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 .
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 21 May 2026.
APPLICANT’S ELECTION
Applicants’ election without traverse of Group I (Claims 23-40; drawn to a method of preparing an acellular skin substitute) in the reply filed on 21 May 2026 is acknowledged
Claim 41-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
CLAIMS UNDER EXAMINATION
Claims 23-40 have been examined on their merits.
PRIORITY
The Applicant claims priority to PCT/KR2021/001866, filed on 15 February 2021. A certified translation has not been provided.
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 24-37 and 40-41 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.
Regarding claim 24: The claim recites a “plurality of slits”. The claim also recites “a first imaginary line extending from the center of the base part of the center of the slit and a second imaginary line connecting the start and end points of the slit is 60-120 degrees”. Because the claim recites a plurality of slits, it is unclear which slit the claim is referring to when determining the recited degree. The metes and bounds of the claim are unclear. Appropriate correction is required. Claims 25-35 are included in this rejection because they depend from claim 24. For the purpose of examination, any degree is interested to read on the claim.
Claim 24 recites two imaginary lines. The term “imaginary” means lacking factual reality (Merriam Webster). It is unclear how two lines which are not real produce an angle of 60-120 degrees. It is unclear if the claimed degree is also imaginary. The metes and bounds of the claimed product are unclear because it recites imaginary structures which do not exist. Appropriate correction is required. Claims 25-35 are included in this rejection because they depend from claim 24.
Regarding claim 28: the claim recites “the protrusion”. The claim depends from claim 27. Claim 27 recites “one protrusion”…and “another protrusion”. It is unclear which protrusion claim 28 is referring (e.g., “one protrusion…” or “another protrusion”). Appropriate correction is required.
Regarding claim 29: the claim recites “the protrusion”. The claim depends from claim 27. Claim 27 recites “one protrusion”…and “another protrusion”. It is unclear which protrusion claim 29 is referring (e.g., “one protrusion…” or “another protrusion”). Appropriate correction is required.
Regarding claim 30: the claim recites “the protrusion”. The claim depends from claim 27. Claim 27 recites “one protrusion”…and “another protrusion”. It is unclear which protrusion claim 30 is referring (e.g., “one protrusion…” or “another protrusion”). Appropriate correction is required.
Regarding claim 31: the claim recites imaginary lines and shapes. The metes and bounds of the claimed product are unclear because it recites imaginary structures which do not exist. Appropriate correction is required. All dependent claims are included in this rejection.
Regarding claim 34: the claim recites the length of “the slit”. Claim 24 recites a “plurality of slits”. It is unclear which slit claim 34 is referring to. The metes and bounds of the claim are unclear. Appropriate correction is required.
Regarding claim 35: The claim recites the product made in claim 24 is used for breast reconstruction. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Regarding claim 35: There is a lack of antecedent basis for “the breast reconstruction implant”. The metes and bounds of the claim are unclear. Appropriate correction is required.
Regarding claim 36: The claim recites “preparing an ADM”. Because the claim does not recite “the ADM”, it is unclear if the claim is referring to the ADM recited in claim 23, or a different ADM. The metes and bounds of the claim are unclear. Appropriate correction is required. Claim 37 is included in this rejection because it depends from claim 36.
Claim 39 recites “the shape and size set by a design program”. There is a lack of antecedent basis for said program. It is unclear what the claim is referring to. Appropriate correction is required.
Claim 40 recites a “CNC” machine. It is unclear what the abbreviation means. The metes and bounds are unclear. Appropriate correction is required.
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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.
Claims 23, 36 and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Jessop et al. (Devices and methods for tissue cryomilling. US2018/0177919) and Sharma et al. (Chromosome Techniques (Third Edition) Chapter 4:Processing. Available online 21 October 2013, pages 71-90).
Jessop teaches a method for processing a soft tissue product ([0006]). The processed tissue include acellular dermal tissue matrices ([0023]). The art teaches cooling the soft tissue product while in contact with a support surface to freeze the soft tissue product, and contacting the soft tissue product with a cutting instrument while the soft tissue product is frozen ([0006] [0029]).The support in Figure 4a is interpreted to read on a plate.
The tissue product, while in contact with the support, can be cooled, thereby freezing the tissue product to produce a more solid and rigid tissue. A solid or rigid tissue will be more readily cut, or otherwise machined, to produce a desired surface or shape or configuration ([0041]).
The art teaches the following regarding temperature of the plate:
The degree of cooling selected is based on the tissue to be processed, the type of subsequent machine processing, and desired rate of cooling ([0044]).The support surface is maintained 5-10°C below the freezing point of the tissue to adequately remove the heat generated during freezing of the issue product and keep the tissue product solid ([0044]). The system may be configured to cool the tissue to between −30° C. and −80° C., but for tissues that have higher or lower freezing or glass transition temperatures the temperature may be altered ([0044]).
The deficiency of Jessop is the reference does not teach adding water onto the cooling plate to reach 20-150% of the ADM thickness before freezing.
