DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Preliminary Amendments and Remarks, filed 16 July 2024, in the matter of Application N° 18/767,430. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-73 have been canceled. Claims 74-93 are newly added and supported by the originally-filed disclosure.
None of the newly added claims has been additionally amended.
No new matter has been added.
Thus, claims 74-93 now represent all claims currently under consideration.
Information Disclosure Statement
Three Information Disclosure Statements (IDS) filed 24 July 2024, 26 January 2026, and 19 March 2026 are acknowledged and have been considered.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claims 75-79 are objected to because they each depend from claim 73 which is a claim that has been canceled. This appears to be a typographical mistake and that the claims should depend from independent claim 74. Herein, for the purpose of consideration on the merits, the dependency of claims 75-79 will be interpreted as such.
Appropriate correction is required.
Allowable Subject Matter
Claims 77-79, 85, and 92 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The limitations of instant claim 77, which includes independent claim 74, are read on by claim 1 of Brewster et al. (USPN 12,064,523) (see Nonstatutory Double Patenting rejection below). Since this claim has been allowed, claim 77 is also free of the prior art.
Similarly, claim 85 recites the same dependent limitations as claim 77 and depends from independent claim 81 which is similar in scope to claim 74. Thus, while instant claims 74, 77, 81, and 85 are still subject to rejections under Double Patenting, claims 77 and 85 remain free of the prior art.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 74-93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of Brewster et al. (USPN 12,064,523 B2). Although the claims at issue are not identical, they are not patentably distinct from each other
Instant claim 74 recites:
A material which is a wound care material comprising:
a flexible polymer foam or fibre matrix comprising a wound facing face and a reverse face or two wound facing faces and therebetween a structural matrix defining a cell network, and
a powder charge comprising a wound dressing additive,
wherein said powder charge is comprised at said wound facing face or said reverse face and within said cell network, wherein said powder charge is within said cell network in diminishing amount with increasing depth within said cell network, and wherein the powder charge is distributed in nodes in the flexible polymer foam or fiber matrix.
Instant claim 77 recites:
The material of claim [74], wherein more than 50% of the powder charge is present within 0.8 mm from a surface of the flexible polymer foam or fibre matrix.
Claim 1 of the ‘523 patent discloses:
Material which is a wound care material comprising:
a flexible polymer foam or fibre matrix comprising a wound facing face and a reverse face or two wound facing faces and therebetween a structural matrix defining a cell network, and
a powder charge comprising a wound dressing additive,
wherein said powder charge is comprised at said wound facing face or said reverse face and within said cell network, wherein said powder charge is within said cell network in diminishing amount with increasing depth within said cell network, and
wherein more than 50% of the powder charge is present within 0.8 mm from a surface of the flexible polymer foam or fibre matrix.
The limitations of instant claim 75 are disclosed by reference claim 2.
The limitations of instant claim 76 are disclosed by reference claim 3.
The limitations of instant claim 77 are disclosed by reference claim 4.
The limitations of instant claim 78 are disclosed by reference claim 5.
The limitations of instant claim 79 are disclosed by reference claim 6.
The limitations of instant claims 80 and 77 are disclosed by reference claim 7.
The limitations of instant claims 81 and 85 are disclosed by reference claim 8.
The limitations of instant claim 82 are disclosed by reference claim 9.
The limitations of instant claim 83 are disclosed by reference claim 10.
The limitations of instant claim 84 are disclosed by reference claim 11.
The limitations of instant claim 86 are disclosed by reference claims 12 and 13.
The limitations of instant claim 87 are disclosed by reference claim 14.
The limitations of instant claim 88 are disclosed by reference claim 15.
The limitations of instant claim 89 are disclosed by reference claim 16.
The limitations of instant claim 90 are disclosed by reference claim 17.
The limitations of instant claim 91 are disclosed by reference claim 18.
The limitations of instant claim 92 are disclosed by reference claim 19.
The limitations of instant claim 93 are disclosed by reference claim 20.
Based on the disclosure presented in the claims of the reference patent, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success in producing the instantly claimed compositions and arriving at the claimed method of treatment. Given the significant overlap in recited subject matter, the invention as a whole would been prima facie obvious to one of ordinary skill in the art, absent a clear showing of evidence to the contrary.
