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
Applicants’ election without traverse of Group I, claims 1, 2, 4-10, 13-16 and 22-23, in the reply filed on 8/24/26 is acknowledged.
Claims 24-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/24/26.
Claim status
Claims 1, 2, 4-10, 13-16 and 22-31 are pending.
Claims 3, 11-12, 17-21, 32 and 33 are cancelled.
Claims 24-31 are withdrawn.
Claims 1, 2, 4-10, 13-16 and 22-23 are presented for examination on the merits.
Priority
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Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/24/26 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 23 is 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.
Regarding claim 23, the phrase "such as" 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). The claim will be interpreted as including all forms of physical stimulation.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 16 recites: “optionally containing an anesthetic, antibiotic, or analgesic” thus embracing embodiments with those therapeutic compounds. However, claim 1 expressly recites: “wherein said microparticles are substantially free of any cells, tissue, or therapeutic compounds.” Claim 16 does not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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 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.
Claims 1, 2, 4, 8-10, 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Asius et al. (US8414657).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a dermal filler research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from biocompatible biomaterials used in dermal filling to provide volume and durability as well as knowledge of the physics of gel flow, elasticity and viscosity of the biomaterials and with a thorough understanding of anatomy and potential complications— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 2, 4, 9 and 16, Asius et al. teach: “A method of performing reparative or esthetic dermatologic surgery, the method comprising subcutaneously or intradermally injecting into a subject a bioresorbable injectable implant consisting essentially of bioresorbable microspheres or microparticles suspended in a gel…wherein said microspheres or microparticles consist of at least one polymer of non-animal origin selected from the group consisting of lactic acid polymers, glycolic acid polymers, and lactic acid-glycolic acid co-polymers” (Claim 1) and “wherein said surgery is for filling wrinkles, fine lines, skin cracks or scars” (Claim 2), thus placing the suspension into a site of implantation by injection, and “wherein said microspheres or microparticles have a mean diameter greater than 5 µm and less than 150 µm” (Claim 5), which overlaps the claimed range of greater than 30 µm and less than 2 mm. Cells, tissue or therapeutic compounds are not present and therefore the microparticles are substantially free of those materials. Asius et al. teach that: “The microspheres or microparticles are included in a gel. This gel, which is used as vector to maintain the microspheres or microparticles in a homogeneous suspension” (Column 3, lines 4-6; claims 14-15), which reads on a hydrogel. Thus, Asius et al. teach a microsphere and diameters, which has a defined 3-D shape or geometry of discrete microspheres, where microparticle/microsphere is a self-sustaining body having an outer surface and defined/discrete 3-dimenstional shape or geometry. Regarding the other physiological locations of instant claim 2, the ordinary artisan in this art can readily determine the best location for injection to achieve the desired result.
Regarding claim 8, the microspheres of Asius et al. are presumed to be spherical and thus have a rounded geometrical shape with a sphericity of greater than 0.25.
Regarding claim 10, since Asius et al. teach the same method with the same materials then the method of Asius et al. will also induce a favorable physiological response, increase amount or quality of tissue volume, or provide a resilient response to produce a natural appearance in the subject at the site of implantation.
Regarding claim 13, since Asius et al. teaches the same method with the same materials then the method of Asius et al. will also have wherein the hydrogel microparticles have a first particle size in said suspension, wherein said microparticles expand after introducing into the site of implantation, wherein said microparticles have a second particle size in said site of implantation that is greater than said first particle size.
Regarding claim 14, Asius et al. teach adding solutes such as polyoxyethylene sorbitan monooleate or pluronic acid (Example 3; claims 14 and 19). The instant specification teaches: “However, when a polymer such as PEG is co-dissolved in the storage solution, a second aqueous phase is formed within the hydrogel network. This ultimately disrupts the interaction of water with the hydrogel polymer, which reduces the swelling force and therefore the size of the microparticle.” (Page 23, lines 20-23). Consequently, it appears that the polyoxyethylene sorbitan monooleate or pluronic acid of Asius et al. will also disrupt the interaction of water with the hydrogel polymer, which reduces the swelling force and therefore the size of the microparticle/microsphere.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Asius et al. is that Asius et al. do not expressly teach smooth porous viscoelastic solid hydrogel microparticles. However, Asius et al. do teach microspheres of the same material as claimed by Applicant and the same material will also possess the same characteristics of having a solid hydrogel with a smooth outer surface, porosity and viscoelasticity as claimed in the absence of evidence to the contrary. Where the claimed and prior art products are identical or substantially identical the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). See MPEP 2112(V).
