DETAILED ACTION
Applicants’ arguments, filed 31 July 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Interpretation
Claim 16, last two lines, recites the phrase “branched substituted or unsubstituted alkyl group.” The examiner understands this to require either a branched substituted alkyl group or a branched unsubstituted alkyl group. The examiner does not understand the scope of this limitation to include an unsubstituted alkyl group that is not branched.
The instant specification appears to define the term “branched” in the following manner, as of the instant specification on page 6, relevant text reproduced below.
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As best understood by the examiner, an unsubstituted aryl or unsubstituted benzyl group is not understood to read on the required branched substituted or unsubstituted alkyl group recited by the last two lines of claim 16. This is at least because a) a ring of carbon atoms is not a branched structure, and b) in the benzyl group, it is the terminal carbon atom substituted with a phenyl ring. This differs from the above-indicated definition which requires that a non-terminal carbon atom be substituted in a branched structure.
Note Regarding Art Area
The examiner notes that the terms “Pluronic” and “poloxamer” refer to a class of synthetic tri-block copolymers containing central hydrophobic chains of poly(propylene oxide) sandwiched between two hydrophilic chains of poly(ethylene oxide). See Zarrintaj et al. (Acta Biomaterialia, Vol. 110, 2020, pages 37-67). These are used as surfactants, as of Zarrintaj, page 37, right column, top paragraph below abstract. As such, a prior art teaching of Pluronic is understood to read on the required non-ionic ethoxylated block copolymer surfactant of claim 28.
Claim Rejections - 35 USC § 103 – Obviousness
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.
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.
Claim(s) 16-17, 20-27 and 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Acta Biomaterialia, Vol. 51, 2017, pages 374-392) in view of Lazreg et al. (WO 2019/007833 A1) and Taratula et al. (US 2018/0028496 A1).
Chen et al. (hereafter referred to as Chen) is drawn to a drug delivery system comprising the following elements, as of page 375, Scheme 1, reproduced below.
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This figure is presented in color in the original document and shows hyaluronic acid (a polysaccharide composite resin), indocyanine green (a near-infrared absorber) and doxorubicin, which is an anti-cancer drug whose release is triggered by a near-infrared laser.
Chen differs from the claimed invention because the chemical structure of the near-infrared dye in Chen differs from that required by the instant claims; as such, Chen does not teach the chemical structure required by Figure 1 of instant claim 1.
Lazreg et al. (hereafter referred to as Lazreg) teaches a near-infrared dye with the following chemical structures, as of Lazreg, page 24, relevant chemical structures reproduced below.
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The above-reproduced chemical structures IR-C1 and IR-C2 are understood to read on the required general formula II, as both structures include the required branched chain. While these structures appear to be comparative examples, they nevertheless are infrared dyes; a known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use. See MPEP 2123(II).
Lazreg does not teach a pharmaceutical or imaging composition.
Taratula et al. (hereafter referred to as Taratula) is drawn to a nanoparticle comprising a photosensitive compound, as of Taratula, title, abstract, and figure on front page, which is reproduced below.
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Taratula teaches the following, as of regarding the use of near-infrared absorption agents, as of paragraphs 0004-0005, relevant text reproduced below.
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Taratula teaches problems regarding NIR absorption agents prior to the Taratula reference, as of paragraph 0005, relevant text reproduced below.
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As such, Taratula teaches that although indocyanine green is the only NIR dye that was approved by the Food and Drug administration in the United States, there are problems with indocyanine green.
Taratula does not teach the chemical structure required by General Formula I.
It would have been prima facie obvious for one of ordinary skill in the art to have substituted the NIR absorber of Lazreg in place of the indocyanine green NIR absorber of Chen and Taratula. Chen and Taratula are drawn to a pharmaceutical composition comprising indocyanine green which is used as a NIR absorber. Lazreg teaches a compound which is used as a NIR absorber. As such, the skilled artisan would have been motivated to have substituted the compound of Lazreg in place of the NIR absorber of Chen and Taratula for predictable absorption of near-infrared radiation with a reasonable expectation of success. The simple substitution of one known element (e.g. the compound of Lazreg) in place of another (e.g. indocyanine green, as of Chen and Taratula) in order to obtain predictable results (e.g. absorbing near-infrared and converting to heat, e.g. as of Lazreg, paragraph 007) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
As to claim 16, the examiner notes that Taratula indicates that indocyanine green is the only NIR absorber approved by the Food and Drug Administration. Nevertheless, the skilled artisan would have been motivated to have tried other compounds known as NIR absorbers for effectiveness in pharmaceutical compositions. See MPEP 2143, Exemplary Rationale E regarding the “obvious to try” rationale. Chen and Taratula are also understood to teach the required resin. The examiner has provided the following explanation regarding the issue of obviousness to try below.
In accordance with MPEP 2143(I)(E), which relates to MPEP 2143, Exemplary Rationale E, the examiner must articulate the following to rely on an obviousness to try rationale, as addressed below.
