DETAILED ACTION
This is a Final Rejection for Application 18/133,139 filed April 11, 2023. This application is a continuation-in-part of U.S. Patent Application 17/169,929, filed on February 8, 2021. Claims 1, 3 and 5-12 are currently pending.
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 .
Election/Restrictions
Claims 5-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 9, 2025. The requirement was made final in the prior Office action filed August 22, 2025 and is maintained.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Response to Amendment
The examiner acknowledges the amendments to claims 1 and 3 and the cancellation of claims 2 and 4. The amendments overcome the claim objections and 35 U.S.C. 101 rejections previously indicated. The claim objections and 35 U.S.C. 101 rejections are hereby withdrawn. The amendments change the scope of the claims, therefore new grounds of rejection are presented below.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 3 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.
Claim Rejections - 35 USC § 103
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) 1 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0318551 (Daly) in view of US 2019/0183590 (Hladio) and US 2011/0041995 (Adams).
Regarding claim 1, Daly discloses a surgical drape assembly (Daly discloses a sterile craniotomy drape 10 as shown in Figs. 1-4. The drape is configured for use in brain surgery procedures. See [0025].), comprising:
a surgical table, wherein the surgical table is configured for a patient to be located thereon (As shown in Figs. 3 and 4, the system comprises an operating table with an upper patient support surface 40. See [0026]. According to [0026], the patient P is positioned on the operating table.);
a surgical drape, wherein a first portion of the surgical drape is configured to cover the patient while on the surgical table and wherein a second portion of the surgical drape includes an opening (Drape 10 as shown in Figs. 1-2 and 4 and is a surgical drape. See [0025]. The drape 10 comprises a sterile wall 12 and an open end 30. See [0024]. The sterile wall is interpreted as a first portion while the open end 30 is interpreted as a second portion. The sterile wall covers a patient. See Fig. 4. The open end 30 includes an opening 24. See Fig. 2.);
an extendable sleeve assembly operatively connected to the opening (The open end 30 and opening 24 are operatively connected to sleeve 28 which is extendible in a telescopic fashion. See Fig. 2 and [0024].), wherein the extendable sleeve assembly further comprises;
an extendable sleeve having a first end and a second end (Sleeve 28 has a second end where the opening 24 is positioned and a first end called an optically transparent or clear free end 31. See [0024] and Figs. 2 and 4.),
a plurality of sleeve folds located along a length of the extendable sleeve when the extendable sleeve is in a non-extended condition (The sleeve 28 is initially folded in a telescopic fashion prior to use which would create a plurality of sleeve folds along the length of the folded sleeve.), and
a sleeve attachment located on the second end of the extendable sleeve such that the sleeve attachment is operatively connected to the opening (According to [0024], the sleeve 28 is attached in sealed relation about the entire periphery of the respective opening 24, such as by being adhered to an underside of the wall 12 via any suitable adhesive. The adhesive is interpreted as a sleeve attachment. The adhesive is located on the second end of the sleeve and operatively connected to the opening 24.); and
a surgical instrument, the surgical instrument is covered by the second portion of the surgical drape and the extendable sleeve assembly and a portion of the surgical instrument is located within the extendable sleeve assembly when the extendable sleeve assembly is in an extended condition (The system comprises a head clamp 36, a stabilizer arm 32 and a navigator tracker 34 which make up a surgical instrument. See [0025]. The head clamp 36, stabilizer arm 32 and navigator tracker 34 are covered by the open end 30 and sleeve 28 and are located within the sleeve 28 when the sleeve 28 is in an extend position. See [0027] and Fig. 4.).
Daly does not disclose a removable sleeve folds retainer operatively connected to the plurality of sleeve folds when the extendable sleeve is in the non-extended condition, wherein the removable sleeve folds retainer is constructed of tape, the surgical instrument connected to the surgical table, and removal of the removable sleeve folds retainer.
