DETAILED ACTION
Objections and rejections raised in prior Office Actions are withdrawn unless restated below.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/10/2026 has been entered.
Claim Objections
Claims 1, 4, 7, 9 and 11 are objected to because of the following informalities:
Claims 1 (line 3) is grammatically incorrect and is missing a conjunction: “the oxidase enzyme and the free amino acid glycine.”
In claim 9, claim 9 (line 1) should be corrected to recite “A composition comprising an oxidase enzyme and glycine.”
In claim 1, “wherein the oxidase enzyme and glycine are dried” is understood as being an active step of the required method. As such, the claims should be restated to recite such active step in a gerund verb form, such as drying the admixing oxidase enzyme and glycine.
In claim 7, since claim 1 recites a method that forms a dried composition, the oxidase enzyme and glycine are admixed in an aqueous solution is understood that the same are admixed prior to the performance of the dried/drying step in claim 1, and the same is required to be recited in claim 7.
In claims 4 and 11, claims should indicated that no amino acids other than glycine are present. Further, the definite article “the” should be avoid unless necessary. For example, “glycine is present in [[the]] substantial absence of other free amino acids.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 depends from claims 1 and 7. Claim 1 requires an active step that forms a dried composition containing the oxidase and the glycine, which is also incorporated into claim 7. As indicated in the claim objections above, claim 7 is understood as requiring the oxidase enzyme and glycine to be admixed in an aqueous solution or suspension prior to forming a dried composition, which is then subsequently dried as recited in claim 1 to form a dried composition. As such, further dependent claim 8 reciting as its only limitation that the admixed oxidase and glycine are subsequently dried does not further limit the subject matter of claim 7 since such drying is already required by claims 1 and 7.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 2, 4-5, 7-12 and 14 (all pending claims) 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.
Claim 1 (line 3) and claim 9 (line 2) recites “the free amino acid glycine.” There is insufficient antecedent basis for this limitation in the claim. Recitation of “the free amino acid glycine” is understood as reference to a specific structural component of a composition. However, there is no prior recitation of a claim limitation that provides a literal nor a reasonable inherent antecedent basis for “the free amino acid glycine.” As such, it is unclear as to what claim element is referenced.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 9-12 and 14 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
“New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (an adequate description of a genus may not support claims to a subgenus or species within the genus)”; MPEP 2163(I)(B). “While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure.” MPEP 2163(I)(B).
“With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘___’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported."); see also MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure."); and MPEP § 2163.04.” MPEP 2163(II)(A).
Independent claim 9 was amended on 04/10/2026 to recite “the composition, when stored for 180 days at 37[Symbol font/0xB0]C and 65% relative humidity in a closed container, retains at least 50% of its enzymatic activity relative to its activity at day 0.”
The applicant has not pointed to a specific portion of the specification to support the amendment to recite “retains at least 50%.” However, it is clear that the claim language relates to Example 3 of the specification.
Example 3, para. [33], provides the following: 5.6 g glycine per g active protein, improved the storage stability of dried enzyme composition produced with spray drying. The spray dried GOx powder compositions with glycine and without glycine (control) were subjected to a 6-month stability study. The samples were contained in closed cap plastic bottles and incubated at 37°C and 65% relative humidity for 180 days. The enzyme activity was monitored during this period by analyzing the samples after 0, 3, 7, 14, 30, 60, 90 and 180 days. The recovered enzymatic activity of the tested samples is tabulated in Table 5. The GOx/glycine composition maintained up to 55% of enzyme activity after 180 days in storage.
“The failure to meet the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, commonly arises when the claims are changed after filing to either broaden or narrow the breadth of the claim limitations, or to alter a numerical range limitation or to use claim language which is not synonymous with the terminology used in the original disclosure.” MPEP 2163.05. “With respect to changing numerical range limitations, the analysis must take into account which ranges one skilled in the art would consider inherently supported by the discussion in the original disclosure. In the decision in In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), the ranges described in the original specification included a range of "25%- 60%" and specific examples of "36%" and "50%." A corresponding new claim limitation to "at least 35%" did not meet the description requirement because the phrase "at least" had no upper limit and caused the claim to read literally on embodiments outside the "25% to 60%" range, however a limitation to "between 35% and 60%" did meet the description requirement.” MPEP 2163.05(III).
Claim 9 has been amended to include a numerical limitation with no upper limit (i.e. at least 50%). As such, disclosure of specific examples fitting within the claimed numerical range is not sufficient for satisfaction of the written description requirement. Rather, the analysis must take into account which ranges one skilled in the art would consider inherently or implicitly supported by the specification.
