DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group III in the reply filed on 7/02/2026 is acknowledged.
Claims 144-159 are pending. CLiams 1-143 have been cancelled.
An action on the merits is set forth below.
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 144-159 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.
Claims 144-159 appear to be attempting to describe the structure of the claimed product by functional terms, however, it is not clear based upon the description of the specification which structures would be required for the “configured to generate a biopolymer”. Therefore the claims are unclear with regard to which structures are and are not required more than the structures specifically recited.
Claim 155 is drawn to only an active step and therefore it is not clear how the claim limits the structure claim of claim 144.
Claim 159 is drawn to configuring the system to ligate said biopolymer to a second biopolymer, however, it is not clear how this recitation alters or adds to the structure of the claimed system of claim 144.
Claim limitation “configured to” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The claims are drawn to A system “configured to generate a biopolymer” however, the claims do not recite a specific structure that generates a biopolymer. Furhtermore the system is described in the claims to generate a biopolymer, and also the system is configured to subject said first ….. The specification provides multiple different structures but does not provide a specific structure that generates a biopolymer or subject the first and second droplets to motion. As such it is not clear which structures presented int eh specification are required by the claim language.
Claim 148 is drawn to “system is configured to perform one or more washing steps”. However the specification has not provided any specific structure that is required for the washing. For example, on p 88 the specification states that washing steps can be performed with vibrations or dielectric layer over electrodes.
Claim 157 requires “system is configured to remove said protective group”. Page 89 of the specification states that the protective group can be removed during the reaction. However, the specification does not provide any structure.
Claim 159 is drawn to “system is configured to ligate said biopolymer to a second biopolymer”. However, the specification provides numerous structures for ligation including indexed barcodes, adapters (p. 79) and as such it is not clear which structures are required.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 144-159 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (US Patent Publication 20140080717 March 20, 2014).
With regard to claim 144, Li et al. teaches a system that generates biopolymers comprises a plurality of droplet adjacent to a surface wherein the droplets comprise reagents (para 762). As noted in the 35 USC 112b it is not clear how the function of a to b effects the structure of the system, however, Li et al. teaches using the droplets to merge and generate a biopolymer (para 762-764). The limitation of timings does not appear to alter the claimed structures and as such it is considered an intended use. As Li et al. teaches all the required structure, Li et al. teaches a structure that would be capable of such functionality.
With regard to claim 145, Li et al. teaches that the biopolymer is a polynucleotides (para 762).
With regard to claim 146, Li et al. taches that the biopolymer can be a polypeptide (para 555-556).
With regard to claim 147, Li et al. teaches that the polynucleotide can be 10000 Kb (para 950).
With regard to claim 148, Li et al. teaches washing (para 953) using motion (para 1050).
With regard to claim 149, Li et al. teaches that the surface can be a dielectric layer (para 931 and 935).
With regard to claim 150, Li et al. teaches that the surface can have a fluid layer (para 867).
With regard to claim 151, Li et al. teaches multiple droplets and reagents (e.g. three) (para 761).
With regard to claim 152, Li et al. teaches that the reagents can be beads with a support immobilized primer (e.g. oligonucleotide) (para 98).
With regard to claims 153-154, Li et al. teaches that the polymerase can include X family (para 809).
With regard to claim 155, as noted by the 35 USC 112b rejection it is not clear how the claim limits the structure. As Li et al. teaches the required structure, the claim is rejected.
With regard to claims 156-157, LI et al .teaches a merged droplet that is temperature controlled with dNTPS (para 458, 763).
With regard to claim 158, Li et al. teaches a volume that is less than 1 microliter (para 746).
With regard to claim 159, Li et al. teaches structures that are capable of ligation (para 1053).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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