DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group III (claims 13 and 15), drawn to a method of using a filler composition, in the reply filed on March 30th, 2026 is acknowledged. Claims 1-12 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. The requirement is deemed proper and is therefore made FINAL.
The applicant has canceled claim 15 and added new claims 16-24.
Claims 13 and 16-24 are pending and were examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copies have been filed in the instant application. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 22nd, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on March 22nd, 2024. These drawings are acceptable.
Specification
The use of the terms Tween, Gibco, Restylane, and Sculptra, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, each term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 20 is objected to because of the following informalities: the term "expression" should be modified to "surface expression" to correspond to the subject matter enabled in the instant specification (paragraphs [0053] and [00175]). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 recites the limitation "dialyzing with the exosomes" in step (d). There is insufficient antecedent basis for this limitation in the claim. T.
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.
Claim 13 is 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 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 inventors, at the time the application was filed, had possession of the claimed invention. The species and tissue origin of the stem cell from which the exosome is derived is not recited in claim 13. The instant specification recites the definition of “stem cells” in the present invention as broader than the human adipose stem cells referred to in the examples (paragraphs [00119]-[00195]). Claim 13 should be amended to recite human adipose stem cells, such that it corresponds to the disclosed examples.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163 does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163.
In the instant case, the claims are drawn to a method
(1) Level of skill and knowledge in the art:
One
(2) Partial structure:
Exosomes derived from different types of stem cells have partially shared structure as a specific class of extracellular vesicles
(3) Physical and/or chemical properties:
Stem cells from different species of organism
(4) Functional characteristics:
Álvarez-Viejo .
(5) Method of making the claimed invention:
The method of making the claimed invention would not predictably change depending on the type of stem cells from which the exosomes originate
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad genus. Claim 13 is a broadly generic to all possible stem cells encompassed by the claims. The possible variations are enormous to any class of stem cell. Since the MPEP states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of stem cell beyond those disclosed in the examples in the specification. Moreover, the specification lacks sufficient variety of species to reflect this variance in the genus since the specification does not provide any examples of exosomes derived from stem cells .
While having written description of adipose stem cell derived exosomes identified in the specification tables and/or examples, the specification is devoid of any exosomes derived from any stem cell population that qualify for the functional characteristics claimed.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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 13, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Son (KR 1020200023613 A) and further in view of Cho et al. (US 20170209365 A1), abbreviated "Cho".
Claim 13 recites “A method for reducing skin wrinkles, comprising a step of administering to a subject in need thereof a filler composition containing exosomes derived from stem cells, hyaluronic acid, and 1,4-butanediol diglycidyl ether (BDDE) as active ingredients”. Claim 16 recites “The method according to claim 13, wherein the stem cells are human adipose stem cells”. Claim 17 recites “The method according to claim 13, wherein the hyaluronic acid is crosslinked with BDDE to form a hydrogel”.
Son summarizes the technical field of the reference invention:
“The present invention relates to the use to the nano hydration for the filler procedure forming three dimensional network structure using the exosome surface protein.
And the present invention relates to the nano hydration gel for the filler procedure in which the bio compatibility is improved including the stem cell culture material origin exosome. Specifically, it is about the nano hydration gel for the exosome derived from the stem cell culture material and the filler procedure in which PMMA is combined and the physical property is improved. More specifically, it is about the nano hydration gel for the filler procedure in which the control is possible with the nano size and the percentage of water content and bio compatibility are improved since the physical property is improved including the exosome” (Technical Field, paragraphs 1 and 2; instant claim 13; emphasis by the USPTO examiner).
Son further recites “The filler procedure is the procedure which mainly injects the filler (Dermal filler) for skin into the dermal layer and amends the function of the human body or is used as the cosmetic effects purpose including the removing wrinkle of the facial area etc. under skin” (Background Art, paragraph 1; instant claim 13). Son further recites the use of hyaluronic acid in fillers:
“The hyaluronic acid filler which is 2 generation filler has the human body composition ingredient the duration of effect is longer than the collagen filler and the GlcNAc which is the polysaccharide which is similar and the advantage of consisting of the D-glucuronic acid and the discoloration, and the procedure and one being facilitated and the side effect including the skin nervousness reaction etc. attracting water and the skin moisture holding, and the volume and elasticity maintenance being possible and being suitable as the filler for skin” (Background Art, paragraph 4; instant claim 13).
