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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/24/26 has been entered.
Claim Status
Claims 1-31 and 33-40 are cancelled.
Claims 43-47 are withdrawn.1
Claims 32 and 41-47 are pending.
Claims 32, 41 and 42 are under examination.
Terminal Disclaimer
The terminal disclaimer does not comply with 37 CFR 1.321 because: The person who has signed the disclaimer has not stated the extent of the applicant’s or assignee’s interest in the application/patent. See 37 CFR 1.321(b)(3). To remedy this, see the Terminal Disclaimer review decision filed 3/16/26.
Withdrawn rejections
Applicant's amendments and arguments filed 2/24/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claims 32, 41 and 42 were rejected under 35 U.S.C. 103 as being unpatentable over Ko et al. (US9999598) and Okazaki et al. (EP0311244). Applicant’s amendments and arguments are persuasive.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 32, 41 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US20050123613) and Okazaki et al. (EP0311244).
Applicant claims:
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Claim interpretation: The limitation beginning “wherein when used…” is an intended use of the composition. An intended use will not limit the scope of the claim because it merely defines a context in which the invention operates. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). See also MPEP 2111.02(II): “In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus).” Consequently, the prior art composition which recites the same components as instantly claimed can also be administered into the respiratory system as claimed. While the limitation has been considered, it is not further limiting to the composition of matter claims.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of an activated carbon materials research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from carbon material forms and chemistry and applications— without being told to do so. In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 32, 41 and 42, Chen et al. teach activated carbon powder compositions ([0011; Example 2 [0049-0055];) with a diameter of 2 nm to 35 µm with with particles size mainly distributed in a range of 6 um-2 nm (Abstract; claim 1), thus overlapping the claimed mean particle diameter range of 0.5-50 µm, and drug delivery of dried activated carbon powder (Example 3 [0056-0057; dehydrated/desiccated]) with anticoagulation drugs [0059; combined materials dehydrated and dessicated], antibiotics [0060], antibody [0061] as well an anticancer, antibiotics and antivirus drugs (Claims 1 and 4-5; [0018]). Thus, the pharmaceutical composition is made in the form of a dry powder. Chen et al. also teach that vaccines and antigens are well-known to be adsorbed on activated carbon [0003]. Chen et al. teach that the activated carbon can adsorb antibiotics, dipped in chitosan excipient/adjuvant solution and dehydrated to treat pulmonary tuberculosis [0060], which provides dry powder and would implicitly improve any respiratory damage caused by the pulmonary tuberculosis. In fact, Chen et al. treated a patient with pulmonary cancer with presentation of respiratory symptoms including chest distress, palpitation, tachypnea, and inability to lie down ([0037]. After intravenous injection of 20 mg activated carbon agent of the present invention, symptoms of distress, palpitation, tachypnea were alleviated 24 hours later. The patient was also able to lie down. [0037] Chen et al. teach that the therapeutic effect is to treat acute organic and inorganic toxicosis [0003, 0020]. Thus, Chen et al. teach an overlapping particle size of a dry powder pharmaceutical composition that can also absorb inflammatory factors or toxic substances and treat a patient with respiratory symptoms by systemic injection of the composition into the respiratory system and improve those symptoms thereby improving respiratory damage. Instant claim 32 also allows for injection/perfusion of the composition for administration. Chen et al. teach that the activated carbon particles have a specific surface area greater than or equal to 400 to 10000M°/g and pore volume of > 0.3-6 cm3/g (Claim 1), which overlaps the claimed ranges.
Regarding claim 32, Okazaki et al. teaches that spherical active carbons an average particle diameter of 0.1 to 1 mm, a specific surface area of 500 to 2,000 m2/g and a pore volume, with a radius of 100 to 75,000Ǻ, of 0.1 to 1.0 cm3/g are especially preferred because this specified type of spherical active carbons show an excellent adsorptivity and causes no adverse side effects (Page 4, lines 4-9).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
1. The difference between the instant application and Chen et al. is that Chen et al. do not expressly teach a micropore diameter ranging from 1 to 500 nm. This deficiency in Ko et al. is cured by the teachings of Okazaki et al.
1. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to measure the micropore diameter Chen et al. and determine a micropore diameter ranging from 1 to 500 nm, as suggested by Okazaki et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the activated carbon particles of Chen et al. have porosity and Okazaki et al. teach spherical active carbons that have an average particle diameter of 0.1 to 1 mm, a specific surface area of 500 to 2,000 m2/g and a pore volume, with a radius of 100 to 75,000Ǻ, of 0.1 to 1.0 cm3/g, where the pore diameter is twice the radius and when converted to nanometers is 20 nm to 15000 nm, thus overlapping the claimed range to render it obvious. Consequently, it appears merely measurement of the pore diameter of the activated carbon of Chen et al. with a reasonable expectation of obtaining a micropore diameter of 1 to 500 nm in the absence of evidence to the contrary. In reviewing the instant specification for any unexpected results connected to the micropore diameter, the Examiner did not find anything characterized as surprising or unexpected by Applicant.
