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 .
In light of the amendments to the claims filed 11/19/2025 in which claims 58, 85, and 108 were amended and claims 90-94 and 100-104 were cancelled, claims 58-61 and 64-89, 95-99, and 105-108 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/DK2019/050363 which claims priority to DKPA/2018/00892 filed on 11/21/2018.
Claims 58-61 and 64-89, 95-99, and 105-108 receive priority to the prior-filed application, filed on 11/21/2018.
Response to Arguments
Objections to the Claims
The previous objections to the claims are withdrawn in view of the amendments to the claims filed 11/19/2025.
Claim Rejections under 35 U.S.C. 112(b)
The rejections of the claims under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims filed 11/19/2025.
Claim Rejections under 35 U.S.C. 103
Applicant's arguments filed 11/19/2025 have been fully considered but they are not persuasive.
Regarding the independent claims, the applicant asserts on pg. 11-12 and 14-22 that the Office has erred in its inherency analysis under Federal Circuit precedent to Par. Pharm. Inc. because the functional limitations in at least claims 58 and 85 are not present in the prior art, or the natural result of the combination of elements explicitly disclosed by the prior art.
In response to the applicant’s argument, the examiner respectfully disagrees. The rejection of the independent claims in view of Carlsson acknowledge that Carlsson fails to explicitly disclose their catheter being an intermittent catheter and that Carlsson fails to explicitly disclose wherein a largest dimension of the plurality of drainage openings is between 0.2-1 mm (claim 58) or 0.2-0.7 mm (claim 85). It should be noted that Carlsson further discloses all structure of the catheter as claimed and is capable of being used as an intermittent catheter; therefore, this limitation adds no structure that Carlsson does not have. It should further be noted that Carlsson discloses that the plurality of drainage openings have a hole diameter between 0.75-2.0 mm (pg. 11 ln. 7-9), which overlaps the claimed range of claim 58 and is in close proximity to the claimed range of claim 85. The applicant argues that Carlsson does not disclose “substantially identical structure” to the claimed invention as is required in an analysis under in re Best. As noted above, the intermittent catheter limitation adds no structure to the claim and Carlsson’s drainage holes have a hole diameter that overlaps or is in close proximity, i.e. within 0.05 mm, of the claimed hole diameters. Carlsson further provides motivation to one of ordinary skill to modify the range of hole diameters as this may be considered a result effective variable. This can be considered “substantially identical structure” to the claimed invention.
The applicant further argues that the functional limitations cannot be obvious as inherent over Carlsson in view of Par. Pharm. Inc. Par. Pharm. Inc. states “[I]n order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis – the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art”. The applicant states that the Federal Circuit requires that the functional limitations at issue must necessarily be present to support an obviousness rejection as inherent. The citation to Par. Pharm. Inc. suggests that the functional limitations may also be the natural result of the combination of elements explicitly disclosed by the prior art. It is the examiner’s position that the functional limitations of at least claims 58 and 85 are the natural result of the combination of elements explicitly disclosed by the prior art. As explained above, Carlsson discloses or suggests the structure of the claim as a combination of elements either as a combination of all of the elements of Carlsson or as a combination of Carlsson’s elements with the suggestion of modifying the range of hole diameters. The rejections of the claims under inherency are maintained.
Further regarding the independent claims, the applicant asserts on pg. 12-13 and pg. 21 that Carlsson fails to teach or suggest the claimed hole sizes because if one were to modify Carlsson in the manner suggested by the Office, one would need to make many small openings to keep the open hole area larger than the lumen area which would make Carlsson’s catheter weak.
In response to the applicant’s argument, the examiner respectfully notes that Carlsson teaches that the disadvantages of known catheter opening solutions may be alleviated by the catheter of their disclosure (pg. 3 ln. 6-15). Carlsson further discloses that their invention may have a decreased risk for kinking by utilizing smaller drainage holes than those of known catheters (pg. 5 ln. 15-19). Even further, Carlsson discloses a range of diameters for the hole openings that overlaps the range claimed or is in close proximity to the range claimed (Carlsson: 0.75-2 mm; claim 58: 0.2-1 mm; claim 85: 0.2-0.7 mm). It would seem from the disclosure of Carlsson that utilizing many small openings at an open hole area that is equal to or larger than the lumen area decreases kinking (pg. 5 ln. 15-19; pg. 10 ln. 30-33 and pg. 11 ln. 1-6, the total hole area…is equal to or larger than the circular area of the catheter lumen), such that one of ordinary skill in the art would have a reasonable expectation of success when modifying the largest diameter of the holes of Carlsson to be within the claimed range. Further, the weakness of Carlsson’s catheter is irrelevant unless the applicant is arguing that the catheter shaft is too weak to function such that the proposed modification would render Carlsson unsatisfactory for its intended purpose. Without any such analysis, the supposed weakness of Carlsson’s catheter is not germane to patentability. The rejections of the claims are maintained.
