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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
The amendment filed 04/08/2026 has been entered. Claims 1-7, 9, 11-16, 18-19, 23-28, and 30 remain pending in the application. Claims 17, 20-22, and 29 have been cancelled.
Response to Arguments
Applicant's arguments filed 04/08/2026 have been fully considered but they are not persuasive.
The Examiner retains the previous argument of disagreement of Applicant’s claim that all of the figures are the same embodiment and representative of the same method, and therefore, collectively, teach against the Application. Applicant’s assertion on page 11 that “the suture may be attached to the proximal femur or distal tibia bone first but is then attached to the other bone second… as it is evident through the use of reference numeral 12 in Figures 2A-3B” is respectfully disagreed upon. There is no clear statement by the reference saying that the embodiment 1C involves the suture being connected to both bones. In paragraph [0055] the reference states that the scaffold is connected to the anchor by the suture, and that the anchor may be attached to EITHER the tibia OR the femur. The reference goes on to say a [0057] staple may be used to hold the suture in position, the staple being in the femur. Applicants continual assertion that all of the figures are the same embodiment, as they are all Murray’s method, is also disagreed upon. The Examiner agrees that all the figures are representative of the method of Murray, but within those figures are different embodiments or “examples” of how said method could manifest. For example, paragraph [0061] denotes that aspects of the invention provide methods (not a singular method, but multiple methods) of repairing a ruptured ligament involve drilling of hole at or near a repair site, “a bone” being a femur and/OR a tibia (the “and” meaning one embodiment could include a connection to the tibia and femur, and the “or” meaning another embodiment could include a suture connection to only the femur or only the tibia). The reference later goes on to explain multiple embodiments of this drilling, one being to drill a hole in the femur (paragraph [0063], and “another example” being drilled in the tibia.
For clarity, as the previous arguments are still relevant and build upon the first paragraph of arguments of the office action, the Examiner will include them in the current arguments. As explained in the previous final rejection, advisory action, and non-final rejection Figure 1C shows suture 12 attached to ACL 2, and further illustrates the embodiment in which it is attached to the femur bone (4) and not the tibia bone (6) (see also [0055] further describing anchor 8 can be attached to either the tibia bone or the femur bone). Therefore, Murray discloses an embodiment in which the suture is not connected to the tibia, as seen in Fig. 1C. Regarding the argument that Figures 1A-1C do not represent the full method, the Examiner disagrees. There is no basis to conclude that this is not a “full method”. Figures 1A-1C describe a method of connecting an anchor to a bone with a scaffold and sutures, whilst Figure 4D illustrates another embodiment. The assertion by the Applicant that since Figure 3 of Murray shows a tibia connection and since the specification discloses that this tibial connection is a “distal fixation,” therefore “presupposing” that there is a proximal fixation already in place at the opposite end, making it mean that the embodiments of Figure 1C and Figure 3 then “come together” in Figures 4B and 4D, is additionally respectfully disagreed upon by the Examiner. Figure 3 is a different embodiment than Fig. 1C, not an additional method step. Figure 4D is also a different embodiment than Fig. 1C, and not an additional method step. Furthermore, paragraph [0055] states “a suture 12 may be attached to one or both ends of a ruptured ligament by its first end and/or its second end 18….the anchor 8 may be attached to either the tibia bone 6 or the femur bone 4 to secure the scaffold in position.” Additionally, paragraph [0064] states “another example is depicted in Fig. 3A,” illustrating that Figure 3 is another embodiment, not an additional method step or completion to the method of Figures 1A-1C. Additionally, Fig. 3B illustrates anchor 8 in tibia bone 6 which is the alternate placement of the anchor in the tibia bone, as described in paragraph [0055]. Finally, paragraph [0024] describes Fig. 4 illustrating an embodiment treating an ACL with only sutures, no anchors, therefore proving against the assertion that Figure 4B and 4D are the combination of all of the disclosed Figures 1-3, as Figures 1-3 disclose methods of connecting an anchor to a bone. Therefore, as asserted previously Figures 4B and 4D are not illustrating the completion of the method of Fig. 1C, but instead alternate embodiments to the method illustrated in Fig. 1C. The claim that “these two attachments (Figure 1 and Figure 3) come to together in Figure 4B” is not explicitly said in the reference and therefore has no basis. It is clear these are alternate embodiments of a method of repairing an ACL. Additionally, applicant's presumption that because the specification says Figure 3 shows a "distal fixation" means that there must be a "proximal" fixation does not have sufficient evidence to hold the claim that all Figures are the same embodiment. The reference is clearly using “distal” and “proximal” to describe the bones related to the center of the person’s body, the femur being proximal and the tibia being distal. A “distal connection” just means a connection distal, or situated away from the center of the body, not that it would need a corresponding “proximal” connection. The term “distal” means “situated away from a central point especially of the body” (see Merriam Webster online definition 1 for distal). As Applicant states in page 10 of the Arguments, Murray and directed to “methods and devices for the repair of a ruptured ligament”. A different embodiment of a method does not represent the “collective” of the reference. The embodiment of Figures 1A-1C read on the claims as asserted by the rejections below.
