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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first radial line” (claim 4) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 2 is objected to because of the following informalities: Lines 1-2 should be amended as follows:
“2. The method of claim 1, wherein [[inserting]] the balloon is inserted into the vertebral body…” since the claim is clarifying what is done during the step of inserting the balloon and not adding an additional step of inserting the balloon. Appropriate correction is required.
Claim 3 is objected to because of the following informalities:
Lines 1-2 should be amended as follows:
“3. The method of claim 1, wherein the step of inserting the balloon comprises placing the balloon into the vertebral body…” since the claim is clarifying what is done during the step of inserting the balloon and not adding an additional step of inserting the balloon.
In Line 7, the word –and—should be added at the end of the line after the semi-colon.
Appropriate correction is required.
Claim 4 is objected to because of the following informalities and should be amended as follows:
“4. A method of kyphoplasty comprising the steps of: providing a kyphoplasty balloon catheter comprising a catheter tube and a balloon disposed on the distal end of the catheter tube; wherein the catheter tube comprises a proximal end and a distal end, a lumen extending therethrough, and a long central axis extending through a center of the lumen; wherein the balloon[[,]] is disposed on the distal end of the catheter tubeand comprises a long axis, a width axis measured from the catheter tube and perpendicular to the long central axis of the catheter tube, and a height axis displaced from the long central axis of the catheter tube and perpendicular to the long central axis of the catheter tube and the long axis of the balloon, wherein the long axis of the balloon, when inflated, is displaced from the long axis of the catheter tube[[,]] and said balloon is in fluid communication with the lumen of the catheter tube; inserting the catheter tube distal end within the vertebral body, to position the balloon inside the cortical shell of the vertebral body and amidst the cancellous bone of the vertebral body such that the long axis of the catheter tube is proximate a lateral area of the vertebral body, [[and]] wherein the balloon is expandable toward a medial area of the vertebral body, with the width axis disposed on a first radial line relative to the catheter tube from the catheter tube central axis toward the medial area of the vertebral body, said first radial line lying in a first plane transecting the vertebral body; inflating the balloon within the vertebral body, inside the central axis of the catheter tube and into an area of the cancellous bone medial to the catheter tube, to create an intraosseous cavity medial to the distal end of the catheter tube and centered on the first transverse cross section of the vertebral body; deflating the balloon; thereafter, without withdrawing the balloon or catheter tube; rotating the catheter tube to align the width axis and the first radial line along a second plane transecting the vertebral body; inflating the balloon to enlarge the intraosseous cavity centered on the second transverse cross section, or create a second intraosseous cavity centered on the second transverse cross section.” Appropriate correction is required.
Claim 5 is objected to because of the following informalities and should be amended as follows:
“5. A kyphoplasty balloon catheter comprising: a catheter tube, said catheter tube having a proximal end and a distal end, a lumen extending therethrough, and a long central axis extending through a center of the lumen, said catheter tube having a side-facing aperture in a side aperture segment near the distal end of the catheter tube, with a partial cylinder portion opposite the side aperture; and a balloon disposed on the distal end of the catheter tube, proximate the side-facing aperture, said balloon comprising a long axis corresponding to the long central axis of the catheter tube, a width axis measured from the catheter tube and perpendicular to the long central axis of the catheter tube, and a height axis displaced from the long central axis of the catheter tube and perpendicular to the long central axis of the catheter tube and the long axis of the balloon, said balloon having a small cross-section uninflated configuration in which it fits within the side aperture segment of the catheter tube; said balloon having a large cross-section inflated configuration in which it extends from the side aperture segment of the catheter tube, extending radially away from the side-facing aperture in a direction opposite the partial cylinder portion; wherein the long axis of the balloon, when inflated, is displaced from the long central axis of the catheter tube; said balloon in fluid communication with the lumen of the catheter tube.” Appropriate correction is required.
