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 .
Claim Rejections - 35 USC § 112
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 33 and 42-45 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.
It is unclear how the scope of components differ for the required powder coating of instant claim 21, when the instantly claimed powder coating is also a paste or gel as in claims 33 and 42-45. The boundary on what constitutes a powder coating is not clear.
A paste is a viscous mass of solids dispersed in a liquid (see Lewis, Sr., Larrañaga, M. D., Robert A., & Richard J., L. (Eds.). (2016). Paste. In Hawley’s Condensed Chemical Dictionary (16th ed.). Wiley. //access.infobase.com/article/1030260-paste?aid=279753). In the context of a “paste made from the powder coating”, a powder is present in the paste along with an unspecified liquid; however, a paste is a “wet” mass and is not a powder. Thus it is unclear if a coating is still a powder coating when the powder has been integrated into another material that takes on a different form (e.g., a wet mass). Evaporation of the solvent in a paste can regenerate a powder structure, but it is not clear that this capability qualifies the viscous mass that is a paste as also being a powder.
The gel embodiments of the powder coating are also unclear regarding the required arrangement of the particles and the implied, but unrecited, additional components. The specification details that the polyethylene glycol and trilysine, that are currently recited as components of a population of particles in the powder coating, form a hydrogel upon wetting (see instant paragraph 47). It is unclear if these particles retain a particle/powder form when sufficient water is present to form a hydrogel from the polyethylene glycol and trilysine. FMC (previously cited) details that oxidized cellulose powder can form a gel when combined at proportions between 5 and 50% with water (see example V). However, they detail these gels to be thixotropic gels which are gels that reduce in viscosity due to the application stress (e.g., stirring) (see Thixotropic. In Collins English Dictionary (12th ed.). 2014 Collins. //access.infobase.com/article/1619107-thixotropic?aid=279753). This property seems to imply that the gel is a mass of material, since it has a viscosity that can be altered. The presence of this property also makes it unclear in what manner a gel of oxidized cellulose could qualify as a powder coating. Thus it is unclear how the components of the powder coating of instant claim 21 are arranged such that it also meets the limitations of the gel coating of instant claims 42-45.
Claim 46 recites that “the particles are configured to release between about 70% and about 100% of the rifampin and minocycline between 48 and 60 hours”. It is not clear what is required for the particles to be “configured to” yield the recited function. One interpretation could require the particles themselves to provide the recited release kinetics while another interpretation could rely up the presence of other components with the particles, such that the composite yields the release kinetics. There is no elaboration on the manner in which either avenue influences release kinetics. The instant specification discloses a variety of tyrosine derived polyarylate polymers, but none of them are associated with any a particular release kinetics when formed as particles comprising minocycline an rifampicin (see paragraphs 124-128). Thus the scope of coatings in the claimed device that yield the recited functionality is not clear.
Claims that are rejected but are not elaborated upon are also indefinite because they depend from an indefinite claim and do not add clarity.
For the sake of compact prosecution and the application of prior art, the limitations of a powder coating will be interpreted as being met by a coating composed of powder, whether dry or wet, and any gel that forms from the powder constituents will be deemed sufficient to meet the limitations of a gel coating. The functional limitations of instant claim 46 will be viewed as met when the recited structure has been met. Clarification is still required
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, and 35-37, 41, and 46 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 21). 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 and 36-37). 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 a 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 claim 23). 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 claim 1). 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 also 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 powder coating that is the particles comprising tyrosine-derived polyarylate (biodegradable polymer), minocycline, and rifampin and hemostatic matrix that is the particles comprising oxidized cellulose, polyethylene glycol and trilysine (see instant claim 21). 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 particles because Bahulekar et al. suggests to do so. Therefore claims 21, 23, and 35-37, 41, and 46 are obvious over Hardy et al. in view of Pulapura et al., Bahulekar et al., Serraro et al., and Veriset™ Haemostatic Patch reference.