Regarding the argument that Woo teaches away from the Instant Application, as it shows a tibial connection, and therefore Woo is not able to be used in rejecting the endocortical button/endobutton limitation, the Examiner respectfully disagrees. In response to applicant's arguments against the references individually, specifically Woo, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Since the claims rely on the combination of Murray and Woo, Murray having a method that involves fixation to only the femur and Woo bringing in only to show that an endobutton is well known in the art to be used as an anchor to connect suture to a bone, the combination references read on the claims.
The only modification that Woo is making to Murray is using the endocortical button/endobutton as an anchor, as opposed to another type of anchor. The modification is merely a substitution of two types of anchors, in which, as described in the final office action, the endocortical button anchor enables the suture to pass through an entire femoral bone tunnel and onto the endobutton to secure the suture to the ruptured ligament and bone as taught by Woo (see paragraph [0050]). Additionally, in Woo, the endocortical button/endobutton is used to anchor the femur to the ligament (see Figure 12 in Final Office action), not the tibia. The method of Woo also showing another end of the ligament connected to the tibia by another suture and another anchoring means does not mean that the Examiner is saying that that component of Woo should be added to Murray.
Similarly, the argument that Woo teaches away from the Instant Application, as it shows a tibial connection, and therefore US 2020 is not able to be used in rejecting the notchplasty limitation, the Examiner respectfully disagrees. US 2020 is a secondary reference. A secondary reference does not need to disclose all of the components of the independent claim to bring in a teaching. In response to applicant's arguments against the references individually, specifically US 2020, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Since the claims rely on the combination of Murray and US 2020, Murray having a method that involves fixation to only the femur and US 2020 bringing in only to show that performing a notchplasty is well known in the art, the combination references read on the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7, 9, 11-16, 18-19, 23-28, and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitations "performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch to provide space for a larger ligament to form after repairing the ligament using the scaffold" and "wherein threading the suture through the scaffold and advancing the scaffold along
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 1-7, 9, 11-16, 18-19, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Murray US 20090306776 A1 (--hereafter-- Murray), in view of US 20160000554 A1 (hereafter --Woo--), and further in view of Myers US 20100249930 A1 (hereafter-- Myers--).
Regarding Claim 1, Murray discloses a method for repairing an anterior cruciate ligament, the method comprising (see paragraph [0004]): drilling a hole in a femur (4; see Figure 1C below and paragraph [0058]); connecting a suture (12) to the femur using a fixation device (see paragraph [0055], anchor 8 mentioned is the fixation device); connecting the suture to a ruptured end of the ligament (see paragraph [0055]); threading a scaffold (14) onto the suture (see paragraph [0055]); and positioning the scaffold along the suture between the femur and the ruptured end of the ligament (see paragraph [0055] and Figure 1C below), wherein the method does not comprise connecting the suture to a tibia (see tibia 6 in Figure 1C below), and wherein positioning the scaffold along the suture comprises positioning the scaffold between the femur and the ruptured end of the ligament without passing the suture through a tibial tunnel or securing the suture to a tibial cortex (see scaffold and tibia in Figure 6C below).
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Furthermore, Murray discloses the method of claim 1, wherein the first device is an anchor (see paragraph [0047] and first device 8 in Figure 1C below).
Murray fails to disclose wherein the first device comprises an endobutton or an extracortical button alone, or in combination with, an anchor, as well as fails to disclose performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch to provide space for a larger ligament to form after repairing the anterior cruciate ligament using the scaffold; wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament.
