Detailed Action
► Applicant's election of Group I (Claims 1-15) without traverse in the paper(s) filed 14 SEP 05 is acknowledged. Claim(s) 16-20 is/are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. The restriction requirement has been reconsidered, is deemed proper and is therefore, herein made FINAL.
► 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.
Sequence Rules
► This application complies with the sequence rules and the sequence(s) have been entered by the Scientific and Technical Information Center.
Priority
► The priority date afforded the instant invention is the filing date of the US provisional application 63040557 filed 18 JUN 2020.
35 U.S.C. 112(b)/ 112 (pre-AIA ), second paragraph
► 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 Rejection(s) under 35 U.S.C. 112(b)/ 112 (pre-AIA ), second paragraph
► Claim(s) 2 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language.
In Claim 2 , the phrase “ and immunoglobulin Y (Ig Y) molecules from chicken” is nonsequitur. Please clarify.
Abbreviation(s)
► The following abbreviation(s) may be used in this Office Action:
AOC = Antibody-Oligonucleotide conjugate
35 U.S.C. 102
► The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that may 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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, 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.
► 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 Interpretation
►Attention is directed to MPEP 904.01.
The breadth of the claims in the application should always be carefully noted; that is, the examiner should be fully aware of what the claims do not call for, as well as what they do require. During patent examination, the claims are given the broadest reasonable interpretation consistent with the specification. See In re Morris, 127 F.3d 1048, 44 USPQ2d 1023 (Fed. Cir. 1997). See MPEP § 2111 - § 2116.01 for case law pertinent to claim analysis.
Narrowing limitations found in the specification cannot be inferred in the claims where the elements not set forth in the claims are linchpin of patentability. In re Philips Industries v. State Stove & Mfg. Co, Inc.., 186 USPQ 458 (CA6 1975). While the claims are to be interpreted in light of the specification, it does not follow that limitations from the specification may be read into the claims. On the contrary, claims must be interpreted as broadly as their terms reasonably allow. See Ex parte Oetiker, 23 USPQ2d 1641 (BPAI, 1992).
Claim Rejection(s) under 35 U.S.C. 102
► Claim 1 and 4-12 and 14 is/are rejected under 35 U.S.C. 102(a)(2) or (a)(1) as being anticipated by Iyer et al. [US 2015/0283154 -hereinafter “Iyer”] OR Stiller et al. [Bioconjugate Chemistry 27:217-225 (DEC 2015) – hereinafter “Stiller”] OR van Buggenum et al.[Scientific Reports 6:22675 (12 pgs) (2016) – hereinafter “van Buggenum”].
Claim 1 is drawn to a DNA-barcoding reagent comprising an affinity moiety, a DNA portion and a linker part intervening between said affinity moiety and said DNA portion.
Iyer teach teaches an AOC comprising a linker part intervening between an antibody portion (i.e. an affinity moiety) and an oligo (i.e. DNA) portion. See at least Fig.10 and para 398 It is also noted that numerous prior art references anticipate the invention of Claim 1. For example consider :: Stiller cited by the International Examiner against Claim 1 in the corresponding WIPO Examination, see especially Fig. 1 and van Buggenum , see especially Fig.1. van Buggenum teach an AOC comprising a linker part which comprises a disulfide linkage as recited by Claim 12
Claim Rejection(s) under 35 U.S.C. 103
► Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iyer OR Stiller as applied above against Claim 1 and further in view of Pleiner et al. [J. of Cell Biology 217(3) : (1985) – hereinafter Pleiner] and Abbas et al. [Human Vaccines & Immunotherapeutics 15(1) : 264-275(2019) – hereinafter “Abbas”] and Fodor et al. [US 2001/0053519 – hereinafter “Fodor].
Claim 2 is drawn to an embodiment of the composition of Claim 1 wherein the affinity moiety is a Fab fragment of an antibody originated from goat or donkey targeting specific immunoglobulin G (IgG) class molecules from mouse, rat, rabbit, goat, or guinea pig; and immunoglobulin Y (IgY) molecules from chicken.
