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 claims 50-53 (Group I) in the reply filed on 12/23/25 is acknowledged.
Claims 54-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/25.
Applicant’s election of species, without traverse, of the embodiment at the top of Fig. 94A, “including 25 kDa, 1.0 wt % of silk fibroin protein fragments, 1% hyaluronic acid, 10% Zinc Oxide, and 0.66% sodium ascorbyl phosphate” in the reply filed on 12/23/25 is acknowledged. Based on Fig. 94A, a “viscous HA solution” into which the zinc oxide was added, falls within what can be considered a “serum”, even after which the zinc oxide is added, with the water representing, by calculation, over 88% of the “serum” aqueous solution (which also includes, as best as understood, zinc oxide dispersed in the noted viscous hyaluronic acid solution).
Applicant’s elected species as best understood was searched and found free of the art. There is no claim specifically directed to this species.
The examiner has extended the search and examination to a non-elected species, this species being a 24 kDa silk fibroin fragment dissolved in 0.2 M sodium phosphate buffer solution. The 24 kDa silk fibroin fragment is a proper alternatively useable member of the genus of silk fibroin protein fragments set forth in claim 46.
Priority
The instant application, filed 07/11/2022 is a Continuation of 16180939 , filed 11/05/2018, now abandoned
16180939 is a Continuation of 14503076 , filed 09/30/2014 ,now U.S. Patent # 10166177
14503076 Claims Priority from Provisional Application 61884820 , filed 09/30/2013
14503076 Claims Priority from Provisional Application 62000928 , filed 05/20/2014
14503076 Claims Priority from Provisional Application 62036450 , filed 08/12/2014.
Status of the Claims
Claims 1-45 are cancelled.
Claims 46-62 are pending.
Claims 54-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/25.
Claims 46-53 are examined on the merits.
Claims 46-53 are rejected.
Claims 46 is objected to.
Information Disclosure Statement
The Examiner has considered the references provided in the 7/11/22, 3/20/23, 5/30/23, 7/27/23, 1/3/24, 5/15/24, 10/1/24, 2/6/25, 6/10/25, 12/23/25 and 3/3/26 Information Disclosure Statements, and provides a signed and dated copy of each herewith.
Claim Objections
Claim 46 is objected to because of the following informalities: the first “average” in line 2 of claim 46 appears unnecessary given that weight average molecular weight (WAMW) already imparts an average.
Claim 46 also is objected to because of the following informalities: “selected from” in line 3 of claim 46 appears unnecessary given that there is only one weight range in the claim (as opposed to other claims such as in the preceding parent in which multiple ranges were alternatively claimed in one claim).
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.
Claims 46-53 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.
Claim 46 is directed to a “composition comprising silk protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.”
The last two lines of claim 46 impose a functional requirement. However, the combination(s) of concentration of the silk protein fragments of a particular average WAMW within the claimed range, and/or a particular polydispersity within “a polydispersity of between about 1.5 and about 3.0,” at a particular pH of aqueous solution, and the temperature at which such changes are assessed over the period of “at least 10 days”, such that one of ordinary skill in the art understands the metes and bounds of what is claimed, are not set forth and as such this establishes one basis for lack of clarity and indefiniteness. Even assuming that no additives, including those that can alter the pH of the noted aqueous solution being evaluated for gelation and/or one or more gel-forming additives such as hyaluronic acid, are added to the aqueous solution for any such evaluation to determine whether or not a particular composition falls within or outside of claim 46’s functional limitation (notwithstanding that such additions are evaluated in the application as to time to gel, visible changes, etc.), merely evaluating at different concentrations of silk fibroin protein fragments, and/or the ambient temperature of evaluation, and/or the pH of the aqueous solution, reasonably will have a substantial effect on the outcome of whether or not “the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.” The same composition comprising silk fibroin protein fragments within the average WAMW range and polydispersity of claim 46, at 4 degrees Celsius versus 25 degrees Celsius, both at pH 7 aqueous solution, reasonably would be expected to gel differently over a period of at least 10 days, this also depending on the concentration (consider for example differing results with 0.01 versus 0.1 versus 4 versus 8 percent concentration in such aqueous solution). If there are no gelation nor visible changes in color or turbidity over the 10 days for the 0.01 percent concentration solution, but is gelation for the 8 percent concentration solution, at 25 degrees Celsius, how would one of ordinary skill in the art ascertain whether the composition falls within or outside the metes and bounds of claim 46? A similar problem arises if comparing a single concentration at 4 and at 25 or 40 degrees Celsius. Because the limitations for such evaluations are not set forth with clarity, one of ordinary skill in the art is left with major and unanswerable questions as to what is, and what is not, within the metes and bounds of and encompassed by claim 46. (While applicant may prefer to opt for maximum breadth, a competitor may prefer setting forth evaluations where the concentrations and temperatures result in rapid gelation. Who would be correct given that there are no concentration/temperature requirements as to the claimed “composition comprising” in the evaluation aqueous solution, but varying these can result in different outcomes for the functional limitation?)