Woo discloses a method for repairing an anterior cruciate ligament, the method comprising (see paragraph [0004]): drilling a hole in a femur (see paragraph [0050]); connecting a suture (32) to the femur using a fixation device (see fixation device 35 in Figure 12 below); connecting the suture to a ruptured end of the ligament (see suture 32 connected to the ligament in Figure 12 below). Woo teaches wherein the first device comprises an endobutton (see paragraph [0050], see also annotated fixation device that is an endobutton in Figure 12 below).
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Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the first device be an endobutton, as taught by Woo, as by doing so would enable the suture to pass through an entire femoral bone tunnel and onto the endobutton to secure the suture to the ruptured ligament and bone as taught by Woo (see paragraph [0050]).
Murray as modified further fails to disclose performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch to provide space for a larger ligament to form after repairing the anterior cruciate ligament using the scaffold; wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament.
Myers discloses a method to fix an injured ACL with implanting a compressible and biodegradable scaffold, (see paragraph [0032]), and forming a femoral tunnel at a point on a femur near a femoral ACL footprint (see paragraph [0030]), and comprising introducing a blood composition to the scaffold (see paragraph [0037]). Myers teaches performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch, wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament (ACL repair) (see paragraph [0023]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the method of Murray to further include performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch, wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament (ACL repair), as taught by Myers, as by doing so would prevent the impingement of the PCL during the surgery, loss of eventual knee flexion, eventual stretching, and failure of tissue in the future (see paragraph [0023] of Myers).
The intended use limitation “to provide space for a larger ligament to form after repairing the anterior cruciate ligament using the scaffold” has been considered but deemed not to impose any structural difference between the claimed invention and Murray as modified by Myers method. Since the method of Murray modified by Myers includes enlarging an intercondylar notch of the femur prior to the ACL repair surgery (see paragraph [0023]), it would provide the purpose of providing space for larger ligament to form after repairing the ACL using the scaffold, as the space within the notch would be larger.
Regarding Claim 2, Murray as modified discloses the method of claim 1, further comprising attaching the first device only indirectly to the scaffold (see paragraph [0050]).
Regarding Claim 3, Murray as modified discloses the method of claim 1, wherein the scaffold comprises a porous collagen sponge (see paragraph [0044] and [0045]).
Regarding Claim 4, Murray as modified discloses the method of claim 1, further comprising treating the scaffold with a repair material (see paragraph [0065]).
Regarding Claim 5, Murray as modified discloses the method of claim 4, wherein the repair material is a platelet or plasma (see paragraph [0065]).
Regarding Claim 6, Murray as modified discloses the method of claim 1, wherein the fixation device is bioabsorbable (see paragraph [0014] and [0051]).
Regarding Claim 7, Murray as modified discloses the method of claim 1, wherein the suture is bioabsorbable (see paragraph [0015]).
Regarding Claim 9, Murray discloses a method for repairing an anterior cruciate ligament exposed to synovial fluid, comprising (see paragraph [0032]): threading a suture (12) though a fixation device (see paragraph [0055], anchor 8 mentioned is the fixation device, and see also Figure 1C below), the fixation device attached to a femur (4) and positioned on the femur (see paragraph [0055]) to resist load directed through the synovial fluid; threading the suture through a scaffold (14; see paragraph [0055]); and connecting the suture to a ruptured end of the ligament (see paragraph [0055]), wherein the method does not comprise connecting the suture to a tibia (see tibia 6 in Figure 1C below), and wherein positioning the scaffold along the suture comprises positioning the scaffold between the femur and the ruptured end of the ligament without passing the suture through a tibial tunnel or securing the suture to a tibial cortex (see scaffold and tibia in Figure 6C below).
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Murray fails to disclose wherein the fixation device comprises an endobutton or an extracortical button, as well as fails to disclose performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch to provide space for a larger ligament to form after repairing the anterior cruciate ligament using the scaffold; wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament.
Woo discloses a method for repairing an anterior cruciate ligament, the method comprising (see paragraph [0004]): drilling a hole in a femur (see paragraph [0050]); connecting a suture (32) to the femur using a fixation device (see fixation device 35 in Figure 12 above); connecting the suture to a ruptured end of the ligament (see suture 32 connected to the ligament in Figure 12 above). Woo teaches wherein the first device comprises an endobutton (see paragraph [0050], see also annotated fixation device that is an endobutton in Figure 12 above).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the first device be an endobutton, as taught by Woo, as by doing so would enable the suture to pass through an entire femoral bone tunnel and onto the endobutton to secure the suture to the ruptured ligament and bone as taught by Woo (see paragraph [0050]).
