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
Summary
This is a Final Office action based on the 17/924958 application response filed 01/30/2026.
Claims 1, 3, 5-6, 8, 11, & 13-15 have been elected and fully considered.
Claims 2, 4, 7, 9-10, 12 & 16-18 are cancelled.
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Notably, a new primary reference, FUJIWARA is used as shown below.
Applicant argues that VORPHAL and MCNAUGHTON do not teach of the significant amendments made 01/30/2026.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
This is especially true since—the examiner notes that FUJIWARA, the new primary references teaches of most of the newly amended instant claim language, especially with respect to how the claims can be interpreted due to the many clarity issues, as shown in the below rejection.
The examiner notes that there are many clarity issues with respect to the instant claim language filed 01/30/2026, as noted in the below 112 (b) rejection. If applicant is able to clear up these issues, while maintaining the limiting claim scope, such amendments would be likely to overcome the instant prior art as 3 references are required to teach on the instant claim language. However, further search and consideration would be needed upon this time.
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, 3, 5-6, 8, 11, & 13-15 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.
With respect to Claim 1, the last paragraph in Claim 1 is unclear/confusing. It uses the phrase “consisting of,” many times in the last paragraph. “Consisting of,” is a transitional phrase that excludes any element, step, or ingredient not listed in the claim. However, since consisting of is used many times it is unclear if applicant intends the claims to be one option from one of the groups in what is claimed as “consisting of,” or if instead “comprising,” is meant. Further it is unclear since “consisting of,” is used so many times if the claims are really limited to what is listed after each “consisting of, “or not. See MPEP 2111.03.
Further with respect to Claim 1, in the paragraph that starts with “wherein said separating the bound motion,” there are a few issues:
everything that follows and including “depending on the configuration of a visualization device,” is unclear. This is a conditional/contingent statement, since it is only performed “depending on the configuration of a visualization device.”
Further, “the configuration,” fails to have proper antecedent basis in this paragraph since “configuration,” was not referred to priorly in this claim.’
Even further, in this paragraph--- it is confusing as it seems like whether certain particles “move through the viscous medium faster,” or not is also dependent on “depending on the configuration of a visualization device.”
And even further, it is claimed that both the “bound motion-resistant/analyte/force-driven particle conjugates,” and “the unbound force-driven particles,” “move through the viscous medium faster compared,” to the other. Since the term “faster,” is a relative term, both of these things cannot be true at the same time. Therefore, the claim is unclear.
Further with respect to overall Claim 1- “force-driven,” and “motion-resistant,” are relative terms and whether something is “force-drive,” or “motion-resistant,” depends on what type of force is used. In Claim 1, the claimed force is now “under magnetic force,” and “magnetic force,” however this seems to depend, “depending on the configuration of a visualization device.” Therefore, it is unclear whether the particles really are magnetic force-drive or resistant or not. And otherwise, the terms are relative terms.
Further with respect to Claim 1, step b), “when present,” in lines 3 of step 3 makes it unclear if any separation actually occurs in the claim or not--- since “when,” is a conditional term. However, in Claim 1, step c, line 1)--- it claims “after separating,” which makes it seem like its required. Further, since no “the,” is used in front of separating in Claim 1, step c), line 1 it is unclear if this refers back to the separating in Claim 1, step b) or not--- and this part fails to have proper antecedent basis.
Even further with respect to Claim 1, in the last paragraph it is claimed that both the crowding agent and thickening agent can be “polyethylene glycol,” and that the crowding agent can include “consisting of,” and “mixtures thereof,” which reads broader than the claimed “consisting of.” Therefore, this is another reason the last paragraph is unclear as to what is required.
With respect to Claim 11, “an incubation time,” fails to have proper antecedent basis as “the,” incubation time was already referred to in Claim 1 and therefore it is unclear if applicant is referring back to the incubation time already mentioned or not.
With respect to Claim 14, “said force,” is unclear as to whether it refers back to the magnetic force referred to in Claim 1 or not.
Claims 3, 5-6, 8, 11, & 13-15 are also rejected by virtue of their dependency on Claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 5-6, 8, 11, & 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over FUJIWARA in US 5238810 in view of VORPHAL in US 5770388 and further in view of MCNAUGHTON in US 20130337455.
