DETAILED ACTION
Status of the Claims
Claims 1-36 are pending in the instant application. Claims 12-36 have been withdrawn based upon Restriction/Election as discussed below. Claims 1-11 are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Restriction/Election
Applicant's election of Group I drawn to compositions of matter, currently claims 1-11, in the reply filed on 05/04/2026 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)).
Applicants have elected the following species in the reply filed 05/04/2026: (a) a polymer shell comprising albumin; (b) the therapeutic agent comprises siRNA; and the targeting agent comprises alendronate.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-36 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/04/2026.
Priority
The instant Application, filed 09/29/2023, is a 371 entry of PCT/US2022/022459 filed 03/30/2022, and claims priority to U.S. Provisional Application 63/169,535 filed 04/01/2021.
The U.S. effective filing date has been determined to be 03/30/2022, the filing date of the PCT/US2022/022459. The examiner finds no support in 63/169,535 for: “at least one therapeutic agent […] encapsulated within the polymer shell; and at least one targeting agent […] attached to a surface of the polymer shell” (instant claim 1, lines 4-7).
Information Disclosure Statement
The information disclosure statement submitted on 09/29/2023 was filed before the mailing date of the first office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
The examiner objects to the - Content of Specification, particularly the Specification fails to include: (g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts: (1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled "Technical Field." - (h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
The abstract of the disclosure is objected to because the Abstract is 63 words, many of which simply repeats the content of the title. The examiner suggest that Applicant include more specific concepts disclose, such as nanobubble shell is an albumin shell, a gas core containing perfluorocarbon gas, the therapeutic agent is siRNA and specifically Cathepsin K (CTSK) siRNA (osteoporosis-related silencing gene) targeted to bone tissue by alendronate, for the treatment of osteoporosis.
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.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112(b)
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 2-11 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 pre-AIA the applicant regards as the invention.
Claims 5 is rejected as being indefinite because the claims recite “comprises at least one gene sequence selected from the group consisting of vascular endothelial growth factor (VEGF), bone morphogenic protein (BMP), hepatocyte growth factor (HGF), and combinations thereof.” It is unclear how the “gene sequence” correlates with the members of the Markush group which are proteins and not “gene sequences”. Particularly the claim is ambiguous as to what exactly the claim requires: (1) the actual nucleic acid sequence that encodes the proteins (VEGF, BMP and/or HGF), (2) the proteins themselves (3) some hybrid fusion construct, or (4) something else entirely. Additionally, the claim does not provide any guidance as to what structural features (e.g. specific nucleotide sequences, SEQ ID Nos, coding regions, promoters, etc.) that would satisfy the claimed limitation, as a result, the metes and bounds of claim 5 cannot be determined with reasonable certainty. One of ordinary skill would not be able to ascertain whether a given nanobubble composition containing a particular nucleic acid or protein meets the limitation (MPEP §2173.02(I)). Appropriate clarification is required.
Claim 6 is similarly rejected for reciting “at least one gene sequence selected from BMP and VEGF.” As discussed above, and incorporated herein by reference, the it is unclear how the “gene sequence” correlates with the members of the Markush group which are proteins and not “gene sequences”. Appropriate clarification is required.
Claims 2-11 each recites the limitation "The nanobubble composition" in line 1. There is insufficient antecedent basis for this limitation in the claim. The examiner notes that claim 1 from which each of claims 2-11 ultimately depend, recites “An ultrasound responsive targeted nanobubble composition” which different from “The nanobubble composition” in the dependent claims. Appropriate clarification is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Razavi et al. (“A novel ultra-sound mediated nanodroplet-based gene delivery system for osteoporosis treatment, 30-JAN-2022 (online-date), Nanomedicine: Nanotechnology, Biology, and Medicine, Vol 41, Article 102530, pp. 1-16).
