DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/19/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 13, 19 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. New rejections were made in view of Garcia US 2020/0194946 which has a hook with a spiral shape (#12, Fig 2, paragraph 40 and discussed further below).
Examiner notes that it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Garcia is reasonably pertinent to the particular problem with which the inventor was concerned. One of the purposes for spiral shape of the hook is that the hook needs to be manipulated in order to be placed or removed onto an object, as opposed to just placing it or removing it from the object, thus providing the hook to be “more securely fastened” to the object (paragraph 59 in the current specification). Garcia is also concerned with a similar problem, as opposed to regular hooks, the spiral shaped hook of Garcia enables the attachment of an object by means of the progressive pressing, due to a reduction in diameter from the initial entry diameter to the final diameter, where an object located in the hook may be moved gradually to the point where the desired pressure and grip is obtained (paragraph 40). Just like the current invention, the hook and/or object to be coupled to are manipulated in order to couple the two together.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “locking mechanism” in claim 1, 13, “first/second locking mechanism” in claim 19.
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 § 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 1, 4-5, 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Schlapfer US 5,312,402 in view of Garcia US 2020/0194946 and Brault US 5,170,662.
Regarding Claim 1, Schlapfer discloses a hook anchor (Fig 8) for anchoring a fixation rod to a bone, comprising:
a hook body (#75) shaped in a curve (Fig 8) and is configured to be removably coupled to the bone (Fig 8, able to be hooked onto and out of bone, Col 5 lines 30-40), and
a locking mechanism (#73, which is threaded, Col 5 lines 35-40) coupled to the hook body (Fig 8), the locking mechanism being configured to securely fix the hook anchor to the fixation rod (“rod” Col 5 lines 35-40).
Regarding Claim 4, Schlapfer discloses the locking mechanism is removably coupled to the hook body (Col 5 lines 35-40, removed by unthreading).
Regarding Claim 5, Schlapfer discloses the locking mechanism is coupled to the hook body by a threaded connection (Col 5 lines 35-40, threaded connection).
Regarding Claim 11-12, Schlapfer discloses the hook body is configured to engage a portion of bone that includes at least one of a rib, a pelvis, and a vertebra, the hook body is configured to engage with at least one of a spinous process a transverse process, and a pedicle of the vertebra (Fig 8, Claim 20, the hook can hook onto the vertebra and is able to engage a pedicle, spinous process or a transverse process).
Schlapfer does not disclose the curve rotated by at least 270 degrees and has a shape equivalent to a logarithmic spiral.
Garcia, pertinent to the problem of securing a hook to an object, discloses a hook body (Fig 2) shaped in a curve (#12, Fig 2), the hook body is shaped in a curve of continuous diminishing radius rotated by at least 270 degrees (Fig 2, Fig below paragraph 40 where the curve is a spiral shape where the spiral shape spans at least three of the four quadrants identified below and as such, the curve is rotated by at least 270 degrees), where this shape enables the attachment of an object by means of the progressive pressing, due to a reduction in diameter from the initial entry diameter to the final diameter, where an object located in the hook may be moved gradually to the point where the desired pressure and grip is obtained (paragraph 40). Examiner notes that Garcia already discloses a spiral shape (paragraph 40) and appears to have a shape of a logarithmic spiral due to its increasing diameter (see Fig 2 below paragraph 40) but does not explicitly state that it is a logarithmic spiral.
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Brault, pertinent to the problem of securing a hook to an object, discloses a hook body (Fig 10) shaped in a curve (#273, Fig 10), the curve has a shape equivalent to a logarithmic spiral (Col 5 line 67 – Col 6 lines 6), where this shape allows for absolute locking of the hook and makes it impossible for the hook to become accidentally released without positive action on the hook (Col 5 lines 67 – Col 6 lines 6).
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 curve of Shlapfer to have a shape with a curve of continuous diminishing radius rotated by at least 270 degrees, in view of Garcia above because this shape enables the attachment of an object, such as bone, by means of the progressive pressing, due to a reduction in diameter from the initial entry diameter to the final diameter, where the bone and/or hook may be moved gradually to the point where the desired pressure and grip is obtained.
