DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In view of the appeal brief filed on 5/06/2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below. This Office Action is non-final.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Status of Claims
Claims 1, 2, 4, 5, 9-15, and 17-22 remain pending, of which claims 1, 2, 4, 5, and 9 are under consideration on the merits. Claims 10-15 and 17-22 remain withdrawn from consideration. References not included with this Office action can be found in a prior action.
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, 2, 4, 5, and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product without significantly more.
Claim 1 recites a natural product, neutrophils, and further recites product-by-process limitations. Claim 9 incorporates the limitations of claim 1. The neutrophils of claim 1 are disclosed as being obtained from subjects having been treated with 5 ng/kg body weight of for 4 weeks with lipopolysaccharide (i.e. “low dose LPS”) or neutrophils co-cultured in vitro with the same low dose LPS and which collectively induces the opposite/inverse gene and/or protein expression pattern of claim 1 (see [0158]-[0160] of the specification), which is then restored to the prior gene and/or protein expression pattern by contacting the neutrophils having been contacted with low dose LPS in vitro with 4-pheynlbutyrate (4-PBA)(see [0166], Fig. 6. and Fig 19A-B of the disclosure). G-CSF is only disclosed as polarizing the neutrophils and delaying neutrophil apoptosis (see [0163] of the specification). Thus, the claims when read in light of the specification appear to be directed to a restored neutrophil after it has been activated. It appears this is similar to a naturally occurring neutrophil prior to an inflammatory response.
Therefore, the claimed neutrophils do not reasonably possess any markedly different characteristic at this time because claims 1 and 9 as a whole only serve to generate an intermediate neutrophil phenotype and then restore the neutrophils to their original and natural gene and/or protein expression pattern that existed prior to any intervention by Applicant.
Additionally and when the claims are read in light of the specification, the neutrophils of claims 1 and 9 do not reasonably possess any markedly different characteristic at this time because the claimed marker expression pattern is reasonably presumed to be inherently generated by routine and conventional methods in this art of 4-phenylbutyrate administration to subjects; see M.P.E.P. § 2112 and 2113. Kim (Scientific Reports (2013), 3(1142), 10 pages; Reference V2) teaches that administration of 200 mg/kg of 4-phenylbutyrate (i.e. 4-PBA) to subjects reduces the increase in ER stress markers in the lung and reduces lung inflammation both caused by prior treatment with LPS (see the Abstract, Fig. 2-3, and page 2; page 9, subheading “Administration of 4-PBA” for the dosage). Miller (International Journal of Radiation Biology (2017), 93(9), 13 page author manuscript; Reference W2) teaches administering 10 mg/kg of 4-phenylbutyrate confers protect against radiation (Abstract and Figure 3). Claims 1 and 9 are generic towards any particular product-by-process manipulations (e.g. ex vivo, in vitro, and chemically programmed), and so only generally links the use of the judicial exception to a particular technological environment or field of use and do not clearly discriminate between the routine and conventional neutrophils treated with 4-phenylbutyrate and the inherent properties of the treated neutrophils therein.
Regarding claim 4, See 2106.04(c)(I)(B), in that for product-by-process claims the markedly different analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart and is similar to the analysis of product-by-process claims as set forth in M.P.E.P. § 2113. In this case, the combination of the product-by-limitations, gene and/or protein expression patterns, and comparison to a neutrophil population having a non-resolving inflammation phenotype (e.g. disclosed as low dose LPS treatment in vivo or in vitro) as a whole effectively cancel each other out in the markedly different analysis to yield a composition comprising neutrophils that having the gene and/or protein expression pattern of claim 1 prior to any inflammatory response
Regarding claim 2, neutrophils naturally encode for and express death-associated proteins such as the caspases as species of suicide genes as taught by Geering and Simon (Cell Death and Differentiation (2011) 18, 1457–1469; Reference X) (see Table 1). Therefore, claim 2 does not possess any markedly different characteristic from naturally-occurring neutrophils as the claim is generic towards any particular species of exogenous suicide gene and so only generally links the use of the judicial exception to a particular technological environment or field of use, and for the reasons in the preceding paragraph for claim 1.
Regarding claim 9, neutrophils exist naturally in blood (as a species of aqueous pharmaceutically acceptable carrier) as taught by Orfanakis et al. (American Journal of Clinical Pathology (1970), 53(5), 647–651; Reference U2). Therefore, claim 9 does not possess any markedly different characteristic from naturally-occurring neutrophils and for the reasons in the preceding paragraph for claim 1.
