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 .
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.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,203,882. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of ‘882 teach all the limitations of claims 1-20 of the current application.
Claims 1-6 and 8-10 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-21 of U.S. Patent No. 11,946,885. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 14-21 of ‘885 teach all the limitations of claims 1-6 and 8-10 of the current application.
Claims 7 and 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over 14-21 of U.S. Patent No. 11,946,885 in view of Yu (“Water Proton NMR for Noninvasive Chemical Analysis and Drug Product Inspection”).
Regarding claim 7, ‘885 teaches all the limitations of claim 1, which this claim depends from.
‘885 does not disclose wherein the aqueous-based pharmaceutical product that has experienced freeze-induced damage is not used or distributed as intended.
Yu teaches wherein the aqueous-based pharmaceutical product that has experienced freeze-induced damage is not used or distributed as intended [See Introduction section. See also rest of reference.].
It would have been obvious to a person having ordinary skill in the art before the filing date of the claimed invention to combine the teachings of ‘885 and Yu because both references are in the field of wNMR and comparing relaxation values for determining freezing.
Regarding claims 11-20, ‘885 teaches all the limitations of claims 11-16 and 18-20 except for measuring T2, instead of R2 values.
Yu teaches measuring T2 [See Examples of Using 1 H2 O NMR to Monitor Solutes in Aqueous Environment section. See also rest of reference.].
It would have been obvious to a person having ordinary skill in the art before the filing date of the claimed invention to combine the teachings of ‘885 and Yu because both references are in the field of wNMR and comparing relaxation values for determining freezing.
Regarding claim 17, the same reasons for rejection as claim 7 above also apply to claim 17.
Claims 1-3, 8 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Patent No. 11,346,908. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 11 of ‘882 teach all the limitations of claims 1-3, 8 of the current application.
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 1-20 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.
Regarding claim 1, the claim discloses “a method of determining if an aqueous-based pharmaceutical product has experienced freeze-induced damage”. However, the limitations of the claim disclose “comparing the measured R2,mto a reference transverse relaxation rate of solvent R2,r for the aqueous-based pharmaceutical product, wherein the reference R2,rrepresents an acceptable range for non-frozen aqueous-based pharmaceutical product, wherein when the measured R2,m of the aqueous-based pharmaceutical product is inside the reference R2,r range, the aqueous-based pharmaceutical product has not experienced freeze-induced damage.” To summarize, the claim limitations only positively recite that it is determined if no freezing has occurred, not that freezing has occurred. For example, if the measured R2,m is outside the reference R2,r range then it is not clear that freezing has occurred or if another stress has occurred (other stresses include temperature excursion, agitation and sunlight). Therefore, the claim is considered indefinite.
Claims 2-10 are rejected for depending on claim 1.
Claim 8 recites the limitation "the vial". There is insufficient antecedent basis for this limitation in the claim. It is not clear whether this claim should depend from claim 5 instead of claim 1.
The term “substantially similar” in claim 9 is a relative term which renders the claim indefinite. The term “substantially similar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, it is unclear what constitutes as a substantially similar temperature.
The term “substantially similar” in claim 10 is a relative term which renders the claim indefinite. The term “substantially similar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, it is unclear what constitutes as a substantially similar magnetic field.
Regarding claim 11, the same reasons for indefiniteness as claim 1 also apply to claim 11.
Claims 12-20 are rejected for depending on claim 11.
Regarding claim 18, the same reasons for indefiniteness as claim 8 also apply to claim 18.
Regarding claim 19, the same reasons for indefiniteness as claim 9 also apply to claim 19.
Regarding claim 20, the same reasons for indefiniteness as claim 10 also apply to claim 20.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taraban (“Water Proton NMR: A Tool for Protein Aggregation Characterization”).
Regarding claim 1, Taraban teaches a method of determining if an aqueous-based pharmaceutical product has experienced freeze-induced damage, wherein the aqueous-based pharmaceutical product is formulated as an emulsion, said method comprising:
measuring a transverse relaxation rate of solvent R2,m of the aqueous-based pharmaceutical product [See R2, specifically see R2 of stressed samples. See also rest of reference.]; and
determining if the aqueous-based pharmaceutical product has been frozen by comparing the measured R2,mto a reference transverse relaxation rate of solvent R2,r for the aqueous-based pharmaceutical product, wherein the reference R2,rrepresents an acceptable range for non-frozen aqueous-based pharmaceutical product [See R2, specifically see R2 of nonstressed (control) sample. See Experimental and Results and Discussion sections. See also rest of reference.],
wherein when the measured R2,mof the aqueous-based pharmaceutical product is inside the reference R2,rrange, the aqueous-based pharmaceutical product has not experienced freeze-induced damage [See R2, specifically see R2 of stressed and nonstressed (control) samples. See Experimental and Results and Discussion sections. See also rest of reference.].
