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 .
Response to Amendment
Applicant’s amendments filed on 04/29/2026 has been fully considered. Claims 1-3, 5-14, 16-19, and 24-25 are pending. Claims 1-3, 7, 14, and 19 amended. Claims 4, 15, , and 20-23 are cancelled. Claims 24-25 are newly added.
Response to Arguments
Applicant’s arguments with respect to amended independent claims 1, 7, and 24 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. More specifically, the claim amendment further narrows the scope of the independent claims by requiring a lubricious coating with a hyaluronic-acid-based hydrophilic coating.
Though some of the same prior art reference is re-used herein, amended independent claims 1, 7, and 24 required a change in the grounds of rejection relying on additional prior art as detailed below in the prior art rejection.
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.
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) 1-3, 5, 7, 12-14, 16, 18-19, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Yin et al. (Publication No. US 2018/0104444 A1) in view of Sileika et al. (Publication No. WO 2021/086843 A1).
Regarding claim 1, Yin teaches a urinary catheter (urinary catheter 100; Figure 3a; Paragraph 0035), comprising:
a catheter tube of a polymeric material (catheter shaft 104 is made of silicone, a polymeric material; Paragraph 0035; Figure 3a);
a lubricious coating over a surface of at least a distal portion of the catheter tube (hydrophilic base coating 154 and pre-hydrated outer coating 156; Figure 3a-3b; Paragraph 0036), the lubricious coating including a hydrophilic coating over the surface of the catheter tube (hydrophilic base coating 154 on the surface of tube 104; Paragraph 0036; Figure 3a-3b) and lubricant over the hydrophilic coating (pre-hydrated outer coating 156 is applied over base coating 154; Figure 3a-3b; Paragraph 0036), wherein water of the lubricant is at least partially absorbed by the hydrophilic coating (lubricant made of LUBRAJEL, consisting of glycerin, water, glyceryl acrylate/acrylic acid copolymer, and propylene glycol, is in contact with hydrophilic base coating – hydrophilic nature of base coating will absorb a part of the water in the lubricant coat 156; Figure 3B; Paragraph 0036-0037); and
a funnel coupled to a proximal portion of the catheter tube (funnel 106 connected at the proximal end of tube 104; Paragraph 0035; Figure 3a), the funnel including a funnel opening in a proximal end of the funnel for voiding urine (funnel 106 has opening at proximal end to connect to drain bags; Paragraph 0035; Figure 3a). Yin does not teach the lubricious coating including a hyaluronic-acid-based hydrophilic coating.
However, Sileika teaches the lubricious coating including a hyaluronic-acid-based hydrophilic coating (hydration medium can be a hyaluronic acid based hydrophilic coating; Paragraph 0017 and 0024).
Yin and Sileika are both 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 Yin to incorporate the teachings of Sileika to have the hydrophilic coating of Yin be the hyaluronic based hydrogel coating of Sileika. This allows for the coating to physically entrap and prevents bacteria from swarming or moving (Sileika; Paragraph 0024).
Regarding claim 2, Yin in view of Sileika teaches the catheter of claim 1. The combination of Yin in view of Sileika further teaches wherein the hydrophilic coating is a hyaluronic acid-based hydrogel (Sileika; hyaluronic acid hydrogel; Paragraph 0024).
Regarding claim 3, Yin in view of Sileika teaches the catheter of claim 1. Yin further teaches wherein the lubricant is a combination of glycerin, water, glyceryl acrylate/acrylic acid copolymer, and propylene glycol (lubricant 156 made of LUBRAJEL, consisting of glycerin, water, glyceryl acrylate/acrylic acid copolymer, and propylene glycol; Figure 3B; Paragraph 0036-0037). The claim limitation “that limits evaporation of any water from the lubricious coating” is a recitation of an intended use of the lubricant. Although the prior art of Yin does not expressly discuss “that limits evaporation of any water from the lubricious coating”, since the lubricant of the prior art combination is substantially identical to the claimed catheter, it must also necessarily produce the same outcome. Therefore, the claim limitation is taught by the prior art combination of Yin in view of Sileika. Wherein the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 5, Yin in view of Sileika teaches the catheter of claim 1. Yin further teaches wherein the polymeric material is thermoplastic polyurethane ("TPU"), silicone, polyvinyl chloride, or a rubber (catheter shaft 104 is made of silicone, a polymeric material; Paragraph 0035; Figure 3a).
