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 .
Specification
The abstract of the disclosure is objected to because:
In line 3, “the distal side” should be changed to “a distal side”
In line 3, “liquid” should be changed to “a liquid”
In line 9, “the elongated medical body” should be changed to “an elongated medical body”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 3, 6-12, 15, and 18 are objected to because of the following informalities:
In regards to claim 1, line 8, “liquid” should be changed to “a liquid”.
In regards to claim 3, line 1, “the elongated body” should be changed to “the elongated medical body”.
In regards to claim 6, line 2, “the elongated body” should be changed to “the elongated medical body”.
In regards to claim 7, line 4, “the board 20” should be changed to “the board”.
In regards to claim 7, line 6, “a groove depth of 6.2 mm, a groove width of 6.2 mm” should be changed to “a groove depth of 6.2 mm and a groove width of 6.2 mm”.
In regards to claim 7, line 9, “the proximal side” should be changed to “a proximal side”.
In regards to claim 7, line 10, “the distal side” should be changed to “a distal side”.
In regards to claim 7, line 11, “the proximal side” should be changed to “a proximal side”.
In regards to claim 7, line 12, “the distal side” should be changed to “a distal side”.
In regards to claim 8, line 12, “collected liquid” should be changed to “a collected liquid”.
In regards to claim 8, line 14, “the liquid” should be changed to “the collected liquid”.
In regards to claim 8, line 16, “a converted value” should be changed to “the converted value”.
In regards to claim 9, line 12, “a liquid” should be changed to “the liquid”.
In regards to claim 9, lines 12-13, “into the tube such a manner” should be changed to “into the tube in such a manner”.
In regards to claim 9, line 13, “collected liquid” should be changed to “a collected liquid”.
In regards to claim 9, line 15, “a number” should be changed to “the number”.
In regards to claim 9, line 15, “collected liquid” should be changed to “the collected liquid”.
In regards to claim 10, line 1, “the plurality of repeating” should be changed to “the plurality of times of repeating”.
In regards to claim 11, line 4, “a number” should be changed to “the number”.
In regards to claim 11, lines 4-5, “a converted value” should be changed to “the converted value”.
In regards to claim 12, line 2, “a distal side” should be changed to “the distal side”.
In regards to claim 15, line 10, “distal side” should be changed to “a distal side”.
In regards to claim 15, line 10, “liquid” should be changed to “a liquid”.
In regards to claim 15, line 19, “the distal end” should be changed to “the distal end of the tube”.
In regards to claim 15, line 28, “collected liquid” should be changed to “a collected liquid”.
In regards to claim 15, line 30, “the number” should be changed to “a number”.
In regards to claim 15, line 30, “the liquid” should be changed to “the collected liquid”.
In regards to claim 15, line 32, “a converted value” should be changed to “the converted value”.
In regards to claim 18, line 11, “distal side” should be changed to “a distal side”.
In regards to claim 18, line 11, “liquid” should be changed to “a liquid”.
In regards to claim 18, line 21, “the distal end” should be changed to “the distal end of the tube”.
In regards to claim 18, line 30, “collected liquid” should be changed to “a collected liquid”.
In regards to claim 18, line 32, “the number” should be changed to “a number”.
In regards to claim 18, line 32, “the liquid” should be changed to “the collected liquid”.
In regards to claim 18, line 34, “a converted value” should be changed to “the converted value”.
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.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 5, lines 2-3 recite “the insertion start point to the insertion end point of the tube”. However, there is insufficient antecedent basis for this limitation in the claim. Claim 5 depends upon claim 4, which depends upon claim 2. Claim 2, lines 3-5 recite “an insertion start point of the elongated medical body” and “an insertion end point of the elongated medical body”. Thus, there is antecedent basis for the insertion start point and the insertion end point being of the elongated medical body, but there is not antecedent basis for the insertion start point and the insertion end point being of the tube.
Claim Rejections - 35 USC § 102
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.
Claims 1-5, 9, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matsuhashi (WO 2023/276995).
