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 .
Specification
The disclosure is objected to because of the following informalities: in paragraph [0037], “The first section (202, 302) may be defined with a diameter (D1)” should instead recite - - The first section (202, 302) may be defined with a diameter (D2) - -, since D1 is referring to the diameter of the second section as discussed in paragraph [0038].
Appropriate correction is required.
Claim Objections
Claims 4, 6, 7, 10 and 13 are objected to because of the following informalities:
In claims 4 and 6, “a aperture” should recite - - an aperture - - to be grammatically correct.
In claim 7, “the first section and the second section is composed of” should recite - - the first section and the second section are composed of” to be grammatically correct.
In claim 10, “the diameter (D1) should recite - - a diameter (D1) - - to properly introduce the term,
In claim 13, “wherein radius of a chamfer” should recite - - wherein a radius of a chamfer - -.
Appropriate correction is required.
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 4 and 6 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 4 recites the limitation “the first imaginary axis…and the second imaginary axis". There is insufficient antecedent basis for this limitation in the claim.
Claims 4 and 6 each recite “each of the plurality of provisions is a slotted aperture with a slot extending inwardly from a circumferential surface of the first section to [an] aperture”. It is unclear if the latter recited aperture is the same aperture as the one recited in “a slotted aperture”, or if it is an additional aperture. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret the aperture as the same, and interpret the language as - - each of the plurality of provisions is a slotted aperture comprising a slot extending inwardly from a circumferential surface of the first section to [an] aperture - -.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 4 and 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hosseini et al (US 2024/0081808).
Hosseini et al discloses the following limitations:
Claim 1. A cortical button (100) surgical fixation, the cortical button comprising: a first section (the area of the button existing between lower surface 107 and upper surface 108, and bound by sides 106a, 106b and ends 105a, 105b; as labeled as ‘T’ in Figs. 1C, 1D) defining a substantially flat head ([0078]); and a second section (portion of rib 140 extending past the first section, labeled as ‘TR’ in Fig. 1E) defining a solid stub, the second section being coaxial to and extending substantially vertically from the first section (Figs. 1C-1E), wherein, the first section being defined with a plurality of provisions (120a, 120b, 121a, 121b), the plurality of provisions extending partially along an outer circumference of the second section and being configured to receive a suture (30) (Figs. 1A, 1B; [0077], [0085]).
Claim 3. The cortical button as claimed in claim 1, wherein each of the plurality of provisions is an aperture (120a, 120b), the aperture is adapted to adjustably accommodate the suture *[0080], [0081], [0085]).
Claim 4. The cortical button as claimed in claim 1, wherein each of the plurality of provisions is a slotted aperture comprising a slot (121a, 121b) extending inwardly from a circumferential surface (outer surface) of the first section to an aperture (120a, 120b) defined about a first imaginary axis (A-A′) and a second imaginary axis (B-B′) (see annotated figures of axis below shown from different views, wherein each axis extends through the center of its respective aperture 120a, 120b).
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Claim 15. A surgical fixation device, the device comprising: a cortical button (100) configured to be ingressed into a tunnel defined in a bone ([0005], [0078]; Fig. 3G, the cortical button comprising: a first section (the area of the button existing between lower surface 107 and upper surface 108, and bound by sides 106a, 106b and ends 105a, 105b; as labeled as ‘T’ in Figs. 1C, 1D) defining a substantially flat head ([0078]); and a second section (portion of rib 140 extending past the first section, labeled as ‘TR’ in Fig. 1E) defining a solid stub, the second section being coaxial to and extending substantially vertically from the first section (Figs. 1C-1E), wherein, the first section being defined with a plurality of provisions (120a, 120b, 121a, 121b), the plurality of provisions extending partially along an outer circumference of the second section (Figs. 1A, 1B; [0077], [0085]); a suture (30) adjustably accommodatable in the plurality of provisions defined in the cortical button and being configured to secure and handle tendons and to apply tension to the graft ([0077], [0079], [0090]).
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al (WO 2022/187614).
