Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Priority and Status of Claims
1. This application is a CON of 16284035 02/25/2019 PAT 11660286, which is CON of 14349010 04/01/2014 ABN, which is a 371 of PCT/US2012/058964 10/05/2012, which claims benefit of the provisional application 61544375 with a filing date 10/07/2011.
2. Claims 1-2, 5, 10, 13-15, 19, 21, 23, 25-26, 29-31, 35, 38, 41, 46 and 84 are pending in the application.
Claim Rejections - 35 USC § 112
3. 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 1-2, 5, 10, 13-15, 19, 21, 23, 25-26, 29-31, 35, 38, 41, 46 and 84 are
rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph (pre-AIA ), because
the specification does not reasonably provide enablement of the instant
“modulator of hemoglobin” without limitation (i.e., no named compound or formula).
The specification does not enable any person skilled in the art to which it pertains, or
with which it is most nearly connected, to make the invention commensurate in scope
with these claims.
ln In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining
whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first
paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or Iack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case:
The nature of the invention
The nature of the invention is a method of use using “modulator of hemoglobin” without limitation (i.e., no named compound or formula), see claims 1 and 25.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Oronsky et al. US 11,660,286, it discloses a
compound of formula (I) as a modulator of hemoglobin, see column 3.
The amount of direction or guidance present and the presence or absence
of working examples
The only direction or guidance present in the instant specification is the description of a number of “modulator of hemoglobin” of formula (I) or (II) on page 8 of the specification. There is no data present in the instant specification for the “modulator of hemoglobin” without limitation (i.e., no named compound or formula).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “modulator of hemoglobin” is without limitation (i.e., no named compound or formula).
The quantity or experimentation needed and the Ievel of skill in the art
While the level of the skill in the chemical arts is high, it would require
undue experimentation of one of ordinary skill in the art to resolve any “modulator of hemoglobin” without limitation. There is no guidance or working examples present for constitutional any “modulator of hemoglobin” without limitation for the instant invention. Incorporation of the limitation of “modulator of hemoglobin” (i.e., formula (I) and (II) of claim 14) supported by specification into claims 1 and 25 respectively would overcome this rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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, Renee Claytor can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1629
November 04, 2025