DETAILED ACTION
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/25/2025 has been entered.
Status of Claims
Applicant's arguments, filed 11/25/20258, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 11/25/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-10 are the current claims hereby under examination.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 11/25/2025 and 08/25/2026 have been considered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “"fluid sample optimization device” in claim 3.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
mIn 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) 1-2, 4-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yan
et al. (US Patent Pub. No. 20210069483 – previously cited) hereinafter Yan.
Regarding Claim 1, Yan discloses bodily fluid collection system for collecting a bodily fluid from a patient ([0029] an exemplary extravascular system 10 kit; fig 1), the bodily fluid collection system comprising:
a patient needle ([0029] an exemplary winged needle set 12; fig 1) for venipuncture of the patient to access a sample of the bodily fluid from the patient ([0009] the kit may be used… during a blood draw sampling; [0031] the exemplary winged needle set 12 may include a blood draw catheter 62; [0073] inserting the blood draw catheter 62 of embodiments described herein into the skin of a patient; fig 12A);
a fluid channel ([0031] integrated extension tubing 64; fig 1) having a distal end (see annotated fig 1 based on fig 12A of Yan) connected with the patient needle to convey at least a sampling portion of the sample of the bodily fluid accessed from the patient ([0073] method comprises inserting the blood draw catheter 62… into the skin of a patient…and withdrawing a blood sample; fig 12A);
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a syringe ([0033] additional components of the extravascular system 10 may further
include... conventional syringes... sample container collection devices and blood sample
containers...Said components are interchangeable with components of embodiments
described herein; fig 1) having a barrel (fig 1; Examiner notes the syringe 16 has a barrel with internal space capable of containing bodily fluid) to contain bodily fluid,
a plunger (fig 1) that can be activated to produce a vacuum in the barrel to draw at least some of the sampling portion of the bodily fluid into the barrel (Examiner notes a conventional syringe is capable of drawing blood and includes a plunger capable to produce a vacuum to draw bodily fluid),
and a hub ([0030] syringe includes a female luer fitting 16a; fig 1) opposite the plunger to create an inlet into the barrel;
a collection adapter ([0047] sample container collection device 14; figs 4B, 4C, 5, 8A) comprising:
a connection port ([0047] fastener 52; fig 4B) configured to connect with the hub of the syringe ([0047] fastener 52 fastens the sample container collection device 14 to blood sample extraction devices; fig 4B),
an internal volume configured to receive a collection device for receiving a transferred fluid from the syringe ([0047] sample container collection device 14… the substantially open end 44 defines an interior cavity; fig 4b; Examiner notes the interior cavity of 24 is capable of receiving a transferred fluid from the syringe. A collection device can be inserted into the interior cavity of 14. The syringe can be separated from the sample container collection device 14, the plunger of the syringe can be pushed so that fluid is transferred into the collection device that has been inserted into the interior cavity of 14.);
and a collection interface ([0047] sample container collection device 14; fig 4B; Examiner notes the sample container collection device 14 accomplishes the same function as the collection interface of the claimed invention) opposite the connection port that creates a fluid conduit to the barrel via the connection port and the inlet of the hub ([0047] fastener 52 fastens the sample container collection device 14 to blood sample extraction devices… of the extravascular system 10 having corresponding adapters; [0048] fastener 52 may be adapted to utilize such couplers, fittings and ports; fig 4B; Examiner notes blood sample extraction devices include syringes that fluidly connect with the sample container collection device 14)
and a proximal adapter ([0029] a proximal adapter fitting 166; fig 3) connected to the
proximal end of the fluid channel (see annotated fig 2 based on fig 1 of Yan),
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the proximal adapter being configured to removably interact with the collection interface
of the collection adapter to connect the proximal end of the fluid channel to the barrel via the
fluid conduit and inlet to the barrel to allow conveyance into the barrel of the at least some of the
sampling portion of the sample of bodily fluid ([0046] a connector of the syringe 16 is connected to the proximal adapter fitting 166 of the access device adapter 110 and the vascular access device adapter 110 is inserted into a barrel of the sample container collection device 14; fig 3 & 4C; see annotated fig 3 based on fig 4C of Yan; Examiner notes the proximal adapter fitting 166 removably interacts with the sample container collection device and is configured to convey bodily fluid when the proximal end of the extension tubing is connected to the fastener 52 of the sample container collection device).
