DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 8 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.
Claim 5 recites “wherein the excipient comprises one or more of benzoic acid, sodium carbonate, meglumine, sodium phosphate tribasic, myristyl sulfobetaine, Kollidon HS 15, dodecylphosphocholine, L-Glutamine, PIPES, and/or sodium succinate”. A lack of clarity arises as it is unclear whether this is a listing of a group where at least one is selected. For the purposes of examination it is interpreted that at least one from the group listed is selected.
Claim 8 recites “wherein the pH-responsive polymer comprises one of shellac, methyl acrylate-methacrylic acid copolymers, cellulose acetate phthalate, cellulose acetate succinate, hydroxypropyl methyl cellulose phthalate, hydroxypropyl methyl cellulose acetate succinate, polyvinyl acetate phthalate, methyl methacrylate-methacrylic acid copolymers, cellulose acetate trimellitate, or zein”. A lack of clarity arises as it is unclear if the listing is a grouping where only one is chosen. For the purposes of examination, it is interpreted that only one is chosen.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6-9 and 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu (US 20210393543 A1).
With respect to claim 1, Wu discloses a glucose-responsive system for delivering glucagon to a mammalian subject (see paragraph 0077, microneedle patch composed of glucagon loaded glucose responsive microgels to delivery glucagon to user), the glucose-responsive system comprising:
a polymeric release structure (see paragraph 0077-0079, microgel) comprising:
a readily soluble and thermostable (ReST) glucagon formulation (see paragraph 0077-0079: glucagon-loaded glucose responsive microgels);
at least one of glucose oxidase (see paragraph 0082: microgel has glucose-responsive moiety which is a glucose sensing molecule such as glucose oxidase), glucose oxidase derivative, or glucose oxidase analogue; and
a pH-responsive polymer (see paragraph 0078-0080, microgel has polymer that is responsive to pH; see paragraph 0039: alkalize conditions; and see paragraph 0101),
wherein the polymeric release structure swells and/or dissolves (see paragraph 0090: polymeric microneedle patch may be prepared from dissolvable or swellable materials) at a pH level of about 6 or greater (see paragraph 0094 and 0105: alkaline conditions means a pH of greater than 7), and
wherein glucagon is released from the polymeric release structure when the mammalian subject has a glucose concentration of about 100 milligrams per deciliter or less (see paragraph 0009: polymers containing glucose responsive moieties from secondary crosslinks in response to low glucose levels thereby causing shrinking of the microgel and rapid release of the blood glucose raising therapeutic agent; and see paragraph 0051 and 0075: glucose concentration of 100 mg/dL).
With respect to claim 6, all limitations of claim 1 apply in which Wu further discloses wherein the at least one of glucose oxidase, glucose oxidase derivative, or glucose oxidase analogue is incorporated into the pH-responsive polymer (see paragraph 0078-0082, microgel has polymer that is responsive to pH with glucose-responsive moiety which is a glucose sensing molecule such as glucose oxidase).
With respect to claim 7, all limitations of claim 1 apply in which Wu further discloses wherein the polymeric release structure further comprises at least one of catalase, catalase derivative, catalase analogue, or MnO2 (see paragraph 0038: catalase).
With respect to claim 8, all limitations of claim 1 apply in which Wu further discloses wherein the pH-responsive polymer comprises one of shellac, methyl acrylate-methacrylic acid copolymers, cellulose acetate phthalate, cellulose acetate succinate, hydroxypropyl methyl cellulose phthalate, hydroxypropyl methyl cellulose acetate succinate, polyvinyl acetate phthalate, methyl methacrylate-methacrylic acid copolymers, cellulose acetate trimellitate, or zein (see paragraph 0016-0017, 0031-0032).
With respect to claim 9, all limitations of claim 1 apply in which Wu further discloses further comprising: a hydrogel layer loaded with the at least one of glucose oxidase, glucose oxidase derivative, or glucose oxidase analogue and disposed on the pH-responsive polymer (see paragraph 0078-0082, microgel has polymer that is responsive to pH with glucose-responsive moiety which is a glucose sensing molecule such as glucose oxidase).
With respect to claim 14, all limitations of claim 1 apply in which Wu further discloses wherein the polymeric release structure is formed into a microneedle of a microneedle transdermal patch, wherein the glucagon is released from at least one of an interior bore of the microneedle or an outer surface of the microneedle (see paragraph 0077, microneedle patch composed of glucagon loaded glucose responsive microgels to delivery glucagon to user).
With respect to claim 15, all limitations of claim 1 apply in which Wu further discloses wherein the polymeric release structure is formed into an implantable structure configured to be implanted into the mammalian subject beneath a stratum cornea of the mammalian subject using a hypodermic needle or trocar (see paragraph 0077, microneedle patch composed of glucagon loaded glucose responsive microgels to delivery glucagon to user; and see paragraph 0028: administered to patient via subcutaneous injection).
With respect to claim 16, all limitations of claim 1 apply in which Wu further discloses wherein the polymeric release structure is formed into a microparticle configured to be implanted into the mammalian subject beneath a stratum cornea of the mammalian subject using a hypodermic needle or trocar (see paragraph 0077, microneedle patch composed of glucagon loaded glucose responsive microgels to delivery glucagon to user; and see paragraph 0028: administered to patient via subcutaneous injection).