The limitation(s) Claim 2 is/are directed to how the invention is made and used and as such fail to further limit the invention of Claim 1. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. In re Casey , 152 USPQ 235 (CCPA 1967); In re Otto , 136 USPQ 458, 459 (CCPA 1963).
, a product is not limited by the why it is made but rather by its structure. If the product in a claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985).
That said, Iyer teaches an AOC comprising most of the limitation(s) of Claim 2 for at least the reason(s) recited above against Claim1 As regards the DNA/Oligonucleotide portion, see Table 3 in Stiller’s Supplementary Information. Neither Iyer nor Stiller teach a goat derived antibody targeting a mouse IgG molecules. However, goat derived antibodies targeting a mouse IgG molecule was known as evidenced by Pleiner. See at least the section entitled “Western Blotting” on pg. 1152 Accordingly, absent an unexpected result it would have been prima facie obvious to the PHOSITA at the time of the invention to substitute the goat antibody of Peiner for the antibody disclosed by Stiller. Please note that substitution of one known second method/reagent with known properties for a first known method/reagent with known properties would have been prima facie obvious to the ordinary artisan at the time of the invention in the absence of an unexpected result. As regards the motivation to make the substitution recited above, the motivation to combine arises from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. Support for making this obviousness rejection comes from the M.P.E.P. at 2144.07 and 2144.09, as well as, the SCOTUS decision in KSR International. Co. v. Teleflex, Inc., et al., 550 U.S.398 (2007).
As regards the limitation in Claim 2 which reads “and IgY molecules from chicken”, it is noted that Abbas teach IgY antibodies from chicken, see at least the abstract.
As regards Claim 3, also note that Pleiner also teach camelidae antibodies.
► Claim(s) 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iyer OR Stiller or van Buggenum as applied above against Claim 1 and 14 further in view of Wang et al. [Agnew Chem Intl. Ed.48 : 856-870 (2009) – hereinafter “Wang”].
Claim 13 is drawn to an embodiment of the composition of Claim 1 wherein the linker has a particular structure. Claim 15 is drawn to an embodiment of the composition of Claim 1 wherein the linker has a particular structure.
Iyer or Stiller or van Buggenum teach a composition comprising most of the limitation(s) of Claim(s) 13 and/or 15 except these reference(s) do not teach a linker as recited , however, linker(s) having the structure recited were known see Wang, see at least Fig. 5 . Accordingly, absent an unexpected result it would have been prima facie obvious to the PHOSITA at the time of the invention to substitute the linkers for joining two biomolecules of Wang for those of any of Iyer OR Stiller or van Buggenum. Please note that substitution of one known second method/reagent with known properties for a first known method/reagent with known properties would have been prima facie obvious to the ordinary artisan at the time of the invention in the absence of an unexpected result. As regards the motivation to make the substitution recited above, the motivation to combine arises from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. Support for making this obviousness rejection comes from the M.P.E.P. at 2144.07 and 2144.09, as well as, the SCOTUS decision in KSR International. Co. v. Teleflex, Inc., et al., 550 U.S.398 (2007).
Conclusion
C. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ethan Whisenant whose telephone number is (571) 272-0754. The examiner can normally be reached Monday-Friday from 8:30 am -5:30 pm EST or any time via voice mail. If repeated attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anne Gussow, can be reached at (571) 272-6047.
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ethan.whisenant@uspto.gov
EXAMINER SEARCH NOTES
20 JAN 2026 - ECW
Databases searched: All available via PE2E SEARCH
CAplus, Medline and BIOSIS via STNext; and Google Scholar (note the search terms used below)
Reviewed the parent(s), if any, and any search(es) performed therein : see the BIB data sheet
Reviewed, the search(es), if any, performed by prior examiners including any international examiners.
Planned Search
Search terms:
All Inventor(s) e.g. Lai H?/au
Antibody Oligonucleotide Conjugate
Linker$2
► See the Examiner’s PE2E SEARCH notes/strategy in IFW