Son further recites the use of cross-linking in hyaluronic acid fillers: “In the meantime, the hyaluronic acid filler made with the cross-linking (cross-linking) was developed to so that it be increased the stay period since decomposition the hyaluronic acid of the natural state was easily accomplished, the cross-linking agent be added in the hyaluronic acid and contribute with cross coupling” (Background Art, paragraph 6; instant claims 13 and 17). Son further recites “The hydration gel in which the unlicensed reference 1 uses the hyaluronic acid polymer and 1,4- butanediol die glycidyl ethers (1,4-Butanediol diglycidyl ether, BDDE) is disclosed” (Summary of Invention, Problem to be solved, paragraph 1; instant claims 13 and 17). Son later recites BDDE as a component of a cross linking agent able to a hyaluronic acid main chain with an exosome to make a nano hydration gel (Description of Embodiments, paragraphs 9, 11, and 12; instant claims 13 and 17). Although not explicitly recited by Son, one of skill in the art could also use the BDDE to cross link hyaluronic acid main chains, as suggested earlier in the case where no exosome was mentioned (Summary of Invention, Problem to be solved, paragraph 1; instant claims 13 and 17). Although not explicitly recited by Son, the hyaluronic acid and BDDE are active ingredients, in that they constitute the physical hydrogel structure that fills in wrinkles through a volumizing effect (instant claim 13).
Although not explicitly recited by Son, the stem-cell derived exosome is reasonably an active ingredient, in that it promotes adipose tissue regeneration, as recited by Cho. Cho summarizes the reference invention: “One embodiment of the present invention provides a composition for inducing differentiation into adipocytes or regenerating adipose tissues. The composition may include, as an active ingredient, an exosome derived from proliferating stem cells, or an exosome derived from stem cells differentiating into adipocytes” (paragraph [0012]; instant claim 13). Cho clarifies the term “stem cells differentiating into adipocytes”: “As used herein, the “stem cells differentiating into adipocytes” refer to stem cells which are differentiating into adipocytes, for example, from adipose tissue-derived stem cells (ASCs). An example of adipose tissue-derived stem cells is shown in FIG. 1. From this, the exosomes containing genetic information, proteins and growth factors may be isolated” (paragraph [0013]; instant claims 13 and 16). Cho further recites the utility of the reference invention for adipose tissue regeneration and explicitly states cosmetic utilities, one of which is a cosmetic filler:
“The composition for stem cell differentiation and adipose tissue regeneration according to the above embodiment includes the exosomes containing genetic information, proteins and growth factors of adipocytes related to the differentiation into adipocytes. Thus, the composition can be effectively used for the differentiation of stem cells as it is not necessary to add complex and various growth factors for differentiation. The stem cells differentiate into adipocytes by the exosomes derived from the stem cells differentiating into adipocytes of the present invention, thereby exerting an advantageous effect on the regeneration of adipose tissues when applied in vivo. The exosome derived from the stem cells differentiating into adipocytes of the present invention is a cell-derived material and thus is biocompatible, minimizing the side effects of the existing cell therapy agents. Further, the exosome itself can act as a carrier, which enables easy application of the components carried therein to the human body. Thus, the exosome can be applied as a stem cell differentiation inducer, an injectable preparation for tissue regeneration, a filler for cosmetic purposes, a formulation for tissue engineering and the like” (paragraph [0051]; instant claims 13 and 16).
Cho further recites that the stem cells may be human-derived (paragraph [0055]; instant claim 16). From the teachings of Cho, it would be obvious to one of skill in the art to select exosomes from human adipose stem cells for the formulation of a cosmetic filler (instant claim 16), and that the exosomes derived from these stem cells could serve as an active agent for adipose tissue regeneration (instant claim 13). It is within the knowledge of one of skill in the art that adipose tissue regeneration would enhance the filling (volumizing) effect of a filler, that would reduce skin wrinkles (instant claim 13).
Claims 13, 16, 17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Son (KR 1020200023613 A) and further in view of Cho et al. (US 20170209365 A1), abbreviated "Cho", as applied to claims 13, 16, and 17 above, and further in view of Shook et al. (Science 2018, 362, eaar2971), abbreviated "Shook"; and in further view of Raes et al. (J Leukoc Biol. 2005, 77 (3), 321-327), abbreviated "Raes"; and Shook et al. (Journal of Investigative Dermatology 2016, 136 (9), 1885-1891), abbreviated "Shook and Xiao".