Claim 8 is objected to because of the following informalities and should be amended as follows:
“8. The kyphoplasty balloon catheter of claim 5 wherein: the balloon comprises: an inner layer which is radiolucent; [[and]] a distal radiopaque polymer layer covering a distal portion of the inner layer of the balloon, said distal radiopaque polymer layer disposed around [[the]] an entire circumference of the distal portion of the inner layer of the balloon; a proximal radiopaque polymer layer covering a proximal [[of]] portion of the inner layer of the balloon, said proximal radiopaque polymer layer disposed around [[the]] an entire circumference of the proximal portion of the inner layer of the balloon; and a middle region of radiolucent balloon located between the distal radiopaque polymer layer and the proximal radiopaque polymer layer, said middle region disposed around the entire circumference of the middle region of the balloon.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim limitations in this application that are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph are as follows:
“means for locking” (Claim 9).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites “locking the catheter tube to the cannula prior to inflating the balloon”. There is insufficient antecedent basis for this limitation since this claim depends from Claim 1 and not Claim 2. For purposes of examination, the limitation is being interpreted as “locking a catheter tube to the cannula prior to inflating the balloon”. Appropriate correction is required.
Claim 3 recites “unlocking the catheter tube from the cannula prior to orienting the balloon in a second direction;” which renders the claim indefinite as it is unclear if this is the same “second direction” as previously recited in Claim 1 at Line 11, or a different direction. For purposes of examination, the limitation is being interpreted as “unlocking the catheter tube from the cannula prior to orienting the balloon in the second direction”. Appropriate correction is required.
Claim 4 at Lines 10-11 recites the limitation “a width axis measured from the catheter tube and perpendicular to the long central axis of the catheter tube” which renders the claim indefinite as it is unclear what is meant by the width axis being “measured from” the catheter tube. Is this indicating a position of the axis, an orientation of the axis, a position of the catheter tube, or something else? For purposes of examination, the limitation is being interpreted as “a width axis perpendicular to the long central axis of the catheter tube”. Appropriate correction is required.
Claim 4 at Lines 19-21 recites the limitation “inserting the catheter tube distal end within the vertebral body, to position the balloon inside the cortical shell of the vertebral body and amidst the cancellous bone of the vertebral body such that the long axis of the catheter tube is proximate a lateral area of the vertebral body, and the balloon is expandable toward a medial area of the vertebral body”. There is insufficient antecedent basis for the limitations “the vertebral body”, “the cortical shell”, and “the cancellous bone”. For purposes of examination, the limitations are being interpreted as “a vertebral body”, “a cortical shell”, and “cancellous bone”. v
Claim 4 at Lines 35-36 recites the limitation “the first transverse cross section of the vertebral body”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the limitation is being interpreted as “a first transverse cross section of the vertebral body”. Appropriate correction is required.
Claim 4 at Line 44 & 45-46 recites the limitation “the second transverse cross section”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the limitation is being interpreted as “a second transverse cross section of the vertebral body”. Appropriate correction is required.
Claim 5 at Lines 12-13 recites the limitation “a width axis measured from the catheter tube and perpendicular to the long central axis of the catheter tube” which renders the claim indefinite as it is unclear what is meant by the width axis being “measured from” the catheter tube. Is this indicating a position of the axis, an orientation of the axis, a position of the catheter tube, or something else? For purposes of examination, the limitation is being interpreted as “a width axis perpendicular to the long central axis of the catheter tube”. Appropriate correction is required.
Claim 8 at Lines 15-16 recites the limitation “said middle region disposed around the entire circumference of the middle region of the balloon.” Which renders the claim indefinite as it is unclear how the middle region can be disposed around the entire circumference of itself? For purposes of examination, the limitation is being interpreted as “said middle region disposed around an entire circumference of the balloon”. Appropriate correction is required.
Claim 9 at Line 3 recites the limitation “means for locking the catheter tube to the vertebral body” which renders the claim indefinite as Fig. 11 depicts a locking device for locking the catheter tube to the cannula and the specification discloses in Paragraph [0031] that “In performing the method, after an inflation and creation of a first cavity, the balloon may be deflated, the locking mechanism may be released to allow twisting of the catheter tube. The surgeon may then rotate the catheter tube to redirect the side aperture, and optionally translate the catheter tube within the trocar to adjust the longitudinal position of the balloon, and then operate the locking mechanism to prevent inadvertent longitudinal or rotational movement of the catheter tube. With the balloon and side aperture directed in a new direction, the surgeon can re-inflate the balloon to create a second cavity or enlarge the first cavity.” Furthermore, the disclosure does not seem to disclose any of the structural components therein being locked to the vertebral body. It appears that the means for locking is not for locking anything to the vertebral body, it is instead for locking the catheter tube to a cannula/trocar which the balloon is attached to. Thus, for purposes of examination, the claim is being interpreted as “means for locking the catheter tube to a cannula”. Appropriate correction is required.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schaus et al. (US PG Pub No. 2015/0257809).
