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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
`
`17/621,401
`
`12/21/2021
`
`Andrew J. McGregor
`
`82203US004
`
`9101
`
`Solventum Intellectual Properties Company
`2510 Conway Ave E
`3M Center, 275-6E-21
`St Pal, MN S514
`
`SMITH, KAITLYN ELIZABETH
`
`3794
`
`07/15/2024
`
`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):
`
`IPDocketing @ Solventum.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-20 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`CL] Claim(s)__is/are allowed.
`Claim(s) 1,4-13,15 and 18-20 is/are rejected.
`Claim(s) 2-3,14 and 16-17 is/are objected to.
`C) 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)( The specification is objected to by the Examiner.
`11)M The drawing(s) filed on 21 December 2021 is/are: a) 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)2) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)() None ofthe:
`b)( Some**
`a) 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.
`3.1.) 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)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`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 20240708
`
`Application No.
`Applicant(s)
`17/621,401
`McGregor et al.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`KAITLYN E SMITH
`3794
`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 23 February 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.
`
`

`

`Application/Control Number: 17/621 ,401
`Art Unit: 3794
`
`Page 2
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`DETAILED ACTION
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`Notice of Pre-AlA or AIA Status
`
`The present application, filed on or after March 16, 2013,
`
`is being examined
`
`underthefirst inventor to file provisions of the AIA.
`
`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-AlA) for the rejection will
`
`not be considered a new groundofrejection if the prior art relied upon, and the rationale
`
`supporting the rejection, would be the same undereither status.
`
`Claim Rejections - 35 USC § 112
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.—The specification shall concludewith one or more claims particularly
`pointing out and distinctly claiming the subject matter which the inventor ora jointinventor
`regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph:
`The specification shall conclude with one or more claims particularly pointing outand distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`Claims 4, 19 and 20 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-AIA 35 U.S.C. 112, the applicant), regards as the
`
`invention.
`
`Claim 4 recites “configured to provide the stream of pressurized, warmed air to
`
`the opening capable of generating a hose end temperature of at least 37 degrees C’”
`
`and this does not makesenseasit is unclear how the opening would be capable of
`
`generating a hose end temperatureor airflow.
`
`It is believed that Applicant meant--
`
`

`

`Application/Control Number: 17/621 ,401
`Art Unit: 3794
`
`Page 3
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`configured to provide the stream of pressurized, warmedair to the opening at a
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`temperature of at least 37 degrees C--.
`
`Itis suggested that the claim be amended as
`
`such.
`
`Claim 19 recites “the convective warming unit” in line 5. There is insufficient
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`antecedent basis for this claim limitation.
`
`It is suggested that this limitation be amended
`
`to --a convective warming unit--.
`
`Claim 20 is unclear asit recites “wherein the pneumatic convective deviceis the
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`second pneumatic convective device” and it is unclear what Applicantis trying to claim
`
`with this limitation.
`
`Is this limitation meant to reference the “pneumatic convective
`
`device” of claim 18? If so claim 19, from which claim 20 depends, requires the
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`application of heat to the patient using a first pneumatic convective deviceforat least 5
`
`minutes. Therefore,it is unclear how the pneumatic device is the second pneumatic
`
`device. No prior art has been applied.
`
`Claim Rejections - 35 USC § 102
`
`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 madein this Office action:
`
`A person shall be entitled to a patent unless —
`
`(a)(1) the claimed invention waspatented, described in a printed publication, orin public use,
`on sale, or otherwise available to the public before the effectivefiling date of the claimed
`invention.
`
`(a)(2) the claimed invention was described in a patentissued under section 151, orinan
`application for patent published or deemed published under section 122(b), in which the
`patentor application, as the case may be, namesanother inventor and waseffectively filed
`beforethe effectivefiling date of the claimed invention.
`
`Claim(s) 1, 5, 7 and 9-13 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2)
`
`as being anticipated by EP 1 937 196 A1 to Anderson etal. (Anderson).
`
`

