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 .
Priority
This application is a National Stage entry of PCT/CA2022/051452, filed 9/29/2022, claims priority to provisional 63/261,803, filed 9/29/2021.
Information Disclosure Statement
The IDS filed on 3/28/2024 has been considered. See the attached PTO 1449 form.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 4/15/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 28-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.
Claim Status
Receipt of Remarks filed on 4/15/2026 is acknowledged. Claims 1-2, 4-5, 8-11, 14-17, 19, 21-25, 28-29 are currently pending. Claims 28-29 have been withdrawn. Accordingly, claims 1-2, 4-5, 8-11, 14-17, 19, 21-25 are currently under examination.
Claim Objections
Claim 5 is objected to because of the following informalities:
In claim 5, the recitation “crosslinkers comprises” should recite “crosslinkers comprise”.
Appropriate correction is required.
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 10, 23 and 25 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.
Regarding claims 10 and 23, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “long term” in claim 25 is a relative term which renders the claim indefinite. The term “long term” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear what exactly constitutes long term attachment (e.g. is it in hours, days, weeks, etc.) and the specification also do not clearly define what exactly constitutes long term.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5, 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tian (Chem. Mater. 2019, 31, 5442-5449).
Tian teaches hierarchically structured, self-healing, fluorescent, bioactive hydrogels. Specifically, Tian discloses hydrogels which comprise crosslinked M13 bacteriophage (biomolecule) which are crosslinked with a crosslinker which is glutaraldehyde. Tian teaches the bacteriophage exhibit micron scale order and the hydrogel having microstructure, which reads on the hydrogel comprising microscale structure. Tian also teaches the bacteriophage undergoes biodegradation. (see e.g. Title, Abstract, Introduction, Result and Discussion).
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, 2, 5, 10, 11, 14, 16, 19 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Bennett (EP2389926A2; 2012-07-25)(cited in IDS).
Bennett throughout the reference teaches hydrogel implants with varying degree of crosslinking (abstract).
Bennett teaches hydrogels comprising biodegradable crosslinkers which may be reacted with proteins such as albumin, which reads on crosslinked biomolecule and where biomolecule is a protein. The crosslinker can be glutaraldehyde (para 0053-0055). A bioactive may be included in the hydrogel and the bioactive can be in microspheres, which reads on hydrogel comprising microscale structures and the microscale structures comprising rounded projections (para 0133). The hydrogel can also include collagen, casein, gelatin and proteins and peptides such as bovine lactoferrin, which read on further comprising heat sensitive molecule. (para 0035; 0116). Bennet also teaches the hydrogel can be hydrophilic and biodegradable (para 0036; 0047). Bennet teaches the bioactive can also include antibiotics which read on claim 19. Bennet does not require the hydrogel include antibacterials or state that the hydrogels kill bacteria. Thus, the hydrogel taught by Bennet also reads on claim 24 wherein the hydrogel does not kill bacteria.
The teachings of Bennett have been set forth above.
While Bennett does not expressly exemplify a hydrogel which comprises crosslinked albumin and also comprises microspheres, Bennett does teach wherein the crosslinked albumin can be used and the bioactive can be in microsphere. Bennet also teaches different bioactive agent that can be included and the hydrogel can be hydrophilic and biodegradable. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding claim 14, Bennet teaches the hydrogel comprising microsphere (microscale structure) and a sphere has an aspect ratio of about 1, which merely overlaps the claimed aspect ratio of about 0.9. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). See: MPEP 2144.05(I). Changes in size, shape, or sequence of adding ingredients generally have limited impact on patentability unless they produce unexpected results or solve a specific problem. See: MPEP 2144.04.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Claims 4, 8, 9, 15, 17, 21-23, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Bennett (EP2389926A2; 2012-07-25) as applied to claims 1, 2, 5, 10, 11, 14, 16, 19 and 24 above and further in view of Zhu (Adv. Mater. 2019, 31, 1804950) and Wang (Applied Surface Science 265 (2013) 480-488).
The teachings of Bennett have been set forth above.
Bennett does not teach the microscale structures form ordered arrays on a surface of the hydrogel, further comprises nanoscale features, wherein microscale and nanoscale features form hierarchical structures, the contact angle of the hydrogel and wherein the hydrogel exhibits repellency to bacteria and inhibits long term attachment of multidrug resistant staphylococcus aureus. However, these deficiencies are cured by Zhu and Wang.
