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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/22/2026 has been entered.
Claims 1-4, 6, and 8-23 are pending in the present application with claim 20 being withdrawn from consideration. Claims 1 and 19 are amended and claims 21-23 are new. Claims 1-4, 6, 8-19 and 21-23 are examined on the merits.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conway remains as the primary reference in rejecting the present claims, for disclosing a majority of the claimed invention.
Horowitz is being introduced as a secondary reference in the present rejection for disclosing and/or rendering obvious the newly amended limitations of claims 1 and 19.
Eriksson and Sakaguchi remain in the present rejection for disclosing and/or rendering obvious the remaining limitations of the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Case law holds that applicant's specification must be "commensurately enabling [regarding the scope of the claims]" Ex parte Kung, 17 USPQ2d 1545, 1547 (Bd. Pat. App. Inter. 1989) otherwise undue experimentation would be involved in determining how to practice and use applicant's invention. Although the statute itself does not use the phrase "undue experimentation", it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation as stated in Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. Inter. 1986) and in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Specifically, in In re Wands the Court set forth a non-exhaustive list of factors to be considered in determining whether undue experimentation would be involved in making and/or using the claimed invention. These factors include, but are not limited to:
(a) the breadth of the claims;
(b) the nature of the invention;
(c) the state of the prior art;
(d) the level of one of ordinary skill;
(e) the level of predictability in the art;
(f) the amount of direction provided by the inventor;
(g) the existence of working examples; and
(h) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In the instant case, according to the nature of the invention (Wands factor [b]) amount of direction provided by the inventor (Wands factor [f]), one of ordinary skill in the art would not be appraised of how Applicant prevents any movement inside the pouch such that the pouch “is at all times visible through the window”. Based on Applicant’s figures and specification, the join would only restrict movement, not completely prevent it, and the pouch would appear reasonably capable of being moved out of view of the window. This would also render the catheter to no longer be hidden as required by claim 22.
Claims 21-22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 states “the fluid reservoir does not move inside the pouch and is at all times visible through the window”. However, Applicant only indicates the invention “restricts” movement of the fluid reservoir, which is distinct from fully preventing any movement.
Claim 22 states the “fluid reservoir… at all times hides the catheter”. However, the catheter of Applicant’s invention is intended to be removed from the pouch, at which point it would no longer be hidden.
In an effort to promote compact prosecution, this limitation is interpreted as being met by a pouch with movement restricted by a join, where the pouch is positionable to hide the catheter while the catheter is stored in the pouch.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6, 8-9, 13-19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Conway et al (US 2004/0074794 A1), in view of in view of Horowitz (US 2009/0036874 A1), Eriksson (US 2022/0126057 A1).
Regarding claim 1, Conway teaches a packaged catheter assembly (all elements in Figs. 1 and 6; Abstract) comprising an opaque pouch (pouch 1 made up of sheets 6 and 7; ¶s 23 and 29 indicate the pouch being opaque) and a catheter (catheter 2), wherein:
the opaque pouch (¶s 23 and 39 indicate the pouch being opaque) comprises a transparent window (¶s 23 and 39 indicate a transparent cover sheet serving as a window), wherein at least part of the window is patterned to provide a graduated appearance to the window (Figs. 4-6 show pouch dividers 16, which are interpreted as providing a graduated i.e. divided appearance; further), two walls (¶s 23 and 39 describe how the pouch is made from two sheets 6 and 7) and a peripheral seal between the two walls (seam 5);
a join is provided between the two walls (pouch dividers 16 in Figs. 4-6), wherein:
the join and an internal base of the peripheral seal define a channel (Fig. 6 best shows fluid filling the chamber formed by channels 18,19, and also joins 16; ¶ 49) to be filled with fluid before withdrawal of the catheter from the opaque pouch (Figs. 5-6 best show how fluid 14 is released before withdrawal; also see ¶s 50-51), and the reservoir configured to release fluid into the opaque pouch to form a pool of fluid (Figs. 5-6 best show how fluid 14 is released before withdrawal; also see ¶s 50-51).
