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 .
Applicant’s response to restriction requirement filed on July 10, 2026 have been received and entered. Claims 1-21 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of claims 1-14 (group I) in the reply filed on July 10, 2026 is acknowledged.
Claims 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 10, 2026.
Priority
This application is a continuation of PCT/JP2022/040387 filed on 10/28/2022, which claims priority from foreign application JP 2021-177910 filed on 10/29/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/29/2024 and 02/25/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claims 1-14 are under consideration.
Claim Rejections - 35 USC § 102
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, 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sagawa et al (EP 1175907, dated 01/30/2002) as evidenced by Sigma X-100 product information sheet (see pages 1-2).
Claims are directed to a cell dissociation solution used in dissociation of, from a substrate, a cell disposed on the substrate, by application of ultrasonic vibration to the cell, the cell dissociation solution comprising a polymer including a polyalkylene glycol structure.
Claim interpretation: Independent claim recite a solution comprising any polymer comprising any polyalkylene glycol structure. Dependent claim limits the polymer is polyethylene glycol. Recitation of solation used in dissociation of, from a substrate, a cell disposed on the substrate, by application of ultrasonic vibration to the cell is interpreted as intended use limitation and therefore is not given any patentable weight.
With respect to claim 1, 6-11, Sagawa teaches a buffer solution for use in an ultrasonic treatment to cells situated on a cell culture plate, wherein said buffer maintains a pH of7.4, and contains 0.1 % Triton X-100, 10 mM EDTA, and HEPES, but does not contain a proteolytic enzyme such as trypsin or a divalent cation such as Ca2+ and Mg2+ (see para. 238). In the instant case, Triton X-100 is known to contain PEG of molecular weight of 650 as evidenced by Sigma catalogue.
Regarding claims 2 -3, Sagawa teaches preparing 0.1% Triton X-100 solution in a 500 microL solution (see para. 238), which would require 0.5 microL Triton X-100. Therefore, molarity of the solution will be about 1.6 mM using Triton X-100 molar mass of 625g/mol as per Signa information sheet. The buffer solution disclosed by Sagawa and those embraced by the instant claims appear to be structurally same. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). ''When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.'' In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Accordingly, Sagawa anticipates claims 1-3, 6-10 and 11.
Claims 1-3, 6, 9-10, 12 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kwon et al (Biomaterials, 2003, 24(7), 1223-1232).
Claims are directed to a cell dissociation solution used in dissociation of, from a substrate, a cell disposed on the substrate, by application of ultrasonic vibration to the cell, the cell dissociation solution comprising a polymer including a polyalkylene glycol structure.
Claim interpretation: Independent claim recite a solution comprising any polymer comprising any polyalkylene glycol structure. Dependent claim limits the polymer is polyethylene glycol. Recitation of solation used in dissociation of, from a substrate, a cell disposed on the substrate, by application of ultrasonic vibration to the cell is interpreted as intended use limitation and therefore is not given any patentable weight.
With respect to claim 1-3, 6, Kwon teaches a solution comprising PIPAAm(PEG)PM (abstract , page 1224 col. 2, para. 2, section 2.2). It is further disclosed that the content of the polymer relative to a total mass of the solution is 0.0.5 or 1.0% (see page table 1, 2.4).
Regarding claims 9-10, 12-13, Kwon teaches that the solution comprising PIPAAm(PEG)PM is in 0.26 mM EDTA in PBS that is free of protease and free of divalent cation including Calcium or Magnesium (see page 1225, col. 1, section 2.5).
Accordingly, Kwon anticipates claims 1-3, 6, 9-10, 12 and 13.
Claims 1- 10, 12 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshihisa et al (JP2020048446, 2020-04-02) as evidenced by Wisent Bioproducts.
Claims are directed to a cell dissociation solution used in dissociation of, from a substrate, a cell disposed on the substrate, by application of ultrasonic vibration to the cell, the cell dissociation solution comprising a polymer including a polyalkylene glycol structure.
Claim interpretation: Independent claim recite a solution comprising any polymer comprising any polyalkylene glycol structure. Dependent claim limits the polymer is polyethylene glycol. Recitation of solation used in dissociation of, from a substrate, a cell disposed on the substrate, by application of ultrasonic vibration to the cell is interpreted as intended use limitation and therefore is not given any patentable weight.
