DETAILED ACTION
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/21/2026 has been entered.
Response to Amendment
The amendment filed 01/21/2026 has been entered. Claims 1-14 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Final Office Action mailed 07/21/2025.
Response to Arguments
Applicant's arguments with respect to claims 1-14 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. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
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.
Claims 1-14 are rejected under 35 U.S.C 103 as being unpatentable over Lunderqvist et al. (US 20050209662) herein referred to as Lunderqvist, in view of Rozenberg (US 20130073015) herein referred to as Rozenberg.
Regarding claim 1, Lunderqvist discloses A device for indirect temperature regulation of the brain of a human via a nasal cavity thereof (Figure 1 & Figure 3, wherein Figure 3 shows the device inserted into the nasal cavity), the device comprising: a membrane having a membrane surface area (Figure 1, 38; wherein everything has a surface area therefore the membrane has a surface area), a length (Figure 1, L), a center point with respect to the length (Figure 1, L; wherein the center point is the center of L), a width ((Figure 1, A), and a center point with respect to the width (Figure 1, A; wherein the center point is the center of A), said membrane adapted to be arranged in contact with a surface of the nasal cavity (Figure 3, 38), said membrane defining a closed volume and having the shape of the nasal cavity such that when in use it expands and conforms to the nasal cavity (Figure 3, 38; Paragraph [0044]; wherein membrane 38 is expanded to completely cover the inner surface of the nose), a first catheter extending along a distal-proximal axis (Figure 1, 31), said first catheter having a first distal portion for introducing fluid into said closed volume and a first end portion (Paragraph [0028]; catheter is arranged to provide fluid communication with the reservoir 20), said first distal portion having at least one first cranially placed hole having a first total area (Figure 1, 34), second catheter extending along the distal-proximal axis (Figure 1, 33), said second catheter having a second distal portion for removing fluid from said closed volume and a second end portion (Paragraph [0028]), said second distal portion having at least one second cranially placed hole having a second area (See annotated Figure 1 below; wherein everything has an area therefore the hole has an area), wherein the first distal portion protrudes in the closed volume further than the second distal portion (Figure 1, 31 & 33), and wherein the first total area of the at least one cranially placed first hole is smaller than the total area of area of the second area, and area combined (See annotated Figure 1 below ; wherein there are 9 holes on the first catheter that appear to be approximately the same size as the hole on the first catheter therefore would area of one hole would be smaller than all the areas combined), and wherein the membrane length extends along a portion of the distal- proximal axis such that the membrane surface area on a distal side of the center point with respect to length (See annotated Figure 1 below;), is larger than the membrane surface area on a proximal side of the center point with respect to length (See annotated Figure 1 below; wherein the surface area is greater due to distal sides end surface), and means for circulating said fluid into said volume via said at least one first cranially placed hole on the first distal portion of said first catheter and out of said volume via said at least one second cranially placed hole and distal opening on the second distal portion of said second catheter (Figure 1, 12, 14, 16). However, Lunderqvist does not explicitly disclose a distal bevel opening having a third area, at least one hole having a fourth area and a distal slit positioned on a distal bevel opening.
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Rozenberg discloses A device for indirect temperature regulation of the brain of a human via a nasal cavity thereof (Figure 1) comprising a distal bevel opening having a third area (Figure 43C, 940), at least one hole having a fourth area (Paragraph [0160]; wherein holes could be cut along the length of the tip) and a distal slit positioned on a distal bevel opening (Paragraph [0160]; wherein a slit could be cut into the tip). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal portion of the catheter taught by Lunderqvist to include the teachings of Rozenberg’s distal portion. The motivation being to further disperse a spray as well as cover a wider surface area (Rozenberg, Paragraph [0160])
Regarding claim 2, Lunderqvist in view of Rozenberg discloses the device according to claim 1. Lunderqvist also discloses wherein a center point with respect to length is located at equal distance from the first end portion and second end portion (See annotated Figure 1).