Regarding claim 7, Yin teaches a method of making a urinary catheter (Abstract; Paragraph 0015 and 0036-0038), comprising: applying a hydrophilic coating over a surface of a catheter tube of the urinary catheter (hydrophilic base coating 154 is applied to the surface of tube 104; Paragraph 0015 and 0036; Figure 3b); and dipping at least a distal portion of the catheter tube into a reservoir of a lubricant, thereby disposing the lubricant over the hydrophilic coating (lubricant coating 156 is dipped over the hydrophilic coating 154 so coating 156 is over coating 154; Paragraph 0036-0038; Figure 3b), water of the lubricant at least partially absorbed by the hydrophilic coating (lubricant made of LUBRAJEL, consisting of glycerin, water, glyceryl acrylate/acrylic acid copolymer, and propylene glycol, is in contact with hydrophilic base coating – hydrophilic nature of base coating will absorb a part of the water in the lubricant coat 156; Figure 3B; Paragraph 0036-0037). Yin does not teach a hyaluronic-acid-based hydrophilic coating.
However, Sileika teaches the lubricious coating including a hyaluronic-acid-based hydrophilic coating (hydration medium can be a hyaluronic acid based hydrophilic coating; Paragraph 0017 and 0024).
Yin and Sileika are both 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 Yin to incorporate the teachings of Sileika to have the hydrophilic coating of Yin be the hyaluronic based hydrogel coating of Sileika. This allows for the coating to physically entrap and prevents bacteria from swarming or moving (Sileika; Paragraph 0024).
Regarding claim 12, Yin in view of Sileika teaches the method of claim 7. Yin further teaches wherein the dipping of the catheter tube into the reservoir of the lubricant includes dwell time in the lubricant between 0.1-10 seconds (Paragraph 0038). Yin does not expressly teach wherein the dipping of the catheter tube into the reservoir of the lubricant includes substantially no dwell time in the lubricant.
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 dwell time of Yin in view of Sileika to be substantially no dwell time in the lubricant 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 Yin in view of Sileika would not operate differently with the claimed dwell time since the urinary catheter is constructed with similar components, structure, and material characteristics (see disclosed above) and is intended to be inserted into the urethra of the user for draining of urine. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the dwell time is “substantially no dwell time” (specification; paragraphs 0015 and 0052).
Regarding claim 13, Yin in view of Sileika teaches the method of claim 7. Yin further teaches wherein the dipping of the catheter tube into the reservoir of the lubricant includes a single dip in the lubricant (Paragraph 0038 – “The catheter (with or without a base coating) may be dipped into the coating solution and left to dwell for between 0.1-10 seconds. The catheter may then be removed from the coating solution and directly placed into packaging without any further drying process.”).
Regarding claim 14, Yin in view of Sileika teaches the method of claim 7. Yin further teaches wherein the lubricant is a combination of glycerin, water, glyceryl acrylate/acrylic acid copolymer, and propylene glycol (lubricant 156 made of LUBRAJEL, consisting of glycerin, water, glyceryl acrylate/acrylic acid copolymer, and propylene glycol; Figure 3B; Paragraph 0036-0037). The claim limitation “that limits evaporation of any water from the lubricious coating” is a recitation of an intended use of the lubricant. Although the prior art of Yin does not expressly discuss “that limits evaporation of any water from the lubricious coating”, since the lubricant of the prior art combination is substantially identical to the claimed catheter, it must also necessarily produce the same outcome. Therefore, the claim limitation is taught by the prior art combination of Yin in view of Sileika. Wherein the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 16, Yin in view of Sileika teaches the method of claim 7. Yin further teaches further comprising packaging the urinary catheter without air drying the urinary catheter after the dipping of the catheter tube into the reservoir of the lubricant (Paragraph 0038 – “The catheter (with or without a base coating) may be dipped into the coating solution and left to dwell for between 0.1-10 seconds. The catheter may then be removed from the coating solution and directly placed into packaging without any further drying process.”).
