DETAILED ACTION
Status of Application
The response filed 08/11/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 9, 12, 14 have been amended.
Applicant had previously elected Group II in response to restriction requirement and elected the species for the composition form to be a powder (dry, lyophilized powder), the organic base to be metformin, and the disease species to be diabetic nephropathy the examination. Upon review, the species for the composition form was expanded to include tablets, the organic base is expanded to include choline, the disease species is expanded to include diabetes and hyperuricemia and metabolic syndrome along with its symptoms including obesity and hyperglycemia (i.e. elevated fasting plasma glucose.
Due to restriction, based on election of Group II and species elections above, claims 1-8, 19-24 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-24 are pending.
Claims 9-18 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All grounds not addressed in the action are withdrawn as a result of amendment.
New grounds of rejection are set forth in the current office action as a result of amendment.
Priority
This application repeats a substantial portion of prior Application No. 14776905 filed 03/17/2014, and adds disclosure not presented in the prior application wherein the instant application is a continuation-in-part of the prior application.
The instant claims recites a method of treating a disease/condition associated with increased expression of xanthine oxidase enzyme or increased activity of xanthine oxidase enzyme or elevated uric acid levels or a combination thereof in a patient, comprising administering a therapeutically effective amount of a xanthine oxidase inhibitor and an organic base, and optionally a pharmaceutical carrier with a molar ratio of oxypurinol to organic base of about 1:1-about 1:10 with 50-1000mg of oxypurinol and the organic base is optionally lysine, arginine, choline or metformin or a combination thereof. The content for the organic base to possibly include metformin was not previously present in the prior application wherein the priority date of these claims is given the filing date of the instant application of 09/15/2015.
Information Disclosure Statement
The information disclosure statement filed 07/16/2026 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because there is no English translation of the reference. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
New Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
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.
Claim 10 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.
The claim recites the composition comprises a formulation comprising an aqueous solution of a xanthine oxidase inhibitor, an organic base in an amount effective to increase solubility, or bioavailability of said xanthine oxidase inhibitor compared to an absence of the organic base, and an antioxidant. This is unclear and indefinite. The claim recites the presence of a xanthine oxidase inhibitor which is broader than the recited oxypurinol recited in the independent claim, wherein it is unclear if the claim is directed to the oxypurinol or to another xanthine oxidase inhibitor. It does not allow one to ascertain the metes and bounds of the claim as written. The claim also recited the presence of an organic base which is broader than the recited L-arginine, L-lysine, metformin, and combinations thereof, wherein it is unclear if the claim is directed to the recited L-arginine, L-lysine, metformin, and combinations thereof or to another organic base. It does not allow one to ascertain the metes and bounds of the claim as written
Additionally, the claim recites that the amount of organic base is an amount effective to increase solubility, or bioavailability of the xanthine oxidase inhibitor compared to an absence of the organic base; which is unclear and indefinite as it is broader than the molar ratio of about 1:1-about 1:10 of oxypurinol to the organic base that is L-arginine, L-lysine, metformin, and combinations thereof, where the amount of oxypurinol is 50-1000mg. It does not allow one to ascertain the metes and bounds of the claims as written. For purposes of examination, the claims is treated to be the composition of claim 9 with the inclusion of an antioxidant.
Claim 12 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.
The claim is indefinite as it recites that the administered composition “is disposed in a bottle, sachet, or gelatin capsule, in a powered preparation for mixing with water by the user to make a liquid formulation”; wherein it is unclear what is meant by “bottle, sachet, or gelatin capsule, in a powdered preparation for mixing with water….” – the composition can be in a bottle or a sachet or a gelatin capsule but how is that related to “in a powdered preparation for mixing with water”? How is a composition that is in a bottle (i.e. tablets) or alternatively as a gelatin capsule related to “in a powdered preparation for mixing with water”? It’s also unclear if it is a powder or a liquid as it recites a future intended use but is not the form of administration. It does not allow one to ascertain the metes and bounds of the claimed invention. For purposes of examination it is treated where the composition can be in a bottle or a sachet or a gelatin capsule or a powder or a liquid.
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 10 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.
The claim recites the composition comprises a formulation comprising an aqueous solution of a xanthine oxidase inhibitor, an organic base in an amount effective to increase solubility, or bioavailability of said xanthine oxidase inhibitor compared to an absence of the organic base, and an antioxidant. Wherein the claim recites the presence of a xanthine oxidase inhibitor which is broader than the recited oxypurinol recited in the independent claim from which it depends, and also recited the presence of an organic base which is broader than the recited L-arginine, L-lysine, metformin, and combinations thereof recited in the independent claim from which it depends.
