Can anyone suggest me topics for a project in biotechnology?

Question

I need a good project topic and it's abstract in biotechnology. help me plz.

Answer 1

Trilateral Project 24.1 - Biotechnology

Comparative Study on Biotechnology Patent Practices

Comparative Study Report



Contents


Foreword

1. Requirements for Disclosure and Claims

General

1.1 Claims

1.1.1 Clarity of Claims

1.1.1.1 General rules

1.1.1.2 Details

1.1.1.2.1 Structural gene

1.1.1.2.2 Recombinant protein : Protein as obtained by using recombinant DNA technology

1.1.1.2.3 DNAs, other than structural gene

1.1.1.2.4 Transformant, Fused cell

1.1.2 Relationship between Claims and Description of the Invention

1.2 Description of the invention

1.2.1 Enablement Requirement (Adequacy of Disclosure)

1.2.1.1 General rules

1.2.1.2 Details

1.2.2 Deposition

2. Patentability

2.1 Industrial Applicability (Utility)

2.2 Novelty

2.3 Inventive step (Non-obviousness)

3. Unity of Invention

4. Amendment

4.1 Amendment of DNA/amino acid sequence

4.2 Addition or Conversion of deposit number

5. Patentable subject matters



Foreword

In the beginning, the JPO notices that the JPO explains relevant provisions and practices mainly on the basis of 1994-Revised Patent Law (applicable to applications filed on and after 1995.7.1.)

EPO JPO USPTO

1. Requirements for Disclosure and Claims

General

The three Offices explain the reasons for rejection.

The USPTO explains, based on the Patent Act, Sections 101, 102, 103 and 112.

The EPO shows all the reasons, including the substantive requirements for disclosure and claims. On the other hand, the JPO explains in detail the requirements for disclosure and claims.

EPO JPO USPTO

1.1 Claims

1.1.1 Clarity of Claims

1.1.1.1 General rules

(1) Is it allowed that a claim is defined only by the objective to be reached ?

If they can, how should such a claim be interpreted ?

Should such a claim be called a "single-means" claim ?

The three Offices point out that a claim defined only by the objective to be reached has problems in the light of clarity of claims and of enabling disclosure.

The USPTO states that a claim may not be defined only by the objective to be reached because it would not be commensurate in scope with the enabling disclosure.

The EPO states that the scope of a claim must be clearly and unambiguously defined and in general, claims which attempt to define the invention by a result to be achieved are not allowed, in particular if they only amount to claiming the underlying problem, in other words the result to be achieved, however, claims worded in terms of functional features may be allowed if the invention either can only be defined in such terms or cannot otherwise be defined more precisely without unduly restricting the scope of the claims and if the result is one which can be directly and positively verified by tests or procedures adequately specified in the description or known to the person skilled in the art and which do not require undue experimentation.

In the JPO, a patent application shall not be rejected on the ground of the lack of clarity of claims merely because a claim includes a statement defining a product only by the objective to be reached, however, it is the lack of clarity of claims, if a claimed invention cannot be clearly identified by a skilled person as a result of such claim statements, particularly, if the extent of the claimed invention is unclear to a skilled person even taking into account the specification, drawings and common general knowledge as of the filing.

EPO JPO USPTO

(2) Is it allowed to use a result to be achieved as one of the elements (technical features) of the claimed invention in combination with the other elements (technical features) ?

Does the judgement depend on whether such an element is known to the public as of filing ?

Should such claim be called a "means-plus-function" claim ?

The three Offices allow to use a result to be achieved as one of the elements (technical features) of the claimed invention in combination with the other elements (technical features), however, the EPO allows such a claim only on the specific conditions as mentioned above 1.1.1.1(1) if such a element is the essential one.

EPO JPO USPTO

(3) Is it allowed to refer to drawings or tables (including DNA sequence, amino acid sequence, cleavage map of the DNA, etc.) in the claims ?