In the section titled “Frozen section technique”, Sharma et al. teach the frozen section technique is based on the principle of freezing the tissue directly to harden it, and cutting sections while the tissue is frozen (first sentence; page 2 of Abstract). The art teaches the use of a microtome for cutting frozen sections (second paragraph of page ).
Sharma teaches trimming a piece of tissue, placing it “on a little water on the microtome table freezer to freeze the tissue to the table”, the temperature depending on the nature of the tissue. Tissues with compact cells should be frozen at about −10 to −15 °C while others can be cut at −20 to −30 °C (See third paragraph of page 2). Sharma teaches if a tissue is over frozen it cracks, but if it is under frozen too soft it may disintegrate (fourth paragraph if page 2).
It would have been obvious to add water to the cooling plate taught by Jessop. Jessop teaches cutting a frozen tissue on a cooling plate and Sharma teaches adding water to a cooling plate to freeze a tissue. Jessop teaches a solid or rigid tissue will be more readily cut. The skilled artisan would optimize the amount of water based on the size/thickness of the tissue to produce sufficient cutting by the cutting machine. One would have had a reasonable expectation of success since Sharma teaches water can be added to a freezing table of a cutting device.
It would have been obvious to maintain the cooling plate taught by Jessop at a temperature of -30°C -0°C. Sharma teaches tissues can be frozen between -10°C and - 30°C. Sharma teaches if a tissue is over frozen it cracks, but if it is too soft it may disintegrate. One would optimize the temperature based on the tissue type and desired rigidity for cutting. One would have expected similar results since Jessop and Sharma are both directed to methods of cutting frozen tissue. Because the claimed method is rendered obvious, the prepared ADM is suitable for the claimed intended use. Therefore claim 23 is rendered obvious.
Jessop teaches an acellular dermis. Acellular is interpreted to man cells have been removed. It is well known in the art that dermis is distinct from epidermis. Therefore an acellular dermis is interpreted to have the epidermis removed. Therefore claim 36 is included in this rejection.
Sharma teaches an apparatus to section cut within 5 hours (first sentence of page 3). claim 38 is rejected.
The art teaches a cutting instrument movable to a position near the support surface and capable of being horizontally translated over the support surface to machine a soft tissue product in contact with the support surface (claim 16 of Jessop) comprising a system for controlling movement of the cutting instrument to maintain the cutting instrument at a substantially uniform distance from the support surface while moving the cutting instrument horizontally over the support surface (see claim 19 of Jessop). This is broadly interpreted to read on a design program. Therefore claim 39 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claims 37 are rejected under 35 U.S.C. 103 as being unpatentable over Jessop in
view of Sharma as applied to claim 36 above, and further in view of
Richters et al. (Development of a dermal matrix from glycerol preserved allogeneic skin. Cell Tissue Bank 9, 309–315; 2008).
Claim 36 is rejected on the grounds set forth above. The teachings of the prior art are reiterated. Jessop teaches an acellular dermis. The art does not teach how the epidermis is removed.
Richter teaches a dermal substitute. The art teaches a cost-effective method using low concentrations of NaOH for the decellularization of skin (Abstract). Richter teaches it is effective in removing donor cells and hairs , which are antigenic structures which must be removed to avoid adverse inflammatory response after implantation (Abstract; page 310, right column second paragraph).
It would have been obvious to use sodium hydroxide to produce the acellular dermis taught by Jessop. One would do so to remove antigenic structures present in skin which may cause an adverse response as taught by Richter. One would have had a reasonable expectation of success since Richter teaches sodium hydroxide can successfully remove cells. One would have expected similar results since Jessop and Richter are both directed to acellular dermal products. Therefore claim 37 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Jessop in view of Sharma as applied to claim 23 above, and further in view of Huang et al. (Microtome knife. CN109693264A. 2019).
Claim 23 is rejected on the grounds stated above. The teachings of the prior art.
Jessop teaches a machine with a cutting blade (see claim 8 of Jessop). Jessop teaches the type of cutting machine is selected based on the type of tissue milling to be performed ([0045]). Sharma teaches a microtome with a knife (a cutting blade). The art is silent regarding the shape and size of the blade.
Huang teaches a microtome knife including a blade 4-8 mm thick with square or round shape (see Figure 1; see second to last paragraph of disclosure).
It would have been obvious to use a cutting device with a circular blade and a diameter of 0.1-5mm. Jessop and Sharma teach machines for frozen cutting and Sharma teaches the machine is a microtome. It would have been obvious to the person of ordinary skill in the art at the time of the invention was made to choose a blade with a round shape since Huang teaches the knife cam be round or square. KSR E. Huang teaches a knife with a diameter which overlaps with the claimed range. See MPEP 2133.03. Therefore, the examiner asserts the claimed concentration is prima facie obvious. Therefore claim 40 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claims 24-35 are rejected under 35 U.S.C. 103 as being unpatentable over Jessop in view of Sharma as applied to claim 23 above, and further in view of Young et al. (Size Adjustable Device to Cover and Secure Implantable Devices In Surgical Applications. US110909146 2021, filed 18 Jul 2019).