The difference between the instant application and Asius et al. is that Asius et al. do not expressly teach plurality of porous viscoelastic solid hydrogel microparticles comprise at least two different populations of microparticles, wherein a first population of microparticles comprises a plurality of microparticles having a first characteristic, and a second population of microparticles comprises a plurality of microparticles having a second characteristic, wherein said first characteristic is different from said second characteristic. However, because Asius et al. teach: “The microspheres or microparticles are suspended in a gel. They should have a diameter greater than 5 µm and preferably greater than 20 µm, so as not to be absorbed by the macrophages. They should have a diameter of less than 150 µm, and preferably less than 40 µm, so that, on the one hand, they can be injected by a fine needle, and, on the other hand, they do not create a granular mass under the finger.” Given the range of particle sizes, the ordinary artisan can select smaller particles for packing between the interstitial spaces of the larger particles to provide higher viscosity and elasticity and where the larger particles provide structural support and voluminization for the dermal filler. The ordinary artisan would do so and arrive at a bimodal particle size distribution with 2 populations of microparticles each with different characteristics with a reasonable expectation of success.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Asius et al. (US8414657), as applied to claims 1, 2, 4, 8-10, 13-16 above, in view of Salamone et al. (US20160303281) and Chun et al. (Polymer(Korea), Vol. 40, No. 4, pp. 600-606 (2016)).
Applicant claims:
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The reference of Asius et al. is discussed in detail above and that discussion is incorporated by reference.
Regarding claim 1, 6 and 7, Salamone et al. teach a method of treating a soft tissue lesion or injury, comprising: providing a composition according to claim 1, and injecting the composition into soft tissue, wherein said injection is intradermal, subcutaneous,…intrafascial (Claim 22). Intradermal injection would make the composition a dermal filler. Salamone et al. teach the composition contains plurality of water-insoluble, hydrogel microparticles comprising PEGylated gel microparticles selected from the group consisting of (1) crosslinked, PEGylated proteins, (2) crosslinked, PEGylated protein-based biological macromolecules, and (3) combinations thereof, that have solid viscoelastic properties (Claims 1, 4, 30) where the proteins include fibrin, collagen (Claim 5) as well as water soluble polymers such as poly(ethylene glycol), poly( ethylene oxide), poly(vinyl alcohol) and copolymers, poly(N-vinylpyrrolidone) (Claim 9). Salamone et al. teach the microgel particles described herein can be irregular in shape, or can have a defined shape, such as a sphere or ellipse. In some embodiments, the microgel particles can be microporous, mesoporous, or macroporous [0097]. Salamone et al. report that: “Many synthetic polymers have been investigated for use as a matrix for tissue engineering scaffolds, including poly( ethylene glycol) (PEG), poly(lactic acid), poly(glycolic acid), poly(lactic-co-glycolic acid), polycaprolactone, poly(hydroxyalkanoate)s, and poly(vinyl alcohol).” [0005]. Salamone et al. teach: “a "hydrogel" is an insoluble polymeric network composed of normally water-soluble macromolecules that exist in a crosslinked or pseudo-crosslinked state by covalent, ionic, or physical interaction among macromolecular chains” [0128]. Salamone et al. also teach that: “"microspheres" are spherical particles, with diameters typically 1 μm to 1,000 μm. Microspheres are sometimes referred to as microparticles.” [0153].
Regarding claims 1, 6 and 7, Chun et al. teach crosslinked hyaluronic microspheres as dermal fillers (Title; abstract; Figure 1), where the crosslinking agent was divinyl sulfone (DVS) (Page 603, left column 2nd paragraph) where HA hydrogels (HAHs) are biphasic products consisting of the crosslinked beads (1058 kDa) suspended in non-crosslinked HA (1368 kDa) used as a carrier (Page 601, right column last paragraph).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Asius et al. is that Asius et al. do not expressly teach using hydrogel microparticles are characterized as self-sustaining bodies having a 3-dimensional matrix of covalently or ionically crosslinked polymer compounds as claimed. This deficiency in Asius et al. is cured by the teachings of Salamone et al. and Chun et al. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ hydrogel microparticles are characterized as self-sustaining bodies having a 3-dimensional matrix of covalently or ionically crosslinked polymer compounds as claimed, as suggested by Salamone et al. and Chun et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because both Salamone et al. and Chun et al. teach crosslinked microparticles, which are self-sustaining bodies having a 3-dimensional matrix of covalently or ionically crosslinked polymer compounds, for the same purpose of dermal filling and are therefore functional equivalents. “Where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious." In re Fout 675 F.2d 297, 301 (CCPA 1982). Consequently, it is obvious to employ any of the dermal fillers taught by Salamone et al. and Chun et al. in the method of Asius et al. with a reasonable expectation of success.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Asius et al. (US8414657), as applied to claims 1, 2, 4, 8-10, 13-16 above, in view of Nurse Key ([online] retrieved on 10/1/26 from: https://nursekey.com/and-corrections-of-temporary-dermal-fillers/; 2020; 4 pages).
