DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03 November 2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 30 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 30, it is not clear what structural elements are required by either “stiff” or “super-stiff” guidewires. The specification puts those terms in quotes and lists commercially available guidewires as mere examples ([106] of the submitted specification) such that it remains unclear exactly what “stiff” and “super-stiff” mean in this context.
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.
Claims 2, 5, 6, 12, 21, 22, 24, 25 and 27-33 are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan (US 2017/0007310) in view of Heisel (US 2014/0336572), Kauphusman (US 2010/0324552) and Johanson (US 5,596,996).
Regarding claims 2, 5, 6, 12 and 28-32, Rajagopalan discloses a device for performing a medical procedure (e.g. fig. 6A) on at least a portion of the duodenum ([0135]) which includes an elongate, multi-lumen, multi-conduit shaft (110, [0150], [0152]), with at least three portions having different flexibilities ([0150], see also [0481]). Rajagopalan teaches that the shafts can have a different flexibility due to “one or more discrete steps” where “more” is at least two discrete steps ([0481]). Therefore, Rajagopalan discloses the shaft can be divided into at least three portions between the two discrete steps: a first portion defined as some part of the shaft connected to the functional assembly (130), and a second portion defined as some part of the shaft connected to the first portion by a discrete change in flexibility and a third portion defined as some part of the shaft connected to the second portion by a discrete change in flexibility. Rajagopalan teaches that this change in flexibility increases in the distal direction (that is, the stiffness decreases in the distal direction, [0481]). The functional assembly includes an expandable element that expands to a diameter of at least 18 mm ([0134]), and a “stiff” (i.e. functional) guidewire (60, fig. 2) slidably extending through a guidewire lumen in the shaft (111, [0152]). The expandable element includes a “fluid manifold” secured between the first, second and third sections (i.e. from the expandable element to a proximal end of the device, fig. 1) which allow fluid inflow and outflow and would, by virtue of existing, “mechanically reinforce” the entire spanned shaft against kinking at least to some degree (note “fluid transport conduit” for delivery and extraction of fluids in [0152]). Rajagopalan does not disclose the particular hardness of the portions, or a distal tip having a proximal tip segment with a stiffness is equal to or less than the stiffness of the first section, and a distal tip segment, where the guidewire has a stiffness between the stiffness of the first tip segment and the second tip segment.
Regarding the particular hardnesses of the portions, choosing a hardness for a medical shaft is well within the level of ordinary skill in the art and there is no evidence that the particularly claimed hardnesses produce an unexpected result (within the meaning of MPEP 716.02(a)). Heisel discloses a shaft with increasing flexibility in a distal direction and provides that increasing flexibility by using portions with decreasing hardness including durometers of 63D, 55D and 40D ([0056]). Therefore, before the application was filed, it would have been obvious to modify the device of Rajagopalan to increase flexibility in the distal direction using any commonly known mechanism, including decreasing hardness of the three portions from 63D to 55D and then 40D as taught by Heisel, that would produce the predictable result of a device with desired operating characteristics.
Regarding the tip section hardness, Kauphusman discloses an elongate medical device with a balloon and teaches that the portion of the shaft assembly distal to the balloon has a hardness less than the hardness of the rest of the shaft assembly portions, more specifically a hardness of 35D ([0036]). Kauphusman teaches that this tip configuration allows an atraumatic functionality ([0036]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Rajagopalan to include a fourth shaft section distal of the expandable functional assembly having a lower hardness than the rest of the shaft portions such as taught by Kauphusman, that would produce the predictable result of providing the device with an atraumatic tip for navigating the device through the body. Since the claim only defines the first section, second section, third section, proximal tip segment and distal tip segment by their relationship to each other, the device of Rajagopalan as modified can be understood to have the claimed proximal tip segment and distal tip segment having different stiffnesses by defining the distal tip to include the part of the shaft distal to the balloon (see e.g. fig. 6A), which will have the same stiffness as the first section (40D) and can be considered the proximal tip segment, and the atraumatic tip fourth portion which will have a lower stiffness (35D) and can be considered the distal tip segment.
Rajagopalan as modified still does not disclose the stiffness of the guidewire relative to the distal tip. However, guidewires both of different stiffness and of multiple stiffness, where the claim does not recite which stiffness is in view, are common in the art and there is no evidence that using a guidewire of a particular stiffness produces an unexpected result. Johanson gives an example of the latter, teaching that a guidewire can have three portions of different stiffnesses, including a portion with a stiffness between 25-55D (75, fig. 1, claim 10). Therefore, before the application was filed it would have been obvious to further modify the device of Rajagopalan to use any commonly known guidewire, including a guidewire having a stiffness between 25-55D, as taught by Johanson, including a stiffness between 35-40D (i.e. the stiffness of the proximal and distal tip segments), that would produce the predictable result of allowing the functional element to be navigated to a desired part of the body by the guidewire. Thus modified, Rajagopalan includes a guidewire with a stiffness that is between the stiffnesses of the proximal and distal tip segments of the distal tip as defined above.
