DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
2. Claims 4-9 and 14-37 are presently pending. Applicant’s election of Group I (claims 1-26) in the reply filed on May 15, 2026 is acknowledged. Claims 1-3 and 10-13 are canceled; claims 4-5, 14-15, 18 and 27 are presently amended; claims 27-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 May 15, 2026. Accordingly, claims 4-9 and 14-26 are presently subject to examination.
Note: Applicant failed to properly indicate that the non-elected claims were withdrawn by using “withdrawn” claim status identifiers—appropriate claim status indicators are respectfully solicited with the response to this Office action. See MPEP § 714 (II) C.
Information Disclosure Statement
3. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objection to the Specification
4. The instant specification is objected to for the following reasons:
a. There are trademarks in this application that do not meet the requirements.
The use of the term (e.g., “Tween 20” and “Triton X-100” at para. [0088]), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicant should review the specification for other trademarks and make corrections as required.
b. There are references in this specification that should be placed on an information disclosure statement if application would like them considered.
Claim Rejections - 35 USC § 112
5. 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 5, 9, 14, 17, 20, 22, and 24-25 are 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.
a. The claims recite the term “about” (e.g., about 11 mg/ml to about 55 mg/ml eflapegrastim, see claim 20) however no definition for the term “about” is provided in the specification. Therefore, the term “about” is a relative term of degree that renders the claim indefinite—for example, does about 11 mg/ml eflapegrastim include 1 mg/ml eflapegrastim? Appropriate clarification and/or correction is required.
b. Claims 4 and 26 are 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. The claims recite the term “or less” (e.g., 4 cP or less, see claim 4) however the term “or less” includes zero and negative numbers. Therefore, the true scope of this term in unclear. Appropriate clarification and/or correction is required.
c. Claim 20 is 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 20 recites “and a concentration of the surfactant after the liquid formulation is concentrated is about 0.001% to about 5%(w/v) of the total liquid formulation, and a concentration of the surfactant after the liquid formulation is concentrated is about 0.001% to about 5%(w/v) of the total liquid formulation.” The same limitation is repeated twice, and so it is unclear if this was a typographical error or there is some different meaning between the repeated limitation. Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 103
6. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
7. 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.
8. Claims 5-9, 14-24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (WO 2011/090305 A2, published July 28, 2011) in light of Invensys FOXBORO price sheet (effective October 3, 1999) in view of Mathaes et al. ("Subcutaneous injection volume of biopharmaceuticals—pushing the boundaries." Journal of pharmaceutical sciences 105.8 (2016): 2255-2259).
Claim 5 is drawn to the liquid eflapegrastim formulation of claim 20, wherein a concentration of the buffer material is about 5 mM to about 100 mM.
Claim 6 is drawn to the liquid eflapegrastim formulation of claim 5, wherein the buffer material is citric acid and/or citrate.
Claim 7 is drawn to the liquid eflapegrastim formulation of claim 20, further comprising a stabilizing agent.
Claim 8 is drawn to the liquid eflapegrastim formulation of claim 7, wherein the stabilizing agent comprises mannitol.
Claim 9 is drawn to the liquid eflapegrastim formulation of claim 8, wherein a concentration of the mannitol is about 1% to about 20%(w/v) of the liquid formulation.
Claim 14 is drawn to the liquid eflapegrastim formulation of claim 20, wherein the liquid formulation has a pH of about 4 to about 8.
Claim 15 is drawn to the liquid eflapegrastim formulation of claim 20, further comprising a tonicity modifier.
Claim 16 is drawn to the liquid eflapegrastim formulation of claim 15, wherein the tonicity modifier is sodium chloride.
Claim 17 is drawn to the liquid eflapegrastim formulation of claim 15, wherein a concentration of the tonicity modifier is about 5 mM to about 200 mM.
Claim 18 is drawn to the liquid eflapegrastim formulation of claim 20, wherein the liquid formulation is pre-treated using a purification column.
Claim 19 is drawn to the liquid eflapegrastim formulation of claim 18, wherein the pre- treated liquid formulation is concentrated after buffer exchange with a buffer which does not contain a polysorbate-based non-ionic surfactant.
Claim 20 is drawn to a liquid eflapegrastim formulation comprising eflapegrastim, a buffer material, and a surfactant, wherein a concentration of the eflapegrastim is about 11 mg/mL to about 66 mg/mL; a concentration of the buffer material is about 5 mM to about 100 mM; and a concentration of the surfactant after the liquid formulation is concentrated is about 0.001% to about 5%(w/v) of the total liquid formulation, and a concentration of the surfactant after the liquid formulation is concentrated is about 0.001% to about 5%(w/v) of the total liquid formulation.
