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 2, 4 and 7-8 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 pre-AIA the applicant regards as the invention.
Claim 2 recites the limitation “the biodegradable polymer” in line 1. There is insufficient antecedent basis for the limitation of “the biodegradable polymer” in the claim because claim 1 only recites “biodegradable molecule”.
Regarding claim 4, the phrase "such as" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Claim 7 is indefinite because the claim contains the trademark “Span 20” and “Span 80”. Generally, trademarks are not appropriate claim language because the mark identifies the product but not its composition. The composition of trademarked products can change with no notice.
Regarding claim 7, the parenthetical phrases “(Span 20)” and “(Span 80)” renders the claims indefinite because it is unclear whether the limitation(s) in the parentheses are part of the claimed invention.
Claim 8 is included in the rejection because it does not correct for the defect of the claim from which it depends.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Baek et al. (KR20190012397A Machine Translation) hereinafter Baek in view of Ameri et al. (US20050256045A1) hereinafter Ameri.
Regarding claims 1-15, Baek is drawn to a microneedle according to the disclosed invention comprises: preparing at least one tip portion which is capable of penetrating skin and includes a liquid medicine melted in the skin; preparing at least one guide portion for separating the tip portion which penetrated the skin; and mutually coupling at least one tip portion and the guider portion. The coupling step couples at least one of the tip portion and the guider portion to each other with a binding force smaller than a force that the skin grips the tip portion. In accordance with such a configuration, since the tip portion penetrating the skin can be separated immediately from the guide portion in a short time, the present invention has an advantage in terms of the supply of a fixed amount of the liquid medicine (abstract).
Baek discloses the biocompatible material hyaluronic acid (HA) [0021], the
water-soluble substance comprises sucrose [0030], a SPAN-type surfactant, polysorbate [0048], The active ingredient may include erythropoietin (peptide drug) [0072], waterproofing agent is castor oil [0075], and discloses vitamin E (d-α-tocopherol/Vitamin E) (an antioxidant) [0075].
Baek discloses The micro needle (1) manufactured as described above has a tip portion (2) made of a water soluble material combined with a base portion (6) and a guide portion (3) made of a water insoluble material [0076]. the frame of the tip part (2) may or may not contain a chemical solution, and if a chemical solution is contained, a temperature-sensitive chemical solution can be adjusted to suit the range and used.
At this time, it is preferable that the bonding strength between the tip part (2) and the guide part (3) be set to be high so that separation is easy using a high temperature of 30 to 200 or a low/ultra-low temperature of -200 to 0 [0077].
Baek does not explicitly disclose the presence of parathyroid hormone in a microneedle.
However, Ameri is drawn to Parathyroid hormone (PTH)-based agent is contained in a biocompatible coating that is applied to the microprojection member (abstract).
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Baek, wherein the microneedle comprises parathyroid hormone, as disclosed by Ameri, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Baek and Ameri are both in the field of microneedles comprising peptide active drug, and Ameri focuses on parathyroid hormone delivery with microprojections (abstract). Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANGLONG N TRUONG whose telephone number is (571)270-0719. The examiner can normally be reached on 8:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUANGLONG N TRUONG/Examiner, Art Unit 1615
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