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
1. Claims 1-14 are under consideration.
Priority
2. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Since a certified English translation has not been provided for JAPAN 2022-060805, until foreign priority is perfected, the effective filing date for the purposes of applying prior art is 3/13/2023.
Information Disclosure Statement
3. The information disclosure statement (IDS) was submitted on 3/13/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
4. Claims 1, 3, 4, 13 are objected to because of the following informalities:
As to claim 1, for improved language, there should be a space after “(a)” and “(b)”.
As to claim 3, for improved grammar, the claim should recite “wherein the microscopic substances are viruses…”. Such language should also be repeated in claim 4.
As to claim 13, for improved language, there should be a space before “wherein”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
5. Claims 1-14 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.
See claims 1-14 as submitted 3/13/2023.
As to claim 1, it is not clear where or when the polyethylene glycol precipitation step is in the recited method, as no active steps in claim 1 actually recite a step of use of or precipitation of polyethylene glycol. Further claim 1 recites “adding” but it is not clear what is being added to, whether or not that is the aqueous solution or not.
Further as to claim 3, it is not clear if the claim intends to recite that the substances are vesicles, plasmids, nucleic acids and proteins. or not, or if they are merely intended as examples or not as they follow “including” (See MPEP 2173.05(d)). It is not clear if or how organelles include vesicles, etc. Further, it is not clear what “them” refers to.
Further as to claim 8, the claim recites “their salts alone”. It is not clear if the claim intends to recite that the agent is selected from an individual salt or “their salts alone” (as a group).
Further as to claim 14, the claim recites “The detection method of nucleic acid in PEG precipitate”. There is insufficient antecedent basis for this limitation in the claim.
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.
6. Claims 1, 2, 3, 7, 9, 14 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 claims 1, 2, 3, 7, 9, 14 as submitted 7/17/2025.
See also the 35 U.S.C. 112(b) rejection above.
Claim 1 recites a concentration method of microscopic substances in an aqueous solution by concentration method of microscopic substances in an aqueous solution by polyethylene glycol (PEG) precipitation comprising: (a) adding basic substance and chelating agent individually or in the mixed state (b)subsequently centrifuging to concentrate the microscopic substances. Each of the claims is drawn, inherently or explicitly, to “any” microscopic substances, “any” basic substances and “any” chelating agent. Further, claims 2, 7, 9 recite “any” reducing agent and “any” protein component and “any” aminocarboxylic acid chelating agent. Claim 3 recites organelles. Thus, the claims are drawn to methods of concentrating a genus of substances and organelles using a genus of substances, agents and components.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
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... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the application teaches: concentration of coronavirus (Example 1, 3, 4); using sodium hydroxide (Example 1, 9); EGTA (Examples 2, 4, 9); DTT (Example 4); BSA (Example 5); norovirus (Example 9). The specification does not teach organelles in the Examples.
However it is known in the art that: chelating agents read on diverse components such as arsenic chelators, copper chelators, iron chelators, lead chelator (See LiverTox Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-Chelating agents” found at https://www.ncbi.nlm.nih.gov/books/ (2017))(See PTO-892: Notice of References Cited). Similarly basic substances, organelles, microscopic substances and protein components are recited and read broadly on a variety of structurally distinct compounds and organisms including parasites, phages, and bacteria.
However, while the specification teaches viruses specifically as well as EGTA, EDTA, DTT and BSA, given the breadth of the terms “substances”, “organelles”, “agents”, and “components”. the specification does not identify a representative sample of methods using such substances, agents, and components, especially in view of the breadth of the claims. Thus, the application does not identify a representative sample of concentrating methods for substances and organelles and using substances, agents and components within the breadth of the claimed genus.
There is no apparent common conserved structure to the different substances, agents and components that distinguishes those that can be used in concentrating methods as compared to those that cannot. There is therefore a high level of uncertainty as to which substances, agents and components can used in concentration methods for microscopic substances and organelles and fall within the scope of the indicated genus.
Further, the specification has identified substances, agents and components only by use in concentrating microscopic substances. The specification does not provide a specific structure of any substances, agents and components within the genus that correlates with the required function of concentrating microscopic substances and organelles. Because there is no identification of structures common to each substance, agent or component, nor sufficient representative examples of the substances, agents and components by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of methods through identification of a structure and function for the substances, agents and components. This is because the mere presence of substances, agents and components does not demonstrate that using them in a method for concentrating microscopic substances and organelles would have sufficient concentrating effect.
