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
Acknowledgement is hereby made of receipt and entry of the communication filed on Jan. 31, 2026. Claims 1-20 are pending. Claims 8-20 are withdrawn. Claims 1-7 are currently examined.
Election/Restrictions
Applicant's election without traverse of Group I (claims 1-7), in the reply filed on Jan. 31, 2026, is acknowledged.
Accordingly, claims 8-20 are withdrawn as being directed to a non-elected group.
Claim Objection
Claim 1 is objected for reciting a phrase “each subsample of only a subset of the subsamples including at least one of the viral particles” that need to be rewritten for clarification.
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.
Claims 1-7 are 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.
The base claim 1 recites a phrase “the populations being defined based on the tag-related data and the amplification data” that renders the claims indefinite. It is unclear what the criteria are needed to use the “tag-related data and the amplification data” to define a “population”. Also, it is not clear what the relationships between the “tag-related data” and “the amplification data” are, and how the “tag-related data” is acquired because the instant clam 1 only requires that “the amplification data” is from a genome of the viral particles and not from the “tag”. In addition, it is not clear if the “amplifying one or more targets from a genome of the viral particles” generates the “amplification data” or not. Also, it is unclear how “tagging capsids of the viral particles with a tag” can form a “subsample of a sample”, how to amplify one or more targets from a gnome of the viral particles, and how to “amplification data for the one or more targets, from the subsamples”.
Claim 2 recites a phrase “…determining an occupancy of the capsids by the genome using the subsample counts directly, or count values derived there from, in a ratio” renders the claim indefinite. It is not clear how the “subsample counts”, the “count values” and a “ratio” is used to determine an occupancy of the capsids.
Claim 3 recites that “the count values are used in the ratio, and wherein the count values are derived from the subsample counts at least in part by normalization to scale the subsample counts and/or by adjustment based on a no particle control(s) (NPC)” that renders the claim indefinite. It is unclear where the ratio of the count values from, and what the relations between the “by normalization to scale the subsample counts” and “by adjustment based on a no particle control(s) (NPC)” and if the “NPC’ is used for the normalization or adjustment or both. Also, it is not clear what the” at least in part” means.
Claim 4 recites a phrase “…determining inherently incorporates the same tagging efficiency into a numerator and a denominator of the ratio…” that renders the claim indefinite. It is unclear how “the same tagging efficiency” can be incorporated into the “a numerator and a denominator of the ratio” inherently.
Claim 5 recites a phrase “wherein collecting tag-related data includes collecting amplification data for the first target” that renders the claims indefinite. It is unclear what the relations between the “tag-related data” and the amplification data for the first target”. There is no “second target” in the claims.
Claim 6 recites “wherein tagging includes binding copies of a pair of Proximity Assay (PA) probes including a pair of oligonucleotides to individual capsids of the viral particles, and wherein tagging also includes creating the template using the pair of oligonucleotides of the copies of the pair of PA probes for a ligation reaction or an extension reaction while the copies of the pair of PA probes remain bound to the same individual capsids”, which renders the claim indefinite. It is not clear what the “copies of a pair of Proximity Assay (PA) probes” are represented for, and how to make the probe copies. It is unclear what the relations between the “a pair of oligonucleotides” and the “PA probes”, and how a pair of oligonucleotides get to “to individual capsids of the viral particles”. It is also unclear how the template be created with “tagging”, “oligonucleotides” and “copies of PA” while “the copies of the pair of PA probes remain bound to the same individual capsids”. It is not clear how to identify the “same individual capsids” too. Also, it is not clear how the tagging can create the template as “tagging also includes creating the template using the pair of oligonucleotides of the copies of the pair of PA probes”.
It is noted that generally, the claims as written are confusing and vague. Applicant is invited to rewrite the claims to be clearer and more concise.
Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claims.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01.
Claim 6 is directed to a method of claim 5, wherein tagging includes binding copies of a pair of Proximity Assay (PA) probes including a pair of oligonucleotides to individual capsids of the viral particles, and wherein tagging also includes creating the template using the pair of oligonucleotides of the copies of the pair of PA probes for a ligation reaction or an extension reaction while the copies of the pair of PA probes remain bound to the same individual capsids.
