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 .
Formal Matters
Claims 3-5, 7, 9-11, 13-15, 26-36, and 38 are cancelled. Claims 1, 2, 8, 12, and 37 are currently amended. New claims 39-44 are added. Claims 1, 2, 6, 8, 12, 16-25, 37, and 39-44 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9 April 2026 has been considered by the examiner. A signed copy is attached.
Objections/Rejections Withdrawn
The rejection of claims 2-5 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by Balboa et al., US 20200245997 (6 August 2020), is withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant argues that Balboa does not teach or suggest a “widened shaft portion” (Remarks, p. 8). Applicant argues that while Balboa teaches a proximal portion 11b, it is not described as being widened relative to any other shaft portion (Remarks, p. 8). Applicant argues that Balboa does not teach that the widened shaft portion “tightly fits” within the inner surface of the cannulated screw (Remarks, p. 8). Applicant argues the degree of fit as “suggesting a sliding fit, not a tight fit” referencing ¶29 (Remarks, p. 8). Applicant argues that Balboa teaches that the anchor body is held in position by a mechanical stop (protrusion 11e) and bone thread, not by a tight fit with the tip (Remarks, p. 8). Applicant argues that the phrase “tightly fits” is not a design preference, but serves a functional purpose (Remarks, p. 9). Applicant argues that Balboa does not teach the recited limitations, some of which are incorporated from now-cancelled claims 3, 4, and 7 (Remarks, pp. 9-10).
Applicant argues that the examiner has conflated axial movement (pull-out) with rotational movement (swiveling) (Remarks, p. 10). Applicant’s arguments have been fully considered, but they are not persuasive. No conflation was made or is apparent as a matter of basic mechanical motion in a cartesian space. Applicant’s reiteration of the amendments to claim 1 (Remarks, p. 10) are noted.
Applicant argues that the design of Balboa is “completely different from that of the presently claimed invention” (Remarks, p. 10). Applicant argues that Balboa’s anchor body 13 has eternal threads 13a that screw into bone. Applicant argues that these bone threads hold the anchor body in position (Remarks, p. 10). Applicant argues that protrusion 11e prevents over0insertion and that the tip doesn’t need to be rotationally locked to the anchor body because the anchor body is independently secured by its bone threads (Remarks, p. 10).
Applicant argues that there is no discussion of friction between the anchor body and tip, tight fit for preventing rotation, rotational locking mechanisms, or prevention of relative rotation (Remarks, p. 10). Applicant argues that Balboa’s teaching that the anchor body “may be advanced over” the proximal portion (¶26) is inconsistent with a tight engagement that would prevent swiveling (Remarks, p. 10). Applicant argues that the examiner has not explained how Balboa’s teaching of easy axial advancement is consistent with prevention of rotational movement (Remarks, p. 11). Applicant argues that by contrast, prevention of rotational movement is specifically recited in claim 1 (Remarks, p. 11). Applicant points out claim amendments in the Remarks, pp. 11-12.
Regarding the rejection under 35 USC 103 over Balboa in view of McDevitt, Applicant traverses. None of claims 20-25 are amended. However, claim 6 is dependent on claim 1, which has been amended. Applicant argues that Balboa does not teach the amended claims and McDevitt does not cure the deficiencies of Balboa. Regarding claims 20-25 Applicant argues that McDevitt teaches threaded engagement for a different purpose (connecting two threaded components) while the presently claimed invention uses teeth specifically to prevent swiveling in a pound-in tip design where the tip is not primarily threaded into bone (Remarks, p. 13). Applicant argues that the examiner has not established why a PHOSITA would apply McDevitt’s threaded coupling design to Balboa’s pound-in tip system. Applicant argues that this would result in an inoperative device as the structural requirements of each taught device are mutually incompatible.
Applicant argues that Balboa’s system requires smooth cavity walls in the anchor body to allow sliding advancement over the widened shaft portion (¶26). McDevitt’s system requires internal threads inside the proximal main member (¶54, FIG 12). Applicant argues that if a PHOSITA were to add McDevitt’s internal threads to Balboa’s anchor body cavity, in the resultant construction the anchor body cannot “be advanced over (side over” the widened shaft portion (Remarks, p. 13). Applicant argues that the resulting construction of adding McDevitt’s external threads to Balboa’s widened shaft portion the system cannot function because the threaded widened shaft portion cannot slide through the smooth anchor body cavity. Protrusion 11e would prevent the anchor body from being threaded on, as it isn’t possible to screw past a larger-diameter mechanical stop (Remarks, p. 13).
Applicant argues the rejection of claims 8, 12, and 16-19 under 35 USC 103 as being unpatentable over Balboa in view of Preiss-Bloom for the reasons that the claims depend from amended claim 1 (Remarks, p. 14).
Applicant argues that the new claims are novel and non-obvious over Balboa, McDevitt, and Preiss-Bloom for the reasons set forth in the Remarks (Remarks, p. 14).
Applicant’s arguments have been fully considered, but are not persuasive.
As an initial concern, several of Applicant’s amendments introduce new matter that does not have originally filed support. The examiner has full considered that mere rephrasing of a passage does not constitute new matter (MPEP 2163.07). However, introducing new limitations that are not supported in the originally filed disclosure, claims, or drawings constitutes new matter. The examiner has provided a detailed explanation of the amendments containing new matter features in the rejection, below. For the purposes of compact prosecution and to the extent that the prior art teaches the amendments, even though they are also new matter, the modified prior art rejections are set forth below addressing the amendments.
Modified rejections and new rejections, necessitated by Applicant’s amendments, are provided below.