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Regarding Claim 2, Yan discloses the invention as discussed above in claim 1. Yan
further discloses wherein the fluid channel includes tubing ([0031] integrated extension
tubing 64; fig 1).
Regarding Claim 4, Yan discloses the invention as discussed above in claim 1. Yan
further discloses wherein the collection interface of the collection adapter includes a collection
needle ([0049] a concentrically placed integrated hollow small gauge needle 54; fig 4B), the
collection needle being self-sealing ([0050] protective elastomeric sleeve 46 substantially
covering the hollow small gauge needle 54. The protective elastomeric sleeve 46 is
configured to collapse on itself upon advancement of the vascular access device adapter
110… protective elastomeric sleeve 46 is configured to protect the hollow small gauge
needle 54 when not in use… the protective elastomeric sleeve 46 is also configured to
provide a sterile barrier from atmosphere; fig 4B-4C; Examiner notes if the elastomeric
sleeve 46 is also configured to provide a sterile barrier from the atmosphere, the elastomeric sleeve 46 would unretract when the vascular device adapter 110 is removed, making the hollow small gauge needle self-sealing).
Regarding Claim 5, Yan discloses the invention as discussed above in claim 4. Yan
further discloses wherein the proximal adapter includes a self-sealing septum ([0032] The
septum… is self-healing and self-healing when a needle is removed from the septum or
stopper; fig 3) that is pierceable by the collection needle to secure the proximal adapter to the
collection adapter ([0051] the small gauge hollow needle 54 punctures the septum 130; fig
4C; see annotated fig 4 based on fig 4C of Yan). Examiner notes the proximal adapter fitting
166 is part of the vascular access device adapter 100, as is the septum 130. Therefore, the
proximal adapter fitting 166 includes the septum 130.
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Regarding Claim 6, Yan discloses the invention as discussed above in claim 1. Yan
further discloses wherein the collection interface of the collection adapter includes a first Luer
interface ([0047] the fastener 52 is a female luer lock; fig 4B), and wherein the proximal
adapter includes a second Luer interface ([0030] the proximal adapter fitting 116 is a male
luer fitting; fig 3) to removably interact with the first Luer interface ([0075] the particular
features, structures, materials, or characteristics may be combined in any suitable manner
in one or more embodiments; Examiner notes male and female luer locks are configured to
removably interact).
Regarding Claim 7, Yan discloses the invention as discusses above in claim 4. Yan
further discloses wherein the collection adapter includes a housing (cylindrical body 40,
substantially open end 44; fig 4A-B) to receive a vacuum-providing transfer bottle to connect
to the collection needle ([0011] inner housing of a sample collection device such as a VACUTAINER®; fig 4C) and transfer at least a portion of the sampling portion of the sample of the bodily fluid from the barrel to the transfer bottle. Examiner notes the sample container
collection device 14 is configured to receive a VACUTAINER® or any equivalents and transfer
at least a portion of the sampling portion of the sample of the bodily fluid from the barrel to the
transfer bottle.
