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 .
Election/Restrictions
Applicant’s election of Invention I, Species F, claims 1-7, 10-19 in the reply filed on 08/12/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8, 9, 20-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/12/2026.
Claim Objections
Claim 4 is objected to because of the following informalities: In order to avoid any antecedent issues and for clarity purposes, line 2 of the claim should be amended to read “…the at least one cut or opening comprises a plurality of cuts or openings…” or an amendment of a similar scope. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: In order to avoid any antecedent issues and for clarity purposes, line 2 of the claim should be amended to read “…the at least one cut or opening comprises a plurality of cuts or openings…” or an amendment of a similar scope. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: In order to avoid any antecedent issues and for clarity purposes, lines 2-3 of the claim should be amended to read “the tubing is provided with the [[a]] plurality of cuts or openings…” or an amendment of a similar scope. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: In order to avoid any antecedent issues and for clarity purposes, lines 2-3 of the claim should be amended to read “the tubing is provided with the [[a]] plurality of cuts or openings…” or an amendment of a similar scope. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: Since the scope of the claim 16 is to a device claim and not a method, the claim should read “the punch obturator is configured to be employed in arthroscopic shoulder surgery”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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 1-4, 10, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2020/0023168 to Hayakawa.
As to claim 1, Hayakawa discloses a device capable of being a punch obturator (paragraph 9) comprising a handle (37, figure 3b, paragraph 60b), a shaft (13, 15) attached to the handle and configured to extend between an obturator position (figure 8b) and a punch position (figure 8a), and a tubing (any of the covers comprising the deformation portions, 30 90, 100, 110, ) housing the shaft (figure 3a,b).
As to claim 2, Hayakawa discloses the tubing is configured to act as a soft stop (figure 8a, paragraph 55). The cover portion is elastic and stops as it hits tissue.
As to claim 3, Hayakawa discloses the tubing is provided with at least one cut or opening (figure 3a, 12, 13a).
As to claim 4, Hayakawa discloses the tubing is provided with a plurality of cuts or openings forming a spiral around the shaft (figure 12a,b, 13a,b,).
As to claim 10, Hayakawa discloses the tubing is formed of foam, rubber, elastomers, polymers, or combinations thereof (paragraph 62).
Claims 1-3, 5-7, 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 5,242,418 to Weinstein.
As to claim 1, Weinstein discloses a device capable of being a punch obturator (col. 1 ll. 38-50) comprising a handle (12, figure 1), a shaft (11) attached to the handle and configured to extend between an obturator position (figure 1) and a punch position (figure 2), and a tubing (10) housing the shaft (figure 1). Any of the sheaths (10, 40, 50) can read on the tubing.
As to claim 2, Weinstein discloses the tubing is configured to act as a soft stop (figure 1, 2). The tubing is protective and deformable.
As to claim 3, Weinstein discloses the tubing is provided with at least one cut or opening (16, 31, 52).
As to claims 5, 6, Weinstein discloses the tubing is provided with a plurality of cuts or openings extending parallel to a longitudinal axis of the tubing forming a regular pattern (figure 1, 7).
As to claim 7, Weinstein discloses the tubing is provided with a plurality of cuts or openings extending parallel to a longitudinal axis of the tubing forming an irregular pattern (figure 3, 8). The cuts 31 or strips 52 can be interpreted to be irregular since they seem not to be the same but still have the parallel cuts.
As to claim 10, Weinstein discloses the tubing is formed of foam, rubber, elastomers, polymers, or combinations thereof (col. 4 ll. 16-25, 53-55).
Claims 1-3, 5, 6, 10, 12, 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 5,882,340 to Yoon.
As to claim 1, Yoon discloses a device capable of being a punch obturator (col. 2 ll. 19-24) comprising a handle (124, figure 8), a shaft (160) attached to the handle and configured to extend between an obturator position (figure 11) and a punch position (figure 8, 10), and a tubing (130 similar to 132 in figure 1-5, col. 11 ll. 10, which can include the membrane 54) housing the shaft (figure 8-11).