However, Hladio discloses a surgical system with a head-clamp 200 that further comprises a connector to connect the head-clamp 200 to an operating table. See [0072].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to for the head clamp 36 of Daly to include a connector to attach to the operating table of Daly as taught by Hladio. As a result, Daly in view of Hladio teaches that it would be obvious for the surgical instrument to be connected to the surgical table (The head clamp 36 is now operatively connected by a connector to the operating table of Daly as taught by Hladio.). A skilled artisan would have been motivated to do so because Hladio teaches that the connector, when secured, provides a highly rigid structure that is unlikely to shift when forces or impacts are applied ([0072]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to head clamp devices with operating tables.
Additionally, Adams discloses a drape to cover a C arm of a medical device. The drape is retained in a folded fashion by a tape portion to prevent the drape from unfolding while positioning and attaching the drape. See [0026], [0028] and Claims 7-8. While Adams discloses separating the tape using a perforation line, it would also be obvious to one of ordinary skill in the art to remove the tape portion since such a modification would have involved making a component removable. The court has held that making a component separable would be obvious if it were considered desirable for any reason. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). Making the tape of Adams removable is desirable because it would remove the tape from the surgical environment and would allow for new surgical tape to replace the removed tape if so desired.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to use a tape portion to secure the sleeve 28 of Daly as taught by Adams. As a result, Daly in view of Adams teaches that it would be obvious for a removable sleeve folds retainer to be operatively connected to the plurality of sleeve folds when the extendable sleeve is in the non-extended condition (Daly teaches a plurality of sleeve folds folded in a telescopic fashion and Adams provides support for a tape to be used to hold a surgical drape in a folded configuration. The tape being removable is an obvious matter of design choice.),
wherein the removable sleeve folds retainer is constructed of tape (Adams provides support for a tape to be used to hold a surgical drape in a folded configuration.), and
to remove the removable sleeve folds retainer (The tape being removable is an obvious matter of design choice.). A skilled artisan would have been motivated to do so because Adams teaches the use of the tape portion to retain the drape in a folded configuration ([0028]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to foldable surgical drapes.
Regarding claim 3, Daly discloses a method of making a surgical drape assembly (Daly discloses a sterile craniotomy drape 10 as shown in Figs. 1-4. The drape is configured for use in brain surgery procedures. See [0025].), comprising the steps of:
providing a surgical table (As shown in Figs. 3 and 4, an operating table is provided with an upper patient support surface 40. See [0026].);
providing a patient, wherein the patient is located on the surgical table (According to [0026], the patient P is provided and is positioned on the operating table.);
providing a surgical instrument (The system comprises a head clamp 36, a stabilizer arm 32 and a navigator tracker 34 which make up a surgical instrument. See [0025].);
providing a surgical drape, wherein a first portion of the surgical drape is configured to cover the patient while on the surgical table and wherein a second portion of the surgical drape includes an opening (Drape 10 is provided as shown in Figs. 1-2 and 4 and is a surgical drape. See [0025]. The drape 10 comprises a sterile wall 12 and an open end 30. See [0024]. The sterile wall is interpreted as a first portion while the open end 30 is interpreted as a second portion. The open end 30 includes an opening 24. See Fig. 2.);
attaching an extendable sleeve assembly to the opening (The open end 30 and opening 24 are attached to sleeve 28 which is extendible in a telescopic fashion. See Fig. 2 and [0024].), wherein the surgical drape assembly further comprises;
providing an extendable sleeve having a first end and a second end (Sleeve 28 has a second end where the opening 24 is positioned and a first end called an optically transparent or clear free end 31. See [0024] and Figs. 2 and 4.),
creating a plurality of sleeve folds along a length of the extendable sleeve in order to create a non-extended condition of the extendable sleeve (The sleeve 28 is initially folded in a telescopic fashion prior to use which would create a plurality of sleeve folds along the length of the folded sleeve in a non-extended condition.), and
