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 30 and 41 have been amended. Claims 1-2, 4-5, 10, 16, 20, 24, 47-48, 50, 56-57, 59-60 and 62-63 remain withdrawn as being directed to non-elected inventions.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Withdrawn Rejections
All rejections of claims not reiterated herein, have been withdrawn.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 § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 30-31, 33-36, 39, 41 and 44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The instant claims recite “wherein the coating reagent substantially encapsulates at least some of the analyte binding agents”. The specification on page 10, paragraph 0049 discloses that the coating reagent encapsulates the plurality of analyte binding agents. There is no description in the specification disclosing substantial encapsulation (which encompassed partial coverage). The is no description of substantial or a specific definition of substantially. The only disclosure in the specification is directed to the coating reagent encapsulating the plurality of analyte binding agents. Furthermore, none of the originally filed claims recited the limitations in question. Recitation of claim limitations lacking literal or adequate descriptive support in the specification or originally filed claims constitutes new matter.
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 30-31, 33-36, 39, 41 and 44-46 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 30, the recitation “substantially encapsulates” is vague and indefinite. The definition does not provide a definition for the term “substantially” and it is unclear if the Applicant intends 51% is encapsulated, if ¾ is encapsulated, 90% is encapsulated or if the applicant intends something else. The specification on page 10, paragraph 0049 discloses that the coating encapsulates the plurality of analyte binding agents. The specification does provide a definition for substantial or provide support for partial coverage or to what degree of partial coverage. Therefore, it is unclear what the term encompasses. See also deficiency found in claim 41.
Claim 30 is vague and indefinite because it is unclear how the sensor as currently claimed would work because if the binding agents are encapsulated then the binding agents would not be capable of binding to one or more analytes. Thus, it appears essential that the limitations of claim 39 be incorporated into claim 30 to provide for capability of the binding agents to bind to one or more analytes.
Conclusion
No claims are allowed.
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.
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, Gregory Emch can be reached at 571-272-8149. 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.
/GARY COUNTS/ Primary Examiner, Art Unit 1678