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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) below have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejection made with Wentz were modified accordingly in view of applicant’s amendment. In response to applicant’s arguments regarding “housing is suspended” the examiner notes that this limitation is intended use and paragraph 82 makes it clear that base #577 is option and “may be” used. Likewise with regard to the “suspending…” step, based of paragraph 82 and the optional use of base #577, it is inherent/obvious that Wentz would also teach the “suspending” step. See rejections below. Applicant is welcome to contact the examiner if they have any questions.
Claim Interpretation
The examiner notes that Claim 1 recites “the first extension arm being configured for attachment to a first vertebrae with an anchor assembly […] the second extension arm being configured for attachment to a second vertebrae with an anchor assembly.” Claim 18 recites “A spinal curvature correction system, comprising: at least a first distraction device and a second distraction device according to claim 1; and a joint member […] to connect the first and second distraction devices together in series.” It is understood by the examiner for Claim 18 that both the first and second distraction devices have the same structure as recited in claim 1 and that each be placed on first and second vertebrae (as recited in claim 1) but when placed in series, the first and second distraction devices would not be placed on first and second vertebrae.
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. Such claim limitation(s) is/are: “drive element” in claims 1, 24, 27.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 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.
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 § 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 27-28, 31 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 27 recites the limitation "a first anchor assembly" in line 17. There is insufficient antecedent basis for this limitation in the claim. “A first anchor assembly” was already recited in parent Claim 24 and it is not clear if this is referring to the anchor assembly in claim 24 or is different. For examination purposes, the examiner is treating is as a different anchor assembly.
Claim 27 recites the limitation "the first anchor assembly" in line 31. There is insufficient antecedent basis for this limitation in the claim. “The first anchor assembly” was already recited in parent Claim 24 and it is not clear if this is referring to the anchor assembly in claim 24 or the one in line 17. For examination purposes, the examiner is treating is as the anchor assembly recited in line 17.
Claim 27 recites the limitation "a second anchor assembly" in line 23-24. There is insufficient antecedent basis for this limitation in the claim. “A second anchor assembly” was already recited in parent Claim 24 and it is not clear if this is referring to the anchor assembly in claim 24 or is different. For examination purposes, the examiner is treating is as a different anchor assembly.
Claim 27 recites the limitation "the second anchor assembly" in line 32. There is insufficient antecedent basis for this limitation in the claim. “The first anchor assembly” was already recited in parent Claim 24 and it is not clear if this is referring to the anchor assembly in claim 24 or the one in line 23-34. For examination purposes, the examiner is treating is as the anchor assembly recited in line 23-24.
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.
Claims 1-8, 11-13, 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wentz US 2016/0270825.
Regarding Claim 1, Wentz discloses a distraction device (Fig 1-3) for subcutaneous attachment to vertebrae for correcting curvature of a spine, comprising:
a housing (#502) that includes a generally hollow interior (Fig 3), the housing extending longitudinally between an opening to the hollow interior at a first end and an opening to the hollow interior at an opposite second end (Fig 1-3 where both ends of the housing are open);
a drive system (Fig 3), comprising:
a drive rod (#518, #528, #542, paragraph 71-72) operatively supported in the hollow interior of the housing (Fig 3) so as to be rotatable (paragraph 75, 76, 78) therein about an axis of rotation (axis #526, Fig 3 paragraph 70), the drive rod including a first member (#528) at a first end of the drive rod (Fig 3) and a second member (#542) at an opposite, second end of the drive rod (Fig 3); and
a drive element (#516) coupled to the drive rod, the drive element being configured to induce rotation of the drive rod about the axis of rotation (paragraph 70-72, 78);