In regards to claim 1, Matsuhashi teaches a testing device (Figure 6) for measuring a number of particles generated from a lubricating layer formed on an elongated medical body, the testing device comprising:
a flexible tube (62) provided with a lumen, the lumen extending from a distal end of the tube to a proximal end of the tube
a board (63), the board including a holding groove having a recessed shape configured to hold the tube in a deformed state (Figure 6)
a collecting container configured to be placed on a distal side of the tube arranged in the holding groove and configured to store liquid flowing in from an injection tool ([Particle test]: specimen liquid discharged from the tip of the catheter is collected)
wherein the holding groove has a groove shape including a first straight portion, a first meandering portion adjacent to a distal end of the first straight portion, a second straight portion adjacent to a distal end of the first meandering portion, a second meandering portion adjacent to a distal end of the second straight portion, and a third straight portion adjacent to a distal end of the second meandering portion as seen from an insertion direction of the elongated medical body, and the holding groove deforms and holds the tube according to the groove shape when the tube is fitted into the holding groove (Figure 6)
In regards to claim 2, Matsuhashi teaches the elongated medical body ([Particle test]: samples 16 to 21 of Examples 16 to 21)(Example 16: lubricating layer (dry film thickness: 4 μm) was formed on the PVC intermediate layer)(Example 17: lubricating layer (dry film thickness: 4 μm) was formed on the PVC intermediate layer)(Example 18: lubricating layer (dry film thickness: 4 μm) was formed on the PVC intermediate layer)(Example 19: lubricating layer (dry film thickness: 4 μm) was formed on the PVC intermediate layer)(Example 20: lubricating layer (dry film thickness: 4 μm) was formed on the PVC intermediate layer)(Example 21: lubricating layer (dry film thickness: 4 μm) was formed on the PVC intermediate layer); and wherein an insertion start point of the elongated medical body is set in a portion corresponding to the first straight portion of the holding groove, and an insertion end point of the elongated medical body is set in a portion corresponding to the third straight portion of the holding groove (Figure 6).
In regards to claim 3, Matsuhashi teaches wherein the elongated body is configured to be inserted into the tube and a portion of the elongated medical body provided with the lubricating layer is configured to be inserted and retracted in a reciprocating manner between the insertion start point and the insertion end point ([Particle test]: each sample is set in a catheter tube 62 filled with distilled water and reciprocated (slid) 10 times with a sliding distance (stroke) of 100 cm).
In regards to claim 4, Matsuhashi teaches wherein the insertion start point and the insertion end point of the elongated medical body are set at positions that secure at least a length equal to or longer than a predetermined length of the elongated medical body provided with the lubricating layer (Figure 6).
In regards to claim 5, Matsuhashi teaches wherein when the elongated medical body is inserted from the insertion start point to the insertion end point of the tube, the predetermined length provided with the lubricating layer is inserted into the tube (([Particle test]: each sample is set in a catheter tube 62).
In regards to claim 9, Matsuhashi teaches a testing method using the testing device of claim 1, the testing method comprising:
preparing the testing device and the elongated medical body provided with a lubricating layer having a predetermined length ([Particle test]: samples 16 to 21 of Examples 16 to 21 above were subjected to fine particle generation under more severe conditions using the test system shown in FIG. 6 according to the following method)
setting a distal end of the elongated medical body at an insertion start point of the tube, and repeating insertion and retraction of the elongated medical body a plurality of times by inserting the distal end of the elongated medical body from the insertion start point to an insertion end point of the tube in such a manner that a portion of the elongated medical body provided with the lubricating layer is completely inserted and by subsequently retracting the distal end of the elongated medical body to the insertion start point ([Particle test]: each sample is set in a catheter tube 62 filled with distilled water and reciprocated (slid) 10 times with a sliding distance (stroke) of 100 cm)
retracting the elongated medical body from the tube and injecting a liquid into the tube such a manner that a predetermined amount of collected liquid is collected in the collecting container ([Particle test]: the sample is taken out from the catheter tube 62, 100 mL of distilled water is injected into the catheter tube 62, and the specimen liquid discharged from the tip of the catheter is collected)
measuring a number of particles in the predetermined amount of collected liquid ([Particle test]: The number of particles of 10 μm size (diameter) or more in the sample liquid and the blank liquid (100 mL each) collected above is measured with a liquid particle counter (manufactured by HIAC, device name: light shielding type automatic particle measuring device). Then, the value obtained by subtracting the measured value of the number of particles in the blank liquid (Y .sub.0 ) from the number of particles in the sample liquid (Y .sub.1 ) is the number of particles in the sample (=Y .sub.1 -Y .sub.0 (pieces)). did)
In regards to claim 12, Matsuhashi teaches placing the collecting container on a distal side of the tube and collecting the predetermined amount of the collected liquid in the collecting container ([Particle test]: specimen liquid discharged from the tip of the catheter is collected).
