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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/24/2025 has been entered.
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.
Claim 1: identification device, wherein “device” is the nonce term, “configured to enhance detectable visibility of the medical guidewire” and “identification” are the functional language, and the term is not modified by any structure.
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.
Upon reviewing the specification, the claim elements correspond to the following features:
Claim 1: identification device – element 112, Fig. 2-4 of which the disclosure is implied to be hardware; the implied corresponding hardware structure disclosed is echogenic elements (Specification as originally filed Para 0045) and radiopaque elements (Specification as originally filed Para 0044).
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 § 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) 1-4, 6, 9, 14-15 & 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al. (U.S. Patent Application 2013/0296911 A1) and further in view of Skujins et al. (U.S. Patent Application 2004/0106878 A1).
Claim 1: Kurth teaches –
A medical guidewire [transseptal guidewire] (Figure 10, Element 220 and Para 0101) configured for puncturing a tissue [after the intra-atrial septum has been punctured] (Para 0101), the medical guidewire comprising:
Examiner’s Note: Figure 10, 11A-11B & 12 are all describing the same embodiment (Para 0032-0035)
an elongate guidewire body [transseptal guidewire] (Para 0101; Figure 10, Element 222 and Figure 11A, Element 222) having a circulate cross-section (as shown in Figure 10), wherein the elongate guidewire body comprises:
a proximal portion [elongated body] [imagable section] (Figure 11A, Element 221 & 224) with a first outer diameter (Figure 12, Element [B]), the proximal portion having a proximal portion distal end (see attached Drawing 1 on Page 8);
a distal portion [end section] (Figure 11A, Element 226) with a second outer diameter (Figure 12, Element [A]),
wherein the second outer diameter is smaller than the first outer diameter [end section 226 is thinner in thickness [A] and more flexible in at least one direction as compared to proximal portion 221 and imagable section 224 of the transseptal guidewire 220] (Para 0116 and as shown in Figure 11A, between Element 224 & 226), and
a tapered section between the first outer diameter and second outer diameter (Figure 12, Element [G] and as shown in Figures 10-12), the tapered section having a beginning proximate the proximal portion distal end (see attached Drawing 1 on Page 8);
a piercing device [perforating tip] (Figure 10, Element 229) extending from the distal portion (Figure 11A, Element 226),
forming a puncturing distal tip [the perforating tip 229 may be tapered or otherwise formed to a sharp perforating point] (Para 0100); and,
an identification device [radiopaque coil] [printed markers] (Figure 11A, Element 225 & 240a-c) positioned on the elongate guidewire body [transseptal guidewire] (Para 0101; Figure 10, Element 222 and Figure 11A, Element 222),
wherein the identification device is located on the first outer diameter at the beginning of the tapered section (as shown in Figure 11A and see attached Drawing 1 on Page 8)
whereby the identification device is configured to enhance detectable visibility of the medical guidewire [marker distances may also be used to allow a physician to ascertain the insertion depth of the transseptal guidewire 220 when used in a patient] (Para 0106).
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[AltContent: textbox (Drawing 1 – Annotated Figure 10 of Kurth)]Kurth fails to teach wherein the proximal portion and the distal portion includes the same circular cross-sectional shape. However, Skujins teaches wherein the proximal portion and the distal portion includes the same circular cross-sectional shape [proximal portion 14 and distal portion 16 may be generally tubular] (Para 0042) [manufacture the connection of the core member 11 of the guidewire 10, the ends 20/22 of the proximal and distal guidewire sections 14/16 may be ground to form the desired shape (…a taper…)] (Para 0037) in order to provide strain relief adjacent the connector assembly (Para 0037).
The Examiner is applying KSR from MPEP § 2143(I)(B); Simple Substitution of One Known Element for Another To Obtain Predictable Results for the combination of Kurth and Skujins as described below:
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
The Examiner finds that the prior art of Kurth contained a device which differed from the claimed device by substitution of:
a) different cross-sectional shape between the ovalized distal end and the tubular proximal end of Kurth
with
b) same circular cross-sectional shape between the tubular distal end and the tubular proximal end of Skujins
(2) a finding that the substituted components and their functions were known in the art;
The Examiners finds that the substituted same circular cross-sectional shape between the tubular distal end and the tubular proximal end of Skujins and the function of connecting sections of guidewire with imaging markers (Para 0013 & 0015) to improve visibility in fluoroscopy (Para 0002-0003) with the same circular cross-sectional shape with a taper to provide strain relief adjacent the connector assembly (Para 0037) were known within the art as described by Skujins. Skujins teaches that the proximal and distal guidewire can be formed to the desired shape (Para 0037). Thus, the Examiner has demonstrated that Kurth and Skujins are teaching art recognized equivalences for performing the function of controlling the bending of the guidewire in terms of strain relief.
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable;
The Examiner finds that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable because substituting a) different cross-sectional shape between the ovalized distal end and the tubular proximal end of Kurth with b) same circular cross-sectional shape between the tubular distal end and the tubular proximal end of Skujins would have been obvious. The result is predictable in that either the tubular shape provides strain relief in the connection between the proximal and distal sections for improving visibility in fluoroscopy (Para 0002-0003) and the controlling of the bending of the guidewire to provide strain relief adjacent the connector assembly (Para 0037).
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the different cross-sectional shape between the ovalized distal end and the tubular proximal end of Kurth with the same circular cross-sectional shape between the tubular distal end and the tubular proximal end of Skujins in order to provide strain relief adjacent the connection (Para 0037).
Examiner’s Note: The claim is directed to a same circular cross-sectional shape, which is different than the same circular cross-sectional diameter. Therefore, tapering is within the claim interpretation.
Claim 2/1: Kurth teaches wherein the identification device comprises a plurality of identification devices [radiopaque coil] [printed markers] (Figure 11A, Element 225 & 240a-c).