(1) The examiner must address a finding that at the relevant time, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem. In response, the examiner notes that (a) NIR absorbers were known to be used in the pharmaceutical arts prior to the effective filing date, as taught by both Chen and Taratula. Taratula also teaches indocyanine green was the only known NIR absorber and has drawbacks; as such, there would have been a design need or market pressure to solve the problem of the drawbacks of indocyanine green.
(2) The examiner must address a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem. In this case, Lazreg teaches a finite number of compounds which were identified by Lazreg to be NIR absorbers. The examiner notes that Lazreg’s teachings of a large number of compounds does not render the teachings of Lazreg as being other than finite.
(3) The examiner must address a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. In this case, the skilled artisan would have had a reasonable expectation of successfully preparing a nanoparticle such as that of Chen or Taratula using the NIR absorber of Lazreg. There would have been a reasonable expectation that the compounds of Lazreg designated as NIR absorbers would have successfully served the function of providing NIR absorption desired by Chen and Taratula.
(4) The examiner must address whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. In this case, the examiner notes that although Lazreg is in a different field of endeavor as of the instant application as well as Chen and Taratula, it is still reasonably pertinent to the problem faced by the inventor because Lazreg is drawn to NIR absorption, which is the subject of the claimed invention.
As to claim 17, Taratula teaches PLGA in paragraph 0109.
As to claim 20, the structures of Lazreg would appear to be non-ionic at neutral pH. The examiner notes that although these chemical structures include nitrogen atoms, the nitrogen atoms are either amides, which do not become ionized, or aromatic amines, whose protonated forms have a significantly lower pKa than aromatic amines and remain non-ionic at neutral pH, thereby meeting the claimed requirement.
As to claim 21, Taratula teaches a particle size of 250 nm in paragraph 0123; this is 0.25 microns and is within the claim scope.
As to claims 22-23, Taratula teaches a cancer drug in paragraph 0137, including doxorubicin. Chen also teaches doxorubicin in the above-reproduced figure, which is a cancer drug.
As to claims 24-25, both Taratula and Chen teach doxorubicin, which reads on the required anthracycline.
As to claims 26-27, Taratula teaches emulsifiers in paragraph 0083. The examiner understands this to read on the required surfactant because the examiner understands the terms “emulsifier” and “surfactant” to have the same meaning.
As to claim 31, Taratula teaches that the composition is a pharmaceutical composition because it is intended to treat cancer, as of the abstract of Taratula. Taratula also teaches a pharmaceutically acceptable excipient, as of at least paragraph 0015.
As to claim 32, Taratula teaches cancer therapy in the abstract. Chen also teaches cancer treatment in the abstract.
As to claim 33, Taratula teaches use in medical imaging as of paragraph 0005 of Taratula.
The examiner notes that this rejection relies upon a different structure in Lazreg than was relied upon in the rejections set forth in the prior office action mailed on 14 May 2026. As such, this is understood to be a new ground of rejection that is necessitated by the claim amendment. See MPEP 1207.03(a)(I), factual situation #4.
Claim(s) 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Acta Biomaterialia, Vol. 51, 2017, pages 374-392) in view of Lazreg et al. (WO 2019/007833 A1) and Taratula et al. (US 2018/0028496 A1), the combination further in view of Shaw et al. (US 2011/0008453 A1).
Chen and Taratula are drawn to nanoparticles in the pharmaceutical arts which comprise a near infrared (NIR) absorber which is indocyanine green. Lazreg is drawn to a different compound which functions as a NIR absorber. See the rejection above over the combination of Chen, Taratula, and Lazreg. Taratula teaches stabilizers generically as of at least paragraph 0083.
None of the above references teach a non-ionic ethoxylated block copolymer surfactant or poly(vinyl alcohol).
Shaw et al. (hereafter referred to as Shaw) is drawn to a nanoparticle composition comprising a corticosteroid, as of Shaw, title and abstract. Shaw teaches the use of surface stabilizers to prepare nanosuspensions, and these include polyvinyl alcohol and Pluronics, as of Shaw, paragraph 0019. The skilled artisan would have understood “Pluronics” to refer a trade name that is used in the art to refer to block copolymers comprising poly(ethylene oxide) and poly(propylene oxide).
Shaw does not teach the required NIR absorber.
It would have been prima facie obvious for one of ordinary skill in the art to have used the polyvinyl alcohol or Pluronics of Shaw as the stabilizers in the composition of Taratula, whether by itself or as modified by other references. Taratula is drawn to a nanoparticle composition which may include stabilizers. Shaw teaches that Pluronics and polyvinyl alcohol are stabilizers for nanoparticle compositions. As such, the skilled artisan would have been motivated to have used the Pluronic and/or polyvinyl alcohol of Shaw to have predictably stabilized the composition of Taratula with a reasonable expectation of success. Generally, it is prima facie obvious to select a known material (i.e. Pluronic and/or polyvinyl alcohol) for incorporation into a composition (that of Taratula, whether by itself or in view of other references), based on its recognized suitability for its intended use (e.g. as a stabilizer for nanoparticles). See MPEP 2144.07.
As to claim 28, the Pluronic of Shaw, paragraph 0019, is understood to read on the required non-ionic ethoxylated block copolymer surfactant. See the above section entitled “Note Regarding Art Area.”
