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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 21, 2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 39-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims embrace a configuration of components that was not discussed in the original disclosure. It is not clear that the full scope of a hemostatic matrix powder composed of oxidized cellulose, polyethylene glycol and trilysine was contemplated with particles dispersed therein, where the particles comprise a biodegradable polymer with rifampin and minocycline, as recited in claim 39 (e.g., hemostatic matrix powder encapsulating rifampin/minocycline containing particles). Claim 40 recites a hemostatic matrix composed of oxidized cellulose, polyethylene glycol and trilysine with particles dispersed therein, where the particles comprise tyrosine-derived polyarylate, rifampin and minocycline whose full scope also was not clearly contemplated. The specification discusses converting an oxidized cellulose substrate coated with polyethylene glycol and trilysine into a powder as well as converting a coating composed of tyrosine-derived polyarylate with dispersed antimicrobial agents into a powder and mixing the two powders (see paragraphs 47-48). It is not clear that other configurations of particles comprising biodegradable polymer, rifampin and minocycline dispersed in a hemostatic matrix of oxidized cellulose, polyethylene glycol and trilysine were contemplated in the original disclosure. The applicant’s most recent remarks argue that prior art does not teach the claimed invention and assert that it does not teach “embedding drug-polymer particles within a hemostatic matrix”. The specification mentions “hemostatic matrix” three times, but does not recite the term ”embed” in reference to its combination with other coating components. In addition, the claimed hemostatic matrix requires three components, but the disclosure does not specify how the three components are arranged relative to drug-polymer particles also present, other than as a blend of powders of hemostatic matrix and drug-polymer particles. Instead, the specification recites “[b]y mixing these particles into a hemostatic matrix, such as oxidized cellulose, it will create combinational coatings and other products for reducing bleeding and infection” (see paragraph 47). The identity of “these particles” is presumably antimicrobial agent containing polymer discussed earlier in the paragraph and the oxidized cellulose is presumably that previously discussed in the paragraph which is an oxidized cellulose substrate. The paragraph also discusses “processing” the coating into particles. However, it is not clear that the configuration of the instantly claimed particles comprising tyrosine-derived polyarylate, minocycline, and rifampin embedded in hemostatic matrix composed of oxidized cellulose, polyethylene glycol and trilysine would be the result of implementing this description of components from the specification. The applicant does not point to a particular location in the disclosure that provides basis for the scope of configurations embraced by the current claim limitations or in support of the arguments about an “embedded” arrangement. Therefore the artisan of ordinary skill would not have deemed the applicant to be in possession of the invention as instantly claimed.
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 21, 23-24, and 33-41 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 21 recites “the coating comprising a hemostatic matrix and particles comprising a biodegradable polymer and rifampin and minocycline; wherein the hemostatic matrix comprises oxidized cellulose, polyethylene glycol, and trilysine, and forms a hydrogel upon wetting, and the particles comprise a tyrosine-derived polyarylate having rifampin and minocycline dispersed therein.” It is unclear if the “forms a hydrogel upon wetting” requires the formation of a contiguous hydrogel structure amongst the oxidized cellulose, polyethylene glycol, and trilysine or if singular particles of the combination of components separately forming a hydrogel upon wetting is sufficient. The applicant’s most recent remarks argue that they view the teachings of Hardy et al. (previously cited) as not meeting the hemostatic matrix/hydrogel forming claim limitation with their chitosan particles and ground oxidized cellulose coating because they deem these particles as not forming a continuous matrix upon wetting. Such continuity in the hydrogel that can form from the hemostatic matrix components is not discussed in the instant specification, but could be embraced by the claim recitation. The applicant’s most recent arguments confusingly discount that the Veriset™ patch can fulfill the hydrogel forming limitations currently recited when taught by the prior art, but this is the same component the applicant repeatedly discusses in the specification as the source of the instant hemostatic matrix (see specification paragraphs 47-48, 50, and 154). Thus the scope of the required hydrogel forming capability is unclear
In addition to the hydrogel forming recitation present in claim 21, claims 39 and 40 additionally recite “wherein hemostatic matrix has dispersed therein particles comprising the particles comprising biodegradable polymer and rifampin and minocycline” or “the hemostatic matrix having dispersed therein particles comprising a tyrosine-derived polyarylate, rifampin, and minocycline”. Here it seems that particles comprising the minocycline and rifampin mixed into particles of hemostatic matrix could qualify as “dispersed” in the hemostatic matrix while the recitation also seems to embrace hemostatic matrix is a contiguous unit in which they are distributed or “dispersed”. Again, the applicant’s most recent remarks suggest only the latter configuration is permissible, but the specification does not clearly discuss such a configuration. Therefore the scope of this recitation is also unclear.
For the sake of compact prosecution and the application of prior art, “forms a hydrogel upon wetting” will be interpreted not to require the formation of a single contiguous hydrogel. In addition, a mixture of hemostatic matrix particles/powder comprising oxidized cellulose, polyethylene glycol, and trilysine and particles/powder comprising biodegradable polymer/tyrosine-derived polyarylate, rifampin and minocycline (B particles) will be deemed sufficient to meet the limitations of the B particles dispersed in the hemostatic matrix, when the hemostatic matrix particles/powder composes a larger weight percent in the mixture than the B particles.
