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 .
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 06/26/2023, 08/22/2024, 01/09/2025, have been considered by the examiner.
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 1-12 and 16-18 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 1] 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). For purposes of examination, it is interpreted that “a dimple structure” and “wrinkles” are merely exemplary structures meeting the limitation of a “groove.”
[Claim 1] The claim recites the limitation of “the skin” and “the body” in the 6th and 7th lines of the claim. There is a lack of antecedent basis for these limitations in the claims. For purposes of examination, it is interpreted that the limitations should recite “a skin” and “a body.”
[Claim 1] The claim recites the limitation of “improved residence time” in the 6th line of the claim. The examiner is unable to determine the metes and bounds of the claim, since the term “improved” is a relative term which renders the claim indefinite. The term “improved” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the term “residence time” has been rendered indefinite. For purposes of examination, it is interpreted that any soluble microneedle meets the limitations of the claim.
[Claim 4] The claim recites the limitation of “the average size” in the 1st line of the claim. There is a lack of antecedent basis for this limitation in the claims. For purposes of examination, it is interpreted that the limitation should recite “an average size.”
[Claim 6] The claim recites the limitation of “a hormone” in the 3rd line of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if this recitation of “a hormone” is the same or different from the recitation in claim 1. For purposes of examination, it is interpreted that the limitation is the same as the recitation of claim 1 and should recite “the hormone.”
[Claim 8] The claim recites the limitations of “the solid content ratio,” “the weight ratio,” and “the spray dryer,” in the 1st, 2nd, and 3rd, lines of the claim, respectively. There is a lack of antecedent basis for these limitations in the claims. For purposes of examination, it is interpreted that the limitations should recite “a solid content ratio,” “a weight ratio,” and “a spray dryer.”
[Claim 11] The claim recites the limitations of “the shape” and “the needle part” in the 1st line of the claim. There is a lack of antecedent basis for these limitations in the claims. For purposes of examination, it is interpreted that the limitations should recite “a shape” and “a needle part.”
[Claim 12] The claim recites the limitations of “the length” and “the needle part” in the 1st line of the claim. There is a lack of antecedent basis for these limitations in the claims. For purposes of examination, it is interpreted that the limitations should recite “a length” and “a needle part.”
[Claims 2-12 and 16-18] The claims are rejected based upon their dependency from independent claim 1.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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 1-5, 9-12, and 16-18, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kwon (PGPub 2009/0035446).
[Claims 1-3 and 16-18] Kwon teaches a transdermal microneedle path (figure 6, item 600) comprising microneedles (figure 4a, item 400; “SSPP system”) comprising surface-modified (figure 4b) microspheres (figures 4a/4c, items 402/404) containing a drug (paragraph [0053]),
wherein the drug is a hormone (leuprolide) (paragraphs [0069], [0100]), the surface-modified microspheres (figures 4a/4c, items 402/404) are biodegradable (paragraph [0011]) and have a surface on which grooves such as a dimple structure or wrinkles (figure 4b, via item 405) are formed (figure 4b), and
the microneedles (figure 4a, item 400) are soluble (paragraph [0011]) in the skin and have improved residence time in the body (paragraph [0011]),
which is for treatment and alleviation of prostate cancer, breast cancer, endometriosis, uterine leiomyomas, or precocious puberty (the examiner notes the limitation does not provide for any additional structure; as such, the product taught by Kwon would meet this functionality).
[Claims 4 and 12] Kwon teaches the limitations of claim 1, upon which claims 4 and 12 depend. In addition, Kwon discloses the average size of the microspheres (figures 4a/4c, items 402/404) is 50 µm or less (paragraph [0054]) and the length of the needle part of the microneedles is 500 to 1,000 µm (paragraph [0054]).
[Claim 5] Kwon teaches the limitations of claim 1, upon which claim 5 depends. Kwon also discloses the microspheres (figures 4a/4c, items 402/404) are prepared by any one method of solvent evaporation method, spray drying method, and sonication method (paragraphs [0016], [0059]).
[Claim 9 and 10] Kwon teaches the limitations of claim 1, upon which claims 9 and 10 depend. Kwon further teaches the soluble material that forms the microneedles (figure 4a, item 400) is a mixture of alginic acid (alginate) (paragraph [0060]) and trehalose (paragraph [0061]).
[Claim 11] Kwon teaches the limitations of claim 1, upon which claim 11 depends. Kwon also teaches the shape of the needle part of the microneedles (figure 4a, item 400) has any one of a conical, pyramidal, spear-shaped, truncated, wedge-shaped, or blade-shaped (figures 4a and 6).
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 (i.e., changing from AIA to pre-AIA ) 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 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 6-8 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 Kwon (PGPub 2009/0035446).
[Claims 6-8] Kwon teaches the limitations of claim 5, upon which claims 6-8 depend. The examiner notes that the claims are directed to product-by-process limitations for preparing the claimed microspheres. However, the product taught by Kwon appears to be substantially identical to the product claimed upon which said limitations depend. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020). "[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JASON E FLICK/Primary Examiner, Art Unit 3783 12/28/2025