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
Claims 1-20 are pending and the subject of this FINAL Office Action.
Election/Restrictions
Applicant’s election with traverse of various species in the reply filed on 07/06/2026 is acknowledged. The species election is withdrawn.
Claim Rejections - 35 USC § 112- Indefiniteness
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Critically, the metes and bounds of “closing the active regions with a second surface” are so expansive, encompassing very different inventions, that it is impossible to apply art without conjecture. Specifically, “active regions” is not defined in the specification; it can be any region anywhere. And “surface” is not defined; it can mean any surface of anything. To this end, the claims encompass completely different iterations. For example, “closing the active regions with a second surface” could mean closing a glass histology slide with a fluid (e.g. xylene); or covering a bead array with oil; or covering a nanowell with oil; or covering a nanowell with a bead; or covering a microfluidic compartment with oil; or covering an acrylamide gel pad with aqueous reaction solution; or covering a hydrogel with aqueous reaction solution; or any other imaginable covering of any imaginable material. Yet, as is clear form the face of the examples, these are completely different techniques. In light of the completely different meanings of “closing the active regions with a second surface,” it would require one to conjecture as to the actual invention here.
In claim 1, step c, “the surface” lacks antecedent basis. Only a “first surface” is previously recited.
The metes and bounds of “immobilization tag” are unclear because this is never defined, and is not a common phrase in the art.
The metes and bounds of “temporary molecule” are unclear because this is never defined, and is not a common phrase in the art.
In claims 12-13, “preferably” introduces confusion as to whether what follows is required or optional.
Claim Rejection - 35 USC § 112 – Written Description
The following is a quotation 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.
Claims 1-20 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the full scope of the claimed invention.
The specification fails to demonstrate possession of the full scope of any and all methods of “closing the active regions with a second surface.” Claim 1 generically states that the method steps are to provide a surface with active regions, onto which is presented “molecules,” which are then fixed onto the surface, followed by adding a second “molecule” to the active region, then closing the “active region” with a surface. This encompass “closing” any generic “active region” using any “surface.” For example, a bead has a surface, so does a fluid, or any other physical object. To this point, “closing” using a “surface” encompasses the use of any physical object. And “Active region” can be any conceivable “region” on anything. Yet, the only such closing of an “active region” with a surface disclosed in the Figures and specification requires closing a well using a glass or PDMS slide which captures the complexed first and second molecules. This is shown in Figures 1 and 4-5. A single, very specific embodiment does not provide written description support for every imaginable “surface” used to close any and all “active regions.”
In claim 4, there is no detailed description how all of immobilization tag, adsorption, ionic interaction, van der Waals forces, a specific chemical reaction and drying could be used together to fixed molecules on the surface.
Similarly, in claim 10, there is no detailed description how all of spotting liquid comprising the first molecules, synthesizing the first molecules, applying particles comprising the first molecules, and establishing contact between the active regions of the first surface and a DNA microarray comprising spots of DNA, wherein the DNA encodes the first molecules could be used together to introduce the first molecules into the active regions.
Prior Art
The following prior art is pertinent to well arrays with biomolecules on glass covers, or glass covers over reaction wells: US10093954, Fig. 2; US20100009872; US20160251651; US 20090054264 fig 2; US 9415392; US 20120261256 fig 5; US 20190218607; US11384392; US20140378320; US20120129248; US8298834.
Allowable Subject Matter
The following subject matter from the specification is allowable:
1. A method for the in-situ production of a molecular complex microarray comprising:
a) providing a first bottom surface comprising a plurality of separate active regions,
b) introduction of first molecules into a plurality of wells resulting in presented first molecules,
c) fixing the presented first molecules onto the first bottom surface,
d) adding a second molecule to each well with presented first molecule,
e) closing, with a lid, the wells with a second top surface,
f) complexation between the first and second molecules,
g) immobilization of the formed molecular complex on a capture surface, the capture surface is the second top surface, wherein the top surface is glass or PDMS.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELODY TSUI whose telephone number is (571)272-1846. The examiner can normally be reached Monday - Friday, 9am - 5pm.
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, Heather Calamita can be reached at 571-272-2876. 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.
/YUNG-SHENG M TSUI/ Primary Examiner, Art Unit 1684
Prosecution Insights