Zhu teaches Hierarchical hydrogel composite interfaces with robust mechanical properties for biomedical applications. Cells sense and respond to a wide range of external signals, including topography, via interactions with the extracellular matrix (ECM). Based on micro/nanoscale-topography-coupled mechanical action, recent advances in the fabrication and application of hydrogel composites with tunable mechanical properties and topography in biomedicine are summarized. In particular, recent findings showing that hydrogels with specifically designed structures not only influence a range of cellular processes and fit the needs of engineered tissues but also have pharmacological effects are emphasized. The development of materials with a robust micro/nanoscale surface with suitable mechanical properties is a major goal in the field of biomedicine. Hydrogels prepared with micro/nano surface topography not only influence cell adhesion, spreading, and migration, but can also induce cells to form different patterns or to differentiate into desired cell types. (see e.g. Abstract; Introduction; Hierarchical Hydrogel with Robust Micro/Nanoscale Interfaces; Figure 3; Entire Document).
Wang teaches fabricating a biomimetic interface with multiscaled surfacial architecture can greatly improve biomaterials’ function and property. Bioinspired micro/nano fabrication on dental implant–bone interface can be potentially applied in the update of dental implant in patients’ clinical therapy and provide a new strategy for fabricating other osteocompatible materials. Some natural tissues are designed and assembled in controlled ways from microscale to nanoscale building blocks. This hierarchical organized micro/nano structure has a substantial effect on natural tissues’ function. Hierarchical micro/nano surface usually presents extreme wettability such as superhydrophilicity or superhydrophobicity. As to dental implant, highly hydrophilic interface seems to present better biocompatibility in comparison with the hydrophobic one. It is suggested that hierarchical architectures with micro/nano size may increase surface energy to improve the stability and osseointegration of dental implants. It was observed clearly that the micro-scale (Fig. 3b) and micro/nano (Fig. 3c) interface are far more rough in comparison with smooth Ti substrate interface. The nano/micro interface displayed a considerable hydrophilic property, the water contact angle was only 23.3 ± 7.9°. (see e.g. abstract; introduction; Materials and Methods; Results and Discussion; section 3.1-3.3; entire document).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Bennett, Zhu and Wang and incorporate microscale and nanoscale surface topography on the surface of the hydrogel of Bennett as taught by Zhu and Wang. As discussed supra, Zhu and Wang teach hierarchical organized micro/nano structure. Bennett teaches hydrogel implants and Zhu teaches hydrogels prepared with micro/nano surface topography not only influence cell adhesion, spreading, and migration, but can also induce cells to form different patterns or to differentiate into desired cell types. Wang teaches hierarchical organized micro/nano structure has a substantial effect on natural tissues’ function. Hierarchical architectures with micro/nano size may increase surface energy to improve the stability and osseointegration of dental implants. Thus, it would have been obvious to one skilled in the art to make the hydrogels of Bennett have a surface topography which comprises hierarchical and ordered micro and nano-scale structures/features. Further, as taught by Wang, the nano/micro interface display a considerable hydrophilic property and water contact angle was only 23.3 ± 7.9°, which was less than smooth surface topography.
Regarding the claimed limitation wherein the hydrogel exhibits repellency to bacteria and inhibits long term attachment of multidrug resistant staphylococcus aureus, the instant specification disclose hydrogels with hierarchical microbumps are more hydrophilic than smooth microbumps, but exhibit remarkable bacteria repellency, mitigating adhesion of staphylococcus aureus by 100 times. Thus, incorporate micro/nano scale features on the surface of the hydrogel of Bennet would also provide repellency against bacteria and inhibit long term attachment of multidrug resistant staphylococcus aureus.
Regarding claims 21-23, these claims depend from claim 19 which recites bacteriophages in a list of Markush alternatives and does not require the hydrogel comprising bacteriophages. The examiner interprets that claims 21-23, as currently written, also do not require the hydrogel comprises bacteriophages because these claims do not recite the hydrogel comprises specifically bacteriophages. Thus, claims 21-23 are also included in the rejection.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
In the instant claims 21-23 require the hydrogel comprises bacteriophages of claims 21-23, then the following 103 rejection applies.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bennett (EP2389926A2; 2012-07-25) as applied to claims 1, 2, 5, 10, 11, 14, 16, 19 and 24 above and further in view of Tian (Chem. Mater. 2019, 31, 5442-5449).
The teachings of Bennett have been set forth above.
Bennett does not teach the hydrogel further comprises bacteriophages and the specifics of the bacteriophages recited in claims 21-23. However, Tian cures this deficiency.
