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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-10 in the reply filed on 04/24/2026 is acknowledged. The traversal is on the ground(s) that Groups I, II, and III inventions are not independent or distinct because they share overlapping subject matter (e.g., a biological specimen container, an openable seal, and a gas sensor). This is not found persuasive. Although there may be some overlap of the search for Groups I, II, and III, there is nothing to indicate that the search would be coextensive. Furthermore, the office action dated 01/27/2026 explains why Groups I, II, and III do not overlap the scope (See MPEP § 806.05 and CTRS dated 01/27/2026). Therefore, the extra search and/or examination burden for addressing Groups I, II, and III poses a serious burden to the examiner which makes the restriction requirement proper.
Therefore, the requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claim(s) 1-20 is/are pending in the application.
Claim(s) 11-20 is/are withdrawn from consideration.
Claim(s) 1-10 are examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10/06/2023, 04/25/2024, and 12/04/2025 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner.
Claim Rejections - 35 USC § 102
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 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 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.
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.
Claim(s) 1-2, 5, and 10 is/are rejected under 35 U.S.C 102(a)(1) as being anticipated by Blackwell (WO 2020044004).
Regarding claim 1, Blackwell discloses a device (an apparatus 2: pg. 9, ¶4, and Figs. 1-2) for providing access to a biological specimen container (a first container 4: pg. 9, ¶4, and Figs. 1-2), the device comprising:
a fitting sized and shaped (securing means 12 enables a second container 10 to be secured to a lid 6: pg. 9, ¶5, and Figs. 1-2) to be coupled to a sealed aperture of the specimen container (at/near element 18: Figs. 1-3), the fitting including a lumen for allowing fluid communication between first and second ends of the lumen (Figs. 1-6);
a perforator (opener means 20 comprises a puncturing formation 46: pg. 10, ¶2; pg. 12, ¶3; and Figs. 1-3) configured to irreversibly sever and unseal an openable fluid-impermeable seal in the sealed aperture of the specimen container (an openable portion 18: pg. 10, ¶2; pg. 12, ¶3; and Figs. 1-3) via coupling of the fitting to the aperture (Figs. 1-3) and to connect the first end of the lumen to a fluid headspace of the specimen container (Figs. 1-3); and
a user-replaceable sealing enclosure sized and shaped (a housing 24: pg.10, ¶2; and Figs. 1-3) to house at least one biological specimen growth indicator at the second end of the lumen (a response chart 14: pg. 10, ¶1 – pg. 11, ¶1; pg. 12, ¶5 – pg. 13, ¶1; and Figs. 1-3), the sealing enclosure selectively user- engageable to confine fluid escaping from the second end of the lumen of the fitting, after the seal has been unsealed by the perforator (pg. 14, ¶3; and Figs. 1-3).
Regarding claim 2, Blackwell further discloses the at least one biological specimen growth indicator arranged to be enclosed by the sealing enclosure separately from an ambient environment external to the specimen container (Figs. 1-3 and 7-11).
Regarding claim 5, Blackwell further discloses the perforator includes a seal dilator that is sized and shaped to irreversibly sever the openable seal of the specimen container (opener means 20 comprises a puncturing formation 46: pg. 12, ¶3; and Figs. 1-3) so as to displace greater than 20% of a surface area of the openable seal (the perforator of Blackwell is capable of displacing greater than 20% of a surface area of the openable seal 18: Figs. 1-3).
Regarding claim 10, Blackwell further discloses at least one of the fitting or the sealing enclosure is formed of at least one of a translucent or transparent material (a viewing portion 32 made of transparent plastics material: pg. 10, ¶3 – pg. 11, ¶1 and Figs. 1-2) to allow imaging into the specimen container while the sealing enclosure is engaged (pg. 10, ¶3 – pg. 11, ¶1 and Figs. 1-2).
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 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.
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) 3 is/are rejected under 35 U.S.C 103 as being unpatentable over Blackwell (WO 2020044004) in view of Christensen (US PAT 5942408).
Regarding claim 3, Blackwell does not disclose the at least one biological specimen growth indicator includes a biological culture media arranged to be contacted by fluid from the specimen container via liquid travel from the specimen container through the lumen.
In an analogous art for being directed to solve the same problem, determine growth of indicator organisms, Christensen discloses a device comprising a biological indicator 12 within a first chamber 17 and a second chamber 18 (Col. 8, line 50 – Col. 9, line 16 and Figs. 3-4). Christensen further discloses the biological indicator comprising a biological culture media (cellulose substrate: Col. 5, lines 14-28) arranged to be contacted by fluid from the chamber 17 for the benefit of determining growth of indicator organism to indicate a successful sterilization, biological inactivation process or disinfection process (Col. 9, lines 10-17).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the device of Blackwell in view of Christensen by incorporating a biological culture media within the at least one biological specimen growth indicator, in order to determine growth of indicator organism, as suggested in Col. 9, lines 10-17 of Christensen.