Regarding claims 21, 22, 24 and 25, Rajagopalan further discloses all the trivial “functional assembly” components recited (see discussion associated with the elements of fig. 6A-B, particularly 139, such as [0155] and [0157]). Any inflatable balloon is “configured to” be filled with any fluid, including a fluid with a temperature sufficient to cause some amount of thermal damage to tissue (although Rajagopalan explicitly discloses that both hot and cold fluid can be used for ablation, [0160]).
Regarding claim 27, the embodiment of Rajagopalan cited above does not specially disclose the use of a needle. However, other embodiments of Rajagopalan do include a needle and associated structure for allowing fluid to be delivered through a needle (see discussion associated with 139c, fig. 1). Therefore, before the application was filed, it would have been obvious to provide the embodiment of Rajagopalan with a needle such as taught by Rajagopalan that would produce the predictable result of allowing a fluid to be delivered to a target region.
Regarding claim 33, this claim is being interpreted as extremely broad rather than indefinite. The device of Rajagopalan as modified, having the proximal tip portion stiffer than the distal portion, will perform as recited in the claim when so tested.
Claims 7, 8, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan, Heisel, Kauphusman and Johanson, further in view of Shuffler (US 2014/005647).
Regarding claims 7, 8 and 10, Rajagopalan as modified does not disclose the lengths of the sections, presumably because that is a matter for a person of ordinary skill in the art to determine. Applicant appears to agree with this assessment, having claimed ranges of 2 inches to infinity for the length of the first section, 10 inches to infinity for the length of the second section and 32 inches to infinity for the third section. Shuffler discloses another shaft assembly having portions with variable flexibility and teaches that the proximal portion can have a length of about 39.37 inches, a middle portion with a length of about 11.81 inches and a distal portion with a length of about 11.81 inches ([0094]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the third, second and first shaft portions of Rajagopalan to have any commonly known length, including at least 32 inches, at least 10 inches and at least 2 inches, respectively as taught by Shuffler, that would produce the predictable result of allowing the device to reach a specific location within a specific person.
Regarding claim 11, Rajagopalan does not disclose the respective lengths of the sections, presumably because that is a matter for a person of ordinary skill in the art to determine. Applicant appears to agree with this assessment, having claimed an infinite range of values for the three sections. Shuffler discloses another shaft assembly having portions with variable flexibility and teaches that the proximal portion can have a length of about 39.37 inches, a middle portion with a length of about 11.81 inches (+/- 0.39 inches) and a distal portion with a length of about 11.81 inches (+/- 0.39 inches, [0094]). Thus, Shuffler discloses that the third portion is longer than the second portion, and the second portion can be longer than the first portion. There is no evidence the first portion being, for example, infinitesimally smaller than the second portion produces an unexpected result. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the third, second and first shaft portions of Rajagopalan to have any commonly known length, including the third portion being longer than the second portion, and the second portion being longer than the first portion, such as taught by Shuffler, that would produce the predictable result of allowing the device to reach a specific location within a specific person.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan, Heisel, Kauphusman and Johanson, further in view of Derbin (US 6,562,021) and Javier (US 6,036,677).
Regarding claim 13 and 14, Rajagopalan does not disclose the respective lengths of the sections, presumably because that is a matter for a person of ordinary skill in the art to determine. Applicant provides no explanation of why lengths of 57, 10 and 5 inches produce an unexpected result and ranges of values for portions of a flexible shaft are very common in the art. Derbin discloses a medical device with a shaft of variable flexibility and teaches a proximal portion can be between 39.37 inches and 59.06 inches (col. 9 lines 49-54), Javier discloses a medical device with a shaft of variable flexibility and teaches that an intermediate portion can be between 1.57 inches and 19.69 inches (claim 11) and Heisel discloses a medical device with a shaft of variable flexibility and teaches various portions can be between 0.25 inches and 6 inches ([0081]). It has been held that the simple substitution of one known element for another is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to further modify the shaft of Rajagopalan to have portions of any commonly known length, including values in the ranges as taught by Derbin, Javier and Heisel, that would produce the predictable result of a device having desired operating characteristics.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan, Heisel, Kauphusman and Johanson, further in view of Edwards (US 6,425,877).
Regarding claim 20, Rajagopalan does not disclose the tip is tapered. However, tapering ends of medical devices is extremely common in the art and there is no evidence that a tapered tip produces an unexpected result. Edwards, for example, discloses a device with a functional assembly and a distal tapered tip (fig. 1). Therefore, before the application was filed, it would have been obvious to further modify the device of Rajagopalan to have a tapered distal tip as taught by Edwards to produce the predictable result of a functional medical device.
Response to Arguments
Applicant’s arguments with respect to claims 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.
Conclusion
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794