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 .
Priority
This application claims priority from provisional application 63/741803, filed 01/03/2025.
Status of Claims
Claims 8-11 and 13-22 are pending.
Claims 21 has been withdrawn from consideration.
Claims 1-9 and 12 have been cancelled.
With respect to the claim numbering. The original claims included two claim 11s. In the most recent response the applicant attempted to cancel the second claim 11 and continue the numbering as if it was never filed. However, this is not the proper procedure, because claims cannot be skipped. The second claim 11, now claim 12, has still been cancelled but it’s number has been adjusted. The following claims are then all renumbered from being claims 12-21 to claims 13-22. The claim are being addressed by their new numbers in this office action and moving forward. The applicant’s next response must include the proper claim numbering as well as proper dependency.
Information Disclosure Statement
The Information Disclosure Statement filed on 01/05/2626 and 05/29/2026 have been considered by the examiner.
The information disclosure statement filed 01/05/2626 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because there is no publication date included in the citation for the crossed out reference. It has been placed in the application file, but the information referred to therein has not been considered on the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The specification is objected to because of improper formatting. Specifically the First paragraph on the first page must include the priority information. The current specification includes a general address and the details of the inventors. This should be moved to be below the priority information or deleted from the specification.
Claim Objection
The claims define the outer diameter of the pin as a given outer diameter, which is excessive and unnecessary. This is also an issue when describing the length of the pin. The applicant is advised to delete given from all recitations.
Claim 9 is objected to for being unnecessarily long and wordy. The first 4 lines do nothing more than define the two lengths. The applicant is advised to amend claim 9 to say the pin has a length that is shorter than 150% of a length of the guide. If desired the applicant can also add on the recitation about penetrating the subchondral bone beyond the guide to the end, but this is considered intended use anyways.
Claim 12 is objected to for a minor typo in line 2. The applicant is advised to amend line 2 to say: “positionable in a flush orientation”.
Claim 18 is objected to for including the reference number 255 in line 2. The applicant is advised to delete the reference number.
Claim 18 is objected to for grammatical errors. The last line should be amended to say “adjacent to the reamer to obtain a precise measurement”. The term highly should be deleted because it is redundant with the term precise.
Claim 19 is objected to for being unnecessarily long and wordy. As best understood the applicant intended to define the core of the tamp as being concave. The applicant is advised to amend claim 19 to recite: The instrument kit in accordance with claim 8, further comprising a dilator with tamp, the tamp comprising a concave core which aids with direct contact distributed across the core which minimizes damage and allows for optimized insertion.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke § 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke § 112(f) except as otherwise indicated in an Office action.
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 8-11, 13-20, and 22 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 lacks antecedent basis for “the width” in line 7. It should be amended to say “a width”.
Claim 8 also has antecedent basis issues because it uses the same names for the ends and passageways of the guide and reamer. In the last paragraph it is unclear if the applicant is referring to the ends and passageways of the reamer or guide. The applicant is advised to amend all recitations to identify the component or to further define them and third/fourth ends and second passageway.
Claim 9 is rendered indefinite by the word suitable. Suitable is not a term of specific degree. It is a term open to interpretation and its scope is a matter of opinion. What is suitable for one person is not necessarily suitable for the next person. Therefore the scope of suitable is indefinite. The applicant is advised to delete all recitations of suitable.
Claim 19 lacks antecedent basis for “the entire surface” in line 3. The applicant is advised to replace “the” with “a”.
Claim 20 lacks antecedent basis for “the dilator with tamp” in line 1. The applicant is advised to amend claim 20 to depend upon claim 19, which introduced the dilator.
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.
Claim(s) 8-11, 13-17, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steiner et al (Steiner) US 2009/0299371 A1 in view of Ribeiro et al (Ribeiro) US 2013/096680 A1.