For the reasons above, the application has not provided sufficient written description support for the genus of methods and organelles, substances, agents and components identified in claims 1, 2, 3, 7, 9, 14.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
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.
7. Claims 1-12, 14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Tonoike et al. (CN101297037A)(See PTO-892: Notice of References Cited)(See also the WIPO English translation of CN101297037A)(See PTO-892: Notice of References Cited).
See claims 1-12, 14 as submitted 3/13/2023.
See also the 35 U.S.C. 112(b) rejection above.
Tonoike et al. teaches extracting RNA from RNA inclusion bodies (viruses)[0002]; including retroviruses (reading on enveloped virus as recited in claims 3, 4); recovering RNA inclusion bodies, wherein any method that can isolate RNA inclusion bodies from the sample can be used; such as centrifugation and methods using co-precipitants such as polyethylene glycol … can be employed for separation [0157](interpreted as reading upon concentrating substances as recited in claim 1); including adding sodium hydroxide [0035], including at 1.30mM (as recited in claims 1, 5, 6); as well as adding EGTA or EDTA [0177], including at 1 mM EDTA [0236](as recited in claims 1, 7, 8, 9); as well as sample processing and centrifugation [0189](as recited in claim 1); adding DTT [0227]; including at 2mM [0232](as recited in claims 10, 11); as well as BSA [0212](as recited in claim 12); as well as wherein RNA sample processing solution can be obtained easily and stably without purifying RNA inclusion bodies in biological samples [0219]; using unpurified RNA [0136]; amplifying RNA without purification [0145]; detecting and amplifying RNA [0220](as recited in claim 14).
Thus, Tonoike et al. anticipates or renders obvious the instant claims.
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.
8. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tonoike et al. as applied to claims 1-12, 14 above.
See claim 13 as submitted 3/13/2023.
See the teachings of Tonoike et al. above as to BSA. It is noted that Tonoike et al. references amount of albumin as referenced in Japanese publication No. 2001-8685 [0213].
As to claim 13, such a recitation is considered to be that determined by routine optimization to one of ordinary skill in the art in view of the teachings of Tonoike et al., absent a showing of unexpected results (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before 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.
9. Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,969,309 in view of Tonoike et al. (cited above).
See claims 1-14 as submitted 3/13/2023.
It is noted the instant claims recite “comprising” and are interpreted in an open ended fashion and as such do not exclude additional components (See MPEP 2111).
Claims 1-5 of U.S. Patent No. 10,969,309 recite a virus concentration method comprising: (a) adding a concentration liquid containing polyethylene glycol, salt and glycogen, either individually or in a mixed state, to a liquid in which the virus is suspended, (b) subsequently centrifuging to concentrate the virus, and wherein the glycogen has a final concentration of glycogen of 0.02-0.08% in the concentration liquid; wherein the salt added to the concentration liquid is selected from among sodium chloride, lithium chloride, ammonium sulfate, and lithium sulfate; wherein the sodium chloride has a final concentration of sodium chloride of 0.021% or higher but lower than 6.6% when the final concentration of glycogen is 0.02-0.08%; wherein the centrifuging comprises allowing to stand before centrifugation and the centrifugation does not comprise cooling; wherein the centrifuging comprises conducting centrifugation for within 10 minutes after allowing to stand for within 10 minutes.
Claims 1-5 of U.S. Patent No. 10,969,309 do not recite basic substance; chelating agent.
See the teachings of Tonoike et al. above.
One of ordinary skill in the art would have been motivated to further add substances and agents and steps as taught by Tonoike et al. with the method as recited in claims 1-5 of U.S. Patent No. 10,969,309. Claims 1-5 of U.S. Patent No. 10,969,309 recite concentrating method using PEG and centrifugation, and Tonoike et al., which also teaches concentrating method using PEG and centrifugation, teaches the advantages of using and adding components such as sodium hydroxide and EDTA in such methods.
One of ordinary skill in the art would have had a reasonable expectation of success for
using substances and agents and steps as taught by Tonoike et al. with the method as recited in claims 1-5 of U.S. Patent No. 10,969,309. There would have been a reasonable expectation of success given the underlying materials and methods (concentrating viruses as taught by Tonoike et al. with the method as recited in claims 1-5 of U.S. Patent No. 10,969,309) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672