Regarding the rejections over claims 20-25, which were not amended, are maintained for the reasons of record and the reasons set forth herein. In response to applicant's arguments against the references individually (Remarks, pp. 12-13), 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). Regarding the arguments against McDevitt, the features of McDevitt do not have to be made for the same purpose as Applicant. In response to applicant's argument that McDevitt teaches threaded engagement for a different purpose (connecting two threaded components), the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant’s attention is drawn to the fact that none of claims 20-25 require any particular type of joining mechanism. In this regard, Applicant is arguing inoperability related to limitations that are not claimed. Claim 20 recites that proviso that “such that when they are engaged the tip component is not swivelable with respect to the canulated screw.” As explained of record, McDevitt teaches a fastening system (5) where tip component (FIG 9, distal tip member 160; ¶152 ) further comprises one or more tip teeth (threads) disposed circumferentially around the shaft (threaded projection 170); the cannulated screw (FIG 12, proximal main member 165) further comprises one or more screw teeth that are arranged circumferentially within the lumen (counter thread bore 175), and the tip teeth and the screw teeth are configured to engage each other (¶53), such that when they are engaged the cannulated screw is not swivelable with respect to the tip component (¶54). Because Balboa teaches the same type of cannulated bone screw assembly without the teeth, a person of ordinary skill in the art, seeking to attach a fastener body to a fastener tip would reasonably consult McDevitt’s fastener system so as to form a complete fastener body. McDevitt’s fastener system can be incorporated alongside Balboa’s cannulated screw assembly (same tip location and interaction with the advancing fastener) using known assembly methods without redesigning Balboa’s core cannulated screw assembly. Because the references address the same engineering problem (deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an engagement feature between the proximal main member as a counter thread bore and the threaded projection of the tip to the existing cannulated bone screw assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. The key concerns addressed by the reasoning of the examiner were that these devices are fasteners and that the “widened shaft portion” of concern is an engagement feature of the instant application. It is also an engagement feature of Balboa and McDevitt. The means of engagement differs, but the engagement feature is still able to connect the tip to the shaft such that when the two components are engaged, the cannulated screw is not swivelable with respect to the tip component. McDevitt expressly teaches “whereby the two elements may be secured to one another so as to form the complete expandable body 100.”
The “widened shaft portion” is also not expressly recited in claims 20-23. It only appears in claims 24 and 25 of this claim grouping, but was previously indicated as structure 11b of Balboa in the Office Action mailed 12/18/2025 at p. 4. The examiner also cited to FIG 9 and ¶53 of McDevitt where proximally-extending threaded projection 170 is a widened shaft portion.
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Annotated FIG 1 of Balboa, showing widened shaft portion 11b; FIG 1 of the application showing widened shaft portion 42; FIG 9 of McDevitt, showing widened shaft portion 170.
Applicant’s arguments states that combination of Balboa and McDevitt would result in an inoperable device. This is not supported by the evidence. Rather, Applicant’s argument to this effect appears to take the position of a half-and-half mechanism of combining a piece from Balboa, such as a tip, with the shaft of McDevitt, and vice versa. This half-and-half combination would not make any mechanical sense.
Applicant also argues that the differences in the mechanistic connections of a linear sliding mechanism taught by Balboa for joining the shaft to the tip are incompatible with the screw mechanism taught by McDevitt. Applicant may have overlooked that both modalities permit the advancement of a component cannulated screw system to join a tip to a shaft. This is a fastening mechanism for an engagement feature of the device. In this case, both joining or fastening mechanisms functions are the same and are therefore combinatorial as obvious substitutes. Both systems, whether linear translational sliding mechanisms or screw mechanisms, join the tip and the shaft into one unit that is not swivelable when connected. One of ordinary skill in the art would be well versed in the ability to join component parts by different engagement features and would have a reasonable expectation of success that multiple fastening/joining mechanisms would be among a finite group of options that one could select from depending on the particular anatomical placement of a cannulated screw and any requirements for the force pull-out strength needed in the particular application for the specific anatomical location. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Accordingly, the rejection is maintained.
Objections/Rejections Maintained
Claim Rejections - 35 USC § 103
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.
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 20-25 remain rejected under 35 U.S.C. 103 as being unpatentable over Balboa et al., US 20200245997 (6 August 2020) in view of McDevitt et al., US 20020115999 (22 August 2002), for the reasons of record and the reasons set forth herein.
Regarding independent claim 20, Balboa teaches apparatus for securing a suture to a bone (FIG 1), the apparatus comprising:
a non-swivel suture anchor (anchor assembly 10), comprising:
a tip component (anchor tip 11) configured to be advanced into a hole within the bone (bone hole 32), the tip component (11) comprising:
a widened end portion (distal portion 11a) that defines an eyelet (hole 11d; ¶6) that is configured to receive the suture (suture 30; FIG 5);
a shaft that projects axially from the widened end portion (proximal end of tip 11); and
a cannulated screw (anchor body 13) configured to secure the tip component (11) within the hole (32) within the bone (34), the cannulated screw (13) defining a lumen therethrough (anchor body cavity 13c),
the tip component further comprises one or more tip (11) teeth (“barbs (not shown)” ¶24) disposed circumferentially around the shaft (¶24).
Balboa does not teach the cannulated screw further comprising one or more screw teeth that are arranged circumferentially within the lumen, and the tip teeth and the screw teeth are configured to engage each other, such that when they are engaged the cannulated screw is not swivelable with respect to the tip component.