The claims and the teachings of the cited references are of record above.
Claim 19 recites: “The method according to claim 13, wherein the filler composition activates anti-inflammatory macrophages”. Claim 20 recites: “The method according to claim 19, wherein the filler composition increases expression of CD301b, an anti-inflammatory marker, in macrophages”. Claim 21 recites: “The method according to claim 19, wherein the filler composition increases fibroblast proliferation and collagen production by activating anti-inflammatory macrophages”.
Shook recites “We analyzed profibrotic cells during mouse skin wound healing, fibrosis, and aging and identified distinct subpopulations of myofibroblasts, including adipocyte precursors (APs). Multiple mouse models and transplantation assays demonstrate that proliferation of APs but not other myofibroblasts is activated by CD301b-expressing macrophages through insulin-like growth factor 1 and platelet-derived growth factor C” (Abstract, instant claim 21). Shook also recites “SMA and Col I were expressed by APs and CD29High cells in wound beds regardless of the cells’ CD26 or CD9 expression; however, few CD29Low cells expressed SMA, Col I, CD90, or ER-TR7 (Figs. 1,D to F, and 2, D and E, and fig. S4, C to H)” (subheading Mesenchymal cell heterogeneity under fibrotic conditions, paragraph 7), where “Col I” refers to Collagen I (subheading Mesenchymal cell heterogeneity under fibrotic conditions, paragraph 3). Therefore, it would be obvious to one of skill in the art that activation of macrophages to express CD301b would increase the proliferation of certain fibroblasts, adipocyte precursors (APs); and that by increasing the APs, collagen production would also increase (instant claim 21). It would also be obvious to one of skill in the art that this increase in collagen production, and consequently the upstream expression of CD301b in macrophages, would be useful in a cosmetic skin filler composition (instant claims 19-21).
Although Shook does not recite a means of inducing CD301b expression in macrophages, one of skill in the art would have a reasonable expectation of success doing so by incorporating the interleukin-4 (IL-4) protein in the filler composition (Raes, Abstract). Raes recites: “In addition, we demonstrate that in vitro, interleukin-4 (IL-4) and IL-13 up-regulate mMGL1 and mMGL2 expression and that in vivo, induction of mMGL1 and mMGL2 is dependent on IL-4 receptor signaling” (Abstract). MGL2 is known in the art as the gene encoding the CD301b protein (Shook and Xiao, Discussion paragraph 3), which corresponds to an anti-inflammatory phenotype switch in the macrophage (Shook and Xiao, Abstract). Considering the upregulation of mMGL2 expression by IL-4, and the teachings of Shook, and Shook and Xiao, of record above, it would have been obvious to one of skill in the art to prepare a filler composition that activates an anti-inflammatory macrophage by inducing the expression of CD301b in the macrophage, producing the downstream, cosmetically-useful, effects of record above (instant claims 19-21).
Claims 13-18 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Son (KR 1020200023613 A) and further in view of Cho et al. (US 20170209365 A1), abbreviated "Cho", as applied to claims 13, 16, and 17 above, and further in view of Son (KR 1020200023613 A) in further view of Lee and Bae (Registration No.1021866460000) abbreviated "Lee".
The claims and the teachings of the cited references are of record above.
Claim 18 recites “The method according to claim 13, wherein a dry weight ratio of the hyaluronic acid: BDDE in the filler composition is 1: 0.001 to 0.05”. Claim 22 recites “The method according to claim 13, wherein the filler composition is prepared by steps of:(a) extracting exosomes from stem cells; (b) crosslinking hyaluronic acid by adding BDDE thereto; (c) dialyzing the crosslinked hyaluronic acid using a dialysis membrane; and (d) mixing the crosslinked hyaluronic acid after the dialyzing with the exosomes”. Claim 23 recites “The method according to claim 22, wherein the crosslinking in step (b) is performed at a temperature of 20°C to 60°C for 12 to 36 hours”. Claim 24 recites “The method according to claim 22, wherein the dialyzing in step (c) is performed for 36 to 60 hours”. Son recites a method of making a nano hydration gel:
“Referring to Figure 5, the manufacturing method of the nano hydration gel for the filler procedure according to a preferred embodiment of the present invention comprises the hyaluronic acid solution, and the bifunctional cross-linking agent and the step (S200) aging the mixture the step of preparing the mixture (S100) mixing the stem cell culture liquid and the step (S300) which it reacts while the above-mentioned aged mixture being stirred. Specifically, the mixture (S100) comprises the step of mixing these the stem cell culture liquid including the exosome is prepared for (S130) the hyaluronic acid solution is prepared for and the bifunctional cross-linking agent is prepared for. In the example embodiment, the concentration of the hyaluronic acid solution can use 30mg / mL to which is 40mg / mL and the additive content of the bifunctional Cross-linking agent may be the hyaluronic acid solution comparison 0.1wt% to 8.0wt% and the polyethylene glycoldimethacrylate can be used. But the invention is not thus limited it is of course” (machine translation page 11 of 19, lines 3-23 from the top; instant claim 22) where the bifunctional cross-linking agent is reasonably BDDE, as of record above.
