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 .
Claim Interpretation
Claim limitations “according to gel permeation chromatography” refer to the method of testing and are therefore considered to be product-by-process limitations which do not limit the structure.
The PEG modifier being “substantially anhydrous” is taken to mean “PEG modifier component may contain up to about 10% by weight water,” as in Specification Par. 0038.
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, 3, 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill et al. US 2012/0101519 A1, hereinafter “Hill”] in view of Rhee et al. [US 20080187591 A1, newly cited, hereinafter “Rhee”]
Re. claim 1, Hill discloses a tissue sealing plug [Fig. 1B] comprising a compressed [Par. 0027] substrate [220] comprising foamed gelatin having an interconnected pore structure [Par. 0026] impregnated with a polyethylene glycol modifier component that is liquid at room temperature [PEG 600, Par. 0026, applied via dip coating, Par. 0036],
Hill fails to disclose the weight ratio of PEG to foamed gelatin. Hill suggests that “the hydrogel [i.e. PEG] component may also be used to modulate the rate of swelling of the porous structure….” [Par. 0026], but fails to disclose further details. However, Rhee teaches, in a tissue sealing material, the concentration of PEG compared to other elements (including gelatin, Par. 0020) is a result-effective variable determining the swell ratio [Fig. 14]. Thus, It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tissue sealing plug of Hill using routine experimentation to determine the optimal range of amount (and thus weight) of PEG vs. gelatin in order to optimize the desired swell ratio, which in turn determines, at least in part, the effectiveness of the plug (longevity, sealing ability; amount of pressure on body, see e.g. Rhee Par. 0281]. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Note that Applicant has not asserted criticality or unexpected results for the claimed range of weight ratios.
Re. claim 3, Hill discloses the polyethylene glycol has an average molecular weight of about 100 to about 600 Da [600 Da, Par. 0026] according to gel permeation chromatography.
Re. claim 5, Hill discloses the tissue sealing plug of claim 1 in the form of a cylinder [Fig. 1B].
Re. claim 6, Hill discloses the tissue sealing plug as set forth with respect to claim 1 above, but fails to teach the taper. However, Larsen further teaches the plug has a longitudinally tapered width [pyramid shaped, Par. 0281]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hill by forming the device to have a tapered shape as taught by Larsen because this prevents the plug from exiting the wound through one side.
Re. claim 7, Hill discloses an additive selected from the group consisting of procoagulants, antifibrinolytics, would healing agents, contrast agents and combinations thereof [hemostatic material, anti-microbial, growth promoter, and thrombus enhancing agents, Par. 0026].
Re. claim 8, Hill discloses the substrate comprises a surface feature selected from the group consisting of lines, ribs, barbs, grooves, notches, slits and combinations thereof [grooves 222, Fig. 1B].
Claim(s) 2 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill in view of Rhee, as applied to claim 1, and further in view of Fisher et al. [US 2009/0286886 A1, hereinafter “Fisher”]
Re. claim 2, Hill discloses the tissue sealing plug as set forth with respect to claim 1 above, but fails to teach the PEG being substantially anhydrous. However, Fisher teaches, in a material composition usable in tissue sealing, the polyethylene glycol is substantially anhydrous [Par. 0055]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hill by forming the PEG to be substantially anhydrous as taught by Fisher because “[t] he anhydrous formulation has the benefit of protecting the activity of compounds that have limited stability in an aqueous environment, not only during manufacture and storage, but also after the material is implanted in the body,” [Fisher Par. 0055].
Re. claim 9, Hill fails to teach the claimed structure of the gelatin foam. However, Rhee further teaches the foamed gelatin is crosslinked [Par. 0025] foam. Fisher teaches the porous foam having open cells [Par. 0050]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hill by forming the foamed gelatin to be crosslinked and open cell as taught by Rhee and Fisher because this improves the strength of the foam and allows for tissue ingrowth [Fisher Par. 0051], respectively.
Claim(s) 4, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill in view of Rhee, as applied to claim 1, and further in view of Kaully et al. [WO 2010064251 A1, hereinafter “Kaully”]
Re. claim 4, Hill discloses the tissue sealing plug as set forth with respect to claim 1 above, but fails to teach the claimed molecular weight of the PEG. However, Kauly teaches, in a hydrogel sponge, PEG has a molecular weight of about 300 to about 450 Da according to gel permeation chromatography [400 Da, Page 11, line 6]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hill by using, in place of 600 Da PEG, 400 Da PEG as taught by Kauly because this amounts to a simple subistution of one molecular weight PEG known in the art for another with predictable results [Kauly teaches the PEG “can be any molecular weight” including 400 Da].
Re. claim 10, Hill as modified by Rhee and Kaully discloses the device as set forth above with respect to claims 1 and 4, and wherein the substrate is dry [Hill Par. 0036].
Reissue Applications
Applicant’s arguments against Hill, filed 12/11/25, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 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 Rhee.
Conclusion
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771