DETAILED ACTION
This action is responsive to the “RESPONSE AND AMENDMENT” filed 30 March 2026. The Examiner acknowledges the amendments to claims 1, 4, 7, 11, 13, 15, 17-18, and 21, the cancelation of claim 6, and the addition of new claim 22. Claims 1-5 and 7-22 are pending.
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 .
Specification
The disclosure is objected to because of the following informalities:
Pages 4-5, 7, 19, 22, and 25 of the Specification appears to have misnumbered or missing page lines.
Appropriate correction is required.
Claim Objections
Claim(s) 17 is/are objected to because of the following informalities:
Claim 17 should read “wherein the one or more barriers” [line 1].
Appropriate correction is required.
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: “separation mechanism” in claim(s) 1 and 7.
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.
The Examiner’s interpretations of the claim limitation(s) that invoke interpretation under § 112(f) are as follows:
Claim(s) 1 and 7 recite(s) the limitation “separation mechanism”, which recites a generic placeholder [mechanism], modified by functional language [“configured to separate the component of whole blood and direct the separated component from the whole blood fill zone to the other fill zone” in claim 1; “configured to retain the cellular fraction of the whole blood at a predetermined location on the support and conduct the cellular fraction to the other fill zone” in claim 7], wherein the identified generic placeholder is not further modified by sufficient structure, material, or acts for performing the claimed function. Accordingly, the Examiner has interpreted the recited limitation of “separation mechanism” as further limiting the previously claimed capillary microstructure, or being a separate gel, filter paper, or particle [the separation mechanism is selected from the capillary microstructure, a gel, filter paper, and a particle (Applicant’s Specification p. 6), which particularly notes that the separation mechanism may be the capillary microstructure itself; The separation mechanism may be a gel, filter paper, a foam structure, pillars, or particle (Applicant’s Specification p. 30)], or an equivalent thereof. The Examiner further notes that claim 8 provides sufficient structure for performing the claimed functions of the separation mechanism, such that § 112(f) interpretation is not invoked in claim 8.
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 § 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) 1-5, 7-8, 10, 14-17, 19-20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rostaing (US-20110124984-A1) in view of Sloan (US-20140323911-A1).
Regarding claim 1, Rostaing teaches
A blood collection device, comprising:
a plurality of microneedles disposed on a support [a collector element 10 constituted by an array of microneedles 11, preferably hollow microneedles, and by a reservoir 12 incorporated in the plane element 100 and located beneath said array (Rostaing ¶0033, Fig. 3)];
at least one whole blood fill zone [hole 30 (Rostaing Fig. 3)] and at least one other fill zone disposed within the support [absorbent element 4 (Rostaing Fig. 3)], the whole blood fill zone capable of receiving and holding a quantity of whole blood [the blood S reaches the filter membrane 3 via the hole 30 (Rostaing ¶0026)] and the other fill zone capable of receiving a separated component of whole blood distributed into the other fill zone [The absorbent element 4 soaks up the plasma (Rostaing ¶0029)];
a capillary microstructure extending through the support and capable of conducting the whole blood from the microneedles into the whole blood fill zone [Once the well 1 is filled sufficiently, the blood S begins to penetrate into the duct 2 into which it is sucked by capillarity. When the duct 2 is completely filled, the blood S reaches the filter membrane 3 via the hole 30 (Rostaing ¶0026, Figs. 1-5)];
a separation mechanism configured to separate the component of whole blood and direct the separated component from the whole blood fill zone into the other fill zone [The filter membrane 3 is adapted to retain blood cells while allowing plasma to pass. The plasma is thus collected downstream from said membrane (Rostaing ¶0028)].
However, while Rostaing discloses calibrating the fluid channels of the device to indicate reception of a pre-determined amount of blood [Since the volume of the well 1 plus the volume of the duct 2 are calibrated, the quantity of liquid inside the device is known accurately: this constitutes aliquoting (Rostaing ¶0026)], Rostaing fails to explicitly disclose a fill indicator channel fluidically connected to the capillary microstructure, the fill indicator channel configured to indicate when the whole blood fill zone has received a pre- determined quantity of whole blood.
