www.uspto.gov
`
`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
`
`11/25/2024
`
`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 08 August 2024.
`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*
`1-3,5,31-34,37-38,41-42,45-46,51-53 and 56-63 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`Claim(s) 31-32 and 59 is/are allowed.
`Claim(s) 1-2,5,33-34,38,41-42,45-46,51-53,56-58 and 60-63 is/are rejected.
`)
`Claim(s) 3and37 is/are objectedto.
`are subject to restriction and/or election requirement
`() Claim(s)
`* If any claims have been determined allowable, you may beeligible 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 20241116
`
`

`

`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.
`
`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 jointinventor regards as the
`invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`The specification shall conclude with one or moreclaims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`Claims 41 and 42 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), 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-AlA 35 U.S.C.
`
`112, the applicant), regards as the invention.
`
`In both claims 41 and 42, “the cap” lacks antecedent basis in claim 5. For examination
`
`purposes, and as best understood, claims 41 and 42 will be treated as depending from claim 3.
`
`Appropriate correction is required.
`
`Claim Rejections - 35 USC § 102
`
`In the event the determination of the status of the application as subjectto AIA35
`
`U.S.C. 102 and 103 (or as subjectto pre-AlA 35 U.S.C. 102 and 103) is incorrect, any correction
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 3
`
`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 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 ina 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, 2, 5, 33, 34, 38, 45, 46, 52, 53, 58, 60, 62 and 63 are rejected under 35 U.S.C.
`
`102(a)(1) as being anticipated by Hesset al. (2014/0194930).
`
`Regarding claim 1, Hess et al. disclose a screw device (annotated Figs. 10 and 11, below,
`
`and cf. Figs. 6-15) capable of decorticating, comprising:
`
`a substantially cylindrical body, e.g., 200, the body having a distal threaded section, e.g.,
`
`212, a proximal threaded section, a central ring, having one or more decorticating elements;
`
`wherein the central ring (e.g., the portion thereof indicated) is independently rotatable
`
`from the distal threaded section (see annotated Figs. 10 and 11, below).
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 4
`
`
`portion of central ring
`independentlyrotatable from
`
`
`cutting flutes
`
`distal threaded secthan
`
`proximal lateral
`openings (slots)
`
`
`
`
`
`proximal threacied sectian
`
`ceriral ring
`
`
`
`
`Fig. 77
`
`* decoarticating elements
`ispikes}
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 5
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`Regarding claim 2, the screw device furthercomprises a lumen (annotated Figs. 10 and
`
`11) running betweena proximal opening and a distal opening (id.).
`
`Regarding claim 5, the screw device furthercomprises one or morelateral openings
`
`fluidly connected to the lumen (id.).
`
`Regarding claim 33, the screw device comprises one or more cutting flutes at a distal
`
`end (id.).
`
`Regarding claim 34, the screw device comprises one or more round pointed tips ata
`
`distal end (id.).
`
`Regarding claim 38, the central ring is movable in proximal and distal directions to
`
`increase the reach of the one or more decorticating elements (cf. annotated Figs. 10 and 11).
`
`Regarding claim 45, the one or more decorticating elements are moveable betweena
`
`closed position and an open position (cf. annotated Fig. 10 vis-a-vis Fig. 11).
`
`Regarding claim 46, the closed position positions the decorticating elements(e.g., those
`
`on element 216; Fig. 10) adjacent to the central ring such that they have a diameter
`
`substantially equal to a diameter of the distal threaded section (annotated Fig. 10), and
`
`wherein the open position positions the decorticating elements away from the central ring such
`
`that the decorticating elements extend beyond the diameter of the distal threaded section
`
`(annotated Fig. 11).
`
`Regarding claim 52, the one or more decorticating elements (annotated Fig. 10)
`
`comprises at least one serration (each spike is considered to be one serration).
`
`Regarding claim 53, the proximal threaded section has a minor diameter that is less than
`
`a major diameter of the distal threaded section (cf. Fig. 6).