Further regarding claims 83-84 and 87-88, the applicant asserts on pg. 22-23 that the claims are patentable for depending upon either of independent claims 58 and 85.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Claim Objections
Claims 105-107 are objected to because of the following informalities: The claim identifiers have not been updated from “(New)”. They should read “(Previously Presented)”. Appropriate correction is required.
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 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.
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Ex. Fig. 1 of Carlsson Fig. 5a
Claims 58-61, 64-82, 85-86, 89, 95-99, and 105-108 are rejected under 35 U.S.C. 103 as being unpatentable over WO/2017/108879 A1 to Carlsson.
Regarding claim 58, Carlsson discloses a catheter (Fig. 5A) comprising:
a urinary catheter (pg. 1 ln. 3-6; Fig. 5A, catheter 2) having a tubular portion extending from a proximal insertion end to a distal outlet end (see Ex. Fig. 1, tubular portion extending proximal insertion end 5 to distal outlet end 4; pg. 1 ln. 23-27), with the proximal insertion end insertable into a bladder to drain urine (pg. 1 ln. 9-28) and the tubular portion formed to include a lumen adapted to transport the urine through the tubular portion and out of the distal outlet end (pg. 1 ln. 9-28; pg. 18 ln. 9-11); and
a drainage area provided on an exterior surface of the tubular portion immediately distal the proximal insertion end (see Ex. Fig. 1 showing drainage area on the exterior surface of the tubular portion immediately distal proximal insertion end 5),
wherein the drainage area includes a plurality of drainage openings that combine to provide an open drain area (see Ex. Fig. 1 showing drainage area including drainage openings 17a-c providing an open drain area); wherein the drainage area is defined by a length measured from a proximal edge of a proximal most one of the plurality of the drainage openings that is closest to the proximal insertion end to a distal edge of a distal most one of the plurality of the drainage openings that is closest to the distal outlet end multiplied by a circumference of the exterior surface of the tubular portion measured along the length of the drainage area (see Ex. Fig. 1 showing the drainage area having a length from a proximal most to distal most drainage opening; Fig. 5d showing catheter 2 comprising a circumference),
wherein the plurality of drainage openings comprises multiple small openings having a hole diameter in a range between 0.75 to 2.0 mm (pg. 11 ln. 7-9).
Carlsson differs from the instantly claimed invention in that Carlsson fails to disclose the catheter of their invention being an intermittent catheter.
The limitation of “comprising an intermittent catheter” is considered functional language as the term “intermittent catheter” is used to denote “the use, function, and/or positioning of the device” as being a catheter used by a patient for a few minutes in a day. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Carlsson discloses all the structure as claimed, and is further used as a urinary catheter (pg. 1 ln. 3-6). As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning as an intermittent device).
Further, Carlsson differs from the instantly claimed invention in that Carlsson fails to disclose wherein a largest dimension of the plurality of drainage openings is in a range between 0.2 mm to 1 mm.
Carlsson discloses that the total hole area of the small drainage openings needs to be optimized such that “the total hole area…is equal to or larger than the circular area of the catheter lumen [such that it] will perform the same or greater flow rate than conventional oval catheter eyes with a total hole area that is significantly larger than the circular area of the catheter lumen” (pg. 10 ln. 30-33 and pg. 11 ln. 1-6) while maintaining the advantage of a decreased risk of kinking that results in less risk for injury and discomfort for patients (pg. 5 ln. 15-25). Carlsson further discloses that dependent upon the intended application and particular needs of the catheter, the number of pairs of drainage openings can be any suitable number (pg. 18 ln. 13-16); therefore, for any specific size of catheter, as the total number of pairs of drainage openings increase, the size of the drainage openings would need to be adjusted to maintain the total hole area equal to or larger than the circular area of the catheter lumen.
It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Carlsson to have drainage openings within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Carlsson by making the largest dimension of any one of the plurality of openings between 0.2-1 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."
