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 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.
DETAILED NON-FINAL ACTION
This is the initial Office Action (OA), on the merits, based on the 18/249,325 application filed on April 17, 2023. Claims 1-23 are pending. Claims 14-23 are examined, on the merits, in this Office action. The examined claims are directed to an apparatus.
Election/Restrictions
Applicant’s election without traverse of Group III, claims 14-23, in the reply filed on January 9, 2026 is acknowledged. Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The Examiner has considered the information disclosure statements (IDS) submitted on 04/17/2023 and 5/10/2024. Please refer to the signed copy of the PTO-1449 form attached herewith.
Claim Interpretation
The examined claims are apparatus claims requiring only the positively recited structural components, although structured with physical features that can perform the stated functions or accomplish the intended uses. Functional limitations state either an intended use or operation, a manner of operating a device, apparatus or system, or what the apparatus/system does. Apparatus claims cover what a device is, not what a device does. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Also, a claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Of course, in the patentability analysis of these apparatus claims, functional features are considered/not ignored and Applicant can and should employ such language where appropriate and helpful. However, if a prior art structure is capable of performing the intended use, or if such apparatus can operate in the manner described, then it meets the claim limitation (MPEP §§ 2114, 2173.05(g)).
The recited antigen and saliva-containing solution, for example, are considered materials potentially contained within, transient or passing through, generated or produced, or otherwise worked upon by the apparatus/system rather than structural components of the apparatus.
According to the MPEP §2115 [R-2], a material or article worked upon does not limit apparatus claims: Expressions relating an apparatus to contents thereof during an intended operation are of no significance in determining patentability of apparatus claims. Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, “inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)).
In summary, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997).
In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification. However, specific limitations from the specification are not read into the claims. See MPEP §§2111, 2173.01 I. Unless otherwise specified, any citation to Applicant’s specification will generally refer to the original and any substitute or amended specification rather than a published application.
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 14-23 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 pre-AIA the applicant regards as the invention.
Alternatively or in addition, claims 14-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements and/or essential structural cooperative relationships of elements and/or essential steps, such omission amounting to a gap between the necessary structural connections, essential elements or essential steps. See MPEP § 2172.01.
Claim 14 recites “an elution buffer solution of a second volume configured to release the antigen bound to the negatively-charged surface of the binding medium to produce a resulting antigen solution . . .”
It is unclear how to interpret ‘an elution buffer solution’ in the context of this apparatus claim. On the one hand this appears to be a material worked upon by the system. However, it appears to be a requirement for operation of the system. The specification mentions that a collection apparatus with an opening for introducing an amount of elution buffer solution into a space ([0009], [0089]), implying that the buffer solution is not necessarily a structural component of the system. The disclosure also references an elution buffer container 122, 322 ([0036], [0037], [0061]). However, a collection apparatus or buffer container is not mentioned in the claim.
By contrast the reagent member contains one or more reagents where one may readily interpret the reagent as incorporated into the system.
Therefore, it is unclear how the elution buffer solution is incorporated into the system.
Claims 15-23 depend on claims 14.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. The inventive entity for a particular application is based on some contribution to at least one of the claims made by each of the named inventors. MPEP §2137.01.
Claims 14-23 are rejected under 35 U.S.C. 103 as being unpatentable over Egan et al. (US20100323343, Egan) in view of Muller et al. (Concentration of Influenza Virus by a Cation Exchange Resin, 1952, pp. 27-29)(IDS of 04/17/2023) and Moreno-Contreras et al. (Saliva Sampling and Its Direct Lysis, J. of Clinical Microbiology, 9-2020, 6 pages, Moreno).
Note that these are apparatus claims. In the patentability analysis below, the italicized portions represent functional aspects, whereas the bolded portions represent structure. The analysis considers the alternate concepts of the various potential embodiments in a particular reference.
Regarding claims 14-16, 21 and 23, Egan discloses a collection system configured to collect and concentrate an antigen of a respiratory virus (Abstract), comprising:
a collection device configured to receive a sample of saliva-containing solution of a first volume ([0038], [0039], [0143], [0144], where one may collect body fluid such as saliva as a sample);
a reagent member having one or more reagents configured to contact the sample within the collection device and to lyse the sample so as to release antigen in the sample ([0076], [0105], [0141], [0143], [0144]);
a binding medium configured to contact the lysed sample and bind the antigen in the lysed sample to the binding medium ([0014], [0038]-[0043]); and
an elution buffer solution of a second volume configured to release the antigen of the binding medium to produce a resulting antigen solution (interpreted here as a material worked upon by the system).
