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 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 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.
Claims 1-26 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.
Regarding claim 1, the phrase “preferably” is being treated as indefinite, similar to how "for example" renders the claim indefinite, because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See, e.g., MPEP § 2173.05(d).
Claims 2-26 are similarly rejected by virtue of their dependency upon claim 1.
Regarding claim 10, the phrase “e.g.” (used twice in the claim) is the Latin abbreviation for “exempli gratia”, which is equivalent for "for example," and renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 11, the phrase “optionally” is being treated as indefinite, similar to how "for example" renders the claim indefinite, because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See, e.g., MPEP § 2173.05(d).
Claim 16 is unclear because it recites “the agent” in line 1. Claim 16 depends from claim 15. In claim 15, a therapeutic agent, a prophylactic agent, and a diagnostic agent were introduced into the claim. As such, it is unclear which “agent” claim 16 is meant to refer to.
The Examiner also notes that claim 17 depends from claim 16, and makes explicit reference to “the therapeutic agent” in line 1, suggesting that the instance of “agent” in claim 16 could possibly be “the therapeutic agent”.
Claim 17 is similarly rejected by virtue of its dependency upon claim 16.
Regarding claim 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 19 recites the limitation "the length" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites “a three-dimensional array of needles” in lines 1-2. It is unclear if the instance of “needles” is meant to refer back to the “plurality of microneedles” introduced in claim 1. Is the three-dimensional array of needles of claim 21 different than the plurality of microneedles introduced in claim 1?
Claim 25 recites the limitation "the skin” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 11, 15-18, 21-22 and 24-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2015/0182703 to Fohrman et al.
As to claim 1, Fohrman et al. discloses a microneedle device comprising
a plurality of microneedles (fibers 20) each having a base end and a tip (base attaches to substrate 50, tip end is opposite; see Fig. 7 and paragraph 133);
b) a substrate (substrate 50) to which the base end of the microneedle is secured or integrated (see Figs. 6A-7 and paragraph 133); and
c) an effective amount of liothyronine (LT3) or a salt thereof (paragraph 240) when administered transdermally (paragraphs 55, 87, 120) to maintain:
(i) stable serum levels of free or total T3, preferably total T3, T4, preferably free T4, or both,
(ii) normal serum free T3: free T4 ratio,
(iii) normal serum total T3: free T4 ratio,
(iv) normal serum levels of thyroid stimulating hormone (TSI), or
(v) a combination of (i), (ii), (iii), and (iv) (the Examiner is of the position that the recitation “to maintain: (i) stable serum levels of free or total T3, preferably total T3, T4, preferably free '4, or both, (ii) normal serum free T3: free T4 ratio, (iii) normal serum total T3:free T4 ratio, (iv) normal serum levels of thyroid stimulating hormone (TSI), or (v) a combination of (i), (ii), (iii), and (iv); “ is a functional recitation and the structure of the device of Fohrman et al. is fully capable of achieving the recited function. See MPEP 2114(II));
in a patient with hypothyroidism (paragraphs 119, 121, and 240), wherein the patient is not a pregnant female or a female planning to be pregnant (the Examiner is of the position that the recitation of “wherein the patient is not a pregnant female or a female planning to be pregnant” is an intended use recitation, and the structure of the device of Fohrman et al. is fully capable of achieving the recited intended use. See MPEP 2114(II)).
Regarding claim 2, Fohrman et al. discloses the claimed invention as discussed above concerning claim 1, and while Fohrman et al. does not expressly state that the amount of LT3 or salt thereof maintains stable levels of serum free or total T3, Fohrman et al. does disclose that the device of claim 1 comprises an effective amount of liothyronine (LT3) or a salt thereof (paragraph 240) when administered transdermally (paragraphs 55, 87, 120). The Examiner is of the position that the recitation “the amount of LT3 or salt thereof maintains stable levels of serum free or total T3 “is a functional recitation and the structure of the device of Fohrman et al. is fully capable of achieving the recited function. See MPEP 2114(II).
Regarding claim 3, Fohrman et al. discloses the claimed invention as discussed above concerning claim 1, and Fohrman et al. further discloses that the microneedle device is a controlled release device (sustained release; paragraph 272), an immediate release device (paragraph 271), or both (paragraph 272).
Regarding claim 4, Fohrman et al. discloses the claimed invention as discussed above concerning claim 1, and Fohrman et al. further discloses that the microneedle device is a controlled release device (sustained release; paragraph 272).
Regarding claim 5, Fohrman et al. discloses the claimed invention as discussed above concerning claim 1, and Fohrman et al. further discloses that the microneedles comprise LT3 or a salt thereof (paragraph 240).