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Regarding claim 3, Lunderqvist in view of Rozenberg discloses the device according to claim 1. Lunderqvist also discloses wherein a center point with respect to length is located closer to the first end portion than to the second end portion (See annotated Figure 1)
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Regarding claim 4, Lunderqvist in view of Rozenberg discloses the device according to claim 1. Lunderqvist also discloses wherein a membrane surface area on one side of the center point with respect to width is larger than the membrane surface area annotated Figure 1; wherein the surface area is greater due distal sides end surface and holes 34 are facing out towards the distal side)
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Regarding claim 5 & 6, Lunderqvist in view of Rozenberg discloses the device according to claim 1. However, Lunderqvist in view of Rozenberg does not explicitly disclose wherein the at least one cranially placed hole has an individual area of between 0.1 - 1 mm2. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lunderqvist et al. to have at least one cranially placed hole has an individual area of between 0.1 - 1 mm2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Lunderqvist in view of Rozenberg would not operate differently with the claimed individual hole areas since the diameter of the membrane is 20-40mm and the length is 200-250mm (Lunderqvist, Paragraph [0030]) therefore the catheter is smaller then the overall membrane by approximately 1/3 (Lunderqvist, Figure 1) which at its largest would have a diameter range of approximately 13-26mm, therefore the device would function appropriately having the claimed area. Further, applicant places no criticality on the range claimed, indicating the holes are within the claimed range (see specification page 4 lines 26-32).
Regarding claim 7, Lunderqvist in view of Rozenberg discloses the device according to claim 1. Lunderqvist also discloses wherein the number of at least one first cranially placed on the first catheter equals or exceeds the number of at least one second cranially placed on the second catheter (See annotated Figure 1).
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Regarding claim 8, Lunderqvist in view of Townley discloses the device according to claim 1. Rozenberg also discloses wherein the number of at least one second cranially placed holes on the second catheter equals or exceeds the number of at least one first cranially placed holes on the first catheter (Figure 31; wherein there is an equal number of holes on both catheters 540 & 545) Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheters taught by Lunderqvist in view of Rozenberg to include the number of holes on the catheter taught by Rozenberg. The motivation being it would be obvious to try different number of holes on each catheter to see which number allows for cooling fluid to recirculate at a fast enough rate to maintain the low temperatures within the balloon (MPEP 2143 (E))
Regarding claims 9, Lunderqvist in view of Rozenberg discloses the device according to claim 1. Lunderqvist also discloses wherein the number of at least one first cranially placed is at least 2 (Figure 1, 34; wherein 34 is a plurality of holes).
Regarding claim 10, Lunderqvist in view of Rozenberg discloses the device according to claim 1. Rozenberg also discloses wherein the number of at least one second cranially placed is at least 2 (Figure 43A; wherein there is 6 holes). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal portion of the catheter taught by Lunderqvist to include the teachings of Rozenberg’s distal portion. The motivation being it would be obvious to try different number of holes on the second catheter to see which number allows for cooling fluid to recirculate at a fast enough rate to maintain the low temperatures within the balloon (MPEP 2143 (E))
Regarding claim 11, Lunderqvist in view of Rozenberg discloses the device according to claim 3. Lunderqvist also discloses wherein a center point with respect to length can be located 1.5 times closer to the first end portion than to the second end portion (See annotated Figure 1 below; wherein the center point can be shifted to be exactly 1.5 times closer).
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Regarding claim 12, Lunderqvist in view of Rozenberg discloses the device according to claim 3. Lunderqvist also discloses wherein the center point with respect to length is located 2 times closer to the first end portion than to the second end portion (See annotated Figure 1 below; See annotated Figure 1 below; wherein the center point can be shifted to be exactly 2 times closer).
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Regarding claim 13, Lunderqvist in view of Rozenberg discloses the device according to claim 4. Lunderqvist also discloses wherein the membrane surface area on the side of the center point with respect to width faced by the at least one first cranially placed hole is 2 times larger than the membrane surface area on the other side of the center point (See annotated Figure 1 below).
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Regarding claim 14, Lunderqvist in view of Rozenberg discloses the device according to claim 4. Lunderqvist also discloses wherein the membrane surface area on the side of the center point with respect to width faced by the at least one first cranially placed hole is 3 times larger than the membrane surface are on the other side of the center point with respect to width.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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