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 .
The instant application is a continuation of 16/134,225 (now US 12,016,750). Therein was a restriction amongst five species. The original claims herein (independent claims 1 and 8) were directed to species I (figures 6-9). Applicant is reminded of 37 CFR 1.145 regarding subsequent presentation of claims for different inventions; commonly referred to as election by original presentation. MPEP 821.03.
The claims received 6/12/2026 are entered. Claims 1-13 and 29-30 are cancelled and claims 14-28 are all previously presented.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 14-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,016,750. Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims include all features of the identified instant claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 14-15 and 17-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wiesman (US 6,230,515).
Regarding claim 14, Wiesman discloses a bodily fluid transport unit, comprising:
an elongated housing (100), the elongated housing includes a bottom portion, a top portion, a first end portion and a second end portion (top, bottom, and two ends ports shown in cross section of figure 1);
the first end portion includes a first passageway;
the second end portion includes a second passageway, the second passageway providing a different shape than a shape of the first passageway (figures 3 and 4 show two passageways axially aligned and of different shapes).
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Regarding claim 15, Wiesman further discloses the first passageway is a u-shape passageway (as identified in the annotated figure above the u-shape is formed by two parallel vertical portions connected at their bottom).
Regarding claim 17, Wiesman discloses the first passageway extends along a first length of the elongated housing (the first passageway, identified in annotated figure above, extends along a length of the housing).
Regarding claim 18, Wiesman discloses the second passageway extends along a second length of the elongated housing, distinct from the first length (the second passageway, identified in annotated figure above, extends along a length of the housing distinct from the first passageway).
Regarding claim 19, Wiesman discloses the top portion is open along the second length (as shown in at least figure 2 the top portion of the housing is open along the length).
Regarding claim 20, Wiesman discloses the top portion is closed along the first length (with the lid in place the top portion is closed).
Regarding claim 21, Wiesman discloses a bodily fluid transport unit, comprising:
a container (100) having a top surface (100e), the top surface includes a ridge (ridge inward of 114) circumferentially surrounding a chamber of the container, the container includes a groove (114) circumferentially surrounding the ridge, an outer edge of top surface of the container surround the groove; and
a lid (102), the lid includes a bottom surface, the bottom surface has a ridge (116) that is sized and located to extend into the groove of the container, the lid further includes a step circumferentially surrounding the ridge of the lid and bears against the top surface of the container (shown in figure 1).
Regarding claim 22, Wiesman discloses the ridge of container is sized and located to fit tightly against an inside surface of ridge of the lid (as shown in figure 1 the fit between lid and container is gapless and thus is a tight fit).
Regarding claim 23, Wiesman discloses a mating of the container and the lid results in a chamber of the container being air-tight and moisture tight (6:10-12).
Regarding claim 24, Wiesman discloses the container is composed of rigid foamed plastic (16:31-33).
Regarding claim 25, Wiesman discloses the lid is composed of rigid foamed plastic (16:31-33).
Regarding claim 26, Wiesman discloses a syringe housing (100c) is positioned within the chamber.
Regarding claim 27, Wiesman discloses a refrigerant pack (112) is positioned within the chamber.
Regarding claim 28, Wiesman discloses the lid extends into the chamber of the container (16:44-46; also shown in figure 1).
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.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiesman (US 6,230,515) in view of Douglas-Hamilton (US 6,675,605).
Regarding claim 16, Wiesman discloses the bodily fluid transport unit of claim 15, but lacks that the second passageway is a circular passageway. Douglas-Hamilton discloses a bodily fluid transport container having first and second passageways, wherein the second passageway is a circular passageway (shown in figures 1A and 1B). It would have been obvious to one of ordinary skill in the art to have provided Wiesman with a circular passageway as taught by Douglas-Hamilton in order to provide a secure friction fit which enhances protection of the syringe.
Response to Arguments
Applicant’s arguments, received 6/12/2026, have been fully considered but are not persuasive.
The remarks at page 5 references a terminal disclaimer. No terminal disclaimer has been received.
Pages 6-8 discuss claims 14 and 21. Applicant purports that the mapping of Wiesman to claim 14 is not sufficient. However applicant provides no rationale as to why the asserted “areas” of Wiesman are not passageways. Applicant goes on to discuss further disclosed detail and assert In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Similarly applicant purports that the “specific mating interface between the lid and container” is not shown by Wiesman without pointing any particular claimed feature that is lacking.
At pages 8-9 applicant purports that the rejection does not explain why a PHOSITA would modify Wiesman. However the above rejection provided as a motivation “in order to provide a secure friction fit which enhances protection of the syringe.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Metz (US 10,350,141) – syringe housing
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER R ZERPHEY whose telephone number is (571)272-5965. The examiner can normally be reached M-F 7:00-4:00 PM.
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, Jianying Atkisson can be reached on 5712707740. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER R ZERPHEY/Primary Examiner, Art Unit 3799
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