Further still, regarding the limitation “wherein the multiple small openings provide resistance to the urine entering the open drain area that distributes a flow of the urine across the drainage area to eliminate clogging of the openings and ensure complete emptying of the bladder” as that the invention of Carlsson discloses substantially identical structure to the claimed prior art, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where 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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Regarding claim 59-61, Carlsson suggests the invention of claim 58; however, Carlsson differs from the instantly claimed invention in that Carlsson fails to explicitly disclose wherein the ratio of the open drain area to the drainage area on the exterior surface of the tubular portion is in a range from (Claim 59) 0.2 to 0.5 and (Claim 60) 0.51 to 0.7, or wherein there is (Claim 61) more open area than closed area on the drainage area on the exterior surface of the tubular portion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Carlsson to have a ratio of the open drain area to the drainage area on the exterior surface of the tubular portion is in a range from (Claim 59) 0.2 to 0.5 and (Claim 60) 0.51 to 0.7, or wherein there is (Claim 61) more open area than closed area on the drainage area on the exterior surface of the tubular portion 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 Carlsson would not operate differently with the claimed ratios and since the device of Carlsson comprises a plurality of drainage openings, the device would function appropriately having the claimed ratios. Further, it appears that applicant places no criticality on the ranges claimed, indicating simply that the ratios are within the ranges (specification pg. 16 ln. 9-15).
Regarding claim 64, Carlsson suggests the invention of claim 58. Carlsson further discloses: wherein each of the plurality of drainage openings has an open area of about 0.0314-0.78 mm2 (Carlsson as modified by routine optimization comprises drainage openings with a largest dimension between 0.2-1 mm; open area may be understood by the area formula of a circle:
π
r
2
) and the intermittent urinary catheter comprises 6 drainage openings (pg. 18 ln. 13-14). Carlsson further discloses that dependent upon the intended application and particular needs of the catheter, the number of pairs of drainage openings can be any suitable number (pg. 18 ln. 13-16).
Carlsson differs from the instantly claimed invention in that Carlsson fails to explicitly disclose wherein each of the plurality of drainage openings has an open area of about 0.44 mm2.
Per the above reasoned routine optimization, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Carlsson to have drainage openings with an open area of about 0.44 mm2, as it involves only adjusting the dimension of a component disclosed to require adjustment (size of the openings). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Carlsson by making the open area of the drainage openings about 0.44 mm2 as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."
Further, Carlsson differs from the instantly claimed invention in that Carlsson fails to explicitly disclose wherein the intermittent urinary catheter comprises more than 12 drainage openings.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of drainage openings from 6 to more than 12 as applicant appears to have placed no criticality on the claimed value ([pg. 17 ln. 23-27] “In an embodiment, the number of drainage openings are more than 20. Thereby, the likelihood of all drainage openings being blocked at once is significantly reduced. In embodiments, the number of drainage openings can be significantly higher, for example more than 200 or even around 260 drainage openings. The number can also be around 100, 120 or 150 or close to 200 such as 180.”; Table 5) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Carlsson would not operate differently with the claimed value and since the tubular portion is configured to have 6 drainage openings. Further, applicant places no criticality on the value claimed, indicating simply that the amount of openings are within ranges ([pg. 17 ln. 23-27] “In an embodiment, the number of drainage openings are more than 20. Thereby, the likelihood of all drainage openings being blocked at once is significantly reduced. In embodiments, the number of drainage openings can be significantly higher, for example more than 200 or even around 260 drainage openings. The number can also be around 100, 120 or 150 or close to 200 such as 180.”; Table 5).
Regarding claims 65-80, Carlsson suggests the invention of claim 58. Carlsson further suggests: wherein a largest dimension of any one of the plurality of drainage openings is between 0.2-1.0 mm (pg. 11 ln. 7-9; Carlsson as modified by routine optimization comprises drainage openings with a largest dimension between 0.2-1 mm), and the urinary catheter comprises 6 drainage openings (pg. 18 ln. 13-14). Carlsson further discloses that dependent upon the intended application and particular needs of the catheter, the number of pairs of drainage openings can be any suitable number (pg. 18 ln. 13-16).
