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 .
DETAILED ACTION
This office action is a response to Applicant’s amendments/remarks after non-final rejection filed 11/14/2025.
As filed, claims 4 and 10 are pending; and claims 1-3, 5-9, and 11-20 are cancelled.
Response to Amendments/Remarks
Applicant’s amendments/remarks, filed 11/14/2025, with respect to claims 4 and 10, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below.
The § 102(a)(1) rejection of claim 4 by CAS846 is withdrawn per amendments.
The § 103(a) rejection of claim 4 by Ramachandran is maintained because the Applicant’s remarks are not persuasive. As mentioned in the previous office action, the intended use statement, such as “for treating infection in a patient in need of relief from said infection”, in the beginning of claim 4, have not been accorded patentable weight for prior art purpose because such statement fails to limit the structure of the compound of instant formula (I). Any prior art compound having the same structure as the compound of instant formula (I) or obvious variant thereof would be capable of performing the intended use.
With regards to the phrase, “wherein said pharmaceutical composition is effective for treating infection in a patient in need of relief from said infection” at the end of claim 4, the Examiner finds “for treating infection in a patient in need of relief from said infection” is not given patentable weight for prior art purpose because it is an intended use. The remainder of the abovementioned phrase, which is “wherein said pharmaceutical composition is effective”, Ramachandran has shown that its pharmaceutical composition is therapeutically effective. Lastly, “wherein said pharmaceutical composition is effective for treating infection in a patient in need of relief from said infection” can also be interpreted as simply stating an inherent property within the instant pharmaceutical composition, and such inherent property need not be recognized at the time of the invention. The claiming of a new, unknown property, which is inherently present in the prior art does, not necessarily make the claim patentable.
The § 103(a) rejection of claim 10 by Ramachandran and Cho is maintained for the reasons stated in #4 and because the Applicant’s remarks are not persuasive. In addition, the motivation to modify Ramachandran to include Cho derives from the person of ordinary skill in the art would want to optimize the therapeutic profile of the compound of Ramachandran against pancreatic carcinoma cells and to reduce toxicity in normal cells at the same time through the use of the nanoparticle technology.
Claim Interpretation
With regards to the intended use statement, such as “for treating infection in a patient in need of relief from said infection”, in claims 4 and 10, they have not been accorded patentable weight for prior art purpose because such statement fails to limit the structure of the compound of instant formula (I).
The Examiner finds that any prior art compound having the same structure as the compound of instant formula (I) would be capable of performing the intended use, according to the guidance in MPEP 2111.02(II).
With regards to the phrase, “wherein said pharmaceutical composition is effective for treating infection in a patient in need of relief from said infection” in claims 4 and 10, the Examiner finds such phrase as simply stating an inherent property within the instant pharmaceutical composition, and such inherent property need not be recognized at the time of the invention. In addition, the claiming of a new, unknown property, which is inherently present in the prior art does not necessarily make the claim patentable. See MPEP 2112.02(I) and (II).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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(a) 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 4 is rejected under 35 U.S.C. 103 as being unpatentable over “Tailored α-methylene-γ-butyrolactones and their effects on growth suppression in pancreatic carcinoma cells”, hereinafter Ramachandran. See PTO-892 form mailed on 1/18/2023.
Regarding claim 4:
Determining the scope and contents of the prior art:
Ramachandran, for instance, teaches a therapeutically effective amount of following compounds in a pharmaceutical composition for treating pancreatic carcinoma cells.
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67
496
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(abstract)
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762
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764
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Wherein: instant variables X and Y are O; instant variable n is 1; variables R1 and R2 are H; one of instant variables R3 and R4 is H and the other is phenyl; and both instant variables R5 and R6 are H.
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682
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Wherein: instant variables X and Y are O; instant variable n is 1; one of variables R1 and R2 are H and the other is 4-methoxy substituted phenyl; one of instant variables R3 and R4 is H and the other is methyl; and both instant variables R5 and R6 are H.
(pg. 6622, Table 1, Compounds 2 and 6)
The Examiner finds that the abovementioned pharmaceutical composition (in pharmaceutically acceptable carrier) will be inherently made when the abovementioned compounds tested for their efficacy in proliferation assay.
According to guidance in MPEP 2112(I)-(II), the Examiner finds the discovery of using the instant pharmaceutical composition for treating infection does not make the instant claims patentably new, because treating infection is a previously unappreciated property that is inherently present in the structure of the abovementioned compounds, which needs not be recognized by Ramachandran at the time of the invention.
Ascertaining of the difference between the prior art and the claim at issue:
In the abovementioned compound, Ramachandran, for instance, did not explicitly recite a particular stereochemistry of the phenyl group.
Finding of prima facie obviousness --- rationale and motivation:
Although the phenyl group of abovementioned compound of Ramachandran is in a racemic mixture, a person of ordinary skill in the art (i.e. organic chemist) would have the knowledge and skill to resolve a racemic mixture of enantiomers into optical isomers. In addition, a person of ordinary skill in the art would understand that racemic mixture should be separated into the optical isomers and screened separately. Thus, the production of a mixture or of one particular optical isomer is itself motivation to produce the opposite optical isomer because all three substrates would need to be screened for therapeutic potential (see Rydzewski, Real World Drug Discovery 2008, 42-43, see PTO-892 form mailed on 11/5/2025). Because the isolation of both optical isomers is obvious in drug development, the Examiner finds that one particular optical isomer of the instant claims is prima facie obvious over the racemic mixture of the abovementioned compound of Ramachandran.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the combined teaching of Ramachandran; and “Therapeutic Nanoparticles for Drug Delivery in Cancer”, hereinafter Cho.
Regarding claim 10:
Determining the scope and contents of the prior art:
Ramachandran, for instance, teaches the abovementioned obvious variant for treating pancreatic carcinoma cells.
Cho, for instance, teaches that nanoparticles, by using both passive and active targeting strategies, can enhance the intracellular concentration of drugs in cancer cells, while avoiding toxicity in normal cells.
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(pg. 1310, left column, 2nd paragraph)
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554
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(pg. 1310, abstract)
Ascertaining of the difference between the prior art and the claim at issue:
Ramachandran, for instance, did not explicitly teach the abovementioned obvious variant in a nanoparticle.
Cho for instance, did not explicitly teach the instant pharmaceutical composition.
Finding of prima facie obviousness --- rationale and motivation:
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to modify the abovementioned obvious variant of Ramachandran to include nanoparticle, as taught by Cho, in order to arrive at the instantly claimed pharmaceutical composition because a person of ordinary skill in the art would be motivated to optimize the therapeutic profile of the compound of Ramachandran against pancreatic carcinoma cells and to reduce toxicity in normal cells at the same time through the use of the nanoparticle technology. There is a reasonable expectation of success that the nanoparticle of Cho can enhance the anti-cancer efficacy of the compound of Ramachandran and reduce the toxicity of the said compound in normal cells.
Claim Objections
Claims 4 and 10 are objected to because of the following informalities:
Regarding claims 4 and 10, the claims recite the compound,
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, which is a typographical error because such compound does not match with
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230
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, which needs to be corrected.
Appropriate correction is required.
Conclusion
Claims 4 and 10 are rejected.
Claims 4 and 10 are objected.
Claims 1-3, 5-9, and 11-20 are cancelled.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621