DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8 and 10-17 in the reply filed on June 25, 2026 is acknowledged.
Claim Objections
Claim 1 is objected to because of the following informalities: In line 8, the phrase “are selected to” is superfluous and may be deleted.
Claim 17 is objected to because of the following informalities: Since drug names are generic, please remove capitalization on all elements of the Markush group, i.e., replace “Aldesleukin” with “aldeslukin”.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
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 1-6, 8, 12-13, and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sevinc et al. (US 12,649,017).
Table 1 of Sevinc et al. discloses material formulations for construction of medical tubing for an IV set. The inner layer comprises an ethylene-octene copolymer, commercially available as Exxelor VA1840, that has an elongation at break ranging from 400 % to over 600 % (ASTM D638). The outer layer comprises a thermoplastic polyurethane elastomer, commercially available as Pellethan 2362-80A having an elongation at break of 550 %, or Ellastollan 1180A having an elongation at break of 600 % to 650 %. In one embodiment, the outer layer comprises a sytrenic block copolymer (SBC) which is blended with a polyolefin to improve kink resistance (col. 8, lines 1-5). One such SBC is Ineos 4G80 which has an elongation at break of greater than 500 % (Table 5). The inner layer has a thickness of about 0.1 mm to about 0.8 mm (col. 5, line 32). In one embodiment, the tubing is transparent to visible light (col. 9, line 35). The tubing is free of polyvinyl chloride.
Claims 10, 11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sevinc et al. (US 12,649,017).
The discussion of the disclosure of the prior art from the preceding paragraph is incorporated here by reference. Sevinc et al. is silent with regard to properties described in claim 10 and 11. In light of the fact that prior art tubing is substantially the same as that described in instant claims, one of ordinary skill in the art would reasonably expect prior art tubing to exhibit substantially the same features. Since the PTO cannot perform experiments, the burden is shifted to the Applicants to establish an unobviousness difference. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP § 2112-2112.02.
Inventors teach that the outer layer comprises 10 to 90 % of a side wall thickness and the inner layer comprises 90 % to 10 % of a side wall thickness. In one embodiment of tubing, the outer layer has a thickness of 0.1 mm to 0.8 mm and the inner layer has a thickness of 0.05mm to 0.2 mm. Where the tubing has an outer layer thickness of 0.8 mm, an inner layer thickness of 0.05 mm is 6 % of thickness of the outer layer.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sevinc et al. (US 12,649,017) in view of Nizuka et al. (US 2001/0021429).
One of ordinary skill in the art would have found it obvious from Nizuka et al. to include antioxidant and lubricant (slip agent) in tubing to aid in extrusion molding (paragraph [0027]).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sevinc et al. (US 12,649,017) in view of Miner et al. (US 7,722,577).
One of ordinary skill in the art would have found it obvious to use connector 16 to attach medical tubing 24 to a fluid reservoir 16 of an IV set. With respect to claim 17, intended use 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. See MPEP § 2111.02.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rip A. Lee whose telephone number is (571)272-1104. The examiner can be reached on Monday through Friday from 9:00 AM - 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Jones, can be reached at (571)270-7733. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/RIP A LEE/
Primary Examiner, Art Unit 1762
September 9, 2026
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