`

`Application/Control Number: 17/621 ,401
`Art Unit: 3794
`
`Page 4
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`Regarding claim 1, Anderson teaches a warming system (title which states
`
`“Multifunction Warming Device for Perioperative Use”), comprising a warming device
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`(Fig. 3A-3F), comprising a clinical garment (22) comprising a body portion adapted to
`
`cover a portion of a patient (Fig. 3F), an inner surface (43) for facing the patient, and an
`
`outer surface ([Fig. 3F) for facing away from the patient, wherein the body portion
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`includes sleeves (53) sized and positioned for receiving the patient’s arms, wherein the
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`body portion includes a torso portion, adapted to cover an anterior torso of the patient
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`(Fig. 3F), a first pneumatic convective device (70) disposed adjacent to the inner
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`surface (Fig. 3D) and an opening formedin the clinical garment for admitting steam of
`
`pressurized, warmedair into the first pneumatic convective device (85), and a second
`
`pneumatic convective device (60) in a fully-folded configuration or partially -folded
`
`configuration and disposed on a portion of the clinical garment ([0038)).
`
`Regarding claim 5, Anderson teaches the system of claim 1 as well as wherein
`
`the body portion further includes a neck opening (Fig. 3F) and a hemline (47), a rearslit
`
`(Fig. 3F) extending from the neck opening to a hemline (Fig. 3F) and fastening devices
`
`(59) near the rearslit for attaching opposing sides of the rearslit ((0036] which states in
`
`part “the opening may be closed by means 59 along the lateral hems 45 which
`
`releasably connect to keep the hems together.”), a longitudinal axis (49) extending from
`
`the neck opening to the hemline (Fig. 3F).
`
`Regarding claim 7, Anderson teaches the system of claim 1 as well as wherein
`
`the warming device comprises a pocket (58) dimensioned to receive the second
`
`pneumatic convective device ([0061] which states in part “an end 63 folded and tucked
`
`into a cuff 58”).
`
`

`

`Application/Control Number: 17/621 ,401
`Art Unit: 3794
`
`Page 5
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`Regarding claim 9, Anderson teaches the system of claim 7 as well as wherein
`
`the pocket comprisesafirst sheet of material ((0061] which states “The second pattern
`
`of perforations 91 permits a user to separate the two sides of the end of a sleeve, at or
`
`near the end of the sleeves in the mannerillustrated in Fig. 5C.”) having a first pocket
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`end, a second pocket end and a side portion ([0061]), wherein the first sheet of material
`
`is attached to the clinical garment at the second pocket end and the side portion (Figs.
`
`5A-5E).
`
`Regarding claim 10, Anderson teaches the system of claim 7 as well as wherein
`
`the first pocket end comprises an indented region (Figs. 5c-5E).
`
`Regarding claim 11, Anderson teaches the system of claim 9 wherein thefirst
`
`sheet of material is fastened to the clinical garment along a fastened region ofthefirst
`
`sheet of material using a fastening device, the fastening deviceis a fixed fastener, and
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`the fastened region is continuous along a perimeterof the first sheet of material ([0062]
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`which states in part “Once folded, the end of each sleeve is attached inside the sleeve
`
`by a single elongate strip of adhesive bonding extending transversely across the
`
`sleeve.”).
`
`Regarding claim 12, Anderson teaches the system of claim 11 as well as wherein
`
`the first sheet of material has a line of weakness (90) disposed proximateto thefirst
`
`pocketend.
`
`Regarding claim 13, Anderson teaches the system of claim 12 as well as wherein
`
`the first sheet of material is unattached or releasably attached to the clinical garment at
`
`the first pocket end to form a pocket opening (Figs. 5A-5E).
`
`

