DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/11/2025 has been entered.
Response to Arguments
Applicant argues in the response filed 12/11/2025 that new drawings were filed showing the trapping mechanism with a number. The applicant argues the feature was previously shown in the drawings but was not numbered, and therefore no new matter was added. However, the examiner disagrees. The new drawings are highlighting the trapping mechanism of figure 1b. The slot does not seem to be narrowed in figure 1b, however is shown to be narrowed in new figures 1c,d. Further the specification as originally filed does not support the trapping mechanism of figure 1b would have the narrowing slot. The amendments to the specification filed 12/11/225 do not support the limitations since they are new amendments not supported the specification as originally filed. The drawings, and specification amendments, are considered to be new matter.
The applicant argues Dougherty (both Dougherty ‘901 and Dougherty ‘795) does not disclose the narrowing geometry of the slot “which creates the mechanical basis for the directional trapping functionality and represents a specific structural feature that must be preset in the prior art to anticipate or render obvious the claimed invention”. However, it is to be noted the inventive entity of the claims are “an apparatus for securing a suture to bone” so the suture is not, and wouldn’t be interpreted to be, positively recited. If the cleat/trapping mechanism has a lateral extension and a slot which has a narrowing width from an entry point to the slot end, the prior art will be able to read on the claimed limitation since the prior art will be able to read on the structure. Further, there is no further support and limitations of the specific narrowing so any narrowing would be able to read on the narrowing limitation. In other words, the specific type of narrowing is not positively claimed and/or supported by the specification. Even if the prior art has a different functionality of how the suture can engage the slots (with respect to the suture spinning for example), the prior art would still be able to read on the claim limitations since the structure of the cleat/trapping mechanism is disclosed by the prior art so the function of how the suture is inserted and won’t be pulled out can be known.
The examiner maintains that if prior art reads on a cleat that extends laterally, and a trapping mechanism which can mechanically trap a suture, where the trapping mechanism has a slot which has a narrowing width, the prior art will be able to read on the claim limitations of record. See rejections below
The applicant further argues prior art Martinek, Dougherty ‘795, and Gordon does not disclose the stay-suture release tab comprises a tearable or a pullable fabric. The examiner agrees and the rejections have been withdrawn.
Based on the filings of the RCE, new drawings, new claim/specification amendments, and for compact prosecution, the objections/rejections have been made below.
Drawings
The new drawings filed 12/11/2025 are objected to because they contain new matter. The drawings filed 12/11/2025 illustrate a narrowing of the trapping member of figure 1b. The original figure 1b does not support that the trapping mechanism have the similar narrowing features as shown in new figures 1c,d. Further the specification as originally filed does not support the trapping mechanism comprising a slot with a narrowing width from an entry point to and end of the slot. Therefore the new drawings filed 12/11/2025 are considered to be new matter. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The amendment filed 12/11/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “Figs. 1C and 1D show a closeup view of a portion of figure 1B” on page 13 line 4, and “Figs. 1C and 1D show a closeup view of a portion of Figure 1B showing trapping mechanism 200 in more detail. Trapping mechanism has two parts, a left trapping mechanism 200A and a right trapping mechanism 200B as shown. Each of the left trapping mechanisms 200A and right trapping mechanism 200B feature a slot into which the proximal ends of the tissue-affixing suture(s) are inserted laterally” on page 19 lines 11-15. The amendment, specifically the slot of trapping mechanism as highlighted in new figures 1C,D with the narrowing width, is considered new matter. There is no support in original figures 1b that there will be a slot with narrowing width where the ends of the suture can be inserted. Therefore the amendment is considered to be new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
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, 9, 21, 22, 27, 30, 36, 38, 49, 50-52 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.
Independent claims 1, 50 claims “wherein said trapping mechanism comprises a slot at each shoulder, and wherein a proximal end of the suture enters said slot; wherein said slot features a narrowing width from an entry point of said slot to an end of said slot” in lines 20-23 and 21-23 respectively. The specification as originally filed does not support a slot with a narrowing width from an entry point of said slot to an end of said slot. The new figures filed 12/11/2025 do not support the limitations since they are considered new matter. Since the specification does not support the specific narrowing, the limitation is considered new matter.
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 1, 2, 9, 17, 20, 21, 22, 27, 30, 36, 38, 49, 50-52 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 1 recites the limitation "a proximal end of the suture” in lines 21-22. However claim 1 already claims “proximal ends of the suture” in lines 15-16. It is unclear if the “a proximal end of the suture” of lines 21-22 is one proximal end of the proximal ends of suture in lines 15-16 or its own distinct proximal end. For examination purposes, the “a proximal end of the suture” of lines 21-22 will be interpreted to be one end of the proximal ends of lines 15-16.