Regarding claims 1-13, Yoshihisa teaches a solution containing a cell aggregation inhibitor that is added to HEPES buffered saline (i.e., HBS solution) that contains PEG-2000 at a final concentration ranging from 0.01 to 1 mg/m and a .001 to 99% of chelating agent EDTA (para. 72) . It is relevant to note that solution does not contain a proteolytic enzyme such as trypsin, or a divalent cation such as Ca2+ or Mg2+ (see para. 60, 69-76, 93-117). It is further noted that the pH of the HEPES buffered solution inherently has pH of 7.4 as evidenced by Wisent bioproduct sheet. The buffer solution disclosed by Yoshihisa and those embraced by the instant claims appear to be structurally same. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). ''When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.'' In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Accordingly, Yoshihisa anticipates claims 1-12 and 13.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshihisa et al (JP2020048446, 2020-04-02)/ Sagawa et al (EP 1175907, dated 01/30/2002) as evidenced by Wisent Bioproducts and Kirincic et al (Fluid Phase Equilibria 155 1999 311–325), Murugesan (J. Chem. Eng. Data 2005, 50, 1290-1293).
Regarding claims 1-13, Yoshihisa teaches a solution containing a cell aggregation inhibitor that is added to HEPES buffered saline (i.e., HBS solution) that contains PEG-2000 at a final concentration ranging from 0.01 to 1 mg/m and a .001 to 99% of chelating agent EDTA (para. 72) . It is relevant to note that solution does not contain a proteolytic enzyme such as trypsin, or a divalent cation such as Ca2+ or Mg2+ (see para. 60, 69-76, 93-117). It is further noted that the pH of the HEPES buffered solution inherently has pH of 7.4 as evidenced by Wisent bioproduct sheet. The buffer solution disclosed by Yoshihisa and those embraced by the instant claims appear to be structurally same. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). ''When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.'' In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Likewise, Sagawa teaches a buffer solution for use in an ultrasonic treatment to cells situated on a cell culture plate, wherein said buffer maintains a pH of7.4, and contains 0.1 % Triton X-100, 10 mM EDTA, and HEPES, but does not contain a proteolytic enzyme such as trypsin or a divalent cation such as Ca2+ and Mg2+ (see para. 238). In the instant case, Triton X-100 is known to contain PEG of molecular weight of 650 (limitation of claims 1, 6-11). Sagawa teaches preparing 0.1% Triton X-100 solution in a 500 microL solution (see para. 238), which would require 0.5 microL Triton X-100. Therefore, molarity of the solution will be about 1.6 mM using Triton X-100 molar mass of 625g/mol
Yoshihisa/ Sagawa differs from claimed invention by not disclosing implicit property of the cell dissociation solution has viscosity at 37°C of 1.80 mPa·s or less.
However, before the effective filing date of instant application, Kirincic teaches a method of measuring viscosities of aqueous solutions of some poly ethylene glycol s PEG with nominal molecular weights ranging from 300 to 35000 g mol including PEG2000 at 298.15L (abstract, fig. 1). It is apparent that PEG2000 viscosity varies from 0.962-2.7mPa.s as a function of concentration (table 1). Murugesan uses PEG2000 to determine the viscosity that covers from ) 298.15 K (250C) to ) 318.15 K (450C) and results show viscosity decreases with increasing temperature and increases with PEG concentration (see table 1, page 1291, col. 1, to col. 2).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to combine the respective teachings of Yoshihisa/ Sagawa to further characterize and optimize the viscosity of the solution by adjusting the concentration and temperature of PEG as suggested in Kirincic in view Murugesan, as a matter of design choice, in order to prepare cell dissociation solution, as instantly claimed, with a reasonable expectation of success, before the effective filing date of instant application. Said design choice amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so in order to optimize the temperature of solution to standard cell culture incubation temperature that would further reduce reduces resistance viscosity as suggested in prior art. It is well settled that routine optimization is not patentable, even if it results in significant improvements over the prior art. In support of this position, attention is directed to the decision in In re Aller, Lacey, and Haft, 105 USPQ 233 (CCPA 1955): Normally, it is to be expected that a change in temperature, or in concentration, or in both, would be an unpatentable modification. More particularly, where 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 re Swain et al., 33 C.C.P.A. (Patents) 1250, 156 F.2d 239, 70 USPQ 412; Minnesota Mining and Mfg. Co. v. Coe, 69 App. D.C. 217, 99 F.2d 986, 38 USPQ 213; Allen et al. v. Coe, 77 App. D. C. 324, 135 F.2d 11,57 USPQ 136. (Emphasis added). With regards to determining experimental parameters, such as time in culture, the court has held that "[d]iscovery of optimum value of result effective variable in known process is ordinarily within skill of art (In re Boesch and Slaney, 205 USPQ 215 (CCPA 1980)). One of skill in the art would have been expected to have a reasonable expectation of success in optimizing the viscosity of PEGsolution at the standard cell culture incubation temperature because prior art reported PEG2000 viscosity varies from 0.962-2.7mPa.s as a function of concentration and increasing temperature from 250C to 370C further reduces viscosity. It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Smith , --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007)(citing KSR , 82 USPQ2d at 1396) (available at http: www.uspto.gov/web/ offices/dcom/bpai/prec/fd071925.pdf).
Conclusion
No claims allowed.
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/ANOOP K SINGH/ Primary Examiner, Art Unit 1632
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