DETAILED ACTION
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
Claims 34-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/5/26.
Product by Process Limitations
Initially, and with respect to claim(s) 23-26 note that a "product by process" claim is directed to the product per se, no matter how actually made. See In re Thorpe et ah, 227 USPQ 964 (CAFC, 1985) and the related case law cited therein which makes it clear that it is the final product per se which must be determined in a "product by process" claim, and not the patentability of the process, and that, as here, an old or obvious product produced by a new method is not patentable as a product, whether claimed in "product by process" claims or not. As stated in Thorpe, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972); In re Pilkington, 411 F.2d 1345, 1348, 162 USPQ 145, 147 (CCPA 1969); Buono v. Yankee Maid Dress Corp., 77 F.2d 274, 279, 26 USPQ 57, 61 (2d. Cir. 1935).
Note that Applicant has burden of proof in such cases as the above case law makes clear.
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 21-33 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 claim 21:
The claim is unclear because of the limitation “A delivery device formed by an aggregation of a plurality of individual particles in a host fluid” in line 1. It’s unclear where the preamble of the claim ends and where the body of the claim begins which raises a question of what structurally is required by the claim. For the sake of examination, the office has interpreted the limitation as “A delivery device comprising: an aggregation of a plurality of individual particles in a host fluid” however the applicant should amend the claims to clarify.
The claim recites the limitation "the initially separate individual particles " in line 4. There is insufficient antecedent basis for this limitation in the claim.
The limitation “the individual particles” in line 5 is unclear. The limitation is unclear because several individual particles (see lines 1 and 4) have been established in the claim and it’s unclear of which this limitation refers to. For the sake of examination, the office has assumed all of these limitations refer to the same structure at different phases of production. However, the applicant should amend the claim to clarify.
Claims 22-33 are rejected due to their dependence on claim 21.
Regarding claim 27:
The claim recites the limitation "the individual particle" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 29:
The claim recites the limitation "the particles" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 31:
The claim recites the limitation "the particles" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 32:
The claim recites the limitation "the particles" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 33:
The claim is unclear because of the limitation “i.e. infrared light or acoustic field, such as ultrasound” in line 3. It’s unclear if this limitation requires the external physical field to be infrared light, an acoustic field or ultrasound of if these are not required by this limitation. For the sake of examination, the office has assumed that the limitations are suggestions and not required however the applicant should amend the claim to clarify.
The claim is unclear because of the limitation “i.e. the fluid,” in line 6. It’s unclear if the claim requires the fluid to cause the activation of the chemical bonding to bring about the aggregation of the individual particles or not. For the sake of examination, the office has assumed that this limitation is not required by the claim however the applicant should amend the claim to clarify.
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 21-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20020162798 A1 to Johnson et al. (Johnson).
Johnson discloses:
Regarding claim 21:
A delivery device (figure 6) formed by an aggregation of a plurality of individual particles (11-13) in a host fluid (see fluid mentioned in ¶0014), wherein one or more individual particles (11-13) of the plurality of individual particles (11-13) has a density of less than the host fluid (see how the mixture of particles makes the assembly shown in figure 6 buoyant; ¶0014), and a bonding property (see the active material 14 which bonds 11-13 as indicated in ¶0049) which permits the initially separate individual particles (11-13) to aggregate in said host fluid to form the aggregation (see the aggregation as shown in figure 6), wherein the individual particles (11-13) have a size in at least one dimension selected in the range of 0.1 µm to 1 mm (particles can be in the range of 5 µm to 200µm which overlaps with 0.1 µm to 1mm; ¶0044), and the device has a size in at least one dimension selected in the range of 1µm to 10 mm (the aggregate can range in size of 10 µm to 300 µm which overlaps with 0.1 µm to 1 mm; ¶0044).
Regarding claim 22:
The delivery device according to claim 21, wherein the delivery device (figure 6) is a device carrying a cargo (active material 14; ¶0058) that can be deployed at a target site (target substance; ¶0057).
