DETAILED ACTION
Claims 1-20 are currently pending and are rejected.
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 .
Specification
The abstract of the disclosure is objected to because the abstract is speculative applications. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
It is suggested that the abstract be amended and rewritten as follows:
The present invention relates to pharmaceutical compositions which comprise a reverse transcription inhibitor for retrotransposon L1.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The instant title includes speculative applications.
The following title is suggested: Pharmaceutical Compositions Which Comprise A Reverse Transcription Inhibitor For Retrotransposon L1
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Specifically, see page 23, paragraph [0036]:
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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 1-20 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 Rett syndrome, autism spectrum disorder, and schizophrenia , comprising lamivudine or stavudine, does not reasonably provide enablement for a pharmaceutical composition for treating and/or preventing any developmental disorder or a mental disease with any reverse transcription inhibitor for retrotransposon L1. 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.
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 treating and/or preventing a developmental disorder or a mental disease comprising a reverse transcription inhibitor for retrotransposon L1, wherein the inhibitor excludes a non-nucleoside reverse transcriptase inhibitor, nevirapine (independent claim 1). Dependent claims 2-20 define the developmental disorder to Rett syndrome (claims 5, 10, 13, 16, 19 and 20), autism spectrum disorder (claims 6, 11, 14, 17, 19, and 20), and schizophrenia (claims 7, 12, 15, and 18-20) and define the reverse transcription inhibitor for retrotransposon L1 to a reverse transcriptase inhibitor (claim 2), to a nucleoside analog reverse transcriptase inhibitor (claim 3), to lamivudine or stavudine (claim 4, 8, and 9).
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 autism spectrum disorder, Rett Syndrome or schizophrenia, can be said to be preventable.
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 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 a pharmaceutical composition comprising any reverse transcription inhibitor for retrotransposon L1 can treat or prevent any developmental disorder or mental disease. The specification only provides data for the treatment of Rett syndrome, autism spectrum disorder, and schizophrenia with a pharmaceutical composition comprising lamivudine or stavudine, see pages 28-43 examples. Additionally, as provided on page 19, nevirapine, which is excluded from the instant claims, is a non-nucleoside reverse transcriptase inhibitor which falls within the definition of reverse transcription inhibitor for retrotransposon L1, se page 16 of the instant specification. As seen on page 19, even though nevirapine is a non-nucleoside reverse transcriptase inhibitor, it does not have any inhibitor activity for L1 reverse transcriptase, and is therefore excluded. Applicant has not provided data for the multitude of compounds that are covered by reverse transcription inhibitor for retrotransposon L1, reverse transcriptase inhibitor, nucleoside analog reverse transcriptase inhibitor, and non-nucleoside reverse transcriptase inhibitor, to indicate which ones may or may not have any inhibitor activity for L1 reverse transcriptase.
h) It would clearly require an extraordinary - and thus undue - amount of experimentation in order to determine if, in fact, administration of a pharmaceutical compositions comprising any reverse transcription inhibitor for retrotransposon L1 would treat or prevent any developmental disorder or mental disease.
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 1 and its dependent claims 2-20 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. 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, claim 1 recites the broad recitation “wherein the inhibitor excludes a non-nucleoside reverse transcriptase inhibitor” and the claim also recites “, nevirapine” 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. As there is only a comma between “non-nucleoside reverse transcriptase inhibitor” and “nevirapine” it is unclear if the “non-nucleoside reverse transcriptase inhibitor” excluded is “nevirapine” or if “nevirapine” is just an example of a “non-nucleoside reverse transcriptase inhibitor”. Additionally, it is unclear if the pharmaceutical composition “comprising” the “a reverse transcription inhibitor for retrotransposon L1” can have nevirapine in the composition as the exclusion is only from the “inhibitor”. It is suggested that the last two lines of claim 1 be amended to read “wherein the pharmaceutical composition excluded nevirapine.”
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication No. 2002/0187957 A1.
US Pre-Grant Publication No. 2002/0187957 A1 provides pharmaceutical compositions comprising a reverse transcriptase inhibitor (abstract). Page 1 provides that a reverse transcriptase inhibitor in a time-release formulation is administered to a patient suffering from a viral infection. Page 1 provides table 1 which provides the drugs lamivudine and stavudine. Additionally, see claim 6 which provides a pharmaceutical composition comprising a reverse transcriptase inhibitor selected from lamivudine and stavudine. Lastly, US Pre-Grant Publication No. 2002/0187957 does not mention nevirapine as part of the pharmaceutical composition. The pharmaceutical compositions in US Pre-Grant Publication No. 2002/0187957 comprising a reverse transcriptase inhibitor selected from lamivudine and stavudine anticipates applicant’s instant claims 1-20 as lamivudine and stavudine are reverse transcription inhibitors for retrotransposon L1 (instant claim 10, specifically reverse transcriptase inhibitors (instant claim 2), specifically nucleoside analog reverse transcriptase inhibitor (instant claim 3) as evidenced by instant dependent claims 4, 8 and 9 which state that the nucleoside analog reverse transcriptase inhibitor is lamivudine or stavudine. While instant claim 1 includes the intended use of “for treating and/or preventing a developmental disorder or a mental disease) along with dependent claims 5-7 and 11-20 including the intended use for treating and/or preventing “Rett syndrome”, “autism spectrum disorder” and “schizophrenia”, it is noted that these are intended uses for the claimed pharmaceutical composition. As US Pre-Grant Publication No. 2002/0187957 provides a pharmaceutical composition comprising lamivudine or stavudine, instant claims 1-20 are anticipated. In regards to the intended use of the pharmaceutical composition claims, while these product claims include an intended use, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the prior art structure, a pharmaceutical composition comprising lamivudine or stavudine is capable of performing the intended use of treating a developmental disorder or a mental disease, specifically Rett syndrome, autism spectrum disorder, or schizophrenia. Additionally, an intended use generally is not limiting when the claim body describes a structurally complete invention such that deletion of the intended use phrase does not affect the structure of the claimed invention. As is the instant case, the deletion of the intended use phrase does not affect the structure of the claimed invention as the structure is still a pharmaceutical composition comprising a reverse transcription inhibitor for retrotransposon L1, specifically lamivudine or stavudine. It is noted that recitation of the intended utility into a compound claim which can otherwise stand alone is not considered a further limitation of the claim. Additionally, a recitation of the intended utility does not impart patentability to a known composition. A pharmaceutical composition claim comprising lamivudine or stavudine is a known composition as seen in US Pre-Grant Publication 2002/0187957.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ February 6, 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600