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 .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 7/17/2023.
Claims 1-21 are pending.
Claims 1-21 are under examination in this Office 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 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception an abstract idea (mental processes) without significantly more. Claims 2-21 depend directly or indirectly from claim 1.
The claim 1 limitations directed to an abstract idea (mental processes) are performing screening to obtain an evolved product depending on different spatial distribution patterns formed in the solid culture space during the process of growth and movement of the host.
This judicial exception is not integrated into a practical application because the selecting step does not add a meaningful limitation to the method as it is insignificant extra-solution activity.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites additional elements that consist of well understood, routine, conventional activity already engaged in by the scientific community.
The claim 1 limitations directed to well understood, routine, conventional activity already engaged in by the scientific community are (i) inoculating a host at a first site of a solid culture space, (ii) inoculating a parasitic organism corresponding to the host at a second site of the solid culture space, wherein a target gene to be evolved is located in the parasitic organism, and further wherein the host itself containing a gene element that assists the evolution of the target gene, wherein the target gene is correlated with the growth and movement of the host, (iii) allowing the host to grow and move in the solid culture space, and upon contacting with the parasitic organism, to be infected by the parasitic organism.
Xiao et al. Science China Chinese Bulletin of Life Science Scientia Sinica Vitae volume 45 pages 915 to 927 cited in the 11/9/2023 IDS (hereinafter referred to as "Xiao") and Esvelt et al. (2011) Nature volume 472 pages 499 to 503 and supplemental materials pages 1 to 2 cited in the 11/9/2023 IDS (hereinafter referred to as "Esvelt") teach a continuous directed evolution method, comprising: (i) inoculating a host, (ii) inoculating a parasitic organism, wherein a target gene to be evolved is located in the parasitic organism, and further wherein the host itself containing a gene element that assists the evolution of the target gene, wherein the target gene is correlated with the growth of the host, (iii) allowing the host to grow and move in the culture, and upon contacting with the parasitic organism, to be infected by the parasitic organism, and (iv) performing screening to obtain an evolved product depending on the process of growth of the host (see Xiao entire document especially Figure 3 and page 922; Esvelt is referred to in Xiao see Esvelt entire document).
Jin et al. (2011) International Journal of Molecular Sciences volume 12 pages 3055 to 3071 cited in the 11/9/2023 IDS (hereinafter referred to as "Jin") teaches a visual spatial method, comprising: inoculating a host at a first site of a solid culture space, allowing the host to grow and move in the solid culture space, and performing screening to obtain a product depending on different spatial distribution patterns formed in the solid culture space during the process of growth and movement of the host (see entire document especially Figure 1, Abstract and pages 3055 to 3059).
Claim Rejections - 35 USC § 103(a)
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103(a) 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.
5. Secondary considerations (objective evidence of nonobviousness): a) commercial success; b) long felt need; c) evidence of unexpected results; d) skepticism of experts; and e) copying.
Common Ownership of Claimed Invention Presumed
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the Examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the Examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-15, 19 and 21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Xiao et al. Science China Chinese Bulletin of Life Science Scientia Sinica Vitae volume 45 pages 915 to 927 cited in the 11/9/2023 IDS (hereinafter referred to as "Xiao"), Esvelt et al. (2011) Nature volume 472 pages 499 to 503 and supplemental materials pages 1 to 2 cited in the 11/9/2023 IDS (hereinafter referred to as "Esvelt") in view of Jin et al. (2011) International Journal of Molecular Sciences volume 12 pages 3055 to 3071 cited in the 11/9/2023 IDS (hereinafter referred to as "Jin").
