DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 18 September 2024, in the matter of Application N° 17/169,195. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application is being examined under the pre-AIA first to invent provisions.
Claims 62-81 are pending, where claims 79-81 remain withdrawn from consideration.
No claims have been added or canceled.
Claims 62 and 68 have been amended. Claim 62 has been amended to recite the property that “the second layer is impermeable to aqueous solution under physiological conditions.” Claim 68 has been editorially amended. The amendment to claim 62 appears to be supported by originally-filed ¶[0046].
No new matter has been added.
Thus, claims 62-78 continue to represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 18 June 2024 since the art that was previously cited continues to read on the amended and previously recited limitations.
Claim Rejections - 35 USC §103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 62-64, 66-71, and 74-78 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lovett et al. (WO 2009/023615 A1; of record).
The instant invention is directed to a method of wound healing or repairing (i.e., treating) a tissue defect comprising the application of a composition comprising a first layer comprising a porous biomaterial matrix layer, and a second layer comprising an impermeable biomaterial.
Regarding the term “impermeable,” the Examiner notes that Applicants’ instant specification defines the term at ¶[0046] as “refer[ring] to material being able to prevent the passage of an aqueous solution across the material at a particular temperature, tension, and fluid pressure” and that in some embodiments, “the impermeable layer can have no observable pores.”
Thus, having weighed this term as defined by Applicants (see MPEP §2111.01), as well as the material recited as being used to construct it, the Examiner broadly and reasonably interprets any showing in the art of a layer that is not porous to meet the recited term and properties thereto.
Lovett discloses a method of repairing a blood vessel (i.e., a hollow organ) comprising implanting a tubular composition having a wall defining an inner lumen diameter of less than 6 mm (see e.g., claim 40). The applied composition is disclosed in claims 1-3 as being a tubular composition comprising a plurality layers, each comprising silk fibroin. The wall of the lumen is disclosed in claim 3 as being not porous (i.e., impermeable). Claim 20 discloses that the wall defining the inner lumen has a diameter of less than 6 mm and comprises silk fibroin and polyethylene oxide (PEO). The positioning of the non-porous wall layer in the lumen is such that it prevents the movement of material into or out of the tissue being repaired.
The foregoing is considered to teach the limitations of claims 62-64, 66-70, 74, and 78.
The limitations of claim 71 further requiring the presence of an agent are met by claims 18 and 19.
Claims 75 and 76 respectively recite that the composition of claim 62 is characterized by an elastic modulus of up to about 2.7 MPa and an extensibility of between about 25% and 500%. Looking to Applicants’ instant specification, these limitations appear to be properties that are tethered to and definitive of the instantly encompassed composition discussed therein (see Spec., ¶0047). As such, consistent with MPEP §2111.01(IV), and §2112.01(I) and (II), the Examiner submits that where Applicants’ defining composition is disclosed in the prior art, the recited limitations of claims 75 and 76, will also be considered met.
Paragraph [0077] discloses that the practiced tubular compositions can be implanted into a subject in need thereof, stating further the tubes themselves are made essentially of silk, and will support sutures, which themselves are most often made from silk. What this conveys to a person of ordinary skill is that the practiced layered silk tube compositions can also be affixed into place using silk sutures, thereby teaching the limitations of claim 77.
Based on the combined teachings of the reference, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition as well as arriving at the method of treating a wound with it. As discussed above, Lovett discloses a multilayered silk fibroin composition having a wall that is impermeable and which contains bioactive material for release. The tubular composition is further taught and suggested as being attached to the site of interest using sutures that also comprise silk. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 62-64, 66-71, and 74-78 under 35 USC 103(a) as being unpatentable over the teachings of Lovett et al. have been fully considered but they are not persuasive.
Applicants’ paragraph-by-paragraph traversal of the rejection argues that the rejection is silent regarding the claimed porous biomaterial matrix. The Examiner notes that Applicants address the first paragraph of the rejection as simply reciting claim language.
The Examiner, in response, disagrees and maintains the rejection for the reasons of record. From the first paragraph of the above rejection, [c]laim 20 discloses that the wall defining the inner lumen has a diameter of less than 6 mm and comprises silk fibroin and polyethylene oxide (PEO).
