subset, 9 in the third subset) thus making it unclear exactly what is intended to be claimed. Given initially the total is 16 but the subset of the total can be 17. This is impossible, so the claim is rendered indefinite. It will be interpreted as if one of the subsets has a max total of one less than is claimed such that the max of the subsets can only be 16.
Claim 6 recites the limitation "remaining wires" in Lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is meant to refer to the first subset of wires, the third subset of wires, or some other wires.
Claim 7 recites ‘wires’ and it is unclear if this is meant to be the same element as the ‘a plurality of wires’ as recited in claim 1 or not. For examination purposes it will be treated as the same as ‘a plurality of wires’.
Claim 15 recites ‘windings’ and is dependent back to claim 14 which recites the same making it unclear if the recitation in claim 15 is meant to refer to that in claim 14 or not. For examination purposes it will be treated as referring to the recitation in claim 14.
Claim 22 recites the limitation "wires of the second subset of wires’ and is dependent back to claim 6 which recites the same making it unclear if the recitation in claim 22 is meant to refer to that in claim 6 or not. For the purposes of examination they will be treated as the same element.
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.
Claim(s) 1-5, 8, 12-17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds et al. (US 2003/0069521) in view of Feller, III (US 2006/0074478) and Shimogami et al. (US 2011/0144538).
Regarding claim 1, Reynolds teaches an intravascular device (Abstract; Paragraph 0003), comprising:
an elongated sheath (468) having a proximal end and a distal end, the elongated sheath being sized and configured to traverse human vasculature (Figures 13-14; Paragraph 0003); and
an elongated coil (458) secured to the distal end of the elongated sheath (Figures 13-14), the elongated coil extending between a proximal end of the elongated coil and a distal end of the elongated coil to define a longitudinal axis (Figures 13-14), wherein the elongated coil comprises:
Reynolds is silent explicitly on:
a first coil segment formed from a plurality of wires, wherein the plurality of wires of the first coil segment are helically-wound in the first coil segment at a first coil angle relative to the longitudinal axis,
a second coil segment distal to the first coil segment, the second coil segment formed from a first subset of wires of the plurality of wires, wherein the first subset of wires is helically-wound in the second coil segment at a second coil angle that is different from the first coil angle,
a third coil segment distal to the second coil segment, the third coil segment formed from a second subset of wires of the plurality of wires, wherein the second subset of wires is helically-wound in the third coil segment at a third coil angle that is different from the first coil angle and the second coil angle, and
a fourth coil segment situated between the first coil segment and the second coil segment, the fourth coil segment formed from a third subset of wires of the plurality of wires that includes more wires than the first and second subsets of wires,
wherein the third subset of wires is helically-wound in the fourth coil segment at a fourth coil angle that is larger than the first coil angle and smaller than the second coil angle, and
wherein the first, second, third, and fourth coil segments of the elongated coil are configured such that flexibility of the elongated coil increases in a longitudinal direction toward the distal end of the elongated coil.
Reynolds does teach that the coil can have various different segments with different coil angles along the length of the coil (Paragraph 0092; ‘The pitch...can vary, depending upon the desired characteristics, for example flexibility’).
Feller teaches being able to have a coil that can be altered to desired system performance based on the number of wires as well as varying pitch (Paragraph 0055; coils can be similar to the braid thus braid wires would be considered coil wires; ‘The configuration of braid layer can be changed to change system performance. This is achieved by changing the pitch of the braid, the shape of the individual braid wires, the number of braid wires, and the braid wire diameter’).
Shimogami teaches being able to change the number of wires in a coil (Figure 15; Paragraph 0108; ‘sequentially decreasing the number of strands constituting the stranded coil 612 as illustrated by 630a, 630b, and 630c increases the flexibility of the stranded coil 612 toward the tip’).
