DETAILED ACTION
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 .
Withdrawn Rejections
The rejection of claims 69-81, 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn. The amendments remove the new matter from the claims.
The rejection of claim(s) 69, 70, 73, and 80, under 35 U.S.C. 102(a) and 102(b) as being anticipated by Cheng (US 5,814,507 pub date:7/29/1998 effectively filed: 5/24/1996), is withdrawn. Cheng does not disclose sarcosine and/or melezitose.
The rejection of claim(s) 69-71, 73, and 80, under 35 U.S.C. 102(a) and 102(b) as being anticipated by Williams (US2002/0150568 A1 pub date:10/17/2002 effectively filed: 6/2000), is withdrawn. Williams does not disclose sarcosine and/or melezitose.
The rejection of claim(s) 69, 70, 73, and 80, under 35 U.S.C. 102(a) and 102(b) as being anticipated by Klinghoffer (US2004/0077574 pub date:4/22/2004 effectively filed: 5/2002), is withdrawn. Klinghoffer does not disclose sarcosine and/or melezitose.
The rejection of claim(s) 69, 70, 73, and 80, under 35 U.S.C. 102(a) and 102(b) as being anticipated by Brasel (WO2009/026303 A1 Pub date: 2/26/2009; effectively filed:8/2007), is withdrawn. Brasel does not disclose sarcosine and/or melezitose.
The rejection of claim(s) 69-74, and 78-81 under 35 U.S.C. 102(a) and 102(b) as being anticipated by Deng (US2011/0027771 pub date:02/3/2011), is withdrawn. Deng does not disclose sarcosine and/or melezitose.
The rejection of claims 69 and 70- 81, under 35 U.S.C. 103 as being unpatentable over Deng et al. (US 2011/0027771 A1) (ref. of record) in view of Whitney et al. (US 2011/0081363 A1) (ref. of record), is withdrawn. Deng in view of Whitney does not teach sarcosine and/or melezitose.
The rejection of claims 69 and 75-77, under 35 U.S.C. 103 as being unpatentable over Deng et al. (US 2011/0027771 A1) (ref. of record) in view of Whitney et al. (US 2011/0081363 A1) (ref. of record) in further view of Muller et al. (US 2008/0176209) (ref. of record) as evidenced by Sigma-Aldrich, Product Specification, Product Number P8136, Poly(vinyl alcohol), accessed on 03/22/2025), is withdraw. Deng in view of Whitney and Muller does not teach sarcosine and/or melezitose.
The rejection of claims 69, 78 and 81, under 35 U.S.C. 103 as being unpatentable over Deng et al. (US 2011/0027771 A1) (ref. of record) in view of in view of Whitney et al. (US 2011/0081363 A1) (ref. of record) in further view of Bronshtein et al. (US 6,872,357 B1) (ref. of record), is withdrawn. Deng in view of Whitney and Bronstein does not teach sarcosine and/or melezitose.
The following new rejections are necessitated by the claims:
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.
(1) Claim(s) 69-74 and 78-80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deng (US 2011/0027771 A1) (ref. of record) in further view of Ivarsson (WO 2011/131720 pub date;10/27/2011).
Regarding claim 69, Deng teaches compositions for the stabilizing of cells in a blood sample, which comprising a ph buffer (TRIS or PBS [0019]-[0020]), EDTA ([0018]), at least one polyol (sorbitol, mannitol, inositol {0015]-[0016]; [0087]) and at least one phosphatase inhibitor (2-glycerol phosphatase) [0107].
Deng dose not teach that the composition has hydroxyethyl starch (HES) and at least one of sarcosine and/or melezitose. Ivarsson teaches composition comprising human blood or plasma proteins and the protein stabilizing agent melezitose (p. 7, lines 11-15). Ivarsson teaches that the proteins can be further covalently bound to HES (p. 5, last paragraph). Ivarsson teaches the composition can comprise pH buffers including TRIS, as well as additional amino acids and sugars such as arginine, glycine, sucrose, trehalose, maltose, lactose, and mannitol (p. 8).
As such, it would have been obvious to an artisan of ordinary skill at the time of effectively filing to further add HES and melezitose, as taught by Ivarsson to the composition of Deng to predictably arrive at the limitations of amended claim 69. One would have a reasonable expectation of success in adding the HES and melezitose to the composition of Deng because Ivarsson teaches that the HES and melezitose has been used in blood sample composition successfully. Further, an artisan would be motivated to add HES and melezitose to the composition of Deng because Ivarsson teaches that these agents successfully stabilize proteins, particularly blood proteins. As such, Deng in view of Ivarsson render claim 69 obvious.
Regarding claims 70, Deng teaches TRIS or PBS as discussed above.
Regarding claim 71-72, Deng teaches the inclusion of membrane stabilizers disaccharides, sucrose and trehalose, and trisaccharide, raffinose ([0087])
Regarding claim 73 and 74, Deng teaches 2-glycerol phosphatase as discussed above. This is a serine threonine phosphatase inhibitor as claimed.
Regarding claim 78 and 79, Deng teaches that the composition further comprising an amino acid, more particularly glycine ([0008]).
Regarding claim 80, Deng teaches sorbitol, mannitol, inositol ({0015]-[0016]; [0087]).
The combination of prior art cited above in all rejections under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A and G are applicable. The claimed method was known in the art at the time of filing as indicated by Deng in view of Ivarsson. Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
(2) Claim(s) 69-74 and 78-80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deng (US 2011/0027771 A1) (ref. of record) in view of Ivarsson (WO 2011/131720 pub date;10/27/2011) in further view of Whitney (US2011/0081363).