Regarding Claim 1, Schaus et al. discloses a method of kyphoplasty on a vertebral body of a patient (Figs. 4A-4H and 6A, Paragraphs [0045-0056 & 0016, 0024, 0057]), said method comprising: inserting a balloon (cavity forming device including balloon 462, Figs. 4D-4E) into the vertebral body (500) through a pedicle (502, Fig. 4F), to position the balloon in a lateral portion of cancellous bone (508) within the vertebral body (Figs. 4E-4F); inflating the balloon in a first direction (Fig. 4F & 6A) within the vertebral body to create a first void (cavity 721, Fig. 6A) within the cancellous bone (Paragraph [0057]); deflating the balloon (Paragraph [0016], Claim 5]) without removing the balloon from the vertebral body, orienting the balloon in a second direction (reposition, Fig. 6A) within the vertebral body; re-inflating the balloon while oriented in the second direction to enlarge the first void (Claim 5); and withdrawing the balloon from the vertebral body; and injecting cement into the void (Claim 5, Paragraphs [0024, 0028], Figs. 6A, 4H).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lenchig (US PG Pub No. 2021/0338298).
Regarding Claims 5-6 as best understood, Lenchig discloses a kyphoplasty balloon catheter (Figs. 10-13, Paragraphs [0035, 0040]) comprising: a catheter tube (trocar 901, Fig. 10) having a proximal end (rear end) and a distal end (working end/tip near 1010, Fig. 10), a lumen (hollow) extending therethrough, and a long central axis (central longitudinal axis through 901, Fig. 10) extending through a center of the lumen, said catheter tube having a side facing aperture (orifice 1010) in a side aperture segment near the distal end of the catheter tube (Paragraph [0035]), with a partial cylinder portion opposite the side aperture (Fig. 10); a balloon (910, Figs. 11-13, Paragraph [0035]) disposed on the distal end of the catheter tube, proximate the side-facing aperture (Paragraph [0036]), said balloon characterized by a long axis (1002, Figs. 11-12) extending through the long central axis of the catheter tube (Figs. 11-12), a width axis (lateral side to side axis through 910, Fig. 13) measured from the catheter tube and perpendicular to the long central axis of the catheter tube, and a height axis (vertical axis through 910, Figs. 11-12) displaced from the long central axis of the catheter tube and perpendicular to the long central axis of the catheter tube and the long axis of the balloon, said balloon having a small cross-section uninflated (Fig. 11 shows a partially inflated, not fully deflated configuration) configuration in which it fits within the side aperture segment of the catheter tube (Abstract); said balloon having a large cross-section inflated configuration (Figs. 12-13) in which it extends from the side aperture segment of the catheter tube, extending radially away from the side aperture in a direction opposite the partial cylinder portion (Figs. 12-13); wherein the long axis of the balloon, when inflated, is displaced from the long axis of the catheter tube (Figs. 12-13); said balloon in fluid communication with the lumen of the catheter tube (Paragraph [0040], “The balloon tamponade 910 is inflated until being of sufficient size such that the vertebral body takes the desired structure.”); wherein: the balloon catheter is configured to limit expansion of the balloon to a minor arc about the catheter tube (Figs. 11-12).
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) 2 & 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaus et al. (US PG Pub No. 2015/0257809) in view of Lenchig (US PG Pub No. 2021/0338298).
Regarding Claim 2, Schaus et al. discloses the claimed invention as stated above in claim 1, and further discloses the balloon being attached to a catheter tube (tube of cavity forming device as seen in Fig. 4G), and the balloon in an uninflated configuration (Fig. 4E) and in an inflated configuration (Fig. 4F, 4G). Schaus et al. does not disclose inserting the balloon into the vertebral body through the catheter tube comprising a side-facing aperture in the distal end of the catheter tube, wherein, in the uninflated configuration, the balloon is disposed in the catheter tube proximate the side facing aperture, and the balloon, in the inflated configuration, extends radially away from the side aperture of the catheter tube.