Claim 3/2/1: Kurth teaches wherein the plurality of identification devices are separated from one another at a distance between 0.1 mm and 20 mm [the printed marker bands 240a-c may be spaced at a distance [J] of about 2 mm from each other] (Para 0107 and Figure 11A, Element 0106).
Claim 4/3/2/1: Kurth in view of Skujins fails to specifically teach the distance being 1.25 mm.
However, Kurth teaches that the printed marker may be any width and spaced at any spacing distance from each other so long as they allow a physician to ascertain the length of the guidewire (Para 0106-0107).
Generally, differences in width and spacing will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such width or spacing is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05(II)(A)). A review of the Specification did not reveal evidence to support the criticality of 1.25 mm and merely states that the 1.25 mm is preferable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a distance between each of the plurality of identification devices being 1.25 mm with the guidewire of Kurth as routine optimization within prior art conditions or through routine experimentation in order to allow the physician to ascertain the length of the guidewire (Para 0107).
According to MPEP 2144.05(II)(A):
In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range.
Kurth teaches the distance being any width or spacing as long as it allows the physician to ascertain the length of the guidewire. The Examiner contends that 1.25 mm distance would be within the range that allows the physician to ascertain the length of the guidewire and a person of ordinary skill in the art would have had a reasonable expectation of success with the claimed distance. For example, the Examiner notes that Kurth teaches the distance [J] being about 2 mm, which giving or taking 1 mm on either side also covers the 1.25 mm (Figure 11A and Para 0107) although the Examiner recognizes this distance covers between identification devices and not groups. It would thus be a reasonable expectation of success for a person of ordinary skill in the art to put the identification devices or groups of identification devices at 1.25 mm. As placement between identification devices or groups of identification devices would require similar manufacturing processes.
Claim 6/3/2/1: Kurth further teaches wherein the elongate guidewire body comprises at least two discrete groupings (Figure 11A, Element 240a, 240b & 240c and Figure 11A, Element 225).
Examiner’s Note: One grouping is Figure 11A, Element 240a, 240b and 240c and the other grouping is Figure 11A, Element 225. The Examiner contends that the coil acts as a grouping because of the pitch of the coil creates spaces between the coils.
Claim 9/1: Kurth teaches wherein the identification device has a width between 0.1 mm and 40 mm [the printed marker bands 240a-c may have a width [H] of about 5 mm with a tolerance of +/-1 mm] (Para 0107).
Claim 14/1: Kurth teaches wherein the identification device is a radiopaque element [radiopaque coil] (Figure 11A, Element 225).
Claim 15/14/1: Kurth teaches wherein the radiopaque element is a radiopaque coil [radiopaque coil] (Figure 11A, Element 225).
Claim 18: Kurth teaches –
A method of accessing a left atrium of a heart, the method comprising the steps of:
advancing a medical guidewire into a right atrium of the heart [transseptal guidewire 20 is abruptly extended from the lumen of outer needle 14 to perforate the fossa ovalis 103] (Para 0050 and as shown in Figure 1 and Figure 2) and positioning a puncturing distal tip of the medical guidewire on a target location of a septum [transseptal guidewire 20 may extend so that pointed tip 29 perforates intra-atrial septum] (Para 0054),
the medical guidewire comprising:
an elongate guidewire body [transseptal guidewire] (Para 0101; Figure 10, Element 222 and Figure 11A, Element 222) having a circular cross-section (as shown in Figure 10), wherein the elongate guidewire body comprises:
a proximal portion [elongated body] [imagable section] (Figure 11A, Element 221 & 224) with a first outer diameter (Figure 12, Element [B]), the proximal portion having a proximal portion distal end (see attached Drawing 1 on Page 8);
a distal portion [end section] (Figure 11A, Element 226) with a second outer diameter (Figure 12, Element [A]),
wherein the second outer diameter is smaller than the first outer diameter [end section 226 is thinner in thickness [A] and more flexible in at least one direction as compared to proximal portion 221 and imagable section 224 of the transseptal guidewire 220] (Para 0116 and as shown in Figure 11A, between Element 224 & 226); and
a tapered section between the first outer diameter and second outer diameter (Figure 12, Element [G] and as shown in Figures 10-12), the tapered section having a beginning proximate the proximal portion distal end (see attached Drawing 1 on Page 8);
a piercing device [perforating tip] (Figure 10, Element 229) extending from the distal portion (Figure 11A, Element 226),
forming the puncturing distal tip [the perforating tip 229 may be tapered or otherwise formed to a sharp perforating point] (Para 0100);
an identification device [radiopaque coil] [printed markers] (Figure 11A, Element 225 & 240a-c) positioned on the elongate guidewire body [transseptal guidewire] (Para 0101; Figure 10, Element 222 and Figure 11A, Element 222),
wherein the identification device is located on the first outer diameter proximal the tapered section (as shown in Figure 11A);
puncturing the septum and advancing the distal portion of the medical guidewire into the left atrium [transseptal guidewire 20 may extend so that pointed tip 29 perforates intra-atrial septum] (Para 0054 and Figure 1) while visualizing the identification device on a medical imaging system [Radiopaque markers 25a-e may be made of a platinum/iridium alloy and are sufficiently visible under fluoroscopy (x-ray) to assist with imaging of the operative area] (Para 0057); and,
advancing the medical guidewire into the left atrium until the identification device has reached the septum [when a portion of imagable section 24 extends into the left atrium 105 from the perforation hole (not shown), x-ray imaging of radiopaque markers 25a-e may confirm successful perforation of the intra-atrial septum 104] (Para 0058),
whereby the medical guidewire is in a position [once sheath 10 and/or dilator 12 is positioned in the left atrium 105] to facilitate and support an exchange of an ancillary device [other components of the transseptal trocar device 50…can be retracted and the sheath 10 can be used to deliver implants, for example, such as an atrial occluder for the treatment of a patent foramen ovale, electrophysiology catheters, or other intracardiac therapeutic devices] (Para 0080)
Examiner’s Note: The exchange is the retraction of the other components of the trocar device and the delivery of the ancillary device, which is the disclosed implant.