Disclosure of the Prior Art
Razavi et al. discloses “an ultrasound-responsive targeted nanodroplet system for the delivery of osteoporosis related silencing gene Cathepsin K small interfering RNA (CTSK siRNA) for osteoporosis treatment. The nanodroplet (ND) is composed of a gas core made from perfluorocarbon, stabilized with albumin, encapsulated with CTSK siRNA, and embedded with alendronate (AL) for bone targeting (CTSK siRNA-ND-AL).” (abstract, lines 1-4, see whole document, particularly Figure 1A)(instant claims 1-4, 6-9). Razavi et al. discloses that: “Using DLS, the ND size was shown to be 200 ± 50 nm (Figure 1, H).” (p. 4, col. 2, §Results – Characterization of nanodroplets, 1st paragraph, lines 5-6)(instant claim 10). Razavi et al. discloses that: “The siRNA internalization into the hOCP can also be quantified using labeling siRNA with either FITC or Cy3 and imaging cellular internalization via fluorescence microscopy.” (p. 14, col. 1, last paragraph, lines 9-12)(instant claim 11). Razavi et al. discloses that: “Regenerative genes such as vascular endothelial growth factor (VEGF), bone morphogenetic proteins (BMP), and hepatocyte growth factor (HGF) can be incorporated into the nanodroplets for promoting angiogenesis and osteogenesis. Different targeting biomolecules can also be functionalized onto the nanodroplets to improve the skeletal targeting.” (p. 13, col. 1, 3rd paragraph)(instant claims 5-6).
Applicant may rely on the exception under 35 U.S.C. 102(b)(1)(A) to overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore not prior art under 35 U.S.C. 102(a)(1). Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by SHAR (“DEVELOPING A TARGETED ULTRASOUND-RESPONSIVE NANOBUBBLE-BASED GENE DELIVERY SYSTEM FOR OSTEOPOROSIS TREATMENT,” 11-JAN-2021 (Release-date), Honors Undergraduate Thesis, University of Central Florida - STARS, pp. 69-pages).
Disclosure of the Prior Art
SHAR discloses that: “The overall goal of this project was to develop, optimize, and test an ultrasound-responsive targeted nanobubble for delivering osteoporosis-related silencing genes such as Cathepsin K small interfering RNA (CTSK siRNA) for osteoporosis treatment. The nanobubbles were synthesized using an in situ sonochemical method. The nanobubble (NB) is composed of a gas core made from perfluorocarbon, stabilized with albumin, encapsulated with CTSK siRNA, and embedded with alendronate (AL) for bone targeting (CTSK siRNA-NB-AL). Following its development, the responsiveness of CTSK siRNA-NB-AL to a therapeutic ultrasound probe was examined.” (p. ii, Abstract, see whole document)(instant claims 1-4, 7-9). SHAR discloses that: “Using DLS, the NB size was shown to be 200±50 nm (Figure 2G).” (p. 15, line 4)(instant claim 10). SHAR discloses imaging with Nanodrop Spectrophotometer using L-tryptophan loaded in to PFC HSA nanobubbles (p. 12, §6)(instant claim 11). SHAR discloses that: “Regenerative genes such as vascular endothelial growth factor (VEGF), bone morphogenetic proteins (BMP), and hepatocyte growth factor (HGF) can be incorporated into the nanobubbles for promoting angiogenesis and tissue regeneration.” (p. 44, last paragraph)(instant claims 5-6).
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. 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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over IRUDAYARAJ (US 2020/0249221; published August 2020) in view of Chen et al. (“Bone Targeted Delivery of SDF-1 via Alendronate Functionalized Nanoparticles in Guiding Stem Cell Migration,” 2018, ACS, Applied Materials and Interfaces, Vol. 10, pp. 23700-23710); Shapiro et al. (“Recent Advances and Future of Gene Therapy for Bone Regeneration,” 2018, Current Osteoporosis Reports, Vol. 16, pp. 504–511) and LONG (WO 2007/137149 A2; published May, 2007).