Carlsson differs from the instantly claimed invention in that the Carlsson fails to disclose the largest dimension of any one of the plurality of drainage openings to be (Claim 65) about 0.2 mm, (Claim 66) about 0.4 mm, (Claim 67) about 0.6 mm, (Claim 68) about 0.7 mm, (Claim 69) about 0.2 mm, (Claim 70) about 0.4 mm, (Claim 71) about 0.6 mm, (Claim 72) about 0.7 mm, (Claim 73) about 0.2 mm, (Claim 74) about 0.4 mm, (Claim 75) about 0.6 mm, (Claim 76) about 0.7 mm, (Claim 77) about 0.2 mm, (Claim 78) about 0.4 mm, (Claim 79) about 0.6 mm, or (Claim 80) about 0.7 mm.
Per the above reasoned routine optimization, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Carlsson to have drainage openings within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment (size of the openings). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Carlsson by making the largest dimension of any one of the plurality of openings (Claim 65) about 0.2 mm, (Claim 66) about 0.4 mm, (Claim 67) about 0.6 mm, (Claim 68) about 0.7 mm, (Claim 69) about 0.2 mm, (Claim 70) about 0.4 mm, (Claim 71) about 0.6 mm, (Claim 72) about 0.7 mm, (Claim 73) about 0.2 mm, (Claim 74) about 0.4 mm, (Claim 75) about 0.6 mm, (Claim 76) about 0.7 mm, (Claim 77) about 0.2 mm, (Claim 78) about 0.4 mm, (Claim 79) about 0.6 mm, or (Claim 80) about 0.7 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Further, Carlsson differs from the instantly claimed invention in that the prior art fail to disclose the urinary catheter comprising about (Claim 65) 128, (Claim 66) 32, (Claim 67) 15, (Claim 68) 11, (Claim 69) 176, (Claim 70) 44, (Claim 71) 20, (Claim 72) 15, (Claim 73) 261, (Claim 74) 66, (Claim 75) 29, (Claim 76) 22, (Claim 77) 351, (Claim 78) 88, (Claim 79) 39 or (Claim 80) 29 drainage openings.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of drainage openings from 6 to about (Claim 65) 128, (Claim 66) 32, (Claim 67) 15, (Claim 68) 11, (Claim 69) 176, (Claim 70) 44, (Claim 71) 20, (Claim 72) 15, (Claim 73) 261, (Claim 74) 66, (Claim 75) 29, (Claim 76) 22, (Claim 77) 351, (Claim 78) 88, (Claim 79) 39 or (Claim 80) 29 as applicant appears to have placed no criticality on the claimed values ([pg. 17 ln. 23-27] “In an embodiment, the number of drainage openings are more than 20. Thereby, the likelihood of all drainage openings being blocked at once is significantly reduced. In embodiments, the number of drainage openings can be significantly higher, for example more than 200 or even around 260 drainage openings. The number can also be around 100, 120 or 150 or close to 200 such as 180.”; Table 5) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Carlsson would not operate differently with the claimed values and since the tubular portion is configured to have more than 6 drainage openings. Further, applicant places no criticality on the values claimed, indicating simply that the amount of openings are within ranges ([pg. 17 ln. 23-27] “In an embodiment, the number of drainage openings are more than 20. Thereby, the likelihood of all drainage openings being blocked at once is significantly reduced. In embodiments, the number of drainage openings can be significantly higher, for example more than 200 or even around 260 drainage openings. The number can also be around 100, 120 or 150 or close to 200 such as 180.”; Table 5).
Regarding claim 81, Carlsson suggests the invention of claim 58.
Carlsson fails to explicitly disclose “wherein a measured suction pressure in the lumen is less than 50 Mbar when the distal most one of the plurality of the drainage openings is immersed under 10 cm H2O”; however, it would be considered inherent that the intermittent catheter of Carlsson would satisfy this condition in that the drainage openings of the combined invention may have a surface area between about 0.0314-0.78 mm2 (Carlsson as modified by routine optimization comprises drainage openings with a largest dimension between 0.2-1 mm; open area may be understood by the area formula of a circle:
π
r
2
) and the instant application has disclosed that this condition may occur when the drainage openings have a cross-sectional area of less than 0.8 mm2 (spec.: pg. 17 ln. 8-14).
Regarding claim 82, Carlsson suggests the invention of claim 82. Carlsson further discloses: wherein the proximal insertion end comprises a closed end (see Ex. Fig. 1 showing proximal insertion end 5 comprising a closed end).
