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 .
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 1-2, 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Meng (CN 108272529 A) in view of Greener (US 20100100022 A1).
Regarding Claim 1, Meng discloses a brain protection pad comprising an artificial dura mater layer configured to cover brain exposed to an outside after craniotomy surgery (Fig 1-4 ¶[abstract][0034-0035] self adhesive patch having an artificial dura layer 1 used during cranial surgery), wherein the artificial dura mater layer includes: an artificial dura mater body having a predetermined area to cover the brain (Fig 1-4 ¶[abstract][0034-0035] artificial dura layer 1 is configured to cover and prevent damage to brain tissue);
Meng is silent regarding an incision part configured to allow the artificial dura mater body to expand in a direction perpendicular to an incision direction when the artificial dura mater body is partially incised.
However, Greener teaches a wound dressing comprising a plurality of incisions, thus from the same field of endeavor, wherein an incision part is configured to allow the dressing to expand in a direction perpendicular to an incision direction when the dressing is partially incised (Figs 1, 3 ¶[0079][0092] FIG. 1 demonstrates the extension of a slit, in three stages, under an extensive force, indicated by the arrows F, and in a direction perpendicular to the longitudinal axis of the slit. Fig 3 shows the lattice material having a plurality of slits) to increase the extensibility of the material without significant material waste (¶[0010]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Meng so that an incision part configured to allow the artificial dura mater body to expand in a direction perpendicular to an incision direction when the artificial dura mater body is partially incised, as taught by Greener to increase the extensibility of the material without significant material waste (as motivated by Greener ¶[0010]).
Regarding Claim 2, Meng is silent whether the incision part is provided as a plurality of incision parts, and the plurality of incision parts have parallel incision directions.
However, Greener teaches a wound dressing comprising a plurality of incisions, thus from the same field of endeavor, wherein the incision part is provided as a plurality of incision parts, and the plurality of incision parts have parallel incision directions (Fig 3 shows the lattice comprising a plurality of parallel slits) to increase the extensibility of the material without significant material waste (¶[0010]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Meng so that the incision part is provided as a plurality of incision parts, and the plurality of incision parts have parallel incision directions, as taught by Greener to increase the extensibility of the material without significant material waste (as motivated by Greener ¶[0010]).
Regarding Claim 5, Meng/Greener discloses an absorption layer disposed on one surface of the artificial dura mater layer, wherein the absorption layer includes an absorption body made of an absorption material (Figs 1-4 ¶[0041] artificial dura layer 1 may comprise a collagen sponge).
Regarding Claims 6, 7, and 8, The Examiner recognizes claim 6, 7, and 8 as "product-by-process" claims. Even 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 (see MPEP 2113).
As a product claim, Examiner has determined claims 6, 7, and 8 require the brain protection pad to comprise the following structural elements in addition to those in the claims from which they depend: an absorption body made from an absorption material having a thickness.
In the prior art rejection in this Office action, Examiner considers claims 6, 7, and 8 to be met when a reference teaches these structural limitations.
Regarding Claim 9, Meng is silent whether the absorption layer further includes an absorption body incision part formed to correspond to the incision part and formed by incising the absorption body such that the absorption body is unfolded along with the incision part when the incision part is unfolded.
However, Greener teaches a wound dressing comprising a plurality of incisions, thus from the same field of endeavor, wherein the absorption layer further includes an absorption body incision part formed to correspond to the incision part and formed by incising the absorption body such that the absorption body is unfolded along with the incision part when the incision part is unfolded (Figs 1, 3 ¶[0045-0046][0089-0092] slits are cut into a foam layer, creating the expanding lattice of Figure 3) to increase the extensibility of the material without significant material waste (¶[0010]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Meng/Greener so that the absorption layer further includes an absorption body incision part formed to correspond to the incision part and formed by incising the absorption body such that the absorption body is unfolded along with the incision part when the incision part is unfolded, as taught by Greener to increase the extensibility of the material without significant material waste (as motivated by Greener ¶[0010]). In combination, the sponge layer of Meng would comprise the plurality of slits taught by Greener.
