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 .
REJECTIONS WITHDRAWN
All previous rejections are withdrawn.
REJECTIONS REPEATED
There are no rejections repeated.
NEW REJECTIONS
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 1-3 and 5-9 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, “between the medical tubing and another component” which renders claim 1 indefinite because “another component” is not defined in the claim. It is also not clear whether “another component” is the same for the monolayer tube medical tube and the multilayer medical tube. It is also not clear if the dimensions of the tubes are different or the same.
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) 1-3 and 6-9 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 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 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.
Modified Siddhamalli does not disclose the limitation, “wherein the medical tubing exhibits a bond strength between the medical tubing and another component that is at least 25% higher relative to a corresponding bond strength of a medical tube comprised of a monolayer of the thermoplastic polymer.” However, said limitation is provided upon the combination of Siddhamalli and Ishikawa since Siddhamalli and Ishikawa disclose the same structure and materials for the individual layers recited by applicant (see above). It would have been obvious to have provided applicant’s recited bond strength in order to provide Improved overall adhesion (see column 3, lines 26-36 of Ishikawa).
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(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 Ishikawa et al. (US 5,908,656), as applied to claims 1-3 and 6-9 above, and further 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.
ANSWERS TO APPLICANT’S ARGUMENTS
Applicant’s arguments of 8/7/26 have been carefully considered but are deemed unpersuasive. Applicant’s arguments with regards to the 102 rejection are moot since the rejection has been withdrawn.
Applicant argues, “Regarding the indication in claim 1 that the inner layer ‘comprises a polyolefin consisting of a maleic anhydride modified polyethylene, a maleic anhydride modified polypropylene, or a combination thereof’, the Office Action expressly acknowledges on page 5 in a discussion of claim 4 that Siddhamalli et al. does not disclose this subject matter. However, in an attempt to overcome this shortcoming, the Office Action cites column 3, lines 25-26, column 3, line 62 through column 4, line 45, and Inventive Example 1 of Ishikawa et al. and asserts it teaches ‘an inner layer consisting of a maleic anhydride in a catheter for the purpose of improved adhesion between layers and/or improved lubricity.’ Based on these asserted teachings, the Office Action goes on to assert on page 5 that it would have been obvious to modify Siddhamalli et al. such that the inner layer thereof consists of a maleic anhydride modified polyethylene, a maleic anhydride modified polypropylene, or a combination thereof ‘in order to provide improved adhesion between layers and/or improved lubricity as taught or suggested by Ishikawa.’
Notably, Ishikawa relates to improving adhesion between inner and outer polymer layers, and does not recognize or suggest improving bond strength between medical tubing and an external component. Even further, both Siddhamalli et al. and Ishikawa are silent as to any relationship between an inner layer (which comprises ‘a polyolefin consisting of a maleic anhydride modified polyethylene, a maleic anhydride modified polypropylene, or a combination thereof’) and an outer layer (which comprises a thermoplastic polymer as defined in claim 1), and ‘a bond strength between the medical tubing and another component that is at least 25% higher relative to a corresponding bond strength of a medical tube comprised of a monolayer of the thermoplastic polymer.’”
In response to applicant's argument that neither reference contemplates improved adhesion between the medical tube and another component, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The prior art does not need to solve the same problem as applicant (MPEP 2144).
Applicant argues, “Applicant notes that medical tubing in accordance with claim 1 (PE1 Lined TPU2 & PE2 Lined TPU2 from Table 6 of the subject application for example) exhibited a 100% and 91%, respectively, higher bond strength with another component relative to a medical tube (Mono-TPU2 from Table 6 of the subject application) comprised of a monolayer of the thermoplastic polymer from PE1 Lined TPU2 & PE2 Lined TPU2. Further details relating to these results are provided in paragraphs [0053]-[0058] and Figure 4 of the subject application. The improvement in bond strength is attributable to the specific combination of the inner layer and outer layer, rather than the outer layer material alone, as demonstrated by comparison to the monolayer control.”
The examples referred to by applicant describe specific polyolefins (polyethylene) and TPU’s which are not recited in claim 1.
Applicant argues, “Further, neither Siddhamalli et al. nor Ishikawa identifies deficient bonding between tubing and external components as a problem, and thus neither reference provides any motivation for a person of ordinary skill in the art to modify the inner layer composition of Siddhamalli et al. based on Ishikawa. Moreover, even assuming for the sake of argument only that the suggested modification of Siddhamalli et al. was undertaken, there is no teaching or reasonable expectation that altering the inner layer in the manner proposed would result in improved bond strength at the outer surface of the tubing-i.e., at the interface with the external component-particularly given that Ishikawa is concerned with adhesion between internal polymer layers. Indeed, such a result is counterintuitive, as a person of ordinary skill in the art would have expected bond strength to be governed primarily by the outer layer material, not by the composition of the inner layer.”
In response to applicant's argument that neither reference contemplates improved adhesion between the medical tube and another component, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The prior art does not need to solve the same problem as applicant (MPEP 2144).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Aaron Austin can be reached at 571-272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL C MIGGINS/Primary Examiner, Art Unit 1782
MCM
August 23, 2026
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