The USPTO explains that a reference is allowed, as long as the meaning of the claims is definite. On the other hand, in the EPO, claims shall not, except where absolutely necessary, rely on the references to the description or drawings. An exceptional case is a claim for a DNA or protein; in these cases a reference to a drawing or table containing the DNA sequence, amino acid sequence or restriction map of the DNA, respectively, is allowed. This handling is equal to that of the JPO on the basis of 1987-Revised Law, but the JPO explains that a reference is available when it leaves the claimed invention clear and concise under the 1994-Revised Law.

EPO JPO USPTO

1.1.1.2 Details

1.1.1.2.1 Structural gene

(1) Where a claimed invention concerning structural gene is not characterized by its DNA sequence but only by its function, is the claim specified clearly ?

ex. A DNA isolate consisting essentially of a DNA sequence encoding human protein X. (Notes) The word "protein X" stands for a certain protein, like immune IFN, t-PA, etc. In the following, the word "protein X" is used as the same meaning.

Is such a claim described above regarded as a "means-plus-function" claim or as a "single-means" claim ?

The practices in the three Offices are common in that a claim directed to a structural gene characterized only by its function (encoding "protein X") is allowed provided the human "protein X" is clearly defined in the specification and is sufficiently characterized by structural features.

Concerning the terminology of "means-plus-function" and "single-means", the USPTO states that such a claim is not normally labeled as a kind of "means" claim. The EPO mentions, in the prior questionnaire, such a terminology does not apply in the practice. The JPO explains that the claimed invention should be denied its novelty if any one of the every possible means for achieving the objective (result) stated in the claim is publicly known, and there is no distinction in the claim construction between so-called "single-means" and "means-plus-function" in this sense.

EPO JPO USPTO

(2) Where a DNA is characterized by "having some extent of identity to a DNA sequence" in a claim, is the claim specified clearly ?

ex. A DNA sequence encoding protein X, said DNA sequence having at least 40% identity to the DNA sequence in Fig. 1.
(Notes) Suppose that a specific DNA/amino acid sequence is described in "Fig. 1". In the following, "Fig. 1" is used as the same meaning.

The three Offices, in principle, agree that it is clear if an appropriate definition of "identity" (homology) is provided in the specification, however, the EPO states that the limit of "at least 40% identity to the DNA sequence in Fig. 1" is too low to ensure that the protein encoded by the degenerated DNA sequences remains the same and the JPO states that enablement requirement should be examined because the claimed DNA having identity (homology) with the specific DNA may be unlikely to have similar activity as the specific DNA.

EPO JPO USPTO

(3) What are the requirements for specifying a claim in which a DNA is characterized by "hybridizing" to a specific DNA sequence ?

For example, i) a DNA sequence has to be a naturally-occurring product, ii) the condition of hybridization must be defined, iii) the source of a DNA must be specified (ex. human being, mouse etc.)

ex. A DNA sequence encoding human protein X, said DNA sequence being selected from the groups consisting of:

a) the DNA sequence set out in Fig. 1 or its complementary strand; and

b) naturally obtainable

DNA sequence which hybridizes under stringent conditions to the DNA sequence defined in a).

There are some differences in the answers of the three Offices.

In the USPTO, for the purposes of clarity, there are no requirements for specifying the term "hybridizes", and the term "hybridizes" is itself a term of art which is clear though broad.

The EPO answers that it is possible in a claim to characterize a DNA sequence by "hybridizing" to a specific DNA sequence only on condition that the hybridization conditions are defined in the claim.

The JPO states that a hybridization claim can be defined by a description containing all the elements listed below as 1) - 3);

1) one or more nucleotide sequences defined in, for example, working example

2) the phrase of "under stringent conditions" in the claim (the conditions be provided in the detailed description of the invention)

3) property or function of encoded protein

EPO JPO USPTO

(4) What are the requirements for specifying a claim like the following example ?

ex. A DNA encoding a protein which has the function of protein X and which comprises a derivative, by way of amino acid substitution, deletion, addition or insertion of the amino acid sequence set out in Fig. 1.

For example, is it necessary to define the number of bases which may be added, deleted or substituted ?

