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 .
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.
Claim Objections
Claim(s) 4-21 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claim(s) 4-21 have not been further treated on the merits.
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.
Claim(s) 1-21 is/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.
For claim 1, the claim terms “a biological sample” (line 3) and “a biological sample” (line 10) are ambiguous. It is unclear whether the same or different biological samples are being referred to. The claim is examined under the former interpretation.
For claim 1, the claim terms “a threaded connection member” (line 23) and “a threaded connection member” (line 35) are ambiguous. It is unclear whether the same or different threaded connection members are being referred to. The claim is examined under the latter interpretation.
For claim 1, the claim term “the proximal open end” (lines 35-36) is ambiguous. Claim 1 previously recites a proximal open end of a sample collector and a proximal open end of sample collection vessel and it is unclear which proximal open end is being referred to. The claim is examined as the proximal open end of the sample collection vessel.
For claim 1, the claim terms “a connection member” (line 5) and “a connection member” (line 39) are ambiguous. It is unclear whether the same or different connection members are being referred to. The claim is examined under the latter interpretation.
For claim 3, the claim term “the sealing engagement” (line 1) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 5, the claim term “the proximal open end” (line 2) is ambiguous. Claim 1, from which claim 5 depends, previously recites a proximal open end of a sample collector and a proximal open end of sample collection vessel and it is unclear which proximal open end is being referred to. The claim is examined as the proximal open end of the sample collection vessel.
For claim 9, the claim language “about 0.1 mL to about 10 mL” is ambiguous. How much is “about” 0.1 ml to “about” 10 ml? Are 0.099 ml and 10.01 ml included? Are 0.09 ml and 10.1 ml included? Are 0.1 ml and 11 ml included? The claim is examined as meaning “0.1 mL to 10 mL.”
For claim 12, the claim language “about one-quarter turn” is ambiguous. How much beyond one quarter can the turn occur and still be considered “about” one-quarter turn? The claim is examined as meaning “one-quarter turn.”
For claim 14, the claim language “about one-quarter turn” is ambiguous. How much beyond one quarter can the turn occur and still be considered “about” one-quarter turn? The claim is examined as meaning “one-quarter turn.”
For claim 17, the claim terms “a biological sample” (line 2) and “a biological sample” (line 3) are ambiguous. It is unclear whether the same or different biological samples are being referred to. The claim is examined under the former interpretation.
For claim 18, the claim language “about one-quarter turn” is ambiguous. How much beyond one quarter can the turn occur and still be considered “about” one-quarter turn? The claim is examined as meaning “one-quarter turn.”
For claim 19, the claim language “about one-quarter turn” is ambiguous. How much beyond one quarter can the turn occur and still be considered “about” one-quarter turn? The claim is examined as meaning “one-quarter turn.”
For claim 20, the claim terms “a biological sample” (line 2) and “a biological sample” (line 3) are ambiguous. It is unclear whether the same or different biological samples are being referred to. The claim is examined under the former interpretation.
For claim 21, the claim language “about one-quarter turn” is ambiguous. How much beyond one quarter can the turn occur and still be considered “about” one-quarter turn? The claim is examined as meaning “one-quarter turn.”
Dependent claim(s) 2-21 fail to cure the ambiguity of independent claim 1, thus claim(s) 1-21 is/are rejected under 35 U.S.C. 112(b).
Allowable Subject Matter
Claim(s) 1-21 would be allowable if rewritten or amended to overcome the objections and rejection(s) under 35 U.S.C. 112(b), set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: U.S. Patent Application Publication No. 2020/0156056 to Williams et al. (hereinafter “Williams”) discloses a biological sample collection system (Abstract), the system comprising: a containment vessel (102) (Fig. 1) (para [0046]) comprising: a first open end for receiving a biological sample (end of the left side in Fig. 1 that is open), a second end comprising a sample storage chamber (103) (Fig. 1) (para [0046]), and a connection member (114) (Fig. 1) (para [0048]) disposed at the first open end (as can be seen in Fig. 1) (see para [0048]); a sample collection assembly (Examiner’s Note: made up of the elements it comprises) configured to be connected to the first open end of the containment vessel when the biological sample is being collected (see Fig. 1 and para [0046]-[0048]), the sample collection assembly comprising: a sample collector (“funnel,” para [0046]) comprising: a proximal open end for receiving a biological sample (see Fig. 1); a distal open end in fluid communication with the proximal open end (see Fig. 1); a valve stem (106) (Fig. 1) (para [0046]) comprising: a first stem end (unlabeled, but as can be seen in Fig. 1), and an opposing second stem end (unlabeled, but as can be seen in Fig. 1) comprising a valve face (108) (Fig. 1) (para [0046]), the valve stem extending along a longitudinal axis of the sample collector and in a direction away from the proximal open end of the sample collector (unlabeled, but as can be seen in Fig. 1); and a sample collection vessel configured to be in fluid communication with the sample collector when the biological sample is being collected, the sample collection vessel comprising: a proximal open end for receiving the biological sample from the sample collector; a distal open end configured to be in fluid communication with the proximal open end; one or more walls defining a sample receiving area and a valve seat, wherein the valve seat is complementary to the valve face of the sample collector; a threaded connection member disposed at the proximal open end, wherein the threaded connection member is complementary to and configured to be engaged with the threaded connection member of the sample collector; and a connection member (112) (Fig. 1) (para [0048]) disposed at the distal open end (as can be seen in Fig. 1), wherein the connection member is complementary to and configured to be engaged with the connection member of the containment vessel (para [0048]); wherein the valve stem and the valve seat form a valve (104) (Fig. 1) (para [0046]) comprising: a closed configuration (para [0048]-[0050]); and an open configuration (para [0048]-[0050]).
However, the prior art of record does not disclose and would not have rendered obvious the ordered combination of elements recited in the claim(s).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