Thus Reynolds in view of Feller and Shimogami could be modified through design choice to teach a first coil segment formed from a plurality of wires, wherein the plurality of wires of the first coil segment are helically-wound in the first coil segment at a first coil angle relative to the longitudinal axis, a second coil segment distal to the first coil segment, the second coil segment formed from a first subset of wires of the plurality of wires, wherein the first subset of wires is helically-wound in the second coil segment at a second coil angle that is different from the first coil angle, a third coil segment distal to the second coil segment, the third coil segment formed from a second subset of wires of the plurality of wires, wherein the second subset of wires is helically-wound in the third coil segment at a third coil angle that is different from the first coil angle and the second coil angle, and a fourth coil segment situated between the first coil segment and the second coil segment, the fourth coil segment formed from a third subset of wires of the plurality of wires that includes more wires than the first and second subsets of wires, wherein the third subset of wires is helically-wound in the fourth coil segment at a fourth coil angle that is larger than the first coil angle and smaller than the second coil angle, and wherein the first, second, third, and fourth coil segments of the elongated coil are configured such that flexibility of the elongated coil increases in a longitudinal direction toward the distal end of the elongated coil (Paragraph 0092 of Reynolds; Paragraph 0055 of Feller; Paragraph 0108 of Shimogami).
It would have been obvious to one of ordinary skill in the art to have modified Reynolds with Feller because both Reynolds and Feller teach these variables of designing a coil as being dependent on user desires regarding system performance and desired characteristics (Paragraph 0092 of Reynolds; Paragraph 0055 of Feller). It would have been obvious to one of ordinary skill in the art to have modified Reynolds with Shimogami because Shimogami teaches this as allowing for an increase in flexibility of the coil towards the tip (Paragraph 0108 of Shimogami).
Regarding claim 2, Reynolds in view of Fuller and Shimogami are silent explicitly on wherein the plurality of wires comprises between six wires and sixteen wires, the first subset of wires comprises between three wires and eight wires, the second subset of wires comprises one wire or two wires, and the third subset of wires comprises between four wires and nine wires. The applicant’s specification provides no specifical reasoning or critical functionality for the use of the number of wires in each subset, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the number of wires in each subset as desired by the user as a matter of routine engineering design choice.
Regarding claim 3, Reynolds in view of Fuller and Shimogami are silent explicitly on wherein the plurality of wires comprises ten wires, the first subset of wires comprises three wires, the second subset of wires comprises one wire, and the third subset of wires comprises five wires. The applicant’s specification provides no specifical reasoning or critical functionality for the use of the number of wires in each subset, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the number of wires in each subset as desired by the user as a matter of routine engineering design choice.
Regarding claim 4, Reynolds in view of Fuller and Shimogami is silent explicitly on wherein the second coil angle is larger than the first coil angle and smaller than the third coil angle. Reynolds does teach being able to alter the coil angle as desired (Paragraph 0092; ‘The pitch...can vary, depending upon the desired characteristics, for example flexibility’). The applicant’s specification provides no specifical reasoning or critical functionality for the use of various coil angles beyond what would be known to one of ordinary skill in the art as noted above Reynolds does teach that the coil can have various different segments with different coil angles along the length of the coil (Paragraph 0092; ‘The pitch...can vary, depending upon the desired characteristics, for example flexibility’), thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the use of various coil angles as desired by the user as a matter of routine engineering design choice.
Regarding claim 5, Reynolds in view of Fuller and Shimogami is silent explicitly on wherein the first coil angle is between 550 and 650, the second coil angle is between 650 and 750, and the third coil angle is between 750 and 850. Reynolds does teach being able to alter the coil angle as desired (Paragraph 0092; ‘The pitch...can vary, depending upon the desired characteristics, for example flexibility’). The applicant’s specification provides no specifical reasoning or critical functionality for the use of various coil angles beyond what would be known to one of ordinary skill in the art as noted above Reynolds does teach that the coil can have various different segments with different coil angles along the length of the coil (Paragraph 0092; ‘The pitch...can vary, depending upon the desired characteristics, for example flexibility’), thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the use of various coil angles as desired by the user as a matter of routine engineering design choice.