Regarding claims 2, 17, 20, 27 and 36, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 50 recites the limitation "the trapping mechanism" in line 21. There is insufficient antecedent basis for this limitation in the claim. The trapping mechanism of line 21 has a slot which engages proximal ends of the suture. However the claim recites cleats which engages proximal end of the suture as well in lines 13-17. It is unclear if the trapping mechanism should be its own structure with respect to “a trapping mechanism” or connected with the cleats. If the trapping mechanism is “a trapping mechanism” it would be unclear how the proximal ends of the suture would engage both the cleats and another structure with respect to the trapping mechanism. For examination purposes, the trapping mechanism will be interpreted to a trapping mechanism with respect to the cleats.
Claim 50 recites the limitation "a proximal end of the suture” in line 22. However claim 50 already claims “proximal ends of the suture” in line 15. It is unclear if the “a proximal end of the suture” of line 22 is one proximal end of the proximal ends of suture in lines 15 or its own distinct proximal end. For examination purposes, the “a proximal end of the suture” of lines 22 will be interpreted to be one end of the proximal ends of lines 15.
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, 21, 22, 27, 30, 36, 38, 49, 50 are rejected under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2008/0208253 to Dreyfuss in view of U.S. Patent Publication 2016/0374795 to Dougherty (herein Dougherty ‘795).
As to claim 1, Dreyfuss discloses an apparatus for securing a suture to a bone (paragraph 3), the apparatus comprising: a suture anchor (42/200) configured to be inserted into a hole in the bone, the suture anchor comprising: a tip component (tips seen in figure 8,9, figure 11) configured to be advanced into the hole, the tip component comprising: a widened end portion (figure 8; 11a ) that defines an eyelet (eyelet of 30; 555) that is configured to receive the suture; a shaft (560, figure 11a) that projects axially from the widened end portion; and a cannulated screw (42) configured to secure the tip component within the hole within the bone by being advanced over the shaft of the tip component (paragraph 25, 26, 19); and a suture-anchor insertion device (figure 29) comprising: a handle portion (22); one or more rods (68/20); but is silent about one or more shoulder cleats extending substantially laterally at a distal end of the handle portion, where the one or more shoulder cleats comprise a trapping mechanism which comprises a slot. Dreyfuss teaches multiple of different tip component embodiments that can read on the limitations with respect to the widened end portion with an eyelet and shaft that projects axially from the widened portion. Further Dreyfuss seems to disclose the anchor is nominal structure that will be able to deploy the anchor.
Dougherty ‘795 teaches a similar device (anchor placement system, abstract) having a suture-anchor insertion device comprising a handle portion (2402; 3402), one or more rods (2510/2442; 3512/3412), and one or more shoulder cleats (2432; 3405) extending substantially laterally at a distal end of the handle portion (figure 11, 18, 25, see annotated figure I, II below), the shoulder cleats being configured to releasable secure proximal ends of the suture by the proximal ends of the suture being inserted into the one or more shoulder cleats, wherein the one or more shoulder cleats comprise a trapping mechanism (paragraph 158, 159, 161, 164, figure 11, 18, 25, the narrowing of the cleat/slot see annotated figures I, II below) configured to mechanically trap the proximal ends of the suture such that the proximal ends of the suture cannot be pulled out of the shoulder cleats longitudinally but can be removed from the shoulder cleats by pulling the proximal ends of the suture laterally (paragraph 158, 159, 161, 164, figure 11, 18, 25), wherein the trapping mechanism comprises a slot (2432/slots seen in figure 23-25, see annotated figures I, II below) at each shoulder, and wherein a proximal end of the suture enters said slot (the proximal end of the suture is capable of entering the slot), wherein said slot features a narrowing width from an entry point of said slot to an end of said slot (figure 11, 18, 23-25, the slots have a wider entry which does narrow towards the end of the slot, see annotated figure I, II below) for the purpose of maintain tension on the suture during delivery of the anchor. Dougherty ‘795 teaches multiple of different cleat embodiments that can read on the cleat’s limitations. The cleats extend laterally where the slots of the cleats are structured that they have a narrowing width. It is to be noted the suture is not positively claimed since the inventive entity of the device is an apparatus for securing a suture. Paragraph 125, 134 and of the specification of the application as originally filed reads that the shoulder cleats have a trapping mechanism based on a male-female interlocking structure where the suture is laterally slid into the trapping mechanism. However, there isn’t any further support for the male-female interlocking mechanism. The cleats of Dougherty ‘795 can read on the trapping mechanism since a suture sliding into the slots can read on the “male-female interlocking mechanism” where the suture is laterally slid into the cleat. This mechanism can read on the “trapping mechanism”. The “trapping mechanism of Dougherty ‘795 will be able to read on the slots / trapping mechanism since the mechanism has a lateral direction extension, has a slot that tapers from an entry to an end, and a proximal end of a suture which is inserted into the slot won’t be pulled out if it is pulled longitudinally based on the slots dimension and the friction therein, but can be removed if it gets pulled laterally. Either of the handle embodiments with the cleats as taught by Dougherty ‘795 can be used be used to deliver the anchor of Dreyfuss and will yield the predictable result of allowing the anchor to be delivered while be able to secure the suture during delivery. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the handle portion with the cleats, trapping mechanism, and narrowing slots of Dougherty ‘795 in the device of Dreyfuss in order to allow the user to maintain tension on the suture during delivery of the anchor.
