DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 6/16/2026 wherein claim 1 has been amended.
Claims 1-11 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s arguments filed 6/16/2026 regarding the rejection of claims 8-11 made by the Examiner under 35 USC 102(a)(1) over Huo et al. (CN 109865141) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 3/16/2026.
Applicant’s arguments filed 6/16/2026 regarding the rejection of claims 1-3 and 5-11 made by the Examiner under 35 USC 103 over Huo et al. (CN 109865141) in view of Zhang et al. (WO 2020/199368) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 3/16/2026.
Applicant’s arguments filed 6/16/2026 regarding the rejection of claim 4 made by the Examiner under 35 USC 103 over Huo et al. (CN 109865141) in view of Zhang et al. (WO 2020/199368), further in view of Elsome et al. (US 6562258) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 3/16/2026.
In regards to the 102(a)(1) and 103 rejections, Applicant asserts the following:
Huo’s process applies extreme axial pressure to mix drug and MOF to force self-assembly whereas the claimed process uses dry mechanical pre-mixing in the absence of grinding fluid which results in fundamentally different preparation mechanisms. Moreover, Huo is silent as to the ‘device’ as required by instant claim 11;
Zhang teaches that if one wishes to avoid milling damage, one should not mill at all but instead use a solution-phase process. Moreover, Zhang is nonanalogous as it is directed to fuel cell applications rather than pharmaceutical compositions. Thus, a person of ordinary skill in the art would not desire to modify Huo’s pharmaceutical process/formulation with that of Zhang.
In response to A, Applicant has not provided sufficient evidence that the MOF-drug complex of Huo is different from that resulting from the process of claim 1. Huo discloses a process of making a MOF-drug complex whereby drug and MOF are combined and milled together to produce the final product. It is not clear what differences in outcomes would be observed/expected between the complex of the prior art and that of the claim. If Applicant has some evidence that differentiates the instantly claimed composition from the composition of the prior art, then that evidence should be provided for consideration. See MPEP 2145(I) which states that argument does not replace evidence where evidence is necessary.
Regarding the ‘device’ limitation of instant claim 11, Applicant’s argument is acknowledged but found unpersuasive because ‘device’ is a broad word. According to Merriam-Webster (see evidence), ‘device’ is defined as ‘something devised or contrived’. Certainly, a composition made by mixing ingredients together to form a new composition for providing drug could broadly be considered a device as that composition is ‘devised or contrived’. Adding to instant claim 11 so as to identify the ‘device’ could be useful in overcoming this broad reading of the claim.
In response to B, Huo’s method is slightly different from that claim. Example 1 of Huo teaches a process of producing the MOF-drug complex wherein MOF and drug are ‘fully mixed’ and then axially pressurized. Huo teaches that after the process of applying axial pressure, the pressurized mixture may be ground together. Zhang teaches that MOF and catalyst may be ground together in the presence of solvent so as to reduce damage to the MOF during the milling process. It would be reasonable to expect that the grinding process of Huo could be beneficially supplemented with this feature so as to minimize damage to the MOF during the grinding process so as to ensure stable MOF structure and retain drug within the MOF. Additionally, the Examiner respectfully disagrees that Zhang would teach away from the solvent assisted grinding process but instead motivate one to do so as it is taught that “compared to the ball milling method, the solvent method can minimize the damage to the MOF compound during the ball milling process.”
Regarding the disparity in technologies (pharmaceutical v catalyst), this difference is noted but is not considered mitigating because the process of adding solvent to the grinding process is be expected to convey across all technologies and processes for preparing MOF complexes. As it is known that adding solvent reduces structural damage to the MOF during processing, one would desire, whatever the technology, to perform such a step so as to reduce damage to the MOF used in the composition.
Maintained Rejections, of Record
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 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huo et al. (CN 109865141; translation provided).
Huo discloses a metal-organic framework containing an anticancer drug (see abstract, Example 1 and claim 1). The composition of Huo is made by a different process than that used to make the pharmaceutical composition of claims 8-11, however, this difference is a product-by-process limitation. See MPEP 2113(I) which states that if the product in the product-by-process claim is the same as the product of the prior art, then the claim is unpatentable even if made by a different process. Here, in the current circumstance, the product of the art is deemed identical to the product claimed despite being made by a different process because the end result is a MOF comprising drug.
The release of the drug according to Huo is to exhibit slow release (i.e. delayed) (see Example 1, page 5) or may exhibit quick release (i.e. accelerated) depending on the environment which the composition is provided (see page 2).
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.
Claims 1-3 and 5-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huo et al. (CN 109865141; translation provided) in view of Zhang et al. (WO 2020/199368; translation provided).
Huo describes a method of making a MOF comprising an anticancer agent (a drug) the method comprising combining powdered MOF (ZIF-8) together with an anti-cancer drug, mixing the mixture (‘pre-mixing, in a grinding vessel and in the absence of a grinding fluid and in the absence of a grinding element… to form a dry pre-mixed powdered mixture’), axially pressurizing the mixture and then grinding together. The ground mixture may then be combined with a solvent (e.g. ethanol, propanol, butanol, etc.) followed by centrifugation, washing and then drying the mixture under vacuum (see page 2 and Example 1) (see instant claims 2 and 3).
Regarding claims 8-11, Huo describes a metal-organic framework containing an anticancer drug (see abstract, Example 1 and claim 1). Although the composition of Huo is made by a different process than that used to make the pharmaceutical composition of claims 8-11, this difference is considered immaterial as it is due to a product-by-process limitation. See MPEP 2113(I) which states that if the product in the product-by-process claim is the same as the product of the prior art, then the claim is unpatentable even if made by a different process. Here, in the current circumstance, the product of the art is deemed overlapping with the product claimed despite being made by a different process because the end result is a MOF comprising drug.
Huo’s method fails to teach mixing the drug and MOF together with a grinding fluid and then grinding the mixture.
Zhang is directed to preparing an MOF that contains a metal catalyst such that the metal catalyst is trapped in the MOF. The composition may be made by a method of milling (i.e. grinding) the MOF and catalyst together to product a mixed powder. However, it is taught that the mixture may be provided with solvent so as to reduce the damage to the MOF compound during the milling process (see page 5). Thus, it would have been obvious to modify Huo’s process such that a solvent was added during the grinding process so as to minimize damage to the MOFs structure to ensure maximum anticancer drug retention by the framework. See MEP 2143(I)(C) which states that the use of a known technique to improve similar methods in the same way is evidence of obviousness.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Huo et al. (CN 109865141; translation provided) in view of Zhang et al. (WO 2020/199368; translation provided) as applied to claims 1-3 and 5-11 above, and further in view of Elsome et al. (US 6562258).
Huo and Zhang fail to teach drying in an inert atmosphere comprising a nonreactive gas such as nitrogen or argon.
Elsom is directed to drying dispersion in an inert atmosphere wherein the drying is done under vacuum (like Huo) or in an inert atmosphere such as nitrogen or argon (see claim 13). It would have been obvious to provide an inert atmosphere such as argon or nitrogen for the drying process of Huo as such gasses were known variants to the use of vacuum drying techniques taught by Huo. See MPEP 2143(I)(A).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/KYLE A PURDY/Primary Examiner, Art Unit 1611
Prosecution Insights