Applicants Claims
Applicant claims an ultrasound responsive targeted nanobubble composition, comprising: a hollow core containing at least one gas; a polymer shell encircling the hollow core; at least one therapeutic agent disposed in the hollow core and/or encapsulated within the polymer shell; and at least one targeting agent incorporated in the polymer shell and/or attached to a surface of the polymer shell, wherein the at least one targeting agent targets the nanobubble composition to at least a portion of a musculoskeletal system of a patient (claim 1). Applicant further claims the at least one therapeutic agent comprises an siRNA (claim 2) and wherein the siRNA is a Cathepsin K (CTSK) siRNA (claims 3-4) and “at least one gene sequence selected from the group consisting of vascular endothelial growth factor (VEGF) and bone morphogenic proteins (BMP) (claims 6-7). Applicant claims the nanobubble polymer shell comprises albumin (instant claim 8), the targeting agent comprises alendronate, and further comprising an imaging agent (claim 11). Applicant claims the nanobubble composition has a diameter in a range of from about 20 nm to about 200 nm in diameter (claim 10), and contains a perfluorocarbon gas (claim 7).
Determination of the scope
and content of the prior art (MPEP 2141.01)
IRUDAYARAJ teaches nanobubbles (title, see whole document), particularly "oxygenized nano bubbles and their uses in imaging and cancer treatment when combined with therapeutic drugs and precise ultrasound beam steering." (abstract).
IRUDAYARAJ teaches that: “a nanobubble comprising a continuous outer shell, the outer shell comprising a cross-linked polymeric material, an inner wall of the continuous outer shell and a hollow core within the continuous outer shell. The nanobubble may be less than 250 nm in diameter. In a further aspect of the invention, the cross-linked polymeric material is a cellulose-based material.” ([0011]). And that: “In another aspect of the present invention, the outer shell may further comprise a fluorophore, a pharmaceutical, a biomolecule, a ligand, contrast imaging agents, antibodies, lipids, protein receptors, aptamers or combinations thereof. The hollow core may be filled with a solid, a liquid, a gas or combinations thereof.” [emphasis added]([0012])(instant claim 11).
IRUDAYARAJ teaches that: “FIG. 6 is a graphic representation of one embodiment of a nanobubble incorporating a therapeutic drug and a targeting agent in a crosslinked, cellulosic outer shell, and a hollow inner core comprising oxygen;” [emphasis added]([0021])(instant claim 1, “An ultrasound responsive targeted nanobubble composition, comprising: a hollow core containing at least one gas; a polymer shell encircling the hollow core; at least one therapeutic agent disposed in the hollow core and/or attached to a surface of the polymer shell, at least one targeting agent incorporated in the polymer shell and/or attached toa surface of the polymer shell”).
IRUDAYARAJ teaches that: “The composition of a nanobubble may comprise an outer shell of a polymer material. This polymer material is chosen from the group consisting of […] albumin […].” [emphasis added]([0079])(instant claim 8).
IRUDAYARAJ teaches that: “In certain aspects the composition is a hollow, sphere or sphere-like shaped nano bubble ranging in size of about 10 nm diameter to about 250 nm diameter across.” ([0065])(instant claim 10).
IRUDAYARAJ teaches that: “The hollow core of the nanobubble will have about the same diameter as the nanobubble itself. The hollow core may comprise cargo of a solid, liquid or gas for various applications. Additional elements described previously, fluorphores, small molecules such as pharmaceuticals, biomolecules such as growth factors, glucose, steroids, ligands for targeting such as prostate-specific membrane antigen PSMA or folate, sticky molecules, antibodies in whole or in part, ultrasound contrast imaging agents, lipids, protein receptors, or aptamers such as an oligonucleic acids or peptide molecules, may be bound to the inner wall of the outer shell and directed towards the hollow core of the nano bubble. The additional elements in the hollow core may be free-floating, or unattached to the inner wall of the outer shell of the nanobubble. The hollow core may comprise a gas including but not limited to oxygen, nitrogen, carbon dioxide, plasma, perfluorocarbons, perfluorohexane, or tetradecafluorohexane. The hollow core of the nano bubble may comprise a liquid including but not limited to water, contrast imaging agents, saline solution, perfluorocarbon, fluorinated liquids, liquid drug formulations, nitric oxide, chemical oxygen generators, or oxygen release compounds.” [emphasis added]([0081])(instant claim 7).