Regarding Claim 8, Yan discloses a bodily fluid transfer system for transferring a
sampling portion of a bodily fluid ([0029] an exemplary extravascular system 10 kit; fig 1)
collected by a syringe ([0033] additional components of the extravascular system 10 may further include... conventional syringes... sample container collection devices and blood sample containers...Said components are interchangeable with components of embodiments described herein; fig 1) from a fluid channel ([0031] integrated extension tubing 64; fig 1),
the syringe having a barrel (fig 1; Examiner notes the syringe 16 has a barrel with internal space capable of containing bodily fluid) to contain bodily fluid,
a plunger (fig 1) that can be activated to produce a vacuum in the barrel to draw at least some of the sampling portion of the bodily fluid into the barrel (Examiner notes a conventional syringe is capable of drawing blood and includes a plunger capable to produce a vacuum to draw bodily fluid), and a hub ([0030] syringe includes a female luer fitting 16a; fig 1) opposite the plunger to create an inlet into the barrel,
the bodily fluid transfer system comprising:
a collection adapter ([0047] sample container collection device 14; fig 4b) comprising:
a connection port ([0047] fastener 52; fig 4B) configured to connect with the hub of the syringe ([0047] fastener 52 fastens the sample container collection device 14 to blood sample extraction devices; fig 4B),
an internal volume configured to receive a collection device for receiving a transferred fluid from the syringe ([0047] sample container collection device 14… the substantially open end 44 defines an interior cavity; fig 4b; Examiner notes the interior cavity of 24 is capable of receiving a transferred fluid from the syringe. A collection device can be inserted into the interior cavity of 14. The syringe can be separated from the sample container collection device 14, the plunger of the syringe can be pushed so that fluid is transferred into the collection device that has been inserted into the interior cavity of 14.);
and a collection interface ([0047] sample container collection device 14; fig 4B; Examiner notes the sample container collection device 14 accomplishes the same function as the collection interface of the claimed invention) opposite the connection port that creates a fluid conduit to the barrel via the connection port and the inlet of the hub ([0047] fastener 52 fastens the sample container collection device 14 to blood sample extraction devices… of the extravascular system 10 having corresponding adapters; [0048] fastener 52 may be adapted to utilize such couplers, fittings and ports; fig 4B; Examiner notes blood sample extraction devices include syringes that fluidly connect with the sample container collection device 14) and a proximal adapter ([0029] a proximal adapter fitting 166; fig 3) connected to a proximal end of the fluid channel (see annotated fig 2 based on fig 1 of Yan),
the proximal adapter being configured to removably interact with the collection interface of the collection adapter to connect the proximal end of the fluid channel to the barrel via the fluid conduit and inlet to the barrel to allow conveyance into the barrel of the at least some of the sampling portion of the sample of bodily fluid ([0046] a connector of the syringe 16 is connected to the proximal adapter fitting 166 of the access device adapter 110 and the vascular access device adapter 110 is inserted into a barrel of the sample container collection device 14; fig 3 & 4C; see annotated fig 3 based on fig 4C of Yan; Examiner notes the proximal adapter fitting 166 removably interacts with the sample container collection device and is configured to convey bodily fluid when the proximal end of the extension tubing is connected to the fastener 52 of the sample container collection device),
and upon removal of the proximal adapter from the collection interface ([0046] proximal
adapter fitting 166 of the access device adapter 110 and the vascular access device adapter 110 is inserted into a barrel of the sample container collection device 14; [0036] Said connectors [proximal adapter fitting 166] are configured to removably or non-removably mate with components of the extravascular system 10), allow transfer of at least some of the sampling portion of the sample of the bodily fluid in the barrel to a second collector connected with the collection interface of the collection adapter ([0047] the sample container collection device 14 includes… a substantially open first end 44… the substantially open end 44 defines an interior cavity, fig 4B; [0051] insertion of the vascular access device adapter 110 [which includes proximal adapter fitting 166] inside the cylindrical body 40, fig 4C). Yan discloses [0033] “Separate, additional components of the extravascular system 10 may further include… sample container collection devices and blood sample containers. Said components are interchangeable with components of embodiments described herein”. Therefore, a second collector can be configured to directly mate with the sample container collection device 14 without the proximal adapter fitting 166 and allow transfer of bodily fluid. The examiner notes that “allow transfer of at least some of the sampling portion of the sample of the bodily fluid in the barrel to a second collector connected with the collection interface of the collection adapter” of claim 8 is functional language, not positively recited, and is given no weight.
Regarding Claim 9, Yan discloses the invention as discussed above in claim 8. Yan
further discloses wherein the collection interface of the collection adapter includes a collection
needle ([0049] a concentrically placed integrated hollow small gauge needle 54; fig 4B), the
collection needle being self-sealing ([0050] protective elastomeric sleeve 46 substantially
covering the hollow small gauge needle 54. The protective elastomeric sleeve 46 is
configured to collapse on itself upon advancement of the vascular access device adapter
110… protective elastomeric sleeve 46 is configured to protect the hollow small gauge needle 54 when not in use… the protective elastomeric sleeve 46 is also configured to provide a sterile barrier from atmosphere; fig 4B-4C; Examiner notes if the elastomeric sleeve 46 is also configured to provide a sterile barrier from the atmosphere, the elastomeric sleeve 46 would unretract when the vascular device adapter 110 is removed, making the hollow small gauge needle self-sealing).