McDevitt teaches a fastening system (5) where tip component (FIG 9, distal tip member 160; ¶152 ) further comprises one or more tip teeth (threads) disposed circumferentially around the shaft (threaded projection 170); the cannulated screw (FIG 12, proximal main member 165) further comprises one or more screw teeth that are arranged circumferentially within the lumen (counter thread bore 175), and the tip teeth and the screw teeth are configured to engage each other (¶53), such that when they are engaged the cannulated screw is not swivelable with respect to the tip component (¶54).
Balboa and McDevitt teach in the same field of endeavor, cannulated anchor screw assemblies for bone and tissue repair. Although Balboa discloses the claimed base anchor assembly (tip component, widened end portion, eyelet, shaft, cannulated screw defining a lumen), Balboa does not disclose that the tip component further comprises one or more tip teeth disposed circumferentially around the shaft; the cannulated screw further comprises one or more screw teeth that are arranged circumferentially within the lumen, and the tip teeth and the screw teeth are configured to engage each other. McDevitt teaches a fastening system (5) where tip component (FIG 9, distal tip member 160; ¶152 ) further comprises one or more tip teeth (threads) disposed circumferentially around the shaft (threaded projection 170); the cannulated screw (FIG 12, proximal main member 165) further comprises one or more screw teeth that are arranged circumferentially within the lumen (counter thread bore 175), and the tip teeth and the screw teeth are configured to engage each other (¶53), such that when they are engaged the cannulated screw is not swivelable with respect to the tip component (¶54). Because Balboa teaches the same type of cannulated bone screw assembly without the teeth, a person of ordinary skill in the art, seeking to attach a fastener body to a fastener tip would reasonably consult McDevitt’s fastener system so as to form a complete fastener body. McDevitt’s fastener system can be incorporated alongside Balboa’s cannulated screw assembly (same tip location and interaction with the advancing fastener) using known assembly methods without redesigning Balboa’s core cannulated screw assembly. Because the references address the same engineering problem (deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an engagement feature between the proximal main member as a counter thread bore and the threaded projection of the tip) to the existing cannulated bone screw assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 21, Balboa modified by McDevitt teaches the apparatus according to claim 20, as set forth above.
McDevitt teaches wherein the tip teeth (threaded projection 170) and screw teeth (counter thread bore 175) have ramped surfaces that are configured to engage each other (McDevitt: ¶53).
Regarding claim 22, Balboa modified by McDevitt teaches the apparatus according to claim 20, as set forth above.
McDevitt teaches wherein the tip component comprises between 2 and 10 teeth (FIG 9, 170; ¶54) and the cannulated screw comprises between 2 and 10 teeth (FIG 12, 175; ¶54).
Regarding claim 23, Balboa modified by McDevitt teaches the apparatus according to claim 22, as set forth above.
McDevitt teaches wherein the tip component comprises between 2 and 6 teeth (FIG 9, 170; ¶54) and the cannulated screw comprises between 2 and 6 teeth (FIG 12, 175; ¶54).
Regarding claim 24, Balboa modified by McDevitt teaches the apparatus according to claim 20, as set forth above.
McDevitt teaches wherein the shaft (FIG 9; ¶53) of the tip component (FIG 9; ¶53) defines a widened shaft portion proximate to the widened end portion (FIG 9; ¶53), the widened shaft portion being narrower than the widened end portion and being wider than a remainder of the shaft (FIG 9; ¶53), and the lumen of the cannulated screw (FIG 12; ¶54) is sized such that as the cannulated screw is advanced over the widened shaft portion, an inner surface of the cannulated screw engages the widened shaft portion (FIG 12; ¶54). Balboa also teaches the widened shaft portion at FIG 1, 11b, as set forth of record and in the annotated figures above. This widened shaft portion is comparable to the applications element 42 of FIG 1 and to element 170 of McDevitt, as explained in (FIG 9, 170; ¶53) as set forth of record.
Regarding claim 25, Balboa modified by McDevitt teaches the apparatus according to claim 24, as set forth above.
McDevitt teaches wherein the tip teeth are disposed circumferentially around the widened shaft portion teeth (FIG 9, 170; ¶53).
Modified Rejections – Necessitated by Amendment
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 37, and 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balboa et al., US 20200245997 (6 August 2020).
Regarding claim 1, teaches apparatus for securing a suture to a bone (FIG 1), the apparatus comprising:
a non-swivel suture anchor (anchor assembly 10), comprising:
a tip component (anchor tip 11) configured to be advanced into a hole (bone hole 32) within the bone (bone 34), the tip component (FIG 1, 11) comprising: a distal portion having a pointed distal end for penetrating bone (¶24, “a distal end 11f of the tip 11 may be pointed, for creation of a bone hole”)
a proximal portion extending proximally from the distal portion (FIG 1, tip 11, plug 12);
a widened end portion (protrusion 11e) at a distal region of the distal portion (FIG 1, 11), the widened end portion (11e) defining an eyelet (first region, 11g; hole 11d; ¶6) that is configured to receive the suture (suture 30; FIG 5) wherein the eyelet extends through the widened end portion transversely (FIG 1, 11d; FIG 7A-B);
a shaft that projects axially from the widened end portion (proximal end of tip 11) toward the proximal portion (FIG 1, 11), the shaft defining a widened shaft portion (proximal portion 11b) proximate to the widened end portion (FIG 1),
the widened shaft portion (11b) being wider than a remainder of the shaft and being narrower than the widened end portion (FIG 1; ¶26);
wherein the widened shaft portion is configured to center the tip component (FIG 6, dotted lines showing 11b) and prevent the tip component from swiveling once a cannulated screw is advanced over the widened shaft portion (11b) (FIG 6; ¶29); and
a cannulated screw (anchor body 13) configured to secure the tip component (11) within the hole (32) within the bone (34), the cannulated screw (13) defining a lumen therethrough (anchor body cavity 13c) that is sized such that as the cannulated screw (13) is advanced over the widened shaft portion (11b), an inner surface of the cannulated screw (13) engages the widened shaft portion (11b) (¶26);
wherein the widened shaft portion is sized such that when the cannulated screw is advanced over the widened shaft portion (11b) (FIGs 1, 6), the widened shaft portion tightly fits within the inner surface of the cannulated screw (FIGs 1, 6) such that the tip component is unable to swivel with respect to the canulated screw (FIG 6; ¶29).
