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 .
Claims 1-40 are pending.
Election/Restrictions
Applicant’s election of Group I, claims 1-16, in the reply filed on 11-25-25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 17-40 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11-25-25.
Written Description
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 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification lacks written description for any amphibian that has a transgene encoding a fluorescent protein in its genome as broadly encompassed by claim 1 other than a frog. Claim 1 encompasses frogs, toads, newts, salamanders, caecilians. The specification is limited to a genetically modified frog whose genome comprises an exogenous nucleic acid sequence encoding a fluorescent protein operably linked to a promoter, wherein the frog visibly fluoresces. The specification does not correlate the genetically modified frogs to genetically modified toads, newts, salamanders, caecilians. Accordingly, the specification lacks written description for any amphibian that has a transgene encoding a fluorescent protein in its genome as broadly encompassed by claim 1 other than a frog.
The specification lacks written description for any amphibian that expresses a fluorescent protein via an eye-, skin- or bone-specific promoter as required in claims 6-8. The specification discusses such promoters on pg 6, line 1, but does not teach any such promoters. The Examples do not teach obtaining any such amphibians. Accordingly, the concept lacks written description.
Indefiniteness
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 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 metes and bounds of a “leucistic variant” of the genus Hymenochirus in claim 12 cannot be determined. The specification and the art at the time of filing do not define when the genus of Hymenochirus is a “leucistic variant”. The meaning of “leucistic” cannot be determined. Therefore, those of skill would not be able to determine when they were infringing on the claim.
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 1-9, 13, 16 are rejected under 35 U.S.C. 102a1 as being anticipated by Yoshizato (JP 2000279053).
Yoshizato taught a genetically modified frog whose genome comprises a nucleic acid sequence encoding eGFP operably linked to a metallothionein gene regulatory region (MRE). (pg 20-21 of translation; para 28-29). The MRE regulatory region is a tissue specific promoter as required in claim 1. The frog exhibits fluorescence as required in claim 1 (Examples; Fig. 3).
Yoshizato used eGFP as required in claim 2.
The promoter may be EF1α as required in claim 3 (para 19).
The promoter may be β-actin which is a muscle-specific promoter as required in claim 4 (para 19) and specifically recited as such in claim 5.
The promoter may be β-actin as required in claim 5 (para 19).
Claims 6-8 further limit the tissue specific promoter of claim 1 without excluding the ubiquitous promoter described by Yoshizato.
Yoshizato taught the frog was Xenopus (para 31) as required in claim 9.
Without evidence to the contrary, the frog was fertile as required in claim 13.
Without evidence to the contrary, the transgene was heritable as required in claim 16.
Claims 1-3, 7, 9, 13, 16 are rejected under 35 U.S.C. 102a1 as being anticipated by Sanger (“Eye specific expression of GFP driven by the tryptophan hydroxylase promoter in transgenic xenopus”, Univ. Kansas Med. Cent., Kansas City, KS, USA SO IOVS, (March 15, 1998) Vol. 39, No. 4, pp. S47).
Sanger taught a genetically modified frog whose genome comprises a nucleic acid sequence encoding GFP operably linked to a tryptophan hydroxylase promoter (title). The tryptophan hydroxylase promoter is skin specific as required in claim 1. The frog exhibits fluorescence as required in claim 1 (title).
Sanger used GFP as required in claim 2.
Claim 3 further limits the ubiquitous promoter without excluding the tissue specific promoter as described by Sanger.
The tryptophan hydroxylase promoter is eye specific as required in claim 7 (title).
Sanger taught the frog was Xenopus (para 31) as required in claim 9.
Without evidence to the contrary, the frog was fertile as required in claim 13.
Without evidence to the contrary, the transgene was heritable as required in claim 16.
Claims 1-4, 6-9, 13, 16 are rejected under 35 U.S.C. 102a1 as being anticipated by Demeniex (WO 2003102176).
Demeniex taught a genetically modified frog whose genomes comprises a nucleic acid sequence encoding eGFP operably linked to a TRE-tk promoter (pg 18, section 3.2 of translation) (see pg 4, lines 12-16 of the specification which describes them as transgenic frogs).
Demeniex used eGFP as required in claim 2.
Claim 3 further limits the ubiquitous promoter without excluding the tissue specific promoter as described by Demeniex.