Claims 42-45 are rejected under 35 U.S.C. 103 as being unpatentable over Hardy et al. in view of Pulapura et al., Bahulekar et al., Serraro et al., and Veriset™ Haemostatic Patch reference as applied to claims 21, 23, and 35-37, 41, and 46 above, and further in view of Pulapura et al. (US PGPub No. 2017/0319756 – henceforth Pulapura B).
Hardy et al. in view of Pulapura et al., Bahulekar et al., Serraro et al., and Veriset™ Haemostatic Patch reference render obvious the limitations of instant claims 21, 23, and 35-37, 41, and 46. Hardy et al. additionally teach applying their product to a bleeding site in a subject which wets the product and yields hemostasis (see example 8). Patterning or particular localization of the particle coating on the substrate surface is not explicitly detailed.
Pulapura B teaches a substrate with both hemostat and pharmaceutically active agent selectively positioned on the surface to permit the user to apply these active components at a location in a subject as desired (see paragraph 3). Patterns that are envisioned include various shapes such as squares, circles, and rectangles that are spaced away from one another with intervening uncoated space and are arranged in rows and columns (see paragraphs 5-8; instant claims 43-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the modified device of Hardy et al. as intended to produce hemostasis via application to a bleeding wound. The result is the product surface being wet and the occurrence of a gel. In addition, it also would have been obvious to pattern their powder coating of hemostat and antimicrobial particles as taught by Pulapura B. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Again the application of this embodiment to a bleeding wound as intended would follow. Therefore claims 42-45 are obvious over Pulapura et al., Bahulekar et al., Serraro et al., Veriset™ Haemostatic Patch reference, and Pulapura B.
Claims 21, 23, 33, 36-37, 41-43, and 46 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 claim 33). 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 that include batting, gauze, and preformed dressings (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 claim 21). 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 in 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 21). 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 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 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 powder coating that includes the particles comprising tyrosine-derived polyarylate (biodegradable polymer), minocycline, and rifampin and a hemostatic matrix that is particles composed of oxidized cellulose, polyethylene glycol and trilysine (see instant claim 21). 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. As an alternative to the paste from, a gel from the 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, 36, 41, and 46 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 claim 23). 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, 36, 41, and 46 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 42-45 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 as applied to claims 21, 23, 36, 41, and 46 above, and further in view of Pulapura B.
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 render obvious the limitations of instant claims 21, 23, 36, 41, and 46. Hardy et al. additionally teach applying their product to a bleeding site in a subject which wets the product and yields hemostasis (see example 8). Patterning or particular localization of the particle coating on the substrate surface is not explicitly detailed.
Pulapura B teaches a substrate with both hemostat and pharmaceutically active agent selectively positioned on the surface to permit the user to apply these active components at a location in a subject as desired (see paragraph 3). Patterns that are envisioned include various shapes such as squares, circles, and rectangles that are spaced away from one another with intervening uncoated space and are arranged in rows and columns (see paragraphs 5-8; instant claims 43-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the modified device of the patented claims as intended for similar devices, as detailed by Hardy et al., to produce hemostasis via application to a bleeding wound. The result is the product surface being wet and the occurrence of a gel. In addition, it also would have been obvious to pattern their powder coating of hemostat and antimicrobial particles as taught by Pulapura B. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Again the application of this embodiment to a bleeding wound/surgical site as intended would follow. Therefore claims 42-45 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., the Veriset™ Haemostatic Patch reference, and Pulapura B.
Claims 21, 35-36, 41, and 46 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 claim 23). 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, 35-36, 41, and 46 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 42-45 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 as applied to claims 21, 35-36, 41, and 46 above, and further in view of Pulapura B.
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 render obvious the limitations of instant claims 21, 35-36, 41, and 46. Hardy et al. additionally teach applying their product to a bleeding site in a subject which wets the product and yields hemostasis (see example 8). Patterning or particular localization of the particle coating on the substrate surface is not explicitly detailed.
