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.
Claim 6 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 6 recites the limitation "the microneedle" in line 5. 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 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.
Claim(s) 1, 4-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (US 20180289616 hereinafter “Chen”).
Regarding Claim 1, Chen teaches (Fig 2) a transdermal microneedle patch (1) containing poly-lactic acid (PLA) microneedles that are easily absorbable into skin, the microneedle patch comprising (See [0063]):
at least one needle base (12) disposed to protrude on a surface of the microneedle patch while having a patch layer as a flat layer (11), and made of hyaluronic acid (HA) (See [0056-0057] teaching 11, 12 are made of hyaluronic acid); and
a needle tip (13) disposed on an upper surface of the needle base, separated from the needle base by being inserted into a dermis layer of the skin (See [0068] teaching 13 is separable from 11; also see [0064] teaching 13 is able to penetrate dermal layer of skin), and made of the PLA, a biodegradable polymer (See [0063] teaching 13 made of polylactic acid).
Regarding Claim 4, Chen teaches the microneedle patch of claim 1, wherein the needle base (12) and the needle tip (13) are coupled to each other by physical adsorption or adhesion, chemical adsorption, or adhesion (see [0026] "The adhesive is disposed on each of the dissolvable supporting structures to stick with each of the corresponding degradable carriers.", the dissolvable supporting structures are the base 12, and the carriers are needle tips 13)
Regarding Claim 5, Chen teaches the microneedle patch of claim 1, wherein a microneedle composed of the needle base (12) and the needle tip (13) is provided in a conical shape (See [0062] teaching a cone shape) with a diameter of 300 μm or less ([0064] teaches the width being 100 -500 μm, preferably 200-400μm) and a length of 300 to 800 μm (see [0064] teaching height of 12 and 13 each being in a range between 200-1000 μm, in the case where 12 is 200 μm and 13 is also 200 μm, the total length is 400 μm which is within the recited range of the instant claim).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 20180289616) in view of Taylor et al. (US 20220296866 hereinafter “Taylor”)
Regarding Claim 2, Chen teaches all elements of claim 1 as described above. Chen does not specify the microneedle patch wherein the PLA, a biodegradable polymer, is characterized by after adding 0.01 ~ 0.5 g of epidermal growth factor (EGF) to 0.1 ~ 0.5 g of PLA and dissolving in 10 ㎖ of dichloromethane (DCM) as an organic solvent, mixing same with 50 ㎖ of 1 wt% poly vinyl alcohol (PVA) solution, and then mixing the prepared PLA microparticles with a size of 30 ~ 150 ㎛ with 3 wt% carboxylic methyl cellulose (CMC) solution. However, this limitation is considered a product by process limitation. The recitation of “the PLA, a biodegradable polymer, is characterized by after adding 0.01 ~ 0.5 g of epidermal growth factor (EGF) to 0.1 ~ 0.5 g of PLA and dissolving in 10 ㎖ of dichloromethane (DCM) as an organic solvent, mixing same with 50 ㎖ of 1 wt% poly vinyl alcohol (PVA) solution, and then mixing the prepared PLA microparticles with a size of 30 ~ 150 ㎛ with 3 wt% carboxylic methyl cellulose (CMC) solution” is the process of making a PLA microneedle tip. Since Chen already teaches the microneedle tips are made of PLA, it is interpreted that the Chen meets the recitations of this claim.
Furthermore, Taylor teaches a degradable microneedle array device which teaches using multiple materials such as PLA, PVA (see [0070]), DCM (See [0261]), EGF (see [0148], and CMC (see [0168]).