Here, there is no discussion of a range nor a specific example of exactly 50% retained activity that forms the lower limit of the recited range of “at least 50% of its enzymatic activity relative to its activity at day 0.” In order for the numerical limitation “at least 50% of its enzymatic activity relative to its activity at day 0” to have written description support, the specification must indicated to an ordinarily skilled artisan that the inventors intended the specific value of at least 50% to be part of the invention. “"[T]he specification does not clearly disclose to the skilled artisan that the inventors... considered the... ratio to be part of their invention.... There is therefore no force to Purdue’s argument that the written description requirement was satisfied because the disclosure revealed a broad invention from which the [later-filed] claims carved out a patentable portion.” MPEP 2163.05(III). Here, the specification discloses the general concept of increased retention of activity of glucose oxidase when formulated with glycine. Table 5 of the specification (lower right cell) sets forth 55% retained activity after storage time of 180 days. While the value of 55% is identified as a maximum value of retained activity after 180 days as recited, the same does not allow for identification of 50% as a minimum degree of retained activity wherein the range of “at least 50%” after 180 days includes 60%, 70%, 80%, 90%, etc., retained activity. As such, one skilled in the art cannot consider a range with a lower limit of 50% retained activity as recited in claim 9 to be explicitly, inherently nor implicitly supported by the as-filed disclosure. For these reasons, there is no disclosure in the specification that would allow a skilled artisan to recognize that the inventors considered specific retention of at least 50% activity to be part of the invention.
Since applicant has not pointed out any disclosure of the specification that supports the amendment as argued, nor does there appear to be a written description of the claim limitation “the composition, when stored for 180 days at 37[Symbol font/0xB0]C and 65% relative humidity in a closed container, retains at least 50% of its enzymatic activity relative to its activity at day 0,” the same lack adequate written description in the specification.
The following rejection is for claim 14:
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus.”). Regents of the University of California v. Eli Lilly & Co., 119, F.3d 1559, 1568, 43 USPQ2d 1398, 1405 (Fed. Cir. 1997).
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the biomolecule, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed biomolecule.”
“The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice . . ., reduction to drawings . . ., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” MPEP 2163(II)(3)(a).
Furthermore, a “‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure ‘indicates that the patentee has invented species sufficient to constitute the gen[us].’ See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (‘[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.’). ‘A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.’ In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).” MPEP 2163(II)(3)(a).
Claim 14, depending from claim 9, recites a composition that is in the form of a gel or a liquid composition, which are both understood to directly include aqueous compositions. Claim 9 and all claims depending therefrom require embodiment compositions to have the following properties: the composition, when stored for 180 days at 37 °C and 65% relative humidity in a closed container, retains at least 50% of its enzymatic activity relative to its activity at day 0.
The specification, Example 3 and Table 5, describes a “spray dried composition” having improved stability properties after storage for 180 days at 37 °C and 65% relative humidity. It is understood in the art that aqueous compositions of glucose oxidase are substantially less stable than dried compositions. From Bankar (Glucose Oxidase-An overview, Biotechol. Adv. 27, 2009, 489-501), pages 497-98:
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That is, Bankar describes that dried/lyophilized glucose oxidase is substantially more stable than non-dried glucose oxidase. Bankar further indicates that glucose oxidase is generally not stable at 37[Symbol font/0xB0]C. Example 3 of the specification only show stability exceeding retention of 50% activity for a dried composition stored for a period of 180 days at 37 °C as recited.
“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.’). ‘A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.”
Here, in view of Bankar teaching that non-dried compositions of glucose oxidase are substantially less stable than dried compositions, a ordinarily skilled artisan at time of filing cannot predict the operability of glucose oxidase compositions in the form of a gel or a liquid, as recited in claim 14, to have the recited property of “the composition, when stored for 180 days at 37 °C and 65% relative humidity in a closed container, retains at least 50% of its enzymatic activity relative to its activity at day 0” regardless of the presence of glycine are recited. As such, the demonstration in the specification of a spray dried composition having stability similar to as recited in claim 14 does not allow for predictability of operability nor a showing of possession of a genus of gel or liquid compositions having the stability properties discussed above. There is a lack of written description for a genus of gel or liquid compositions comprising a glucose or hexose oxidase compositions as recited in claim 14 for these reasons.
