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 . Claims included in the prosecution are claims 1-4, 7, 8, 10, 12, 13 and 16-19.
Continued Examination Under 37 CFR 1.114
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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/27/2026 has been entered.
Applicants' arguments, filed 05/27/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 fails to further limit the subject matter of claim 1 since claim 12 limits the fiber polymer to oxidized regenerated cellulose, which contradicts claim 1 since claim 1 recites wherein the fiber polymer comprises both oxidized cellulose and poly(lactic-co-glycolic acid) (PLGA).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
1. Claims 1, 7, 8, 10, 12, 13, 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bender et al. (WO 2016/056901, Apr. 14, 2016) (hereinafter Bender 1) in view of Sehl et al. (US 2010/0233246, Sep. 16, 2010) (hereinafter Sehl), Bender et al. (US 2015/0045507, Feb, 12, 2015) (hereinafter Bender 2), and Pulapura et al. (US 2017/0319756, Nov. 9, 2017) (hereinafter Pulapura).
Bender 1 discloses a tissue-adhesive haemostatic product coated with an electrophilically activated polyoxazoline (EL-POX) containing at least 2 reactive electrophilic groups, wherein the product is a coated mesh. The porous substrate absorbs body fluids, such as blood (abstract). A mesh (i.e., structure comprising a three-dimensional interconnected interstitial space) is a sheet made from woven or non-woven fibres. The fibres contained in the mesh are preferably made of biocompatible polymers, like oxidized regenerated cellulose (page 12, lines 22-24). The mesh may contain at least 50% oxidized regenerated cellulose (page 9, lines 14-16). The electrophilic groups present in the EL-POX include carboxylic acid esters, sulfonate esters, phosphonate esters, and combinations thereof (page 8, lines 8-25). An example of EL-POX is star-shaped POX-polymers end-functionalized with NHS-esters (page 8, lines 5-6). The coating may include a nucleophilic cross-linking agent (page 15, lines 27-28). The nucleophilic cross-linking agent preferably contains at least 3 reactive nucleophilic groups (page 16, lines 1-2). Examples of nucleophilic cross-linking agents include nucleophilically activated POX (NU-POX), chitosan, chitosan derivatives, and combinations thereof (page 16, lines 17-19). As noted in the specification on page 22, line 10, NU-POX is poly(2-ethyl/aminoethylamidoethyl-2-oxazoline) copolymer). The EL-POX coating typically represents 5-75% of the haemostatic product (page 19, line 30). The EL-POX coated haemostatic product has excellent adhesive properties due to the presence of electrophilic reactive groups that are capable of reacting with e.g., amine groups that are naturally present in tissue, under the formation of covalent bonds (page 3, line 33-34 – page 4, lines 1-2).
Bender 1 differs from the instant claims insofar as not disclosing wherein the EL-POX and the nucleophilic cross-linking agent are present together in a particle and wherein the particles are distributed within the interstitial space.
However, Sehl discloses a crosslinkable, biocompatible, adhesive composition comprising a hydrophilic polymer, a crosslinkable component A having m nucleophilic groups, and a crosslinkable component B having n electrophilic groups (¶ [0020]). Each of the crosslinkable components may be polymeric. Alternatively, one or two of the crosslinkable components A and B may be a low molecular weight crosslinking agent (¶ [0021]). The crosslinkable composition can be coated on a suitable fibrous material (¶ [0049]). The adhesive composition components may be in dry form when coated on a patch (¶ [0068]). The reactive components may be in powder form (¶ [0071]). A collagen sheet may be impregnated with the crosslinkable composition in powder form (claim 28).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have provided the electrophilically activated polyoxazoline (EL-POX) and the nucleophilic cross-linking agent of Bender 1 as a composition in powder form since this is a known and effective alternate method of providing a coating of electrophilic polymer and nucleophilic crosslinking agent to a fibrous material to form an adhesive product as taught by Sehl.
It would have been prima facie obvious to one of ordinary skill in the art to have coated the interstitial space of the mesh of Bender I with the powders since it is desirable in the art to have sheets impregnated with the electrophilic polymer and nucleophilic crosslinking agent as taught by Sehl.
The combined teachings of Bender 1 and Sehl do not disclose wherein the particles have a diameter of 0.5-100 µm and wherein particles are in the form of an agglomerate comprising electrophilic particles and nucleophilic particles.
However, Bender 2 discloses a kit for producing a biocompatible, cross-linked polymer, said kit comprising a NU-POX and an electrophilic crosslinking agent of claim 33, wherein the kit comprises a powder consisting of particles having a weight averaged mean diameter of 0.01-1000 µm, said particles including particles containing NU-POX and particles containing the electrophilic crosslinking agent (claim 43). The NU-POX and the electrophilically activated cross-linking agent may be contained in the same particles or they may be contained in different particles within the same powder (¶ [0129]).
