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 .
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 the 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/10/25 has been entered.
According to the Amendment filed on 10/10/25, Claim 45 is amended.
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) 1-6, 8, 30-34, 41-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hess et al. (US. 20190022273) in view of Weinzweig (US 20160051296 A1).
Hess discloses a method for stabilizing bone fragments figs 3-4 in a body, the method comprising the steps of: forming a first anchor on a first bone fragment (paragraph 186) by heating an adhesive composition (paragraphs 170, 191) to form a softened adhesive composition and contacting the softened adhesive composition to the first bone fragment, and (b) permitting the softened adhesive composition to cool (paragraph 211) to form the first anchor affixed to the first bone fragment; forming a second anchor on a second bone fragment (paragraph 186) by heating an adhesive composition (paragraphs 170, 191) to form a softened adhesive composition and contacting the softened adhesive composition to the second bone fragment, and permitting the softened adhesive composition to cool (paragraph 211) to form the second anchor affixed to the second bone fragment; wherein the adhesive composition has a tackifying temperature of at least 40 °C (paragraph 224), and wherein the first anchor and the second anchor are connected to a support structure for stabilizing the bone fragments figs 3b, 4b, wherein the support structure is a flexible support (paragraph 184) comprising a biodegradable and biocompatible polymer linking the first anchor to the second anchor (paragraph 121, 187), wherein the support structure, the first anchor, and the second anchor are formed from a tape comprising (x) a non-adhesive top layer that is the support structure, and (y) a bottom layer that is adhesive when softened to form the first anchor and the second anchor (paragraph 3, 14, 50, 58, 69, 90, 120-121, 161, 167, 174, 175, 187, 190, 213, 230), wherein the support structure and at least one of the first anchor and the second anchor are arranged to form an adhesive portion and a support portion that forms a backing to the adhesive portion figs. 10a-b, and wherein the adhesive portion when heated is capable of softening without deformation of the support portion, wherein the adhesive composition is not water soluble (paragraphs 187, 192, 195, 198, 201), wherein the adhesive composition comprises a heat transfer agent, wherein the heat transfer agent is selected from the group consisting of sodium chloride, iron(II) phosphate dihydrate, iron(II) citrate monohydrate, hydroxyapatite, tetracalcium phosphate, and sodium carbonate, or a combination thereof (paragraphs 41, 146).
Hess fails to teach that both of the adhesive compositions of the first and second anchors are reversible and that the adhesive composition is not dependent upon in situ curing reactions for adhesion, wherein the heating comprises applying an energy source, wherein the energy source is ultrasonic energy, wherein the ultrasonic energy is applied in an amount sufficient to displace fluids between the adhesive composition and the bone fragment prior to the formation of the first anchor and the second anchor, wherein the ultrasonic energy is applied using an ultrasonic welder.
Weinzweig teaches adhesive composition of anchors is reversible (para. 71), and that the adhesive composition is cured when exposed to energy ( heat, pressure or light , para. 71), therefore it is not dependent upon in situ curing reactions for adhesion as claimed.
Weinzweig also teaches heating biocompatible adhesives (tacks) comprises applying an energy source, wherein the energy source is ultrasonic energy (para. 4), which is known in the art that the ultrasonic energy will displace fluids between the adhesive composition and the bone fragment prior to the formation of the first anchor and the second anchor, wherein the ultrasonic energy is applied using an ultrasonic welder (Sonic welding technology) (para. 4).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a reversible adhesive composition of Weinzweig in the anchors of Hess in order to facilitate ease of handing, placement, workflow and control of device application.
Also, It would have been obvious to one having ordinary skill in the art at the time the invention was made to use an ultrasonic welder of Weinzweig to produce ultrasonic energy to heat the adhesives in order to effectively enhancing curing or hardening the adhesives composition to effectively securing the support structure on bones.