a first extension arm (#558) operatively coupled to the first end of the housing (Fig 1-3), the first extension arm extending between a first end and an opposite second end (Fig 1-3) configured to be movably disposed within the hollow interior of the housing for engagement by the first member of the drive rod (Fig 3, paragraph 74), the first extension arm being configured for attachment to a first vertebrae with a first anchor assembly (Fig 3a, 6a, first anchor assembly coupled via #568, paragraph 74); and
a second extension arm (#588) operatively coupled to the second end of the housing (Fig 1-3), the second extension arm extending between a first end and an opposite second end (Fig 1-3) configured to be moveably disposed within the hollow interior of the housing for engagement by the second member of the drive rod (Fig 3 paragraph 76), the second extension arm being configured for attachment to a second vertebrae with second anchor assembly (Fig 3a, 6a second anchor assembly coupled via rod #596, paragraph 76);
wherein the housing is suspended unattached relative to at least a third vertebrae by attachment of the first extension arm to the first vertebrae and attachment of the second extension arm to the second vertebrae (the examiner notes that this limitation is intended use and that device can be used without using the coupler #577, likewise, paragraph 82 “The housing 502 may be coupled to a third portion of the spinal system, for example, a third vertebra via a third extension member 581 having a rod portion 579 and a base portion 577” where coupler #577 is optional)(in other words, coupler #577 is optional and the housing is capable of being suspended relative to a third vertebrae as claimed); and
wherein rotation of the drive rod causes the first extension arm to move into or out from the opening at the first end of the housing in a first movement direction and the second extension arm to move into or out from the opening at the second end of the housing in a second movement direction to vary a length of the distraction device (paragraph 75-76).
Regarding Claim 2, Wentz discloses the first extension arm moves linearly in the first movement direction (paragraph 75-76), and the second extension arm moves linearly in the second movement direction (paragraph 75-76).
Regarding Claim 3, Wentz discloses the first movement direction is opposite to the second movement direction (Fig 1-3, paragraph 75-76, the first and second extension arms move outward from the housing in opposite directions).
Regarding Claim 4, Wentz disclose the first member of the drive rod includes at least one external thread (#560) that extends in a clockwise or counterclockwise direction (paragraph 74-75) and the second member of the drive rod includes at least one external thread (#586) that extends in an opposite clockwise or counterclockwise direction (paragraph 74, 76).
Regarding Claim 5, Wentz disclose each second end of the first and the second extension arms includes a threaded socket (socket #574 having threads #576, paragraph 75, and socket #597 having threads #595, Paragraph 76), the threaded socket of the second end of the first extension arm being configured to threadably receive the at least one external thread of the first member of the drive rod and the threaded socket of the second end of the second extension arm being configured to threadably receive the at least one external thread of the second member of the drive rod (as seen in Fig 3, paragraph 75-76).
Regarding Claim 6, Wentz disclose the drive system is configured to receive energy from an external device (energy from external device #180, Figs 4-5), wherein the drive element is configured to receive the conveyed energy to rotate the drive rod in a first rotational direction or an opposite, second rotational direction (paragraph 84).
Regarding Claim 7, Wentz disclose the drive element rotates with the drive rod (paragraph 70, 72, 78, 84).
Regarding Claim 8, Wentz disclose the drive element comprises at least one dipole magnet (#516, paragraph 68).
Regarding Claim 11, Wentz disclose the drive rod includes a body (#518 and/or #520, Fig 3a) arranged axially between the first member and the second member (Fig 3a), the body being configured to receive the drive element (Fig 3a, paragraph 68).
Regarding Claim 12, Wentz disclose the body comprises a cradle (Fig 3a, interior of the body defines a cradle for magnet/drive element #516).
Regarding Claim 13, Wentz disclose wherein the housing includes a pair of annular shoulders within the interior of the housing, the body being arranged between the pair of annular shoulders to limit axial movement of the drive rod relative to the housing (as seen in Fig 3a-c, figs below, where the body is held between the shoulders).
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Regarding Claim 16, Wentz disclose the first and second anchor assemblies each comprises a pedicle screw (one of the pedicle screws #604a-604d, paragraph 85, Fig 6a) with a tulip (#570 or #598, Fig 1-3a) configured to receive the first or second extension arm (Figs 1-3a).