Regarding claim 85, Carlsson discloses a catheter (Fig. 5A) comprising:
a urinary catheter (pg. 1 ln. 3-6; Fig. 5A, catheter 2) having a tubular portion extending from a proximal insertion end to a distal outlet end (see Ex. Fig. 1, tubular portion extending proximal insertion end 5 to distal outlet end 4; pg. 1 ln. 23-27), with the tubular portion formed to include a lumen adapted to transport urine through the urinary catheter (pg. 1 ln. 21-28; pg. 18 ln. 9-11); and
a drainage length provided on an exterior surface of the tubular portion (see Ex. Fig. 1 showing drainage length on the exterior surface of the tubular portion), wherein the drainage length is sized for positioning within a bladder (pg. 1 ln. 9-28) and includes a plurality of drainage openings that combine to provide an open drain area configured to drain the urine from the bladder (see Ex. Fig. 1 showing drainage area including drainage openings 17a-c; pg. 1 ln. 9-28);
wherein the drainage length is defined by a length measured from a proximal edge of a proximal most one of the plurality of the drainage openings that is closest to the proximal insertion end to a distal edge of a distal most one of the plurality of the drainage openings that is closest to the distal outlet end (see Ex. Fig. 1 showing the drainage area having a length from a proximal most to distal most drainage opening),
wherein a largest dimension of the plurality of drainage openings is in a range between 0.75 to 2.0 mm (pg. 11 ln. 7-9), and the catheter comprises 6 drainage openings (pg. 18 ln. 13-14).
Carlsson differs from the instantly claimed invention in that Carlsson fails to disclose the catheter of their invention being an intermittent catheter.
The limitation of “comprising an intermittent catheter” is considered functional language as the term “intermittent catheter” is used to denote “the use, function, and/or positioning of the device” as being a catheter used by a patient for a few minutes in a day. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Carlsson discloses all the structure as claimed, and is further used as a urinary catheter (pg. 1 ln. 3-6). As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning as an intermittent device).
Further, Carlsson differs from the instantly claimed invention in that Carlsson fails to disclose wherein a largest diameter of the plurality of drainage openings is in a range between 0.2 mm to 0.7 mm.
Carlsson discloses that the total hole area of the small drainage openings needs to be optimized such that “the total hole area…is equal to or larger than the circular area of the catheter lumen [such that it] will perform the same or greater flow rate than conventional oval catheter eyes with a total hole area that is significantly larger than the circular area of the catheter lumen” (pg. 10 ln. 30-33 and pg. 11 ln. 1-6) while maintaining the advantage of a decreased risk of kinking that results in less risk for injury and discomfort for patients (pg. 5 ln. 15-25). Carlsson further discloses that dependent upon the intended application and particular needs of the catheter, the number of pairs of drainage openings can be any suitable number (pg. 18 ln. 13-16); therefore, for any specific size of catheter, as the total number of pairs of drainage openings increase, the size of the drainage openings would need to be adjusted to maintain the total hole area equal to or larger than the circular area of the catheter lumen.
It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Carlsson to have drainage openings within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Carlsson by making the largest dimension of any one of the plurality of openings between 0.2-0.7 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."
Further still, Carlsson differs from the instantly claimed invention in that Carlsson fails to disclose wherein the urinary catheter comprising 11-351 drainage openings. Carlsson further discloses that dependent upon the intended application and particular needs of the catheter, the number of pairs of drainage openings can be any suitable number (pg. 18 ln. 13-16).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of drainage openings from 6 to 11-351 as applicant appears to have placed no criticality on the claimed values ([pg. 17 ln. 23-27] “In an embodiment, the number of drainage openings are more than 20. Thereby, the likelihood of all drainage openings being blocked at once is significantly reduced. In embodiments, the number of drainage openings can be significantly higher, for example more than 200 or even around 260 drainage openings. The number can also be around 100, 120 or 150 or close to 200 such as 180.”; Table 5) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Carlsson would not operate differently with the claimed values and since the tubular portion is configured to have more than 6 drainage openings. Further, applicant places no criticality on the values claimed, indicating simply that the amount of openings are within ranges ([pg. 17 ln. 23-27] “In an embodiment, the number of drainage openings are more than 20. Thereby, the likelihood of all drainage openings being blocked at once is significantly reduced. In embodiments, the number of drainage openings can be significantly higher, for example more than 200 or even around 260 drainage openings. The number can also be around 100, 120 or 150 or close to 200 such as 180.”; Table 5).