8. Steiner discloses the invention substantially as claimed being an instrument kit (20 Figure 16) for a cryopreserved osteochondral allograft (COCA) transplantation procedure (the kit has all the same components and is fully capable of being used to implant a COCA), the instrument kit comprising:
a pin 50 having a first end and a second end in opposition to one another (left and right sides of 50 in Figure 16), a given outer diameter (every cylindrical object inherently has a diameter), and the first end configured to penetrate subchondral bone (drill tip 54 Figure 7);
a pin guide 30 having a first end and a second end (top and bottom sides of 30 in Figures 2, 3, and 6), the pin guide forming a passageway 42 extending between the first end and the second end (Figure 6), the passageway configured to slidingly receive the pin, with the width of the passageway corresponding to the given outer diameter of the pin to allow sliding motion of the pin therein without deflection from a longitudinal axis extending between the first end and the second end of the pin [0059] Figure 6; and
a reamer 90, the reamer having a first end and a second end (left and right sides of 90 in Figures 8, 9, and 12), the reamer forming a passageway (cannulation shown in Figure 12) extending between the first and the second end (Figure 12), the passageway configured to slidingly receive the pin (Figure 14), with the width of the passageway corresponding to the given outer diameter of the pin to allow sliding motion of the pin therein without deflection from a longitudinal axis extending between the first end and the second end of the pin [0062] Figure 14, a set of blades 94 at the first end (left side Figure 9), and a rotational drive connector 97 at the second end (right side Figure 9).
However, Steiner does not disclose a reamer with an adjustable stop configured with a selectable depth adjustment button.
Ribeiro teaches the use of a reamer (Figure 19) comprising an adjustable stop 380 configured with a selectable depth adjustment button (adjustable strips 386/392) [0073] in the same field of endeavor for the purpose of allowing the stop to be moved along the drill shaft to achieve the desired stop measurement.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to combine the adjustable stop of Ribeiro with the button with reamer of Steiner in order to allow the user to apply a stop to the reamer that is adjustable during surgery in order to achieve a precise reaming depth.
9. Steiner as modified discloses the pin guide has a given length (everything has a length), the pin has a suitable length corresponding to the given length of the pin guide (Figure 1), the suitable length being longer than the given length of the pin guide to penetrate subchondral bone beyond the pin guide (Figure 1), and the suitable length being shorter than 150 percent of the given length of the pin guide (the pin has a variety of lengths that can be identified including measuring the length of different components, the length from the threads to the opposite end, the length from a specific thread to the opposite end, and length from different drill markings to the drill tip, at least one of these identifiable lengths is less than 150% of the length of the guide).
10. Steiner as modified discloses the pin guide has a pin guide window (between posts 38) having a given diameter (the diameter is the same as the diameter of the posts 38), and the pin guide window configured to center the passageway of the pin guide with respect to an osteochondral defect and encompass the osteochondral defect (the window allows visual tracking of the pin relative the defect to center the passageway 42).
11. Steiner as modified discloses the pin guide window (between posts 38) positionable to in a flush orientation with the osteochondral defect (the window and posts 38 are capable of being flushly placed adjacent any defect) and provide the passageway of the pin guide in a perpendicular orientation with a surface of the cartilage (the passageway 42 will extend perpendicularly if the windows in the tip of the guide are placed parallel to the cartilage surface).
12. (Cancelled)
13. Steiner as modified discloses the reamer has a blade construction with winged blades (94 Figures 8-12), and the blade construction is configured to score cartilage before cutting the subchondral bone so as to provide a cut in the subchondral bone with a clean profile at a surgical site [0062].
14. Steiner as modified discloses the reamer includes a reamer bit portion and scoring bit portion integral with one another, the reamer providing the scoring bit portion at a location to first score surrounding cartilage prior to the reamer bit portion reaming the subchondral bone to the desired depth [0062][0063] (Figures 8-12).
15. Steiner as modified discloses the adjustable stop of the reamer is configured to adjust the cutting depth of the reamer by depressing the selectable depth adjustment button and sliding the reamer to a desired depth (The modification includes the adjustable stop 380 of Ribeiro configured with a depressible depth adjustment buttons 386/392 which allow sliding to any desired depth [0073]).