Regarding claims 1, 2 and 9, the judicial exception is not integrated into a practical application because claims are only directed towards a natural product, neutrophils, without any clear and persuasive indication of markedly different characteristics at this time and do not recite any additional elements that might rise to “significantly more”. See M.P.E.P. § 2106.05.
Claims 4 and 5 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these claims only recite limitations that are routine and conventional in this art. Regarding claims 4 and 5, Savickiene (Cellular & Molecular Biology Letters (2012), 17, 501-525; Reference U). teaches a composition comprising granulocytes, wherein the granulocytes have been differentiated from HL-60 cells with 1 mM sodium phenyl butyrate (i.e. PB, and synonymous for 4-phenylbutyrate as set forth in PubChem CID 4775) (subheading “Cell culture” on page 503). While Savickiene is silent if the granulocytes comprise neutrophils, Savickiene further teaches quantifying granulocyte differentiation by NBT reduction (page 504, the 1st paragraph) and Segal and Levi (Clin. exp. Immunol. (1975), 19, 309-318; Reference V) teach that the NBT is reduced by neutrophils (Summary and 1st paragraph of the Introduction). Therefore, the differentiated granulocytes of Savickiene inherently comprises neutrophils as evidenced by Segal and Levi; see M.P.E.P. § 2112.
Regarding claim 4, Wolach (Experimental Hematology 35 (2007) 541-550) teaches that contacting neutrophils in vitro with granulocyte colony-stimulating factor (G-CSF) at 20 ng/ml increases the number of viable neutrophils (Abstract; Fig. 1, middle panel).
For the reasons given above, claims 1, 2, 4, 5, and 9 are rejected as patent-ineligible under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 112
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.
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, 2, 4, 5, and 9 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.
See MPEP § 2163 for a review of the written description requirement. The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117 and M.P.E.P. § 2163.02.
M.P.E.P. §2163 (II)(A)(3)(a) ii) further recites, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus”. When there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Finally, satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed; for inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation.", the latter of which may be established by the inventor as described in the specification or the state of the art at the time of filing.
In this case, claim 1 recites “wherein the control is a neutrophil or population thereof having a non-resolving inflammation phenotype”, which lacks adequate written description. While “control” is defined at [0053] of the specification, the definition itself is generic and the disclosure as a whole does not provide further detail on what structural features are or are not required for any representative number of species of “control” neutrophils as the basis for comparing the claimed marker phenotype. Similarly, “non-resolving inflammation phenotype” is not defined in the disclosure. The disclosure never sets forth any baseline marker expression across any representative number of species of “control” neutrophils (both the generic embodiment and the non-resolving inflammation phenotype) such as to be in possession of the genus of “control” neutrophils as the basis for evaluating relative changes in marker expression for claim 1. Claim 1 and the disclosure as a whole fails to adequately correlate any representative number of species of changes in marker expression to either the generic “control” or the non-resolving inflammation phenotype.
Notwithstanding the other rejections made in this Office Action, possession of the “control” neutrophil population is critical and essential to evaluate the patentability of the neutrophils of claim 1 against naturally-occurring neutrophils and neutrophils found in the prior art before the effective filing date of the instant Application. By not adequately describing any representative number of species of changes in marker expression to clearly set forth the “control” neutrophils, Applicant cannot adequately describe the relative changes in marker expression in claim 1 because a person skilled in this art would not be guided towards any particular structure-function correlation in the “control” neutrophils as any basis for comparing the claimed neutrophils for relative changes in the expression of the claimed markers.
For the reasons given above, claim 1 is found to lack descriptive support and fail to comply with the written description requirement. In so much that claims 2, 4, 5, and 9 depend from claim 1, these claims must also be rejected with claim 1 for lacking adequate written description.
Claims 1, 2, 4, 5, and 9 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 “wherein the control is a neutrophil or population thereof having a non-resolving inflammation phenotype”, which blurs the metes and bounds of the claim because a generic control neutrophil population and a non-resolving inflammation phenotype population (e.g. activated) are contradictory and therefore mutually exclusive. While “control” is defined at [0053] of the specification, the definition itself is generic and does not clarify what population of neutrophils are or are not required as the basis for comparing the claimed marker phenotype. Furthermore, it is unclear if the claimed neutrophils are intended to occupy an intermediate phenotype of marker expression between the natural neutrophils and the activated neutrophils of the prior art as any increase and/or decrease in marker expression as claimed is also generic. Clarification and/or correction is required.
