Detailed Office Action
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 14 August, 2026. Claims 1-19 are pending in the instant application. Applicant’s election of Group III (claims 2-17) with traverse is noted. Applicant argues that search and examination of all the groups would not constitute an undue burden on the Office. Applicant’s argument has been carefully considered but is unpersuasive for the reasons of record clearly set forth in the requirement mailed 16 June, 2026. The requirement is still deemed proper and is therefore made FINAL. Claims 1, 18, and 19 have been withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.
37 C.F.R. § 1.98
The information disclosure statements filed 24 June, 2024, and 22 August, 2024, have been placed in the application file and the information referred to therein has been considered.
37 C.F.R. § 1.84
Acknowledgement is hereby made of receipt and entry of the drawings filed on 12 April, 2024. Applicant is reminded that color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 C.F.R. § 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 C.F.R. § 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 C.F.R. § 1.84(b)(2).
Accordingly, the drawings are objected to because they are in color and a petition to accept color drawings has not been received and granted. Corrected drawing sheets in compliance with 37 C.F.R. § 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 C.F.R. § 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.
Marks Used in Commerce
The use of the term Simple WesTM and JesTM which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. See M.P.E.P. § 608.01(v).
Graham v. Deere
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 U.S.P.Q. 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.
35 U.S.C. § 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 of this title, 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.
Claims 2-17 are rejected under 35 U.S.C. § 103 as being unpatentable over the combined teachings of Li et al. (2017), Plotzki et al. (2016), Rustandi et al. (2016), and Gu et al. (2013). The claims are directed toward a method for detecting an anti-porcine cytomegalovirus (PCMV) antibody in a biological sample from a subject, the method comprising:
(a) introducing into one or more capillaries of a microfluidic device one or more engineered PCMV antigens; a biological sample from the subject,one or more anti-immunoglobulin antibodies, and one or more chemiluminescent molecules;
(b) separating the one or more engineered PCMV antigens electrophoretically;
(c) immobilizing the one or more electrophoretically separated engineered PCMV antigens on a capillary wall;
(d) contacting the one or more immobilized engineered PCMV antigens with the biological sample from the subject;
(e) incubating the one or more immobilized engineered PCMV antigens with the biological sample for about 10 minutes to about 120 minutes; and
(f) detecting the binding of the one or more engineered PCMV antigens to the biological sample by immunodetection and/or chemiluminescent detection, wherein the presence of an immunodetection signal and/or a chemiluminescent signal indicates the presence of one or more anti-PCMV antibodies in the biological sample.
Li et al. (2017) disclose the detection of HCMV antibodies using capillary Western WesTM. HCMV gB-specific antibodies were detected using this system. Recombinant HCMV gB antigens were utilized in antibody capture assays. Details of the protocol were provided by Rustandi et al. (2016). This teaching provides steps (a)-(e) in the aggregate and is the same detection system disclosed in the specification. These teachings do not disclose the utilization of PCMV recombinant antigens.
However, Plotzki et al. (2016) provides a Western blot assay for the detection of PCMV-specific antibodies. In particular, two recombinant proteins from the PCMV gB protein were used as capture antigens in this assay. Gu et al. (2013) provides the complete nucleotide and amino acid sequences for PCMV, including the glycoproteins. These sequences correspond to those currently claimed.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare recombinant PCMV glycoprotein and U100 (gQ) antigens, as taught by Plotzki et al. (2016) and Gu et al. (2013), and to employ these antigens in the quantitative capillary electrophoresis (CE) Western blot method of Li et al. (2017) and Rustandi et al. (2016). One of ordinary skill in the art would have been motivated to employ this method because it is automated, rapid, and quantitative as compared to other detection methods.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Michael Allen, Ph.D., can be reached at (571) 270-3497. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
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Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671
30 September, 2026
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