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 .
Election/Restriction
Inventor’s election, without traverse, of the compound 2E-1-2-Aminophenyl-3-3-nitrophenyl-2-propen-1-one (BIA) (specification page 4, [0018]; page 29, [0170], last table entry) as the species elected to begin prosecution is acknowledged. The election/restriction is hereby made FINAL.
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 1, 6-9 and 14-22 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 a pharmaceutical composition for treating BI-1 related diseases and methods of its use etc., does not reasonably provide enablement for preventing such diseases. 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 (MPEP 2164.01(a)): 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 pharmaceutical composition for preventing or treating BI-1 related diseases comprising compounds of [diagramed] Formula I…” (independent claim 1). Dependent claims 6, 7, 14 and 20 further define the composition of Formula I. Dependent claims 8, 9, 15, 18 and 19 teach methods of utilizing the composition (preventing, treating). Dependent claims 16, 17, 21 and 22 teach a dietary supplement, a kit and an antagonist of BI-1 comprising the composition or its Formula I component.
b,c) The nature of the invention is determined in part by the state of the prior art.
As even a cursory perusal of the medicinal arts reveals, they have not advanced to the point where complex diseases with a significant genetic component, such as BI-1 related diseases such as cancers and autoimmune diseases (specification page 26, [0161]), can be said to be prevented.
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.
Cancer, for instance, is neither a simple disease, nor a single disease. While some cancers can be treated in some hosts using specific compounds, the effective treatment - let alone prevention - of various forms of cancer remains highly unpredictable in the art.
Note that the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art (MPEP 2164.03).
f,g) The amount of direction provided by the inventor is considered to be determined by the specification and the working examples. Inventor’s data do not demonstrate that the instant composition prevents cancers and autoimmune diseases.
h) It would clearly require an extraordinary - and thus undue - amount of experimentation (clinical trials, etc.) in order to determine if, in fact, the instant composition is actually efficacious in the prevention of cancers and autoimmune diseases.
Claims 2 and 10 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 a pharmaceutical composition for treating mTORC2 related diseases and its method of use, does not reasonably provide enablement for preventing such diseases. 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 (MPEP 2164.01(a)): 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 pharmaceutical composition for preventing or treating mTORC2 related diseases comprising compounds of [diagramed] Formula I…” (independent claim 2). Dependent claim 10 teaches a method of utilizing the composition.
b,c) The nature of the invention is determined in part by the state of the prior art.
As even a cursory perusal of the medicinal arts reveals, they have not advanced to the point where complex diseases with a significant genetic component, such as mTORC2 related diseases such as cancers and autoimmune diseases like lupus (specification page 26, [0162]), can be said to be prevented.
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.
Cancer, for instance, is neither a simple disease, nor a single disease. While some cancers can be treated in some hosts using specific compounds, the effective treatment - let alone prevention - of various forms of cancer remains highly unpredictable in the art.
Note that the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art (MPEP 2164.03).
f,g) The amount of direction provided by the inventor is considered to be determined by the specification and the working examples. Inventor’s data do not demonstrate that the instant composition prevents cancers and autoimmune diseases such as lupus.
h) It would clearly require an extraordinary - and thus undue - amount of experimentation (clinical trials, etc.) in order to determine if, in fact, the instant composition is actually efficacious in the prevention of cancers and autoimmune diseases.
Claims 3 and 11-13 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 a pharmaceutical composition for treating ATK-related diseases and its method of use, does not reasonably provide enablement for preventing such diseases. 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 (MPEP 2164.01(a)): 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 pharmaceutical composition for preventing or treating ATK-related diseases comprising compounds of [diagramed] Formula I…” (independent claim 3). Dependent claims 11-13 teach methods of utilizing the composition.
b,c) The nature of the invention is determined in part by the state of the prior art.
As even a cursory perusal of the medicinal arts reveals, they have not advanced to the point where complex diseases with a significant genetic component, such as ATK-related diseases such as cancers (specification page 26, [0163]), can be said to be prevented.
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.
Cancer is neither a simple disease, nor a single disease. While some cancers can be treated in some hosts using specific compounds, the effective treatment - let alone prevention - of various forms of cancer remains highly unpredictable in the art.
Note that the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art (MPEP 2164.03).
f,g) The amount of direction provided by the inventor is considered to be determined by the specification and the working examples. Inventor’s data do not demonstrate that the instant composition prevents cancers.
h) It would clearly require an extraordinary - and thus undue - amount of experimentation (clinical trials, etc.) in order to determine if, in fact, the instant composition is actually efficacious in the prevention of cancers.
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.
Claims 1-3 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.
It is unclear why a proviso “…and wherein, when B or C is N…” is included in the claims. Variables B and C can only be C (i.e. carbon).
The identity of the variable “…or an alkynyl of C 1 to C 10 IM…” is unclear. What is the meaning of “IM”?
The identity of variable RA is unclear because it is undefined.
Claim 6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
There is insufficient antecedent basis for the compound (19) E-1-(2-aminophenyl)-3-(pyridine-3-yl)prop-2-en-1-one (GM-90285).