Regarding claim 6, Fohrman et al. discloses the claimed invention as discussed above concerning claim 5, and Fohrman et al. further discloses that the microneedles comprise LT4 or a salt thereof (levothyroxine; paragraph 179; paragraph 123 indicates that one or more agents disclosed in Fohrman et al. can be used, concurrently or serially).
Regarding claim 11, Fohrman et al. discloses the claimed invention as discussed above concerning claim 1, and Fohrman et al. further discloses that the patient with hypothyroidism is optionally obese (the Examiner notes that the recitation of claim 11 is merely directed to function of the device, or an intended use, and that the recitations of claim 11 are not directed to any structure of the present invention. When the prior art apparatus teaches all the structural limitations of an apparatus claim, a recitation of function does not distinguish over the prior art since an apparatus claim covers what a device is, not what it does. A recitation directed to the manner in which a claimed apparatus is intended to be used does not differentiate the claimed apparatus from a prior art apparatus. See MPEP 2114(II)). As such, the Examiner is of the position that Fohrman et al. anticipates claim 11).
Regarding claim 15, Fohrman et al. discloses the claimed invention as discussed above concerning claim 1, and Fohrman et al. further discloses further comprising another agent (paragraph 177), wherein the agent is a therapeutic agent (analgesics, for example; paragraph 178), a prophylactic agent (agents for treating infections, for example, see paragraph 179), or a diagnostic agent (radioactive iodine; paragraph 241/fluorescein sodium is a fluorescent tracer; paragraph 260).
Regarding claim 16, Fohrman et al. discloses the claimed invention as discussed above concerning claim 15, and Fohrman et al. further discloses that the agent is selected from the group consisting of peptides (paragraph 122), proteins (paragraphs 29, 122), carbohydrates, nucleic acids (paragraph 122), lipids (glycolipids; paragraph 267), organic molecules (paragraph 122), biologically active inorganic molecules (paragraph 122), and combinations thereof (paragraph 177).
Regarding claim 17, Fohrman et al. discloses the claimed invention as discussed above concerning claim 16, and Fohrman et al. further discloses that the therapeutic agent is selected from the group consisting of non-peptide hormones including LT4, analogues of thyroid hormones, such as LT4 or LT3 N-methyl, LT4 or LT3 N-ethyl, LT4 or LT3 N-triphenyl, LT4 or LT3 N-propyl, LT4 or LT3 N- isopropyl, LT4 or LT3 N-tertiary butyl, 3,5- dimethyl-4-(4'-hydroy-3'- isopropylbenzyl)-phenoxy acetic acid (GC-I), 3,5- diiodothyropropionic acid (DITPA), tetraiodothyroacetic acid (TETRAC), and triiodothyroacetic acid (TRIAC), or their salts; antibiotics (antibiotics; paragraph 179); steroids (corticosteroids and other steroids; paragraphs 178, 202, 235-236); neuroactive agents (central and peripheral neuromuscular disorder agents; paragraph 178, 195); anesthetics (paragraph 266); and sedatives (paragraphs 179 and 182).
Regarding claim 18, Fohrman et al. discloses the claimed invention as discussed above concerning claim 15, and Fohrman et al. further discloses that the diagnostic agent is selected from the group consisting of radioactive isotopes; radioopaque agents; metals; gases; and labels including chromatographic, fluorescent, or enzymatic labels (radioactive iodine; paragraph 241/fluorescein sodium is a fluorescent tracer; paragraph 260).
Regarding claim 21, Fohrman et al. discloses the claimed invention as discussed above concerning claim 1, and Fohrman et al. further discloses further comprising a three-dimensional array of needles (paragraph 22 and Fig. 7).
Regarding claim 22, Fohrman et al. discloses the claimed invention as discussed above concerning claim 1, and Fohrman et al. further discloses further comprising an adhesive for securing the microneedle device during delivery (paragraph 282).
Regarding claim 24, Fohrman et al. discloses the claimed invention as discussed above concerning claim 1, and Fohrman et al. further discloses a method for delivering LT3 or salt thereof (paragraph 240) transdermally to a patient (paragraphs 119, 121) with hypothyroidism, comprising: providing the microneedle device of claim 1 (see rejection for claim 1 above).
Regarding claim 25, Fohrman et al. discloses the claimed invention as discussed above concerning claim 24, and Fohrman et al. further discloses further comprising placing the microneedle device on the skin of the patient (paragraphs 119, 121) with hypothyroidism (treatment using liothyronine; paragraph 240).
Regarding claim 26, Fohrman et al. discloses the claimed invention as discussed above concerning claim 24, and Fohrman et al. further discloses that the patient is a human or a veterinary patient (paragraph 119, 121).
Claim(s) 1 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2019/0105261 to Waugh et al.