Claims 74-93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 10-20 of Brewster et al. (USPN 11,730,852 B2). Although the claims at issue are not identical, they are not patentably distinct from each other
Claim 1 of the ‘852 patent discloses:
Material which is a wound care material comprising:
a flexible hydrophilic polymer foam or fibre matrix comprising a wound facing face and a reverse face or two wound facing faces and therebetween a structural matrix framework defining a network of cells having a cell network surface and therein a network of pores or cell openings, and
a powder charge comprising a wound dressing additive or combinations thereof,
wherein said matrix provides a tortuous pore network;
wherein said powder charge is comprised at said wound facing face or said reverse face and within said cell network, wherein said powder charge is within said cell network in diminishing amount with increasing depth within said network; wherein more than 50% of the powder charge is present within 0.8 mm from a surface of the foam or fibre matrix; and
wherein the powder charge further comprises a flowing agent selected from a group consisting of clay, silica, charcoal, graphite and a combination thereof;
wherein the flowing agent has a particle size distribution D50<10 micron.
The foregoing is considered to teach the limitations of instant claims 74, 75, and 77.
The limitations of instant claim 76 are disclosed by reference claim 2.
The limitations of instant claim 77 are disclosed by reference claim 3.
The limitations of instant claim 78 are disclosed by reference claim 4.
The limitations of instant claim 79 are disclosed by reference claim 5.
The limitations of instant claims 80, 75, and 77 are disclosed by reference claim 6.
The limitations of instant claims 81-83, and 85 are disclosed by reference claim 7.
The limitations of instant claim 84 are disclosed by reference claim 8 and 10.
The limitations of instant claim 86 are disclosed by reference claim 11 and 12.
The limitations of instant claim 87 are disclosed by reference claim 13.
The limitations of instant claim 88 are disclosed by reference claim 14.
The limitations of instant claim 89 are disclosed by reference claim 15.
The limitations of instant claim 90 are disclosed by reference claim 16 and 17.
The limitations of instant claim 91 are disclosed by reference claim 18.
The limitations of instant claim 92 are disclosed by reference claim 19.
The limitations of instant claim 93 are disclosed by reference claim 20.
Based on the disclosure presented in the claims of the reference patent, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success in producing the instantly claimed compositions and arriving at the claimed method of treatment. Given the significant overlap in recited subject matter, the invention as a whole would been prima facie obvious to one of ordinary skill in the art, absent a clear showing of evidence to the contrary.
Claims 81, 83, 86-91, and 93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-14 of Dagger et al. (USPN 11,730,854 B2). Although the claims at issue are not identical, they are not patentably distinct from each other
Claim 1 of the ‘854 patent discloses:
A wound dressing, comprising:
a loaded wound dressing layer comprising:
a polyurethane foam comprising a wound facing face and a reverse face; and
a powder charge of antimicrobial release additive pre-loaded within the foam, wherein the antimicrobial release additive is homogeneously distributed within the loaded wound dressing layer, wherein the antimicrobial release additive is distributed by admixing one or more slurry phases of the powder charge or admixing solid concentrate of the powder charge with one or more of an isocyanate phase precursor, an aqueous phase precursor, and a liquid carrier phase for the polyurethane foam prior to polymerization;
wherein the powder charge of antimicrobial release additive retains powder form after polymerization of the polyurethane foam and the antimicrobial release additive has a particle size on the order of 4 micron<D50<60 micron;
wherein the antimicrobial release additive comprises silver salt.
The foregoing is considered to read on the limitations of instant claims 81, 83, and 86.
The limitations of instant claim 86 are disclosed by reference claim 5.
The limitations of instant claim 87 are disclosed by reference claim 6.
The limitations of instant claim 88 are disclosed by reference claim 7.
The limitations of instant claim 89 are disclosed by reference claims 8 and 9.
The limitations of instant claim 90 are disclosed by reference claims 10 and 11.
The limitations of instant claim 91 are disclosed by reference claim 12.
The limitations of instant claim 83 are disclosed by reference claim 13.
The limitations of instant claim 93 are disclosed by reference claim 14.