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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 9-10, 13-16, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Plouvier et al. (WO 2006/083687) in view of Smith (U.S. Pat. Pub. 2002/0004515).
Rejection:
Plouvier et al. teaches treating conditions including diabetes and kidney disease and hyperuricemia, with the administration of a crystalline choline salt of oxypurinol (molar ratio of 1:1 oxypurinol to choline, claims 19-20). The composition forms administered for the method include a powder, tablet, sachet (claim 19 and 10). The amount of oxypurinol choline is from about 0.1-90%wt. of the composition and can be in the range of 1-750mg (Page 21 3rd paragraph) and can be in combination with other therapeutic actives (Page 3 2nd paragraph, Page 21 last paragraph- Page 22 1st paragraph). The composition can contain various excipients including citric acid (antioxidant, Page 18 2nd paragraph, see full document specifically areas cited).
While Plouvier et al. does not teach the exact same values for the oxypurinol, they do overlap (1-750mg of oxypurinol choline=about 0.6-about 445 mg oxypurinol) wherein even a slight overlap in ranges establishes a prima facie case of obviousness to attain the desired therapeutic profile absent evidence of criticality for the claimed range
Plouvier et al. does not expressly teach the inclusion of metformin but does teach the treatment of diabetes and kidney disease and hyperuricemia, with the administration of a crystalline choline salt of oxypurinol from 1-750mg and the inclusion of other therapeutic agents.
Smith teaches that metformin is a biguanide that is useful for treating diabetes and its related conditions like renal/kidney disease which can be given up to 3000mg/day such as 500mg and 850mg (abstract, [2, 38, 59], claim 1-2) and the metformin can be in the form of tablets, capsules powders, liquids [51, 61-62].
Wherein it would be obvious to incorporate metformin as suggested by Smith and produce the claimed invention; as Plouvier et al. teaches the inclusion of other therapeutic actives and it is prima facie obvious to incorporate a known therapeutic active for treating diabetes for its additive effect with a reasonable expectation of success.
While the prior art does not expressly teach the exact claimed molar ratio of oxypurinol:metformin, they either embrace or overlap the range (i.e. oxypurinol:metformin of about 0.6mg-about 445mg oxypurinol, 500mg and 850mg metformin, has a molar ratio of about 1:1.32 to about 1:1,645 (about 445mg oxypurinol: 500mg metformin=2.93mol:3.87mol=1:1.32, about 0.6mg oxypurinol:850mg metformin=about 0.004mol:6.58mol=1:1.645)) wherein even a slight overlap in ranges establishes a prima facie case of obviousness to attain the desired therapeutic profile absent evidence of criticality for the claimed range.
Response to Arguments:
Applicant's arguments are centered on the assertion that Plouvier et al. does not teach all the elements of the amended claim. This is fully considered but not persuasive as addressed by the new rejection as a result of claim amendment addressed above.
Accordingly, the rejection stands.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Plouvier et al. (WO 2006/083687) in view of Smith (U.S. Pat. Pub. 2002/0004515). as applied to claims 9-10, 13-16, 18 above, in view of Winfield (Powders and granules).
The teachings of Plouvier et al. are addressed above.
Plouvier et al. does not recite the type/size of the powder or a container for the powder but does teach the composition form administered to include powders.
Winfield teaches that powders (dry) are known to have standard particle size descriptions where they would normally be “moderately fine” or a “fine" powder where they would pass through a nominal mess aperture of 355um and 180um respectively (both micronized size dry powder, Particle size). Winfield also teaches that the powder can be placed in containers like glass or plastic, and in sachet (Containers for internal powders).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have powders in its known size and place the powder in containers/sachets as suggested by Winfield and produce the claimed invention; as it is prima facie obvious to have powders in its conventional size and place powders in its conventional packaging with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are to Plouvier et al. which are addressed above. Applicant’s remaining arguments to Winfield are against the reference individually and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Accordingly, the rejection stands.
Claims 9-10, 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Melani et al. (WO 2011/141419) in view of Jenkins et al. (U.S. Pat. Pub. 2010/0160351).
