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 2/26/2026.
Election/Restrictions
Applicant’s election without traverse in the Reply filed on 2/26/2026 of Group I, Claim(s) 1, 5-6 and 8-9 is acknowledged.
Applicant has elected without traverse in the Reply filed on 2/26/2026 the following species:
A. the method with the steps using identifying the cell type of a cell determined to have been effected by the delivery vehicle (claim 9)
The Restriction/Election Requirements are deemed proper and are made FINAL.
Claims 1, 5-6, 8-9, 29, 31-32, 34-38, 40, 42-44 and 50-52 are pending.
Claims 29, 31-32, 34-38, 40, 42-44 and 50-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 2/26/2026.
Claims 1, 5-6 and 8-9 are under examination in this Office Action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 5-6 and 8-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception, an abstract idea (mental processes), without significantly more. Claims 5-6 and 8-9 depend directly or indirectly from claim 1.
The claim 1 limitations directed to an abstract idea (mental processes) are to identify a delivery vehicle that results in a change in a cell state or a likelihood of a cell state of a cell of the animal or the organoid and thereby the vector; and to identify the type of cells having the change in cell state and to determine the relative rate of transduction for one of the distinct vectors in the different cell types, thereby identifying the vehicle.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites additional elements that consist of well understood, routine, conventional activity already engaged in by the scientific community.
The claim 1 limitations directed to well understood, routine, conventional activity already engaged in by the scientific community are a method for identifying a vehicle effective in targeting a particular cell type comprising: a) administering to an animal or an organoid a library comprising two or more distinct delivery vehicles, each delivery vehicle comprising: i) distinct variant of a virus; ii) a nucleic acid sequence encoding a distinct virus-identifying barcode region specific for each of the virus variants, wherein the barcode sequence is different than a nucleic acid sequence encoding a protein of the variant of the virus; and iii) a nucleic acid sequence encoding at least one reporter, which when expressed in a cell, is indicative of a cell state or a likelihood of a cell state of a cell; b) obtaining a sample from the animal or organoid to generate a cell population; c) enriching the cell population for those cells containing a reporter; d) using single cell sequencing; and e) using single cell sequencing.
Davidsson et al. (2019) PNAS USA volume 116 pages 27053 to 27062 cited in the 10/13/2022 IDS (hereinafter refereed to as "Davidsson") teaches a method for identifying a vehicle effective in targeting a particular cell type comprising: a) administering to an animal or an organoid a library comprising two or more distinct delivery vehicles, each delivery vehicle comprising: i) distinct variant of a virus; ii) a nucleic acid sequence encoding a distinct virus-identifying barcode region specific for each of the virus variants, wherein the barcode sequence is different than a nucleic acid sequence encoding a protein of the variant of the virus; and iii) a nucleic acid sequence encoding at least one reporter, which when expressed in a cell, is indicative of a cell state or a likelihood of a cell state of a cell; b) obtaining a sample from the animal or organoid to generate a cell population; c) enriching the cell population for those cells containing a reporter; d) using single cell sequencing; and e) using single cell sequencing (see entire document especially Figure 2, Figure 2 legend, abstract, pages 27053 to 27054, 27059 to 27061 and Supplemental pages 4 to 9).
This judicial exception is not integrated into a practical application because the addition of an abstract idea (mental processes) involving identification does not add a meaningful limitation as it is merely a nominal or token extrasolution component of the claim, and is nothing more than an attempt to generally link the product of nature to a particular technological environment.
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, 5-6 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davidsson et al. (2019) PNAS USA volume 116 pages 27053 to 27062 cited in the 10/13/2022 IDS (hereinafter refereed to as "Davidsson").
With regards to claims 1, 5-6 and 8-9, Davidsson teaches:
a) as in claims 1, 5-6 and 8-9, a method for identifying a vehicle effective in targeting a particular cell type comprising: a) administering to an animal or an organoid a library comprising two or more distinct delivery vehicles, each delivery vehicle comprising: i) distinct variant of a virus; ii) a nucleic acid sequence encoding a distinct virus-identifying barcode region specific for each of the virus variants, wherein the barcode sequence is different than a nucleic acid sequence encoding a protein of the variant of the virus; and iii) a nucleic acid sequence encoding at least one reporter, which when expressed in a cell, is indicative of a cell state or a likelihood of a cell state of a cell; b) obtaining a sample from the animal or organoid to generate a cell population; c) enriching the cell population for those cells containing a reporter; d) using single cell sequencing to identify a delivery vehicle that results in a change in a cell state or a likelihood of a cell state of a cell of the animal or the organoid and thereby the vector; and e) using single cell sequencing to identify the type of cells having the change in cell state and to determine the relative rate of transduction for one of the distinct vectors in the different cell types, thereby identifying the vehicle; wherein the change in cell state or likelihood of a change in cell state indicates the successful delivery and expression of the nucleic acid sequences to a cell of the cell population after enriching; wherein the cell state or likelihood of cell state is determined by the presence of increased or decreased levels of proteins or nucleic acid sequences; wherein identifying comprises identifying the delivery vehicle based on the presence of a reporter and vector-identifying barcode within a cell of the cell population after enriching; wherein the identification step further comprises identifying the cell type of a cell determined to have been effected by the delivery vehicle (see entire document especially Figure 2, Figure 2 legend, abstract, pages 27053 to 27054, 27059 to 27061 and Supplemental pages 4 to 9).
Thus, Davidsson 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.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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 .
/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
Prosecution Insights