Sloan discloses blood collection devices, wherein Sloan discloses a fill indicator channel fluidically connected to sample collection pathways, the fill indicator channel configured to indicate when the device has received a pre-determined quantity of bodily fluid [In another embodiment described herein, a device for collecting a bodily fluid sample is provided comprising: a first portion comprising at least one fluid collection location leading to at least two sample collection pathways configured to draw the fluid sample therein via a first type of motive force; a second portion comprising a plurality of sample containers for receiving the bodily fluid sample collected in the sample collection pathways, the sample containers operably engagable to be in fluid communication with the sample collection pathways, whereupon when fluid communication is established, the containers provide a second motive force different from the first motive force to move a majority of the bodily fluid sample from the pathways into the containers; wherein at least one of the sample collection pathways comprises a fill indicator to indicate when a minimum fill level has been reached and that at least one of the sample containers can be engaged to be in fluid communication with at least one of the sample collection pathways (Sloan ¶0007)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Rostaing to employ a fill indicator channel fluidically connected to the capillary microstructure, the fill indicator channel configured to indicate when the whole blood fill zone has received a pre-determined quantity of whole blood, so as to allow for indication of a minimum fill level for a collected sample being reached, and would further amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [indicate a fill level] [MPEP § 2143(I)(D)].
Regarding claim 2, Rostaing in view of Sloan teaches
The device of claim 1, wherein the microneedles are hollow [Rostaing ¶0033].
Regarding claim 3, Rostaing in view of Sloan teaches
The device of claim 1, wherein the microneedles are solid [Rostaing ¶0033, wherein the microneedles are considered to be in a “solid” form].
Regarding claim 4, Rostaing in view of Sloan teaches
The device of claim 1, wherein the support is configured to allow a user to place a finger in contact with the device for a time sufficient to allow the whole blood fill zone to receive a desired quantity of whole blood [When taking a blood sample, the patient presses a finger onto said collector element, possibly after pricking the finger with a lancet (if the device does not have microneedles). The adhesive region 50 serves to form a sealed connection between the finger and the device so as to prevent any dispersion of blood and the associated biological risks and also prevent any prolonged contact between blood and air that would be likely to accelerate coagulation. The patient keeps the finger on the device throughout the filling stage. Once the duct 2 is fill, the patient takes the finger away (Rostaing ¶0035)].
Regarding claim 5, Rostaing in view of Sloan teaches
The device of claim 4, wherein the finger is held in place by a surface that conforms to the finger and guides a placement of the finger for piercing by the microneedles [Rostaing ¶0035, wherein the adhesive region 50 adhering to a finger is considered to read on the claimed limitation].
Regarding claim 7, Rostaing in view of Sloan teaches
The device of claim 1, wherein the device comprises a separation mechanism is configured to retain the cellular fraction of the whole blood at a predetermined location on the support and conduct the cellular fraction to the other fill zone [Rostaing ¶0028].
Regarding claim 8, Rostaing in view of Sloan teaches
The device of claim 7, wherein the separation mechanism is selected from a group consisting of the capillary microstructure, a gel, filter paper [a filter membrane 3, typically a paper membrane (Rostaing ¶0022)], and a particle.
Regarding claim 10, Rostaing in view of Sloan teaches
The device of claim 1, wherein the support is a substantially flat surface [Rostaing Figs. 1, 3].
Regarding claim 14, Rostaing in view of Sloan teaches
The device of claim 1, wherein the support further comprises a substrate [an element 100 of hard or flexible plastics material. A soft plastic such as polydimethyl siloxane (PDMS) or a silicone is particularly preferred for implementing the invention as is a moldable or machineable plastics material that is transparent and preferably hydrophilic. The following are formed on a surface of the element 100 that is referred to as its "top" surface 101: a well or depression 1 for collecting whole blood that is to be aliquoted and filtered; and a closed capillary duct 2 in fluid flow communication with the well 1. A cover needs to be placed over the duct 2 (Rostaing ¶¶0020-0021, Fig. 3)].
Regarding claim 15, Rostaing in view of Sloan teaches
The device of claim 14, wherein the substrate is a hydrophilic, porous media for receiving the whole blood [Rostaing ¶¶0020-0021].
Regarding claim 16, Rostaing in view of Sloan teaches
The device of claim 1, wherein the support further comprises:
one or more layers [Rostaing Fig. 3]; and
one or more barriers disposed on the one or more layers [wherein any surface of each layer as depicted in Rostaing Fig. 3 may define a “barrier”].
Regarding claim 17, Rostaing in view of Sloan teaches
The device of claim 16, wherein the barriers define one or more of a sample addition zone, the capillary microstructure, the whole blood fill zone, the at least one other fill zone, and the fill indicator channel [Rostaing Fig. 3].
Regarding claim 19, Rostaing in view of Sloan teaches
The device of claim 16, wherein the one or more layers define a top surface and a bottom surface [Rostaing Fig. 3].
Regarding claim 20, Rostaing in view of Sloan teaches
The device of claim 1, wherein the capillary microstructure comprises lateral distribution channels [Rostaing Fig. 1].
