DETAILED ACTION
Claims 1-4, 6-10 and 12-18 are currently pending. Claims 1-4, 6 and 12-16 are currently under examination.
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 .
Withdrawn Rejections
The prior rejection of claims 1-4, 6 and 12-16 under 112(a) new matter is withdrawn in light of applicant amending the claims to remove the limitation of continuous through the adhesive which was the subject of the new matter rejection, which the Examiner finds persuasive.
Examiner’s Note
Applicant's amendments and arguments filed 06/25/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 06/25/2026, it is noted that claims 1-2, 12 and 14 have been amended.
New Rejection:
The following rejection is newly applied based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 112 (b)
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 12-16 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 12 recites the limitation "the connecting layer". There is insufficient antecedent basis for this limitation in the claim. Claim 12 recites a second phase that connects, however does not recite a connecting layer. Claims 13-16 are further rejected as not curing the ambiguity of claim 12.
Modified Rejection:
The following rejections are modified based on Applicant’s claim amendments.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-4, 12 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0319101 (Applicant provided) in view of US 2014/0257027 (previously applied) and WO 2016/056901 (previously applied).
Regarding claims 1, 12 and 16, the limitation of a tissue adhesive comprising an adhesive resin layer, the adhesive resin layer including a first reactant made of an aldehyded glycan and a second reactant made of partially carboxylated polylysine and the adhesive resin layer having a molar ratio of 1 as a ratio of an aldehyde group of the first reactant to an amine group of the second reactant, a structuring of granules derived from powder of the first reactant and a connecting layer derived from the second reactant, the connecting layer connecting the granules with each other and fixing each of the granules throughout the tissue adhesive, the connecting layer being continuous throughout the adhesive resin layer while the each of the granules are embedded in the connecting layer and the partially carboxylated polylysine having a weight average molecular weight of 1000 to 200,000 is met by the ‘101 publication teaching a two part medical adhesive comprising an aqueous solution or powder of aldehyde groups introduced alpha-glucan and a second part comprised of a powder of amino-groups containing a polymer that is formed of a polymer chain of amino group-containing units and has a molecular weight in a range of 1000 to 20,000, as well as the hydrogel an obtained from curing the adhesive (abstract). The amino group containing polymer is epsilon-poly-L-lysine [0027]. The molar ratio of aldehyde groups to amino groups in the mixture of the first and second liquids are 0.1 to 2 [0028] or a 1:1 ratio [0078]. The first and second parts are taught to be mixed and applied as powder to form a powder mixture adhesive [0029]. The alpha-glucan aldehyde is taught to include dextran [0056]. The composition is taught to have a pH adjuster, preferably an anhydride such as succinic acid or glutaric acid ([0073], claim 4) to be used as a quasi-linking between polymer chains [0074], leading to partially carboxylated polylysine. Wherein the first and second powder with anhydride linking agent reacts to form a hydrogel, thus connecting layer from the first reactant granules and second reactant. Wherein the two powder components are mixed and applied both ingredients would be formed continuously through the adhesive resin layer, thus meeting the limitation granules being embedded in the connecting layer so as to be fixed by the connecting layer derived from the second reactant.
Regarding claims 3 and 15, the limitation of wherein the granules derived from the powder of the first reactant has an average particle size of 20 to 100 um is met by the ‘101 publication teaching the particle sizes of the powder were evaluated to be about 90 micrometers [0152].
Regarding claim 4, the limitation of wherein the aldehyded glycan of the first reactant has 0.2 to 0.5 aldehyde groups per monosaccharide unit and the partially carboxylated polylysine of the second reactant has a residual amino group ratio of 70 to 93% is met by the ‘101 publication teaching the amount of the introduced aldehyde groups per anhydro glucose unit was 0.28 [0151] and wherein anhydride is added to the polylysine solution to prepare a 10 wt% neutral polylysine [0098] wherein the amount of succinic anhydride used is optimizable [0073], wherein the anhydride amount necessarily affects the residual amino group ratio as evidenced by the instant specification [0042]. The ‘101 publication teaches the molar ratio of the aldehyde groups to amino groups at the time powder form is 0.1 to lower than 5, wherein the molar ratio exceeds the corresponding range, prompt gelation or cuing is not achievable [0076] thus teaching the amount of residual amino groups is optimizable parameter.
The ‘101 publication does not specifically teach a porous base sheet having a biodegradability and a communicative porous structure and an adhesive resin layer fixed and formed on the base sheet (claim 1).
The ‘901 publication teaches preparing an adhesive hemostatic product comprising providing a porous solid substrate, coating the substrate with a coating liquid to produce a coated substrate. The product has excellent adhesive properties. The product is taught to be a coated mesh, a coated foam and a coated powder (abstract). The coating is taught to leave the pore structure largely intact so that the ability of the porous substrate to absorb bodily fluid remains essentially unaffected (page 3, lines 28-35). The porous substrate can include dextran (page 9, lines 10-20). The sheet is taught to have a thickness of 0.5 mm to 10 mm (page 13, lines 15-20). The mesh is taught to be a nonwoven fabric formed of biodegradable polymer (page 13, lines 20-25). The adhesive is taught by application by spray (page 18, lines 1-5). The porous solid substrate is taught to be a foam or a mesh with a pore size of 10 to 200 um, preferably 4 to 50 um (page 13, lines 5-12).
