DETAILED ACTION
Status of the Claims
Claims 1-5, 11, 13, 15, 17-23, and 29-33 are currently pending.
Claims 15, 17-23, and 29-33 have been withdrawn as being drawn to non-elected subject matter (see below).
Claims 1-5, 11, and 13 are examined herein.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Instant application 18/580,283 filed on 01/18/2024 is a 371 national stage entry of PCT/US2022/037673 filed on 07/20/2022, which claims priority to U.S. provisional application 63/224,295 filed 07/21/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/18/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Restriction Requirement
Applicant’s election without traverse of Group I (claims 1-5, 11, and 13) in the reply filed on 04/22/2026 is acknowledged.
Claims 15, 17-23, and 29-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/22/2026.
Claim Rejections - 35 USC § 112(a) – 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-5, 11 and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain 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 or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As per MPEP 2163.03(V), while there is a presumption that an adequate written description of the claimed invention is present in the specification as filed, In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. As per MPEP 2163(I), "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
As per MPEP 2163.02, the courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it").
Finally, MPEP 2163.04 describes the burden on the examiner with regard to the Written Description requirement, stating that in rejecting a claim, the examiner must set forth express findings of fact which support the lack of written description conclusion. These findings should:
(A) Identify the claim limitation(s) at issue; and
(B) Establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed.
In the present case, the claim limitations at issue are:
The term “insertion vector” and specifically the breadth of the limitation
The term “barcoding agent” and specifically the breadth of the limitation
The identity of the target polynucleotide
Specifically, for the term “insertion vector” in claim 1, which does not appear to be a standard term of the art, is described in para [0101] of the specification as being “one or more structures (e.g., a protein, DNA, RNA, and/or other substances or structures) configured to fragment the target polynucleotide and to attach the payload polynucleotides onto the neighboring ends of the newly-formed fragments of the target polynucleotide.” Similarly, para [0087] states, in part, that “an insertion vector could include a single protein, DNA, RNA, or other substance to perform both of these functions, or could include elements (e.g., ligases) for ligating the payload polynucleotides onto the ends of the fragments and separate elements (e.g., restriction enzymes) for fragmenting the target polynucleotide.” This is consistent with other discussion in the specification of said “insertion vector”, for example, at para [0020], [0024], [0087], [0091], [0101], [0108], and/or [0113], and as depicted in Fig. 2. Therefore, the broadest reasonable interpretation of the invention as claimed includes any enzymatic or other means for performing such a fragmenting and attaching/ligating/inserting function, including but not limited to transposases, CRISPR-associated complexes, nucleases, polymerases, ribozymes, and/or ligase/restriction-enzyme systems, as well as chemical means of cleaving and ligating nucleic acids, such as with click chemistry, etc. Also note that since the claim does not particularly limit the identity of the target polynucleotides (as discussed below), included would be ssDNA and/or RNA, such that at least some of the “insertion vectors” should be able to perform said function on such substrates. In contrast, the only specifically recited species in the disclosure as originally filed for an “insertion vector” are CRISPR-Cas9, CRISPR-Cas12a, and Tn5 or Tn7 transposases (e.g., as per para [0016], [0021], [0087], [0091], [0108], and/or [0113]). These few and specific species disclosed do not reasonably allow one to immediately envision the much larger genus of “insertion vectors” as instantly claimed, and therefore it would not be apparent to one of ordinary skill in the art as of the effective filing date that Applicant was in possession of full scope of the claim.
Regarding the term “barcoding agent” in claim 1, the broadest reasonable interpretation of the limitation in light of the specification encompasses any agent that specifically targets a recognition sequence to extend instances of the payload sequences to include a polynucleotide barcode (e.g., as per para [0009]-[0010], [0017], [0025]-[0038], [0080]-[0088] and [0093]-[0094]). This genus of barcoding agents reasonably includes any component capable of performing this function, including enzymes such as ligases, polymerases, terminal transferases, etc. as well as chemical means, such as reagents for click chemistry, etc. However, the disclosure as originally filed only appears to disclose dsDNA barcoding oligonucleotides having complementary recognition overhangs, and attaching them to payload or barcoded payload ends using T7 or T4 ligase in split-and-pool cycles (e.g., as per para [0015], [0033], [0086], [0093], [0103], [0121-0124], and [0133]). Again, these few and specific species mentioned do not reasonably allow one to immediately envision the much larger genus of “barcoding agents” as instantly claimed, and therefore it would not be apparent to one of ordinary skill in the art as of the effective filing date that Applicant was in possession of full scope of the claim.
Finally, the identity of the target polynucleotide is not particularly limited in claim 1, and the broadest reasonable interpretation of this limitation encompasses dsDNA, ssDNA, RNA, DNA/RNA hybrids, and polynucleotides with non-standard bases and/or backbones. However, the specification as filed appears to only have sufficient support for using target polynucleotides of dsDNA, which is generally the required substrate for Tn5, Tn7, CRISPR-Cas9, and CRISPR-Cas12a. There is no actual reduction to practice nor any showing that the invention as claimed was “ready for patenting” for any target polynucleotide other than dsDNA. Therefore, it would not be apparent to one of ordinary skill in the art as of the effective filing date that Applicant was in possession of full scope of the claim.
None of claims 2-5, 11, and 13 resolve the written description issues detailed above, and are therefore similarly rejected.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEREMY FLINDERS whose telephone number is (571)270-1022. The examiner can normally be reached M-F 10-6:00 EST.
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/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684
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