Further, 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 curve of Shlapfer as modified by Garcia to be a logarithmic spiral in view of Brault above because this shape is already inferred by Garcia and this allows for absolute locking of the hooks and makes it impossible for the hook to become accidentally released without positive action on the hooks. Note that positive action is already required in Garcia due to the progressively increasing diameter of the curve (discussed above, paragraph 40, Fig 2 in Garcia).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Schlapfer US 5,312,402, Garcia US 2020/0194946 and Brault US 5,170,662, as applied to claim 1 above, and in further view of Agarwal US 2016/0058478.
Schlapfer as modified discloses the claimed invention as discussed above but does not disclose wherein at least a portion of an interior surface of the hook body is concave so that a first side ridge is formed along an entire length of a first edge of the interior surface of the hook body and a second side ridge is formed along an entire length of a second edge of the interior surface of the hook body,
wherein the interior surface of the hook body at a first end of the hook body includes a projection extending towards an interior of the hook body.
Agarwal discloses a hook body (Fig 1), wherein at least a portion of an interior surface of the hook body is concave (Fig 1-5) so that a first side ridge (see Fig below) is formed along an entire length of a first edge (see Fig below) of the interior surface of the hook body and a second side ridge (see Fig below) is formed along an entire length of a second edge (see Fig below) of the interior surface of the hook body (see Fig below), the first side ridge runs a length of the interior surface (see Fig below, Fig 1), the second side ridge runs the length of the interior surface (see Fig below, Fig 1) wherein the interior surface of the hook body at a first end of the hook body includes a projection (see Fig below) extending towards an interior of the hook body (see Fig below), the ridges define a groove (#34) for a clamp (#16) that is secured via the projection (paragraph 69, 71, Fig 1-5) so that the clamp will help conform to the shape of the bone the hook is hooked onto to help capture and secure the hook body to the desired bone (paragraph 75).
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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 Schlapfer as modified to include the first and second side ridges, a projection at a first end and a clamp in view of Agarwal above because the ridges define a groove for the clamp (#16) that is secured via the projection so that the clamp will help conform to the shape of the bone the hook is hooked onto to help capture and secure the hook body to the desired bone. The examiner notes that since Schlapfer as modified has the curve as being logarithmic (as taught by Brault), then the first and second side ridges would each extend along a length of the interior surface and be shaped in the logarithmic spiral as well.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Schlapfer US 5,312,402, Garcia US 2020/0194946 and Brault US 5,170,662.
Regarding Claim 7-9, Schlapfer as modified discloses the claimed invention as discussed above but does not disclose a length of the hook body is between 60 millimeters and 70 millimeters, a width of the hook body is between 8 millimeters and 20 millimeters, a thickness of the hook body is between 3 millimeters and 5 millimeters.
However, it would have been an obvious matter of design choice to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Schlapfer as modified and have a length of the hook body be between 60 millimeters and 70 millimeters, a width of the hook body be between 8 millimeters and 20 millimeters, a thickness of the hook body be between 3 millimeters and 5 millimeters, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). MPEP 2144.04 (IV). Furthermore, 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 Schlapfer as modified to have a length of the hook body be between 60 millimeters and 70 millimeters, a width of the hook body be between 8 millimeters and 20 millimeters, a thickness of the hook body be between 3 millimeters and 5 millimeters, 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. MPEP 2144.05
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Schlapfer US 5,312,402, Garcia US 2020/0194946 and Brault US 5,170,662, as applied to claim 1 above, and in further view of Ginsburg US 2003/0187437.
Regarding Claim 7-9, Schlapfer as modified discloses the claimed invention as discussed above but does not disclose a length of the hook body is between 60 millimeters and 70 millimeters, a width of the hook body is between 8 millimeters and 20 millimeters, a thickness of the hook body is between 3 millimeters and 5 millimeters.