Lenchig discloses a method of performing vertebroplasty “including the steps of: creating a pedicular access channel in a pedicle to access the interior of a vertebral body; inserting an introducer cannula into the pedicle; inserting a steerable injection needle through the introducer cannula into the interior of a vertebral body, the steerable injection needle having a proximal end and a distal end, the distal end having a first configuration substantially coaxial with a long axis of the proximal end, the steerable injection needle also having a first cavity creating element and a second cavity creating element; rotating a control to deflect the distal end of the steerable injection needle to a second configuration that is not substantially coaxial with the long axis of the proximal end; actuating the first cavity creating element to create a first cavity within the interior of the vertebral body; actuating a second cavity creating element to create a second cavity within the interior of the vertebral body; and flowing bone cement through the steerable injection needle into the interior of the vertebral body” (Paragraph [0016]), wherein Figs. 10-13 depict a particular embodiment of the system (900) which comprises a hollow tube/trocar (901) and a balloon (910) extending from the distal end thereof (Paragraphs [0035, 0040]), wherein the trocar comprises a side-facing aperture (orifice 1010, Fig. 10) in the distal end thereof, wherein in an uninflated configuration, the balloon is disposed in the catheter tube proximate the side facing aperture (Abstract, “the balloon tampanade is inserted into a second end of the trocar, through and out of the orifice at the first end of the trocar”), and the balloon, in the inflated configuration, extends radially away from the side aperture of the catheter tube (Figs. 11-13, Paragraph [0040]) such that during deployment, the inflated balloon expands mainly along an axis that is orthogonal or perpendicular to a longitudinal axis of the trocar (Paragraph [0036]). Lenchig teaches that the benefit of using this balloon tamponade in a kyphoplasty procedure is the making of only one incision and a resulting savings in time, medical expenditure and patient recovery.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to replace the cavity forming device used in the method of Schaus et al. with the hollow tube comprising the distal side-facing aperture and spheroid balloon disposed therein as taught by Lenchig as an alternate and functionally equivalent balloon tamponade device which can be used on its own in multiple configurations to create a specific void in the vertebral material as necessary based on a particular patients needs and surgeons preference.
Regarding Claim 4 as best understood, Schaus et al. discloses a method of kyphoplasty (Abstract, Figs. 4A-4H, 6A, Paragraphs [0045-0053 and 0016, 0024, 0057]) comprising the steps of: providing a kyphoplasty balloon catheter (cavity forming delivery device with balloon 462, Figs 4D-4E) comprising a catheter tube (shaft delivery device as seen in Fig. 4G) and a balloon (462, Fig. 4D) disposed on the distal end of the catheter tube (Paragraph [0050]) and in fluid communication with a lumen of the catheter tube (Fig. 4G); wherein the catheter tube comprises a proximal end (rear end), a distal end (working end/tip near 462, Fig. 4G) and a long central axis (central, longitudinal axis through tube of CFD, Fig. 4G); the balloon, disposed on the distal end of the catheter tube (Fig. 4E), comprising a long axis (axis through length of 462, Fig. 4E, 4F, 4G), a width axis (lateral side to side distance, Fig. 4F) perpendicular to the long central axis of the catheter tube, and a height axis (vertical distance, Fig. 4G) displaced from the long central axis of the catheter tube and perpendicular to the long central axis of the catheter tube and the long axis of the balloon, inserting the catheter tube distal end within a vertebral body (500, Fig. 4D-4F), to position the balloon inside a cortical shell (506) of the vertebral body and amidst cancellous bone of the vertebral body (508) such that the long axis of the catheter tube is proximate a lateral area of the vertebral body (Fig. 4G), and the balloon is expandable toward a medial area of the vertebral body (Fig. 4F), with the width axis disposed on a first radial line relative to the device from the device central axis toward the medial area of the vertebral body (Fig. 4F), said radial line lying in a first plane transecting the vertebral body (Fig. 4G); inflating the balloon within the vertebral body (Fig. 4G), inside the cancellous bone (Paragraph [0050]); and deflating the balloon (Claim 2).
Schaus et al. does not disclose wherein the long axis of the balloon, when inflated, is displaced from the long axis of the catheter tube, wherein inflating the balloon within the vertebral body is such that the balloon expands away from the long axis of the catheter tube and into an area of the cancellous bone medial to the catheter tube , to create an intraosseous cavity medial to the distal end of the catheter tube and centered on the first transverse cross section of the vertebral body; deflating the balloon without withdrawing the balloon or catheter tube; rotating the catheter tube to align the width axis and radial line along a second plane transecting the vertebral body; inflating the balloon to enlarge the intraosseous cavity centered on the second transverse cross section, or create a second intraosseous cavity centered on the second transverse cross section.
