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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/09/2026 has been entered.
Response to Amendments
Regarding the previous claim objections, the amendments to claims 2 and 3 are acknowledged and the claim objections are withdrawn.
Response to Arguments
Applicant’s arguments, see pages 1-2, filed 06/09/2026, with respect to the rejection(s) of claim(s) 1 under Sjoberg and alternatively Barker in view of Sjoberg have been fully considered and are persuasive. The examiner agrees that Sjoberg fails to teach or suggest “wherein the blade carrier comprises a recess arranged to receive a drive pin of the dermatome such that oscillating motion of the drive pin causes reciprocating motion of the at least two blades of the dermatome blade assembly”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Barker in view of Zeevi (US 20100057100).
Claim Objections
Claims 2 and 4 are objected to because of the following informalities:
Claim 2, line 5: “said at least one blade” should recite “said at least one blade of the at least two blades”.
Claim 4, line 3: “at least one of the two blades” should recite “the at least one blade of the at least two blades”.
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 7 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 7 recites the limitation "the spacer element" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the spacer element” is interpreted as “the at least one spacer element”.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Such claim limitation(s) is/are:
a) “blade connecting means for connecting each of the at least two blades to the blade carrier” in claims 1-3. The limitation describing the “means for connecting each of the at least two blades to the blade carrier” in claim 1 fails to include sufficient structure to perform the recited function of "connecting". In the specifications, the “blade connecting means” is further defined structurally as a cylindrical projection used to connect the blades to the blade carrier in para. 0026-0027 of the instant application. However, “Other suitable cross-sectional shapes of the projections are also encompassed in the present disclosure” as stated in para. 0027 of the instant application. Therefore, the limitations will be interpreted as a cylindrical projection or any equivalent structure thereof that functions to connect the blades to the blade carrier.
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.
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.
Claim(s) 1-10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Barker et al. (US 20090157095) [hereinafter Barker] in view of Zeevi (US 20100057100).
Regarding claim 1, Barker discloses a dermatome blade assembly 20 (Fig. 1, para. 0021), comprising:
a blade 24 (Fig. 2, para. 0021) including a cutting edge 28, a rear edge spaced from the cutting edge, and two side edges joining the cutting edge and the rear edge (see annotated Fig. 2 below, para. 0021), wherein the blade 24 comprises at least one throughgoing aperture (interpreted as the apertures that retain pins 52, 54) (Fig. 2, para. 0024); and
a blade carrier 26 including a main body extending in a transverse direction (Fig. 2, para. 0021-0022) and blade connecting means (interpreted as pins 52, 54, see 112(f) interpretation above) for connecting each of the at least two blades to the blade carrier (Fig. 2, para. 0024);
wherein the blade carrier 26 comprises a recess 34 arranged to receive a drive pin 30 of a dermatome such that oscillating motion of the drive pin causes reciprocating motion of the blade of the dermatome blade assembly (para. 0022, 0024).
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Annotated Fig. 2 of Barker
However, Barker fails to disclose at least two blades and that the oscillating motion of the drive pin causes reciprocating motion of the at least two blades.
Zeevi in the same field of endeavor of surgical cutting devices for cutting skin grafts (para. 0019: “the present invention which includes a multiple bladed surgical knife 10 for scoring of a hair-laden skin strip from a donor's scalp. This donor strip is subsequently removed from a donor's scalp and cut into individual grafts for transplantation to a donee's scalp”) teaches that it is known in the art to comprise at least two blades 50 (para. 0019: “As shown in FIGS. 1 and 2, the multiple bladed surgical knife 10 includes a handle 32, a pair of surgical blades 50, and at least one spacer or spacing element 80 positioned between the pair of blades 50”). Zeevi further teaches that it is known in the art to utilize a pin 130 causes reciprocating motion of the at least two blades 50 (para. 0034: “As shown in FIG. 3, the pin 130 and the openings 60, 64, 90 and 110 cause the blade ends or tips 57 and the forward ends 82 of the spacers or spacing elements 80 to longitudinally shift to a plurality of positions in accordance with an exemplary embodiment”).
Since modified Barker discloses a single blade and a single drive pin, one skilled in the art would have readily recognized that providing the at least two blades, as taught by Zeevi, is known in the art of dermatomes and would result in the at least two blades oscillating by way of the single drive pin, in light of the teaching of Zeevi, since both the drive pin of Barker and the pin of Zeevi both extend perpendicular through a through-hole of the device to cause reciprocating motion of multiple blades during use; KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 2, modified Barker discloses wherein the blade connecting means 52, 54 extend from the main body (of blade carrier 26) in alignment with the at least one throughgoing aperture on the at least one blade of the at least two blades (see Fig. 2 of Barker, para. 0024: “The slots 44 and 46 respectively receive pins 52 and 54 that extend downwardly from a lower surface 56 of the blade assembly 20”), wherein the blade connecting means 52, 54 are arranged to be engaged with said at least one throughgoing aperture for connecting said at least one blade to the blade carrier 26 (see Fig. 2 of Barker).