With respect to Claims 1, FUJIWARA teaches of a method for detection of small amounts of analyte solution.
The method involves the steps of:
affixing an antibody or antigen on the surface of non-magnetic carrier particles (instantly claimed motion-resistant particles);
immunoreacting the affixed antibody or antigen to capture a target analyte contained in a specimen (to form a motion-resistant particle/analyte conjugate) wherein the antibody or antigen are the “fist sensing element,” as instantly claimed;
preparing magnetic labeled microparticles treated so as to bind with the target analyte (which reads on the claimed force driven particles coated with second sensing element, capable of binding to analyte);
reacting the labeled complex to sandwich the target analyte between the magnetic particles and the non-magnetic carrier particles;
separating the free species from the bound (complex/conjugate of magnetic, non-magnetic/ analyte particle) species by centrifugation;
dispersing the precipitated solid to make an analyte solution;
applying a spot magnetic field gradient on the analyte solution and irradiating a selected spot with a laser beam; and analyzing/ “observing,” as instantly claimed via a visualization device the resulting interference patterns to quantitatively determine the quantity of target analyte (abstract). As the instant claiming of how the magnetic field is applied is unclear as shown in the 112 (b) rejection--- this application of the magnetic field reads on what is instantly claimed through broadest reasonable interpretation.
The examiner notes that any period of mixing can be considered “incubation,” incubating through broadest reasonable interpretation. FUJIWARA specifically teaches of sitting/incubating at both of the claimed times, wherein the incubation time can be adjusted (Claim 1 & see Examples 22 & 23).
FUJIWARA teaches that the non-magnetic carrier particle/instantly claimed motion resistant particle can be polystyrene latex, which is one of the claimed possibilities (See Example 10, Column 37, lines 56-57). Further—as the claimed “viscous medium,” can be a base liquid with a thickening agent, and the thickening agent can be latex, this also reads on the thickening agent as well and as it is dispersed in a liquid this reads on “base liquid,” though broadest reasonable interpretation, and therefore this teaches of the claimed “viscous medium,” and also would have the claimed viscosity ( of 8 Pasto 10 Pas), since this is a material property of the claimed composition and the temperature.
FUJIWARA teaches of paying attention to viscosity and of a claimed compound that reads on the claimed viscous medium and of selecting other parameters based on the viscosity, as it does not call out specific separation based on viscous medium (Column 10, lines 26-44).
FUJIWARA also does not teach of the claimed vortexing to mix and separate components.
VORPAHL teaches of methods for separating a component of interest from a mixture containing the component of interest and other components. The method comprises contacting a first liquid medium containing the component of interest and other components with a second liquid medium that is of different density than and/or of different viscosity than the first liquid medium. Different viscosities form the claimed interface. The component of interest is bound to magnetic particles. The contacted first liquid medium and second liquid medium are subjected to a magnetic field gradient to allow the magnetic particles to migrate into the second liquid medium and separation of the component of interest from other components is realized (abstract).
VORPAHL more specifically teaches of using a viscous fluid such as glycerol and more specifically that (Column 18, last 5 paragraphs). It is noted that viscosity level is a material property of the composition at the temperature it’s at, and again--- FUJIWARA teaches of the claimed viscous medium compound as claimed, as shown above.
Even further—VORPAHL teaches that the temperatures used generally range from 0 to 50 degrees C, temperatures which would result in glycerol viscosity or other viscous agent in the claimed range (Column 16, 2nd paragraph from bottom). At 50 degrees Celsius, glycerol has a material property of a viscosity 14.6mPas (mega pascals), and between 25 and 50 degrees Celsius, the viscosity would be in the claimed range of 8 to 10 Pascals.
VORPAHL also teaches that viscosity, concentrations of binding members, desired rate of reaction, temperature and solubility can all be optimized and adjusted with respect to one another and the concentration of other reagents (Column 17, paragraphs 2-3).
VORPHAL even further teaches of vortexing the solutions to aid in mixing and separation (Example 1, C.).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use a viscous fluid as is done to separate components as is done in VORPAHL in the method of FUJIWARA due to the advantage controlling viscosity offers for controlling flow of the medium and components within it in separation reactions (VORPHAL, Column 15, last paragraph, Column 16, first paragraph).
