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 .
Applicants' arguments, filed July 9, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
In view of the claim amendments filed July 9, 2026, new prior art rejection and nonstatutory double patenting rejections are set forth below that use the same prior art references and a new reference. Applicants arguments that the previously applied prior art do not teach all of the limitations of the claims are addressed by the new rejections. No other arguments regarding the material previously used to reject the claims still used in the rejections below were presented for the Examiner to address herein.
Claim Rejections - 35 USC § 112 – New Matter
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 – 6, 9, 12 and 14 - 20 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. This is a new matter rejection.
Claim 1, from which all other claims depend, has been amended to require that the “human cells comprise DNA encoding a gene-expressed fluorophore and a stop codon preventing expression of the gene-expressed fluorophore, wherein the imaging agent comprises a gene-editing agent that deletes the stop codon upon successful delivery of the imaging agent into the human cells, thereby providing expression of the gene-expressed fluorophore within the human cells”. This limitation is not supported by the disclosure as originally filed.
¶ [0011] of the PGPub of the instant application and original claims 7 and 8 recite that the imaging agent can be a gene-editing agent and that the gene-editing agent activates fluorescence within the human-based cells. However, this general disclosure is not sufficient to support the very specific limitations in amended claim 1. A review of the specification did not find any discussion of fluorescent proteins containing a stop codon that was then edited by the gene editing agent such that the fluorescent protein was expressed to produce a fluorescent product that would be required since there are other ways for gene-editing agents to activate fluorescence within the human-based cells such that inherent or implicit support is not present.
The dependent claims fall therewith.
If Applicant is in disagreement with the Examiner regarding support for the amended claim, Applicant is respectfully requested to point to page and line number wherein support may be found for the instant invention.
Claim Rejections - 35 USC § 112 – 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 20 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.
While claim 20 has been amended in response to the previous indefiniteness rejection, the scope of the amended claim 20 still cannot be determined.
Just as when phrased as rejecting failed drug delivery vehicles, no criteria for what data or factors is considered to select a drug vehicle is given in either the claims or the specification to determine if a particular drug delivery vehicle system should be selected or not. Is there some threshold level of color change occurring and/or the color change must occur in certain parts of the model systems (e.g., not just the outermost cells directly exposed to the drug delivery vehicle containing solution) that would lead to a drug delivery vehicle being selected? Or would any changes result in selection? Without any such guidance as to when a drug vehicle would be selected or rejected, the scope of the step of claim 20 cannot be determined.
Please clarify.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 2, 6, 9, 12, 14 – 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ingber et al. (US 2016/0313306) in view of Chen et al. (Sci Reports, 2015) and Simovic et al. (Nanomed Nanotech Biol Med, 2015) further in view of Liu et al. (Biomacromolecules, April 2018 and Li et al. (Genome Biology, 2018).
Ingber et al. discloses systems and methods that can be used to grow and differentiate primary cells such as lung or other cells requiring low shear and/also stratified structures or simulation of a microenvironment in living tissues and/or organs that permit co-culture with one or more different cell types (whole document, e.g., abstract). The device can produce artificial tissue layers by being grown under conditions that mimic the appropriate physiological conditions (¶ [0305]). While many examples focus on mimicking the operation of the airway (e.g., ¶ [0078]), that the device can be used for the formation of 3-D gut or intestinal tissue such that the intestinal epithelial grow into folds that resemble the villi are also disclosed (¶¶ [0127] and [0255]). In some embodiments, the devices modeling the function of an intestinal villus structure as described above can be used to assess intestinal absorption, metabolism, and/or excretion of a test agent for the prediction of its bioavailability (¶ [0269]). Amongst the disclosed applications for the organ mimic devices are assessing pharmacokinetics and/or pharmacodynamics of various chemical or biological agents; testing gene therapy vectors; and studies on bioavailability and transport of chemical or biological agents across epithelial or endothelial layers (¶ [0073]). To study the effects of a test agent, one can add these into the desired cell culture medium suitable for growing the cells attached to the membrane in the channel (¶ [0321]). Imaging tools such as fluorescence microscopy can be used for real-time analysis of cellular behavior in the multilayered tissues in the device (¶ [0357]). The movement of fluorescent beads in an airway model is shown in Figures 14A and 14B (¶ [0044]) and fluorescently labeled pathogens can be used to monitor infection of cells with the pathogen with light or fluorescent microscopy (¶ [0301]).