Regarding claim 37, Balboa teaches a method (claim 11) comprising: securing a suture to a bone (claim 11), using the non-swivel suture anchor (10; claim 11) of claim 1, by:
creating a hole in the bone (claim 11);
inserting the suture into an eyelet of a tip component of the non-swivel suture anchor (claim 11);
advancing the tip component into the hole (claim 11),
the tip (11) component including:
a widened end portion (11a) that defines the eyelet (11d), and
a shaft that projects axially from the widened end portion (proximal end of tip 11),
the shaft (proximal end of tip 11) defining a widened shaft portion (11b) proximate to the widened end portion (FIG 1),
the widened shaft portion (11b) being wider a remainder of the shaft and being narrower than the widened end portion (FIG 1; ¶26); and
securing the tip component within the hole by advancing a cannulated screw over the shaft of the tip component (claim 11),
the cannulated screw (13) defining a lumen therethrough (anchor body cavity 13c) that is sized such that as the cannulated screw (13) is advanced over the widened shaft portion (11b), the inner surface of the cannulated screw (13) engages the widened shaft portion (11b) (¶26).
Regarding new claim 43, Balboa teaches the apparatus according to claim 1, as set forth above. Balboa teaches wherein the tip component (11) is configured to be more securely anchored within the cannulated screw (cavity 13c) due to the inner surface of the cannulated screw engaging the widened shaft portion (¶26), relative to if the tip component did not define the widened shaft portion, and wherein:
the widened shaft portion (11b) is configured to support engagement features (11b) (FIGs 1, 6), thereon that interact with corresponding features of the inner surface of the cannulated screw (FIGs 1, 6) to enhance retention of the tip component within the cannulated screw (FIG 6; ¶¶26, 29).
Because the Patent Office does not have the facilities to determine whether the tip component of claim 1 or Balboa has the requisite pull-out strength due to the widened shaft portion relative to if the tip component did not define the widened shaft portion, the burden is on the application to show a novel and unobvious difference between the claimed tip component and that of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
Claim Rejections - 35 USC § 103
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.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Balboa et al., US 20200245997 (6 August 2020).
Regarding claim 2, Balboa teaches the apparatus according to claim 1, as set forth above.
Balboa teaches wherein the tip component (11) is configured to be more securely anchored within the cannulated screw (cavity 13c) due to the inner surface of the cannulated screw engaging the widened shaft portion (¶26), relative to if the tip component did not define the widened shaft portion, and wherein: the widened shaft portion (11b) defines a circumferential engagement surface configured for engagement (11b) with the inner surface of the cannulated screw around a full circumference of the widened shaft portion (FIGs 1, 6), such that engagement forces are distributed circumferentially to resist both axial pull-out forces and rotational forces applied to the tip component (FIG 6; ¶¶26, 29).
It is best understood, based on the rejections set forth under 112(a), that the components of Balboa would be capable of resisting the forces set forth. See In re Hutchison, 69 USPQ 138, 33 CCPA 879 (1946).
Because the Patent Office does not have the facilities to determine whether the tip component of claim 1 or Balboa has the requisite engagement forces distributed circumferentially to resist both axial pull-out forces and rotational forces applied to the tip component, due to the widened shaft portion relative to if the tip component did not define the widened shaft portion, the burden is on the application to show a novel and unobvious difference between the claimed tip component and that of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Balboa et al., US 20200245997 (6 August 2020) in view of McDevitt et al., US 20020115999 (22 August 2002).
Regarding claim 6, Balboa teaches the apparatus according to claim 1, as set forth above.
Balboa teaches that the tip component further comprises one or more tip (11) teeth (“barbs (not shown)” ¶24) disposed circumferentially around the shaft (¶24);
Balboa does not teach the cannulated screw further comprising one or more screw teeth that are arranged circumferentially within the lumen, and the tip teeth and the screw teeth are configured to engage each other, such that when they are engaged the cannulated screw is not swivelable with respect to the tip component.
McDevitt teaches a fastening system (5) where tip component (FIG 9, distal tip member 160; ¶152 ) further comprises one or more tip teeth (threads) disposed circumferentially around the shaft (threaded projection 170); the cannulated screw (FIG 12, proximal main member 165) further comprises one or more screw teeth that are arranged circumferentially within the lumen (counter thread bore 175), and the tip teeth and the screw teeth are configured to engage each other (¶53), such that when they are engaged the cannulated screw is not swivelable with respect to the tip component (¶54).