Ginsburg discloses a hook body (#10), disclose a length of the hook body can be of any size (paragraph 24 where depending on the patient it would be obvious to have a length of 60-70mm), a width of the hook body is between 8 millimeters and 20 millimeters (end of paragraph 23, width of 2-24 mm), a thickness of the hook body is between 3 millimeters and 5 millimeters (end of paragraph 22, thickness can be 1-30 mm).
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 Schlapfer as modified to have a length of the hook body is between 60 millimeters and 70 millimeters, a width of the hook body is between 8 millimeters and 20 millimeters, a thickness of the hook body is between 3 millimeters and 5 millimeters in view of Ginsburg above because these provide known dimensions for spinal hooks.
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Schlapfer US 5,312,402, Garcia US 2020/0194946 and Brault US 5,170,662, as applied to claim 1 above, and in further view of Ginsburg US 2003/0187437.
Schlapfer as modified discloses the claimed invention as discussed above but does not disclose the hook body includes titanium, titanium alloy, stainless steel, ceramic, and/or a polymer.
Ginsburg discloses a hook body (#10) made from biocompatible materials such as stainless steel or titanium (paragraph 32).
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 Schlapfer as modified and have the hook body made be made from titanium or stainless steel in view of Ginsburg above because these are known type of biologically acceptable materials for hook bodies.
Claims 1, 4-6, are rejected under 35 U.S.C. 103 as being unpatentable over Errico US 5,688,274 in view of Garcia US 2020/0194946 and Brault US 5,170,662.
Regarding Claim 1, Errico discloses a hook anchor (Fig 22) for anchoring a fixation rod to a bone, comprising:
a hook body (#116) shaped in a curve (#115, Fig 22), and
a locking mechanism (threaded member #170, Col 10 lines 25-30) coupled to the hook body (Col 10 lines 25-30), the locking mechanism being configured to securely fix the hook anchor to the fixation rod (“rod” Col 17 lines 55-62).
Regarding Claim 4, Errico discloses the locking mechanism is removably coupled to the hook body (Col 10 lines 25-30, removed by unthreading).
Regarding Claim 6, Errico discloses the hook body includes a plurality of locking mechanism mount points (#120 and #120, Fig 22) and the locking mechanism is configured to be selectively coupled to each locking mechanism mount point of the plurality of locking mechanism mount points (Col 10 lines 25-30, Col 17 lines 55-62 the locking mechanism #170 can be threaded to either points #120, Fig 22).
Errico does not disclose the curve is rotated by at least 270 degrees and has a shape equivalent to a logarithmic spiral.
Garcia, pertinent to the problem of securing a hook to an object, discloses a hook body (Fig 2) shaped in a curve (#12, Fig 2), the hook body is shaped in a curve of continuous diminishing radius rotated by at least 270 degrees (Fig 2, Fig below paragraph 40 where the curve is a spiral shape where the spiral shape spans at least three of the four quadrants identified below and as such, the curve is rotated by at least 270 degrees), where this shape enables the attachment of an object by means of the progressive pressing, due to a reduction in diameter from the initial entry diameter to the final diameter, where an object located in the hook may be moved gradually to the point where the desired pressure and grip is obtained (paragraph 40). Examiner notes that Garcia already discloses a spiral shape (paragraph 40) and appears to have a shape of a logarithmic spiral due to its increasing diameter (see Fig 2 below paragraph 40) but does not explicitly state that it is a logarithmic spiral.
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Brault, pertinent to the problem of securing a hook to an object, discloses a hook body (Fig 10) shaped in a curve (#273, Fig 10), the curve has a shape equivalent to a logarithmic spiral (Col 5 line 67 – Col 6 lines 6), where this shape allows for absolute locking of the hook and makes it impossible for the hook to become accidentally released without positive action on the hook (Col 5 lines 67 – Col 6 lines 6).
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 curve of Errico to have a shape with a curve of continuous diminishing radius rotated by at least 270 degrees, in view of Garcia above because this shape enables the attachment of an object, such as bone, by means of the progressive pressing, due to a reduction in diameter from the initial entry diameter to the final diameter, where the bone and/or hook may be moved gradually to the point where the desired pressure and grip is obtained.
