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
Summary
This is the Non-Final Office action based on the 18/716146 filed 06/04/2024.
This application has been examined as part of the Pendency Balance program.
Claims 1-20 are pending.
Claims 1-6 have been elected and fully considered.
Claims 7-20 are withdrawn from prosecution.
Election/Restrictions
DETAILED ACTION
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-6, drawn to a glycerol containing biological kit.
Group II, claim(s) 7-20, drawn to a method of separating an electronegative low density lipoprotein specimen.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
There is lack unity of invention because even though the inventions of these groups require the technical feature of a kit have the three reagents as claimed in Claim 1, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of BAXALTA in WO 2020/0264411 in view of KOHNO in US 20040241744 as shown in the rejection below.
During a telephone conversation with Winston Hsu on 08/25/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-6. Affirmation of this election must be made by applicant in replying to this Office action. Claims 7-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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.
Claims 1-6 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.
With respect to Claim 1, it is unclear for the second a third reagent if “the first buffer,” and “the second buffer,” and also “the salt,” are the same exact buffer from the first reagent and thus all three reagents are actually one reagent, or if instead applicant just means that the same two kinds of buffers are used in all three reagents.
Even further for Claim 1, a kit is claimed, but all that is in the claim body are reagents which are compositions. Therefore, as claimed, it is unclear if all of the reagents, first, second, and third, are divided in any way, or if instead they are all mixed together in the claimed “kit,” so that they are really just one reagent.
With respect to Claim 3, “the third buffer,” fails to have proper antecedent basis as no third buffer was mentioned prior to this in the claims so it is unclear what is referred back to.
With respect to Claim 4, it is unclear what a concentration “based on the third reagent,” means. How can a concentration be based on another concentration?
Claims 2-6 are also rejected by virtue of their dependency on Claim 1.
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 non-obviousness.
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 1- 6 are rejected under U.S.C. 103 as being obvious by BAXALTA in WO 2020/0264411 in view of KOHNO in US 20040241744.
With respect to Claim 1, BAXALTA teaches a glycerol-containing biological system (buffer system, paragraph 0294).
BAXALTA teaches that various buffers can be used in the wash steps (Abstract), and that the buffer further comprises glycerol (paragraph 0107).
BAXALTA further teaches that multiple wash steps and elution steps are performed and that they can either use the same or different buffers and overall reagent (paragraphs 0084-0088).
BAXALTA further teaches that in a situation where three wash steps are performed for example then 3 wash reagents/buffers are used and for example:
a first reagent can comprise a first buffer and a salt,
a second reagent can comprise a second buffer which includes Tris (Tris Hcl) and a salt,
and a third reagent comprising a buffer and a salt (paragraph 0163-0164).
More specifically with respect to the instant claims, BAXALTA teaches that each individual (of the multiple) wash or elution reagent/buffers can comprise one or more of TrisHcl buffer, Bis-Tris buffer among many other buffers, so each of the multiple reagents/ buffers (1,2, and 3 as claimed) can comprise a first buffer and a second buffer as each individual buffer is claimed as doing (paragraph 0097-0098).
For each wash/elution buffer, they also all contain a salt which can be NaCl or KCl (paragraph 0100).
BAXALTA teaches that at least one of the wash reagents/buffer comprises a salt (paragraph 0025), but that they are not all required to have a salt (which is the same as instantly claimed), and that the wash solutions can optionally also contain glycerol (paragraph 0096, 010, 0107, 0164).
BAXALTA does not teach of a kit containing the reagents or of the claimed densities of the 3 different reagents, however does in fact teach of using all of the claimed buffers and reagent components in the claimed concentrations.
