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 (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.
Rejoinder
The examiner has decided to withdraw the applied species election because prior art found by the examiner appears to include multiple modes of radiation application together in the same reference. As such, there does not appear to be a search burden in searching all of the species together.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 1-42 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.
A single claim which claims both an apparatus (or composition) and the method steps of using the apparatus (or composition) is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). Instant claim 1 is drawn to a system, which the examiner understands to be the combination of an apparatus and composition. However, the claims appear to include a large number of limitations that appear to be drawn to the method of using said apparatus and composition. The examiner has provided examples of selected instances of this below.
For example, claim 1 recites the following, which is reproduced below with annotation by the examiner:
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The term “producing” would appear to indicate that the claims require that the equipment produce an unfocused heating radiation. However, this would appear to be an example of the instant claims reciting a method step; namely, of producing unfocused heating radiation. This would appear to be an example of the claims reciting a composition/apparatus and method in the same claim.
For the purposes of examination under prior art, the examiner will examine the above-indicated limitation as if it requires that the equipment be capable of producing unfocused heating radiation. Limitations focusing on the capabilities of the system would appear to be definite; see MPEP 2173.05(p)(II). However, in view of this claim interpretation, the examiner takes the position that equipment capable of producing both focused and unfocused heating radiation is within the claim scope. Additionally, prior art which teaches using such equipment to produce focused radiation may be within the claim scope if the equipment is also capable of producing unfocused radiation.
There are many additional limitations which appear to recite both a product and a process together in the same claim. See the following text reproduced below from claim 1.
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The examiner notes that use of the recited system to increase the temperature of a body part would appear to be drawn to both a product and process in the same claim. For the purposes of examination under prior art, the claim is drawn to a system that is capable of increasing the temperature of a body part, regardless of whether or not the prior art uses the system to do so.
Another example of claim 1 reciting both a product and a process is the following, wherein relevant text is reproduced below.
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In the above-reproduced text, the above limitations regarding administering nanoparticles and/or applying heating would appear to be process limitations recited in a product claim. This would appear to render the above-indicated limitations indefinite in view of the provisions of MPEP 2173.05(p)(II).
Various recited dependent claims appear to further limit the method by which the claimed invention is used, rather than the claimed invention itself. For example, claim 2, part (ii), recites the following:
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The above-reproduced limitation would appear to indicate that a method step of administering the nanoparticle to the body part is required. However, such a step would appear to further limit the process of using the recited composition rather than the recited composition itself. This would appear to render the above-indicated limitations indefinite in view of the provisions of MPEP 2173.05(p)(II). For the purposes of examination under prior art, the examiner further interprets this limitation as requiring that the recited nanoparticle is capable of producing heat under the above-indicated conditions.
The examiner notes that due to the large number of claim limitations which would appear to be indefinite in view of issues relating to MPEP 2173.05(p)(II), the above-indicated text should not be construed as addressing every single issue in the claims relating to indefiniteness in view of MPEP 2173.05(p)(II).
Claims 1-42 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.
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. See MPEP 2173.05(d). The instant claims recite the term “preferentially” on multiple occasions, which would appear to be an example of the claims reciting examples and preferences which lead to confusion of the intended claim scope. See MPEP 2173.05(c)(I), item (A) in the first paragraph of this MPEP section, wherein the examiner understands the terms “preferentially” (as recited in the instant claims) and “preferably” (as in MPEP 2173.05(c)(I), item (A) in first paragraph) to have the same meaning.
The term “preferentially” is recited in the instant claims as of claims 1, 3-5, 8-14, 18, 24, 32, 37, and 41-42, which would appear to lead to indefiniteness in view of the above-discussed issues. The language “wherein in some cases” in claim 14 would also appear to be indefinite for this reason.
The examiner will proceed in examination with the understanding that all preferential limitations are optional.
Claim Rejections - 35 USC § 103 – Obviousness
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.
Claim(s) 1-7, 9, 11-21, 24-27, 30-31, 33-37, 40, and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US 2012/0089137 A1).