Regarding claim 8, Reynolds in view of Feller and Shimogami is silent on wherein at wherein at least one wire of the plurality of wires has a distal end that is situated proximally from the distal end of the elongated coil. But Feller teaches being able to have a coil that can be altered to desired system performance based on the number of wires as well as varying pitch (Paragraph 0055; coils can be similar to the braid thus braid wires would be considered coil wires; ‘The configuration of braid layer can be changed to change system performance. This is achieved by changing the pitch of the braid, the shape of the individual braid wires, the number of braid wires, and the braid wire diameter’) and further it would have been obvious to one having ordinary skill in the art at the time the invention was made to have at least one wire of the plurality of wires have a distal end that is situated proximally from the distal end of the elongated coil since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C).
Regarding claim 12, Reynolds in view of Feller and Shimogami are silent on wherein the third coil segment has a greater axial length than the second coil segment and the fourth coil segment. The applicant’s specification provides no specifical reasoning or critical functionality for the use of the third coil segment has a greater axial length than the second coil segment and the fourth coil segment, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the third coil segment has a greater axial length than the second coil segment and the fourth coil segment as desired by the user as a matter of routine engineering design choice.
Regarding claim 13, Reynolds in view of Feller and Shimogami are silent on wherein the fourth coil angle is between 550 and 650. Reynolds does teach being able to alter the coil angle as desired (Paragraph 0092; ‘The pitch...can vary, depending upon the desired characteristics, for example flexibility’). The applicant’s specification provides no specifical reasoning or critical functionality for the use of various coil angles beyond what would be known to one of ordinary skill in the art as noted above Reynolds does teach that the coil can have various different segments with different coil angles along the length of the coil (Paragraph 0092; ‘The pitch...can vary, depending upon the desired characteristics, for example flexibility’), thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the use of various coil angles as desired by the user as a matter of routine engineering design choice.
Regarding claim 14, Reynolds and Feller and Shimogami are silent on wherein spaces are formed between windings of the elongated coil in a first region of the elongated coil. Reynolds does teach that the coil can have various different segments with different coil angles along the length of the coil (Paragraph 0092; ‘The pitch...can vary, depending upon the desired characteristics, for example flexibility’). Feller teaches being able to have a coil that can be altered to desired system performance based on the number of wires as well as varying pitch (Paragraph 0055; coils can be similar to the braid thus braid wires would be considered coil wires; ‘The configuration of braid layer can be changed to change system performance. This is achieved by changing the pitch of the braid, the shape of the individual braid wires, the number of braid wires, and the braid wire diameter’). Thus Reynolds in view of Feller could be modified through design choice to teach wherein spaces are formed between windings of the elongated coil in a first region of the elongated coil, given that various pitch angles/shape of the wires can be altered to include spaces. It would have been obvious to one of ordinary skill in the art to have modified Reynolds with Feller because both Reynolds and Feller teach these variables of designing a coil as being dependent on user desires regarding system performance and desired characteristics (Paragraph 0092 of Reynolds; Paragraph 0055 of Feller).
Regarding claim 15, Reynolds and Feller and Shimogami are silent on wherein the first region of the elongated coil is situated within the third coil segment and extends axially to the distal end of the elongated coil, wherein the spaces between the windings in the first region are spaced having a regular interval between windings. Reynolds does teach that the coil can have various different segments with different coil angles along the length of the coil (Paragraph 0092; ‘The pitch...can vary, depending upon the desired characteristics, for example flexibility’). Feller teaches being able to have a coil that can be altered to desired system performance based on the number of wires as well as varying pitch (Paragraph 0055; coils can be similar to the braid thus braid wires would be considered coil wires; ‘The configuration of braid layer can be changed to change system performance. This is achieved by changing the pitch of the braid, the shape of the individual braid wires, the number of braid wires, and the braid wire diameter’). Thus Reynolds in view of Feller could be modified through design choice to teach wherein the first region of the elongated coil is situated within the third coil segment and extends axially to the distal end of the elongated coil, wherein the spaces between the windings in the first region are spaced having a regular interval between windings. It would have been obvious to one of ordinary skill in the art to have modified Reynolds with Feller because both Reynolds and Feller teach these variables of designing a coil as being dependent on user desires regarding system performance and desired characteristics (Paragraph 0092 of Reynolds; Paragraph 0055 of Feller).