Regarding claim 18, Yin in view of Sileika teaches the method of claim 7. Yin further teaches wherein the catheter tube is of a polymeric material selected from thermoplastic polyurethane ("TPU"), silicone, polyvinyl chloride, and a rubber (catheter shaft 104 is made of silicone, a polymeric material; Paragraph 0035; Figure 3a).
Regarding claim 19, Yin in view of Sileika teaches the method of claim 7. The combination of Yin in view of Sileika further teaches wherein the hydrophilic coating is a hyaluronic acid-based hydrogel (Sileika; hydrophilic coating is a hyaluronic acid hydrogel; Paragraph 0024).
Regarding claim 24, Yin teaches a packaged urinary catheter (catheter 10 in gel package 20; Abstract; Paragraph 0034; Figure 1), comprising:
outer packaging (packaging 20; Paragraph 0034; Figure 1; Abstract); and
a urinary catheter disposed in the outer packaging (catheter 10 is inside of packaging 20; Paragraph 0034; Abstract; Figure 1), the urinary catheter including:
a catheter tube of a polymeric material (catheter shaft 104 is made of silicone, a polymeric material; Paragraph 0035; Figure 3a);
a lubricious coating over a surface of at least a distal portion of the catheter tube (hydrophilic base coating 154 and pre-hydrated outer coating 156; Figure 3a-3b; Paragraph 0036), the lubricious coating including a hydrophilic coating over the surface of the catheter tube (hydrophilic base coating 154 on the surface of tube 104; Paragraph 0036; Figure 3a-3b) and lubricant over the hydrophilic coating (pre-hydrated outer coating 156 is applied over base coating 154; Figure 3a-3b; Paragraph 0036), wherein water of the lubricant is at least partially absorbed by the hydrophilic coating (lubricant made of LUBRAJEL, consisting of glycerin, water, glyceryl acrylate/acrylic acid copolymer, and propylene glycol, is in contact with hydrophilic base coating – hydrophilic nature of base coating will absorb a part of the water in the lubricant coat 156; Figure 3B; Paragraph 0036-0037); and
a funnel coupled to a proximal portion of the catheter tube (funnel 106 connected at the proximal end of tube 104; Paragraph 0035; Figure 3a), the funnel including a funnel opening in a proximal end of the funnel for voiding urine (funnel 106 has opening at proximal end to connect to drain bags; Paragraph 0035; Figure 3a). Yin does not teach the lubricious coating including a hyaluronic acid-based hydrophilic coating.
However, Sileika teaches the lubricious coating including a hyaluronic-acid-based hydrophilic coating (hydration medium can be a hyaluronic acid based hydrophilic coating; Paragraph 0017 and 0024).
Yin and Sileika are both 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 Yin to incorporate the teachings of Sileika to have the hydrophilic coating of Yin be the hyaluronic based hydrogel coating of Sileika. This allows for the coating to physically entrap and prevents bacteria from swarming or moving (Sileika; Paragraph 0024).
The claim limitation “wherein water of the lubricant is at least partially absorbed by the hydrophilic coating such that no added water is needed for urethral insertion by urinary catheter users or their caregivers” and “wherein the lubricious coating mitigates water evaporation and any resulting tackiness, thereby giving the urinary catheter users or their caregivers adequate time for successful urethral insertion” are a recitation of an intended use of the lubricant. Although the prior art of Yin does not expressly disclose “wherein water of the lubricant is at least partially absorbed by the hydrophilic coating such that no added water is needed for urethral insertion by urinary catheter users or their caregivers” and “wherein the lubricious coating mitigates water evaporation and any resulting tackiness, thereby giving the urinary catheter users or their caregivers adequate time for successful urethral insertion”, since the lubricant of the prior art combination is substantially identical to the claimed catheter, it must also necessarily produce the same outcome. Therefore, the claim limitation is taught by the prior art combination of Yin in view of Sileika. Wherein the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 25, Yin in view of Sileika teaches the packaged urinary catheter of claim 24. The combination of Yin in view of Sileika further teaches wherein the hydrophilic coating is a hyaluronic acid-based hydrogel (Sileika; hydrophilic coating is a hyaluronic acid hydrogel; Paragraph 0024).