Claim 21 is drawn to the liquid eflapegrastim formulation of claim 20, wherein the surfactant is a polysorbate-based non-ionic surfactant.
Claim 22 is drawn to the liquid eflapegrastim formulation of claim 20, wherein the liquid formulation comprises: about 11 mg/mL to about 66 mg/mL of the eflapegrastim; about 5 mM to about 100 mM of citric acid and/or citrate; and about 0.001% to about 5%(w/v) of a polysorbate-based non-ionic surfactant.
Claim 23 is drawn to the liquid eflapegrastim formulation of claim 21, wherein the polysorbate-based non-ionic surfactant is selected from the group consisting of Polysorbate 20, Polysorbate 40, Polysorbate 60, and Polysorbate 80.
Claim 24 is drawn to the liquid eflapegrastim formulation of claim 21, wherein the liquid formulation comprises: about 11 mg/mL to about 66 mg/mL of the eflapegrastim; about 5 mM to about 100 mM of sodium citrate; about 0.001% to about 0.5%(w/v) of Polysorbate 80; about 1% to about 20%(w/v) of mannitol; and about 5 mM to about 200 mM of sodium chloride.
Claim 26 is drawn to the liquid eflapegrastim formulation of claim 20, wherein the liquid formulation has a conductivity of 15 mS/cm or less.
Lee et al. at claim 1 teaches a liquid eflapegrastim formulation having a “long-acting granulocyte-colony stimulating factor conjugate in which G-CSF, a non-peptide polymer and an immunoglobulin Fc fragment are covalently linked” (eflapegrastim); see instant specification at para. [0055] for corresponding eflapegrastim features. Lee et al. discloses at para. [0031] that the G-CSF / eflapegrastim is preferably present in the formulation at a concentration of 11 mg/ml to 22 [mg/ml] in the liquid formulation. Lee et al. discloses the liquid formulation has a buffer martial having a concentration of 5 to 100 mM (at claims 1-2 of Lee et al.). Lee et al. discloses the liquid formulation, after it achieves its final concentration, has a surfactant concentration of .001% to .05% (w/v) (at claims 6 and 11 of Lee et al.). Lee et al. further teaches features of the instant dependent claims. For example, Lee et al. discloses that the buffer ranges in concentration from 5 to 10 mM (at claim 4 of Lee et al.) (instant Claim 5); wherein the buffer material is citrate (at claim 3 of Lee et al.) (instant claim 6); that the liquid formulation further comprising a stabilizing agent (at claim 1 of Lee et al.) (instant claim 7); wherein the stabilizing agent comprises mannitol (at claim 1 of Lee et al.) (instant claim 8); wherein mannitol ranges in concentration from 1% to 20% (w/v) (at claim 2 of Lee et al.) (instant claim 9); wherein the buffer, and thus the liquid formulation, has a pH from 4 to 8 (at claim 5 of Lee et al.) (instant claim 14); wherein the liquid formulation further comprises an isotonic agent (i.e., tonicity agent) (at claim 6 of Lee et al.). (instant claim 15); that the tonicity agent is sodium chloride (at claim 7 of Lee et al.) (instant claim 16); that the tonicity agent has concentration from 5 to 200 mM (at claim 8 of Lee et al.) (instant claim 17); wherein the surfactant is polysorbate-based non-ionic surfactant (at claim 9 of Lee et al.) (instant claim 21); wherein the wherein the liquid formulation comprises 11 mg/ml to 22 [mg/ml] eflapegrastim; citrate buffer; from 5 to 100 mM of the buffer; polysorbate-based non-ionic surfactant; and from 0.001% to 0.05% of the non-ionic surfactant at para. [0031] and claims 3, 4, 9, 11 of Lee et al. (instant claim 22); wherein the polysorbate-based non-ionic surfactant is selected from the group consisting of Polysorbate 20, Polysorbate 40, Polysorbate 60, and Polysorbate 80 (at claim 10 of Lee et al.) (instant claim 23); and wherein the liquid formulation comprises: about 11 mg/mL to about 66 mg/mL of the eflapegrastim; about 5 mM to about 100 mM of sodium citrate; about 0.001% to about 0.5%(w/v) of Polysorbate 80; about 1% to about 20%(w/v) of mannitol; and about 5 mM to about 200 mM of sodium chloride (at claims 2, and 7-11 of Lee et al.) (instant claim 24). Lee et al. also teaches that its formulation is intended for injection, and that frequent injections can cause patient pain. See e.g., Lee et al. at para. [0004]. The long-lasting G-CSF of Lee et al. requires fewer injections and therefore results in less patient pain. Lee et al. is also concerned with the osmolarity of the liquid eflapegrastim formulation, but does not provide a specific osmolarity value (see, e.g., para. [0041]: “isotonic agent acts not only to maintain a suitable osmotic pressure when the long-acting G-CSF conjugate in the liquid formulation is allowed to enter the body, but to further stabilize the long-acting G-CSF conjugate in the liquid formation.”)
