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 .
Summary
Claims 1-17 are pending in this office action. All pending claims are under examination.
Priority
The current application was filed on October 11, 2024 and is a 371 of PCT/EP2023/059629 filed on April 13, 2023. The current application claims foreign priority to EP22305549.2 filed on April 14, 2022.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on October 11, 2024 is acknowledged. A signed copy of the document is attached to this office action.
Claim Interpretation
The Examiner is unsure whether “use” claims 1-8 and 16-17 are a for a method of use or for an intended use. For rejection purposes the Examiner is interpreting the claims 1-8 and 16 as a method of “use” and claim 17 as an intended “use.”
Duplicate Claim Warning
Applicant is advised that should claim 1 be found allowable, claim 9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01 (m).
Claim Objections
Claims 1-17 are objected to because of the following informalities:
Claims 1 and 7: Please amend the phrase to read “…-COO-t-Bu in which t-Bu means tert-butyl;” instead of -COOtBu, tBu, and ter-butyl. Also, please amend the phrase to include a comma “…when R1 represents a phosphonate group, PG,…”
Dependent claims 2-17 are included here because they fail to cure the defects of claim 1.
Claims 4 and 5: Please amend the terms “…decanyl, and dodecanyl…” to “…decyl, and dodecyl…”.
Claim 6: Please amend the term “…methyloxy….” to be “…methoxy…”.
Claim 8: Please amend the text to include two commas, “…of R1 to R5, m, n, p, and q are…”.
Appropriate correction is required.
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 1-17 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.
Independent claim 1 uses the term "preferably" or phrase “more preferably” which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Dependent claims 2-17 are included here because they fail to cure the defect of claim 1.
Independent claim 1 is written as also a “use” claim and does not recite process steps. Additionally, claim 1 does not comply with the four statutory categories. It is therefore, indefinite. Please define this use claim as either a method or an intended use claim.
Dependent claims 2-17 are included here because they fail to cure the defect of claim 1. Where appropriate, please define these use claims as either a method or an intended use claims.
Furthermore, claim 16 is additionally written as a “use” claim and does not recite process steps. Also, claim 16 does not comply with the four statutory categories. It is therefore, indefinite. Please define this use claim as either a method or an intended use claim.
Claim 8 recites the substituents in table form. Claims may contain tables either if necessary to conform to 35 U.S.C. 112 or if otherwise found to be desirable. See MPEP 2173.05(s). When such a patent is printed, however, the table will not be included as part of the claim, and instead the claim will contain a reference to the table number. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant' s convenience.” Ex parte Fressola, 27USPQ2d 1608, 1609 (Bd, Pat. App. & Inter. 1993) (citations omitted). In the instant case, please remove the grid lines of the table.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Independent claim 1 is directed to non-statutory subject matter. The claim 1 does not fall within at least one of the four categories of patent eligible subject matter because it is written as a “use” claim.
Dependent claims 2-17 are included here because they fail to cure the defect of claim 1.
In addition, claim 16 is directed to non-statutory subject matter. Claim 16 does not fall within at least one of the four categories of patent eligible subject matter because it is written as a “use” claim.
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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Shi et al. (Molecules, 2019) in view of Ullmann et al. [Advanced Materials Interfaces, 2021 (published in December 2020)], Begin-Colin et al. (US2017/0014533A1), and Ertl et al. (J Med Chem, 2020).
[The Examiner is going to introduce each reference and then combine them where appropriate to reject the instant claims.]