Claim 39 recites “the coating comprising a powder blend of hemostatic matrix and particles, wherein the hemostatic matrix comprises oxidized cellulose, polyethylene glycol, and trilysine, and forms a hydrogel upon wetting, and wherein hemostatic matrix has dispersed therein particles”. It is unclear if the second recitation of the word “particles” is referring to the same particles recited in the powder blend earlier in the claim or if it is a different set of particles.
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.
Claims 21, 23-24, and 34-41 are rejected under 35 U.S.C. 103 as being unpatentable over Hardy et al. in view of Pulapura et al. (previously cited), Bahulekar et al. (previously cited), Serraro et al. (previously cited), and Veriset™ Haemostatic Patch reference (previously cited).
Hardy et al. teach a hemostatic material that may be applied on or in an a animal during surgery (implantable surgical device) (see paragraph 13). The device is disclosed as a carrier layer (substrate) and at least one hemostat present in the form of five possible particulate varieties, most of which can also be considered powders (see claim 1). The carrier is a woven or non-woven material envisioned in sheet forms and is envisioned as various degradable materials such as oxidized cellulose and polylactide (see paragraph 44; instant claim 35). The carrier is coated with the hemostat, where the hemostat is recited to be one or more hemostats and to include an inert additive that is also a hemostat (see paragraphs 53-55 and claims 3 and 7). An example combines ground oxidized regenerated cellulose as an inert additive hemostat and granules of a chitosan based hemostat, then applies them to a substrate as a coating that is adhered via a meltable bonding net or due to combination with a meltable bonding agent powder (see paragraph 67 and examples 6-7). This combination of chitosan powder and oxidized regenerated cellulose powder is a hemostatic matrix (see instant claim 21). Hardy et al. teaches that the chitosan forms a gel (hydrogel) upon wetting and the basis of function of the hemostatic coating is predicated upon gel formation due to wetting with blood (see paragraphs 32 and 47-49). The coating is a powdered coating adhered to a substrate (see instant claim 34 and 39). Therefore, the hemostatic matrix of Hardy et al. forms a hydrogel upon wetting due to the gel forming capabilities of at least the chitosan powder portion. Hardy et al. also detail ground Surgicel® as the ground oxidized regenerated cellulose (see example 7). Additionally, the chitosan is taught to have mild antibacterial properties (see paragraph 34). The presence of trilysine and polyethylene glycol is not explicitly detailed nor is the presence of minocycline and rifampin.
Serraro et al. teach oxidized cellulose implants for use as hemostats (see abstract and paragraphs 12-15). They detail the utility of Surgicel® and Veriset™ as known commercial oxidized cellulose products in this capacity due to their similarity (see paragraph 31). The Veriset™ Haemostatic Patch reference details that Veriset™ is a hemostatic patch composed of oxidized regenerated cellulose, trilysine, and polyethylene glycol (see page 3).
Pulapura et al. teach an implantable hemostatic device that is structured as a fabric, mesh, or envelope substrate coated with a hemostatic agent and/or an active pharmaceutical ingredients (see paragraphs 3-5 and 85; instant claims 21, 36-37, and 39-40). The substrate is woven or non-woven (see paragraph 85). Example 10 details a mesh coated in at least one hemostat. The example then details a biodegradable mesh coated in a tyrosine polymer that contains minocycline, rifampin, and is subsequently coated with chitosan. Oxidized regenerated cellulose is taught as an envisioned hemostatic agent and the inclusion of components such as polyethylene glycol as part of the hemostatic agent is also detailed (see paragraph 93 and claim 4). Further, Pulapura et al. also exemplify the combination of oxidized regenerated cellulose with tyrosine polymer that contains minocycline and rifampin (see example 3).
Bahulekar et al. teach particles composed of a tyrosine-derived polyarylate in which the antibacterial agents minocycline and rifampin are dispersed (see paragraphs 205-207, example 7, and claims 1-6, 8, 42,and 45; instant claims 23-24, and 38). They prepare a paste form of the particles in polyethylene glycol (see example 4). This polymer and others that are named permit added control over the extended release provided by the particles and is envisioned for antibacterial use at a surgical site (see paragraphs 25-28 and 291 and claim 1). They show that the cumulative release of rifampin and minocycline is lower when a lower proportion of the drugs are present in a particle containing composition, making the amount of these drugs provided by the particles a result effective variable (see examples 5 and 6-1 and figures 1-2). Bahulekar et al. additionally teach blending additional polymers with the tyrosine-derived polyarylate (see paragraph 208 and example 1). The envisioned polymers include poly(lactide-co-glycolide) (PLGA) (see paragraph 208; instant claim 41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to grind Veriset™ instead of Surgicel® to produce the oxidized regenerated cellulose in the powder coated substrate of Hardy et al. This modification would have been obvious because Serraro et al. teach them as known alternative oxidized regenerated cellulose webs, thus the modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The result is a hemostatic matrix particle expected to be composed of oxidized regenerated cellulose, trilysine and polyethylene glycol, in light of the Veriset™ Haemostatic Patch reference which details its constituents (see instant claims 22, 29, 31, and 39-40). It additionally would have been obvious to include antibacterial actives, namely minocycline and rifampin in the powdered mixture of hemostats coated on the substrate of Hardy et al. This choice would have been obvious because Hardy et al. desire antibacterial functionality in their powdered coating, given