In regards to claim 13, Matsuhashi teaches forming the lubricating layer by adding a non-lubricating material to a lubricating material (Example 16: lubricating layer (dry film thickness: 4 μm) was formed on the PVC intermediate layer)(Example 17: lubricating layer (dry film thickness: 4 μm) was formed on the PVC intermediate layer)(Example 18: lubricating layer (dry film thickness: 4 μm) was formed on the PVC intermediate layer)(Example 19: lubricating layer (dry film thickness: 4 μm) was formed on the PVC intermediate layer)(Example 20: lubricating layer (dry film thickness: 4 μm) was formed on the PVC intermediate layer)(Example 21: lubricating layer (dry film thickness: 4 μm) was formed on the PVC intermediate layer).
In regards to claim 14, Matsuhashi teaches wherein the lubricating material is a hydrophilic material (Example 16: lubricating layer containing hydrophilic polymer 1)(Example 17: lubricating layer containing hydrophilic polymer 1)(Example 18: lubricating layer containing hydrophilic polymer 1)(Example 19: lubricating layer containing hydrophilic polymer 1)(Example 20: lubricating layer containing hydrophilic polymer 1)(Example 21: lubricating layer containing hydrophilic polymer 1), and the non-lubricating material being vinyl chloride resin (Example 16: PVC intermediate layer)(Example 17: PVC intermediate layer)(Example 18: PVC intermediate layer)(Example 19: PVC intermediate layer)(Example 20: PVC intermediate layer)(Example 21: PVC intermediate layer).
Claims 15-16 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rooijmans et al (US 2011/0059874).
In regards to claim 15, Rooijmans et al teaches an elongated medical body comprising:
a main body (paragraph [0010]: guide wires and catheters)(paragraph [0011]: medical device, such as a catheter)
a lubricating layer formed on an outer surface of the main body in a predetermined area, the predetermined area having a distal end and a proximal end (paragraph [0010]: hydrophilic coating)(paragraph [0002]: A coating or layer which becomes lubricious after wetting is hereinafter referred to as a hydrophilic coating)(paragraph [0011]: A coating on the outer or inner surface of a medical device, such as a catheter, is considered lubricious)
wherein the lubricating layer has no more than 5000 particles having a particle size of 10 μm or more (paragraph [0010]: less than 3000, more preferably less than 2000, most preferably less than 1000, in particular less than 500 particles larger than 10 .mu.m)
In regards to “when measured with a testing device that includes a tube having flexibility and provided with a lumen communicating a distal end and a proximal end of the tube and a collecting container placed on distal side of the tube and used to store liquid flowing in from an injection tool, the tube being deformed and held to have a shape including a first straight portion, a first meandering portion adjacent to a distal end of the first straight portion, a second straight portion adjacent to a distal end of the first meandering portion, a second meandering portion adjacent to a distal end of the second straight portion, and a third straight portion adjacent to a distal end of the second meandering portion as seen from an insertion direction of the elongated medical body”, it is noted that claim 15 is drawn to an elongated medical body intended to be used with a testing device having a tube and a collecting container, thus the testing device having the tube and the collecting container is not a positively recited structure of the claimed elongated medical body. Rooijmans et al teaches the claimed elongated medical body which has the ability to be used with a testing device having a tube and a collecting container, as claimed, as the structure of the elongated medical body of Rooijmans et al is capable of interacting with the testing device having the tube and the collecting container.