Claim 1. Patel et al discloses a cortical button (1600) (Figs. 16A-16D) for surgical fixation, the cortical button comprising: a first section (1610); and a second section (1620) defining a solid stub (Fig. 16D), the second section being coaxial to and extending substantially vertically from the first section ([0078]), wherein, the first section being defined with a plurality of provisions (1615a, 1615b), the plurality of provisions extending partially along an outer circumference (outer surface) of the second section and being configured to receive a suture (1720) (Fig. 17; [0078]).
Patel et al fails to disclose in the embodiment of Figs. 16A-16D that the first section (1610) defines a substantially flat head. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first section of Patel et al to be a substantially flat head since Patel et al incorporates by reference in its entirety PCT/US20/059175 in paragraph [0077] (which is published as WO/2021/101724 to Boileau et al; hereinafter referred to as “Boileau et al”), and discusses the button (1600) may be similar to embodiments of buttons disclosed in Boileau et al. Boileau et al a button (102) having a first section (112) (equivalent of first section of Patel et al) and a second section (118) (equivalent of second section of Patel et al) coaxial to and extending vertically from the first section, wherein the first section defines a substantially flat head (via flat surface 114) (p. 5, ll. 19-29). Therefore, since Patel et al discloses its button 1600 may be similar to the buttons disclosed in Boileau et al, it would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the first section of Patel et al with a flat head as taught by Boileau et al.
Claim 2. Patel et al as modified discloses the invention substantially as claimed above, wherein Patel et al discloses the plurality of provisions is defined about a first imaginary axis (A-A′) and a second imaginary axis (B-B′) extending longitudinally along the outer circumference of the second section, the first imaginary axis (A-A′) and the second imaginary axis (B-B′) is separated by a distance equal to a diameter (D1) of the second section (see Figs. 16C and 16D and annotated Fig. 17 below; wherein axis A-A’ in Fig. 16C is defined as the axis extending through the center of opening 1615a, into and out of the page; axis B-B’ is defined as the axis extending through the center of opening 1615b, into and out of the page. In Figs. 16D and 17, it can be seen these that axes are separated by a distance equal to a diameter (D1) of the second section at the junction of where the second section is joined to the first section)1.
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Claim 3. Patel et al as modified discloses the invention substantially as claimed above, wherein Patel et al discloses each of the plurality of provisions is an aperture (1615a, 1615b), the aperture is adapted to adjustably accommodate the suture (1720) ([0078], [0082]).
Claim 4. Patel et al as modified discloses the invention substantially as claimed above, wherein Patel et al discloses each of the plurality of provisions is a slotted aperture (1615a, 1615b) comprising a slot extending inwardly from a circumferential surface of the first section to an aperture defined about a first imaginary axis (A-A′) and a second imaginary axis (B-B′) (Fig. 16C; [0078]; see annotated figure of claim 2 as well as discussion of axes in claim 2).
Claim 5. Patel et al as modified discloses the invention substantially as claimed above, wherein Patel et al discloses each of the plurality of provisions is an aperture (1615a, 1615b), the aperture is adapted to adjustably accommodate the suture (1720) ([0078]).
Claim 6. Patel et al as modified discloses the invention substantially as claimed above, wherein Patel et al discloses each of the plurality of provisions is a slotted aperture (1615a, 1615b) comprising a slot extending inwardly from a circumferential surface of the first section to a aperture defined about the first imaginary axis (A-A′) and the second imaginary axis (B-B′) (Fig. 16C; [0078]; see annotated figure of claim 2 as well as discussion of axes in claim 2).
Claim 7. Patel et al as modified discloses the invention substantially as claimed above, wherein it would have been further obvious to one of ordinary skill in the art before the effective filing date of the invention for the first section and the second section to be composed of magnetic resonance imaging (MRI) compatible material including polyether-ether-ketone (PEEK) since Patel et al incorporates by reference in its entirety Boileau et al ([0077]) and Boileau et al discloses PEEK as a known biocompatible material for surgical buttons (p. 5, ll. 4-6).