1. Shi et al.
Shi et al. is considered the closest prior art to the claimed invention as it teaches interfacial behavior of oligo(ethylene glycol) dendrons spread alone and in combination with a phospholipid as Langmuir monolayers at the air/water interface (see title). Furthermore, Shi et al. disclose dendrons consisting of two phosphonate functions and three oligo(ethylene glycol) (OEG) chains grafted on a central phenoxyethylcarbamoyl-phenoxy group were synthesized and investigated as Langmuir monolayers at the surface of water. The OEG chain in the para position was grafted with a t-Bu end-group, a hydrocarbon chain, or a partially fluorinated chain. These dendrons are models of structurally related OEG dendrons that were found to significantly improve the stability of aqueous dispersions of iron oxide nanoparticles when grafted on their surface. Compression isotherms showed that all OEG dendrons formed liquid-expanded Langmuir monolayers at large molecular areas. Further compression led to a transition ascribed to the solubilization of the OEG chains in the aqueous phase. Brewster angle microscopy (BAM) provided evidence that the dendrons fitted with hydrocarbon chains formed liquid-expanded monolayers throughout compression, whilst those fitted with fluorinated end-groups formed crystalline-like domains, even at large molecular areas. Dimyristoylphosphatidylcholine and dendron molecules were partially miscible in monolayers. The deviations to ideality were larger for the dendrons fitted with a fluorocarbon end-group chain than for those fitted with a hydrocarbon chain. Brewster angle microscopy and atomic force microscopy supported the view that the dendrons were ejected from the phospholipid monolayer during the OEG conformational transition and formed crystalline domains on the surface of the monolayer (see abstract).
2. Ullmann et al.
Ullmann et al. teach water-in-fluorocarbon nanoemulsions stabilized by phospholipids and characterized for pharmaceutical applications (see title). In addition, Ullmann et al. disclose that fluorocarbons are one of the most promising hydrophobic phases for future pharmaceutical production processes and various biomedical applications. Yet, because of their specific characteristics such as high density and refractive index similar to water, analysis of water-in-fluorocarbon (w/fc) nanoemulsions remains a challenge. The present work examines w/fc nanoemulsions stabilized with phospholipids as natural emulsifiers and tackles the measuring problems of photon correlation spectroscopy (PCS) when used for investigation of fluorocarbon nanoemulsions. These emulsions are suitable to form liposomes via centrifugation and thus, are required to meet certain criteria such as stability and size. The results imply a stability of up to 4 weeks with an average size of 180 nm. The intensity mean diameter gained from PCS measurements shows large scattering directly after sonication which is due to gas bubbles from sonication. The number mean is not influenced by gas bubbles and gives a more accurate depiction of the produced nanoemulsions. These findings are supported by small-angle X-ray scattering data, which are additionally applied for liposome analysis measuring a size of approximately 60 nm (see abstract).
3. Begin-Colin et al.
Begin-Colin et al. teach dendronized metallic oxide nanoparticles, a process for preparing the same and their uses (see title). Additionally, Begin-Colin et al. disclose dendronized metallic oxide nanoparticles, a process for preparing the same and their uses (see abstract).
4. Ertl et al.
Ertl et al. teach the most common functional groups in bioactive molecules and how their popularity has evolved over time (see title). Furthermore, Ertl et al. disclose that concept of functional groups (FGs), sets of connected atoms that can determine the intrinsic reactivity of the parent molecule and in part are responsible for the overall properties of the molecule, form a foundation within modem medicinal chemistry. In this article, we analyze the occurrence of various FGs in molecules described in the medicinal chemistry literature over the last 40 years and show how their development and utilization over time has varied. The popularity of various FGs has not evolved randomly, but instead, clear patterns of use are evident. Various factors influencing these patterns, including the introduction of new synthetic methods, novel techniques, and strategies applied in drug discovery and the better knowledge of molecular properties affecting the success of candidate development, are discussed (see abstract).
Combination of Shi et al. and Ullmann et al.
Regarding instant claim 1, Shi et al. and Ullmann et al. teach the use of an oligo(ethylene oxide) dendritic molecule. The necessary citations of Shi et al. and Ullmann et al. that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 1
Shi et al. and Ullmann et al. Citations
Use of an oligo(ethylene oxide) dendritic molecule of formula (I) below:
Shi et al. disclose oligo(ethylene glycol) dendrons which can be grafted on iron nanoparticles and, together which a phospholipid such as dimyristoyl-phosphatidylcholine, form monolayers and are thus suitable for the formation of fluorocarbon contrast agents microbubbles (see p. 2, paragraphs 3-4, Scheme 1 on p. 3 and p. 6, paragraph 1 all within Shi et al.). The compounds tBuOEGxDen fall within the scope of present claim 1 (see below).
