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 .
Status of Claims
Claims 1-16 and 18-23 are pending and examined on the merits.
Claims 4-12, 14, 16, and 18-22 are currently amended.
Claims 17 and 24 are cancelled.
Information Disclosure Statement
No information disclosure statement (IDS) was provided.
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.
Claims 20 and 21 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.
Claim 20 recites the limitation "the container of wetting fluid" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the wetting fluid" in line 12. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-5, 7-14, 18-19, and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Imai (U.S. Pre Grant Pub. No. 2009/0187117 A1)
Regarding claim 1, Imai teaches A packaged catheter assembly (see at least Fig. 1 and Abstract) comprising
a catheter (see tube 4 in Fig. 1) arranged within a sterile (see at least para. [0006]) sealed pouch (see packaging material 15 at least in Fig. 1);
the pouch having an openable top (see opening 17 at least in Fig. 1) and a resealing arrangement (see lid 20 at least in Fig. 1) proximal the openable top (see Fig. 1) for resealing the pouch after use (para. [0102] teaches that the lid 20 closes the opening 17; therefore, lid 20 is capable of resealing the opening 17 after use);
wherein a portion of the catheter is arranged in the sealed pouch (see at least Fig. 1) so as to obstruct the resealing arrangement (when tube 4 is partially removed from the packaging material 15, as shown in Figs. 1 and 2, the tube 4 will obstruct the resealing arrangement as a portion of the tube 4 will extend outside the opening 17 and will interfere with the lid 20 closing the opening 17; see also para. [0102]).
Regarding claim 2, Imai teaches the invention as discussed above in claim 1. Additionally, Imai teaches wherein the resealing arrangement comprises opposing resealing elements (para. [0118] teaches that the lid 20 is bonded to the peripheral region of the opening 17 by adhesive; therefore, the surface of the lid 20 has adhesive and the peripheral region of the opening 17 is made of a material that allows the adhesive to adhere and is thus considered an opposing resealing element).
Regarding claim 4, Imai teaches the invention as discussed above in claim 2. Additionally, Imai teaches wherein the portion of catheter is arranged between the opposing resealing elements to obstruct the resealing arrangement (when tube 4 is partially removed from the packaging material 15, as shown in Figs. 1 and 2, the tube 4 will obstruct the resealing arrangement as a portion of the tube 4 will extend outside the opening 17 and will interfere with the lid 20 closing the opening 17; see also para. [0102]).
Regarding claim 5, Imai teaches the invention as discussed above in claim 2. Additionally, Imai teaches wherein the portion of the catheter is arranged adjacent to the opposing resealing elements to obstruct the resealing arrangement (as shown in Figs. 1-2, the catheter 4 is arranged adjacent the resealing elements and obstructs the resealing arrangement when tube 4 is partially removed from the packaging material 15, as shown in Figs. 1 and 2).
Regarding claim 7, Imai teaches the invention as discussed above in claim 1. Additionally, Imai teaches wherein the portion of the catheter extends across at least 50% of the height of the resealing arrangement (as shown in Fig. 2, tube 4 extends across at least 50% of the height of lid 20).
Regarding claim 8, Imai teaches the invention as discussed above in claim 1. Additionally, Imai teaches wherein the resealing arrangement comprises a strip of adhesive (para. [0118] teaches that the lid 20 comprises an adhesive; as broadly recited, the area on lid 20 on which the adhesive would be placed, peripheral to adhesive layer 22, is considered a strip since lid 20 as a whole can be considered a strip) arranged adjacent the openable edge on one wall in order to reseal it by engagement with an opposing wall (as taught by para. [0118], the lid 20 comprises an adhesive, therefore, when the lid 20 is placed over opening 17, the lid 20 will reseal the packaging material 15); preferably wherein the portion of the catheter is arranged between the strip of adhesive and the region of the opposing wall that opposes the strip of adhesive (see for example Figs. 1-2).
Regarding claim 9, Imai teaches the invention as discussed above in claim 1. Additionally, Imai teaches wherein the portion of the catheter extends over at least 90% of the height of the interior of the pouch, and/or at least 90% of the distance from the base of the interior of the pouch to the top of the resealing arrangement (see at least Fig. 2).
