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 the claims
Currently, claims 1-2, 4-5, 10, 16, 20, 24, 30-31, 33-36, 39, 41, 44-48, 50, 56-57, 59-60 and 62-63 are pending. Claims 1-2, 4-5, 10, 16, 20, 24, 47-48, 50, 56-57, 59-60 and 62-63 remain withdrawn as being directed to non-elected inventions. Accordingly, claims 30-31, 33, 36-39, 41 and 44-46 are under examination.
Withdrawn Rejections
All rejections of claims not reiterated herein, have been withdrawn.
Claim Rejections - 35 USC § 103
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 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.
Claims 30-31, 33-35, 41 and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (US 2018/0031549) in view of Messersmith et al (US 2012/0237605).
Chen et al discloses a multiplex LSPR sensor comprising an array of gold nanorods (e.g. para’s 0007-0008, Figs. 1 & 6). Chen et al discloses that the gold nanorods comprises a plurality of antibodies that are capable of binding to one or more analytes (e.g. para 0008, 0053, Figs. 1 & 6). Chen et al discloses that the antibodies can be linked to the surface by a bifunctional linker (e.g. para 0008, page 15, 2nd col). Chen et al discloses that the gold nanorod particles are within a microarray pattern on a substrate (e.g. para 0020, 0043, 0048).
Chen et al differs from the instant invention in failing to teach a coating agent, wherein the coating agent forms a coating around at least some of the analyte binding agents.
Messersmith et al discloses gold nanorods coated with PEG molecules and a polydopamine layer wherein the coating agent forms a coating around at least some of the antibodies and discloses that coating provides a layer around the plurality of antibodies (e.g. para’s 0055-0060, 0104, Figures 18-19). Messersmith et al discloses that this provides a chemical repertoire to form evolutionary modulatory metal nanoparticles which are multifunctional and multicomponent (e.g. para’s 0055-0056). Messersmith also teaches that this provides for enhanced colloidal stability (e.g. para 0104).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate a coating such as taught by Messersmith et al on the gold nanorods of Chen et al because Messersmith et al teaches that this provides a chemical repertoire to form evolutionary modulatory metal nanoparticles which are multifunctional and multicomponent. Messersmith also teaches that this provides for enhanced colloidal stability. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a coating such as taught by Messersmith et al on the gold nanorods of Chen et al.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al in view of Messersmith et al as applied to claims 30-31, 33-35, 41 and 44-46 above, and further in view of Singamaneni et al (US 2019/0360933).
See above for the teachings of Chen et al and Singamaneni et al.
Chen et al and Singamaneni et al differ from the instant invention in failing to teach the linker is a polymer.
Singamaneni et al teaches that it is known and conventional in the art to utilize a bifunctional PEG (polymer) to conjugate a biomolecule to a gold nanostructure (e.g. para’s 0065-0067).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate a PEG linker such as taught by Singamaneni et al into the modified gold nanorod of Chen et al because Singamaneni et al shows that it is well known and conventional in the art. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a PEG linker such as taught by Singamaneni et al onto the modified gold nanorod of Chen et al.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al in view of Messersmith et al as applied to claims 30-31, 33-35, 41 and 44-46 above, and further in view of Singamaneni et al (WO 2015/058046) (submitted in the IDS filed 08/24/22).
See above for the teachings of Chen et al and Singamaneni et al.
Chen et al and Singamaneni et al differ from the instant invention in failing to teach the coating agent is an organosiloxane polymer.
Singamaneni et al teaches that it is known and conventional in the art to coat a nanostructure with organosiloxane polymers (e.g. para’s 0009, 0054) Singamaneni et al discloses that this provides for the capability of using a readily available polymer base that can be formed at room temperature in a relative short time period (e.g. para’s 0078, 00104)..
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate an organosiloxane coating such as taught by Singamaneni et al onto the modified nanostructures of Chen et al because Singamaneni et al teaches that this provides for the capability of using a readily available polymer base that can be formed at room temperature in a relative short time period. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating an organosiloxane coating such as taught by Singamaneni et al onto the modified nanostructures of Chen et al.
Response to Arguments
Applicant's arguments filed 05/11/26 have been fully considered but they are not persuasive.
103 Rejections:
Applicant argues that the structural arrangement in Messersmith is: gold nanorod polydopamine primer antibodies (on top). The polydopamine coating is beneath and serves as an attachment platform for the antibodies-it does not form a coating "around" the antibodies. The antibodies are the outermost functional layer in Messersmith's construct. This is the opposite of what claim 30 requires, wherein pre-existing analyte binding agents are coated by the coating agent such that the coating agent surrounds the binding agents.
This argument is not found persuasive because (1) the applicant is arguing Messersmith individually and not the combination of Chen et and Messersmith and (2) current claim 30 does not recite “surrounds the binding agents”. Applicant’s argument appears to be implying that the analyte binding agents are encapsulated or are completely coated. However, the current recitation in claim 30 is as follows: “wherein the coating agent forms a coating around at least some of the analyte binding agents”. Thus, Applicant’s argument is not on point because the current claims broadly read on any portion of the binding agents being coated (e.g. only a very small portion of an Fc region of an antibody having a coating on it, while the remainder of the antibody is exposed.
Applicant argues that the PEG molecules in Messersmith are used to "passivate the surface" and "inhibit non-specific interactions" of the nanorod surface itself, not to coat antibodies that are already immobilized on the transduction agent. Indeed, when PEG is added along with antibodies in Messersmith, PEG serves to "backfill the PD layer with passivating polymers" in areas not occupied by antibodies. This backfilling of unoccupied surface areas is fundamentally different from the claimed coating agent that forms a coating "around at least some of the analyte binding agents."
This argument is not found persuasive because as stated above the coating has to only be around some of the analyte binding agents and as shown by Messersmith the PEG coating would coat at least some of the antibody (e.g. Figures 18-19 showing the PEG layer is surrounded near the bottom area of the antibody while the binding portion is exposed). The current claim does not recite the binding agents are encapsulated or completely surrounded.
Applicant argues that the combination of references does not teach or suggest first immobilizing analyte binding agents and then applying a coating agent around thos binding agents.
This argument is not found persuasive because (1) the instant claims are not directed to a method of making but rather to a device and therefore the timing of the addition of a coating is irrelevant and (2) the instant claims to do recite the coating agent encapsulates are completely surrounds or completely covers the binding agents.
Applicant again argues that the combination of references does not address the structural requirement of claim 30 that the coating agent forms a coating around the analyte binding agents.
This argument is not found persuasive because as stated above the instant claims to do recite the coating agent encapsulates are completely surrounds or completely covers the binding agents.
Applicant argues that the addition of Singamaneni ‘933 and Singamaneni (WO 2015/058046) fails to cure the deficiencies of Chen and Messersmith.
This argument is not found persuasive because of reasons stated supra that the combination of Chen and Messersmith read on the instantly recited claims and therefore the combination with Singamaneni ‘933 and Singamaneni (WO 2015/058046) is considered appropriate and therefore maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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