Further, Rooijmans et al is silent about “by a testing method comprising: preparing the elongated medical body provided with the lubricating layer in an area having a predetermined length from the distal end toward the proximal end of the tube; setting a distal end of the elongated medical body at an insertion start point of the tube and repeating insertion and retraction 5 times by inserting the distal end of the elongated medical body from the insertion start point to an insertion end point of the tube in such a manner that a portion of the elongated medical body provided with the lubricating layer is completely inserted and by subsequently retracting the distal end of the elongated medical body to the insertion start point; retracting the elongated medical body from the tube and injecting the liquid into the tube in such a manner that collected liquid stored in the collecting container becomes 100 mL in total; and using the collected liquid to measure the number of particles in the liquid and multiplying an obtained value by 10 to convert the obtained value into the number per 100 mL and regarding a converted value as a sum of the particles”. But the limitation “by a testing method comprising: preparing the elongated medical body provided with the lubricating layer in an area having a predetermined length from the distal end toward the proximal end of the tube; setting a distal end of the elongated medical body at an insertion start point of the tube and repeating insertion and retraction 5 times by inserting the distal end of the elongated medical body from the insertion start point to an insertion end point of the tube in such a manner that a portion of the elongated medical body provided with the lubricating layer is completely inserted and by subsequently retracting the distal end of the elongated medical body to the insertion start point; retracting the elongated medical body from the tube and injecting the liquid into the tube in such a manner that collected liquid stored in the collecting container becomes 100 mL in total; and using the collected liquid to measure the number of particles in the liquid and multiplying an obtained value by 10 to convert the obtained value into the number per 100 mL and regarding a converted value as a sum of the particles” are held as process terms in a product-by-process claim, and thus the patentability of a product does not depend on its method of use. Structurally, Rooijmans et al teaches the same product structure claimed of an elongated medical body comprising a main body and a lubricating layer on an outer surface of the main body having no more than 5000 particles having a particle size of 10 μm or more.
In regards to claim 16, Rooijmans et al teaches wherein the lubricating layer is formed by adding a non-lubricating material to a lubricating material (paragraph [0060]: binding between the primer coating and the hydrophilic coating); the lubricating material being a hydrophilic material (paragraph [0002]: A coating or layer which becomes lubricious after wetting is hereinafter referred to as a hydrophilic coating); and the non-lubricating material being vinyl chloride resin (paragraph [0062]: polyvinylchloride).
In regards to claim 18, Rooijmans et al teaches an elongated medical body comprising:
a main body (paragraph [0010]: guide wires and catheters)(paragraph [0011]: medical device, such as a catheter)
a lubricating layer formed on an outer surface of the main body in a predetermined area, the predetermined area having a distal end and a proximal end (paragraph [0010]: hydrophilic coating)(paragraph [0002]: A coating or layer which becomes lubricious after wetting is hereinafter referred to as a hydrophilic coating)(paragraph [0011]: A coating on the outer or inner surface of a medical device, such as a catheter, is considered lubricious)
wherein the lubricating layer has no more than 5000 particles having a particle size of 10 μm or more (paragraph [0010]: less than 3000, more preferably less than 2000, most preferably less than 1000, in particular less than 500 particles larger than 10 .mu.m)
In regards to “when measured with a testing device that includes a tube having flexibility and provided with a lumen communicating a distal end and a proximal end of the tube, a board provided with a holding groove for holding the tube in a deformed state, and a collecting container placed on distal side of the tube and used to store liquid flowing in from an injection tool, the holding groove having a groove shape including a first straight portion, a first meandering portion adjacent to a distal end of the first straight portion, a second straight portion adjacent to a distal end of the first meandering portion, a second meandering portion adjacent to a distal end of the second straight portion, and a third straight portion adjacent to a distal end of the second meandering portion as seen from an insertion direction of the elongated medical body, and the tube being deformed and held according to the groove shape when fitted into the holding groove”, it is noted that claim 18 is drawn to an elongated medical body intended to be used with a testing device having a tube, a board, and a collecting container, thus the testing device having the tube, the board, and the collecting container is not a positively recited structure of the claimed elongated medical body. Rooijmans et al teaches the claimed elongated medical body which has the ability to be used with a testing device having a tube, a board, and a collecting container, as claimed, as the structure of the elongated medical body of Rooijmans et al is capable of interacting with the testing device having the tube, the board, and the collecting container.