With regards to claims 1-14, 19 and 21, Xiao teaches:
a) as in claims 1-14, 19 and 21, a continuous directed evolution method, comprising: (i) inoculating a host, (ii) inoculating a parasitic organism, wherein a target gene to be evolved is located in the parasitic organism, and further wherein the host itself containing a gene element that assists the evolution of the target gene, wherein the target gene is correlated with the growth of the host, (iii) allowing the host to grow and move in the culture, and upon contacting with the parasitic organism, to be infected by the parasitic organism, and (iv) performing screening to obtain an evolved product depending on the process of growth of the host; wherein the parasitic organism is a bacteriophage; wherein the parasitic organism is a bacteriophage and the host is a non-defective strain of a natural host bacterium of the bacteriophage; wherein the host is Escherichia coli; wherein the host is Escherichia coli carrying fertility (F) factor; wherein the bacteriophage is a temperate bacteriophage; wherein the bacteriophage is a filamentous bacteriophage; wherein the filamentous bacteriophage is M13 filamentous bacteriophage; wherein the target gene is a combination of one or more coding sequences, wherein the one or more coding sequences code for one or more proteins; wherein the target gene comprises a T7 RNA polymerase gene; wherein the gene element that assists the evolution of the target gene is a mutagenesis plasmid, and the expression of the mutagenesis plasmid is activated or induced by one or more genes in a pre-evolution bacteriophage or a post-evolution bacteriophage; wherein the one or more genes in the pre-evolution bacteriophage or the post-evolution bacteriophage comprises a pre-evolution target gene; wherein the mutagenesis plasmid contains one or more mutagenic genes; wherein the one or more mutagenic genes comprise a DNAQ gene mutant DNAQ926 gene in which the 12- and 14-position amino acids are each mutated to Ala; wherein the target gene is correlated with the growth and movement of the host through a helper plasmid in the host; wherein the target gene is correlated with the growth and movement of the host through a helper plasmid; wherein the directed evolution is carried out using different hosts in succession, and a latter host contains genetic elements that support bacteriophage proliferation, the genetic elements comprising a helper plasmid that supports the proliferation of a post-evolution bacteriophage and a helper plasmid that inhibits the proliferation of a pre-evolution bacteriophage (see Xiao entire document especially Figure 3 and page 922; Esvelt is referred to in Xiao see Esvelt entire document).
Xiao does not explicitly teach:
a) as in claims 1 and 15, a visual spatial method, comprising: inoculating a host at a first site of a solid culture space, allowing the host to grow and move in the solid culture space, and performing screening to obtain a product depending on different spatial distribution patterns formed in the solid culture space during the process of growth and movement of the host; wherein the solid culture space is a two-dimensional planar culture structure or a three-dimensional space culture structure, wherein the continuity of the movement and evolution in the vertical direction in the solid culture space is maintained by regularly forming a cast solid culture system, and the directed evolution is a high-throughput evolution, which is achieved by using multiple sets of solid culture spaces or by using different positions in the solid culture space.
With regards to claims 1 and 15, Jin teaches:
a) as in claims 1 and 15, a visual spatial method, comprising: inoculating a host at a first site of a solid culture space, allowing the host to grow and move in the solid culture space, and performing screening to obtain a product depending on different spatial distribution patterns formed in the solid culture space during the process of growth and movement of the host; wherein the solid culture space is a two-dimensional planar culture structure or a three-dimensional space culture structure, wherein the continuity of the movement and evolution in the vertical direction in the solid culture space is maintained by regularly forming a cast solid culture system, and the directed evolution is a high-throughput evolution, which is achieved by using multiple sets of solid culture spaces or by using different positions in the solid culture space (see entire document especially Figure 1, Abstract and pages 3055 to 3059).
One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have had a reasonable expectation of success in arriving at the Applicant's invention as claimed with the above cited references before them. One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have recognized the advantages of combining Jin's visual solid culture space method with Xiao's continuous directed evolution method to reduce the amount of time needed to screen binding proteins directed to specific targets. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the time of the effective filing date of the claimed invention.
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 1-21 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent Number 11702764.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claim 1 is drawn to a visual continuous spatial directed evolution method, comprising: (i) inoculating a host at a first site of a solid culture space, (ii) inoculating a parasitic organism corresponding to the host at a second site of the solid culture space, wherein a target gene to be evolved is located in the parasitic organism, and further wherein the host itself containing a gene element that assists the evolution of the target gene, wherein the target gene is correlated with the growth and movement of the host, (iii) allowing the host to grow and move in the solid culture space, and upon contacting with the parasitic organism, to be infected by the parasitic organism, and (iv) performing screening to obtain an evolved product depending on different spatial distribution patterns formed in the solid culture space during the process of growth and movement of the host and claim 1 in U.S. Patent Number 11702764 is drawn to a visual continuous spatial directed evolution method, comprising: allowing a host to grow and move in a solid culture space, the host carrying a foreign target gene to be evolved, and the host itself containing a gene element that assists the evolution of the target gene, wherein the target gene is correlated with the growth and movement of the host; and performing screening to obtain an evolved product depending on different spatial distribution patterns formed in the solid culture space during the process of growth and movement of the host, wherein the target gene is located in a parasitic organism corresponding to the host and the parasitic organism is a bacteriophage.
Therefore, the present claims are obvious in view of the claims of U.S. Patent Number 11702764.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