Hess et al. in view of Weinzweig fail to teach that the heat transfer agent is present in an amount that permits the adhesive composition to soften within 120 seconds or less of applying energy or within 10 seconds or less of applying energy, the ultrasonic energy is applied at a frequency of from 35kHz to 70kHz and from 1.5 to 5.0 J, the backing portion has a thickness of from 0.05 to 0.31 mm, optionally wherein the backing portion has a thickness of from 0.12 to 0.20 mm, the adhesive portion has a thickness of from 0.05 to 0.16 mm, optionally wherein the adhesive portion has a thickness of 0.075 ± 0.025 mm, wherein the adhesive portion has a thickness of 0.13 ± 0.03 mm.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the heat transfer agent to permits the adhesive composition to soften within 120 seconds or less of applying energy or within 10 seconds or less of applying energy, and to apply the ultrasonic energy at a frequency of from 35kHz to 70kHz and from 1.5 to 5.0 J, and construct the backing portion of a thickness of from 0.05 to 0.31 mm, optionally from 0.12 to 0.20 mm, and construct the the adhesive portion of a thickness of from 0.05 to 0.16 mm, optionally a thickness of 0.075 ± 0.025 mm or a thickness of 0.13 ± 0.03 mm, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Hess et al. in view of Weinzweig fail to teach that the frequency of the ultrasonic energy is 70 kHz.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the frequency of the ultrasonic energy of 70 kHz, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hess et al. in view of Weinzweig, and further in view of WO 2017/044896.
Hess et al. in view of Weinzweig fail to teach that the adhesive composition comprises a polymer having the structure of formula (I):
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109
455
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formula (I) wherein n is an integer from 0 to 4 (e.g., n = 1, 2, 3, or 4); Block B comprises an oligomer derived from a polyester, polalkylene glycol, polysilicone, or polycarbonate with a MW S 4,000 g/mol; Block A comprises an optionally substituted C1-Ce alkylene, wherein Block A is derived from a diisocyanate crosslinker; Block W comprises an optionally substituted Co-C3 alkyl-benzene-diol or optionally substituted Co-C3 alkyl-benzene-triol; Linker L' comprises a carbamate; and Linker L comprises a urea.
WO teaches bio-adhesives comprising a block copolymer useful for bandages and covering in [002]. The following structure as the block copolymer is taught in Figure 15 (Medhesive-224).
Catechol-urea-alkylene (the instant Block A)-carbamate-polyoxyalkylene (the instant block B)-carbamate-alkylene (the instant Block A)--urea-catechol which would meet the instant formula (I) except the instant MW < 4,000 g/mol of the Block B.
The adhesive comprising the block copolymer of WO would be expected to have the recited tackifying temperature of at least 40oC since it comprises a similar or same block copolymer and a filler and amounts thereof further discussed below.
WO teaches that the synthetic medical adhesives are adherent in moisture conditions and are useful to adhere a medical component such as EKG and barrier membranes to tissue in [002]. The [002] further teaches the adhesive formulations would avoid flowing undesirably to adjacent tissue surfaces. A temperature of a human/tissue would be about 36.5oC and thus the synthetic medical adhesives and formulations thereof would be expected to be non-tacky (e.g. solid or non-flowing) at a temperature similar to that of a human/tissue in order to maintain the medical component on tissue surfaces. Further, WO teaches employing an active inorganic filler such as hydroxyapatite and at least 50 wt.% thereof [030-031] and presence of at least 50 wt.% of the hydroxyapatite in the bio-adhesives of WO would be expected to increase the tackifying temperature of the bio-adhesives due to presence of a higher amount of non-tackifying hydroxyapatite.
The Figure 15 shows Mw of 5984 for the polyoxyalkylene (the instant block B)-
WO further teaches generic formulae in [049-051] and [056-060] in which a repeating unit (n) for the polyoxyalkylene (the instant block B) is further taught as 50-2300 ([051], [060]). Thus, utilization of lower n such as 50 would make the recited MW < 4,000 g/mol of the Block B obvious and see the following case laws.