Peyman is drawn to a method and composition for hyperthermally diagnosing and monitoring cells with photoacoustic sound and nanoparticles, as of Peyman, title and abstract. Peyman teaches ferromagnetic nanoparticles or gold nanoparticles in paragraph 0036. Peyman teaches a device for delivering ultrasonic hyperthermia as of paragraph 0038. Peyman teaches that this equipment preferably includes [a] suitable heat or energy source that is able to focus the heat or energy on the target, as of paragraph 0038.
As to claim 1, the claim requires that the nanoparticles and equipment are combined to form a system. Peyman teaches both the nanoparticles and the ultrasound device, though in separate paragraphs. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 1, the claim requires that the equipment produces unfocused heating radiation. Peyman teaches that the radiation produced is preferably focused, as of paragraph 0038. The examiner understands this to teach that the heating radiation may be unfocused, even if this is not the most preferred option of Peyman. This is sufficient to read on the claimed requirements. A known or obvious composition (or in this case device, e.g. a device that produces unfocused radiation) does not become patentable simply because it has been described as somewhat inferior to some other product (e.g. that which produces focused ultrasound) for the same use (e.g. producing ultrasound for hyperthermia). See MPEP 2123(II).
As to claim 1, the claim has requirements of concentration of the nanoparticles. Peyman provides teachings related to the concentration of the nanoparticles as of paragraph 0067-0068. Generally, differences in concentration between the claimed invention and prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality appears to have been provided. Additionally, the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of nanoparticles that are either ferromagnetic or comprise gold has been taught by Peyman, and their concentration has also been discussed by Peyman. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of these nanoparticles via routine experimentation.
As to claim 1, the claim is understood to require that the radiation be an acoustic wave. Peyman’s teaching of a device capable of delivering ultrasonic hyperthermia in paragraph 0038 is understood to read on this requirement.
As to claim 1, the claim requires that the equipment have various features including a transducer. Peyman teaches this as of at least paragraphs 0063-0064. Peyman also teaches probes or catheters in paragraph 0005.
As to claim 1, the claim requires that the piece of equipment is configured or used to apply a heating radiation. This would appear to be an indefinite limitation because it appears to be drawn to a process rather than a product; see the above rejection under 35 U.S.C. 112(b) and MPEP 2173.05(p)(II). For the purposes of examination under prior art, the examiner will proceed with the understanding that the instant claims require that the system be capable of increasing the body temperature in the recited manner. As the nanoparticles and device of Peyman can be used together to produce in vivo heating, the skilled artisan would have expected that the combination of Peyman would have been usable to have provided the required temperature increase.
As to claim 1, the claim recites a property of the unfocused radiation. The claim also recites requirements regarding the time of application as well as a break time between one application and the next. However, these properties appear to be drawn to the method by which the system is used rather than the system itself as they further limit the body part upon which the system is used. These limitations are indefinite in view of MPEP 2173.05(p)(II). The skilled artisan would have expected that the ultrasound device of Peyman could have been capable of having been varied to have achieved this, which is understood to be sufficient to meet the claimed requirements.
As to claim 2 part (i), the concentration of Peyman, paragraphs 0067-0068 appears to be in liquid.
As to claim 3, the skilled artisan would have expected that the system of Peyman could have been capable of increasing the temperature in the required manner. This is sufficient to meet the requirement of this indefinite claim.
As to claim 4, the skilled artisan would have expected that the system of Peyman could have been capable of increasing the temperature of the body part in the required manner. This is sufficient to meet the requirement of this indefinite claim.
As to claim 5, the skilled artisan would have expected that the transducer containing ultrasound device of Peyman would have been capable of producing ultrasound oriented in the direction of the body part to which ultrasound was being applied.
As to claim 6, Peyman teaches that the nanoparticle is intravenously injected, as of paragraph 0071.
As to claim 7, the skilled artisan would have expected that the ultrasound transducer of Peyman could have been oriented in direct contact with a body part.
