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.
Claims 3 and 7 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.
Regarding claim 3, it is unclear what the claim limitation “the drainage hole region of the proximal insertion end portion extending from a most proximal drainage hole through the sidewall to a most proximal drainage hole through the sidewall” refers to, since the most proximal drainage hole to the most proximal drainage hole refers to the same most proximal drainage hole and not a region of drainage holes. For the purposes of examination, the claim limitation is interpreted to be “the drainage hole region of the proximal insertion end portion extending from a most proximal drainage hole through the sidewall to a most distal drainage hole through the sidewall”, as described in the specification of the instant application in Paragraph 00029.
Regarding claim 7, it is unclear if the claim limitation “wherein the drainage hole region is located between 2 mm and 30 mm” refers to the length of the drainage hole region or the distance of the drainage hole region with respect to the location of another component on the catheter of the claimed invention. For the purposes of examination, the claim limitation “wherein the drainage hole region is located between 2 mm and 30 mm” is the distance between the drainage hole region and the terminal proximal end, as described in Paragraph 00029 in the Specification of the instant application.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 8-9, 13, 15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hannon et al. (Publication No. US 2015/0297863 A1).
Regarding claim 1, Hannon discloses an intermittent urinary catheter (Abstract; Figure 1-5; Paragraph 0039), comprising:
a catheter shaft (urinary catheter body 10 having a shaft; Figures 1-5; Paragraph 0039) having a proximal insertion end portion for advancement through a urethra into a bladder (proximal end region extends between the tip 16 and slits/cuts 26; Figures 1-5; Paragraph 0039) and a distal drainage end portion having a drainage opening (distal end portion 18 has an opening at end of funnel 24; Figures 1-4; Paragraph 0039-0040), the catheter shaft having a drainage lumen in communication with the drainage opening (funnel 24 is a drainage lumen that is in communication with opening of funnel at the distal end for draining; Paragraph 0040; Figures 1-4);
the proximal insertion end portion comprising a terminal proximal end and a drainage hole region distal of the terminal proximal end (proximal end region has a terminal tip portion 16 and region with cuts/slits 26 that is distal from the terminal tip portion; Figures 1-4; Paragraph 0039-0040), the drainage hole region including a plurality of drainage holes extending through the proximal insertion end portion of the catheter and in communication with the drainage lumen (region with cuts/slits 26 extends through the length of the proximal end region; Figures 1-4); and
wherein the plurality of drainage holes are in a pattern that is configured so that the drainage hole region has a greater flexibility than a portion of the catheter shaft distal to the drainage hole region (cuts/slits 26 provide greater flexibility compared to regions without cuts/slits; Paragraph 0044-0045).
Regarding claim 3, Hannon discloses the catheter of claim 1. Hannon further discloses wherein the catheter shaft includes a sidewall having an outer surface and an inner surface (shaft 10 has a sidewall with an inner and outer surface; Figures 1-4; Paragraph 0039-0040), wherein the inner surface defines the drainage lumen (inner surface of the shaft is a drainage lumen/passageway for urine to drain through; Figures 1-4; Paragraphs 0039-0040);
the plurality of drainage holes extend through the sidewall (cuts/slits 26 extend through the sidewall; Figures 1-4; Paragraph 0041-0042); and
the drainage hole region of the proximal insertion end portion extending from a most proximal drainage hole through the sidewall to a most distal drainage hole through the sidewall (region with cuts/slits 26 extend from proximal most to distal most cut/slits 26; Figures 1-4).
Regarding claim 8, Hannon discloses the catheter of claim 1. Hannon further discloses wherein the pattern of the plurality of drainage holes comprises the drainage holes being arranged in a plurality of columns and a plurality of rows, each column having an axis parallel to the longitudinal axis of the catheter shaft and each row extending circumferentially about the longitudinal axis of the catheter shaft (catheter shaft 10 has slits/cuts 26 that are perpendicular to the central axis of the body, or rows, and extend parallel along the central axis, or columns; Figures 1-4).
Regarding claim 9, Hannon discloses the catheter of claim 8. Hannon further discloses wherein the each of the drainage holes have the same shape and same size (cuts/slits 26 are uniform; Figures 1-4; Paragraph 0042-0043).