Conway does not explicitly teach there being two opaque walls, the transparent window being formed in one of the opaque walls, the window having an area less than 25% of an area of the one of the opaque walls, the catheter being arranged in the opaque pouch in a curved configuration; the catheter is coiled or coiled around the join, the pool of fluid corresponds to a channel fill level of at least 90% of the volume of the channel, and the opaque pouch and catheter being arranged such that during withdrawal of the catheter from the opaque pouch, the distal end of the catheter does not pass through the channel.
However, Horowitz teaches a catheter assembly (catheter system 100, Fig. 1; Abstract), thus being in the same field of endeavor, comprising a pouch (covering device 104) comprising two opaque walls, and a window provided in one of the opaque walls (¶ 32 indicates the covering device can be made of an opaque material with a window formed therein, or from an opaque back wall with a transparent front wall).
Thus, Horowitz shows that having a pouch comprising two opaque walls, and a transparent window in an opaque wall is an equivalent structure to having a transparent wall joined to an opaque wall, and known in the art. Therefore, because these two viewing means were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute the transparent window in an opaque wall for the transparent wall joined to an opaque wall as originally taught by Conway. Doing so would allow for analogously observing the interior of the pouch (as recognized in ¶ 32 of Horowitz).
The combination of Conway and Horowitz still does not explicitly teach transparent window being formed in one of the opaque walls, the window having an area less than 25% of an area of the one of the opaque walls, the catheter being arranged in the opaque pouch in a curved configuration; the catheter is coiled or coiled around the join, the pool of fluid corresponds to a channel fill level of at least 90% of the volume of the channel, and the opaque pouch and catheter being arranged such that during withdrawal of the catheter from the opaque pouch, the distal end of the catheter does not pass through the channel.
However, Eriksson teaches a urinary catheter assembly (assembly 2 in Fig. 1; Abstract), thus being in the same field of endeavor, which is stored in a curve configuration (as shown in Fig. 1; ¶s 7-8), and also is curved around a join to form a channel (Fig. 7 shows join 23b; ¶ 116; ¶ 122 describes how these inner boundaries are formed by welds in the compartment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Conway and Horowitz to be arranged in a curved configuration and to be curved around a join, as taught by Eriksson. Doing so thus comprise a channel formed at least partially by the join, and the catheter curved around said join. Doing so would be advantageous in enabling the catheter packaging to be shorter and more discreet, and would also aid in straightening the catheter as it is removed (¶s 8, 112 and 116 of Eriksson).
Eriksson also teaches the pouch and catheter being arranged such that during withdrawal of the catheter from the pouch, the distal end of the catheter does not pass through the channel (¶s 57 and 103 describe how the non-insertable part 12, as well as cap 41 are used as a grip; while ¶ 67 indicates only the shaft as being lubricated).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combination of Conway, Horowitz, and Eriksson to comprise and arrange a non-insertable portion in the manner of Eriksson. Doing so would thus comprise the opaque pouch and catheter being arranged such that during withdrawal of the catheter from the opaque pouch, the distal end of the catheter does not pass through the channel. Doing so would be advantageous in providing a grip for clean manipulation and insertion of the catheter (¶s 13, 99, and 103 of Eriksson).
Further, limitations of the channel being “filled with fluid before withdrawal”, “the opaque pouch and catheter being are arranged such that during withdrawal of the catheter from the opaque pouch, the distal end of the catheter is withdrawn from the opaque pouch before the proximal end and the proximal end of the catheter passes through the channel”, “configured to release fluid into the opaque to form a pool of fluid within the channel”, and the opaque pouch and catheter are “arranged such that during withdrawal of the catheter from the opaque pouch, the distal end of the catheter does not pass through the channel”, are considered functional language.
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. See MPEP 2144. 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, catheter assembly of Conway, Horowitz, and Eriksson has all the structure as claimed. As such, it is capable of performing of being used as claimed (i.e. the channel is capable of being filled with fluid before withdrawal, the distal end of the catheter is capable of being withdrawn from the opaque pouch before the proximal end such that the proximal end of the catheter passes through the channel, the fluid reservoir is configured to release fluid to form a pool in the channel).