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Regarding claim 58, the screw device comprises:
`
`Page 6
`
`a substantially cylindrical body, e.g., 200, the body having a distal threaded section, e.g.,
`
`212, a proximal threaded section (annotated Fig. 11), a central ring (id.) having one or more
`
`decorticating elements(id.);
`
`a lumen running betweena proximal opening and a distal opening of the body (id.); and
`
`two or more externalslots (annotated Fig. 11) formed between the distal threaded
`
`section, the central ring, and the one or more decorticating elements, such that each external
`
`slot has a size that is capable of receiving a pin of a screw driving device, e.g., a tip thereof,if
`
`desired.
`
`Regarding claim 60, the screw device comprises:
`
`a substantially cylindrical body, e.g., 200, the body having a distal threaded section, e.g.,
`
`212, a proximal threaded section (annotated Fig. 11), a central ring (id.) having one or more
`
`decorticating elements(id.); and
`
`a lumen (id.) running betweena proximal opening and a distal opening of the body;
`
`wherein the one or more decorticating elements are moveable betweena closed
`
`position and an open position (cf. annotated Fig. 10 vis-a-vis Fig. 11); and
`
`wherein the one or more decorticating elements are hingedly connected to the central
`
`ring along an axis that is perpendicular to a long axis 12, 13 of the body and splay outwards
`
`from the closed position to the open position (cf. annotated Figs. 10 and 11).
`
`Regarding claim 62, Hesset al. disclose a decorticating screw device 300 (Figs. 14-17; cf.
`
`annotated Figs. 10 and 11, supra) comprising:
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 7
`
`a substantially cylindrical body 300, the body having a distal threaded section 312, a
`
`proximal threaded section (cf. annotated Figs. 10 and 11), a central ring (id.) having one or
`
`more decorticating elements(id.); and
`
`a lumen (id.) running betweena proximal opening and a distal opening of the body (id.);
`
`wherein the one or more decorticating elements are moveable betweena closed
`
`position and an open position (cf. Figs. 14 and 15); and
`
`wherein the one or more decorticating elements are sheathed within the central ring in
`
`a closed position (Fig. 14) and are slidable outwards from the closed position to the open
`
`position (Fig. 15).
`
`Regarding claim 63, the screw device comprises:
`
`a substantially cylindrical body. e.g., 200, the body having a distal threaded section 212,
`
`a proximal threaded section (annotated Fig. 11), a central ring (id.) having one or more
`
`decorticating elements;
`
`a lumen (id.) running betweena proximal opening and a distal opening of the body; and
`
`a lock screw portion 260 of the central ring having a diameter larger than a diameter of
`
`the screw device lumen (id.), the lock screw being drivable into a proximal opening (back of
`
`224, 226) of the screw device to expand a proximal end of the screw device (annotated Figs. 10
`
`and 11, cf. Fig. 13).
`
`Claim Rejections - 35 USC § 103
`
`In the event the determination of the status of the application as subjectto AIA35
`
`U.S.C. 102 and 103 (or as subjectto pre-AlA 35 U.S.C. 102 and 103) is incorrect, any correction
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 8
`
`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 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 ownedas 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 51 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Hess etal.
`
`(2014/0194930)
`
`in view of Aschmann et al. (2007/0032790).
`
`Regarding claim 51, Hess et al. disclose the claimed invention, as set forth above, except
`
`for explicitly reciting that the decorticating elements are at least partially pliable and bendable.
`
`Aschmann et al. teach that bone engaging projections can be configured to berigid or
`
`pliable and bendable, as desired, e.g., to withstand the forces exerted thereon without breaking
`
`(see, e.g., para. 0057).
`
`It is noted that in Hesset al. the projections include the base thereof,
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 9
`
`e.g.,224, and are for engaging bone, while also being capable of decorticating because of their
`
`sharp shape).
`
`It would have been obvious to a person having ordinaryskill in the art before the
`
`effective filing date to configure the decorticating elements of Hesset al. (e.g., the base 224
`
`thereof), in view of Aschmann et al., to withstand the forces exerted thereon without breaking.