Based on the disclosure presented in the claims of the reference patent, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success in producing the instantly claimed compositions and arriving at the claimed method of treatment. Given the significant overlap in recited subject matter, the invention as a whole would been prima facie obvious to one of ordinary skill in the art, absent a clear showing of evidence to the contrary.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Applicants are 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 74-76, 80-84, 86-91, and 93 are rejected under 35 U.S.C. 103 as being unpatentable over Trogolo et al. (WO 2003/055941 A1; new IDS reference) in view of Shah et al. (US Pre-Grant Publication Nº 2010/0260824 A1; of record), Durdag et al. (US Pre-Grant Publication Nº 2014/0336557 A1; of record) and Patel et al. (US Pre-Grant Publication Nº 2012/0177720 A1; of record).
The instantly claimed invention is directed to a material which is a wound care material comprising a flexible polymer foam or fibre matrix comprising a wound facing face and a reverse face or two wound facing faces and therebetween a structural matrix defining a cell network, and a powder charge comprising a wound dressing additive, wherein said powder charge is comprised at said wound facing face or said reverse face and within said cell network, wherein said powder charge is within said cell network in diminishing amount with increasing depth within said cell network, and wherein the powder charge is distributed in nodes in the flexible polymer foam or fiber matrix.
Trogolo discloses a polymer composition comprising a microcapsule (per claim 1) and a matrix wherein the microcapsule comprises a discrete phase within the matrix polymer (see Abstract; claim 38). The product of the practiced invention is presented, for instance in Figure 2. It should be noted that Trogolo presents Figure 1 as a showing of what is known in the prior art (see pg. 6, line 9). However, certain elements of Fig. 1 are referred to and relied upon in the present teaching. Figure 2 is thus presented first:
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Figure 1 is as follows:
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A key element depicted by both Figures is that the antimicrobial agent particles (items 4, 5, and 6) are not only dispersed within the matrix from which they are delivered, but also more concentrated at the outward facing surface of the product (item 3) than they are towards the inner reaches of the product.
Turning to Figure 2, the antimicrobial particles (items 4, 5, and 6) are disclosed as possessing a coating formed using a polymer that is different from the polymer that is used to form the matrix (see e.g., claim 46) and that the two polymers will possess differing degrees of hydrophilicity such that the microcapsule remains as a second phase within the matrix polymer (see pg. 18, lines 12-15). The reference additionally defines the polymer of the matrix as being formed using hydrophilic polymers such as polyethylene, polyurethanes, and various acrylic-based polymers (see e.g., pg. 18, lines 15-23).
The microcapsules disclosed in claim 1 are taught as having a diameter of about 2,000 microns (2 mm) or less and that they encapsulate an inorganic antimicrobial agent. Claim 2 defines the inorganic antimicrobial agent as being selected from such metals or metal ions as silver (see also pg. 8, lines 8-11). The silver metal or silver metal ion is further taught as being in the form of a simple salt such as the oxide, chloride, carbonate, nitrate, and sulfate forms (e.g., silver nitrate (see pg. 8, line 30 to pg. 9, line 2). More critically still, the reference discloses that a preferred antimicrobial agent is an antimicrobial zeolite; in particular Type A zeolite containing ion-exchanged silver (aka silver zeolite). This agent is further disclosed as possessing a mean average particle size ranging from 1-3 microns (see pg. 10, line 28 to pg. 12, line 11). Of importance with respect to Trogolo’s disclosure of silver zeolite Type A is that the “zeolite” component is defined as being an aluminosilicate compound (see pg. 10, line 31 to pg. 11, line 8). The Examiner also notes that Trogolo teaches its dispersed particles as including particles that are partially embedded in the surface of the hydrophilic polymer matrix, thereby teaching the limitations of instant claim 74.
The foregoing is considered to teach the compositional limitations of the recited material of claims 74-76, 80-84, and 93.
Trogolo is acknowledged as possessing one structural deviation in its disclosure with respect to the claimed composition; it does not teach that its hydrophilic matrix is in the form of a foam or a fibrous matrix having a porous network.
The disclosure of Shah, already of record, is considered to remedy this deficiency.