Balboa and McDevitt teach in the same field of endeavor, cannulated anchor screw assemblies for bone and tissue repair. Although Balboa discloses the claimed base anchor assembly (tip component, widened end portion, eyelet, shaft, cannulated screw defining a lumen), Balboa does not disclose that the tip component further comprises one or more tip teeth disposed circumferentially around the shaft; the cannulated screw further comprises one or more screw teeth that are arranged circumferentially within the lumen, and the tip teeth and the screw teeth are configured to engage each other. McDevitt teaches a fastening system (5) where tip component (FIG 9, distal tip member 160; ¶152 ) further comprises one or more tip teeth (threads) disposed circumferentially around the shaft (threaded projection 170); the cannulated screw (FIG 12, proximal main member 165) further comprises one or more screw teeth that are arranged circumferentially within the lumen (counter thread bore 175), and the tip teeth and the screw teeth are configured to engage each other (¶53), such that when they are engaged the cannulated screw is not swivelable with respect to the tip component (¶54). Because Balboa teaches the same type of cannulated bone screw assembly without the teeth, a person of ordinary skill in the art, seeking to attach a fastener body to a fastener tip would reasonably consult McDevitt’s fastener system so as to form a complete fastener body. McDevitt’s fastener system can be incorporated alongside Balboa’s cannulated screw assembly (same tip location and interaction with the advancing fastener) using known assembly methods without redesigning Balboa’s core cannulated screw assembly. Because the references address the same engineering problem (deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an engagement feature between the proximal main member as a counter thread bore and the threaded projection of the tip) to the existing cannulated bone screw assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 8, 12, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Balboa et al., US 20200245997 (6 August 2020) in view of McDevitt et al., US 20020115999 (22 August 2002), and further in view of Preiss-Bloom et al., WO 2019049062 A1 (14 March 2019) (all previously cited of record).
Regarding claim 8, Balboa modified by McDevitt teaches the apparatus according to claim 1, as set forth above.
Balboa modified by McDevitt does not teach wherein a difference between a diameter of the widened shaft portion and a diameter defined by the inner surface of the cannulated screw is less than 0.5mm, 0.4mm, 0.2mm or 0.1mm.
Preiss-Bloom teaches cannulated bone anchors where the hollow section in the middle of a cannulated screw is generally larger than 1mm diameter and the external screw diameter can be as small as 0.5 or 1.0mm, but is generally less than 3.0mm for smaller bone fixation (p. 32, first paragraph). Preiss-Bloom also teaches that the implant comprises cannulation and the cannulation is in a diameter range of 0.5-3.5mm and optionally the cannulation is in a range of 0.85- 1.7mm (p. 12, lines 13-14). See also, FIG 2A. The mathematical difference between a diameter of the widened shaft portion and a diameter defined by the inner surface of the cannulated screw, given the express disclosure of Preiss-Bloom meets and overlaps the cited ranges of less than 0.5mm, for example where the cannulated screw middle hollow section is 0.5-3.5mm and the external screw diameter is in a range of 0.5mm or 1.0mm or less than 3.0mm.
Balboa, McDevitt, and Preiss-Bloom teach in the same field of endeavor, cannulated anchor screw assemblies for bone and tissue repair. Although Balboa discloses the claimed base anchor assembly (tip component, widened end portion, eyelet, shaft, cannulated screw defining a lumen), Balboa does not disclose a difference between a diameter of the widened shaft portion and a diameter defined by the inner surface of the cannulated screw is less than 0.5mm, 0.4mm, 0.2mm or 0.1mm. Preiss-Bloom specifically teaches mm diameter ranges for the various component portions of bone anchors, including cannulated bone anchors where the hollow section in the middle of a cannulated screw is generally larger than 1mm diameter and the external screw diameter can be as small as 0.5 or 1.0mm, but is generally less than 3.0mm for smaller bone fixation (p. 32, first paragraph) and Preiss-Bloom also teaches that the implant comprises cannulation and the cannulation is in a diameter range of 0.5-3.5mm and optionally the cannulation is in a range of 0.85- 1.7mm (p. 12, lines 13-14; claim 53). The mathematical difference between a diameter of the widened shaft portion and a diameter defined by the inner surface of the cannulated screw, given the express disclosure of Preiss-Bloom meets and overlaps the cited ranges of less than 0.5mm, for example where the cannulated screw middle hollow section is 0.5-3.5mm and the external screw diameter is in a range of 0.5mm or 1.0mm or less than 3.0mm.
Because Balboa teaches the same type of cannulated bone screw assembly, including where the shaft defining a widened shaft portion (proximal portion 11b) proximate to the widened end portion (FIG 1), and where the widened shaft portion (11b) is wider than a remainder of the shaft and being narrower than the widened end portion (FIG 1; ¶26), but where Balboa is silent as to the specific dimensions, a person of ordinary skill in the art, seeking to improve the mechanical properties of the anchor implant for use in load-bearing medical implant applications or where high strength and stiffness of the implant are important (Preiss-Bloom, p. 8, first paragraph) would consult the dimensions taught by Preiss-Bloom in order to find an optimal dimensional range for improved mechanical strength when using a cannulated bone screw assembly. Preiss-Blooms dimensions can be incorporated alongside Balboa’s cannulated screw assembly (same tip location and interaction with the advancing fastener) using known assembly methods without redesigning Balboa’s core cannulated screw assembly. Because the references address the same engineering problem (deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (improving mechanical properties for strength and stiffness in existing cannulated bone screw assemblies), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 12, Balboa modified by McDevitt teaches the apparatus according to claim 1, as set forth above.
Balboa modified by McDevitt does not teach wherein the inner surface of the cannulated screw has a polygonal shape, or wherein a difference between a diameter of the widened shaft portion and a distance between opposing edges of the polygon defined by inner surface of the cannulated screw is less than 0.5 mm, 0.4mm, 0.2mm, or 0.1mm.