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(see Scheme 1 within Shi et al.)
Shi et al. fails to disclose a fluorocarbon-based nanoemulsion.
However, Ullmann et al. disclose a fluorocarbon-based nanoemulsion.
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Ullmann et al. disclose a water-in-fluorocarbon nanoemulsions stabilized by phospholipids and characterized for pharmaceutical applications (see title and abstract; also see the Experimental Section; all within Ullmann et al.).
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(see Figure 6 within Ullmann et al.).
Despite a oligo(ethylene oxide) dendron of formula (I) not being used by Ullmann et al. a skilled artisan (POSITA; person of ordinary skill in the art) would use the oligo(ethylene oxide) dendron of formula (I) based on the positive interaction of phospholipid-embedded OEG dendrons containing a t-butyl end group to facilitate the delivery (medical microbubbles) of dendronized magnetic nanoparticles in vivo as concluded by Shi et al. (see p. 8 of 13; 3. Conclusions and Perspectives within Shi et al.).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Shi et al. with the teachings of Ullmann et al. The motivation to combine the two references would be to create a therapeutic or imaging delivery system incorporating the fluorocarbon-based nanoemulsion consisting of a dispersion of nanodroplets of a liquid fluorocarbon stabilized in a continuous aqueous phase by a thin lipid film present at the interface between said aqueous phase and said liquid fluorocarbon, said lipid film comprising phospholipid(s) and at least one oligo(ethylene oxide) dendron of formula (I).
Regarding instant claim 2, Shi et al. and Ullmann et al. teach wherein the oligo(ethylene oxide) dendritic molecule of formula (I) is a compound in which q = 2 and R1 represents a phosphonate group of formula (PG) in which each of R5 represents a hydrogen atom or an alkyl group having from 4 to 12 carbon atoms.
Shi et al. disclose two phosphonate groups on the terminal aryl ring, having identical alkyl substituents [-PO(OEt)2; please see Scheme 1 within Shi et al. and the discussion and citations within instant claim 1 for the necessary rejection text.].
Combination of Shi et al., Ullmann et al., and Begin-Colin et al.
Regarding instant claim 3, Shi et al., Ullmann et al., and Begin-Colin et al. teach wherein said oligo(ethylene oxide) dendritic molecule of formula (I) are grafted on magnetic nanoparticles.
Begin-Colin et al. teach dendronized metallic oxide nanoparticles, a process for preparing the same and their uses (see title within Begin-Colin et al.), and is within the oligo(ethylene oxide) dendritic molecule arts (see abstract and paragraph [0009] within Begin-Colin et al.). Begin-Colin et al. disclose wherein said oligo(ethylene oxide) dendritic molecule of formula (I) are grafted on magnetic nanoparticles (see paragraphs [0007]-[0009] within Begin-Colin et al.).
Regarding instant claim 4, Shi et al., Ullmann et al., and Begin-Colin et al. teach wherein the oligo(ethylene oxide) dendritic molecule of formula (I) is a compound in which q = 2 and R1 represents an alkyl group selected among octyl, decanyl, and dodecanyl or a fluorinated group selected among -(CH2)6-CF2CF3 and -(CH2)2-CF(CF3)2.
Begin-Colin et al. disclose wherein the oligo(ethylene oxide) dendritic molecule of formula (I) is a compound in which q = 2 and R1 represents an alkyl group selected among octyl, decyl, and dodecyl groups (see paragraphs [0009]-[0017] and [0059] within Begin-Colin et al.).
Combination of Shi et al., Ullmann et al., Begin-Colin et al., and Ertl et al.