Further, Rooijmans et al is silent about “by a testing method comprising: preparing the testing device and the elongated medical body provided with the lubricating layer in an area having a predetermined length from the distal end toward the proximal end of the tube; setting a distal end of the elongated medical body at an insertion start point of the tube and repeating insertion and retraction 5 times by inserting the distal end of the elongated medical body from the insertion start point to an insertion end point of the tube in such a manner that a portion of the elongated medical body provided with the lubricating layer is completely inserted and by subsequently retracting the distal end of the elongated medical body to the insertion start point; retracting the elongated medical body from the tube and injecting the liquid into the tube in such a manner that collected liquid stored in the collecting container becomes 100 mL in total; and using the collected liquid to measure the number of particles in the liquid and multiplying an obtained value by 10 to convert the obtained value into the number per 100 mL and regarding a converted value as a sum of the particles”. But the limitation “by a testing method comprising: preparing the testing device and the elongated medical body provided with the lubricating layer in an area having a predetermined length from the distal end toward the proximal end of the tube; setting a distal end of the elongated medical body at an insertion start point of the tube and repeating insertion and retraction 5 times by inserting the distal end of the elongated medical body from the insertion start point to an insertion end point of the tube in such a manner that a portion of the elongated medical body provided with the lubricating layer is completely inserted and by subsequently retracting the distal end of the elongated medical body to the insertion start point; retracting the elongated medical body from the tube and injecting the liquid into the tube in such a manner that collected liquid stored in the collecting container becomes 100 mL in total; and using the collected liquid to measure the number of particles in the liquid and multiplying an obtained value by 10 to convert the obtained value into the number per 100 mL and regarding a converted value as a sum of the particles” are held as process terms in a product-by-process claim, and thus the patentability of a product does not depend on its method of use. Structurally, Rooijmans et al teaches the same product structure claimed of an elongated medical body comprising a main body and a lubricating layer on an outer surface of the main body having no more than 5000 particles having a particle size of 10 μm or more.
In regards to claim 19, Rooijmans et al teaches wherein the lubricating layer is formed by adding a non-lubricating material to a lubricating material (paragraph [0060]: binding between the primer coating and the hydrophilic coating); the lubricating material being a hydrophilic material (paragraph [0002]: A coating or layer which becomes lubricious after wetting is hereinafter referred to as a hydrophilic coating); and the non-lubricating material being vinyl chloride resin (paragraph [0062]: polyvinylchloride).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 6-8 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuhashi, as applied to claims 1-2 and 9 above.
In regards to claim 6, Matsuhashi teaches a length from the insertion start point to the insertion end point is at least 30 cm or greater ([Particle test]: mold 63 with a total length of 450 mm); however, Matsuhashi is silent about wherein the lubricating layer of the elongated medical body is at least 30 cm from a distal end of the elongated body. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the lubricating layer of the elongated medical body, of the device of Matsuhashi, to be at least 30 cm from a distal end of the elongated body, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Matsuhashi would not operate differently with the claimed distance of the lubricating layer from a distal end of the elongated body. Further, it appears that Applicant places no criticality on the range claimed for the distance of the lubricating layer from a distal end of the elongated body.
In regards to claim 7, Matsuhashi is silent about wherein the tube has an inside diameter of 4 mm. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the tube, of the device of Matsuhashi, to have an inside diameter of 4 mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Matsuhashi would not operate differently with the claimed inside diameter of the tube. Further, it appears that Applicant places no criticality on the value claimed for the inside diameter of the tube.
Further, Matsuhashi does not teach wherein the tube has an outside diameter of 6 mm and a total length of 1 m, as Matsuhashi instead teaches wherein the tube has an outside diameter of 1.33 mm ([Particle test]: 4 Fr catheter tube 62) and a total length of 100 cm or longer ([Particle test]: 4 Fr catheter tube 62 of 100 cm or longer). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the tube, of the modified device of Matsuhashi, to have an outside diameter of 6 mm and a total length of 1 m, as Applicant has not disclosed that such an outside diameter and such a total length provide an advantage, are used for a particular purpose, or solve a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the tube having an outside diameter of 1.33 mm and a total length of 100 cm or longer, as taught by Matsuhashi, as a person having ordinary skill in the art would have known how to size the tube to be received within the holding groove of the board.