Preiss-Bloom teaches the inner surface of the cannulated screw has a polygonal shape (FIG 2A, 208). Preiss-Bloom also teaches cannulated bone anchors where the hollow section in the middle of a cannulated screw is generally larger than 1mm diameter and the external screw diameter can be as small as 0.5 or 1.0mm, but is generally less than 3.0mm for smaller bone fixation (p. 32, first paragraph). Additionally, Preiss-Bloom teaches that the implant comprises cannulation and the cannulation is in a diameter range of 0.5-3.5mm and optionally the cannulation is in a range of 0.85- 1.7mm (p. 12, lines 13-14; claim 53). The mathematical difference between a diameter of the widened shaft portion and a diameter defined by the inner surface of the cannulated screw, given the express disclosure of Preiss-Bloom meets and overlaps the cited ranges of less than 0.5mm, for example where the cannulated screw middle hollow section is 0.5-3.5mm and the external screw diameter is in a range of 0.5mm or 1.0mm or less than 3.0mm. Exemplary embodiment 200, lower portion 208 (FIG 2A) shows a cross-sections of the cannulated screws where the width of the implant is 2.60mm and the cross section of the polygon is 1.10mm. However, one of ordinary skill in the art, using the suggestions of Preiss-Bloom where the implant comprises cannulation in a diameter range of 0.5-3.5mm and optionally the cannulation is in a range of 0.85- 1.7mm (p. 12, lines 13-14), would find that the difference between a diameter of the widened shaft portion and a distance between opposing edges of the polygon defined by inner surface of the cannulated screw overlaps the claimed range of less than 0.5 mm, 0.4mm, 0.2mm, or 0.1mm.
Balboa, McDevitt, and Preiss-Bloom teach in the same field of endeavor, cannulated anchor screw assemblies for bone and tissue repair. Although Balboa discloses the claimed base anchor assembly (tip component, widened end portion, eyelet, shaft, cannulated screw defining a lumen), Balboa does not disclose a difference between a diameter of the widened shaft portion and a diameter defined by the inner surface of the cannulated screw is less than 0.5mm, 0.4mm, 0.2mm or 0.1mm. Preiss-Bloom specifically teaches mm diameter ranges for the various component portions of bone anchors, including cannulated bone anchors where the hollow section in the middle of a cannulated screw is generally larger than 1mm diameter and the external screw diameter can be as small as 0.5 or 1.0mm, but is generally less than 3.0mm for smaller bone fixation (p. 32, first paragraph) and Preiss-Bloom also teaches that the implant comprises cannulation and the cannulation is in a diameter range of 0.5-3.5mm and optionally the cannulation is in a range of 0.85- 1.7mm (p. 12, lines 13-14; claim 53). The mathematical difference between a diameter of the widened shaft portion and a diameter defined by the inner surface of the cannulated screw, given the express disclosure of Preiss-Bloom meets and overlaps the cited ranges of less than 0.5mm, for example where the cannulated screw middle hollow section is 0.5-3.5mm and the external screw diameter is in a range of 0.5mm or 1.0mm or less than 3.0mm.
Because Balboa teaches the same type of cannulated bone screw assembly, including where the shaft defining a widened shaft portion (proximal portion 11b) proximate to the widened end portion (FIG 1), and where the widened shaft portion (11b) is wider than a remainder of the shaft and being narrower than the widened end portion (FIG 1; ¶26), but where Balboa is silent as to the specific dimensions, a person of ordinary skill in the art, seeking to improve the mechanical properties of the anchor implant for use in load-bearing medical implant applications or where high strength and stiffness of the implant are important (Preiss-Bloom, p. 8, first paragraph) would consult the dimensions taught by Preiss-Bloom in order to find an optimal dimensional range for improved mechanical strength when using a cannulated bone screw assembly. Preiss-Blooms dimensions can be incorporated alongside Balboa’s cannulated screw assembly (same tip location and interaction with the advancing fastener) using known assembly methods without redesigning Balboa’s core cannulated screw assembly. Because the references address the same engineering problem (deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (improving mechanical properties for strength and stiffness in existing cannulated bone screw assemblies), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 16, Balboa modified by McDevitt teaches the apparatus according to claim 1, as set forth above.
Balboa modified by McDevitt does not teach wherein the tip component comprises a fiber-reinforced biocomposite material comprising a polymer and one or more reinforcing fibers.
Preiss-Bloom teaches screws and threaded implants comprising a fiber-reinforced biocomposite material comprising a polymer and one or more reinforcing fibers (p. 17, second paragraph from the bottom of the page; claims 95, 97). However, Preiss-Bloom does not expressly teach that the tip comprises the fiber-reinforced biocomposite. Rather the threaded screws and implants of Preiss-Bloom comprising the fiber-reinforced biocomposite are not limited to the tip. Because the entire implant of Preiss-Bloom comprises a fiber-reinforced biocomposite material comprising a polymer and one or more reinforcing fibers (p. 49, line 19,”fill the whole implant cavity”), one of ordinary skill in the art would reasonably understand that the tip component would also reasonably be included as part of the whole and could comprise the fiber-reinforced biocomposite material (claim 1).