`

`Application/Control Number: 17/621 ,401
`Art Unit: 3794
`
`Page 6
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`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis forall
`
`obviousness rejections set forth in this Office action:
`
`A patent fora claimed invention may notbe obtained, notwithstanding thatthe claimed
`invention is not identically disclosed as set forth in section 102, if the differences between the
`claimed invention and the prior artare such that the claimed invention as a whole would have
`been obvious beforethe effective filing date of the claimed invention to a person having
`ordinary skill in the art to which the claimed invention pertains. Patentability shall notbe
`negated by the mannerin whichthe invention was made.
`
`The factual inquiries for establishing a background for determining obviousness
`
`under 35 U.S.C. 103 are summarized asfollows:
`
`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
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`obviousness or nonobviousness.
`
`This application currently namesjoint inventors.
`
`In considering patentability of the
`
`claims the examiner presumes that the subject matter of the various claims was
`
`commonly ownedasof the effective filing 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
`
`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.
`
`Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over
`
`Andersonin view of US 6,245,096 B1 to Tomic-Edgaret al. (Tomic-Edgar).
`
`

`

`Application/Control Number: 17/621 ,401
`Art Unit: 3794
`
`Page 7
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`Regarding claim 4, Anderson teaches the system of claim 1 as well as the
`
`convective apparatus being operated by receiving warmed, pressurized air froma
`
`heater/blower unit ([0035]), but not specifically a convective warming unit configured to
`
`provide the stream of pressurized, warmed air at a temperature of at least 37 degrees C
`
`and an airflow of a least 20 cfm. Tomic-Edgar teaches an analogous deviceto that of
`
`Anderson as well as that when a patient is being treated to prevent hypothermia, a hot
`
`air flow usually within a temperature range of 36-42 degrees C is provided to the cover
`
`whichis inflated as a result of the pressurized air providing a pressure of 1.5
`
`centimeters of water with a delivery rate of 60 cubic feet of air per minute (Col. 3, lines
`
`10-14).
`
`It would have been obvious to one having ordinary skill
`
`in the art before the
`
`effective filing date of the claimed invention to have modified Anderson with the
`
`teaching of Tomic-Edgarto allow for the appropriate treatment of the patient as taught
`
`by Tomic-Edgar (Col. 3, lines 10-14).
`
`Claim(s) 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable
`
`over Anderson.
`
`Regarding claim 6, Anderson teaches the system of claim 1, but not wherein a
`
`thickness of the fully-folded configuration is no greater than 1
`
`inch and a thicknessof
`
`the partially-folded configuration is no greater than 0.5 inches.
`
`It would have been an
`
`obvious matter of design choice to one having ordinary skill in the art before the
`
`effective filing date of the claimed invention to have selected the claimed thickness,
`
`since such a modification would have involved a mere changein the size of a
`
`component. A changein size is generally recognized as being within the level of
`
`ordinary skill
`
`in the art.
`
`

`

`Application/Control Number: 17/621 ,401
`Art Unit: 3794
`
`Page 8
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`Regarding claim 8, Anderson teaches the system of claim 7, as well as that the
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`opening of the pockets is a circumference of the sleeve (Figs. 5A-D) but not wherein the
`
`pocket has a pocket opening that has an openable circumferenceof at least 15 inches.
`
`It would have been an obvious matter of design choice to one having ordinary skill in the
`
`art before the effective filing date of the claimed invention to have selected the claimed
`
`opening circumference, since such a modification would have involved a mere change
`
`in the size of a component. A changein size is generally recognized as being within the
`
`level of ordinary skill in the art.
`
`Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over
`
`Anderson in view of US 4,867,230 to Voss (Voss).
`
`Regarding claim 15, Anderson teaches the system of claim 1, but not wherein the
`
`warming device further comprises an insulative material, wherein the insulative material
`
`has an R-value of between 0.5 and 3 R, inclusive. Voss teaches an analogous device
`
`to that of Anderson including insulating second and third layers (30 and 32) using
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`MYLAR to minimize the temperature gradient across the device (Col. 3, line 56-Col. 4,
`
`line 5).
`
`It would have been obvious to one having ordinary skill in the art before the
`
`effectivefiling date of the claimed invention to have modified Anderson to include the
`
`insulating layers of Voss to minimize the temperature gradient across the device thus
`
`optimizing performance.
`
`While Voss does not specifically discuss an R-value between 0.5 and 3R,
`
`inclusive,
`
`it is asserted that it would have been obvious to one having ordinary skill in
`
`the art to have selected an R-value as claimed, since it has been held that where the
`
`