As discussed above, it would have been obvious to one of ordinary skill in the art to have provided the electrophilically activated polyoxazoline (EL-POX) and the nucleophilic cross-linking agent of Bender 1 as a composition in powder form. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the powders as powder agglomerates comprising particles of EL-POX and particles of the nucleophilic cross-linking agent since containing NU-POX and EL-POX in the same particle is another known and effective alternate method of providing NU-POX and EL-POX particles as taught by Bender 2.
In regards to instant claim 1 reciting wherein the particles have a diameter of 0.5-100 µm, since it was known in the art that electrophilic particles and nucleophilic particles each have a diameter of 0.01-1000 µm as taught by Bender 2, combining the particles would produce a powder with a diameter that overlaps with the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
The combined teachings of Bender 1, Sehl, and Bender 2 do not teach wherein the mesh is made from poly(lactic-co-glycolic acid) (PLGA).
However, Pulapura discloses an anchorage device including a substrate having a hemostatic agent and an active pharmaceutical ingredient selectively positioned on the substrate (abstract). The substrate may be a mesh (¶ [0009]). The substrate may be formed with one or more biocompatible materials (¶ [0084]). Suitable biocompatible materials include poly(lactide-co-glycolide) (PLGA) (¶ [0087]).
Bender 1 discloses wherein the mesh is made of biocompatible polymers. Accordingly, it would have been obvious to one of ordinary skill in the art to incorporate PLGA into the mesh of Bender 1 since it is a known and effective biocompatible polymer for meshes used to provide haemostasis as taught by Pulapura.
In regards to the mesh comprising both oxidized regenerated cellulose and PLGA, since the use of various biocompatible polymers for mesh substrates are known individually by the prior art, the use of the individual species in combination would have been obvious since it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; the idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
In regards to instant claim 1 reciting a flexible sheet, since the instant specification discloses on page 10 wherein the claimed fibrous carrier structure comprises at least 50 wt. % oxidized regenerated cellulose and Bender 1 discloses substantially the same fibrous carrier structure, the product of Bender 1 would necessarily be flexible like the claimed invention.
In regards to instant claim 1 reciting a water-resistant fibrous carrier, since the product of Bender 1 absorbs blood and blood comprises mostly of water, it would have been obvious to one of ordinary skill in the art that product of Bender 1 is water-resistant.
In regards to instant claim 1 reciting a cohesive fibrous carrier, Bender 1 discloses a mesh and a mesh is a cohesive.
In regards to instant claim 1 reciting wherein the particles are present in an amount of at least 3%, this would have been obvious since Bender 1 discloses wherein the coating represents 5-75% of the haemostatic product.
In regards to instant claim 8 reciting wherein the particles comprise at least 10 wt. % of the electrophilic polymer, since Bender 1 discloses wherein EL-POX provides the haemostatic product with excellent adhesive properties, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount based on the level of adhesiveness desired. 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 experimentation. See 2144.05(II)(A).
In regards to instant claim 19, this is a product-by process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113. In the instant case, instant claim 19 recite the process of forming the particle agglomerate. As discussed in the rejection, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the powders as powder agglomerates comprising particles of EL-POX and particles of the nucleophilic cross-linking agent from the teachings of Bender 2. Thus, since powder agglomerates would have been obvious from the prior art, the claim is unpatentable even though the prior art does not disclose forming the powder agglomerate in the same manner as recited in instant claim 19.
Response to Arguments
Applicant argues that the combination of NU-Pox particles with an electrophilically activated cross-linking agent produces a physical mixture rather than an agglomerate, which possesses distinctly different morphological characteristics.
The Examiner does not find Applicant’s argument to be persuasive. Bender 2 does not teach merely mixing NU-Pox particles with an electrophilically activated cross-linking agent to form a physical mixture. As discussed in the rejection, Bender 2 teaches the NU-POX and the electrophilically activated cross-linking agent contained in the same particle. As discussed in the advisory action, as Applicant has pointed out, an agglomerate is a granule that comprises two or more particles that are bound together. Thus, combining NU-POX (i.e., a particle) and an electrophilically activated cross-linking agent (i.e., a particle) together in a particle (i.e., bound together) is an agglomerate. A such, an agglomerate is taught an Applicant’s argument is unpersuasive.
Applicant argues that Bender 1 attributes the enhanced properties of its tissue-adhesive haemostatic product to the liquid coating process. Accordingly, there is no motivation to modify the liquid-coated product to a fibrous carrier structure containing a dispersion of particle agglomerates in the form of reactive granules.
The Examiner does not find Applicant’s argument to be persuasive. No where in Bender 1 do they disclose that the enhanced properties are due to the coating being a liquid. To the contrary, as discussed in the rejection, Bender 1 discloses that the EL-POX coated haemostatic product has excellent adhesive properties due to the presence of electrophilic reactive groups that are capable of reacting with e.g., amine groups that are naturally present in tissue, under the formation of covalent bonds (page 3, line 33-34 – page 4, lines 1-2). As such the enhanced properties are due to the presence of electrophilic reactive groups and not due to the coating being a liquid. As such, Applicant’s argument is unpersuasive.
2. Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Bender et al. (WO 2016/056901, Apr. 14, 2016) (hereinafter Bender 1) in view of Sehl et al. (US 2010/0233246, Sep. 16, 2010) (hereinafter Sehl), Bender et al. (US 2015/0045507, Feb, 12, 2015) (hereinafter Bender 2), Pulapura et al. (US 2017/0319756, Nov. 9, 2017) (hereinafter Pulapura), and further in view of Arthur et al. (US 20130337036, Dec. 19, 2013) (hereinafter Arthur).
The teachings of Bender 1, Sehl, Bender 2, and Pulapura are discussed above. Bender 1, Sehl, Bender 2, and Pulapura do not teach wherein the fibers of the mesh have a mean diameter of 1-500 µm and wherein the mesh is a felt structure.
However, Arthur discloses a fibrous tissue sealant in the form of an anhydrous fibrous sheet comprising a first component which is a fibrous polymer containing electrophilic or nucleophilic groups and a second component capable of crosslinking the first component when the sheet is exposed to an aqueous medium. The fibrous tissue sealant may be useful as a general tissue adhesive for medical applications (abstract). The fibrous polymer sheet may have a fiber diameter of about 1-3 µm (¶ [0187]). The fibers may be laid down to give a fine felt (¶ [0220]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the fibers of the mesh to have a diameter of about 1-3 µm since Bender 1 does not disclose a fiber diameter for the mesh and this is a known and effective diameter for fibers forming a sheet for tissue adhesion as taught by Arthur.
Bender 1 discloses wherein a mesh is a sheet made of fibers. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have laid down the fibers to give a fine felt since this is another known and effective configuration to formulate a sheet for tissue adhesion as taught by Arthur.
Response to Arguments
Applicant argues that Arthur does not remedy the deficiencies of Bender 1, Sehl, and Bender 2.
The Examiner submits that arguments regarding Bender 1, Sehl, and Bender 2 have been discussed above and are unpersuasive. Therefore, the rejection is maintained.
3. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Bender et al. (WO 2016/056901, Apr. 14, 2016) (hereinafter Bender 1) in view of Sehl et al. (US 2010/0233246, Sep. 16, 2010) (hereinafter Sehl), Bender et al. (US 2015/0045507, Feb, 12, 2015) (hereinafter Bender 2), Pulapura et al. (US 2017/0319756, Nov. 9, 2017) (hereinafter Pulapura), and further in view of Nur et al. (US 2011/0045034, Feb. 24, 2011) (hereinafter Nur).
The teachings of Bender 1, Sehl, Bender 2, and Pulapura are discussed above. Bender 1, Sehl, and Bender 2, and Pulapura do not teach wherein the product is in a sealed package.
However, Nur discloses a sealed package containing a sterile ready to use cross-linked gelatin sponge, which enables removal of the patch without contamination (¶ [0116]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have the product in a sealed package in order to avoid contamination as taught by Nur.
Response to Arguments
Applicant argues that Nur does not remedy the disclosure deficiencies of Bender 1, Sehl, and Bender 2.
The Examiner submits that arguments regarding Bender 1, Sehl, and Bender 2 have been addressed above and are unpersuasive. Therefore, this rejection is maintained.
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 1-4, 7, 8, 10, 12, 13 and 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16, 27 and 28 of copending Application No. 17/573,537 (reference application) in view of Bender et al. (WO 2016/056901, Apr. 14, 2016) (hereinafter Bender 1) and Pulapura et al. (US 2017/0319756, Nov. 9, 2017) (hereinafter Pulapura). The pending claims differ from the copending claims insofar as reciting wherein the fiberous carrier comprises oxidized cellulose and PLGA. However, Bender discloses a tissue-adhesive haemostatic product coated with an electrophilically activated polyoxazoline (EL-POX) containing at least 2 reactive electrophilic groups, wherein the product is a coated mesh. The fibres contained in the mesh are preferably made of biocompatible polymers, like oxidized regenerated cellulose (page 12, lines 22-24). Pulapura discloses an anchorage device including a substrate having a hemostatic agent and an active pharmaceutical ingredient selectively positioned on the substrate (abstract). The substrate may be a mesh (¶ [0009]). The substrate may be formed with one or more biocompatible materials (¶ [0084]). Suitable biocompatible materials include poly(lactide-co-glycolide) (PLGA) (¶ [0087]). Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated oxidized cellulose and PLGA into the pending claimed composition since these are known and effective materials for forming a fibrous carrier as taught by Bender and Pulapura.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s argument has been considered but is moot because a new rejection necessitated by Applicant’s amendment has been made.
Conclusion
Claims 1-4, 7, 8, 10, 12, 13 and 16-19 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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