Claim(s) 4 is/are rejected under 35 U.S.C 103 as being unpatentable over Blackwell (WO 2020044004) in view of Ishimaru (US PGPUB 20210207072).
Regarding claim 4, Blackwell further discloses the at least one biological specimen growth indicator 14 comprising response portions which are contacted by the liquid specimen, and which become differently colored to indicate different characteristics present in the liquid specimen (pg. 12, ¶5 – pg. 13, ¶1), but does not disclose the at least one biological specimen growth indicator includes a gas sensor including at least one of: a field effect transistor (FET) including at least one of: carbon nanotube (CNFET); silicon carbide (SiCFET); metal-oxide-silicon (MOSFET); graphene (GFET); transition metal dichalcogenide (TMDFET); or black phosphorus (BPFET); a camera; a spectroscopic imaging sensor; a hyperspectral imaging sensor; a colorimetric imaging sensor; a fluorescence response imaging sensor; or a chromatic sensor or array of chromatic sensors.
In an analogous art for being directed to solve the same problem, having a gas sensor to identify microbial species, Ishimaru discloses a cell detector 4 comprising a culture bottle 400, a gas sensor 402, wherein the culture bottle 400 containing a culture medium 403 (¶0094 and Fig. 8). Ishimaru further discloses the gas sensor comprising a camera 406 (¶0100 and Fig. 8) and/or a colorimetric imaging sensor (identification of the microbial species based on the color tone of the gas sensor: ¶0099-0100) for the benefit of identify of the microbial species (¶0099-0100).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the device of Blackwell in view of Ishimaru by having a gas sensor as a biological specimen growth indicator and wherein the gas sensor comprising a camera and/or a colorimetric imaging sensor, in order to identify of the microbial species, as suggested in ¶0099-0100 of Ishimaru.
Claim(s) 6-7 is/are rejected under 35 U.S.C 103 as being unpatentable over Blackwell (WO 2020044004).
Regarding claim 6, Blackwell further discloses the sealing enclosure 24 includes a cap configured to couple with a coupling feature of the fitting 12 (Figs. 1-3), but Blackwell does not disclose the cap is removable and the cap is configured to removably couple with a coupling feature of the fitting.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the device of Blackwell by making the cap removable, as it has been held that constructing formerly integral structure in various elements involves only routing skill in art. One would have been motivated to make the cap separable/removable for the purpose of facilitating maintenance and disassembly (see MPEP § 2144.04 (V) (C)).
Regarding claim 7, Blackwell does not disclose the lumen includes a cross-sectional diameter greater than 3 mm; however, the lumen of Blackwell is configured to fit into the biological specimen container 4 (Figs. 1-6) and the container 4 is a tube of a diameter for fitting into laboratory test equipment (pg. 7, ¶1; thus, Blackwell discloses/suggests that the container has different diameters depending on which laboratory test equipment using).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the device of Blackwell by changing a cross-sectional diameter of the lumen to be greater than 3 mm, motivated by the desires to fit the lumen into the container for fitting into laboratory test equipment, and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)).
Claim(s) 8 is/are rejected under 35 U.S.C 103 as being unpatentable over Blackwell (WO 2020044004) in view of Corso (US PGPUB 20120305092).
Regarding claim 8, Blackwell does not disclose the device includes an internal fluid sensor for measuring at least one fluid condition within at least one of the lumen or the specimen container.
In an analogous art for being directed to solve the same problem, measuring fluid condition within a lumen/tube, Corso discloses a system for making fluidic connections to be established between tubes, ports, fluidic components and fluidic devices (Abstract, ¶0067, and Fig. 1). Corso further discloses the system comprising a sensor for measuring fluid condition within a fluid delivery system or a conduit/tube/lumen (¶0067).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the device of Blackwell in view of Corso by incorporating a fluid sensor within the lumen, in order to measure fluid condition within the lumen, as suggested in ¶0067 of Corso.
Claim(s) 9 is/are rejected under 35 U.S.C 103 as being unpatentable over Blackwell (WO 2020044004) in view of Corso (US PGPUB 20120305092), as applied to claim 8 above, and further in view of Repko (US PGPUB 20050268712).
Regarding claim 9, Blackwell/Corso does not disclose electrical contacts located external to the specimen container and electrically coupled to the internal fluid sensor, the electrical contacts configured to communicate internal fluid sensor data to an external location while the sealing enclosure is engaged.
In an analogous art for being directed to solve the same problem, providing electrical signals and communicate with fluid flow sensor, Repko discloses a disposable fluid flow sensor 100 comprising a flow channel tube 102 (¶0021 and Fig. 1). Repko further discloses electrical contacts 112/114/116/118/120/124/126/128 located external to the tube 102 (¶0021 and Fig. 1) for the benefit(s) of providing electrical signals and communicating with fluid flow sensor (¶0021).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the device of Blackwell in view of Repko by incorporating electrical contacts located external to the specimen container and electrically coupled to the internal fluid sensor, in order to provide electrical signals and communicate with the flow sensor, as suggested in ¶0021 of Repko.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781
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