There is insufficient antecedent basis for the compound (28) 1-(2-aminophenyl)-3-(2-ethoxy-5-nitrophenyl)-3-(hydroxypropan-1-one (GM-90230).
There is insufficient antecedent basis for the compound (30) (E)-1-(2-aminophenyl)-3-(pyridine-4-yl)prop-2-en-1-one (GM-90228).
There is insufficient antecedent basis for the compound (33) (E)-1-(2-aminophenyl)-3-(napthalen-2-yl)prop-2-en-1-one (GM-90225).
Claim 7 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
There is insufficient antecedent basis for the limitations “…a racemate, an enantiomer, a diastereomer, or a diastereomer [sic]…” in the claim.
Claim 8 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites the broad recitation “…the BI-1 related diseases…”, and the claim also recites “…include [emphasis added] liver diseases such as…” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Furthermore, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Finally, the limitation at the end of the claim is unclear: “…Neurological disease, characterized in that it is selected from the group consisting of insulin resistance, pharmaceutical composition…”. This makes no sense. Is this perhaps an editing error?
Claim 9 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The limitation at the end of the claim is unclear: “…non- Pharmaceutical composition, characterized in that it is selected from the group consisting of Hodgkin’s lymphoma, multiple myeloma and undifferentiated thyroid cancer…”. This makes no sense. Is this perhaps an editing error?
Claim 10 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Furthermore, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites the broad recitation “…respiratory diseases…”, and the claim also recites “…including [emphasis added] COPD…” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Finally, the limitation at the end of the claim is unclear: “…and systemic lupus erythematosus, pharmaceutical composition…”. This makes no sense. Is this perhaps an editing error?
Claim 11 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The limitation at the end of the claim is unclear: “…and viral infectious disease, wherein the pharmaceutical composition…”. This makes no sense. Is this perhaps an editing error?
Claim 12 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term general (“…general allergic asthma…”) is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The examiner respectfully suggests deleting the term.
Claim 13 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term similar (“…similar coronavirus infection…”) is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What is, or is not, similar would seem to be a rather subject evaluation and depend entirely on the criteria utilized to define any similarity.
Claim 14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
It is unclear how the instant composition can be “…controlled [emphasis added] by the antagonism of BI-1.” What does this mean? Is this, rather, a desired characteristic or property of the composition?
Claim 16 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 depends directly from independent composition claim 1. That being the case, it is unclear how the dietary supplement of claim 16 does not encompass this composition but, apparently, only the Formula I component of the composition.
Claim 17 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The limitation “…the related disease…” is unclear. Related to what exactly?
The examiner respectfully suggests simply deleting the term related.
Claim 18 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 depends directly from independent composition claim 1. That being the case, it is unclear how the method of claim 18 does not encompass this composition but, apparently, only the Formula I component of the composition.
Clarification is in order.
Claim 19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
It is unclear why the claim refers to the “…method of claim 17…”. Claim 17 is a composition claim (a dietary supplement).
Claim 20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Given the teaching of the specification, the limitation “…for inhibiting BI-1, mTORC2, or AKT inhibition…” is not correct. Inhibiting the inhibition? That is not what the specification teaches. This appears to be an editing error. The examiner respectfully suggest deleting the term inhibition (which follows the term AKT).
Furthermore, claim 20 depends directly from independent composition claim 1. That being the case, it is unclear how the composition of claim 20 does not encompass this composition but, apparently, only the Formula I component of the composition.
Claim 22 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 depends directly from independent composition claim 1. That being the case, it is unclear how the antagonist of claim 22 does not encompass this composition but, apparently, only the Formula I component of the composition.
Clarification is in order.
Claims 15 and 21 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.
The claims depend, or ultimately depend, from an indefinite claim yet do not relieve the indefiniteness. Dependent claims 15 and 21 are also, therefore, indefinite.
Markush Search
All claims have been examined with respect to formal matters.
The elected species has been searched and is not deemed free of the prior art.
All claimed subject matter which does not read on the elected species is hereby withdrawn from consideration, for purposes of this Office Action, as being drawn to non-elected subject matter. This subject matter will be rejoined as appropriate as the Markush examination progresses.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6, 7, 14, 20 and 21, in so far as they read on the elected species, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chemistry of Natural Compounds (2018), 54(1), pp. 158-160.
The reference teaches inventor’s compound as a component of an antifungal pharmaceutical composition utilized in the inoculation of microtest plates containing T. rubrum to test for antifungal activity (abstract; page 158, Table 1, compound 15; page 160, Antifungal Activity Assay).
With respect to the instant claim limitations drawn to the purpose, or desired use or characteristics of the instant composition (claims 14 and 20; note also the 112(b) rejections of these claims), the examiner notes that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the instant case, the instant composition and that of the prior art are the same and thus must necessarily exhibit the same properties. (MPEP 2112.01 (I).) (Because a compound and its properties are inseparable (MPEP 2112.01; 2141.02 (V).) Likewise, claim 21 drawn, apparently, to the compound itself, is anticipated. (Note the 112(b) rejection of claim 21 above.)
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 EST.
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, Ali Soroush, can be reached at 571-272-9925. 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.
/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 1/23/2026