DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant's election with traverse of Invention I (claims 1-10) in the reply filed on 9/16/25 is acknowledged. The traversal is on the ground(s) that there is no search burden. This is not found persuasive because the product as claimed can be used in a materially different process of using that product not limited to the bone such as being used to close an opening in a vessel, close a wound, or plug a fistula; therefore, the prior art applicable to one invention might not be applicable to another invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9/16/25.
Applicant's election with traverse of Species II (Fig. 5-6) in the reply filed on 9/16/25 is acknowledged. The traversal is on the ground(s) that the method used in Fig. 3-4 could be used with the other embodiments of anchors. The examiner agrees that the method can be used with the other embodiments however the restrictions was based on the device embodiment not the method therefore the embodiment of the device seen in Fig. 3-4 is a separate species than the one in Fig. 5-6.
The requirement is still deemed proper and is therefore made FINAL.
Specification
The disclosure is objected to because of the following informalities: in paragraph [0001], the corresponding patent number for the parent application must be added.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: On line 8, “entirely inside the lumen of the sleeve from the second opening and the third opening” should be --entirely inside the lumen of the sleeve from the second opening to the third opening--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 introduces an inserter, however the inserter was previously introduced in claim 1; therefore, it is unclear if this is the same or different inserter than that of claim 1. It appears to the examiner that it should be –the inserter—and will be interpreted in this manner.
Claim 9 introduces an inserter in line 11, however the inserter was previously introduced in line 4; therefore, it is unclear if this is the same or different inserter than that of line 4. It appears to the examiner that it should be –the inserter—and will be interpreted in this manner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of U.S. Patent No. 10,448,944. Although the claims at issue are not identical, they are not patentably distinct from each other because each of the structural limitation recited in claim 1 are found in the combination of claims 1 and 8 of U.S. Patent No. 10,448,944. The difference in the terminology used would be obvious to one of ordinary skill in the art.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-5 and 8-10 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Stone et al. (2007/0185532).
Stone discloses the following claimed limitations:
Claim 1: A filamentary fixation system (100), comprising: a sleeve (102) (Fig. 7e and [0043] where it states that 102 can be a cylinder with a bore such as the one seen in Fig. 1) formed of filamentary material ([0043]) having a lumen (105) (Fig. 1 and 7e and [0043] where it states that 102 can be a cylinder with a bore such as the one seen in Fig. 1) defined therethrough (Fig. 1 and 7e and [0043]), the sleeve defining first (see figure below), second (see figure below), third (see figure below), and fourth openings (see figure below), and a bottom portion (see figure below) configured to engage an inserter (120) for inserting the sleeve into a bone hole (Fig. 13-15 where the embodiment of Fig. 7e is capable of performing this function), the bottom portion being located between the second and third openings (see figure below); and a filament (103) (Fig. 7e and [0043]) formed of filamentary material ([0045]) including a first free end (end that connects to 140 in Fig. 7e) and a second free end (opposite end in Fig. 7e), the filament being disposed entirely outside the sleeve from the first opening to the second opening (see figure below), entirely inside the lumen of the sleeve from the second opening and the third opening (see figure below), and entirely outside the sleeve from the third opening to the fourth opening (see figure below), wherein the filament does not overlap itself within an interior of the sleeve (see figure below).
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Claim 2: Wherein a diameter of the lumen is larger than a diameter of the filament such that the filament is slidable within the lumen (Fig. 1 and [0043] where the sleeve would be like the one seen in Fig. 1 but with the openings seen in Fig. 7e).
Claim 3: wherein the sleeve includes an inner surface (inner wall of the sleeve as seen in Fig. 1 and 7c and [0043] where the sleeve would be like the one seen in Fig. 1 and 7c but with the openings seen in Fig. 7e) defining the lumen (Fig. 1 and 7c and [0043] where the sleeve would be like the one seen in Fig. 1 and 7c but with the openings seen in Fig. 7e) and an exterior surface (outer wall of the sleeve as seen in Fig. 1 and 7c and [0043] where the sleeve would be like the one seen in Fig. 1 and 7c but with the openings seen in Fig. 7e and where the openings go through as seen in Fig. 7c), and the first, second, third, and fourth openings extend entirely through the sleeve from the exterior surface to the lumen (Fig. 1 and 7c and [0043] where the sleeve would be like the one seen in Fig. 1 and 7c but with the openings seen in Fig. 7e and where the openings go through as seen in Fig. 7c).
Claim 4: wherein the filament exits the lumen through the first opening, enters the lumen through the second opening, exits the lumen through the third opening, and enters the lumen through the fourth opening (see figure above).
Claim 5: wherein the filament is positioned entirely within the lumen of the sleeve within the bottom portion (see figure above).
Claim 8: further comprising an inserter (120) having a distal end provided with a forked tip (Fig. 13-15 and [0053]).