Regarding claim 13, Hannon discloses the catheter of claim 8. Hannon further discloses wherein each row of drainage holes is the same distance from adjacent rows (row of slits/cuts 26are the same distance from each other; Figures 1-4; Paragraph 0043).
Regarding claim 15, Hannon discloses the catheter of claim 8. Hannon further discloses wherein each column of drainage holes is the same distance from adjacent columns (columns of slits 26 are the same distance from adjacent columns; Paragraph 0043; Figures 1-4).
Regarding claim 17, Hannon discloses the catheter of claim 8. Hannon further discloses wherein the rows are offset from adjacent rows (slits/cuts 26 is offset to each other at each row; Figure 1-4; Paragraph 0043).
Regarding claim 18, Hannon discloses the catheter of claim 17. Hannon further discloses wherein each row is offset from an immediately adjacent row (slits/cuts 26 is offset to each other at immediately adjacent rows; Figure 1-4; Paragraph 0043).
Regarding claim 19, Hannon discloses the catheter of claim 17. Hannon further discloses wherein the drainage holes comprise elongated slots (slits/cuts 26 are elongated slots; Figures 1-4; Paragraph 0042-0043).
Regarding claim 20, Hannon discloses the catheter of claim 19. Hannon further discloses wherein the elongated slots are elongated (slits/cuts 26 are elongated in shape; Figures 1-4; Paragraph 0042-0043).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to 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 owned as of the effective filing 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) 2, 4-7, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Hannon et al. (Publication No. US 2015/0297863 A1).
Regarding claim 2, Hannon discloses the catheter of claim 1. Hannon further teaches wherein the flexibility of the drainage hole region is more flexible than a flexibility of the portion of the catheter shaft distal of the drainage hole region. Hannon does not expressly teach wherein the flexibility of the drainage hole region is 10% to 70% more flexible than a flexibility of the portion of the catheter shaft distal of the drainage hole region, as measured by an end loaded cantilever deflection test.
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 flexibility of the drainage hole region to be 10% to 70% more flexible than a flexibility of the portion of the catheter shaft distal of the drainage hole region, as measured by an end loaded cantilever deflection test, 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 catheter of Hannon would not operate differently with the claimed percentage of flexibility of the drainage hole region since the catheter is constructed with similar components and structure and is intended to provide flexibility and drainage of urine out of the user for disposal. Further, applicant places no criticality on the range claimed, indicating simply that the claimed flexibility “may be” the claimed ranges (specification; Paragraph 00032). Additionally, it is the Office’s position that the testing method for a material or structural property does not impart a patentable weight. The property is attributed to the material and structure, not the testing method. As such, a reference does not need to recite using the end loaded cantilever deflection test of the claimed invention to determine the material properties of the claimed invention.
Regarding claim 4, Hannon discloses the catheter of claim 1. The embodiment of Figures 1-5 of Hannon does not teach wherein the drainage hole region varies in flexibility along a longitudinal axis of the catheter shaft.
However, the embodiment of Figures 8-12 of Hannon teaches wherein the drainage hole region varies in flexibility along a longitudinal axis of the catheter shaft (cuts or slits at the proximal section 32 are more flexible compared to the distal section 34 of the shaft; Paragraph 0047; Figures 8-12).
Hannon is considered to be analogous to the claimed invention because they are in the same field of urinary catheters. 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 the embodiment of Figures 1-5 of Hannon to incorporate the teachings of the embodiment of Figures 8-12 of Hannon and have the slits/cuts of Hannon with the varying of longitudinal spacing/flexibility of the cuts/slits of the embodiment of Figures 8-12 of Hannon to be incorporated in the catheter of the Figures 1-5 of Hannon. This allows a greater curvature that is flexible to allow for the catheter to traverse the curvature of the urethra (Hannon; Paragraph 0047).
Regarding claim 5, Hannon teaches the catheter of claim 4. Hannon further teaches wherein the proximal end of the drainage hole region has a greater flexibility than the distal end of the drainage hole region (cuts or slits at the proximal section 32 are more flexible compared to the distal section 34 of the shaft; Paragraph 0047; Figures 8-12).