Rejection:
Melani et al. teaches treating conditions including metabolic syndrome and diabetes (exemplified models, Page 8-10) and the hyperglycemia associated with the condition (including fasting plasma glucose) with the administration of a composition comprising a xanthine oxidase inhibitor and biguanide (abstract, Page 8, Page 2 line 26-Page 3 line 3, Page 4 line 2-9). Metabolic syndrome manifestations also include obesity (Page 7 line 4-5). The xanthine oxidase inhibitor can be febuxostat and the biguanide can be metformin (Page 2 line 26-35, Page 3 line 25-Page 4 line 9 and line 16-21).
The xanthine oxidase inhibitor can be from 10-200mg per dose and metformin is from 100-1500mg dose, and the dose is known to lowered or raised according to the response and assessment of the patient (Page 7 line 7-24). Composition forms include powders, granules, and tablets (Page 4 line 37- Page 5 line 13 line 30-32, Page 5 line 36-Page 6 line 14). The powder can also be used for reconstitution for injectable solutions/dispersions (Page 6 line 6-8). Excipients include sodium citrate (an antioxidant, Page 5 line 13-15) and bentonite (an antioxidant, Page 5 line 23, see full document specifically areas cited).
Melani et al. does not recite the inclusion of oxypurinol but does teach the inclusion of xanthine oxidase inhibitors like febuxostat.
Jenkins et al. teaches that known xanthine oxidase inhibitors include allopurinol, febuxostat, oxypurinol, tisopurine or an inositol (claim 6).
Wherein it would be obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to incorporate oxypurinol into the composition for administration as suggested by Jenkins et al. and produced the claimed invention; as simple substitution of one known xanthine oxidase inhibitor for another is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the specifically claimed xanthine oxidase inhibitor. While the prior art does not teach the exact claimed values for oxypurinol, they do overlap and even a slight overlap in ranges establishes a prima facie case of obviousness. It would also be prima facie obvious to optimize within the taught ranges for the amount of xanthine oxidase inhibitors and metformin to arrive at the claimed ratio (xanthine oxidase inhibitor from 10-200mg (about 0.07-about 1.32 mole oxypurinol) and metformin is from 100-1500mg (about 0.77-about 11.61 mole metformin), molar ratio with oxypurinol to metformin is from 1:0.58-1:165.86) absent evidence of criticality for the claimed values.
Response to Arguments:
Applicant's arguments are centered on the assertion that Melani does not teach the combination of oxypurinol and metformin, that neither Melani nor Jenkins teach any specific dose of oxypurinol or a particular molar ratio of oxypurinol to metformin, and the points to the specification that asserts that metformin unexpectedly increases the solubility of oxypurinol from 0.2mg/ml to 16.8mg/ml when in a 1:2 or 1:3 ratio of oxypurinol to metformin (Page 10 line 9-15).
This is fully considered but not persuasive.
The assertion that Melani must teach the combination of oxypurinol and metformin within a single reference is not the standard for obviousness. Obviousness is not restricted to a single reference as obviousness may be to a combination of references as addressed in the rejection above.
As for the assertion that neither Melani nor Jenkins teach any specific dose of oxypurinol or a particular molar ratio of oxypurinol to metformin is neither persuasive nor accurate. Melani teaches treating the conditions with a xanthine oxidase inhibitor and biguanide like metformin, and the amount of xanthine oxidase inhibitor can be from 10-200mg per dose and metformin from 100-1500mg dose; wherein a dose for the xanthine oxidase inhibitor is taught - which includes oxypurinol which is a xanthine oxidase inhibitor as established by Jenkins; and simple substitution of one known xanthine oxidase inhibitor for another is prima facie obvious absent evidence of criticality for the specific xanthine oxidase inhibitor. It is also prima facie obvious to optimize within the taught amounts for the xanthine oxidase inhibitor and metformin to arrive at the claimed ratio (xanthine oxidase inhibitor from 10-200mg (about 0.07-about 1.32 mole oxypurinol) and metformin is from 100-1500mg (about 0.77-about 11.61 mole metformin), molar ratio with oxypurinol to metformin is from 1:0.58-1:165.86) as Melani teaches the dose is known to lowered or raised according to the response and assessment of the patient - absent evidence of criticality for the claimed values which have not been presented.
As to the assertion that metformin unexpectedly increases the solubility of oxypurinol from 0.2mg/ml to 16.8mg/ml when in a 1:2 or 1:3 ratio of oxypurinol to metformin citing the specification (Page 10 line 9-15), this is not persuasive as there is no showing demonstrating criticality for an unexpected increase in solubility and arguments without factual support are mere allegations and are not found persuasive. It is noted that the claims must be commensurate in scope with any evidence of criticality.