Claim(s) 6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Yin et al. (Publication No. US 2018/0104444 A1) in view of Sileika et al. (Publication No. WO 2021/086843 A1), as applied to claims 1 and 7 above, and further in view of Whitbourne (Patent No. US 5,001,009 A).
Regarding claim 6, Yin in view of Sileika teaches the urinary catheter of claim 1. The combination of Yin in view of Sileika does not teach wherein the surface of the catheter tube is a plasma-treated surface with a surface energy that promotes adhesion of the hydrophilic coating.
However, Whitbourne teaches wherein the surface of the catheter tube is a plasma-treated surface with a surface energy that promotes adhesion of the hydrophilic coating (Column 4, lines 60-68).
Yin in view of Sileika and Whitbourne are both considered to be analogous to the claimed invention because they are in the same field of 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 Yin in view of Sileika to incorporate the teachings of Whitbourne to have the surface of the catheter tube of Yin in view of Sileika to be plasma-treated, as taught by Whitbourne. This allows for the surface of the device to allow for the hydrophilic lubricant to adhere onto the surface (Whitbourne; Column 4, lines 60-68).
Regarding claim 17, Yin in view of Sileika teaches the urinary catheter of claim 7. The combination of Yin in view of Sileika does not teach further comprising treating at least the distal portion of the catheter tube with a plasma treatment to modify the surface of the catheter tube before the applying of the hydrophilic coating over the surface of the catheter tube.
However, Whitbourne teaches further comprising treating at least the distal portion of the catheter tube with a plasma treatment to modify the surface of the catheter tube before the applying of the hydrophilic coating over the surface of the catheter tube (Column 4, lines 60-68).
Yin in view of Sileika and Whitbourne are both considered to be analogous to the claimed invention because they are in the same field of 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 Yin in view of Sileika to incorporate the teachings of Whitbourne to have the at least distal portion of the surface of the catheter tube of Yin in view of Sileika to be plasma-treated, as taught by Whitbourne. This allows for the surface of the device to allow for the hydrophilic lubricant to adhere onto the surface (Whitbourne; Column 4, lines 60-68).
Claim(s) 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Yin et al. (Publication No. US 2018/0104444 A1) in view of Sileika et al. (Publication No. WO 2021/086843 A1), as applied to claim 7 above, and further in view of Matsumoto et al. (Publication No. US 2015/0018962 A1).
Regarding claim 8, Yin in view of Sileika teaches the urinary catheter of claim 7. The combination of Yin in view of Sileika does not expressly teach wherein the dipping of the catheter tube into the reservoir of the lubricant includes immersing the catheter tube in the lubricant with an immersion speed from about 0.15 in/s to about 0.50 in/s.
However, Matsumoto teaches wherein the dipping of the catheter tube into the reservoir of the lubricant includes immersing the catheter tube in the lubricant with an immersion speed from about 0.15 in/s to about 0.50 in/s (tube was dipped into lubricant and pulled out at a constant speed of 10 mm/sec, or 0.39 in/s; Paragraph 0165).
Yin in view of Sileika and Matsumoto are both considered to be analogous to the claimed invention because they are in the same field of 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 Yin in view of Sileika to incorporate the teachings of Matsumoto to have the immersion speed of Matsumoto in the method of dipping the catheter tube in the lubricant of Yin in view of Sileika. This allows for the adherence of the lubricant layer to the surface of the tube (Matsumoto; Paragraph 0165).
Furthermore, 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 immersion speed of about 0.15 in/s to about 0.5 in/s 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 Yin in view of Sileika and Matsumoto would not operate differently with the claimed immersion speed since the urinary catheter is constructed with similar components, structure, and material characteristics (see disclosed above) and is intended to be inserted into the urethra of the user for draining of urine. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the immersion speed is “about” the claimed ranges (claim 8; specification; paragraphs 0011 and 0053).
Regarding claim 9, Yin in view of Sileika teaches the urinary catheter of claim 7. The combination of Yin in view of Sileika does not expressly teach wherein the dipping of the catheter tube into the reservoir of the lubricant includes immersing the catheter tube in the lubricant with an immersion speed of about 0.33 in/s.