The limitations of claims 18-19, i.e., wherein the liquid formulation is pre-treated using a purification column (claim 18); and wherein the pre-treated liquid formulation is concentrated after buffer exchange with a buffer which does not contain a polysorbate-based non-ionic surfactant (claim 19) renders these claims as product by process claims. As instructed by the MPEP at § 2113: I. product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps; II. once a product appearing to be substantially identical is found and a prior art rejection is made, the burden shifts to the applicant to show an nonobvious difference. In this case, the manipulations recited in the steps, intending to prevent the polysorbate-based non-ionic surfactant concentration from accidentally exceeding the values recited in the claims (see instant specification at para [0092], [0179]) do not (i) alter the structure of the liquid eflapegrastim product, nor (ii) render the claimed formulation materially different from that disclosed by Lee et al. The recited steps do not result in a materially different product, rather the additional steps merely ensure the liquid eflapegrastim formulation conforms to the structure recited in independent claim 20. Therefore, the process steps do not confer patentability to the claims (Claims 18-19).
Regarding the limitation of claim 26, which is “wherein the liquid formulation has a conductivity of 15 mS/cm or less,” Invensys FOXBORO price sheet (effective October 3, 1999) provides a conversion table of NaCl concentrations to conductivity, by the weight % of the NaCl. 5 mM NaCl is equivalent to .029 weight % NaCl1; and 200 mM NaCl is equivalent to 1.17 weight % NaCl2. The table indicates .029 weight % NaCl formulations will have a conductivity of about 1,780 micro-S/cm (1.78 mS/cm3); and 1.17 weight % NaCl formulations will have a conductivity of about 53,200 micro-S/cm (53.2 mS/cm4). As discussed above, Lee et al. teaches that the liquid formulation may have 5 to 200 mM sodium chloride (at claims 7-8 of Lee et al.). Therefore, Lee et al. through disclosing 5 to 200 mM sodium chloride in the liquid formulation implicitly discloses a range of conductivities (i.e., 1.78 mS/cm to 53.2 mS/cm) that overlaps the instantly claimed conductivity range of 15 mS/cm or less (Claim 26).
Lee et al. does not explicitly disclose that the liquid eflapegrastim formulation is concentrated as required by instant claim 20.
Mathaes et al. broadly teaches the advantage of concentrated therapeutic protein formulations for fewer injections and/or less painful administration of the therapeutic protein formulation. Mathaes et al. is a review the state of the art of subcutaneous injection volume considerations. Mathes et al. at title. Mathes et al. is concerned with patient pain caused by injecting liquid protein therapeutics, e.g., caused by the volume injected, and teaches the solution of concentrating the liquid protein therapeutic to enable a lower injection volume and therefore less patient pain when injecting the liquid protein therapeutic. Mathaes et al. teaches that “Administration into the subcutaneous (SC) tissue is a typical route of delivery for therapeutic proteins,” and discusses injection pain and tolerability associated with the injections. See the abstract. Mathes et al. teaches: “SC injection volumes larger than 2 mL are associated with various issues including injection pain, adverse events at the injection site[.]” and that “Several strategies can be considered to overcome the challenges of SC administration of biologics requiring significant dosing. Traditionally, high concentration formulations are developed aiming to be administered at low volumes by the SC route (Fig.1).” See the introduction and Mathaes et al. at pg. 2257, right col. Fig. 1 is provided below for Applicant’s convenience:
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Fig. 1 shows that lower concentrations of a therapeutic protein require a higher injection volume, and are there therefore more likely to cause pain. Mathaes et al. also shows that lower concentrations require more injections at pg. 2256, left col, thereby being more likely to cause pain. Therefore, Mathaes et al. broadly teaches the advantage of concentrated therapeutic protein formulations for fewer injections and/or less painful administration of the therapeutic protein formulation.
