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 .
Election/Restrictions
Applicant's election with traverse of Group I: an implantable hair with a silk protein in the reply filed on 1/12/26 is acknowledged. The traversal is on the ground(s) that there is no undue burden. This is not found persuasive because the two groups or inventions have clearly different fields of search and different scope. However, the Applicant is incorrect as to what the technical feature is, alleging the claims require a coated silk protein on an implantable hair, but fail to acknowledge claims are given their broadest reasonable interpretation. In this instance, claim 26 does not state implantable hair is coated, but an implantable section, which can be some anchor means to place within a patient and the hair extends from that. In addition claim 39, which recites features differently, specifically that the coating of silk protein is on an implantable section of hair, whereas claim 26, used comprising to introduce another feature. Thus, the broad technical feature is a coating of silk protein on a substrate. The examiner is not required to interpret claims how Applicant believes they should be read.
The requirement is still deemed proper and is therefore made FINAL.
Claims 39-46, 49, 50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention (a method of coating), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/12/26.
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 34-37 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 claims 34-37, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is also noted that claim 37 is further ambiguous because the recitation “partially removed” is used with the term “optional” to cause confusion whether the silk protein coating is removed. Further it is also not evident if the “partially removed” is referring to a reduced thickness, but again as mentioned this would imply a product-by-process clause and then one can apply coatings and achieve different thicknesses in many ways on a substrate. Thus, clarification is required because one does not know where the partially removed silk protein occurred or what this final configuration is actually intended to be.
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) 26,27,29,30,32-34,38,47,48 are rejected under 35 U.S.C. 103 as being unpatentable over Loria (WO 2019/027864) in view of Hedhammar (WO 2017/198655). Loria shows (Fig. 30) an implantable hair 28 comprising at least one implantable section 22. Loria further discloses (paragraphs 193,207) the at least one implantable section is coated with a composition. It is noted Loria further discloses (paragraph 207) the composition comes into direct contact with the implantable hair. However, Loria did not explicitly state the composition comprises at least one silk protein. Hedhammar teaches (page 3, lines 19,20) a coating on an implant surface. Hedhammar further teaches (page 9, lines 18-22) that the composition is to include spider silk proteins and applied to an implant surface. It would have been obvious to one of ordinary skill in the art to include spider silk protein in a composition applied to an implant surface as taught by Hedhammar and use with the implantable hair of Loria such that it provides a stable coating, see Hedhammar page 8, lines 18-20, 25-28. Regarding claim 27, Hedhammar teaches (page 14, lines 1-4) the at least one silk protein has at least 90% amino acid sequence homology to a spider silk protein or an insect silk protein, i.e. if less than 10% non-spider silk sequence, then more than 90% would be a silk protein with an amino acid sequence homology to spider silk protein. Regarding claim 29, Loria further disclose (Fig. 28) an embodiment the at least one implantable section 74 includes an implantable terminal end of the hair 28. Regarding claim 30, Loria further discloses (paragraph 45) the implantable hair is a human hair. Regarding claim 32, Loria also discloses (paragraph 45) the implantable hair is synthetic hair. Regarding claim 33, Loria additionally discloses (paragraph 22) the implantable hair over its entire length, has an average diameter of 0.02 to 0.15 mm. With respect to claim 34, Loria shows (Figs. 1,2A,2B,3A-D,5A,5B,10A,10B,30-33) the implantable section 20 comprising at least one notch 44. Regarding claim 38, it can be construed that the silk protein taught by Hedhammar is solid as the material of the coating is applied in fibril form, see Fig. 4, page 28, lines 9-12. Regarding claim 47, Loria also discloses (paragraph 64) a cosmetic use by implanting into human or animal skin the implantable hair. Regarding claim 48, Loria also discloses (paragraphs 36,242,317) a cosmetic method by implanting into human or animal skin the implantable hair using a needle.
Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Loria (WO 2019/027864) in view of Hedhammar (WO 2017/198655) as applied to claim 26 above, and further in view of Scheibel et al. (2007/0214520). Loria in view of Hedhammar is explained supra. However, Loria as modified by Hedhammar did not explicitly disclose the silk protein is selected to be fibroin. Scheibel et al. teach (paragraph 34) a fibroin silk protein or spidroin 2 is used to provide a fiber coating for skin grafts, paragraph 108. It would have been obvious to one of ordinary skill in the art to select a fibroin or spidroin 2 for the silk protein as taught by Scheibel et al. in the implantable hair of Loria as modified by Hedhammar such that it improves strength, see paragraphs 14,16 of Scheibel.
Claim(s) 31 is rejected under 35 U.S.C. 103 as being unpatentable over Loria (WO 2019/027864) in view of Hedhammar (WO 2017/198655) as applied to claim 26 above, and further in view of Lindner et al. (EP 2105499). Loria in view of Hedhammar is explained supra. However, Loria as modified by Hedhammar did not explicitly disclose the human hair was removed from its follicle, root, and bulb. Lindner et al. teach (paragraph 9) a hair implant. Lindner et al. further teach (paragraph 43) to separate hair from its follicle, root and bulb. It would have been obvious to one of ordinary skill in the art to use a hair separated from its follicle along with root and bulb as taught by Lindner et al. for the implantable hair of Loria as modified with Hedhammar in order to produce a reduced biologically active hair, see paragraph 14 of Lindner.
Claim(s) 35 is rejected under 35 U.S.C. 103 as being unpatentable over Loria (WO 2019/027864) in view of Hedhammar (WO 2017/198655) as applied to claim 26 above, and further in view of Asgari (CN 10121990). Loria in view of Hedhammar is explained supra. However, Loria as modified by Hedhammar did not explicitly disclose the composition comprising at least one silk protein is coated onto the hair using 3D shaping, optionally 3D printing. Asgari teaches that a medical implant (page 3 of translation) can be coated using 3D printing, page 22 of translation. It would have been obvious to one of ordinary skill in the art to use 3D Printing onto a surface as taught by Asgari with the implantable hair of Loria as modified with Hedhammar such that one can accurately coat the desired surface to assure it is provided with the protective silk coating.
Claim(s) 36 is rejected under 35 U.S.C. 103 as being unpatentable over Loria (WO 2019/027864) in view of Hedhammar (WO 2017/198655) as applied to claim 26 above, and further in view of Talton (WO 03/061840). Loria in view of Hedhammar is explained supra. However, Loria as modified by Hedhammar did not explicitly disclose the composition comprising at least one silk protein is at least partially melted when coated on the implantable section, optionally wherein a femtosecond laser is used to melt the at least one silk protein. Please note the recitation of “melted when coated” is a product-by-process limitation, along with use of a femtosecond laser to melt the silk protein. Thus, if the same material is used it inherently possesses the same physical properties capable of being coated by the same process. However, in the alternative Talton teaches (page 4) to coat substrate implant surfaces using laser ablation, which inherently melts material to enable application onto the surface, the coating can be a protein. It would have been obvious to one of ordinary skill in the art to select known techniques of coating such that one can melt and use laser to perform the process of enabling application of a protein to a form suitable to coat by melting as taught/implied by Talton on the implantable hair of Loria as modified by Hedhammar in order to effectively cover the desired surface.
Claim(s) 37 is rejected under 35 U.S.C. 103 as being unpatentable over Loria (WO 2019/027864) in view of Hedhammar (WO 2017/198655) as applied to claim 26 above, and further in view of Beniash et al. (WO 2017/136624). Loria in view of Hedhammar is explained supra. However, Loria as modified by Hedhammar did not explicitly disclose the silk protein was partially removed, optionally by using plasma ablation or a femtosecond laser. Please note the recitation of “partially removed” is a product-by-process limitation, along with use of alternative clauses “plasma ablation or a femtosecond laser” to remove the silk protein. As best understood, if some surface feature or arrangement is meant, Beniash et al. teach partial removal of a coating, see paragraph 23. It would have been obvious to one of ordinary skill in the art to provide partially removed silk protein (sections) of coating such that one can use laser ablation to create the desired pattern of the coating as taught by Beniash et al. on the implantable hair of Loria as modified by Hedhammar in order to provide the desired surface property due to the removed material, see Beniash et al. paragraphs 14,23.
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