Shah discloses compositional and structural limitations of the recited composition claims. Figure 6, for instance, discloses the following antimicrobial-loaded, foam material structure:
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Paragraph [0043] defines the variables seen within the Figure. The foam material (100) possesses a porosity gradient (120) that is achieved when larger cells or pores (140) shown as being present on the wound-facing surface of the material (160) decrease in size as their presence progresses towards the inner reaches of the foam material (180, 200).
The pores are disclosed further as containing one or more antimicrobial agents, and are possibly combined with other therapeutic agents. The larger pores that are present at the wound-facing surface of the dressing are also taught as containing a relatively high level of agent(s) to be released initially.
Antimicrobial agents disclosed as being loaded within the porous network are taught as including such compounds as PHMB or PEHMB, or in the alternative, metals such as silver. See, for example, claim 1 and ¶[0022]. The antimicrobial agents are also disclosed as being in such forms as powder form. See ¶[0031].
The key deficiency of Shah with respect to the instantly claimed composition is that it does not teach or suggest formulating its products using a flowing agent as instantly defined or amended.
Despite their respective deficiencies, the Examiner respectfully submits that a person of ordinary skill in the pharmaceutical arts would have had a reasonable expectation of success in producing the instantly claimed composition. Furthermore, said artisan would have found the recited method of treatment to be prima facie obvious.
The teachings of both Trogolo and Shah are directed to polymeric matrices that are hydrophilic and which contain a silver or a silver salt antimicrobial agent to be delivered from it. Trogolo is more universal in the medical applications of its practiced composition, but nevertheless teaches that the practiced composition may be incorporated into bandages (see e.g., pg. 18, lines 24-29). Shah on the other hand expressly discloses that its practiced compositions are used to form wound dressings (see e.g., Abstract; claim 2).
MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... the idea of combining them flows logically from their having been individually taught in the prior art.”
In the instant case, the Examiner submits that not only are the purposes of the practiced products of Trogolo and Shah aligned, but so too are the compositional and structural disclosures nearly perfectly aligned as well. Shah simply lacks the added silica-based agent at the recited particle distribution and Trogolo lacks an express teaching that its hydrophilic matrix is porous.
Thus, based on the combined teachings of Trogolo and Shah, the instantly claimed composition and method of treatment would have been prima facie obvious to one of ordinary skill in the art ahead of the effective filing date of the instant application, absent a clear showing of evidence to the contrary.
The limitations of claim 84 are disclosed, for instance, by claim 7 of Shah which teaches that the polymer foam comprises such dissolvable polymers as polyurethane foam, alginate foam, and hyaluronic acid foam. See also ¶[0029].
The limitations recited by claims 90 and 91 are also met by Shah at ¶[0052] which teaches that the polymer matrix will also comprise structural fibers (e.g., CMC fibers). Disclosure of the CMC or carboxymethylcellulose material is considered to read on claim 91 as the practiced cellulose material meets Applicants’ definition of a “superabsorbent polymer” as set forth in the instant specification (see ¶[0059]).
The limitations recited in claims 88 and 90 are each directed to layers that are in direct contact with the loaded wound dressing layer. Disclosure of the non-adherent layer in Figures 1 and 2 of Shah, defined further in ¶[0034], is considered to meet the limitations of each of these claims.
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The above Figures depict embodiments of the practiced patch. Item (12) in the left figure is the antimicrobial-loaded polymeric matrix. Around the matrix, resides a non-adherent layer (14) which has perforations (16) that facilitate the absorption of fluid into the loaded foam, which in turn facilitates the release of the antimicrobial container therein.