Regarding claim 10, Imai teaches the invention as discussed above in claim 1. Additionally, Imai teaches wherein the portion of the catheter obstructs the resealing arrangement such that it is not fully closed before use (when tube 4 is partially removed from the packaging material 15, as shown in Figs. 1 and 2, the tube 4 will obstruct the resealing arrangement as a portion of the tube 4 will extend outside the opening 17 and will interfere with the lid 20 closing the opening 17; see also para. [0102]); preferably wherein the portion of the catheter obstructs the resealing arrangement such that it is at least at least 50%, unsealed before use (this can be accomplished, for example, if the tube 4 is sufficiently located outside opening 17 such it interferes with lid 20 being placed on opening 17).
Regarding claim 11, Imai teaches the invention as discussed above in claim 1. Additionally, Imai teaches wherein the catheter is formed of a resilient material (as broadly recited, any material has a certain degree of resilience, therefore, tube 4 is a resilient material; additionally, para. [0053] teaches that a needle tube 43 is included with tube 4, which is made of metal, which is resilient), and urged against the base of the pouch and towards the top of the pouch (see for example Figs. 1-2 showing tube 4 being urged towards the opening 17).
Regarding claim 12, Imai teaches the invention as discussed above in claim 1. Additionally, Imai teaches wherein the portion of the catheter extends into a region between the openable edge and the resealing arrangement (see for example Figs. 1-2 showing a portion of tube 4 extending between opening 17 and lid 20).
Regarding claim 13, Imai teaches the invention as discussed above in claim 12. Additionally, Imai teaches wherein the pouch has a construction comprising a body (see packing material body 16 in Figs. 1-2), in which the majority of the catheter assembly, and optionally a container of wetting fluid is located, the resealing arrangement and the region between the openable edge and the resealing arrangement, with the portion of the catheter which obstructs closure of the resealing arrangement before use extending all the way to the region between the resealing arrangement and the openable edge (when tube 4 is partially removed from the packaging material 15, as shown in Figs. 1 and 2, tube 4 will extend between opening 17 and lid 20).
Regarding claim 14, Imai teaches the invention as discussed above in claim 1. Additionally, Imai teaches wherein the portion of catheter that is arranged to obstruct the resealing arrangement is the distal end of the catheter (when a distal end of tube 4 is partially removed from the packaging material 15, as shown in Figs. 1 and 2, the distal end of tube 4 will obstruct the resealing arrangement as a portion of the tube 4 will extend outside the opening 17 and will interfere with the lid 20 closing the opening 17; see also para. [0102]).
Regarding claim 18, Imai teaches the invention as discussed above in claim 1. Additionally, Imai teaches wherein the catheter is a closed-catheter assembly (see for example Fig. 3), with a catheter tube attached to a fluid collection bag (see bag body 30 at least in Fig. 2 and para. [0050]), and wherein the fluid collection bag is arranged to obstruct the resealing arrangement (for example when bag body 30 is located outside opening 17, such as in Fig. 2, the bag body 30 will obstruct the lid 20).
Regarding claim 19, Imai teaches the invention as discussed above in claim 1. Additionally, Imai teaches further comprising a tear-away region at the openable edge of the pouch (see perforations 18 in Figs. 1-2 and para. [0113]), wherein the tear away region is configured to open the openable edge (para. [0113] teaches that the perforations 18 permit expansion of opening 17 by breaking the perforations 18) and thereby break the sterile seal (para. [0018] teaches that when the perforations 18 are not broken, outside air is prevented from entering the packaging material 15).
Regarding claim 22, Imai teaches the invention as discussed above in claim 1. Additionally, Imai teaches the pouch having a pair of lateral edges, a top and an opposing base (see Figs. 1-2); wherein the base protrudes downwards beyond the point where it meets the lateral edges (as shown in Figs. 1-2, the packaging material 15 has a base that extends below the lateral edges).