Regarding instant claim 5, Shi et al., Ullmann et al., Begin-Colin et al., and Ertl et al. teach wherein the oligo(ethylene oxide) dendritic molecule of formula (I) is a compound in which q = 2 and R1 represents a group -OR4 or -COOR4 in which R4 represents an alkyl group selected among octyl, decanyl, and dodecanyl or a fluorinated group selected among -(CH2)6-CF2CF3 and -(CH2)2-CF(CF3)2.
Begin-Colin et al. fails to disclose ethers or esters within the R1 position. However, within medicinal chemistry exploration of structure-activity relationships (SARs), it is common for researchers to substitute in both ethers and ester groups for alkyl groups. Ertl et al. disclose this substitution (see Figure 1; 38.8 ethers and 5.2 esters; within Ertl et al.). Furthermore, Begin-Colin et al. has established that alkyl group selected among octyl, decanyl, and dodecanyl groups are disclosed within their reference (see instant claim 4).
It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to have modified the oligo(ethylene oxide) dendritic molecule, as disclosed by Shi et al. and Ullmann et al., to provide the oligo(ethylene oxide) dendritic molecule wherein both ethers and esters are substituted for alkyl groups, as disclosed by Ertl et al., for the benefit that the SAR analysis is expanded within Begin-Colin et al. to provide additional oligo(ethylene oxide) dendritic molecule analogues.
Combination of Shi et al. and Ullmann et al.
Regarding instant claim 6, Shi et al. and Ullmann et al. teach wherein the
oligo(ethylene oxide) dendritic molecule of formula (I) is a compound in which each of R2 represents a methyloxy group.
Shi et al. disclose R2 substituents having methoxy groups (please see Scheme 1 within Shi et al. and the discussion and citations within instant claim 1 for the necessary rejection text.].
Regarding instant claim 7, Shi et al. and Ullmann et al. teach wherein the
oligo(ethylene oxide) dendritic molecule of formula (I) is a compound in which R3 represents a methyloxy group, a carboxyl group or a group -COOtBu in which tBu means tert-butyl.
Shi et al. disclose R3 substituents having -COOtBu groups (please see Scheme 1 within Shi et al. and the discussion and citations within instant claim 1 for the necessary rejection text.].
Regarding instant claim 8, Shi et al. and Ullmann et al. teach wherein the
oligo(ethylene oxide) dendritic molecule of formula (I) is a compound selected among compounds of formulae (I-A) to (1-T) whose significations of R1 to R5, m, n, p and q are given in the following Table 1.
Shi et al. disclose t-BuOEG8Den, which is identical to the compound of I-Q within the table of instant claim 8 (please see Scheme 1 within Shi et al. and the discussion and citations within instant claim 1 for the necessary rejection text.).
Regarding instant claim 9, Shi et al. and Ullmann et al. teach fluorocarbon-based nanoemulsion comprising an aqueous continuous phase and a dispersion of nanodroplets consisting of a membrane of a lipid phase encapsulating at least one liquid fluorocarbon, wherein the lipid phase comprises at least one phospholipid and at least one oligo(ethylene oxide) dendritic molecule of formula (I) as defined in instant claim 1.
Ullmann et al. disclose the instant claim 9 fluorocarbon-based nanoemulsion within Table I of instant claim 1.
Regarding instant claim 10, Shi et al. and Ullmann et al. teach wherein the at least one fluorocarbon is chosen among perfluorobutane, perfluoropentane, 2H,3H-perfluoropentane, perfluorohexane, perfluoroheptane, perfluorooctane, perfluorononane, perfluorodecalin, perfluorooctylbromide and perfluorotripropylamine.
Ullmann et al. fails to disclose any of the selected fluorocarbon group members above. However, Shi et al. disclose the use of perfluoroalkyl halides (lower alkyl) to alkylate the central tert-butyl ester moiety (see Scheme 2 within Ullmann et al.). Additionally, Ullmann et al. uses the long-chain cyclic molecule perflouroperhydrophen-anthrene (PFPH). But the use of small perfluoroalkyls by Shi et al. suggests to a skilled artisan (POSITA) that selecting compounds such as perfluorobutane, perfluoropentane, or perfluorohexane, all of which are commercial, and easily obtainable for the fluorocarbon-based nanoemulsion would be routine.