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As to claim 21, with the device of Dreyfuss and Dougherty ‘795 above, Dreyfuss discloses the one or more rods comprise a rotation rod that is configured to rotate the cannulated screw (paragraph 21). Dougherty ‘795 further teaches the rotation in paragraph 160.
As to claim 22, with the device of Dreyfuss and Dougherty ‘795 above, Dreyfuss discloses the one or more rods further comprise a pushing rod configured to push the cannulated screw, while it is being rotated (paragraph 21).
As to claim 27, with the device of Dreyfuss and Dougherty ‘795 above, Dougherty ‘795 further teaches the one or more cleats are configured to secure the proximal ends of the suture (figure 25) such as to hold the proximal ends of the suture out of the way of the suture anchor insertion device and prevent twisting and/or knotting of the suture.
As to claim 30, with the device of Dreyfuss and Dougherty ‘795 above, Dreyfuss discloses the suture anchor insertion device is configured to be provided to a user without the suture passing through the eyelet and wherein the apparatus is configured for a user to insert the suture through the eyelet (figure 7a), and to insert the proximal ends of the suture into the one or more shoulder cleats (of Dougherty ‘795).
As to claim 36, with the device of Dreyfuss and Dougherty ‘795 above, Dougherty ‘795 further teaches the shoulder cleats extend laterally, such as to define lateral extensions that extend laterally past lateral edges of the handle portion (figure 9, 15, 18, 20).
As to claim 38, with the device of Dreyfuss and Dougherty ‘795 above, Dougherty ‘795 further teaches the shoulder cleats are configured to allow the user to secure the suture at a desired tightness by sliding the proximal ends of the suture laterally from the lateral extensions and into the mechanisms (figure 9, 15, 18, 20).
As to claim 49, with the device of Dreyfuss and Dougherty ‘795 above, Dougherty ‘795 further teaches the one or more shoulder cleats are configured for dynamic tensioning of the suture (figure 9, 15, 18, 20, paragraph 18). The application does not seem to support or define the dynamic tensioning and/or how the cleats are structured to allow dynamic tensioning. Since the cleats are configured to maintain tension, therefore are structured to be capable of allow for dynamic tension.
As to claim 50, Dreyfuss discloses an apparatus for securing a suture to a bone (paragraph 3), the apparatus comprising: a suture anchor (42/200) configured to be inserted into a hole in the bone, the suture anchor comprising: a tip component (tips seen in figure 8,9, figure 11) configured to be advanced into the hole, the tip component comprising: a widened end portion (figure 8; 11a) that defines an eyelet (eyelet of 30; 555) that is configured to receive the suture; a shaft (560, figure 11a) that projects axially from the widened end portion; and a cannulated screw (42) configured to secure the tip component within the hole within the bone by being advanced over the shaft of the tip component (paragraph 25, 26, 19); and a suture-anchor insertion device (figure 29) comprising: a handle portion (22); one or more rods (68/20); wherein the suture anchor defines a stay suture eyelet (the eyelet where 71 passes in figure 8 or the second proximal eyelet as seen in figure 11a-e), the apparatus further comprising: a stay suture (71) configured to pass through the stay suture eyelet and into the handle portion, by passing along a lumen (paragraph 22 , the suture 71 is threaded through the driver) defined by one of the one or more rods (figure 7c), but is silent about one or more shoulder cleats extending substantially laterally at a distal end of the handle portion, where the one or more shoulder cleats comprise a trapping mechanism which comprises a slot, and the stay-suture suture release tab. Dreyfuss teaches multiple of different tip component embodiments that can read on the limitations with respect to the widened end portion with an eyelet and shaft that projects axially from the widened portion. Further Dreyfuss seems to disclose the anchor is nominal structure that will be able to deploy the anchor.
