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 .
Applicant’s filing of claims 24-42 on 7/18/23 is acknowledged. Claims 1-23 were canceled. Claims 24-42 are pending and are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/18/23 was acknowledged. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See e.g., [0048] and [0084] of PG Pub.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the lofted fluid passageway (claim 24); fluids entering the in-line tester via the inlet are directed so as to form a flat sheet of fluid with a substantially linear front that passes across a rear surface of the said colorimetric tester (claim 24) comprising must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 24-42 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.
Claim 24 is rejected because 1) the scope of the preamble is unclear; 2) “an inlet connectable in use to an NG tube” is unclear; 3) “connectable in use to a vacuum source” is unclear; 4) “an exhaust port in fluid communication with air surrounding the main body” is unclear; 5) “the in-line tester additionally comprising, and each of the following being connected in-line with the fluid passageway” is unclear; and 6) “fluids entering the in-line tester via the inlet are directed so as to form a flat sheet of fluid with a substantially linear front that passes across a rear surface of the said colorimetric tester” is unclear.
Claims 24 and 33 is rejected because it claims a process, e.g., “in use” in a system claim, which is an apparatus-type of claim. Thus, it is unclear how the “in use” step structurally further defines the claimed system. For examination purposes, the claim language will be given the appropriate weight and interpreted as functional claim language.
Claim 39 is rejected because it is unclear how the claim language structurally further defines the claimed in-line tester.
Claim Interpretation
The Office asserts that terms and phrases like “manufactured” and “wherein” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “manufactured” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. Similarly, a “wherein” clause may have a limiting effect on a claim if the language limits the claim to a particular structure. MPEP 2111.04. The determination of whether a “wherein” clause is a limitation in a claim depends on the specific facts of the case. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
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.
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 24-42 are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher (US Pub. No. 2019/0167171, cited in IDS) in view of Cecca et al. (“Cecca,” US Pub. No. 2019/0021702, cited in IDS).
As to claim 24, Gallagher discloses an in-line tester comprising main body (e.g., main body in [0057] et seq.), an inlet (inlet in [0057] et seq.) connectable in use to an NG tube (NG tube in [0057] et seq.), an outlet (outlet in [0057] et seq.), connectable in use to a vacuum source (e.g., [0057] et seq.), an exhaust port ([0057] et seq.) in fluid communication with air surrounding the main body and a fluid passageway interconnecting the inlet and the outlet, the in-line tester additionally comprising, and each of the following being connected in-line with the fluid passageway: a lofted fluid passageway (e.g., [0058] et seq.) comprising a loft that transitions from a circular cross-section to a rectangular cross-section, said lofted fluid passageway being located between the inlet and a first chamber containing a colorimetric tester (e.g., [0032] et seq.), the rectangular cross-section being substantially perpendicular to an edge of the colorimetric tester of the first chamber such that, during aspiration, fluids entering the in-line tester via the inlet are directed so as to form a flat sheet of fluid with a substantially linear front that passes across a rear surface of the said colorimetric tester (this is considered intended use and/or functional claim language, also see 112 rejection above); a second chamber also containing a colorimetric tester (e.g., [0032] et seq.); a first one-way valve (e.g., [0025] et seq.) in-line with the fluid passageway permitting the flow of fluids from the inlet to the outlet; a liquid-stop device (e.g., [0020] et seq.) interposed between the first and second chambers that permits the flow of gasses, but which inhibits or prevents the flow of liquids, towards the second chamber; and a reservoir (e.g., [0016] et seq.) interposed between the first and second chambers; the in-line tester further comprising: a second one-way valve (e.g., [0025] et seq.) permitting the flow of fluids from the outlet to the exhaust port; and the in-line tester being characterised by: a first port connecting the fluid passageway upstream of the attachment formation to the interior of the container; and a second port connecting the fluid passageway downstream of the attachment formation to the interior of the container (e.g., [0018] et seq.).
Regarding claims 24 and 28-29, Gallagher does not specifically disclose the reservoir comprising a container that is detachably connected to the main body; and the main body comprising an attachment formation comprising: a seal that sealingly and detachably connects the container to the main body. Cecca discloses in e.g., [0049] et seq., a vacutainer 44, removably connected to one end of said collecting duct 41. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have a container that is detachably connected to the main body because it would be desirable to allow the container to be reusable.
As to claim 25, see e.g., fig. 2 et seq. of Gallagher.
As to claims 26 and 31, see e.g., [0016] et seq. of Gallagher.
As to claims 27 and 30, see e.g., [0018] et seq. of Gallagher.
As to claim 32, see e.g., [0057] et seq. of Gallagher.
As to claim 33, see e.g., [0003] et seq. of Gallagher.
As to claim 34, see e.g., [0018] et seq. of Gallagher.
As to claims 35-36, see e.g., [0016] et seq. of Gallagher.
As to claim 37, see e.g., [0023] et seq. of Gallagher.
As to claims 38-39, see e.g., [0016] et seq. of Gallagher.
As to claim 40, see e.g., [0017] et seq. of Gallagher.
As to claims 41 and 42, see e.g., [0109] et seq. of Gallagher.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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, Lyle Alexander can be reached at 571-272-1254.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LORE R JARRETT/Primary Examiner, Art Unit 1797
3/21/2026