DETAILED ACTION
Claims 1-16 are pending and hereby under examination.
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 .
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.
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:
“actuation portion” first recited in claim 1; and
“post member” first recited in claim 1;
The identified structure for the corresponding claim limitations are as follows:
“actuation portion” is identified as “the actuation portion 24 includes a pumping member 36 for applying pressure to the sample source, e.g., the finger 19. In one embodiment, the pumping member 36 comprises a pair of opposed tabs or wings 38” (Paragraph 0085).
“post member” is identified as “P15 the post member may be positioned within the blood collector attachment so as to be directly beneath the patient's finger to make contact with the blood sample drawn from the patient's finger. A top edge of the post member may be shorter than a top edge of the blood collector attachment. The post member may be positioned within the blood collector attachment so as not to contact the patient's finger when held in the holder” (Paragraph 0015).
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 Objections
Claim 12 is objected to because of the following informalities:
Regarding claim 12, the acronym “EDTA” should be spelled out when first introduced. The claim should read “wherein the coating comprises ethylenediaminetetraacetic acid (EDTA)”.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9, 13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic (US 20190216380 – cited by Applicant) and Bokka Srinivasa Rao (US 20190223772), hereinafter Bokka.
Regarding claims 1-6, Ivosevic discloses a device for obtaining a blood sample, the device comprising:
a holder for receiving a sample source (Figs. 1-2, holder 12 and finger 19), the holder having an actuation portion and a port (Figs. 1-7B, actuation portion 24 and port 26);
a blood collector attachment removably connected to the holder (Fig. 8, collection container 16); and
a collection container removably connectable to the blood collector attachment, the container defining a collection cavity (Fig. 8, blood collector portion 74 with collection cavity 70).
With regards to the limitations of claims 1-6, Ivosevic discloses a blood flow channel to direct blood into the collection cavity (Fig. 19, blood flow channel 120). However, Ivosevic fails to disclose a post member where it is positioned within the blood collector so as not to contact a finger, wherein the top edge of the member is shorter than the top edge of the collector attachment and comprises a guided flow path connected to the post member.
However, Bokka teaches a collection device wherein a housing contains a flow directing attachment portion (Figs. 1-2, housing 12 and flow directing attachment portion 32) that is positioned within the housing so as to be directly beneath the patient's finger to make contact with the blood sample drawn from the patient's finger (Fig. 2, flow directing attachment portion 32 under finger F and collecting blood 15; Paragraph 0063). The top edge of the flow directing attachment portion is shorter than a top edge of the housing (Figs. 1-2, flow directing attachment portion 32 shorter than edge of housing 12) and is positioned within the blood collector attachment so as not to contact the patient's finger when held in the holder (Fig. 2, not contacting the finger). A guided flow path is connected to the flow directing attachment portion for directing the blood sample from the flow directing attachment portion to the collection container (Fig. 1, flow channel 24). Ivosevic discloses wherein the blood collector attachment further comprises a transition path provided between the flow directing attachment portion and the guided flow path (Fig. 19, wherein blood flow channel 120 curves into capillary tube 110).
Bokka discusses the flow directing attachment portion useful as it provides a pillar for the blood to flow in a controlled manner (Paragraph 0063). Therefore, 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 Ivosevic to incorporate the teachings of Bokka to direct the blood flow in a controlled manner.
Regarding claim 7, Ivosevic further discloses wherein the transition path has a curvature (Fig. 19, wherein blood flow channel 120 curves into capillary tube 110).
Regarding claim 8, Ivosevic further disclose wherein a coating is applied to at least one of the blood collector attachment and the collection container to reduce adhesion of at least part of the blood sample thereto (Paragraph 0092, wherein the collection container 16 includes an anticoagulant to stabilize a blood sample and/or a component of a blood sample).
Regarding claim 9, Ivosevic discloses using an anticoagulant as above and Bokka teaches the flow directing attachment portion as above. In combination, one of ordinary skill would necessarily apply an anticoagulant to the flow directing attachment portion to stabilize the blood sample.
Regarding claim 13, Ivosevic further discloses wherein a bottom edge of the blood collector attachment has a curvature to direct the blood sample from the blood collector attachment to the collection container (Fig. 19, wherein the surface leading blood from the finger 19 to blood flow channel 120 is curved).
Regarding claim 15, Ivosevic further discloses wherein the blood collector attachment defines an open channel flow path between the patient's finger and the collection container (Fig. 19, blood flow channel 120 and capillary tube 110).
Regarding claim 16, Ivosevic further discloses wherein the open channel flow path comprises at least one rib (Paragraph 0074, In some embodiments, the port 26 of the holder 12 includes a plurality of ribs for securing and locking the lancet 14 or the collection container 16 in the port 26”).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic and Bokka as applied to claim 8 above, and further in view of Taylor (US 20210015413 – cited by Applicant).
Regarding claim 10, while modified Ivosevic discloses a coating, modified Ivosevic fails to explicitly disclose wherein the coating is a protein coating.
However, Taylor teaches a method for collecting fluids wherein a portion of the fluid collection device may comprise a treated surface with proteins (Paragraph 0067) and discusses this is useful to give the collection device anti-coagulant properties and/or hydrophilic or hydrophobic properties (Paragraph 0067). The substitution of one known anti-coagulant for another yields predictable results to one of ordinary skill in the art. Therefore, 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 coating of Ivosevic and Bokka with the protein coating of Taylor.
Regarding claim 11, Taylor further teaches wherein the protein coating comprises Bovine Serum albumin (Paragraph 0067, bovine serum albumin as an example of protein coating).
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic and Bokka as applied to claims 8 and 1 above, respectively, and further in view of McHale (US 10856791 – cited by Applicant).
Regarding claim 12, while modified Ivosevic discloses a coating, modified Ivosevic fails to explicitly disclose wherein the coating is EDTA.
However, McHale teaches a bodily fluid sample collection system wherein a channel of the sample collection device includes EDTA (Col 37, lines 30-66). McHale discusses EDTA is useful as it is a non-limiting anti-coagulant (Col 22, lines 25-26). The substitution of one known anti-coagulant for another yields predictable results to one of ordinary skill in the art. Therefore, 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 coating of Ivosevic and Bokka with the EDTA coating of McHale.
Regarding claim 14, Ivosevic as modified fails to explicitly disclose a vent.
However, McHale teaches a bodily fluid sample collection system wherein vents are included (Col 8, lines 24-36; Col 79, lines 1-13; Col 80, lines 47-50) and discusses vents are useful for limiting flow rate (Col 8, lines 24-36) or to allow displaced gas to escape the vessel (Col 81, lines 22-24). Therefore, 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 Ivosevic to incorporate the teachings of vents of McHale.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791