The USPTO answers that definition of the terms substitution, deletion, addition and insertion do not require numerical definition for the purposes of clarity and specificity. However, the USPTO points out that the broadest interpretation of these terms would result in a very broad claim encompassing many DNAs. Moreover, proteins have many functions and the intended function of protein X is not recited possibly making the DNA indefinite. In contrast, the EPO and the JPO state that an addition/deletion/substitution type claim can be defined with elements 1) - 3);

1) one or more nucleotide sequences or amino acid sequences defined in, for example, working example

2) a clear definition of the term "addition, deletion, substitution," provided that "the sequences added, deleted or substituted" have a high degree of identity (homology) with the sequences of 1)

3) property or function of encoded protein

EPO JPO USPTO

(5) Allelic mutant, Derivative, Equivalent, Variant

Where a claim states as an "allele or allelic mutant", or a "derivative", or an "equivalent", or a "variant" of a specific DNA sequence, is the claim specified clearly ?

ex. A DNA sequence encoding human protein X of the amino acid sequence depicted in Fig. 1 hereof or allele or derivative thereof having the function of human protein X.

Again, there are some differences between the practices in the two Offices (the EPO and the JPO) and these in the USPTO.

In the JPO, it depends on the definition of the terms in a specification whether or not the claim containing the above-mentioned terms is clear. To be judged clear, it is necessary to provide a clear description that the differences between the amino acid sequences of allele or derivative and the standard sequence shown in Fig. 1 are within a certain range.

The EPO states that on condition that a DNA sequence is clearly defined in a claim, the variants etc. of the DNA sequence fulfill the requirements of clarity provided that the variants etc. of said DNA sequence are additionally all defined as encoding proteins which have the same properties as protein X.

On the other hand, the USPTO states that "derivative", "equivalent" and "variant" do not have well recognized, specific meaning in the art of molecular biology and their use as in this question would raise an issue as to specificity. The USPTO states that one would look to the specification and the state of the art to determine the definition of allele or allelic mutant.

EPO JPO USPTO

1.1.1.2.2 Recombinant protein : Protein as obtained by using recombinant DNA technology

Where claims related to recombinant proteins are described in the same form as the claims of structural genes discussed in 1.1.1.2.1(1) - (5) above, would they be regarded in the same way ? If different judgement is made about those proteins, please discuss in this paragraph.

(1) In case where its amino acid sequence is not described and only its function is described in a claim.

ex. A recombinant protein having the function of human protein X.

(2) In case where a protein is described as "having some extent of identity" to a specific sequence in a claim.

ex. A protein having protein X function and which is encoded by a DNA, said DNA having at least 40% identity to the DNA sequence in Fig. 1.

(3) In case where a protein is characterized by "hybridizing" to a specific sequence.

ex. A protein having protein X function and which is encoded by a DNA sequence, said DNA sequence being selected from the groups consisting of:

a) the DNA sequence set out in Fig. 1 ;and

b) naturally obtainable DNA sequence which hybridizes under stringent conditions to the DNA sequence defined in a).

(4) In case where a protein is characterized by "addition-deletion-substitution".

ex. A protein having protein X function and which comprises a derivative, by way of amino acid deletion, substitution, insertion, inversion or addition of the amino acid sequence as encoded by the DNA in Fig. 1.

(5) Allelic mutant, Derivative, Equivalent, Variant

ex. Protein X of the amino acid sequence depicted in Fig. 1 hereof or allele or derivative thereof having the function of protein X.

These questions (1) - (5) correspond to the prior questions 1.1.1.2.1(1) - (5).

Concerning (1), the USPTO and the EPO comment that a recombinant protein being defined only by having the function of a certain protein X would lack clarity because a protein has several different functions.

As to (2) - (5), the answers of the two Offices (the EPO and the JPO) are the same as their answers of corresponding questionnaire 1.1.1.2.1(2) - (5); the USPTO gives answers that differ from their answer to the corresponding question 1.1.1.2.2(2), (3) and (5). The differences arise from the recitation of a protein function in the protein claims which is not present in DNA claims 1.1.1.2.1(2) and (3). The USPTO points out that the specification must be consulted to determine the meaning and clarity. The USPTO supplements its explanation for 1.1.1.2.1(2) by pointing out that it is often possible to arrive at different extents of sequence identity between sequences because of many different algorithms for comparing and many different variables in these algorithms.