`
`Regarding claim 61, Hesset al. disclose a decorticating screw device, e.g., 200,
`
`comprising:
`
`a substantially cylindrical body 200 (annotated Figs. 10 and 11), the body havinga distal
`
`threaded section, e.g., 212, a proximal threaded section (id.), a central ring (id.) having one or
`
`more decorticating elements(id.); and a lumen (id.) running betweenaproximal opening and a
`
`distal opening of the body (id.);
`
`wherein the one or more decorticating elements are moveable betweenaclosed
`
`position and an open position (cf. Fig. 10 vis-a-vis Fig. 11); and
`
`wherein the decorticating elements are retracted into the central ring in a closed
`
`position and are pushable outwards from the central ring to the open position (id.).
`
`Thus, Hess et al. disclose the claimed invention except for explicitly reciting that the
`
`decorticating elements comprise flexible wire blades.
`
`Aschmann et al. teach that bone engaging projections can be configured to berigid or
`
`flexible wire blades, e.g., 14 (Fig. 3), as desired, e.g., to withstand the forces exerted thereon
`
`without breaking (see, e.g., para. 0057). It is noted that in Hesset al. the projections include the
`
`base thereof, e.g.,224, and are for engaging bone, while also being capable of decorticating
`
`because of their sharp shape).
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 10
`
`It would have been obvious to a person having ordinary skill inthe art before the
`
`effective filing date to configure the decorticating elements of Hesset al. (e.g., the base 224
`
`thereof), to comprise flexible wire blades, in view of Aschmann et al., to withstand the forces
`
`exerted thereon without breaking.
`
`Claims 56 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Hessetal.
`
`(2014/0194930).
`
`Regarding both claims 56 and 57, Hess etal. disclose the claimed invention except for
`
`explicitly reciting the length between about 10 - 150 mm and the diameter between about 5 -
`
`50 mm.
`
`However, it would have been obvious to a person having ordinary skill in the art before
`
`the effective filing date to form the screw device to have any desired dimensions, including, a
`
`length between about 10 - 150 mm and a diameter between about 5 - 50 mm, e.g., to address
`
`the physical requirements of different size bones and patients.
`
`Allowable Subject Matter
`
`Claims 31, 32 and 59 are allowed.
`
`Claims 3 and 37 are objected to as being dependent upona rejected base claim, but
`
`would be allowable if rewritten in independent form including all of the limitations of the base
`
`claim and any intervening claims.
`
`It is notedthat claims 41 and 42 are rejected under 35 U.S.C.
`
`112, above, but if anendedto depend from claim 3, would be objected to as described with
`
`regard to claim 3.
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 11
`
`Response to Arguments
`
`Applicant’s arguments,filed 08 August 2024, with respect to the amended and newly
`
`presented claims, have been fully considered and are persuasive. Therefore, the non-final
`
`rejection mailed 09 May 2024 has been withdrawn. However, upon further search and
`
`consideration, new grounds of rejection have been discovered and are set forth above. It is
`
`noted that Examiner called Applicant on 15 November 2024 in the interest of prosecution
`
`efficiency to attempt to place the application into condition for allowance by wayof an
`
`Examiner's amendment, but was unable to reach Applicant.
`
`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 C COMSTOCK whosetelephone number is (571)272-
`
`4710. The examinercan normally be reached M-F 9:00-5:00 PST.
`
`Examiner interviewsare 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, Eduardo Robert can be reached on 571-272-4719. The fax phone number for the
`
`organization wherethis application or proceeding is assigned is 571-273-8300.
`
`

`

`Application/Control Number: 17/639,038
`Art Unit: 3773
`
`Page 12
`
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`
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`
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`DAVID C. COMSTOCK
`
`Examiner
`
`Art Unit 3773
`
`/DAVID C COMSTOCK/
`Examiner, Art Unit 3773
`
`/EDUARDO C ROBERT/
`Supervisory Patent Examiner, Art Unit 3773
`
`