DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment and Claim Status
The amendment filed 12/11/2025 has been entered:
Claims 1, 3-4, 6-7, 10, and 12-16, 18-26 remain pending in the present application. Claims 1 and 18-19 are amended, claims 23-26 is new, and claims 2, 5, 8-9, 11 and 17 are cancelled. Claims 20-21 remain withdrawn from consideration and claims 1, 3-4, 6-7, 10, 12-16, 18-19, and 22-26 are examined on the merits.
Response to Arguments
Applicant’s amendments, particularly in requiring details of the join, and the positioning of the fluid reservoir as an obscuring object, necessitated a new grounds of rejection. Applicant’s arguments with respect to claim(s) 1 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.
Bezek and Eriksson, previously cited, are being introduced as a secondary references in the present rejection for disclosing and/or rendering obvious the newly amended limitations of 1.
Horowitz remains in the present rejection for disclosing and/or rendering obvious the remaining claim limitations.
In response to applicant's argument that Bezek is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Bezek is relied upon to teach limitations with respect to creating opaque and transparent regions in packaging. Applicant characterizes Bezek as providing a viewing window to enable visual access to a product therein (specifically a food product). One of ordinary skill in the art would appreciate the mechanisms of providing visual access into a package would be analogous whether the contents was food or a catheter. The relevant limitations are only with respect to opacity/transparency patterning, which are not concepts unique only to catheter or medical device packaging. Horowitz also establishes the use of windows for medical packaging.
Applicant further argues Bezek teaches a desire to view some of the product, which would teach away from discrete packaging. However, the standard of “teaching away” is not applied to the intentions behind Applicant’s only invention; it is applied between combined references (i.e. Conway would need to teach away from incorporating the graduated appearance as incorporated from Bezek).
In addition, whether or not something is “discrete” is subjective. Further, Applicant’s invention still enables some degree of visual access via the claimed window. The combination appears to teach all the structure as claimed, and thus the motivations or intended use of Applicant’s invention is not sufficient to patentably distinguish the claimed invention from the prior art.
Applicant’s arguments regarding the dependent claims on the same grounds as claim 1 are similarly moot as claim 1 remains rejected, as set forth below.
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 25 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.
New Claim 25 recites the limitation "the join in the pouch" in line 2. There is insufficient antecedent basis for this limitation in the claim as the join is only discussed as a separate element and not as being “in” the pouch. In an effort to promote compact prosecution, “the join in the pouch” is interpreted as “the join”.
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, 3-4, 6-7, 10, 12-16, 18-19, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Conway et al (US 2004/0074794 A1) in view of Horowitz (US 2009/0036874 A1), Bezek et al. (US 2010/0062196 A1), and Eriksson (US 2022/0126057 A1).
Regarding claim 1, Conway teaches a catheter assembly (all elements in Figs. 1 and 6; Abstract);
a catheter (catheter 2);
a fluid reservoir (fluid sachet 3);
an opaque pouch containing the fluid reservoir and the catheter (¶s 23 and 39 indicate the pouch being opaque); wherein the opaque pouch comprises an opaque wall joined by a peripheral seal, and a transparent window (¶s 23 and 39 indicate a transparent cover sheet serving as a window),
a join comprising a weld between the two walls (pouch dividers 16 in Figs. 4-6; ¶s 39 and 47 describe welding),
wherein the catheter in the pouch is hidden behind the fluid reservoir (Figs. 4-6; ¶s 23 and 39 indicate the pouch being opaque, and thus would hide the pouch from the opaque side), and wherein 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) 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) 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).
Conway does not explicitly teach there being two opaque walls, the window being provided in one of the opaque walls, the window comprising a pattern thereon that provides a graduated appearance that softens the boundary between the window and the rest of the opaque wall, wherein the join comprises a circular weld located closer to a base of the peripheral seal than an upper edge of the peripheral seal.
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 still does not explicitly teach the window comprising a pattern thereon that provides a graduated appearance that softens the boundary between the window and the rest of the opaque wall, or the join being a circular weld located closer to a base of the peripheral seal than an upper edge of the peripheral seal,
In addressing the same problem as applicant, the problem being the provision of windows for reviewing the contents of opaque packages, Bezek teaches a partially opaque packaging (Figs. 7-8, 10, and 16; Abstract), comprising an opaque pouch (¶s 41 and 49-50 opaque, metallic films) and a window provided in an opaque wall (transparent film 234) with either a sharp or a graduated appearance that softens the boundary between the window and the rest of the opaque wall (¶s 49-50 describes having a gradual transition to transparency, as shown in Fig. 10; also see Fig. 16 and ¶ 59).