The ‘027 publication teaches mesh implantable medical device (title, abstract). The implant is taught to be a mesh and a fixation mechanism. The mesh may be synthetic or biological material wherein the fixation mechanism can be an adhesive, wherein the adhesive can be polysaccharides [0027]. The fixation mechanism can be coupled to the side of the mesh [0045]. The fixation mechanism can be applied to the mesh using an applicator such as being sprayed on. In some embodiments the adhesive may be activated by any such triggers such as body fluid [0046]. The coating of the adhesive on the medical device reads on the limitation of ‘fixes’ and ‘fixed’ absent a clear definition.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the adhesive taught by the ‘101 publication on a biodegradable mesh as the ‘101 publication teaches a two part adhesive in powder form to be cured into a hydrogel wherein dextran sheets may be used in combination with the two part adhesive [0174] and the ‘901 publication teaches application of adhesive to porous devices formed of dextran. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success in using the adhesive taught by the ‘101 publication on a porous medical device as taught by the ‘901 publication because the ‘101 publication teaches an adhesive to tissue and a dextran and the ‘901 publication teaches the use of adhesive on porous medical devices such as dextran. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use the adhesive taught by the ‘101 publication on porous medical devices as taught by the ‘901 publication with an expectation of success as the ‘027 publication teaches it is known to apply adhesives to implantable medical devices wherein the adhesive is activated by bodily fluid and the ‘101 publication teaches the adhesive being mixed in powder form and activated when applied on the living body portion which is wet [0029], thus teaching activation by bodily fluids, making it obvious to use the mixed powder of the ‘101 publication on an implant taught by the ‘901 publication and have the adhesive activated by bodily fluid as is taught by the ‘027 publication. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘101 publication is taught to be used in combination with substrates and bonding to the living body and the ‘027 publication and the ‘901 publication are directed to the use of adhesive to bond a medical device to the body.
Claim(s) 2 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0319101, 2014/0257027 and WO 2016/056901 as applied to claims 1, 3-4, 12 and 15-16 above, and further in view of WO 2005/051333 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 1, 3-4, 12 and 15-16 are taught by the combination of the ’101 publication, the ‘027 publication and the ‘901 publication.
Regarding claim 2, the limitation of the base sheet is non-woven fabric, woven fabric, knitted fabric, mesh sheet, sponge sheet or other continuous porous sheet and has a thickness of 15 um to 500 um, the base sheet has a pore size smaller than an average size of the granule derived from powder of the first reactant is met by the ‘101 publication teaching the particle sizes of the powder were evaluated to be about 90 micrometers [0152] and the ‘027 publication teaching the porous substrate can include dextran (page 9, lines 10-20). The sheet is taught to have a thickness of 0.5 mm to 10 mm (page 13, lines 15-20). The mesh is taught to be a nonwoven fabric formed of biodegradable polymer (page 13, lines 20-25) with a pore size between 4 and 50 um (page 13, lines 5-12), thus teaching the particles to be larger than the pore size. The adhesive is taught by application by spray (page 18, lines 1-5).
The combination of references does not specifically teach the adhesive resin layer has a thickness of 100 um to 800 um (claim 2).
The ’333 publication teaches a patch for covering the surface of a living being such as a wound and an adhesive for adhering to the skin or mucosa (abstract). The thickness of the adhesive layer is 20 to 300 um (page 3, lines 15-35).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use known thickness of adhesives on medical devices for the medical device taught by the combination of the ‘101 publication and the ‘901 publication because the ‘333 publication teaches a known ranges of thicknesses of adhesives applied to medical devices for adhesion to the body and the ‘901 publication teaches the use of an adhesive applied to a medical device for adhesion to the body. As MPEP 2144.05 recites “where 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 optimization”.
Claim(s) 6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0319101, 2014/0257027 and WO 2016/056901 as applied to claims 1, 3-4, 12 and 15-16 above, and further in view of US 2016/0243159 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 1, 3-4, 12 and 15-16 are taught by the combination of the ’101 publication, the ‘027 publication and the ‘901 publication.
The combination of references does not specifically teach 5 to 30 wt% of hydroxypropyl cellulose, or other biodegradable polymer and/or 1 to 25 wt% of glycerin or other moisturizing component, and except for the biodegradable polymer and the moisturizing component the adhesive resin layer includes the first and second reactant (claim 6).