Claims 3-4 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Meng (CN 108272529 A) in view of Greener (US 20100100022 A1), further in view of Locke (US 20210177662 A1).
Regarding Claim 3, Meng/Greener is silent whether the artificial dura mater layer further includes a wrinkle part formed by folding the artificial dura mater body and configured to allow the artificial dura mater body to expand in an unfolding direction.
However, Locke teaches a wound dressing, thus from the same field of endeavor, wherein the dressing includes a wrinkle part formed by folding the dressing and configured to allow the dressing to expand in an unfolding direction (Fig 7 ¶[0090-0091] ridges 134 are configured to allow the dressing to expand in an unfolding direction) in order to allow the dressing to expand without providing any resistance to stretching (¶[0091]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Meng/Greener to include a wrinkle part formed by folding the artificial dura mater body and configured to allow the artificial dura mater body to expand in an unfolding direction, as taught by Locke in order to allow the artificial dura mater body to expand without providing any resistance to stretching (as motivated by Locke ¶[0091]).
Regarding Claim 4, wherein the wrinkle part is formed by folding the artificial dura mater body in the incision direction: The combination of Meng/Greener teaches the incisions as set forth above for claims 1-2, and the combination of Meng/Greener/Locke teaches the wrinkle part as set forth above for claim 3.
In combination, Meng/Greener/Locke would have the wrinkle part formed by folding the artificial dura mater body in the incision direction in order to allow the artificial dura mater body to expand without providing any resistance to stretching (as motivated by Locke ¶[0091]).
Regarding Claim 10, Meng/Greener is silent whether the artificial dura mater layer further includes a wrinkle part formed by folding the artificial dura mater body and configured to allow the artificial dura mater body to expand in an unfolding direction, and the absorption layer further includes an absorption body wrinkle part formed to correspond to the wrinkle part and formed by folding the absorption body such that the absorption body is unfolded along with the wrinkle part when the wrinkle part is unfolded.
However, Locke teaches a wound dressing, thus from the same field of endeavor, wherein the dressing includes a wrinkle part formed by folding the dressing and configured to allow the dressing to expand in an unfolding direction (Fig 7 ¶[0090-0091] ridges 134 are configured to allow the dressing to expand in an unfolding direction) and the absorption layer further includes an absorption body wrinkle part formed to correspond to the wrinkle part and formed by folding the absorption body such that the absorption body is unfolded along with the wrinkle part when the wrinkle part is unfolded (Fig 7 ¶[0090-0091] ridges 134 are configured to allow the dressing including absorbent layer 106 to expand in an unfolding direction) in order to allow the dressing to expand without providing any resistance to stretching (¶[0091]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Meng/Greener to include a wrinkle part formed by folding the artificial dura mater body and configured to allow the artificial dura mater body to expand in an unfolding direction, and the absorption layer further includes an absorption body wrinkle part formed to correspond to the wrinkle part and formed by folding the absorption body such that the absorption body is unfolded along with the wrinkle part when the wrinkle part is unfolded, as taught by Locke in order to allow the artificial dura mater body to expand without providing any resistance to stretching (as motivated by Locke ¶[0091]).
Regarding Claims 11 and 12, Meng/Greener is silent whether a drug layer formed by coating one surface of the absorption layer with a drug, wherein the drug is an antibiotic agent or a hemostatic agent.
