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 8 is objected to because of the following informalities: Line 3 recites the abbreviation “Cys” three times on line 3. Since “Cys” is known in the art to be the abbreviation for the amino acid “cysteine”, line 3 should be amended to recite “the –SH group or the NH2 group of cysteine (Cys)” since it is best practice to fully recite a term prior to using its abbreviation. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: The term “the” should be removed from the phrase “the concentrations” on lines 1-2 since this is the first time that “concentrations” have been introduced in the claim. 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 lines 1-2 to recite “A method of establishing a crosslinked material at an intradermal site by topical application of first and second crosslinkable entities, the method comprising” in order to be in proper form. Appropriate correction is required.
Claim 54 is objected to because of the following informalities: The claim language is not in proper form. It is suggested to amend lines 1-3 to recite “A method of establishing a crosslinked material at an intradermal site, by application of first and second crosslinkable entities, at least one of which is topically applied to a skin location, the method comprising”. Appropriate correction is required.
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 8, 19, 23 and 25 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 8 recites the abbreviation “CBT” twice on line 2. However, it is unclear as to what this abbreviation stands for since it is not defined in the claim and its definition would not be automatically known to one of ordinary skill in the art. Para 43 defines “CBT” as being an abbreviation for “cyanobenzothiazole”. Therefore, this is the interpretation applied for the sake of examination. Accordingly, it is suggested to amend lines 1-2 to recite “the first crosslinkable entity comprises cyanobenzothiazole (CBT), a CBT mimetic”.
Claim 8 recites “another molecule that reacts with either the –SH or the NH2 group of Cys (e.g., D-Cys, L-Cys, or combinations thereof)” on lines 2-3. However, the abbreviation “e.g.” (which stands for "for example") renders the claim indefinite because it is unclear whether the limitations following the abbreviation are part of the claimed invention (see MPEP § 2173.05(d)). For the sake of examination, the limitations following the abbreviation are not interpreted as being a part of the claimed invention; that is, the “another molecule” is not interpreted as being limited to only “D-Cys, L-Cys or combinations thereof”. Accordingly, it is suggested to delete the entire recitation located within the parentheses.
Claim 19 recites “epidermis (e.g., stratum corneum, stratum lucidum, stratum granulosum, stratum spinosum, stratum basale)” on lines 2-3. However, the abbreviation “e.g.” (which stands for "for example") renders the claim indefinite because it is unclear whether the limitations following the abbreviation are part of the claimed invention (see MPEP § 2173.05(d)). For the sake of examination, the limitations following the abbreviation are not interpreted as being a part of the claimed invention; that is, the “epidermis” is not interpreted as being limited to only “stratum corneum, stratum lucidum, stratum granulosum, stratum spinosum, stratum basale”. Accordingly, it is suggested to delete the entire recitation located within the parentheses.
Claim 23 recites “the first crosslink moiety and the second crosslink moiety” on line 2. These phrases lack proper antecedent basis since claim 1 (upon which claim 23 depends) does not introduce these “moieties”. It is unclear if claim 23 intended to refer to the first and second “crosslinkable entities” introduced on line 3 of claim 1 or if claim 23 intended to introduce first and second “crosslink moieties”. For the sake of examination, claim 23 is interpreted as intended to refer to the first and second “crosslinkable entities” introduced in claim 1. Accordingly, it is suggested to amend line 2 to recite “the first crosslinkable entity able entity
Claim 25 recites “(e.g., two, three, four, five, six, seven, eight, nine, ten times) greater” on lines 3-4. However, the abbreviation “e.g.” (which stands for "for example") renders the claim indefinite because it is unclear whether the limitations following the abbreviation are part of the claimed invention (see MPEP § 2173.05(d)). For the sake of examination, the limitations following the abbreviation are not interpreted as being a part of the claimed invention; that is, the amount by which the weight averaged molecular weight of the crosslinked material is greater than a weight averaged molecular weight of the first crosslinkable entity is not interpreted as being limited to only “two, three, four, five, six, seven, eight, nine, ten times”. Accordingly, it is suggested to delete the entire recitation located within the parentheses.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 9 requires the step of “applying to the skin location the first and second crosslinkable entities” but claim 1 (upon which claim 9 depends) already recites the step of “applying to a skin location first and second crosslinkable entities” on line 3. Therefore, claim 9 fails to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 8, 9 and 54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 12,311,048. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the present claims is fully disclosed in patented claim 13 (which depends from claims 1, 10 and 11). Regarding present claims 1,9 (which, as set forth in the 112(d) rejection above does not further limit claim 1) and 54, patented claim 1 requires a method comprising topically applying two crosslinkable entities to a skin location and crosslinking them to form a crosslinked material at an intradermal target site, patented claim 11 requires microneedling the location, and patented claim 13 requires the microneedling to be performed after the topical application. Regarding present claim 8, patented claim 1 requires one of the crosslinkable entities to comprise CBT.
