DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 5/14/2026.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/14/2026 has been entered.
Status of the Claims
Claims 1, 6, 13, 14 and 16 have been amended. Claims 2-4 are cancelled. Claims 18-20 are newly added. Accordingly, claims 1 and 5-20 remain pending in the application and are currently under examination.
Withdrawn Rejections
Applicant’s amendment renders the rejection of claims 16-17 under 35 USC 112(a) moot. Specifically, applicant has deleted the limitation, “combining into the beads at least one filler polymer including at least one of a hyaluronic acid or a derivative thereof and water”. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejections of claims 1 and 4-13 under 35 USC 112(b) moot. Specifically, the claims have been amended such that the average diameter has either been amended to fall within the diameter range or the average diameter has been deleted. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejections of claim 4 under 35 USC 112(d) moot. Specifically, the claim has been cancelled. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection of claims 1 and 5 under 35 USC 102 over Ninan moot. Specifically, the claims have been amended to require the beads to have an average diameter of about 500 microns and a range in diameter of between about 400 microns and about 650 microns. Ninan teaches diameters ranging from 20-120 microns which is outside of the claimed diameters. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection of claims 14-17 under 35 USC 102 over Khoshbin moot. Specifically, the claims have been amended to require the beads to have a range in diameter of between about 400 microns and about 650 microns. Khoshbin teaches diameters ranging from 50-170 microns which is outside of the claimed diameters. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection of claims 1, 5-8, 10, 14 and 15 under 35 USC 103 over Li moot. Specifically, the claims have been amended to require the beads to have an average diameter of about 500 microns and a range in diameter of between about 400 microns and about 650 microns. Li teaches average diameters ranging from 10-150 microns which is outside of the claimed diameters. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection of claims 1 and 5- 15 under 35 USC 103 over Olsson moot. Specifically, the claims have been amended to require the beads to have an average diameter of about 500 microns and a range in diameter of between about 400 microns and about 650 microns. Olsson teaches average diameters ranging from 0.5-100 microns which is outside of the claimed diameters. Thus, said rejection has been withdrawn.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 5-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 1, 5, 14 and 16 recite the limitation, “polylactide base” or “polylactide based”. After review of the instant specification, said limitations are not defined and, as such, there is no guidance as to how little or how much polylactide is required to be polylactide base/based. Applicant has not described the subject matter in such a way that reasonably conveys to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention, i.e., the full scope of polylactide base/based. Dependent claims 6-13, 15 and 17-20 do not remedy the written description issue and as such said dependent claims suffer from the same deficiency.
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 and 5-20 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.
The terms “polylactide base” and “polylactide based” in claims 1, 5, 14 and 16 are relative terms which render the claim indefinite. The terms “polylactide base” and “polylactide based” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no guidance as to how little or how much polylactide is required to be polylactide base/based. Accordingly, a skilled artisan would not be able to ascertain the metes and bounds of said terms. Dependent claims 6-13, 15 and 17-20 do not remedy the indefinite issue and as such said dependent claims suffer from the same deficiency.
Claim 16 recites, “A method for injecting a dermal filler, comprising: providing a sealed container containing beads characterized in that the beads are spherical, have an average diameter between 400 microns and 650 microns, and are polylactide based, wherein the dermal filler comprises at least one filler polymer including at least one of a hyaluronic acid or derivative thereof; and injecting with a syringe the dermal filler into nasolabial skin folds of a patient’s face”. The method sets out the steps of providing a sealed container of beads and injecting a dermal filler, wherein the dermal filler comprises at least one filler polymer including at least one of a hyaluronic acid or derivative thereof. The claim is indefinite because it is unclear whether the beads are part of the dermal filler. Dependent claims 17 and 20 do not remedy the indefinite issue and as such said dependent claims suffer from the same deficiency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Mistry et al. (WO 2005/097074 A1, Oct. 20, 2005, hereafter as “Mistry”).
The claimed invention is drawn to beads for use in dermal filler polymers, the beads being characterized in that the beads; are spherical; are polylactide base; have an average diameter of about 500 microns; and range in diameter between about 400 microns and about 650 microns.
Regarding instant claims 1 and 5, Mistry teaches microparticles for cell delivery, wherein the microparticles comprise a biodegradable polymer and wherein the biodegradable polymer can be polylactide-based (abstract; claims 1-3; Example 1). Mistry teaches that the microparticles can range up to 500 microns in diameter (page 6, lines 27-29). Mistry also teaches that the term microparticles encompass microspheres (page 4, lines 10-15).
Mistry is silent to the particular diameter range of about 400 microns to about 650 microns and an average diameter of about 500 microns.
However, MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. Because the claimed range of 400-650 microns overlaps with the range disclosed in Mistry (i.e., up to 500 microns), a prima facie case of obviousness exists. Furthermore, MPEP 2144.05(II)(A) states, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation’.” Therefore, it would have further been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the particle size ranges to arrive at the claimed ranges by way of routine experimentation with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Mistry teaches the general conditions of the claim, that is, to include polylactic acid based particles having an particle sizes of up to 500 microns and it is the normal desire of scientists or artisans to improve upon what is already generally known.
It is noted that the limitation, “for use in dermal filler polymers” is considered an intended use limitation and does not alone show patentable distinction. A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In other words, if the prior art structure is capable of performing the intended use, then it meets the claim.