`

`Application/Control Number: 17/621 ,401
`Art Unit: 3794
`
`Page 9
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`general conditions of a claim are disclosed in the prior art, discovering the optimum or
`
`workable rangesinvolvesonly routine skill in the art.
`
`Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being
`
`unpatentable over Anderson.
`
`Regarding claim 18, Anderson teaches a method ([0010]) comprising providing
`
`the warming system of claim 1
`
`to the patient, allowing the patient to wear the warming
`
`device in a first configuration during a period andin a location ([0057]) changing the
`
`warming device to a second configuration before or during anesthesia of a patient at a
`
`second location ([0057]) and applying heat via a pneumatic device to the patient during
`
`an operative period ([0010 and 0057]). Anderson additionally teaches that therapeutic
`
`warming maybeindicated during any one or more of the perioperative periods. For
`
`example, Anderson teaches that preoperative, postoperative and a combination thereof
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`depending on the patient and the surgery. However, Anderson is silent with respectto
`
`the duration of wearing before anesthesia during a perioperative period and when the
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`device is changed to a second configuration at a second location.
`
`It is asserted that it
`
`would have been obvious to one having ordinary skill in the art before the effectivefiling
`
`date of the claimed invention to have modified Anderson with the duration of wearing
`
`before anesthesia during a perioperative period and whenthe device is changed to a
`
`second configuration at a second location as claimed, since it has been held that where
`
`the general conditions of a claim are disclosed in the prior art, discovering the optimum
`
`or workable rangesinvolvesonly routine skill in the art.
`
`Regarding claim 19, Anderson teaches the method of claim 18 as well as
`
`wherein the first configuration of the warming device comprisesafirst pneumatic
`
`

`

`Application/Control Number: 17/621 ,401
`Art Unit: 3794
`
`Page 10
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`convective device (70) fixedly attached to the clinical garment and a pocket with the
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`second pneumatic convective device (60) contained therein (Fig. 3D), but not
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`specifically wherein the method further comprises applying heat to the patient through
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`the first pneumatic convective device via the convective warming unit for at least 5
`
`minutes.
`
`It is asserted that it would have been obvious to one having ordinaryskill in
`
`the art before the effectivefiling date of the claimed invention to have modified
`
`Anderson to apply heat to the patient through the first pneumatic convective device for
`
`at least 5 minutes, since it has been held that where the general conditions of a claim
`
`are disclosed in the prior art, discovering the optimum or workable ranges involves only
`
`routine skill in the art.
`
`Allowable Subject Matter
`
`Claims 2, 3, 14, 16 and 17 are objected to as being dependent upon a rejected
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`base claim, but would be allowable if rewritten in independent form including all of the
`
`limitations of the base claim and anyintervening claims.
`
`Conclusion
`
`Anyinquiry concerning this communication or earlier communications from the
`
`examiner should be directed to KAITLYN E SMITH whosetelephone numberis
`
`(571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
`
`Examinerinterviews 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 AutomatedInterview Request
`
`(AIR) at http:/Avwww.uspto.gov/interviewpractice.
`
`

`

`Application/Control Number: 17/621 ,401
`Art Unit: 3794
`
`Page 11
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Linda Dvorak can be reached on (571)272-4764. The fax phone numberfor
`
`the organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of published or unpublished applications may be
`
`obtained from Patent Center. Unpublished application information in Patent Centeris
`
`available to registered users. To file and manage patent submissions in Patent Center,
`
`visit: httos://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-
`
`center for more information about Patent Center and
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`https://www.uspto.gov/patents/docx for information aboutfiling in DOCX format. For
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`additional questions, contact the Electronic Business Center (EBC) at 866-217-9197
`
`(toll-free).
`
`If you would like assistance from a USPTO Customer Service
`
`Representative, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/KAITLYN E SMITH/
`Primary Examiner, Art Unit 3794
`
`