Kurth fails to teach wherein the proximal portion and the distal portion includes the same circular cross-sectional shape. However, Skujins teaches wherein the proximal portion and the distal portion includes the same circular cross-sectional shape [proximal portion 14 and distal portion 16 may be generally tubular] (Para 0042) [manufacture the connection of the core member 11 of the guidewire 10, the ends 20/22 of the proximal and distal guidewire sections 14/16 may be ground to form the desired shape (…a taper…)] (Para 0037) in order to provide strain relief adjacent the connector assembly (Para 0037).
The Examiner is applying KSR from MPEP § 2143(I)(B); Simple Substitution of One Known Element for Another To Obtain Predictable Results for the combination of Kurth and Skujins as described below:
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
The Examiner finds that the prior art of Kurth contained a device which differed from the claimed device by substitution of:
a) different cross-sectional shape between the ovalized distal end and the tubular proximal end of Kurth
with
b) same circular cross-sectional shape between the tubular distal end and the tubular proximal end of Skujins
(2) a finding that the substituted components and their functions were known in the art;
The Examiners finds that the substituted same circular cross-sectional shape between the tubular distal end and the tubular proximal end of Skujins and the function of connecting sections of guidewire with imaging markers (Para 0013 & 0015) to improve visibility in fluoroscopy (Para 0002-0003) with the same circular cross-sectional shape with a taper to provide strain relief adjacent the connector assembly (Para 0037) were known within the art as described by Skujins. Skujins teaches that the proximal and distal guidewire can be formed to the desired shape (Para 0037). Thus, the Examiner has demonstrated that Kurth and Skujins are teaching art recognized equivalences for performing the function of controlling the bending of the guidewire in terms of strain relief.
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable;
The Examiner finds that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable because substituting a) different cross-sectional shape between the ovalized distal end and the tubular proximal end of Kurth with b) same circular cross-sectional shape between the tubular distal end and the tubular proximal end of Skujins would have been obvious. The result is predictable in that either the tubular shape provides strain relief in the connection between the proximal and distal sections for improving visibility in fluoroscopy (Para 0002-0003) and the controlling of the bending of the guidewire to provide strain relief adjacent the connector assembly (Para 0037).
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the different cross-sectional shape between the ovalized distal end and the tubular proximal end of Kurth with the same circular cross-sectional shape between the tubular distal end and the tubular proximal end of Skujins in order to provide strain relief adjacent the connection (Para 0037).
Examiner’s Note: The claim is directed to a same circular cross-sectional shape, which is different than the same circular cross-sectional diameter. Therefore, tapering is within the claim interpretation.
Claim 19/18: Kurth teaches wherein the identification device is either a radiopaque element or an echogenic element or a combination of the radiopaque element and the echogenic element [radiopaque coil] (Figure 11A, Element 225).
Claim(s) 7-8, 10 & 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al. (U.S. Patent Application 2013/0296911 A1) and Skujins et al. (U.S. Patent Application 2004/0106878 A1) and further in view of Barton et al. (U.S. Patent Application 2004/0034342 A1).
Claim 7/6/3/2/1: Kurth in view of Skujins fails to specifically teach wherein the at least two discrete groupings are separated from one another at a distance between 1 mm and 40 mm. However, Barton teaches the discrete groupings [markings such as…Dots [and] Dashes…are used to segment the distal portion of optical fiber 28 into regions] (Para 0034) are separated from one another at a distance between 1 mm and 40 mm [distance from the second primary mark 102 to the third primary mark 103 is preferably about 10 mm] (Para 0042) in order to make it easy for the surgeon to do the procedure with precision and control (Para 0039) as the surgeon by using optimally sized markings with no two in the same order along the length of the fiber, the surgeon can readily discern tip penetration into tissue when only two markings are visible in the operative field of view (Para 0038)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to space the discrete groups of dots and dashes to 10 mm in as taught by Barton with the discrete groups of Kurth in view of Skujins in order to make it easy for the surgeon to do the procedure with precision and control (Para 0039 of Barton) as the surgeon by using optimally sized markings with no two in the same order along the length of the fiber, the surgeon can readily discern tip penetration into tissue when only two markings are visible in the operative field of view (Para 0038 of Barton).
Examiner’s Note: The Examiner is interpreting the markings as disclosed by Barton of dots and dashes to be discrete groupings of identification devices (See Figure 8, Element 107, 106 & 105; wherein, for example, one discrete group is Element 105 consisting of a group of markers in the form of dashes). Element 102 and Element 103 are disclosed in Figure 8 as an example as being complete bands. However, Barton discloses that the particular marking is not important and that the markings can replace each other (Para 0045). The important aspect of the invention is having distinct markings that the operator understands what the markings mean before the procedure.
Claim 8/7/6/3/2/1: Kurth in view of Skujins fails to specifically teach the distance being 1.25 mm.
However, Kurth teaches that the printed marker may be any width and spaced at any spacing distance from each other so long as they allow a physician to ascertain the length of the guidewire (Para 0106-0107).
Generally, differences in width and spacing will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such width or spacing is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05(II)(A)). A review of the Specification did not reveal evidence to support the criticality of 1.25 mm and merely states that the 1.25 mm is preferable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a distance between each of the plurality of identification devices being 1.25 mm with the guidewire of Kurth as routine optimization within prior art conditions or through routine experimentation in order to allow the physician to ascertain the length of the guidewire (Para 0107).
