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 .
Information Disclosure Statement
The information disclosure statement filed 2/13/23 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
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, 2 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.
Claim 1 recites in the preamble “for perichondrium and subcutaneous tissue…” and then recites “for skin grafting on….” which are technically two different uses or possibly totally different layers of material of the body to replace. Thus, it is not clear if one is intending to replace/repair the “perichondrium and subcutaneous tissue” or is the filling/cushioning member a replacement “skin graft” as these are what appear to be different anatomical tissue materials to treat/repair. Thus which one is it?
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites the recitation of “used for a skin graft on an auricular skin defect” and depends from claim 1 that had included the recitation already. Thus, it appears the limitation is not further limiting. Unless claim 1 is intended to be recited as a Markush type format or use alternative format recitations to make clear these are different uses, the claim seems to not further limit. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1,2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shojaku et al. (Effect of Hyperdry Amniotic Membrane Patches attached over the bony surface of mastoid cavities in canal wall down tympanoplasty). Shojaku et al. disclose human amniotic membrane patches as a dressing substitute for fascia grafts of the temporal muscle (temporalis fascia graft) in canal wall down tympanoplasty (abstract). The amniotic membranes were dried under consecutive far-infrared rays and microwaves at temperatures of less than 60°C under low air pressure conditions using a hyperdry device, then they were cut into 5-cm squares and vacuum packaged. For sterilization, the packages underwent gamma-ray (25-kGy) irradiation; subsequently, the packages could be stored safely at room temperature (page 1954, left-hand column, lines 1-15). When the dried amniotic membranes absorb water, they return to a layered structure similar to that of fresh amniotic membranes (page 1957, left-hand column, lines 30-31). Although Shojaku does not disclose the use of the amniotic membrane material for skin grafting on auricular skin defects, the material is prepared by the same method and thus has the same properties as in the present application, i.e. it is suitable for skin grafting on auricular skin defects and capable of being used for the same purpose. Thus, the preamble of claim 1 and the limitation of claim 2 recite intended uses of the “filling/cushioning member” and since the material is the same as detailed above it is fully capable of performing the function. Please note the recitation of “produced by …drying” and further reciting “has been dehydrated” and also the limitation of “produced by rehydrating….by immersion in water or a buffer..” are all recitations of “product by process” and these type of claims are not limited by or defined by the process, but determination of patentability is based on the product itself. These claims are product claims and 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113(I). Since there is no structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art, the amniotic membrane of Shojaku et al. meets the claim. In addition since the material or amniotic membrane was said (page 1956 of document to Shojaku) to be a “restorative member” it inherently has the epithelial cells, basement membrane and connective tissue as recited and was stated to be functioning as a basement membrane and expression of growth factors along with cytokines must be a result of epithelial cells.
Claim(s) 1,2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nikaido et al. (2009/0258082). Nikaido et al. disclose (paragraph 20) a “filling/ cushioning member” that comprises an amniotic membrane of which has the epithelial cells, basement membrane and connective tissue after processing. Please note the recitation of “produced by …drying” and further reciting “has been dehydrated” and also the limitation of “produced by rehydrating….by immersion in water or a buffer..” are all recitations of “product by process” and these type of claims are not limited by or defined by the process, but determination of patentability is based on the product itself. These claims are product claims and 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113(I). Since there is no structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art, the amniotic membrane of Nikaido et al. meets the claim. Nikaido does disclose (paragraph 19) the raw amniotic membrane is dried. Nikaido also disclose (paragraph 20) the dried membrane is dehydrated and dried to enable storage in an aseptic atmosphere. Nikaido et al. further disclose (paragraph 34) that the amniotic membrane produced by rehydrating the dry amniotic membrane by immersion in water or a buffer retains epithelial cells, basement membrane, and connective tissue constituting the raw amniotic membrane. Although Nikaido et al. does not disclose the use of the amniotic membrane material for skin grafting on auricular skin defects, the material is prepared by the same method and thus has the same properties as in the present application, i.e. it is suitable for skin grafting on auricular skin defects and capable of being used for the same purpose. Thus, the preamble of claim 1 and the limitation of claim 2 recite intended uses of the “filling/cushioning member” and since the material is the same as detailed above it is fully capable of performing the function.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Brahm (9498327) teaches a treatment of ear defects with amniotic membrane material.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799