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 (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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9-12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pyne et al. (Solute Crystallization in Mannitol–Glycine Systems—Implications on Protein Stabilization in Freeze-Dried Formulations, J. Pharm. Sci. 92, 2003, 2272-83) further in view of Liu et al. (Freeze-Drying of Proteins From a Sucrose-Glycine Excipient System: Effect of Formulation Composition on the Initial Recovery of Protein Activity, AAPS PharmSciTech 6, 2005, 23) and Bankar (Glucose Oxidase-An overview, Biotechol. Adv. 27, 2009, 489-501).
Pyne, abstract, states:
The use of mannitol in combination with glycine has resulted in stable freeze-dried protein formulations. Our objectives were to (1) study solute crystallization in ternary systems containing mannitol, glycine, and water during all the stages of freeze drying as a function of processing conditions and formulation variables; (2) investigate the effect of sodium phosphate buffer salts on the crystallization of both mannitol and glycine and vice versa; and (3) investigate the effects of these excipients in a freeze-dried lactate dehydrogenase (LDH) formulation. X-ray powder diffractometry (XRD) and differential scanning calorimetry (DSC) were used to study the frozen aqueous solutions. Phase transitions during primary and secondary drying were monitored by simulating the entire freeze-drying process in situ in the sample chamber of the diffractometer. LDH activity after freeze drying was determined spectrophotometrically. In frozen aqueous solutions containing mannitol and glycine, each solute influenced the extent of crystallization of the other. The solutes crystallized as δ-mannitol and β-glycine during primary drying. Glycine had a stronger tendency to crystallize, while it was easier to influence mannitol crystallization. The buffer salts inhibited the crystallization of mannitol and glycine. However, in some cases, during primary drying, glycine crystallization was followed by that of disodium hydrogen phosphate dodecahydrate. The latter underwent dehydration forming an amorphous anhydrate. It was possible to correlate the extent of crystallization of mannitol and glycine in the lyophile with the retention of protein activity. An increase in buffer concentration decreased the crystallinity of mannitol and glycine. This translated to increased retention of protein activity.
“Although cryoprotectants provide stability in the frozen state, lyoprotectants protect the
protein during the entire freeze-drying cycle and subsequent storage. The physical state of the ingredients influences the stability, appearance, and performance of the freeze-dried formulation.” Pyne, page 2272, right col. “Nonreducing sugars and amino acids are often used as lyoprotectants and cryoprotectants, respectively. Mannitol (a nonreducing sugar) and glycine (an amino acid) are commonly used as bulking agents, because of their strong tendency to crystallize during the freeze-drying cycle. If retained amorphous, they may have lyoprotectant activity.” Pyne, page 2272-73.
“Our objectives were to investigate the crystallization of mannitol and glycine in mannitol–glycine mixtures during the various stages of freeze drying, and to evaluate the influence of sodium phosphate buffers on the crystallization behavior of these solutes. To investigate potential lyoprotectant activity of such systems, the recovery of L-lactate dehydrogenase (LDH) activity after freeze drying was also investigated.” Pyne, page 2273, left col.
That is, Pyne teaches that inclusion of buffer salts, mannitol and glycine in protein compositions is beneficial for retention of protein activity in protein compositions subjected to freeze drying. It is emphasized that LDH is an example protein to demonstrate the concept wherein glycine is described as a cryoprotectant for proteins wherein stability of the protein during freeze drying is dependent upon a lack of crystallization of mannitol and glycine. Again, LDH is a model protein to show the ability of mannitol and glycine to reduce crystallization during a freeze drying process regardless of the identity of the protein. For example, Liu, abstract, discusses combinations of sorbitol and glycine as protectants for freeze drying of lactate dehydrogenase and glucose 6-phosphate dehydrogenase as “model proteins.” Similar to Pyne, “When both sucrose and glycine are used and the ratio of the 2 excipients is varied, however, activity recovery decreases in a pattern that is consistent with the inhibition of activity recovery by glycine crystals.” Liu, abstract.
However, neither Pyne nor Liu teach that the protein admixed with glycine and subjected to freeze drying is glucose oxidase. However, it is known in the prior art that lyophilized (i.e. freeze-dried) compositions of glucose oxidase are desirable. For example, “The lyophilized GOD preparation remains stable for a minimum of 6 months at −20 °C.” Bankar, page 498, left col.
