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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 31-43 and 45-52 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 13-20 of U.S. Patent No. US 10,737,001 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite the claim limitations required in the current application. The table below shows the mapping of the overlapping claims between the current application and the patented case.
Instant Claims
Claims from Patent (US 10,737,001 B2)
31
1
32
2
33
3
34
4
35
1
36
8
37
9
38
10
39
11
40
5
41
6
42
7
43
14
45
13
46
15
47
16
48
17
49
18
50
19
51
15
52
20
Claim Objections
Claim 35 is objected to because of the following informalities:
Claim 35, line 3: “an elastic sleeve” should read “the elastic sleeve”. Appropriate correction is required.
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.
Claims 44 and 53 are 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.
The term “resembles” in claims 44 and 53 are a relative term which renders the claim indefinite. The term “resembles” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how to assess the extent that the claimed invention “resembles” a Poole suction device, since it is not a measurable quantity. For the purposes of examination, the prior art references that discloses/teaches the structure and components of the claimed invention is interpreted to “resemble” a Poole suction device.
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) 31-45 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Yarger (Publication No. US 2007/0203449 A1), hereby referred to as “Yarger ‘449”, in view of Yarger (Publication No. US 2003/0220611 A1), hereby referred to as “Yarger ‘611”.
Regarding claim 31, Yarger ‘449 teaches an aspirator (Figure 1; Paragraph 0035; Abstract) comprising:
an elastic sleeve defining a sleeve inner surface (aspirator sleeve 40, made of elastic material, having a sleeve inner surface to receive aspirator tip 13; Figure 1; Paragraph 0035 and 0043);
a handle (grip portion 22; Paragraph 0036; Figure 2) comprising a shoulder (portion between grip portion 22 and male coupling member 26; Figure 2; Paragraph 0036) and a sleeve coupler (male coupling member 26; Figure 2; Paragraph 0036), the sleeve coupler defining an aperture (opening through coupler 26 to allow for fluid flow; Figure 2; Paragraph 0036), the handle and the sleeve coupler comprising a longitudinal axis, wherein the sleeve coupler is in relief relative to the shoulder (longitudinal axis is parallel with handle 22 and sleeve coupler 26; Figure 2 and 3A);
a tubular member (member 14; Figure 2 and 3A; Paragraph 0036) defining a bend (member 14 is at a bend; Figure 2 and 3A), the tubular member comprising a proximal tube end and a distal tube end (member 14 has a proximal tube end and a distal tube end; Figure 2 and 3A), the sleeve coupler and tubular member oriented to receive the elastic sleeve (sleeve coupler 26 and tubular member 14 are oriented to receive sleeve 40; Figure 1; Paragraph 0035-0036); and
a suction head (enlarged tip end portion 18; Figure 2 and 3A; Paragraph 0038) comprising a distal end face (distal end face has an opening 16; Figure 3A; Paragraph 0038), the suction head attached to the tubular member (portion 18 is attached to tubular member 14; Figure 3A; Paragraph 0038),
wherein a clearance is defined between the sleeve inner surface and the suction head (tip end projections 54 space suction head 18 from sleeve 40 inner surface; Paragraph 0056; Figure 4A). Yarger ‘449 does not teach the proximal tube end disposed in the handle, the tubular member extending from the sleeve coupler and the aperture.
However, Yarger ‘611 teaches the proximal tube end disposed in the handle (tubular neck member 14 has a proximal tube end within the handle 22; Figure 1; Paragraph 0016-0017), the tubular member extending from the sleeve coupler and the aperture (tubular member 14 extend from the sleeve coupler 26 and the aperture/opening of the sleeve coupler 26; Figure 1; Paragraph 0016-0017).