According to MPEP 2144.05(II)(A):
In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range.
Kurth teaches the distance being any width or spacing as long as it allows the physician to ascertain the length of the guidewire. The Examiner contends that 1.25 mm distance would be within the range that allows the physician to ascertain the length of the guidewire and a person of ordinary skill in the art would have had a reasonable expectation of success with the claimed distance. For example, the Examiner notes that Kurth teaches the distance [J] being about 2 mm, which giving or taking 1 mm on either side also covers the 1.25 mm (Figure 11A and Para 0107) although the Examiner recognizes this distance covers between identification devices and not groups. It would thus be a reasonable expectation of success for a person of ordinary skill in the art to put the identification devices or groups of identification devices at 1.25 mm. As placement between identification devices or groups of identification devices would require similar manufacturing processes.
Kurth fails to specifically state the distance between the discrete groups. However, Barton teaches the distance between each of the at least two discrete groupings [markings such as…Dots [and] Dashes…are used to segment the distal portion of optical fiber 28 into regions] (Para 0034) is 10 mm [distance from the second primary mark 102 to the third primary mark 103 is preferably about 10 mm] (Para 0042) in order to make it easy for the surgeon to do the procedure with precision and control (Para 0039) as the surgeon by using optimally sized markings with no two in the same order along the length of the fiber, the surgeon can readily discern tip penetration into tissue when only two markings are visible in the operative field of view (Para 0038)
Examiner’s Note: The Examiner is interpreting the markings as disclosed by Barton of dots and dashes to be discrete groupings of identification devices (See Figure 8, Element 107, 106 & 105; wherein, for example, one discrete group is Element 105 consisting of a group of markers in the form of dashes). Element 102 and Element 103 are disclosed in Figure 8 as an example as being complete bands. However, Barton discloses that the particular marking is not important and that the markings can replace each other (Para 0045). The important aspect of the invention is having distinct markings that the operator understands what the markings mean before the procedure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to space the discrete groups of dots and dashes to 10 mm in as taught by Barton with the discrete groups of Kurth in order to make it easy for the surgeon to do the procedure with precision and control (Para 0039 of Barton) as the surgeon by using optimally sized markings with no two in the same order along the length of the fiber, the surgeon can readily discern tip penetration into tissue when only two markings are visible in the operative field of view (Para 0038 of Barton).
Claim 10/9/1: Kurth teach the identification device [radiopaque coil] [printed markers] (Figure 11A, Element 225 & 240a-c).
Kurth fails to teach wherein the width of the identification device is 2.5 mm. However, Barton teaches wherein the width of the identification device is 2.5 mm [each diamond is from one to 5 mm long, and preferably about 2.5 mm long] (Para 0042) in order to make it easy for the surgeon to do the procedure with precision and control (Para 0039) as the surgeon by using optimally sized markings with no two in the same order along the length of the fiber, the surgeon can readily discern tip penetration into tissue when only two markings are visible in the operative field of view (Para 0038)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a width of 2.5 mm in as taught by Barton with the identification devices of Kurth in order to make it easy for the surgeon to do the procedure with precision and control (Para 0039 of Barton) as the surgeon by using optimally sized markings with no two in the same order along the length of the fiber, the surgeon can readily discern tip penetration into tissue when only two markings are visible in the operative field of view (Para 0038 of Barton).
Examiner’s Note: The Examiner is interpreting long to be analogous with width.
Claim 16/14/1: The Examiner notes that Claim 16 is a product-by-process claim. MPEP 2113 states:
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
Kurth teaches the printed markers as described in the rejection of Claim 1 above. The Examiner contends that the claimed product of the printed markers is the same or obvious from the prior art product of the printed markers as taught by Kurth. Thus, the claim is unpatentable even though the prior product was made by a different process. In case it is determined that Claim 16 is not a product-by-process claim or that the product of the prior art is not the same or obvious, the Examiner in the alternative rejects Claim 16 in view of Barton.
Kurth teaches the radiopaque element [radiopaque coil] (Figure 11A, Element 225).
Kurth in view of Skujins fails to teach pad printing. However, Barton teaches wherein the element is formed by pad printing [Markings may be printed, etched, mask-sprayed or otherwise produced by techniques such as, for example, pad printing, or other marking techniques known in the art] (Para 0043) in order to print markings that are visible and distinguishable around the entire circumference (Para 0043)
The Examiner is applying KSR from MPEP § 2143(I)(A); Combining Prior Art Elements According to Known Methods To Yield Predictable Results for the combination of Kurth and Barton as described below:
(1) a finding that the prior art included each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference;
The Examiner finds that the prior art of Kurth and Barton included each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention of pad printing of identification devices and the pad printing of printer markers of the prior art of Kurth and Barton being the lack of the actual combination of the elements in a single prior art reference.
(2) a finding that one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately;
The Examiner finds that one of ordinary skill in the art could have combined the elements of pad printing of identification device as claimed by known methods as taught by Kurth and Barton, and that in combination, each element merely performs the same function as it does separately. The printed markers of Kurth merely perform the same function of insertion depth measurement as it does separately from the function of pad printing as taught by Barton.
(3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable; and
The Examiner finds that one of ordinary skill in the art would have recognized that the results of the combination were predictable in that the pad printing of Barton would predictably be used to print the printed markers of Kurth.
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to print the printed markers of Kurth with the pad printing of Barton in order to print markings that are visible and distinguishable around the entire circumference (Para 0043).
Claim(s) 11-12 & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al. (U.S. Patent Application 2013/0296911 A1) and Skujins et al. (U.S. Patent Application 2004/0106878 A1) and further in view of Fearnot et al. (U.S. Patent Application 2015/0320979 A1).