As to claim 2, Yoon discloses the tubing is configured to act as a soft stop (figure 3, 11). The tubing can expand and can abut or stop at tissue, so the tubing can read on a soft stop.
As to claim 3, Yoon discloses the tubing is provided with at least one cut or opening (figure 11, the cuts that define the expandable portion 142, col. 11 ll. 10-34, similar to the cuts/openings as seen in figure 3).
As to claims 5, 6, Yoon discloses the tubing is provided with a plurality of cuts or openings extending parallel to a longitudinal axis of the tubing forming a regular pattern (figure 3).
As to claim 10, Yoon discloses the tubing is formed of foam, rubber, elastomers, polymers, or combinations thereof (col. 8 ll. 15-46).
As to claim 12, Yoon discloses the shaft is in the obturator position, the shaft is located about fully within the tubing (figure 11).
As to claim 14, Yoon discloses the handle is spring actuated handle (figure 8, 10, 11, col. 10 67 - col. 11 ll. 9).
Claims 1, 10-12, 14, 16, 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2022/0409212 to Krasniak.
As to claim 1, Krasniak discloses a punch obturator (paragraph 4) comprising a handle (276, 204, figure 3-6) a shaft (274, paragraph 79) attached to the handle and configured to extend between an obturator position (figure 4) and a punch position (figure 6), and a tubing (203) housing the shaft (figure 8-11).
As to claim 10, Krasniak discloses the tubing is formed of foam, rubber, elastomers, polymers, or combinations thereof (paragraph 175).
As to claim 11, Krasniak discloses the tubing is formed of Polyether Block Amide material (paragraph 175).
As to claim 12, Krasniak discloses the shaft is in the obturator position, the shaft is located about fully within the tubing (figure 4, paragraph 86). The tip can be separate from the shaft
As to claim 14, Krasniak discloses the handle is spring actuated handle (via 211, paragraph 87, 88).
As to claim 16, Krasniak discloses the punch obturator is employed in arthroscopic shoulder surgery (paragraph 75). The device is used on the shoulder and therefore read on the claim.
As to claim 17, Krasniak discloses a surgical kit comprising a punch obturator as in claim 1 (see above), and at least one fixation device (staples, fasteners, paragraph 75, figure 15).
Claim 1, 12 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2019/0150953 to Budyansky.
As to claim 1, Budyansky discloses a device capable of being a punch obturator (paragraph 4) comprising a handle (1204, figure 15a,b), a shaft (1206) attached to the handle and configured to extend between an obturator position (figure 15a) and a punch position (figure 15b), and a tubing (1202) housing the shaft (figure 15a,b).
As to claim 12, Budyansky discloses the shaft is in the obturator position, the shaft is located about fully within the tubing (figure 15a).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 11 is rejected under 35 U.S.C. 103 as obvious over U.S. Patent 5,242,418 to Weinstein.
As to claim 11, Weinstein discloses the device above but is silent about the tubing is formed of Polyether Block Amide. Hayakawa does disclose the tubing can be made from similar deforming polymers (paragraph 62). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the tubing comprise Polyether Block Amide 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.
Claim 11 is rejected under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2020/0023168 to Hayakawa.
As to claim 11, Hayakawa discloses the device above but is silent about the tubing is formed of Polyether Block Amide. Hayakawa does disclose the tubing can be made from similar deforming polymers (paragraph 62). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the tubing comprise Polyether Block Amide 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.
Claim 13, 15 are rejected under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2022/0409212 to Krasniak.
