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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-9 in the reply filed on 2/13/26 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/13/26.
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 1-9 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.
Claim 1 recites the limitation, “wherein the medical tubing has a bond strength that is at least 25% higher relative to a medical tube comprised of a monolayer of the thermoplastic polymer” which renders claim 1 indefinite because it is not clear what “bond strength” refers to. Is applicant referring to chemical bonds within a layer or between layers? It is also unclear how one of ordinary skill in the art could have improved bond strength between layers if the tube is a monolayer. For purposes of examination, said limitation has been interpreted as improved bond strength between layers.
Claim Rejections - 35 USC § 102
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) 1-3 and 6-9 is/are rejected under 35 U.S.C. 102(a1) as being anticipated by Siddhamalli et al. (US 2014/0037880, cited by applicant).
Siddhamalli discloses medical tubing comprising a continuous inner layer having a continuous outer layer thereon; wherein the inner layer comprises a polyolefin;
wherein the outer layer comprises a thermoplastic polymer selected among a
thermoplastic polyurethane (TPU), a thermoplastic olefin (TPO), a thermoplastic elastomer (TPE), a styrene-containing thermoplastic elastomer (S-TPE), a polyolefin elastomer (POE), a styrenic blocking copolymer (SBC) (paragraphs [0003], [0018], [0031-0033], [0043], [0050]).
Siddhamalli does not disclose the limitation, “wherein the medical tubing has a bond strength that is at least 25% higher relative to a medical tube comprised of a monolayer of the thermoplastic polymer.” However, said limitation is inherent in Siddhamalli since Siddhamalli discloses the same structure and materials for the individual layers recited by applicant (see above). Something which is old does not become patentable upon the discovery of a new property (MPEP 2112 (I)).
Siddhamalli also discloses wherein the inner layer consists of the
polyolefin and the outer layer consists of a thermoplastic polymer, wherein the polyolefin consists of a polyethylene or a polypropylene, wherein the thermoplastic polymer is one
or more of, or a blend including a styrene-containing thermoplastic elastomer (S-TPE), a
polyolefin elastomer (POE), a styrenic blocking copolymer (SBC), wherein the outer layer and inner layer do not include polyvinyl chloride (since PVC is not used), wherein the inner layer directly contacts the outer layer, wherein the medical tubing has a Shore A hardness of less than about 65 (paragraphs [0003], [0018], [0031-0033], [0043], [0050]).
Claim Rejections - 35 USC § 103
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siddhamalli et al. (US 2014/0037880, cited by applicant) in view of Ishikawa et al. (US 5,908,656).
Siddhamalli does not disclose wherein the polyolefin consists of a maleic
anhydride modified polyethylene, a maleic anhydride modified polypropylene, or a combination thereof.
Ishikawa discloses an inner layer consisting of a maleic anhydride in a catheter for the purpose of provided improved adhesion between layers and/or improved lubricity (column 3, lines 25-36, column 3, line 62 through column 4, lines 45, Inventive Example 1).
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided wherein the inner layer consists of a maleic anhydride modified polyethylene, a maleic anhydride modified polypropylene, or a combination thereof in Siddhamalli in order to provide improved adhesion between layers and/or improved lubricity as taught or suggested by Ishikawa.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siddhamalli et al. (US 2014/0037880, cited by applicant) in view of McShane et al. (US 2023/0405294).
Siddhamalli does not disclose wherein the thermoplastic polymer consists
of a thermoplastic urethane.
McShane discloses an outer layer which is a thermoplastic urethane in medical tubing for the purpose or providing secure bonding to fitments during post tube manufacturing operations (paragraphs [0001], [0011-0016]).
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided an outer layer which consists of a thermoplastic urethane in Siddhamalli in order to provide secure bonding to fitments during post tube manufacturing operations as taught or suggested by McShane.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL C MIGGINS whose telephone number is (571)272-1494. The examiner can normally be reached Monday-Friday, 1-9 pm EST.
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/MICHAEL C MIGGINS/Primary Examiner, Art Unit 1782
MCM
March 16, 2026