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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the recitation of the “middle section having a length and width with the length at least twice as long as the width” was not found in the written disclosure. Also the limitation of the “matrix having a length and a width, the length at least twice as long as the width” was not found in the specification.
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 1-19 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.
It is not understood in claim 1, how the "group of openings configured to alter the stretchiness and elasticity of the middle section varies from the stretchiness and elasticity of the first and second end sections that each have a cutout" because the entire support is a sheet of acellular tissue matrix. Thus the same material is used for the entire length of support and since the claim gives no indication that the percent of openings is not equivalent to the amount of material missing or absent to equal the cutout. In other words there is no evidence or indication in the claim that the percent of material missing for a cutout is not equal to the percent of material established for the entirety of openings, to thus establish an equivalent amount of for the middle section and an end portion so how can there be a difference in stretchiness and elasticity when the same material is present for all sections? Dependent claims carry the same issue as the independent.
The same issue is present for claim 10, as to how the "group of perforations configured to create a zone of stretchiness and elasticity that varies from the stretchiness and elasticity of the two anchoring sections, that each have a cutout" because the entire support is an acellular tissue matrix. Thus the same material is used for the entire length of tissue support and since the claim gives no indication that the percent of perforations is not equivalent to the amount of material missing or absent to equal the cutout. In other words there is no evidence or indication in the claim that the percent of material missing for a cutout is not equal to the percent of material established for the entirety of perforations, to thus establish an equivalent amount of for the zone of perforations and an anchoring section so how can there be a difference in stretchiness and elasticity when the same material is present for all sections? Dependent claims carry the problem of the independent. Dependent claims carry the same issue as the independent claim they depend on.
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.
Claim(s) 1-4,8-14,18,19 are rejected under 35 U.S.C. 103 as being unpatentable over Ringo (WO 2017/044682) in view of Malaviya et al. (WO 03/007784). Ringo discloses (paragraph 22) a sheet of acellular tissue matrix. Fig. 4 shows the sheet of acellular tissue matrix comprises a first end section, a second end section, and a middle section connecting the first and second (anchoring) end sections, wherein the middle section includes a group of openings (perforations) 20 spaced in multiple columns 90 along a length of the middle section and multiple rows 91 across a width of the middle section (zone) to alter the stretchiness and elasticity of the middle section (paragraph 7) to vary from the stretchiness and elasticity of the first and second end sections, since Ringo discloses (paragraph 34) to use no holes at the ends. Regarding claim 1, it can also be construed the middle section is almost twice the length of the width since the row of openings is almost twice the number of openings in comparing length to width, see Fig. 4. Thus it would have been obvious to one of ordinary skill in the art to select the length of the middle section to be at least twice the length of the width of the middle section since one of ordinary skill in the art is highly skilled and a plastic surgeon is capable of selecting the appropriate dimensions needed for sufficient tissue repair/remodeling. Additionally it can also be seen (Fig. 4 of Ringo) the length of the tissue matrix is almost twice the length of the width. Regarding claim 10, it would have been obvious to one of ordinary skill in the art to select the length of the matrix to be at least twice the length of the width since one of ordinary skill in the art is highly skilled and a plastic surgeon is capable of selecting the appropriate dimensions needed for sufficient tissue repair/remodeling. Ringo discloses the first and second end sections are configured to anchor the sheet (paragraph 24) to at least one of (intended uses) native facial issue and native neck tissue (paragraph 26 suggests many uses) at areas of the tissue matrix without openings, paragraph 34. However, Ringo did not disclose an end section include a first attachment flap and a second attachment flap with them separated by a cutout so that the end sections are configured to be anchored to tissue such as facial and native neck