Lenchig discloses a method of performing vertebroplasty “including the steps of: creating a pedicular access channel in a pedicle to access the interior of a vertebral body; inserting an introducer cannula into the pedicle; inserting a steerable injection needle through the introducer cannula into the interior of a vertebral body, the steerable injection needle having a proximal end and a distal end, the distal end having a first configuration substantially coaxial with a long axis of the proximal end, the steerable injection needle also having a first cavity creating element and a second cavity creating element; rotating a control to deflect the distal end of the steerable injection needle to a second configuration that is not substantially coaxial with the long axis of the proximal end; actuating the first cavity creating element to create a first cavity within the interior of the vertebral body; actuating a second cavity creating element to create a second cavity within the interior of the vertebral body; and flowing bone cement through the steerable injection needle into the interior of the vertebral body” (Paragraph [0016]), wherein Figs. 10-13 depict a particular embodiment of the system (900) which comprises a hollow tube/trocar (901) and a balloon (910) extending from the distal end thereof (Paragraphs [0035, 0040]), wherein the trocar comprises a side-facing aperture (orifice 1010, Fig. 10) in the distal end thereof, wherein in an uninflated configuration, the balloon is disposed in the catheter tube proximate the side facing aperture (Abstract, “the balloon tampanade is inserted into a second end of the trocar, through and out of the orifice at the first end of the trocar”), and the balloon, in the inflated configuration, extends radially away from the side aperture of the catheter tube (Figs. 11-13, Paragraph [0040]) such that during deployment, the inflated balloon expands mainly along an axis that is orthogonal or perpendicular to a longitudinal axis of the trocar (Paragraph [0036]). Lenchig teaches that the benefit of using this balloon tamponade in a kyphoplasty procedure is the making of only one incision and a resulting savings in time, medical expenditure and patient recovery.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to replace the cavity forming device used in the method of Schaus et al. with the hollow tube comprising the distal side-facing aperture and spheroid balloon disposed therein, and modify the method with the steps of inflating the balloon within the vertebral body such that the long axis of the balloon, when inflated, is displaced from the long axis of the catheter tube, wherein inflating the balloon within the vertebral body is such that the balloon expands away from the long axis of the catheter tube and into an area of the cancellous bone medial to the catheter tube, to create an intraosseous cavity medial to the distal end of the catheter tube and centered on the first transverse cross section of the vertebral body, deflating the balloon without withdrawing the balloon or catheter tube, rotating the catheter tube to align the width axis and radial line along a second plane transecting the vertebral body, inflating the balloon to enlarge the intraosseous cavity centered on the second transverse cross section, and create a second intraosseous cavity centered on the second transverse cross section, as taught by Lenchig as an alternate and functionally equivalent balloon tamponade device which can be used in a kyphoplasty method on its own in multiple configurations to create a specific void in the vertebral material as necessary based on a particular patients needs and surgeons preference.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaus et al. (US PG Pub No. 2015/0257809) in view of Lenchig (US PG Pub No. 2021/0338298) and Hayes (US PG Pub No. 2006/0085022).
Regarding Claim 3 as best understood, Schaus et al. discloses the claimed invention as stated above in claim 1, and further discloses placing the balloon into the vertebral body through a cannula (422, Figs. 4D-4F) inserted into the vertebral body (Paragraph [0045]).
Schaus et al. does not disclose locking the catheter tube to the cannula prior to inflating the balloon; unlocking the catheter tube from the cannula prior to orienting the balloon in a second direction; and locking the catheter tube to the cannula prior to re-inflating the balloon.