Therefore, Egan discloses the claimed invention, except wherein
the binding medium has a negatively charged surface, and
an elution buffer solution of a second volume configured to release the antigen bound to the negatively-charged surface of the binding medium to produce a resulting antigen solution;
wherein the second volume is less than the first volume.
Egan mentions potential use of silica gels which will typically have a negative charge (Egan, [0163]).
With respect to the elution buffer solution and its configuration, which may be employed to release bound purified target molecules from a column or matrix, Examiner addresses this aspect below, but as presently recited, this does not appear to be clearly disclosed as a structural component of the system.
Muller discloses the application of ion exchange resins to the separation of closely related chemical substances by adsorption or exchange of ions which has proven to be a valuable adjunct in the purification and concentration of biological products (p. 27, 1st col.), which one may employ to purify and concentrate strains of the influenza virus (p. 27, 2nd col.). Although Muller employs a cation exchange resin in the example, the disclosure broadly allows for the use of ion exchange resins. Alternately, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to routinely experiment with alternate ion exchange resins and to thereby employ any suitable ion exchange resin which resin will be suitable as a negatively charge surface capable of assisting in bind the antigen in the lysed sample.
Muller also teaches an elution buffer solution, where “columns were then eluted with four 5 ml portions of 10% sodium chloride and the eluates were collected separately” (p. 28, 1st col., 2nd ¶).
Also, Moreno discloses research related to the efficient use of lysed saliva samples that can serve as a suitable source for viral RNA detection (Abstract). Moreno teaches the use of nucleic acid extraction in an elution buffer protocol (“purified RNA was eluted in 60 µl of elution buffer,” p. 2).
At the time when the claimed invention was effectively filed, it would have been obvious to an ordinarily skilled artisan to include an appropriate volume of elution buffer solution, where through experimentation, such elution volume may be less than the first volume of saliva-containing solution, to work in conjunction with an appropriate binding medium since this is a traditional method of releasing bound target molecules, which facilitates the collection, purification and concentration of the respiratory virus within the apparatus.
Additional Disclosures Included: Claim 15: The reagent member includes a reagent configured to increase a pH of the sample (Egan, [0308]); Claim 16: The collection device is configured to collect a sample of saliva-containing solution having a first concentration of antigen and the elution buffer solution is configured to release antigen into the elution buffer solution to produce a resulting solution containing the antigen in a second concentration, wherein the second concentration of antigen in the resulting solution is higher than the first concentration of antigen in the sample (claim 14 analysis, where the higher concentration implies that the antigen is being concentrated as expected; Examiner also interprets this as a manner of operating the apparatus rather than a further structural limitation; alternately, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to collect the collect the saliva at a given concentration and release the antigen at a higher concentration for effective purification/concentration); Claim 21: The reagent member and the binding medium are located within the collection device (claim 14 analysis; alternately, it would have been a matter of obvious engineering choice to one of ordinary skill in the art before the effective filing date of the claimed invention to suitably locate all components with the collection device as a matter of convenience and to reduce the footprint of the device); and Claim 23: The collection system of claim 14 wherein the antigen is from a coronavirus or an influenza virus (Egan, [0185], [0330]; Muller, Title; Moreno, Abstract).
Regarding claim 17-20 and 22, Egan, Muller and Moreno combined discloses or suggests the collection system of claim 14 except further comprising a syringe including the binding medium, the syringe configured to couple to the collection device and draw the sample from the collection device through the binding medium so as to bind antigen in the sample to the negatively-charged surface of the binding medium.
Egan discloses the use of a syringe for potential introduction of a gas ([0100]). Also disclosed is the use of a pipette and suitable containers ([0143], [0150]).
When the claimed invention was effectively filed, it would have been obvious to one of ordinary skill in the art to employ a syringe with the binding medium and suitable contained for holding and later dispensing all necessary materials, since a syringe is a traditional means of drawing and dispensing large sample volumes and the like. Also, a pipette is a method of enacting small-volume measurement, and a container is a traditional manner of holding solutions and the like before its eventual use or for later storage.
