DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 7/31/2026 wherein claims 13, 11 and 125 have been amended.
Claims 1, 13, 18, 20, 21, 28, 34, 35, 42, 56, 62, 68-70, 86, 91, 105, 108-111, 122, 125, 130, 135 and 136 are presented for examination on the merits.
The following rejections are made.
Response to Applicants’ Arguments
Applicant’s arguments filed 7/31/2026 overcome the rejection of claims 1, 13, 18, 20, 21, 28, 34, 35, 42, 56, 62, 68-70, 86, 91, 105, 108-111, 122, 125, 130, 135 and 136 over non-statutory obviousness type double patenting. This rejection has been withdrawn.
Applicant’s arguments filed 7/31/2026 regarding the rejection of claims 13, 18, 20, 21, 28, 34, 35, 42, 108, 110, 111, 125, 135 and 136 made by the Examiner under 35 USC 103 over Shah et al. (WO 2020/0033903; of record), evidenced by Sigma Aldrich: Pluronic F-127) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 5/8/2026.
Applicant’s arguments filed 7/31/2026 regarding the rejection of claim 9 made by the Examiner under 35 USC 103 over Shah et al. (WO 2020/0033903; of record), evidenced by Sigma Aldrich: Pluronic F-127), further in view of Rubsamen et al. (US 2013/0142878) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 5/8/2026.
Applicant’s arguments filed 7/31/2026 regarding the rejection of claims 1, 18, 20, 21, 28, 34, 35, 42, 56, 62, 68-70, 86, 91, 105, 122 and 130 made by the Examiner under 35 USC 103 over Shah et al. (WO 2020/0033903; of record), evidenced by Sigma Aldrich: Pluronic F-127) in view of Rubsamen et al. (US 2013/0142878) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 5/8/2026.
In regards to the 103 rejections, Applicant asserts the following:
A) The composition is a solid anhydrous powder composition which is not described by Shah. The ‘powder’ embodiment of Shah is within a large grouping of potential pharmaceutical forms and even if a powder were obvious, there is nothing that points to the powder being anhydrous. Lastly, Shah’s general teaching is to pharmaceutical powders and tablets which are for a fundamentally different purpose than that claimed.
In response to A, the Examiner acknowledges that Shah provides a broad disclosure inclusive to many potentialities. However, in the present case, this is not seen as mitigating because Shah is directed to a method of providing a temporary tattoo by intradermally injecting colored particles (see abstract), the particles being present in a carrier solution which may be ‘solid’. Shah also teaches that the particles/composition be anhydrous at [00111] where it is taught that the colored particles contain core polymers or hydrogels, matrix material and coloring agents which may be “anhydrous”. The framework of the present method is generally described by Shah and one of ordinary skill in the art would only have to be capable of reading and selecting from the various embodiments to arrive at a method such as that claimed.
The general purpose of Shah is to provide a temporary tattoo to a subject. Shah teaches that powders, particles, tablets, dispersed in a solid carrier etc are each capable of achieving this outcome. Assuming Applicant’s characterization of Shah is correct in the preference for powders and tablets, this does not preclude the other compositions described by the reference in being used in methods of providing a temporary tattoo. The selection of the type of composition used to achieve this is within ones ability to decide and one would have a reasonable expectation for success in selecting from within those types of compositions.
Maintained Rejections, of Record
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 13, 18, 20, 21, 28, 34, 35, 42, 108, 110, 111, 125, 135 and 136 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (WO 2020/0033903; of record), evidenced by Sigma Aldrich: Pluronic F-127.
Shah describes particles that contain a coloring agent that are used in method of creating a temporary tattoo (see abstract) wherein the particles are applied by topically to the skin (see [0116]), intradermally (see abstract), subcutaneously (see [0197]) or intramuscularly (see [0197]) (see instant claim 13).
The colored particles of Shah’s method are to be solid (see [0072, 0156, 0183]) (see instant claim 13), anhydrous (see [0111]) and have a core-shell morphology (see [0006]), the core comprising a polymeric material and a coloring agent (see abstract) and the shell comprising a thermosensitive polymer (see [0013]) so as to induce aggregation upon incorporation into the subjects dermis (see [0009]). According to Figure 1, the shell appears to cover about 99% of the cores outer surface (see instant claim 35).
Exemplified core polymers include polycaprolactone (PCL), poly D-lactic acid (PDLA), poly L-lactic acid (PLLA), poly(lactic-co-glycolic acid), (PLGA), polyethylene glycol (PEG), polyethylene glycol-diacrylate (PEGDA), polyorthoester, aliphatic polyanhydride, and/or aromatic polyanhydrides, or a block copolymer thereof (see [0006]) (see instant claim 13a and 18). The core polymer is present in the particle in an amount of about 7-92% by weight (see [0016]) (see instant claim 20).