Yarger ‘449 and Yarger ‘611 are considered to be analogous to the claimed invention because they are in the same field of aspirators. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yarger ‘449 to incorporate the teachings of Yarger ‘611 and have the tubular member of Yarger ‘449 be separate and attached into the sleeve coupler and the handle, as taught by Yarger ‘611, and the skewing angle between a portion of the sleeve and a portion of the tubular member after the bend, as taught by Yarger ‘611. This allows for the tubular member to be made of a different material from the handle member, if desired (Yarger ‘611; Paragraph 0016), allows for the removable detachment of the tubular member from the handle (Yarger ‘611; Paragraph 0016), and allows for both the sleeve and the tubular member to be bent for the delivery of aspiration towards the direction of the target site (Yager ‘611; Figure 5).
Regarding claim 32, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 31. The combination of Yarger ‘449 in view of Yarger ‘611 does not expressly teach wherein the clearance ranges from about 0.080 inches to about 0.11 inches, wherein the clearance is between the distal end face of the suction head and the sleeve inner surface.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the clearance ranges from about 0.080 inches to about 0.11 inches 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)(MPEP 2144.04(IV)(A)). In the instant case, the sleeve inner surface and the suction head would not operate differently with the claimed clearance ranges since it has the same function of aspirating fluid from the patient. Further, applicant places no criticality on the range claimed, the specification stating that the ranges are “about” the given ranges (Paragraph 0047 of specification).
Regarding claim 33, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 31. The combination of Yarger ‘449 in view of Yarger ‘611 does not expressly teach wherein the clearance ranges from about 0.001 inches to about 0.02 inches, wherein the clearance is between the distal end face of the suction head and the sleeve inner surface.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the clearance ranges from about 0.001 inches to about 0.02 inches 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)(MPEP 2144.04(IV)(A)). In the instant case, the sleeve inner surface and the suction head would not operate differently with the claimed clearance ranges since it has the same function of aspirating fluid from the patient. Further, applicant places no criticality on the range claimed, the specification stating that the ranges are “about” the given ranges (Paragraph 0047 of specification).
Regarding claim 34, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 31. The combination of Yarger ‘449 in view of Yarger ‘611 does not expressly teach wherein the clearance ranges from about 0.005 inches to about 0.1 inches, wherein the clearance is between the distal end face of the suction head and the sleeve inner surface.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the clearance ranges from about 0.005 inches to about 0.1 inches 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)(MPEP 2144.04(IV)(A)). In the instant case, the sleeve inner surface and the suction head would not operate differently with the claimed clearance ranges since it has the same function of aspirating fluid from the patient. Further, applicant places no criticality on the range claimed, the specification stating that the ranges are “about” the given ranges (Paragraph 0047 of specification).
Regarding claim 35, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 31. The combination of Yarger ‘449 in view of Yarger ‘611 further teaches wherein a section of the tubular member distal to the bend defines a tubular longitudinal axis (Yarger ‘449; section of tubular member 14 distal to the bend is a tubular longitudinal axis; annotated Figure 7A below),
wherein the sleeve coupler is sized to receive an elastic sleeve such that the bend is disposed within the elastic sleeve (Yarger ‘449; sleeve coupler is sized to receive sleeve 140/40 such that bend of tubular member 14 is within the sleeve 140/40; annotated Figure 13 below),
wherein a section of the elastic sleeve distal to the bend defines a sleeve longitudinal axis (Yarger ‘449; annotated Figure 13 below).
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Annotated Figure 7A
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Annotated Figure 13
Regarding claim 36, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 35. The combination of Yarger ‘449 in view of Yarger ‘611 further teaches wherein the clearance constrains a first skewing angle range between the longitudinal axis and the sleeve longitudinal axis (Yarger ‘449; first skewing angle range between longitudinal axis and sleeve longitudinal axis; annotated Figure 13 above).
Regarding claim 37, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 36. The combination of Yarger ‘449 in view of Yarger ‘611 does not expressly teach wherein the first skewing angle range is from about 24° to about 32°.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first skewing angle range is from about 24° to about 32° 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)(MPEP 2144.04(IV)(A)). In the instant case, the sleeve and handle of the device would not operate differently with the claimed first skewing angle range since it has the same function of aspirating fluid from the patient. Further, applicant places no criticality on the range claimed, the specification stating that the ranges are “about” the given ranges (Paragraph 0048 of specification).