Although Son does not explicitly recite extracting exosomes from the stem cells as a first step, this step would be obvious to one of skill in the art to produce a “stem cell culture liquid” for the above procedure that is enriched in exosome, in view of the technical field of the invention which involves using a nano hydration gel including an exosome of a stem cell culture material origin (Son, Technical Field; instant claim 22, step (a)). Son does not recite dialyzing the crosslinked hyaluronic acid, and mixing the exosome with the crosslinked hyaluronic acid (claim 22 steps (c) and (d)). However, Lee recites a crosslinking step, followed by a dialysis stage of removing (more accurately, minimizing the concentration of the unreacted cross-linker included in the cross-linked composition (Summary of Invention, Means to solve the problem, paragraph 7; instant claim 22, steps (b) and (c)). Minimizing the concentration of unreacted cross linker would have been obvious to improve the safety of the composition, by avoiding reaction between the cross-linker and chemicals comprising the body of the subject organism. Therefore, it would have been obvious to one of skill in the art to improve on the method recited by Son by dialyzing the crosslinked hyaluronic acid (instant claim 22, step (c)). One of skill in the art would have been motivated to perform this dialysis step before adding the exosome, to minimize the possibility to losing exosome during dialysis, for instance through accidental tears in the dialysis membrane or small openings where the membrane is clipped (instant claim 22, step (d)). One of skill in the art would have had a reasonable expectation of success at mixing an exosome sample with the dialyzed material through pipetting (instant claim 22, step (d)).
Although neither Son nor Lee explicitly recite performing the dialysis step for 36-60 hours, this time range is achievable over routine optimization. One of skill in the art could measure dialysis time using a timer, and could measure the content of remaining crosslinker by filtering the dialyzed composition and analyzing the filtrate using an HPLC-MS/MS instrument. The dialysis time could be optimized to minimize crosslinker content in the dialyzed material, and to be completed upon equilibration, i.e. when the BDDE concentration in the dialyzed material stabilizes. Therefore, the dialysis time of 36 -60 hours is obvious to one of skill in the art over routine optimization (instant claim 24).
Although Son does not explicitly recite performing the crosslinking step crosslinking in step (b) at a temperature of 20°C to 60°C for 12 to 36 hours, Lee recites that the crosslinking temperature of 22-28 C and reaction time of 12-18 hours (machine translation page 9 of 17, lines 17-21 from the top; instant claim 23). For context, Lee teaches a method of making a cross-linked hyaluronic acid composition in which the cross linker can be BDDE (machine translation page 8 of 17, lines 2-19 from the bottom).
Although neither Son nor Lee explicitly recite the weight ratio of hyaluronic acid: BDDE of 0.001 to 0.05, one of skill in the art could achieve such ratios through routine optimization. One of skill in the art could use a scale instrument to weigh the hyaluronic acid and BDDE separately, and a rheometer to measure the viscosity of the resulting cross-linked material, to evaluate its suitability for use as a hydrogel (Son, Summary of Invention, Means to solve the problem, paragraph 7; instant claim 18). Therefore, the weight ratio range of hyaluronic acid: BDDE of 0.001 to 0.05 is obvious to one of skill in the art over the course of routine optimization.
Son and Lee are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the steps for making a crosslinked hyaluronic acid hydrogel, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the [type of composition or method]), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Son in view of Lee, the invention as a whole, drawn to a method of reducing wrinkles using a filler composition as described in Claims 13, 18, and 22-24, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ methods with the methods (including compositions thereof) of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed methods and the methods of the prior art (and compositions thereof). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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