Claim 93 recites that the matrix comprises a plurality of cells in which the antimicrobial release additive is at least partially embedded within said cells. Paragraph [0046], describing the embodiment of Figure 8, is considered to meet the limitations of the claim. Here, the antimicrobial agent is in the form of dissolvable beads (e.g., starch particles) that are then incorporated into the polymer foam matrix. The incorporation of the beads within the matrix is considered to expressly teach that the active agent fills the pores or cavities within inherently created by the presence of the beads. Paragraph [0009] offers additional teaching on this point as well stating that “dissolvable beads of varying size containing an antimicrobial agent and embedded in foam not only act as a carrier and delivery matrix for the antimicrobial agent, but also because of varying bead size and/or concentration gradient(s), deliver different concentrations of the antimicrobial agent at different times as needed; dissolvable beads embedded in foam present a dressing that has on-demand absorptive capacity; controlling pH to a slightly acidic level in the range of 6 to 7 to reduce chance of wound infections.” Notably, the teachings of Shah expressly disclose a wound dressing material that comprises an absorbent, hydrophilic, polymeric, foam matrix that is porous. Within the cavities of these pores resides antimicrobial agents whose concentration is greater at the skin-contacting surface that it is within the inner structure of the foam. The foam matrix is additionally taught as containing a fibrous structure, which according to the reference, may be prepared using such polymers as carboxymethylcellulose.
At the outset, Shah is considered to be deficient with respect to claims 86, 87, and 89.
However, the teachings of Durdag, already of record, are considered to remedy these perceived deficiencies.
Claim 86 recites that the antimicrobial release additive is elemental silver, silver salts, silver complexes, caged forms thereof, caged forms of iodine, and combinations thereof. This limitation is met by the teachings of Shah and Trogolo, both of which use of silver as an antimicrobial agent that is loaded into its practiced foam matrix wound dressing. Trogolo, as discussed above, discloses combining silver with zeolite (aka metal oxide silica compound) and embedding it in a hydrophilic matrix.
Claim 86, though, also recites narrower species of silver and iodine that may embody the antimicrobial release additive. Durdag, like Trogolo, teaches that the at least one antimicrobial agent comprises silver species (see e.g., Durdag claims 13 and 14). Defining species of silver are disclosed throughout the reference: silver sulfadiazine (see ¶[0004]), silver salts such as silver zeolite (see e.g., Example 3); elemental silver and nano-silver SmartSilver® (see e.g., ¶[0142]).
Claim 87 recites that the wound dressing has a surface concentration of 1.4 mg/cm2 to 4 mg/cm2.
Durdag discloses the claimed wound dressing composition as discussed above, and additionally discloses that the embedded antimicrobial agent may be silver, a silver salt (e.g., silver zeolite) or silver sulfadiazine. Regarding the concentration of silver within the practiced device, Durdag teaches that resulting concentrations of silver within the medical dressings will range from 1-200 ppm or 0.001-0.2 mg/cm3. See Example 6 at ¶[0177].
Durdag does not teach the concentration in terms of mass per unit area. Dimensional analysis of the produced layers reveals that the wound dressing will have a thickness of up to 1-mm (0.1 cm) when cast as a thin layer, but when cast as a thick layer, it will have a thickness that ranges as high as 30-mm or 3 cm. Thus, at its greatest, the Examiner submits that the produced dressings will possess a maximum of (0.2 mg/cm3)(3 cm) or 0.6 mg/cm2. While close to the recited range, the Examiner concedes that this mass/area concentration falls short of it.
Despite this shortcoming, the Examiner respectfully maintains the position that the teachings of Durdag raise to the level of a prima facie teaching of obviousness. MPEP §2144.05(I) states that, “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”
MPEP §2144.05(II)(A.) states further that, “[g]enerally, differences in concentration … will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration … is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Lastly, MPEP §2144.05(II)(B.) states that, “[i]n order to properly support a rejection on the basis that an invention is the result of “routine optimization [or routine experimentation]”, the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range.”
In the instant case, the calculated mass of antimicrobial silver per area disclosed by Durdag appears to have an upper limit of 0.6 mg/cm3 whereas the lower limit of the claimed invention is 1.4 mg/cm3, a slightly-greater than two-fold difference.
The Examiner submits that a person of ordinary skill in the art, before the effective filing date of the claimed invention, would have had a reasonable expectation of success of producing the claimed invention possessing the claimed concentration of silver, relying upon the teachings of Durdag alone. Therein, on its face, the Examiner submits that it would have been obvious to try increasing the concentration of a known antimicrobial agent under the reasonable expectation of increasing the available agent to treat a wound and minimize the risk of bacterial infection. Stated another way, the application of more antimicrobial agent breeds the reasonable expectation of a reduction in the risk of infection in the wound.