As to claim 9, Peyman teaches ultrasound frequency between 0.5 kHz to 200 MHz in paragraph 0039.
As to claim 11, Peyman appears to teach a temperature increase to 56°C, in the abstract; therefore the skilled artisan would have expected the temperature to have been able to have been increased to this level.
As to claim 12, the skilled artisan would have expected that the nanoparticles in combination with the ultrasound device of Peyman would have been able to have heated a pathological site in the required manner.
As to claim 13, Peyman teaches treating cancer in paragraphs 0006-0008; this would entail application to a pathological site that is unhealthy tissue, as cancerous tissue is unhealthy.
As to claim 14, the device of Peyman and the nanoparticles of Peyman would appear to be two separate parts.
As to claim 15, this limitation further limits the method by which the claimed system is used rather than the system itself. This renders the claim indefinite in view of MPEP 2173.05(p)(II). As such, the applied rejection of claim 1 also applies to claim 15.
As to claim 16, this claim is rejected for the same reason that claim 15 is rejected.
As to claim 17, this claim is rejected for the same reason that claims 15 and 16 are rejected.
As to claim 18, the ultrasonic generator of paragraph 0038 of Peyman is understood to read on the required ultrasound.
As to claim 19, Peyman teaches that this equipment preferably includes [a] suitable heat or energy source that is able to focus the heat or energy on the target, as of paragraph 0038. Peyman teaches that the radiation produced is preferably focused, as of paragraph 0038. The examiner understands this to teach that the heating radiation may be unfocused, even if this is not the most preferred option of Peyman. This is sufficient to read on the claimed requirements. A known or obvious composition (or in this case device, e.g. a device that produces unfocused radiation) does not become patentable simply because it has been described as somewhat inferior to some other product (e.g. that which produces focused ultrasound) for the same use (e.g. producing ultrasound for hyperthermia). See MPEP 2123(II). As such, the teachings of Peyman are understood to render obvious a device that produces ultrasound that is not focused.
As to claim 20, Peyman teaches intravenous administration of nanoparticles, as of at least paragraph 0068.
As to claim 21, although Peyman does not teach the phrase “sono-sensitizers”, it is nevertheless the case that the skilled artisan would have expected the particles of Peyman would have been sono-sensitizers even if this characteristic was not recognized by Peyman. This is because the nanoparticles of Peyman are magnetic nanoparticles, which is the same material as the nanoparticles disclosed in the instant application. Something which is old (e.g. the nanoparticles of Peyman) does not become patentable upon the discovery of a new property (e.g. that these nanoparticles are sonosensitizers), and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II).
As to claim 24, this claim is rejected for the same reason that claim 13 is rejected.
As to claims 25, this claim is rejected for the same reason that claim 24 is rejected.
As to claim 26, Peyman teaches treating breast cancer in paragraph 0036, cervical cancer in paragraph 0037, bladder cancer in paragraph 0037, and melanoma in paragraph 0077.
As to claim 27, the examiner understands that the cancer taught by Peyman is due to the malfunction of the body part in which the cancer is located; namely, by destroying the ability of the cells of said body part to properly regulate cell division.
As to claim 30, the skilled artisan would have expected that had the ultrasound of Peyman been applied sequentially, this would have prevented a decrease in temperature.
As to claim 31, Peyman teaches absorption of light waves in paragraph 0059. Peyman also teaches killing cancer cells in paragraph 0003.
As to claim 33, this claim limitation appears to limit the method by which the radiation is applied rather than the device for applying radiation and/or the nanoparticles. For the purposes of examination under prior art, the examiner understands this claim to require that the system of the prior art be capable of applying radiation in the claimed manner. The skilled artisan would have understood the system of Peyman to have been capable of applying radiation in the claimed manner.
As to claim 34, this claim is rejected for essentially the same reason that claim 33 is rejected.
As to claim 35, this claim is rejected for essentially the same reason that claim 34 is rejected.
