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 .
Status of the Claims
Claims 1-6, 8, 10-13, 15-17, 19-21, and 23-25 are pending.
Claims 15-17, 19-21 and 23 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-6, 8, 10-13, 24, and 25 are presented for examination and rejected as set forth in greater detail below.
Claim Interpretation
Applicants’ claims are directed to compositions combining a network of bacterial cellulose nanofibers fibers with a bioadhesive polymer or dendrimer having a moiety grafted onto which forms covalent interactions when triggered by a stimulus. Claim 2 narrows the identity of the polymer as well as the moiety, with Claim 12 specifying the types of stimulus which triggers the covalent bonding. Taken in context with the description of Claim 1 as specifying that the moiety is triggerable by a stimulus, the Examiner considers the language of Claim 12 as a functional description of the moiety claimed, which applicants specification indicates is addressed by the diazirine of Claim 2. See Specification [00138]. Claims 3, 4, 6, 10 and 11 narrow the identity of the bacterial cellulose. Claims 5 and 8 specify the configuration of the bioadhesive relative to the cellulose. Claim 13 incorporates a drug within the mucoadhesive, and/or incorporates an additional nonspecific polymeric coating on the mucoadhesive. New Claim 24 defines a “formulation” incorporating the mucoadhesive of Claim 1, with Claim 25 indicating that the formulation is “smearable.” As no conditions concerning the threshold of force required for smearability are provided by the claims, any physical form not explicitly described as a solid will be considered “smearable.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-6, 8, 10-13, 24, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Steele (WO2014/081391) in view of Wan (WO2005/016397)(each of record).
Steele describes bioadhesive compositions which incorporate a diazirene-modified biocompatible bioadhesive polymer addressing the limitations of Claims 1, 2, and 12, including each of the polycaprolactone and polyamides of Claim 2, [0010-12] provided in the form of a hydrogel, which the Examiner considered sufficiently “smearable” to address the limitations of newly added claims 24 and 25. [0016]. Steele teaches that these compositions may incorporate additives such as drugs, addressing the limitations of Claim 13. [0015]. Steele specifically indicates that these bioadhesives may be combined with nanofibers of biodegradable polymer to modify the biomechanics of such an adhesive to match that of soft tissues. [0018]. Steele indicates that additional polymers may be incorporated into the composition, suggesting the additional polymeric coating required by Claim 14. [0019].
While Steele does not describe such nanofibers as being bacterial cellulose as is required by the present claims, that is addressed by the teachings of Wan, which also describes hydrogel bioadhesives. (Abs.). While exemplifying polyvinyl alcohol compositions, Wan indicates that bioadhesive hydrogels for medical applications are suitably modified to provide desirable mechanical properties by the incorporation of bacterial cellulose nanofibers. (Pg.6-7). Wan describes the hydrated cellulose nanofibers as being provided as a “matrix” of hydrated nanofibers where the orientation of the fibers, such as random or unidirectional arrangement of the fibers, gives rise to modifications in composite strength and stiffness, sufficient to address the generic “network” of fibers provided in the claims as amended. (Pg.8). Particular bacterial cellulose fibers include rehydrated, and therefore hydrogel, nanofiber matrices obtained from acetobacter recited by Claims 3-5, 8, and 10 incorporated into hydrogel composites. Pg.9-10. While not described in the same manner as the functional limitations of Claim 11, applicants are reminded that where the claimed invention and prior art are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (indicating that “products of identical chemical composition cannot have mutually exclusive properties.”). Here, as the bacterial cellulose of Wan is obtained from acetobacter species as is required by the claims, the properties of light transmission recited by applicants are presumed to be present.