Furthermore, the teachings of Patel provide the ordinarily skilled artisan the requisite guidance to motivate one to: a) increase the concentration of antimicrobial agents such as silver within a given layer of a multilayer wound dressing, and b) provide the antimicrobial compound using a concentration gradient.
Patel, like Durdag, is directed to a multilayered antimicrobial-loaded, wound dressing (see e.g., Abstract; Figure 2; claims). The practiced devices focus primarily on the use of PHMB as the antimicrobial agent (see e.g., claims). However, the reference additionally teaches that a full substitute for one or more of the disclosed antimicrobial agents can include such compounds as silver. Silver is then exemplified as being present in the dressing in amounts which may range from 1-3 wt% of the composition.
1 wt% = 1 part in 100 or 0.01 or 10-2.
Parts-per-million = 1 part in 1,000,000 or 0.000001 or 10-6.
Dividing 0.01/0.000001 = 1/0.0001 = 10,000
Thus, converting weight percent to parts-per-million (ppm) is done by multiplying the weight percent value by 10,000. Patel discloses that the concentration of silver, in this instance will range from 10,000-30,000 ppm. See ¶[0054].
Patel also teaches broader concentrations for the antimicrobial agent(s) that may be used in the practiced composition. Paragraph [0052] teaches that the concentration of the agent(s) will range from about 2,500 to about 30,000 ppm (0.25-3 wt%). The same passage also teaches that the antimicrobial agent can be present in the dressing in any suitable level which provides an adequate antimicrobial effect and that exemplary concentrations will include, but not be limited to 2,000 ppm, 2,500 ppm, 3,000 ppm, 3,500 ppm, 5,000 ppm, 10,000 ppm, 13,000 ppm, 30,000 ppm, (aka 0.2-3 wt%) and gradients thereof.
The concentration expressed as ppm may also be converted to units of mg/mL.
1 ppm = 1 mg/L
Given that 1L = 1,000 mL; 1 ppm = 1 mg/1,000 mL = 0.001 mg/mL = 0.001 mg/cm3
This provides a concentration conversion factor of: 1 mg/cm3 = 1,000 ppm
Patel is thus considered to teach its antimicrobial agents as being present in the practiced dressing in a range of 2-30 mg/cm3.
The Examiner lastly acknowledges that Patel discloses its antimicrobial agents as volumetric concentration rather than in terms of mass/per area. The Examiner submits that a person of ordinary skill in the art would be adept at determining the thickness of such a dressing and calculating the mass of antimicrobial agent per unit of area.
For instance, a wound dressing layer having a thickness of 0.5 cm, as disclosed by Durdag, would produce an area concentration ranging from about 1-15 mg/cm2, a range that encompasses the instantly claimed concentration of claim 64.
Next, regarding the limitations of instant claim 89, Durdag teaches in claim 20, a method of treating a wound comprising the application of the practiced wound dressing (e.g., of claim 1). Application of the wound dressing is such that it is placed in contact with the surface of the wound so that it wicks exudate from the by way of either absorption or negative pressure (see also claims 28 and 29).
The Examiner thus submits that the foregoing teachings of Trogolo, Shah, Durdag, and Patel, each contribute to guiding the ordinarily skilled artisan to the instantly claimed composition and method of treatment that are based in the recitation of the material of instant claim 1.
The basis of Applicants’ argument with respect to the previously maintained rejection was that the combined teachings failed to disclose the flow agent as compositionally and dimensionally defined.
The teachings of Trogolo, as discussed above, particularly in combination with the disclosures of Shah and Durdag, present a showing in the art of whereby an antimicrobial agent such as silver zeolite discloses a combination of silver active co-formulated with a silica agent, in microparticulate form and embedded within the matrix of a hydrophilic polymer. The combined teachings of Trogolo and Shah additionally present common findings that the presence of the recited active and flow agents would have been present at the skin-contacting surface at a concentration that is greater than that found in the middle of the matrix.
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of successfully producing the claimed polymer material, the wound dressing made from it, and the method of using the wound dressing to treat a subject in need thereof.
Thus, absent a clear showing of evidence to the contrary, the amended invention as a whole would have been prima facie obvious to one of ordinary skill in the art ahead of Applicants’ effective filing date.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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