Thus, Bezek shows that having a transparent window with a graduated appearance that softens the boundary between the window and the rest of the opaque wall (¶ 49 of Bezek). Therefore, because these two window transmission 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 sharp transitions of Horowitz with the graduated transition of Bezek. Doing so would allow for analogous viewing of the interior of the pouch, and may be beneficial for appearance reasons (Abstract and ¶ 49 of Bezek).
The combination of Conway, Horowitz, and Bezek still do not explicitly teach the join being a circular weld located closer to a base of the peripheral seal than an upper edge of the peripheral seal.
Eriksson teaches a urinary catheter assembly (assembly 2 in Figs. 1 and 7; Abstract),thus being in the same field of endeavor, which is stored in a curve configuration (as shown in Figs. 1 and 7; ¶s 7-8) around a circular weld located closer to a base of the peripheral seal than an upper edge of the peripheral seal (boundary 23b comprises two rounded welds at opposite ends of the package; ¶ 75 indicates the boundaries are formed by welding).
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 Bezek to comprise the join as a circular weld located closer to a base of the peripheral seal than an upper edge of the peripheral seal, as taught by Eriksson. Doing so would be advantageous in maintaining a curved shape during storage, enabling the catheter packaging to be shorter and more discreet (¶s 116 and 8 of Eriksson).
Regarding claim 3, 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, Horowitz, Bezek, and Eriksson 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 4, 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, Horowitz, Bezek, and Eriksson has all the structure as claimed. As such, it is capable of performing of being used as an intermittent catheter as claimed.
Regarding claim 6, Conway further teaches the window corresponds to the position of an indicator region in the pouch, wherein the indicator region is configured to indicate successful release of the fluid from the reservoir (¶s 23 and 39 describe how cover sheet 7 is transparent; Fig. 1 shows how cover sheet 7 corresponds with pouch 3; also see Fig. 6; Figs. 4-6 in particular shows how fluid 14 can be seen through the window 7, and thus would serve to indicate to a user that fluid was successfully released).
Regarding claim 7, Conway further teaches the window corresponds to a wetting region into which fluid is intended to flow from the fluid reservoir (¶s 23 and 39 describe how cover sheet 7 is transparent; Fig. 1 shows how cover sheet 7 corresponds with pouch 3; also see Fig. 6; Figs. 4-6 in particular shows how fluid 14 wetting catheter 2, such as at shaft 9, can be seen through the window 7, and thus correspond to a wetting region into which fluid is intended to flow).
Regarding claim 10, Conway further teaches the catheter is hidden by the pouch (¶s 23 and 39 indicate the pouch being opaque, and thus would hide the pouch from the opaque side).
Regarding claim 12, 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).
Regarding claim 13, Conway further teaches the fluid reservoir being a different color than the pouch (¶ 42 indicates the sachet being made of aluminum foil, which is an opaque material while ¶s 23 and 39 indicate the pouch being partially transparent, thus being a different color/shade).
Regarding claim 14, Conway further teaches the pouch being substantially rectangular in shape with two lateral edges, a base, and an upper edge (Figs. 1-6 all show pouch 1 being rectangular; also see ¶ 48).
Regarding claim 15, Conway further teaches the window spanning at least 30% the height of the pouch, wherein the height is defined as the distance from the base to the upper edge of the pouch (Figs. 1-6 show the window formed by sheet 7 spans the entire dimensions beyond seam 5, comprising the majority of the height of the pouch).
Regarding claim 16, the combination Conway, Horowitz, Bezek, and Eriksson does not explicitly teach the window being between 15-20% of the width of the pouch, wherein the width of the pouch is defined as the distance between the lateral edges of the pouch.
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 window of Conway to be between 15-20% of the width of the pouch 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 Bezek would not operate differently with the claimed window as a window of different size would still allow for viewing of the internal pouch contents. Further, applicant places no criticality on the range claimed (Page 17, lines 25-32 disclose a number of suitable dimensions, and indicate the claimed range of 15-20% as only being in one embodiment).
Regarding claim 18, Conway further teaches 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 a distal end (flared outlet 8); 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 pouch (Figs. 5-6 best show how fluid 14 is released before withdrawal; also see ¶s 50-51), wherein the fluid reservoir is 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).