Regarding claim 38, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 36. The combination of Yarger ‘449 in view of Yarger ‘611 does not expressly teach wherein the first skewing angle range is from about 33.5° to about 41.5°.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first skewing angle range is from about 33.5° to about 41.5° 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)(MPEP 2144.04(IV)(A)). In the instant case, the sleeve and handle of the device would not operate differently with the claimed first skewing angle range since it has the same function of aspirating fluid from the patient. Further, applicant places no criticality on the range claimed, the specification stating that the ranges are “about” the given ranges (Paragraph 0048 of specification).
Regarding claim 39, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 36. The combination of Yarger ‘449 in view of Yarger ‘611 does not expressly teach wherein the first skewing angle range is from about 32° to about 40°.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first skewing angle range is from about 32° to about 40° 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)(MPEP 2144.04(IV)(A)). In the instant case, the sleeve and handle of the device would not operate differently with the claimed first skewing angle range since it has the same function of aspirating fluid from the patient. Further, applicant places no criticality on the range claimed, the specification stating that the ranges are “about” the given ranges (Paragraph 0048 of specification).
Regarding claim 40, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 34. The combination of Yarger ‘449 in view of Yarger ‘611 further teaches wherein the clearance constrains a second skewing angle range between a portion of the sleeve and a portion of the tubular member after the bend (Yarger 611; second skewing angle between a portion of the sleeve and a portion of the tubular member after the bend; annotated Figure 5 below).
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Annotated Figure 5
Regarding claim 41, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 40. The combination of Yarger ‘449 in view of Yarger ‘611 does not expressly teach wherein the second skewing angle range is from about 5° to about 15°.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second skewing angle range is from about 5° to about 15° 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)(MPEP 2144.04(IV)(A)). In the instant case, the sleeve and tubular member of the device would not operate differently with the claimed second skewing angle range since it has the same function of aspirating fluid from the patient. Further, applicant places no criticality on the range claimed, the specification stating that the ranges are “about” the given ranges (Paragraph 0049 of specification).
Regarding claim 42, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 40. The combination of Yarger ‘449 in view of Yarger ‘611 does not expressly teach wherein the second skewing angle range is from about 2° to about 6°.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second skewing angle range is from about 2° to about 6° 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)(MPEP 2144.04(IV)(A)). In the instant case, the sleeve and tubular member of the device would not operate differently with the claimed second skewing angle range since it has the same function of aspirating fluid from the patient. Further, applicant places no criticality on the range claimed, the specification stating that the ranges are “about” the given ranges (Paragraph 0049 of specification).
Regarding claim 43, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 31. The combination of Yarger ‘449 in view of Yarger ‘611 further teaches wherein the elastic sleeve defines a plurality of vent holes (Yarger ‘449; cross-holes 60 is within elastic sleeve 40; Figure 4A; Paragraph 0056), a sleeve lumen and the sleeve inner surface (Yarger ‘449; sleeve lumen of sleeve 40 and sleeve inner surface; Figure 4A) , the elastic sleeve comprising a sleeve tip and a sleeve rim (Yarger ‘449; distal tip 45 and sleeve rim; Figure 4A; Paragraph 0040), wherein the sleeve rim defines a sleeve opening (Yarger ‘449; sleeve end portion 45 has a sleeve opening; Figure 4A; Paragraph 0042).
Regarding claim 44, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 35. The combination of Yarger ‘449 in view of Yarger ‘611 further teaches wherein a distal end face of the sleeve is next to the shoulder (Yarger ‘449; sleeve 140/40 at the distal end face is next to shoulder; Figure 13), wherein combination of sleeve and aspirator resembles a Poole suction device (obvious that sleeve and aspirator resembles a Poole suction device since the prior art combination teaches the same structure and component of the claimed invention; Figure 13 of Yarger ‘449).