If the claimed sequential vortexing is still unclear to one of ordinary skill in the art, MCNAUGHTON is used to remedy this.
MCNAUGHTON teaches of a method of detecting an analyte in the sample. Specifically, MCNAUGHTON teaches of forming a sandwich complex with a magnetic bead (force driven particle), buoyant bead (motion resistant particle), and a target. Once a sandwich formation is created, the sandwich can be separated using its dual physical properties, namely magnetism and buoyancy. Sandwich separation is highly specific, allows for removal of the beads that do not have any attached target, and reduces the number of background beads (abstract, paragraph 0013-0017).
MCNAUGTHON further teaches of using this for quantitative immunoassays (paragraph 0083).
MCNAUGHTON further teaches of a plurality of motion resistant particles such as non-magnetic or buoyant beads/particles (paragraph 0020);
and a plurality of force driven particles such as magnetic particles (paragraph 0020)
wherein said motion resistant particles and the force-driven particles are coated with a first sensing element and a second sensing element respectively, that can specifically bind to a target analyte in a test sample (these are the moiety/ies that are separately taught for each of the magnetic beads and the buoyant beads, which specifically associate with/bind to the targets to form, “complexes comprising the target and one or more magnetic beads and one or more buoyant beads” which read on the claimed conjugates) (paragraph 0020, 0034, 0069, 0074, 0076).
Further, MCNAUGHTON teaches of incubating the motion resistant particles coated with a first sensing element/moiety and force driven particles coated with second sensing element/moiety with a test sample to form bound motion resistant/analyte/force-driven particle conjugates (paragraph 0020, 0034, 0069, 0074, 0076). It is noted that any time of contact can be considered “incubation,” through broadest reasonable interpretation/BRI.
MCNAUGHTON further teaches of sequential incubation steps such as for 10, 15, or 30 minutes, and additionally with vortexing in between steps (paragraph 0074).
Then MCNAUGHTON teaches of applying magnetic force, or centrifugation to separate the conjugates from the unbound motion-resistant and unbound force driven particles (paragraph 0020, 0033-0034, 0069, 0073-0075).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to vortex as is done in MCNAUGHTON in the methods of FUJIWARA and VORPHAL due to the advantage this offers for adequately separating the analyte for counting (MCNAUGHTON, paragraph 0074).
With respect to Claim 3, FUJIWARA teach of the non-magnetic/motion resistant particle having a size between .1 and 10 micrometers (Column 22, line 61-67), which falls in the claimed range.
With respect to Claim 5, FUJIWARA teaches of the force driven particles as shown above, but does not teach of particles with the claimed size.
VORPAHL is used to remedy this and teaches of the magnetic particles having a size of 10 to 100 nm (Column 4, paragraph 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the magnetic particles the size used in VORPAHL since this offers advantage in being relatively small and allowing for colloidal capabilities (Column 12, paragraphs 2 & 3 from bottom).
Claim 6, FUJIWARA teaches of the magnetic force driven particles as taught above, however do not call out what they are.
VORPHAL is used to remedy this and teaches that the magnetic component particles are iron, cobalt, or nickel (Column 12, 2 paragraphs from bottom). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use the magnetic particle types used in VORPHAL in the method of FUJIWARA due to the advantage these particles have in being intrinsically magnetic or magnetically responsive (VORPHAL, column 12, 2 paragraphs from bottom).
With respect to Claim 8, MCNAUGHTON teaches of the analyte having multiple binding sites wherein binding sites are different for the first and second sensing element (paragraph 0069, and Figures 1 A & B).
With respect to Claim 11, MCNAUGHTON teaches of sequential incubation steps such as for 10, 15, or 30 minutes, and additionally with vortexing in between steps (paragraph 0074).
With respect to Claims 13-14, MCNAUGHTON teaches of the force application being vertically or horizontally or both (centrifuging provides both directions of force), or both vertically and horizontally across a viscous medium as well as during the duration of the force application such as 10 seconds to 60 minutes (paragraph 0074-0075).
With respect to Claim 15, MCNAUGHTON teaches of collecting conjugates after step b) (paragraph 0075-0077).
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 FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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