Exemplified coloring agents include one or more of the following non-limiting examples: melanin, [Phthalocyaninato(2-)] copper, FD&C Red 40 (Food Red 17, Allura Red), FD&C Yellow 5, Nigrosin, Reactive Black 5, Acid Blue 113, Brilliant black BN Granular (Food Black 1), D&C Yellow 10, FD&C Blue 1 (Food Blue 2), FD&C Blue 2, Acid Black t, Acid Black 24, Acid Black 172, Acid Black 194 and so on (see [0014]) (see instant claim 28). The coloring agent is present in the particle via absorption, physical entrapment or covalently bonded (see [0017]) (see instant claim 21) wherein the coloring agent is present in the particle in an amount of between 0.01-10% (see [0017]) (see instant claim 20).
Exemplified thermosensitive polymers include Pluronic F-127 and poluisopropylacrylamide (see [0013]). It is noted that Pluronic F-127 is a polyethylene oxide-polypropylene oxide-polyethylene oxide block copolymer (see Sigma Aldrich as evidence) which is a ‘poly(alkene-oxide) block copolymer’ surfactant/surface active agent (see instant claim 42a). Moreover, Pluronic F-127 is also known as poloxamer 407 (see Sigma Aldrich as evidence) (see instant claim 42c). The shell material, e.g. Pluronic F-127, is present in an amount of from 0.2-50% by weight of the particle (see [0013]) (see instant claim 20)
Shah teaches that the composition may comprise a surfactant, such as Pluronic F-127 (i.e. poloxamer 407), sorbitan esters (see [0144]). It is taught that surfactants are included in to the composition to stabilize the emulsions phases during manufacture of the particles which controls the size, size distribution, surface morphology, loading, dye/pigment release, and performance of the multi-particulate product (see [0152]).
The particle is to have a diameter of less than or equal to 5 mm, or less than or equal to 100 um (see [0015, 0096]) (see instant claims 13i and 34a). As Shah’s particles are spherical in nature (see [0097]), their volume can be calculated using V=4/3πr3. Applying the equation using the particles diameters described by Shah results in a volume of 0.0052 mm3 (D=100 microns, R 50 microns) or 65.5 mm3 (D=5mm, R=2.5 mm). It is observed that both volumes using the particle diameters suggested by Shah results in particle volumes overlapping with instant claims 13ii, 122, 135 and 136. See MPEP 2144.05 regarding obviousness of overlapping ranges.
Particles are to have a bioabsorption/biodegradation lag phase of about 2-12 months (see [0012]) (see instant claim 108). The particles may be administered by injection using a needle (see [0148]) (see instant claim 111).
The only difference between Shah and the instant claims is that Shah does not teach the specific combination of components as claimed in a single embodiment, or with sufficient specificity to be anticipatory. The specific combination of features claimed is described within the teaching of Shah, but ‘such ‘picking and choosing’ within several variable does not necessarily give rise to anticipation as “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” See MPEP 2141(I). Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within Shah to arrive at compositions overlapping with that claimed.
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 109 is rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (WO 2020/0033903; of record), evidenced by Sigma Aldrich: Pluronic F-127, as applied to claims 13, 18, 20, 21, 28, 34, 35, 42, 108, 110, 111, 135 and 136 above, and further in view of Rubsamen et al. (US 2013/0142878; of record).
Shah fails to teach impermeant marking a target location for a medical procedure.
Rubsamen is directed to temporary tattoos for use in medical procedures such as surgery (see [0214-0218]) or radiation therapy (see [0199]). Temporary tattoos are desired in such procedures as they are not permanent. It would have been obvious to use the temporary tattoo of Shah in medical procedures that required surgical outlines or a location for where radiation therapy is to be administered. See MPEP 2143(I)(C) which states that the use of a known technique to improve similar methods in the same way is supportive of a finding 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.
Claims 1, 18, 20, 21, 28, 34, 35, 42, 56, 62, 68-70, 86, 91, 105, 122 and 130 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (WO 2020/0033903; of record), evidenced by Sigma Aldrich: Pluronic F-127, in view of Rubsamen et al. (US 2013/0142878; of record).
Shah describes particles that contain a coloring agent that are used in method of creating a temporary tattoo (see abstract) wherein the particles are applied by topically to the skin (see [0116]), intradermally (see abstract), subcutaneously (see [0197]) or intramuscularly (see [0197]) (see instant claim 1).