Regarding claim 1, Waugh et al. discloses a microneedle device comprising
a) a plurality of microneedles each having a base end and a tip (microneedle; paragraph 174, 185, 232, 237, 341);
b) a substrate to which the base end of the microneedle is secured or integrated (microneedle; paragraph 174, 185, 232, 237, 341); and
c) an effective amount of liothyronine (LT3) or a salt thereof (paragraph 92, 95) when administered transdermally (paragraph 232, 237) to maintain:
(i) stable serum levels of free or total T3, preferably total T3, T4, preferably free T4, or both,
(ii) normal serum free T3: free T4 ratio,
(iii) normal serum total T3: free T4 ratio,
(iv) normal serum levels of thyroid stimulating hormone (TSI), or
(v) a combination of (i), (ii), (iii), and (iv) (the Examiner is of the position that the recitation “to maintain: (i) stable serum levels of free or total T3, preferably total T3, T4, preferably free '4, or both, (ii) normal serum free T3: free T4 ratio, (iii) normal serum total T3:free T4 ratio, (iv) normal serum levels of thyroid stimulating hormone (TSI), or (v) a combination of (i), (ii), (iii), and (iv); “ is a functional recitation and the structure of the device of Waugh et al. is fully capable of achieving the recited function. See MPEP 2114(II));
in a patient with hypothyroidism (paragraphs 119, 121, and 240), wherein the patient is not a pregnant female or a female planning to be pregnant (the Examiner is of the position that the recitation of “wherein the patient is not a pregnant female or a female planning to be pregnant” is an intended use recitation, and the structure of the device of Waugh et al. is fully capable of achieving the recited intended use. See MPEP 2114(II)).
Regarding claim 19, Waugh et al. discloses the claimed invention as discussed above concerning claim 1, and Waugh et al. further discloses that the length of the microneedles is between 10 µm and 1 mm, inclusive (0.3mm-2.5mm, which is equivalent to 300µm-2500µm; paragraph 237).
Regarding claim 20, Waugh et al. discloses the claimed invention as discussed above concerning claim 1, and Waugh et al. further discloses that the microneedles provide an insertion depth less than about 100 µm to 700 µm (0.3mm, which is equivalent to 300µm; paragraph 237).
Claim(s) 1, 7-10, 12 and 22-23 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Publication No. 2022/0296866 to Taylor et al.
Regarding claim 1, Taylor et al. discloses a microneedle device (paragraph 20) comprising
a) a plurality of microneedles (microneedle array; paragraphs 20, 64) each having a base end and a tip;
b) a substrate (patch of microneedle array; paragraphs 20, 64) to which the base end of the microneedle is secured or integrated; and
c) an effective amount of liothyronine (LT3) or a salt thereof (paragraph 131) when administered transdermally (paragraphs 3, 29) to maintain:
(i) stable serum levels of free or total T3, preferably total T3, T4, preferably free T4, or both,
(ii) normal serum free T3: free T4 ratio,
(iii) normal serum total T3: free T4 ratio,
(iv) normal serum levels of thyroid stimulating hormone (TSI), or
(v) a combination of (i), (ii), (iii), and (iv) (the Examiner is of the position that the recitation “to maintain: (i) stable serum levels of free or total T3, preferably total T3, T4, preferably free '4, or both, (ii) normal serum free T3: free T4 ratio, (iii) normal serum total T3:free T4 ratio, (iv) normal serum levels of thyroid stimulating hormone (TSI), or (v) a combination of (i), (ii), (iii), and (iv); “ is a functional recitation and the structure of the device of Taylor et al. is fully capable of achieving the recited function. See MPEP 2114(II));
in a patient with hypothyroidism, wherein the patient is not a pregnant female or a female planning to be pregnant (the Examiner is of the position that the recitation of “in a patient with hypothyroidism, wherein the patient is not a pregnant female or a female planning to be pregnant” is an intended use recitation, and the structure of the device of Taylor et al. is fully capable of achieving the recited intended use. See MPEP 2114(II)).
Regarding claim 7, Taylor et al. discloses the claimed invention as discussed above concerning claim 1, and Taylor et al. further discloses that at least one of the microneedles comprises biodegradable and/or biodissolvable compounds (paragraph 49-50).
Regarding claim 8, Taylor et al. discloses the claimed invention as discussed above concerning claim 7, and Taylor et al. further discloses that the biodegradable and/or biodissolvable compounds comprise polymers (paragraphs 49-50, 68-70), low molecular weight GRAS organics, or a combination of these.
Regarding claim 9, Taylor et al. discloses the claimed invention as discussed above concerning claim 7, and Taylor et al. further discloses that the biodegradable and/or biodissolvable compounds comprise polymers (paragraphs 49-50, 68-70).