The Examiner directs Applicants to ¶[0101], not mentioned in the rejection, but certainly providing supporting definition to the inner porous lumen of the practiced composition. Paragraph [0101] further defines the inner lumen:
“The ability to form small tubes (0.1 to 6.0 mm ID) with controllable pore sizes with silk fibroin aqueous solution, the superior mechanical properties, slow biodegradation and the biocompatibility of this protein provides a novel option for microvascular grafts. These properties can be tailored through the addition of various concentrations of polyethylene oxide (PEO) or other biocompatible polymer to silk fibroin before forming the silk microtubes through a simple dipping technique, and leaching out the PEO or other polymer to generate the porous silk microtubes. Recent reports have suggested the need for porous scaffolds for vascular tissue engineering applications.”
Thus, the disclosure of claim 20 is considered to teach the instantly claimed, porous biomatrix material.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
Claims 62-71, 73, 75, and 76 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zhang et al. (WO 2011/008842 A2; of record).
The instant invention is directed to a method of wound healing or repairing (i.e., treating) a tissue defect comprising the application of a composition comprising a first layer comprising a porous biomaterial matrix layer, and a second layer comprising an impermeable biomaterial.
Regarding the term “impermeable,” the Examiner notes that Applicants’ instant specification defines the term at ¶[0046] as “refer[ring] to material being able to prevent the passage of an aqueous solution across the material at a particular temperature, tension, and fluid pressure” and that in some embodiments, “the impermeable layer can have no observable pores.”
Thus, having weighed this term as defined by Applicants (see MPEP §2111.01), as well as the material recited as being used to construct it, the Examiner broadly and reasonably interprets any showing in the art of a layer that is not porous to meet the recited term and properties thereto.
Zhang discloses a method of promoting wound healing comprising contacting a wound with at least one electrospun silk mat comprising a silk fibroin protein, a polyethylene oxide (PEO) and optionally, at least one active agent (see e.g., claim 31). Paragraph [0093] further defines silk-based barriers as being permeable to gases (e.g., O2 and CO2) while remaining impermeable to gram-negative bacilli and gram-positive cocci sepsis-initiating bacterial pathogens.
Silk mats that are prepared by the practiced invention are taught as having a thickness ranging from about 20-80 microns and will further comprise an active agent (see e.g., claims 10-14 and 17).
The foregoing is considered to teach and suggest the limitations recited by claims 62, 66, 68-71, and 73.
Claims 75 and 76 respectively recite that the composition of claim 62 is characterized by an elastic modulus of up to about 2.7 MPa and an extensibility of between about 25% and 500%. Looking to Applicants’ instant specification, these limitations appear to be properties that are tethered to and definitive of the instantly encompassed composition discussed therein (see Spec., ¶0047). As such, consistent with MPEP §2111.01(IV), and §2112.01(I) and (II), the Examiner submits that where Applicants’ defining composition is disclosed in the prior art, the recited limitations of claims 75 and 76, will also be considered met.
Paragraphs [0091] and [0092] are considered to teach and suggest the limitations presented by instant claims 63-65. Therein, for instance, the practiced biomaterial is taught as being used for organ repair and replacement or regeneration strategies using such structures as scaffolds in association with organs such as kidneys and bladders.
Based on the combined teachings of the reference, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition as well as arriving at the method of treating a wound with it. As discussed above, Zhang discloses a multilayered silk fibroin composition having a layer that is impermeable and a matrix which contains bioactive material for release. The practiced compositions are further taught and suggested as being used to treat hollow organs as well as various tissues and defects. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 62-71, 73, 75, and 76 under 35 USC 103(a) as being unpatentable over the teachings of Zhang et al. have been fully considered but they are not persuasive.
Applicants again traverse the rejection on the grounds that the reference (Zhang) is silent regarding the claimed porous biomaterial matrix.
The Examiner again disagrees and maintains the rejection for the reasons already of record. Regarding the disclosed porous layer, the reference expressly discloses that at least one electrospun silk mat comprising a silk fibroin protein, PEO and optionally, an active agent is produced. Added disclosures such as ¶[0096] discuss that such “modified electrospun silk fibers (silk/PEO blend ratio of 4:1) have a porosity of up to 68%,” thereby teaching that the disclosed mat is in fact porous, and controllably so.
Lastly, Applicants’ remarks asserting unsupported inherency are not persuasive.