Regarding claim 6, Hannon discloses the catheter of claim 1. Hannon further teaches wherein the drainage hole region has a longitudinal axis (region of cuts/slits 26 have a longitudinal axis; Figures 1-4). Hannon does not expressly teach when 0.7 to 1.1 N of force is applied to the terminal proximal end in a direction perpendicular to the longitudinal axis of the catheter shaft, the drainage hole region bends such that the longitudinal axis of the drainage hole region is about 30 to 50 degrees relative to the longitudinal axis of the catheter shaft.
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 drainage hole region bends such that the longitudinal axis of the drainage hole region is about 30 to 50 degrees relative to the longitudinal axis of the catheter shaft when 0.7 to 1.1 N of force is applied to the terminal proximal end in a direction perpendicular to the longitudinal axis of the catheter shaft, 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 catheter of Hannon would not operate differently with the claimed bend of the drainage hole region since the catheter is constructed with similar components and structure and is intended to provide flexibility and drainage of urine out of the user for disposal. Further, applicant places no criticality on the range claimed, indicating simply that the claimed flexibility “about” the claimed ranges (specification; Paragraph 00032). Additionally, it is the Office’s position that the testing method for a material or structural property does not impart a patentable weight. The property is attributed to the material and structure, not the testing method. As such, a reference does not need to recite using the bendability force test of the claimed invention to determine the material properties of the claimed invention.
Regarding claim 7, Hannon discloses the catheter of claim 1. Hannon does not expressly teach wherein the drainage hole region is located between 2 mm and 30 mm.
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 drainage hole region be located between 2 mm and 30 mm from the terminal proximal end 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 catheter of Hannon would not operate differently with the claimed distance of the drainage hole region since the catheter is constructed with similar components and structure and is intended to provide flexibility and drainage of urine out of the user for disposal. Further, applicant places no criticality on the range claimed, indicating simply that the claimed distance is “about” the claimed ranges (specification; Paragraph 00029).
Regarding claim 23, Hannon discloses the catheter of claim 1. The embodiment of Figures 1-5 of Hannon does not teach the pattern of the plurality of drainage holes comprises elongated slots extending in a helical pattern about the catheter shaft.
However, the embodiment of Figure 21 of Hannon teaches the pattern of the plurality of drainage holes comprises elongated slots extending in a helical pattern about the catheter shaft (spiral cuts 94 are extending in a helical pattern about the catheter body 82; Paragraph 0059; Figure 21).
Hannon is considered to be analogous to the claimed invention because they are in the same field of urinary catheters. 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 the embodiment of Figures 1-5 of Hannon to incorporate the teachings of the embodiment of Figure 21 of Hannon and have the slits/cuts of Hannon with the helical pattern of the embodiment of Figure 21 of Hannon to be incorporated onto the catheter of the embodiment of Figures 1-5 of Hannon. This allows for variable flexibility of the catheter shaft to navigate tortuous pathways (Hannon; Paragraph 0058-0059).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hannon et al. (Publication No. US 2015/0297863 A1) in view of Venturelli (Publication No. US 2006/0100571 A1).
Regarding claim 14, Hannon discloses the catheter of claim 8. Hannon does not teach wherein a distance between adjacent rows varies.
However, Venturelli teaches wherein a distance between adjacent rows varies (Figures 9 and 12; Paragraph 0039-0040).
Hannon and Venturelli are considered to be analogous to the claimed invention because they are in the same field of medical catheters. 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 Hannon to incorporate the teachings of the embodiment of Venturelli and have the distance between adjacent rows of slits/cuts of Hannon vary, as taught by Venturelli. This allows for the gradual increase of flexibility from the proximal end to the distal end (Venturelli; Paragraph 0040).
Claim(s) 10-12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hannon et al. (Publication No. US 2015/0297863 A1) in view of Gross et al. (Publication No. US 2007/0255230 A1).
Regarding claim 10, Hannon discloses the catheter of claim 9. Hannon does not teach wherein at least some rows of drainage holes have a smaller size than an immediately adjacent row of drainage holes.
However, Gross teaches wherein at least some rows of drainage holes have a smaller size than an immediately adjacent row of drainage holes (rows of holes are smaller than the immediate adjacent row towards the proximal end of the cannula; Figures 1-2; Paragraph 0033).