that they note chitosan provides a mild degree of it. Further, Pulapura et al. teach that the combination is already known in a coating with chitosan and oxidized regenerated cellulose on a hemostatic composite substrate. Additionally, Bahulekar et al. teaches minocycline and rifampicin in the same tyrosine polyacrylate that Pulapura et al. employ for the combination, but configure the polymer and two antibacterial actives in particle form. This particle form is directly compatible with the coating material of Hardy et al. because it is in particle form. Thus the addition of the minocycline and rifampicin containing tyrosine polyacrylate microparticles of Bahulekar et al. to the hemostatic mixture of chitosan particles and ground Veriset™ coated onto the substrate of Hardy et al. would have been obvious. This modification is also obvious as the application of the same technique to a similar product in order to yield the same improvement. The particular amount of the minocycline and rifampin containing particles in the coating would be a matter of routine optimization. To maintain the functionality of the coating of Hardy et al., including them in an amount such that their presence does not outweigh that of the hemostatic coating would have been obvious. This choice of a range of proportions also would have been obvious because Hardy et al. already envision the chitosan providing some antibacterial properties thus the minocycline and rifampin would be a supplement that provides additional antibacterial properties to a degree as desired by the artisan. Such a configuration then provides a coating that is the particles comprising tyrosine-derived polyarylate (biodegradable polymer), minocycline, and rifampin dispersed in a hemostatic matrix comprising oxidized cellulose, polyethylene glycol and trilysine (see instant claims 39 and 40). Application of this coating to a carrier envisioned by Hardy et al., such as oxidized cellulose, would follow. It also would have been obvious to configure this coated substrate of Hardy et al. as an envelope configuration or employ a mesh substrate, as taught by Pulapura et al., because these substrate options/configurations are employed with hemostatic coatings for surgical applications. It further would have been obvious to include PLGA in the tyrosine-derived polyarylate microparticles because Bahulekar et al. suggests to do so. Therefore claims 21, 23-24, and 34-41 are obvious over Hardy et al. in view of Pulapura et al., Bahulekar et al., Serraro et al., and Veriset™ Haemostatic Patch reference.
Claims 21, 23-24, 33, and 36-41 are rejected under 35 U.S.C. 103 as being unpatentable over FMC (previously cited) in view of Pulapura et al., Bahulekar et al., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference.
FMC teaches powdered oxidized cellulose as a hemostatic wound dressing material (see page 1 lines 63-69). The powdered material may be combined with water to form a gel (forms hydrogel upon wetting) or paste alone or may be included on a carrier (see page 2 lines 32-40 and page 4 lines 4-37; instant claims 33-34). An example details regenerated cellulose that is oxidized to yield the desired powder (see page 4 lines 84-115). In addition, FMC teaches applying the spreadable forms (gel and paste) to a substrate (see example I). Minocycline and rifampicin in particle form with biodegradable polymer is not detailed.
Pulapura et al. teach an implantable hemostatic device that is structured as a mesh or envelope substrate coated with a hemostatic agent and/or active pharmaceutical ingredients (see paragraphs 3-5 and 85; instant claims 36-37). Hemostatic agents are taught individually and in combination and are contemplated to include oxidized regenerated cellulose (see paragraph 93; instant claims 21 and 38). Pulapura et al. also teach an example with a mesh coated in a mixture of a tyrosine-derived polyarylate polymer that contains minocycline, rifampin, and a particulate hemostatic agent (see example 11). They teach the contemplated hemostatic agents to include chitosan as well as a polymer such as organic regenerated cellulose and may be present in combination (see paragraph 166; instant claim 21). It is noted that the recitation of “organic regenerated cellulose” may be in error, given that all the other discussions of a regenerated cellulose as a hemostatic agent states oxidized not organic. Further, oxidized regenerated cellulose and chitosan are taught as envisioned hemostatic agents (see paragraph 93 and claim 4). Example 10 details a mesh coated in at least one hemostat. The example then details a biodegradable mesh coated in a tyrosine-derived polyarylate polymer that contains minocycline, rifampin, and is subsequently coated with chitosan. The inclusion of chitosan as a slab layer or as a particle member of a coating indicates the exchangeability of such configurations in these hemostatic structures. In addition, the inclusion of minocycline and rifampicin an a polymer matrix shows the recognized utility of this approach for their inclusion in hemostatic compositions.
Bahulekar et al. teach particles composed of a tyrosine-derived polyarylate in which the antibacterial agents minocycline and rifampin are dispersed (see paragraphs 205-207, example 7, and claims 1-6, 8, 42,and 45; instant claim 38). They prepare a paste form of the particles in polyethylene glycol (see example 4). This polymer and others that are named permit added control over the extended release provided by the particles and is envisioned for antibacterial use at a surgical site (see paragraphs 25-28 and 291 and claim 1). They show that the cumulative release of rifampin and minocycline is lower when a lower proportion of the drugs are present in a particle containing composition, making the amount of these drugs provided by the particles a result effective variable (see examples 5 and 6-1 and figures 1-2). Bahulekar et al. additionally teach blending additional polymers with the tyrosine-derived polyarylate (see paragraph 208 and example 1). The envisioned polymers include poly(lactide-co-glycolide) (PLGA) (see paragraph 208; instant claim 41).