Murray as modified further fails to disclose performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch to provide space for a larger ligament to form after repairing the anterior cruciate ligament using the scaffold; wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament.
Myers discloses a method to fix an injured ACL with implanting a compressible and biodegradable scaffold, (see paragraph [0032]), and forming a femoral tunnel at a point on a femur near a femoral ACL footprint (see paragraph [0030]), and comprising introducing a blood composition to the scaffold (see paragraph [0037]). Myers teaches performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch, wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament (ACL repair) (see paragraph [0023]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the method of Murray to further include performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch, wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament (ACL repair), as taught by Myers, as by doing so would prevent the impingement of the PCL during the surgery, loss of eventual knee flexion, eventual stretching, and failure of tissue in the future (see paragraph [0023] of Myers).
The intended use limitation “to provide space for a larger ligament to form after repairing the anterior cruciate ligament using the scaffold” has been considered but deemed not to impose any structural difference between the claimed invention and Murray as modified by Myers method. Since the method of Murray modified by Myers includes enlarging an intercondylar notch of the femur prior to the ACL repair surgery (see paragraph [0023]), it would provide the purpose of providing space for larger ligament to form after repairing the ACL using the scaffold, as the space within the notch would be larger.
Regarding Claim 11, Murray as modified discloses the method of claim 9, further comprising positioning the scaffold between the ruptured end of the ligament and the femur (see paragraph [0007] and [0062]).
Regarding Claim 12, Murray as modified discloses the method of claim 9, wherein the scaffold comprises a porous collagen sponge (see paragraph [0044] and [0045]).
Regarding Claim 13, Murray as modified discloses the method of claim 9, further comprising treating the scaffold with a repair material (see paragraph [0065]).
Regarding Claim 14, Murray as modified discloses the method of claim 13, wherein the repair material is a platelet or plasma (see paragraph [0065]).
Regarding Claim 15, Murray discloses a method for repairing a tear of an anterior cruciate ligament (ACL), comprising: contacting a torn tibial stump of the ACL with a scaffold (14; see paragraphs [0060] or [0062]), wherein the torn tibial stump has a tibial stump length that is less than 75% but greater than 5% of a total length of the ACL (see Figure 1A below, illustrating a torn tibial stump that appears to be less than 75% but greater than 5% of the total ACL length); securing the torn tibial stump of the ACL to a suture (12; see paragraph [0055] and Figure 1C below or see paragraph [0062]); fixing the suture to a femur (4) (see paragraph [0055] and Figure 1C below, or see paragraphs [0062] and [0063], where the “bone” is the femur); passing the suture along the scaffold (see paragraph [0055] and Figure 1C below, or see paragraph [0062]); sliding the scaffold along the suture towards an intercondylar notch between the femur and a torn femoral stump of the ACL (see paragraph [0085] and Figure 1C below, or see paragraph [0085], see also paragraph [0062] mentioning the scaffold that is on the suture can be attached to one end of the torn ligament, or both); and pulling the torn tibial stump of the ACL to contact the scaffold (see paragraph [0055] explaining the suture connection with the “distal ACL” and Figure 1C below, or see paragraph [0062] mentioning the scaffold that is on the suture can be attached to one end of the torn ligament, or both, using one or more sutures), wherein the method does not comprise connecting the suture to a tibia (see tibia 6 in Figure 1C below), and wherein positioning the scaffold along the suture comprises positioning the scaffold between the femur and the ruptured end of the ligament without passing the suture through a tibial tunnel or securing the suture to a tibial cortex (see scaffold and tibia in Figure 6C below).
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Murray fails to disclose wherein the fixation device comprises an endobutton or an extracortical button, as well as fails to disclose performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch to provide space for a larger ligament to form after repairing the anterior cruciate ligament using the scaffold; wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament.