A two-dimensional or three-dimensional model system as in claims 17 and 1 respectively are not disclosed.
Chen et al. discloses an in vitro human intestinal epithelium (whole document, e.g., title). A 2D transwell culture system with the human derived H-MyoFib cell on the bottom of the a 24-well transwell culture system with a pore size of 0.4 µm, reading on the lower plate of claim 17, with the Caco-2 and HT29-MTX cells cultured on the membrane of the transwell cell culture inserts, reading on the upper plate of claim 17, were cultured and maintained routinely in DMEM:SMGM (1:1) for up to 40 days (p 8, ¶ 2), reading on maintaining under physiologically relevant conditions. As shown in this schematic of the transwell system, the upper and lower plates are separated by distance/space as required by claim 17:
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. Caco-2 cells are enterocyte-like cells while HT29-MTX cells are Goblet-like cells routinely used to establish intestinal model systems for nutrient/drug absorption studies while H-InMyoFibs are fibroblasts that secrete cytokines and growth factors to support the growth, differentiation, and expansion of the human intestinal epithelium (p 2, ¶ 3). The same cell types were cultured on a 3D silk scaffold (p 8, ¶ 3) and that scaffold comprises the biologically-based polymer silk fibroin (p 7, ¶ 5) and comprises a porous material with an interconnected network of pores (p 7, ¶ 7). This model reads on the artificial intestine system of claim 1. The 3D model system better mimicked features such as mucus secretion compared to the transwell, 2D system (p 2, ¶ 4). The bioengineered 3D human intestine model using silk protein-based scaffold demonstrated its powerful and enduring strength to reconstitute and sustain both architectural and functional imperatives of human intestine in vitro (p 6, ¶ 2).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the intestinal model systems of Chen et al. to carry out studies as disclosed by Ingber et al. on the absorption of materials across the intestinal model system. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because tissue model systems can be used for such studies as taught by Ingber et al. but the 2D and 3D systems disclosed by Chen et al. provide mimicry of intestinal properties including mucus secretion that would reasonably be expected by one of ordinary skill in the art to possibly affect the absorption of the materials being studied. Results obtained from the 3D system would be reasonably expected to be a good mimic of in vivo results without resorting to an in vivo model. A 2D study can be readily carried out in a multi well system to provide initial test results, with the most promising candidates then being tested in the 3D silk fibroin system disclosed by Chen et al. that provides an improved intestinal system compared to the 2D system.
The use of a drug delivery vehicle comprising an imaging agent is not explicitly disclosed.
Simovic et al. discloses that nanoparticles are not generally administered orally mainly because of physiologically obstacles and various strategies have been tried to increase intestinal uptake of such particles (p 1169, col 2, ¶ 2). Various nanoparticle materials are a major tool in intravenous targeted anticancer therapy and the pharmaceutical industry (¶ bridging cols 1 and 2 on p 1169). Model micellar nanoparticles with a hydrophobic phospholipid core, a PEG (polyethylene glycol) corona loaded with the fluorophore coumarin 6 were used in the studies to study in vivo drug delivery characteristics (p 1169, col 2, ¶ 3 and p 1172, col 2). To study the mechanism of endocytosis across healthy intestinal tissues, pieces of rat ileum were incubated with the fluorescently labeled nanoparticles and images as shown in Figure 3 were collected over different times to nanoparticle movement in the tissue (p 1175, col 1, ¶ 2).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use a fluorescently labeled version of a drug delivery system to study absorption in intestinal cells using the methods and models of Ingber et al. and Chen et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the use of fluorescent materials is generally taught by Ingber et al. but not specifically for studying absorption of nanoparticles that can act as drug delivery systems across the intestine. Simovic et al. discloses using such particles to study intestinal absorption but uses actual tissue samples. The need for such samples is obviated by the use of the model systems of Ingber et al. and Chen et al. that comprise various cells that together create a model of intestinal tissue that is not obtained from an animal.
The presence of a cargo in the drug delivery vehicle that can edit genetic material and result in the expression of a fluorescent protein with a stop codon that is then deleted upon successful delivery of gene-editing imaging agent to the cell is not disclosed.