However, Locke teaches a wound dressing, thus from the same field of endeavor, wherein a drug layer is formed by coating one surface of the absorption layer with a drug (¶[0077] absorbent layer 106 may include drugs), wherein the drug is an antibiotic agent or a hemostatic agent (¶[0077] absorbent layer 106 includes an antimicrobial agent or other active agents to promote effective wound healing. Non-limiting examples of such active materials may include antimicrobial silver, silver oxidized regenerated cellulose (ORC) (e.g., approximately 25 wt % ionically bound silver), polyhexamethylene biguanide (PHMB), non-steroidal anti-inflammatory drugs such as acetaminophen, steroids, anti-inflammatory cytokines, anesthetics, antimicrobial agents such as penicillin or streptomycin, antiseptics such as chlorhexidine, growth factors such as a fibroblast growth factor (FGF), a platelet derived growth factor (PDGF), or an epidermal growth factor (EGF), and other therapeutic agents, individually or in any combination.) to promote effective wound healing (¶[0077]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Meng/Greener to include a drug layer formed by coating one surface of the absorption layer with a drug, wherein the drug is an antibiotic agent or a hemostatic agent, as taught by Locke to promote effective wound healing (as motivated by Locke ¶[0077]).
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Meng (CN 108272529 A) in view of Locke (US 20210177662 A1).
Regarding Claim 13, Meng discloses a brain protection pad comprising an artificial dura mater layer configured to cover brain exposed to an outside after craniotomy surgery (Fig 1-4 ¶[abstract][0034-0035] self adhesive patch having an artificial dura layer 1 used during cranial surgery), wherein the artificial dura mater layer includes: an artificial dura mater body having a predetermined area to cover the brain (Fig 1-4 ¶[abstract][0034-0035] artificial dura layer 1 is configured to cover and prevent damage to brain tissue).
Meng is silent regarding a wrinkle part formed by folding the artificial dura mater body and configured to allow the artificial dura mater body to expand in an unfolding direction.
However, Locke teaches a wound dressing, thus from the same field of endeavor, wherein the dressing includes a wrinkle part formed by folding the dressing and configured to allow the dressing to expand in an unfolding direction (Fig 7 ¶[0090-0091] ridges 134 are configured to allow the dressing to expand in an unfolding direction) in order to allow the dressing to expand without providing any resistance to stretching (¶[0091]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Meng to include a wrinkle part formed by folding the artificial dura mater body and configured to allow the artificial dura mater body to expand in an unfolding direction, as taught by Locke in order to allow the artificial dura mater body to expand without providing any resistance to stretching (as motivated by Locke ¶[0091]).
Regarding Claim 14, Meng/Locke discloses an absorption layer disposed on one surface of the artificial dura mater layer, wherein the absorption layer includes an absorption body made of an absorption material (Figs 1-4 ¶[0041] artificial dura layer 1 may comprise a collagen sponge).
Regarding Claim 15, Meng is silent whether the absorption layer further includes an absorption body wrinkle part formed to correspond to the wrinkle part and formed by folding the absorption body such that the absorption body is unfolded along with the wrinkle part when the wrinkle part is unfolded.
However, Locke teaches a wound dressing, thus from the same field of endeavor, wherein the absorption layer further includes an absorption body wrinkle part formed to correspond to the wrinkle part and formed by folding the absorption body such that the absorption body is unfolded along with the wrinkle part when the wrinkle part is unfolded (Fig 7 ¶[0090-0091] ridges 134 are configured to allow the dressing including absorbent layer 106 to expand in an unfolding direction) in order to allow the dressing to expand without providing any resistance to stretching (¶[0091]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Meng so that the absorption layer further includes an absorption body wrinkle part formed to correspond to the wrinkle part and formed by folding the absorption body such that the absorption body is unfolded along with the wrinkle part when the wrinkle part is unfolded, as taught by Locke in order to allow the artificial dura mater body to expand without providing any resistance to stretching (as motivated by Locke ¶[0091]).
Regarding Claim 16, Meng is silent regarding a drug layer formed by coating one surface of the absorption layer with a drug.
However, Locke teaches a wound dressing, thus from the same field of endeavor, wherein a drug layer formed by coating one surface of the absorption layer with a drug (¶[0077] absorbent layer 106 may include drugs) to promote effective wound healing (¶[0077]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Meng so that a drug layer is formed by coating one surface of the absorption layer with a drug, as taught by Locke to promote effective wound healing (as motivated by Locke ¶[0077]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781