Regarding instant claim 11, Shi et al. and Ullmann et al. teach wherein the concentration of fluorocarbon varies from 1 to 30% w/w.
Ullmann et al. disclose the use of a 1% water-in-fluorocarbon nanoemulsion (see Figure 2 within Ullmann et al.). Therefore, this percentage would give a skilled artisan (POSITA) a starting point for the fluorocarbon level of the nanoemulsion.
Regarding instant claim 12, Shi et al. and Ullmann et al. teach wherein the at least one phospholipid is chosen among dimyristoylphosphatidylcholine (DMPC), dipalmitoylphosphatidylcholine (DPPC), and distearoylphosphatidylcholine (DSPC).
Ullmann et al. disclose the use DMPC, DPPC, DSPC, DPPS, DPPG, and DPPE (see Figure 3 within Ullmann et al.). Regarding instant claim 13, Shi et al. and Ullmann et al. teach wherein the concentration of the at least one phospholipid varies from 0.25 to 10% w/w.
Ullmann et al. disclose a phospholipid range of 0.0025% to 0.03% (see Table 1 within Ullmann et al.). [Additionally, Shi et al. afford the monolayer of a phospholipid (DMPC) to an OEG dendron at a molar ratio of 75:25 optimal for the formation of microbubbles (see p. 6 of 13, 1st paragraph within Shi et al.).] The low percent of phospholipid presented by Ullmann et al. would be increased as a matter of routine practice to modify the resulting liposome formed. A skilled artisan (POSITA) would adjust the resulting phospholipid to be within the instant claim 13 range, in order to maximize the liposome formed within the fluorocarbon-based nanoemulsion.
Regarding instant claim 14, Shi et al. and Ullmann et al. teach wherein the concentration of the oligo(ethylene oxide) dendritic molecule of formula (I) varies from 0.07 to 0.7 % w/w.
Shi et al. affords the monolayer of a phospholipid (DMPC) to an OEG dendron at a molar ratio of 75:25 (3:1) optimal for the formation of microbubbles (see p. 6 of 13, 1st paragraph within Shi et al.), and Ullmann et al. disclose a phospholipid range of 0.0025% to 0.03% (see Table 1 within Ullmann et al.). Therefore, if the phospholipid level of approximately 0.21 to 2.1% w/w is used to maximize the liposome formed to encapsulate the active pharmaceutical as eluded to within Ullmann et al. (see p. 6 of 8, 3. Conclusions within Ullmann et al.), then a oligo(ethylene oxide) dendritic molecule of formula (I) range value of 0.07 to 0.7% is obtained, which is within the instant claim 14 limitation.
Regarding instant claim 15, Shi et al. and Ullmann et al. teach wherein the phospholipid/oligo(ethylene oxide) dendritic molecule of formula (I) molar ratio varies from about 5:1 to 50:1.
Shi et al. affords the monolayer of a phospholipid (DMPC) to an OEG dendron at a molar ratio of 75:25 optimal for the formation of microbubbles (see page 6 of 13, 1st paragraph within Shi et al.). However, a skilled artisan (POSITA) would increase the phospholipid level from 3:1 to be within the range of instant claim 15 in order to obtain a stronger liposome from the fluorocarbon-based nanoemulsion, as eluded to within Ullmann et al. (see p. 6 of 8, 3. Conclusions within Ullmann et al.).
Combination of Shi et al., Ullmann et al., and Begin-Colin et al.
Regarding instant claim 16, Shi et al., Ullmann et al., and Begin-Colin et al. teach the use of a fluorocarbon-based nanoemulsion as defined in instant claim 9, as a contrast agent.
Begin-Colin et al. disclose a magnetic resonance imaging contrast agent, and
having a sufficient heating power for a magnetic hyperthermia treatment (see claim 21 within Begin-Colin et al.).