Hannon and Gross are considered to be analogous to the claimed invention because they are in the same field of medical catheters. 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 Hannon to incorporate the teachings of the embodiment of Gross and have at least some rows of drainage holes have a smaller size than an immediately adjacent row of drainage holes, as taught by Gross, applied to the catheter of Hannon. This allows for the greater delivery of treatment in the area where the distal region is located, compared to the proximal region (Gross; Paragraph 0035).
Regarding claim 11, Hannon discloses the catheter of claim 9. Hannon does not teach wherein each row of drainage holes has a smaller size than an immediately adjacent proximal row of drainage holes.
However, Gross teaches wherein each row of drainage holes has a smaller size than an immediately adjacent proximal row of drainage holes (rows of holes are smaller than the immediate adjacent row towards the proximal end of the cannula; Figures 1-2; Paragraph 0033).
Hannon and Gross are considered to be analogous to the claimed invention because they are in the same field of medical catheters. 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 Hannon to incorporate the teachings of the embodiment of Gross and have each row of drainage holes has a smaller size than an immediately adjacent proximal row of drainage holes, as taught by Gross, applied to the catheter of Hannon. This allows for the greater delivery of treatment in the area where the distal region is located, compared to the proximal region (Gross; Paragraph 0035).
Regarding claim 12, Hannon discloses the catheter of claim 9. Hannon does not teach wherein each row of drainage holes has a smaller size than an immediately adjacent distal row of drainage holes.
However, Gross teaches wherein each row of drainage holes has a smaller size than an immediately adjacent distal row of drainage holes (rows of holes are smaller than the immediate adjacent row towards the distal end of the cannula; Figures 3; Paragraph 0036).
Hannon and Gross are considered to be analogous to the claimed invention because they are in the same field of medical catheters. 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 Hannon to incorporate the teachings of the embodiment of Gross and have each row of drainage holes has a smaller size than an immediately adjacent distal row of drainage holes, as taught by Gross, applied to the catheter of Hannon. This allows for the greater delivery of treatment in the area where the proximal region is located, compared to the proximal region (Gross; Paragraph 0036).
Regarding claim 16, Hannon discloses the catheter of claim 8. Hannon does not teach wherein a distance between adjacent columns varies.
However, Gross teaches wherein a distance between adjacent columns varies (distance of adjacent columns varies since there is a change in drainage hole sizes from the proximal to the distal end of the catheter; Figures 1-2; Paragraph 0033).
Hannon and Gross are considered to be analogous to the claimed invention because they are in the same field of medical catheters. 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 Hannon to incorporate the teachings of the embodiment of Gross and have the distance between adjacent columns varies by the change in size of the drainage holes from the proximal end to the distal end, as taught by Gross, applied to the catheter of Hannon. This allows for the greater delivery of treatment in the area where the distal region is located, compared to the proximal region (Gross; Paragraph 0035).
Claim(s) 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Hannon et al. (Publication No. US 2015/0297863 A1) in view of Erbey, II et al. (Publication No. US 2019/0091442 A1).
Regarding claim 21, Hannon discloses the catheter of claim 1. Hannon does not teach wherein the pattern of the plurality of drainage holes comprises a plurality of adjacent rows wherein rows have less drainage holes than an adjacent proximal rows.
However, Erbey, II teaches wherein the pattern of the plurality of drainage holes comprises a plurality of adjacent rows wherein rows have less drainage holes than an adjacent proximal rows (number of drainage holes increase towards the end 2220 of the catheter where the catheter is inserted into the user; Figure 12; Paragraph 0279-0280).
Hannon and Erbey, II are considered to be analogous to the claimed invention because they are in the same field of medical catheters. 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 Hannon to incorporate the teachings of the embodiment of Erbey, II and have the pattern of the plurality of drainage holes comprises a plurality of adjacent rows wherein rows have less drainage holes than an adjacent proximal rows, as taught by Erbey, II, applied to the catheter of Hannon. This allows for the increase in flow rate at the catheter end with the greater drainage openings versus at the opposing region with lesser drainage openings (Erbey, II; Paragraph 0279-0280).
Regarding claim 22, Hannon in view of Erbey, II teaches the catheter of claim 21. The combination of Hannon in view of Erbey, II further teaches wherein each row has less drainage holes than an immediately adjacent proximal rows (Figure 12; Paragraph 0279-0280; see rejection of claim 21 above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781