DETAILED ACTION
The receipt is acknowledged of applicants’ amendment filed 03/11/2026.
Claims 2-19 previously presented.
Claims 2-10 are currently canceled and claim 20 is currently added. Claims 11-20 are pending.
Claims 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention I and species of invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/25/2025.
Claims 11-13 and 16-20 are subject of this office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/938,234, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. There is no adequate support for currently claimed “LEAP-2 peptide” in the parent application 16/938,234. Applicant first disclosed “LEAP-2 peptide” in the present application.
Thus, Applicant does not have sufficient support in the parent application to earn the priority date of the instantly claimed “LEAP-2 peptide”. Accordingly, the filing date of the present application, which is 07/24/2020, will be considered for examining instant claimed delivery device for “LEAP-2 peptide”.
Claim Rejections - 35 USC § 112 (a)
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claim recites “ghrelin blockers”. While the specification mention ghrelin blockers, however, nowhere applicants enumerate or describe any specific ghrelin blockers. What are drugs considered as ghrelin blockers? Mere indistinct terms (such as "ghrelin blocker" used herein), may not suffice to meet the written description requirement. This is particularly true when a compound is claimed in purely functional terms. See Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886 (CAFC 2004) at 1892, stating:
“The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. Ghrelin blocker is a generic structural term not described even in terms of its function when combined with LEAP-2 peptide. Even description of what a material does, rather than of what it is, usually does not suffice .... The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. (Emphasis added).”
Conversely, a description of a chemical genus will usually comprise a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. See Univ. of Calf. V. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997). This is analogous to enablement of a genus under Section 112, ¶ 1, by showing the enablement of a representative number of species within the genus.
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 11-13 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of the article by Hanson et al. (Design of a topical antimicrobial peptide delivery vehicle for the treatment of acne vulgaris), and Lui et al. (US 108/0236215), both references are cited on PTO 892, and copy of Hanson reference is currently provided.
Applicant Claims
Claim 11 is directed to dermal patch, comprising:
a substrate;
a plurality of projections extending from the substrate and configured to be at least partially insertable into the skin,
at least one of Liver-Expressed-Antimicrobial peptide 2 (LEAP-2) and peptide and a LEAP-2 peptide fragment incorporated in at least one of said plurality of projections,
wherein said plurality of projections comprise a biocompatible material that is dissolved in the skin to allow release of said at least one of the LEAP-2 peptide and the LEAP-2 peptide fragment in the skin.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Hanson teaches antimicrobial peptides applied topically. LEAP-2 is an antimicrobial peptide. Microneedles used to facilitate the penetration of the topically applied peptides and by-pass stratum cornium layer. Microneedles consist of hundreds of micrometer-scale needles loaded with drug solution and placed on the skin to deliver the drug. Microneedles are provided in arrays of microneedles that customizable and flexible. Microneedles are used for transdermal and intradermal delivery of drugs to blood stream (see entire document; and in particular pages: 25, 37-38, 41).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Hanson teaches microneedles, Hanson however, does not teach the structure of the microneedles as claimed by claim 11 that comprises substrate, and dissolvable microneedles.
Liu teaches device comprising microneedle array projecting from a substrate to deliver active agent that are loaded into the microneedles to a patient through the skin (abstract; ¶¶ 0006-0008). The microneedles are made of dissolvable polymer that dissolve when inserted into skin and release the active agent (¶¶ 0009, 0014, 0015, 0052, 0053). The microneedle dissolve after separation from the substrate (¶¶ 0086, 0087). The dissolvable polymer includes carboxymethyl cellulose (¶ 0058). The active agent is incorporated in the microneedles within a matrix defined by a dissolvable polymer (¶ 0011). The active agents include proteins, and is present in amount of 0.001-15% (¶ 0018). Advantages of the microneedle arrays include increasing skin permeability for a variety of biological entities or active ingredients, permitting slow therapeutic release while reducing complications from localized or systemic diffusion, providing a large treatment area relative to a single-site injection, and creating less pain for a subject compared to hypodermic administration of an active material (¶ 0072).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to deliver antimicrobial peptide that may include LEAP using microneedles as taught by Hanson, and use the microneedle device taught by Lui comprising substrate and dissolvable microneedles. One would have been motivated to do so because Liu teaches proteins can be delivered from polymer matrix incorporated in microneedles that have the advantages of increasing skin permeability for the active ingredients, permitting slow therapeutic release while reducing complications from localized or systemic diffusion, providing a large treatment area relative to a single-site injection, and creating less pain for a subject compared to hypodermic administration of an active material. One would reasonably expect formulating device comprising substrate and polymer microneedles comprising antimicrobial peptides including LEAP-2 peptide that is delivered without pain to subject in need thereof.
Regarding claim 12 that at least some of the plurality of microneedles are configured to be fully inserted into the skin, this is taught by Lui.
Regarding the material of the microneedle as claimed by claim 13, Lui teaches the claimed carboxymethyl cellulose that is biocompatible.
Regarding the concentration of LEAP-2 peptide in the projections as claimed by claims 16-19, one having ordinary skill in the art would have determined the required concentration based on the desired intended use.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hansen and Lui as applied to claims 11-13, 16-19 above, and further in view of the article to Massadi et al. (“Ghrelin and LEAP-2: Rival in energy metabolism”, currently provided).
