DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 5 is objected to because of the following informalities: “lateral defined” in line 3 is grammatically incorrect and should be “laterally defined”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites the limitation “a single continuous patterned frame structure formed within the elongate tubular body:” in lines 4-5 of claim 1 on page 18 of the claims from 30 December 2024. There is no description of the device which includes these adjectives “single” or “continuous” are used together or apart to accurately describe the structure. This lack of description is new matter as there is no point in which it would show that this device with said description belonged to applicant.
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 23 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.
Claim 23 recites the limitation “the distal end of the polymer tube” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6 and 11-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zeng et al. (hereinafter “Zeng”, US 2018/0231162).
Regarding claim 1, Zeng discloses a tubular support structure for use in an elongate intravascular medical device, comprising:
an elongate tubular body (Fig. 1, 1);
a single continuous patterned frame structure formed within the elongate tubular body (Fig. 1, 100, where 1 is a single continuous structure that includes tabs and cutouts including 100);
an inner lumen axially disposed within the elongate tubular body (Fig. 1, 1, where the tube body 1 has an internal lumen within the body); and
a first set of floating tabs (Fig. 1, 6, 4, where both 6 and 4 are separated pieces of the device that have a cutout portion that surrounds them and allow for flexible movement when the device is bent or stretched) the axially spaced apart along the patterned frame structure (Fig. 1, where the tabs 6 are spaced along the structure 100), each of the first set of floating tabs having a cantilevered end affixed (Fig. 1, 6, where the stem portion of the “T-Shape” is connected to 1) to the patterned frame structure (where 6 is connected to the body portion 100 at the stem portion of the T-Shape) and a free end configured for translating relative to the patterned frame structure (Fig. 1, where the cross “T” end of the part 6 is a free end that can translate relative to 100) and then engaging the patterned frame structure as the tubular support structure is laterally deflected in a first bending direction (¶[0015], where the free end of 6 deflects laterally and engages with limiting structure 7,8).
Regarding claim 2, Zeng discloses the tubular support structure of claim 1, wherein each of the first set of floating tabs is configured for translating relative to the patterned frame structure when the tubular support structure is in a primary lateral deflection range (¶[0015], where the deflection range has a first deflection range as the part 6 translates within 5 before contacting the structure 7,8), and engaging the patterned frame structure when the tubular support structure is in a secondary lateral deflection range greater than the primary lateral deflection range (¶[0015], where the part 6 translates further than the primary deflection range towards the limiting structure 7,8).
Regarding claim 3, Zeng discloses the tubular support structure of claim 1, wherein the free end of each of the first set of floating tabs is configured for translating relative to the patterned frame structure and then engaging the patterned frame structure as the tubular support structure is axially stretched (Fig. 1, ¶[0015], where the axial stretching of the structure would result in the part 6 translating toward the limiting structure 7 at the cross end part of the tab 6).
Regarding claim 4, Zeng discloses the tubular support structure of claim 3, wherein each of the first set of floating tabs is configured for translating relative to the patterned frame structure when the tubular support structure is in a first axial stretch range, and engaging the patterned frame structure when the tubular support structure is in a second axial stretch range greater than the first axial stretch range (Fig. 1, ¶[0015], where further axial stretching would result in the translation of 6 towards the limiting structure 7 which would the contact the cross portion of 6 and limit further movement in the axial direction).
Regarding claim 5, Zeng discloses the tubular support structure of claim 1, wherein the first set of floating tabs is configured for incrementally engaging the patterned frame structure as the tubular support structure is lateral deflected in the first bending direction (¶[0015], where the part 6 is translated relative to the support structure as bending or stretching occurs and different engagement points are present relative to the amount of bending or stretching that would occur as described by the strengthening and limiting of the part 6 in paragraph 0015 and part 4 additionally allows for flexible movement of the connected parts due to the cutout “u-shaped” portion shown in the figures as the part 4 is not a solid connection between the parts).
Regarding claim 6, Zeng discloses the tubular support structure of claim 5, wherein at least two of the floating tabs have different lengths (Fig. 1, where 6 and 4 are different lengths of tabs).