Having considered the breadth of Applicants’ claimed compositions and the properties that are used in an attempt to further limit the claimed composition, the Examiner submits that compositionally, the claim recites no compounds. It simply recites a method for treating a wound comprising the application of a composition comprising a porous layer and an impermeable layer.
In an attempt to ascertain exactly what Applicants are attempting to claim (e.g., by their properties instead of an actual composition), the Examiner is allowed to interpret the instantly claimed invention in light of the instant specification. See MPEP §2111. The Examiner acknowledges that it is improper to import claim limitations from the specification, and assures Applicants that is has not been done here. Instead, pursuant to MPEP §2111.01(II) and (IV), the Examiner has interpreted the claimed invention in light of the specification, giving them [the claimed biomaterials] their broadest reasonable interpretation. Understandably, the full breadth of the “biomaterials” meant to embody two different layers in claim 62 are not commensurate in scope with the later recited properties of claims 75 and 76. Thus, in allowing Applicants’ to be their own lexicographer, the Examiner considers the limitations of the claimed invention in light of the instant specification.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
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 62-78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 20 of Mauney et al. (USPN 10,912,862 B2; of record). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the reference ‘862 patent discloses:
A multilayer biomaterial composition, comprising:
a first and second layer;
the first layer comprising a porous biomaterial matrix, wherein the porous biomaterial matrix comprises silk fibroin, and
the second layer comprising an impermeable biomaterial layer, wherein the impermeable biomaterial layer is characterized in that it prevents passage of liquid water across it,
wherein a bottom surface of the second layer contacts and/or covers a top surface of the first layer,
wherein the multilayer biomaterial composition has a shape selected from the group consisting of approximately a contoured sheet, a plane, a cuboid a sheet, and a tube, so that the multilayer biomaterial composition, when positioned at a site of a wound or defect, a bottom surface of the first layer is oriented such that the porous biomaterial matrix of the first layer is in contact with the wound or defect and provides a scaffold for tissue regeneration and the impermeable biomaterial layer provides a seal that prevents passage of cellular material, fluids, hollow organ contents, and/or particles into the site.
The foregoing reads on the recitations of instant claims 62, 63, 65, 66, 68, 69, and 78, with the limitations of claims 65 being further defined by the reference ‘862 patent (see e.g., col. 3, lines 28-44).
Reference claim 2 discloses the limitations of instant claim 67.
Reference claim 3 discloses the limitations of instant claim 68.
Reference claim 4 discloses the limitations of instant claim 69.
Reference claim 5 discloses the limitations of instant claim 70.
Reference claim 6 discloses the limitations of instant claim 71.
Reference claims 7 and 8 disclose the limitations of instant claim 72.
Reference claim 9 discloses the limitations of instant claim 73.
Reference claim 10 discloses the limitations of instant claim 74.
Reference claim 11 contributes to and discloses limitations of instant claim 62.
Reference claim 12 discloses the limitations of instant claim 63 and 64.
Reference claim 13 discloses the limitations of instant claim 64.
Reference claim 14 discloses the limitations of instant claim 77.
Reference claim 15 discloses the limitations of instant claim 75.
Reference claim 16 discloses the limitations of instant claim 76.
Reference claims 17 and 18 disclose the limitations of instant claim 78.
Reference claim 20 discloses the limitations of instant claim 69.
The Examiner respectfully submits that a person of ordinary skill in the art practicing the invention of Mauney (‘862) would have had a reasonable expectation of successfully achieving and practicing the instantly claimed method of treating wounds and defects.
Therefore, were the reference available as prior art, the instant invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ filed response to the rejection of claims 62-78 on the grounds of nonstatutory double patenting over the copending/patented teachings of Mauney et al. has been fully considered, but is not persuasive.
At the outset, the Examiner acknowledges the typographical mistake present in the grounds of rejection and notes that while it previously inadvertently omitted claims 62-64, the claims, as acknowledged by Applicants were addressed in the body of the rejection.
Regarding the filed amendment to claim 62, as discussed above, the claimed composition has simply been amended to recite a functional limitation of the already rejected second layer that is comprised of impermeable biomaterial. Notably, since the defining material is later recited as being formed of silk fibroin and the reference continues to teach this compositional limitation, Applicants’ amendment fails to overcome the rejection.
Thus, the double patenting rejection of record is maintained.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are 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 extension fee 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.
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).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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