Regarding claim 2, Taraban further teaches wherein the aqueous-based pharmaceutical product comprises biologics or small molecules [See Page 5494. See also rest of reference.].
Regarding claim 3, Taraban further teaches wherein the aqueous-based pharmaceutical product further comprises at least one component selected from the group consisting at least one surfactant, at least one water-soluble organic solvent, at least one dispersant, at least one biocide, at least one buffering agent, at least one pH adjusting agent, at least one peptide, at least one polypeptide, at least one protein, at least one antibody or fragment thereof, at least one nucleic acid, at least one oil, and any combination thereof [See protein. See solvent. See antibodies (mAbs). See also rest of reference.].
Regarding claim 4, Taraban further teaches wherein the R2,m is measured using nuclear magnetic resonance (NMR) [See R2, specifically see R2 of stressed samples. See Experimental and Results and Discussion sections. See also rest of reference.].
Regarding claim 5, Taraban further teaches wherein the R2,m is measured without opening a vial containing the aqueous-based pharmaceutical product or otherwise accessing the contents of the vial containing the aqueous-based pharmaceutical product [Page 5495, wherein the drug product vial is not opened with the benchtop NMR. See noninvasive mentioned throughout reference. See Experimental and Results and Discussion sections. See also rest of reference.].
Regarding claim 6, Taraban further teaches wherein the solvent is water [See H2O. See water proton. See also rest of reference.].
Regarding claim 7, Taraban further teaches wherein the aqueous-based pharmaceutical product that has experienced freeze-induced damage is not used or distributed as intended [See Page 5495, wherein the disclosed method would be used for batch release. See also rest of reference.].
Regarding claim 8, Taraban further teaches wherein no additives or probes are added to the vial prior to measurement of the transverse relaxation rate of solvent R2,m [Page 5495, wherein the drug product vial is not opened with the benchtop NMR. See noninvasive mentioned throughout reference. See Experimental and Results and Discussion sections. See also rest of reference.].
Regarding claim 9, Taraban further teaches wherein R2,m and R2,r are measured at a substantially similar temperature [Page 5497, see wNMR: Transverse Relaxation Rate Measurements section. See also rest of reference.].
Regarding claim 10, Taraban further teaches wherein R2,m and R2,r are measured at a substantially similar magnetic field strength [Page 5497, see wNMR: Transverse Relaxation Rate Measurements section. See also rest of reference.].
Regarding claim 11, Taraban teaches a method of determining if an aqueous-based pharmaceutical product has experienced freeze-induced damage, wherein the aqueous-based pharmaceutical product is formulated as an emulsion, said method comprising:
measuring a transverse relaxation time of solvent T2,m of the aqueous-based pharmaceutical product [See R2, specifically see R2 of stressed samples. Page 5497, wherein measuring T2 values were converted to corresponding R2 values. See also rest of reference.]; and
determining if the aqueous-based pharmaceutical product has been frozen by comparing the measured T2,m to a reference transverse relaxation time of solvent T2,r for the aqueous-based pharmaceutical product, wherein the reference T2,r represents an acceptable range for non-frozen aqueous-based pharmaceutical product [See R2, specifically see R2 of nonstressed (control) sample. See Experimental and Results and Discussion sections. Page 5497, wherein measuring T2 values were converted to corresponding R2 values. See also rest of reference.],
wherein when the measured T2,mof the aqueous-based pharmaceutical product is inside the reference T2,rrange, the aqueous-based pharmaceutical product has not experienced freeze-induced damage [See R2, specifically see R2 of stressed and nonstressed (control) samples. See Experimental and Results and Discussion sections. See also rest of reference.].
Regarding claim 12, Taraban further teaches wherein the aqueous-based pharmaceutical product comprises biologics or small molecules [See Page 5494. See also rest of reference.].