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.
From the combined 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. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s remarks filed on 2/24/26 have been carefully considered but are not persuasive.
Applicant asserts that Chen et al. expressly teaches intravenous administration for systemic circulation. However, the Examiner has shown in the rejection above that Chen et al. teach an overlapping particle size of a dry powder pharmaceutical composition that can also absorb inflammatory factors or toxic substances and treat a patient with respiratory symptoms by injection and improve those symptoms thereby improving respiratory damage. A composition of matter claim is under examination and there is no component in claim 32 that would structurally distinguish Applicant’s pharmaceutical composition from that of Chen et al. Especially when the claimed pharmaceutical composition can also be administered by injection or perfusion.
On page 7 of remarks, Applicant argues that the composition of claim 32 is configured for administration to the respiratory system. However, claim 32 only requires that the adsorbent medicament is configured to adsorb inflammatory factors or toxic substances in the respiratory system. The same activated carbon of Chen et al. is so configured. Especially in view of the improvement in respiratory symptoms of the patient after administration.
On page 8 of remarks, Applicant discusses Okazaki. The reference Okazaki is relied upon as characterized by the Examiner in the rejection. Applicant asserts that the ordinary artisan would have to re-engineer an intravenous transfusion agent into a pulmonary delivery system. However, Chen et al. has shown that intravenous injection treats pulmonary symptoms, thus effectively adsorbing any inflammatory factors in the respiratory system, and is thus a pulmonary delivery system. No re-engineering is required at all. The ordinary artisan would administer the dry powder activated carbon of Chen et al. with a reasonable expectation of success in treating pulmonary conditions because Chen et al. has done so. Applicant argues that claims 41 and 42 further limit the composition of claim 32 and it is Applicant’s position that the combination of reference fail to teach or suggest the base composition of claim 32. Respectfully, the Examiner has a different perspective. As discussed in detail above, the Examiner has shown that the combined references render obvious the base composition of claim 32 as well as the components in claims 41 and 42. Applicant’s arguments are not persuasive.
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 32, 41 and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18591896. The copending has the same inventive entity. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending is also directed to pharmaceutical compositions for improving respiratory damage comprising adsorbent carbon materials such as activated carbon powder with BET ranging from 300 to 3000 m2/g (Claims 1 and 3), a mean particle diameter ranging from 0.1 to 500 microns (Claim 4), a volume in pores ranging from 0.1 to 3.0 ml/g (Claim 5), a micropore diameter ranging from 1-500 nm (Claim 6), in the form of a dry powder (Claims 7-8), with an adjuvant, excipient or propellant (Claim 9), and medicines (Claim 10), functionalized carbon material (Claim 11) and further comprising an element such as metal ions or halogen ions (Claim 12).
The copending does not expressly teach the claimed “wherein when used” clause. However, such is implicit in the copending pharmaceutical compositions.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 32, 41 and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-6 and 11 of U.S. Patent No. 9999598B1. The patent has a common inventor.
Instant claims 32, 41 and 42 are obviated by claims 1, 3, 5-6 and 11 of ‘598. ‘598 teaches a pharmaceutical composition comprising an activated carbon powder, where powders are interpreted to be dry, and antimicrobial silver and zinc (Claims 1 and 3) with a BET surface area of 10-2500 m2/g (claim 5) a pore diameter (twice the radius disclosed) of not more than 0 nm but less than 5 nm (Claim 11), which overlaps the claimed ranges, and further comprising an additive (Claim 9), which reads on at least an excipient. The particle size is from 1 nm to 500 microns (Claim 6). The claimed intended uses are not further limiting and implicit in the composition.
The patent does not expressly teach a pore volume of 0.1 to 3.0 ml/g. However, since the surface area and pore diameters overlap with the claimed ranges then it would appear that the pore volume would also overlap and it nothing more than measuring the pore volume of the patented activated carbon powder.
The patent does not expressly teach the claimed “wherein when used” clause. However, such is implicit in the patented pharmaceutical composition used in the method of the patent.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Response to Arguments:
Applicant’s Terminal Disclaimer was not approved.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
1 Claims 43-47 are indicated as “Previously added” but were withdrawn in the FINAL Office Action filed 11/25/25. In the interest of stakeholder interaction and compact prosecution, the Examiner is not filing a notice of non-compliant claim amendment but rather alerting Applicant to the issue for future reference.