DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on 12/4/2025 has been entered.
Election/Restrictions
Applicant’s election without traverse of species of claim 1 in the reply filed on 12/4/2025 is acknowledged. Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/4/2025.
Response to Amendment
The amendment of claim 1 is supported by the specification. The new claim 27 is supported by the specification.
Any rejections and/or objections made in the previous Office action and not repeated below are hereby withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Objections
Claim 1 objected to because of the following informalities: the claim status identifier is incorrect. Appropriate correction is required.
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 1-2, 6-9, 11-13, 16, 22, 27 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 pre-AIA the applicant regards as the invention.
Claim 1 recites “a total amount of xylene soluble”, which is a measurement to determine the crystallinity. A crystallinity depends on the cooling rate, i.e. sample preparation condition. A slower cooling rate allows more time for polymer chains to re-organize into a crystalline structure, resulting in a higher degree of crystallinity. Conversely, a faster cooling rate gives the chains less time to organize, which leads to a lower degree of crystallinity and a larger amorphous (non-crystalline) phase. Therefore, the value of xylene soluble is an extrinsic property which depends on the cooling rate. A xylene soluble value without reciting a sample preparation condition is not meaningful from a scientific point of view and has no patentable weight.
Claim Rejections - 35 USC § 103
Claim(s) 1-2, 6-9, 11-13, 16, 22, 27 is/are rejected under 35 U.S.C. 103 as obvious over Wang et al (US 2021/0214478) and in view of King, III (US 2002/0086924) and Ko et al (US 5,738,923) and Wang et al (US 2017/0158788, hereafter ‘788).
Wang teaches a medical article made from a composition comprising 70-99.9 wt% of a random propylene-ethylene copolymer, UV stabilizers and antioxidants, alpha-nucleating agents (i.e. a clarifier additive) [0020-0027, 0034, 0224]. The copolymer has an ethylene content of 2-4.8wt%, a xylene soluble below 10wt%.
Wang does not teach the details of antioxidants.
However, King teaches a phenol-free stabilizer system effective towards protecting polyolefins against the deleterious effects of gamma irradiation which is used to sterilize medical articles. The stabilizer system can be a mixture of Tinuvin 622, Irgafos 168 and FS-042 (table 3, example G, claim 19). The amount of the hindered amine can be 0.05-5 wt% [0034]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize a stabilizer system of King in the composition of Wang to protect polyolefins against the deleterious effects of gamma irradiation.
Wang does not teach the composition comprises less than 150 ppm of phthalates.
However, Ko teaches medical articles preferably contain no phthalate to leach into pharmaceutical fluids (6:10-16). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize a phthalate-free polyolefin for a medical article.
Wang does not teach the molecular weight distribution of the random propylene ethylene copolymer.
However, Wang teaches the random copolymer is preferably prepared by a sequential polymerization process in the presence of a metallocene catalyst [0062]. Polymer prepared by metallocene sequential polymerization process has a broader molecular weight distribution than metallocene single stage process, the latter typically exhibits an Mw/Mn in the range of about 1.8-2.5. ‘788 teaches a medical article made from a composition comprising a random propylene-ethylene copolymer, antioxidants, and alpha-nucleating agents (i.e. a clarifier additive) [0007, 0045, 0068]. The copolymer has a Mw/Mn of 2.5-6.5 [0040], overlapping the claimed range. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to use a random propylene-ethylene copolymer having a Mw/Mn of 2.5-6.5 because it is recognized in the art that the polymer with such a feature is suitable for a medical article.
Wang is silent with respect to the claimed properties of the article. However, the combination of teachings from Wang, King and Ko have rendered obvious the instantly claimed ingredients and amounts thereof. Therefore, it is reasonable that one of ordinary skill in the art would expect the claimed physical properties to naturally arise.
Claim 27: aTREF separates polymer fractions based on crystallizability. In propylene-ethylene copolymer, ethylene incorporation disrupts PP crystallinity; when the more PP-like sequences, the more elute at higher temperatures, when the more defects, the more elutes at lower temperature. Wang use metallocene catalyst to polymerize the copolymer, which is a single-site catalyst and results in uniform ethylene incorporation, less PP-rich sequences, and homogeneous crystallizability. Therefore, the aTREF curve from the metallocene P-E copolymer has a narrow, symmetric peak and much smaller or absent high temperature fraction when compared to Ziegler-Natta copolymer. Therefore, the claimed high temperature fraction T-120°C of at most 5% is expected from the copolymer of Wang.
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground(s) of rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WENWEN CAI whose telephone number is (571)270-3590. The examiner can normally be reached on M-F 9am-6pm.
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, Joseph Del Sole can be reached on (571)272-1130. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WENWEN CAI/
Primary Examiner, Art Unit 1763