The colored particles of Shah’s method are to be solid (see [0072, 0156, 0183]) and have a core-shell morphology (see [0006]), the core comprising a polymeric material and a coloring agent (see abstract) and the shell comprising a thermosensitive polymer (see [0013]) so as to induce aggregation upon incorporation into the subjects dermis (see [0009]). According to Figure 1, the shell appears to cover about 99% of the cores outer surface (see instant claim 35).
Exemplified core polymers include polycaprolactone (PCL), poly D-lactic acid (PDLA), poly L-lactic acid (PLLA), poly(lactic-co-glycolic acid), (PLGA), polyethylene glycol (PEG), polyethylene glycol-diacrylate (PEGDA), polyorthoester, aliphatic polyanhydride, and/or aromatic polyanhydrides, or a block copolymer thereof (see [0006]) (see instant claim 1a and 18). The core polymer is present in the particle in an amount of about 7-92% by weight (see [0016]) (see instant claim 20).
Exemplified coloring agents include one or more of the following non-limiting examples: melanin, [Phthalocyaninato(2-)] copper, FD&C Red 40 (Food Red 17, Allura Red), FD&C Yellow 5, Nigrosin, Reactive Black 5, Acid Blue 113, Brilliant black BN Granular (Food Black 1), D&C Yellow 10, FD&C Blue 1 (Food Blue 2), FD&C Blue 2, Acid Black t, Acid Black 24, Acid Black 172, Acid Black 194 and so on (see [0014]) (see instant claim 28). The coloring agent is present in the particle via absorption, physical entrapment or covalently bonded (see [0017]) (see instant claim 21) wherein the coloring agent is present in the particle in an amount of between 0.01-10% (see [0017]) (see instant claim 20).
Exemplified thermosensitive polymers include Pluronic F-127 and poluisopropylacrylamide (see [0013]). It is noted that Pluronic F-127 is a polyethylene oxide-polypropylene oxide-polyethylene oxide block copolymer (see Sigma Aldrich as evidence) which is a ‘poly(alkene-oxide) block copolymer’ surfactant/surface active agent (see instant claim 42a). Moreover, Pluronic F-127 is also known as poloxamer 407 (see Sigma Aldrich as evidence) (see instant claim 42c). The shell material, e.g. Pluronic F-127, is present in an amount of from 0.2-50% by weight of the particle (see [0013]) (see instant claim 20)
Shah teaches that the composition may comprise a surfactant, such as Pluronic F-127 (i.e. poloxamer 407), sorbitan esters (see [0144]). It is taught that surfactants are included in to the composition to stabilize the emulsions phases during manufacture of the particles which controls the size, size distribution, surface morphology, loading, dye/pigment release, and performance of the multi-particulate product (see [0152]).
The particle is to have a diameter of less than or equal to 5 mm, or less than or equal to 100 um (see [0015, 0096]) (see instant claim 34a). As Shah’s particles are spherical in nature (see [0097]), their volume can be calculated using V=4/3πr3. Applying the equation using the particles diameters described by Shah results in a volume of 0.0052 mm3 (D=100 microns, R 50 microns) or 65.5 mm3 (D=5mm, R=2.5 mm). It is observed that both volumes using the particle diameters suggested by Shah results in particle volumes overlapping with instant claims 105 and 122. See MPEP 2144.05 regarding obviousness of overlapping ranges.
Particles are to have a bioabsorption/biodegradation lag phase of about 2-12 months (see [0012]) (see instant claim 69).
Shah’s particles are to be in a carrier liquid, such as sterile saline, buffer, ethanol or water (see [0115]) (see instant claims 56, 68b and 86c) at a concentration of between about 400-800 mg/mL (see claim 1) (see instant claim 68a). Alternatively, the Shah’s particles may be in the form of a solid preparation, e.g. tablet, including binders which promote adhesion of the particles of the formulation to hold together the final dosage form (see [0137]) (see instant claim 130). Although Shah is silent regarding the particle being ‘compressed’, this limitation is considered obvious as the particles of Shah retain the structure. It is not clear how a compressed particle would differ from a particle. Moreover, this is a product-by-process limitation. See MPEP 2113.
Shah fails to teach impermeant marking a target location for a medical procedure.
Rubsamen is directed to temporary tattoos for use in medical procedures such as surgery (see [0214-0218]) or radiation therapy (see [0199]). Temporary tattoos are desired in such procedures as they are not permanent. It would have been obvious to use the temporary tattoo of Shah in medical procedures that required surgical outlines or a location for where radiation therapy is to be administered. See MPEP 2143(I)(C) which states that the use of a known technique to improve similar methods in the same way is supportive of a finding 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.
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.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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