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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submissions filed on 09/10/2025 and 09/19/2025 have been entered.
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 12, 14, 21, 27, 28-29 and 34-35are 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.
The applicants amended the claims to recite “performing a friction force test on the polymeric recoating to test a lubricity of the polymeric recoating, wherein the lubricity is measured in grams grand average force over a 15-pull test cycle; and confirming the polymeric recoating has a lubricity within an acceptance criteria, wherein the acceptance criteria includes a grams grand average force of less than or equal to 171 grams grand average force”.
The applicants allege that the support for the newly introduced limitations is provided by [0146-149] of the specification and Table 10.
This is not persuasive.
Neither cited parts of the original disclosure, nor any other part of the original disclosure supports the newly introduced limitation for the entire scope.
Table 10 of the original disclosure clearly shows that the referenced test cycle and the grams grand average force only for the friction force test that is conducted using a friction force test system operable to provide the friction force test using a clamp force of 500 grams, a velocity of the single-use medical device through the clamps of 1 cm/second, an acceleration time of the single-use medical device of 1 second, a pull distance of 10 cm, and a sample rate of 1 sample/mm.
There is no support for the non-specified 15-pull test cycle (which is now recited by the claims) is provided by the original disclosure.
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 27-29 and 35 are 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.
The claims are indefinite because it appears that some text is missing in claim 27 in the clause “performing a friction force test the at least one polymeric recoating to test a lubricity of the at least one polymeric recoating”.
Have the applicants meant “performing a friction force test on the at least one polymeric recoating to test a lubricity of the at least one polymeric recoating”?
Allowable Subject Matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 28 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
As to claims 13 and 28:
The applicants amended the claims to recite:
“performing a friction force test on the polymeric recoating to test a lubricity of the polymeric recoating, wherein the lubricity is measured in grams grand average force over a 15-pull test cycle; and confirming the polymeric recoating has a lubricity within an acceptance criteria, wherein the acceptance criteria includes a grams grand average force of less than or equal to 171 grams grand average force” “wherein the friction force test cycle and the grams grand average force only for the friction force test that is conducted using a friction force test system operable to provide the friction force test using a clamp force of 500 grams, a velocity of the single-use medical device through the clamps of 1 cm/second, an acceleration time of the single-use medical device of 1 second, a pull distance of 10 cm, and a sample rate of 1 sample/mm.”
The prior art cited and applied in the previous Office actions is still considered to be the closest prior art with respect to the amended claims.
WO 0002613 is cited to show the state of the art with respect to catheters and method of testing.
ISO 10555-1-2013 is cited to show a conventional testing procedures for catheters.
The specifics of the test recited by the claims are not disclosed by the prior art.
The test cycle recited by the claims does not appears to be conventional in the art.
The prior art taken alone or in combination fails to teach or fairly suggest a method comprising the referenced limitations together with all other limitations recited by the claims.
Response to Arguments
Applicant's arguments filed 09/19/2025 have been fully considered but they are not persuasive.
The applicants amended the claims and allege that the claims are supported by the original disclosure.
The applicants cited [0146-149] of the specification and Table 10.
This is not persuasive.
Neither cited parts of the original disclosure, nor any other part of the original disclosure supports the newly introduced limitation for the entire scope.
Table 10 of the original disclosure clearly shows that the referenced test cycle and the grams grand average force only for the friction force test that is conducted using a friction force test system operable to provide the friction force test using a clamp force of 500 grams, a velocity of the single-use medical device through the clamps of 1 cm/second, an acceleration time of the single-use medical device of 1 second, a pull distance of 10 cm, and a sample rate of 1 sample/mm.
There is no support for the non-specified 15-pull test cycle (which is now recited by the claims) is provided by the original disclosure.
The amended claims have been examined and addressed in the rejections above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER MARKOFF whose telephone number is (571)272-1304. The examiner can normally be reached 9:00 am - 5:30 pm.
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/ALEXANDER MARKOFF/Primary Examiner, Art Unit 1711
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