Further, Matsuhashi does not teach the board 20 has a length of 230 mm, as Matsuhashi instead teaches the board has a length of 450 mm ([Particle test]: mold 63 with a total length of 450 mm). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the board, of the modified device of Matsuhashi, to have a length of 230 mm, as Applicant has not disclosed that such a length provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the board having a length of 450 mm, as taught by Matsuhashi, as a person having ordinary skill in the art would have known how to size the board in order to receive the lengths of the elongated medical body and the tube.
Further, Matsuhashi is silent about the board 20 has a width of 380 mm and a thickness of 19 mm. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the board, of the modified device of Matsuhashi, to have a width of 380 mm and a thickness of 19 mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified device of Matsuhashi would not operate differently with the claimed width and thickness of the board. Further, it appears that Applicant places no criticality on the values claimed for the width and thickness of the board.
Further, Matsuhashi is silent about the holding groove has a groove depth of 6.2 mm. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the holding groove, of the modified device of Matsuhashi, to have a groove depth of 6.2 mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified device of Matsuhashi would not operate differently with the claimed groove depth of the holding groove. Further, it appears that Applicant places no criticality on the values claimed for the groove depth of the holding groove.
Further, Matsuhashi does not teach a groove width of 6.2 mm, the second straight portion has a length of 40 mm, the third straight portion has a length of 60 mm, the first meandering portion has a curved portion on the proximal side with a radius of curvature of 50 mm and a curved portion on the distal side with a radius of curvature of 40 mm, and the second meandering portion has a curved portion on the proximal side with a radius of curvature of 70 mm and a curved portion on the distal side with a radius of curvature of 40 mm, as Matsuhashi instead teaches a groove width of 3 mm (a mold 63 with… an inner diameter of 3 mm), the second straight portion has a length of 80 mm (Figure 6), the third straight portion has a length of 80 mm (Figure 6), the first meandering portion has a curved portion with a radius of curvature of 15 mm, and the second meandering portion has a curved portion with a radius of curvature of 15 mm ([Particle test]: three wavy curved portions… with a radius of curvature of 15 mm). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the holding groove, of the modified device of Matsuhashi, to have a groove width of 6.2 mm, the second straight portion has a length of 40 mm, the third straight portion has a length of 60 mm, the first meandering portion has a curved portion on the proximal side with a radius of curvature of 50 mm and a curved portion on the distal side with a radius of curvature of 40 mm, and the second meandering portion has a curved portion on the proximal side with a radius of curvature of 70 mm and a curved portion on the distal side with a radius of curvature of 40 mm, as Applicant has not disclosed that such a groove width, such lengths, and such radiuses of curvature provide an advantage, are used for a particular purpose, or solve a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the holding groove having a groove width of 3 mm, the second straight portion having a length of 80 mm, the third straight portion having a length of 80 mm, the first meandering portion having a curved portion with a radius of curvature of 15 mm, and the second meandering portion having a curved portion with a radius of curvature of 15 mm, as taught by Matsuhashi, as a person having ordinary skill in the art would have known how to size the holding groove in order to receive the sizes of the elongated medical body and the tube.
Further, Matsuhashi teaches the first straight portion has a length of 80 mm (Figure 6).
