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 .
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 17-37 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.
In independent claims 17 and 37, it is not clear what is meant by “self-sticking”. Does this refer to a cohesive adhesive which preferentially adheres to itself? The scope of the claims is not clear. Also in claim 17, it is not clear whether the limitation “and/or an activator”, refers to what the thread body comprises or whether the and/or is in relation to “the biological tissue”. Additionally, in claim 16, it is not clear what is meant by “configured” or how the claimed configured self-sticking material differs from the same material which has not been so configured.
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) 17-26, 30, 31, 33-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostapoff et al, U.S. Patent Application Publication No. 2014/0371767 in view of Winter, U.S. Patent No. 3,524,537.
Ostapoff discloses surgical sutures which include an adhesive precursor material. The adhesive precursor can include collagen. See paragraph 0011. The adhesive precursor can include first and second adhesive precursors, which are present in the core and sheath of a suture material and which can be released by and interact with each other and/or bodily fluids to become an adherent material. See paragraph 0033. The inner core and outer sheath can be made of biocompatible polymers. See paragraph 0054. Since the adhesive precursors can be present in the sheath, they are considered to be a coating as per claim 37. The sutures can include filaments which can include alginates which are known to be hydrogels. See paragraph 0055. The adhesive precursor can include cyanoacrylate monomers which interact with bodily fluids such as blood, sweat, tears, water, saline, etc. to polymerize and adhere to tissue. See paragraph 0063. This is equated with the self-sticking material. Additionally, the adhesive precursor can include combinations of precursors which can act upon exposure to ions, UV light, and other chemical components. See paragraph 0065. The activator can be water, body fluid, tissues or blood. These substances are also chemicals and thus can be considered chemical activators and they act to initiate polymerization and thus are polymerization initiators. Similarly, these substances are all physically present and thus can be considered to be physical activators. Additionally, UV light is listed as an activator for the precursors.
Ostapoff differs from the claimed invention because it does not disclose that the cyanoacrylate is an alkyl 2-cyanoacrylae monomer or that the composition includes a polymerization retarder.
However, Winter discloses useful surgical adhesives comprising cyanoacrylates wherein the adhesive properties result from the polymerization of cyanoacrylate monomers in the presence of a substance or substances which instigate anionic polymerization, such as water contained in body tissue fluid. See col. 1, lines 42-55. Suitable cyanoacrylates include alkyl 2 cyanoacrylates. See col. 4, lines 32-44. Polymerization inhibitors (retarders) such as anionic inhibitors and free radical inhibitors can be added to the cyanoacrylates to prevent premature polymerization. See col. 4, lines 69-70. UV absorbing materials can also be included in order to prevent premature polymerization due to exposure to UV light. See col. 7, lines 1-48.
Therefore, it would have been obvious to have employed the known and useful cyanoacrylates taught by Winter as the cyanoacrylates in Ostapoff in view of their art recognized suitability for this intended purpose as a surgical adhesive and to have included polymerization inhibitors and absorbers in the composition of Ostapoff in order to control the timing of the polymerization and thus the adhesive activity of the cyanoacrylate adhesives.
It further would have been obvious to have provided the sutures of Ostapoff as modified by Winter in the form of a kit in order to provide all the necessary components including a light source and/or polymerization initiator to successfully employ the sutures of Ostapoff.
Claim(s) 27, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostapoff in view of Winter as applied to claims above, and further in view of Wicker et al, U.S. Patent No. 3,527,341
Ostapoff does not clearly teach incorporating viscosity modifiers.
However, Wicker discloses modifying the viscosity of a cyanoacrylate by including a lactic acid, (which is a carboxylic acid). See examples.
Therefore, it would have been obvious to one of ordinary skill in the art to have incorporated a viscosity modifying agent in the composition of Ostapoff in order to control the resulting viscosity of the composition.
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostapoff in view of Winter as applied to claims above, and further in view of Hammerslag et al, U.S. Patent Application Publication No. 2005/0245966.
Ostapoff differs from the claimed invention because it does not disclose incorporating a viscosity lowering agent.
However, Hammerslag teaches that it was known to incorporate solvents into cyanoacrylate adhesives in order to lower the viscosity. See paragraph 0049.
Therefore, it would have been obvious to one of ordinary skill in the art to have incorporated a solvent into the composition of Ostapoff in order to control the viscosity of the adhesive.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostapoff in view of Winter as applied to claims above, and further in view of Xia et al, U.S. Patent Application Publication No. 2019/0099513.
Ostapoff differs from the claimed invention because it does not disclose that the self-sticking material is lyophilized.
However, Xia teaches freeze drying a material including a cyanoacrylate adhesive on a suture in order to provide for controlled release of the adhesive. See abstract and paragraph 0050.
Therefore, it would have been obvious to have provided the self-sticking material of Ostapoff in a lyophilized form in order to provide for the controlled release of the self-sticking material as taught by Zia.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wojciak, U.S. Patent No. 6,433,036.Wojciak discloses that cyanoacrylates are known to be polymerized by a nucleophile, free radical polymerization, or exposure to heat or light. Such compositions can include free radical stabilizers to extend the shelf life of the compositions. See col. 1, lines 17-65. Such compositions can include viscosity modifiers. See col. 11, lines 17-30.
Narang et al, U.S. Patent Application Publication No. 2004/0137067. Narang discloses that it is known to add components which control the rate at which polymerization of cyanoacrylate adhesives will polymerize including polymerization inhibitors or stabilizers, such as Lewis acids, (paragraph 0010), as well as catalysts or accelerators, (see paragraph 0055).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH M IMANI whose telephone number is (571)272-1475. The examiner can normally be reached Monday-Wednesday 7AM-7:30; Thursday 10AM -2 PM.
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/ELIZABETH M IMANI/ Primary Examiner, Art Unit 1789
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