DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
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 ("BRI") 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 BRI 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(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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), 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), except as otherwise indicated in an Office action.
Claim Objections
Claim 9 is a duplicate of claim 4. Claim 10 is a duplicate of claim 5. Accordingly, Applicant is advised that should claim(s) 4 and/or 5 be found allowable, claim(s) 9 and/or 10, respectively, will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
The examiner believes Applicant may have intended claim 9 to be dependent on claim 1 (rather than claim 2 as recited), and claim 10 to be dependent on claim 9 (rather than claim 4 as recited). The examiner notes amendments to claims 9 and 10 to change the respective dependencies thereof to claims 1 and 9 would obviate the objection noted above.
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 1 and claims dependent thereon, the structure of the claimed "tube" is indefinite in view of the specification as filed and the dependent claims (particularly claim 11). Applicant discloses a "tubular member" (22) that is provided with a sensor, and a "tube" (80). Applicant further discloses a "proximal end tube" (90) that may be arranged between tube 80 and a connector assembly (40), i.e., extends from tube 80 to a proximal end of the core wire, wherein the proximal end tube 90 is formed of a material having higher strength than that of the tube 80 (¶ [0069]). Applicant does not appear to make any disclosure with respect to the strength of either of tube 80 or proximal end tube 90 relative to the tubular member 22. In view of the above, most of the recited "tube" features of the claims, including independent claim 1, appear to correspond to features described with respect to tubular structure 22, while the recited "tube" features and/or relationships of claim 11 appear to correspond to feature described with respect to tube 80. Accordingly, it is unclear to which disclosed tube (tubular member 22, tube 80) the claimed "tube" refers.
Regarding claim 11 and claims dependent thereon, the limitation "a proximal end tube that extends from the tube to a proximal end of the core wire and surrounds the core wire" is indefinite. As noted above with respect to claim 1, Applicant discloses proximal end tube 90 "extends from" tube 80, rather than a tube/tubular member that is provided with a sensor as recited in claim 1, on which claim 11 depends. As such, it is unclear in what manner the proximal end tube "extends from the tube to a proximal end of the core wire…" as recited in claim 11. For the purpose of this Office action, this limitation will be discussed with the understanding that the proximal end tube extends proximally in a direction away from the tube of claim 1, but does not necessarily extend "from the tube" (i.e., a component/element may be disposed between the tube and the proximal end tube).
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) 1-2, 4-5, 9-10 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0180141 A1 (Millet).
Regarding claim 1, Millet discloses a guide wire with a sensor comprising:
a core wire (Fig. 2, ¶ [0052], core/core wire 226 and 214; Figs. 3-23, core/core wire 331);
a first coil body surrounding a distal end portion of the core wire (Fig. 2, flexible element 210; Figs. 3-23, distal coil 304);
a distal tip that joins a distal end of the core wire and a distal end of the first coil body (Fig. 2, distal tip 207 defined by element 208 that is solder secured to flexible element 210 and flattened tip core 212, as described in ¶ [0050]); and
a tube (Fig. 2, mounting structure 218; Figs. 3-23, mounting structure 300) provided with a sensor (Fig. 2, ¶ [0050] component 220; Figs. 3-23, sensing component 306), wherein:
the tube surrounds the core wire (e.g., Figs. 7-8, ¶ [0071], etc.),
a distal end portion of the tube (Figs. 3-23, distal portion 318) is inside a proximal end portion of the first coil body, and the distal end portion of the tube and the proximal end portion of the first coil body are joined to each other (e.g., ¶ [0074] distal portion 318 defines an alignment feature for mounting distal coil 304 (as shown in Fig. 3) to the mounting structure 300).
Regarding claim 2, Millet discloses an outer diameter of the proximal end portion of the first coil body is larger than an outer diameter of the tube including the sensor (¶ [0067] central portion 316 may have a diameter that is less than the outer diameter of the guide wire, e.g., Figs. 22-23).