Accordingly, the rejection stands.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Melani et al. (WO 2011/141419) in view of Jenkins et al. (U.S. Pat. Pub. 2010/0160351) as applied to claims 9-10, 13-18 above, further in view of Winfield (Powders and granules).
The teaching of Melani et al. in view of Jenkins et al. are addressed above.
Melani et al. in view of Jenkins et al. does not recite the type/size of the powder or a container for the powder but does teach the composition form administered to include powders.
Winfield teaches that powders (dry) are known to have standard particle size descriptions where they would normally be “moderately fine” or a “fine” powder where they would pass through a nominal mesh aperture of 355um and 180um respectively (both micronized size dry powder, Particle size). Winfield also teaches that the powder can be placed in containers like glass or plastic, and in sachet (Containers for internal powders).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have powders in its known size and place the powder in containers/sachets as suggested by Winfield and produce the claimed invention; as it is prima facie obvious to have powders in its conventional size and place powders in its conventional packaging with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are to Melani et al. and Jenkins et al. which are addressed above. Applicant’s remaining arguments to Winfield are against the reference individually and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Accordingly, the rejection stands.
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 9-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-12, 14-18 copending Application No. 19102611 (reference application).
The copending claim recites the same method with the same composition form wherein the copending claim is obvious over the instant claims.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Response to Arguments:
Applicant asks the rejection to be held in abeyance.
There is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 9-10, 13-16, 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/722330 in view of Melani et al. (WO 2011/141419).
The copending claim is directed to a method of treating kidney disease progression comprising administering a xanthine oxidase inhibitor comprising oxypurinol and an organic base such as biguanide.
The copending claim does not recite the amount of oxypurinol or the ratio to the biguanide, or the composition form.
Melani et al. teaches that the combination of a xanthine oxidase inhibitor and biguanide for treating conditions is known (abstract, Page 8, Page 2 line 26-Page 3 line 3, Page 4 line 2-9). The biguanide can be metformin (Page 2 line 26-35, Page 3 line 25-Page 4 line 9 and line 16-21) and the xanthine oxidase inhibitor can be from 10-200mg per dose and metformin is from 100-1500mg dose, and the dose is known to lowered or raised according to the response and assessment of the patient (Page 7 line 7-24). Composition forms include powders, granules, and tablets (Page 4 line 37- Page 5 line 13 line 30-32, Page 5 line 36-Page 6 line 14). The powder can also be used for reconstitution for injectable solutions/dispersions (Page 6 line 6-8). Excipients include sodium citrate (an antioxidant, Page 5 line 13-15) and bentonite (an antioxidant, Page 5 line 23).
Wherein it would be obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to incorporate oxypurinol along with the biguanide metformin into the composition for administration at their known ranges as suggested by Melani et al. and produced the claimed invention; as the inclusion of the active at its known therapeutic range is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the specifically claimed amount. It would also be prima facie obvious to optimize within the taught ranges for the amount of xanthine oxidase inhibitors and metformin to arrive at the claimed ratio (xanthine oxidase inhibitor from 10-200mg (about 0.07-about 1.32 mole oxypurinol) and metformin is from 100-1500mg (about 0.77-about 11.61 mole metformin), molar ratio with oxypurinol to metformin is from 1:0.58-1:165.86) absent evidence of criticality for the claimed values.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments:
Applicant asks the rejection to be held in abeyance.
There is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 11-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/722330 in view of Melani et al. (WO 2011/141419) as applied to claims 9-10, 13-16, 18 above, further in view of Winfield (Powders and granules).
The teachings of the copending claim in view of Melani et al. are addressed above.
The copending claim in view of Melani et al. does not recite the type/size of the powder or a container for the powder but does teach the composition form administered to include powders.
Winfield teaches that powders (dry) are known to have standard particle size descriptions where they would normally be “moderately fine” or a “fine" powder where they would pass through a nominal mess aperture of 355um and 180um respectively (both micronized size dry powder, Particle size). Winfield also teaches that the powder can be placed in containers like glass or plastic, and in sachet (Containers for internal powders).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have powders in its known size and place the powder in containers/sachets as suggested by Winfield and produce the claimed invention; as it is prima facie obvious to have powders in its conventional size and place powders in its conventional packaging with a reasonable expectation of success.
Response to Arguments:
Applicant asks the rejection to be held in abeyance.
There is no terminal disclaimer.
Accordingly, the rejection stands.
Conclusion
Claims 9-18 are rejected.
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 GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