Further, 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 curve of Shlapfer as modified by Garcia to be a logarithmic spiral in view of Brault above because this shape is already inferred by Garcia and this allows for absolute locking of the hooks and makes it impossible for the hook to become accidentally released without positive action on the hooks. Note that positive action is already required in Garcia due to the progressively increasing diameter of the curve (discussed above, paragraph 40, Fig 2 in Garcia).
Claim 13, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Schlapfer US 5,312,402 in view of Garcia US 2020/0194946.
Regarding Claim 13, Schlapfer discloses a hook anchor (Fig 8) comprising:
a hook body (#75, see Fig below), wherein the hook body is configured to engage a portion of bone that includes at least one of a spinous process a transverse process, and a pedicle of a vertebra (Fig 8, Claim 20, the hook can hook onto the vertebra and is able to engage a pedicle, spinous process or a transverse process); and
a locking mechanism (#73 which is threaded, Col 5 lines 35-40) coupled to the hook body (Col 5 lines 35-40), the locking mechanism being configured to securely fix the hook anchor to a fixation rod (“rod” Col 5 lines 35-40).
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Schlapfer does not disclose the hook body is shaped in a curve of continuous diminishing radius rotated by at least 270 degrees.
Garcia, pertinent to the problem of securing a hook to an object, discloses a hook body (Fig 2) shaped in a curve (#12, Fig 2), the hook body is shaped in a curve of continuous diminishing radius rotated by at least 270 degrees (Fig 2, Fig below paragraph 40 where the curve is a spiral shape where the spiral shape spans at least three of the four quadrants identified below and as such, the curve is rotated by at least 270 degrees), where this shape enables the attachment of an object by means of the progressive pressing, due to a reduction in diameter from the initial entry diameter to the final diameter, where an object located in the hook may be moved gradually to the point where the desired pressure and grip is obtained (paragraph 40).
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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 the curve of Shlapfer to have a shape with a curve of continuous diminishing radius rotated by at least 270 degrees, in view of Garcia above because this shape enables the attachment of an object, such as bone, by means of the progressive pressing, due to a reduction in diameter from the initial entry diameter to the final diameter, where the bone and/or hook may be moved gradually to the point where the desired pressure and grip is obtained.
Regarding Claim 16, Schlapfer as modified discloses the locking mechanism (#73 in Schlapfer) is removably coupled to the hook body (Col 5 lines 40-45 in Schlapfer, able to be unthreaded from the book body).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Schlapfer US 5,312,402 and Garcia US 2020/0194946, as applied to claim 13 above, and in further view of Agarwal US 2016/0058478.
Schlapfer discloses the claimed invention as discussed above but does not disclose wherein at least a portion of an interior surface of the hook body is concave so that a first side ridge is formed along an entire length of a first edge of the interior surface of the hook body and a second side ridge is formed along an entire length of a second edge of the interior surface of the hook body and wherein the first side ridge runs a length of the interior surface of the hook body so that the first side ridge is shaped in the curve of diminishing radius and the second side ridge runs the length of the interior surface of the hook body so that the second side ridge is shaped in the curve of diminishing radius,
wherein the interior surface of the hook body at a first end of the hook body includes a projection extending towards an interior of the hook body.
Agarwal discloses a hook body (Fig 1), wherein at least a portion of an interior surface of the hook body is concave (Fig 1-5) so that a first side ridge (see Fig below) is formed along an entire length of a first edge (see Fig below) of the interior surface of the hook body and a second side ridge (see Fig below) is formed along an entire length of a second edge (see Fig below) of the interior surface of the hook body (see Fig below), the first side ridge runs a length of the interior surface (see Fig below, Fig 1), the second side ridge runs the length of the interior surface (see Fig below, Fig 1),
wherein the interior surface of the hook body at a first end of the hook body includes a projection (see Fig below) extending towards an interior of the hook body (see Fig below), the ridges define a groove (#34) for a clamp (#16) that is secured via the projection (paragraph 69, 71, Fig 1-5) so that the clamp will help conform to the shape of the bone the hook is hooked onto to help capture and secure the hook body to the desired bone (paragraph 75).