EPO JPO USPTO

Is there any difference to define claims between recombinant DNAs and recombinant proteins, in case that structural genes which encode proteins with a biological function are cloned ? If there are some differences, what is the reason for the differences ? For example, is the claim "a DNA encoding a protein X and which comprises a derivative by way of amino acid substitution, deletion, addition or insertion of the amino acid sequence set out in Fig. 1" definite ?

On the contrary, is the claim "a protein which has the function of protein X and which comprises a derivative by way of amino acid substitution, deletion, addition or insertion of amino acid sequence set out in Fig. 1" indefinite ? If it is indefinite, does it become definite by describing "the function of protein X " more clearly and concretely ?

The EPO and the JPO reply that there are no differences between them.

The USPTO answers that such a claim as "a protein which has the function of protein X and which comprises a derivative ... in Fig. 1" is not clear, because a protein rarely has only one function. However, it may become clear, if the function of protein X is defined precisely.

EPO JPO USPTO

1.1.1.2.3 DNAs, other than structural gene

(1) Where a claimed invention is directed to a DNA fragment used as a probe for analysis, are those forms of claims described in 1.1.1.2.1(2) - (4) above allowed ? If there are any more suitable words to define DNA fragments, please discuss them in this paragraph.

The three Offices agree, in principle, that a DNA fragment must be clearly defined by technical features, but there are some differences in their answers.

The USPTO explains that a probe claim relating to addition/deletion/substitution would be very difficult to draft because encompassed within the claim are probes which may be specific for a region of the disclosed sequence that is varied.

The EPO emphasizes a precise definition of the fragment/probe length or of the part of the amino acid sequence of the protein or peptide.

The JPO shows the two requirements for being a DNA probe for analysis; 1) it can strictly hybridize with polynucleotides to be detected, 2) it does not hybridize with polynucleotides concerning similar polypeptide, and as a result, enablement requirement is generally considered not to be satisfied in many cases where DNA probes for analysis are specified by homological, hybridization and addition/deletion/substitution sequences.

EPO JPO USPTO

(2) Where a claimed invention is directed to a regulatory sequence like promoters and so on, are those forms of claims described in 1.1.1.2.1(2) - (4) above allowed ? If there are any more suitable words to define regulatory sequences, please discuss them in this paragraph.

Again, the three Offices coincide that a regulatory sequence must be clearly defined by technical features.

In particular, the USPTO and the EPO explain the requirements for such a claim, that is, mainly certain extent of identity, hybridization conditions and/or the kind and extent of mutations of the specific DNA sequence.

The JPO shows that the length of a nucleotide sequence corresponding to actual regulatory function in sequence confirmed to possess some regulatory function is extremely shorter than that of structural genes, therefore, it is likely that a DNA defined by identity (homology), hybridization, or addition/deletion/substitution relating to a regulatory sequence would lose the function of the original sequence.

EPO JPO USPTO

1.1.1.2.4 Transformant, Fused cell

(1) Where the word "transformant" implies not only cell cultures and microorganisms but also plants and animals themselves, is a claim using the word "transformant" specified clearly ?

ex. The claim is, "A transformant transformed with a DNA sequence encoding for protein X.", and in the description of the invention defines "transformant" to include cell cultures, microorganisms, animals themselves and plants themselves.

The three Offices agree that the term "transformant" itself is not unclear.

In addition, the USPTO and the EPO point out that "transformant" may not be acceptable if the definition in the specification would be considered repugnant to the normally accepted usage of the term. Furthermore, the two Offices notice that a broad interpretation to include humans would be unacceptable.

EPO JPO USPTO

(2) Where the claimed invention is directed to a fused cell which produces a monoclonal antibody, what is the element necessary in the claim other than the monoclonal antibody itself ? (ex. name of the used host cell or parental cell etc.)

