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 .
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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6-8 of U.S. Patent No. 10022079. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a housing, an actuator mechanism, a pre-sample container defining a pre-sample reservoir, a removable plunger cap, a plunger tube, a cannula assembly, a plunger seal, the actuator mechanism transitions from a first configuration…to a second configuration, pre-sample container volume from 3-5 ml, decoupling the removable plunger cap from the plunger tube, pre-sample container is selectively removable from the plunger tube, a sample collection reservoir attached to the cannula assembly after the pre-sample container is removed such that the sample collection reservoir draws the second portion of the bodily fluid from the second fluid reservoir.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11311669. Although the claims at issue are not identical, they are not patentably distinct from each other because a housing, an actuator mechanism, a pre-sample container defining a pre-sample reservoir, a removable plunger cap, a plunger tube, a cannula assembly, a plunger seal, the actuator mechanism transitions from a first configuration…to a second configuration, pre-sample container volume from 3-5 ml, decoupling the removable plunger cap from the plunger tube, pre-sample container is selectively removable from the plunger tube, a sample collection reservoir attached to the cannula assembly after the pre-sample container is removed such that the sample collection reservoir draws the second portion of the bodily fluid from the second fluid reservoir, a port configured to be coupled with a lumen-defining device.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12178999. Although the claims at issue are not identical, they are not patentably distinct from each other because Although the claims at issue are not identical, they are not patentably distinct from each other because a housing, an actuator mechanism, a pre-sample container defining a pre-sample reservoir, a removable plunger cap, a plunger tube, a cannula assembly, a plunger seal, the actuator mechanism transitions from a first configuration…to a second configuration, pre-sample container volume from 3-5 ml, decoupling the removable plunger cap from the plunger tube, pre-sample container is selectively removable from the plunger tube, a sample collection reservoir attached to the cannula assembly after the pre-sample container is removed such that the sample collection reservoir draws the second portion of the bodily fluid from the second fluid reservoir, a port configured to be coupled with a lumen-defining device, a vacuum collection device can be selectively coupled with the cannula assembly.
Allowable Subject Matter
Claim 20 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Objections
Claim 8, 16 is objected to because of the following informalities: “with the with the”. 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 1-20 is 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.
The term “at least partially” in claim 1, 8, 16 is a relative term which renders the claim indefinite. The term “at least partially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 103
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 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) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bullington (20140163419) in view of Mahurkar (US 20100286609).
Regarding claim 16, Bullington discloses A syringe-based device (100 and/or 200) for procuring bodily fluid samples (paragraph 0035, 0046) comprising:
(a) a housing (201) being configured to receive fluid (paragraph 0047-0048); and
(b) an actuator mechanism (240) being retainable at least partially within the housing (paragraph 0049),
the actuator mechanism including:
(i) a pre-sample container defining a pre-sample reservoir (280) (paragraph 0059-0060, 0064);
(ii) a plunger cap (258) being configured to be operably coupled with the with the pre-sample container;
(iii) a plunger tube (251), the plunger tube being selectively engaged with the plunger cap,
(iv) a cannula assembly (241) retained by the plunger tube (251); and
(v) a plunger seal, the plunger seal being movable relative to the housing to define a second fluid reservoir in cooperation with the housing (paragraph 0057).
Bullington discloses all of the claim limitations except a plunger cap being configured to be operably coupled with the with the pre-sample container. Mahurkar teaches a plunger cap being configured to operably coupled with the pre-sample container (paragraph 0156-0158). Therefore, it would have been obvious at the time of the invention to modify Bullington’s plunger cap by Mahurkar’s removable plunger cap for the purpose of allowing for air release for the plunger tube as well as an area to attach sample containers.
Regarding claim 17, Bullington discloses The syringe-based device of claim 16, wherein the pre-sample container is a fluid collection vial having a defined volume (paragraph 0064).
Regarding claim 18, Bullington discloses The syringe-based device of claim 17, wherein the pre-sample container is selectively removable from the plunger tube (paragraph 0040).
Regarding claim 19, Bullington discloses the syringe-based device of claim 16, further comprising a sample collection reservoir, wherein the sample collection reservoir is attached to the cannula assembly after the pre-sample container is removed such that the sample collection reservoir draws a portion of a bodily fluid from the second fluid reservoir (paragraph 0045).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASMEEN S WARSI whose telephone number is (571)272-9942. The examiner can normally be reached Monday-Friday 9 am to 5 pm.
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/YASMEEN S WARSI/Examiner, Art Unit 3791
/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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