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 Objections
Claims 9-10 objected to because of the following informalities:
Claim 9 recites, “wherein mating features include” and should be corrected to recite, “wherein the mating features include” to more clearly refer back to the previously defined “mating features” introduced in claim 7.
Claim 10 recites, “as mating features for receiving” and should be corrected to recite, “as the mating features for receiving” to more clearly refer back to the previously defined “mating features” introduced in claim 7.
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 10 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 10 recites, “wherein the bottom plate includes pairs of opposed posts” and it is unclear if these “posts” are the same post(s) introduced in claim 7, or whether this limitations seeks to introduce additional posts separate and distinct from those introduced in claim 7. For the purposes of examination, the “posts” of claim 10 are seen to refer to and further modify the “post” previously introduced in claim 7.
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.
Claim(s) 1-4-11, 14-15 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poyarekar (US 2024/0423659 A1).
Regarding claim 1, Poyarekar discloses:
A mesher for creating a repeating pattern of slits in a skin graft (see Fig. 1), comprising:
a bottom plate (bed 104, see Fig. 1A) having a support surface (template 110, see Fig. 1A) that engages the skin graft from below (see Abstract and Para. [0028]);
a top plate (support part 102, see Fig. 1A) having a holding surface that engages the skin graft from above (surface of support part 102; see Fig. 1A and Para. [0028]); and
a registration element (fasteners 108 and corresponding slots 108/108B, see Fig. 1A and Para. [0028] and [0030]-[0032]) shared between the top and bottom plates that sets and maintains a relative alignment of the plates (see Para. [0028] and [0030]-[0032]);
wherein the support surface includes an array of recesses defined by a column spacing and a row spacing (see Para. [0028] mentioning wherein template 110 comprises a mesh-like structure including cavities and slots therein which facilitate passage of blades to pass below the skin graft surface (i.e., by allowing the blade to penetrate into the template surface through the plurality of cutting grooves therein)), wherein the holding surface includes a plurality of parallel slots (cutting slots 114, see Fig. 1A and Para. [0028]); and
wherein the repeating pattern of slits in the skin graft is created by positioning the skin graft between the bottom and top plates (see Fig. 1A; see also Abstract and Para. [0028] mentioning wherein the tissue is placed on template 110 which is positioned between the top support portion and bottom bed), inserting a cutting blade into a slot of the top plate until it engages the skin graft, pulling the cutting blade through a length of the slot such that it preferentially cuts the graft between the recesses, and repeating the process of inserting and pulling for at least one additional slot (see Para. [0028]-[0032]).
However, while Poyarekar discloses wherein the template comprises slots and cavities configured to allow passage of a blade through the secured tissue (i.e., allowing the blade to pass through the tissue through the plurality of slots/cavities), Poyarekar does not provide a detailed description of the structure of these slots/cavities and thus does not expressly disclose wherein the plurality of parallel slots within the holding surface are spaced apart by the same lateral distance the separates each slot within the template.
Since Poyarekar provides a disclosure of wherein a blade passing through tissue would need to pass through both the cutting slots of the support part and the cutting slots of the template but does not provide a detailed disclosure pertaining to the alignment of the cutting slots of the template with the cutting slots of the support part, one of ordinary skill in the art would have modified the device of Poyarekar, as a matter of being “obvious to try” (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), to have obtained the predictable result of aligning the cutting slots of the support part and template with one-another such that they are spaced apart from one-another by a common lateral distance. Poyarekar provides ample disclosure to suggest these two cutting slots are aligned with one-another in their shared function (see Para. [0028]) to allow a cutting blade to pass along pre-defined paths to carve tissue such that one of ordinary skill in the art would expect the two sets of cutting slots to be aligned with one-another to facilitate and allow each cutting path to be smooth and unimpeded. Since there are only a finite number of possible arrangements that allow for this to occur (i.e., to align the cutting slots), one of ordinary skill in the art would expect the cutting slots of the support part and template to function appropriately should they be aligned and separated from adjacent cutting slots be a shared common lateral distance.
Regarding claim 2, Poyarekar discloses the invention of claim 1, Poyarekar further discloses wherein a spacing between adjacent recesses in a given row of recesses in the bottom plate is an integral multiple of a spacing between adjacent slots in the top plate (see Para. [0028]; the given spacing of slots/cavities within template may be expressed as an integral multiple of a spacing between adjacent cutting slots within the support portion).