Pulapura B teaches a substrate with both hemostat and pharmaceutically active agent selectively positioned on the surface to permit the user to apply these active components at a location in a subject as desired (see paragraph 3). Patterns that are envisioned include various shapes such as squares, circles, and rectangles that are spaced away from one another with intervening uncoated space and are arranged in rows and columns (see paragraphs 5-8; instant claims 43-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the modified device of the patented claims as intended for similar devices, as detailed by Hardy et al., to produce hemostasis via application to a bleeding wound. The result is the product surface being wet and the occurrence of a gel. In addition, it also would have been obvious to pattern their powder coating of hemostat and antimicrobial particles as taught by Pulapura B. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Again the application of this embodiment to a bleeding wound/surgical site as intended would follow. Therefore claims 42-45 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, and Pulapura B.
Claims 21, 23, 37, 41, and 46 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 claim 23). 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. This combination of the oxidized cellulose containing hemostatic particles and the particles of Bahulekar et al. yield a powder coating. 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, 37, 41, and 46 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, 36-37, 41, and 46 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 as applied to claims 21, 23, 37, 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., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference render obvious the limitations of instant claim 21, 23, 26, 36, 41, and 46. 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, 36-37, 41, and 46 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.
Claims 42-45 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 as applied to claims 21, 23, 37, and 41 above, and further in view of Pulapura B.
Claims 1, 14-15, and 17-19 of U.S. Patent No. 10,736,99 in view of Bahulekar et al., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference render obvious the limitations of instant claim 21, 23, 26, 36, 41, and 46. Hardy et al. additionally teach applying their product to a bleeding site in a subject which wets the product and yields hemostasis (see example 8). Patterning or particular localization of the particle coating on the substrate surface is not explicitly detailed.
Pulapura B teaches a substrate with both hemostat and pharmaceutically active agent selectively positioned on the surface to permit the user to apply these active components at a location in a subject as desired (see paragraph 3). Patterns that are envisioned include various shapes such as squares, circles, and rectangles that are spaced away from one another with intervening uncoated space and are arranged in rows and columns (see paragraphs 5-8; instant claims 43-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the modified device of the patented claims as intended for similar devices, as detailed by Hardy et al., to produce hemostasis via application to a bleeding wound. The result is the product surface being wet and the occurrence of a gel. In addition, it also would have been obvious to pattern their powder coating of hemostat and antimicrobial particles as taught by Pulapura B. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Again the application of this embodiment to a bleeding wound/surgical site as intended would follow. Therefore claims 42-45 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 B.
Provisional
The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 21, 23, 36, 41, and 46 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 claim 23). 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. This combination of the oxidized cellulose containing hemostatic particles and the particles of Bahulekar et al. yield a powder coating. Therefore claims 21, 23, 36, 41, and 46 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.
Claims 42-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 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 as applied to claims 21, 23, 36, 41, and 46 above, and further in view of Pulapura B.
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 render obvious the limitations of instant claims 21, 23, 36, 41, and 46. Hardy et al. additionally teach applying their product to a bleeding site in a subject which wets the product and yields hemostasis (see example 8). Patterning or particular localization of the particle coating on the substrate surface is not explicitly detailed.
Pulapura B teaches a substrate with both hemostat and pharmaceutically active agent selectively positioned on the surface to permit the user to apply these active components at a location in a subject as desired (see paragraph 3). Patterns that are envisioned include various shapes such as squares, circles, and rectangles that are spaced away from one another with intervening uncoated space and are arranged in rows and columns (see paragraphs 5-8; instant claims 43-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the modified device of the copending claims as intended for similar devices as detailed by Hardy et al. to produce hemostasis via application to a bleeding wound. The result is the product surface being wet and the occurrence of a gel. In addition, it also would have been obvious to pattern their powder coating of hemostat and antimicrobial particles as taught by Pulapura B. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Again the application of this embodiment to a bleeding wound/surgical site as intended would follow. Therefore claims 42-45 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., the Veriset™ Haemostatic Patch reference, and Pulapura B.
Response to Arguments
Applicant's arguments filed June 3, 2026 have been fully considered. In light of the amendment to the claims, the rejections under 35 USC 112(b) are hereby withdrawn. Arguments against the double patenting rejections and those under 35 USC 103 against the pending claims are not persuasive.
