DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/04/2025 has been entered.
Priority
This application claims priority from application 12/408,391 filed on 03/20/2009.
Status of Claims
Claims 1-11 are pending.
Election/Restrictions
Applicant elected Species 1 (Figures 1-7, 14, and 15) and Species A (Figures 5-6) on 10/28/2024. 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 § 818.03(a)).
Drawings
The drawing objections have been withdrawn in view of the applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112
The 112 rejections have been withdrawn in view of the applicant’s amendments.
Claim Rejections - 35 USC § 103
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 1-11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al (Jones) US 2007/0219638 A1 in view of Walch et al (Walch) USPN 5,702,447.
Claim 1. Jones discloses a method of implanting a glenoid assembly 1 (Figures 16-17) , comprising: forming a first bore in a glenoid region of a scapula [0032] and Figure 17; inserting a first peg 8 of a glenoid component into the first bore (Figure 17)
However, Jones does not disclose step of slightly elastically deforming the passageways within the pegs, while the pegs are inserted into the first bore, by inserting stiffening pins into the passageways (it is noted that the phrase slightly elastically deforming is being broadly interpreted to mean any deformation within the range of a minimal change to anything other than a drastic change).
Walch teaches the use of a glenoid component (Figures 1-5) comprising a peg 2b with a passageway (large central bore) and a stiffening member 4 which when inserted slightly elastically deforms the sidewalls of the passageway (Figures 2-5 show advancement and rotation of the screw pulls the nut further into the passageway to slightly deform the sidewalls of the passageway) in the same field of endeavor for the purpose of providing additional anchoring forces and helping the peg to remain in the bore and resist pullout.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify both pegs of Jones to include elastically deformable sidewalls and screw members as taught by Walch in order to provide pegs with improved attachment to the implant site.
Claim 2. Jones discloses forming a second bore in the glenoid region of the scapula [0032]; inserting a second peg 9 of the glenoid component into the second bore (Figure 17). The step of slightly elastically deforming the passageways within the pegs, while the pegs are inserted into the first bore, by inserting stiffening pins into the passageways is taught by the combination described above with respect to the other peg.
Claim 3. Jones discloses flexing the first peg in a direction toward a second peg to a flexed position (Figure 12), whereat the first ped is curved along a length of the first peg (Jones shows the Pegs have a straight initial configuration so when bent inward, they will inherently have at least a small curved portion along their length in the same manner as the applicant’s invention) before inserting the first peg of the glenoid component into the first bore (Figure 12), wherein inserting the first peg of the glenoid component into the first bore comprises: partially inserting the first peg of the glenoid component into the first bore while the first peg is in the flexed position [0074].
Claim 4. Jones discloses inserting the first peg of the glenoid component into the first bore further comprises: releasing the first peg from the flexed position with the first peg partially within the first bore [0074]; and fully inserting the first peg into the first bore after releasing the first peg from the flexed position (this step is inherent because without releasing the peg the tool would block it from being fully inserted).
In regards to Claims 5-8, the claim limitations are merely providing specific dimensions for the pegs and passageways. However the original disclosure of this application and the parent applications have failed to provide any evidence of the criticality of the claimed ranges. The specifications merely say that the pegs with these dimensions possess a flexible quality, but then attributes this partially to the material used. A person of ordinary skill in the art would recognize that these specific ranges are not an unexpected product of novelty or invention. The ranges are a mere optimization of known variables which could be achieved through routine experimentation. These ranges are at or near those of common usage within the art see USPN 4,964,865 and USPN 5,549,691. Therefore it would have been obvious to one of ordinary skill in the art of glenoid implants to provide the first and second anchor pegs with lengths of 19-21 mm and diameters which resulted in a diameter to length ratio between 0.16 and 0.22 in order to provide optimal anchoring ability and minimize the bores made in the implant site. Additionally, it would have been obvious to one of ordinary skill in the art to make the anchor peg passageways have unbiased width between 0.6 and 0.8 mm in order to provide optimal stiffening/strengthening of the pegs.
Claim 9. Jones discloses partially inserting the first peg of the glenoid component into the first bore while the first peg is in the flexed position comprises (Figure 12) [0074]: inserting at least one fin (defined between grooves 20) of the first peg into the first bore.
Claim 10. Jones discloses flexing the first peg in a direction toward a second peg to a flexed position (Figure 11s and 12), before inserting the first peg of the glenoid component into the first bore (Figure 12), comprises: applying pressure to the first peg at a location between a fin of the first peg and a scapula-facing side of a base component of the glenoid component (Figure 12 appears to show a lower location but there is plenty of room on the pegs for the location to be moved closer to the scapula facing side of the base. It would have been obvious to one of ordinary skill in the art to move the contact location closer to the scapula facing side of the base at the time the invention was filed in order to provide more peg length for aligning and partial insertion into the hole, thereby stabilizing the implant better after release from the insertion tool).
Claim 11. Jones as modified by Walch discloses the modified first passageway extends through a base component of the glenoid component (Walch Figures 1-5)(Jones only provides a single base component); and inserting the first stiffening pin into the first passageway includes inserting the first stiffening pin through the base component and into the first passageway (Figure 41C).
Response to Arguments
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
It is noted that the beginning of the applicant’s arguments with respect to Walch on page 8 have been cut off by reformatting of a Figure.
It appears the applicant is arguing that the screw does not cause deformation by insertion because the nut causes deformation. This is not persuasive because for the device of Walsh to work the nut and peg must be inserted into the bone bore prior to insertion of the screw. The screw is then advanced using rotation and translation. The combination of translation and rotation causes the nut to translate and rotate along the screw which then slightly deforms and walls of the peg to have an enlarged shape. The enlarged shape applies frictional and compressive forces to the bore thereby locking the screw and nut in the passageway as well as locking the screw, nut, passageway, and bore together. After the enlarging the peg through slight deformation all of the structures are locked together.
The applicant further argues that the screw cannot be called a stiffening pin. There is no factual evidence as to support this claim. Prior to insertion of the screw the nut and walls of the peg would be flexible and able to move within the bore. Inserting the screw causes the expansion to thereby stiffen the entire peg structure within the bore.
The applicant then argues that deformation of this sidewall does not aid in retaining the nut within the wing and that the nut cannot be a stiffening pin. This argument is misplaced because this is not required by the claims or speculated by the rejection. Furthermore, as explained above the expansion of the peg side walls by advancement of the screw which pulls the nut would inherently help retain both the screw and the nut within the passageway because the expansion causes frictional and compressive forces due to the new enlarged shape.
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 on (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