Tian teaches hierarchically structured, self-healing, fluorescent, bioactive hydrogels. Specifically, Tian discloses hydrogels which comprise filamentous bacteriophages of Escherichia coli (f1, M13 and fd). Tian specifically discloses hydrogels of self-organized M13 bacteriophage bundles. Filamentous phage M13 has garnered significant attention in the past decade for the development of functional materials, ranging from tissue engineering scaffolds to batteries. Tian teaches M13 also provides fluorescent. (see e.g. Title, Abstract, Introduction, Result and Discussion; conclusion).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Bennett and Tian and further include bacteriophages taught by Tian into the hydrogel of Bennett. Bennett teaches the hydrogel may act as a tissue scaffold, providing means for tissue integration/ingrowth and the hydrogel may also include visualization agents such fluorescent compound (para 0072; 0109). Tian discloses hydrogels which comprise filamentous bacteriophages of Escherichia coli (f1, M13 and fd). Tian specifically discloses hydrogels of self-organized M13 bacteriophage bundles. Filamentous phage M13 has garnered significant attention in the past decade for the development of functional materials, ranging from tissue engineering scaffolds to batteries. Tian teaches M13 also provides fluorescent. Thus, it would have been obvious to include the bacteriophages of Tian into the hydrogel of Bennett because they provide development for use in tissue scaffolds and as fluorescent.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
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, 4, 5, 8, 9, 15-17, 21-23, 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, 11, 15, 16, 18-20, 24, 26, 28 of copending Application No. 17626295 (US20220265739A1) in view of Tian (Chem. Mater. 2019, 31, 5442-5449), Zhu (Adv. Mater. 2019, 31, 1804950) and Wang (Applied Surface Science 265 (2013) 480-488).
‘295 claims a hydrogel composition comprising crosslinked bacteriophages (biomolecule). The bacteriophages are crosslinked with one ore more crosslinkers including nanoparticles. The hydrogel exhibits degradability. The hydrogel comprises at least two different bacteriophages. Bacteriophages self-assemble into bundles, comprise filamentous bacteriophages, comprise Escherichia coli bacteriophages, f1, m13 or fd. The hydrogel further comprises microstructures on the surface of the hydrogel.
‘295 does not teach the microstructures form ordered array and the hydrogel further comprises nanoscale features. ‘295 also does not teach the crosslinking agent recited in claim 5, contact angle of the hydrogel, and repellency to bacteria as recited in instant claims. However, Tian, Zhu and Wang cure these deficiencies.
The teachings of Tian, Zhu and Wang discussed supra are incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of ‘295, Tian, Zhu and Wang and include glutaraldehyde as the crosslinker because Tian also teaches hydrogels which comprise crosslinked M13 bacteriophage (biomolecule) which are crosslinked with a crosslinker which is glutaraldehyde. Thus, it would have been obvious to use a crosslinker which was known to be used with the M13 bacteriophages.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of ‘295, Tian, Zhu and Wang and incorporate both microscale and nanoscale surface topography on the surface of the hydrogel because both Zhu and Wang teach hierarchical organized micro/nano structure. Zhu teaches hydrogels prepared with micro/nano surface topography not only influence cell adhesion, spreading, and migration, but can also induce cells to form different patterns or to differentiate into desired cell types. Wang teaches hierarchical organized micro/nano structure has a substantial effect on natural tissues’ function. Hierarchical architectures with micro/nano size may increase surface energy to improve the stability and osseointegration of dental implants. Thus, it would have been obvious to one skilled in the art to make the hydrogels of ‘295 have a surface topography which comprises hierarchical and ordered micro and nano-scale structures/features. Further, as taught by Wang, the nano/micro interface display a considerable hydrophilic property and water contact angle was only 23.3 ± 7.9°, which was less than smooth surface topography.
Regarding the claimed limitation wherein the hydrogel exhibits repellency to bacteria and inhibits long term attachment of multidrug resistant staphylococcus aureus, the instant specification disclose hydrogels with hierarchical microbumps are more hydrophilic than smooth microbumps, but exhibit remarkable bacteria repellency, mitigating adhesion of staphylococcus aureus by 100 times. Thus, incorporate micro/nano scale features on the surface of the hydrogel would also provide repellency against bacteria and inhibit long term attachment of multidrug resistant staphylococcus aureus.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/ALI S SAEED/ Examiner, Art Unit 1616
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