Lenchig discloses a method of performing vertebroplasty “including the steps of: creating a pedicular access channel in a pedicle to access the interior of a vertebral body; inserting an introducer cannula into the pedicle; inserting a steerable injection needle through the introducer cannula into the interior of a vertebral body, the steerable injection needle having a proximal end and a distal end, the distal end having a first configuration substantially coaxial with a long axis of the proximal end, the steerable injection needle also having a first cavity creating element and a second cavity creating element; rotating a control to deflect the distal end of the steerable injection needle to a second configuration that is not substantially coaxial with the long axis of the proximal end; actuating the first cavity creating element to create a first cavity within the interior of the vertebral body; actuating a second cavity creating element to create a second cavity within the interior of the vertebral body; and flowing bone cement through the steerable injection needle into the interior of the vertebral body” (Paragraph [0016]), wherein Figs. 10-13 depict a particular embodiment of the system (900) which comprises a hollow tube/trocar (901) and a balloon (910) extending from the distal end thereof (Paragraphs [0035, 0040]), wherein the trocar comprises a side-facing aperture (orifice 1010, Fig. 10) in the distal end thereof, wherein in an uninflated configuration, the balloon is disposed in the catheter tube proximate the side facing aperture (Abstract, “the balloon tampanade is inserted into a second end of the trocar, through and out of the orifice at the first end of the trocar”), and the balloon, in the inflated configuration, extends radially away from the side aperture of the catheter tube (Figs. 11-13, Paragraph [0040]) such that during deployment, the inflated balloon expands mainly along an axis that is orthogonal or perpendicular to a longitudinal axis of the trocar (Paragraph [0036]). Lenchig teaches that the benefit of using this balloon tamponade in a kyphoplasty procedure is the making of only one incision and a resulting savings in time, medical expenditure and patient recovery.
Hayes discloses a fiber-reinforced medical balloon device (10, Figs. 30-31, Paragraphs [0129-131]) for use in a kyphoplasty procedure and configured to be inserted between vertebrae (408) and inflated such that the space created by the device can be filled with a cementing substance, wherein the device depicted in Fig. 26 comprises “A coupling device 230, such as a conventional syringe luer,” “used to couple the catheter tube 208 to a syringe 214 used to inflate the fiber-reinforced balloon 10. The flange portion 232 of the coupling device 230 may be adapted to screw into a coupling portion 216 of the syringe 212, forming a seal. The wing portions 234 of the coupling device 230 may be used to twist the flange portion 232 into the coupling portion 216 of the syringe 214. The coupling body 236 of the coupling device 230 allows the medium, typically a liquid such as a radio-contrast solution to pass from the syringe 214 to the fiber-reinforced balloon 10.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to replace the cavity forming device used in the method of Schaus et al. with the hollow tube comprising the distal side-facing aperture and spheroid balloon disposed therein as taught by Lenchig, and add a coupling device for coupling the catheter tube to the hollow tube prior to inflation of the balloon, wherein the catheter tube is unlocked and locked as needed such as unlocked from the hollow tube prior to repositioning the balloon and relocked prior to re-inflation, as taught by Hayes as an alternate and functionally equivalent approach to a kyphoplasty procedure using a balloon tamponade device which can be used on its own in multiple configurations to create a specific void in the vertebral material as necessary based on a particular patients needs and surgeons preference.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lenchig (US PG Pub No. 2021/0338298) in view of Berger (US PG Pub No. 2003/0050702).
Regarding Claim 7, Lenchig discloses the claimed invention as stated above in claim 5, except a stiffening spine secured to the partial cylinder portion of the catheter tube.
Berger discloses a balloon apparatus (Figs. 3-4) for treatment of vertebrae, comprising a balloon catheter device comprising a tube (40, Paragraph [0030]) having a lumen (48) therethrough and a distal end with a balloon (50, Paragraph [0031]) disposed thereon, the distal end of the tube comprising a side-facing aperture (beveled section 47, Fig. 3) and a partial cylinder portion opposite the side-facing aperture (Fig. 3), wherein a stiffening spine (reduced height protrusion extending distally from 47 as seen in Fig. 3) extends from the partial cylinder portion forming a cutout end (44) having a blunt rounded tip (45), wherein the stiffening spine is used for the purpose of forming a seat at the distal end for the balloon.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter tube of Lenchig to add a stiffening spine which comprises a cutout and extends distally from the side-facing aperture at the tip thereof as taught by Berger in order to provide the catheter tube of Lenchig with a protective seat for the balloon to lie in prior to inflation thereof during a procedure.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lenchig (US PG Pub No. 2021/0338298) in view of Lau et al. (US PG Pub No. 2009/0299828).
Regarding Claim 8 as best understood, Lenchig discloses the claimed invention as stated above in claim 5, except wherein the balloon comprises: an inner layer which is radiolucent; a distal radiopaque polymer layer covering a distal portion of the inner layer of the balloon, said distal radiopaque polymer layer disposed around an entire circumference of the distal portion of the inner layer of the balloon; a proximal radiopaque polymer layer covering a proximal portion of the inner layer of the balloon, said proximal radiopaque polymer layer disposed around an entire circumference of the proximal portion of the inner layer of the balloon; and a middle region of radiolucent balloon located between the distal radiopaque polymer layer and the proximal radiopaque polymer layer, said middle region disposed around an entire circumference of the balloon.
