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 .
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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:
“a first portion” in claims 1 and 11;
“a second portion” in claims 1 and 11.
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
Claims 3, 13, and 16 are objected to because of the following informalities: there appears to be a missing “.” at the end of the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10 and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 10 and 14 positively recite “an “industry-standard microtainer”. Although the limitation finds support in the originally filed claims, the instant Specification appears devoid of any mention of the “industry-standard microtainer”. There does not appear any corresponding specificity of the “industry-standard microtainer” and/or structural description thereof, let any alone corresponding description(s) of the microtainer and/or industry. Given the deficient corresponding description in the disclosure, the “industry-standard microtainer” limitation does not have the requisite demonstrated possession and thus lacks written description.
Claim Rejections - 35 USC § 112(b)
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 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.
The term “small-format” in independent claims 1 and 11 is a relative term which renders the claim indefinite. The term “small-format” 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. The scope of the claim is indeterminate with respect to what necessarily is explicitly, implicitly, inherently, and/or inferentially required and/or excluded to be considered “small-format” and/or the degree of small-ness required for the format to be considered small. For example, and in light of the instant Specification, it is unclear if any or all of a micro-sample, a capillary pipette, a milligram vacutainer, a syringe, or a standard pint blood donation bag may or may not be considered “small-format”. In light of the instant Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention given the infinite number of possibilities that may and/or may not be considered “small-format”. Depending claims 2-20 inherit and do not remedy the indefiniteness.
The term “SPI-A2 rated surface” in claims 7 and 20 is a relative term which renders the claim indefinite. The term “SPI-A2 rated surface” 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. The scope of the claim is indeterminate with respect to what necessarily is explicitly, implicitly, inherently, and/or inferentially required and/or excluded to be considered “SPI-A2 rated surface” and/or the degree of surface features required for SPI-A2 rating. For example, and in light of the instant Specification (e.g. [0013]), the Examiner respectfully notes that Society of Plastic Industry finish rating standards change or are modified over time and are thus relative. In light of the instant Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention given the dynamic and relative nature of industry standards that may and/or may not be considered “SPI-A2 rated surface”.
The term “industry-standard microtainer” in claims 10 and 14 is a relative term which renders the claim indefinite. The term “industry-standard microtainer” 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. The scope of the claim is indeterminate, particularly in light of the lack of written description hereinabove, with respect to what necessarily is explicitly, implicitly, inherently, and/or inferentially required and/or excluded to be considered “industry-standard microtainer” and/or the degree of industry-standard required for the microtainer to be considered and/or the size of the microtainer. For example, and in light of the instant Specification, it is unclear if any or all of a micro-sample, a capillary pipette, a milligram vacutainer, a syringe, or a standard pint blood donation bag may or may not be considered “industry-standard microtainer”. In light of the instant Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention given the infinite number of possibilities that may and/or may not be considered “industry-standard microtainer”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-6, and 8-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toomey et al. (US 2005/0010189 A1, hereinafter Toomey).
For claim 1, Toomey discloses a funnel (12) for interfacing with a small-format blood collection container (22,28) (Figs 1-7) ([0042-0063]), the funnel comprising inter alia:
a first portion (12) having a conical shape (18) (Figs 1-7) ([0042-0063]);
a second portion (56) having a cylindrical shape (56) with a major axis (Figs 1-7) ([0042-0063]); and
a shoulder (48) attached surrounding the cylindrical-shaped portion at a confluence of the conical-shaped portion and the cylindrical portion (Figs 1-7) ([0042-0063]), the shoulder shaped to match a contour of a mating small-format container (Figs 1-7) ([0042-0063]).
For claim 3, Toomey discloses the funnel of claim 1, wherein a bottom end of the cylinder-shaped portion comprises a 45-degree chamfer (about threaded bottom) (Figs 1-7) ([0042-0063]).
For claim 4, Toomey discloses the funnel of claim 1, wherein conical shaped portion comprises a top end aperture (opening about 36) having an opening at least three times as large in diameter as an aperture (42) opening of the conical-shaped portion (Figs 1-7) ([0042-0063]).
For claim 5, Toomey discloses the funnel of claim 1, further comprising a polypropylene material (Figs 1-7) ([0042-0063]).
For claim 6, Toomey discloses the funnel of claim 1, wherein the conical-shaped portion comprises a height dimension that is approximately equal to a height dimension of the cylinder-shaped portion (Figs 1-7) ([0042-0063]).
For claim 8, Toomey discloses the funnel of claim 1, wherein the shoulder contour shape comprises:
a first shoulder portion (lowermost portion of 48) (Figs 1-7) ([0042-0063]) having a first flat edge disposed at a first horizontal level (bottom edge of 48);
a second shoulder portion (uppermost portion of 48) (Figs 1-7) ([0042-0063]) having a second flat edge (top edge of 48) disposed at a second horizontal level that is different than the first horizontal level; and
a third shoulder portion (middle threaded portion of 48) (Figs 1-7) ([0042-0063]) that is angled between the first shoulder portion and the second shoulder portion (Figs 1-7) ([0042-0063]).