Regarding claim 23, Imai teaches A method of forming a packaged catheter assembly (see at least Fig. 1 and Abstract) comprising a catheter (see tube 4 in Fig. 1) arranged within a sterile (see at least para. [0006]) sealed pouch (see packaging material 15 at least in Fig. 1); method comprising
forming a pouch (see Fig. 1) having an openable top (see opening 17 at least in Fig. 1);
providing a resealing arrangement (see lid 20 at least in Fig. 1) proximal the openable top (see Fig. 1) for resealing the pouch after use (para. [0102] teaches that the lid 20 closes the opening 17; therefore, lid 20 reseals the opening 17 after use);
arranging a portion of the catheter (see at least Fig. 1) so as to obstruct the resealing arrangement when the pouch is sealed with the sterile seal (when tube 4 is partially removed from the packaging material 15, as shown in Figs. 1 and 2, the tube 4 will obstruct the resealing arrangement as a portion of the tube 4 will extend outside the opening 17 and will interfere with the lid 20 closing the opening 17; see also para. [0102]); and
sealing (accomplished by placing lid 20 on opening 17; see para. [0102]) and sterilising the pouch (see at least para. [0006]).
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.
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.
Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Imai (U.S. Pre Grant Pub. No. 2009/0187117 A1) in view of Thorne, Jr. (U.S. Pre Grant Pub. No. 2009/0194453 A1)
Regarding claim 3, Imai teaches the invention as discussed above in claim 2. However, Imai fails to explicitly teach that the opposing resealing elements are opposing strips, which engage to reseal the pouch, as required by the claim.
Thorne, Jr. teaches an analogous packaged catheter assembly (see Abstract) comprising a catheter (see syringe 30 in Fig. 15) within a resealable pouch (see bag 280 in Fig. 15 and para. [0130]) and a resealing arrangement (see section 296 in Fig. 15). Additionally, Thorne, Jr. teaches wherein the opposing resealing elements are opposing strips, which engage to reseal the pouch (para. [0133] teaches that section 296 has a pair of conforming sides which may be zipped together to provide a resealed bag 280 after each use).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Imai to incorporate the teachings of Thorne, Jr. by including opposing strips which engage to reseal the pouch at least in order to provide protection for items during transit, as taught by Thorne, Jr. (see para. [0133]). Additionally, one of ordinary skill in the art would have been motivated to include opposing strips which engage to reseal the pouch at least because the inclusion of opposing strips will result in a better seal.
Regarding claim 16, Imai teaches the invention as discussed above in claim 2. However, Imai fails to explicitly teach wherein the portion of catheter that is arranged to obstruct the resealing arrangement is a gripping element comprising a handling tube extending around part of the catheter tube and moveable along the length of the catheter tube, as required by the claim.
Thorne, Jr. teaches a clip 70 that provides a handle or grip (see para. [0108]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Imai to incorporate the teachings of Thorne, Jr. by including a gripping element comprising a handling tube extending around part of the catheter tube and moveable along the length of the catheter tube at least in order for a user to be able to grip the catheter, as taught by Thorne, Jr. (see para. [0108]), for better manipulation of the catheter.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Imai (U.S. Pre Grant Pub. No. 2009/0187117 A1) in view of Bockol (U.S. Pre Grant Pub. No. 2014/0213981).
Regarding claim 6, Imai teaches the invention as discussed above in claim 2. However, Imai fails to explicitly teach wherein the opposing resealing elements comprise complementary attachment features on their opposing surfaces which interlock to reseal, as required by the claim.
Bockol teaches an analogous resealable bag for medial use (see Abstract) comprising an enclosure bag 320 (see Fig. 16 and para. [0074]) having opposing resealing elements comprising complementary attachment features on their opposing surfaces which interlock to reseal (para. [0075] teaches that the resealable closure 425 comprises connectable edges 426); preferably wherein the opposing resealing elements are opposing resealing strips having a tongue and groove arrangement (para. [0075] teaches that the resealable closure 425 can be a ZIPLOCK type seal/closure, which is a tongue and groove arrangement).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Imai to incorporate the teachings of Bockol by making the opposing resealing elements comprise complementary attachment features on their opposing surfaces which interlock to reseal and which preferably comprises opposing resealing strips having a tongue and groove arrangement at least in order for the pouch to be configured to repeatedly open and close, as taught by Bockol (see para. [0074]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Imai (U.S. Pre Grant Pub. No. 2009/0187117 A1) in view of Kearns (U.S. Patent No. 9,649,472 B2).
Regarding claim 15, Imai teaches the invention as discussed above in claim 14. However, Imai fails to explicitly teach wherein the portion of the catheter that is arranged to obstruct the resealing arrangement is a funnel, as required by the claim.