Additional Disclosures Included: Claim 18: The collection system further comprises an elution buffer solution container containing the elution buffer solution, wherein the syringe is configured to couple to the elution buffer solution container and draw elution buffer solution from the elution buffer solution container through the binding medium so as to release antigen into the elution buffer solution (claim 17 analysis); Claim 19: The collection system further comprises a pipette including the binding medium, the pipette configured to draw the sample from the collection device through the binding medium so as to bind antigen to the negatively- charged surface of the binding medium (claim 17 analysis); Claim 20: The pipette includes a first bulb for use during capture of antigen from the sample by the binding medium and a second bulb for use during release of antigen from the binding medium by the elution buffer solution (claim 17 analysis, where a pipette will have at least one bulb, and a pipette with a second bulb is merely a duplication of parts that is expected to provide greater fluid control; this has no patentable significance unless a new and unexpected result is produced); and Claim 22: The reagent member comprises one or more dry reagents and wherein the binding medium comprises a plurality of resin structures each having a negatively-charged surface (Egan, [0308], [0374]; where Muller uses a plurality of resin structures).
Conclusion
Examiner recommends that Applicant carefully review each identified reference and all objections/rejections before responding to this office action to properly advance the case in light of the pertinent objections/rejections and the prior art. With respect to the patentability analysis, Examiner has attempted to claim map to one or more of the most suitable structures or portions of a reference. However, with respect to all OAs, Examiner notes that citations to specific pages, columns, paragraphs, lines, figures or reference numerals, in any prior art or evidentiary reference, and any interpretation of such references, should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably disclosed and/or suggested to one having ordinary skill in the art. The use of publications and patents as references is not limited to what one or more applicant/inventor/patentee describes as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. MPEP §2123.
Examiner further recommends that for any substantive claim amendments made in response to this Office Action, or to otherwise advance prosecution, or for any remarks concerning support for added subject matter or claim priority, that Applicant include either a pinpoint citation to the original Specification (i.e. page and/or paragraph and/or line number and/or figure number) to indicate where Applicant is drawing support for such amendment or remarks, or a clear explanation indicating why the particular limitation is implicit or inherent to the original disclosure.
Electronic Inquiries
Any inquiry concerning this communication or an earlier communications from the examiner should be directed to Hayden Brewster whose telephone number is (571) 270-1065. The examiner can normally be reached M-Th 9 AM - 4 PM.
Alternatively, to contact the examiner, Applicant may send a communication, via e-mail or fax. Examiner’s direct fax number is: (571) 270-2065. Examiner's official e-mail address is: "Hayden.Brewster@uspto.gov." However, since e-mail communication may not be secure, Examiner will not respond to a substantive e-mail unless Applicant’s communication is in accordance with the provisions of MPEP §502.03 & related sections that discuss the required Authorization for Internet Communication (AIC). Nonetheless, all substantive communications will be made of record in Applicant’s file.
To facilitate the Internet communication authorization process, Applicant may file an appropriate letter, or may complete the USPTO SB439 fillable form available at https://www.uspto.gov/sites/default/files/documents/sb0439.pdf, preferably in advance of any substantive e-mail communication. Since one may use an electronic signature with this particular form, Applicant is encouraged to file this form via the Office’s system for electronic filing of patent correspondence (i.e., the electronic filing system (Patent Center)). Otherwise, a handwritten signature is required. In addition to Patent Center, Applicant can submit their Internet authorization request via US Postal Service, USPTO Customer Service Window, or Central Fax. Examiner can also provide a one-time oral authorization, but this will only apply to video conferencing. It is improper to request Internet Authorization via e-mail.
Examiner interviews are available via telephone, in-person, and via 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) form available at http://www.uspto.gov/interviewpractice, or Applicant may call Examiner, if preferable. Applicant can access a general list of patent application forms at either https://www.uspto.gov/patent/forms/forms-patent-applications-filed-or-after-september-16-2012 (applications filed on or after September 16, 2012) or https://www.uspto.gov/patent/forms/forms (applications filed before September 16, 2012). Note that the language in an AIR form is not a substitute for the requirements of an AIC, where appropriate. The mere filing of an Applicant Initiated Interview Request Form (PTOL-413A) or a Letter Requesting Interview with Examiner, in EFS-Web, may not apprise Examiner of such a request in a timely manner.
If attempts to reach the Examiner are unsuccessful, Applicant may reach Examiner’s supervisor, Bobby Ramdhanie at 571-270-3240. The central fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/HAYDEN BREWSTER/Examiner, AU 1779
Prosecution Insights