For claim 9, Toomey discloses the funnel of claim 1, wherein the cylinder-shaped portion of the funnel comprises an outer diameter suited to be inserted into a small-format container (Figs 1-7) ([0042-0063]).
For claim 10, Toomey discloses the funnel of claim 1, further comprising wherein the cylinder-shaped portion of the funnel comprises an outer diameter suited to be inserted into an industry-standard microtainer (Figs 1-7) ([0042-0063]).
For claim 11, Toomey discloses a system for facilitating capillary blood collection (Figs 1-7) ([0042-0063]), the system comprising inter alia:
a small-format blood collection container (28) (Figs 1-7) ([0042-0063]) having a cylindrical top-end aperture with a contoured edge (Figs 1-7) ([0042-0063]); and
a funnel (12) (Figs 1-7) ([0042-0063]) for interfacing with the small-format blood collection container (Figs 1-7) ([0042-0063]), the funnel including:
a first portion (18) shaped conically (Figs 1-7) ([0042-0063]);
a second portion (56) shaped cylindrically having a major axis (Figs 1-7) ([0042-0063]); and
a shoulder (48) (Figs 1-7) ([0042-0063]) attached surrounding the cylindrical portion at a confluence of the conical portion and the cylindrical portion (Figs 1-7) ([0042-0063]), the shoulder shaped to match the contoured edge of the top-end aperture of the small-format blood collection container (Figs 1-7) ([0042-0063]).
For claim 12, Toomey discloses the system of claim 11, further comprising a holding device (22) (Figs 1-7) ([0042-0063]) suited to hold the small-format blood collection container upright during a capillary blood collection procedure (Figs 1-7) ([0042-0063]).
For claim 13, Toomey discloses the system of claim 11, further comprising a cap (58) suited to interface with the top- end aperture of the small-format blood collection container (Figs 1-7) ([0042-0063]).
For claim 14, Toomey discloses the system of claim 11, wherein the small format container comprises an industry- standard microtainer (Figs 1-7) ([0042-0063]).
For claim 15, Toomey discloses the system of claim 11, wherein conically shaped portion comprises side walls disposed at an angle between 30 degrees and 60 degrees with respect to the major axis (Figs 1-7) ([0042-0063]).
For claim 16, Toomey discloses the system of claim 11, wherein a bottom end of the cylindrical shaped portion comprises a chamfer having and angle between 30 degrees and 60 degrees (Figs 1-7) ([0042-0063]).
For claim 17, Toomey discloses the system of claim 11, wherein conically shaped portion comprises a top end aperture having an opening (about 36) (Figs 1-7) ([0042-0063]) at least three times as large in diameter as an aperture (42) opening of the conically shaped portion (Figs 1-7) ([0042-0063]).
For claim 18, Toomey discloses the system of claim 11, wherein the funnel and the small-format container comprise a polypropylene material (Figs 1-7) ([0042-0063]).
For claim 19, Toomey discloses the system of claim 11, wherein: the shoulder contour shape comprises:
a first shoulder portion (lowermost portion of 48) (Figs 1-7) ([0042-0063]) having a first flat edge (bottom edge of 48) disposed at a first horizontal level suited to interface contiguously with a first flat edge of the contour of the top-end of the small-format container at the first horizontal level ([0042-0063]);
a second shoulder portion (uppermost portion of 48) (Figs 1-7) ([0042-0063]) having a second flat edge (uppermost edge of 48) disposed at a second horizontal level suited to interface contiguously with a second flat edge of the contour of the top-end of the small-format container at the second horizontal level ([0042-0063]); and
a third shoulder portion (middle threaded portion of 48) (Figs 1-7) ([0042-0063]) that is angled between the first shoulder portion and the second shoulder portion and suited to interface contiguously with third portion of the contour of the top-end of the small-format container between the first horizontal level and second horizontal level ([0042-0063]).
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.
Claim(s) 2, 7, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toomey et al. (US 2005/0010189 A1, hereinafter Toomey).
For claims 2, 7, and 20, Toomey discloses the claimed invention as set forth hereinabove, expect for explicitly disclosing the conical-shaped portion comprises side walls disposed at 45 degrees with respect to the major axis or the conical-shaped portion surface with an SPI-A2 rated surface. Although Toomey does not expressly disclose the angle or surface feature, Toomey is concerned with configuring a funnel’s configuration, material properties, and geometry to facilitate blood collection. At the time of filing it would have been obvious to one having ordinary skill in the art to try using a funnel angle of 45 degrees with a smooth SPI-A2 surface. One of ordinary skill would have had a finite number of possibilities of funnel angles and surfaces smoothnesses to try configuring the device with to achieve the predictable solution with a reasonable expectation of success of configuring a funnel for facilitating efficient capillary blood collection. Thus, claims 2,7, and 20 are unpatentable over Toomey as being obvious.
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for configuring a blood receiving funnel to interface with a blood collection container.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791