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`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/639,038
`
`02/28/2022
`
`Stephen Kalhorn
`
`206085-0059-00US
`
`1599
`
`Riverside Law LLP
`175 Strafford Avenue
`Suite 100
`Wayne, PA 19087
`
`COMSTOCK, DAVID C
`
`ART UNIT
`3773
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`05/09/2024
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`dcoccia @riversidelaw.com
`dockets @riversidelaw.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Application No.
`Applicant(s)
`17/639,038
`Kalhornet al.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`DAVID C COMSTOCK
`3773
`Yes
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1) Responsive to communication(s)filed on 22 August 2022.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)() This action is FINAL. 2b)¥)This action is non-final.
`3) An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4)(2) Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`
`
`Disposition of Claims*
`1-5,31-34,37-39,41-42 45-53 and 55-57 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`Claim(s) 31-32 is/are allowed.
`Claim(s) 1-5,33-34,37-38,41-42,45-46,51-53 and 56-57 is/are rejected.
`)
`Claim(s) 39,47-50 and 55 is/are objected to.
`(J Claim(s
`are subject to restriction and/or election requirement
`)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:/Awww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`Application Papers
`10)C) The specification is objected to by the Examiner.
`11) The drawing(s) filed on 14 March 2022 is/are: a)[v) accepted or b)( objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`Priority under 35 U.S.C. § 119
`12)() Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`__c)LJ None ofthe:
`b)LJ Some**
`a)L) All
`1.1 Certified copies of the priority documents have been received.
`2.1) Certified copies of the priority documents have been received in Application No.
`3.2.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`*“ See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`2) (J Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20240503
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA or AIA Status
`
`The presentapplication, filed on or after March 16, 2013,
`
`is being examined underthe
`
`first inventor to file provisions of the AIA.
`
`Specification
`
`The abstract of the disclosure is objected to because it uses terminology that is implied:
`
`“The present invention provides”.
`
`The language should be clear and concise and should not repeat information given in
`
`the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,”
`
`“The disclosure defined by this invention,” “The disclosure describes,” etc. See MPEP
`
`§ 608.01(b)(I)(C).
`
`Appropriate correction is required.
`
`Claim Objections
`
`Claim 4 is objected to because of the following minor informality:
`
`Line 2, “the threaded distal section” lacks consistent antecedent basis (in claim 1, from
`
`which claim 4 depends, the term is “distal threaded section”).
`
`Appropriate correction is required.
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 3
`
`Claim Rejections - 35 USC § 103
`
`In the eventthe determination of the status of the application as subjectto AIA 35
`
`U.S.C. 102 and 103 (or as subjectto pre-AlA 35 U.S.C. 102 and 103) is incorrect, any correction
`
`of the statutory basis (i.e., changing from AIA to pre-AlA) forthe rejection will not be
`
`considered a new ground ofrejection 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 forthin 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.
`
`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
`
`ownedas of the effectivefiling date of the claimed invention(s) absent any evidenceto 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 effectivefiling 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.
`
`Claims 1-5, 34, 37, 38, 41, 45, 46, 51-53, 56 and 57 are rejected under 35 U.S.C. 103 as
`
`being unpatentable over Lorio (2015/0313720)
`
`in view of Dawson et al. (2006/0276790).
`
`Regarding claim 1, Lorio discloses a screw device (Fig. 6) for stabilizing a joint,
`
`comprising:
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 4
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`a substantially cylindrical body 204, the body having a distal threaded section 212, a
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`proximal threaded section 222, and a central ring 240.
`
`Lorio does not disclose decorticating elements.
`
`Dawson et al. disclose a decorticating device 20 (Fig. 1E) comprising decorticating
`
`elements 32 (paras. 0010 and 0028). The decorticating device facilitates joint preparation ina
`
`simple minimally invasive manner (para. 0008).
`
`It would have been obvious before the effective filing date of the claimed invention to a
`
`person having ordinary skill in the art to configure the screw device of Lorio with decorticating
`
`elements, as taught by Dawson et al., to facilitate joint preparation in a simple minimally
`
`invasive manner.
`
`Regarding claim 2, the screw device of the combination comprises a lumen 208 running
`
`betweena proximal opening and a distal opening (cf. 188 in Fig. 3 of Lorio).
`
`Regarding claim 3, the screw device of the combination further comprises a cap 262
`
`(Fig. 6 of Lorio) having a threaded lumen (para. 0059 of Lorio) sized to fit overthe proximal
`
`threaded section 222 of the body 204 andaproximal lip 264 (Fig. 6 of Lorio) having a diameter
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`greater than a diameter of the cap 262(id.).
`
`Regarding claim 4, the central ring 240 is independently rotatable from the threaded
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`distal section 212 (paras. 0061-0062 of Lorio).
`
`Regarding claim 5, the screw device of the combination furthercomprises one or more
`
`lateral openings 190 (cf. Fig. 3 of Lorio and see para. 0067) fluidly connected to the lumen 208.
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 5
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`Regarding claim 34, the screw device of the combination comprises a pointed tips (e.g.,
`
`sharp edge formed between portion 214 and 216; Fig. 6 of Lorio) at a distal end.
`
`Regarding claim 37, the central ring 240 is attached to the proximal threaded section
`
`222, such that the central ring and proximal threaded section are independently rotatable from
`
`the distal threaded section 212 (paras. 0061-0062 of Lorio).
`
`Regarding claim 38, the central ring 240 of the combination is movable in proximal and
`
`distal directions to increase the reach of the one or more decorticating elements(cf. Fig. 2 and
`
`paras. 0035-0036 of Lorio, and Fig. 1£ of Dawson et al.).
