DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim 1-7, 9-15, 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US Patent No. 6,012,586 to Misra in view of US Patent No. 7,789,873 to Kubalak and US 2006/0264822 to Nagamatsu.
Regarding claim 1, Misra discloses a catheter packaging system comprising a contoured surface (Fig 1) defining at least three compartments (94, 88, 78) separated by barriers (60) and a perimeter wall, the at least three compartments comprising a first compartment (94) comprising a first compartment base member, a second compartment (88) comprising a second compartment base member, a first barrier (60) separating the first compartment from the second compartment, a first syringe disposed in first compartment, a second syringe disposed in first compartment (col. 5, ll. 50-55), a catheter assembly disposed within second compartment (col. 5, ll. 25-30), the assembly comprising a catheter, a sterile specimen jar (sealed cup, col. 5, ll. 1) which can be used for capturing samples taken from a catheter (intended use). Misra does not teach the catheter being coupled to a fluid bag. However, Kubalak discloses a catheter assembly (Fig 8A) comprising a catheter couple to a fluid bag (125) by coiled tubing (20, Fig 5b). One of ordinary skill in the art would have found it obvious to substitute the catheter of Misra with the catheter taught by Kubalak in order to drain urine to the bag. Misra further does not teach the first compartment comprising a mnemonic device that orders the syringes according to their use and supporting the syringes at different heights. However, Nagamatsu discloses a tray with syringe compartments having base members of different size and depths (Fig 2) that can be used as a mnemonic device, i.e., smaller syringes to be used first. One of ordinary skill in the art would have found it obvious to change the dimensions of the syringe compartments base members as suggested by Nagamatsu in order to hold different size syringes. In particular, the size of the recesses can be used as a mnemonic device in accordance with their use during a catheterization procedure (intended use).
Regarding claim 2, Misra further discloses the first compartment (94) defining a lubricating jelly applicator in that it can be hold lubricating jelly to lubricate a portion of the catheter assembly since it has the structure as recited.
Regarding claim 3, the modified Misra further discloses first compartment comprising a base member defining a mnemonic device indicating which syringe to be used first in catherization procedure. In particular, the size of the recess in the compartment base member can indicate as such as taught by Nagamatsu.
Regarding claim 4, the modified Misra further teaches the first compartment base member defining an incline (curved incline, Nagamatsu, Fig 2) to hold syringes of different sizes.
Regarding claim 5, the modified Misra further teach non-parallel orientation of the compartment base members since Nagamatsu discloses tray (Fig 2) with syringe compartment base members defining an incline (curved incline) to hold syringes of different sizes.
Regarding claim 6, the modified Misra further teaches the first compartment (94) to support first syringe at shallower depth than second syringe (Nagamatsu, Fig 2).
Regarding claim 7, the modified Misra further teaches the first barrier (60) defining a catheter passage in that a catheter can be moved from second compartment (88) to first compartment (94) by passing the first barrier (60)
Regarding claim 9-10, the modified Misra further discloses the first compartment (94) defining a lubricating jelly applicator in that it can be hold lubricating jelly to lubricate a portion of the catheter assembly since it has the structure as recited.
Regarding claim 11, the modified Misra further discloses the compartments open alongside of the tray (top openings) opposite the base member.
Regarding claim 12, Misra discloses a catheter packaging system comprising a tray (Fig 1) having a first compartment (94) for accommodating one or more syringes and a second compartment (88) for accommodating a coiled medical device, the first compartment comprising a first compartment base member and the second compartment comprising a second compartment base member, with a barrier (60) separating the first and second compartments, a first and second syringe disposed in the first compartment (col. 5, ll. 50-55), a catheter assembly disposed in the second compartment (col. 5, ll. 25-30), the assembly comprising a catheter, a container that can hold specimen disposed within the tray (sealed cups, col. 5, ll. 1-2) for capturing patient samples taken from the catheter (intended use), the first compartment capable of supporting the first syringe at a shallower depth within the tray than the second syringe depending on how the syringe is placed within the compartment. Misra does not teach the catheter being coupled to a fluid bag. However, Kubalak discloses a catheter assembly (Fig 8A) comprising a catheter couple to a fluid bag (125) by coiled tubing (20, Fig 5b). One of ordinary skill in the art would have found it obvious to substitute the catheter of Misra with the catheter taught by Kubalak in order to drain urine to the bag. Misra further does not teach the first compartment comprising a mnemonic device. However, Nagamatsu discloses a tray with syringe compartments having base members of different size and depths (Fig 2) that can be used as a mnemonic device, i.e., smaller syringes to be used first. One of ordinary skill in the art would have found it obvious to change the dimensions of the syringe compartments base members as suggested by Nagamatsu in order to hold different size syringes. In particular, the size of the recesses can be used as a mnemonic device.
Regarding claim 13, Misra further discloses a third compartment (78) with specimen container (sealed cups) disposed in the third compartment.
Regarding claim 14, Misra further discloses the first compartment (94) defining a lubricating jelly applicator in that it can be hold lubricating jelly to lubricate a portion of the catheter assembly since it has the structure as recited.
Regarding claim 15, Misra further discloses the first compartment (94) can be used to support the first syringe at a shallower depth within the tray than the second syringe depending on how the syringe is placed.
Regarding claim 18, the modified Misra further teaches first compartment defining one or more contours for accommodating flanges (12a) of the syringes (Fig 1, Nagamatsu).
Claim 16-17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Misra in view of Kubalak, Nagamatsu and US Patent No. 4,523,679 to Paikoff et al. (Paikoff).
Regarding claims 16-17, the modified Misra teaches the system of claim 12 but does not teach printed instructions with the tray. However, Paikoff discloses incorporating printed instructions (12) with a catheter tray and one of ordinary skill in the art would have found it obvious to do the same with the Misra tray in order to indicate the nature of the package contents and origin of the package (Paikoff, col. 4, ll. 45-50). Furthermore, not that where the only different between prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, **>367 F.3d 1336, 1339,70 USPQ2d 1862, 1864 (Fed. Cir. 2004).
Response to Arguments
Applicant's arguments filed 3/30/2026 have been fully considered but they are not persuasive. Applicant argues that Misra does not teaches a contoured surface defining at least three compartments because element 94 is not a compartment formed by the tray/contoured surface. However, the claims only require that the contoured surface defines at least three compartments and does not require the compartments to be formed by the tray/contoured surface. Applicant further argues that Misra is directed to an angiographic medical procedure kit and not a urinary catherrization/tray packaging system. This is not persuasive because Misra does not limit the medical procedure to be only performing angiographic and can be used for other medical procedures such as catheterization (abstract).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., catheter passage and/or jelly-applicator architecture) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that prior art does not teach a tray/barrier/applicator architecture, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., opening/channel through the barrier) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that Misra does not teach a lubrication workflow in which a syringe dispenses lubricant into a compartment and the catheter is passed through that lubricant during cross-compartment transit, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT POON whose telephone number is (571)270-7425. The examiner can normally be reached Monday thru Friday, 8:30 am to 6:00 pm.
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, Anthony Stashick can be reached at (571)272-4561. 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.
/ROBERT POON/Examiner, Art Unit 3735
Prosecution Insights