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 .
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 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.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Group I. Claims 1-15, drawn to a composition comprising hydrogen peroxide and an acid, classified in class A61L 27-26.
Group II. Claims 16-20, drawn to a method of cleaning and disinfecting a surface, classified in class A61L 2400/06.
The inventions are distinct, each from the other because of the following reasons:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process of using that product, such as in vitro safety testing. Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention. Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i). The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined. In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101,102, 103 and 112. Until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Telephonic Election
During a telephone conversation with attorney David Bonham on January 27, 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action.
Claims 16-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Status
Claims 1-20 are pending.
Claims 16-20 are withdrawn.
Claims 1-15 are examined on the merits in this prosecution.
Objection to the Specification
The disclosure is objected to because of the following informalities: the description of the size of the claimed microparticles (pg 10, [0050]) recites: “Microparticles for use in the injectable shear-thinning compositions of the present disclosure may have a size ranging from 10 nm or less to 600 μm or more in longest dimension”. This stated range appears to recite a range of less than or equal to 10 nm and greater than or equal to 600 μm, and would exclude the exemplary ranges in paragraph [0050] as well as the claimed range in instant claim 8.
Appropriate correction is required.
CLAIM REJECTIONS
Anticipation Rejection
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.
1) Claims 1-4 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gaharwar (US 2020/0071550 A1).
Claim 1 is drawn to an injectable shear-thinning composition comprising one or more types of polymers, one or more types of microparticles, and water.
Gaharwar teaches an embodiment comprising biodegradable and biocompatible three dimensional construct comprising a combination of a nano silicate (e.g., laponite ) and two different polymers, the two polymers each individually providing at least one covalently linked polymer chain and at least one ionically linked polymer chain, the polymeric chains forming a dual strengthening intertwined polymeric system (Abstract). Gaharwar teaches the composition can comprise a carrier such as water, and may be in the form of a gel (pg 1, [0007]).
Gaharwar teaches the composition is a dually reinforced nanocomposite ionic - covalent entanglement (“NICE”) hydrogel bioink (pg 1, [0011]). Gaharwar teaches the non - crosslinked NICE bioink possesses physical cross-linking and shear-thinning characteristics (pg 3, [0041] and [0046]), reading on claim 2.
For claims 3 and 4, Gaharwar teaches the polymers of the NICE composition comprise gelatin methacrylate and kappa-carrageenan (pg 2, [0017]). It is noted that gelatin is a polyelectrolyte that has a positive net charge at low pH and a net negative charge at high pH, while carrageenan has a net negative charge. It is further noted that gelatin is a protein and carrageenan is a charged polysaccharide.
For claims 6-8, Gaharwar teaches the particles are a nano-silicate known as laponite ([0007]). Laponite is known in the art to have a particle size of about 25 nm, within the limitations of claims 6 and 8, and has a negative charge face and a positively charged rim (pg 6, [0090]), reading on claim 7.
For claim 9, Gaharwar teaches gelatin, possessing a positive net charge at low pH and a net negative charge at high pH, carrageenan possessing a net negative charge, and laponite having a negative charge face and a positively charged rim (see references above).
For claim 10, Gaharwar teaches the composition can be used with drugs like antibiotics or bioactive factors to encourage healing and reduce inflammation (pg 9, [0118]-[0119]).
Obviousness Rejection
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.
1) Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gaharwar (US 2020/0071550 A1, cited above).
The teachings of Gaharwar with regard to anticipation are discussed above.
In addition, for claims 11-13, Gaharwar teaches the NICE hydrogel can be injected into a wound site via syringe (pg 9, [0119]). One of ordinary skill would expect a composition injected into a wound to be sterile, and Gaharwar further teaches that a composition that is pre-crosslinked can be applied to a wound; such compositions may be stored in a pre-loaded syringe.
For claims 14 and 15, one of ordinary skill in the art would have been motivated to prepare a kit comprising the claimed composition and a syringe comprising a needle because the preparation of a kit comprising a pharmaceutical composition is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art, and Gaharwar teaches the injection of the claimed composition with a syringe. While Gaharwar does not specifically teach a needle in the kit (claim 15), one of ordinary skill would recognize that a needle is required to administer a composition from a syringe to a site below the skin of a subject.