Regarding claim 45, Yarger ‘449 in view of Yarger ‘611 teaches the aspirator of claim 35. The combination of Yarger ‘449 in view of Yarger ‘611 further teaches wherein a surface of the tubular member at the bend contacts the sleeve inner surface at one or more regions (bent tubular member 14 contacts at the surface contacts sleeve inner surface at one or more projections 54; Figure 4A and 4C; Paragraph 0040).
Regarding claim 54, Yarger ‘449 teaches a method of assembling a suction device (Abstract; Figure 1 and 13; Paragraph 0035) comprising:
providing an aspirator comprising a sleeve mount and a tubular member extending therefrom (aspirator 13 have a sleeve mount 26 and a tubular member 14; Figure 1; Paragraph 0035-0036), the tubular member comprising a bend (tubular member 14 has a bend; Figure 1);
providing an elastic sleeve defining an opening (sleeve 40 is elastic and has an opening; Figure 1 and 4A; Paragraphs 0035-0041), an inner sleeve wall and a lumen to receive the sleeve mount and tubular member (sleeve 40 has inner sleeve wall and lumen to receive tubular member 14; Figure 1, 4A, and 13; Paragraph 0035). Yarger ‘449 does not teach skewing the elastic sleeve relative to a portion of the tubular member distal to the bend by a skewing angle after sleeve mount is installed within the lumen.
However, Yarger ‘611 teaches skewing the elastic sleeve relative to a portion of the tubular member distal to the bend by a skewing angle after sleeve mount is installed within the lumen (a portion of the tubular member and a portion of the sleeve form a skewing angle; see annotated Figure 5 above).
Yarger ‘449 and Yarger ‘611 are considered to be analogous to the claimed invention because they are in the same field of aspirators. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yarger ‘449 to incorporate the teachings of Yarger ‘611 and have the skewing angle between a portion of the sleeve and a portion of the tubular member after the bend, as taught by Yarger ‘611. This allows for both the sleeve and the tubular member to be bent for the delivery of aspiration towards the direction of the target site (Yager ‘611; Figure 5).
The combination of Yarger ‘449 in view of Yarger ‘611 does not expressly teach the skewing angle being greater than about 2 degrees.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the skewing angle being greater than about 2 degrees 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)(MPEP 2144.04(IV)(A)). In the instant case, the sleeve and tubular member of the device would not operate differently with the claimed skewing angle range since it has the same function of aspirating fluid from the patient. Further, applicant places no criticality on the range claimed, the specification stating that the ranges are “about” the given ranges (Paragraph 0053 of specification).
Claim(s) 46-50 and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Yarger (Publication No. US 2007/0203449 A1) in view of Yarger (Publication No. US 2011/0028939 A1), hereby referred to as “Yarger ‘939”.
