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 .
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 joint inventor 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 out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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 12 recites “the distance between the distal end of the cuff and the distal tip may range …” making it unclear if the range recited subsequently is required or not.
Claim Rejections - 35 USC § 103
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-AIA ) for the rejection will not be considered a new ground of rejection 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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 obviousness or nonobviousness.
Claim(s) 1 and 4-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hipolito et al. (US 2003/0121521 A1) in view of Nelson et al. (US 2007/0295337 A1).
Regarding claim 1, Hipolity discloses: A device for a trachea, comprising:
a tubular body (10) having a proximal end (at 16) and a distal end (at 12) opposite the proximal end, the distal end having A) an opening for ventilation (opening at end 12), and B) a distal tip (tip at 12);
a cuff disposed around the tubular body and configured to be inflated to seal the cuff against a wall of a trachea [0045]; and
a plurality of markings (18, 22a-d) disposed on an outer surface of the tubular body (see figure 3), the markings configured to allow the device to be placed in the trachea such that the cuff is positioned below the cricoid of the trachea (as shown in figure 3).
Hipolito does not explicitly disclose the cuff being pear-shaped and having a distal end and a tapered proximal end opposite the distal end.
However, Nelson teaches a cuff (12) disposed around the tubular body and configured to be inflated to seal the cuff against a wall of a trachea (shown for example in figure 2), the cuff being pear-shaped (see figure 7) and having a distal end (bottom of 12 in figure 7) and a tapered proximal end opposite the distal end (see figure 7).
Therefore it would have been obvious to have modified Hipolity with the cuff of Nelson as both cuffs serve the same purpose of sealing. Both cuffs have known functions in the art and one of ordinary skill in the art could have substituted one known cuff for another. The result of the substitution would have been predictable. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). Further the tapered shape reduces irritation [0044]-[0045]
Regarding claim 4, Hipolity further discloses wherein the plurality of markings depict vocal cord markings (18) based on customized anatomical measurements of a patient's airways [0044].
Regarding claim 5, Hipolity further discloses wherein the plurality of markings are further configured to position the distal tip above the patient's carina (see figure 3).
Regarding claim 6, Hipolity further discloses wherein the plurality of markings have a width of about 10.0 mm- 15.0 mm [0041] (1cm =10mm).
Regarding claim 7, Hipolito further discloses wherein the distance between the plurality of markings and the distal tip range from about 28.0 mm to about 66.0 mm ([0038] 6.5 cm = 65 mm).
Regarding claim 8, Hipolity as modified further discloses wherein the tapered proximal end of the cuff is further configured to prevent pressure injury if the cuff is in the cricoid (the cuff of Nelson is tapered as claimed: see claim 1 above).
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) It is the examiner’s position that the prior art discloses the claimed structural limitations of the claim.
Regarding claim 9, Hipolito as modified does no explicitly disclose wherein the cuff (12 of Nelson) has a length of about 8.0 mm to about 18.0 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention such that the cuff (12 of Nelson) has a length of about 8.0 mm to about 18.0 mm 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 Hipolito would not operate differently with the claimed dimensions and the device would function appropriately having the claimed range of cuff lengths.
Claim(s) 1 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (WO 2007/130579 A2) in view of Nelson et al. (US 2007/0295337 A1).
Regarding claim 1, Steward discloses: A device for a trachea [0023], comprising:
a tubular body (tubular body of 20) having a proximal end (60) and a distal end (at 64) opposite the proximal end, the distal end having A) an opening for ventilation (opening at end 64 as shown in figure 1 and at 62), and B) a distal tip (tip at 62);
a cuff (40) disposed around the tubular body (see figures 1 and 2) and configured to be inflated to seal the cuff against a wall of a trachea [0024]; and
a plurality of markings (28) disposed on an outer surface of the tubular body (see figure 1), the markings configured to allow the device to be placed in the trachea such that the cuff is positioned below the cricoid of the trachea ([0026] between the vocal cords and the corina. [0031]).
Steward does not explicitly disclose the cuff being pear-shaped and having a distal end and a tapered proximal end opposite the distal end.
However, Nelson teaches a cuff (12) disposed around the tubular body and configured to be inflated to seal the cuff against a wall of a trachea (shown for example in figure 2), the cuff being pear-shaped (see figure 7) and having a distal end (bottom of 12 in figure 7) and a tapered proximal end opposite the distal end (see figure 7).