The omitted steps in claim 6 are how the tagging can create the template as “tagging also includes creating the template using the pair of oligonucleotides of the copies of the pair of PA probes”.
Claim Rejections - 35 USC § 112 (Written Description)
The following is a quotation of the first paragraph 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 pre-AIA 35 U.S.C. 112:
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 1-7 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 claim(s) contains 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings. See MPEP 2163. I.
In Regents of the University of California v. Eli Lilly and Co. 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997), the Court decided that adequate written description of genetic material "requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention." Id. 43 USPQ2d at 1404 (quoting Fiefs, 984 F.2d at 1171, 25 USPQ2d at 1606). In AbbVie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (Court of Appeals, Federal Circuit 2014), the Court ruled that “[W]ith the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that “merely recite a description of the problem to be solved while claiming all solutions to it and . . .cover any compound later actually invented and determined to fall within the claim' s functional boundaries.”).”
The base claim 1 is directed to a method of analyzing viral particles, the method comprising: tagging capsids of the viral particles with a tag; forming subsamples of a sample containing the viral particles, each subsample of only a subset of the subsamples including at least one of the viral particles; amplifying one or more targets from a genome of the viral particles; collecting tag-related data, and amplification data for the one or more targets, from the subsamples; and enumerating populations of the subsamples, the populations being defined based on the tag-related data and the amplification data.
Based on the instant base claim 1, the tagging capsids of the viral particles with a tag can form subsample. However, the instant specification discloses that the tagging capsids of the viral particles with a tag can form partitions not subsample (See instant specification, Fig. 2 and below). The instant specification discloses that the “"Partitions" are discrete volumes of fluid (i.e., fluid volumes) that are isolated from one another (also called isolated volumes). Each partition of a set of partitions may contain a portion of the same sample. The partitions may be separated from one another by fluid (e.g., oil or air), a wall(s) of a device(s), or a combination thereof, among others. Accordingly, the partitions may be droplets of an emulsion, or volumes held by wells, chambers (e.g., nanochambers having a capacity ofless than 1 μL), tubes (e.g., micro tubes having a diameter of less than 1 mm), or microfluidic devices, among others. The partitions may be the same diameter as one another and/or may be composed of the same amount of fluid as one another” (See Instant specification, [0056]). Here the descriptions define the meaning of the “partitions “, but does not provide evidence to support if the “partitions” and “subsample” are the same or not. Thus, there is no evidence to support or demonstrate that the tagging capsids of the viral particles with a tag can form subsamples as claimed.
PNG
media_image1.png
980
772
media_image1.png
Greyscale
In addition, the instant base claim 1 only recites one amplification step at “amplifying one or more targets from a genome of the viral particles”. However, the instant specification discloses a flow diagram schematically illustrating two amplification steps (See Fig. 3 and below). In [0107] of the instant specification, it discloses that the amplification reagents include a pair of first primers 168a, 168b to amplify a first target 170 from template 164, and a first amplification probe 171 for detecting amplification of first target 170 (see FIG. 5 and below). The amplification reagents also include a pair of second primers 172a, 172b for amplification of a second target 174 from genome 138, and a second amplification probe 175 for detecting amplification of second target 174 (see FIG. 6 and below).
Accordingly, there is no evidence to support or demonstrate in the instant specification that the amplification is only for the targets from a genome of the viral particles as claimed.
PNG
media_image2.png
665
954
media_image2.png
Greyscale
PNG
media_image3.png
548
596
media_image3.png
Greyscale
PNG
media_image4.png
451
661
media_image4.png
Greyscale
Accordingly, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph. The specification does not provide sufficient written description support for the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am-4:30 pm, EST.
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, Thomas J. Visone can be reached on (571) 270-0684. 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.
/RUIXUE WANG/ Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/ Primary Examiner, Art Unit 1672