The ‘159 publication teaches a composition for use in wound treatment (abstract). The wound gel is preferably 1 to 15 wt% by weight of glycerine and 0.2 to 5 wt% hydroxyethyl cellulose [0053]. The composition for use as a wound treatment agent gel contains additives such as binding agents which can be used in the usual quantities [0055].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to include hydroxyethyl cellulose and glycerin as taught by the ‘159 publication in the gel layer taught by the ’101 publication because the ‘159 publication teaches hydroxyethyl cellulose and glycerin are known components to be used in wound gel and the ‘101 publication teaches a hydrogel layer to be used until wounds are healed. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to include agents taught by the ‘159 publication in the adhesive forming hydrogel taught by the ‘101 publication because the ‘159 publication teaches moisturizing gel which is beneficial for wound treatment ([0051], [0059]). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977), thus rending hydoxypropylcellulose obvious over a teaching of hydroxyethyl cellulose taught by the ‘159 publication.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-4, 12 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 7,834,065 in view of WO 2016/056901. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘065 patent are directed to two-part adhesive comprising aldehyde glycol and partially carboxylated polylysine through modification with succinic anhydride wherein the molar ratio of aldehyde group to the first reactant to an amine group of the second reactant is 1 and the granules are in the form of a powder which are mixed and the polylysine has overlapping molecular weight and wherein the mixed powder reads on grains embedded in the connecting layer. The instant application and the ‘065 patent differ in that the instant claims contains a base sheet having biodegradability and a communicative porous structure to which the adhesive resin layer is fixed.
The ‘901 publication teaches preparing an adhesive hemostatic product comprising providing a porous solid substrate, coating the substrate with a coating liquid to produce a coated substrate. The product has excellent adhesive properties. The product is taught to be a coated mesh, a coated foam and a coated powder (abstract). The coating is taught to leave the pore structure largely intact so that the ability of the porous substrate to absorb bodily fluid remains essentially unaffected (page 3, lines 28-35). The porous substrate can include dextran (page 9, lines 10-20). The sheet is taught to have a thickness of 0.5 mm to 10 mm (page 13, lines 15-20). The mesh is taught to be a nonwoven fabric formed of biodegradable polymer (page 13, lines 20-25). The adhesive is taught by application by spray (page 18, lines 1-5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the adhesive taught by the ‘065 patent on a biodegradable mesh as the ‘065 patent teaches a two-part adhesive in powder form to be cured into a hydrogel wherein dextran sheets may be used in combination with the two-part adhesive [0174] and the ‘901 publication teaches application of adhesive to porous devices formed of dextran.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: The ‘101 publication (Nakajima, The ‘027 publication (Palmisano) and the ‘901 publication (Bender)
Applicant argues the newly added features of the granules is embedded in the connecting layer so as to be fixed by the connecting layer derived from the second reactant. Applicant points to Figure 14 where parts considered to be formed by fusing of succinic anhydride modified poly-lysine, the powders were bonded to each other at locally dried parts. The two reactant adhesives were bonded to each other to form one adhesive resin layer. This adhesive resin layer each powder of random shapes of aldehyde dextran formed a convex portion and was adhered on a paper wiper sheet which is a base sheet. This enables quick and uniform dissolving of the connecting layer and subsequent dissolving of the granules of the first actant resulting uniform reaction and curing would be achieved so that strong adhesion is achieved.
In response, it appears Applicant is arguing unexpected results however has not presented factual data regarding quick and uniform dissolving. The ‘101 publication teaches the first and second parts to be mixed and applied as powder to form a powder mixture adhesive [0029]. Wherein the first and second powder with anhydride linking agent reacts to form a hydrogel, thus connecting layer from the first reactant granules and second reactant. Wherein the two powder components are mixed and applied both ingredients would be formed continuously through the adhesive resin layer, thus meeting the limitation granules being embedded in the connecting layer so as to be fixed by the connecting layer derived from the second reactant.
Applicant argues the ‘027 publication merely shows an adhesive onto a mesh sheet. The ‘901 publication merely shows a single and unform adhesive layer formed by a non-reactive resin. None of the reference teach or suggest a porous base sheet that has pore size smaller than the average size of the granules. The prior art fil to recognize these benefits and do not motive a skilled in the art to employ a porous sheet having pores of a size smaller than average size of the granules.
In response, the ‘101 publication teaching the particle sizes of the powder were evaluated to be about 90 micrometers [0152] and the ‘027 publication teaching the porous substrate can include dextran (page 9, lines 10-20). The sheet is taught to have a thickness of 0.5 mm to 10 mm (page 13, lines 15-20). The mesh is taught to be a nonwoven fabric formed of biodegradable polymer (page 13, lines 20-25) with a pore size between 4 and 50 um (page 13, lines 5-12), thus teaching the particles to be larger than the pore size. The adhesive is taught by application by spray (page 18, lines 1-5).
Applicant argues hindsight.
As for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art.
Double Patenting:
Applicant argues in view of the amendments to claim 1 and 12 the double patenting rejection should be withdrawn.
In response, Applicant is referred to the modified double patenting rejection above. The ‘065 patent teaches the powders to be mixed, thus reading on the granules embedded within the connecting layer so as to be fixed by the connecting layer derived from the second reactant.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613
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