Regarding Claim 17, Wentz disclose the length of the distraction device is configured to span the at least one third vertebrae to which the distraction device is not attached (Fig 6a, where the distraction device has a length to span at least one vertebra and with regards to “not attached” this is treated as an intended use limitation and the distraction device is capable of being used with only two anchor assemblies as discussed above in claim 1).
Regarding Claim 29, Wentz discloses the first member, the second member, and the body of the drive rod comprises a unitary piece (as seen in Fig 3a, where the members and body are rigidly coupled together to make up a unitary piece)(examiner notes that applicant is not claiming monolithic).
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.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wentz US 2016/0270825 in view of Meyer WO 2024/059465.
Wentz discloses the claimed invention as discussed above but does not disclose wherein the at least one dipole magnet is disc-shaped, wherein the drive element comprises at least two dipole magnets arranged in a stack where the polarities of the at least two dipole magnets are diametrically opposite.
Meyer discloses a drive system (Fig 9) comprising a first member (#304), a second member (#302), a drive element (#300) that rotates with the first and second members (paragraph 65), wherein the drive element comprises at least two dipole magnets (#306, #308) that are disc shaped (Fig 9, end of paragraph 79) and arranged in a stack (Fig 9) where the polarities of the at least two dipole magnets are diametrically opposite (paragraph 79, Fig 9), where this configuration allows rate of rotation between of the first and second members to be adjusted (paragraph 81).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the magnet of Wentz to be two disc shaped magnets in view of Meyer above because this allows the rate of rotation of the two magnets to be adjusted. One of ordinary skill in the art can recognize that this would allow the first and second extension arms of Wentz to move at different rates, which would be useful in patients where uniform expansion is not desired.
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Wentz US 2016/0270825 in view of Sharifi US 2019/0328425.
Wentz discloses the claimed invention as discussed above but does not disclose
the second end of the first extension arm includes an annular shoulder configured to abut an annular lip at the opening at first end of the housing to retain the second end of the first extension arm within the housing, and wherein the second end of the second extension arm includes an annular shoulder configured to abut an annular lip at the opening at second end of the housing to retain the second end of the second extension arm within the housing.
Sharifi discloses a distraction device (Fig 6) with a housing (#230), an extension arm (#220), a second end of the extension arm incudes an annular shoulder (#222) to abut an annular lip at an opening of the housing to retain the second end of the extension arm within the housing (see Fig below, paragraph 55 where due to the shoulder being bigger than the annular lip, the second end of the extension arm would be retained within the housing and would not slide off).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Wentz to have the second ends of the extension arms to include an annular shoulder, the openings at the first and second ends of the housing to have an annular lip in view of Sharifi above because this would prevent the first and second extension arms from over translating out of the housing.
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wentz US 2016/0270825 in view of Seme US 2010/0249837.
Wentz discloses the claimed invention as discussed above wherein the first extension arm and the second extension arm each include a neck between the first end and the second end (see fig below), where the neck has a smaller cross section as compared to the second end of their respective extension arm (see Fig below)
where the neck of the first extension arm is configured to be received by the first anchor assembly and the neck of the second extension arm is configured to be received by the second anchor assembly (see Fig below where the neck each receive a portion of the bone anchor assemblies) but does not disclose the neck having a smaller cross-sectional area compared to both the first and second ends.
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Seme discloses an extension arm (Fig 15c) having first and second ends (#286b, #286c, Fig 15c) a neck (where #14a is located along #286a) between the first end and the second end (Fig 15c) that is configured to be received by an anchor assembly (#14a), the neck having a smaller cross-sectional area compared to the first and second ends (Fig 15c) due to the first end including a stop (#286c, paragraph 81-82, where the stop is able to be crimped onto the extension arm after the anchor assembly is coupled to the extension arm), where the stop limits axial sliding of the anchor assembly (paragraph 81) .