Eriksson further teaches the catheter is stored in a curve 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 combination of Conway, Horowitz, Bezek, and Eriksson to explicitly have the catheter arranged in a curved configuration. Doing so would be advantageous in enabling the catheter packaging to be shorter and more discreet (¶ 8 of Eriksson).
Further, limitations of the channel being “filled with fluid before withdrawal”, “the pouch and catheter being are arranged such that during withdrawal from the catheter from the pouch, the distal end of the catheter is withdrawn from the pouch before the proximal end and the proximal end of the catheter passes through the channel”, and “the peripheral seal and the join thereby acts to restrict the movement of the fluid reservoir in the pouch” 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, Bezek, 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 pouch before the proximal end such that the proximal end of the catheter passes through the channel, and the peripheral seal and join are capable of restricting movement of the fluid reservoir in the pouch).
Regarding claim 19, Conway further teaches 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 a distal end (flared outlet 8); 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 pouch (Figs. 5-6 best show how fluid 14 is released before withdrawal; also see ¶s 50-51), wherein the fluid reservoir is 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), and wherein the window corresponds to a location that is closer to the internal base of the peripheral seal than the join (Figs. 1-6 show the window formed by sheet 7 spans the entire dimensions beyond seam 5, and thus would overlap, i.e. correspond, with a location that is closer to the internal base of the peripheral seal than the join).
Eriksson further teaches the catheter is stored in a curve 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 combination of Conway, Horowitz, Bezek, and Eriksson to explicitly have the catheter arranged in a curved configuration. Doing so would be advantageous in enabling the catheter packaging to be shorter and more discreet (¶ 8 of Eriksson).
The combination of Conway, Horowitz, Bezek, and Eriksson still does not explicitly teach the volume of the fluid reservoir being sufficient to completely fill the channel or more.
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 and Eriksson to have a volume sufficient to fill 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, Bezek, and Eriksson would not operate differently with the claimed relative volumes between the reservoir fluid and channel. Further, applicant places no criticality on the relative volumes as claimed (Page 4, lines 14-19 merely describe this feature as preferable and provides a wide range of values).
Further, limitations of the channel being “filled with fluid before withdrawal” and “the pouch and catheter being are arranged such that during withdrawal from the catheter from the pouch, the distal end of the catheter is withdrawn from the pouch before the proximal end and the proximal end 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, Bezek, 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 pouch before the proximal end such that the proximal end of the catheter passes through the channel, and the peripheral seal and join are capable of restricting movement of the fluid reservoir in the pouch).
Regarding claim 22, Conway further teaches the fluid reservoir comprises a sachet of fluid (fluid sachet 3 defined by fluid chamber 12) which is burstable (¶ 41 describes opening by pressure or striking).
Regarding claim 23, Conway further teaches the fluid reservoir is silver (¶s 28 and 42 indicates the sachet being made of aluminum foil, or metalized film, which would be silver in color).
Regarding claim 24, Conway further teaches the fluid reservoir comprises an elongate rectangular shape and the window comprises the same shape as the fluid reservoir (Figs. 1 and 6 show the pouch and the panel making up the window being elongate rectangular shapes).
The combination of Conway, Horowitz, Bezek, and Eriksson do not explicitly teach the window being smaller than the fluid reservoir.
However, Bezek teaches that the transparent and opaque regions may be controlled by a practitioner during manufacturing (¶s 57-58).
Thus, it would have been an obvious matter of design choice to make the different portions of the window of whatever form or shape was desired or expedient, such as to make window smaller than the reservoir. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Also see MPEP 2144.04 (IV)(B) which relates to Changes in Shape. Further, Applicant has placed no criticality on the claimed shape as this feature (Page 16, line 27 – Page 17, 4 indicate that the window may be a number of different sizes).
Regarding claim 25, Conway further teaches a portion of the window corresponds to a location that is lower than the join (Fig. 6 shows how the pouch is below the join 16, and would be visible; therefore the transparent window would also correspond to the location of the pouch and would correspond to a location that is lower than the join in the same manner).
Regarding claim 26, the combination of Conway, Horowitz, Bezek, and Eriksson do not explicitly teach the join comprises a radius of 5 percent of a height of the pouch and is disposed between about 20-30 percent the height of the pouch.
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 device of Conway, Horowitz, Bezek, and Eriksson to have the join comprises a radius of 5 percent of a height of the pouch and is disposed between about 20-30 percent the height of the pouch 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, Bezek, and Eriksson would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed (Page 11, lines 12-23 disclose a wide variety of suitable dimension ranges for the join radius and height).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781