Liu et al. discloses that various vectors are known for the delivery of gene therapy with various advantages and disadvantages that are discussed on p 2957. The aim was to develop a highly efficient vector for large-sized CRISPR-Cas9 plasmids to realize genome editing in targeted tumor cells (p 2958, col 1, ¶ 2). Plasmids with and without the CDK11 knockout but both comprising green fluorescent protein, GFP, were prepared (p 2958, col 2, ¶ 2) and loaded into nanoparticles with and without targeting groups (p 2958, col 2, ¶ 7). GFP expression in cells after plasmid delivery was used to assess plasmid delivery efficacy (p 2961, col 2, ¶ 2).
Li et al. discloses a method of determining editing efficiencies for the PABE (fusion proteins of an adenosine deaminase with nCas9 with different positions of the adenosine deaminase and number and locations of the nuclear localization sequence; p 1, col 2, ¶ 2) constructs using a green fluorescent protein (GFP) with a mutation within the expression cassette converting glutamine-69 (CAG) into the stop codon TAG (p 1, col 2, ¶ 3). Upon correction of the T to C single nucleotide substitution, active GFP, meaning a functional fluorescent protein, is produced, allowing for mutageneses efficiency to be measured (p 1, col 2, ¶ 3) by the fluorescent arising from the functional GFP once the gene editing has taken place.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use cells in the model system with a GFP as taught by Li et al. and a gene editing cargo comprising gene editing agents to study the efficacy of different drug vehicles with a GFP construct wherein successful gene editing removes the stop codon preventing functional GFP expression. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Simovic et al. discloses that fluorescence can be used to track intestinal absorption of nanoparticles and the use of a construct as in Liu et al. and Li et al. will demonstrate if the constructs would have orally availability and deliver the gene editing cargo contained therein to a cell with a no-functional GFP in the absence of successful gene editing that alters the behavior of that cell, in this case the expression of at least a fluorescent protein, that can serve as a proxy for either gene editing as a therapeutic effect or delivery or other cargoes that do not required gene editing to bring about a therapeutic effect. In the system of Li et al. there is no fluorescence in the absence of gene editing so the observed change is gain of fluorescence rather than a decrease over a larger signal of expressed GFP in the absence of successful gene editing.
Claim(s) 3, 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ingber et al., Chen et al., Simovic et al., Liu et al. and Li et al. as applied to claims 1, 2, 6, 9, 12, 14 – 18 and 20 above, and further in view of Huang et al. (Molecular Pharmaceutics, 2014).
Ingber et al., Chen et al., Simovic et al., Liu et al. and Li et al. are discussed above.
Repeated cycles of analysis with different drug delivery vehicles and the same model system is not explicitly disclosed.
Huang et al. discloses a biomimetic colon tissue composed of Matrigel, Caco-2 cells and THP-1 cells for the in vitro evaluation of the delivery efficacy of nanoparticles - quantum dots (QDs), polyetherimide (PEI)/antisense oligonucleotide (ASO) and galactosylated low molecular weight chitosan (G-LMWC)/ASO nanoparticles - as an in vitro test platform which may be applied to select the most effective nanoparticle for further clinical trials (p 2051, col 2, ¶ 1). The image in the abstract shows a 96 well plate format for high throughput screening. Tissue and cellular uptake of three different nanoparticles in the artificial model (see p 2052, ¶ bridging cols 1 and 2 for details) were similar to that in 2,4,6-trinitrobenzenesulfonic acid (TNBS) colitic mice (abstract). Figure 3 shows images with the biodistribution of the fluorescent QD (quantum dots) in normal or inflamed colon tissue (p 2054, col 2, ¶ 2).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the same model system to test the performance of different drug delivery vehicle systems. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because as taught by Huang et al., in vitro model systems can be used to screen the behavior of different nanoparticle systems to select those that are most effective. While Huang et al. uses high throughput screening in a 96-well plate format, for a more involved model system particularly the 3D functional model of Chen et al., the preparation of many parallel systems for concurrent screening may not be practical so the use of the same underlying intestinal tissue model system but with different systems, sufficiently spaced out so that the system can ‘reset’ from the previous trial rather than preparing the substrate and allowing the proper layers of cells to grow on numerous separate intestinal tissue models. Parallel high throughput screening and sequential screening using the same model system have their owns pros and cons but the more involved model system that provides a better mimic of the actual tissue can render sequential testing of samples a suitable option. The generation of images, data analysis such as graphs of the performance of the different systems and rating of the performance of the different systems relative to one another would be obvious to one of ordinary skill in the art to analyze each system individually and collectively to determine the most effective nanoparticle under a particular set of conditions in the model system.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 – 6, 9, 12 and 14 - 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 21 and 23 of U.S. Patent No. 9,808,557 in view of Chen et al. (Sci Reports, 2015), Ingber et al. (US 2016/0313306), Simovic et al. (Nanomed Nanotech Biol Med, 2015), Liu et al. (Biomacromolecules, April 2018) and Li et al. (Genome Biology, 2018) optionally further in view of Huang et al. (Molecular Pharmaceutics, 2014).