Claim 23 is rejected on the grounds set forth above. The teachings of the prior art are reiterated. Jessop teaches an acellular dermal product. The art teaches processing for use as a graft ([0022]) and suggests implantation ([0026]).
The art does not teach the features recited in claim 24.
Young teaches a size adjustable dermal matrix cover for enveloping an implantable device adapted for use with a breast implant (column 1, lines 17-20). The art teaches an acellular dermal matrix (column 3, lines 19-21; column 4, lines 34-35). Young teaches the cover has a circular base (see Figure 2). The art teaches multiple radially projecting fringes (hence, protrusions) which project outward from the base at different positions along the circumference of the base (see column 3, lines 22-25; column 4, lines 49-50; Figure 7 element 14). The plurality of fringes are folded inwardly to envelop an implantable device (column 4, lines 61-65). Any of the fringes not folded inwardly constitute a stabilization tab (element 16) (column 4, line 67 bridging line 2 of column 5). The fringes used for stabilization tabs are also interpreted to be protrusions.
The art teaches a plurality of radial cuts (hence, slits) (element 28; illustrated in Figure 7) divide the dermal matrix from the inner circle diameter and outer circular circumference to form the fringes (column 3, lines 49-54). Figure 7 illustrates each slit has a start and end point. The distance between the cuts (slits) illustrated in Figure 2 is interpreted to read on the claimed imaginary distance.
It would have been obvious to use the acellular dermal matrix taught by Jessop
to prepare the cover taught by Young. One would have been motivated to do so when making a cover for a breast implant. One would have had a reasonable expectation of success Therefore claim 24 is rendered obvious.
Regarding claim 25: Young teaches the cover may have a diameter of approximately twenty-five centimeters as measured between the outer circle circumference 22C. The inner circle 20 (see Figure 7) may have a diameter which is approximately one third the diameter of the outer circle 22. Examiner notes one third of 25 cm is 8.33 cm (divide 25 by 3). This reads on the range recited in claim 25.
Regarding claim 26: Young teaches a plurality of fringes (protrusions). As set forth above, the art teaches some fringes are folded to encase the implant and any which are not folded are used as stabilization tabs (protrusions). The art teaches any number of stabilization tabs can be created by excluding any of the fringes from the loop of suture thread (column 6, lines 26-27). The skilled artisan would optimize the number of projections based on the desired number of stabilization tabs required to secure the device. Therefore claim 26 is rendered obvious as claimed.
The fringes (tabs) illustrated in Figure 7 do not intersect. The fringes form a surface. Therefore claim 27 is included in this rejection.
Regarding claim 28: The area of the protrusions disclosed by Young increase a protruding direction. The only difference between the protrusions taught by Young and those which are claimed are the size. The claimed device is not patentably distinct MPEP 2144.04 IV A. Therefore claim 28 is included in this rejection.
Regarding claim 29: The claim is directed to a triangular shape. The lines of the protrusions taught by Young do not meet to form a triangle. Absent evidence to the contrary, a change in shape is obvious absent persuasive evidence that the particular shape is significant. MPEP 2144.04 IV B. Therefore claim 29 is rejected.
Regarding claim 30: Young teaches the fringe tips which can be trimmed in length to adjust for the diameter of the implantable device (column 6, lines 42-50). One would optimize the length of the fringe (protrusion) to adapt to the size of the implant. MPEP 2144.04 IV A. Therefore claim 30 is rendered obvious.
Regarding claim 31: The claim is directed to an imaginary triangular shape. Absent evidence to the contrary, a change in shape is obvious absent persuasive evidence that the particular shape is significant. MPEP 2144.04 IV B. Therefore claim 31 is rejected.
Young teaches a plurality of radial cuts (slits) which define the fringes (protrusions). (column 5, lines 45-47). The art teaches the use of a cutter which allows for variation in the number of fringes and stabilization tabs (protrusions) (column 5, lines 60-65). The art teaches the size and dimensions can be adjusted based on the size of the implant. The skilled artisan would optimize the number of slits on the desired number of fringes. Therefore claim 32 is rendered obvious.
The cuts (slits) taught by Young are interpreted to be straight lines. Claim 33 is included in this rejection.
Regarding claim 30: Young teaches a plurality of radial cuts (slits) which define the fringes (protrusions). (column 5, lines 45-47). Young teaches the fringe tips which can be trimmed in length to adjust for the diameter of the implantable device (column 6, lines 42-50). One would optimize the length of the slits based on the desired size of the protrusions. See MPEP 2144.04 IV A. Therefore claim 34 is rendered obvious.
Young teaches a size adjustable dermal matrix cover for enveloping an implant (supra). Figures 2 and 8 illustrate protrusions fixed with surgical threads. Therefore claim 35 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 270-8439.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
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