The teachings of Mistry render the instant claim(s) prima facie obvious.
Claims 1 and 5-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hagedorn et al. (TW 201625276 A, July 16, 2016, machine translation, hereafter as “Hagedorn”).
The claimed invention is described above.
Regarding instant claims 1 and 5-7, Hagedorn teaches an injectable dermal filler composition, a kit, method of preparing, and a method of use thereof, wherein the dermal filler composition is in the form a colloid and comprises hyaluronic acid, carboxymethylcellulose (CMC), and, optionally, microparticles (title; abstract). Hagedorn teaches that the microparticles are resorbable and spherical and have an average diameter of from 5 to 500 microns (paragraph bridging pages 8-9). Said resorbable particles can be biodegradable polyesters such as polylactide (page 9, 2nd and 5th full paragraphs). The injectable dermal filler generally comprises a physiologically acceptable carrier fluid, such as a non-pyrogenic isotonic buffer, especially a physiological saline solution having a preferred buffer (water) (paragraph bridging pages 5-6).
Hagedorn does not teach a particular embodiment comprising polylactide-based beads, however Hagedorn teaches that polylactide microparticles are suitable for the invention and, as such, it would have been prima facie obvious to one or ordinary skill in the art to select the particular microparticle material, polylactide, with a reasonable expectation of success. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (MPEP 2144.07).
Hagedorn does not explicitly teach the particular diameter range of about 400 microns to about 650 microns and an average diameter of about 500 microns.
However, MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. Because the claimed range of about 500 microns overlaps with the range disclosed in Hagedorn (i.e., 5-500 microns), a prima facie case of obviousness exists. Furthermore, MPEP 2144.05(II)(A) states, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation’.” Therefore, it would have further been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the particle size ranges to arrive at the claimed ranges by way of routine experimentation with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Hagedorn teaches the general conditions of the claim, that is, to include polylactic acid based particles having an average particle sizes of 5-500 microns and it is the normal desire of scientists or artisans to improve upon what is already generally known.
Regarding instant claim 8, Hagedorn teaches the elements discussed above and further teaches that the microparticles are present in a concentration of preferably 0.5-50%, or from 1.0% to 50%, more preferably from 1.0% to 40%, particularly preferably from 5.0% to 35%, particularly from 15.0% to 30%, or 20% to 25% and optimally 25.0% to 35% by volume/volume (page 9, 2nd paragraph). While Hagedorn does not explicitly teach “between about 5 and 50 mg/ml beads”, 0.5-50% can be converted to 5-500 mg/ml which overlaps with the claimed range of 5-50 mg/ml. MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. MPEP 2144.05(II)(A) also states, Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the amount of the beads and arrive at the claimed range by way of routine experimentation with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Hagedorn teaches the general conditions of the claim, that is, to include beads in an amount of 0.5-50% and it is the normal desire of scientists or artisans to improve upon what is already generally known.
Regarding instant claim 9, Hagedorn teaches the elements discussed above. Hagedorn’s teaching that the composition is in colloid form necessarily meets the limitation, “wherein the filler polymer is a particulate product, the particles being round” because by definition, a colloid is a substance that consists of round particles dispersed throughout another substance.
Regarding instant claims 10 and 11, Hagedorn teaches the elements discussed above and further teaches that the hyaluronic acid is crosslinked with 1,4-butanediol diglycidyl ester (BDDE) (page 4; 3rd paragraph).
Regarding instant claims 12 and 13, Hagedorn teaches the elements discussed above and further teaches that the crosslinked hyaluronic acid is present in a concentration of from 0.1% to 4.0% by weight/volume, for example 1% to 4% (page 4, 4th paragraph).
While Hagedorn does not specifically teach the range of 1-3%, MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. Because the claimed range of 1-3% microns overlaps with the range disclosed in Hagedorn (i.e., 1-4% or 0.1-4%), a prima facie case of obviousness exists.
Regarding instant claims 14 and 15, Hagedorn teaches the elements discussed above and further teaches that the dermal filler is contained in a syringe (a sealed container) (page 11, 2nd paragraph).
Regarding instant claims 16 and 17, Hagedorn teaches the elements discussed above and further teaches that the dermal filler is intended to be injected subcutaneously for the treatment of wrinkles and fine lines of the skin including the nasolabial folds (page 5, 5th paragraph; page 12, 2nd and 5th paragraphs).
Regarding instant claims 18-20, Hagedorn teaches the elements discussed above.
Hagedorn does not explicitly teach the particular average diameter of about 500 microns.
However, MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. Because the claimed range of about 500 microns overlaps with the range disclosed in Hagedorn (i.e., 5-500 microns), a prima facie case of obviousness exists. Furthermore, MPEP 2144.05(II)(A) states, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation’.” Therefore, it would have further been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the particle size range to arrive at the claimed ranges by way of routine experimentation with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Hagedorn teaches the general conditions of the claim, that is, to include polylactic acid based particles having an average particle sizes of 5-500 microns and it is the normal desire of scientists or artisans to improve upon what is already generally known.
Thus, the teachings of Hagedorn render the instant prima facie obvious.
Response to Arguments
The arguments, filed 5/14/2026, regarding the previously presented rejections are moot in view of the withdrawn rejections discussed above.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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