Regarding claim 3, Poyarekar discloses all of the limitations of the invention of claim 1.
However, Poyarekar does not expressly disclose wherein there are about twice as many rows of recesses as there are recesses in a column of recesses.
While Poyarekar indicates wherein the template comprises cutting paths both laterally and longitudinally along the surface thereof (see Para. [0028]-[0032] mentioning wherein the top support part can be rotated to carve incisions within tissue at a 90 degree angle to an initial position, implying the template has cutting slots in both orientations), Poyarekar does not provide an express disclosure of how the cutting slots are arranged and thus does not expressly disclose wherein there are about twice as many rows of recesses as there are recesses in a column of recesses.
Since the claims do not describe how each “row” and “column” is defined, any number of slots can be interpreted to define a single “row” or column” and thus it appears that the device of Poyarekar would operate equally well with the claimed row-to-column ratio since the template comprises cutting slots extending both laterally (defining rows) and longitudinally (defining columns) with any number of sets of these “rows” and “columns” defining a single “row” or “column” (unless otherwise specified by the claims). Further, applicant has not disclosed that the ratio claimed solves any stated problem or is for any particular purpose, indicating that the plate of recesses “may have any suitable numbers of columns and rows and of recesses in each” (see Spec. Para. [0019]).
It would have therefore been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Poyarekar et al. to have about twice as many rows of recesses as there are recesses in a column of recesses because it appears to be an arbitrary design consideration which fails to patentably distinguish over Poyarekar et al.
Regarding claim 4, Poyarekar discloses the invention of claim 1, Poyarekar further discloses wherein there is a column of recesses in the bottom plate for each slot in the top plate (see Para. [0028]; since each slot/cavity within the template is aligned with a corresponding cutting path of the support part and configured to allow the blade to pass therethrough when cutting tissue along a set path, there would reasonably be an equal number of cutting slots within the template as there are cutting slots within the support portion since it is the function of the two pairs of cutting slots to allow a blade to pass therethrough; since the only way a blade would extend into the template would be to extend through a cutting path in the support part, the two sets of cutting paths would reasonably be aligned with one-another).
Regarding claim 5, Poyarekar discloses the invention of claim 1, Poyarekar further discloses the recesses having a diameter in the plane of the support surface (diameter of the cavities/slots within the template of Poyarekar are along the plate of the bed within which the template is disposed, see Fig. 1A).
However, Poyarekar does not provide an express disclosure of relative dimensions of the cutting slots and thus does not expressly disclose wherein the diameter of the recesses is at least approximately equal to a lateral separation between slots in the top plate.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to cause the cutting slots within the template of Poyarekar et al. to have a diameter equal to the lateral separation between cutting slots within the top support part since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, since each slot/cavity within the template is configured to allow the blade to pass therethrough when cutting tissue (see Para. [0028]), having an equal number of cutting slots within the template as there are cutting slots within the support portion would cause the two sets of cutting slots to be spaced spart by a common diameter of separation (i.e., each cutting slot within the template would correspond to a cutting slots within the support portion). The resulting device would not operate differently with the claimed template cutting slot diameter since it is the expressly disclosed function of these cutting slots to allow the cutting blade to pass through the surface of the template to carve tissue placed thereon and would thus require the cutting slots within the template to at least be somewhat aligned with the cutting slots of the top support part. Further, applicant places no criticality on the relative diameters of the two sets of recesses claimed, indicating simply that the diameter, shape and sizes of the cutting array can have any suitable sizes (see Specification Para. [0013]).
Regarding claim 6, Poyarekar discloses the invention of claim 1, Poyarekar further discloses wherein recesses in immediately adjacent rows and columns are offset from one another (since two slots cannot be in the same place at the same time, adjacent cutting rows would be offset from one-another).
Regarding claim 7, Poyarekar discloses the invention of claim 1, Poyarekar further discloses wherein the registration element includes mating features in the top and bottom plates (apertures 108A and 108B, see Fig. 1A and Para. [0028])
Regarding claim 8, Poyarekar discloses the invention of claim 7, Poyarekar further discloses wherein the mating features include a post in the bottom plate and a corresponding aperture configured to receive the post in the top plate (when secured together, fasteners 108 extend through apertures 108A and 108B; see Fig. 1A and Para. [0028] and [0030]-[0032]).