The USPTO answers that it may be specified with a deposit designation.

Concerning the specific hybridoma, the similar answer is revealed by the EPO and the JPO. The two Offices, though, explain that a broad claim directed to a fused cell can be characterized by a combination of parent cells, function/properties and production (produced monoclonal antibody). And the USPTO concurs with the EPO and the JPO for such a broad claim.

EPO JPO USPTO

1.1.2 Relationship between Claims and Description of the Invention [ex. Support in description of the invention (Relationship between working examples and claims), Adequate written Description, etc.]

Please discuss those issues mentioned below in "1.2.1 Enablement Requirement" in this paragraph, if the USPTO or the EPO finds it more proper to handle those issues as a matter of "support" or "adequate written description" for the invention described in the claims.

(For example, if those issues mentioned below are considered under EPC Article 84 rather than EPC Article 83, it might be reasonable to handle them in this paragraph.)

The different thinking around this question is recognized between the EPO and the JPO.

In the JPO, it is enough to satisfy a requirement for the Patent Law Section 36(6)(i) that the matter corresponding to what is claimed is formally written in the detailed description of the invention. Consequently, it is usually discussed as the matter of "enablement requirement."

On the other hand, the EPO explains that an objection of lack of support under Article 84 EPC can often also be considered as an objection of insufficient disclosure under Article 83 EPC.

The USPTO gives answers that the specification must provide both a written description of the invention and sufficient enablement to practice the invention as claimed. These are separate and distinct requirements of the statute 35 U.S.C.112, first paragraph.

EPO JPO USPTO

1.2 Description of the invention

1.2.1 Enablement Requirement (Adequacy of Disclosure)

1.2.1.1 General rules

The report "Consolidated Comparative Study of Patent Practices in the Field of Biotechnology Related Mainly to Microbiological Inventions"(1990.1) of Project 12.3 and the report "Comparative Study Report on Requirements for Disclosure and Claims"(1990) of Project 12.6 have been made. Considering these reports, please explain the following items.

(1) Please explain the examining practice related to "Enablement Requirement (Adequacy of Disclosure)" in detail.

For example, please refer to "how to make" and "how to use".

The three Offices coincide that enough or sufficient information is needed to carry out the claimed invention by a person skilled in the art, without undue experimentation and using his common general knowledge as of the filing.

In addition, the EPO states that the description must disclose any feature essential for carrying out the invention in sufficient detail to render it obvious to the skilled person how to put the invention into practice. Also, the JPO explains that normally one or more representative embodiments or working examples are necessary in the case of inventions in technical fields where it is generally difficult to infer how to make and use a product on the basis of its structure.

for more
http://www.jpo.go.jp/shiryou_e/toushin_e/kenkyukai_e/contents.htm

Answer 2

If yu need a good topic for yur project then my suggestion are u should do topics like :
a)cloning.
b)new plant hybrids which can resist pest and grow in less fertilizer eg BT cotton.
c)making a extinct animal alive by taking its DNA and exchanging with its nearest species.

Answer 3

Animals

Encyclopedia Smithsonian Science Fair
Great ideas for projects involving insects.

Life Cycle of the Drosophila Fly
Experiments to determine the life span of drosophila flies.

Science Fair Ideas: Zoology
A nice compilation of animal project ideas including projects with insects, crayfish, rodents, and more.

Answer 4

you're able to do a project at right here subjects: one million. present day Agriculture ( GM vegetation/single cellular proteins). 2. Gene Expression or present day genetics ( Mendelian and the extensions of the mendelian genetics) 3. Human Evolution. 4. Biotechnology ( cellular cuture/ Tissue lifestyle). 5. Any branch of Human physique shape ( Reproductive, frightened, endocrine or circulatory gadget). 6. nutrients (animal and Plant). wish u benefit. thank you.

Answer 5

dna replication
detailed structure n functions of cell organelles

Answer 6

yes i can

go and talk with your class master, he will give you proper answer

Answer 7

I cannot