The claims of US’557 recite a tubular silk fibroin material with an inner lumen (claim 1) that can have bioactive materials such as cells associated with the silk fibroin material (claims 8 and 9). Methods of making the tubular silk fibroin material are also claimed (claims 18 – 21).
That the tubular material forms an artificial intestine as required by claim 1 is not claimed.
Chen et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the silk fibroin tubular composition of US’557 to form the robust bioengineered functional human intestinal epithelium disclosed by Chen et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Chen et al. discloses that silk fibroin based tubes can serve as the base material to form a functional human intestinal epithelium.
The use of the functional human intestinal epithelium comprising a silk fibroin material to screen for screening drug delivery vehicles is not disclosed.
Ingber et al. and Simovic et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the intestinal model systems of US’557 and Chen et al. to carry out studies disclosed by Ingber et al. such as the absorption of materials across the intestinal model system. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because tissue model systems can be used for such studies as taught by Ingber et al. but the 2D and 3D systems disclosed by Chen et al. provide mimicry of intestinal properties including mucus secretion that would reasonably be expected by one of ordinary skill in the art to possibly affect the absorption of the materials being studied. Results obtained from the 3D system would be reasonably expected to be a good mimic of in vivo results without resorting to an in vivo model. A 2D study can be readily carried out in a multi well system to provide initial test results, with the most promising candidates then being tested in the 3D silk fibroin system disclosed by Chen et al. that provides an improved intestinal system compared to the 2D system. A fluorescently labeled version of a drug delivery system to studied absorption in intestinal cells can be used in such methods as Simovic et al. discloses using such particles to study intestinal absorption without the need for actual tissue samples.
The presence of a cargo in the drug delivery vehicle that can edit genetic material and result in the expression of a fluorescent material in the cell is not disclosed.
Liu et al. and Li et al. are discussed above.
CHANGE ONCE EDITED ABOVE
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use cells in the model system with a GFP as taught by Li et al. in the model system claimed by US’557 and a gene editing cargo comprising gene editing agents to study the efficacy of different drug vehicles with a GFP construct wherein successful gene editing removes the stop codon preventing functional GFP expression. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Simovic et al. discloses that fluorescence can be used to track intestinal absorption of nanoparticles and the use of a construct as in Liu et al. and Li et al. will demonstrate if the constructs would have orally availability and deliver the gene editing cargo contained therein to a cell with a no-functional GFP in the absence of successful gene editing that alters the behavior of that cell, in this case the expression of at least a fluorescent protein, that can serve as a proxy for either gene editing as a therapeutic effect or delivery or other cargoes that do not required gene editing to bring about a therapeutic effect. In the system of Li et al. there is no fluorescence in the absence of gene editing so the observed change is gain of fluorescence rather than a decrease over a larger signal of expressed GFP in the absence of successful gene editing.
The repeated use of the same system to evaluate different drug delivery vehicles is not disclosed.
Huang et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the same model system to test the performance of different drug delivery vehicle systems. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because as taught by Huang et al., in vitro model systems can be used to screen the behavior of different nanoparticle systems to select those that are most effective. While Huang et al. uses high throughput screening in a 96-well plate format, for a more involved model system particularly the 3D functional model of Chen et al., the preparation of many parallel systems for concurrent screening may not be practical so the used of the same underlying intestinal tissue model system but with different systems, sufficiently spaced out so that the system can ‘reset’ from the previous trial rather than preparing the substrate and allowing the proper layers of cells to grow on numerous separate intestinal tissue models. Parallel high throughput screening and sequential screening using the same model system have their owns pros and cons but the more involved model system that provides a better mimic of the actual tissue can render sequential testing of samples a suitable option. The generation of images, data analysis such as graphs of the performance of the different systems and rating of the performance of the different systems relative to one another would be obvious to one of ordinary skill in the art to analyze each system individually and collectively to determine the most effective nanoparticle under a particular set of conditions in the model system.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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