Regarding claim 3, modified Barker discloses wherein the blade connecting means 52, 54 of the blade carrier 26 are in alignment with apertures of the at least one throughgoing aperture on each of the at least two blades (see Fig. 2 of Barker; see rejection above in claim 1 which modified Barker to include at least two blades to the device such that each blade would have apertures to attach to the Barker blade carrier), wherein the blade connecting means 52, 54 are arranged to be engaged with the respective apertures of the at least one throughgoing aperture on each of the at least two blades for connecting each of the at least two blades to the blade carrier 26 (see Fig. 2 of Barker).
Regarding claim 4, modified Barker discloses wherein the blade connecting means 52, 54 comprise at least one projection (see Fig. 2 of Barker which illustrates pins 52, 54 as cylindrical projections) arranged to be received in the at least one through-going aperture on at least one of the at least two blades (see Fig. 2 of Barker).
Regarding claim 5, modified Barker discloses wherein at least one of the at least two blades is integrally formed with or joined to the blade carrier by means of an adhesive, welding, crimping, moulding, soldering, brazing, or a combination thereof (para. 0021 of Barker).
Regarding claims 6 and 7, modified Barker discloses all of the limitations set forth above in claim 1. However, modified Barker fails to disclose at least one spacer element arranged to be mounted to the dermatome blade assembly in a position between each of the at least two blades to regulate a thickness of a skin graft cut by one of the at least two blades (claim 6), wherein the spacer element is adjustable (claim 7).
Zeevi further teaches that it is known in the art of multi-blade cutters to comprise at least one spacer element 80 arranged to be mounted to the dermatome blade assembly in a position between each of the at least two blades 50 to regulate a thickness of a skin graft cut by one of the at least two blades 50 (Figs. 1-2, para. 0019 of Zeevi: “the multiple bladed surgical knife 10 includes a handle 32, a pair of surgical blades 50, and at least one spacer or spacing element 80 positioned between the pair of blades 50. In accordance with an exemplary embodiment, the spacer or spacing element 80 limits the depth of penetration of the pair of surgical blades 50 into the scalp”), wherein the at least one spacer element is adjustable (para. 0030: “the pair of blades 50 (and the spacers or spacing elements 80) can be longitudinally shifted with respect to each other to a plurality of positions whereby the forward ends (or tips) 57 of the blades 50 (and the forward ends 82 of the spacers or spacing elements 80) form a plurality of different angled lines)”).
In light of this teaching, 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 blade assembly in modified Barker to include at least one spacer element, wherein the at least one spacer element is adjustable as taught by Zeevi in order to allow the user to adjust the thickness of the skin graft and the angle of the cut of the skin graft, thereby increasing the utility of the device (para. 0019, 0030 of Zeevi).
Regarding claim 8, modified Barker discloses all of the limitations set forth above in claim 1. However, modified Barker fails to disclose wherein a first, upper blade of the at least two blades is arranged offset from a second, lower blade of the at least two blades in a cutting direction of the dermatome blade assembly.
Zeevi further teaches that it is known in the art for a multi-blade cutting device to comprise a first, upper blade of the at least two blades 50 is arranged offset from a second, lower blade of the at least two blades 50 in a cutting direction of the dermatome blade assembly (see Fig. 3 of Zeevi, para. 0031 of Zeevi), as opposed to being arranged perpendicular to a longitudinal axis of the blade assembly (Fig. 1, para. 0030).
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 at least to blades in modified Barker to have an offset arrangement, as taught by Zeevi, such that “donor strips of uniform depth may be removed without damaging the follicles or injuring the donor” as discussed by Zeevi (see para. 0044).
Regarding claim 9, modified Barker discloses wherein the recess 34 of the blade carrier 26 is a through-going aperture arranged in a central position on the main body (as shown in Fig. 3 of Barker which illustrates the aperture 34 at a central position relative to the side edges of the main body of the blade carrier 26, para. 0022 of Barker).
Regarding claim 10, modified Barker discloses wherein each of the at least two blades are attached to a bottom side of the blade carrier (Figs. 3-4 illustrates the blade being attached to a bottom side of the blade carrier 26, para. 0021-0022 of Barker. The combination of Barker in view of Zeevi would result in a product wherein each of the at least two blades of Zeevi (Fig. 1, para. 0019 of Zeevi) are attached to the bottom side of the blade carrier of Barker (as shown in Figs. 3-4, para. 0021-0022 of Barker).