Hardy et al. teach a hemostatic material that may be applied on or in an a animal during surgery (implantable surgical device) (see paragraph 13). The device is disclosed as a carrier layer (substrate) and at least one hemostat present (see claim 1). The carrier is coated with the hemostat and the hemostat is recited to be a mixture of two hemostats (see claims 3 and 7). An example combines ground oxidized regenerated cellulose as a hemostat (hemostatic matrix) and granules of a chitosan based hemostat (particles) (see paragraph 67 and examples 6-7). Specifically, they detail ground Surgicel® as the ground oxidized regenerated cellulose (see example 7). Hardy et al. also described ground oxidized regenerated cellulose as a hemostat that gels within the 30 seconds to a minute of application to a bleeding wound (forms hydrogel upon forming) (see paragraphs 55-56).
Serraro et al. teach oxidized cellulose implants for use as hemostats (see abstract and paragraphs 12-15). They detail the utility of Surgicel® and Veriset™ as known commercial oxidized cellulose products in this capacity due to their similarity (see paragraph 31). The Veriset™ Haemostatic Patch reference details that Veriset™ is a hemostatic patch composed of oxidized regenerated cellulose, trilysine, and polyethylene glycol (see page 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the minocycline and rifampicin microparticles of Bahulekar et al. to the oxidized cellulose paste on a carrier embodiment of FMC. This modification would have been obvious in light of Pulapura et al. who teach the recognized desire for this combination of antibacterial agents in a polymer matrix and mixed along with oxidized cellulose in a hemostatic composition/preparation. The particle version of these antibacterial agents integrates readily into the paste of FMC that already includes a powder component in the form of the oxidized cellulose. Further, Pulapura et al. suggest that active components in a coating that are part of a hemostatic carrier/web can be employed in slab/layer form or particle form in their discussion of different configurations of chitosan. The modification is also obvious as the application of the same technique to a similar product in order to yield the same improvement (e.g. inclusion of antibacterial combination in a polymer matrix). It additionally would have been obvious to provide ground Veriset™ as the oxidized cellulose in the product because Hardy et al. teach ground Surgicel® regenerated oxidized cellulose as the source of oxidized cellulose as a hemostatic agent for application to surgical sites. In addition, Serraro et al. teach Surgicel® and Veriset™ as known alternative oxidized regenerated cellulose webs. Thus their exchange would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The result is a hemostatic matrix particle that forms a hydrogel upon wetting composed of oxidized regenerated cellulose, trilysine and polyethylene glycol, in light of the Veriset™ Haemostatic Patch reference which details its constituents. The particular amount of the minocycline and rifampin containing particles would be a matter of routine optimization. To maintain the functionality of the coating of FMC, their inclusion amount such that their presence does not outweigh that of the hemostatic oxidized cellulose would have been obvious. This choice of a range of proportions also would have been obvious because Hardy et al. suggest the benefit of hemostatic and antibacterial properties in hemostatic coatings because they note that the chitosan in their coating provides both. Such a configuration then provides a coating that is the particles of comprising tyrosine-derived polyarylate (biodegradable polymer), minocycline, and rifampin dispersed in a hemostatic matrix comprising oxidized cellulose, polyethylene glycol and trilysine (see instant claims 39 and 40). An envelope or mesh substrate as detailed by Pulapura et al. would also have been an obvious known alternative substrate for such hemostatic compositions. It further would have been obvious to include PLGA in the tyrosine-derived polyarylate microparticles because Bahulekar et al. suggest to do so. Therefore claims 21, 23-24, 33, and 36-41 are obvious over FMC in view of Pulapura et al., Bahulekar et al., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference.
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.
Non-provisional
Claims 21, 23-24, 34, 36, 38, and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, and 9-10 of U.S. Patent No. 12,133,936 in view of Pulapura et al., Bahulekar et al., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite an implantable surgical device comprising an envelope substrate which is coated. The patented claims recite pharmaceutical agent in the coating envisioned as being selected from rifampin minocycline, hemostatic material, and their mixtures. The patented claims recite oxidized cellulose as the hemostatic material as well as a tyrosine-derived polyarylate in the coating. Particles present along with a hemostatic matrix are not explicitly recited.
Pulapura et al. teach an implantable hemostatic device that is structured as a envelope that can be composed of mesh coated with a hemostatic agent and/or active pharmaceutical ingredients (see paragraphs 3-5 and 85). An example is detailed with a mesh coated in a mixture of tyrosine-derived polyarylate that contains minocycline, rifampin, and a particulate hemostatic agent (see example 11). They teach the contemplated hemostatic agents to organic (oxidized) regenerated cellulose and they may be present in combination (see paragraph 166).
Bahulekar et al. teach particles composed of a tyrosine-derived polyarylate in which the antibacterial agents minocycline and rifampin are dispersed (see paragraphs 205-207, example 7, and claims 1-6, 8, 42, and 45; instant claims 23-26 and 38). They prepare a paste form of the particles in polyethylene glycol (see example 4). This polymer and others that are named permit added control over the extended release provided by the particles and is envisioned for antibacterial use at a surgical site (see paragraphs 25-28 and 291 and claim 1). Bahulekar et al. additionally teach blending additional polymers with the tyrosine-derived polyarylate (see paragraph 208 and example 1). The envisioned polymers include poly(lactide-co-glycolide) (PLGA) (see paragraph 208; instant claims 41).