Regarding Claim 10, Yan discloses the invention as discussed above in claim 8. Yan
further discloses wherein the collection interface of the collection adapter includes a first Luer
interface ([0047] the fastener 52 is a female luer lock; fig 4B), and wherein the proximal
adapter includes a second Luer interface ([0030] the proximal adapter fitting 116 is a male
luer fitting; fig 3) to removably interact with the first Luer interface ([0075] the particular
features, structures, materials, or characteristics may be combined in any suitable manner
in one or more embodiments; male and female luer locks are configured to removably
interact).
Claim Rejections - 35 USC § 103
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(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yan (US Patent Pub. No. 20210069483 – previously cited) as applied to claim 1 above, and further in view of Bullington et al. (US Patent Pub. No. 20200289039 – previously cited) hereinafter Bullington.
Regarding Claim 3, Yan discloses the invention as discussed above in claim 1. Yan fails
to disclose a fluid sample optimization device provided on the fluid channel between the patient
needle and the collection adapter, the fluid sample optimization device being configured to divert
and sideline a first portion of the sample of the bodily fluid accessed by the patient needle, and to
subsequently allow passage of the sampling portion of the sample of the bodily fluid accessed
from the patient toward the collection adapter.
Bullington teaches a fluid sample optimization device (control device 100; fig 1) provided on the fluid channel between the patient needle ([0051] the housing 110 can be coupled to and/or can include a lumen-containing device that is in fluid communication with the inlet 113 and that is configured to be percutaneously disposed in a patient (e.g., a butterfly needle, intravenous (IV) catheter, peripherally inserted central catheter (PICC), intermediary lumen-containing device, and/or the like). Thus, bodily fluid can be transferred from the patient and/or other bodily fluid source to the housing 110 via the inlet 113… outlet 114 can be placed in fluid communication with a fluid collection device 180; fig 1), the fluid sample optimization device being configured to divert and sideline a first portion of the sample of the bodily fluid accessed by the patient needle ([0057] initiate a flow of bodily fluid from the patient and into the device 100 such that a first or initial portion of the flow of bodily fluid is transferred into and sequestered by the sequestration chamber 130; fig 1), and to subsequently allow passage of the sampling portion of the sample of the bodily fluid accessed from the patient ([0057] a second or subsequent portion of the flow of bodily fluid bypasses and/or is otherwise diverted away from the sequestration chamber 130 and into the fluid collection device 180; fig 1).
Bullington does not teach a collection adapter. Therefore, Bullington does not explicitly
teach the fluid sample optimization device is between the patient needle and the collection
adapter, and it does not explicitly teach the fluid sample optimization device allows passage of
the sampling portion of the sample of the bodily fluid toward the collection adapter. It would
have been obvious to one having ordinary skill in the art before the effective filing date of the
claimed invention to combine the control device 100 of Bullington within the exemplary winged
needle set 12 of Yan and position the control device between the patient needle and the collection adapter. The control device 100 is used for procuring bodily fluid samples with
reduced contaminants such as dermally residing microbes and/or other contaminants exterior to
the bodily fluid source [0008 of Bullington], as such, integrating the control device 100 of Bullington within the exemplary winged needle set 12 of Yan would provide an additional precaution to decrease culture contamination rates. All of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Response to Arguments
Applicant’s arguments, see page 1 of Remarks, filed 11/25/2025, with respect to the 112(b) rejections have been fully considered and are persuasive. The 112(b) rejections of claims 1 and 8 have been withdrawn.
Applicant's arguments, see page 2 of Remarks, filed 11/25/2025, with respect to the 102 rejections have been fully considered but they are not persuasive. Upon reconsideration, it has been determined that Yan does disclose the elements of amended claims 1 and 8. The interior cavity of 14 is perfectly capable of receiving a collection device for receiving a transferred fluid from the syringe, see figure 4B. The interior cavity of 14 is big enough to receive a collection device such as a tube, see figures 4B, 4C, and 5. As seen in figure 5, the syringe 16 can be separated from the collection adapter 14. Then, a collection device can be inserted into the interior cavity of 14 and fluid can be transferred from the syringe into the collection device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANKI M BAVA whose telephone number is (571)272-0416. The examiner can normally be reached Monday-Friday 9:00-6:00 ET.
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, Jason Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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