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Wentz and have the first end of each extension arm to include a stop at the first end such that the neck has a smaller cross-sectional area compared to the first and second ends in view of Seme above because this helps to limit axial sliding of the anchor assemblies.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wentz US 2016/0270825 in view of Pool US 2013/0338714.
Regarding Claim 18, Wentz discloses a spinal curvature correction system (Fig 1-3), comprising:
at least a first distraction device according to claim 1 (see rejection for claim 1 above) and a second distraction device according to claim 1 (see rejection for claim 1, see also Fig 6 a where the device of claim 1 is applied to three spinal levels, where paragraph 108 discloses that treatment can be applied to six of more levels [“six vertebrae or even more vertebrae, as needed”] and thus there would be another second distraction device of Fig 1-3 [“one or more complete drive system”]),
wherein the first extension arm of the second distraction device is configured for attachment to a fourth vertebrae and the second extension arm of the second distraction device is configured for attachment to a fifth vertebra (as discussed above and in claim 1 where the second distraction device is similar to the first distraction device and is able to extend across additional vertebra, where the first extension arm of the second distraction device can attach to a fourth vertebra via rod #568 and the second extension arm can couple to fifth vertebra via rod #596).
Wentz does not disclose a joint member connected at a first end to either the first or second extension arm of the first distraction device and at an opposite second end to either the first or second extension arm of the second distraction device to connect the first and second distraction devices together in series.
Pool discloses a spinal curvature correction system (Fig 12) comprising first (#707) and second (#708) distraction devices that have the same configuration (paragraph 62) a joint member (#725) connected ends (#713, #715) of the first and second distraction devices to connect the first and second distraction devices together in series (Fig 12), where the joint allows the first and second distraction devices to be set at an angle that matches the current curvature of a patient or a desired curvature of the patient (paragraph 61).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the system of Wentz to include a joint that connects the first and second distraction devices together in series in view of Pool above because the joint member allows the first and second distraction devices to be set at an angle that matches the current curvature of a patient or a desired curvature of the patient. The examiner notes that with the modification and the joint connecting the distraction devices, the joint member would be connected at a first end to either the first or second extension arm of the first distraction device and at an opposite second end to either the first or second extension arm of the second distraction device.
Regarding Claim 19, Wentz as modified discloses wherein the joint member is positioned to bridge over at least one vertebrae to which the first distraction device and the second distraction device is not attached (the examiner notes that applicant is not claiming a method and that the joint member would be capable of performing the claimed function, for example, when the first distraction device to the second distraction device are already extended/expanded, the joint member is capable of placed /bridging over a vertebrae that neither distraction device is attached to).
Regarding Claim 20, Wentz as modified discloses n at least one of the first end of the first extension arm or the second extension arm of the first distraction device includes a socket configured to receive the first end of the joint member for connection thereto (with the modification, the first end of the extension or second extension arm of the first distraction device would include a socket that receives a first/top end of the joint member #725, seen in Fig 13-14, paragraph 61 in Pool), and
wherein at least one of the first end of the first extension arm or the second extension arm of the second distraction device includes a socket configured to receive the second end of the joint member for connection thereto (with the modification, the first end of the extension or second extension arm of the second distraction device would include a socket that receives a second/bottom end of the joint member #725, seen in Fig 13-14, paragraph 61 in Pool).
Regarding Claim 32, Wentz as modified discloses the joint member is positioned to bridge between vertebrae to which the first distraction device and the second distraction device are attached (Fig 12 in Pool, paragraph 61 where since the joint member is positioned between the first and distraction devices, it would bridge between vertebrae to which the first and second distraction devices are attached to) (it is also noted that the joint member is not directly attached to the vertebra).
Claims 18, 21, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Wentz US 2016/0270825 in view of Noordeen US 20130274803.