Hardy et al. teach a hemostatic material that may be applied on or in an a animal during surgery (implantable surgical device) (see paragraph 13). The device is disclosed as a carrier layer (substrate) and at least one hemostat present (see claim 1). The carrier is coated with the hemostat and the hemostat is recited to be a mixture of two hemostats (see claims 3 and 7). An example combines ground oxidized regenerated cellulose as a hemostat (hemostatic matrix) and granules of a chitosan based hemostat (particles) (see paragraph 67 and examples 6-7). Specifically, they detail ground Surgicel® as the ground oxidized regenerated cellulose (see example 7). Hardy et al. also described ground oxidized regenerated cellulose as a hemostat that gels within the 30 seconds to a minute of application to a bleeding wound (forms hydrogel upon forming) (see paragraphs 55-56).
Serraro et al. teach oxidized cellulose implants for use as hemostats (see abstract and paragraphs 12-15). They detail the utility of Surgicel® and Veriset™ as known commercial oxidized cellulose products in this capacity due to their similarity (see paragraph 31). The Veriset™ Haemostatic Patch reference details that Veriset™ is a hemostatic patch composed of oxidized regenerated cellulose, trilysine, and polyethylene glycol (see page 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the coated implantable envelope of the patented claims with oxidized regenerated cellulose in combination with the minocycline and rifampin in the coating. This modification would have been obvious because their short listing of components lists them as options for the pharmaceutical active agent where their combinations are also envisioned. In addition, Pulapura et al. teach the combination of rifampicin, minocycline, and a particle hemostat envisioned to be oxidized regenerated cellulose which further supports the obviousness of their combination. It additionally would have been obvious to provide ground Veriset™ as the oxidized cellulose in the product because Hardy et al. teach ground Surgicel® regenerated oxidized cellulose as the source of oxidized cellulose as a hemostatic agent for application to surgical sites. In addition, Serraro et al. teach Surgicel® and Veriset™ as known alternative oxidized regenerated cellulose webs. Thus their exchange would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The result is a hemostatic matrix particle that forms a hydrogel upon wetting composed of oxidized regenerated cellulose, trilysine and polyethylene glycol, in light of the Veriset™ Haemostatic Patch reference which details its constituents. The configuration of the envelope as a mesh also would have been obvious as a known form in light of Pulapura et al. as well. Additionally, it would have been to select the particles of Bahulekar et al. to provide the minocycline and rifampin recited by the patented claims. This modification would have been obvious because tyrosine-derived polyarylate is already recited in the coating and as the application of the same technique to a similar product in order to yield the same improvement, namely more control over extended release. It further would have been obvious to include PLGA in the tyrosine-derived polyarylate microparticles from Bahulekar et al. because they suggest to do so. Therefore claims 21, 23-24, 34, 36, 38, and 41 are obvious over claims 1, 4-5, and 9-10 of U.S. Patent No. 12,133,936 in view of Pulapura et al., Bahulekar et al., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference.
Claims 21, 24, 35-36, 38 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Patent No. 12,168,085 in view of Pulapura et al., Bahulekar et al., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite an implantable surgical device comprising an envelope substrate which is coated with a polymer in which a hemostatic material is dispersed. The patented claims recite the presence of rifampicin and minocycline. Oxidized regenerated cellulose is not explicitly recited as an option for the hemostatic material.
Pulapura et al. teach an implantable hemostatic device that is structured as a envelope that can be composed of mesh coated with a hemostatic agent and/or active pharmaceutical ingredients (see paragraphs 3-5 and 85; instant claims 36-37). Hemostatic agents are taught individually and in combination and are contemplated to include oxidized regenerated cellulose and tranexamic acid (see paragraph 93). An example is detailed with a mesh coated in a mixture of tyrosine-derived polyarylate that contains minocycline, rifampin, and a particulate hemostatic agent (see example 11). Pulapura et al. also teach the substrate to be composed of oxidized/organic regenerated cellulose (see paragraphs 171 and 178-186).
Bahulekar et al. teach particles composed of a tyrosine-derived polyarylate in which the antibacterial agents minocycline and rifampin are dispersed (see paragraphs 205-207, example 7, and claims 1-6, 8, 42, and 45; instant claims 23-26 and 38). They prepare a paste form of the particles in polyethylene glycol (see example 4). This polymer and others that are named permit added control over the extended release provided by the particles and is envisioned for antibacterial use at a surgical site (see paragraphs 25-28 and 291 and claim 1). Bahulekar et al. additionally teach blending additional polymers with the tyrosine-derived polyarylate (see paragraph 208 and example 1). The envisioned polymers include poly(lactide-co-glycolide) (PLGA) (see paragraph 208; instant claims 41).
Hardy et al. teach a hemostatic material that may be applied on or in an a animal during surgery (implantable surgical device) (see paragraph 13). The device is disclosed as a carrier layer (substrate) and at least one hemostat present (see claim 1). The carrier is coated with the hemostat and the hemostat is recited to be a mixture of two hemostats (see claims 3 and 7). An example combines ground oxidized regenerated cellulose as a hemostat (hemostatic matrix) and granules of a chitosan based hemostat (particles) (see paragraph 67 and examples 6-7). Specifically, they detail ground Surgicel® as the ground oxidized regenerated cellulose (see example 7). Hardy et al. also described ground oxidized regenerated cellulose as a hemostat that gels within the 30 seconds to a minute of application to a bleeding wound (forms hydrogel upon forming) (see paragraphs 55-56).