Regarding claim 13, Taraban further teaches wherein the aqueous-based pharmaceutical product further comprises at least one component selected from the group consisting at least one surfactant, at least one water-soluble organic solvent, at least one dispersant, at least one biocide, at least one buffering agent, at least one pH adjusting agent, at least one peptide, at least one polypeptide, at least one protein, at least one antibody or fragment thereof, at least one nucleic acid, at least one oil, and any combination thereof [See protein. See solvent. See antibodies (mAbs). See also rest of reference.].
Regarding claim 14, Taraban further teaches wherein the T2,m is measured using nuclear magnetic resonance (NMR) [See R2, specifically see R2 of stressed samples. See Experimental and Results and Discussion sections. Page 5497, wherein measuring T2 values were converted to corresponding R2 values. See also rest of reference.].
Regarding claim 15, Taraban further teaches wherein the T2,m is measured without opening a vial containing the aqueous-based pharmaceutical product or otherwise accessing the contents of the vial containing the aqueous-based pharmaceutical product [Page 5495, wherein the drug product vial is not opened with the benchtop NMR. See noninvasive mentioned throughout reference. See Experimental and Results and Discussion sections. Page 5497, wherein measuring T2 values were converted to corresponding R2 values. See also rest of reference.].
Regarding claim 16, Taraban further teaches wherein the solvent is water [See H2O. See water proton. See also rest of reference.].
Regarding claim 17, Taraban further teaches wherein the aqueous-based pharmaceutical product that has experienced freeze-induced damage is not used or distributed as intended [See Page 5495, wherein the disclosed method would be used for batch release. See also rest of reference.].
Regarding claim 18, Taraban further teaches wherein no additives or probes are added to the vial prior to measurement of the transverse relaxation time of solvent T2,m [Page 5495, wherein the drug product vial is not opened with the benchtop NMR. See noninvasive mentioned throughout reference. See Experimental and Results and Discussion sections. Page 5497, wherein measuring T2 values were converted to corresponding R2 values. See also rest of reference.].
Regarding claim 19, Taraban further teaches wherein T2,mand T2,r are measured at a substantially similar temperature [Page 5497, see wNMR: Transverse Relaxation Rate Measurements section. Page 5497, wherein measuring T2 values were converted to corresponding R2 values. See also rest of reference.].
Regarding claim 20, Taraban further teaches wherein T2,m and T2,rare measured at a substantially similar magnetic field strength [Page 5497, see wNMR: Transverse Relaxation Rate Measurements section. Page 5497, wherein measuring T2 values were converted to corresponding R2 values. See also rest of reference.].
Supplemental 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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu (“Water Proton NMR for Noninvasive Chemical Analysis and Drug Product Inspection”).
Regarding claim 1, Yu teaches a method of determining if an aqueous-based pharmaceutical product has experienced freeze-induced damage, wherein the aqueous-based pharmaceutical product is formulated as an emulsion, said method comprising:
measuring a transverse relaxation rate of solvent R2,m of the aqueous-based pharmaceutical product [See Examples of Using 1 H2 O NMR to Monitor Solutes in Aqueous Environment section. See also rest of reference.]; and
determining if the aqueous-based pharmaceutical product has been frozen by comparing the measured R2,mto a reference transverse relaxation rate of solvent R2,r for the aqueous-based pharmaceutical product, wherein the reference R2,rrepresents an acceptable range for non-frozen aqueous-based pharmaceutical product [See Examples of Using 1 H2 O NMR to Monitor Solutes in Aqueous Environment section. See Introduction section, where freeze/thawing is an example of a stress. See also rest of reference.],
wherein when the measured R2,mof the aqueous-based pharmaceutical product is inside the reference R2,rrange, the aqueous-based pharmaceutical product has not experienced freeze-induced damage [See Examples of Using 1 H2 O NMR to Monitor Solutes in Aqueous Environment section. See Introduction section, where freeze/thawing is an example of a stress. See also rest of reference.].
Regarding claim 2-10, Yu further teaches the rest of the limitations [See Introduction, Borrowing from Medical Diagnosis, Examples of Using 1 H2 O NMR to Monitor Solutes in Aqueous Environment, and Conclusion sections.].