Dougherty ‘795 teaches a similar device (anchor placement system, abstract) having a suture-anchor insertion device comprising a handle portion (2402; 3402), one or more rods (2510/2442; 3512/3412), and one or more shoulder cleats (2432; 3405) extending substantially laterally at a distal end of the handle portion (figure 11, 18, 25, see annotated figures I, II above), the shoulder cleats being configured to releasable secure proximal ends of the suture by the proximal ends of the suture being inserted into the one or more shoulder cleats, wherein the trapping mechanism comprises a slot (2432/slots seen in figure 23-25, see annotated figures I, II above) at each shoulder, and wherein a proximal end of the suture enters said slot (the proximal end of the suture is capable of entering the slot), wherein said slot features a narrowing width from an entry point of said slot to an end of said slot (figure 18, 23-25, see annotated figures I, II above, the slots have a wider entry which does narrow towards the end of the slot) for the purpose of maintain tension on the suture during delivery of the anchor. The cleats extend laterally where the slots of the cleats are structured that they have a narrowing width. It is to be noted the suture is not positively claimed since the inventive entity of the device is an apparatus for securing a suture. Paragraph 125, 134 and of the specification of the application as originally filed reads that the shoulder cleats have a trapping mechanism based on a male-female interlocking structure where the suture is laterally slid into the trapping mechanism. However, there isn’t any further support for the male-female interlocking mechanism. The cleats of Dougherty ‘795 can read on the trapping mechanism since a suture sliding into the slots can read on the “male-female interlocking mechanism” where the suture is laterally slid into the cleat. This mechanism can read on the “trapping mechanism”. The “trapping mechanism of Dougherty ‘795 will be able to read on the slots / trapping mechanism since the mechanism has a lateral direction extension, has a slot that tapers from an entry to an end, and a proximal end of a suture which is inserted into the slot won’t be pulled out if it is pulled longitudinally based on the slots dimension and the friction therein, but can be removed if it gets pulled laterally. Either of the handle embodiments with the cleats as taught by Dougherty ‘795 can be used be used to deliver the anchor of Dreyfuss and will yield the predictable result of allowing the anchor to be delivered while be able to secure the suture during delivery. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the handle portion with the cleats, trapping mechanism, and narrowing slots of Dougherty ‘795 in the device of Dreyfuss in order to allow the user to maintain tension on the suture during delivery of the anchor. Dougherty ‘795 further teaches a stay-suture release tab (3906) configured to releasably hold a proximal end of the stay suture within the handle portion. The pull tab 3906 makes it easier to pull the elongate element or suture. It would have been obvious to one ordinary skill in the art before the effective filing date to use the stay-suture release tab of Dougherty ‘795 with the device of Dreyfuss in order to make it easier to pull the stay suture.
Claims 9, 51, 52 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2008/0208253 to Dreyfuss in view of U.S. Patent Publication 2016/0374795 to Dougherty (herein Dougherty ‘795) as applied to claims 1, 21, 22, 27, 30, 36, 38, 49, 50 above, and as evidenced by of U.S. Patent Publication 2006/0021270 to Hanley.
As to claim 9, 51 with the device of Dreyfuss and Dougherty ‘795 above, Dreyfuss discloses the suture anchor defines a stay suture eyelet (the eyelet where 71 passes in figure 8 or the second proximal eyelet as seen in figure 11a-e), the apparatus further comprising: a stay suture (71) configured to pass through the stay suture eyelet and into the handle portion, by passing along a lumen (paragraph 22 , the suture 71 is threaded through the driver) defined by one of the one or more rods (figure 7c), but is silent about a stay-suture release tab configured to releasably hold a proximal end of the stay suture within the handle portion.
Dougherty ‘795 further teaches a stay-suture release tab (3906) configured to releasably hold a proximal end of the stay suture within the handle portion. The pull tab 3906 makes it easier to pull the elongate element or suture. It would have been obvious to one ordinary skill in the art before the effective filing date to use the stay-suture release tab of Dougherty ‘795 with the device of Dreyfuss in order to make it easier to pull the stay suture.
However, Dougherty ‘795 is silent about the tab comprises a tearable or pullable fabric. The tab 3906 is pulled but Dougherty ‘795 is specific silent about the material (fabric). If the material is fabric, the fabric can be tearable (see prior art Hanley, paragraph 22, as evidence). Having the tab 3906 be fabric will yield the predictable result of allowing a structure of the user to pull. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the tab be made from a tearable fabric since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
As to claim 52, Dreyfuss as modified by Dougherty ‘795 discloses the above with respect to claim 50, but is iseltn about the stay-suture release tab comprises a tearable or pullable fabric. The tab 3906 of Dougherty ‘795 is pulled but Dougherty ‘795 is specific silent about the material (fabric). If the material is fabric, the fabric can be tearable (see prior art Hanley, paragraph 22, as evidence). Having the tab 3906 be fabric will yield the predictable result of allowing a structure of the user to pull. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the tab be made from a tearable fabric since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Allowable Subject Matter
Claims 4, 8, 10, 11, 13, 15, 16, 19, 23, 48 are allowed. The applicant can be in condition for allowance with cancelation of independent claims 1, 50 and their dependent claims, and correcting the drawing/specification, 112 issues above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on (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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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771