CTNF 18/897,922 CTNF 95453 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim s 1-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Edelhauser et al (WO 2016205779 A2, hereinafter Edelhauser) . Regarding Claim 1 , Edelhauser discloses a closure (See Fig. 7A) for a biological fluid collection device (See Fig. 6; “Figs. 1-6 illustrate an exemplary embodiment of a biological fluid collection device”, [0066]) , comprising: a cap (Element 140, Fig. 6) having a first cap end (See the left end of element 140, Fig. 7A( , a second cap end (See the end of element 140 closer to element 142, Fig. 7A) , and defining a cap channel therein (See Fig. 6; the inside of element 140 where elements 142, 144, and 16 are, Figs. 7A and 7C) , the cap having a pierceable self-sealing stopper (Element 142, Fig. 7A) positioned within a portion of the cap channel (See Fig. 6) ; and an adapter (Element 144, Fig. 7A) having a first adapter end, a second adapter end, and defining an adapter channel extending between the first adapter end and the second adapter end (See Fig. 7A; element 144 has a channel extending between both a first and second end) , the second cap end joined with the first adapter end (See Figs. 6-7C) , and wherein the closure is connectable to a first blood collection device (Element 200, Figs. 8-9) via the first cap end of the cap (See Fig. 9) . Edelhauser discloses the claimed invention except for expressly disclosing wherein the cap and the adapter are formed as a single integral component, with the second cap end joined with the first adapter end. However, it has been held that making separate components integral would be merely a matter of obvious engineering choice unless such a modification would be contrary to the understandings and expectations of the art. See In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965), In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965), and MPEP 2144.04(V)(B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Edelhauser and make the cap and adapter a single integral component (with the stopper remaining a separate component). Regarding Claim 2 , modified Edelhauser discloses the closure of claim 1, wherein the stopper is a separate component from the single integral component of the cap and the adapter (See Figs. 6 and 7A) . Regarding Claim 3 , modified Edelhouser discloses the closure of claim 2. Modified Edelhauser discloses the claimed invention except for expressly disclosing wherein the stopper is snap-fit into engagement with the cap within the cap channel. However, Edelhauser discloses different elements snap fit into engagement (“For example, the connection portions 40, 42, 92, 94 of the upper and lower housing 20, 22 may include a threaded portion, snap fit mechanism, a ball detent, locking tabs, spring loaded locking mechanism, latch, adhesive, or other similar connection mechanism”, [0075]) . It has been held that optimizations within prior art conditions or through routine experimentation is obvious. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II). Snap-fit mechanisms are well-known in arts of removably coupling elements together. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Edelhauser wherein the stopper is snap-fit into engagement with the cap within the cap channel. Regarding Claim 4 , modified Edelhauser discloses the closure of claim 3, wherein the stopper comprises a cylindrical stopper (See Figs. 6 and 7A) . Regarding Claim 7 , modified Edelhauser discloses the closure of claim 1. Modified Edelhauser discloses the claimed invention except for expressly disclosing wherein the stopper is integrally formed with the single integral component of the cap and the adapter. However, it has been held that making separate components integral would be merely a matter of obvious engineering choice unless such a modification would be contrary to the understandings and expectations of the art. See In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965), In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965), and MPEP 2144.04(V)(B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Edelhauser wherein the stopper is integrally formed with the single integral component of the cap and the adapter . 07-21-aia AIA Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Edelhauser in view of Rogers et al (US 20210361207 A1, hereinafter Rogers) . Regarding Claim 5 , modified Edelhauser discloses the closure of claim 3. Modified Edelhauser discloses the claimed invention except for expressly disclosing wherein the stopper comprises a spherical stopper. However, Rogers, which also discloses a biological fluid collection device (“A fluid sample optimization device for optimizing a fluid sample collected by a fluid collection device from a fluid source”, Abstract) teaches a spherical stopper (Element 3402, Figs. 34A-34C; “FIGS. 34A-34C illustrate various alternative implementations of a displaceable plug or stopper, shown in the form of a ball or rounded object”, [0053]; [0195]) . It has been held that changes in the shape of apparatus elements is obvious absent persuasive evidence that the particular configuration of an element is significant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) and MPEP 2144.04(IV)(B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Edelhauser by making the stopper a spherical stopper . 