Serraro et al. teach oxidized cellulose implants for use as hemostats (see abstract and paragraphs 12-15). They detail the utility of Surgicel® and Veriset™ as known commercial oxidized cellulose products in this capacity due to their similarity (see paragraph 31). The Veriset™ Haemostatic Patch reference details that Veriset™ is a hemostatic patch composed of oxidized regenerated cellulose, trilysine, and polyethylene glycol (see page 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the coated implantable envelope of the patented claims where oxidized regenerated cellulose is the hemostatic material. This modification would have been obvious as in light of Pulapura et al. who teach it as a hemostatic material on a similar envelope. The selection of oxidized regenerated cellulose as the substrate also would have been obvious because it is a particular variety of substrate that is exemplified by Pulapura et al. It additionally would have been obvious to provide ground Veriset™ as the oxidized cellulose in the product because Hardy et al. teach ground Surgicel® regenerated oxidized cellulose as the source of oxidized cellulose as a hemostatic agent for application to surgical sites. In addition, Serraro et al. teach Surgicel® and Veriset™ as known alternative oxidized regenerated cellulose webs. Thus their exchange would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The result is a hemostatic matrix particle that forms a hydrogel upon wetting composed of oxidized regenerated cellulose, trilysine and polyethylene glycol, in light of the Veriset™ Haemostatic Patch reference which details its constituents. Additionally, it would have been to select the particles of Bahulekar et al. to provide the minocycline and rifampin recited by the patented claims. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement, namely more control over extended release. It further would have been obvious to include PLGA in the tyrosine-derived polyarylate microparticles from Bahulekar et al. because they suggest to do so. Therefore claims 21, 24, 35-36, 38 and 41 are obvious over claims 1 and 11 of U.S. Patent No. 12,168,085 in view of Pulapura et al., Bahulekar et al., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference.
Claims 21, 23-24, 34, 37-38, and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14-15, and 17-19 of U.S. Patent No. 10,736,998 in view of Bahulekar et al., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite an implantable surgical device comprising a mesh substrate which is to be coated with a hemostatic material. The patented claims recite the hemostatic material to be at least one of a listing that includes oxidized regenerated cellulose, polyethylene glycol, and polysaccharide spheres. In addition, the patented claims recite the presence of minocycline and rifampin in tyrosine polyester in the coating. The presence of minocycline and rifampin in a particle is not detailed.
Bahulekar et al. teach particles composed of a tyrosine-derived polyarylate that is a polyesteramide in which the antibacterial agents minocycline and rifampin are dispersed (see paragraphs 205-207, example 7, and claims 1-6, 8, 42, and 45; instant claims 23-26 and 38). They prepare a paste form of the particles in polyethylene glycol (see example 4). This polymer and others that are named permit added control over the extended release provided by the particles and is envisioned for antibacterial use at a surgical site (see paragraphs 25-28 and 291 and claim 1). Bahulekar et al. additionally teach blending additional polymers with the tyrosine-derived polyarylate (see paragraph 208 and example 1). The envisioned polymers include poly(lactide-co-glycolide) (PLGA) (see paragraph 208; instant claims 41).
Hardy et al. teach a hemostatic material that may be applied on or in an a animal during surgery (implantable surgical device) (see paragraph 13). The device is disclosed as a carrier layer (substrate) and at least one hemostat present (see claim 1). The carrier is coated with the hemostat and the hemostat is recited to be a mixture of two hemostats (see claims 3 and 7). An example combines ground oxidized regenerated cellulose as a hemostat (hemostatic matrix) and granules of a chitosan based hemostat (particles) (see paragraph 67 and examples 6-7). Specifically, they detail ground Surgicel® as the ground oxidized regenerated cellulose (see example 7). Hardy et al. also described ground oxidized regenerated cellulose as a hemostat that gels within the 30 seconds to a minute of application to a bleeding wound (forms hydrogel upon forming) (see paragraphs 55-56).
Serraro et al. teach oxidized cellulose implants for use as hemostats (see abstract and paragraphs 12-15). They detail the utility of Surgicel® and Veriset™ as known commercial oxidized cellulose products in this capacity due to their similarity (see paragraph 31). The Veriset™ Haemostatic Patch reference details that Veriset™ is a hemostatic patch composed of oxidized regenerated cellulose, trilysine, and polyethylene glycol (see page 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the coated implantable envelope of the patented claims with oxidized regenerated cellulose or polysaccharide spheres as the hemostatic agent because they recite these components as options in this category. It additionally would have been obvious to provide ground Veriset™ as the oxidized cellulose in the product because Hardy et al. teach ground Surgicel® regenerated oxidized cellulose as the source of oxidized cellulose as a hemostatic agent for application to surgical sites. In addition, Serraro et al. teach Surgicel® and Veriset™ as known alternative oxidized regenerated cellulose webs. Thus their exchange would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The result is a hemostatic matrix particle that forms a hydrogel upon wetting composed of oxidized regenerated cellulose, trilysine and polyethylene glycol, in light of the Veriset™ Haemostatic Patch reference which details its constituents. It also would have been obvious to select the particles of Bahulekar et al. to provide the minocycline and rifampin recited by the patented claims. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement and the simple substitution of one known element for another in order to yield a predictable outcome. It further would have been obvious to include PLGA in the tyrosine-derived polyarylate microparticles from Bahulekar et al. because they suggest to do so. Therefore claims 21, 23-24, 34, 37-38, and 41 are obvious over claims 1, 14-15, and 17-19 of U.S. Patent No. 10,736,998 in view of Bahulekar et al., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference.
