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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it does not describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. For example, a key aspect of the claimed invention is the process of cross-linking specific materials under specific conditions and the application of microneedling, but the Abstract is silent to any of these features. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 24 is objected to because of the following informalities: The phrase “the first crosslinkable entity comprises a crosslink moiety” is repetitive due to the amendments made to claim 1; accordingly, the phrase the first crosslinkable entity comprises a crosslink moiety, and” should be removed from lines 1-2. The phrase “the crosslink moiety” on lines 2-3 lacks proper antecedent basis since claim 1 now introduces two crosslink moieties; since it is clear that this is intended to refer to the crosslink moiety of the first crosslinkable entity, lines 2-3 should be amended to recite “the crosslink moiety of the first crosslinkable entity makes up 1-20 mol% of the first crosslinkable entity”. Appropriate correction is required.
Claim 53 is objected to because of the following informalities: The claim language is not in proper form. It is suggested to amend line 1 to recite “A method” and to amend lines 7-8 to recite “wherein the improvement [[that]] comprises” in order to be in proper form. Appropriate correction is required.
Double Patenting
The amendments filed 4/8/2026 overcome the double patenting rejection set forth in the last Office Action.
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.
Claims 1, 4-7, 10-14, 16-21, 25, 53 and 56-60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitragotri et al. (WO 2020/093022)1.
Re claim 1, Mitragotri discloses a method (Para 134, 217-218) of establishing a crosslinked material at an intradermal target site (Para 217, “porcine skin”), the method comprising steps of: (i) applying first and second crosslinkable entities to a skin location at a pH within a range of 3 ± 1% to 5 ± 1% (Para 190 states that “the system comprises a first formulation and a second formulation of sections 3.1-3.11 which are paired together so long as the crosslinkable entity of the first formulation can react with the cross-linkable entity of the second formulation to form a crosslinked material”; Section 3.2 (Para 193, Table 3.2) describes a first crosslinkable entity in the form of a lotion having a pH of 5.0 and comprising the crosslink moiety of HA-gly-CBT and Section 3.8 (Para 208, Table 3.8) describes a second crosslinkable entity in the form of a spray having a pH of 5.0 and comprising the crosslinking moiety of Cys-PEG-Cys Para 187 sets forth that Cys-PEG-Cys and HA-gly-CBT can react with each other to form a crosslinked material) and (ii) microneedling the skin location (Para 134, “skin is abraded with microneedles”), such that the crosslinked material becomes present at an intradermal target site (Para 218, since the degree of penetration into the porcine skin can be “assessed at one or more time points”), wherein: the first crosslinkable entity comprises a crosslink moiety which is or comprises cyanobenzothiazole (CBT), a CBT mimetic, or another molecule that reacts with either the -SH or the NH2 group of cysteine (“HA-gly-CBT”, Table 3.2); and (b) the second crosslinkable entity comprises a crosslink moiety which is or comprises cysteine (Cys) (“Cys-PEG-Cys”, Table 3.8).
Re claim 4, Mitragotri disclose that the crosslinked material becomes present within a time period of 1 minute to 1 hour (Para 218, “1, 4, 12, 24 and 48 hours”).
Re claim 5, Mitragotri discloses that the first crosslinkable entity comprises a polymer moiety and a weight averaged molecular weight of the polymer moiety prior to the applying step is within a range of 1kDa to 500kDa (Para 69).
Re claim 6, Mitragotri discloses that the weight averaged molecular weight of the polymer moiety prior to the applying step is within a range of 5 to 20 kDa (Para 69).
Re claim 7, Mitragotri discloses that the polymer moiety is hyaluronic acid (“HA”) polymer (Table 3.2).
Re claim 10, Mitragotri discloses that the first and second crosslinkable entities are applied simultaneously (Para 109, “administered simultaneously”).
Re claim 11, Mitragotri discloses mixing the first and second crosslinkable entities before the applying step (Para 109, “combined prior to or as they are administered”).
Re claim 12, Mitragotri discloses that the mixing step is performed 0 to 30 minutes before the applying step (Para 109, “within about 1 minute of administration”).
Re claim 13, Mitragotri discloses that the second cross linkable entity is applied after the first cross linkable entity (Para 111, “administered sequentially”).