Regarding Claim 18, Wentz discloses a spinal curvature correction system (Fig 1-3, paragraph 7, treats scoliosis), comprising:
at least a first distraction device according to claim 1 (see rejection for claim 1 above) and a second distraction device according to claim 1 (see rejection for claim 1, see also Fig 6a where the device of claim 1 is applied to three spinal levels, where paragraph 108 discloses that treatment can be applied to six of more levels [“six vertebrae or even more vertebrae, as needed”] and thus there would be another second distraction device of Fig 1-3 [“one or more complete drive system”]),
wherein the first extension arm of the second distraction device is configured for attachment to a fourth vertebrae and the second extension arm of the second distraction device is configured for attachment to a fifth vertebra (as discussed above and in claim 1 where the second distraction device is similar to the first distraction device and is able to extend across additional vertebra, where the first extension arm of the second distraction device can attach to a fourth vertebra via rod #568 and the second extension arm can couple to fifth vertebra via rod #596).
Wentz does not disclose a joint member connected at a first end to either the first or second extension arm of the first distraction device and at an opposite second end to either the first or second extension arm of the second distraction device to connect the first and second distraction devices together in series.
Noordeen discloses a spinal curvature correction system (Fig 9, paragraph 2, treats scoliosis) comprising first (one of the devices #203) and second (another one of the devices #203, Fig 9) distraction devices (paragraph 39, 70, 83, 88, it is noted that the embodiment of Fig 9 is similar to that of Fig 1) that have the same configuration (Fig 9), a joint member (ball and socket joint #215, paragraph 88, Fig 9-10) that connects the ends of the first and second distraction devices to connect the first and second distraction devices together in series (Fig 9), where the joint allows the first and second distraction devices to be set at a desired angle and have the ability to adjust the angle over time to address the spinal deformity being treated to achieve a desired correction (paragraph 21-22, 76, 80, 88).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the system of Wentz to include a joint member that connects the first and second distraction devices together in series in view of Nordeen above because the joint allows the first and second distraction devices to be set at a desired angle and have the ability to adjust the angle over time to address the spinal deformity being treated to achieve a desired correction. The examiner notes that with the modification and the joint connecting the distraction devices, the joint member would be connected at a first end to either the first or second extension arm of the first distraction device and at an opposite second end to either the first or second extension arm of the second distraction device.
Regarding Claim 21, Wentz as modified discloses the joint member is shaped as an elliptical cylinder, including a major axis and a minor axis (with the modification and Fig 9-10, Fig below, paragraph 89 of Nordeen, the joint member includes an elliptical cylinder casing #219)(it is noted that casing #219 is circular in shape, where a circle is a special type of ellipse where the two foci are located at the same point).
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Regarding Claim 22, Wentz as modified discloses the major axis of the joint member is configured to be generally aligned with a frontal plane of a subject and the minor axis is configured to be generally aligned with a sagittal plane of the subject (see Fig in claim 1 above where one is able to manipulate the joint such the major axis can is capable of being aligned with a frontal plane of a subject and the minor axis is capable of aligning with a sagittal plane of the subject)(it is noted that a method of use is not being claimed).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Wentz US 2016/0270825 in view of Noordeen US 20130274803, as applied to claim 22 above, and in further view of Malek US 2005/0113927.
Wentz as modified discloses the claimed invention as discussed above but does not disclose the joint member limits angular deviation between the first distraction device and the second distraction device in the sagittal plane to about 30 degrees angular deviation between the first distraction device and the second distraction device in the frontal plane to about 10 degrees.
Malek discloses a similar joint (Fig 2-3) where the ball (#215) is elongated (Fig 2-3), the joint member limits angular deviation between the ball and socket in the sagittal plane to a certain degree and angular deviation between the ball and socket in the frontal plane to a lesser degree (paragraph 63, where due to the shape of the ball/ellipse and clearance of the socket #210, pivoting in the sagittal plane is greater than in the frontal/lateral plane) in order to provide desired movement between spinal segments (paragraph 47, 63).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Wentz as modified and have the ball shaped as an ellipse (as seen in Fig 2-3 in Malek) and adjust the clearance of the socket in view of Malek above such that the joint member limits angular deviation between the ball and socket in the sagittal plane to a certain degree and angular deviation between the ball and socket in the frontal plane to a lesser degree.