Regarding the rejection over Hardy et al. in view of Pulapura et al., Bahulekar et al., Serraro et al., and Veriset™ Haemostatic Patch reference under 35 USC 103:
The applicant argues against singular portions of the collection of provided reasons that detail why the addition of the particles of Bahulekar et al. to the coating of Hardy et al. would have been obvious. In addition, the applicant argues against the references individually as if each references’ teachings are only available in a vacuum that is disparate from the rest of the cited prior art and knowledge of the artisan of ordinary skill. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The applicant argues “the fact that two materials are particulate does not, without more, provide a reason to combine them in the claimed coating”. This is not the sole reason provided for the modification. The rejection provides several more reasons why the combination of minocycline, rifampicin, and tyrosine polyacrylate polymer particles with oxidized cellulose in the configuration of Hardy et al. was obvious. Furthermore, Bahulekar et al., who provide these particles themselves, detail a variety of carriers and additives that can be employed along with their particles. There is no evidence that the instantly claimed pairing of oxidized cellulose in powdered form with a powder form of minocycline, rifampicin, and tyrosine polyacrylate polymer provides anything unexpected, given that this combination of components is already taught in Pulapura et al.
The applicant argues that Hardy et al. do not teach or suggest a desire to add a separate drug-loaded biodegradable polymer particle system to its hemostatic powder coating. The applicant appears to argue that the only viable path to the combination of teachings in a prima facia case of obviousness is a teaching, suggestion, or motivation (TSM) explicitly provided by one of the source references. MPEP 2141(I) details that a reliance solely upon a TSM rationale is overly rigid and does not serve as the only route to a case of obviousness. As the applicant notes in their argument, the rationale based upon the use of known technique to improve similar devices (methods, or products) in the same way, was employed to support the prima facia case of obviousness. This line of reasoning is explicitly detailed as a viable path to building a prima facie case of obviousness (see MPEP 2141(III)). Contrary to the applicant’s argument, Hardy et al. is not required to articulate a desire to improve upon the antibacterial properties they note in a material that they employ in order for the addition of antibacterial components to their composition to be obvious.
The applicant argues that the substitution of the commercial oxidized cellulose products known as Veriset™ for the Surgicel® of Hardy et al. was not a viable substitution, without improper hindsight because other oxidized cellulose products were known to exist. This argument appears to overlook the explicit teaching of Serrao et al. that was cited and details these two known oxidized cellulose membrane materials as alternatives. The fact that one could select another oxidized cellulose option does not negate the suitability of this substitution. Contrary to the applicant’s argument, the inclusion of the Veriset™ does not have to be based upon a rationale predicated on the presence of its crosslinking components. There is no evidence that the presence of the crosslinking components in the Veriset™ oxidized cellulose introduces a variable whose outcome changes the function of the hemostatic product of Hardy et al. in an unpredictable manner. According to MPEP 2144 IV, “[t]he reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).”
The applicants are not the originators of the idea of grinding a commercial oxidized cellulose membrane to generate a powdered form to then coat on a substrate for application. Nor are they the originators of the combination of components in the Veriset™ material and the comprehension of how they function at a surgical/wound site. The powdered form of minocycline, rifampicin, and tyrosine polyacrylate polymer also was not originated by the applicant nor was its formulation in or on a carry that facilitates its placement as desired. Furthermore, the combination of oxidized cellulose with minocycline, rifampicin, and tyrosine polyacrylate polymer in slab/membrane form was already known as well. There is no evidence of any unexpected outcome due to the claimed combination or arrangement of components, therefore the claimed product remains obvious in light of the cited prior art.
