DETAILED ACTION
Receipt is acknowledged of applicant’s Supplemental Response to Restriction Requirement filed 7/21/2026.
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 .
Status of the Claims
Claims 1, 2, 5-10, 13-20 and 22-25 were previously pending. No new amendments have been made.
Election/Restrictions
Applicant’s election of Group I (claims 1, 2, 5-10 and 13-18) and species, a naturally occurring polymer - collagen (species A), a non-opioid analgesic - lidocaine (species B), and structure A (species C) in the reply filed on 7/21/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13, 14 and 19-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.
Accordingly, claims 1, 2, 5-10 and 15-18 are currently under examination.
Information Disclosure Statement
The IDS dated 6/14/2024 has been considered. A signed copy is enclosed herewith.
Specification
The use of the term Band-Aid®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 10 is objected to because of the following informalities: claim 10 recites,
“wherein said non-opioid analgesic is selected from procaine, chloroprocaine, oxybuprocaine, benzocaine, tetracaine, and-proxymetacaine, and their respective carbonic acid adducts; or wherein said non-opioid analgesic is selected from lidocaine, menivacaine, prilocaine, articaine, bupivacaine, ropivacaine, cinchocaine, etidocaine, and their respective carbonic acid adducts; or wherein said non-opioid analgesic is selected from acetylsalicylic acid, ibuprofen, diclofenac, naproxen, indomethacin, paracetamol, metamizol, phenazone, propyphenazone, parecoxib, celecoxib, etoricoxib, ketamine, capsaicin, ziconotide, cannabinoids, and flupirtine” (emphasis added). The claim recites 3 Markush groups reciting the same genus but different species. It is suggested that the Markush groups are merged together to form a single Markush group to improve readability and clarity.
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.
Claim 16 is 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 16 contains the trademark/trade name Band-Aid®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a bandage and, accordingly, the identification/description is indefinite.
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, 6-10 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lebreton (CN 102170856 A, Aug. 31, 2011, machine translation, hereafter as “Lebreton”).
The claimed invention is drawn to a three-dimensional biocompatible matrix comprising. a three-dimensional scaffold made of a polymeric agent (elected naturally occurring polymer - collagen), and at least one component selected from non-opioid analgesics (elected non-opioid analgesic - lidocaine), extracellular vesicles derived from animal cells, and artificially constructed lipid vesicles having a size in the range of from 20 nm to 150 nm, said at least one component being incorporated in said scaffold.
Regarding instant claims 1, 6-10 and 15, Lebreton teaches hyaluronic acid-based compositions comprising a therapeutically effective amount of at least one anesthetic agent, for example, lidocaine (abstract). In a particular embodiment, Lebreton teaches a hyaluronic acid, collagen, chitosan and lidocaine scaffold composition ([0048]-[0049], [0080], [0103]-[0104]). Lebreton teaches that the hyaluronic acid, collagen, chitosan and lidocaine mixture is homogenized ([0049]).
Thus, the teachings of Lebreton render the instant claims anticipated.
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.
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 1, 2, 5-10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ying et al. (WO 2007/095175 A2, Aug. 23, 2007, hereafter as “Ying”).
The instant claims are described above.
Regarding instant claims 1, 2, 5-10 and 15, Ying teaches injectable scaffolding materials, which comprise a zero-length cross-linking agent encapsulated in a thermo-responsive liposome dispersed in a polymer solution for tissue repair and regeneration and controlled delivery of an agent (abstract; claim 1). Ying teaches that the polymer solution comprises a collagen ([0007]; claim 3). Ying teaches the agent can be lidocaine ([00097]-[00098]). Ying teaches that the injectable scaffolding material solidifies (dimensionally stable) ([00039] and [00041]). It is noted that Ying does not require the scaffold to a spreadable semi-solid or liquid, a knitted fabric, woven or filaments. Ying further exemplifies a gel having a thickness of 1 mm ([000147]). Ying also teaches that any desired cells can be recruited to the scaffolding materials including fibroblasts and keratinocytes ([00092]).
Ying does not teach a particular embodiment combining all of the elements; however, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the particular polymer solution, collagen, with the particular agent, lidocaine, with a reasonable expectation of success because Ying teaches each component is suitable for the scaffolding material.
Thus, the teachings of Ying render the instant claims prima facie obvious.
Claims 1, 5-10, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mohanty et al. (US 2021/0322229 A1, Oct. 21, 2021, hereafter as “Mohanty”).
The instant claims are described above.
Regarding instant claims 1, 5-10, 15 and 16, Mohanty teaches wound healing dressings comprising one or more layers, wherein the one or more layers comprises a scaffold layer comprising an active agent and a water stable polymer (abstract; [0008]-[0011]). Mohanty teaches the particular water stable polymer, collagen ([0051]). Mohanty teaches the particular active agent, lidocaine ([0062]). Mohanty teaches that the water stable layer has a thickness that is optionally 0.1 μm or greater, optionally 0.5 μm, optionally 1 μm, optionally 2 μm, optionally 5 μm, optionally 10 μm, optionally 20 μm, optionally 50 μm, optionally 100 μm, optionally 200 μm, optionally 500 μm, or greater ([0047]). Mohanty illustrates a bandage having an adhesive layer ([0071]; Fig. 2). Said adhesive layer can be gas permeable (semi-permeable) and be made of any suitable material including latex, polyvinyl chloride, polyethylene, etc. which are known as solvent-impermeable materials ([0070]).
Mohanty does not teach a particular embodiment combining all of the elements; however, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the particular polymer solution, collagen, with the particular agent, lidocaine, with a reasonable expectation of success because Mohanty teaches each component is suitable for the scaffold layer in the wound healing dressing.
Regarding the scaffold/first layer thicknesses claimed in instant claims 5 and 17, it is noted that MEPP 2144.05 states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. Because the claimed range of 100 µm to 20 mm overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
Thus, the teachings of Mohanty render the instant claims prima facie obvious.
Claim 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mohanty et al. (US 2021/0322229 A1, Oct. 21, 2021, hereafter as “Mohanty”), as applied to claims 1 and 15 above, and further in view of JP H0648673 U (Jul. 5, 1994, hereafter as “JP ‘673”).
The instant claims are described above.
Mohanty teaches the elements discussed above.
Mohanty does not teach explicit thicknesses of the additional/adhesive layer (instant claim 17).
JP ‘673 teaches a wound dressing having an adhesive layer comprising polyvinyl chloride having a thickness of 50 microns (abstract; Examples).
Both references are drawn to wound dressings comprising an adhesive layer comprising polyvinyl chloride, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an adhesive layer comprising polyvinyl chloride having a thickness of 50 microns into the invention of Mohanty, as suggested by JP ‘673, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because JP ‘673 teaches that a thickness of 50 microns is suitable for an adhesive layer comprising polyvinyl chloride in a wound dressing.
Regarding instant claim 18, Mohanty further teaches a protective layer that is optionally included on the surface of the scaffold layer to protect the wound dressing prior to application to the skin of a subject (i.e., removable/releasable).
Thus, the combined teachings of Mohanty and JP ‘673 render the instant claim prima facie obvious.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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, Sue Liu can be reached on 571-272-5539. 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 https://ppair-my.uspto.gov/pair/PrivatePair. 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.
/CASEY S HAGOPIAN/Examiner, Art Unit 1617