Further still, regarding the limitation “wherein the plurality of drainage openings is distributed along the drain length to allow complete draining of the urine from the bladder and leave no residual urine in the bladder” as that the invention of Carlsson discloses substantially identical structure to the claimed prior art, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where 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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Regarding claim 86, Carlsson suggests the invention of claim 85. Carlsson further discloses: wherein the proximal insertion end comprises a closed end (see Ex. Fig. 1 showing proximal insertion end 5 comprising a closed end).
Regarding claim 89, Carlsson suggests the invention of claim 85. Carlsson further discloses: wherein a drainage area is defined by the drain length multiplied by a circumference of the exterior surface of the tubular portion measured along the drain length (see Ex. Fig. 1 showing the drainage area having a length from a proximal most to distal most drainage opening; Fig. 5d showing catheter 2 comprising a circumference); however, the prior art differ from the instantly claimed invention in that they fail to disclose that a ratio of the open drain area to the drainage area on the exterior surface of the tubular portion is in a range from 0.2 to 0.5.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Carlsson to have a ratio of the open drain area to the drainage area on the exterior surface of the tubular portion in a range from 0.2 to 0.5 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Carlsson would not operate differently with the claimed ratio and since the device of Carlsson comprises a plurality of drainage openings, the device would function appropriately having the claimed ratio. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the ratio is within the range (specification pg. 16 ln. 14-15).
Regarding claim 95, Carlsson suggests the invention of claim 58. Carlsson further discloses: the open drain area (see Ex. Fig. 1 showing drainage area including drainage openings 17a-c providing an open drain area) and the drainage area on the exterior surface of the tubular portion (see Ex. Fig. 1 showing the drainage area having a length from a proximal most to distal most drainage opening; Fig. 5d showing catheter 2 comprising a circumference); however the prior art differ from the instantly claimed invention in that the prior art fail to explicitly disclose the result of the ratio as claimed.
Regarding the limitation “the ratio of the open drain area to the drainage area on the exterior surface of the tubular portion configures the intermittent urinary catheter for a continuous and uninterrupted flow of urine until the bladder is empty” as that the invention of Carlsson discloses substantially identical structure to the claimed prior art, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where 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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Regarding claim 96, Carlsson suggests the invention of claim 58. Carlsson further discloses: the open drain area (see Ex. Fig. 1 showing drainage area including drainage openings 17a-c providing an open drain area) and the drainage area on the exterior surface of the tubular portion (see Ex. Fig. 1 showing the drainage area having a length from a proximal most to distal most drainage opening; Fig. 5d showing catheter 2 comprising a circumference); however the prior art differ from the instantly claimed invention in that the prior art fail to explicitly disclose the result of the ratio as claimed.
Further, regarding the limitation “the ratio of the open drain area to the drainage area on the exterior surface of the tubular portion configures the intermittent urinary catheter for a continuous and uninterrupted flow of urine from a bladder without repositioning of the tubular portion of the intermittent urinary catheter” as that the invention of Carlsson discloses substantially identical structure to the claimed prior art, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where 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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Regarding claim 97, Carlsson suggests the invention of claim 58. Carlsson further discloses: the open drain area (see Ex. Fig. 1 showing drainage area including drainage openings 17a-c providing an open drain area) and the drainage area on the exterior surface of the tubular portion (see Ex. Fig. 1 showing the drainage area having a length from a proximal most to distal most drainage opening; Fig. 5d showing catheter 2 comprising a circumference); however the prior art differ from the instantly claimed invention in that the prior art fail to explicitly disclose the result of the ratio as claimed.
Regarding the limitation “the ratio of the open drain area to the drainage area on the exterior surface of the tubular portion configures the intermittent urinary catheter for a flow of urine from a bladder that reduces or eliminates residual urine remaining in the bladder” as that the invention of Carlsson discloses substantially identical structure to the claimed prior art, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where 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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Regarding claim 98, Carlsson suggests the invention of claim 85. Carlsson further discloses: wherein a number of the plurality of drainage openings is selected to configure the open drain area to be larger than a cross-sectional area of the lumen (pg. 5 ln. 23-28; pg. 10 ln. 32-33 and pg. 11 ln. 1-6).
Regarding claim 99, Carlsson suggests the invention of claim 85. Carlsson further discloses: wherein the plurality of drainage openings includes a plurality of proximal drainage openings and a plurality of distal drainage openings (Fig. 5a showing proximal drainage openings 17a-b and distal drainage openings 17c); however the prior art differ from the instantly claimed invention in that the prior art fail to explicitly disclose the result as claimed.