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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 Schlapfer to include the first and second side ridges, a projection at a first end and a clamp in view of Agarwal above because the ridges define a groove for the clamp (#16) that is secured via the projection so that the clamp will help conform to the shape of the bone the hook is hooked onto to help capture and secure the hook body to the desired bone. The examiner notes that since the curve of Schlapfer already has a diminishing radius (as explained above in claim 13), then the first and second side ridges would each extend along an entire length of the interior surface and be shaped in the diminishing radius as well.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Schlapfer US 5,312,402 and Garcia US 2020/0194946.
Schlapfer as modified discloses the claimed invention as discussed above but does not disclose a length of the hook body is between 60 millimeters and 70 millimeters, a width of the hook body is between 8 millimeters and 20 millimeters, a thickness of the hook body is between 3 millimeters and 5 millimeters.
However, it would have been an obvious matter of design choice to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Schlapfer as modified and have a length of the hook body be between 60 millimeters and 70 millimeters, a width of the hook body be between 8 millimeters and 20 millimeters, a thickness of the hook body be between 3 millimeters and 5 millimeters, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). MPEP 2144.04 (IV). Furthermore, 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 Schlapfer as modified to have a length of the hook body be between 60 millimeters and 70 millimeters, a width of the hook body be between 8 millimeters and 20 millimeters, a thickness of the hook body be between 3 millimeters and 5 millimeters, 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. MPEP 2144.05
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Schlapfer US 5,312,402 and Garcia US 2020/0194946, as applied to claim 13 above, and in further view of Ginsburg US 2003/0187437.
Schlapfer as modified discloses the claimed invention as discussed above but does not disclose a length of the hook body is between 60 millimeters and 70 millimeters, a width of the hook body is between 8 millimeters and 20 millimeters, a thickness of the hook body is between 3 millimeters and 5 millimeters.
Ginsburg discloses a hook body (#10), disclose a length of the hook body can be of any size (paragraph 24 where depending on the patient it would be obvious to have a length of 60-70mm), a width of the hook body is between 8 millimeters and 20 millimeters (end of paragraph 23, width of 2-24 mm), a thickness of the hook body is between 3 millimeters and 5 millimeters (end of paragraph 22, thickness can be 1-30 mm).
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 Schlapfer as modified to have a length of the hook body is between 60 millimeters and 70 millimeters, a width of the hook body is between 8 millimeters and 20 millimeters, a thickness of the hook body is between 3 millimeters and 5 millimeters in view of Ginsburg above because these provide known dimensions for spinal hooks.
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Schlapfer US 5,312,402 and Garcia US 2020/0194946 as applied to claim 13 above, and in further view of Ginsburg US 2003/0187437.
Schlapfer as modified discloses the claimed invention as discussed above but does not disclose the hook body includes titanium, titanium alloy, stainless steel, ceramic, and/or a polymer.
Ginsburg discloses a hook body (#10) made from biocompatible materials such as stainless steel or titanium (paragraph 32).
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 Schlapfer as modified and have the hook body made be made from titanium or stainless steel in view of Ginsburg above because these are known type of biologically acceptable materials for hook bodies.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schlapfer US 5,312,402 in view of Ginsburg US 2003/0187437, Garcia US 2020/0194946 and Brault US 5,170,662.
Regarding Claim 19, Schlapfer discloses a spine stabilization system (Fig 8), comprising:
a fixation rod (#13, Col 5 lines 35-45),
a first hook anchor (Fig 8) including:
a first hook body (#75) shaped in a curve (Fig 8), and
a first locking mechanism (#73, which is threaded, Col 5 lines 35-40) coupled to the first hook body (Fig 8), the first locking mechanism being configured to securely fix the first hook anchor at a first location on the fixation rod (Col 5 lines 35-40).
