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 .
Response to Amendment
The amendment filed 05/11/2026 is acknowledged. Regarding the Office action mailed 02/11/2026:
The objection to claim 15 for typographical errors is withdrawn in view of the amendment.
The rejection of claims 3, 5 and 15 under 35 USC 112(b) is withdrawn in view of the amendment.
The rejection of claim 15 under 35 USC 103 is maintained and reiterated below, modified to address the new limitations of claim 15.
A new rejection of claim 15 under 35 USC 112(b) is set forth below as necessitated by the amendment.
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 15 is 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.
In the newly added limitations at the end of the claim, certain features (e.g., sequence, linker, label, spacer) are recited to be “identical”, but it is not indicated as to what they are identical. It will be assumed for purposes of prior art that this means the feature is identical to the corresponding feature in all other probes of the plurality of probes. However, this should nevertheless be clarified.
In addition, the claim recites a “spacer” in the penultimate line, but no prior recitation of spacer is found in the claim, and the relationship of this “spacer” to the other elements recited for the probe is unclear. For purposes of prior art, “spacer” will be broadly construed in terms of its nature and location.
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 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.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Den Boom (WO 2009/073251 A1, IDS ref) in view of Polansky (US 2004/0023207).
Van Den Boom disclosed an assay in which multiple probes were used to detect multiple target sequences on the Y chromosome; see Example 4, beginning on page 50. These probes comprised a 3’ target-complementary portion and a 5’ target-non-complementary portion. The probes comprised LNA nucleotides between the two portions (LNA being nuclease-resistant) and 3’ phosphates or inverted deoxythymidine (which would prevent polymerase extension). The probes also comprised biotin (a label) at the 5’ end. In this example, on pages 51-54, 10 sets of primers and probes (one for each of the 10 targets on the Y chromosome) are disclosed. Within each set, three alternative versions of the probe are provided: one with no 3’ end modification, one with a 3’ phosphate modification, and one with a 3’ inverted dT modification. The three probe versions within a set are otherwise the same. For purposes of this rejection, the 3’ phosphate modified probes are used (though the inverted dT versions of the probes would also be applicable). The probes are as follows:
PNG
media_image1.png
54
828
media_image1.png
Greyscale
PNG
media_image2.png
44
794
media_image2.png
Greyscale
PNG
media_image3.png
44
786
media_image3.png
Greyscale
PNG
media_image4.png
50
878
media_image4.png
Greyscale
PNG
media_image5.png
54
848
media_image5.png
Greyscale
PNG
media_image6.png
48
798
media_image6.png
Greyscale
PNG
media_image7.png
60
934
media_image7.png
Greyscale
PNG
media_image8.png
62
824
media_image8.png
Greyscale
PNG
media_image9.png
52
896
media_image9.png
Greyscale
PNG
media_image10.png
48
834
media_image10.png
Greyscale
The Examiner has indicated with a box an “identical sequence” comprised by each of the cleavable hydrolysis products of the probes (the cleavable hydrolysis products span from the 5’ end to the 3’ end of the boxed sequences; the next nucleotide begins the target complementary portion of the probes). All probes contain a 5’ biotin as the “label”. While Van Den Boom does not elaborate on the linkage between the biotin and the 5’ nucleotide of the probe (i.e., the “linker”), it would have been obvious to one of ordinary skill in the art to use the same coupling chemistry and thus arrive at the same “linker” for each probe, as Van Den Boom provides no reason to use a different linkage for each probe. The remaining nucleotide sequence, between the 5’ biotin and the boxed sequence, constitutes a “spacer”, and this “spacer” is different in each probe (either having different number of nucleotides, or different sequence based on the incorporation of G’s among the A’s). The claim does not limit the nature or location of the “spacer”. The specification only indicates that spacers “are a subgroup of non-backbone modifications and are defined as chemical structures which are coupled to the 3’ and/or 5’ end of a nucleotide or between two nucleotides” (page 23, lines 8-10 of WO 2022/219122). Nucleotide sequences themselves are not precluded from the term “spacers”.
Van Den Boom did not disclose putting these probes in a “kit”.
Polansky taught (paragraph [0919]): “Well known advantages of commercial kits include convenience and reproducibility due to manufacturing standardization, quality control and validation procedures.”
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the application to put the probes and other reagents for performing Van Den Boom’s method into a kit to obtain the advantages of kits disclosed by Polansky.
Response to Arguments
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive. The reasons why Van Den Boom meets the newly added limitations of claim 15 are explained in the rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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, GARY BENZION can be reached at 571-272-0782. The 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.
/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
Prosecution Insights