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 .
This office action is in response to an amendment filed 4/7/2026.
Claims 1, 3, 4, 6, 8, 10 and 13-25 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 4/24/2026 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, 3, 4, 6, 8, 10 and 13-25 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. This rejection is reworded based upon applicants’ amendments.
Claim 1 is drawn to a method of extracting a biological sample wherein the steps require mixing the solution with a combination of anionic surfactant and zwitterionic surfactant which is then heated and cooled and thereafter mixed with cationic and zwitterionic surfactant. This simply leads to a mixture. It is not described how extraction occurs. Claim 13 is drawn to the same steps except requires separating the protein from the mixed liquid but the steps to do so are not provide and thereafter “analyzing” the protein. These are broadly claimed steps without guidance. As to extraction of a protein, the application as a whole teaches that extraction following formation of the claimed mixture requires separating or analyzing the protein from the mixed liquid. Otherwise, it is not actually extracted. The specification teaches extraction of CEA from lung cancer specimen (example 1) a colon cancer specimen (example 5) pepsinogen I and II was extracted from gastric cancer tissue (example 7), reference example 1, HBsAg was extracted from liver. The method uses an anionic and zwitterionic surfactant in the first step and a cationic and zwitterionic surfactant in the second each with a TWEEN 20 (nonionic surfactant). IN the examples mixed liquids comprising the protein of interest was further subjected to mAbs for immunoprecipitation which then extracted the protein from the liquid. Thereafter analysis was only of levels of protein. The term analysis can embrace many qualities but the disclosure only teaches that one can extract by immunoprecipitation and measure levels.
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).
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, 6, 8, 10 and 13-25 are rejected under 35 U.S.C. 103 as being unpatentable over Nishii et al (translation WO 2019194280) and Mitragotri et al (US 20110212485). This rejection is new based upon applicants’ amendment.
Mitragotri et al provide a method “to provide for rapid tissue sampling, tissue decontamination as well as qualitative and/or quantitative detection of analytes that may be part of tissue constituents (e.g., several types of biomolecules, drugs, and microbes). Like Nishii (see abstract), Mitragotri et al are directed at detecting molecules as an indicator of pathologies (¶0002).
Nishii et al teach pretreatment of sample comprising HBV antigen (a protein) with anionic surfactant (see page 6, ¶3). This pretreatment solution is heated and then cooled and thereafter addition of a cationic surfactant to reduce the influence of the anionic surfactant (page 6, ¶5). The cationic surfactant is used with a zwitterionic surfactant (see page 6, bottom).
In addition to the cationic surfactant, other surfactants such as an amphoteric surfactant and a nonionic surfactant may be further contained. By adding other surfactants, it becomes possible to detect the HBV antigen with higher sensitivity.
While Nishii et al do not teach a combination of anionic and zwitterionic surfactants, 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 combination of anionic and zwitterionic surfactants of Mitragotri et al in the methods of Nishi et al. Such a modification would have resulted in a method encompassed by claim 1. As noted above: 1) Nishii et al and Mitragotri et al teach similar methods for isolation of molecules as indicators of pathology 2) Mitragotri et al teach that such methods are improved by a combination of zwitterionic and anionic surfactants 3) Nishi et al teach the inclusion of zwitterionic and cationic surfactants after anionic/heating to improve sensitivity of molecule detection. 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 isolation and detection of antigen.
As taught by the instant disclosure. SDS is a Cn alkyl sulfuric acid (see instant ¶0069 of the PGPUB) as recited in claim 16-18. Nishii teaches use of SDS as recited in claim 6 (page 6, ¶4). The zwitterionic surfactant of Mitragotri is CHAPS which the instant disclosure teaches is an alkyl group with a as recited in claims 19-21 the zwitterionic surfactant
As recited in claim 8 the temperature is at least 80 c (see e.g. page 9, ¶5). And in claim 10, the cationic surfactant can have an alkyl group (see page 6, ¶6) and as recited in claims 22-25, is dodecyltrimethylammonium chloride (see page 6, ¶6). .
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 sample is washed (see page 10, ¶3) as recited in claim 14. This is immunological measure as recited in claim 15.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Nishii et al (translation WO 2019194280) and Mitragotri et al (US 20110212485) as applied to claims 1, 6, 8, 10 and 13-25 above, and further in view of Wang et al (US 20230151405). This is a new rejection necessitated by applicants amendment.
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.
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 in the methods of Nishi et al and Mitragotri. Such a modification would have resulted in a method encompassed by claims 3 and 4. 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 preservation of samples improving the method and 3) Mitragotri et al teach that a similar method is improved by a combination with zwitterionic and anionic surfactants. 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.
Response to Arguments
Applicants argue that one would not combine Mitragotri with Nishii as the methods are quite different and Nishii by including a heating step would affect the bioactivity of the protein which Mitragotri teaches is preserved by the method. As well, applicants argue that Nishii does not teach pretreatment of a tissue section sample. As to the latter, the claims are not limited to a tissue section sample but simply a biological tissue sample and to that end, Nishii teaches that a biopsy sample can be targeted in the methods. Isolation from a liquid sample is only one part of the method. This is a small amount of tissue sample removed from a body, inherently. As to the former argument, the preservation of bioactivity is only one goal of Nishii. Nishii teaches,
In addition to the cationic surfactant, other surfactants such as an amphoteric surfactant and a nonionic surfactant may be further contained. By adding other surfactants, it becomes possible to detect the HBV antigen with higher sensitivity.
This Mitragotri teaches is accomplished by combining zwitterionic surfactants with anionic surfactants to preserve analytes at high level in tissues ¶(0129). Hence, both references are directed to complementary methods to achieve the same goals.
As to Wang et al, applicants argue that it unlike the instant claims is drawn to in situ detection and not isolation. However, it is noted that the instant claims do not entail isolation and hence a BRI would include in situ detection. The methods of both entail access of the analysis step by treatment with anionic surfactant. The methods of Nishii et al with Mitragotri et al would allow even more access by increasing sensitivity of detection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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/MARIA MARVICH/ Primary Examiner, Art Unit 1634
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