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 .
Status of Claims
Claims 1-20 are pending. Claims 1-12 and 19-20 remain withdrawn as drawn to non-elected inventions. Claim 1 has been amended. Claims 13-18 are been examined.
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 13-18 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.
Claim 13 is indefinite because lines 9-10 state that the synthetic particles are modified in a reservoir to cause them to bind to target particles and now the amended limitation at lines 11-13 recites that the particles are modified according to a surface treatment. It is unclear if the modification to the particles to permit binding is the same modification as the surface treatment – and this amendment is merely limiting the sequence of when the modification takes place or alternatively, if the particles are modified with multiple different entities. Giving the claim it’s broadest reasonable interpretation, the modification according to a surface treatment will be interpreted as any surface treatment to the particle.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (US 2020/0391169, Pub Date: 12/17/2020).
Regarding claim 13, Han teaches throughout the publication a system (see Figure 2A), comprising:
one or more input streams that receive input material to be provided to a droplet generator, the input material selected based on a set of synthetic particle characteristics comprising a synthetic particle density and one or more other physical properties (Figure 2A, component at 220; paragraphs 0105-0110, characteristics to consider include particle density, particle diameter, hydrogel volume, polymer/hydrogel material); and
an output stream that receives one or more synthetic particles created by the droplet generator, the one or more synthetic particles having the set of synthetic particle characteristics (Figure 2A, component at 210; paragraphs 0105-0110,
wherein a surface characteristic of the one or more synthetic particles are modified to cause the one or more synthetic particles to bind to one or more target particles in a solution, wherein the one or more synthetic particles are modified according to a surface treatment performed after formation of the synthetic particles by the droplet generator (paragraph 0113, following hydrogel particle synthesis, beads are conjugated to a specific antibody that targets a desired protein biomarker).
While Han does not explicitly recite that the synthetic particles are modified in a reservoir that stores the one or more synthetic particles, the reference teaches an in depth functionalization process that includes washing, mixing, suspending and centrifuging the beads to enable covalent coupling (see paragraph 0155). It would have been obvious to one having ordinary skill in the art at the time the invention was filed that the functionalization process of Han was conducted within a reservoir that stores the particles as the steps taught by Han are well-known in the art to be conducted within a tube or vial, which reads on the broadly claimed reservoir.
Regarding claim 14, Han teaches the system wherein the one or more other physical properties include a size of the one or more synthetic particles (paragraph 0108).
Regarding claim 15, while Han does not explicitly teach that the input material comprises a polymer selected to modulate a particle density of the one or more synthetic particles, such limitation is drawn to intended use of the system and therefore the prior art only needs to be capable of performing the recited intended use. So long as the input stream in the system of Han is capable of receiving input material comprising a polymer that modulates a particle density of the synthetic particles, it reads on the claims. Han teaches the same structural limitations as recited in the claims, therefore it is considered capable of performing the same intended use.
Regarding claim 16, Han teaches the system wherein the one or more synthetic particles comprise a hydrogel (paragraphs 0011-0013).
Regarding claim 17, Han teaches the system wherein the input material comprises an additive including a metal oxide (paragraph 0124, iron oxide nanoparticles added to the aqueous phase with the monomers and crosslinkers).
Regarding claim 18, Han teaches the system wherein the one or more synthetic particles modified according to a surface treatment including applying antibodies to the one or more synthetic particles (paragraphs 0041 and 0113 and for example, paragraph 0155, antibody functionalization).
Response to Arguments
Applicant’s arguments filed 04/29/2026 have been considered but are not found to be persuasive. Applicant argues Han does not disclose that "the one or more synthetic particles are modified according to a surface treatment performed after formation of the synthetic particles by the droplet generator." While Han discloses surface functionalization, such functionalization is not disclosed as being "performed after particle formation by a droplet generator," as now recited in claim 13. Thus, the specifics of claim 13, including the sequence of the claimed "surface treatment," are not disclosed in Han.”
This argument is not persuasive because as described above in the indefiniteness section, the claim fails to clearly convey which or what type of particle modification is being performed after formation of the particles. Han clearly states at paragraph 0113 “following the synthesis of the electrically distinct polymers (hydrogels), each population of beads is conjugated to a specific antibody that targets the protein biomarker”. As the claim has been broadly interpreted, and without further clarification, the antibody conjugation of the hydrogels after formation reads on the amended limitation.
Remaining arguments are drawn to dependent claims and properties of the input material and how they behave in the system. Examiner would like to remind applicant that the current claims are drawn to a system broadly comprising the structural components of one or more input streams and an output stream. All the other components present in the claim are merely functional limitations drawn to functions of the input and output streams. For example, input material and droplet generator are not active structural components of the system but merely components that the input stream is capable of communicating with. Examiner recommends providing more structural limitations to the components of the system to distinguish from the teachings of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy L Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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