Since these are all materials well known in the field of art to be used in a degradable microneedle device, it would have been an obvious matter of design choice to a person having ordinary skill in the art before the effective filing date of the present invention to modify Chen to include the PLA, a biodegradable polymer, is characterized by after adding 0.01 ~ 0.5 g of epidermal growth factor (EGF) to 0.1 ~ 0.5 g of PLA and dissolving in 10 ㎖ of dichloromethane (DCM) as an organic solvent, mixing same with 50 ㎖ of 1 wt% poly vinyl alcohol (PVA) solution, and then mixing the prepared PLA microparticles with a size of 30 ~ 150 ㎛ with 3 wt% carboxylic methyl cellulose (CMC) solution since applicant has not disclosed that having the PLA, a biodegradable polymer, is characterized by after adding 0.01 ~ 0.5 g of epidermal growth factor (EGF) to 0.1 ~ 0.5 g of PLA and dissolving in 10 ㎖ of dichloromethane (DCM) as an organic solvent, mixing same with 50 ㎖ of 1 wt% poly vinyl alcohol (PVA) solution, and then mixing the prepared PLA microparticles with a size of 30 ~ 150 ㎛ with 3 wt% carboxylic methyl cellulose (CMC) solution solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design (the PLA recited in Chen compared to the instant recitation of PLA). Furthermore, absent a teaching as to the criticality of the PLA, a biodegradable polymer, is characterized by after adding 0.01 ~ 0.5 g of epidermal growth factor (EGF) to 0.1 ~ 0.5 g of PLA and dissolving in 10 ㎖ of dichloromethane (DCM) as an organic solvent, mixing same with 50 ㎖ of 1 wt% poly vinyl alcohol (PVA) solution, and then mixing the prepared PLA microparticles with a size of 30 ~ 150 ㎛ with 3 wt% carboxylic methyl cellulose (CMC) solution, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. Additionally, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 20180289616) in view of Francis et al. (US 20180333899 hereinafter “Francis”).
Regarding Claim 3, Chen teaches all elements of claim 1 as described above. Chen does not specify the microneedle patch wherein the PLA is poly-L-lactic acid (PLLA), poly-D-lactic acid (PDLA), and poly-D, L-lactide (PDLLA), and is characterized by using any one of or a mixture of any one or more of the PLLA, PDLA, and PDLLA.
Francis teaches [0056] PLLA is a known material used for microneedles in a patch device.
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 the microneedle patch of Chen such that the PLA is poly-L-lactic acid (PLLA) as taught by Francis. One of ordinary skill in the art would have been motivated to do so since it has been held that “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp”.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 20180289616) in view of トラウトマン (JP 2010516337 hereinafter “JP ‘ 337”) and シャーハン (JP 2005507708 hereinafter “JP ‘708”)
Regarding Claim 6, Chen teaches all elements of claim 1 as described above. Chen does not specify the microneedle patch wherein the microneedle patch is, after applied, rubbed on the skin for 5 to 10 minutes with an output of 0.1 to 5 W/cm2 using ultrasonic waves with a frequency in a range of 1 to 10 MHz to separate the needle tip from the needle base of the microneedle so that the PLA and an EGF permeate into the dermis layer in the skin.
JP ‘337 teaches (Pg. 14 third paragraph of translated copy) that microneedle patches could be vibrated at high ultrasonic frequencies to improve flow characteristics of the drug being delivered.
JP ‘708 teaches [0091] a known ultrasonic frequency is in the range of 0.1 – 20 MHz, with an output of 0.5 – 5 W/cm2 for a time ranging from 1-15 minutes.
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 the microneedle patch of Chen such that the microneedle patch is, after applied, rubbed on the skin for 5 to 10 minutes with an output of 0.1 to 5 W/cm2 using ultrasonic waves with a frequency in a range of 1 to 10 MHz to separate the needle tip from the needle base of the microneedle so that the PLA and an EGF permeate into the dermis layer in the skin as taught by JP ‘337 and JP ‘708. One of ordinary skill in the art would have been motivated to do so in order to improve the flow characteristics of the drug being delivered (JP ‘337 Pg 14 third paragraph and JP ‘708 [0091]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen (CN 114159551) teaches a microneedle patch made of HA, PLA and EGF.
Baek (US 20180243543) teaches a microneedle patch made of HA, PLA.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783