Applicant claims:
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The reference of Asius et al. is discussed in detail above and that discussion is incorporated by reference.
Nurse Key teaches that dermal fillers can have complications or even be misplaced and on occasion correction may be warranted (Page 1, 18.1 and 18.2). Dermal fillers based on hyaluronic acid can be enzymatically dissolved for correction (Page 1, 18.2). When nodule formation occurs with hyaluronic filler, hyaluronidase may be used to dissolve the product but when other fillers are used other methods for removal of nodules may be warranted including aspiration, surgery, incision and drainage, and/or massage (Page 3, 18.4.1).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Asius et al. is that Asius et al. do not expressly teach further dissolving the microparticles by introducing a chemical or enzyme into the site of implantation or by introducing a physical stimulation1. This deficiency in Asius et al. is cured by the teachings of Nurse Key. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further dissolve the microparticles by introducing a chemical or enzyme into the site of implantation or by introducing a physical stimulation, as suggested by Nurse Key, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because practitioners do make mistakes and the dermal filler can be misplaced into a patient. In such a case, Nurse Key teaches correction by dissolving the dermal filler with enzymes as well as physical stimulation such as massage. It is the Examiner’s position that the ordinary artisan would be aware of the physical nature of the dermal filler and select the best means for dissolving the dermal filler such as by introducing a chemical or physical stimulation such as massage or sonication. The ordinary artisan would do so with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable, pending a search update, if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4, 6-10, 13-16, 22 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11, 13, 17-21 of copending Application No. 18256726 in view of Nurse Key ([online] retrieved on 10/1/26 from: https://nursekey.com/and-corrections-of-temporary-dermal-fillers/; 2020; 4 pages).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending is also directed to methods for viscosupplementation in a joint or surgical site said method comprising: introducing into the joint or surgical site a plurality of porous viscoelastic solid hydrogel microparticles each having a smooth outer surface and a size of greater than about 100 μm, and substantially free of any cells, tissue, or therapeutic compounds (Claims 1, 5 and 21) where the hydrogel microparticles are introduced as a dermal filler (Claim 11) in and/or around a site of implantation (Claim 13) suspended or dispersed in a suitable delivery vehicle (Claim 17) such as buffered saline solution, viscous solution, putty, paste, or gel (Claim 18) and directly injected into the site of implantation (Claims 19-20). The copending also teaches that the hydrogel microparticles are characterized as self-sustaining bodies having a 3-dimensional matrix of covalently or ionically crosslinked polymer compounds such as functionalized hyaluronic acid (Claim 3) and the plurality of porous viscoelastic solid hydrogel microparticles comprise at least two different populations of microparticles, wherein a first population of microparticles comprises a plurality of microparticles having a first characteristic, and a second population of microparticles comprises a plurality of microparticles having a second characteristic, wherein said first characteristic is different from said second characteristic (Claim 4).
The copending does not expressly teach that each microparticle is a self-sustaining body having a defined/discrete 3-dimensional shape and geometry wherein said defined/discrete 3-dimensional shape and geometry is a rounded shape and geometry having a sphericity of greater than 0.25. However, the scope of the claims of the co-pending application includes discrete smooth round microspheres (Figure 3), which implicitly have a sphericity of greater than 0.25. (See MPEP 804: “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.”
The copending does not expressly teach the anatomical site of implantation as claimed in instant claim 2. However, the ordinary artisan can determine the best site for injection of the composition for use as a dermal filler such as in any of the dermal layers with a reasonable expectation of success.
The copending does not expressly teach further dissolving the microparticles by introducing a chemical or enzyme into the site of implantation or by introducing a physical stimulation. However, practitioners of the method do make mistakes, and the dermal filler can be misplaced into a patient. In such a case, Nurse Key teaches correction by dissolving the dermal filler with enzymes as well as physical stimulation such as massage. It is the Examiner’s position that the ordinary artisan would be aware of the physical nature of the dermal filler and select the best means for dissolving the dermal filler such as by introducing a chemical or physical stimulation such as massage or sonication. The ordinary artisan would do so with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
1 See the 112 second paragraph rejection above.
Prosecution Insights