Regarding claims 4 and 9, Millet discloses the guide wire further comprises a second coil body surrounding the core wire in a proximal end side from the first coil body, wherein a proximal end portion of the tube (Figs. 3-23, proximal portion 320) is inside a distal end portion of the second coil body, and the proximal end portion of the tube and the distal end portion of the second coil body are joined (e.g., ¶ [0062] proximal portion 320 serves as an alignment feature for mounting proximal coil 302 (as shown in Fig. 5) to the mounting structure).
Regarding claims 5 and 10, Millet discloses an outer diameter of the distal end portion of the second coil body is larger than an outer diameter of the tube including the sensor (¶ [0067] central portion 316 may have a diameter that is less than the outer diameter of the guide wire, e.g., Figs. 22-23).
Regarding claim 13, Millet discloses the sensor is attached directly to an outer surface of the tube (¶ [0063] sensing component 306 is mounted to surface 327 of mounting structure 300, e.g., Figs. 9-11).
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2024/0299052 A1 (Carreel) in view of Millet; or alternatively, over Millet in view of Carreel.
Regarding claims 1 and 12-14, Carreel discloses/suggests a guide wire with a sensor (e.g., Figs. 31-37), the guide wire comprising:
a core wire (Fig. 31, 36, etc., core wire 1);
a first coil body surrounding a distal end portion of the core wire (e.g., Fig. 31, coil 9);
a distal tip that joins a distal end of the core wire and a distal end of the first coil body (e.g., Fig. 31, tip 10); and
a tube (e.g., Figs. 33, 35-36, etc., housing 6) provided with a sensor sheet that surrounds and is directly attached to an outer periphery of the tube (e.g., Fig. 36, sensor array 25 of flex circuit 5 provided on housing 6), wherein:
the tube surrounds the core wire (Figs. 31, 36, ¶ [0275] each end of the housing 6 may have an opening 15 through which core wire 1 may be passed), and
a distal end portion of the tube and a proximal end portion of the first coil body are joined to each other (regions of the housing near its ends include respective flared or enlarged bosses 17, which may be designed for the multi-filar coil 2 and the coil 9 to be inserted and bonded to the housing).
Carreel does not disclose the distal end portion of the tube is inside the proximal end portion of the first coil body.
Millet discloses/suggests a comparable guide wire comprising, inter alia, a tube (Fig. 2, mounting structure 218; Figs. 3-23, mounting structure 300) provided with a sensor (Fig. 2, ¶ [0050] component 220; Figs. 3-23, sensing component 306), wherein: the tube surrounds a core wire (e.g., Figs. 7-8, ¶ [0071], etc.), wherein a distal end portion of the tube (Figs. 3-23, distal portion 318) is inside a proximal end portion of the first coil body, and the distal end portion of the tube and the proximal end portion of the first coil body are joined to each other (e.g., ¶ [0074] distal portion 318 defines an alignment feature for mounting distal coil 304 (as shown in Fig. 3) to the mounting structure 300).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide wire of Carreel with a distal end portion of the tube being inside a proximal end portion of the first coil body as taught/suggested by Millet in order to provide an alignment feature sized and shaped to align engagement of the first coil body with the tube (Millet, ¶ [0009]).
Alternatively/Additionally, with respect to claims 12-14, Millet discloses the limitations of claim 1, as discussed above, but does not disclose the sensor is a sensor sheet that surrounds the tube, or the sensor is attached directly to an outer peripheral surface of the tube. Carreel discloses these features, as discussed above. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide wire of Millet with the sensor being a sensor sheet that surrounds and is directly attached to an outer peripheral surface of the tube as taught/suggested by Carreel in order to facilitate increasing a number of components provided on the guide wire to enable increased functionality thereof while maintaining a small size of the tube (Carreel, ¶ [0136]).
Claim(s) 3 and 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Millet in view of US 2017/0055908 A1 (Radman).
