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 .
Applicant’s filing of claims 30-59 on 11/17/23 is acknowledged. Claims 1-29 were canceled. Claims 30-59 are pending and are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/16/24 was acknowledged. Accordingly, the information disclosure statement is being considered by the examiner.
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 51-59 are 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.
Claims 51-59 are rejected because the preamble in each dependent claim recites, “apparatus”. The preamble in independent claim 50 recites a “system”.
Claim Interpretation
The Office asserts that terms and phrases like “configured to” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “configured to” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
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.
Claims 30-59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bullington et al. (“Bullington,” US Pub. No. 2018/0353117, cited in IDS).
As to claim 30, Bullington discloses an apparatus for procuring bodily fluid samples with reduced contamination ([0003] et seq.), the apparatus comprising:
a housing forming a sequestration chamber (fig. 1, [0238] et seq.), the housing having an inlet (1332, [0238] et seq.) configured to be fluidically coupled to a bodily fluid source and an outlet (1336, [0238] et seq.) configured to be fluidically coupled to a fluid collection device ([0070] et seq.);
a flow controller (e.g., [1351, [0239] et seq.) disposed in the sequestration chamber; and
an actuator (e.g., spring 1354 connecting the actuator (or plunger) 1351 to a wall or surface of the sequestration portion 1334, [0241] et seq.) coupled to the housing, the actuator having a first configuration in which the inlet is in fluid communication with the sequestration chamber and a second configuration in which the inlet is in fluid communication with the outlet, the actuator in the first configuration defining a portion of a first fluid flow path between the inlet and a first side of the flow controller and defining a portion of a second fluid flow path between the outlet and a second side of the flow controller (e.g., [0246] et seq.),
the flow controller configured to transition from a first state to a second state in response to a suction force being exerted at the outlet, the flow controller allowing a negative pressure differential between the sequestration chamber and the inlet as the flow controller transitions from the first state to the second state operable to draw an initial volume of bodily fluid into the sequestration chamber (e.g., [0245] et seq.),
the actuator configured to be transitioned to the second configuration after the initial volume of bodily fluid is drawn into the sequestration chamber to fluidically couple a portion of the first fluid flow path to a portion of the second fluid flow path and allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to the suction force (e.g., [0246] et seq.).
As to claim 31, see [0238] et seq.
As to claim 32, see e.g., [0062] et seq. See e.g., 343 of [0104].
As to claims 33-34, see e.g., [0061] et seq.
As to claims 35-36, see e.g., [0245] et seq.
As to claim 37, see e.g., [0235] et seq.
As to claim 38-40, see e.g., [0239] et seq.
As to claim 41, see e.g., [0246] et seq.
As to claim 42, Bullington discloses an apparatus for procuring bodily fluid samples with reduced contamination ([0003] et seq.), the apparatus comprising:
a housing forming a sequestration chamber (1334, [0238] et seq.), the housing having an inlet (1332, [0238] et seq.) configured to be fluidically coupled to a bodily fluid source and an outlet (1336, [0238] et seq.) configured to be fluidically coupled to a fluid collection device;
an actuator disposed in the housing (1354, [0241] et seq.), the actuator in a first configuration allowing fluid communication between the inlet and a first portion of the sequestration chamber via a first fluid flow path and allowing fluid communication between the outlet and a second portion of the sequestration chamber via a second fluid flow path, the actuator in a second configuration fluidically coupling a portion of the first fluid flow path and a portion of the second fluid flow path to place the inlet in fluid communication with the outlet ([0246] et seq.); and
a flow controller disposed in the sequestration chamber (1351, [0241] et seq.), the flow controller transitioning from a first state to a second state in response to a suction force being exerted through the second fluid flow path and the second portion of the sequestration chamber when the outlet is fluidically coupled to the fluid collection device, the flow controller allowing a negative pressure differential between the first portion of the sequestration chamber and the inlet as the flow controller transitions from the first state to the second state operable to draw an initial volume of bodily fluid into the first portion of the sequestration chamber via the first fluid flow path ([0241] et seq.),
the actuator configured to transition from the first configuration to the second configuration after the initial volume of bodily fluid is in the first portion of the sequestration chamber to allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to the suction force ([0246] et seq.).
As to claims 43-44, openings 1359 in [0240] et seq.
As to claim 45, see e.g., [0062] et seq. See e.g., 343 of [0104].
As to claims 46-49, [0240] et seq.
As to claim 50, Bullington discloses a system for procuring bodily fluid samples with reduced contamination ([0003] et seq.), the system comprising:
a fluid control device ([0258] et seq.), including: a housing (fig. 30, [0258] et seq.) forming a sequestration chamber, the housing having an inlet configured to be fluidically coupled to a bodily fluid source and an outlet; a flow controller disposed in the sequestration chamber; and an actuator coupled to the housing, the actuator having a first configuration in which the inlet is in fluid communication with the sequestration chamber, and a second configuration in which the inlet is in fluid communication with the outlet, the actuator in the first configuration defining a portion of a first fluid flow path between the inlet and a first side of the flow controller and defining a portion of a second fluid flow path between the outlet and a second side for the flow controller (see control devices 100-1400, [0258] et seq.); and
a fluid collection device fluidically coupleable to the outlet of the fluid control device, the fluid collection device configured to exert a suction force through the second fluid flow path when fluidically coupled to the outlet (e.g., [0070] et seq.),
the flow controller configured to transition from a first state to a second state in response to the suction force being exerted through the second fluid flow path, the flow controller allowing a negative pressure differential between the sequestration chamber and the inlet as the flow controller transitions from the first state to the second state operable to draw an initial volume of bodily fluid into the sequestration chamber (e.g., [0070] et seq.),
the actuator configured to be transitioned to the second configuration after the initial volume of bodily fluid is drawn into the sequestration chamber to fluidically couple a portion of the first fluid flow path to a portion of the second fluid flow path and allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to the suction force (e.g., [0070] et seq.).
As to claims 51-59, see e.g., [0258] et seq. ,which refer to control devices 100-1400.
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 30-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,857,321. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims and the patented claims comprise substantially the same subject matter. For example, examined claim 30 and patented claim 1 comprise an apparatus for procuring bodily fluid samples with reduced contamination, the apparatus comprising: a housing forming a sequestration chamber, the housing having an inlet configured to be fluidically coupled to a bodily fluid source and an outlet configured to be fluidically coupled to a fluid collection device; an actuator coupled to the housing, the actuator having a first configuration in which the inlet is in fluid communication with the sequestration chamber, and a second configuration in which the inlet is in fluid communication with the outlet and fluidically isolated from the sequestration chamber; and a flow controller disposed in the sequestration chamber, the flow controller separating a first portion of the sequestration chamber from a second portion of the sequestration chamber, the flow controller having a first state in which the first portion of the sequestration chamber has a first volume and a second state in which the first portion of the sequestration chamber has a second volume greater than the first volume, the actuator in the first configuration allowing fluid communication between the inlet and the first portion of the sequestration chamber via a first fluid flow path and allowing fluid communication between the outlet and the second portion of the sequestration chamber via a second fluid flow path, the flow controller transitioning from the first state to the second state in response to the suction force being exerted through the second fluid flow path by the fluid collection device, the transitioning of the flow controller operable to draw an initial volume of bodily fluid into the first portion of the sequestration chamber, the actuator configured to be transitioned to the second configuration after the initial volume of bodily fluid is drawn into the sequestration chamber to (1) sequester the sequestration chamber from the inlet, and (2) fluidically couple a portion of the first fluid flow path to a portion of the second fluid flow path to allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to the suction force.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
10/18/2025