The examiner acknowledges that some picking and choosing was used to arrive at the instantly claimed methods in view of Gaharwar. However, the claimed combination of components, including the one or more polymers, microparticles, and water, used and stored in a syringe in which one of ordinary skill would maintain sterility in order to reduce the possibility of bacterial contamination, is taught as known and used for administration to a subject with a wound. It would have therefore been prima facie obvious to a person having ordinary skill in the art to administer the claimed combination of ingredients by syringe to a subject with a reasonable expectation of success that the treatment would be efficacious, as taught by Gaharwar.
2) Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Appel (US 2017/0319506 A1).
Appel teaches network materials which exhibit both shear thinning and self - healing properties. The networks contain particles and gel-forming compounds and are useful for a variety of biomedical uses, including drug delivery (Abstract). Appel teaches the networks are comprised of nanoparticles and polymers (pg 1, [0012]). The nanoparticles may be comprised of poly(ethylene glycol)-b-poly (lactic acid) (PEG-b-PLA) polymer and the polymer may be a negatively charged polymers such as hyaluronic acid (HA) or carboxymethyl cellulose (CMC) (pg 2, [0026]). Appel teaches the solvent is water (pg 3, [0036]).
For claim 2, Appel teaches the composition is a gel and it may be non-covalently cross-linked ([0036]).
For claim 3, Appel teaches the polymer may be a negatively charged polymers such as hyaluronic acid or carboxymethyl cellulose ([0026]).
For claims 4 and 5, Appel teaches the polymers hyaluronic acid, a polysaccharide, and carboxymethyl cellulose, a synthetic polymer. The teaching of the synthetic polymer carboxymethyl cellulose reads on claim 5.
For claim 6, Appel teaches the particles may be clays, such as silicates; minerals, including sulfides, oxides, halides, carbonates, sulfates, and phosphates; apatites; and/or one or more metals, such as gold, silver, copper, platinum, palladium, and ruthenium (pgs 6-7, [0086]).
For claim 7, silicates have a net negative charge.
For claim 8, Appel teaches size of the particles is from about 10 nm to about 1,000 nm (pg 6, [0085]), overlapping the claimed range. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
For claim 9, Appel teaches the polymers can be cationically charged (pg 7, [0099]), or anionically charged, as discussed above.
For claim 10, Appel teaches the composition can contain an injectable drug (pg 8, [0106]). Appel also teaches the composition is useful for delivering diagnostic agents (pg 9, [0112]).
For claim 11, Appel’s teaching of an injection indicates a sterile composition since one of ordinary skill would not inject a non-sterile material into a subject.
For claim 12, Appel teaches the composition is useful for DNA vaccines, and these can be stored, necessitating a container. See pg 9, [0111].
For claim 13, preparing and storing a stable composition in a sealed syringe is within the skill of an ordinary practitioner.
For claims 14-15, one of ordinary skill in the art would have been motivated to prepare a kit comprising the claimed composition because the preparation of a kit comprising a pharmaceutical composition, a syringe, and a needle is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art.
As discussed above, Appel teaches a range of particle sizes that overlap with the claimed range of “microparticles” in claim 8.
The examiner acknowledges that some picking and choosing was used to arrive at the instantly claimed methods in view of Appel. However, the claimed combination of components, including the polymers and microparticles, is taught as known. Further, Appel teaches a composition within the ranges recited for the microparticles. As such, the invention claimed in claims 1-15 is taught as obvious over the prior art of Appel.
Nonstatutory Double Patenting Rejections
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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
1) Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/252,740 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims in the reference application recite injectable shear-thinning composition comprising (a) one or more types of fibrous proteins, (b) one or more types of silicate microparticles, (c) one or more types of radiopaque additives, (d) one or more types of block copolymers, and (e) water. It is noted that the “fibrous protein” in reference claim 1 is a polymer comprising positive and negative charges, which can yield a physically crosslinked hydrogel composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2) Claims 1-7 and 9-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 11-15 of copending Application No. 18/817,662 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims in the reference application recite injectable shear-thinning composition comprising (a) one or more types of fibrous proteins, (b) one or more types of silicate microparticles, (c) one or more types of radiopaque additives, (d) one or more types of block copolymers, and (e) water. It is noted that the “fibrous protein” in reference claim 1 is a polymer comprising positive and negative charges, which can yield a physically crosslinked hydrogel composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612