In so much that claims 2, 4, 5, and 9 depend from claim 1 and do not resolve the point of confusion, these claims must also be rejected with claim 1 as indefinite.
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, 4, 5, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (Scientific Reports (2013), 3(1142), 10 pages; Reference V2).
The claims are read in light of the specification that 4-phenylbutyrate treatment of neutrophils inherently yields the marker expression pattern of claim 1. See [0166], Fig. 6. and Fig 19A-B of the disclosure. Regarding claims 4 and 5, G-CSF is only disclosed as polarizing the neutrophils and delaying neutrophil apoptosis (see [0163] of the specification). Therefore, any treatment of neutrophils in the prior art with 4-phenylbutyrate is reasonably presumed to inherently generate/yield the marker pattern of claim 1 absent any showing to the contrary. See M.P.E.P. § 2112; "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).
Kim teaches that administration of 200 mg/kg of 4-phenylbutyrate (i.e. 4-PBA) to subjects reduces the increase in ER stress markers in the lung and reduces lung inflammation both caused by prior treatment with LPS (see the Abstract, Fig. 2-3, and page 2; page 9, subheading “Administration of 4-PBA” for the dosage), anticipating claims 1, 2, 4, 5, and 9.
Claims 1, 2, 4, 5, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. (International Journal of Radiation Biology (2017), 93(9), 13 page author manuscript; Reference W2)
The claims are read in light of the specification that 4-phenylbutyrate treatment of neutrophils inherently yields the marker expression pattern of claim 1. See [0166], Fig. 6. and Fig 19A-B of the disclosure. Regarding claims 4 and 5, G-CSF is only disclosed as polarizing the neutrophils and delaying neutrophil apoptosis (see [0163] of the specification). Therefore, any treatment of neutrophils in the prior art with 4-phenylbutyrate is reasonably presumed to inherently generate/yield the marker pattern of claim 1 absent any showing to the contrary. See M.P.E.P. § 2112; "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).
Miller teaches administering 10 mg/kg of 4-phenylbutyrate confers protect against radiation (Abstract and Figure 3), anticipating claims 1, 2, 4, 5, and 9.
Claims 1, 4, 5, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Savickiene et al. (Cellular & Molecular Biology Letters (2012), 17, 501-525; Reference U) as evidenced by Segal and Levi (Clin. exp. Immunol. (1975), 19, 309-318; Reference V).
The claims are read in light of the specification that 4-phenylbutyrate treatment of neutrophils inherently yields the marker expression pattern of claim 1. See [0166], Fig. 6. and Fig 19A-B of the disclosure. Regarding claims 4 and 5, G-CSF is only disclosed as polarizing the neutrophils and delaying neutrophil apoptosis (see [0163] of the specification). Therefore, any treatment of neutrophils in the prior art with 4-phenylbutyrate is reasonably presumed to inherently generate/yield the marker pattern of claim 1 absent any showing to the contrary. See M.P.E.P. § 2112; "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).
Savickiene teaches a composition comprising granulocytes, wherein the granulocytes have been differentiated from HL-60 cells with 1 mM sodium phenyl butyrate (i.e. PB, and synonymous for 4-phenylbutyrate as set forth in PubChem CID 4775) (subheading “Cell culture” on page 503).
Regarding claim 1, Savickiene is silent if the granulocytes comprise neutrophils. However, Savickiene further teaches quantifying granulocyte differentiation by NBT reduction (page 504, the 1st paragraph) and Segal and Levi teach that the NBT is reduced by neutrophils (Summary and 1st paragraph of the Introduction). Therefore, the differentiated granulocytes of Savickiene inherently comprise neutrophils as evidenced by Segal and Levi and so anticipates claims 1, 4, 5, and 9; see M.P.E.P. § 2112.
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.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Savickiene et al. (Cellular & Molecular Biology Letters (2012), 17, 501-525; Reference U) in view of Wolach et al. (Experimental Hematology (2007) 541-550) and as evidenced by Segal and Levi (Clin. exp. Immunol. (1975), 19, 309-318; Reference V).
In the interest of compact prosecution, this rejection is made if the G-CSF imparts a structural difference to the cell; see M.P.E.P. § 2112 and 2113.