Claim 11/1: Kirth in view of Skujins fails to teach wherein the identification device is an echogenic element. However, Fearnot teaches wherein the identification device is an echogenic element [First guide body portion 130 has one or more longitudinally spaced discrete echogenic markers 129 interspersed along its length which are operable to appear during ultrasonic imaging procedures] (Para 0017) in order to appear during ultrasonic imaging procedures (Para 0026).
The Examiner is applying KSR from MPEP § 2143(I)(A); Simple Substitution of One Known Element for Another To Obtain Predictable Results for the combination of Kurth and Fearnot as described below:
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
The Examiner finds that the prior art of Kurth contained a device (identification device with a radiopaque element) which differed from the claimed device by substitution of some components (radiopaque element of Kurth) with other components (echogenic element of Fearnot).
(2) a finding that the substituted components and their functions were known in the art;
The Examiner finds that the substituted components (echogenic element of Fearnot) and their functions were known in the art. The echogenic element of Fearnot and its function of enhancing ultrasound imaging of the medical guidewire is known within the art as demonstrated by the disclosure of Fearnot.
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and
The Examiner finds that one of ordinary skill in the art could have substituted one known element (radiopaque element of Kurth) for another (echogenic element of Fearnot), and the results of the substitution would have been predictable. The substitution would have been predictable in that it would have enhanced the ultrasound imaging of the medical guidewire.
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the radiopaque element of Kurth with the echogenic element of Fearnot in order to appear during ultrasonic imaging procedures (Para 0026). Due to the differences between radiology (x-ray imaging) and ultrasonography (ultrasound imaging), each imaging modality has benefits and consequences in what structural are visible during a procedure. When a procedure would require ultrasound imaging or x-ray imaging, the guidewire can have the appropriate imaging element required for the respective x-ray imaging or ultrasound imaging procedure.
Claim 12/11/1: Kurth in view of Skujins fails to teach the echogenic element and that the echogenic element is comprised of surface irregularities on a section of the elongate guidewire body.
However, Fearnot teaches the echogenic element [First guide body portion 130 has one or more longitudinally spaced discrete echogenic markers 129 interspersed along its length which are operable to appear during ultrasonic imaging procedures] (Para 0017) in order to appear during ultrasonic imaging procedures (Para 0026). Fearnot teaches wherein the echogenic element is comprised of surface irregularities on a section of the elongate guidewire body [metal strands or fibers adhered to the external surface of guide member] (Para 0028)
Examiner’s Note: The surface irregularities on a section of the elongated guidewire body are formed when the metal strands or fibers are placed on the external surface of the guide member, which would create the irregularities.
The Examiner is applying KSR from MPEP § 2143(I)(A); Simple Substitution of One Known Element for Another To Obtain Predictable Results for the combination of Kurth and Fearnot as described below:
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
The Examiner finds that the prior art of Kurth contained a device (identification device with a radiopaque element) which differed from the claimed device by substitution of some components (radiopaque element of Kurth) with other components (echogenic element of Fearnot).
(2) a finding that the substituted components and their functions were known in the art;
The Examiner finds that the substituted components (echogenic element of Fearnot) and their functions were known in the art. The echogenic element of Fearnot and its function of enhancing ultrasound imaging of the medical guidewire is known within the art as demonstrated by the disclosure of Fearnot.
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and
The Examiner finds that one of ordinary skill in the art could have substituted one known element (radiopaque element of Kurth) for another (echogenic element of Fearnot), and the results of the substitution would have been predictable. The substitution would have been predictable in that it would have enhanced the ultrasound imaging of the medical guidewire.
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the radiopaque element of Kurth with the echogenic element of Fearnot in order to appear during ultrasonic imaging procedures (Para 0026). Due to the differences between radiology (x-ray imaging) and ultrasonography (ultrasound imaging), each imaging modality has benefits and consequences in what structural are visible during a procedure. When a procedure would require ultrasound imaging or x-ray imaging, the guidewire can have the appropriate imaging element required for the respective x-ray imaging or ultrasound imaging procedure.
Claim 17/1: Kirth in view of Skujins fails to teaches wherein the identification device is a combination of an echogenic element and a radiopaque element. However, Fearnot teaches wherein the identification device is a combination of an echogenic element [First guide body portion 130 has one or more longitudinally spaced discrete echogenic markers] (Para 0017) and a radiopaque element [first guide body portion 130 partially or completely radio opaque] (Para 0026 and Figure 3, Element 130) in order to be useful when two different imaging technologies are used during the same procedure (Para 0026)
The Examiner is applying KSR from MPEP § 2143(I)(A); Simple Substitution of One Known Element for Another To Obtain Predictable Results for the combination of Kurth and Fearnot as described below:
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
The Examiner finds that the prior art of Kurth contained a device (identification device with a radiopaque element) which differed from the claimed device (combined radiopaque and echogenic element of the Applicant) by substitution of some components (radiopaque element of Kurth) with other components (combined radiopaque and echogenic element of Fearnot).
(2) a finding that the substituted components and their functions were known in the art;
The Examiner finds that the substituted components (combined radiopaque and echogenic element of Fearnot) and their functions were known in the art. The combined radiopaque echogenic element of Fearnot and its function of enhancing x-ray imaging and ultrasound imaging of the medical guidewire is known within the art as demonstrated by the disclosure of Fearnot.
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and
The Examiner finds that one of ordinary skill in the art could have substituted one known element (radiopaque element of Kurth) for another (combined radiopaque and echogenic element of Fearnot), and the results of the substitution would have been predictable. The substitution would have been predictable in that it would have enhanced x-ray and ultrasound imaging of the medical guidewire.
