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 .
Claim Status
Claims 1-6, 8, 10 and 11-20 are pending.
Claims 11-20 are withdrawn as being drawn to non-elected inventions.
Claims 1-6, 8 and 10 are being examined.
All previous rejections of claims 7 and 9 are moot in light of Applicant’s cancellation of claims 7 and 9.
All previous objections and rejections not set forth below is withdrawn in view of claim amendments.
Claim Rejections - 35 USC § 112(b)
Claims 1-6, 8 and 10 remain 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, “… enhancing at least one of photosynthetic rate and photosynthetic efficiency…”. However, the Applicant defines the two terms “photosynthetic rate” and “photosynthetic efficiency” to be the same. Instant specification defines, “”The term “enhanced photosynthetic rate and/or efficiency” refer(s) to a measure of photosynthesis of a modified organism relative to the wild-type or otherwise unmodified organism”” (spec, page 8, para 00046). It is unclear what is the difference between the two terms, “photosynthetic rate” vs “photosynthetic efficiency”, as used by the Applicant. All the claims directly or indirectly depending from claim 1, inherit the indefiniteness of the claim 1.
Response to Applicant’s Argument:
Applicant’s arguments are fully considered but not found persuasive. The Applicant argues, “Applicant strongly submits that an ordinary artisan would readily understand that photosynthetic rate measures the amount of photosynthesis that is occurring within a certain time period, while photosynthetic efficiency refers to the amount produced based on available resources (e.g., light, feedstock, etc.)..” (response, p.6, para 2, line 1-4). The Examiner agrees with the Applicant that an ordinary artisan would readily understand the difference between photosynthetic rate and photosynthetic efficiency. However, Applicant’s own description of the invention and definition of the two terms (“photosynthetic rate” and “photosynthetic efficiency”) made the two terms similar or synonymous. The claim interpretation in light of the instant specification does not differentiate between “photosynthetic rate” and “photosynthetic efficiency”, as explained in the indefinite rejection above.
Claim Rejections - 35 USC § 112(a) – Scope of Enablement
The previous rejections under 35 USC 112(a) - Scope of Enablement are withdrawn in light of the claim amendments and accompanying applicant’s arguments.
Claim Rejections - 35 USC § 103
Claims 1-6, 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Emlyn-Jones et al. (Nitrogen-Regulated Hypermutator Strain of Synechococcus sp. for Use in In Vivo Artificial Evolution, 2003, Applied and Environmental Microbiology, 69:6427–6433) in view of Roberts et al. (US 10654901 B2) and Foster, P. (Stress-Induced Mutagenesis in Bacteria, 2007, Crit Rev Biochem Mol Biol., 42: 373–397).
Claim 1 is drawn to a method of identifying a genetic mutation capable of enhancing at least one of photosynthetic rate and/or photosynthetic efficiency by modifying bacterial cells to enhance mutation rate relative to wild-type organisms in presence of an environmental stressor.
Emlyn-Jones et al. teaches that inactivation of mutS gene greatly increased mutation rate in cyanobacteria (abstract). Emlyn-Jones et al. describes an inducible expression system using the nirA promoter in Synechococcus sp. strain PCC 7942 (as recited in claim 8) by inactivating or repressing the mutS gene which is in the DNA mismatch repair pathway (as recited in claim 6) (abstract). Such hypermutator strains play a role in evolutionary adaptation to a new environment (page 6431, right column, para 1, line 5-7) and reads on to “adaptive mutation”, as recited in claim 2. Emlyn-Jones et al. also describes a vector comprising the nirA promoter (page 6429, right column, para 1, line 1-4, and line 33-34; Fig. 3). The recombinant vector comprising the nirA promoter was transformed into wild type cyanobacteria (Synechocystis sp. strain PCC 7942) to form modified cells (page 6429, right column, para 2, line 1-2), as recited in claim 5. Emlyn-Jones et al. also teaches that the PnirA-mutS (ϕ) system makes a useful addition to the toolbox of molecular genetic techniques available for study and manipulation of cyanobacteria (p. 6432, left col., para 4, line 1-3) which can be used to develop cyanobacteria strains for numerous and wide ranging uses including directed mutation of genes related to, inter alia, photosynthesis (p. 6432, left col., para, line 14-16).
However, Emlyn-Jones et al. does not explicitly describe photosynthetic rate/efficiency/capacity or screening cyanobacterial mutants based on its ability to have increased photosynthetic rate/efficiency and/or increased production of sucrose.
Roberts et al. describes a method of increasing photosynthetic capacity by downregulating activity of the RpaB pathway in cyanobacterial cells (as recited in claim 7) including in (wild type) Synechococcus elongatus PCC7942 (as recited in claim 8) (abstract; column 6, line 46-52) and also genetically modified cyanobacterial cells (abstract; column 6, line 55-56). Roberts et al. describes that increased photosynthetic capacity increases total carbon fixation, production of carbon containing compounds, and growth (biomass accumulation) (column 9, line 24-26).