In regards to claim 8, Matsuhashi teaches a testing method using the testing device according to claim 1, the testing method comprising:
preparing the testing device and the elongated medical body provided with the lubricating layer in an area having a predetermined length ([Particle test]: samples 16 to 21 of Examples 16 to 21 above were subjected to fine particle generation under more severe conditions using the test system shown in FIG. 6 according to the following method)
setting a distal end of the elongated medical body at an insertion start point of the tube and repeating insertion and retraction by inserting the distal end of the elongated medical body from the insertion start point to an insertion end point of the tube in such a manner that a portion of the elongated medical body provided with the lubricating layer is completely inserted and by subsequently retracting the distal end of the elongated medical body to the insertion start point ([Particle test]: each sample is set in a catheter tube 62 filled with distilled water and reciprocated (slid) 10 times with a sliding distance (stroke) of 100 cm)
retracting the elongated medical body from the tube and injecting the liquid into the tube in such a manner that collected liquid stored in the collecting container becomes 100 mL in total ([Particle test]: the sample is taken out from the catheter tube 62, 100 mL of distilled water is injected into the catheter tube 62, and the specimen liquid discharged from the tip of the catheter is collected)
using the collected liquid to measure the number of particles in the liquid ([Particle test]: The number of particles of 10 μm size (diameter) or more in the sample liquid and the blank liquid (100 mL each) collected above is measured with a liquid particle counter (manufactured by HIAC, device name: light shielding type automatic particle measuring device). Then, the value obtained by subtracting the measured value of the number of particles in the blank liquid (Y .sub.0 ) from the number of particles in the sample liquid (Y .sub.1 ) is the number of particles in the sample (=Y .sub.1 -Y .sub.0 (pieces)). did)
Matsuhashi does not teach repeating insertion and retraction 5 times, as Matsuhashi instead teaches repeating insertion and retraction 10 times ([Particle test]: each sample is set in a catheter tube 62 filled with distilled water and reciprocated (slid) 10 times with a sliding distance (stroke) of 100 cm). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify repeating insertion and retraction, of the method of Matsuhashi, to be 5 times, as Applicant has not disclosed that such a number of times provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with repeating insertion and retraction 10 times, as taught by Matsuhashi, as a person having ordinary skill in the art would have known how many times to insert and retract the elongated medical body in testing to determine the strength of the lubricating layer.
Further, Matsuhashi does not teach multiplying an obtained value by 10 to convert the obtained value into the number per 100 mL and regarding a converted value as a sum of the particles, as Matsuhashi instead teaches 100 mL of distilled water is injected from the hub 61 of the catheter, and the liquid that flows out from the tip of the catheter is collected and used as a blank liquid, 100 mL of distilled water is injected into the catheter tube 62, and the specimen liquid discharged from the tip of the catheter is collected, and the value obtained by subtracting the measured value of the number of particles in the blank liquid (Y .sub.0 ) from the number of particles in the sample liquid (Y .sub.1 ) is the number of particles in the sample (=Y .sub.1 -Y .sub.0 (pieces)). did ([Particle test]). But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method, of Matsuhashi, with multiplying an obtained value by 10 to convert the obtained value into the number per 100 mL and regarding a converted value as a sum of the particles, as an obvious matter of design choice, as either multiplying an obtained value by 10 to convert the obtained value into the number per 100 mL and regarding a converted value as a sum of the particles, as taught by Applicant, or 100 mL of distilled water is injected from the hub 61 of the catheter, and the liquid that flows out from the tip of the catheter is collected and used as a blank liquid, 100 mL of distilled water is injected into the catheter tube 62, and the specimen liquid discharged from the tip of the catheter is collected, and the value obtained by subtracting the measured value of the number of particles in the blank liquid (Y .sub.0 ) from the number of particles in the sample liquid (Y .sub.1 ) is the number of particles in the sample (=Y .sub.1 -Y .sub.0 (pieces)). did, as taught by Matsuhashi, will arrive at the same end result of determining the number of particles generated from the lubricating layer for testing the strength of the lubricating layer.
In regards to claim 10, in the modified method of Matsuhashi, Matsuhashi does not teach wherein the plurality of repeating the insertion and the retraction of the elongated medical body is 5 times, as Matsuhashi instead teaches wherein the plurality of repeating the insertion and the retraction of the elongated medical body is 10 times ([Particle test]: each sample is set in a catheter tube 62 filled with distilled water and reciprocated (slid) 10 times with a sliding distance (stroke) of 100 cm). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the plurality of repeating the insertion and the retraction of the elongated medical body, of the modified method of Matsuhashi, to be 10 times, as Applicant has not disclosed that such a number of times provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the plurality of repeating the insertion and the retraction of the elongated medical body being 10 times, as taught by Matsuhashi, as a person having ordinary skill in the art would have known how many times to insert and retract the elongated medical body in testing to determine the strength of the lubricating layer.