Claims 8-12. Patel et al as modified discloses the invention substantially as claimed above, but fails to disclose the first section is defined with a pre-determined thickness ranging from about 1.2 mm to about 1.7 mm (as per claim 8), the second section is defined with a pre-determined height ranging from about 5.8 mm to about 6.3 mm (as per claim 9), a diameter (D1) of the second section ranges from about 7.1 mm to about 7.9 mm (as per claim 10), a diameter (D2) of the first section ranges from about 15.8 mm to about 16.2 mm (as per claim 11), or a diameter (D3) of the plurality of provisions ranges from about 1.72 mm to about 1.76 mm (as per claim 12). However, Patel et al discloses varying different aspects of the button ([0074]) and that the selection of buttons may vary in thickness ([0114]). Therefore, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Patel et al button to have a thickness, height or diameters within the claimed ranges, as it involves only adjusting the dimension of a component disclosed to allow for adjustment as Patel et al discloses variations in button configurations. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the button of Patel et al to the claimed thickness, height or diameters as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, Applicant has not provided evidence of the criticality of the claimed ranges in the instant specification. In the published specification, Applicant discloses in [0037]: “[t]he first section (202, 302) may be defined with a diameter (D1) ranging from about 15.8 mm to about 16.2 mm” and “[t]he flat head of the first section (202, 302) may be defined with a thickness (t1) ranging from about 1.2 mm to about 1.7 mm. In an implementation”. Applicant discloses in [0038]: “[t]he second section (204, 304) may be defined with a diameter (D1) ranging from about 7.1 mm to about 7.9 mm. Further, the second section (204, 304) may be defined with a height (t2) ranging from about 5.8 mm to about 6.3 mm. Although, the dimensions of the second section (204, 304) is illustrated in the present disclosure, the same should not be construed as a limitation of the present disclosure. The dimension of the second section (204, 304) may vary based on the type of such surgical techniques”. Applicant discloses in [0039]: “[t]he diameter (D3) of the aperture (308) may range from about 1.72 mm to about 1.76 mm.”
However, Applicant has not provided evidence, such as how the claimed numerical ranges have unexpected results in the performance of the cortical button. Instead, Applicant discloses as noted above that these sizes should not be construed as a limitation and instead may change depending on the surgical technique to be used or performed. It is therefore the Examiner's position that one of ordinary skill in the art at the time the invention was made would have known the approximate dimensions and properties of the bone tunnel in the surgical technique and determined the necessary dimensions of the button for anchoring to a cortical bone. Therefore, the claimed ranges are merely ranges discoverable by routine skill in the art and fail to patentably distinct the claimed invention of claims 8-12 from the prior art.
Claim 13. Patel et al as modified discloses the invention substantially as claimed above, wherein it would have been further obvious to one of ordinary skill in the art before the effective filing date of the invention that a circumferential surface of the first section is chamfered, since Patel et al incorporates by reference in its entirety Boileau et al ([0077]), and Boileau et al discloses a circumferential surface of the first section is chamfered (at surface labeled 112 in Fig. 2A and seen more clearly from a side view in Figs. 3C-3E). However, Patel as modified fails to disclose a radius of a chamfer ranges from about 0.2 mm to 0.3 mm. However, Patel et al discloses varying different aspects of the button ([0074]) and that the selection of buttons may vary in thickness ([0114]), therefore indicating the exact dimensions and shapes of the button is not critical.
Therefore, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Patel et al button to have a radius of a chamfer in the claimed range, as it involves only adjusting the dimension of a component disclosed to allow for adjustment as Patel et al discloses variations in button configurations. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the button of Patel et al to the claimed range of a radius of a chamfer as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, Applicant has not provided evidence of the criticality of the claimed range in the instant specification. In the published specification, Applicant discloses in [0037]: “[t]he radius of the chamfered circumferential surface of the first section (202, 302) ranges from about 0.2 mm to about 0.3 mm.” However, Applicant has not provided evidence, such as how the claimed range has unexpected results in the performance of the cortical button. It is therefore the Examiner's position that one of ordinary skill in the art at the time the invention was made would have known the approximate dimensions and properties of the bone tunnel in the surgical technique and determined the necessary dimensions of the radius of chamfer of the button for anchoring to a cortical bone. Therefore, the claimed range is merely a range discoverable by routine skill in the art and fails to patentably distinct the claimed invention of claim 13 from the prior art.
