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 .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 11/21/2025.
Election/Restrictions
Applicant’s election with traverse in the Reply filed on 11/21/2025 of Group I, Claim(s) 1-14 is acknowledged.
Applicant argues that the amendment to claim 1 adds a new special technical feature not taught by Wang (see Reply starting page 10).
In response, the Examiner notes the restriction was based on the claims of record at the time of the restriction, not the amended claims filed in reply to the restriction.
Applicant has elected in the Reply filed on 11/21/2025 the following species:
A. the number of random bases is three (claims 4 and 7)
Because applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The Restriction/Election Requirements are thus deemed proper and are made FINAL.
Claims 1 and 3-19 are pending.
Claims 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the Reply filed on 11/21/2025.
Claims 1 and 3-14 are under examination in this Office Action.
Claim Rejections - 35 USC § 112-1st paragraph (Written Description)
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of 35 U.S.C. 112 (pre-AIA ):
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 3-14 depend directly or indirectly from claim 1.
The specification discloses chemicals, such as the pairs of sequences listed in Tables 2, 4 and 6 which meet the written description and enablement provisions of 35 USC 112, first paragraph. However, claim(s) 1 and 3-14 is(are) directed to encompass any unique molecular identifier (UMI), comprising: at least one random base and at least one fixed base, which only correspond in some undefined way to specifically instantly disclosed chemicals. None of these unique molecular identifier (UMI), comprising: at least one random base and at least one fixed base, meet the written description provision of 35 USC § 112, first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus encompassed by the claim.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
With the exception of the above specifically disclosed chemical structures, the skilled artisan cannot envision the detailed chemical structure of the encompassed derivatives, analogs, etc., regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmacentical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966.
Therefore, only the above chemically structurally defined chemicals, but not the full breadth of the claim(s) meet the written description provision of 35 USC § 112, first paragraph. A search of the prior art fails to identify any examples of unique molecular identifier (UMI), comprising: at least one random base and at least one fixed base. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that 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.
Claims 1 and 3-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yik et al. (01/26/2021) Journal of Pharmaceutical and Biomedical Analysis volume 196 article 113920 pages 1 to 6.
With regards to claims 1 and 3-14, Yik teaches:
a) as in claims 1 and 3-14, a unique molecular identifier (UMI), comprising: at least one random base and at least one fixed base; wherein the at least one random base includes a plurality of random bases, and/or the at least one fixed bases includes a plurality of fixed bases; and at least two random bases of the plurality of random bases are arranged at intervals, and/or at least two fixed bases of the plurality of fixed bases are arranged at intervals; wherein in a case where the at least one random base includes the plurality of random bases, and the at least two random bases of the plurality of random bases are arranged at intervals, every two random bases arranged at intervals are separated by one to five fixed bases; wherein the at least one random base includes at least three random bases; and every two of the at least three random bases are arranged at intervals from each other and separated by a group of fixed bases, and every two groups of fixed bases each include a same number of fixed bases; wherein for the every two adjacent groups of fixed bases, at least one fixed base of one group of fixed bases is different from a fixed base of another group of fixed bases; wherein the every two random bases arranged at intervals are separated by 2 to 4 fixed bases, and the 2 to 4 fixed bases are different from each other; wherein the at least one random base includes three random bases; wherein the UMI comprises 7 to 11 bases; a molecular identifier group, comprising: two unique molecular identifiers (UMIs) binding to each other through complementary pairing of at least a portion of bases thereof, wherein at least one UMI is a unique molecular identifier (UMI), comprising: at least one random base and at least one fixed base; wherein the at least one random base includes a plurality of random bases, and/or the at least one fixed bases includes a plurality of fixed bases; and at least two random bases of the plurality of random bases are arranged at intervals, and/or at least two fixed bases of the plurality of fixed bases are arranged at intervals; an adapter, comprising: a first strand and a second strand; and at least one unique molecular identifier (UMI), each UMI being located on the first strand or the second strand, the at least one UMI being a unique molecular identifier (UMI), comprising: at least one random base and at least one fixed base; wherein the at least one random base includes a plurality of random bases, and/or the at least one fixed bases includes a plurality of fixed bases; and at least two random bases of the plurality of random bases are arranged at intervals, and/or at least two fixed bases of the plurality of fixed bases are arranged at intervals; wherein the at least one UMI includes two UMIs; the two UMIs are respectively located on the first strand and the second strand, and bind to each other through complementary pairing of at least a portion of bases thereof; wherein the first strand is a forward strand, and the second strand is a reverse strand, wherein the first strand includes a first sequencing primer sequence; the second strand includes a second sequencing primer sequence; a UMI located on the first strand is located downstream of the first sequencing primer sequence; and a UMI located on the second strand is located upstream of the second sequencing primer sequence; an adapter ligation reagent, comprising: a plurality of kinds of adapters, the plurality of kinds of adapters being each an adapter, comprising: a first strand and a second strand; and at least one unique molecular identifier (UMI), each UMI being located on the first strand or the second strand, the at least one UMI being a unique molecular identifier (UMI), comprising: at least one random base and at least one fixed base; wherein the at least one random base includes a plurality of random bases, and/or the at least one fixed bases includes a plurality of fixed bases; and at least two random bases of the plurality of random bases are arranged at intervals, and/or at least two fixed bases of the plurality of fixed bases are arranged at intervals, wherein of the plurality of kinds of adapters, for every two kinds of adapters, at least one random base of at least one UMI included in one kind of adapter is different from at least one random base of at least one UMI included in another kind of adapter; a kit, comprising: an adapter ligation reagent, comprising: a plurality of kinds of adapters, the plurality of kinds of adapters being each an adapter, comprising: a first strand and a second strand; and at least one unique molecular identifier (UMI), each UMI being located on the first strand or the second strand, the at least one UMI being a unique molecular identifier (UMI), comprising: at least one random base and at least one fixed base; wherein the at least one random base includes a plurality of random bases, and/or the at least one fixed bases includes a plurality of fixed bases; and at least two random bases of the plurality of random bases are arranged at intervals, and/or at least two fixed bases of the plurality of fixed bases are arranged at intervals, wherein of the plurality of kinds of adapters, for every two kinds of adapters, at least one random base of at least one UMI included in one kind of adapter is different from at least one random base of at least one UMI included in another kind of adapter (see entire document especially abstract, Tables 1, 2 and 3, Figure 1 and pages 2 to 4).
Thus, Yik anticipates the present claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684