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
Priority and Status of the Claims
1. This application is a DIV of 17696202 03/16/2022 PAT 12011428.
2. Claims 11-13 and 15-20 are pending in the application.
Claim Rejections - 35 USC § 112
3. 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.
Claims 11-13 and 15-20 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 “glutathione alkyl ester” without limitation (i.e., no chemical
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 “a glutathione alkyl ester” without limitation (i.e., no chemical formula), see claim 111.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Lewis et al. US 12,011,428, it discloses a glutathione
alkyl ester of a formula in claim 2, see column 36.
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 “glutathione alkyl ester” with a formula on page 4 of the specification. There is no data present in the instant specification for the “glutathione alkyl ester” without limitation (i.e., no chemical formula).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “glutathione alkyl ester” are without limitation (i.e., no chemical 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 “glutathione alkyl ester” without limitation. There is no guidance or working examples present for constitutional any “glutathione alkyl ester” without limitation for the instant invention. Incorporation of the limitation of ““glutathione alkyl ester” supported by specification (i.e., claim 12) into claim 11 would overcome this rejection.
4. 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 12-13 and 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 pre-AIA the applicant regards as the invention.
Claims 12-13 recite the limitation “comprising” or “comprises” is ambiguous and indefinite, i.e., see line 2 in claim 12. A compound or drug product claim cannot use open-ended language when defining the parameters of the gene or compound, see M.P.E.P. 2111.03. Replacement of the limitation “comprising” or “comprises” with a limitation “is” would overcome this rejection.
Claim 15 recites the limitation “therapeutically affective amount” without a chemical compound name is ambiguous and indefinite. It is unclear what the scope of the limitation “therapeutically affective amount” is. Incorporation of the limitation “therapeutically affective amount” with a chemical name or structure (i.e., glutathione alkyl ester) into claim 15 respectively would obviate the rejection.
5. 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 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.
Claim Rejections - 35 USC § 103
6. The following is a quotation of 35 U.S.C. 103(a) 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 11-12 and 19 are rejected under 35 U.S.C. 103(a) as being obvious over
Goldberg’s US 5,824,693 and Meister’s US 4,784,685.
Applicant claim a method of preventing or reversing at least one of opioid induced respiratory depression in a subject in need thereof, the method comprising: administering to the subject a therapeutically effective amount of a composition comprising glutathione alkyl ester, adduct thereof, or pharmaceutically acceptable salt, tautomer, or solvate thereof, wherein the adduct thereof of the glutathione ethyl ester comprises at least one of an albumin adduct, a glucose adduct, an L-cysteine adduct, an D-cysteine adduct, and an S-nitroso adduct, and the glutathione alkyl ester having the structure of formula:
PNG
media_image1.png
222
722
media_image1.png
Greyscale
, and R1 is alkyl, see claims 11-12.
Applicants claim a composition comprising: an opioid capable of inducing respiratory depression in a subject and an amount of a glutathione alkyl ester, adduct thereof, or pharmaceutically acceptable salt, tautomer, or solvate thereof effective to prevent the opioid induced respiratory depression when the composition is administered to the subject, see claim 19.
Determination of the scope and content of the prior art (MPEP §2141.01)
Goldberg’s ‘693 discloses a method for treating a human in need thereof and at risk of acute respiratory distress syndrome precipitated by primary bacterial or viral pneumonia, aspiration of gastric contents, direct chest trauma, prolonged or profound shock, burns, near drowning, fat embolism, blood transfusion, cardiopulmonary bypass or acute hemorrhagic pancreatitis comprising administering to the human a glutathione ester in an amount sufficient to reduce the risk of acute respiratory distress syndrome in the human in need thereof, and the glutathione ester having the formula:
PNG
media_image2.png
80
406
media_image2.png
Greyscale
, and R is alkyl group, see columns 4 and 6. A specific compound L-2-oxothiazolidine-4-carboxylate has been exemplified in Example 1 in column 4.
Meister’s ‘685 discloses a composition comprising glutathione ester having the formula:
PNG
media_image2.png
80
406
media_image2.png
Greyscale
, wherein R is alkyl group, see column 3.
A specific compound monoethyl ester of glutathione has been exemplified in Example 1 in column 5.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Goldberg’s ‘693 and Meister’s ‘685 is that the instant claims are silent on the scope glutathione alkyl ester (i.e., no formula).
The scope of methods of use of Goldberg’s ‘693 is broader than the instant claims in claims 11-12.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 11-12 and 19 prima facie obvious because one would be motivated to employ methods of use and compositions of Goldberg’s ‘693 and Meister’s ‘685 to obtain instant invention.
The motivation to make the claimed methods of use and compositions derived from the known methods of use and compositions of Goldberg’s ‘693 and Meister’s ‘685 would possess similar activity to that which is claimed in the reference.
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.
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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.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
July 13, 2026
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