Regarding the rejection over FMC in view of Pulapura et al., Bahulekar et al., Hardy et al., Serraro et al., and the Veriset™ Haemostatic Patch reference under 35 USC 103:
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The applicant argues against singular portions of the collection of provided reasons why the addition of the particles of Bahulekar et al. to the coating of the FMC would have been obvious. In addition, the applicant argues against the references individually as if each references’ teachings are only available in a vacuum that is disparate from the rest of the cited prior art and knowledge of the artisan of ordinary skill. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The applicant argues that FMC does not teach or suggest a desire to add a separate drug-loaded biodegradable polymer particle system to its hemostatic powder coating. The applicant appears to argue that the only viable path to the combination of teachings in a prima facia case of obviousness is a teaching, suggestion, or motivation (TSM) explicitly provided by one of the source references. MPEP 2141(I) details that a reliance solely upon a TSM rationale is overly rigid and does not serve as the only route to a case of obviousness. As the applicant notes in their argument, the rationale based upon the use of known technique to improve similar devices (methods, or products) in the same way, was employed to support the prima facia case of obviousness. This line of reasoning is explicitly detailed as a viable path to building a prima facie case of obviousness (see MPEP 2141(III)). The applicant argues that the compositions of FMC are only directed to hemostasis. However, this argument is incorrect, given the explicit teaching of FMC to include various drugs that include antibiotics and antiseptics in their hemostatic product (see page 2 lines 41-61). Further, the applicant argues that the products of FMC are not similar to those of Pulapura et al. To the contrary, both FMC and Pulapura et al. teach products in the form of a substrate with a hemostatic coating material that also can include antibiotic/antiseptic components for wound/surgical applications. The antibiotic/antiseptic components of Pulapura et al. are the same as those of Bahulekar et al. who also teach a composition for wound/surgical applications that also can include hemostats (see paragraphs 252 and 279).
The applicant argues that applying the particles of Bahulekar et al. to the product of FMC requires several unsupported inferences. The reasonings behind the modifications set forth for adding a population of known antibiotic containing particles into a hemostatic composition that is already based on particles are provided in the rejection. There is no evidence refuting the inference that the combination will provide the hemostatic and antimicrobial function that the components are known to achieve. The applicant additionally argues that the inclusion of Veriset™ introduces additional components in the form of crosslinking constituents included in its oxidized cellulose. The presence of these components and how they function was known. There is no evidence or scientific rationale provided showing that their mere presence introduces unpredictability into the composition that is rendered obvious, contrary to the applicant’s argument.
The applicant notes that the rejection highlights the recognition of a material, namely chitosan, being functional in the same capacity when present as a slab coating or particle/powder based coating in a hemostatic product. They argue the connection is insufficient to render the addition of the particles of Bahulekar et al. to the coating of FMC obvious. This connection in the prior art is additional support to the obviousness already set forth and supported by the combined teachings of the cited references. The applicant argues that the suitability of this change in configuration of components in a hemostat is inapplicable to the particles of Bahulekar et al., but the applicant does not provide any evidence of the different geometry yielding an unexpected outcome. Furthermore, the discussion serves as one of several reasons set forth explaining the obviousness of including the particles of Bahulekar et al. in the composition of FMC.
The applicant argues that FMC does not teach a paste form of the polyethylene and trilysine containing oxidized cellulose instantly claimed or anticipate the claims. While true, the rejection is based on obviousness rationales, not anticipation. In addition, the applicant provides no discussion of how a paste is generated from the claimed materials nor any requirements of the viscoelastic properties of a composition in order to qualify as a paste. FMC details the proportion of water added to oxidized cellulose such that a paste form results. They detail generating a paste from oxidized cellulose due to the addition of water, followed by the application of the wet material to a substrate, and application to the target site (see page 3 lines 68-82). Absent evidence to the contrary, it remains the position of the examiner that a “paste” would still occur in the presence of the polyethylene and trilysine, at least initially, if the Veriset™ material is combined with water as FMC teaches for the oxidized cellulose.
The applicant further argues that the cited teachings that are combined are isolated and unsupported by the rationales set forth in the rejection. To the contrary, the cited teachings overlap in regard to their purpose, components, and configurations. As noted in MPEP 2141(II)(C), “[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle."Id. at 420, 82 USPQ2d at 1397.” Here the overlap in teachings and establishment of the same concepts employed by the applicant in the prior art renders the claimed invention obvious in view of the prior art.
Regarding the double patenting rejections:
The applicant argues that the double patent rejections should be reconsidered. Due to an absence of powder coating being recited. The conflicting claims paired with the secondary references provide a powder coating, therefor this argument is unpersuasive.
Conclusion
No claim is 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.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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