As to claims 29-30, Shaw teaches polyvinyl alcohol in paragraph 0019.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Desmet et al. (WO 2020/011601 A1).
Desmet et al. (hereafter referred to as Desmet) is drawn to near-infrared laser processing of resin-based articles, as of Desmet, title and abstract. Desmet teaches a NIR absorber with various structures, including that taught on the bottom half of page 17 of Desmet and is reproduced below.
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The above-reproduced structure appears to be an infrared dye which appears to read on the claimed structure, including having the required branching.
Elsewhere in the reference Desmet teaches a resin, as of page 10, paragraphs 044-051. Desmet teaches polylactic acid, as of page 10, paragraph 051. Desmet teaches a particle, as of page 3, paragraph 029.
As to claim 16, Desmet appears to teach all of the claimed requirements; however, not together in the same embodiment in the reference. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 17, Desmet teaches poly(lactic acid); this is understood to read on the required poly(D,L-lactide) as of page 10, paragraph 051.
The examiner notes that this rejection relies upon a different structure in Desmet than was relied upon in the rejections set forth in the prior office action mailed on 14 May 2026. As such, this is understood to be a new ground of rejection that is necessitated by the claim amendment. See MPEP 1207.03(a)(I), factual situation #4.
Response to Arguments Regarding Obviousness Rejections
Applicant has presented arguments regarding the previously applied obviousness rejections, as of applicant’s response on 31 July 2026 (hereafter referred to as applicant’s response). These arguments are addressed below.
In applicant’s response, applicant makes the following argument on page 9, second to last paragraph
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The examiner disagrees. Lazreg teaches dyes with branched chain alkyl groups on pages 24-25. The dyes labeled IR-C1, IR-C2, IR-C3, and IR-C4 of Lazreg have branched chain alkyl groups. Even if, purely en arguendo, these are taught to be comparative examples, they are still sufficient to render the instant claims prima facie obvious. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use. See MPEP 2123(II) and 2145(X)(D)(1). In this case, the evidence appears to indicate that IR-C1, IR-C2, IR-C3, and IR-C4, as taught by Lazreg, are all infrared dyes. As such, the skilled artisan would have had motivation to have combined these with the teachings of Chen and Taratula for the reasons indicated above. Also, as IR-C1, IR-C2, IR-C3, and IR-C4 were taught by Lazreg to have acted as infrared dyes, there would have been a reasonable expectation that they would have continued to have successfully acted as infrared dyes when combined with Chen and Taratula.
Applicant then makes the following argument, as of page 9, last paragraph.
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In view of this argument, the examiner has reproduced below paragraph 0038 of the instant application.
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Nothing in this paragraph discloses what is asserted by the last paragraph of page 9 of applicant’s response, as nothing in this paragraph makes mention of crystallinity or of branched chain alkyl groups. The examiner has also reproduced below paragraph 0038 from US patent publication 2024/0374762 A1, which is the publication of the instant application.
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Nothing in this paragraph discloses what is asserted by the last paragraph of page 9 of applicant’s response, as nothing in this paragraph makes mention of crystallinity or of branched chain alkyl groups. As such, applicant’s statements on page 9, bottom paragraph of applicant’s response do not appear to be supported by the original application as filed, and these statements are therefore insufficient to overcome the previously applied rejection.
The examiner therefore understands the above-indicated arguments from applicant’s response to be argument that is not persuasive because evidence is necessary. See MPEP 2145(I).
Additionally, the examiner searched the instant specification for the term “planar.” As best understood by the examiner, this term does not appear in the instant specification. The examiner also searched for the instant specification for disclosures regarding crystallization. The examiner was unable to find a disclosure in the instant specification indicating that crystallization was undesired.
Regarding the Desmet reference, applicant argues the following, as of the top of page 11, relevant arguments reproduced below.
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As an initial matter, the examiner disagrees with applicant’s assertion that Desmet does not teach compounds having a branched alkyl group. In fact, Desmet does teach such a compound on the bottom half of page 17 of Desmet, which Desmet refers to as “IR-01.” While elsewhere in the reference, Desmet does teach a chemical structure lacking branched groups, this does not detract from Desmet’s teaching of a chemical structure having branched groups on page 17 of Desmet. Patents are relevant as prior art for all they contain; see MPEP 2123.
Withdrawn Double Patenting Rejection
The examiner previously rejected the instant claims over the claims of copending application 18/284,749 on the grounds of provisional non-statutory double patenting. This rejection has been withdrawn by the examiner. The examiner provides the following explanation in support of this decision.
Claim 19 of the ‘749 application recites a capsule comprising a near-infrared absorber with the following chemical structure.
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Regarding R6, R7, R8, and R9 (which correspond with R3, R4, R5, and R6 of the instantly claimed invention) claim 19 of the ‘749 application recites the following.
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Nothing in the above claim limitation is drawn to a branched alkyl group. As such, the claims of the ‘749 application do not recite a branched alkyl chain, and therefore do not effectively anticipate or render the instant claims obvious. As such, the examiner has withdrawn the previously applied provisional non-statutory double patenting rejection over the claims of copending application 18/284,749.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
Prosecution Insights