The present composition combining bacterial cellulose and a diazirene bioadhesive polymer therefore appears little more than the use of the biocompatible bacterial cellulose nanofibers of Wan as the nanofibers of the compositions of Steele. That is because it is prima facie obvious to incorporate a material taught by the art as useful for a particular purpose or to provide a particular function into a composition where that purpose or function is taught as desirable. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)(indicating that generally it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use). It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected the acetobacter bacterial cellulose nanofiber matrix of Wan taught as usefully providing structural stability to wound dressings as the strengthening fiber matrix in the compositions of Steele, which provide diazirine containing PCL bioadhesive coatings incorporating drugs on and through such strengthening matrices as is required by the present claims, which optionally may be provided with multiple polymeric coatings, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 8, 10-13, 24, and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,005,936 in view of Wan, discussed in greater detail above. The ‘936 patent, the U.S. patent issued from the National Stage entry of the Steele reference relied on above, claims bioadhesive compositions containing diazirine containing polymers and suitable additives, drugs, and nanofibers, which Wan establishes the bacterial cellulose nanofiber matrices of the present claims provide particularly desirable physical properties, rendering their selection prima facie obvious as set forth in greater detail above.
Response to Arguments
Applicant's arguments filed 8 April 2026 have been fully considered but they are not persuasive.
Applicants assert that neither Steele nor Wan describe incorporating the now claimed “network of cellulose fibers” into a bioadhesive composition. Applicants attention is directed to the teachings of Wan, which describes the hydrated cellulose nanofibers as being provided as a “matrix” of fibers where the orientation of the fibers, such as random or unidirectional arrangement of the fibers, gives rise to modifications in composite strength and stiffness which applicants argue their “network” of fibers achieves. (Pg.8).
Applicants next argue that each of the Steele and Wan references, considered in a vacuum, fail to address the totality of the invention claimed. Applicants are reminded that it is not possible to establish the non-obviousness of an invention rendered obvious by the combined teachings of multiple prior art references by arguing that each of the references relied upon fails to teach the entirety of the invention which has been claimed; the absence of a single anticipatory reference is implied by both the reliance on the combined teachings of multiple references as well as the fact that the rejection being made is one of obviousness under 35 U.S.C. 103 rather than any of the subsections of 35 U.S.C. 102. MPEP § 2145(IV), see In re Keller, 642 F.2d 413, 426 (C.C.P.A. 1981) (citing Application of Young, 403 F.2d 754, 757 (C.C.P.A. 1968) (indicating that "[O]ne cannot show non-obviousness by attacking references individually where ... the rejections are based on combinations of references").
Applicants assertion that the exemplary “aligned nanofibers” of Steele are somehow distinct from the “network” of nanofibers presently calied is unpersuasive, as applicants generic term “network” fails to require any particular geometry the “network” is to possess. Moreover, as Wan indicates that at the time of the instant invention persons having ordinary skill in the bioadhesive arts would know that adjusting the orientation of bacterial cellulosic hydrogel nanofibers would serve to alter composite strength and stiffness in the same manner applicants incorporate their cellulosic fiber “network” into the claimed bioadhesives.
Applicants argue that the Wan and Steele references address distinct problems in tissue engineering applications and therefore are non-analogous. Applicants err in this regard, for it is well-understood that the scope of analogous art is to be considered broadly. Wyers v. Master Lock Co., No. 2009-1412, 2010 WL 2901839 (Fed. Cir. 2010). Art is analogous if it is (1) from the same field of endeavor, regardless of the problem addressed, or (2) reasonably pertinent to the particular problem with which the inventor is involved. In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992). Id. at 659 (“If a reference disclosure has the same purpose as the claimed invention, the reference relates to the same problem, and that fact supports use of that reference in an obviousness rejection.”). Here, each of Wan and Steele concern bioadhesive matrices, therefore are from the same field of endeavor, and are properly analogous to be relied on in combination to address the instant claims. See Steele [0010]; Wan Pg.6, L.14-17. Applicants assertion that Steele and Wan address different technical problems in distinct contexts, an assertion the Examiner does not accept, is irrelevant in this case owing to the analogy of the art.
Applicants assertion that Wan fails to describe the network of cellulose fibers into which a bioadhesive is incorporated, again argues piecemeal individual references where the rejection relies on the combination of multiple references, but more importantly is inaccurate. Wan explicitly describes hydrogel/cellulose composite materials combining cellulose hydrogel nanofibers within a PVA matrix, which Wan indicates possess bioadhesive properties. Pg.9, L.27 – Pg.10, L.5; Pg.6, L.14-17.
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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