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 .
It appears the inventor(s) filed the current application pro se (i.e., without the benefit of representation by a registered patent practitioner). While inventors named as applicants in a patent application may prosecute the application pro se, lack of familiarity with patent examination practice and procedure may result in missed opportunities in obtaining optimal protection for the invention disclosed. The inventor(s) may wish to secure the services of a registered patent practitioner to prosecute the application, because the value of a patent is largely dependent upon skilled preparation and prosecution. The Office cannot aid in selecting a patent practitioner.
A listing of registered patent practitioners is available at https://oedci.uspto.gov/OEDCI/. Applicants may also obtain a list of registered patent practitioners located in their area by writing to Mail Stop OED, Director of the U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
This application may qualify for “Small Entity Status” and, therefore, applicant may be entitled to the payment of reduced fees. In order to establish small entity status for the purpose of paying small entity fees, applicant must make a determination of entitlement to small entity status under 37 CFR 1.27(f) and make an assertion of entitlement to small entity status in the manner set forth in 37 CFR 1.27(c)(1) or 37 CFR 1.27(c)(3). Accordingly, if applicant meets the requirements of 37 CFR 1.27(a), applicant must submit a written assertion of entitlement to small entity status under 37 CFR 1.27(c) before fees can be paid in the small entity amount. See 37 CFR 1.27(d). The assertion must be signed, clearly identifiable, and convey the concept of entitlement to small entity status. See 37 CFR 1.27(c)(1). No particular form is required.
If applicant qualifies as a small entity under 37 CFR 1.27, applicant may also qualify for “Micro Entity Status” under 35 U.S.C. 123. See 37 CFR 1.29 for the requirements to establish micro entity status for the purpose of paying micro entity fees.
Specification
The title of the invention is objected to. A new title is required that is clearly indicative of the invention to which the claims are directed. Immortality, in humans and human cells, is not yet possible (Hayflick, British Journal of Cancer, 2000,); Harris (Science, 2000). The following title is suggested: Viral vector mediated transfer of DNA repair genes.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
Claim Objections
Claims 1- 3 are objected to because of the following informalities:
Claim 1
Claim
Claim 3, the recitation of "Any Plasmid" should be amended to recite "A plasmid"
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 - 4 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.
Claim 1 recites: “Any Metamorphic Bio-Machine which are vectors with the usage of a single vector or multiple vectors.” The term “Metamorphic Bio-Machine” has no established, customary, or ordinary meaning in art, and the Specification fails to offer a clear definition of a “Metamorphic Bio-Machine” that would reasonably put one of ordinary skill in the art on notice of the metes and bounds of the term.
For purposes of compact prosecution and applying prior art, the term “Metamorphic Bio-Machine” was broadly interpreted herein to encompass any product having recited components of claim 1, i.e., a single or multiple vectors, as claimed.
Claim 2 recites: “Any Metamorphic Plasmid which is a plasmid with multiple transfer vectors to insert DNA into host cells of two or more different types especially human and bacterial cells.” The term “Metamorphic Plasmid” has no established, customary, or ordinary meaning in art, and the Specification fail to offer a clear definition of a “Metamorphic Plasmid” that would reasonably put one of ordinary skill in the art on notice of the metes and bounds of the term.
For purposes of compact prosecution and applying prior art, the term “Metamorphic Plasmid” was broadly interpreted herein to encompass any product having recited components of claim 2, i.e., multiple genes, as claimed.
Claim 3 recites: “Any plasmid containing the genes for DNA repair pathways of any animal in constructed DNA.”
The claim is indefinite because the term “constructed DNA” can be engineered through purposeful human activity or it can be created and assembled through natural means by any organism and would fail to reasonably put one of ordinary skill in the art on notice of the metes and bounds of the term.
For purposes of compact prosecution and applying prior art, the term “constructed DNA” was broadly interpreted herein to encompass any product having recited components of claim 3, i.e., genes related to DNA repair, as claimed.
Claim 4 recites: The Method of claims 1,2,3 being the Metamorphic Bio-Machine being used to transfer the DNA repair pathways of any animal integrating them into a bacteria or human cell.”
The claim is indefinite because claims 1-3 are drawn to products—not methods of using them. It is also unclear if the claim recites claims 1, 2, and 3, or claims 1, 2, or 3, especially since only claim 1 is drawn to a “Metamorphic Bio-Machine.” The claim is further indefinite because the claim recites an intended use for the method, but to fails recite any steps to actually practice the method.
For purposes of compact prosecution and applying prior art, claim 4 was broadly interpreted herein to encompass a method of transferring DNA repair related genes using the “metamorphic bio-machine” of claim 1, as interpreted above, into bacteria or human cells.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 - 3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because for the reasons set forth below. See MPEP § 2106 for analysis parameters.
The instant claims are drawn to a plasmid or viral vector that is able to transfer multiple genes and in some embodiments for DNA repair into human or bacterial cells, which is a statutory category of invention (Step 1: YES).
The instant claims are directed to the natural phenomenon of a viral vector, a plasmid with multiple genes, and a plasmid with multiple genes related to DNA repair. As mentioned above, claims 1 - 3 are being interpreted as encompassing a viral vector, DNA encoding any multiple genes, and multiple genes related to DNA repair, respectively. As evidenced by Fischer et al. (Virology, 2014, hereinafter "Fischer") a virus can naturally infect a bacterial cell and transfer multiple genes involved in DNA repair (Abstract; Introduction ¶ 1). Furthermore, as evidence by Lodwick et al. (Nucleic Acids Research, 1990, hereinafter “Lodwick) naturally occurring plasmids can and do encode multiple genes related to DNA repair (Abstract; Discussion, ¶ 1). As such recite judicial exceptions (JE) in the form of a natural phenomenon (STEP 2A, Prong One: YES).
The claims are limited to the JE, and not a method of, e.g., using the JE for a particular treatment or prophylaxis. As such, the claims do not recite any additional elements that integrate the JE into a practical application (STEP 2A, Prong Two: NO).
Since the claims are limited to solely the JE, the claims do not recited any additional that amount to significantly more than the JE itself. (STEP2B: NO).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C 101.
Claim Rejections - 35 USC § 102
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 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischer .
Regarding Claims 1 and 4, Fischer discloses a metamorphic bio-machine comprising a viral vector and one or more genes and a method of transferring DNA repair related genes using the metamorphic bio-machine of claim 1 into bacteria or human cells. Specifically, Fischer discloses CroV with a DNA genome of ~730 kilobase pairs encoding for structural proteins as well as enzymes for transcription, DNA repair, redox reactions and protein modification (Abstract).
As such, Fischer anticipates the claimed invention.
Claims 2 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kweon et al. (Oncogene, 2020, hereinafter "Kweon").
Regarding Claims 2 and 3, Kweon discloses a metamorphic plasmid comprising one or more genes and a plasmid comprising one or more genes involved in the DNA repair pathways of a multicellular organism. Specifically, Kweon discloses the use of using plasmids encoding gRNAs to edit BRCA1 in conjunction with lentivirus encoding a CRISPR/Cas9 system for gene editing (Methods, Construction of plasmid DNA).
As such, Kweon anticipates the claimed invention.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danyal H Alam whose telephone number is (571)272-1102. The examiner can normally be reached M - F 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANYAL H. ALAM/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672