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Wentz as modified to have the joint member limit angular deviation between the first distraction device and the second distraction device in the sagittal plane to about 30 degrees angular deviation between the first distraction device and the second distraction device in the frontal plane to about 10 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Wentz US 2016/0270825 and Noordeen US 20130274803, as applied to claim 18 above, and in further view of Malek US 2005/0113927.
Wentz as modified discloses the claimed invention as discussed above but does not disclose the joint member is formed of a flexible, semi-rigid member.
Malek discloses a joint member (as seen in Fig 1) similar to that of Nordeen that is at least partially formed of a flexible, semi-rigid member in the form of a spring (where ref 112 is pointing to in fig 1, see also paragraph 61) in order to provide dampening in translational, flexion, extension or lateral bending motions (paragraph 61).
It would have been obvious to one having ordinary skill in the art a time before the effective filing date of the claimed invention to modify Wentz as modified and include a spring in view of Malek, such that the joint member is at least partially formed of a flexible, semi-rigid member, in order to provide dampening in translational, flexion, extension or lateral bending motions.
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wentz US 2016/0270825.
Regarding Claim 24, Wentz discloses a method for correcting a curvature in a spine, comprising:
providing a distraction device (Fig 1-3), comprising:
a housing (#502) that includes a generally hollow interior (Fig 3), the housing extending longitudinally between an opening to the hollow interior at a first end and an opening to the hollow interior at an opposite second end (Fig 1-3 where both ends of the housing are open);
a drive system (Fig 3), comprising:
a drive rod (#518, #528, #542, paragraph 71-72) operatively supported in the hollow interior of the housing (Fig 3) so as to be rotatable (paragraph 75, 76, 78) therein about an axis of rotation (axis #526, Fig 3 paragraph 70), the drive rod including a first member (#528) at a first end of the drive rod (Fig 3) and a second member (#542) at an opposite, second end of the drive rod (Fig 3); and
a drive element (#526) coupled to the drive rod, the drive element being configured to induce rotation of the drive rod about the axis of rotation (paragraph 70-72, 78); and
a first extension arm (#558) operatively coupled to the first end of the housing (Fig 1-3), the first extension arm extending between a first end and an opposite second end (Fig 1-3) configured to be movably disposed within the hollow interior of the housing for engagement by the first member of the drive rod (Fig 3, paragraph 74), the first extension arm being configured for attachment to a first vertebrae with a first anchor assembly (Fig 3a, 6a, first anchor assembly coupled via #568, paragraph 74); and
a second extension arm (#588) operatively coupled to the second end of the housing (Fig 1-3), the second extension arm extending between a first end and an opposite second end (Fig 1-3) configured to be moveably disposed within the hollow interior of the housing for engagement by the second member of the drive rod (Fig 3 paragraph 76), the second extension arm being configured for attachment to a second vertebrae with a second anchor assembly (Fig 3a, 6a second anchor assembly coupled via rod #596, paragraph 76);
subcutaneously implanting the distraction device by attaching the first extension arm to a first vertebrae with the first anchor assembly (#604a, Fig 6a, paragraph 85) and attaching the second extension arm to a second vertebrae with the second anchor assembly (#604c, Fig 6a and paragraph 9, 85, 109);
suspending the housing of the distraction device so as to be unattached relative to at least a third vertebrae through attachment of the first extension arm to the first vertebrae and attachment of the second extension arm to the second vertebrae (paragraph 82, “The housing 502 may be coupled to a third portion of the spinal system, for example, a third vertebra via a third extension member 581 having a rod portion 579 and a base portion 577” where coupler #577 is optional and thus when base #577 is not used, the housing is suspended over a third vertebrae); and
operating the distraction device by applying energy from an external device (#180, Fig 4-5, paragraph 83) to the drive element of the drive system to rotate the drive rod in a first rotational direction to lengthen the distraction device or an opposite, second rotational direction to shorten the distraction device, to thereby selectively vary a length of the distraction device to obtain a desired spinal curve (paragraph 11, 83, 84).