Regarding all of the claims, Deng in view of Ivarsson teaches the claims as discussed above. Deng in view of Ivarsson only teaches HES and melezitose, not sarcosine in addition to melezitose or in alternative with melezitose as recited in base claim 69.
However, Whitney teaches composition for long term storage and stabilization of biological materials including blood. Whitney teaches that the composition can further comprise osmoprotectants such as sarcosine ([0099]).
As such, it would have been obvious to include sarcosine, as taught by Whitney 2, in the composition of Deng in view of Ivarsson to predictably arrive at the limitations of base claim 69 and all the dependent claims. An artisan of ordinary skill would have a reasonable expectation of success because Whitney teaches that sarcosine can be successfully added to composition for stabilization of blood components. Further, an artisan would be motivated to add sarcosine because it can serve as an osmoprotectant, as taught by Whitney.
The combination of prior art cited above in all rejections under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A and G are applicable. The claimed method was known in the art at the time of filing as indicated by Deng in view of Ivarsson and Whitney. Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
(3) Claim(s) 75-77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deng (US 2011/0027771 A1) (ref. of record) in view of Ivarsson (WO 2011/131720 pub date;10/27/2011), as applied to claims 69-74 and 78-80, in further view of Whitney (US 2011/0081363 A1) (ref. of record) and Muller (US 2008/0176209) (ref. of record) as evidenced by Sigma-Aldrich, Product Specification, Product Number P8136, Poly(vinyl alcohol), accessed on 03/22/2025).
Regarding claim 75, Deng teaches a composition comprising a water-soluble polymer, poly-vinyl-pyrrolidone [0087]. Further, Deng in view of Ivarsson teaches the claims as discussed above. Deng in view of Ivarsson does not teach that the polyol is PVA.
However, Whitney teaches compositions for storage of biological samples such as nucleic acids, proteins and cells with the purpose of improving stabilization and preservation of biological activity in biological samples, and reducing or eliminating factors that can otherwise reduce sample recovery yields, such as undesirable sample denaturation (abstract; [0097]). Whitney’s compositions, like the compositions taught by Deng, comprise a pH buffer, at least one non-reducing sugar, at least one trisaccharide and a water-soluble polymer (see whole document; [0017; 0145; 0156; 0103]). The water-soluble polymer is polyvinyl alcohol [0103].
Thus it would have been obvious to a person of ordinary skill in the art at the effective filing date to include polyvinyl alcohol, as taught by Whitney, in a composition of Deng in view of Ivarsson to predictably arrive at the limitations of claim 75. Therefore, a person of ordinary skill in the art would have been motivated to choose one water-soluble polymer, such as polyvinyl alcohol, from the known and available water-soluble polymers with the purpose of formulating a stabilization and/or preservation composition, and would have done so with a reasonable expectation of success since polyvinyl alcohol has been taught in the prior art, as taught by Whitney, for the same use as poly-vinyl-pyrrolidone, which was taught by Deng as a water-soluble polymer.
With respect to claim 76, Deng in view of Ivarsson and Whitney teaches the use of polyvinyl alcohol but fails to disclose using a polyvinyl alcohol having a molecular weight ranging from about 30,000-70,000 daltons. Regarding claim 77, neither Deng, Ivarsson, nor Whitney teaches the polyvinyl alcohol is at least about 87%-90% hydrolyzed.
However, Muller teaches compositions for storage of biological samples at ambient temperatures (abstract). Muller discloses the use of polyvinyl alcohol (PVA) and teaches that PVA is available in specific discrete molecular weights or as a polydisperse preparation of polymers within several prescribed molecular weight ranges based on variable degrees of polymerization. Muller discloses that PVA is also known as a preparation having average molecular weight of 30-70 kDa (30,000-70,000 daltons) (0143). Such preparation is used and described by Muller as being commercially available and identified as Sigma No. P 8136 [0143]. The product specification sheet of Sigma Product No. P 8136 corresponds to Poly(vinyl alcohol) 87-90% hydrolyzed, average mol wt 30,000-70,000, as evidenced by Sigma-Aldrich. Therefore, Muller teaches using PVA 87-90% hydrolyzed.
Furthermore, Muller discloses that depending on the physicochemical properties (e.g., molecular mass, hydrophobicity, surface charge distribution, solubility, etc.) of a particular biomolecule of interest that is present in a biological sample to be stored, PVA products, or other suitable matrix materials that dissolve or dissociate in a solvent, can be identified readily and without undue experimentation (0143).
Accordingly, it would have been obvious to a person of ordinary skill at the effective filing date of the claimed invention to use a PVA having a molecular weight ranging from 30,000-70,000 daltons since PVA having said molecular weight range was taught in the art as being suitable for using in compositions for preservation and stabilization of biological samples, as taught by Muller, in the composition of Deng in view of Ivarsson and Whitney. Similarly, it would be obvious to select the most appropriate PVA depending on the physicochemical properties of a particular biomolecule of interest that is present in a biological sample to be stored since the prior art discloses that PVA products can be identified readily and without undue experimentation, as taught by Muller.
A person of ordinary skill would have been motivated to make the combination since Muller teaches the use of PVA as a water-soluble polymer for the same purpose of storing biological samples as Deng, Ivarsson, and Whitney, and PVA is commercially available as a preparation having the claimed molecular weight and range of hydrolysis, as evidenced by Sigma-Aldrich.
Therefore, a skilled artisan would have been motivated to select the most appropriate PVA preparation depending on the biological sample to be stored, and would have done so with a reasonable expectation of success since different PVA formulations were known and taught in the prior art and were readily available, as disclosed by Muller.
The combination of prior art cited above in all rejections under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A, B, G are applicable. The claimed method was known in the art at the time of filing as indicated by Deng in view of Ivarsson, Whitney, and Muller. Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
No claims are allowed.
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 MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632