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 .
Claims 1-15 are pending.
This application is a 371 of PCT/JP2022/016827 filed 3/31/2022 which claims priority to JP2021-062584 filed 4/1/2021. Applicant cannot rely upon the foreign priority papers to overcome this rejection because a translation of said papers has not been made of record in accordance with 37 CFR 1.55. See MPEP § 201.15.
Hence, the filing date of the instant claims is 3/31/2022.
Information Disclosure Statement
An IDS filed 9/29/2023 has been identified and the documents considered. The signed and initialed PTO Form 1449 has been mailed with this action. Initials indicate that the document has been considered even if the reference is lined through.
Claim Rejections - 35 USC § 112, first paragraph
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.
Claims 1-15 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is drawn to a method for “treating” a biological sample wherein the treating is not specified as to outcome or goal and the biological sample is any. The steps involve heating a solution that is limited by comprising the biological sample and any ionic surfactant. Thereafter, the heated solution is mixed with a second ionic surfactant limited only in that the charge of the second is opposite that of the first. Claim 2 limits the target molecule to a protein and claim 5 limits the first surfactant to any anionic or zwitterionic surfactant and claim 7 to one that is a combination of the two. Claim 9 limits the second surfactant to a cationic or zwitterionic surfactant or a combination of the two. Claim 13 suffers from similar issues wherein it calls for analyzing a target molecule but does not limit the analysis such that it is clear what the goal or steps of analyzing are. The same issues with breadth of target molecules and surfactants as claim 1 exists. This is a limited descriptive element wherein the claims broadly and incompletely claim the inventive elements.
To the contrary, the disclosure provides a more limited description of elements that do not represent the broad claims. Example 1 teaches that the method of treating is extraction of CEA from lung cancer specimen. The method uses an anionic or zwitterionic surfactant in the first step and a cationic or zwitterionic surfactant in the second each with a TWEEN 20 (nonionic surfactant). The goal appears to be higher extraction levels and identifying what led to the higher levels.
[0105] From these results, it was indicated that in order to detect a specific substance from a tissue, treating a tissue specimen with an anionic surfactant and a zwitterionic surfactant, and then treating the tissue specimen with a zwitterionic surfactant or a cationic surfactant were useful in an immunological measurement of an object to be measured contained in an obtained tissue- treated sample.
Example 2-4 determined concentrations and types of surfactants providing superior levels of extraction.
[0121] From these results, it was found that, in tissue specimen treated with a first ionic surfactant using an anionic surfactant or a zwitterionic surfactant, a synergistic effect could be obtained by combining a zwitterionic surfactant and a cationic surfactant for a second ionic surfactant.
In example 5, the analysis was done to determine extraction of CEA from a colon cancer specimen. This was successful with a first anionic or zwitterionic surfactant and a second cationic plus zwitterionic surfactant. The effect was higher in a range of a molar ratio of 1 to 10 with respect to the anionic surfactant. In example 6, variations of the lung extraction of CEA where made in which use of two zwitterionic surfactants were used to increase extraction- one with a steroid skeleton and another with an alkyl group. But, the pattern was the same. A tissue sample was heated with anionic or zwitterionic surfactant then cooled with a cationic plus zwitterionic surfactant to extract CEA which is an antigen. In example 7, pepsinogen I and II was extracted from gastric cancer tissue. The conditions that were found to lead to high extraction of both was use of anionic and zwitterionic surfactants as a first surfactant and .
In reference example 1, HBsAg was extracted from liver using the methods above wherein both anionic and zwitterionic surfactants were used first and thereafter with cooling cationic and zwitterionic surfactants.
[0146] From this result, it was indicated that the tissue extraction treatment using a first ionic surfactant treatment with an anionic surfactant and a zwitterionic surfactant and a second ionic surfactant treatment with a zwitterionic surfactant and a cationic surfactant was useful also in an immunological measurement using a virus- associated antigen such as hepatitis B virus-positive hepatocellular carcinoma as an object to be measured.