However, Matsumoto teaches wherein the dipping of the catheter tube into the reservoir of the lubricant includes immersing the catheter tube in the lubricant with an immersion speed of about 0.33 in/s (tube was dipped into lubricant and pulled out at a constant speed of 10 mm/sec, or 0.39 in/s; Paragraph 0165).
Yin in view of Sileika and Matsumoto are both considered to be analogous to the claimed invention because they are in the same field of 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 Yin in view of Sileika to incorporate the teachings of Matsumoto to have the immersion speed of Matsumoto in the method of dipping the catheter tube in the lubricant of Yin in view of Sileika. This allows for the adherence of the lubricant layer to the surface of the tube (Matsumoto; Paragraph 0165).
Furthermore, 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 immersion speed of about 0.33 in/s 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 Yin in view of Sileika would not operate differently with the claimed immersion speed since the urinary catheter is constructed with similar components, structure, and material characteristics (see disclosed above) and is intended to be inserted into the urethra of the user for draining of urine. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the immersion speed is “about” the claimed ranges (claim 9; specification; paragraphs 0012 and 0053). Regarding claim 10, Yin in view of Sileika teaches the urinary catheter of claim 7. The combination of Yin in view of Sileika does not expressly teach wherein the dipping of the catheter tube into the reservoir of the lubricant includes withdrawing the catheter tube from the lubricant with a withdrawal speed from about 0.05 in/s to about 0.20 in/s.
However, Matsumoto teaches wherein the dipping of the catheter tube into the reservoir of the lubricant includes withdrawing the catheter tube from the lubricant with a withdrawal speed from about 0.05 in/s to about 0.20 in/s (tube was dipped into lubricant and pulled out at a constant speed of 5 mm/sec, or 0.2 in/s; Paragraph 0173).
Yin in view of Sileika and Matsumoto are both considered to be analogous to the claimed invention because they are in the same field of 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 Yin to incorporate the teachings of Matsumoto to have the withdrawal speed of Matsumoto in the method of dipping the catheter tube in the lubricant of Yin in view of Sileika. This allows for the adherence of the lubricant layer to the surface of the tube (Matsumoto; Paragraph 0173).
Furthermore, 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 withdrawal speed from about 0.05 in/s to about 0.20 in/s 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 Yin in view of Sileika and Matsumoto would not operate differently with the claimed immersion speed since the urinary catheter is constructed with similar components, structure, and material characteristics (see disclosed above) and is intended to be inserted into the urethra of the user for draining of urine. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the withdrawal speed is “about” the claimed ranges (claim 10; specification; paragraphs 0013 and 0053).
Regarding claim 11, Yin in view of Sileika teaches the urinary catheter of claim 7. The combination of Yin in view of Sileika does not expressly teach wherein the dipping of the catheter tube into the reservoir of the lubricant includes withdrawing the catheter tube from the lubricant with a withdrawal speed of about 0.12 in/s.
However, Matsumoto teaches wherein the dipping of the catheter tube into the reservoir of the lubricant includes withdrawing the catheter tube from the lubricant with a withdrawal speed of about 0.12 in/s (tube was dipped into lubricant and pulled out at a constant speed of 5 mm/sec, or 0.2 in/s; Paragraph 0173).
Yin in view of Sileika and Matsumoto are both considered to be analogous to the claimed invention because they are in the same field of 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 Yin in view of Sileika to incorporate the teachings of Matsumoto to have the withdrawal speed of Matsumoto in the method of dipping the catheter tube in the lubricant of Yin in view of Sileika. This allows for the adherence of the lubricant layer to the surface of the tube (Matsumoto; Paragraph 0173).
Furthermore, 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 withdrawal speed of about 0.12 in/s 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 Yin in view of Sileika and Matsumoto would not operate differently with the claimed immersion speed since the urinary catheter is constructed with similar components, structure, and material characteristics (see disclosed above) and is intended to be inserted into the urethra of the user for draining of urine. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the withdrawal speed is “about” the claimed ranges (claim 11; specification; paragraphs 0014 and 0053).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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