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 .
Claim Objections
Claim 1 is objected to because of the following informalities: “. Appropriate correction is required.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “attachment means”, “attachment counter-means”, “lugs” or “collection means”.
The specification is also objected to for not having any headings “background”, “summary”, “brief description of the drawings” and “detailed description” are missing.
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.
The limitations “attachment means” and “attachment counter-means” invoke 35 U.S.C. 112(f). For purposes of examination these imitation have been deemed to claim where the attachment means are wings 35 with free end 48 and hook 49, hinged at reduced section 44 (paragraphs [0035]-[0037]) and where the counter-means are windows 31 with edge 70 (paragraphs [0034] and [0041]).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 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 “conventional” phial in claim 1 is a relative term which renders the claim indefinite. The term “conventional” 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. For purposes of examination the indefinite limitation has been deemed to claim and type of phial.
Regarding claim 1, the limitation “in a test tube which in itself is known” renders the claim indefinite. It is not understood what is meant by this limitation, and how it limits the system and test tube itself, and even if the test tube is positively claimed. For purposes of examination the indefinite limitation has been deemed to claim solely a “test tube”.
Regarding claim 1, the limitation “a container for collection of a first blood taken in a test tube” renders the claim indefinite, because it is unclear whether the container and the test tube are the same element or different elements. Later the claim says “this container or test tube”, which suggests the same. For purposes of examination the indefinite limitation has been deemed to claim the container and the test tube to be the same element.
Regarding claim 1, the limitation “said collection means being lugs” lacks proper antecedent basis. It is unclear whether this limitation refers to the attachment means, the counter-means, or something else. For purposes of examination the indefinite limitation has been deemed to claim the attachment means.
The term “released in a one-way manner” in claim 1 is a relative term which renders the claim indefinite. The term “one-way manner” 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. Claim 1 recites no direction, so it’s unclear what the one way is relative to. For purposes of examination the indefinite limitation has been deemed to claim releasable by only a single movement of the element relative to the retention unit.
Regarding claim 1, the limitation “a cavity which can contain the test tube totally” renders the claim indefinite. In FIG. 67, the stopper 61 of test tube 37 sits within first part 40, not second part 53 (paragraphs [0038]-[0040]). The claim says the second part’s cavity contains the test tube “totally”. Furthermore, it is unclear what “totally” requires, and read literally conflicts with the disclosure. For purposes of examination the indefinite limitation has been deemed to claim the second part’s cavity receives the tube body.
Regarding claim 1, the limitation “the bottom” lacks antecedent basis.
Regarding claim 1, the limitation “the insertion therein of the phial” renders the claim indefinite. It is unclear which end is meant relative to the first part. For purposes of examination the indefinite limitation has been deemed to claim the inner cavity of the retention unit.
Regarding claim 2, the limitation “a container portion” and “an inner cavity” render the claim indefinite because claim 1 already recites “a portion for containing the test tube” and “a cavity” so these are double inclusions of already claimed subject matter. For purposes of examination the indefinite limitation has been deemed to claim the same limitations as set forth in claim 1.
Regarding claim 3, the limitation “large openings in the vicinity of its closed end” renders the claim indefinite. “Large” and “in the vicinity” are relative terms with no standard in the spec. Furthermore, “its closed end” lacks clear antecedent basis. For purposes of examination the indefinite limitation has been deemed to claim openings in the second part adjacent to its closed end, sized to allow extraction of the tube.
Regarding claim 6, the limitation “close to the second end of the cavity” and “this position” render the claim indefinite. “Close to” is a relative term. The limitation “the second end of the cavity” lacks antecedent basis. “This position” has is unclear as to what position is being references. For purposes of examination the indefinite limitation has been deemed to claim the element adjacent to the second end of the retention unit.
Regarding claim 9, “said cylindrical unit”, “the movement of the component”, “the second end of the cavity of the cylindrical unit” and “the wings or lugs” all lack clear antecedent basis.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance:
Claims 1-9 are allowable over the prior art of record. The most relevant prior art of record includes WO 2020/061075 A1 (hereinafter, ‘075 cited in IDS, see cite 4 under Foreign Patent Documents). ‘075 teaches a hollow retention unit (a culture-bottle holder) with a needle, with first and second portions (FIG. 4, stepped housing 428A-428B), a trap (adapter 230) and tube (container assembly 210) as an adapter pre-assembled with an evacuated, and attachment means being flexible tabs on the adapter that engage the holder (FIG. 10, tab portions 1031 with projection portions 1032 in recesses 1022). However, ‘075 does not expressly disclose, teach or suggest the openings in the retention unit (the holder has recesses and a flange, not openings), one-way release (no release in a one-way manner after the first blood is taken) and closed-bottom second part (no second part extending from the first part with a closed-bottom cavity that contains the test tube totally – the adapter only grips the cap).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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