As to claim 36, this claim is rejected for essentially the same reason that claims 33-35 are rejected.
As to claim 37, Peyman teaches nanoparticle size of 50 nm to 250 nm in paragraph 0065, and nanoparticle size in general between 2-700 nm in claims 12-13 of Peyman. There appears to be no evidence that the nanoparticles of Peyman would have aggregated upon administration.
As to claim 40, Peyman teaches administration of a drug in paragraph 0055, including well-known anticancer agents such as cisplatin and Adriamycin (i.e. doxorubicin).
As to claim 42, this claim appears to further modify the method of measuring the effectiveness of the claimed system rather than the claimed system itself. The skilled artisan would have been capable of measuring the specific absorption rate using the recited equation.
Claim(s) 8, 10, and 38-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US 2012/0089137 A1) in view of Deem et al. (US 2010/0049178 A1).
Peyman is drawn to a combination of an ultrasound radiation producing device and nanoparticles. See the rejection above over Peyman.
Peyman differs from the claimed invention because the device of Peyman does not appear to include a cooling element.
Deem et al. (hereafter referred to as Deem) is drawn to the use of radiation to decrease sweat production. Elsewhere in the reference, Deem teaches the following, as of paragraph 0188, relevant text reproduced below.
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As such, the skilled artisan would have been motivated to have used a cooling system to have isolated the target tissue and to have protected non-target tissue.
It would have been prima facie obvious for one of ordinary skill in the art to have included a cooling system, as of Deem, with the ultrasound production device of Peyman. Peyman is drawn to the use of ultrasound in combination with gold or magnetic nanoparticles to selectively heat tissue. Deem teaches that an ultrasound production device may include a cooling element to protect non-target tissue, which is tissue not intended to have been heated. As such, the skilled artisan would have been motivated to have included the cooling element of Deem to have predictably protected non-target tissue from heating in order to have predictably reduced side effects to non-targeted tissue with a reasonable expectation of success.
As to claim 8, Deem teaches keeping the non-targeted tissue cool with the cooling system, as of paragraph 0188, relevant text reproduced above.
As to claim 10, Deem teaches the following as of paragraph 0182, reproduced in part below.
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As such, Deem teaches that combination of iron nanoparticles with certain energy sources would have resulted in heating by induction. As such, the skilled artisan would have expected that heating would have been moderate in the absence of the nanoparticles and more substantial in the presence of the nanoparticles.
As to claims 38-39, the skilled artisan would have expected that heating would have been more significant in the presence of the nanoparticles rather than in their absence at least due to the effect of inductive heating described by Deem, at least paragraph 0182. The skilled artisan would have also expected that absorption of radiation by the nanoparticle would have resulted in greater absorption where the nanoparticle is located rather than where the nanoparticle is not located.
Claim(s) 21, 28-29, and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US 2012/0089137 A1) in view of Qian et al. (Advanced Materials, Vol. 28, 2016, pages 8097-8129).
Peyman is drawn to a combination of an ultrasound radiation producing device and nanoparticles. See the rejection above over Peyman.
For the purposes of examination under prior art, the examiner understands that Peyman does not teach sonosensitizers.
Qian et al. (hereafter referred to as Qian) is drawn to nanoparticle augmented sonodynamic therapy, as of Qian, page 8097, title and abstract. As such, the examiner understands Qian to teach that nanoparticles enhance sonodynamic therapy, thereby rendering the nanoparticles of Qian to be sonosensitizers; also see Qian, page 8098, in which the word “sonosensitizer” is taught extensively. Qian also teaches the following as of page 8115, right column, relevant text reproduced below.