IRUDAYARAJ teaches that: “The nanobubble may be configured to carry therapeutics to a diseased location within a patient. […] The nanobubble configured to carry a therapeutic may be used to treat, inhibit, or reduce […] diseases of the […] bone […]. The therapeutic may be a small molecule, pharmaceutical agent, biomolecule, radiotherapeutic, large molecule, inhibitor, protease, antibiotic, anti-viral, a combination product including a biomolecule and synthetic molecule, or siRNA, […] RNA depending on the disease being treated, inhibited, or symptoms reduced. […] The nanobubble configured to carry a therapeutic may comprise a continuous polymer outer shell including a targeting agent to direct the nanobubble and its cargo to a specific cell or tissue type.” [emphasis added]([0099])(instant claim 1, at least one targeting agent; instant claim 2).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of IRUDAYARAJ is that IRUDAYARAJ does not expressly teach the siRNA species is Cathepsin K (CTSK) siRNA, the targeting agent is alendronate, or the combination of CTSK-siRNA with “at least one gene sequence selected from BMP and VEGF.” (instant claims 3-6 & 9)
Chen et al. teaches that: “Osteoporosis is a worldwide health problem related to the aging population. Unbalanced bone remodeling favoring bone resorption over bone formation results in bone mineral loss. Drugs with antiresorptive and anabolic effects on osteoclast and osteoblast have been applied; however, the restoration of bone mass and strength has not yet been achieved. The decreases in the activities and numbers of osteoblasts and mesenchymal stem cells (MSCs) with aging are the main reasons leading to the reduced osteogenesis and bone formation” (§Introduction, 1st paragraph). Chen et al. teaches that: “Targeted drug delivery provides the benefits in improving therapeutic effect and reducing side effect. Bone targeting could be realized by modifying liposome with alendronate (Aln-Lipo). It has high affinity for bone mineral and has been widely studied in bone targeted drug delivery.” (p. 23701, col. 1, 2nd paragraph & Figure 1).
Shapiro et al. teaches that: “Orthobiologics, including stem cells, scaffolds, growth factors, and osteoanabolic agents, have been delivered both locally and systemically to accelerate fracture repair and treat systemic skeletal conditions such as osteoporosis.” (p. 505, col. 1, 3rd paragraph). And that: “Out of these approaches, protein therapy is probably the most easily translated into clinical care. Proteins can be relatively easily produced in large quantities, making for a consistent product with fewer batch to batch variation than cell products, for example. This is likely the reason that protein growth factors, including bone morphogenetic proteins (BMPs), have been introduced into clinical use as Food and Drug Administration (FDA)-approved products. Yet, heavy scrutiny followed for their elevated price and high incidence of side effects, possibly due to their use in supraphysiological doses. Subsequently, gene therapy has been suggested to produce a more cost-effective product which could be produced by endogenous cells at physiological levels. In this review, we will bring forward recent advances in osteogenic gene therapy, including nonviral delivery, gene-activated matrices, viral delivery, and ex vivo delivery (Table 1). We will discuss the advantages and disadvantages of different approaches and present relevant future research directions and challenges in this field.” (p. 505, col. 2, last paragraph).
Shapiro et al. teaches that: “we optimized microbubble-enhanced ultrasound gene delivery and showed that this method could be used to safely and efficiently regenerate a critical size defect in a clinically relevant large animal model1.” (p. 505, col. 2, lines 15-18).
Shapiro et al. teaches that: “Recently, the first clinical application of a GAM2 was published, wherein a collagen hydroxyapatite scaffold and plasmid DNA encoding vascular endothelial growth factor (VEGF) was implanted in a patient with a bone-autograft reconstructed mandible nonunion. Not only were no adverse events observed over a year of follow up, some bone regeneration was also noted. In the preclinical arena, GAMs have been becoming increasingly complex to better promote fracture healing.” (p. 505, col. 2, last paragraph through p. 506, col. 1, 1st paragraph)(instant claims 5-6, “gene sequence [encoding]” VEGF).
