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 .
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.
No claim elements are interpreted under 112(f).
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 1-7 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.
In regard to Claim 1, the recitation of “an end portion of the slit including one end of the first slit and bent with respect to the central portion along a bending direction, the bending direction intersecting the extending direction and increasing a pitch of the helix” is indefinite because the limitation appears to recite “the bending direction increasing a pitch of the helix,” which doesn’t make sense because the end portion ends the helical slit.
Furthermore, use of the active tense verb “increasing” suggests that the pitch is increasing during a period of time (vs. having an increased pitch at a specific segment of the guidewire), which also doesn’t make sense and is therefore unclear. It has been established that claims that mix apparatus and method limitations are indefinite when it is unclear when infringement occurs due to the fact that both structure and steps of performing are both positively claimed in functional language recitations. Clarification of the limitation is requested.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Sham et al (US Pub No. 20150289815) in view of Kimura (US Pub No. 20140214007) and Kassab et al (US Pub No. 20130096455).
In regard to Claim 1, Sham et al disclose a guide wire comprising:
a wire material 1202 – distal coil 1201, best seen in Figure 12 (0109);
a circular tube-shaped housing 1204 attached to the wire material – slotted tube, best seen in Figure 12 (0109); and
a sensor 108, 510 located in an internal space of the housing, best seen in Figure 1 and 5 – “The sensor(s) 510 can be situated in the laser etched housing at a window 504 in the housing so as to allow blood to contact the sensor(s) 510” (0064, 0075),
wherein the housing has a first slit – slot pattern – penetrating a peripheral wall of the housing, best seen in Figure 12 – “The slotted tube 1204 can include a slot pattern that is configured to provide desired properties and characteristics, such as flexibility and/or torque control” (0109), and
the first slit has: a central portion extending in a constant extending direction along the peripheral wall, best seen in Figure 12 (0109).
However, Sham et al do not expressly disclose the central portion of the slit extending in the helix and an end portion of the slit including one end of the first slit and bent with respect to the central portion along a bending direction, the bending direction intersecting the extending direction and increasing a pitch of the helix. Also see 112 rejection above.
Kimura teach that it is well-known in the art to provide an analogous guide wire comprising a slit 35, 36 with a central portion extending in a helix as an effective configuration for the slit to provide the desired flexibility or torque control as already suggested by Sham et al, best seen in Figure 3 – “it is possible to ensure high flexibility of the guide wire by the slitted pipe” (0017, 0037, 0049-0053).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Sham et al such that the central portion of the slit is extending in a helix as taught by Kimura as an equally as effective configuration for the slit to provide the desired flexibility or torque control as already suggested by Sham et al.
Kassab et al teach that it is well-known in the art to provide an analogous guide wire comprising a helical slit 104 that has an end portion 1500 including one end of the first slit and bent with respect to the central portion along a bending direction, the bending direction intersecting the extending direction and increasing a pitch of the helix, best seen in Figure 15C-D, to effectively provide a transition between the slits between the two portions 1200 and 1202 of the guide wire (0158-0159). Also see 112 rejection above.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Sham et al such that an end portion of the slit including one end of the first slit is bent with respect to the central portion along a bending direction, the bending direction intersecting the extending direction and increasing a pitch of the helix, as taught by Kassab et al, to effectively provide a transition between the plurality of helical slits of Sham et al as modified by Kimura toward an end portion as desired.
2. Kassab et al disclose the guide wire according to claim 1, wherein the bending direction is parallel with an axis of the housing of Sham et al, best seen in Figure 15C-D of Kassab et al.
5. Sham et al in combination with Kimura disclose the invention above but do not expressly disclose the pitch of the helix in the central portion of the first slit is larger in both end sides than at a center. Kimura teaches that the pitch of the helical slit can be modified along the length of the guide wire such as at sections A1, A2, B1, and B2 to achieve the desired flexibility (0049-0053).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the pitch of the helix of Sham et al as modified by Kimura and Kassab et al such that the pitch of the helix in the central portion of the first slit is larger in both end sides than at a center, as suggested by Kimura, as an obvious variant in terms of modification of the pitch of the helical slit to provide the desired flexibility and torque for the guide wire.
6. Sham et al in combination with Kimura disclose the guide wire according to claim 1, wherein the housing further has a second slit – 35, 36 – penetrating the peripheral wall of the housing and extending in a helix, and the first slit and the second slit form a double helix located alternately with respect to an axial direction of the housing, best seen in Figure 3 of Kimura.
Claim(s) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Sham et al (US Pub No. 20150289815) in view of Kimura (US Pub No. 20140214007) and Kassab et al, further in view of Fuller et al (US Pub No. 20190358434).
