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/Restrictions
Applicant’s election without traverse of Group II (claims 19-20) in the reply filed on January 28, 2026 is acknowledged.
Claims 1-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 28, 2026.
Claims 19-20 are under examination.
Information Disclosure Statement
The Information Disclosure Statement filed October 20, 2022 has been considered.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The use of the terms TALEN® at paragraph [00019], HALOTAG® at paragraphs [00013] and [00052], LIPOFECTAMINE® at paragraphs [00095], [00097], and [00098], ENDOFREE® at paragraph [00097], and KARYOMAX® at paragraph [00099], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 19-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hadlaczky et al. (U.S. Patent Application Publication No. 2002/0160410, issued October 31, 2002, and cited in the Information Disclosure Statement filed October 20, 2022).
It is noted that claims 19-20 are deemed to be product-by-process claims, which are not limited to the manipulations of the recited steps, only the structure implied by the steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964,966 (Fed. Cir. 1985) (citations omitted).
Regarding claim 19, Hadlaczky discloses fully functional and stable mammalian artificial chromosomes (MACs) (paragraphs [0012]-[0015]). Hadlaczky discloses that MACs can be distinguished from endogenous chromosomes using fluorescence, with the MACs being labeled with base-specific dyes, such as Hoechst 33258 and chromomycin, which is interpreted as the MACs being tagged in order to identify the synthetic chromosome as distinct from endogenous chromosomes (paragraph [0139]).
Regarding claim 20, Hadlaczky discloses that the MACs can range in size from about 50 to 400 Mb, and that shorter variants can be 50-80 Mb in size.
Hadlaczky discloses each and every element of claims 19-20, and therefore Hadlaczky anticipates claims 19-20.
Claims 19-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lindenbaum et al. (31(21) Nucleic Acids Research e172, 1-15 (2004), and cited in the Information Disclosure Statement filed October 20, 2022).
It is noted that claims 19-20 are deemed to be product-by-process claims, which are not limited to the manipulations of the recited steps, only the structure implied by the steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964,966 (Fed. Cir. 1985) (citations omitted).
Regarding claim 19, Lindenbaum discloses an artificial mouse chromosome platform (ACE) that is pre-engineered to contain multiple recombination acceptor sites, enabling incorporation of single or multiple copies of genes of interest (abstract and Figure 2). Lindenbaum discloses that the artificial chromosomes are fully functional (abstract and page 2, column 1, final two paragraphs). Lindenbaum discloses that the artificial chromosomes can be isolated (i.e., are distinct from endogenous chromosomes) by using two fluorescent tags and sorted and a FACS flow cytometer (page 4, column 2, final paragraph). Lindenbaum discloses that the two tags are Hoechst 33258 and chromomycin (page 4, column 2, final paragraph).
Regarding claim 20, Lindenbaum discloses that yeast and bacterial artificial chromosomes can have carrying capacities greater than 1 Mb (paragraph bridging pages 1 and 2). Lindenbaum discloses that large satellite DNA-based artificial chromosomes can be generated (page 2, column 1, third full paragraph). Lindenbaum discloses that the ACE platform allows for multiple copies of a single gene, or several genes, in the artificial chromosome (paragraph bridging pages 11 and 12). Lindenbaum discloses that the ACE artificial chromosomes have a large carrying capacity, which is interpreted as being at least 1 Mb in size (page 14, column 2, final paragraph).
Lindenbaum discloses each and every element of claims 19-20, and therefore Lindenbaum anticipates claims 19-20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Grimes et al. (114 Chromosoma 230-241 (2005), and cited in the Information Disclosure Statement filed October 20, 2022) is a review article discussing artificial and engineered chromosomes (abstract). Grimes discloses a variety of artificial chromosomes, including the ACE platform of Lindenbaum (discussed above). Grimes discloses that the size of the artificial chromosomes has a wide range, with smaller chromosomes being about 1-3 Mb and larger chromosomes being from about 3 to 20 Mb (page 232, paragraph bridging columns 1 and 2). While Grimes discloses a wide variety of artificial chromosomes, Grimes does not disclose or suggest using at least two tags that provide for distinguishing the artificial chromosomes from endogenous chromosomes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636