Applicant Claims
Claim 20 recites the dermal patch further comprises ghrelin blockers incorporated in at least one of the projections.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teaching of Hanson and Lui are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While the combination of Hanson and Lui teaches device comprising substrate and polymer microneedles comprising antimicrobial peptides including LEAP-2 peptide, the reference does not teach ghrelin blocker as claimed by claim 20.
Massadi teaches LEAP-2 has potential in the treatment of diseases involve dysregulation of ghrelin system because LEAP-2 has inhibitory action of ghrelin (see the entire document, and in particular 685, and 692).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide a device comprising substrate and polymer microneedles comprising antimicrobial peptides including LEAP-2 peptide as claimed by the combination of Hanson and Lui, and further add ghrelin blocker taught by Massadi to the device because Massadi desired to obtain ghrelin blocker effect that is provided by LEAP-2 peptide, therefore, one would reasonably expect enhancing the ghrelin blocker effect by LEAP-2 of Hanson by additionally adding another ghrelin blocker.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 03/11/2026have been fully considered but they are not persuasive.
Rejections Under 35 U.S.C. § 103
Applicants argue that Hanson is directed to designing a delivery vehicle for treating acne vulgaris, explicitly considered and then rejected the use of microneedles. A reference that teaches away from an invention is not a proper basis for an obviousness rejection.
In response to this argument, applicant’s attention is directed to the scope of the present invention that is directed to a product, and all the elements of the claimed product are taught by combination of the cited references. Hanson clearly teaches microneedles and does not teach anywhere not to use microneedles. Further, the intended use of the product taught by Hanson to treat acne does not impart patentability to product claims. Not claims are not directed to method of use.
Applicants argue that Hanson considered microneedle arrays as a potential delivery method but concluded against their use for specific, technical reasons. In particular, Hanson expresses doubt that microneedles would be effective for the intended purpose of targeting the sebaceous gland. (Hanson, page 47, Section 4.2.1.4). Hanson teaching would directly discourage a person of ordinary skill in the art (POSA) from pursuing a microneedle-based approach for treating acne by delivering a peptide to the sebaceous gland. Instead of being motivated to combine Hanson with a microneedle technology like Lui, a skilled artisan would be motivated to look for other solutions, which is precisely what the authors of Hanson did, ultimately pursuing a serum- based design (Hanson, page 51, Section 4.3).
In response to this argument, it is argued that disclosed examples and preferred embodiments do not constitute a teaching away from broader disclosure or nonpreferred embodiments. Hanson clearly teaches the use of microneedles to deliver LEAP-2. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have “relatively acceptable dimensional stability” and “some degree of flexibility,” but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since “Gurley asserted no discovery beyond what was known in the art.” 27 F.3d at 554, 31 USPQ2d at 1132.). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Further, It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. As such, the examiner respectfully submits that there is motivation to combine the teaching of Hanson with Lui with reasonable expectation of success.
Furthermore, obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. V. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir. 1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. V. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Regarding dependent claims 16-19, applicants argue that these claims recite specific concentrations of the LEAP-2 peptide. The Examiner summarily concludes that a POSA "would have determined the required concentration based on the desired intended use." This conclusion is unsupported and ignores Hanson's explicit teachings on the challenges and dangers of AMPs. Even if a POSA were to ignore Hanson's teaching away from microneedles, there is no reason to believe that such a person would arrive at the concentrations in these claims for Acne treatment. Applicant notes in this regard that Hanson warns that a significant limitation of AMPs is their toxicity to human cells, (Hanson, page 28, Section 2.3.3).
In response to this argument, it is argued that Hanson clearly teaches and suggests microneedles, and Lui teaches the microneedles in more details regarding materials and structure, and teaches the advantages of using microneedles. “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the claimed concentrations. However, those of ordinary skill in the art would have been readily optimized effective dosages and concentrations as determined by good medical practice and the clinical condition of the individual patient. Determination of the appropriate dosage for treatment involving each of the above mentioned formulations would have been routinely made by those of ordinary skill in the art and is within the ability of tasks routinely performed by them without undue experimentation.
It is well settled that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007). The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
Applicants argue that the prior art combination is focused solely on treating acne. There is no suggestion or motivation in either Hanson or Lui to incorporate the LEAP-2 peptide at concentrations that would be useful for systemic effects such as appetite modulation, a purpose entirely unrelated to the topical acne treatment problem addressed by the prior art. the Examiner's combination of references is improper hindsight.
In response to this argument, it is argued that the present claims are directed to a product, and the intended use of the claimed product, that is not currently claimed, does not impart patentability to the product claims. It has been decided by the Courts that even in a case where the reference does not teach the same use of the composition, the two different intended uses are not distinguishable in terms of the composition, see In re Thuau, 57 USPQ 324; Ex parte Douros, 163 USPQ 667; and In re Craige, 89 USPQ 393.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, the examiner relied on what was known in the art prior to the present invention to construe the rejection, and not on applicant’s disclosure.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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