Sham et al in combination with Kimura and Kassab et al disclose the invention above but do not expressly disclose the end portion is curved in a round U-shape.
Fuller et al teach that it is well-known in the art to provide an analogous guide wire with a helical slit 835 comprising an end portion that is curved in a round U-shape as an effective shape for its use, best seen in Figure 14 (0103-0105). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the invention of Sham et al as modified by Kimura and Kassab et al such that the end portion is curved in a round U-shape as taught by Fuller et al as an effective shape for its use in the addition of flexibility and torque to Sham et al.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sham et al (US Pub No. 20150289815) in view of Kimura (US Pub No. 20140214007) and Kassab et al, further in view of Hammarstrom et al (US Pat No. 6336906).
Sham et al in combination with Kimura and Kassab et al disclose the invention above but do not expressly disclose a synthetic resin is filled in the internal space of the housing, the internal space surrounded by the peripheral wall on which the slit is located.
Hammarstrom et al teach that it is well-known in the art to provide an analogous guide wire comprising housing 10 with a sensor 12 located in an internal space – slot 11 – of the housing surrounded by a peripheral wall of the housing, best seen in Figure 1 (Col.4: 29-30), and
a synthetic resin, e.g. polymer material, is filled in the internal space of the housing to effectively fix the sensor in the desired position within the housing as well as for protection from fluid or other environmental impact – “The points of attachment of the cables 14 to the sensor 12 are preferably protected from the environment, i.e., from blood or other body fluids. Normally, this may be achieved by filling the slot 11 with silicon rubber or other polymer material to provide adequate protection from such fluids and other environmental impact” (Col.4: 50-55); “the slot 11 is filled with a material such as silicon rubber or other material. The silicon has a protective effect” (Col.6: 20-22).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Sham et al as modified by Kimura and Kassab et al such that a synthetic resin, e.g. polymer material, is filled in the internal space of the housing as taught by Hammarstrom et al to effectively fix the sensor in the desired position within the housing as well as for protection from fluid or other environmental impact.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sham et al (US Pub No. 20150289815) in view of Kimura (US Pub No. 20140214007) and Hammarstrom et al (US Pat No. 6336906).
Sham et al disclose a guide wire comprising:
a wire material 1202 – distal coil 1201, best seen in Figure 12 (0109);
a circular tube-shaped housing 1204 attached to the wire material – slotted tube, best seen in Figure 12 (0109); and
a sensor 108, 510 located in an internal space of the housing, best seen in Figure 1 and 5 – “The sensor(s) 510 can be situated in the laser etched housing at a window 504 in the housing so as to allow blood to contact the sensor(s) 510” (0064, 0075),
wherein the housing has a slit – slot pattern – penetrating a peripheral wall of the housing, best seen in Figure 12 – “The slotted tube 1204 can include a slot pattern that is configured to provide desired properties and characteristics, such as flexibility and/or torque control” (0109).
However, Sham et al do not expressly disclose the slit extending in a helix and a synthetic resin is filled in the internal space of the housing, the internal space surrounded by the peripheral wall on which the slit is located.
Kimura teach that it is well-known in the art to provide an analogous guide wire comprising a slit 35, 36 extending in a helix as an effective configuration for the slit to provide the desired flexibility or torque control as already suggested by Sham et al, best seen in Figure 3 – “it is possible to ensure high flexibility of the guide wire by the slitted pipe” (0017, 0037, 0049-0053).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Sham et al such that the slit is extending in a helix as taught by Kimura as an equally as effective configuration for the slit to provide the desired flexibility or torque control as already suggested by Sham et al.
Hammarstrom et al teach that it is well-known in the art to provide an analogous guide wire comprising housing 10 with a sensor 12 located in an internal space – slot 11 – of the housing surrounded by a peripheral wall of the housing, best seen in Figure 1 (Col.4: 29-30), and
a synthetic resin, e.g. polymer material, is filled in the internal space of the housing to effectively fix the sensor in the desired position within the housing as well as for protection from fluid or other environmental impact – “The points of attachment of the cables 14 to the sensor 12 are preferably protected from the environment, i.e., from blood or other body fluids. Normally, this may be achieved by filling the slot 11 with silicon rubber or other polymer material to provide adequate protection from such fluids and other environmental impact” (Col.4: 50-55); “the slot 11 is filled with a material such as silicon rubber or other material. The silicon has a protective effect” (Col.6: 20-22).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Sham et al such that a synthetic resin, e.g. polymer material, is filled in the internal space of the housing as taught by Hammarstrom et al to effectively fix the sensor in the desired position within the housing as well as for protection from fluid or other environmental impact.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong Q NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791