Regarding claim 11, Zeng discloses the tubular support structure of claim 1, wherein each of the first set of floating tabs axially extends along the patterned frame structure (Fig. 1, where the floating tabs 6 extending along the structure 100 in different sections of the device such as 2 and 3).
Regarding claim 12, Zeng discloses the tubular support structure of claim 1, wherein the patterned frame structure has a plurality of substantially transverse slots (see annotated figure below) disposed at least partially within the elongate tubular body (where the annotated portion is disposed within 1), and the substantially transverse slots are axially spaced apart along the tubular support structure (Fig. 1, where the annotated slots that are present are spaced apart on different parts on the structure), thereby forming a plurality of substantially transverse members (where the parts such as 2 have transverse members) and a plurality of connecting members (where the structure of 2 has transverse sections near the transverse members which connect the whole structure together as shown in figure 1) rigidly coupling the substantially transverse members together (Fig. 1, where the transverse portions such as part 2 are present surrounding the slots 5), wherein the cantilevered end of each of the floating tabs is affixed to a respective one of the substantially transverse members (Fig. 1, where the stem portion of the T-shaped tabs 6 is affixed to the transverse body portions such as 2 in a transverse member part).
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Regarding claim 13, Zeng discloses the tubular support structure of claim 12, wherein the connecting members axially extend along the patterned frame structure (Fig. 1, where sections such as 2, which are repeated, extend axially along the structure 100).
Regarding claim 14, Zeng discloses the tubular support structure of claim 12, wherein the substantially transverse slots are disposed entirely through the elongate tubular body (Fig. 1, where the annotated slots repeat along the body 1).
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Regarding claim 15, Zeng discloses the tubular support structure of claim 1, wherein each of the first set of floating tabs comprises a stem element and an enlarged element that respectively form the cantilevered end and free end of the respective tab (see annotated figure below).
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Regarding claim 16, Zeng discloses the tubular support structure of claim 15, wherein each of the first set of floating tabs is T-shaped (¶ [0013], Fig. 1, where 6 is a T-shaped tab).
Regarding claim 17, Zeng discloses the tubular support structure of claim 15, wherein the patterned frame structure comprises a plurality of retainer openings (Fig. 1, 5) disposed at least partially within the elongate tubular body, and the enlarged element of each of the first set of floating tabs is configured for translating within a respective one of the retainer openings (Fig. 1, where the annotated enlarged section can translate within 5, ¶[0015]) and then engaging an abutment edge of the respective retainer opening as the tubular support structure is laterally deflected in a first bending direction (¶[0015], where the enlarged section can abut 7,8).
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Regarding claim 18, Zeng discloses the tubular support structure of claim 17, wherein each of the retainer openings is coextensive with a respective one of the substantially transverse slots (Fig. 1, where 5 is coextensive with the annotated slot as shown below), and the stem element of each of the first set of floating tabs extends from the respective transverse member (Fig. 1, where the stem part extends from the transverse member as shown in the figure below), across a respective one of the substantially transverse slots (See annotated figure below), and into the respective retainer opening (5).
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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.
Claim(s) 7-10 and 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over Zeng et al. (hereinafter “Zeng”, US 2018/0231162) in view of Griswold et al. (hereinafter “Griswold”, US 2023/0016149).
Regarding claim 7, Zeng discloses the tubular support structure of claim 1, Zeng does not specifically teach further comprising a second set of floating tabs axially spaced apart along the patterned frame structure and circumferentially offset from the first set of floating tabs, each of the second set of floating tabs having a cantilevered end affixed to the patterned frame structure and a free end configured for translating relative to the patterned frame structure and then engaging the patterned frame structure as the tubular support structure is laterally deflected in a second bending direction different from the first bending direction.