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, 2, 4-14, 16-21, 25, 26 and 53-55 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 251-254) of establishing a crosslinked material (Para 254, “HA-gly-CBT”) at an intradermal target site (Para 254, “both the epidermis and the dermis”), the method comprising steps of: (i) applying to a skin location first and second crosslinkable entities that react to form a crosslinked material (Para 251, “HA-gly-CBT was applied to the surface of the skin”; Para 161 set forth that crosslinkable entities CBT-glycine and HA (hyaluronic acid) were combined and reacted to form the crosslinked material HA-gly-CBT); and (ii) microneedling the skin location after application of at least one of the crosslinkable entities (Para 251, “and the skin was then treated with a dermaroller (500 µm needle), rolling over the product 40 times”), such that the crosslinked material becomes present at an intradermal target site (Para 254, “a significant amount of HA-gly-CBT (50 kDa) was detected in both the epidermis and dermis after treatment with a dermaroller”).
Re claim 2, Mitragotri discloses that the first and second crosslinkable entities are at a pH within a range of about 3 to about 5 (Para 140 set forth that the entities are “combined in vitro under physiological conditions” and Para 47 sets forth that a pH of 6-8 defines “physiological conditions”; a pH of 6 is “about 3 to about 5” because Applicant discloses in Para [0060] that the term “about” may encompass a range of values that are within 25% or less of the referred value (resulting in the claimed pH range of “about 3 to about 5” encompassing a pH range of 2.25 – 6.25)).
Re claim 4, Mitragotri disclose that the crosslinked material becomes present within a time period of 1 minute to 1 hour (Para 140, “the first and second crosslinkable entities react with one another within a time period less than about 60 minutes”).
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 polymer (Para 161, “HA”).
Re claim 8, Mitragotri discloses that the first crosslinkable entity comprises CBT (Para 161, “gly-CBT”).
Re claim 9, Mitragotri discloses applying to the skin location the first and second crosslinkable entities (Para 251, “HA-gly-CBT was applied to the surface of the skin”).
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 253, “500 µm needles”).
Re claim 16, Mitragotri discloses that the microneedle device has 1 to 100000 microneedles (inherent in “needles” of Para 253; although Mitragotri does not disclose exactly how many needles the dermaroller has, 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 254, “both the epidermis and dermis”).
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 161, “HA (1 equiv.)” and “gly-CBT (0.18 equiv.)” in 10 mg/mL of water).
Re claim 21, Mitragotri discloses that the second crosslinkable entity is Cysteine-PEG-Cysteine (Para 241).
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 (Para 145, “a crosslinkable entity comprises HA and the amount of crosslinkable entity which penetrates after topical application on porcine skin will exceed the amount of natural HA at the same molecular weight”).
Re claim 26, Mitragotri discloses a method (Para 251-254) of establishing a crosslinked material (Para 254, “HA-gly-CBT”) at an intradermal target site (Para 254, “both the epidermis and dermis”), the method comprising steps of: (i) applying first and second crosslinkable entities to a skin location (Para 251, “HA-gly-CBT was applied to the surface of the skin”; Para 161 set forth that crosslinkable entities CBT-glycine and HA (hyaluronic acid) were combined and reacted to form the crosslinked material HA-gly-CBT) at a pH within a range of about 3 to about 5 (Para 140 set forth that the entities are “combined in vitro under physiological conditions” and Para 47 sets forth that a pH of 6-8 defines “physiological conditions”; a pH of 6 is considered to be “about 3 to about 5” because Applicant discloses in Para [0060] that the term “about” may encompass a range of values that are within 25% or less of the referred value, resulting in the claimed pH range of “about 3 to about 5” encompassing a pH range of 2.25 – 6.25); and (ii) microneedling the skin location (Para 251, “and the skin was then treated with a dermaroller (500 µm needle), rolling over the product 40 times”), such that the crosslinked material becomes present at an intradermal target site (Para 254, “a significant amount of HA-gly-CBT (50 kDa) was detected in both the epidermis and dermis after treatment with a dermaroller”).