Claims 21, 23-24, 34, 36-38, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over claims 1, 14-15, and 17-19 of U.S. Patent No. 10,736,998 in view of Bahulekar et al., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference as applied to claims 21, 23-24, 34, 37-38, and 41 above, and further in view of Pulapura et al..
Claims 1, 14-15, and 17-19 of U.S. Patent No. 10,736,99 in view of Bahulekar et al. render obvious the limitations of instant claim 21, 23-24, 26, 36, 38, and 41. The configuration substrate coated with hemostatic matrix rifampin and minocycline as an envelope is not detailed.
Pulapura et al. teach an implantable hemostatic device that is structured as a mesh or envelope substrate coated with a hemostatic agent and/or active pharmaceutical ingredients (see paragraphs 3-5 and 85). Hemostatic agents are taught individually and in combination and are contemplated to include oxidized regenerated cellulose and tranexamic acid (see paragraph 93). An example is detailed with a mesh coated in a mixture of tyrosine-derived polyarylate that contains minocycline, rifampin, and a particulate hemostatic agent (see example 11). Pulapura et al. also teach the substrate to be composed of oxidized/organic regenerated cellulose (see paragraphs 171 and 178-186).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the substrate of the product rendered obvious by the modified copending claims as an envelope because Pulapura et al. teach it as a known alternative to mesh that is coated with a similar combination of components. Therefore 21, 23-24, 34, 36-38, and 41 are obvious over claims 1, 14-15, and 17-19 of U.S. Patent No. 10,736,998 in view of Bahulekar et al., Hardy et al., Serraro et al., the Veriset™ Haemostatic Patch reference, and Pulapura et al.
Provisional
The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 21, 23-24, 34, 36, 38, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 18 of copending Application No. 17/142712 (reference application) in view of Pulapura et al. in view of Pulapura et al., Bahulekar et al., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite an implantable surgical device comprising a mesh envelope substrate which is coated with a polymer in which a hemostatic material is present. Oxidized regenerated cellulose is not explicitly recited as an option for the hemostatic material and minocycline an rifampicin are not recited components.
Pulapura et al. teach an implantable hemostatic device that is structured as a envelope that can be composed of mesh coated with a hemostatic agent and/or active pharmaceutical ingredients (see paragraphs 3-5 and 85; instant claims 36-37). Hemostatic agents are taught individually and in combination and are contemplated to include oxidized regenerated cellulose and tranexamic acid (see paragraph 93). An example is detailed with a mesh coated in a mixture of tyrosine-derived polyarylate that contains minocycline, rifampin, and a particulate hemostatic agent (see example 11). Pulapura et al. also teach the substrate to be composed of oxidized/organic regenerated cellulose (see paragraphs 171 and 178-186).
Bahulekar et al. teach particles composed of a tyrosine-derived polyarylate in which the antibacterial agents minocycline and rifampin are dispersed (see paragraphs 205-207, example 7, and claims 1-6, 8, 42, and 45; instant claims 23-26 and 38). They prepare a paste form of the particles in polyethylene glycol (see example 4). This polymer and others that are named permit added control over the extended release provided by the particles and is envisioned for antibacterial use at a surgical site (see paragraphs 25-28 and 291 and claim 1). Bahulekar et al. additionally teach blending additional polymers with the tyrosine-derived polyarylate (see paragraph 208 and example 1). The envisioned polymers include poly(lactide-co-glycolide) (PLGA) (see paragraph 208; instant claims 41).
Hardy et al. teach a hemostatic material that may be applied on or in an a animal during surgery (implantable surgical device) (see paragraph 13). The device is disclosed as a carrier layer (substrate) and at least one hemostat present (see claim 1). The carrier is coated with the hemostat and the hemostat is recited to be a mixture of two hemostats (see claims 3 and 7). An example combines ground oxidized regenerated cellulose as a hemostat (hemostatic matrix) and granules of a chitosan based hemostat (particles) (see paragraph 67 and examples 6-7). Specifically, they detail ground Surgicel® as the ground oxidized regenerated cellulose (see example 7). Hardy et al. also described ground oxidized regenerated cellulose as a hemostat that gels within the 30 seconds to a minute of application to a bleeding wound (forms hydrogel upon forming) (see paragraphs 55-56).
Serraro et al. teach oxidized cellulose implants for use as hemostats (see abstract and paragraphs 12-15). They detail the utility of Surgicel® and Veriset™ as known commercial oxidized cellulose products in this capacity due to their similarity (see paragraph 31). The Veriset™ Haemostatic Patch reference details that Veriset™ is a hemostatic patch composed of oxidized regenerated cellulose, trilysine, and polyethylene glycol (see page 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the coated implantable envelope of the copending claims where oxidized regenerated cellulose is the hemostatic material. This modification would have been obvious as in light of Pulapura et al. who teach it as a hemostatic material on a similar envelope. The selection of oxidized regenerated cellulose as the substrate also would have been obvious because it is a particular variety of substrate that is exemplified by Pulapura et al. It additionally would have been obvious to provide ground Veriset™ as the oxidized cellulose in the product because Hardy et al. teach ground Surgicel® regenerated oxidized cellulose as the source of oxidized cellulose as a hemostatic agent for application to surgical sites. In addition, Serraro et al. teach Surgicel® and Veriset™ as known alternative oxidized regenerated cellulose webs. Thus their exchange would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The result is a hemostatic matrix particle that forms a hydrogel upon wetting composed of oxidized regenerated cellulose, trilysine and polyethylene glycol, in light of the Veriset™ Haemostatic Patch reference which details its constituents. Additionally, it would have been to include minocycline and rifampicin via the particles of Bahulekar et al. in light of the teachings of Pulapura et al. to include them in combination with a hemostatic agent in a coating. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement, namely more control over extended release. It further would have been obvious to include PLGA in the tyrosine-derived polyarylate microparticles from Bahulekar et al. because they suggest to do so. Therefore claims 21, 23-24, 34, 36, 38, and 41 are obvious over claims 10 and 18 of copending Application No. 17/142712 in view of Pulapura et al., Bahulekar et al., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference.
