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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/30/26 has been entered.
Claims 67, 69-71, 73-85, 87-88 remain pending, of which claims 77-85 are withdrawn.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 67, 69-71, 73-76, 87-88 is/are rejected under 35 U.S.C. 103 as being unpatentable over HENNESSY (US 2006/0067980) newly cited, in view of CHEN (US 2009/0024223) previously cited.
Regarding claim 67, 70, HENNESSY discloses a device 20 with holder 6 for a drug core (graft holder) comprising:
a base portion 10 (base surface);
a cavity formed from a wall 6,7 extended from the base 10 to top opening 12, configured so that the drug core (graft) is securely nestled therewith (Fig 1);
a cap 1 provided and sized to seal the top opening 12 of the holder 6 (configured to provide protection to a top portion of the graft while allowing fluid access to the graft through a passageway 9 (one or more fluid passages) (Fig 1);
wherein the holder 6 is made of silicone (0018), from which the entire device 20 is molded (integrally formed from molded silicone)(0029).
HENNESSY discloses passageway 9 can be placed in other portions of the holder 6 than the base (gaps in cavity wall) (0018), but does not explicitly disclose the cavity wall further comprises one or more gaps configured to permit passage of a tool.
However, CHEN discloses an osteochondral plug (graft) holder 61 comprising a bottom 60 (base) and a cavity formed from a cavity wall extended from the base 61, 63, the cavity configured so the osteochondral bone portion 7,29 (graft) is secured (securely nested therewith) during use (Fig 7-8, 0075, 0069-70), the holder is configured to provide protection to a top portion of the graft 7, 29 as the cavity walls extend beyond the height of the graft (internal walls of cavity are taller than graft) and has slots 62, 64 (fluid passages and/or one or more gaps) created along a longitudinal direction of the holder around the circumference that allow fluid access to the entirely of the graft and allow tools to move through the slots to access the graft (are capable of permitting passage of an appropriately sized graft retrieval tool) (Fig 7-8, 0075, 0130).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the holder of HENNESSY to include the gaps in the cavity wall as taught by CHEN because they allow for the ability to access the graft inside the holder which would allow for precision placement of the graft to ensure it is entirely within the holder or for the injection of any additional substances deemed necessary by the implant team.
It is noted the limitation regarding “for securely transporting a graft” and “when being transported” refers to an intended use of the device and does not further limit the structure of the claimed device. The holder of HENNESSY in view of CHEN is capable of being transported and to protect the graft as it is fully surrounded by the holder (HENNESSY Fig 1, CHEN Fig 8).
Regarding claim 69, HENNESSY discloses there is an opening 12 (hole) to access the inner cavity that is capable of being used to remove the drug core (graft) out of the cavity, but does not disclose the hole is extended between the base surface and the cavity.
However, CHEN discloses between the bottom surface and the cavity is an opening 59 (hole) through which the graft can be removed when the bottom bolt is unscrewed (0075, Fig 8).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the holder of HENNESSY to include the hole being located extending between the base and cavity as taught by CHEN because it allows the insertion of a support for the bottom portion of the graft (0075).
Furthermore, the location of the hole extending between the base and cavity merely represents a rearrangement of parts without substantially affecting functionality or operation, and therefore is prima facie obvious. See MPEP 2144.04.
Regarding claim 71, HENNESSY discloses the cavity is largely open 12 to reveal a top portion of the drug core (graft) when a cap is not used (Fig 1).
Regarding claim 73, HENNESSY does not explicitly disclose the cavity wall further comprises peripheral surfaces that are reinforced structures.
However, CHEN discloses peripheral surfaces of the cavity wall as set screws positioned in an extremity of the wall for further securing the plug (graft), the screws 57 capable of providing extra support (reinforcing, enhancing structural integrity) and shielding (Fig 7-8, 0075).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the holder of HENNESSY to include the peripheral surfaces with reinforced structures as taught by CHEN because they allow for further securing the graft, adjusting the centerline to the correct placement, and providing extra support on the graft to minimize stress while it is being manipulated (0075).
Regarding claim 74, HENNESSY discloses the dimension of the device can vary depending on the size of the inner drug core (diameter varies depending on size of graft) (0030), but does not explicitly disclose the cavity is configured to house a plurality of different sized grafts.
However CHEN discloses the diameter of the cavity is slightly larger than the largest diameter of graft and the screws adjusted to hold the graft securely (capable of housing a plurality of different sized grafts) (Fig 8d-f).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the holder of HENNESSY to include the diameter of the cavity configured to house a plurality of different sized grafts as taught by CHEN because it allows for use of one holder for a range of sizes of grafts rather than needing to mold or machine each holder individually.
Regarding claim 75, HENNESSY discloses the inner walls of the cavity are taller than the drug core (graft) (Fig 1).
Regarding claim 76, HENNESSY does not explicitly disclose the cavity wall 6 further comprises regions of vertical cavities configured to permit flow of transport fluid to access the graft.
However, CHEN discloses the slots 62, 64 (regions of vertical cavities) in the cavity wall that would allow flow of fluid to access the graft (Fig 8 a, b).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the holder of HENNESSY to include the vertical cavities in the cavity wall as taught by CHEN because they allow for the ability to access the graft inside the holder which would allow for precision placement of the graft to ensure it is entirely within the holder or for the injection of any additional substances deemed necessary by the implant team.
Regarding claim 87-88, CHEN discloses the holder has an open upper end and slots 62, 64 (gaps) created along a longitudinal direction of the holder around the circumference, (Fig 7-8, 0075) either of which are capable of permitting passage of an appropriately sized graft retrieval tool, such as forceps or threaded surfaces. It is noted the limitation regarding “wherein the graft tool is/comprises” are considered functional limitations merely describing the size of the gaps of the holder based on the tools it is used with. The graft retrieval tool itself is not a positively recited structure in the claimed device.
Response to Arguments
Applicant’s arguments with respect to claim(s) 67, 69-71, 73-76, 87-88 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The references cited on the attached PTO 892 are considered related to the state of the art of applicant’s invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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