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The examiner notes that the abbreviation “ROS” refers to reactive oxygen species, and said reactive oxygen species are known to have anti-cancer effects, as of at least Qian, page 8097, right column, last paragraph.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the system and method of Peyman to have used sonosensitizers. The method of Peyman entails administration of ultrasound, as of at least paragraph 0038 of Peyman, and is drawn to treatment of cancer, as of Peyman, at least paragraphs 0036-0037. Qian teaches that the use of sonosensitizers (in combination with ultrasound) produces reactive oxygen species which have anti-cancer effects. As such, the skilled artisan would have been motivated to have modified the system of Qian to have further included sonosensitizers in order to have predictably resulted in the killing of cancer cells by formation of reactive oxygen species with a reasonable expectation of success.
As to claim 21, the particles of Qian are understood to read on the required sono-sensitizers.
As to claims 28-29, Qian teaches ultrasound triggered drug release of the anticancer drug known as doxorubicin (and abbreviated as “DOX”) as of at least page 8115, right column, top paragraph, relevant text reproduced below with annotation by the examiner.
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The skilled artisan would have been capable of using this in a method of multiple dissociations, as recited by instant claim 29.
As to claim 41, the reactive oxygen species taught by Qian reads on this claimed requirement.
Claim(s) 22-23 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US 2012/0089137 A1) in view of Jozefczak et al. (Journal of Magnetism and Magnetic Materials, Vol. 407, 2016, pages 92-100).
Peyman is drawn to a combination of an ultrasound radiation producing device and nanoparticles. See the rejection above over Peyman.
Peyman does not teach magnetosomes.
Jozefczak et al. (hereafter referred to as Jozefczak) is drawn to acoustic properties and heat effects of magnetosomes, as of Jozefczak, page 92, title and abstract. Various magnetosomes taught by Jozefczak appear to have been generated by bacteria, as of Jozefczak, page 92, right column, bottom paragraph and page 93, right column. Jozefczak teaches heat production of magnetosomes, as of at least Jozefczak, page 96, left column, section 4.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the nanoparticles of Peyman to have included magnetosomes, as taught by Jozefczak. Peyman is drawn to the production of heat to a body part, as of at least Peyman, paragraph 0043, and teaches a heat sensitive particle in paragraph 0044. Jozefczak appears to teach that magnetosomes are heat sensitive particles that can be administered in vivo. As such, the skilled artisan would have been motivated to have combined the magnetosomes of Jozefczak with the particles of Peyman for predictable in vivo heating of tissue (e.g. for killing cancer cells or other undesired cells) with a reasonable expectation of success.
As to claim 22, Jozefczak teaches magnetosomes, as of Jozefczak, title.
As to claim 23, Jozefczak teaches synthetic magnetic nanoparticles, as of Jozefczak, page 93, right column, section 2. The examiner understands these to be chemical analogs of magnetosomes.
As to claim 32, Jozefczak teaches that magnetosomes are synthesized from bacteria, as of Jozefczak, page 92, abstract.
Non-Statutory 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 1-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,918,652. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a system comprising nanoparticles and equipment producing radiation.
The conflicting claims are drawn to a method of treating a body part comprising administering nanoparticles and applying an acoustic wave, as of conflicting claim 1.
The instant and conflicting claims differ because the conflicting claims do not explicitly recite equipment to produce the acoustic wave. Nevertheless, the skilled artisan would have understood that equipment would have been needed to have produced the acoustic wave because equipment is used to provide ultrasound radiation, both for diagnostic and therapeutic purposes, and the skilled artisan would have been motivated to have provided said equipment.
Additionally, the instant claims are drawn to a system whereas the conflicting claims are drawn to a method. Nevertheless, the skilled artisan would have been motivated to have used a system of nanoparticles and a device for producing acoustic radiation to have predictably carried out the method recited by the conflicting claims with a reasonable expectation of success.
The examiner notes that this double patenting rejection is not prohibited in view of the third sentence of 35 U.S.C. 121 because the instant application is a continuation in part of parent application 16/486,574 (which has matured into the ‘652 patent), not a divisional of parent application 16/486,574. The third sentence of 35 U.S.C. 121 applies only to divisional applications and not to continuation-in-part applications; see MPEP 804.01, situation (H).
Conclusion
No claim is allowed.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612