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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “fluid collection bag arranged in catheter packaging” in claim 24 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6,14-15,21-22 and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Flynn (US 20200155261 A1)
Regarding claim 1, O’Flynn teaches a catheter packaging (fig.1 shows the device packaging 10a capable of holding a catheter) defined by at least two walls bonded along a pair of lateral edges by lateral edge bonds (fig.1 and 2 show the first wall 14a and 15a bonded along lateral edges 20a and 21a bonded by first and second side seals zones 29a and 30a ), the packaging having an openable top (fig.1 and 2 show the top 18a being openable), wherein the openable top is sealed by a top seal comprising a pair of bond lines which continue from the lateral edge bonds and gradually curve to meet (fig.1 and 2 show the top seal zone 27a comprising two bond line that continue from the lateral edge bond and gradually curve to meet).
Regarding claim 2, the references as applied to claim 1 above discloses all the limitations substantially claimed. O’Flynn further teaches wherein the pair of bond lines meet at a point (fig.1 the lines meet at the top of the tringle).
Regarding claim 3, the references as applied to claim 1 above discloses all the limitations substantially claimed. O’Flynn further teaches wherein the pair of bond lines meet at a centerline (fig.1 the lines meet at centerline at the top of the tringle where the 27a is pointed).
Regarding claim 4, the references as applied to claim 1 above discloses all the limitations substantially claimed. O’Flynn further teaches wherein the pair of bond lines are symmetrical (fig.1 the bond lines are symmetrical).
Regarding claim 5, the references as applied to claim 1 above discloses all the limitations substantially claimed. O’Flynn further teaches wherein at least one of the bond lines comprises a first curved portion and a second straight portion (fig.1 the bond lines 27a have a straight lateral portion and curve portion when it gets to the top near 27a and turns straight on the other side).
Regarding claim 6, the references as applied to claim 5 above discloses all the limitations substantially claimed. O’Flynn further teaches wherein the first curved portion is adjacent to the lateral edge bond and the second straight portion is adjacent to the meeting point of the pair of bond lines (fig.1 and 2 the curved portion is adjacent to the lateral edge 20a and 21a and the second straight portion at the meeting point ).
Regarding claim 14, the references as applied to claim 1 above discloses all the limitations substantially claimed. O’Flynn further teaches wherein the two walls are unbonded beyond the pair of bond lines, the two walls forming two flaps (fig.2 shows the two walls unbonded and creating flaps).
Regarding claim 15, the references as applied to claim 14 above discloses all the limitations substantially claimed. O’Flynn further teaches wherein each flap is provided with a finger hole extending through the wall, and wherein the finger holes are arranged above the point where the pair of bond lines meet (fig.1 and 2 show the finger hole 33a on each wall and they are arranged above the pair of bond lines).
Regarding claim 21, the references as applied to claim 1 above discloses all the limitations substantially claimed. O’Flynn further teaches wherein the lateral edge bonds comprise tear stops (fig.1 shows the peel stops 32a and 31a).
Regarding claim 22, the references as applied to claim 21 above discloses all the limitations substantially claimed. O’Flynn further teaches wherein the tear stops comprise a widened portion of the lateral edge bond, wherein the lateral edge bonds comprise a frangible portion and anon-frangible portion and the tear stop delimits the frangible portion and non-frangible portion (fig.2 shows the peal stops 31a and 32a with widened portion compare to the lateral bond and comprises elements 34a and 35b which are frangible and curves and the rest of the 31a/32a siu non-frangible).
Regarding claim 24. O’Flynn a packaged catheter assembly comprising (fig.1 shows the catheter assembly 10A) a catheter and a fluid collection bag arranged in catheter packaging (fig.1 shows the 36a that can also include a with a tube 12a for collecting fluid), the catheter packaging defined by at least two walls bonded along a pair of lateral edges by lateral edge bonds (fig.1 and 2 show the first wall 14a and 15a bonded along lateral edges 20a and 21a bonded by first and second side seals zones 29a and 30a ), the packaging having an openable top (fig.1 and 2 show the top 18a being openable), wherein the openable top is sealed by a top seal comprising a pair of bond lines which continue from the lateral edge bonds and gradually curve to meet (fig.1 and 2 show the top seal zone 27a comprising two bond line that continue from the lateral edge bond and gradually curve to meet).
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.
Claim(s) 7-9 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Flynn (US 20200155261 A1).