The combination of Conway, Horowitz, and Eriksson still does not explicitly teach the window having an area less than 25% of an area of the one of the opaque walls or the pool of fluid corresponds to a channel fill level of at least 90% of the volume of the channel.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the reservoir of Conway, Horowitz, and Eriksson to have window being less than 25% the area of the total area corresponding to the opaque wall since it has been held that, and to have a volume sufficient to fill at least 90% the volume of the channel or more 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 Conway, Horowitz, and Eriksson would not operate differently with the claimed relative volumes between the reservoir fluid (and released fluid pool) and channel. Further, applicant places no criticality on the relative volumes as claimed (Page 17, lines 5-6 describe a number of suitable total areas that the window “may” comprise; Page 4, lines 19-24 merely describe the fill percentage as preferable and provides a wide range of values).
Regarding claim 2, the limitations of “the catheter is a male urinary catheter” is considered the intended use of the invention. 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. See MPEP 2144. 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, catheter assembly of Conway has all the structure as claimed. As such, it is capable of performing of being used as a male urinary catheter as claimed.
Regarding claim 3, the limitations of “the catheter is an intermittent catheter” is considered the intended use of the invention. 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. See MPEP 2144. 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, catheter assembly of Conway has all the structure as claimed. As such, it is capable of performing of being used as an intermittent catheter as claimed.
Regarding claim 4, Conway further teaches the catheter being arranged between the join and the internal base of the peripheral seal (Figs. 4-6 show the tip of the catheter covered by reservoir 3, but would be arranged between dividers 16, forming the join, and the upper edge of seam 5).
Regarding claim 6, Conway further teaches the catheter comprises a surface configured to be activated by the fluid held in the fluid reservoir (¶s 2-3, 17, and 20 discuss wettable catheters, the catheters being wettable interpreted as having a surface that is activated).
Regarding claim 8, Conway further teaches the distal end of the catheter is arranged closer to an upper edge of the peripheral seal than a base of the peripheral seal (Figs. 4-6 show distal end 8 being closer to an upper edge of peripheral seal 5, at reference numeral 6).
Regarding claim 9, Eriksson teaches the distal end of the catheter is provided with a handling sleeve (protective sleeve 3) and wherein the handling sleeve is at least partially closer to an upper edge of the peripheral seal than the base of the peripheral seal (Fig. 1 shows at least a portion of sleeve 3 being closer to the upper end of package 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Conway, Horowitz, and Eriksson to specifically comprise the protective sleeve of Eriksson. Doing so would thus comprise the handling sleeve is at least partially closer to an upper edge of the peripheral seal than the base of the peripheral seal (as both Conway and Eriksson teach the distal end of the catheter being closer to the upper edge of the peripheral seal). Doing so would be advantageous in protecting the catheter from contamination and also straightening the catheter shaft (¶ 10 of Eriksson).
Regarding claim 13, Eriksson further teaches the join and the peripheral seal are independent (¶ 112 describes boundary 23b being within boundary 23a).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Conway and Horowitz to be arranged in a curved configuration and to be curved around a join, as taught by Eriksson. Doing so thus comprise the join and the peripheral seal as independent (as to allow the catheter to be curved around the join). Doing so would be advantageous in enabling the catheter packaging to be shorter and more discreet, and would also aid in straightening the catheter as it is removed (¶s 8, 112 and 116 of Eriksson).
Further, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the join and peripheral seal independent since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. See MPEP 2144.04 (V)(C). In the instant case, the join would still perform the same function of directing fluid and dividing the pouch when made separable from the peripheral seal.
Regarding claim 14, Conway further teaches the channel is open-ended (see annotated Fig. 4 below; the channel leads to other open areas of the pouch). Eriksson also teaches the channel being open ended (see annotated Fig. 7 below).