Regarding claim 16, Reynolds in view of Feller and Shimogami are silent on wherein a wire gauge of the elongated coil decreases toward the distal end of the elongated coil. Feller teaches being able to alter the wire gauge (Paragraph 0055; see wire diameter), thus Reynolds in view of Feller could be modified through design choice to teach wherein a wire gauge of the elongated coil decreases toward the distal end of the elongated coil. It would have been obvious to one of ordinary skill in the art to have modified Reynolds with Feller because both Reynolds and Feller teach these variables of designing a coil as being dependent on user desires regarding system performance and desired characteristics (Paragraph 0092 of Reynolds; Paragraph 0055 of Feller).
Regarding claim 17, Reynolds teaches wherein material composition of the elongated sheath varies toward the distal end of the elongated sheath (Paragraphs 0058-0059).
Regarding claim 20, Reynolds and Feller and Shimogami teach wherein the first, second, third, and fourth coil segments of the elongated coil are configured to have differing flexibilities, and wherein the coil segments of the elongated coil are aligned axially along the elongated coil to form a unified structure of the elongated coil that has axially variable flexibility (Paragraph 0092; ‘The pitch...can vary, depending upon the desired characteristics, for example flexibility’ of Reynolds; Paragraph 0055; coils can be similar to the braid thus braid wires would be considered coil wires; ‘The configuration of braid layer can be changed to change system performance. This is achieved by changing the pitch of the braid, the shape of the individual braid wires, the number of braid wires, and the braid wire diameter’ of Feller; Paragraph 0108; ‘sequentially decreasing the number of strands constituting the stranded coil 612 as illustrated by 630a, 630b, and 630c increases the flexibility of the stranded coil 612 toward the tip’ of Shimogami).
It would have been obvious to one of ordinary skill in the art to have modified Reynolds with Feller because both Reynolds and Feller teach these variables of designing a coil as being dependent on user desires regarding system performance and desired characteristics (Paragraph 0092 of Reynolds; Paragraph 0055 of Feller).
It would have been obvious to one of ordinary skill in the art to have modified Reynolds with Shimogami because Shimogami teaches this as allowing for an increase in flexibility of the coil towards the tip (Paragraph 0108 of Shimogami).
Claims 6-7 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds et al. (US 2003/0069521) in view of Feller, III (US 2006/0074478) and Shimogami et al. (US 2011/0144538) as applied to claim 1 above and in further view of McFerran et al. (US 2006/0089618).
Regarding claim 6, Reynolds in view of Fuller and Shimogami is silent on wherein the plurality of wires include wires of the second subset of wires and remaining wires of the plurality of wires not included in the wires of the second subset of wires; wherein wires of the second subset of wires are constructed at least partially of a first material and the remaining wires of the plurality of wires are constructed of a second material that is different from the first material. McFerran teaches being able to alter the materials used in various coil segments as desired (Paragraph 0028). It would have been obvious to one of ordinary skill in the art to have modified Reynolds in view of Fuller and Shimogami with McFerran to have wherein the plurality of wires include wires of the second subset of wires and remaining wires of the plurality of wires not included in the wires of the second subset of wires; wherein the wires of the second subset of wires are constructed at least partially of a first material and the remaining wires of the plurality of wires are constructed of a second material that is different from the first material because McFerran teaches being able to alter the materials used in various coil segments as desired (Paragraph 0028 of McFerran) and since it has been held to be 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 as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 7, Reynolds in view of Fuller and Shimogami is silent on wherein wires of the second subset of wires which extend to the distal end of the elongated coil are constructed at least partially from the first material. McFerran teaches being able to alter the materials used in various coil segments as desired (Paragraph 0028). It would have been obvious to one of ordinary skill in the art to have modified Reynolds in view of Fuller and Shimogami with McFerran to have wherein wires extending to the distal end of the elongated coil are constructed at least partially from the first material because McFerran teaches being able to alter the materials used in various coil segments as desired (Paragraph 0028 of McFerran) and since it has been held to be 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 as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 21, Reynolds teaches wherein the first material comprises a radiopaque material (Paragraph 0071; the coils being made of a radiopaque material means the first material would be radiopaque).