Claim 14. Patel et al as modified discloses the invention substantially as claimed above, including the first section is defined with a cavity (1614) defined at a substantially central portion (Figs. 16A-16C) but fails to disclose the cavity extends up to a depth ranging from about 1.8 mm to about 2.2 mm. Instead, Patel et al simply discloses the cavity as being “slightly recessed” ([0078]) and discloses varying different aspects of the button ([0074]). Therefore, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Patel et al button to have a depth of the cavity in the claimed range, as it involves only adjusting the dimension of a component disclosed to allow for adjustment as Patel et al discloses variations in button configurations. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the button of Patel et al to the claimed range of a depth a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, Applicant has not provided evidence of the criticality of the claimed range in the instant specification. In the published specification, Applicant discloses in [0038]: “[t]he cavity (206, 306) may extend up to a depth ranging from about 1.8 mm to about 2.2 mm from the surface of the first section (202, 302).” However, Applicant has not provided evidence, such as how the claimed range has unexpected results in the performance of the cortical button. It is therefore the Examiner's position that one of ordinary skill in the art at the time the invention was made would have known the approximate dimensions and properties of the bone tunnel in the surgical technique and the suture required for repair and determined the necessary dimensions of the depth of the cavity of the button for anchoring to a cortical bone. Therefore, the claimed range is merely a range discoverable by routine skill in the art and fails to patentably distinct the claimed invention of claim 14 from the prior art.
Claim 15. A surgical fixation device (Fig. 17), the device comprising: a cortical button (Figs. 16A-16D) configured to be ingressed into a tunnel defined in a bone (Fig. 21F), the cortical button comprising: a first section (1610); and a second section (1620) defining a solid stub (Fig. 16D), the second section being coaxial to and extending substantially vertically from the first section ([0078]), wherein, the first section being defined with a plurality of provisions (1615a, 1615b), the plurality of provisions extending partially along an outer circumference (outer surface) of the second section and being configured to receive a suture (1720) (Fig. 17; [0078]); a suture (1720) adjustably accommodatable in the plurality of provisions defined in the cortical button and being configured to secure and handle tendons and to apply tension to the graft ([0077]-[0082]).
Patel et al fails to disclose in the embodiment of Figs. 16A-16D that the first section (1610) defines a substantially flat head. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first section of Patel et al to be a substantially flat head since Patel et al incorporates by reference in its entirety PCT/US20/059175 in paragraph [0077] (which is published as WO/2021/101724 to Boileau et al; hereinafter referred to as “Boileau et al”), and discusses the button (1600) may be similar to embodiments of buttons disclosed in Boileau et al. Boileau et al a button (102) having a first section (112) (equivalent of first section of Patel et al) and a second section (118) (equivalent of second section of Patel et al) coaxial to and extending vertically from the first section, wherein the first section defines a substantially flat head (via flat surface 114) (p. 5, ll. 19-29). Therefore, since Patel et al discloses its button 1600 may be similar to the buttons disclosed in Boileau et al, it would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the first section of Patel et al with a flat head as taught by Boileau et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE SHI/Primary Examiner, Art Unit 3771
1 It is noted that though Applicant discloses in [0039[ of its published application that the first imaginary axis (A-A′) and the second imaginary axis (B-B′) is separated by a distance equal to a diameter (D1) of the second section, Fig. 3 of the instant application shows D1 being a diameter of the second section inside a cutout of the first section. D1 extends from the center of left provision 208a to the center of right provision 208a. As seen in Fig. 2, the center of these provisions is a cutout into the second section. Therefore, for examination purposes, this same interpretation will be applied to the prior art.