Griswold teaches a tubular support structure on a flexible shaft that contains cutouts and protrusions. Griswold teaches further comprising a second set of floating tabs (Fig. 10, 346A, which is repeated structure) axially spaced apart along the patterned frame structure (Fig. 9, where the tab structure is repeated along a frame structure) and circumferentially offset from the first set of floating tabs (Fig. 10, where the tabs 346A are a repeating pattern and each cutout is offset from the other) each of the second set of floating tabs having a cantilevered end affixed to the patterned frame structure and a free end configured for translating relative to the patterned frame structure and then engaging the patterned frame structure as the tubular support structure is laterally deflected in a second bending direction different from the first bending direction (¶[0138], where each of the floating tabs has a base and a cross section within the slot 344 and the T-shaped protrusions are designed to be stretched or flexed, additionally, the tabs would necessarily have different translation and engagement patters when stretched or flexed as the tube is cylindrical and the opposite or offset tabs would move in a different direction based on their relative position, ¶[0137], [0140]-[0141], where the first and second portions have different movement and bending patterns as well as different configurations). Modifying the device of Zeng would be a simple design choice as the device of Zeng already includes repeating tab structures designed to move independently along the axial part of the device. Furthermore, the duplication or repetition of a part is a simple concept that is already seen in the device of Zeng and axially offsetting the tabs would not change the function of the tab within the device.
There is no evidence of record that establishes that including tabs at an axial offset would result in a difference in function of the Zeng device. Further, a person having ordinary skill in the art, being faced with modifying the tube of Zeng, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the tab function.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tube of Zeng to have multiple repeated tabs as shown in Griswold as an obvious matter of design choice and duplication of parts within the skill of the art.
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Regarding claim 8, the combination of Zeng and Griswold teaches the tubular support structure of claim 7, Griswold further teaches wherein the second set of floating tabs is circumferentially offset from the first set of floating tabs by one hundred eighty degrees (Fig. 10, where the T-shaped protrusions are a repeating patters that covers the entire cylindrical region and would have an offset of 180 degrees when the repeated pattern is on the other side of the cylindrical tube. ¶[0133], where cut patterns are present on at least a top and bottom portion as shown in figure 23B), and the second bending direction is opposite the first bending direction (the second bending direction that would inversely translate the offset tabs on the other side would be considered a second bending direction, figures 23A-C show the flexible body portion being bent in different directions).
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Regarding claim 9, the combination of Zeng and Griswold teaches the tubular support structure of claim 7, Zeng teaches wherein the first set of floating tabs is configured for translating relative to the patterned frame structure in a first axial direction when the tubular support structure is laterally deflected in the first direction (¶[0015], where the tabs 6 translate in a first direction when the tubular support structure is deflected), Griswold teaches the second set of floating tabs is configured for translating relative to the frame in a second axial direction opposite the first axial direction (¶[0015], where the second set of tabs, that are offset 180 degrees, would have different translation directions from the first set of tabs on the other side of the device when the device is laterally deflected as the two tabs would be opposite and symmetrical, they would translate opposite each other).
Regarding claim 10, the combination of Zeng and Griswold the tubular support structure of claim 9, Griswold further teaches wherein the first set of floating tabs is configured for continuing to translate in the first axial direction relative to the patterned frame structure after all of the second set of floating tabs have engaged the patterned frame structure, and the second set of floating tabs is configured for continuing to translate in the second axial direction relative to the patterned frame structure after all of the first set of floating tabs have engaged the patterned frame structure (¶[0138], where the slot that the T-shaped protrusions are in changes in width based on the bending direction or stretch direction, this limiting structure would prevent movement of the first set of tabs when the second set of tabs still has translation or deflection space available as the two set of tabs are opposite each other and when bending a cylinder, the opposite axial offsets are reflective).
Regarding claim 19, Zeng teaches the tubular support structure of claim 18,
Zeng does not specifically teach wherein each adjacent pair of substantially transverse members comprises a pair of extensions that form a channel between a respective one of the retainer openings and a respective one of the substantially transverse slots that are coextensive with each other, wherein the stem element of each of the first set of floating tabs resides within a respective one of the channels, wherein each pair of extensions defines the abutment edge of the respective retainer opening.