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Regarding claim 15, Conway further discloses the opaque pouch being substantially rectangular in shape with two lateral edges, a base, and an upper edge of the peripheral seal (Figs. 1-6 all show pouch 1 being rectangular, the upper edge being near distal end 8; also see ¶ 48), wherein the join is provided at a point equidistant from the two lateral edges (Figs. 4-6 show collective joins 16 being spaced symmetrically and equidistant from the two lateral edges).
Regarding claim 16, the combination of Conway, Horowitz, and Eriksson do not explicitly teach the join being provided at a distance that is 20-30% of a height of the opaque pouch, wherein, wherein the height of the opaque pouch is defined as the distance between the base of the peripheral seal to an upper edge of the peripheral seal.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the join of Conway to be at a distance of 20-30% the height of the pouch since “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 Conway and would not operate differently with the claimed dimensions as the join would still serve to guide fluid. Further, applicant places no criticality on the range claimed (Page 11, lines 18-29 disclose a wide range of distances and only that the join “can” be arranged within the claimed range).
Regarding claim 17, Eriksson further teaches the catheters stored in a coiled configuration (as shown in Fig. 1; ¶s 7-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Conway to be arranged in a coiled configuration, as taught by Eriksson. Doing so would be advantageous in enabling the catheter packaging to be shorter and more discreet (¶ 8 of Eriksson).
Regarding claim 18, limitations of “the catheter being arranged such that during withdrawal at least 50% of the length of the catheter passes through the channel” are considered functional language. 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. See MPEP 2144. 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, catheter assembly of Conway, Horowitz, and Eriksson has all the structure as claimed. As such, it is capable of performing of being used as claimed (i.e. the catheter is capable of being withdrawn such that at least 50% the length of the catheter passes through the channel).
Regarding claim 19, Conway teaches a packaged catheter assembly (all elements in Figs. 1 and 6; Abstract) comprising:
an opaque pouch (¶s 23 and 39 indicate the pouch being opaque), wherein the opaque pouch comprises a transparent window (¶s 23 and 39 indicate a transparent cover sheet serving as a window), wherein at least part of the window is patterned to provide a graduated appearance to the window (Figs. 4-6 show pouch dividers 16, which are interpreted as providing a graduated i.e. divided appearance; further), defined by two walls (¶s 23 and 39 describe how the opaque pouch is made from two sheets 6 and 7);
a catheter arranged inside the opaque pouch (catheter 2),
a peripheral seal formed between the two walls (seam 5); and
a join is provided between the two walls (pouch dividers 16 in Figs. 4-6).
Thus, Conway inherently teaches providing the two walls to define said opaque pouch including a transparent window and at least part of the window being patterned to provide a graduated appearance to the window;
arranging a catheter inside the opaque pouch;
forming a peripheral seal between said walls to seal the catheter within the opaque pouch; and
forming a join between the walls.
Conway also teaches wherein:
the join and an internal base of the peripheral seal define a channel (Fig. 6 best shows fluid filling the chamber formed by channels 18,19, and also joins 16; ¶ 49) to be filled with fluid before withdrawal of the catheter from the opaque pouch (Figs. 5-6 best show how fluid 14 is released before withdrawal; also see ¶s 50-51);
the catheter comprises a proximal end for insertion into the body (tip 10, described in ¶s 40 and 47; it is known in the art catheter tips are used for insertion into the body), and the reservoir configured to release fluid into the opaque pouch to form a pool of fluid (Figs. 5-6 best show how fluid 14 is released before withdrawal; also see ¶s 50-51).
Conway does not explicitly teach the window having an area less than 25% of an area of one of the two walls, the catheter being arranged in the opaque in a curved configuration; the catheter is coiled or curved around the join, the distal end of the catheter does not pass through the channel, and the pool of fluid corresponds to a channel fill level of at least 90% of the volume of the channel.
However, Horowitz teaches a catheter assembly (catheter system 100, Fig. 1; Abstract), thus being in the same field of endeavor, comprising a pouch (covering device 104) comprising two opaque walls, and a window provided in one of the opaque walls (¶ 32 indicates the covering device can be made of an opaque material with a window formed therein, or from an opaque back wall with a transparent front wall).