Balboa, McDevitt, and Preiss-Bloom teach in the same field of endeavor, cannulated anchor screw assemblies for bone and tissue repair. Although Balboa discloses the claimed base anchor assembly (tip component, widened end portion, eyelet, shaft, cannulated screw defining a lumen), Balboa does not disclose wherein the tip component comprises a fiber-reinforced biocomposite material comprising a polymer and one or more reinforcing fibers. Preiss-Bloom specifically teaches that entire implant (p. 49, line 19,”fill the whole implant cavity”) comprises a fiber-reinforced biocomposite material comprising a polymer and one or more reinforcing fibers (p. 17, second paragraph from the bottom of the page; claims 95, 97). One of ordinary skill in the art would reasonably understand that the tip component would also reasonably be included as part of the whole and could comprise the fiber-reinforced biocomposite material as part of the “fill the whole implant cavity” (p. 49, line 19; see also claim 1).
Because Balboa teaches the same type of cannulated bone screw assembly as Preiss-Bloom, including where the shaft defining a widened shaft portion (proximal portion 11b) proximate to the widened end portion (FIG 1), and where the widened shaft portion (11b) is wider than a remainder of the shaft and being narrower than the widened end portion (FIG 1; ¶26). Balboa is silent as to the compositional construction of the cannulated bone screw assembly. However, a person of ordinary skill in the art, seeking to improve the mechanical properties of the anchor implant for use in load-bearing medical implant applications or where high strength and stiffness of the implant are important (Preiss-Bloom, p. 8, first paragraph) and where reinforced bioabsorbable polymer material exhibiting improved mechanical properties were needed, would consult the fiber-composite reinforcement material of Preiss-Bloom for improved mechanical strength of a cannulated bone screw assembly. Preiss-Blooms fiber-composite reinforcement material can be incorporated alongside or added into Balboa’s cannulated screw assembly using fiber layer material taught by Preiss-Bloom using known assembly methods without redesigning Balboa’s core cannulated screw assembly. Because the references address the same engineering problem (deployment of surgical fasteners with improved mechanical properties) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (improving mechanical properties for strength and stiffness in existing cannulated bone screw assemblies), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 17, Balboa modified by McDevitt and Preiss-Bloom teaches the apparatus according to claim 16, as set forth above.
Preiss-Bloom teaches wherein the cannulated screw comprises a fiber-reinforced biocomposite material comprising a polymer and one or more reinforcing fibers (p. 17, second paragraph from the bottom of the page; claims 95, 97; p. 49, line 19,”fill the whole implant cavity”).
Regarding claim 18, Balboa modified by McDevitt and Preiss-Bloom teaches the apparatus according to claim 16, as set forth above.
Preiss-Bloom teaches wherein at least some of the reinforcing fibers at least partially encircle the eyelet (p. 17, second paragraph from the bottom of the page; claims 95, 97; p. 49, line 19,”fill the whole implant cavity”).
Regarding claim 19, Balboa modified by McDevitt and Preiss-Bloom teaches the apparatus according to claim 18, as set forth above.
Neither Balboa modified by McDevitt nor Preiss-Bloom expressly teach wherein between 8,000 and 20,000 of the reinforcing fibers at least partially encircle the eyelet.
However, Preiss-Bloom teaches that entire implant (p. 49, line 19,”fill the whole implant cavity”) comprises a fiber-reinforced biocomposite material comprising a polymer and one or more reinforcing fibers (p. 17, second paragraph from the bottom of the page; claims 95, 97). One of ordinary skill in the art would reasonably understand that the tip component would also reasonably be included as part of the whole and could comprise the fiber-reinforced biocomposite material as part of the “fill the whole implant cavity” (p. 49, line 19; see also claim 1).
Preiss-Bloom also teaches continuous fibers and chopped fibers (p. 11, lines 11-12). At p. 11, lines 18-19, Preiss-Bloom teaches that the concentration of chopped fibers varies from 1% to 50% of the biocomposite of weight per weight percent. Accordingly, one of ordinary skill in the art would recognize that the number of reinforcing fibers at any given position within the anchor/screw implant assembly would be a results-effective variable depending on the size of the implant and the type of reinforcing fibers selected (e.g. continuous or chopped).
Results-effective variables are variables which can be optimized. In the case of the number of reinforcing fibers at least partially encircling the eyelet, Preiss-Bloom teaches from 1% to 50% of the biocomposite of weight per weight percent, depending on the type of fibers. Accordingly, absent evidence to the contrary, the number of chopped fibers between 1% and 50% of weight per weight percent would be met by the teachings of Balboa modified by Preiss-Bloom. Given the range expressly taught by Preiss-Bloom, the number of fibers at least partially encircling the eyelet would amount to nothing more than routine experimentation that can be optimized on an individual patient basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because Balboa teaches the same type of cannulated bone screw assembly as Preiss-Bloom, including where the shaft defining a widened shaft portion (proximal portion 11b) proximate to the widened end portion (FIG 1), and where the widened shaft portion (11b) is wider than a remainder of the shaft and being narrower than the widened end portion (FIG 1; ¶26). Balboa is silent as to the compositional construction of the cannulated bone screw assembly. However, a person of ordinary skill in the art, seeking to improve the mechanical properties of the anchor implant for use in load-bearing medical implant applications or where high strength and stiffness of the implant are important (Preiss-Bloom, p. 8, first paragraph) and where reinforced bioabsorbable polymer material exhibiting improved mechanical properties were needed, would consult the fiber-composite reinforcement material of Preiss-Bloom for improved mechanical strength of a cannulated bone screw assembly. Preiss-Blooms fiber-composite reinforcement material can be incorporated alongside or added into Balboa’s cannulated screw assembly using fiber layer material taught by Preiss-Bloom using known assembly methods without redesigning Balboa’s core cannulated screw assembly. Because the references address the same engineering problem (deployment of surgical fasteners with improved mechanical properties) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (improving mechanical properties for strength and stiffness in existing cannulated bone screw assemblies), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
New Rejections – Necessitated by Amendment
Claim Rejections - 35 USC § 112(a) – Written Description – New Matter
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, 2, 6, 8, 12, 16-19, 37, and 39-44 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. This is a new matter rejection.