Specifically the first reagent is claimed as having a density from 1.090g/cm^3 to 1.093g/cm^3, the second reagent having a density from 1.060g/cm^3 to 1.063g/cm^3, and the third reagent having a density from 0.98g/cm^3 to 1.001g/cm^3, is not taught by BAXALTA.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have first, second, and third reagents having densities in the range of 1.090g/cm^3 to 1.093g/cm^3, 1.060g/cm^3 to 1.063g/cm^3, and 0.98g/cm^3 to 1.001g/cm^3, respectively, since where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges for the densities of the reagents containing all of the same claimed components at the same concentrations, would involve only routine skill in the art. The motivation for doing so would have been to use a plurality of reagents comprising buffers and salts optimized for purification of AAV products, including ultracentrifugation steps (paragraph 0232-0233). Further, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have packaged the system disclosed by Baxalta as a kit. The motivation for doing so would have been to more readily enable a practitioner to purify AAV vectors for pre-clinical applications (paragraph 0004).
If this is unclear to one of ordinary skill however still KOHNO is used to remedy this.
KOHNO teaches of a method for quantifying lipoprotein (abstract), wherein a kit is used (paragraphs 0037-0040) and further wherein density gradient centrifugation is used for separation, and specifically that a density of the solvent/reagent is used which is 1.063 and that it is also adjusted at 1.21 (paragraph 0079, 0077) and of even further adjusting the density of the solution/s (paragraph 0221, 0224, 0232, 0253, 0355, 0257). KOHNO further teaches of adjusting buffer reagent solutions to a density of 1.150, 1.063, 1.019, 1.006 and 1.21 (paragraphs 0257, 0260).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to adjust the density of the buffer solutions as is done in KOHNO in the reagents of BAZALTA due to the advantage different densities reagent solutions have for taking out LDL and other components like HDL in centrifugal separation (KOHNO, paragraph 0077, 0079).
With respect to Claim 2, BAXALTA teaches that the second buffer can be a Tris-base buffer which has a concentration from 0.01M to 0.05M and a pH value from 7.0 to 9.0 (wash buffer comprises about 50 mM TrisHCI and, has a pH of about 8.5, paragraph 0025).
With respect to Claim 3, BAXALTA teaches that a third buffer can be an EDTA-base buffer which has a concentration from .1mM to 1mM and a pH value from 7.0 to 9.0 (wash buffer comprises about 50 mM (.05 M) TrisHCI and has a pH of about 8.5, (paragraph 0025), “about 3 mM,” EDTA in BAXALTA makes obvious the instantly claimed range (paragraph 0139).
With respect to Claim 4, BAXALTA teaches wherein the glycerol has a concentration from 0.5% (v/v, volume per volume) to 10% (v/v) based on the third reagent. For example, the organic solvent can be, but not limited to, glycerol. In certain embodiments, the organic solvent or detergent is present in the wash buffer comprising from .0005 to 15% (paragraphs 0101-0102).
With respect to Claim 5, BAXALTA teaches wherein the salt is selected from a group consisting of NaCI, KCI, KBr and Csl (wash buffer comprises. from about 50 to about 500 mM salt (paragraph 0025). In some embodiments the salt is NaCI (paragraph 0056).
With respect to Claim 6, BAXALTA teaches of the invention as shown above and further comprising: a fourth reagent comprising water (purified water, paragraph 0272). Purified water has a resistivity, material property of about 18.2 18 MΩ.cm, so therefore this reads on the instant claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
ISMAGILOV in US 20160263577
With respect to Claim 1, ISMAGILOV teaches of fluidic systems for controlling one or more fluids and/or one or more reagents (abstract) and further teaches that the reagents and buffers in the device can be provided in a kit (paragraph 0036, 0343).
ISMAGILOV further teaches that kit can contain one or more, so multiple, including reading on three or four reagents (paragraph 0026, 0242) and further teaches that the reagents can contain TRIS (claimed first buffer), EDTA (claimed second buffer), and also NaCl (a salt), among other components (paragraphs 0348). ISMAGILOV teaches of including glycerol in the reagent/s (paragraph 0348).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
Prosecution Insights