Regarding claim 15, modified Barker discloses a dermatome 10 comprising a dermatome blade assembly according to claim 1 (see Fig. 1, para. 0021 of Barker).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Barker et al. (US 20090157095) [hereinafter Barker] in view of Zeevi (US 20100057100) as applied to claim 1 above, and further in view of Depaz (US 20180161999).
Regarding claim 11, modified Barker discloses all of the limitations set forth above in claim 1. However, modified Barker fails to disclose wherein at least a first, upper blade of the at least two blades is attached to a top side of the blade carrier and at least a second, lower blade of the at least two blades is attached to a bottom side of the blade carrier.
Depaz in the same field of endeavor of blade assemblies teaches a blade assembly 100 (Fig. 1) comprising at least a first, upper blade 120 of at least two blades 120, 130 is attached to a top side of a blade carrier 130 and at least a second, lower blade 140 of the at least two blades 120, 130 is attached to a bottom side of the blade carrier 130 (Fig. 1, para. 0052-0053).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Depaz (i.e. attaching the upper blade to the top side of the blade carrier and attaching the lower blade to the bottom side of the blade carrier) to the dermatome blade assembly of modified Barker would have yielded predictable results, namely, a system that would positively interlock the pair of opposing blades in modified Barker since Depaz teaches it’s a known construction in the art (para. 0053 of Depaz).
Claim(s) 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Barker et al. (US 20090157095) [hereinafter Barker] in view of Zeevi (US 20100057100) as applied to claim 1 above, and further in view of Gratsias et al. (US 20070266564) [hereinafter Gratsias].
Regarding claim 12, modified Barker discloses all of the limitations set forth above in claim 1. Modified Barker further discloses one bottom plate 18 arranged below a lowermost blade of the at least two blades of the dermatome blade assembly (Fig. 2, para. 0021 of Barker). However, modified Barker fails to disclose further comprising at least one intermediate plate, arranged between each of the at least two blades of the dermatome blade assembly.
Gratsias teaches a razor blade assembly 3 comprising at least one intermediate plate 28, 29, arranged between each of at least two blades 25, 26 of the blade assembly (Fig. 3, para. 0031) and one bottom plate 2 arranged below the lowermost blade 25 of the blade assembly 3 (Fig. 5, para. 0102).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Gratsias (i.e. providing spacers/intermediate plates between the at least two blades) to the dermatome blade assembly of modified Barker would have yielded predictable results, namely, the spacers would provide a way to maintain a clearance between the blades, thereby facilitating consistent blade alignment (see Fig. 5, para. 0031 of Gratsias).
Regarding claim 13, modified Barker further discloses all of the limitations set forth above in claim 12. Modified Barker further discloses wherein a forward-facing lower surface of the at least one intermediate plate 28, 29 of Gratsias and the bottom plate 18 of Barker comprises a central recess (see annotated Fig. 3 of Barker and Fig. 3 of Gratsias).
However, modified Barker fails to disclose wherein a width of the central recess the transverse direction is shorter on the bottom plate than on the at least one intermediate plate.
A person having ordinary skill in the art, being faced with modifying the central recess of the at least one intermediate plate of modified Barker, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed dimension. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating simply “wherein an extension of the recess in the transverse direction is shorter on the bottom plate than on the at least one intermediate plate” in para. 0019 of the instant application and there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the width of the central recess along the transverse direction of modified Barker such that the bottom plate central recess is shorter than the central recess of the at least one intermediate plate as an obvious matter of design choice within the skill of the art.
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Annotated Fig. 3 Barker
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Annotated Fig. 3 of Gratsias
Regarding claim 14, modified Barker discloses wherein the central recess (annotated Fig. 3 of Gratsias) in the at least one intermediate plate 28, 29 extends from a front end (interpreted as the front surface of the intermediate plate) to a rear end (interpreted as the rear surface of the intermediate plate) of the at least one intermediate plate 28, 29 to form a cavity (see Fig. 3 of Gratsias) arranged to allow passage of a skin graft cut by a blade 25, 26 of the at least two blades arranged below the at least one intermediate plate (Fig. 5 of Gratsias; see note below).
Note: The limitation “arranged to allow passage of a skin graft cut by a blade 25, 26 arranged below the at least one intermediate plate” is interpreted as functional language. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Claim 14 is rejected in light of claim 13 (see 112(b) rejection above). The modification of claim 13 resulted in the central recess of the at least one intermediate plate being longer than the central recess of the bottom plate along the transverse direction. Since modified Barker includes all of the structure of claim 13 (as stated above) and 14 (i.e. the central recess of the at least one intermediate plate forming a cavity, see annotated Fig. 3 above of Gratsias) to necessitate the functional language, modified Barker also meets the functional limitation of the claim. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771