tissue areas. Malaviya et al. teach (Fig. 40) that a soft tissue support has attachment flaps 332,334,336,338 extending from the end sections of an elongate body member. Malaviya et al. further teach (page 39, lines 15-17) that the attachment flaps enable the attachment of the body of the tissue support to be spread about and secure in stabilizing fashion. It would have been obvious to one of ordinary skill in the art to incorporate the end section attachment flaps as taught by Malaviya et al. with the tissue support apparatus of Ringo in order to improve the securement to the tissue of the patient by utilizing the attachment flaps and further distributing the stress or tension applied on the tissue support. Regarding claims 2,3, 4, 11,12, Ringo discloses (paragraph 33) the acellular tissue matrix can be made from dermal (alloderm) or porcine or human tissue type. Regarding claim 8, it can be seen (throughout figures) the holes are uniform in size and shape, see also paragraph 41, Ringo states the holes are designed to maintain integrity of the matrix and paragraph 42 they are the same. Regarding claims 9, 13,14, Ringo further discloses the end areas can include anchoring elements such as sutures (paragraph 45) to retain the tissue support member at ends to a native tissue of which is fully capable of being facial or neck type. With respect to claims 18,19 Ringo discloses (paragraph 51) the length of the support is between 20cm and 35cm. Ringo also disclose (paragraph 36) there can be widths within a range of 0.5 cm and 8 cm for the support. Thus it would have been an obvious expedient to select dimensions for the length and width as claimed and have the values fall within the claimed range since Ringo discloses the dimensions and one of ordinary skill is highly skilled and capable of selecting the appropriate dimensions to meet the needs of the support site to be treated.
Claim(s) 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ringo (WO 2017/044682) in view of Malaviya et al. (WO 03/007784) as applied to claim 1 above, and further in view of Philippe (FR 2759899). Ringo in view of Malaviya et al. is explained as before. However, Ringo as modified by Malaviya et al. did not disclose the sheet defines a first width side and a second width side, the sheet having at least one cutout formed in the second width side. Philippe teaches (Fig. 3) a tissue sheet 1 that defines a first width side 4 and a second width side 2, the sheet having at least one cutout formed in the second width side. It would have been obvious to one of ordinary skill in the art to utilize a cutout formed in a second width side of a tissue implant material as taught by Philippe in the tissue support of Ringo as modified by Malaviya et al. such that it provides a suitable matching tissue support to conform to the site, see Philippe, page 2 of translation. Regarding claim 6, it can be seen Philippe teaches (Fig. 3) that the first width side 4 of the sheet does not have any cutouts formed therein. With respect to claim 7, it can also be seen (Fig. 3) that Philippe teaches that the cutout does not extend to a length center line of the sheet as it is in a lower half.
Claim(s) 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ringo (WO 2017/044682) in view of Malaviya et al. (WO 03/007784) as applied to claim 1 above, and further in view of Schroeder et al. (2009/0082791). Ringo in view of Malaviya et al. is explained as before. However, Ringo as modified by Malaviya et al. did not disclose the method of using the support involved implanting within a cranio-facial structure tissue and a neck structure tissue. Schroeder et al. teach (Fig. 7) a tissue sheet 4 that is implanted is used within a cranio-facial structure tissue and a neck structure tissue. It would have been obvious to one of ordinary skill in the art to implant a tissue sheet within a cranio-facial structure tissue and a neck structure tissue as taught by Schroeder et al. with the tissue support of Ringo as modified by Malaviya et al. such that it provides the ability to treat a neck and facial abnormality, see Schroeder et al., paragraph 51. Regarding claim 16, it can be seen Schroeder et al. teach (Fig. 7) anchoring at least one of the first or second end sections to tissue within the cranio-facial tissue and the neck tissue. With respect to claim 17, it can also be seen (Fig. 7) that Schroeder teaches to extend about a patient’s jaw. Thus, it would have been obvious to place the support in the method by anchoring the first end section to a first tissue end the second end section to a second tissue that is laterally opposite the first tissue structure to provide support to the tissues so there is balance in the appearance. No patient or individual wants only one side to be repaired or modified, they want their face to be analogous on both sides, thus this is achieved by extending the support from both sides laterally.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799