Applicant amended claim 1 to recite “the tip component comprising: a distal portion having a pointed distal end for penetrating bone” in line 5. The disclosure states that the tip element can be advanced into bone to a greater depth than the pilot hole because of the cancellous bone tissue is spongy (p. 15, lines 15-20), but neither the drawings nor the specification show or discuss a pointed distal end. There is no originally filed textual support for the amendment of “a distal portion having a pointed distal end for penetrating bone”. Similarly, the drawings do not support a tip component comprising a pointed distal end for penetrating bone. The language of concern was also not found in any originally filed claims in the PCT, of which the instant application is a National Stage filing, nor is the language present in the US Provisional application to which the PCT claims benefit. In the Remarks filed 31 December 2025, Applicant did not address where the support came from for the amendments other than from prior, now cancelled, claims 3, 4, and 7, in which the language at issue was not found.
Applicant amended claim 2 to add “engagement forces” in line 7 and “rotational forces” in line 8. There is no originally filed support for this amendment. There is no mention of forces being distributed to “resist”. There is no use of the term resist or the like. The only “force” mentioned in the originally filed disclosure are “pull-out forces exerted by one or more of the sutures” (pages 2, 12, 13, 16, and 21 of 24).
Applicant added new claim 39, which recites “a radial interference fit” in line 5, “radial compression” in lines 6-7. There is no originally filed support for these amendments. Page 14 of 24 of the specification mentions “the cannulated interference screw”, but this is the only reference to an interference of any kind in the disclosure. The word radial is not mentioned at all. Radial compression is a force, but the only “force” mentioned in the originally filed disclosure are “pull-out forces exerted by one or more of the sutures” (pages 2, 12, 13, 16, and 21 of 24).
Applicant added new claim 40, which recites “a fixed rotational orientation relative to the cannulated screw sufficient to prevent rotation of the suture”. There is no originally filed support for this amendment. Page 14 of 24 of the Specification states that there are “two features for preventing or reducing swiveling of the tip component 22 with respect to the cannulated screw 30 (i.e., widened shaft portion 42, as well as tip teeth 44 and screw teeth 46)”. Page 16 of 24 contains similar language. Even allowing for alternative verbiage of rotation with swiveling, the swiveling in the specification is directed to the tip component 22 with respect to the cannulated screw 30, not to the prevention of rotation of the suture.
Applicant added new claim 41, which recites “rotational resistance between the tip component and the cannulated screw is increased by at least 500% compared to rotational resistance between a remainder of the shaft and the cannulated screw”. There is no originally filed support for this amendment. Page 22 of 24 of the Specification recites a test where a “sawbone was fixed to the bottom of a tensile testing system frame with the samples submerged in DPBS solution and the ends of the suture attached to a 500N load cell attached to the tensile testing system.” Table 1a (pp. 22-24) provides data, but none of the data indicate that the “rotational resistance between the tip component and the cannulated screw is increased by at least 500% compared to rotational resistance between a remainder of the shaft and the cannulated screw.” There is no “at least 500%” recited in any of the originally filed documents. There is no support for 500% or any measure of compared rotational resistance in the originally filed disclosure, not just the recited range. The phrase “rotational resistance” does not appear in the originally filed documents, claims, or specification at all.
In new claim 41, no originally filed support is found for the phrase “greater radial compression force”. The only mention of the word “compression” is on page 21 of 24 of the specification where it is indicated that “testing samples were manufactured by compression molding of the multiple layers”. As with the amendments in claim 2, new claim 42 recites the phrases “engagement forces” and “rotational forces” in lines 7, 8, and 12, respectively. There is no originally filed support for this amendment. The only “force” mentioned in the originally filed disclosure are “pull-out forces exerted by one or more of the sutures” (pages 2, 12, 13, 16, and 21 of 24).
Claim 42 also recites “the widened shaft portion extends along the shaft for an axial length that is at least 20% of a total length of the tip component” in lines 9 and 10. There is no originally filed support for this amendment. There are percentages in the specification at pp 18-20 of 24 that are related to the continuous fibers or reinforcing fibers. Pages 14 and 15 of 24 recites that “the pilot hole is shorter than the total length of the suture anchor 20, e.g., up to half of the total length of the suture anchor”. However the “20” in this context is related to the element number of the suture anchor and not a percentage.
New claim 44 recites “wherein the engagement interface is configured to distribute retention forces”. There is no originally filed support for this amendment. The only “force” mentioned in the originally filed disclosure are “pull-out forces exerted by one or more of the sutures” (pages 2, 12, 13, 16, and 21 of 24).
The examiner recognizes that mere rephrasing of a passage does not constitute new matter (MPEP 2163.07 and 608.01(o)). The examiner has given Applicant consideration for being their own lexicographer in the amended and newly added claims. However, there must still be originally filed support even if alternative comparable language (synonyms) are used. For example, new claim 39 recites “a frusto-conical taper”. While there is no textual support for this language, the drawings, including FIGs 1, 2A-2F, and 3 show a frusto-conical taper of the widened shaft portion of the tip, insomuch as the tip is also shown as blunted or does not have a pointed distal end.
Claims 6, 8, 12, 16-19, 37, and 43 are rejected as depending from or otherwise encompassing claims comprising new matter.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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