In the alternative, Wentz discloses the claimed invention as discussed above but does not disclose explicitly disclose suspending the housing of the distraction device so as to be unattached relative to at least a third vertebrae through attachment of the first extension arm to the first vertebrae and attachment of the second extension arm to the second vertebrae.
However, Wentz further disclose that base (#577) may be used and is optional (paragraph 82, “The housing 502 may be coupled to a third portion of the spinal system, for example, a third vertebra via a third extension member 581 having a rod portion 579 and a base portion 577” where coupler #577 is optional).
As such, it would have been obvious to one having ordinary skill in the art at a time before the effective filing date to modify the method of Wentz and not use the base (#577) such that “suspending” step as discussed above is performed since Wentz discloses that the base (#577) may be optionally used and thus not required.
Claims 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wentz US 2016/0270825 in view of Lai CN 107198560 (see English Translation attached).
Wentz discloses the claimed invention as discussed above where the method treats scoliosis (paragraph 7), where implanting the distraction device comprises implanting the device on a concave portion of the curvature or on a convex portion of the curvature of the spine (Fig 6a paragraph 85 where the distraction device can be planted on either the left or right side of the spine, this placed in either the convex or concave portion of the spinal curvature of a patient with scoliosis), where the drive rod is rotated to provide a desired length for the distraction device (paragraph 11, 83-84) but does not disclose:
when on the convex portion, operating the distraction device to rotate the drive rod in the first rotational direction to shorten the distraction device; or
when on the concave portion, operating the distraction device to rotate the drive rod in the first rotational direction to lengthen the distraction device.
Lai discloses distraction devices positioned bilaterally on the spine to treat scoliosis (as seen in Fig 7d, bottom of page 1) such that one distraction device (left #1 and #2) is positioned on the convex portion of the curvature of the spine and the other distraction device (right #1 and #2) is positioned on the concave portion of the curvature (Fig 7d), wherein:
when on the convex portion, operating the distraction device to shorten the distraction device (as indicated by the arrows pointing toward from each other in Fig 7d, top of page 3, page 10 3rd paragraph); or
when on the concave portion, operating the distraction device to rotate the drive rod in the first rotational direction to lengthen the distraction device (as indicated by the arrows pointing away from each other in Fig 7d, top of page 3),
where this is a known method to treat scoliosis and straighten the spine and reduce correction time (page 10 3rd paragraph).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the method of Wentz to have the rotate the drive rod (in the second or first rotational direction) to shorten or lengthen the distraction device when the distraction device is placed on the convex or concave portion of the curvature respectively, in order to treat scoliosis and straighten the spine and reduce correction time in view of Lai above.
Claims 27-28, 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Wentz US 2016/0270825 in view of Pool US 2013/0338714.