Regarding instant claim 17, Shi et al., Ullmann et al., and Begin-Colin et al. teach a fluorocarbon-based nanoemulsion as defined instant claim 9, for its use as drug carrier or as oxygenating agent in a method of treatment by therapy.
The intended use as a drug carrier is discussed within Ullmann et al. (see page 6 of 8, 3. Conclusions within Ullmann et al.). The liposomes produced within the nanoemulsions. Coupled with the fact that fluorocarbons are natural oxygen accumulators (see page 6 of 8, 3. Conclusions within Ullmann et al.), allow the fluorocarbon-based nanoemulsion to afford a drug carrier or as an oxygenating agent within the therapeutic arena.
Analogous Art
The Shi et al., Ullmann et al., Begin-Colin et al., and Ertl et al. references are directed to the same field of endeavor as the instant claims, that is, the use of an oligo(ethylene oxide) dendritic molecule, as disclosed within instant claim 1.
Obviousness Analysis
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the oligo(ethylene glycol) dendrons as disclosed by Shi et al., using the teachings of Ullmann et al., Begin-Colin et al., and Ertl et al. in order to arrive at the subject matter of the instant claims.
The Shi et al., Ullmann et al., Begin-Colin et al., and Ertl et al. references all have considerable overlap in the oligo(ethylene glycol) dendron arts. In this instance, Shi et al. and Begin-Colin et al. supply the template for the oligo(ethylene glycol) dendrons, Ullmann et al. disclose water-in-fluorocarbon nanoemulsions stabilized by phospholipids and characterized for pharmaceutical applications, while Ertl et al. supplies support for the medicinal chemistry exploration of ether and ester functional groups. All references are directed to the application of oligo(ethylene glycol) dendrons and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the four references when seeking to develop an enhanced oligo(ethylene glycol) dendron and fluorocarbon-based nanoemulsion.
Given these teachings, a POSITA would have been motivated to combine the template for the oligo(ethylene glycol) dendrons disclosed by both Shi et al. and Begin-Colin et al. into the fluorocarbon nanoemulsions disclosed by Ullmann et al. Furthermore, Ertl et al. supports the medicinal exploration of both ether and ester functional groups within the oligo(ethylene glycol) dendrons.
The modification constitutes a simple substitution of one known element for another to obtain a predictable results [MPEP §2143(I)(B)].
The combination represents the use of a known technique to improve a similar composition in the same way [MPEP §2143(I)(C)].
The art provides a finite number of identified, predictable solutions, and the POSITA would have pursued the claimed configuration with a reasonable expectation of success [MPEP §2143(I)(E); KSR].
The combination of the oligo(ethylene glycol) dendrons taught by Shi et al. and Begin-Colin et al. along with the use of the necessary claim limitations taught by Ullmann et al. and Ertl et al. would allow a research and development scientist (POSITA) to create the invention taught in the instant application.
Furthermore, the additional claim limitations taught by Ullmann et al., Begin-Colin et al., and Ertl et al. would have been viewed by a POSITA as routine design optimizations or known modifications for oligo(ethylene glycol) dendrons. The motivation to combine the four references would be to create a therapeutic or imaging delivery system incorporating the fluorocarbon-based nanoemulsion consisting of a dispersion of nanodroplets of a liquid fluorocarbon stabilized in a continuous aqueous phase by a thin lipid film present at the interface between said aqueous phase and said liquid fluorocarbon, said lipid film comprising phospholipid(s) and at least one oligo(ethylene oxide) dendron of formula (I). Implementing these features in Shi et al.’s oligo(ethylene glycol) dendrons would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Shi et al., supplemented by Ullmann et al., Begin-Colin et al., and Ertl et al. provides all the elements of the claimed invention. The resulting oligo(ethylene glycol) dendrons constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Double Patenting - Statutory
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process... may obtain a patent therefor…"(Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identica I subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-2 and 6-8 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-8 of co-pending Application No. 18/856,603 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
The claims at issue are identical and both encompass oligo(ethylene glycol) dendrons and their pharmaceutical applications.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
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