With respect to claim 17, Wu discloses a method of delivering glucagon to a mammalian subject with a release structure comprising a readily soluble and thermostable (ReST) glucagon formulation contained within a pH-sensitive polymer that incorporates or is coated with at least one of glucose oxidase, glucose oxidase derivative, or glucose oxidase analogue and that swells and/or dissolves at a pH of about 6 or greater (see paragraph 0077, microneedle patch composed of glucagon loaded glucose responsive microgels to delivery glucagon to user; see paragraph 0090: polymeric microneedle patch may be prepared from dissolvable or swellable materials; and see paragraph 0082: microgel has glucose-responsive moiety which is a glucose sensing molecule such as glucose oxidase; and see paragraph 0094 and 0105: alkaline conditions means a pH of greater than 7)), the method comprising:
inserting the release structure in the mammalian subject or applying the release structure to skin of the mammalian subject (see paragraph 0077, microneedle patch composed of glucagon loaded glucose responsive microgels to delivery glucagon to user; and see paragraph 0028: administered to patient via subcutaneous injection),
wherein the at least one of glucose oxidase, glucose oxidase derivative, or glucose oxidase analogue catalyzes production of gluconic acid and hydrogen peroxide in the presence of glucose and oxygen, thereby keeping the pH of the pH-sensitive polymer below 6, in the presence of glucose and preventing release of the ReST glucagon formulation from the release structure (see paragraph 0075-0077: swelling or shrinking of glucagon loaded microgel at high glucose concentrations), and
wherein the pH of the pH-sensitive polymer rises above 6 in the absence of glucose, causing the pH-sensitive polymer to swell and/or dissolve, thereby releasing the ReST glucagon formulation from the release structure (see paragraph 0075-0077: swelling or shrinking of glucagon loaded microgel at low glucose concentrations).
With respect to claim 18, all limitations of claim 17 apply in which Wu further discloses wherein releasing the ReST glucagon formulation from the release structure occurs at a rate of about 1 mg in 30 seconds to about 1 mg in 4 hours (see paragraph 0075-0078 and 0113: rate of glucagon release).
With respect to claim 19, all limitations of claim 17 apply in which Wu further discloses wherein the release structure further comprises at least one of catalase, catalase derivative, catalase analogue, or MnO2 to catalyze production of oxygen from the hydrogen peroxide (see paragraph 0038: catalase).
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dimarchi (US 20120172295 A1).
With respect to claim 20, Dimarchi discloses a readily soluble and thermostable glucagon formulation (see paragraph 0059) consisting essentially of:
at least one of glucagon, a glucagon analog, or a glucagon derivative (see paragraph 0059, glucagon and excipient); and
an excipient (see paragraph 0059, glucagon and excipient)from the group consisting of benzoic acid, sodium carbonate, meglumine, sodium phosphate tribasic, myristyl sulfobetaine, Kollidon HS 15, dodecylphosphocholine, L- Glutamine, PIPES, or sodium succinate (see paragraph 0380: benzoic acid as excipient).
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.
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.
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.
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Dimarchi.
With respect to claim 2, all limitations of claim 1 apply in which Wu does not discloses wherein the ReST glucagon formulation consists essentially of an excipient and at least one of glucagon, a glucagon analog, or a glucagon derivative.
Dimarchi teaches a glucagon formulation with glucagon and an excipient (see paragraph 0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu with the teachings of Dimarchi to have added an excipient to the glucagon formulation because it would have resulted in the predictable result of adding a pharmaceutically acceptable carrier for the glucagon (Dimarchi: see [0059], [0379]-[0380]).
With respect to claim 3, all limitations of claim 2 apply in which Dimarchi further teaches wherein the ReST glucagon formulation comprises about 0.2 mg to about 2.0 mg of the at least one of the glucagon, the glucagon analog, or the glucagon derivative (see paragraph 0059: glucagon concentration of 0.0001 to 30.0 mg/ml).
With respect to claim 4, all limitations of claim 2 apply in which Dimarchi further teaches wherein the ReST glucagon formulation comprises about 10% to about 90% of the at least one of the glucagon, the glucagon analog, or the glucagon derivative (see paragraph 0029 and 0059: glucagon purity of between 1% and 100%).
With respect to claim 5, all limitations of claim 2 apply in which Dimarchi further teaches wherein the excipient comprises one or more of benzoic acid, sodium carbonate, meglumine, sodium phosphate tribasic, myristyl sulfobetaine, Kollidon HS 15, dodecylphosphocholine, L-Glutamine, PIPES, and/or sodium succinate (see paragraph 0380: benzoic acid).
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Patel (US 20030180352 A1).
With respect to claim 10, all limitations of claim 1 apply in which Wu does not specifically disclose wherein the pH-responsive polymer forms an enteric barrier film configured to swell and/or dissolve at the pH level of about 6 or greater.
Patel teaches an enteric barrier film (see paragraph 0273, enteric barrier film coating).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu with the teachings of Patel to have a polymer form an enteric barrier film because it would have resulted in the predictable result of providing a coating to seal a particle (Patel: see [0273]-[0275]).
With respect to claim 11, all limitations of claim 10 apply in which Patel further teaches wherein the enteric barrier film has a thickness of about 10 microns to about 400 microns (see paragraph 0273-0276: various levels or thicknesses of coats can be made with thin layers being made up of 20 microns).
With respect to claim 12, all limitations of claim 10 apply in which Patel further teaches wherein the at least one of glucose oxidase, glucose oxidase derivative, or glucose oxidase analogue is configured to catalyze production of hydrogen peroxide and gluconic acid in the presence of glucose and oxygen, thereby keeping the pH level below 6 and preventing the enteric barrier film from swelling or dissolving (see paragraph 0275: seal coating provides insulation from anti-catalyzed degradation).
With respect to claim 13, all limitations of claim 12 apply in which Wu further teaches wherein the polymeric release structure further comprises at least one of catalase, catalase derivative, catalase analogue, or MnO2 to catalyze production of oxygen from the hydrogen peroxide (see paragraph 0038: catalase).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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