The conclusion of these experimental was the following,
When the target molecule is a protein, among the [0077] above (Example 1) to (Example 8), (Example 2) to (Example 8) using a zwitterionic surfactant are preferable, (Example 4) to (Example 8) using a first ionic surfactant (a combination of an anionic surfactant and a zwitterionic surfactant) or a second ionic surfactant (a combination of a cationic surfactant and a zwitterionic surfactant) are more preferable, and (Example 8) is still more preferable from a viewpoint of further treating the biological sample or the like.
To this end, the MPEP provides such guidance (emphasis added). If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Compare Fonar, 107 F.3d at 1549, 41 USPQ2d at 1805 (disclosure of software function adequate in that art).
The number of embodiments disclosed in the specification must be commensurate with the magnitude of the claimed genus, particularly if the genus is to cover species that are not known in the prior art. Here, the specification describes a single set of conditions and that is extracting a protein from a tissue sample wherein the conditions are heating a tissue sample comprising the protein with a first surfactant comprising anionic and/or zwitterionic surfactants and thereafter cooling the heated sample and applying a cationic and zwitterionic surfactant. The end result of the method is extraction and analysis of levels of extracted protein. But, the claims recite the sample and surfactants as well as desired outcome in generic terms. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is needed. Since the disclosure fails to describe common attributes or characteristics that identify members of the genera, and because the genera are highly variant the claims lack adequate description.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 5, 6 and 8-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nishii et al (translation WO 2019194280).
Nishii et al teach pretreatment of tissue section sample (as recited in claim 3) comprising HBV antigen (a protein as recited in claim 2) with anionic surfactant (as recited in claim 5) (see page 6, ¶3) and thereafter addition of a cationic surfactant as recited in claim 9 to reduce the influence of the anionic surfactant (page 6, ¶5). The pretreatment step involves heating (see e.g. page 7, ¶5). Hence, the method of Nishii as it teaches all the steps of claim 1 teaches “treating” a biological sample.
As taught by the instant disclosure. SDS is a Cn alkyl sulfuric acid (see instant ¶0069 of the PGPUB). Nishii teaches use of SDS as recited in claim 6 (page 6, ¶4).
The cationic surfactant can have an alkyl group (see page 6, ¶6).
As recited in claim 8 the temperature is at least 80 c (see e.g. page 9, ¶5).
As recited in claim 11, Nishii teaches that the cationic surfactants with amphoteric (zwitterionic) lead to enhanced detection of antigen (see page 6, ¶ 7).
The mixture plus anionic solution (pretreatment) is heated then cooled to 37 c and thereafter for the treatment mixed with cationic surfactant as recited in claim 12.
The step of treatment is to measure HBVAg (see example 4) as recited in claim 13. This involves solid phase magnetic bears with antibody wherein the sampel is washed (see page 10, ¶3) as recited in claim 14. This is immunological measure as recited in claim 15.
Claim Rejections - 35 USC § 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 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 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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nishii et al (translation WO 2019194280) in view of Wang et al (US 20230151405) and Mitragotri et al (US 20110212485).
Nishii et al lack teachings that the sample is a formalin fixed paraffin embedded sample (FFPE) as recited in claim 4. However, Wang et al teach detection of antigen in samples that are FFPE (see e.g. ¶0057). Furthermore, the samples are pretreated with anionic surfactant as in the methods of Nishii et al and hence, the overlap provides missing steps that can be used with predictable results.
As well Nishii et al do not teach a combination of anionic and zwitterionic surfactants as recited in claim 7. However, Mitragotri et al teach that this combination preserves analytes at high level tissues ¶(0129).
Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the use of FFPE samples and the combination of anionic and zwitterionic surfacttants in the methods of Nishi et al. Such a modification would have resulted in a method encompassed by claims 4 and 7. As noted above: 1) Nishii et al teach a method of immunoassay heating a tissue sample with anionic surfactant; 2) Wang teaches that this can be performed by use of FFPE samples which allows presearvatino of samples improving the method and 3) Mitragotri et al teach that a similar method is improved by a combination with zwitterionic and anionic surfactants3). Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the expanded method would allow improved detection of antigen.
Conclusion
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/MARIA MARVICH/ Primary Examiner, Art Unit 1634