Hence, the term “photosynthetic capacity” is interpretated by the Examiner as synonymous to “photosynthetic rate” and “photosynthetic efficiency” (as recited in claim 1) as all these terms are “a measure of photosynthesis”, as defined by the Applicant (as described above). Each of the parameters (i.e., increase total carbon fixation, production of carbon containing compounds, and growth or biomass accumulation) are interpreted as markers of enhanced photosynthetic rate/efficiency.
Roberts et al. also describes culturing the photosynthetic microorganism in specific medium (column 13, line 42-49; column 19, line 37-39 and line 48-67; column 20, line 26-32) and selecting genetically modified cyanobacterial cells (column 22, line 62-65) with increased photosynthetic capacity/efficiency/rate compared to non-transformed or wild type photosynthetic microorganism of the same species (Column 22, line 62-64; column 23, line 2-5). Growth (i.e., increased or enhanced biomass accumulation) of the bacterial cells including the modified bacterial cells are measured by optical density (column 2, line 21-22), as recited in claim 10.
Roberts et al. describes various inducible promoters (column 13, line 1-5 and line 42-50) including the ones induced by osmotic stress (by increasing salinity of the culture) (column 13, line 48-49) and described salt tolerant strains capable of growth in water or media having a salinity (column 7, line 10-24), mostly made of Sodium Chloride (NaCl) (column 6, last line) (as recited in claim 4) in the range of 2.0% (i.e., 341 mM NaCl concentration) to 3.0% (column 7, line 27-29) (i.e., about 512 mM NaCl concentration, as recited in claim 3). Roberts et al. also describes the nirA promoter (as recited in claim 5) to control expression of different coding sequences (column 13, line 24, line 28; column 14, line 41-44, line 52-60).
Before the effective filing date of the invention, it would have been obvious to an ordinarily skilled artisan to repress the mutS gene in a cyanobacteria using the NH4 salt (as a nitrogen source in the medium) inducible nirA promoter (repressed by NH4 salt) to enhance the rate of mutation on the genome of the cyanobacteria, as described by Emlyn-Jones et al., and culturing the modified bacterial cells in a medium comprising salt (NaCl) stress as observed in salt/saline water and brackish water (reads on to “an environmental stressor”) with a realistic goal to select the modified salt-tolerant cyanobacterial cells capable to grow and able to do photosynthesis, as described by Roberts et al. It is known in the art that bacterial cells try to overcome specific stress(es) by initiating stress-induced mutagenesis (SIM) or directed mutations (rather than relying solely on pre-existing random mutations) and selecting specific mutation(s) as the cells grow and divide in the medium under the specific stress(es) (Foster, P.; abstract; page 1, para 1, line 5-7; page 1, para 2, line 1-3). Inactivation or repression of mutS gene under the control of inducible nirA promoter in the modified cyanobacterial cells would only increase the rate of genetic mutation compared to unmodified wild type cells under specific stress including salt stress. The modified cells, which are capable to grow in high salt containing medium, would have increased photosynthetic rate/efficiency/capacity, compared to unmodified cyanobacteria.
Before the effective filing date, an ordinarily skilled artisan would have been motivated to repress the mutS gene in a cyanobacteria using the inducible nirA promoter to enhance the rate of mutation in the cyanobacterial genome and culturing the modified cyanobacterial cells in a medium comprising salt stress with a realistic goal to select the modified salt-tolerant cyanobacterial cells capable to grow by having increased photosynthesis rate/efficiency/capacity as compared to unmodified or wild type cyanobacterial cells.
Response to Applicant’s Argument:
Applicant’s arguments are fully considered but not found persuasive. The Applicant argues, “Applicant does not believe that an ordinary artisan would have combined these teachings for at least two reasons. First, Roberts already intentionally modified certain strains to induce higher photosynthetic capacity (see above) and has already identified specific modified strains that can cope with higher salinity” (response, p. 7, last para, first 4 lines) and “Second, the proposed modification has a likely chance to lead to mutations that show less photosynthetic capacity than the modified strains of Roberts” (response, p.8, para 3, line 1-4).
The Examiner disagrees. Firstly, Roberts et al. does specifically describe modifying wild type cyanobacteria Synechococcus elongatus PCC7942 (abstract; column 6, line 46-52) besides using intentionally modified strains, as discussed above. Moreover, intentionally modified strains (as a starting material) are not excluded but included in the claims. The only relevant limitation is- “… to enhance mutation rate relative to wild-type organisms…”. Any “intentionally modified” strain with further (genetic) modification resulting in enhanced mutation rate relative to wild-type organisms satisfies the limitation of the claims.
Secondly, Emlyn-Jones et al. teaches that the PnirA-mutS (ϕ) system makes a useful addition to the toolbox of molecular genetic techniques available for study and manipulation of cyanobacteria (p. 6432, left col., para 4, line 1-3) which can be used to develop cyanobacteria strains for numerous and wide ranging uses including directed mutation of genes related to, inter alia, photosynthesis (p. 6432, left col., para, line 14-16). The secondary reference of Roberts et al. is cited in the rejection to show that measuring photosynthetic capacity/efficiency/rate is known in the prior art and can be used by an ordinarily skilled artisan to develop cyanobacteria strains for increased photosynthesis capacity/efficiency/ rate, as taught by Emlyn-Jones et al.
Conclusion
No claim is allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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J.C.
/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
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