Thus, Horowitz shows that having a pouch comprising two opaque walls, and a smaller, transparent window in an opaque wall, is an equivalent structure to having a transparent wall joined to an opaque wall, and known in the art. Therefore, because these two viewing means were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute the transparent window in an opaque wall for the transparent wall joined to an opaque wall as originally taught by Conway. Doing so would allow for analogously observing the interior of the pouch (as recognized in ¶ 32 of Horowitz).
The combination of Conway and Horowitz still does not explicitly teach the window having an area less than 25% of an area of the one of the opaque walls, the catheter being arranged in the opaque in a curved configuration; the catheter is coiled or curved around the join, the distal end of the catheter does not pass through the channel, and the pool of fluid corresponds to a channel fill level of at least 90% of the volume of the channel.
However, Eriksson teaches a urinary catheter assembly (assembly 2 in Fig. 1; Abstract), thus being in the same field of endeavor, which is stored in a curve configuration (as shown in Fig. 1; ¶s 7-8), and also is curved around a join to form a channel (Fig. 7 shows join 23b; ¶ 116; ¶ 122 describes how these inner boundaries are formed by welds in the compartment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Conway to be arranged in a curved configuration, and to be curved around a join as taught by Eriksson. Doing so thus comprise arranging the catheter inside the opaque pouch in a curved configuration and would be advantageous in enabling the catheter packaging to be shorter and more discreet, and would also aid in straightening the catheter as it is removed (¶s 8, 112 and 116 of Eriksson).
Eriksson also teaches the opaque pouch and catheter being arranged such that the distal end of the catheter is withdrawn from the opaque pouch before the proximal end, the proximal end of the catheter passes through the channel, and the distal end of the catheter does not pass through the channel (¶s 57 and 103 describe how the non-insertable part 12, as well as cap 41 are used as a grip; while ¶ 67 indicates only the shaft as being lubricated; Fig. 7 also shows how the top end of the catheter, such as at distal section 18’, would be above the channel formed by the bottom of boundary 23b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combination of Conway and Eriksson to comprise and arrange a non-insertable portion in the manner of Eriksson. Doing so would thus comprise the pouch and catheter being arranged such that the distal end of the catheter is withdrawn before the proximal end, and the proximal end passes through the channel while the distal end of the catheter does not pass through the channel. Doing so would be advantageous in providing a grip for clean manipulation and insertion of the catheter (¶s 13, 99, and 103 of Eriksson).
Limitations of the opaque pouch and catheter being arranged “such that during withdrawal of the catheter from the opaque pouch, the distal end of the catheter is withdrawn from the opaque pouch before the proximal end, the proximal end of the catheter passes through the catheter, and the distal end of the catheter does not pass through the channel”, and the fluid reservoir is “configured to release fluid into the opaque pouch to form a pool of fluid in the channel” are considered functional language as the interaction region and opening depend only on how the device is used (i.e. opened). 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. See MPEP 2144. 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, catheter assembly of Conway and Eriksson has all the structure as claimed. As such, it is capable of performing of being used as claimed (i.e. it is capable of being used such that during withdrawal of the catheter from the opaque pouch, the distal end of the is withdrawn from the opaque pouch before the proximal end, and proximal end of the catheter passes through the channel, but the distal end does not pass through the channel, and the fluid released form the fluid reservoir is configured to form a pool in the channel).
The combination of Conway, Horowitz, and Eriksson still does not explicitly teach the window having an area less than 25% of an area of the one of the opaque walls or the pool of fluid corresponds to a channel fill level of at least 90% of the volume of the channel.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the reservoir of Conway, Horowitz, and Eriksson to have window being less than 25% the area of the total area corresponding to the opaque wall since it has been held that, and to have a volume sufficient to fill at least 90% the volume of the channel or more 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 Conway, Horowitz, and Eriksson would not operate differently with the claimed relative volumes between the reservoir fluid (and released fluid pool) and channel. Further, applicant places no criticality on the relative volumes as claimed (Page 17, lines 5-6 describe a number of suitable total areas that the window “may” comprise; Page 4, lines 19-24 merely describe the fill percentage as preferable and provides a wide range of values).