Regarding claims 3 and 6-8, Millet discloses the limitations of claims 1 and 2, as discussed above, and further discloses the guide wire further comprises a second coil body surrounding the core wire in a proximal end side from the first coil body, wherein a proximal end portion of the tube (Figs. 3-23, proximal portion 320) is inside a distal end portion of the second coil body, and the proximal end portion of the tube and the distal end portion of the second coil body are joined (e.g., ¶ [0062] proximal portion 320 serves as an alignment feature for mounting proximal coil 302 (as shown in Fig. 5) to the mounting structure), wherein an outer diameter of the distal end portion of the second coil body is larger than an outer diameter of the tube including the sensor (¶ [0067] central portion 316 may have a diameter that is less than the outer diameter of the guide wire, e.g., Figs. 22-23). Millet does not disclose the guide wire further comprises an inner coil body between the first coil body and the core wire, the inner coil surrounding the distal end portion of the core wire, wherein a proximal end portion of the inner coil body is inside the distal end portion of the tube.
Radman discloses a guide wire with a sensor (e.g., Figs. 11, 25, etc.) comprising, inter alia, a core wire (core 408, 604); a tube (sensor housing 396, 544) provided with a sensor (pressure sensor 398, 546); a first coil body surrounding a distal end portion of the core wire and joined to the tube (coil 412 may be disposed over the tapered core 408 and may extend from the shaft 406 to the atraumatic tip 410; outer coil 584 that extends from the distal end 550 of the sensor housing 544 to an atraumatic tip 586); and inner coil body between the first coil body and the core wire, the inner coil surrounding the distal end portion of the core wire (inner coil 588 extending within the outer coil and surrounding core 604; centering coil 414 may be disposed relative a proximal end 416 of the tapered core 408), wherein a proximal end portion of the inner coil body is inside the distal end portion of the tube (see Figs. 11 and 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide wire of Millet to include an inner coil body between the first coil body and the core wire, the inner coil surrounding the distal end portion of the core wire, wherein a proximal end portion of the inner coil body is inside the distal end portion of the tube, as disclosed/suggested by Radman in order to facilitate centering the core wire with respect to the guide wire and/or tube thereof (Radman, ¶ [0123]), provide the guide wire with a shapeable spring tip (Radman, ¶ [0080], ¶ [0133]), etc.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Millet (or Carreel in view of Millet as applied to claim 1, and further) in view of US 2014/0066791 A1 (Burkett).
Regarding claim 11, Millet (or Carreel as modified) discloses/suggests the limitations of claim 1, as discussed above, and discloses/suggests the guide wire further comprises a proximal end tube that extends in a proximal direction away from the tube to a proximal end of the core wire and surrounds the core wire (Millet, flexible element/hypotube 240; Carreel, jacket 12). Millet (or Carreel as modified) does not disclose the proximal end tube is made of a material of a higher strength than a material of the tube. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the guide wire of Millet (or Carreel) with the proximal end tube being made of a material of a higher strength than a material of the tube because Applicant has not disclosed that the claimed relative strength provides an advantage, is used for a particular purpose, or solves a stated problem. As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the proximal end tube as disclosed by Millet (or Carreel as modified) because either tube provides a sufficiently strong proximal end for pushing/moving the guide wire through the vasculature.
Alternatively/Additionally, Burkett discloses a comparable guide wire comprising, inter alia, a proximal end tube that extends in a proximal direction away from a tube (mounting structure 218) to a proximal end of the core wire and surrounds the core wire (flexible element/hypotube 240), wherein the guide wire with structural support and increased pushability and torqueability (e.g., ¶ [0054]), which one of ordinary skill in the art would require a material of a relatively high strength. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide wire of Millet (or Carreel) with the proximal end tube being made of a material of a higher strength than a material of the tube as taught/suggested by Burkett in order to provide the proximal end of the guide wire with increased structural support, pushability and torqueability (Burkett, ¶ [0054]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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