Regarding claim 9, Poyarekar discloses the invention of claim 8, Poyarekar further discloses wherein the bottom and top plates being at least substantially rectangular with four corners (see Fig. 1A), wherein mating features include four posts (four fasteners 108, see Fig. 1A) in the bottom plate (when secured together, the fasteners extend through slots 108A and 108B; the fasteners are thus part of the bed while extending through slots 108A in the support portion) and a corresponding four apertures in the top plate (108A, see Fig. 1A), and wherein the posts and apertures are respectively positioned at or adjacent the four corners (see Fig. 1A).
Regarding claim 10, Poyarekar discloses the invention of claim 9, Poyarekar further discloses wherein the bottom plate includes pairs of opposed posts (fasteners 108, see Fig. 1A) that can function as supports for the mesher when turned down and as mating features for receiving the apertures in the top plate when turned up (see Para. [0028] and [0030]-[0032]; fasteners 108 act as support to secure the bed and support portion when mated within slots 108A and 108B).
Regarding claim 11, Poyarekar discloses the invention of claim 1, Poyarekar further discloses wherein the recesses and slots are precisely located relative to the registration element (see Fig. 1A).
Regarding claim 14, Poyarekar discloses all of the limitations of the invention of claim 1.
However, Poyarekar does not expressly disclose relative dimensions of the top support part and the bottom bed and thus does not expressly disclose wherein an area of the top plate is larger than an area of the bottom plate.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the top support part of Poyarekar et al. to have an area that is larger than that of the bottom bed since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Poyarekar et al. would not operate differently with the claimed relative diameters and so long as the top support part maintains its fastening elements and central location of cutting slots, the top support part serves no other function purpose than to provide a compression pressure to the underlying tissue graft and would thus function equally well should the top support art have an area that is larger than the bottom bed portion (see Para. [0028]-[0032]). Further, applicant places no criticality on the relative dimensions claimed, indicating simply that the bottom and top plate “may” have any suitable dimensions (see Spec. Para. [0022] without providing and disclosed benefit to the larger top plate).
Regarding claim 15, Poyarekar discloses the invention of claim 1, Poyarekar further discloses wherein the mass of the top plate is sufficient to allow the top plate to apply pressure to the skin graft that holds the graft in place during meshing (see Para. [0028] mentioning wherein the support part applies a pressure to the harvested tissue adhered to the template).
Regarding claim 18, Poyarekar discloses the invention of claim 1, Poyarekar further discloses wherein the top plate includes at least one handle feature (sides of the support portion, see Fig. 1A) to facilitate placing the top plate over the bottom plate before meshing and removing the top plate from the bottom plate after meshing (see Fig. 1A and Para. [0028]-[0032]).
Regarding claim 19, Poyarekar discloses the invention of claim 1, Poyarekar further discloses:
A kit for meshing a skin graft (see Fig. 1), comprising:
the mesher of claim 1 (see Fig. 1); and
at least one of a dermatome, an additional bottom plate, and a cutting blade (see Fig. 2 showing a scalpel blade 202).
Regarding claim 20, Poyarekar discloses the invention of claim 1, Poyarekar further discloses:
A method of creating a meshed skin graft, comprising:
harvesting a section of tissue from a patient (see Abstract mentioning wherein the skin used within the device of Poyarekar is post-harvested skin);
placing the graft between the bottom plate and top plate of the mesher of claim 1 (skin is placed on template 110 positioned between support portion 102 and bed 104; see Fig. 1A and Para. [0028]);
inserting a cutting blade through a slot in the top plate and against the bottom plate (see Fig. 2 and Para. [0028]-[0032]);
pulling the cutting blade with a downward pressure along the slot for the length of the graft (see Fig. 2 and Para. [0028]-[0032]); and
repeating the steps of inserting and pulling for additional slots (see Fig. 2 and Para. [0028]-[0032]).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poyarekar (US 2024/0423659 A1) in view of Carey (US 2024/0016982 A1).
Regarding claim 12, Poyarekar discloses the invention of claim 1, Poyarekar further discloses wherein the bottom plate includes an at least substantially planar slab portion (see Fig. 1A) having opposed surfaces (radially-inward surface of template 110 and radially-outward surface of template 110, see Fig. 1A).