Regarding claim 46, Yarger ‘449 teaches an aspirator (Figure 1; Paragraph 0035; Abstract) comprising:
an elastic sleeve comprising a proximal sleeve end, a distal sleeve end and an inner sleeve wall (aspirator sleeve 40, made of elastic material, having a proximal sleeve end, a distal sleeve end, and an inner sleeve wall; Figure 1; Paragraph 0035 and 0043), the proximal sleeve end and inner sleeve wall defining an elongate tapered cavity (proximal sleeve end and inner sleeve wall define an elongate tapered cavity; Figure 1 and 4A; Paragraph 0043), wherein the elongate tapered cavity defines a handle coupling region (sleeve end portion 43; Figure 4A), a bend region (annotated Figure 13 above), a suction head receiving region (annotated Figure 13 above); and a first clearance region (annotated Figure 13 above); and
a suction head (enlarged tip end portion 18; Figure 3A; Paragraph 0038) defining a suction head bore (suction head bore is enlarged shape of portion 18; Figure 3A), a distal suction head end face and an output aperture (face is at orifice 16; Figure 3A; Paragraph 0038);
a handle (grip portion 22; Paragraph 0036; Figure 2) comprising a sleeve coupler (male coupling member 26; Figure 2; Paragraph 0036) and a suction connector barb (tube coupling member 24 is barbed; Figure 2 and 3A; Paragraph 0036), the handle defining an elongate cavity (grip portion 22 has an elongate cavity; Figure 3A), the sleeve coupler defining a handle opening (coupling member 26 has a handle opening at section between tubular member 14 and coupling member 26; Figure 3A), the elongate cavity in fluid communication with the handle opening and the suction connector barb (elongate cavity in fluid communication with handle opening and suction connector barb 24; Figure 3A); a hollow tubular member (member 14; Figure 2 and 3A; Paragraph 0036) comprising a proximal tubular end (proximal tubular end of member 14; Figure 2), the proximal tubular end extending from the sleeve coupler (proximal tubular end extend from sleeve coupler 26; Figure 3A), wherein a first clearance distance normal to distal suction head end face is formed in the first clearance region when sleeve coupler is disposed in the handle coupling region (tip projections 54 forms a clearance distance normal to the distal suction head end face in the first clearance region when sleeve coupler is within handle coupling region; annotated Figure 13 above; Figure 4A-4C).
Yarger ‘449 does not teach the hollow tubular member comprising a flared end, and a bend disposed between the flared end and the proximal tubular end, the flared end extending from the output aperture.
However, Yarger ‘939 teaches the hollow tubular member comprising a flared end (hollow tubular member 18 has a flared end 86; Paragraph 0024; Figure 3), the flared end extending from the output aperture (flared end 86 extend from face of tip guard; Figure 3; Paragraph 0019).
Yarger ‘449 and Yarger ‘939 are considered to be analogous to the claimed invention because they are in the same field of aspirators. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yarger ‘449 to incorporate the teachings of Yarger ‘939 and have the hollow tubular member of Yarger ‘449 to have a flanged end, as taught by Yarger ‘939. This allows for the flared end to accommodate different tip guards of different size and shape (Yarger ‘939; Paragraph 0022).
The combination of Yarger ‘449 in view of Yarger ‘939 further teaches a bend disposed between the flared end and the proximal tubular end (bend of Yarger ‘449 is between the flared end of Yarger ‘939 and the proximal tubular end of Yarger ‘449; Figure 1).
Regarding claim 47, Yarger ‘449 in view of Yarger ‘939 teaches the aspirator of clam 46. The combination of Yarger ‘449 in view of Yarger ‘939 does not expressly teach wherein the first clearance distance ranges from 0.080 inches to about 0.11 inches.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first clearance distance ranges from about 0.080 inches to about 0.11 inches 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)(MPEP 2144.04(IV)(A)). In the instant case, the sleeve inner surface and the suction head would not operate differently with the claimed clearance distance ranges since it has the same function of aspirating fluid from the patient. Further, applicant places no criticality on the range claimed, the specification stating that the ranges are “about” the given ranges (Paragraph 0051 of specification).
Regarding claim 48, Yarger ‘449 in view of Yarger ‘939 teaches the aspirator of clam 46. The combination of Yarger ‘449 in view of Yarger ‘939 further teaches wherein the elongate tapered cavity defines a second clearance region (Yarger ‘449; annotated Figure 13 above), wherein a second clearance distance normal to surface of tubular member is formed in the second clearance region when sleeve coupler is disposed in the handle coupling region (Yarger ‘449; tip projections 54 forms a clearance distance normal to the distal suction head end face in the second clearance region when sleeve coupler is within handle coupling region; annotated Figure 13 above; Figure 4A-4C).
Regarding claim 49, Yarger ‘449 in view of Yarger ‘939 teaches the aspirator of clam 48. The combination of Yarger ‘449 in view of Yarger ‘939 further teaches wherein the second clearance region is disposed between the first clearance region and the bend region (Yarger ‘449; annotated Figure 13 above).