Regarding claim 23:
The delivery device according to claim 21, wherein the bonding property comprises a magnetic property (magnetic materials 12; ¶0038), which brings about the aggregation of the individual particles (11-13)(as indicated above this is interpreted as product by process limitation that yields the structure as required by claim 21 and since the Johnson reference teaches the required structure the limitation is rejected).
Regarding claim 24:
The delivery device according to claim 21, wherein the bonding property comprises a magnetic property (magnetic materials 12; ¶0038) which, on the application of a magnetic field, brings about the aggregation of the individual particles (11-13) (as indicated above this is interpreted as product by process limitation that yields the structure as required by claim 21 and since the Johnson reference teaches the required structure the limitation is rejected).
Regarding claim 25:
The delivery device according to claim 24, wherein the magnetic property is actuated in the presence of at least one of a homogenous magnetic field and a non- homogenous magnetic field (as indicated above this is interpreted as product by process limitation that yields the structure as required by claim 21 and since the Johnson reference teaches the required structure the limitation is rejected).
Regarding claim 26:
The delivery device according to claim 24, wherein the magnetic field comprises a field strength in the range of 0.1 mT to 20 T (as indicated above this is interpreted as product by process limitation that yields the structure as required by claim 21 and since the Johnson reference teaches the required structure the limitation is rejected).
Regarding claim 27:
The delivery device according to claim 21, wherein the individual particle is shaped spherical (see the spherical shape of 11, 12 and 13), cylindrical, streamlined or a combination of the foregoing or randomly shaped.
Regarding claim 28:
The delivery device according to claim 22, wherein the cargo is selected from the group of drugs, genetic materials, contrast agents, viruses, bacteria, cells, polymeric materials, metals or metallic compounds, sensors, cameras, biopsy tools, radioactive materials, reactive chemicals, dyes and colorants, fluorophores, biological materials (cargo 14 can be “streptavidin, biotin, guanidine”; ¶0058), needles or a combination of the foregoing and/or a combination of both agents and/or pharmaceutically active compounds and/or biological materials, such as enzymes or genetic materials or materials configured to seal a leak or dissolve a blockage in pipelines.
Regarding claim 30:
The delivery device according to claim 21, wherein the host fluid is the fluid of the urological system (¶0073-0074 indicates the fluid the particles can be inserted in is urine), the gastrointestinal system, the peripheral and the central nervous system, the cerebral spinal fluid, the blood circulation system, the immune system, the reproductive system, the ophthalmological system, the extracellular system, microfluidics, pipeline systems, fluidic capillaries or fluidic nozzles.
Regarding claim 31:
The delivery device according to claim 21, wherein the particles comprise a biocompatible and/or biodegradable material, a low density material, such as oil, gas, polymer, protein-containing materials (“proteins”; ¶0058), vesicles, gas-filled protein nanostructures, aerogels, fibrous materials, carbohydrate-containing materials, multi-materials, highly porous materials, and/or or imaging contrast agents, such as gas, iodine, barium, gold and/or silver nanoparticles, gadolinium, hyperpolarized gases, vesicles and/or gas-filled protein nanostructures.
Regarding claim 32:
The delivery device according to claim 21, wherein the particles comprise an inherent dipole moment (ferromagnetic material as indicated in ¶0039) or form a dipole moment on the application of an external field.
Regarding claim 33:
The delivery device according to claim 21, wherein the bonding property comprises a chemical bonding property which, on the application of an external physical field, i.e. infrared light or acoustic field, such as ultrasound, causes the activation of the chemical bonding property to bring about the aggregation of the individual particles (not shown); and/or
wherein the chemical bonding property which, on the insertion of the plurality of individual particles (11-13) into an aggregation environment, i.e. the fluid, causes the activation of the chemical bonding property to bring about the aggregation of the individual particles (as shown in figure 6, the chemical compound 14 bonds the different particles 11-13 together chemically)(11-13).
Allowable Subject Matter
Claim 29 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20150190531-A1
THYAGARAJAN
See the particles 104
US-20100269838-A1
Flanagan
See the particles 26
WO-9934779-A1
VOLKONSKY
See the particles 12
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783