Woo discloses a method for repairing an anterior cruciate ligament, the method comprising (see paragraph [0004]): drilling a hole in a femur (see paragraph [0050]); connecting a suture (32) to the femur using a fixation device (see fixation device 35 in Figure 12 above); connecting the suture to a ruptured end of the ligament (see suture 32 connected to the ligament in Figure 12 above). Woo teaches wherein the first device comprises an endobutton (see paragraph [0050], see also annotated fixation device that is an endobutton in Figure 12 above).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the first device be an endobutton, as taught by Woo, as by doing so would enable the suture to pass through an entire femoral bone tunnel and onto the endobutton to secure the suture to the ruptured ligament and bone as taught by Woo (see paragraph [0050]).
Murray as modified further fails to disclose performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch to provide space for a larger ligament to form after repairing the anterior cruciate ligament using the scaffold; wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament.
Myers discloses a method to fix an injured ACL with implanting a compressible and biodegradable scaffold, (see paragraph [0032]), and forming a femoral tunnel at a point on a femur near a femoral ACL footprint (see paragraph [0030]), and comprising introducing a blood composition to the scaffold (see paragraph [0037]). Myers teaches performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch, wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament (ACL repair) (see paragraph [0023]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the method of Murray to further include performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch, wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament (ACL repair), as taught by Myers, as by doing so would prevent the impingement of the PCL during the surgery, loss of eventual knee flexion, eventual stretching, and failure of tissue in the future (see paragraph [0023] of Myers).
The intended use limitation “to provide space for a larger ligament to form after repairing the anterior cruciate ligament using the scaffold” has been considered but deemed not to impose any structural difference between the claimed invention and Murray as modified by Myers method. Since the method of Murray modified by Myers includes enlarging an intercondylar notch of the femur prior to the ACL repair surgery (see paragraph [0023]), it would provide the purpose of providing space for larger ligament to form after repairing the ACL using the scaffold, as the space within the notch would be larger.
Regarding Claim 16, Murray as modified discloses the method of claim 15, further comprising introducing a blood composition to the scaffold prior to sliding the scaffold along the suture (see paragraphs [0065] and [0066]).
Regarding Claim 18, Murray as modified discloses the method of claim 15, wherein contacting the torn portions of the ACL with a compressible and biodegradable scaffold further comprises (see paragraph [0016]): forming a femoral tunnel (20) at a point on a femur near a femoral ACL footprint (see paragraphs [0062]-[0063] and Figure 2B above); securing the torn tibial stump of the ACL to a first end of the suture (see paragraph [0062]); passing a second end of the suture through the femoral tunnel (see paragraph [0062]); and passing a second end of the suture through the scaffold and then through the torn tibial stump (see paragraph [0062]).
Regarding Claim 19, Murray as modified discloses the method of claim 18, further comprising sliding the scaffold along the suture towards a back of an intercondylar notch to contact the torn tibial stump of the ACL (see paragraph [0108] saying the anchor is placed at the back of the notch, the distal ACL is threaded with sutures, then a presoaked scaffold is threaded onto the sutures and up into the notch).
Regarding Claim 28, Murray as modified discloses the method of claim 1, wherein the ligament comprises a femoral stump and a tibial stump (see annotated femoral and tibial stump in Figure 1C below), wherein a length of the tibial stump is less than about 75% of a length of the ligament and greater than 5% the length of the ligament (see Figure 1A below, illustrating a torn tibial stump that appears to be less than 75% but greater than 5% of the total ACL length).
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Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Murray US 20090306776 A1 (--hereafter-- Murray), in view of US 20160000554 A1 (hereafter --Woo--), in further view of Myers US 20100249930 A1 (hereafter-- Myers--), as applied to claim 1 above, in view of US 20200171203 A1 (hereafter –US 2020--).
Regarding Claim 30, Murray as modified discloses the method of claim 1.
Murray as modified fails to disclose wherein the notchplasty results in a larger cross-sectional area of the ligament.
US 2020 discloses a method of repairing a torn ACL (see Abstract). US 2020 teaches further comprising performing a notchplasty of an intercondylar notch of the femur (see paragraph [0035]), the notchplasty resulting in a larger cross-sectional area of the ligament (see paragraph [0035]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the method of Murray to further performing a notchplasty of an intercondylar notch of the femur, the notchplasty resulting in a larger cross-sectional area of the ligament, as taught by US 2020, as by doing so would can help make a stronger repaired ACL and has been found by the inventors to be beneficial in ACL repair using a scaffold (see paragraph [0035] of US 2020).