Neither Pyne nor Liu teach that the protein admixed with glycine and subjected to freeze drying. However, in view of Pyne and Liu teaching glycine as a cryoprotectant and/or lyoprotectant suitable for addition to protein compositions for producing freeze-dried protein compositions, in producing any lyophilized (i.e. freeze-dried) composition of glucose oxidase and ordinarily skilled artisan at the time of filing would have been motivated to add a suitable lyoprotectant or cryoprotectant in order to achieve the benefit of increased recovery of enzyme activity following freeze drying including glycine as such a lyoprotectant or cryoprotectant as taught by Pyne and Liu. Further, Liu teaches that it is desirable to include a bulking agent in lyophilized compositions of proteins. A “bulking agent is needed to provide a suitable matrix into which a small quantity of protein is dispersed. The process of selecting a suitable formulation, which, in addition to the protein, may consist of a buffer, a bulking agent, one or more stabilizers. . . . Rational design of a freeze-dried protein formulation should consider including an amorphous protective agent, a crystalline bulking agent to improve the freeze-drying characteristics and the physical stability of the cake.” Liu, page E150, right col. The same is a further motivation for an ordinarily skilled artisan at time of filing to admix glucose oxidase and glycine in a composition subjected to freeze drying to result in bulk and other physical properties in the resulting solid product.
Regarding a ratio of at least 1 gram or at least 6.4 gram glycine per gram of oxidase as recited in claims 9 and 10, Table 2 of Pyne indicates that 1 mg/mL of LDH protein is combined with 5% w/w of glycine in an aqueous buffer composition. For an aqueous composition of a density near 1 g/mL, 5% w/w is about 50 mg/mL of glycine as compared to 1 mg/mL of LDH protein. In forming a freeze-dried composition of glucose oxidase, an ordinarily skilled artisan at time of filing would have been motivated to use similar amounts/concentrations of glucose oxidase (i.e. 1 mg/mL) and 5% w/w glycine, since the prior art teaches that the same is appropriate for producing freeze-dried protein compositions, which results in a ratio of glycine to glucose oxidase being much larger than at least 1 gram or at least 6.4 gram glycine per gram of oxidase.
Regarding recitation in claim 9 of “the composition, when stored for 180 days at 37 °C and 65% relative humidity in a closed container, retains at least 50% of its enzymatic activity relative to its activity at day 0,” the claims do not recite a method. As such, the claims do not require any composition to be stored for a period of 180 days. Rather, claim 9 is infringed upon formation of a composition latently having the recited stability properties even after storage of the same for only 0 days.
"The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”; MPEP 2145(II). The stability requirements recited in claim 9, cited above, is recognition of another advantage that flows from following the suggestions of the prior art of inclusion of glycine in a solid composition of glucose oxidase as a lyoprotectant for freeze drying. Further, Pyne directly suggests that inclusion of mannitol and glycine as discussed therein can benefit stability of proteins during subsequent storage: “Although cryoprotectants provide stability in the frozen state, lyoprotectants protect the protein during the entire freeze-drying cycle and subsequent storage.” Pyne, page 2272, right col. As such, the prior art suggests that inclusion of glycine in a freeze-dried composition will improve the stability of protein compositions as compared to absence of such cryoprotectants/lyoprotectants.
Regarding clams 11 and 12, Pyne and Liu teach the addition of glycine in the absence of any other free amino acid including acidic amino acids.
Regarding claim 14, the product of freeze-drying an aqueous mixture of glycine, mannitol and glucose oxidase as discussed above is an “other solid” as recited.
Response to arguments
Applicant argues:
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This disclosure of the specification has been studies. No disclosure that allows for an ordinarily skilled artisan that the inventors intended the specific value range of “retains at least 50% of its enzymatic activity” to be part of the invention.
Due to the amendment to claim 9 requiring certain stability properties that are not achievable by a liquid composition, the grounds of rejection under 35 U.S.C. 103 are modified and no longer rely upon Ye, Arakawa and Bauer. Bankar is still cited only for its teaches that formation of a freeze-dried composition of glucose oxidase is desirable in the art. As such, applicant’s arguments regarding 35 U.S.C. 103 are understood to be moot in view of the new grounds of rejection.
The following observations are made regarding prior art. As prior-discussed on the record, Ye, Arakawa and Bauer have various teachings regarding ability of glycine to stabilize liquid compositions of glucose oxidase. As discussed above, Pyne and Liu teach that glycine is a known lyoprotectant for proteins generally. However, the same do not fairly suggest a significant technical effect on stability for oven drying of glucose oxidase formulated with glycine as required by the methods of claim 1.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Arjmera et al. (Stabilisation of proteins via mixtures of amino acids during spray drying, Int. J. Pharm. 463, 2014, 98-107).
Conclusion
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/TODD M EPSTEIN/Primary Examiner, Art Unit 1652
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