Regarding claim 11, Yu teaches a method of determining if an aqueous-based pharmaceutical product has experienced freeze-induced damage, wherein the aqueous-based pharmaceutical product is formulated as an emulsion, said method comprising:
measuring a transverse relaxation time of solvent T2,m of the aqueous-based pharmaceutical product [See Examples of Using 1 H2 O NMR to Monitor Solutes in Aqueous Environment section. Fig. 5, wherein T2 is measured and is converted R2. See also rest of reference.]; and
determining if the aqueous-based pharmaceutical product has been frozen by comparing the measured T2,mto a reference transverse relaxation time of solvent T2,r for the aqueous-based pharmaceutical product, wherein the reference T2,rrepresents an acceptable range for non-frozen aqueous-based pharmaceutical product [See Examples of Using 1 H2 O NMR to Monitor Solutes in Aqueous Environment section. See Introduction section, where freeze/thawing is an example of a stress. Fig. 5, wherein T2 is measured and is converted R2. See also rest of reference.],
wherein when the measured T2,mof the aqueous-based pharmaceutical product is inside the reference T2,rrange, the aqueous-based pharmaceutical product has not experienced freeze-induced damage [See Examples of Using 1 H2 O NMR to Monitor Solutes in Aqueous Environment section. See Introduction section, where freeze/thawing is an example of a stress. Fig. 5, wherein T2 is measured and is converted R2. See also rest of reference.].
Regarding claim 12-20, Yu further teaches the rest of the limitations [See Introduction, Borrowing from Medical Diagnosis, Examples of Using 1 H2 O NMR to Monitor Solutes in Aqueous Environment, and Conclusion sections.].
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu II (“Improving Biopharmaceutical Safety through Verification-Based Quality Control”).
Regarding claim 1, Yu II teaches a method of determining if an aqueous-based pharmaceutical product has experienced freeze-induced damage, wherein the aqueous-based pharmaceutical product is formulated as an emulsion, said method comprising:
measuring a transverse relaxation rate of solvent R2,m of the aqueous-based pharmaceutical product [See wNMR. Page 1150-1151, wherein R2 is measured for the stressed sample. See also rest of reference.]; and
determining if the aqueous-based pharmaceutical product has been frozen by comparing the measured R2,mto a reference transverse relaxation rate of solvent R2,r for the aqueous-based pharmaceutical product, wherein the reference R2,rrepresents an acceptable range for non-frozen aqueous-based pharmaceutical product [See wNMR. Page 1150-1151, wherein R2 is measured for the unstressed control sample. The R2 values are then compared. See also rest of reference.],
wherein when the measured R2,mof the aqueous-based pharmaceutical product is inside the reference R2,rrange, the aqueous-based pharmaceutical product has not experienced freeze-induced damage [See wNMR. Page 1150-1151, wherein R2 is measured for the unstressed control sample. The R2 values are then compared to see if freezing could have occurred. See also rest of reference.].
Regarding claim 2-10, Yu II further teaches the rest of the limitations [See wNMR. Page 1150-1151. See also rest of reference.].
Regarding claim 11, Yu II teaches a method of determining if an aqueous-based pharmaceutical product has experienced freeze-induced damage, wherein the aqueous-based pharmaceutical product is formulated as an emulsion, said method comprising:
measuring a transverse relaxation time of solvent T2,m of the aqueous-based pharmaceutical product [See wNMR. Page 1150-1151, wherein R2 is measured for the stressed sample. See Page 1142, where T2 is converted to R2. See also rest of reference.]; and
determining if the aqueous-based pharmaceutical product has been frozen by comparing the measured T2,mto a reference transverse relaxation time of solvent T2,r for the aqueous-based pharmaceutical product, wherein the reference T2,rrepresents an acceptable range for non-frozen aqueous-based pharmaceutical product [See wNMR. Page 1150-1151, wherein R2 is measured for the unstressed control sample. The R2 values are then compared. See Page 1142, where T2 is converted to R2. See also rest of reference.],
wherein when the measured T2,mof the aqueous-based pharmaceutical product is inside the reference T2,rrange, the aqueous-based pharmaceutical product has not experienced freeze-induced damage [See wNMR. Page 1150-1151, wherein R2 is measured for the unstressed control sample. The R2 values are then compared to see if freezing could have occurred. See Page 1142, where T2 is converted to R2.See also rest of reference.].
Regarding claim 12-20, Yu II further teaches the rest of the limitations [See wNMR. Page 1150-1151. See also rest of reference.].
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taraban II (“Use of Water Proton NMR to Characterize Protein Aggregates: Gauging the Response and Sensitivity”).