Regarding claim 22, Reynolds teaches wherein wires of the second subset of wires comprise a radiopaque core (Paragraph 0071; the coils being made of a radiopaque material means the wires are thus constituting a radiopaque core).
Claims 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds et al. (US 2003/0069521) in view of Feller, III (US 2006/0074478) and Shimogami et al. (US 2011/0144538) as applied to claim 1 above and in further view of Hammerslag et al. (US Patent No. 4998916).
Regarding claim 18, Reynolds teaches an elongated core wire (core member 413) arranged at least partially within the elongated sheath (Paragraph 0088) arranged at least partially within the elongated sheath and configured such that when the elongated core wire is moved axially, the distal end of the elongated coil bends radially (Paragraph 0092). Reynolds in view of Fuller and Shimogami are silent on the core wire double backing in a loop. Hammerslag teaches further comprising: an elongated core wire (wires 28) arranged at least partially within the elongated sheath and configured such that when the elongated core wire is moved axially, the distal end of the elongated coil bends radially (Figures 1-3), wherein the elongated core wire is doubled back in a loop within the elongated coil such that a terminal distal end of the elongated core wire is spaced from the distal end of the elongated coil (Figures 1-3; the loop formed by two parts of 28 into 22).
It would have been obvious to one of ordinary skill in the art to have modified Reynolds in view of Fuller and Shimogami with Hammerslag because it allows for control of the steering region through a full 360 degree range of motion (Abstract of Hammerslag).
Regarding claim 19, Reynolds in view of Fuller and Shimogami are silent on the movement restrictor. Hammerslag teaches further comprising: a movement restrictor (26/25/22) situated at least partially within the elongated coil (Figures 2-3), the movement restrictor being configured to limit axial movement of the terminal distal end of the core wire in at least one axial direction relative to the elongated coil and to permit the loop of the core wire to buckle, resulting in a bend in the distal end of the elongated coil, when an axial force is exerted on the core wire (Figures 1-3).
It would have been obvious to one of ordinary skill in the art to have modified Reynolds in view of Fuller and Shimogami with Hammerslag because it allows for control of the steering region through a full 360 degree range of motion (Abstract of Hammerslag).
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 1-8 and 12-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11389172 in view of Reynolds et al. (US 2003/0069521) and Feller, III (US 2006/0074478) and Shimogami et al. (US 2011/0144538). Claims 1 and 8 in particular of the claimed invention teach the various structures of the claimed invention. Any differences appear to be design choices. Reynolds teaches that the coil can have various different segments with different coil angles along the length of the coil (Paragraph 0092; ‘The pitch...can vary, depending upon the desired characteristics, for example flexibility’). Feller teaches being able to have a coil that can be altered to desired system performance based on the number of wires as well as varying pitch (Paragraph 0055; coils can be similar to the braid thus braid wires would be considered coil wires; ‘The configuration of braid layer can be changed to change system performance. This is achieved by changing the pitch of the braid, the shape of the individual braid wires, the number of braid wires, and the braid wire diameter’). Shimogami teaches being able to change the number of wires in a coil (Figure 15; Paragraph 0108; ‘sequentially decreasing the number of strands constituting the stranded coil 612 as illustrated by 630a, 630b, and 630c increases the flexibility of the stranded coil 612 toward the tip’). Thus the claimed invention is taught by the U.S. Patent as modified in light of the cited references which disclose the design nature of the configurations.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791