attaching a sleeve attachment located on the second end of the extendable sleeve to the opening (According to [0024], the sleeve 28 is attached in sealed relation about the entire periphery of the respective opening 24, such as by being adhered to an underside of the wall 12 via any suitable adhesive. The adhesive is interpreted as a sleeve attachment. The adhesive is located on the second end of the sleeve and attached to the opening 24.); and
covering the surgical instrument and the patient with the surgical drape (The drape 10 comprises a sterile wall 12. See [0024]. The sterile wall covers a patient. See Fig. 4. The head clamp 36, stabilizer arm 32 and navigator tracker 34 are covered by the open end 30 and sleeve 28 and are located within the sleeve 28 when the sleeve 28 is in an extend position. See [0027] and Fig. 4.),
wherein the patient is covered by the first portion of the surgical drape and the surgical instrument is covered by the second portion of the surgical drape and the extendable sleeve assembly and a portion of the surgical instrument is located within the extendable sleeve assembly when the extendable sleeve assembly is in an extended condition (The drape 10 comprises a sterile wall 12 and an open end 30. See [0024]. The sterile wall is interpreted as a first portion while the open end 30 is interpreted as a second portion. The sterile wall covers a patient. See Fig. 4. The head clamp 36, stabilizer arm 32 and navigator tracker 34 are covered by the open end 30 and sleeve 28 and are located within the sleeve 28 when the sleeve 28 is in an extend position. See [0027] and Fig. 4.).
Daly does not disclose wherein the surgical instrument is attached to the surgical table, attaching a removable sleeve folds retainer to the plurality of sleeve folds such that the removable sleeve folds retainer retains the extendable sleeve in the non-extended condition, wherein the removable sleeve folds retainer is constructed of tape, and removing the removable sleeve folds retainer.
However, Hladio discloses a surgical system with a head-clamp 200 that further comprises a connector to connect the head-clamp 200 to an operating table. See [0072].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to for the head clamp 36 of Daly to include a connector to attach to the operating table of Daly as taught by Hladio. As a result, Daly in view of Hladio teaches that it would be obvious for the surgical instrument to be attached to the surgical table (The head clamp 36 is now operatively connected by a connector to the operating table of Daly as taught by Hladio.). A skilled artisan would have been motivated to do so because Hladio teaches that the connector, when secured, provides a highly rigid structure that is unlikely to shift when forces or impacts are applied ([0072]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to head clamp devices with operating tables.
Additionally, Adams discloses a drape to cover a C arm of a medical device. The drape is retained in a folded fashion by a tape portion to prevent the drape from unfolding while positioning and attaching the drape. See [0026], [0028] and Claims 7-8. While Adams discloses separating the tape using a perforation line, it would also be obvious to one of ordinary skill in the art to remove the tape portion since such a modification would have involved making a component removable. The court has held that making a component separable would be obvious if it were considered desirable for any reason. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). Making the tape of Adams removable is desirable because it would remove the tape from the surgical environment and would allow for new surgical tape to replace the removed tape if so desired.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to use a tape portion to secure the sleeve 28 of Daly as taught by Adams. As a result, Daly in view of Adams teaches that it would be obvious to attach a removable sleeve folds retainer to the plurality of sleeve folds such that the removable sleeve folds retainer retains the extendable sleeve in the non-extended condition (Daly teaches a plurality of sleeve folds folded in a telescopic fashion and Adams provides support for a tape to be used to hold a surgical drape in a folded configuration. The tape being removable is an obvious matter of design choice.),
wherein the removable sleeve folds retainer is constructed of tape (Adams provides support for a tape to be used to hold a surgical drape in a folded configuration.), and
to remove the removable sleeve folds retainer (The tape being removable is an obvious matter of design choice.). A skilled artisan would have been motivated to do so because Adams teaches the use of the tape portion to retain the drape in a folded configuration ([0028]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to foldable surgical drapes.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Seth Brown whose telephone number is (571)272-5642. The examiner can normally be reached 8:00 AM – 11:00 AM or 1:00 PM – 3:00 PM ET.
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786