However, Poyarekar does not provide an adequate disclosure to reasonably suggest wherein each opposed surface includes an array of recesses and can function as a support surface for engaging a skin graft when turned up to receive the top plate.
In the same field of endeavor, namely meshing devices for expanding tissue grafts, Carey teaches a tissue graft expansion device (see Fig. 3C) comprising a bottom plate upon which a tissue graft is placed (surface 100, see Fig. 3C) to have a pressure applied thereto by a top roller (tool 250, see Fig. 3C and Para. [0052]-[0053]); wherein different tissue surfaces are provided within the system (see Figs. 1A-1C and Para. [0050] and [0052]-[0053]) to utilize different cutting edge arrangements and/or to have different tissue expansion ratio(s) depending on which cutting surface is utilized (see Para. [0050]-[0051]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the template of Poyarekar to comprise cavities and slots on both sides of the template having different geometric arrangements as taught and suggested by Carrey to, in this case, provide surfaces having different tissue expansion ratios that a user can easily interchange depending on which surface the tissue is pressed against (see Carrey Para. [0050]-[0051]). Since there are only a finite number of ways in which to include the various surfaces and their different expansion ratios (i.e., to have multiple templates or a single template with multiple expansion surfaces), one of ordinary skill in the art would have chosen from the two possible finite options to incorporate the teachings of Carrey into the device of Poyarekar as a matter of being obvious to try (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)) with both options being viable and interchangeable with one-another without undue experimentation to arrive at the benefit disclosed by Carrey.
Claim 13 the combination of Poyarekar and Carrey disclose the invention of claim 12, Poyarekar, as modified by Carrey, further discloses wherein a geometry of the array of recesses on each surface is different, such that the expansion ratios for skin grafts meshed on each surface is different (the cavities/slots of the template of Poyarekar, as modified by the teachings of Carrey, comprise different geometries to achieve the different expansion ratios; see Carrey Figs. 1A-1C and Para. [0050]-[0051]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poyarekar (US 2024/0423659 A1) in view of Ye (US 2019/0030742 A1).
Regarding claim 16, Poyarekar discloses all of the limitations of the invention of claim 1.
However, Poyarekar does not expressly disclose wherein the slots are uniquely indexed for the user to keep track of which slots have been used with a cutting blade.
The intended purpose of the claimed indexing of cutting slots is disclosed to be in aiding a user to keep track of which slots have been used with a cutting blade (see Spec. Para. [0035] Claims 28-29). In solving this problem, Ye teaches wherein a surgical device (guide tool 110, see Fig. 2) comprises a plurality of openings configured to receive a surgical device therein (see Fig. 2 and Para. [0028]) wherein each of the plurality of openings is provided with a unique visual indicator which reference the distance from an initial starting position (see Para. [0028]) to help a user discern one opening from another in relation to a starting reference point.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified each cutting slot within the top support part of Poyarekar to comprise a unique visual indicator as taught and suggested by Ye to, in this case, allow a user to discern one cutting path from another in regards to a starting reference point (see Ye Para. [0028]) which would help to prevent using an improper cutting slot during use.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poyarekar (US 2024/0423659 A1) in view of Eriksson (US 7708746 B2).
Regarding claim 17, Poyarekar discloses the invention of claim 1, Poyarekar further discloses wherein the bottom plate comprises a polymer (see Para. [0028] mentioning wherein the bed 104 is made of Teflon).
However, while Poyarekar discloses wherein the pressure-applying portion of the top support part is made from non-stick coatings such as Teflon (see Para. [0028]), Poyarekar does not expressly disclose a material used to form the main body of the top support part and thus does not expressly disclose wherein the top plate comprises a metal.
In the same field of endeavor, namely tissue meshers/expanders, Eriksson teaches wherein the main bodies of tissue expanding surfaces are formed from metal (see Col. 5, Lines 43-50).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the main body of the top support part of Poyarekar to be made from a metallic material as disclosed by Eriksson since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s
disclosure. See the attached PTO-892 Notice of Reference Cited. Specifically, US 12133662 B2, US 20230013045 A1, US 20190090897 A1, US 20150182242 A1, US 8978234 B2, US 20140039427 A1, US 20130204273 A1, US 5984936 A, US 3472228 A and US 3613242 A which all disclose surgical graft meshing devices comprising a pad with a plurality of cutting/expansion slots.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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/M.B.H./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771