Mathaes et al. is also concerned with the effects concentrating the protein therapeutic formulations will have on viscosity. Mathaes et al. teaches: “An increased viscosity (rising exponentially with protein concentration) influences processability, the ability to filter and deliver (administration) the drug product.” Mathaes et al. at pg. 2255, right col. Mathes et al. further teaches: “For highly viscous solutions, the choice of an adequate injection needle is critical. As the inner diameter of the needle decreases, the required injection forces increase, following the Hagen Poiseuille law to the power of 4. In cases where very thin needles such as 30G are used, the viscosity at the temperature of administration cannot exceed 10 cP, assuming a maximum injection force of 10 N is desired.” Mathaes et al. at pg. 2256, left col. Therefore, Mathaes et al. teaches the viscosity of the formulation should not exceed 10 cP, which encompasses the claim-recited feature of “4 cP or less at a room temperature of 20°C to 25°C.”
It was prima facie obvious at the time of the claimed invention to modify the liquid eflapegrastim formulation of Lee et al. by concentrating it as taught by Mathaes et al. A person of ordinary skill in the art would be motivated to modify the formulation of Lee et al. to increase the concentration above 22 mg/ml because Lee et al. teaches that its formulation is intended for injection, and that frequent injections can cause patient pain, as discussed above. Mathaes et al. is concerned with the same problem, and provides the solution of increasing the concentration of the protein therapeutic, thereby reducing the volume required to be injected, which reduces pain and/or frequency of required injections. Therefore, a person of ordinary skill in the art would be motivated to concentrate the eflapegrasim formulation taught by Lee et al. to increase the concentration and thereby reduce the pain associated with its administration. There was a reasonable expectation of success that increasing the concentration of the eflapegrastim in the formulation would result in in needing to administer a lower volume of formulation and/or lower frequency of administration, and therefore less pain, because Mathaes et al. broadly teaches that the volume and/or frequency of administration of injectable protein therapeutics is a major contributor to the pain. Regarding Invensys FOXBORO, it is presented to show that the feature: conductivity of 15 mS/cm or less (instantly recited in claim 26) is necessarily present in Lee et al. by its disclosure of NaCl concentrations in the liquid eflapegrastim formulation that necessarily result in the formulation having a conductivity of 15 mS/cm or less.
It is also obvious to apply a known technique to a known product ready for improvement to yield predictable results. Here, the base product is the liquid eflapegrastim formulation of Lee et al. The prior art contained a known techique (i.e., concentrating the protein therapeutic to enable lower injection volumes) as shown by Mathaes et al. One of ordinary skill in the art would have recognized at the time of the claimed invention that concentrating the liquid eflapegrastim formulation of Lee et al. would predictably result in a liquid eflapegrastim formulation that would be better tolerated by subjects, requiring fewer administrations and/or less volume administered, and therefore be less painful to administer. Claim 20 is therefore rendered obvious by Lee et al. in view of Mathaes et al. (Claim 20).
Accordingly, Lee et al. in light of Invensys FOXBORO price sheet and in view of Mathaes et al., renders claims 5-9, 14-24, and 26 obvious.
9. Claim 4, is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. in view of Mathaes et al. and in light of Invensys FOXBORO price sheet as applied to claims 5-9, 14-24, and 26 above, and further in view of Chang (Change, Richard presentation AAM 2020 dated November 19, 2020; of record).
Claim 4 is drawn to the liquid eflapegrastim formulation of claim 20, wherein the liquid formulation has a viscosity of 4 cP or less at a room temperature of 20°C to 25°C.
Lee et al. and Mathaes et al. and Invensys FOXBORO have been described above.
Lee et al. and Mathaes et al., in light of Invensys FOXBORO does not explicitly disclose: wherein the liquid formulation has a viscosity of 4 cP or less at a room temperature of 20°C to 25°C.
Chang provides further motivation to reduce the viscosity below 10 cP.
Chang is a presentation by an FDA representative commenting of FDA guidance for prefilled syringes. Chang at slide 6 specifically teaches the glide force should be no more than 5N. To obtain a lower 5N glide force will require an even lower viscosity that the 10 cP suggested by Mathaes et al. for a 30G needle. Furthermore, Mathaes et al. notes that the “As the inner diameter of the needle decreases, the required injection forces increase, following the Hagen Poiseuille law to the power of 4.” Therefore, the thinner the needle used, the lower the viscosity must be.