Demeniex taught using a muscle specific promoter (pg 5 of translation) as required in claim 4.
Demeniex taught using a skin specific promoter (pg 5 of translation) as required in claim 6.
Demeniex taught using an eye specific promoter (pg 5 of translation) as required in claim 7.
Demeniex taught using a osteoblast specific promoter (pg 4, line 4, of translation) which is a bone specific promoter as required in claim 8.
Demeniex taught the frog was Xenopus (Examples) as required in claim 9.
Without evidence to the contrary, the frog was fertile as required in claim 13.
Without evidence to the contrary, the transgene was heritable as required in claim 16.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-13, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshizato (JP 2000279053) in view of Ballengee ("The art of unnatural selection." Signs of Life. Bio Art and Beyond (2007): 303-307).
Yoshizato taught a genetically modified frog whose genome comprises a nucleic acid sequence encoding eGFP operably linked to a metallothionein gene regulatory region (MRE). (pg 20-21 of translation; para 28-29). The MRE regulatory region is a tissue specific promoter as required in claim 1. The frog exhibits fluorescence as required in claim 1 (Examples; Fig. 3).
Yoshizato did not teach the frog was from the genus Hymenochirus as required in claim 10.
However, Ballengee taught Hymenochirus was worth breeding for its “historically described physical traits” (pg 305, last para) and because they are “actual artworks” (pg 306, line 1).
Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make a genetically modified frog as described by Yoshizato using the Hymenochirus breed described by Ballengee. Those of ordinary skill in the art at the time of filing would have been motivated to obtain a more “artful” frog.
Yoshizato used eGFP as required in claim 2.
The promoter may be EF1α as required in claim 3 (para 19).
The promoter may be β-actin which is a muscle-specific promoter as required in claim 4 (para 19) and specifically recited as such in claim 5.
The promoter may be β-actin as required in claim 5 (para 19).
Claims 6-8 further limit the tissue specific promoter of claim 1 without excluding the ubiquitous promoter described by Yoshizato.
Yoshizato taught the frog was Xenopus (para 31) as required in claim 9.
The frog is Hymenochirus described by Ballengee (Fig. 23.1) as required in claim 10.
The Hymenochirus described by Ballengee is albino (Fig. 23.1) as required in claim 11.
The Hymenochirus described by Ballengee is “a leucistic variant” as required in claim 12 because the metes and bounds are unclear.
Without evidence to the contrary, the frog was fertile as required in claim 13.
Without evidence to the contrary, the transgene was heritable as required in claim 16.
Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary.
Claims 1-9, 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshizato (JP 2000279053) in view of Blake (WO 2008022208).
Yoshizato taught a genetically modified frog whose genome comprises a nucleic acid sequence encoding eGFP operably linked to a metallothionein gene regulatory region (MRE). (pg 20-21 of translation; para 28-29). The MRE regulatory region is a tissue specific promoter as required in claim 1. The frog exhibits fluorescence as required in claim 1 (Examples; Fig. 3).
Yoshizato did not teach the frog was homozygous or heterozygous as required in claim 14-15.
However, Blake taught ornamental fish that were homozygous and heterozygous for the desired mutation (para 22, 23; claims 11, 12).
Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make a genetically modified frog as described by Yoshizato and making them homozygous or heterozygous as described by Blake. Those of ordinary skill in the art at the time of filing would have been motivated to do so as a matter of scientific endeavor.
Yoshizato used eGFP as required in claim 2.
The promoter may be EF1α as required in claim 3 (para 19).
The promoter may be β-actin which is a muscle-specific promoter as required in claim 4 (para 19) and specifically recited as such in claim 5.
The promoter may be β-actin as required in claim 5 (para 19).
Claims 6-8 further limit the tissue specific promoter of claim 1 without excluding the ubiquitous promoter described by Yoshizato.
Yoshizato taught the frog was Xenopus (para 31) as required in claim 9.
Without evidence to the contrary, the frog was fertile as required in claim 13.
Blake taught ornamental fish that were homozygous and heterozygous for the desired mutation (para 22, 23; claims 11, 12) as required in claims 14-15.
Without evidence to the contrary, the transgene was heritable as required in claim 16.
Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C. Wilson who can normally be reached at the office on Monday through Friday from 9:30 am to 6:00 pm at 571-272-0738.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638