Re claim 14, Mitragotri discloses that the microneedling is performed with a microneedle device having microneedles (Para 134, “skin is abraded with microneedles”).
Re claim 16, Mitragotri discloses that the microneedle device has 1 to 100000 microneedles (inherent in “microneedles” of Para 134; although Mitragotri does not disclose exactly how many microneedles are used, all possible numbers are covered by the claim since even a number larger than 100000 encompasses 100000; that is, if the total of microneedles was >100000, this total would still meet the claim limitation since any value over 100000 also includes 100000; that is, the claim does not limit the device to having at most 100000 microneedles).
Re claim 17, Mitragotri discloses that the microneedles have a length between about 100 pm and about 1000 pm (Para 253, “500 µm needles).
Re claim 18, Mitragotri discloses that the microneedle device is a dermaroller (Para 253, “dermaroller”).
Re claim 19, Mitragotri discloses that the intradermal site is epidermis or dermis (Para 101).
Re claim 20, Mitragotri discloses that the concentrations of the first and second crosslinkable entities are independently within a range of 0.1 to 100 mg/mL (Para 187, 15 mg/mL of HA-gly-CBT and 20 mg/mL of Cys-PEG-Cys).
Re claim 21, Mitragotri discloses that the second crosslinkable entity is Cysteine-PEG-Cysteine (Table 3.8).
Re claim 25, Mitragotri discloses that the crosslinked material is characterized that a weight averaged molecular weight of the crosslinked material at the intradermal target site is greater than a weight averaged molecular weight of the first crosslinkable entity (because the cross-linkable entity only forms a portion, not the entirety, of the cross-linked material).
Re claim 53, Mitragotri discloses in a method (Para 134, 217-218) of establishing a crosslinked material at an intradermal site (Para 217, “porcine skin”) by topical application of first and second crosslinkable entities to a skin location (Para 190 states that “the system comprises a first formulation and a second formulation of sections 3.1-3.11 which are paired together so long as the crosslinkable entity of the first formulation can react with the cross-linkable entity of the second formulation to form a crosslinked material”; Section 3.2 (Para 193, Table 3.2) describes a first crosslinkable entity in the form of a lotion having a pH of 5.0 and comprising the crosslink moiety of HA-gly-CBT and Section 3.8 (Para 208, Table 3.8) describes a second crosslinkable entity in the form of a spray having a pH of 5.0 and comprising the crosslinking moiety of Cys-PEG-Cys Para 187 sets forth that Cys-PEG-Cys and HA-gly-CBT can react with each other to form a crosslinked material) and microneedling the skin location (Para 134, “skin is abraded with microneedles”) such that the crosslinked material becomes present at an intradermal target site (Para 218, since the degree of penetration into the porcine skin can be “assessed at one or more time points”), wherein: (a) the first crosslinkable entity comprises a crosslink moiety which is or comprises cyanobenzothiazole (CBT), a CBT mimetic, or another molecule that reacts with either the -SH or the NH2 group of cysteine (“HA-gly-CBT”, Table 3.2); and (b) the second crosslinkable entity comprises a crosslink moiety which is or comprises cysteine (Cys) (“Cys-PEG-Cys”, Table 3.8), the improvement that comprises: contacting the first and second crosslinkable entities with one another at a pH within a range of about 3 to about 5 (Para 193 and 208 both disclose that the pH is 5.0).
Re claim 56, Mitragotri discloses that the microneedling is performed before and/or after the applying step (Para 134 states that the skin has been “pretreated to (e.g. promptly or immediately prior to) administration of a system”).
Re claim 57, Mitragotri discloses that the presence of the crosslinked material is determinable at the intradermal target site (Para 218).
Re claim 58, Mitragotri discloses that the first crosslinkable entity comprises a crosslink moiety which is CBT or a CBT-mimetic (Para 86).
Re claim 59, Mitragotri discloses that the second crosslinkable entity comprises a crosslink moiety which is or comprises D-Cys, L-Cys, or combinations thereof (Para 68 sets forth that Cys-PEG-Cys comprises D-Cys).
Re claim 60, Mitragotri discloses that the intradermal target site is epidermis, specifically stratum corneum (Para 101).