Lau et al. discloses methods and devices for performing vertebroplasty (Abstract) comprising a cavity creation balloon device (Figs. 16H, 16A-16B, Paragraphs [0132, 0123]) comprising a catheter tube (301) with a lumen therethrough (316), and an inflatable balloon (322, Fig. 16A, Paragraph [0126]) disposed at the end of the tube, wherein the balloon comprises a filament layer (340), an exterior layer (342) “made of, for example, a material discussed with respect to polymeric sleeve construction noted above, nylon, urethane, PET, or a thermoplastic.”, and multiple layers, such as made of a polymer, exterior to the filament layer 340 and/or multiple liner layers interior to the filament 340, as well as multiple braided or other filament layers between or amongst the various layers” (Paragraph [0132]), wherein the filament may comprise any of a variety of metallic ribbons or wire-based braids, or braids may from fibrous materials (synthetic or natural), malleable metals such as gold, platinum, palladium, rhodium, or platinum alloy with a few percent of tungsten partially because of its radio-opacity, or non-metallic ribbons such as made from Kevlar, Dacron, nylons, carbon fibers, or shape memory polymer (Paragraphs [0133-0135]), and “In some embodiments, the cavity-creating element could include a reinforcing layer that may be, for example, woven, wrapped or braided (collectively a "filament" layer), for example, over the liner of a balloon. The filament layer can advantageously protect the balloon from damage while in the working space, for example from jagged cancellous bone fragments within the interior of the vertebral body. The filament layer can also significantly elevated the burst pressure of the balloon, such that it exceeds about 20 ATM, in some embodiments exceeds about 25 ATM, and in a preferred embodiment, is at least about 30 ATM. In embodiments with a plurality of braided layers, the balloon could have an additional third, fourth, etc. progressively lower compliance values.” (Paragraphs [0130-0131]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the balloon of Lenchig to include multiple layers including an inner radiolucent polymeric layer, an exterior/reinforcing braided radiopaque polymer layer, a middle radiopaque polymer liner layer, and a third metallic filament layer located in between the exterior and liner layers as taught by Lau et al. in order to protect the balloon from damage while in the working space from jagged cancellous bone fragments and significantly elevate the burst pressure of the balloon.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lenchig (US PG Pub No. 2021/0338298) in view of Hayes (US PG Pub No. 2006/0085022).
Regarding Claim 9 as best understood, Lenchig discloses the claimed invention as stated above in Claim 5, except a means for locking the catheter tube to a cannula. Lenchig does disclose that Figs. 10-12 depict the process of inflating the balloon (910) through the hollow tube/trocar (901) and states in Paragraph [0040] that “The balloon tamponade 910 is inflated until being of sufficient size such that the vertebral body takes the desired structure.” But does not disclose a device by which the inflation occurs. One having ordinary skill in the art would recognize that it is well-known and common to attach a syringe or other delivery means via a luer to an inflatable balloon device to fill the balloon with fluid as needed.
Hayes discloses a fiber-reinforced medical balloon device (10, Figs. 30-31, Paragraphs [0129-131]) for use in a kyphoplasty procedure and configured to be inserted between vertebrae (408) and inflated such that the space created by the device can be filled with a cementing substance, wherein the device depicted in Fig. 26 comprises “A coupling device 230, such as a conventional syringe luer,” “used to couple the catheter tube 208 to a syringe 214 used to inflate the fiber-reinforced balloon 10. The flange portion 232 of the coupling device 230 may be adapted to screw into a coupling portion 216 of the syringe 212, forming a seal. The wing portions 234 of the coupling device 230 may be used to twist the flange portion 232 into the coupling portion 216 of the syringe 214. The coupling body 236 of the coupling device 230 allows the medium, typically a liquid such as a radio-contrast solution to pass from the syringe 214 to the fiber-reinforced balloon 10.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to add a coupling arrangement to the proximal end of the catheter tube for connection to a corresponding coupling arrangement on a delivery cannula for locking the catheter tube to the delivery cannula during use as taught by Hayes in order to provide the catheter tube with a well-known and commonly use means for securably and removably connecting a balloon device to an inflation means for the balloon during use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/JESSICA WEISS/Primary Examiner, Art Unit 3775