In regards to claim 11, in the modified method of Matsuhashi, Matsuhashi teaches wherein the predetermined amount of the collected liquid is 100 mL ([Particle test]: 100 mL of distilled water is injected into the catheter tube 62, and the specimen liquid discharged from the tip of the catheter is collected); however, Matsuhashi does not teach multiplying an obtained value of the predetermined amount of the collected liquid by 10 to convert the obtained value into a number per 100 mL and regarding a converted value as a sum of the particles, as Matsuhashi instead teaches 100 mL of distilled water is injected from the hub 61 of the catheter, and the liquid that flows out from the tip of the catheter is collected and used as a blank liquid, 100 mL of distilled water is injected into the catheter tube 62, and the specimen liquid discharged from the tip of the catheter is collected, and the value obtained by subtracting the measured value of the number of particles in the blank liquid (Y .sub.0 ) from the number of particles in the sample liquid (Y .sub.1 ) is the number of particles in the sample (=Y .sub.1 -Y .sub.0 (pieces)). did ([Particle test]). But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method, of Matsuhashi, with multiplying an obtained value of the predetermined amount of the collected liquid by 10 to convert the obtained value into a number per 100 mL and regarding a converted value as a sum of the particles, as an obvious matter of design choice, as either multiplying an obtained value of the predetermined amount of the collected liquid by 10 to convert the obtained value into a number per 100 mL and regarding a converted value as a sum of the particles, as taught by Applicant, or 100 mL of distilled water is injected from the hub 61 of the catheter, and the liquid that flows out from the tip of the catheter is collected and used as a blank liquid, 100 mL of distilled water is injected into the catheter tube 62, and the specimen liquid discharged from the tip of the catheter is collected, and the value obtained by subtracting the measured value of the number of particles in the blank liquid (Y .sub.0 ) from the number of particles in the sample liquid (Y .sub.1 ) is the number of particles in the sample (=Y .sub.1 -Y .sub.0 (pieces)). did, as taught by Matsuhashi, will arrive at the same end result of determining the number of particles generated from the lubricating layer for testing the strength of the lubricating layer.
Claims 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rooijmans et al, as applied to claims 15 and 18 above.
In regards to claim 17, Rooijmans et al is silent about wherein the lubricating layer is formed on the outer surface of the main body in an area of 30 cm from the distal end of the elongated medical body. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the lubricating layer, of the medical body of Rooijmans et al, to be formed on the outer surface of the main body in an area of 30 cm from the distal end of the elongated medical body, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the medical body of Rooijmans et al would not operate differently with the claimed distance of the lubricating layer from the distal end of the elongated body. Further, it appears that Applicant places no criticality on the value claimed for the distance of the lubricating layer from the distal end of the elongated body.
Further, Rooijmans et al does not teach the main body has an outside diameter of 2.4 mm, as Rooijmans et al instead teaches the main body has an outside diameter of 0.86 mm (paragraph [0075]). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the main body, of the modified medical body of Rooijmans et al, to have an outside diameter of 2.4 mm, as Applicant has not disclosed that such an outside diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the main body having an outside diameter of 0.86 mm, as taught by Rooijmans et al, as a person having ordinary skill in the art would have known how to size the main body in order to access a particular target region in a patient’s body.
In regards to claim 20, Rooijmans et al is silent about wherein the lubricating layer is formed on the outer surface of the main body in an area of 30 cm from the distal end of the elongated medical body. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the lubricating layer, of the medical body of Rooijmans et al, to be formed on the outer surface of the main body in an area of 30 cm from the distal end of the elongated medical body, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the medical body of Rooijmans et al would not operate differently with the claimed distance of the lubricating layer from the distal end of the elongated body. Further, it appears that Applicant places no criticality on the value claimed for the distance of the lubricating layer from the distal end of the elongated body.
Further, Rooijmans et al does not teach the main body has an outside diameter of 2.4 mm, as Rooijmans et al instead teaches the main body has an outside diameter of 0.86 mm (paragraph [0075]). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the main body, of the modified medical body of Rooijmans et al, to have an outside diameter of 2.4 mm, as Applicant has not disclosed that such an outside diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the main body having an outside diameter of 0.86 mm, as taught by Rooijmans et al, as a person having ordinary skill in the art would have known how to size the main body in order to access a particular target region in a patient’s body.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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