Regarding claim 22, Rostaing in view of Sloan teaches
The device of claim 1, wherein the separated cellular fraction comprises one or more of white blood cells, red blood cells, platelets, and plasma, wherein the at least one other fill zone comprises a separate fill zone for each of a desired separated cellular fraction [Rostaing ¶¶0028-0029].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rostaing in view of Sloan, as applied to claim 1 above, in further view of Black (US-20110306853-A1, previously presented).
Regarding claim 9, Rostaing in view of Sloan teaches
The device of claim 1.
However, Rostaing in view of Sloan fails to explicitly disclose wherein the capillary microstructure comprises a plurality of layers.
Black discloses blood collection devices, wherein the device forms a capillary microstructure from a microneedle to a fluid reservoir across a plurality of layers [A plurality of polymeric microchannels 16 are provided, each of a microchannel 16 being is associated a microneedle 14. The plurality of polymeric microchannels 16 are integrally formed with the array of polymeric microneedles 14 without bonding and are integrated as one. At least one polymeric reservoir 18 is coupled to the plurality of microchannels 16 (Black ¶0060); The microchannels 16 can be capillary channels which do not provide for a back pressure for pull (Black ¶0061); As illustrated in FIG. 26, the microchannels 16 with multiple layers of polymer are outlets to the microneedles 14, generated by multiple layers of the polymer (Black ¶0226, Figs. 26-34)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Rostaing in view of Sloan to employ wherein the capillary microstructure comprises a plurality of layers, as this modification would amount to mere simple substitution of one known element for another with similar expected results [define a capillary microstructure to form a fluid pathway] [MPEP § 2143(I)(B)].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rostaing in view of Sloan, as applied to claim 1 above, in further view of Freeman (US-20030088191-A1, previously presented).
Regarding claim 11, Rostaing in view of Sloan teaches
The device of claim 1.
However, Rostaing fails to explicitly disclose wherein the support is flexible to allow conformation to a surface to which the support is applied.
Freeman discloses blood collection devices, wherein Freeman discloses a support that is flexible to allow conformation to a surface to which it is applied, wherein the surface is a finger from which blood is to be collected [Accordingly, the pad 150 applied to the finger 156 seals the area to be lanced so that the finger 156 is not substantially exposed to ambient air. The finger pad 150 also provides a seal for the blood sample being transferred from the lanced area of the finger to the blood reservoir 102 (Freeman ¶0017, Fig. 1); the finger pad 150 may include an elastomer. Furthermore, the elastomer 150 may be formed of relatively soft durometer type compounds, such as silicone rubber, and may be shaped to contour the finger 156. The elastomer 150 provides an air seal between the finger 156 and the opening 120, which leads into the reservoir 102. Thus, in some embodiments, the durometer range of the finger pad/elastomer 150 may be between Shore 20A and 40A, specifically, the range may be between Shore 20A and 30A. In other embodiments, the durometer of the finger pad/elastomer may be 5A to 15A. Typical products known in the art include "Bumpon" or adhesive foam (manufactured by 3M), "Sorbothane" (manufactured by Trelleborg AB), and other gels commonly used in orthotics (Freeman ¶0018, Fig. 1), wherein the Examiner notes that the pad 150 including an elastomer nad having a Shore hardness between 20A-40A, 20A-30A, or 5A-15A is considered to define a flexible and conformable material].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Rostaing in view of Sloan to employ wherein the support is flexible to allow conformation to a surface to which it is applied, so as to facilitate an air seal between a subject’s finger and the microneedles to prevent ambient air from contaminating any collected blood.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rostaing in view of Sloan, as applied to claim 1 above, in view of Barone (US-20190159709-A1, previously presented).
Regarding claim 12, Rostaing in view of Sloan teaches
The device of claim 1.
However, while Rostaing does disclose the use of anticoagulants in the device [Rostaing ¶0025], Rostaing fails to explicitly disclose wherein the microneedles contain a coating comprising an analgesic and/or an anticoagulant.
Barone discloses a blood collection device comprising microneedles configured to puncture skin to allow for blood withdrawal [This movement of the microneedles allows the microneedles to reach and pierce a subject's skin, causing release of bodily fluid such as blood. The bodily fluid enters the device through a device opening (Barone ¶0082)], wherein Barone discloses wherein the microneedles contain a coating comprising an analgesic and/or an anticoagulant [the needles (or microneedles) may be coated. For example, the needles may be coated with a substance that is delivered when the needles are inserted into the skin. For instance, the coating may comprise heparin, an anticoagulant, an anti-inflammatory compound, an analgesic, an anti-histamine compound, etc. to assist with the flow of blood from the skin of the subject, or the coating may comprise a drug or other therapeutic agent such as those described herein (Barone ¶0166)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Rostaing in view of Sloan to employ wherein the microneedles contain a coating comprising an analgesic and/or an anticoagulant, so as to assist with the flow of blood from the skin of the subject.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rostaing in view of Sloan, as applied to claim 1 above, in further view of Renlund (US-20170115236-A1, previously presented).