As to claim 15, Krasniak disclosed the device above but is silent about the shaft protrudes out of the tubing for about 1-5 mm to help penetrate tissue when the shaft is in the obturator position. Krasniak discloses the lever can rotate with respect to the depth of piercing tip (paragraph 93) and the tip can aid in positioning the device (paragraph 86). As seen in paragraph 86, 93 the extent the shaft protrudes disclosed to be a result effective variable in that the more/less the lever rotates the less/more the shaft extends out of the tube and/or helps to aid in positing the device. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Krasniak to have the shaft protrude be within the claimed range as it involves only adjusting the dimensions of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Krasniak by making the shaft protrude out of the tubing 1-5 mm in the obturator position as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claim 15, Krasniak discloses the handle is a lever configured to rotate (figure 4-6, paragraph 87, 88, 91) but is silent the lever rotates for about 90 degrees. Krasniak discloses the lever can rotate with respect to the depth of piercing tip (paragraph 93). As seen in paragraph 93 the amount of rotation is disclosed to be a result effective variable in that the more/less the lever rotates the less/more the tip is driven into bone. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Krasniak to have amount of rotation be within the claimed range as it involves only adjusting the dimensions of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Krasniak by making the amount the lever rotates be about 90 degrees as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 15, 17, 18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2019/0150953 to Budyansky.
As to claim 15, Budyansky discloses the handle is a lever configured to rotate for about 90 degrees relative to a longitudinal axis of the shaft (figure 7a-c, paragraph 88). The handle 1204 can be the lever handle of figures 7a-c. Alternatively, the handle a shaft of figure 7a-c can be used housed in the tubing of figure 15a,b. Budyansky does disclose that different modifications can be made (paragraph 131). If it would not be known that the handle of the punch obturator can be a lever, it would have been obvious to combine embodiments in order to be able to use a known handle to manually advance the shaft to puncture the bone.
As to claim 17, Budyansky discloses a surgical kit comprising a punch obturator as in claim 1 and at least fixation device (2210, 2202, paragraph 1114). The punch of figure 15a,b can be used in a kit that includes the screw/plug. Budyansky does disclose that different modifications can be made (paragraph 131). If it would not be known that the punch obturator can be used in the kit with the fixation device, it would have been obvious to combine embodiments in order to be able to use deploy the screw.
As to claim 18, Budyansky discloses a drill guide (2300, paragraph 115). The guide can be used in the kit to help assist the user in creating the punch (paragraph 1117). Budyansky does disclose that different modifications can be made (paragraph 131). If it would not be known that the kit can comprise the drill guide, it would have been obvious to combine embodiments in order to help assist the user for creating the punch.
Claims 16, 19 are rejected under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2019/0150953 to Budyansky in view of U.S. Patent Publication 10,849,734 to Holowecky.
As to claim 16, Budyansky discloses the device above but is silent about the punch obturator is employed in arthroscopic shoulder surgery.
Holowecky teaches a similar device comprising a similar punch obturator (figure 5,6) capable of being used in an arthroscopic shoulder surgery (paragraph 65) for the purpose of providing reconstruction procedures. It would have been obvious to one of ordinary skill in the art before the effective filing date for the device of Budyansky be employed in arthroscopic shoulder surgery in order for assisting in reconstruction shoulder surgery.
As to claim 19, Budyansky discloses the kit above but is silent about the at least one fixation device is a soft suture anchor comprising a flexible tubular sleeve or sheath and a plurality of flexible strand extending through a passage of the flexible tubular sleeve or sheath.
Holowecky teaches a similar device (soft tissue repairs, abstract) having where a fixation device is a soft suture anchor comprising a flexible tubular sleeve or sheath (10, figure 3, 4, paragraph 22, 25) and a plurality of flexible strands (23, 34, 32) extending through a passage of the flexible tubular sleeve or sheath (figure 3, 4) for the purpose of providing reconstruction procedures (paragraph 65). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the fixation device of kit of Budyansky be the soft suture anchor comprising the flexible tubular sleeve or sheath with strands extending therethrough as taught by Holowecky in order for providing reconstruction procedures.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 5,954,671 to O’Neill, U.S. Patent Publication 2006/0178675 to Hamman, U.S. Patent Publication 2007/0010843 to Green, U.S. Patent Publication 2020/0253604 to Westling, U.S. Patent Publication 2021/0121201 to Tierney all disclose similar devices capable of disclosing, rendering obvious, and/or providing evidence on the claims of record.
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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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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