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 .
Claim Rejections - 35 USC § 112(a)
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 4 and 9-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the instant liposome composition where the ATR protein kinase inhibitor compound is Compound A or a compound defined by formula (I), does not reasonably provide enablement for the instant liposome composition where the ATR protein kinase inhibitor compound is the universe of ATR protein kinase inhibitor compounds. 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 and use the invention commensurate in scope with these claims.
With regard to rejections under 35 USC 112(a) or 35 USC 112, first paragraph, the following factors are considered (In re Wands 8 USPQ 2d 1400, 1404 (CAFC 1988)): a) Breadth of claims; b) Nature of invention; c) State of the prior art; d) Level of ordinary skill in the art; e) Level of predictability in the art; f) Amount of direction and guidance provided by the inventor; g) Working examples and; h) Level of experimentation needed to make or use the invention based on the content of the disclosure.
a) The claims are extraordinarily broad: “A liposome composition comprising an ATR protein kinase inhibitor compound, or a pharmaceutically acceptable salt thereof, encapsulated in a liposome and having a plasma half-life of at least 5 hours in mice, measured according to Example 8” (claim 4). Dependent claims 9-11 further define the liposome composition. Dependent claims 12 and 13 (product-by-process claims), also further define the liposome composition.
b,c) The nature of the invention is determined in part by the state of the prior art.
The prior art, in general, teaches specific, structurally distinct compounds, or small sets of compounds, as ATR protein kinase inhibitors.
d) The level of skill in the art is considered to be relatively high.
e) The level of predictability in the art is considered to be relatively low.
The basis of all modern medicine and biology is, of course, chemistry. Yet even under the best of circumstances, and more than two hundred years after Lavoisier laid the foundations of its modern practice, chemistry remains an experimental science. Neither the medicinal/biological arts nor the chemical arts upon which they are based have advanced to the point where certainty has replaced the need for clinical and/or laboratory experimentation.
Note that the enabled scope varies inversely with the degree of unpredictability in the art. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d, 833, 839, 166 USPQ 18, 24 (1970).
f,g) The amount of direction provided by the inventor is considered to be determined by the specification and the working examples. Inventor working examples are drawn to Compound A and compounds defined by formula (I).
h) The instant invention is predicated upon a particular set of ATR protein kinase inhibitors. Extrapolation from this limited set to the universe of possible ATR protein kinase inhibitors encapsulated in a liposome and having a plasma half-life of at least 5 hours in mice, measured according to Example 8, is unreasonable. It would clearly require an extraordinary – and thus undue – amount of experimentation in order to, first, synthesize the universe of ATR protein kinase inhibitors and then, second, determine which of this universe of compounds encapsulated in a liposome has a plasma half-life of at least 5 hours in mice, measured according to Example 8.
Claim Rejections - 35 USC § 112(b)
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.
Claim 4 is 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.
How exactly the half-life is measured is unclear because it is undefined (except in reference to Example 8 of the specification). Note, however, that incorporation by reference to a specific figure or table, or in this case a procedure, is permitted only in exceptional circumstances where there is no practical way to define the invention in words. Incorporation by reference is a necessity doctrine, not for applicant’s convenience (MPEP 2173.05(s)).
Clarification is in order.
Claims 5 and 14 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.
The identity of compound A is unclear because it is undefined. What exactly is this unknown and unknowable compound?
Clarification is in order.
Claim 15 is 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.
The identity of compound 1 is unclear because it is undefined. What exactly is this unknown and unknowable compound?
Clarification is in order.
Claims 6-13 are also 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.
The claims all depend, or ultimately depend, from an indefinite claim yet do not relieve the indefiniteness. Dependent claims 6-13 are also, therefore, indefinite.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-3, 6-8 and 11 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-3, 5-7 and 9 of prior (parent) U.S. Patent No. 10,570,119 B2, cited in the IDS. This is a statutory double patenting rejection.
The claim sets are drawn to the same inventions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 9/5/2026
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