`
`Regarding claim 41, the cap 262 comprises one or more surface voids (e.g., opening of
`
`lumen 208; Fig. 8) configured to accept graft material (para. 0067).
`
`Regarding claim 45, the one or more decorticating elements 32 (Fig. 1E of Dawson et al.)
`
`of the combination are moveable betweenaclosed position (Fig. 1A) and an open position (Fig.
`
`1E).
`
`Regarding claim 46, the closed position (Fig. 1A of Dawson etal.) positions the
`
`decorticating elements 32 adjacent to the central ring 240 (Fig. 6 of Lorio) of the combination
`
`such that they have a diameter substantially equal to a diameter of the distal threaded section
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`212 (Fig. 6 of Lorio; and cf. 28 in Fig. 1A of Dawson et al.), and wherein the open position (Fig.
`
`1E of Dawson et al.) positions the decorticating elements 32 away from the central ring 240
`
`such that the decorticating elements extend beyond the diameter of the distal threaded section
`
`212 (cf. Fig. 3 of Lorio; and cf. 28 in Fig. 1E of Dawson et al.).
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 6
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`Regarding claim 51, the one or more decorticating elements 32 (Fig. 1E of Lorio) of the
`
`combination are at least partially pliable and are bendable from a closed position (Fig. 1A) to an
`
`open position (Fig. 1E; para. 0026 of Dawson et al.).
`
`Regarding claim 52, the screw device of the combination discloses the claimed invention
`
`including decorticating elements 32 (Fig. 1E of Dawson et al.; elements 32 are blades) but does
`
`not explicitly recite at least one serration. However, it would have been obvious before the
`
`effective filing date of the claimed invention to a person having ordinary skill in the art to
`
`provide the blades in any desired configuration, including serrated, as this is an ef fective and
`
`ubiquitous blade configuration that would be immediately envisaged.
`
`Regarding claim 53, the proximal threaded section 222 (Fig. 6 of Lorio) has a diameter
`
`that is less than a diameter of the distal threaded section 212 (id.).
`
`Regarding claim 56, the screw device (Fig. 6 of Lorio) of the combination has a length
`
`between about 10 mm and about 150 mm (e.g., 90 mm; para. 0051).
`
`Regarding claim 57, the screw device of the combination has an outer diameter
`
`between about 5 mm and about 50 mm (e.g., 20 mm; para. 0052).
`
`Claims 33 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Lorio
`
`(2015/0313720)
`
`in view of Dawson et al. (2006/0276790), as applied above, and furtherin view
`
`of Whipple etal. (2016/02428 20).
`
`The screw device of the combination of Lorio and Dawson et al. discloses the claimed
`
`invention except for one or more cutting flutes at a distal end.
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 7
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`Whipple et al. teach a bone screw 10A (Fig. 1) having one or morecutting flutes 11 ata
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`distal end opening (at 15) to a lumen 12 (paras. 0038 and cf. Figs. 7B and 9 and para. 0040). The
`
`flutes opening to the lumen facilitate cutting and capturing bone tissue fragments during a
`
`surgical proceduretofacilitate fusion (paras. 0040 and 0043).
`
`It would have been obvious beforethe effective filing date of the claimed invention to a
`
`person having ordinary skill in the art to configure the screw device of the combination of Lorio
`
`and Dawson etal. to have one or morecutting flutes at a distal end opening to the lumen, in
`
`view of Whipple et al., to facilitate cutting and capturing bone tissue fragments during a
`
`surgical proceduretofacilitate fusion.
`
`Regarding claim 42, the screw device of the combination of Lorio and Dawson et al.
`
`discloses the claimed invention except for a cap comprising a thread-locking insert positioned
`
`at a proximal end of the threaded lumen (supra).
`
`Whipple et al. teach that a cap 40 comprising a thread-locking insert 33 can be
`
`positioned at a proximal end of a threaded lumen (Fig. 7B and para. 0042). The cap helps retain
`
`bone growth promoting material and provides an alternative means to engage a simple driving
`
`tool where desired.
`
`It would have been obvious before the effective filing date of the claimed invention to a
`
`person having ordinary skill in the art to configure the screw device of the combination of Lorio
`
`and Dawson etal. with a cap comprising a thread-locking insert positioned at a proximal end of
`
`a threaded lumen,in view of Whipple et al., to help retain bone growth promoting material and
`
`provide an alternative means to engage a simple driving tool where desired.
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 8
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`Allowable Subject Matter
`
`Claims 31 and 32 are allowable over the prior art of record.
`
`Claims 39, 47-50 and 55 are objected to as being dependent upona rejected base claim,
`
`but would be allowable if rewrittenin independent form including all of the limitations of the
`
`base claim and anyintervening claims.
`
`Conclusion
`
`The prior art made of record and not relied upon is considered pertinent to applicant's
`
`disclosure.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to David Comstock whose telephone number is (571) 272-4710.
`
`The examiner can normally be reached Monday-Friday, 9 a.m. - 6 p.m.
`
`If attempts to reach the examiner by telephone are unsuccessful, please contact the
`
`examiner’s supervisor, SPE, at (571) 272-4719. The fax phone number for the organization
`
`wherethis application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR
`
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`
`PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 9
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`would like assistance from a USPTO Customer Service Representative or access to the
`
`automated information system, call 800-786-9199 (IN USAOR CANADA) or 571-272-1000.
`
`/DAVID C COMSTOCK/
`Examiner, Art Unit 3773
`
`/TESSA M MATTHEWS/
`Examiner, Art Unit 3773
`
`