It was prima facie obvious at the time of the claimed invention to modify the liquid eflapegrastim formulation as taught by Lee et al. and concentrate it in view of Mathaes et al. and further optimize the viscosity to less than 4 cP. Mathaes et al. suggests using less than 10 cP viscosity if 10 N glide force is desired; Chang suggests and even lower glide force (5 N), and therefore an even lower viscosity; Mathaes et al. notes that the physics of needles requires lower viscosity formulations depending on the gauge of the needle desired. A person of ordinary skill in the art would have a reasonable expectation of success that lowering the viscosity of a liquid protein therapeutic formulation to 4 cP or less would achieve a desirable glide force depending on the combination of syringe and needle gauge used. It is also obvious to try various viscosities of liquid protein therapeutic formulations. Mathaes et al. shows that at the time of the invention there had been a recognized problem with higher concentration liquid protein therapeutic formulations, namely the deleterious effects on viscosity, and thereby syringeability of the higher concentration protein therapeutics. There were a finite number of predictable potential solutions, namely lowering the viscosity of the liquid protein therapeutic formulation. One of ordinary skill in the art would have pursued the known potential solutions, i.e., lowering the viscosity of the liquid protein therapeutic formulation, until a desired glide force was obtained.
Accordingly, Lee et al. in view of Mathaes et al., in light of Invensys FOXBORO price sheet, and further in view of Chang renders claims 4-9, 14-24, and 26 obvious.
10. Claim 25, is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. in view of Mathaes et al., in light of Invensys FOXBORO price sheet, further in view of Chang as applied to claims 4-9, 14-24, and 26 above, and further in view of Wang ("Tolerability of hypertonic injectables." International journal of pharmaceutics 490.1-2 (2015): 308-315).
Lee et al. and Mathaes et al., Invensys FOXBORO and Chang et al are described above.
Lee et al. and Mathaes et al., Invensys FOXBORO and Chang et al do not teach the limitations of claim 25, drawn to the liquid eflapegrastim formulation of claim 20, wherein the osmolarity of the liquid formulation is about 100 mOsm/kg to about 800 mOsm/kg.
Wang is a review directed to the tolerability of injectables and suggests “It is recommended that the upper osmolarity limit should generally controlled under 600 mOsm/kg for drug intended for intramuscular or subcutaneous injection.” Wang at title, abstract.
It was prima facie obvious at the time of the claimed invention to modify the liquid eflapegrastim formulation as taught by Lee et al. and concentrate it in view of Mathaes et al. and further optimize the osmolarity of the formulation to about 100 mOsm/kg to about 800 mOsm/kg as taught by Wang. A person of ordinary skill I the art would be motivated modify the liquid eflapigrastim formulation of Lee. et al. as taught by Wang because Wang teaches that less than 600 mOsm/kg is preferred for subcutaneous injection, which overlaps with the instantly claimed range of osmolarities. A person of ordinary skill in the art would have a reasonable expectation of success that using an osmolarity of less than 600 mOsm/kg would work because that is Wang’s explicit recommendation for, e.g., subcutaneous injections. It is also obvious to substitute one known element for another to obtain predictable results. Here, the prior art contains the liquid eflapegrastim formulation of Lee et al. and Mathaes et al., but without a specific osmolarity recommendation; and a recommendation for the osmolarity of injectable liquid formulations in general. It was predictable that substituting the specific osmolarity recommendation of Wang would result in a beneficial liquid eflapegrastim formulation because Wang specifically teaches that its osmolarities are tolerable.
Accordingly, claims 4-9, 14-26 are rendered obvious by Lee et al. in view of Mathaes et al., as evidenced by Invensys FOXBORO price sheet, in view of Chang, and further in view of Wang.
Pertinent Art
11. The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure:
GE Healthcare Recombinant Protein Purification handbook, 2012: Discloses various techniques for purifying and concentrating proteins using purification columns and buffer exchanges with buffers not containing polysorbate-based non-ionic surfactants.
Conclusion
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON R SCHWECHTER whose telephone number is (571)272-1270. The examiner can normally be reached M-Th 7-5 EST.
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/BRANDON R SCHWECHTER/
Examiner, Art Unit 1674
/VANESSA L. FORD/ Supervisory Patent Examiner, Art Unit 1674
1 The molar mass of NaCl is 58.44 g/mol; 0.005 mol/L (i.e., 5 mM) x 58.44 g/mol = 0.2922 g/L; the density of water is 1000 g/L; therefore 0.2922 g/L is compared to (divided by) 1000 g/L = 0.0002922; and last multiplied by 100 to be expressed as weight % = .029 weight %.
2 The same equations above apply, except using 0.2 mol/L NaCl (i.e., 200 mM)
3 Multiply “micro” by 1000 to obtain “milli,” i.e., mS/cm
4 Multiply “micro” by 1000 to obtain “milli,” i.e., mS/cm
Prosecution Insights