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the radiopaque element of Kurth with the combined radiopaque and echogenic element of Fearnot in order to be useful when two different imaging technologies are used during the same procedure (Para 0026). Due to the differences between radiology (x-ray imaging) and ultrasonography (ultrasound imaging), each imaging modality has benefits and consequences in what structural are visible during a procedure. When a procedure would require both ultrasound imaging or x-ray imaging, the guidewire can have the appropriate imaging element required for the respective x-ray imaging or ultrasound imaging procedure without needing to pull out the radiopaque element medical guidewire from the patient to replace with an echogenic element medical guidewire into the patient. This would allow the surgeon to seamlessly switch between imaging modalities without needing to exchange medical guidewires.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al. (U.S. Patent Application 2013/0296911 A1); Skujins et al. (U.S. Patent Application 2004/0106878 A1) and Fearnot et al. (U.S. Patent Application 2015/0320979 A1) and further in view of Huffmaster et al. (U.S. Patent Application 2021/0121219 A1; support found in provisional 62/927,375 in Para 0054 of the Specification as originally filed, 10/29/2019).
Claim 13/12/11/1: The Examiner notes that Claim 13 is a product-by-process claim. MPEP 2113 states:
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
Kirth in view of Skujins and Fearnot teach the surface irregularities as described in the rejection of Claim 12 above. The Examiner contends that the claimed product of the surface irregularities is the same or obvious from the prior art product of the surface irregularities as taught by Fearnot. Thus, the claim is unpatentable even though the prior product was made by a different process. In case it is determined that Claim 13 is not a product-by-process claim or that the product of the prior art is not the same or obvious, the Examiner in the alternative rejects Claim 13 in view of Huffmaster.
Kirth in view of Skujins fails to teach surface irregularities. Fearnot teaches the surface irregularities cause by the addition of material [metal strands or fibers adhered to the external surface of guide member] (Para 0028) or the surface irregularities caused by empty spaces [each echogenic marker 129 includes one or more echogenic structures such as one or more empty or gas filled spaces or “bubbles” at the proper positions along the length of guide member] (Para 0029). Kirth in view of Skujins and Fearnot fail to teach wherein the surface irregularities are formed by laser etching, centerless grinding, or abrasive blasting, or any combination thereof. However, Huffmaster teaches wherein the surface irregularities are formed by laser etching [echogenic markers 112 may be created using machining techniques, laser cutting, laser etching, and/or controlled punching/stamping] (Para 0057) as a suitable technique for manufacturing of echogenic markers on a device (Para 0057).
The Examiner is applying KSR from MPEP § 2143(I)(A); Combining Prior Art Elements According to Known Methods To Yield Predictable Results for the combination of Kurth, Fearnot and Huffmaster as described below:
(1) a finding that the prior art included each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference;
The Examiner finds that the prior art of Kurth, Fearnot and Huffmaster included each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention of laser etching of echogenic markers on identification devices and the laser etching of echogenic markers of the prior art of Kurth, Fearnot and Huffmaster being the lack of the actual combination of the elements in a single prior art reference.
(2) a finding that one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately;
The Examiner finds that one of ordinary skill in the art could have combined the elements of laser etching of echogenic markers as claimed by known methods as taught by Kurth, Fearnot and Huffmaster, and that in combination, each element merely performs the same function as it does separately. The echogenic markers of Kurth merely perform the same function of ultrasound imaging enhancement as it does separately from the function of manufacturing as taught by Huffmaster and as it does separately from the function of empty spaces of Fearnot.
(3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable; and
The Examiner finds that one of ordinary skill in the art would have recognized that the results of the combination were predictable in that the manufacturing of Huffmaster would predictably be used to manufacture the echogenic markers of Kurth and Fearnot. The Examiner contends that it would have been predictable for the manufacturing process of laser etching to be used to form the empty spaces as taught by Fearnot to form the surface irregularities on the elongated body of Kurth.
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manufacture the echogenic markers of Kurth and Fearnot with the manufacturing technique of Huffmaster as a suitable technique for manufacturing of echogenic markers on a device (Para 0057). In order to create the claimed invention a creation or manufacturing process is required. Otherwise, the device cannot be used if it is not made/manufactured. Huffmaster teaches the manufacturing technique used within the prior art to create the echogenic markers on the device.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skujins et al. (U.S. Patent Application 2004/0106878 A1) and further in view of Kurth et al. (U.S. Patent Application 2013/0296911 A1) and Fearnot et al. (U.S. Patent Application 2015/0320979 A1).
Claim 21: Skujins teaches –
A medical guidewire [guidewire] (Figure 1, Element 10), the medical guidewire comprising:
an elongate guidewire body (Figure 2, Element 14 & 16) having a circular cross-section [proximal portion 14 and distal portion 16 may be generally tubular] (Para 0042),
Examiner’s Note: The Examiner is interpreting circular to be analogous to tubular.
wherein the elongate guidewire body comprises:
a proximal portion [elongated proximal portion or member] with a first outer diameter (Figure 2, Element 14),
the proximal portion having a proximal portion distal end [The distal end 20 of the proximal member 14] (Para 0022 and Figure 2, Element 20);
a distal portion [elongated distal portion or member] with a second outer diameter (Figure 2, Element 16),
wherein the second outer diameter is smaller than the first outer diameter (as shown in comparing Element 14 to Element 16 in Figure 2); and
a tapered section [the ends 20/22 of the proximal and distal guidewire section may be…tapered] (Para 0037) between the first outer diameter and second outer diameter [the ends 20/22 of the proximal and distal guidewire sections 14/16] (Figure 2, Element 20 & 22) [ends 20/22 of the proximal and distal guidewire sections 14/16 each have a reduced diameter portion that is adapted and configured to fit within the connector member 15] (Para 0022),
the tapered section having a beginning proximate the proximal portion distal end (as shown in Figure 2 with Element 14 & 20),
wherein the proximal portion and the distal portion include the same circular cross-sectional shape [proximal portion 14 and distal portion 16 may be generally tubular] (Para 0042) [manufacture the connection of the core member 11 of the guidewire 10, the ends 20/22 of the proximal and distal guidewire sections 14/16 may be ground to form the desired shape (…a taper…)] (Para 0037);
an identification device positioned on the elongate guidewire body [includes one or more radiopaque markers, for example radiopaque marker members 18a, 18b, and 18c] (Para 0015 and Figure 2, Element 18a-18c),
wherein the identification device (Figure 2, Element 18a) is located on the first outer diameter (Figure 2, Element 14) at the beginning of the tapered section (as shown in Figure 2 with Element 20) and
whereby the identification device is configured to enhance detectable visibility of the medical guidewire [to produce a relatively bright image on a fluoroscopy screen or another imaging technique] (Para 0001).