Claims 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Murray US 20090306776 A1 (--hereafter-- Murray), in view of Myers US 20100249930 A1 (hereafter-- Myers--), in even further view of US 20200171203 A1 (hereafter –US 2020--).
Regarding Claim 23, Murray discloses a method for repairing an anterior cruciate ligament, the method comprising (see paragraph [0004]): drilling a hole in a femur (4; see Figure 1C below and paragraph [0058]); connecting a suture (12) to the femur using a fixation device (see paragraph [0055], anchor 8 mentioned is the fixation device); connecting the suture to a ruptured end of the ligament (see paragraph [0055]); threading a scaffold (14) onto the suture (see paragraph [0055]); and positioning the scaffold along the suture between the femur and the ruptured end of the ligament (see paragraph [0055] and Figure 1C below), wherein the method does not comprise connecting the suture to a tibia (see tibia 6 in Figure 1C below), and wherein positioning the scaffold along the suture comprises positioning the scaffold between the femur and the ruptured end of the ligament without passing the suture through a tibial tunnel or securing the suture to a tibial cortex (see scaffold and tibia in Figure 6C below).
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Murray fails to disclose connecting the suture to a ruptured end of the ligament with a whip-stitch, as well as fails to disclose performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch to provide space for a larger ligament to form after repairing the anterior cruciate ligament using the scaffold; wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament.
US 2020 discloses a method of repairing a torn ACL (see Abstract). US 2020 teaches connecting the suture to a ruptured end of the ligament with a whip-stitch (see paragraph [0058]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the suture of Murray be connected to the ligament with a whip stitch, as taught by US 2020, as by doing so would merely involve the substitution of one known means of connection between a suture and a ligament (Kessler stitch, as taught by Murray in paragraph [0108]) for another known means of connection between a suture and a ligament (whip stitch, as taught by US 2020), since the substitution of the sewing technique used to connect the suture to the ligament (the whip stitch) shown in US 2020 would have yielded predictable results, namely, a secure connection between the suture and the ruptured end of the ligament.
Murray as modified further fails to disclose performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch to provide space for a larger ligament to form after repairing the anterior cruciate ligament using the scaffold; wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament.
Myers discloses a method to fix an injured ACL with implanting a compressible and biodegradable scaffold, (see paragraph [0032]), and forming a femoral tunnel at a point on a femur near a femoral ACL footprint (see paragraph [0030]), and comprising introducing a blood composition to the scaffold (see paragraph [0037]). Myers teaches performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch, wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament (ACL repair) (see paragraph [0023]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the method of Murray to further include performing a notchplasty of an intercondylar notch of the femur and enlarging the intercondylar notch, wherein performing the notchplasty is prior to connecting the suture to the ruptured end of the ligament (ACL repair), as taught by Myers, as by doing so would prevent the impingement of the PCL during the surgery, loss of eventual knee flexion, eventual stretching, and failure of tissue in the future (see paragraph [0023] of Myers).
The intended use limitation “to provide space for a larger ligament to form after repairing the anterior cruciate ligament using the scaffold” has been considered but deemed not to impose any structural difference between the claimed invention and Murray as modified by Myers method. Since the method of Murray modified by Myers includes enlarging an intercondylar notch of the femur prior to the ACL repair surgery (see paragraph [0023]), it would provide the purpose of providing space for larger ligament to form after repairing the ACL using the scaffold, as the space within the notch would be larger.
Regarding Claim 24, Murray as modified discloses the method of claim 23, wherein the scaffold comprises a porous collagen sponge (see paragraph [0044] and [0045]).
Regarding Claim 25, Murray as modified discloses the method of claim 23, further comprising treating the scaffold with a repair material (see paragraph [0065]).
Regarding Claim 26, Murray as modified discloses the method of claim 23, wherein the repair material is a platelet or plasma (see paragraph [0065]).
Regarding Claim 27, Murray as modified discloses the method of claim 23, further comprising introducing a blood composition to the scaffold prior to positioning the scaffold along the suture (see paragraphs [0065] and [0066]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20190117375 A1: This reference discloses the use of an endobutton as a fixation dev
US 20150039030 A1: This reference discloses an ACL repair method that comprises connecting an anchor, scaffold, and sutures to a ruptured ACL and to only a femur and not a tibia.
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.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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