Regarding claim 10, Taylor et al. discloses the claimed invention as discussed above concerning claim 9, and Taylor et al. further discloses that the polymers comprise polyvinyl pyrrolidone, polyvinyl alcohols, polysaccharides (e.g. hyaluronic acid, chitosan, cellulose, alginate); poly(esters) (e.g. poly(lactic acid), poly(glycolic acid), poly(lactide-co-glycolide), poly(caprolactones)); poly(orthoesters); polylysine; poly(ethylene imine); poly(acrylic acid); poly(urethanes); poly(anhydrides); poly(trimethylene carbonate); poly(ethyleneimine), poly(beta amino esters), and copolymers of these (paragraph 70).
Regarding claim 12, Taylor et al. discloses the claimed invention as discussed above concerning claim 1, and Taylor et al. further discloses further comprising a chemical permeation enhancer (CPE) (dermal and/or mucosal penetration enhancers; listed in paragraph 124).
Regarding claim 22, Taylor et al. discloses the claimed invention as discussed above concerning claim 1, and Taylor et al. further discloses further comprising an adhesive for securing the microneedle device during delivery (paragraph 64).
Regarding claim 23, Taylor et al. discloses the claimed invention as discussed above concerning claim 1, and Taylor et al. further discloses the substrate is flexible (paragraph 54).
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 of this title, 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.
Claim(s) 2 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Fohrman et al.
Regarding claim 2, Fohrman et al. discloses the claimed invention as discussed above concerning claim 1, and while Fohrman et al. does not expressly state that the amount of LT3 or salt thereof maintains stable levels of serum free or total T3, Fohrman et al. does disclose that the device of claim 1 comprises an effective amount of liothyronine (LT3) or a salt thereof (paragraph 240) when administered transdermally (paragraphs 55, 87, 120).
The Examiner is of the position that the recitation “the amount of LT3 or salt thereof maintains stable levels of serum free or total T3 “is a functional recitation and the structure of the device of Fohrman et al. is fully capable of achieving the recited function. See MPEP 2114(II).
Nonetheless, the Examiner is further of the position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the amount of LT3 or a salt thereof administered transdermally via the device of Fohrman et al. to maintain stable levels of serum free or total T3, as this would be considered “an effective amount of liothyronine” (paragraph 240).
Regarding claim 14, Fohrman et al. discloses the claimed invention as discussed above concerning claim 6, and Fohrman et al. further discloses that the microneedles comprise LT3 or a salt thereof (paragraph 240); that the microneedles comprise LT4 or a salt thereof (levothyroxine; paragraph 179) and paragraph 123 indicates that one or more agents disclosed in Fohrman et al. can be used, concurrently or serially.
Fohrman et al. does not expressly state that the LT4 or salt thereof is in the same microneedle with the LT3 or salt thereof, or a different microneedle from that with the LT3 or salt thereof.
However, the Examiner is of the position that there is sufficient disclosure in Fohrman et al. to teach or suggest that the LT4 or salt thereof is in the same microneedle with the LT3 or salt thereof, or a different microneedle from that with the LT3 or salt thereof because paragraph 240 discloses that the microneedles comprise LT3 or a salt thereof; paragraph 179 discloses that the microneedles comprise LT$ or a salt thereof (levothyroxine); and paragraph 123 indicates that one or more agents disclosed in Fohrman et al. can be used, concurrently or serially.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention that Fohrman et al. teaches or suggest that the microneedles administer both LT3 and LT4 (per the teachings of paragraphs 179, 240 and 123) and that the LT4 or salt thereof is in the same microneedle with the LT3 or salt thereof, since paragraph 123 discloses the administration of the one of more agents is concurrently or serially.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. in view of Dipierro et al. (US 2008/0220092 A1).
As to claim 13, Taylor et al. discloses the microneedle device of claim 12 as described above, but does not expressly recite wherein the CPE is anionic, cationic, zwitterionic, or nonionic.
Dipierro et al. teaches “Additional chemical permeation enhancers such as oleic acid, amino acids, oleyl alcohol, long chain fatty acids, ethoxydiglycol, sodium xylene sulfonate, ethanol, N-methylpyrrolidone, laurocapram, alkanecarboxylic acids, polar lipids, N-methyl-2-pyrrolidone, and the like, which increase the permeability of the skin to the active material and permit the active material to penetrate through the skin and into the bloodstream are also included. Included also are cationic, anionic and non-ionic surfactants and higher molecular weight aliphatic surfactants such as lauryl sulfate salts which change the surface state of the skin and active substance administered, concomitantly which have good percutaneous absorption” (para 0129).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used a CPE that is particularly cationic, anionic or non-ionic. One would have been motivated to do so Dipierro discloses such CPEs as effective for enhancing permeation (see paragraphs 0046, 0129, & 0821 of Dipierro).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783
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