Regarding claim 7, the references as applied to claim 6 above discloses all the limitations substantially claimed. O’Flynn teaches wherein the first curved portion comprises a percentage of the length of the respective bond line (fig.1 and 2 above shows the first curved portion comprise a percentage of the length of the bond line). 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 first curved portion comprises a percentage of the length of the respective bond line of O’Flynn to be 30% of the length in order extend or contract the spacing of the two elements to user’s desire. To modify the size of the first curved portion with respect to the length of the bond line into claimed dimensions would entail a mere change in size of the components and yield only predictable results. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 8, the references as applied to claim 1 above discloses all the limitations substantially claimed. O’Flynn teaches wherein at least one of the bond lines has a radius of curvature (fig.1 and 2 shows the first bond line has a radium of curvature since it turns). 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 radius of curvature of O’Flynn to be 20mm in order extend or contract the spacing of the two elements to user’s desire and by changing the radium will also modify the size of the total packaging increasing or decreasing the size of packaging. To modify the size of radius into claimed dimensions would entail a mere change in size of the components and yield only predictable results. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 9, the references as applied to claim 1 above discloses all the limitations substantially claimed. O’Flynn teaches wherein at least one of the bond lines has a radius of curvature (fig.1 and 2 shows the first bond line has a radius of curvature since it turns). 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 radius of curvature of O’Flynn to be 30mm in order extend or contract the spacing of the two elements to user’s desire and by changing the radium will also modify the size of the total packaging increasing or decreasing the size of packaging. To modify the size of radius into claimed dimensions would entail a mere change in size of the components and yield only predictable results. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 11, the references as applied to claim 1 above discloses all the limitations substantially claimed. O’Flynn teaches wherein at least one of the bond lines has a radius of curvature (fig.1 and 2 shows the bond line has a radius of curvature since it turns). 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 radius of curvature of O’Flynn to be between 20% and 40% of the width of the packaging in order extend or contract the spacing of the two elements to user’s desire and by changing the radium will also modify the size of the total packaging increasing or decreasing the size of packaging. To modify the size of radius into claimed dimensions would entail a mere change in size of the components and yield only predictable results. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 12, the references as applied to claim 1 above discloses all the limitations substantially claimed. O’Flynn teaches wherein at least one of the bond lines has a radius of curvature (fig.1 and 2 shows the bond line has a radius of curvature since it turns). 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 radius of curvature of O’Flynn to be 30% and 40% of the width of the packaging in order extend or contract the spacing of the two elements to user’s desire and by changing the radium will also modify the size of the total packaging increasing or decreasing the size of packaging. To modify the size of radius into claimed dimensions would entail a mere change in size of the components and yield only predictable results. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 13, the references as applied to claim 1 above discloses all the limitations substantially claimed. O’Flynn teaches wherein at least one of the bond lines has a radius of curvature (fig.1 and 2 shows the bond line has a radius of curvature since it turns). 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 radius of curvature of O’Flynn to be at least 3 times the width of the bond line in order extend or contract the spacing of the two elements to user’s desire and by changing the radium will also modify the size of the total packaging increasing or decreasing the size of packaging. To modify the size of radius into claimed dimensions would entail a mere change in size of the components and yield only predictable results. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Flynn (US 20200155261 A1) and further in view of Gustavsson (US 20110295239 A1)
Regarding claim 17, the references as applied to claim 15 above discloses all the limitations substantially claimed. O’Flynn does not teach wherein the finger holes have a rounded triangular shape.
Gustavsson teaches wherein the finger holes have a rounded triangular shape (fig.1B holes at 119a-b that have finger holes with a rounded triangular shape). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of holes of O’Flynn to be rounded triangular shape as disclosed by Gustavsson as a mere change of shape would accomplish same results of holding the packaging. 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.
Regarding claim 18, the references as applied to claim 17 above discloses all the limitations substantially claimed. O’Flynn as modified in claim 17 further teaches wherein the finger holes taper towards the top seal (fig.1a the holes will taper towards the seal).
Regarding claim 19, the references as applied to claim 15 above discloses all the limitations substantially claimed. O’Flynn as modified in claim 15 further teaches wherein the width of the finger holes is between 15% and 25% the width of the packaging (fig.1 shows the width holes 30a is between 15-25%).
Conclusion
See PTO-892 for the prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/PRINCE PAL/Examiner, Art Unit 3735
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