Regarding claim 21, Conway further teaches the fluid reservoir is located as an obscuring object within the pouch at a position corresponding the transparent window (Figs. 4-6 show how the pouch is positioned over catheter 9, obscuring the catheter, and corresponding to the window as formed by the transparent cover sheet; the combination of Conway, Horowitz, and Eriksson does not provide a teaching to the contrary and thus would be expected to maintain this feature) arranged between the join and a lateral edge of the seal (Figs. 4-6 show fluid reservoir 3 bounded by dividers 16, channel 18, and weld 5; obscuring the catheter, and corresponding to the window as formed by the transparent cover sheet; the combination of Conway, Horowitz, and Eriksson does not provide a teaching to the contrary and thus would be expected to maintain this feature) such that the fluid reservoir does not move inside the pouch and is always visible through the window (¶ 26 describes how the fluid packet is fixedly positioned within the catheter container; Fig. 1 shows how cover sheet 7 corresponds with pouch 3; also see Fig. 6).
Regarding claim 22, Conway further teaches the fluid reservoir being opaque (¶ 42
indicates the sachet being made of aluminum foil, which is an opaque material; Figs. 4-6 also
show how the sachet blocks the catheter from view, and thus would be opaque) and at all times hides the catheter (in the same manner as stated in the rejection of claim 21).
Regarding claim 23, limitations of the two opaque walls “hide the catheter from view”, is considered functional language.
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. See MPEP 2144. 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, catheter assembly of Conway, Horowitz, and Eriksson has all the structure as claimed. As such, the opaque walls are capable of hiding the catheter from view as claimed.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Conway, Horowitz, and Eriksson, as applied to claim above, and further in view of Sakaguchi (US 2018/0339128 A1).
Regarding claim 10, the combination of Conway and Eriksson do not explicitly teach the pouch comprising an interaction region configured to create an opening in or near an upper edge of the peripheral seal.
However, Sakaguchi teaches a bagged catheter assembly (holding tool 100; Abstract), thus being in the same field of endeavor, comprising an interaction region configured to create an opening in or near an upper edge of a peripheral seal (grip portion 183; ¶ 175).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Conway and Eriksson to comprise the grip portion of Sakaguchi. Doing so would thus comprise an interaction region configured to create an opening in or near an upper edge of the peripheral seal and would assist in opening the packaging (¶ 75 of Sakaguchi; ¶ 1 of Conway recognizes the package needs to be opened).
Regarding claim 11, the combination of Conway, Eriksson, and Sakaguchi substantially disclose the invention of claim 10.
However, Sakaguchi further teaches the catheter being aligned centrally with the interaction region (Fig. 1 shows distal end at holding portion 150 aligned with grip portion 183).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Conway and Eriksson to comprise the grip portion of Sakaguchi. Doing so would thus comprise the catheter arranged centrally with respect to the resulting opening formed at the grip portion. Doing so would assist in opening the packaging (¶ 75 of Sakaguchi; ¶ 1 of Conway recognizes the package needs to be opened).
Regarding claim 12, the combination of Conway, Eriksson, and Sakaguchi substantially disclose the invention of claim 10.
However, Sakaguchi further teaches the interaction region being located at a corner of the pouch at a first lateral edge of the peripheral seal, and the distal end of the catheter is arranged closer to the first lateral edge of the peripheral seal than a second lateral edge of the peripheral seal (Fig. 1 shows grip portion 183 in a lateral corner).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Conway and Eriksson to comprise the grip portion of Sakaguchi. Doing so would thus comprise the interaction region such that the resulting opening would be created from a first lateral edge of the peripheral seal, and the distal end of the catheter is arranged closer to the and first lateral edge of the peripheral seal than a second lateral edge. Doing so would assist in opening the packaging (¶ 75 of Sakaguchi; ¶ 1 of Conway recognizes the package needs to be opened).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Fletter et al. (US 20200398024 A1) discloses a pouch having a similarly shaped window that is also used for discretion features.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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