Regarding claim 13, Rostaing in view of Sloan teaches
The device of claim 1.
However, Rostaing in view of Sloan fails to explicitly disclose further comprising a capillary tube for extraction of the whole blood from the device.
Renlund discloses blood collection devices, wherein Renlund discloses a capillary tube for extraction of blood from the device [The sensor may comprise a fluid exit port connected to the fluid cavity for drainage of fluid from the fluid cavity (Renlund ¶0022); The fluid cavity is open to the ambient through a fluid exit port 8 to enable capillary suction of the bodily fluid (Renlund ¶0061)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Rostaing in view of Sloan to employ further comprising a capillary tube for extraction of the whole blood from the device, so as to allow for drainage of the device.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rostaing in view of Sloan, as applied to claim 16 above, in further view of Bernstein (US-20110105951-A1, previously presented).
Regarding claim 18, Rostaing in view of Sloan teaches
The device of claim 16.
However, Rostaing in view of Sloan fails to explicitly disclose wherein the one or more barriers is a hydrophobic material.
Bernstein discloses blood collection devices, wherein Bernstein discloses employing hydrophobic elements within the device as at least portions of blood collection channels [A channel generally will include characteristics that facilitate control over fluid transport, e.g., structural characteristics and/or physical or chemical characteristics (hydrophobicity vs. hydrophilicity) and/or other characteristics that can exert a force (e.g., a containing force) on a fluid (Bernstein ¶0172)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Rostaing in view of Sloan to employ wherein the one or more barriers is a hydrophobic material, so as to allow for user control of fluid flow characteristics within the device, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [enable control of fluid transport characteristics] [MPEP § 2143(I)(D)].
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rostaing in view of Sloan, as applied to claim 1 above, in further view of Polsky (US-20180338713-A1).
Regarding claim 21, Rostaing in view of Sloan teaches
The device of claim 1.
However, Rostaing in view of Sloan fails to explicitly disclose wherein the device further comprises a vacuum source sufficient to draw whole blood from a needle puncture site to the capillary microstructure.
Polsky discloses blood collection devices for separating whole blood collected via microneedles into blood cellular fractions [Any of the chambers and channels interconnecting such chambers can be surface modified, as described herein. Furthermore, such chambers and channels can include further structures that would be useful for detecting one or more markers. For instance, one or more filters or membranes can be used to separate particular components from the sample and/or the reaction mixture. For instance, when the sample is whole blood, a filter can be used to separate the plasma from other blood components, such as the red blood cells (Polsky ¶0162)], wherein Polsky discloses a vacuum source sufficient to draw whole blood from a needle puncture site into a capillary microstructure [In other embodiments, the body further includes a pumping mechanism (e.g., a passive channel, an active pump, a vacuum source, etc.) configured to transport the sample from the hollow needles and/or the internal volume into the central bore (Polsky ¶0034)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Rostaing in view of Sloan to employ wherein the device further comprises a vacuum source sufficient to draw whole blood from a needle puncture site to the capillary microstructure, so as to facilitate blood withdrawal, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [facilitate blood withdrawal] [MPEP § 2143(I)(D)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 6, filed 30 March 2026, with respect to the previously presented drawing objections have been fully considered and are persuasive. The objection to a reference character being used to designate different elements has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 6, with respect to the previously presented claim objection(s) have been fully considered and are persuasive. The objection to claim 11 has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7, with respect to the previously applied rejections under § 112(b) have been fully considered and are persuasive. The rejections of claims 17-18 under § 112(b) have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7-11, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom under § 102 and § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rostaing (US-20110124984-A1) in view of Sloan (US-20140323911-A1).
The Applicant asserts that Renlund does not recite the features of amended claim 1, and is instead directed towards a microfabricated radiofrequency sensor to detect changes in the dielectric properties of interstitial fluid to measure glucose [Renlund ¶¶0006-0007, 0059], as opposed to the amended limitations directed towards collecting whole blood samples and separating the whole blood into blood components. The Applicant further asserts that none of Renlund, Bernstein, Sloan, Freeman, Barone, Mao, or Black, alone or in any proposed combination, teaches or suggests the blood collection device of amended claim 1. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Rostaing (US-20110124984-A1) in view of Sloan (US-20140323911-A1) is presently applied to teach amended claim 1 [Rostaing ¶¶0026, 0028-0029, 0033, Figs. 1-5; Sloan ¶0007].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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