The claims are read in light of the specification that 4-phenylbutyrate treatment of neutrophils inherently yields the marker expression pattern of claim 1. See [0166], Fig. 6. and Fig 19A-B of the disclosure. Therefore, any treatment of neutrophils in the prior art with 4-phenylbutyrate is reasonably presumed to inherently generate/yield the marker pattern of claim 1 absent any showing to the contrary. See M.P.E.P. § 2112; "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).
Savickiene teaches a composition comprising granulocytes, wherein the granulocytes have been differentiated from HL-60 cells with 1 mM sodium phenyl butyrate (i.e. PB, and synonymous for 4-phenylbutyrate as set forth in PubChem CID 4775) (subheading “Cell culture” on page 503), reading on claims 1, 4, 5, and 9.
Regarding claim 1, Savickiene is silent if the granulocytes comprise neutrophils. However, Savickiene further teaches quantifying granulocyte differentiation by NBT reduction (page 504, the 1st paragraph) and Segal and Levi teach that the NBT is reduced by neutrophils (Summary and 1st paragraph of the Introduction). Therefore, the differentiated granulocytes of Savickiene inherently comprise neutrophils as evidenced by Segal and Levi; see M.P.E.P. § 2112.
Regarding claims 1 Savickiene does not teach the expression patterns of claim 1 and made by the product-by-process limitation towards contacting neutrophils with G-CSF.
Wolach teaches that contacting neutrophils in vitro with granulocyte colony-
stimulating factor (G-CSF) at 20 ng/ml increases the number of viable neutrophils (Abstract; Fig. 1, middle panel; ), reading on claim 4.
Regarding claim 4, It would have been obvious to a person of ordinary skill in the art before the invention was filed to add the G-CSF of Wolach to the methods and neutrophil composition of Savickiene. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Wolach and Savickiene are directed towards neutrophil compositions, and because Wolach teaches a specific G-CSF concentration. The skilled artisan would have been motivated to do so because Wolach teaches that contacting neutrophils in vitro with granulocyte colony-stimulating factor (G-CSF) at 20 ng/ml increases the number of viable neutrophils, and to the addition would predictably improve upon the methods and neutrophil composition of Savickiene by yielding more viable neutrophils.
Regarding the marker expression pattern of claim 1, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (emphasis added). Also see M.P.E.P. § 2112.01. In this case, the combination of the G-CSF of Wolach with the 1 mM 4-phenylbutyrate and neutrophils of Savickiene would inherently generate the claimed marker expression pattern as compared to control neutrophils or control neutrophils having a non-resolving inflammation phenotype because the combination would necessarily and inherently yield a substantially identical process as set forth in the product-by-process limitations of dependent claims 4 and 5. Therefore and absent any showing to the contrary, the marker expression pattern for the neutrophils of claim 1 is reasonably presumed to be made by the substantially identical process yielded by the combination of Savickiene and Wolach.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Savickiene as evidenced by Segal and Levi as applied to claim 1 above, and further in view of Esendagil et al. (Cytotechnology (2009) 61:45–53; Reference W).
The teachings of Savickiene as evidenced by Segal and Levi are relied upon as set forth above in rejecting claim 1 as anticipated under 35 U.S.C. § 102.
Regarding claim 2, Savickiene as evidenced by Segal and Levi does not teach the embodiment of the exogenous gene is GFP as a species of exogenous selectable marker.
Esendagil teaches methods of transfecting HL-60 cells with a plasmid encoding for EGFP (subheading “Liposomal transfection” on pages 46-47), as an optically selectable marker in downstream methods of flow cytometry to determine transfection efficiency in adherent-cultured or suspension-cultured HL-60 cells (page 47, left column, the paragraph starting “EGFP expression was determined…” and Fig. 1).
It would have been obvious to a person of ordinary skill in the art before the invention was filed to further add the exogenous gene encoding for EGFP of Esendagil to the HL-60 cells of Savickiene. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Savickiene and Esendagil are directed towards HL-60 cells, and Esendagil teaches detailed methods of operably transfecting the HL-60 such as to yield optically detectable EGFP in the cells. The skilled artisan would have been motivated to do so because Esendagil teaches that the addition would be predictably advantageous to optically determine transfection efficiency in adherent-cultured or suspension-cultured HL-60 cells and would thus improve upon the cell composition of Savickiene.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant’s arguments in the appeal brief dated 5/06/2026 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument(s).
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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