16. Steiner as modified discloses the reamer is configured attach to a drill thereto (quick connect 97 is designed to connect to a drill) and ream coaxially along the pin (Figure 14) into the subchondral bone until the adjustable stop is flush with a cartilage surface so as to create a recipient socket (Figure 15).
17. Steiner as modified discloses a depth guide configured for measurement of an osteochondral allograft recipient socket [0063].
22. Steiner as modified the adjustable stop of the reamer is configured to provide adjustments depths of 5 mm, 7.5 mm, 10 mm, 12.5 mm and 15 mm (in view of the modification including the infinitely adjustable reamer of Ribeiro the stop is fully capable of providing a adjustment depth at any depth including 5, 7.5, 10, 12.5, and 15 mm).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steiner and Riberio (Combination 1) as applied to claims 8-11, 13-17, and 22 above, and further in view of Dmitrij et al. (Dmitrij) SU 606578 (cited in the IDS Received on 05/29/2026).
Combination 1 discloses the invention substantially as claimed being described above. However, Combination 1 does not disclose the specific configuration of the depth guide.
Dmitrij teaches the use of a depth guide including a depth stop with a right angle adjacent to the reamer (Guide 3, adjacent to Drill 2, including Clamp 6 at drilling site, including a right-angled distal end, page 4, para [6]; figures 1, 2) in the same field of endeavor for the purpose of providing a stable depth guide preventing lateral movement and providing enhanced accuracy for the depth control
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the depth guide of Dmitrij with the kit of Steiner in order to provide the user with stable precise depth control over the drilling and reaming.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steiner and Riberio (Combination 1) as applied to claims 8-11, 13-17, and 22 above, and further in view of Miller et al. (Miller) US 2011/0054537 A1.
Combination 1 discloses the invention substantially as claimed comprising a dilator [0063] [0070]. However, Combination 1 does not disclose the dilator with a tamp comprising a contoured concavity.
Miller discloses dilator with tamp (Tamp 360 within dilator 322; Figure 25 [0075]), and the tamp contoured with a concavity of a core to ensure contact around the entire surface during insertion of the core so as to ensure direct contact distributed across the core (tamps flat or otherwise shaped tamping ends [can include shape matching core concavity] to press the bone fusion material into the prepared bone, the end shown with slight concavity in the center; figure 25; para 100751).
It would have been obvious to one of ordinary skill in the art at the time of filling to replace the dilator of Steiner with the dilator and tamp of Miller to ensure contact around the entire surface during insertion of the core so as to ensure direct contact distributed across the core.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steiner, Riberio, and Miller (Combination 2) as applied to claims 8-11, 13-17, and 22 above, and further in view of Gustafson et al. (Gustafson) US 2022/0038790 A1.
Combination 2 discloses the invention substantially as claimed comprising a dilator and tamper. However, Combination 2 does not disclose the dilator with a tamp comprising a suture grips.
Gustafson discloses a dilator including suture grips configured to wrap suture around a distal portion of a graft and retain the graft to remain in selective attachment to the suture grips until final placement of the graft (Surgical system 100 includes Outer shaft 102, including a Distal dilator end 114 configured to form a bone hole, and a Proximal end including openings 115a, 115b for passage of Suture 204, wrapped around Tissue 202; when tension is maintained on the Suture 204, the Tissue 202 can be brought closer to the bone hole 212 to position it relative to the bone 200 as desired; figures 6A, 8A-8C; paras [0049], [0066], [0070], [0071]).
It would have been obvious to one of ordinary skill in the art at the time of filling to modify the dilator of Steiner to include suture grips taught by Gustafson in order to wrap suture around a distal portion of a graft and retain the graft to remain in selective attachment to the suture grips thereby providing secure transfer of tissue to a bone defect area.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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