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mitragotri et al. (WO 2020/093022) in view of Pampalone et al. (PG PUB 2011/0009782).
Re claim 15, Mitragotri discloses all the claimed features except that the microneedle density of the microneedle device is within a range of about 20 to 150 microneedles/cm2. Pampalone, however, teaches a dermaroller 10 (Fig 1) having a microneedle density within a range of about 20 to 150 microneedles/cm2 (Para 64, “20 needles per square centimeter”) for the purpose of effective patient treatment (Para 64). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Mitragotri to provide the dermaroller with a microneedle density within a range of about 20 to 150 microneedles/cm2, as taught by Pampalone, for the purpose of effective patient treatment (Para 64).
Claims 23, 24 and 61 are rejected under 35 U.S.C. 103 as being obvious over Mitragotri et al. (WO 2020/093022).
Re claim 23, Mitragotri discloses all the claimed features except explicitly disclosing that a molecular ratio of the crosslink moiety of the first crosslinkable entity and the crosslink moiety of the second crosslinkable entity is within a range of 1:1 to 5:1. However, this molecular ratio is a result-effective variable. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Mitragotri to include a molecular ratio of the crosslink moiety of the first crosslinkable entity an the crosslink moiety of the second crosslinkable entity within a range of 1:1 to 5:1 since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Re claim 24, Mitragotri discloses all the claimed features except explicitly disclosing that 1-20 mol % of the first crosslinkable entity comprises the crosslink moiety. However, the mol % of crosslink moiety in a crosslinkable entity is a result-effective variable. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Mitragotri to include the first crosslinkable entity with 1-20 mol % of the crosslink moiety since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Re claim 61, Mitragotri discloses all the claimed features except explicitly disclosing that the weight averaged molecular weight of the crosslinked material at the intradermal target site is two, three, four, five, six, seven, eight, nine or ten times greater than the weight averaged molecular weight of the first crosslinkable entity. However, the ratio of the weight averaged molecular weight of the crosslinked material and the weight averaged molecular weight of the first crosslinkable entity is a result-effective variable. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Mitragotri to include the crosslinked material with a weight averaged molecular weight at the intradermal site of two, three, four, five, six, seven, eight, nine or ten times greater than the weight averaged molecular weight of the first crosslinkable entity since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Response to Arguments
Applicant's arguments filed 4/8/2026 have been fully considered.
The argument that the Abstract describes the disclosure sufficiently to assist readers in determining whether there is a need for consulting the full patent text for detail is not persuasive. MPEP 608.01(b) states “The content of a patent abstract should be such as to enable the reader thereof, regardless of his or her degree of familiarity with patent documents, to determine quickly from a cursory inspection of the abstract the nature and gist of the technical disclosure and that which is new in the art to which the invention pertains”, “A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains”, and “Where applicable, the abstract should include the following: […] if a process, the steps”. Additionally, the presence of claim 53 indicates that the patent is in the nature of an improvement and MPEP 608.01(b) also states “If the patent is in the nature of an improvement in old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement”. The current Abstract is a single sentence which recites “The present application describes the delivery, formulation and uses of systems comprising agents capable of penetrating skin”. This brief and vague abstract does not meet the requirements set forth in MPEP 608.01(b) as it does not convey to a reader that which is new in the art to which the invention pertains. Accordingly, the objection is maintained.
The argument that claim 53 is in proper form is not persuasive. The claim is not objected to because it is a Jepson-type claim (as Applicant appears to argue), but because it is grammatically incorrect. Accordingly, the objection is maintained.
The arguments directed to the 102(a)(1) rejections of claims 1 and 53 using Mitragotri are moot in view of the present rejections that utilize a different teaching of Mitragotri (based off Para 190) than was used in the last Office Action.
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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 A copy of this reference was provided by Applicant with the 1/5/2024 IDS. It is noted that although this reference shares some inventors with the present application, the reference includes an inventor not named in the present application (Spengler). Therefore, this reference qualifies as prior art under AIA 35 U.S.C. 102(a)(1) as there is no evidence of record that an exception under AIA 35 U.S.C. 102(b)(1) applies. See MPEP 2153 for further guidance.
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