Claim 9: A filamentary fixation kit, comprising: a sleeve (102) (Fig. 7e and [0043] where it states that 102 can be a cylinder with a bore such as the one seen in Fig. 1) formed of filamentary material ([0043]) having an exterior surface (outer wall of the sleeve as seen in Fig. 1 and 7c and [0043] where the sleeve would be like the one seen in Fig. 1 and 7c but with the openings seen in Fig. 7e) and an interior surface (inner wall of the sleeve as seen in Fig. 1 and 7c and [0043] where the sleeve would be like the one seen in Fig. 1 and 7c but with the openings seen in Fig. 7e) defining a lumen (105) (Fig. 1 and 7e and [0043] where it states that 102 can be a cylinder with a bore such as the one seen in Fig. 1) extending through the sleeve (Fig. 1 and 7e and [0043] where it states that 102 can be a cylinder with a bore such as the one seen in Fig. 1), the sleeve defining first, second, third, and fourth openings (see figure above), and a bottom portion (see figure above) configured to engage an inserter (120) for inserting the sleeve into a bone hole (Fig. 13-15 where the embodiment of Fig. 7e is capable of performing this function), the bottom portion being located between the second and third openings (see figure above); and a filament (103) (Fig. 7e and [0043]) formed of filamentary material ([0045]) including a first free end (end that connects to 140 in Fig. 7e) and a second free end (opposite end in Fig. 7e), the filament being disposed entirely outside the sleeve from the first opening to the second opening (see figure above), entirely inside the lumen of the sleeve from the second opening to the third opening (see figure above), and entirely outside the sleeve from the third opening to the fourth opening (see figure above) such that the filament does not overlap itself within an interior of the sleeve (see figure above); and an inserter (120) having a distal end for engaging the bottom portion of the sleeve (Fig. 13-15 where the embodiment of Fig. 7e is capable of performing this function).
Claim 10: wherein the distal end of the inserter comprises a forked tip (Fig. 13-15 and [0053])
Claim(s) 1-6 and 8-10 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Denham et al. (2011/0264141).
Denham discloses the following claimed limitations:
Claim 1: A filamentary fixation system (10), comprising: a sleeve (12) (Fig. 1) formed of filamentary material ([0049]) having a lumen (22) (Fig. 1 and [0041]) defined therethrough (Fig. 1 and [0041]), the sleeve defining first (32), second (34), third (36), and fourth openings (38) (Fig. 1 and [0041]), and a bottom portion (bottom part of sleeve where part 82 is located) configured to engage an inserter (114) (Fig. 2a-b and [0053]) for inserting the sleeve into a bone hole (Fig. 2a-b and [0053]), the bottom portion being located between the second and third openings (Fig. 1); and a filament (16) (Fig. 1) formed of filamentary material ([0049]) including a first free end (72) and a second free end (70) (Fig. 1), the filament being disposed entirely outside the sleeve from the first opening to the second opening (Fig. 1), entirely inside the lumen of the sleeve from the second opening and the third opening (Fig. 1), and entirely outside the sleeve from the third opening to the fourth opening (Fig. 1), wherein the filament does not overlap itself within an interior of the sleeve (Fig. 1).
Claim 2: Wherein a diameter of the lumen is larger than a diameter of the filament such that the filament is slidable within the lumen (Fig. 1 and [0041]).
Claim 3: wherein the sleeve includes an inner surface (inner wall of the sleeve as seen in Fig. 1) defining the lumen (Fig. 1) and an exterior surface (outer wall of the sleeve as seen in Fig. 1), and the first, second, third, and fourth openings extend entirely through the sleeve from the exterior surface to the lumen (Fig. 1).
Claim 4: wherein the filament exits the lumen through the first opening, enters the lumen through the second opening, exits the lumen through the third opening, and enters the lumen through the fourth opening (Fig. 1).
Claim 5: wherein the filament is positioned entirely within the lumen of the sleeve within the bottom portion (Fig. 1).
Claim 6: wherein tensioning of the filament pinches the second opening and the third opening together and compresses the bottom portion upwards such that at least a portion of the sleeve forms a W-shape (Fig. 2a).
Claim 8: further comprising an inserter (114) having a distal end provided with a forked tip (Fig. 2a-b and [0053]).
Claim 9: A filamentary fixation kit, comprising: a sleeve (12) (Fig. 1) formed of filamentary material ([0049]) having an exterior surface (outer wall of the sleeve as seen in Fig. 1) and an interior surface (inner wall of the sleeve as seen in Fig. 1) defining a lumen (22) (Fig. 1 and [0041]) extending through the sleeve (Fig. 1), the sleeve defining first (32), second (34), third (36), and fourth openings (38) (Fig. 1 and [0041]), and a bottom portion (bottom part of sleeve where part 82 is located in Fig. 1) configured to engage an inserter (114) (Fig. 2a-b and [0053]) for inserting the sleeve into a bone hole (Fig. 2a-b and [0053]), the bottom portion being located between the second and third openings (Fig. 1); and a filament (16) (Fig. 1) formed of filamentary material ([0049]) including a first free end (72) and a second free end (70) (Fig. 1), the filament being disposed entirely outside the sleeve from the first opening to the second opening (Fig. 1), entirely inside the lumen of the sleeve from the second opening to the third opening (Fig. 1), and entirely outside the sleeve from the third opening to the fourth opening (Fig. 1) such that the filament does not overlap itself within an interior of the sleeve (Fig. 1); and an inserter (12) having a distal end for engaging the bottom portion of the sleeve (Fig. 2a-b and [0053]).
Claim 10: wherein the distal end of the inserter comprises a forked tip (Fig. 2a-b and [0053])
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stone et al. (2007/0185532) in view of Lashinski et al (2010/0137679).
Stone discloses all the limitations discussed above, however Stone does not disclose
that the filament has at least one marker.
Lashinski discloses another well-known suture anchor where the anchor and filament
can include markers for visualization ([0268]). Thus, Lashinski discloses that it is well known
in the art to use markers for visualization during medical procedures ([0268]).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the filament of Stone to have at least one marker, as taught by Lashinski,in order to be able to visualize the device as it is being placed in the body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art of record when considered alone or in combination appears to teach the claimed limitations.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771