07-21-aia AIA Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Edelhauser in view of Karam et al (JP 2017522241 A, hereinafter Karam; an attached machine translation was relied upon for this rejection) . Regarding Claim 6 , modified Edelhauser discloses the closure of claim 2. Modified Edelhauser discloses the claimed invention except for expressly disclosing wherein the stopper and the single integral component of the cap and the adapter are formed via a two-shot molding process, with the cap and the adapter formed of a hard plastic and the stopper formed of a thermoplastic elastomer. However, Karam, which also discloses a closure (See Abstract) for a biological fluid collection device (“The container can have a closed bottom 14, an open top portion 16, and a sidewall 18 extending therebetween, defining a chamber 19 for receiving a biological specimen therein”, page 3) , teaches wherein the stopper and the cap are formed via a two-shot molding process (“The closure according to claim 1, wherein the cap body and the stopper are formed by a two-shot molding process”, page 8) , with the cap formed of a hard plastic (“Suitable materials for the cap body 20 include, but are not limited to, polypropylene, polyvinyl chloride, polyethylene, and the like. According to one embodiment, the cap body 20 may be formed from high density polyethylene (HDPE)”, page 4) and the stopper formed of a thermoplastic elastomer (“The stopper 30 can be formed from any known thermoplastic elastomer”, page 4) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the stopper and single integral component of the cap and the adapter already in modified Edelhauser such that the stopper and the single integral component of the cap and the adapter are formed via a two-shot molding process, with the cap and the adapter formed of a hard plastic and the stopper formed of a thermoplastic elastomer, as suggested by Karam, because all of the claimed elements (i.e. caps formed of hard plastic, stoppers formed of thermoplastic elastomers, and two-shot molding processes) were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art . 07-21-aia AIA Claim 8 is are rejected under 35 U.S.C. 103 as being unpatentable over Edelhauser in view of Rogers, and further in view of Dykes et al (US 20080025872 A1, hereinafter Dykes) . Regarding Claim 8 , modified Edelhauser discloses the closure of claim 7. Modified Edelhauser discloses the claimed invention except for expressly disclosing wherein the integrally formed stopper, cap and adapter are formed in a one-shot molding process and formed of a thermoplastic elastomer. However, Dykes, which is also directed towards a biological fluid collection device (See Abstract) and a closure for a biological fluid collection device (Element 203, Figs. 1-2; “This analyzer 200 includes an insertion bay 201 with pivoting and latching closure 203 for seating and sealing of the sampling device 100”, [0042]) , teaches wherein the integrally formed stopper, and cap are formed in a one-shot molding process (“The sampling device 100 may be manufactured by one-shot molding”, [0055]) and formed of a thermoplastic elastomer (“The entirety of sampling device 100 may be molded of Pebax.TM. rubber by Atofina Co., or any other flexible elastomer”, [0045]; thermoplastic elastomers are a kind of flexible elastomer) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the integrally formed stopper, and cap already in modified Edelhauser such that the integrally formed stopper, cap and adapter are formed in a one-shot molding process and formed of a thermoplastic elastomer, as suggested by Dykes, because all of the claimed elements (i.e. caps and stoppers formed of thermoplastic elastomers, and one-shot molding processes) were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Grams et al (US 3771965 A) See Savitz et al (US 20020023892 A1) See Sha et al (US 20030235519 A1) See Karam et al (US 20160039578 A1) See Eberhart et al (US 20170002399 A1) See Giraud (EP 1806294 A1). Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN EPHRAIM COOPER whose telephone number is (571)272-2860. The examiner can normally be reached Monday-Friday 7:30AM-5:30PM EST. 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, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JONATHAN E. COOPER/Examiner, Art Unit 3791 /JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791 Application/Control Number: 18/897,922 Page 2 Art Unit: 3791 Application/Control Number: 18/897,922 Page 3 Art Unit: 3791 Application/Control Number: 18/897,922 Page 4 Art Unit: 3791 Application/Control Number: 18/897,922 Page 5 Art Unit: 3791 Application/Control Number: 18/897,922 Page 6 Art Unit: 3791 Application/Control Number: 18/897,922 Page 7 Art Unit: 3791
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