Skujins teaches the genus of intravascular catheters (Para 0013) and tapering catheter tips (Figure 2). Skujins fails to specifically teach puncturing/piercing catheters. However, Kurth teaches –
A medical guidewire [transseptal guidewire] (Figure 10, Element 220 and Para 0101) configured for puncturing a tissue [after the intra-atrial septum has been punctured] (Para 0101), the medial guidewire comprising:
Examiner’s Note: Figure 10, 11A-11B & 12 are all describing the same embodiment (Para 0032-0035)
a piercing device [perforating tip] (Figure 10, Element 229) extending from the distal portion (Figure 11A, Element 226),
forming a puncturing distal tip [the perforating tip 229 may be tapered or otherwise formed to a sharp perforating point] (Para 0100) in order to provide a less invasive surgical equipment ad surgical procedures for treatment of intracardiac arrythmias and defects for pacing, ablating and correction of other cardiac structural defects (Para 0002)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a piercing device of Kurth for the tapered section of Skujins in order to provide a less invasive surgical equipment and surgical procedures for treatment of intracardiac arrythmias and defects for pacing, ablating and correction of other cardiac structural defects (Para 0002)
Skujins and Kurth fail to teach wherein the identification device is a combination of an echogenic element and a radiopaque element. However, Fearnot teaches –
wherein the identification device is a combination of an echogenic element configured to be detectable by an echogenic sensor [First guide body portion 130 has one or more longitudinally spaced discrete echogenic markers] (Para 0017) and a radiopaque element configured to be detectable by a radiopaque sensor [first guide body portion 130 partially or completely radio opaque] (Para 0026 and Figure 3, Element 130);
The Examiner is applying KSR from MPEP § 2143(I)(A); Simple Substitution of One Known Element for Another To Obtain Predictable Results for the combination of Skujins, Kurth and Fearnot as described below:
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
The Examiner finds that the prior art of Skujins and Kurth contained a device (identification device with a radiopaque element) which differed from the claimed device (combined radiopaque and echogenic element of the Applicant) by substitution of some components (radiopaque element of Kurth) with other components (combined radiopaque and echogenic element of Fearnot).
(2) a finding that the substituted components and their functions were known in the art;
The Examiner finds that the substituted components (combined radiopaque and echogenic element of Fearnot) and their functions were known in the art. The combined radiopaque echogenic element of Fearnot and its function of enhancing x-ray imaging and ultrasound imaging of the medical guidewire is known within the art as demonstrated by the disclosure of Fearnot.
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and
The Examiner finds that one of ordinary skill in the art could have substituted one known element (radiopaque element of Kurth) for another (combined radiopaque and echogenic element of Fearnot), and the results of the substitution would have been predictable. The substitution would have been predictable in that it would have enhanced x-ray and ultrasound imaging of the medical guidewire.
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the radiopaque element of Skujins and Kurth with the combined radiopaque and echogenic element of Fearnot in order to be useful when two different imaging technologies are used during the same procedure (Para 0026).
Due to the differences between radiology (x-ray imaging) and ultrasonography (ultrasound imaging), each imaging modality has benefits and consequences in what structural are visible during a procedure. When a procedure would require both ultrasound imaging or x-ray imaging, the guidewire can have the appropriate imaging element required for the respective x-ray imaging or ultrasound imaging procedure without needing to pull out the radiopaque element medical guidewire from the patient to replace with an echogenic element medical guidewire into the patient. This would allow the surgeon to seamlessly switch between imaging modalities without needing to exchange medical guidewires.
Thus, the combination of Skujins, Kurth and Fearnot is obvious to one of ordinary skill in the art.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al. (U.S. Patent Application 2013/0296911 A1) and Skujins et al. (U.S. Patent Application 2004/0106878 A1) and further in view of Shturman et al. (U.S. Patent Application 2003/0139689 A1)
Claim 22: Kurth teaches the identification device positioned overtop of the elongate guidewire body [One or more radiopaque markers (25, FIG. 3) may be mounted to portion 24a of elongate body 22a by various coupling processes. Radiopaque markers, for example, may be mounted by adhesives, swaging, crimping, welding, or printing] (Para 0064)
Kurth and Skujins fail to teach the medical guidewire comprises a liner positioned overtop of the identification device. However, Shturman teaches the medical guidewire (Figure 52) further comprises a liner [flexible monolithic tubular liner] (Figure 52, Element 1300) positioned overtop (as shown in Figure 52 and described in Para 0131) of the identification device [radiopaque markers] (Figure 52, Element 1238a-1238c) in order to reduce friction between the guidewire and the interior surface and thereby prevent the medical guidewire from abrading over time (Para 0131)
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 guidewire of Kurth and Skujins with the liner as taught by Shturnam in order to reduce friction between the guidewire and the interior surface and thereby prevent the medical guidewire from abrading over time (Para 0131)
Response to Arguments
The Applicant requested a scheduling of an interview in the event of a notice of allowance is not issued as a result of the Remarked filed 10/24/2025. According to MPEP § 713.01(IV): Where a complete reply to a first action includes a request for an interview, the examiner, after consideration of the reply, should grant such an interview request if it appears that the interview would result in expediting the allowance of the application. The Examiner has considered the reply and determined that the interview would not result in expediting the allowance of the application. Thus, the request for an interview is denied.