Shapiro et al teaches that: “One of the recent exciting nucleic acid-based approaches to be investigated for fracture repair enhancement is the use of microRNAs (miRNAs). miRNAs are small regulatory noncoding RNAs that recognize target mRNAs by base-pairing. […] Exogenous miRNA delivery has been used to enhance bone regeneration in distraction osteogenesis models and critical-sized defects. A complementary strategy to overexpressing osteogenic miRNAs is identifying miRNAs which inhibit bone formation and therefore if downregulated could be used to drive osteogenesis” [emphasis added](p. 507, col. 2, §Conclusions, 1st paragraph).
LONG teaches the use of Cathepsin K antagonists in bone production (title, see whole document), and particularly that: “The invention regards the modulation of a proteolytic enzyme, Cathepsin K that results in increased bone production by bone forming cells. Drugs that target this enzyme within bone forming cells and inhibit its activity represent a new class of anabolic, or bone building, therapies. Such drugs are useful in the treatment of diseases or disorders such as osteoporosis, Paget’s, disease, metastatic bone cancer, bone fractures, etc.” (abstract).
LONG teaches that: “Thus, in accordance with the present invention, there is provided a method of promoting bone formation comprising (i) selecting a first intracellular Cathepsin K inhibitor; and (ii) administering to a subject the first inhibitor of Cathepsin K. The inhibitor may be a biological or an organopharmaceutical small molecule. The biological may be a peptide, an siRNA […].” (p. 3, lines 1-6). And that: “The role of Cathepsin K in bone formation intracellular signaling networks is supported by three observations: (1) the inventor's Cathepsin K inhibitors stimulate bone formation both in vivo and in vitro, (2) RNA interference studies of Cathepsin K (RNAi; performed via small interfering RNA (siRNA) treatment) demonstrate that inhibition of this message results in a bone-formation phenotype in treated human osteoblasts, and (3) stimulation of bone formation with multiple osteogenic growth factors decreases Cathepsin K message and activity within the osteoblast.” (p. 6, lines 18-25). LONG teaches that: “As expected, siRNA-mediated inhibition of Cathepsin K RNA results in similar tissue like osteoblast aggregates and bone formation as do either small molecule inhibitors like VEL-0230 or osteogenic growth factors (not shown).” (p. 37, lines 33-34, p. 38, lines 1-2).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
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 produce an ultrasound responsive nanobubble including an albumin shell a hollow core containing a perfluorocarbon gas, and a therapeutic agent cargo such as siRNA, for delivery of the same to treat, inhibit, or reduce diseases of the bone, as suggested by IRUDAYARAJ, the bone disease being osteoporosis and the targeting agent being alendronate useful for targeting bone tissue, as suggested by Chen et al., microbubbles having been known for delivery of nucleic acids particularly nucleic acids that enhance bone regeneration (plasmid DNA encoding - vascular endothelial growth factor (VEGF) - or BMP) in combination with, as suggested by Shapiro et al., and further to combined with nucleic acids that “inhibit bone formation and therefore if downregulated could be used to drive osteogenesis”, as suggested by Shapiro et al., the nucleic acid that is downregulated being a Cathepsin K inhibitor, particularly an siRNA targeting Cathepsin K expression which would have been expected to inhibit Cathepsin K RNA and result in osteoblast aggregates and bon formation, as suggested by LONG for the treatment of osteoporosis.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because it would have required no more than an ordinary level of skill to produce a nanobubble encapsulating siRNA and alendronate targeting moiety, as per the teachings/disclosure of the cited prior art, in view of the ordinary level of skill/knowledge in the art to which the invention pertains. 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, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Conclusion
Claims 1-11 are pending and have been examined on the merits. The instant Specification is objected to for Content of the Specification and the Abstract. Claims 2-11 are rejected under 35 U.S.C. 112(b); claims 1-11 are rejected under 35 U.S.C. 102(a)(1) and claims 1-11 are rejected under 35 U.S.C. 103. No claims allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IVAN A GREENE whose telephone number is (571)270-5868. The examiner can normally be reached M-F, 8-5 PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on (571) 272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
1 Bez et al. (“In situ bone tissue engineering via ultrasound-mediated gene delivery to endogenous progenitor cells in mini-pigs,” 2017; Science Translational Medicine, Vol. 9, Article, eaal3128, pp. 1-9; attached).
2 gene-activated matrices.
Prosecution Insights