Response to Arguments
Applicant's arguments filed December 12, 2025 have been fully considered. In light of the amendment to the claims, the rejections under 35 USC 103 over Pulapura et al. in view of others are hereby withdrawn. New grounds of rejection to address new combinations of limitations are detailed. The double patenting rejections are also adjusted in light of the amendment and those detailed are the full set that are currently pending. The arguments against the rejection over Hardy et al. in view of others and FMC in view of others are not persuasive.
Regarding the rejections under 35 USC 103:
The applicant argues that Hardy et al. in view of Pulapura et al., Bahulekar et al., Serraro et al., and Veriset™ Haemostatic Patch reference do not render obvious the limitations of instant claims 39 and 40. This combination of teachings was applied to previous claims 21-24, 26, 29, 31, 34, 36, and 38-41, whose limitations remain in current claims 21, 23-24, 34, 36, 38, and 41. The primary difference between the embodiments embraced by current claim 21 and those of current claims 39 and 40 is the fact that the relative relationship of the hemostatic matrix and particles comprising tyrosine-derived polyarylate/biodegradable polymer, minocycline, and rifampin in the coating on the substrate is not specified or limited in current claim 21. Thus the applicant’s argument that Hardy, Serraro, and Veriset™ do not disclose a hemostatic matrix that upon wetting forms a hydrogel and has dispersed therein drug loaded particles addresses limitations that are not required in claim 21 or those that depend from it. Therefore the argument is unpersuasive in regard to these claims.
The applicant additionally argues that none of Hardy, Serraro, and Veriset™ teaches a matrix that upon wetting forms a hydrogel and has dispersed therein antibiotic loaded particles. This is a subset of the cited references that omits the reference that teaches antibiotic loaded particles as instantly claimed. Hardy et al. teach a matrix that forms a hydrogel upon wetting and contains antibacterial properties while Bahulekar et al. teach antibiotic loaded particles whose inclusion in the matrix is obvious. In addition, the applicant is incorrect in their statement that the compositions in each of these references remain powders or sheets after use. Hardy et al. explicitly teach that the premise of function of their coating material is that it converts into a gel upon wetting, as is now highlighted in the rejection and its citations. Further, both oxidized regenerated cellulose and chitosan powders that the coating of Hardy et al. contains form hydrogels upon wetting and both are hemostatic matrices (see FMC and Hardy et al.).
The applicant additionally argues that Pulapura et al. do not teach embedding drug particles within a hemostatic matrix. While true, the claimed hemostatic matrix comprises oxidized cellulose, trilysine, and polyethylene glycol. It is not clear that the applicant envisioned embedding drug particles in such a matrix either and the claims do not explicitly require such an arrangement. The source of this hemostatic matrix is repeatedly discussed in the specification as a commercially available patch Veriset™ composed of oxidized cellulose coated with trilysine and polyethylene glycol (see instant specification paragraphs 47-48, 50, and 154). There is no discussion of antibiotic containing particles “embedded” in this material; however a mixture of a ground version of the patch and the antibiotic containing particles is detailed. The claims do not employ the term “embedded”, but instead recite “dispersed” which has a broader scope whose boundaries are currently unclear. The cited prior art based on the modified teachings of Hardy et al., that exchanges ground Veriset™ for their ground commercially available oxidized regenerated cellulose and adds the antibacterial particles of Bahulekar et al. to the powdered coating material, renders obvious such a powdered blend, as the current rejection details. Thus contrary to the applicant’s argument, the cited prior art provides both the claimed matrix chemistry and recited phase relationship (e.g., dispersion of one set of particles in another).
Regarding the double patenting rejections:
The applicant argues that double patent rejections should be purely a claim to claim analysis and not rely upon additional references. To the contrary, MPEP 804(II)(B)(3)details that “[a] nonstatutory double patenting rejection, if not based on an anticipation rationale or an "unjustified timewise extension" rationale, is "analogous to [a failure to meet] the nonobviousness requirement of 35 U.S.C. 103 " except that the patent disclosure principally underlying the double patenting rejection is not considered prior art…. Any secondary reference used to support an obviousness analysis for a nonstatutory double patenting rejection must be prior art under 35 U.S.C. 102 or pre-AIA 35 U.S.C. 102. See MPEP § 2120 et seq. for more information on determining if a reference is prior art and MPEP § 2141, subsection II.A, for determining the scope and content of the prior art.” Thus the double patenting rejections are not inappropriate merely due to their reliance upon secondary references in combination with patent or patent application claims.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615