DETAILED ACTION
Claims 1-10 are currently pending in the instant application.
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 .
Election/Restrictions
Applicant's election with traverse of Group I, drawn to claims 1 and 4-9, in the reply filed on 04/20/2026 is acknowledged. The traversal is on the ground(s) that if search and examination of an entire application can be made without serious burden and that a search directed to one group would likely yield results applicable to other groups. This is not found persuasive because as stated in the original restriction requirement, although there is a common structure of
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, the common structure is not a significant structural element and found in the prior art (see the following 102(a)(1) rejection).
The requirement is still deemed proper and is therefore made FINAL.
Claims 2-3 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/20/2026.
Priority
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Information Disclosure Statement
Applicant's Information Disclosure Statement filed on 11/30/2023 has been considered. Please refer to Applicant's copies of the 1449 submitted herewith.
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 7-8 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.
Claim 7 contains the trademark/trade name “Cremophor” and claim 8 contains the trademark/trade name “Pluronic”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe specific polyethoxylated castor oil and poloxamers and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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.
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 1 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yuan et al, (see CN 109020945, pub. 12/18/2018). Yuan et al teach compound
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(see p. 7).
In regards to claims 1 and 9, according to MPEP 2111.02, Section II, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”).
In re Tuominen (213 USPQ 89) states the following:
The composition is the same no matter what its intended use is, and consequently, the appealed claims are not seen to distinguish over the art which also discloses a composition of the recited active ingredient. We will not construe the instant claims to be limited to compositions also containing other ingredients usually utilized in sunscreening compositions merely by the fact that the introductory clause of the claims recites a different contemplated utility for the claimed composition not taught by the art. Rather, as done by the Examiner, we interpret the claims to be drawn to a composition of the active ingredients, per se, and, as such, under the rationale of Pearson, they fail to distinguish over the references.
The compounds of Yuan et al correspond to the same compound described in claims 1 and 9. Since the preamble of claims 1 and 9 merely recites the intended use of the compound, the compounds of Yuan et al would anticipate claims 1 and 9.
Claim Rejections - 35 USC § 103
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.
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al (see CN 109020945, pub. 12/18/2018, cited in IDS filed 11/30/2023) as applied to claim 4 above, and further in view of BHARATE (see US PG Pub 2017/0320802, pub. 11/09/2017, cited in IDS filed 11/30/2023).
Yuan et al teach the compound
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(see p. 7) as described in the above 102(a)(1) rejection and that said compound may be used to prepare medicaments (see p. 6 of enclosed machine translation of CN 109020945).
BHARATE teaches compounds such as
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in the treatment of Alzheimer’s disease. Further the compounds are taught in pharmaceutical compositions with pharmaceutically acceptable excipients, which include polymers (see paragraph [0025], p. 5). Thus it would be obvious to one of ordinary skill in the art to utilize the compound of Yuan et al in compositions as taught by BHARATE. Yuan et al teach the claimed compound can be used in medicaments while BHARATE teaches compounds having the same structural core in compositions with a pharmaceutically acceptable excipient which includes a polymer. Although BHARATE is silent as to the ratio of excipient to active ingredient, according to MPEP 2144.05, Section II, Part A, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). Therefore, the adjustment of particular conventional working conditions (e.g. determining result effective amounts of the ingredients beneficially taught by the cited references), as well as adjustment of reaction temperature, reaction time and use of solvents, rearranging steps in a reaction sequence, is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan (See In re Mostovych, Weber, Mitchell and Aulbach, 144 USPQ 38).
Regarding the limitation “for oral administration”, according to MPEP 2111.02, Section II, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”).
Claims 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al, (see CN 109020945, pub. 12/18/2018, cited in IDS filed 11/30/2023) as applied to claim 4 above, and further in view of BHARATE (see US PG Pub 2017/0320802, pub. 11/09/2017, cited in IDS filed 11/30/2023) and Singhvi (see IN Patent No. 201911011318, pub. 09/25/2020, hereafter referred to as ‘318).
The limitations of claim 4 are discussed above. Regarding the limitations of claims 5-8, ‘318 teaches a composition comprising a drug in concentration of 0.1-5% ww of the total composition (see p. 6, line 26) along with lipids in a concentration of 1-50% w/w or a surfactant in a concentration of 0.1-10% w/w or stabilizer of 0.05-10% w/w of total composition (see p. 6, lines 24-27, p. 7, lines 1-4). ‘318 teaches the lipid may include phosphatidylcholine (see p. 7, line 18 and Table 1, p. 10), the surfactant may include Cremophor (see p. 8, line 8) and Pluronic polymer (see Table 1, p. 10) as a surfactant. ‘318 further teaches that the lipids may act as carrier for delivery of active drug while surfactants provide stabilization to lipid dispersion. Although ‘318 teaches the formulation with an active ingredient of voriconazole rather than the instantly claimed compound, ‘318 teaches the components of the composition having improved permeation, stability, sustained-release and minimum systemic toxicity. Specifically, ‘318 teaches that the presence of lipids in a pharmaceutical composition may be used to entrap the active pharmaceutical ingredient and for carrying active drugs while surfactants would be necessary to stabilize the dispersion of lipids.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
The motivation to utilize pharmaceutical excipients of lipids may act as carrier for delivery of active drug while surfactants such as Pluronic polymer (see p. 8) provide stabilization for the composition. One would be motivated to utilize the excipients to form a pharmaceutical composition for the claimed compound, which is taught to have antitumor activity, in order to deliver said compound.
Regarding the amount of excipients used in claim 5, MPEP 2144.05, Section I states that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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