Regarding claim 1, Taraban II teaches a method of determining if an aqueous-based pharmaceutical product has experienced freeze-induced damage, wherein the aqueous-based pharmaceutical product is formulated as an emulsion, said method comprising:
measuring a transverse relaxation rate of solvent R2,m of the aqueous-based pharmaceutical product [See R2 of stressed samples. See also rest of reference.]; and
determining if the aqueous-based pharmaceutical product has been frozen by comparing the measured R2,mto a reference transverse relaxation rate of solvent R2,r for the aqueous-based pharmaceutical product, wherein the reference R2,rrepresents an acceptable range for non-frozen aqueous-based pharmaceutical product [See R2 of unstressed control sample. See also Pages 4107-4114. See also rest of reference.],
wherein when the measured R2,mof the aqueous-based pharmaceutical product is inside the reference R2,rrange, the aqueous-based pharmaceutical product has not experienced freeze-induced damage [See Pages 4107-4114. See also rest of reference.].
Regarding claim 2-10, Taraban II further teaches the rest of the limitations [See Pages 4107-4114. See also rest of reference.].
Regarding claim 11, Taraban II teaches a method of determining if an aqueous-based pharmaceutical product has experienced freeze-induced damage, wherein the aqueous-based pharmaceutical product is formulated as an emulsion, said method comprising:
measuring a transverse relaxation time of solvent T2,m of the aqueous-based pharmaceutical product [See R2 of stressed samples. See page 4110, which teaches converting T2 to R2. See also rest of reference.]; and
determining if the aqueous-based pharmaceutical product has been frozen by comparing the measured T2,mto a reference transverse relaxation time of solvent T2,r for the aqueous-based pharmaceutical product, wherein the reference T2,rrepresents an acceptable range for non-frozen aqueous-based pharmaceutical product [See R2 of unstressed control sample. See also Pages 4107-4114. See page 4110, which teaches converting T2 to R2. See also rest of reference.],
wherein when the measured T2,mof the aqueous-based pharmaceutical product is inside the reference T2,rrange, the aqueous-based pharmaceutical product has not experienced freeze-induced damage [See Pages 4107-4114. See page 4110, which teaches converting T2 to R2. See also rest of reference.].
Regarding claim 12-20, Taraban II further teaches the rest of the limitations [See Pages 4107-4114. See also rest of reference.].
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yu III (US 2020/0110046).
Regarding claim 1, Yu III teaches a method of determining if an aqueous-based pharmaceutical product has experienced freeze-induced damage, wherein the aqueous-based pharmaceutical product is formulated as an emulsion, said method comprising:
measuring a transverse relaxation rate of solvent R2,m of the aqueous-based pharmaceutical product [See ¶0009-0010, ¶0019. See also rest of reference.]; and
determining if the aqueous-based pharmaceutical product has been frozen by comparing the measured R2,mto a reference transverse relaxation rate of solvent R2,r for the aqueous-based pharmaceutical product, wherein the reference R2,rrepresents an acceptable range for non-frozen aqueous-based pharmaceutical product [See ¶0009-0010, ¶0019, ¶0032. See also rest of reference.],
wherein when the measured R2,mof the aqueous-based pharmaceutical product is inside the reference R2,rrange, the aqueous-based pharmaceutical product has not experienced freeze-induced damage [See ¶0009-0010, ¶0019, ¶0032. See also rest of reference.].
Regarding claim 2-10, Yu III further teaches the rest of the limitations [See entire rest of reference.].
Regarding claim 11, Yu III teaches a method of determining if an aqueous-based pharmaceutical product has experienced freeze-induced damage, wherein the aqueous-based pharmaceutical product is formulated as an emulsion, said method comprising:
measuring a transverse relaxation time of solvent T2,m of the aqueous-based pharmaceutical product [See ¶0009-0010, ¶0019, ¶0037. See also rest of reference.]; and
determining if the aqueous-based pharmaceutical product has been frozen by comparing the measured T2,mto a reference transverse relaxation time of solvent T2,r for the aqueous-based pharmaceutical product, wherein the reference T2,rrepresents an acceptable range for non-frozen aqueous-based pharmaceutical product [See ¶0009-0010, ¶0019, ¶0032, ¶0037. See also rest of reference.],
wherein when the measured T2,mof the aqueous-based pharmaceutical product is inside the reference T2,rrange, the aqueous-based pharmaceutical product has not experienced freeze-induced damage [See ¶0009-0010, ¶0019, ¶0032, ¶0037. See also rest of reference.].
Regarding claim 12-20, Yu III further teaches the rest of the limitations [See entire rest of reference.].
Conclusion
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/RISHI R PATEL/Primary Examiner, Art Unit 2858
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