Regarding Claim 27, Wentz discloses further comprising:
providing a second distraction device (see also Fig 6a where the distraction device of claim 24 is applied to three spinal levels, where paragraph 108 discloses that treatment can be applied to six of more levels [“six vertebrae or even more vertebrae, as needed”] and thus there would be another second distraction device of Fig 1-3 [“one or more complete drive system”])(examiner notes that since the second distraction device would be the same as what is shown in Fig 1-3, reference will be made to Fig 1-3 and would share features with the distraction device of claim 24), comprising:
a housing (#502) that includes a generally hollow interior (Fig 3), the housing extending longitudinally between an opening to the hollow interior at a first end and an opening to the hollow interior at an opposite second end (Fig 1-3 where both ends of the housing are open);
a drive system (Fig 3), comprising:
a drive rod (#518, #528, #542, paragraph 71-72) operatively supported in the hollow interior of the housing (Fig 3) so as to be rotatable (paragraph 75, 76, 78) therein about an axis of rotation (axis #526, Fig 3 paragraph 70), the drive rod including a first member (#528) at a first end of the drive rod (Fig 3) and a second member (#542) at an opposite, second end of the drive rod (Fig 3); and
a drive element (#526) coupled to the drive rod, the drive element being configured to induce rotation of the drive rod about the axis of rotation (paragraph 70-72, 78); and
a first extension arm (#558) operatively coupled to the first end of the housing (Fig 1-3), the first extension arm extending between a first end and an opposite second end (Fig 1-3) configured to be movably disposed within the hollow interior of the housing for engagement by the first member of the drive rod (Fig 3, paragraph 74), the first extension arm being configured for attachment to a fourth vertebrae with a first anchor assembly (Fig 6a, paragraph 108 where the second distraction device would be placed above or below the distraction device of claim 24 and thus the first extension arm would be attached to a fourth vertebra via an anchor #604a or #604c similar to the distraction device of claim 24); and
a second extension arm (#588) operatively coupled to the second end of the housing (Fig 1-3), the second extension arm extending between a first end and an opposite second end (Fig 1-3) configured to be moveably disposed within the hollow interior of the housing for engagement by the second member of the drive rod (Fig 3 paragraph 76), the second extension arm being configured for attachment to a fifth vertebrae with a second anchor assembly (Fig 6a, paragraph 108 where the second distraction device would be placed above or below the distraction device of claim 24 and thus the first extension arm would be attached to a fifth vertebra via an anchor #604a or #60c similar to the distraction device of claim 24);
subcutaneously implanting the second distraction device by attaching the first extension arm to the fourth vertebrae with the first anchor assembly and attaching the second extension arm to the fifth vertebrae with the second anchor assembly (Fig 6a, paragraph 108 where the second distraction device would be placed above or below the distraction device of claim 24 and thus the first extension arm would be attached to the third vertebra and the second extension arm would be attached to the third vertebra via an anchor #604a or #604c similar to the distraction device of claim 24); and
operating the second distraction device by applying energy from an external device (#180, Fig 4-5, paragraph 83) to the drive element of the drive system to rotate the drive rod in a first rotational direction to lengthen the second distraction device or an opposite, second rotational direction shorten the second distraction device, to thereby selectively vary a length of the second distraction device to obtain the desired spinal curve (paragraph 11, 83, 84).
Wentz does not disclose coupling the distraction device and the second distraction device together with a joint member, the joint member being connected at a first end to either the first or second extension arm of the distraction device and at an opposite second end to either the first or second extension arm of the second distraction device to connect the distraction device and the second distraction device together in series.
Pool discloses a spinal curvature correction system (Fig 12) comprising first (#707) and second (#708) distraction devices that have the same configuration (paragraph 62) a joint member (#725) connected ends (#713, #715) of the first and second distraction devices to connect the first and second distraction devices together in series (Fig 12), where the joint allows the first and second distraction devices to be set at an angle that matches the current curvature of a patient or a desired curvature of the patient (paragraph 61).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the system of Wentz to include a joint that connects the first and second distraction devices together in series in view of Pool above because the joint member allows the first and second distraction devices to be set at an angle that matches the current curvature of a patient or a desired curvature of the patient. The examiner notes that with the modification and the joint connecting the distraction devices, the joint member would be connected at a first end to either the first or second extension arm of the first distraction device and at an opposite second end to either the first or second extension arm of the second distraction device.
Regarding Claim 28, Wentz as modified discloses the distraction device and the second distraction device are operated independently of one another (as discussed in claim 27 above, paragraph 108 in Wentz the second distraction device is similar to the distraction device of claim 24 and thus would each have operated independently of each other as each has their own respective drive system).
Regarding Claim 31, Wentz as modified discloses bridging the joint member over at least one vertebra to which the distraction device is not attached (Fig 12 in Pool, paragraph 61 where the ends #717 and #919 are attached to the vertebra and the joint is bridged over a vertebra to which the distraction device is not attached to and with the modification, the joint member would also span/bridge over a vertebra that it is not attached to)(it is also noted that the joint member is not directly attached to the vertebra).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773