Schlapfer does not disclose the curve shaped in a first logarithmic spiral rotated by at least 270 degrees, a second hook body shaped in a second logarithmic spiral, and a second locking mechanism coupled to the second hook body, the second locking mechanism being configured to securely fix the second hook anchor to the fixation rod at a second location on the fixation rod.
Ginsburg discloses a similar system (#1, paragraph 31) comprising a fixation rod (#6), first and second hook bodies (#10, paragraph 31, there would be two hooks #10 in the system), first and second locking mechanisms (#8, paragraph 31), the first locking mechanism being configured to securely fix the first hook anchor at a first location on the fixation rod (paragraph 31), the second locking mechanism being configured to securely fix the second hook anchor to the fixation rod at a second location on the fixation rod (paragraph 31, the first and second hook bodies are placed on different levels of the spine and interconnected by the fixation rod), the first and second hook bodies having the same configuration (paragraph 31 as denoted by the first and second hooks sharing the same designation as #10), the second hook body allows the fixation rod to extend across at least two levels of the spine to align and/or fix a desired relationship between adjacent vertebral bodies (paragraph 2, 31).
Garcia, pertinent to the problem of securing a hook to an object, discloses a hook body (Fig 2) shaped in a curve (#12, Fig 2), the hook body is shaped in a curve of continuous diminishing radius rotated by at least 270 degrees (Fig 2, Fig below paragraph 40 where the curve is a spiral shape where the spiral shape spans at least three of the four quadrants identified below and as such, the curve is rotated by at least 270 degrees), where this shape enables the attachment of an object by means of the progressive pressing, due to a reduction in diameter from the initial entry diameter to the final diameter, where an object located in the hook may be moved gradually to the point where the desired pressure and grip is obtained (paragraph 40). Examiner notes that Garcia already discloses a spiral shape (paragraph 40) and appears to have a shape of a logarithmic spiral due to its increasing diameter (see Fig 2 below paragraph 40) but does not explicitly state that it is a logarithmic spiral.
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Brault, pertinent to the problem of securing a hook to an object, discloses a hook body (Fig 10) shaped in a curve (#273, Fig 10), the curve is a logarithmic spiral (Col 5 line 67 – Col 6 lines 6), where this shape allows for absolute locking of the hook and makes it impossible for the hook to become accidentally released without positive action on the hook (Col 5 lines 67 – Col 6 lines 6).
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 Schlapfer to have a second hook anchor having the same configuration as that of the first hook anchor in view of Ginsburg above such that the first and second hook bodies allows the fixation rod to extend across at least two levels of the spine to align and/or fix a desired relationship between adjacent vertebral bodies.
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 curve of Shlapfer to have a shape with a curve of continuous diminishing radius rotated by at least 270 degrees, in view of Garcia above because this shape enables the attachment of an object, such as bone, by means of the progressive pressing, due to a reduction in diameter from the initial entry diameter to the final diameter, where the bone and/or hook may be moved gradually to the point where the desired pressure and grip is obtained.
Further, 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 curve (of the first hook anchor) and second curve (of the second hook anchor as modified by Ginsburg above) of Shlapfer as modified by Garcia to be a logarithmic spiral in view of Brault above because this shape is already inferred by Garcia and this allows for absolute locking of the hooks and makes it impossible for the hook to become accidentally released without positive action on the hooks. Note that positive action is already required in Garcia due to the progressively increasing diameter of the curve (discussed above, paragraph 40, Fig 2 in Garcia).
Regarding Claim 20, Schlapfer as modified discloses the first locking mechanism (#73 in Schlapfer) is removably coupled to the first hook body (Col 5 lines 35-40 in Schlapfer, the first locking mechanism can be unthreaded from the hook body); and
the second locking mechanism (as discussed in the modification above to have a second bone anchor with the same configuration as the first bone anchor, the second locking mechanism would be similar to locking mechanism #73 in Schapfer) is removably coupled to the second hook body (Col 5 lines 35-40 in Schlapfer, the second locking mechanism can be unthreaded from the hook body in similar fashion to the first locking mechanism discussed above).
Conclusion
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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
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