Griswold teaches wherein each adjacent pair of substantially transverse members comprises a pair of extensions that form a channel between a respective one of the retainer openings and a respective one of the substantially transverse slots that are coextensive with each other, wherein the stem element of each of the first set of floating tabs resides within a respective one of the channels, wherein each pair of extensions defines the abutment edge of the respective retainer opening (Fig. 10, where the cutout structure of 344 has a channel that is shown with the stem portion being connected to the body and the free end within the slot, the adjacent cutout shape of 345 forms transverse slot and opening connection as the limiting structure of each of the opposite facing T-shaped protrusions is forming the abutment edge, retainer opening, slot and channel, see annotated figure below). The device of Zeng already teaches a single set of retainer openings and transverse slots which are coextensive. Modifying the device of Zeng to include additional sets of each that connect and have a channel structure would be obvious and would also be a matter of simple substitution or even a duplication of parts. Having multiple connected parts formed by printing or laser cutting is well0known in the art and would not be a challenge for one skilled in the art to combine. Regarding claim 20, the combination of Zeng and Griswold teaches the tubular support structure of claim 19, Griswold further teaches wherein each pair of extensions is configured for laterally flexing when the enlarged element of the respective floating tab engages the abutment edge of the respective retainer opening (¶[0138], where the T-shaped protrusions are designed to contact an abutment portion and the extensions are configured to flex depending on the flex that is being applied to the device).
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Regarding claim 20, the combination of Zeng and Griswold teaches the tubular support structure of claim 19, Griswold further teaches wherein each pair of extensions is configured for laterally flexing when the enlarged element of the respective floating tab engages the abutment edge of the respective retainer opening (¶[0138], where the T-shaped protrusions are designed to contact an abutment portion and the extensions are configured to flex depending on the flex that is being applied to the device).
Regarding claim 21, Zeng does not specifically teach an elongate intravascular medical device, comprising: an elongate polymer tube; and the tubular support structure of claim 1 coaxially disposed within the polymer tube.
Griswold teaches comprising: an elongate polymer tube (Fig. 4, 316); and the tubular support structure of claim 1 coaxially disposed within the polymer tube (Fig. 6, 324, where the distal end of the support structure has the polymer tube within the structure).This modification would improve the device of Zeng by implementing an inner steerable portion that helps to guide the device while still have flexibility and being coaxially aligned with the rest of the device for movement across the device in a seamless manner (¶[0127] from Griswold).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Zeng to include an elongate polymer tube (Fig. 4, 316 from Griswold); and the tubular support structure of claim 1 coaxially disposed within the polymer tube (Fig. 6, 324, where the distal end of the support structure has the polymer tube within the structure from Griswold).
Regarding claim 22, the combination of Zeng and Griswold teaches the elongate intravascular medical device of claim 21, Griswold further teaches wherein the tubular support structure is disposed at a distal end of the polymer tube (Fig. 6, 330).
Regarding claim 23, the combination of Zeng and Griswold teaches the elongate intravascular medical device of claim 21, Griswold further teaches wherein the tubular support structure is disposed proximal to the distal end of the polymer tube (Fig. 6, 330).
Regarding claim 24, the combination of Zeng and Griswold teaches an elongate intravascular medical device,
Zeng does not specifically teach a core wire; and the tubular support structure of claim 1 disposed over a distal end of the core wire.
Griswold further teaches comprising: a core wire (Fig. 3A, 358); and the tubular support structure of claim 1 disposed over a distal end of the core wire (¶[0133], see annotated below). A core wire in a flexible tube structure is not new and is well-known in the art. This modification further improves the device by having an actuating part that can be manipulated to control flexing or bending of the device (¶[0133] from Griswold).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Zeng to include a core wire (Fig. 3A, 358 from Zeng) inside the tubular support structure (¶[0133] from Zeng).
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Regarding claim 25, the combination of Zeng and Griswold teaches an elongate intravascular medical device,
Zeng does not specifically teach tubular support structure of claim 1; and an inner polymer liner disposed within the inner lumen of the tubular body of the tubular support structure.
Griswold teaches comprising tubular support structure of claim 1; and an inner polymer liner disposed within the inner lumen of the tubular body of the tubular support structure (Fig. 3A, 314). The part 314 is within 3330 and 316 as shown in figure 3 and is a polymer interior as described in paragraph 0123. This modification would be obvious as the interior shaft portion 314 is simply an extra layer that allows for additional flexibility as well as fluid coupling between different parts of the device (¶[0130] from Griswold).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Griswold to include a polymer liner within the inner lumen of the tubular body of the tubular support structure (¶[0123] & [0130] from Griswold).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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