Therefore it would have been obvious to have modified Steward with the cuff of Nelson as both cuffs serve the same purpose of sealing. Both cuffs have known functions in the art and one of ordinary skill in the art could have substituted one known cuff for another. The result of the substitution would have been predictable. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). Further the tapered shape reduces irritation [0044]-[0045]
Regarding claim 9, Steward as modified does no explicitly disclose wherein the cuff (12 of Nelson) has a length of about 8.0 mm to about 18.0 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention such that the cuff (12 of Nelson) has a length of about 8.0 mm to about 18.0 mm 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 Steward would not operate differently with the claimed dimensions and the device would function appropriately having the claimed range of cuff lengths.
Claim(s) 1-3, 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 7,849,857) in view of Nelson et al. (US 2007/0295337 A1) in further view of Hipolito et al. (US 2003/0121521 A1)
Regarding claim 1, Gobel discloses: A device for a trachea (abstract; tracheal ventilation device), comprising:
a tubular body (tubular body of 2) having a proximal end (end oppositive 3 in figure 1) and a distal end (at 3) opposite the proximal end, the distal end having A) an opening for ventilation (opening left end in figure 1 and 3), and B) a distal tip (tip at left end of figure 1 and 3);
a cuff (3) disposed around the tubular body (see figure 1, figure 3) and configured to be inflated to seal the cuff against a wall of a trachea (col. 4, lines 53-59).
Globel does not disclose a plurality of markings disposed on an outer surface of the tubular body, the markings configured to allow the device to be placed in the trachea such that the cuff is positioned below the cricoid of the trachea.
Hipolito teaches a plurality of markings (18, 22a-d) disposed on an outer surface of the tubular body (see figure 3), the markings configured to allow the device to be placed in the trachea such that the cuff is positioned below the cricoid of the trachea (as shown in figure 3). The examiner notes the intended position of Globel is below the cricoid (col. 4, lines 53-59).
It would have been obvious to have utilized markings as taught by Hipolito for the benefit of ensuring proper positioning of the endotracheal tube.
Globel does not explicitly disclose the cuff being pear-shaped and having a distal end and a tapered proximal end opposite the distal end.
However, Nelson teaches a cuff (12) disposed around the tubular body and configured to be inflated to seal the cuff against a wall of a trachea (shown for example in figure 2), the cuff being pear-shaped (see figure 7) and having a distal end (bottom of 12 in figure 7) and a tapered proximal end opposite the distal end (see figure 7).
Therefore it would have been obvious to have modified Globel with the cuff of Nelson as both cuffs serve the same purpose of sealing. Both cuffs have known functions in the art and one of ordinary skill in the art could have substituted one known cuff for another. The result of the substitution would have been predictable. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). Further the tapered shape reduces irritation [0044]-[0045]
Regarding claim 2, Globel further discloses wherein the tubular body further includes an inner diameter of about 3.0 mm to about 6.0 mm (col. 5, lines 58-62).
Regarding claim 3, Globel while disclosing the inner diameter at col. 5, lines 58-62, does not explicitly disclose wherein the tubular body further includes an outer diameter of about 4.2 mm to about 8.2 mm.
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 Globel to have an outer diameter of about 4.2 mm to about 8.2 mm 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 Globel would not operate differently with the claimed dimensions and since the inner diameter is similar to applicant’s inner diameter (see claim 2 above) the device would function appropriately having the claimed range of outer diameters.
Regarding claim 9, Globel as modified further discloses wherein the cuff has a length of about 8.0 mm to about 20.0 mm (Globel: col. 8, lines 57-58).
However, Globel does not explicitly disclose wherein the cuff has a length of about 8.0 mm to about 18.0 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distance of Globel from between 8-20mm to 8mm to about 18 mm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 10 and claim 11, Globel as modified discloses the claimed invention substantially as claimed as set forth above. 10. Globel as modified does not specifically disclose wherein the distance between the plurality of markings and the proximal end of the cuff is about 12.0 mm to about 28.0 mm, nor wherein the distance between the plurality of markings and the distal end of the cuff may range from about 20.0 mm to about 46.0 mm.
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 Globel to have the distance between the plurality of markings and the proximal end of the cuff is about 12.0 mm to about 28.0 mm, nor wherein the distance between the plurality of markings and the distal end of the cuff may range from about 20.0 mm to about 46.0 mm 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 Globel would not operate differently with the claimed dimensions and since the intended location of Globel is also below the cricoid (col. 4, lines 53-59) the device would function appropriately having the claimed distances.
Regarding claim 12, Globel as modified further discloses wherein the distance between the distal end of the cuff and the distal tip may range from about 4.0 mm to about 11.0 mm (Globel: col. 8, lines 60-62: 4-11 mm).
However, Globel does not explicitly disclose the distance between distal end of the cuff and the distal tip may range from about 8.0 mm to about 20.0 mm
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distance of Globel from between 4-11mm to 8-11mm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785