Re claim 53, Mitragotri discloses a method (Para 251-254) of establishing a crosslinked material (Para 254, “HA-gly-CBT”) at an intradermal site (Para 254, “both the epidermis and dermis”) by topical application of first and second crosslinkable entities (Para 251, “HA-gly-CBT was applied to the surface of the skin”; Para 161 set forth that crosslinkable entities CBT-glycine and HA (hyaluronic acid) were combined and reacted to form the crosslinked material HA-gly-CBT), the method comprising: contacting the first and second crosslinkable entities with one another at a pH with a range of about 3 to about 5 (Para 140 set forth that the entities are “combined in vitro under physiological conditions” and Para 47 sets forth that a pH of 6-8 defines “physiological conditions”; a pH of 6 is considered to be “about 3 to about 5” because Applicant discloses in Para [0060] that the term “about” may encompass a range of values that are within 25% or less of the referred value, resulting in the claimed pH range of “about 3 to about 5” encompassing a pH range of 2.25 – 6.25).
Re claim 54, Mitragotri discloses a method (Para 251-254) of establishing a crosslinked material (Para 254, “HA-gly-CBT”) at an intradermal site (Para 254, “both the epidermis and dermis”), by application of first and second crosslinkable entities, at least one of which is topically applied to a skin location (Para 251, “HA-gly-CBT was applied to the surface of the skin”; Para 161 set forth that crosslinkable entities CBT-glycine and HA (hyaluronic acid) were combined and reacted to form the crosslinked material HA-gly-CBT), the method comprising: microneedling the skin location after the topical application of at least one of the crosslinkable entities (Para 251, “and the skin was then treated with a dermaroller (500 µm needle), rolling over the product 40 times”).
Re claim 55, Mitragotri discloses a combination (Para 140, “crosslinked material”) of first and second crosslinkable entities (Para 140, “first and second crosslinkable entities of a system […] react with one another […] to form a crosslinked material”), the combination having a pH within a range of about 3 to about 5 (Para 140 set forth that the entities are “combined in vitro under physiological conditions” and Para 47 sets forth that a pH of 6-8 defines “physiological conditions”; a pH of 6 is “about 3 to about 5” because Applicant discloses in Para [0060] that the term “about” may encompass a range of values that are within 25% or less of the referred value, resulting in the claimed pH range of “about 3 to about 5” encompassing a pH range of 2.25 – 6.25).
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) intended to be used after application of therapeutic material to a skin location (Para 3, “microstructures can be used to enhance penetration of compounds applied before […] treatment with the microstructures”; like the dermaroller of Mitragotri), the dermaroller 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 and 24 are rejected under 35 U.S.C. 103 as being obvious over Mitragotri et al. (WO 2020/093022).
Re claim 23, Mitragotri does not explicitly disclose that a molecular ratio of the first crosslink moiety and the second crosslink moiety is within a range of 1:1 to 5:1. However, Applicant discloses that this molecular ratio is a result-effective variable (as the ratio impacts the size of the produced crosslinked material, Para 215). 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 first crosslink moiety and the second crosslink moiety 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 that the first crosslinkable entity comprises a first crosslink moiety (Para 89, “CBT”) but does not explicitly disclose that 1-20 mol % of the first crosslinkable entity comprises the first crosslink moiety. However, Mitragotri discloses that the mol % of crosslink moiety in a crosslinkable entity is a result-effective variable (as the mol % of crosslink moiety in a crosslinkable entity imparts increased lipocity to the crosslinkable entity, Para 62). 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 first crosslink moiety since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Conclusion
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.