In re Mills, 477 F2d 649, 176 USPQ 196 (CCPA 1972), In re Lamberti, 545 F.2d 747, 750 (CCPA 1976); Reference must be considered for all that it discloses and must not be limited to preferred embodiments or working examples. MPEP 2123.
In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). In re Woodruff, 919F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990): In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
Thus, it would have been obvious to one skilled in the art before the effective filing date of invention to obtain a block copolymer comprising a lower n value for the polyoxyalkylene (the instant block B) in WO and further to obtain bandage devices or other medical devices which would have a flexible support backing substrate inherently as evidenced by membranes taught by WO and bandages such as Band-Aid found in homes or pharmacy since WO teaches various medical devices and n values absent showing otherwise.
The bandages such as Band-Aid would comprises a biocompatible polymer and a non-adhesive top layer.
The bio-adhesives comprising a block copolymer of WO would be non-water soluble since it comprises a similar structure.
WO teaches employing an active inorganic filler in [022] and [030-031] in which hydroxyapatite and at least 50 wt.% thereof are further taught. Thus, further utilization of the hydroxyapatite in an amount 50 wt.% in WO.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hess et al. in view of Weinzweig and further in view of HIROSE et al. (US 20190224776).
Hess et al. in view of Weinzweig fail to teach that the ultrasonic welder comprises a horn tip with individual texture elements, and wherein the individual texture elements are evenly spaced apart with uniform depths.
HIROSE et al. teaches ultrasonic welder fig. 3 comprises a horn tip 5a with individual texture elements 5b, and wherein the individual texture elements 5b are evenly spaced apart with uniform depths fig. 3a-c.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use an ultrasonic welder comprises a horn tip with individual texture elements, and wherein the individual texture elements are evenly spaced apart with uniform depths of HIROSE et al in the process of Hess et al. in view of Weinzweig to effectively enhancing applying evenly welding tacks on the application surface to a uniform depths to produce even ultrasonic energy to effectively enhancing curing or hardening the adhesives composition to effectively securing the support structure on bones.
Hess et al. in view of Weinzweig, and further in view of HIROSE et al fail to teach that the individual texture elements with uniform depths of up to 0.127 mm.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the individual texture elements with uniform depths of up to 0.127 mm, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 45-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hess et al. in view of Weinzweig, and further in view of Morin et al. (US 20200373584) .
Hess et al. in view of Weinzweig fail to teach that the heating comprises application with a welder via a series of consecutive welding tacks normal to the application surface so as to cover the entire surface, or continuous sliding of a welder across the entirety of the device surface in a brushstroke or painting motion.
Morin teaches heating comprises application with a welder via a series of consecutive welding tacks normal to the application surface so as to cover the entire surface, or continuous sliding of a welder across the entirety of the device surface in a brushstroke or painting motion (para. 45).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the process of Hess et al. in view of Weinzweig with the above two ways of apply heating in view of Morin for effectively giving the user options to choose of how to apply heating step to the adhesives composition based on the surface of the application and the size of the surface area.
Examiner’s Comments
US 2010/0137903 A1 teach bioadhesives comprising carbamate and catechol groups in Figures 12 and 13.
US 2017/0210852 A1 teaches bio-adhesives comprising urea and catechol groups in claims.
The examiner does not see any motivation to obtain the instant polymer having a structure of formula (I) of claim 14 in any combination of the prior art of the record.
Response to Arguments
Applicant’s arguments, with respect to the rejection(s) of claim(s) under Hess et al. in view of SANTERRE et al. (US 20230012485) and Frigg have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Weinzweig. Wherein Weinzweig et al teaches adhesive composition of anchors is reversible (para. 71), and that the adhesive composition is cured when exposed to energy ( heat, pressure or light, para. 71), therefore it is not dependent upon in situ curing reactions for adhesion as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMEH RAAFAT BOLES whose telephone number is (571)270-5537. The examiner can normally be reached 9-5 pm.
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/SAMEH R BOLES/Primary Examiner, Art Unit 3775