Regarding claim 50, Yarger ‘449 in view of Yarger ‘939 teaches the aspirator of clam 48. The combination of Yarger ‘449 in view of Yarger ‘939 does not expressly teach wherein the second clearance distance ranges from about 0.001 inches to about 0.020 inches.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second clearance distance ranges from about 0.001 inches to about 0.02 inches 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)(MPEP 2144.04(IV)(A)). In the instant case, the sleeve inner surface and the suction head would not operate differently with the claimed clearance distance ranges since it has the same function of aspirating fluid from the patient. Further, applicant places no criticality on the range claimed, the specification stating that the ranges are “about” the given ranges (Paragraph 0051 of specification).
Regarding claim 52, Yarger ‘449 in view of Yarger ‘939 teaches the aspirator of clam 46. The combination of Yarger ‘449 in view of Yarger ‘939 does not expressly teach wherein the first clearance distance ranges from about 0.005 inches to about 0.100 inches.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first clearance distance ranges from about 0.005 inches to about 0.100 inches 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)(MPEP 2144.04(IV)(A)). In the instant case, the sleeve inner surface and the suction head would not operate differently with the claimed clearance distance ranges since it has the same function of aspirating fluid from the patient. Further, applicant places no criticality on the range claimed, the specification stating that the ranges are “about” the given ranges (Paragraph 0052 of specification).
Regarding claim 53, Yarger ‘449 in view of Yarger ‘939 teaches the aspirator of clam 46. The combination of Yarger ‘449 in view of Yarger ‘939 further teaches wherein combination of the elastic sleeve, the suction head, the hollow tubular member and sleeve coupler resembles a Poole suction device (obvious that sleeve and aspirator resemble a Poole suction device since the prior art combination teaches the same structure and component of the claimed invention; Figure 13 of Yarger ‘449).
Claim(s) 51 is rejected under 35 U.S.C. 103 as being unpatentable over Yarger (Publication No. US 2007/0203449 A1) in view of Yarger (Publication No. US 2011/0028939 A1), as applied to claim 46 above, and further in view of Yarger (Publication No. US 2003/0220611 A1).
Regarding claim 51, Yarger ‘449 in view of Yarger ‘939 teaches the aspirator of clam 46. The combination of Yarger ‘449 in view of Yarger ‘939 does not teach wherein the elastic sleeve has a first longitudinal axis and a portion of the hollow tubular member after the bend has a second longitudinal axis.
However, Yarger ‘611 teaches wherein the elastic sleeve has a first longitudinal axis and a portion of the hollow tubular member after the bend has a second longitudinal axis (portion of sleeve is forming a first longitudinal axis and portion of tubular member forms a second longitudinal axis; annotated Figure 5 above).
Yarger ‘449 and Yarger ‘611 are considered to be analogous to the claimed invention because they are in the same field of aspirators. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yarger ‘449 to incorporate the teachings of Yarger ‘611 and have the skewing angle between a portion of the sleeve and a portion of the tubular member after the bend, as taught by Yarger ‘611. This allows for both the sleeve and the tubular member to be bent for the delivery of aspiration towards the direction of the target site (Yager ‘611; Figure 5).
The combination of Yarger ‘449 in view of Yarger ‘939 and Yarger ‘611 does not expressly teach wherein a skewing angle between the first longitudinal axis and the second longitudinal axis is greater than about 2 degrees and less than about 10 degrees.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the skewing angle being greater than about 2 degrees and less than about 10 degrees 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)(MPEP 2144.04(IV)(A)). In the instant case, the sleeve and tubular member of the device would not operate differently with the claimed skewing angle range since it has the same function of aspirating fluid from the patient. Further, applicant places no criticality on the range claimed, the specification stating that the ranges are “about” the given ranges (Paragraph 0052 of specification).
Conclusion
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
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