Regarding the limitation “to increase resistance to flow of the urine into the lumen through at least the plurality of distal drainage openings to distribute the flow of urine along the drain length” as that the invention of Carlsson discloses substantially identical structure to the claimed prior art, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where 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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Regarding claim 105, Carlsson suggests the invention of claim 58. Carlsson further discloses: wherein the open drain area is equal to or greater than a cross-sectional area of the lumen (pg. 5 ln. 23-28; pg. 10 ln. 32-33 and pg. 11 ln. 1-6).
Regarding claim 106, Carlsson suggests the invention of claim 58.
Carlsson fails to explicitly disclose “wherein a pressure ratio is a difference between a maximum suction pressure measured for the urine entering a first of the multiple small openings and a minimum suction pressure measured for the urine entering a second of the multiple small openings, and wherein the pressure ratio is in a range of 5 to 50”; however, it would be considered inherent that the intermittent catheter of Carlsson would satisfy this condition in that the drainage openings may be provided in multiple rows about the catheter of Carlsson (pg. 8 ln. 2-10, punching of the drainage openings occurs after changing length and/or rotational position of the catheter; pg. 17 ln. 10-27, punching of the drainage openings occurs by rotating the catheter a suitable angular length) and the instant application has disclosed that this condition may occur when the drainage openings are provided in more than two longitudinal rows (spec.: pg. 50 ln. 15-28).
Regarding claim 107, Carlsson suggests the invention of claim 85; however, Carlsson differs from the instantly claimed invention in that Carlsson fails to explicitly disclose the result as claimed.
Regarding the limitation “wherein the plurality of drainage openings is distributed along the drain length to allow complete draining of the urine from the bladder and leave no residual urine in the bladder” as that the invention of Carlsson discloses substantially identical structure to the claimed prior art, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where 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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Regarding claim 108, Carlsson suggests the invention of claim 85; however, Carlsson differs from the instantly claimed invention in that Carlsson fails to explicitly disclose the result as claimed.
Regarding the limitation “wherein the plurality of drainage openings allow complete draining of the urine from the bladder without repositioning of the drain length of the intermittent urinary catheter within the bladder” as that the invention of Carlsson discloses substantially identical structure to the claimed prior art, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where 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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Claims 83 and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson as applied above, and further in view of US/2018/0021481 A1 to Yin.
Regarding claim 83, Carlsson suggests the invention of claim 58; however, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose wherein the distal outlet end comprises a handle.
Yin teaches a urinary catheter wherein the distal outlet end comprises a handle (Fig. 3a showing outlet end of catheter 100 comprising handle 102).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the funnel-shaped outlet of Carlsson to comprise a handle as taught by Yin, because Yin teaches that the handle of their invention provides a gripping surface for easier gripping and handling of the catheter (para. 0062 ln. 10-11).
Regarding claim 87, Carlsson suggests the invention of claim 85; however, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose wherein the distal outlet end comprises a handle.
Yin teaches a urinary catheter wherein the distal outlet end comprises a handle (Fig. 3a showing outlet end of catheter 100 comprising handle 102).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the funnel-shaped outlet of Carlsson to comprise a handle as taught by Yin, because Yin teaches that the handle of their invention provides a gripping surface for easier gripping and handling of the catheter (para. 0062 ln. 10-11).
Claims 84 and 88 are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson as applied above, and further in view of WO/2015/142506 A1 to Foley.
Regarding claim 84, Carlsson suggests the invention of claim 58. Carlsson further discloses: wherein the intermittent urinary catheter comprises a hydrophilic coating that is lubricious when wetted (pg. 21 ln. 23-25); however, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose that the hydrophilic coating is lubricious when wetted with water.
Foley discloses that water is a wetting agent for hydrophilic coatings (pg. 1 ln. 29-33).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application that the hydrophilic coating of Carlsson would become lubricious when wetted with water in view of the teachings of Foley.
Regarding claim 88, Carlsson suggests the invention of claim 85. Carlsson further discloses: wherein the intermittent urinary catheter comprises a hydrophilic coating that is lubricious when wetted (pg. 21 ln. 23-25); however, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose that the hydrophilic coating is lubricious when wetted with water.
Foley discloses that water is a wetting agent for hydrophilic coatings (pg. 1 ln. 29-33).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application that the hydrophilic coating of Carlsson would become lubricious when wetted with water in view of the teachings of Foley.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
5 March 2026