DETAILED ACTION
This office action is responsive to the amendment filed 4/12/2026. Claims 1-5, 7, and 9-11 remain pending and under prosecution.
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 § 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, 3-5, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Sham et al (US Pub No. 20150289815) in view of Eskuri (US Pub No. 20050065456), Kimura (US Pub No. 20140214007), and Itou et al (CN 102188236).
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 through a peripheral wall of the housing and extending continuously along an entire length from a proximal end to a distal end of the first slit as broadly as has been claimed, 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 a helix and an end portion of the slit including one end of the first slit extending from the central portion, the end portion bent with respect to the extending direction of the central portion toward one end of the housing away from the central portion, the housing with a second slit penetrating through the peripheral wall of the housing, the second slit having a helix, the first slit and second slit from a double helix located alternately with respect to an axial direction of the housing.
Eskuri teach that it is well-known in the art to provide an analogous guide wire tube 20 comprising a slit (helical cut 22) with the central portion of the slit extending in a helix, best seen in Figure 3A – “The helical groove or cut 22… may extend through substantially the entire thickness of the tube. The pitch of the helical groove or cut 22 may be selected in order to provide desired functionality, or the pitch may vary along the length of the tubular segment 20” (0046) and a second slit penetrating through the peripheral wall – “The tubular segment 20 may include one or more additional helical grooves or cuts 22 or a combination of grooves or cuts 24 and helical grooves or cuts 22. It is understood that the width and depth of the groove or cut 22, 24 may be of a wide range as may be necessary to attain the desired properties of the tubular segment 20” (0046).
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 slits are a first and second slit penetrating through the peripheral wall and are helical in the manner above as taught by Eskuri to provide desired properties of the guidewire such as the desired flexibility or torque control as already suggested by Sham et al.
Kimura teach that it is well-known in the art to provide an analogous guide wire comprising a first slit 35 and a second slit 36 with a central portion extending in a helix, the first slit and second slit from a double helix located alternately with respect to an axial direction, 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 as modified by Eskuri such that the first slit and second slit from Eskuri form a double helix located alternately with respect to an axial direction as taught by Kimura as an equally as effective configuration for the two slit to provide the desired flexibility or torque control as already suggested by Sham et al as well as suggested by Eskuri.
Itou et al teach that it is well-known in the art to provide an analogous guide wire comprising a helical slit 14 that has an end portion 191, an end portion of the slit including one end of the first slit extending from the central portion, the end portion bent with respect to the extending direction of the central portion toward one end of the housing away from the central portion, best seen in Figure 8 and 12, as an effective configuration for the end portion of the helical slit to prevent undue stress that might crack the slit – “other example as shown in FIG. 12, with a diameter larger than the slit width of the hole slit terminal part 19c of the terminal 191c is formed. the through hole is formed, can further inhibit terminal 191c stress concentration and can more reliably suppress the occurrence of cracks.”
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 Eskuri such that the helical slit has an end portion end extending from the central portion, the end portion bent with respect to the extending direction of the central portion toward one end of the housing away from the central portion, as taught by Itou et al, to prevent undue stress that might crack the slit.
3. Itou et al disclose a portion of the end portion 191 closest to the central portion is bent with respect to the extending direction of the central portion toward said one end of the housing away from the central portion, the end portion curved in a U-shape, best seen in Figure 8 and 12.
4. Itou et al disclose a bending connecting point of the central portion and the end portion 191 has a round shape, best seen in Figure 8 and 12.
5. Sham et al as modified 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 of the central portion 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 Eskuri, Kimura and Itou 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.
9-10. Sham as modified disclose the invention above including the housing 1204 having a through hole 504, best seen in Figure 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 in order to take sensor measurement” (0075), between spirals of said another section as seen in Figure 12, adapted to receive blood to contact the sensor.
However, Sham as modified do not expressly disclose an axial distance between an end of the end portion nearest the central portion and said one end of the first slit is less than a pitch of a section of the helix of the central portion nearest the end portion, the helix of the central portion of the first slit has a first pitch at a section closest to the end portion and has a larger second pitch at another section farther from the end portion.
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). Eskuri similarly teach “the pitch of the helical groove or cut 22 may be selected in order to provide desired functionality, or the pitch may vary along the length of the tubular segment 20” (0046).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing such that an axial distance between an end of the end portion nearest the central portion and said one end of the first slit is less than a pitch of a section of the helix of the central portion nearest the end portion and the helix of the central portion of the first slit has a first pitch at a section closest to the end portion and has a larger second pitch at another section farther from the end portion as obvious variations to the pitch of Sham as modified to provide the desired flexibility, as taught by Kimura and Eskuri.
11. Sham in combination with Eskuri and Kimura disclose the first slit and second slit form a first double helix along a first portion of the housing, and further comprising a third slit and a fourth slit forming a second double helix along a second portion of the housing, the first double helix and second double helix axially separated by a length of the housing having a through hole 504 in Sham to receive blood to contact the sensor, best seen in Figure 5 and 12 of Sham – “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 in order to take sensor measurement” (0075).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sham et al (US Pub No. 20150289815) in view of Eskuri, Kimura, and Itou et al, further in view of Kassab et al (US Pub No. 20130096455).
Sham et al in combination with Eskuri, Kimura, and Itou et al disclose the invention above but do not expressly disclose the end portion is bent with respect to the extending direction of the central portion to extend along a bending direction parallel with an axis of the housing.
Kassab et al teach that it is well-known in the art to provide an analogous guide wire, wherein 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). Kassab et al teach the shape of the bending direction is parallel with an axis of the housing, best seen in Figure 15C-D.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the end portion of Sham as modified by Itou et al such that the end portion is bent with respect to the extending direction of the central portion to extend along a bending direction parallel with an axis of the housing as taught by Kassab et al as an obvious variation in the shape of the end portion already taught by Itou 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 Eskuri, Kimura, and Itou et al, further in view of Hammarstrom et al (US Pat No. 6336906).
Sham et al in combination with Eskuri, Kimura, and Itou 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 Eskuri, Kimura, and Itou 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) above have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The previous 112 rejections are moot in light of applicant’s amendments.
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 Huong 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
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