Applicant's arguments filed 10/24/2025 have been fully considered but they are not persuasive. The Applicant submitted arguments that Kurth in view of Skujins fails to obviously teach the proximal portion and the distal portion includes the same circular cross-section shape. The Applicant specifically focuses on the motivation to combine the two prior art references would not be obvious. The Examiner respectfully disagrees.
It is important to establish how the claim limitation of same circular cross-sectional shape is being interpreted. The same circular cross-sectional shape is being interpreted to not include diameter, circumference or size. The claim limitation only requires the same shape, regardless of diameter, circumference or size. For example, a taper is the same shape even though the size of the taper is reduced along the taper.
Next is it important to establish what the base reference of Kurth does and does not teach. Drawing 1, provided above of Figure 10 of Kurth, discloses a proximal portion that is circular. Element 226 of Figure 10 of Kurth is reading on the distal portion claim limitation as described in the rejection above. The difference between the claims and Kurth is that Kurth teaches a different cross-sectional shape of oval. In other words, Kurth teaches – the proximal portion and the distal portion includes the different cross-sectional shape. Thus, the rejection above addresses the missing claim limitation with the prior art rejection of Kurth in view of Skujins.
The Examiner contends that Skujins teach that the proximal and distal portions do include the same circular cross-sectional shape. Skujins teaches, proximal portion 14 and distal portion 16 may be generally tubular (Para 0042). Skujins teaches the same circular cross-sectional shape in describing the distal and proximal ends are tubular. Figure 1 and 2 show ends with matching shapes, even in the tapered Figure 2 has both ends having the same shape. The argument is unconvincing.
The Applicant submitted arguments that “the same circular cross-sectional shape between the tubular distal ends and the tubular proximal ends of Skujins” provides a “strain relief adjacent the connection” is not at all consistent with the disclosure of Skujins. The Examiner respectfully disagrees. The argument of the Applicant is overly simplifying the rejection of the record. The rejection applied is KSR from MPEP § 2143(I)(B); Simple Substitution of One Known Element for Another To Obtain Predictable Results for the combination of Kurth and Skujins. The simple substitution is the different shape limitation for the same shape limitation. In other words, replacing the oval shape of Kurth with the tubular shape of Skujins. In applying KSR rationale, the Examiner demonstrated the four points as listed in MPEP § 2143(I)(B) in the rejection above. The Examiner notes that Graham factual inquires, according to MPEP § 2143(I)(B), may be necessary. The MPEP does not require the Graham factual inquires. The arguments of the Applicant ignore the KSR rationale and focuses solely on the motivational test of the Graham factual inquires that are not necessary within the KSR rationale of Simple Substitution of One Known Element for Another To Obtain Predictable Results for the combination of Kurth and Skujins.
However, in spite of not requiring additional findings based on the Graham factual inquires, the Examiner contends that the motivation to combine is proper. Figure 10 of Kurth discloses Element 224 and Element 226 being connected, without specifics regarding the connected. Skujins teaches the means for the connection, the specifics regarding the connection of proximal and distal portions being the same shape and the benefits to the connection, with respect to the strain relief. One of ordinary skill in the art would turn to Skujins for the teaches of the proximal and distal portions connection because of the strain relief benefits within the disclosed connection between the known parts. The argument is unconvincing.
The Applicant submits the argument that Kurth would be rendered unsatisfactory for its intended purpose and changes the principle operation of the invention being modified. The Applicant contends that by omitting the ovalized feature, the retention capability is removed without replacing it with another structure. The Applicant recognizes that Kurth teaches mounting in various manners such as crimping, welding or printing (Page 9 of the Remarks filed 10/24/2025). The Applicant further explains that the ovalized section acts as a safety mechanism (Page 9 of the Remarks) so that the band may be retained and not fall off the guidewire. The Examiner respectfully disagrees. It is not understood how the printing or the other modes of mounting of the radiopaque marker bands is at risk of migrating or falling off. Printing the markers on would not result I migration of the printed band. As a result this embodiment of the disclosed radiopaque marker bands do not require the ovalized safety mechanism. In other words, the Examiner contends that the retention capability is removed and replaced with another structure that doesn’t require the ovalized safety mechanism.
Furthermore the invention of Kurth is not directed specifically to this safety feature. Rather the invention of Kurth could use the ovalized mechanism for this purpose of retaining the bands OR the invention of Kurth could use other modes of mounting that do not require the ovalized section such as printing the radiopaque marker bands on. The argument is unconvincing.
The Applicant submits the arguments that Fearnot fails to teach a combination of an echogenic element and a radiopaque element. The Applicant submitted arguments that element 130 was not echogenic but echolucent. The Examiner contends that there appears to be confusion as Element 129 are the echogenic markers as disclosed in Para 0017 and Element 130 is the radiopaque element as disclosed in Para 0026. The argument is unconvincing.
The rejection is deemed proper and is hereby maintained.
Conclusion
All claims are identical to or patentably indistinct from the invention claimed in the parent application prior to the filing of this Continued Prosecution Application under 37 CFR 1.53(d) (that is, restriction would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing under 37 CFR 1.53(d). 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 HELENE C BOR whose telephone number is (571)272-2947. The examiner can normally be reached Mon - Fri 10:30 - 6:30.
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/Helene Bor/Examiner, Art Unit 3797
/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797