Kearns teaches an analogous catheter and package combination (see Abstract) comprising a catheter 12 that has a drainage member 28 which may be a funnel (see col. 4, lines 42-49).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Imai to incorporate the teachings of Kearns by including a funnel on the catheter at least in order to increase the cross-sectional area of the tip of the catheter which may help prevent leakage of fluid (see Fig. 4 of Kearns). Additionally, by including a funnel on a portion of the catheter, the resealing arrangement will necessarily be obstructed when the catheter is removed through opening 17 of pouch of Imai (see Figs. 1-2).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Imai (U.S. Pre Grant Pub. No. 2009/0187117 A1) in view of Lloyd (U.S. Pre Grant Pub. No. 2013/0318922 A1).
Regarding claim 20, Imai teaches the invention as discussed above in claim 1. However, Imai fails to explicitly teach wherein a lateral join is provided, extending inwardly from a major edge, obscuring visibility of and restricting access to the container of wetting fluid, as required by the claim.
Lloyd teaches an analogous packaged catheter assembly (see Abstract) comprising a pouch (see receptacle 110 in Figs. 1A-C) and a catheter (see canula C in Fig. 1C). Lloyd further teaches that the receptacle 110 is at least partially made of a mesh fabric that allows the contents of receptacle 110 to be at least partially visible (see para. [0015] and Figs. 1A-C; as broadly recited, the mesh fabric is considered to be a lateral join since the mesh extends laterally across receptacle 110).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Imai to incorporate the teachings of Lloyd by partially making the pouch out of a mesh fabric at least in order to reduce the likelihood of snagging or catching the catheter, as taught by Lloyd (see para. [0015]). Additionally, since no container of wetting fluid was claimed, the mesh fabric restricts access to the container of wetting fluid at least since it is not provided with the invention.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Imai (U.S. Pre Grant Pub. No. 2009/0187117 A1) in view of Gustavsson (U.S. Pre Grant Pub. No. 2015/0001107 A1).
Regarding claim 21, Imai teaches the invention as discussed above in claim 1. Additionally, Imai teaches wherein the pouch has a tear-away region defined proximal to an upper edge of the pouch (see region of perforations 18 in Figs. 1-2), the tear away region comprising a tear line (see perforations 18 in Figs. 1-2) between a first end and a second end of the tear-away region defining a line (as shown in Fig. 2, the perforations 18 form a tear-away region between a first end of the perforations 18 located on one side of the opening 17 and a second end of the perforations 18 located on an opposite side of the opening 17) along which the pouch may be torn to at least partially separate the tear-away region from the remainder of the pouch to form an open upper end of the pouch (see at least para. [0113]), in use; the tear-away region comprising a first interaction region defining a point of contact for a user to grasp the tear away region (a first interaction region of perforations 18 is located on one side of the opening 17); and the remainder of the pouch having a corresponding second interaction region defining a point of contact for a user to grasp the remainder of the pouch (a second interaction region of perforations 18 is located on an opposing side of the opening 17); the first and second interaction regions comprising one or more visual and/or tactile indicators (this is accomplished at least because perforations 18 are a tactile indicator), being provided at the same major edge and being separated from each other by the tear line (as broadly recited, the first and second interaction regions are located on either end of the opening 17 and are thus separated by the tear line).
However, Imai fails to explicitly teach a container of wetting fluid being arranged at the second interaction, as required by the claim.
Gustavsson teaches an analogous medical device assembly comprising a medical device and a package accommodating said medical device (see Abstract). Gustavsson further teaches a wetting fluid for activation of a surface coating of the catheter (see para. [0001]) which may be arranged in a separate compartment of the package or in a separate container being housed by the package (see para. [0016]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Imai to incorporate the teachings of Gustavsson by including a container of wetting fluid being arranged at the second interaction at least in order to provide easy, clean and efficient wetting and handling of the catheter while also providing sterile conditions, as taught by Gustavsson (see para. [0016]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kendrick (U.S. Pre Grant Pub. No. 2021/0330929 A1) – Packaging for a Medical Device
Justus (U.S. Pre Grant Pub. No. 2019/0381305 A1) - Locking Bag Forming Peripherally Inserted Central Catheter (PICC) Guard
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781
Prosecution Insights