The examiner notes that applicant’s own data, such as Table 19 and paragraphs following it, evidences that different concentrations of silk protein fragments and additives, and temperatures, have effects on whether gelation takes a shorter or longer period of time.
A second basis for indefiniteness of claim 46 is that the gelling speed of “gradually” is unclear, as are, as indicated elsewhere more broadly, the conditions under which the composition is placed for “at least 10 days”. Further, given that the evaluation is in an aqueous solution, the examiner is puzzled as to whether it is the composition or the aqueous solution that may or may not gelate or visibly change in color or turbidity. This is yet another basis for lack of clarity, albeit of lesser criticality given the other bases.
An additional basis for indefiniteness of claim 46 is that the metes and bounds of “does not visibly change in color or turbidity” are not clear. It is not clear whether observation by human eye is the only method to detect such claimed changes in color or turbidity, and even assuming it is (rather than instruments are used, such as a spectrophotometer), there is no standard for what is being observed and under what light conditions, this being important as to a clear determination. For example, visually (by human eye) observing a 1 cm wide clear vessel with aqueous solution (or gel) would reasonably provide a different result as far as color or turbidity, than the same human eye visually observing, under the same lighting conditions, a 10 cm wide clear vessel with aqueous solution (or gel).
Claim 46, a generic linking claim under examination, is rejected on the above bases, and because none of dependent claims 47-53 under examination overcome all of the above bases, claims 46-53 are rejected as unclear and indefinite.
Separately and additionally, claim 48 is rejected based on the relative term “substantially” as it modifies “homogeneous.” The term “substantially” in claim 48 is a relative term which renders the claim indefinite. The term “substantially” is 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. As a result, what is modified, “homogeneous” has been rendered unclear as to its metes and bounds by use of the relative term “substantially”.
A related further basis of rejection based on para 126 of the corresponding PGPUB is made. That para states, “As used herein, the term “substantially homogeneous” may refer to pure silk fibroin-based protein fragments that are distributed in a normal distribution about an identified molecular weight. As used herein, the term “substantially homogeneous” may refer to an even distribution of additive, for example vitamin C, throughout a composition of the present disclosure.” Because there are an infinite number of normal distributions based on an infinite number of standard deviations that fundamentally determine the shape of each such normal distribution, and no center point is set forth, when considering the combined term “substantially homogeneous,” the metes and bounds are unclear rendering the claim indefinite.
Also, it is not clear whether homogenous refers to the state of uniformity of a dry form of the claim 46 composition of silk fibroin protein fragments that have a distribution of molecular weights within the claimed range – which are then claimed in claim 48 to be “substantially homogenous,” or of some other form of composition, such as “when in an aqueous solution.”
Also, as to claim 50, “A serum comprising the composition of claim 46,” and also claims 51-53 depending from it, the metes and bounds of such serum are unclear. The term “serum” is not defined and although as used by applicant appears to be directed to a preparation for cosmetic use on skin rather than a component of blood or other fluid in a living body, however alternately can encompass more than a cosmetic-type serum. For example, TuClinicaHispanaFamiliar, 9 pages, 2026, downloaded from the internet 7/21/26, copy provided, refers to a vitamin serum that “is a solution rich in vitamins, minerals and essential nutrients,” page 2. Further, a cosmetic-type serum is known in the art to be of two broad types – oil-based liquids and water-based liquids, see second page of “Skin serum: What it can and can’t do,” Harvard Health Publishing, 2018, 6 pages.
Further, in contrast to simple solution serums, whether water or oil-based, when Applicant evaluate its compositions for application to skin and considers these serums, per Example 13, Table 32 – the title of which includes “Embodiments of serums of the present disclosure…”, the form of a “serum” per the Observation column includes hyaluronic acid and silk protein fragments combinations that are a liquid (this being aqueous), including viscous liquid, including “with film on top”, and “Non homogenous mix of hard gel and viscous liquid”, to gel and jelly. Applicant’s elected species, per the Results on Figure 94A, state that the Zinc Oxide “is insoluble but can be dispersed with viscous HA solution” and became clumpy. Yet this composition also is a classified as a serum by applicant. The examiner wonders at what higher concentration of zinc oxide - combined with water, hyaluronic acid and silk fibroin, the composition becomes so thick and paste-like, or mud-like, that such composition is no longer a “serum”. There is no guidance for this.
Given the above, considering serums to include water-based liquids that per the elected species can include a clumpy component, a serum as best understood and as interpreted herein for purposes of rejection is any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds, including but not limited for application to a subject’s skin.
Applicant is encouraged to provide clear metes and bounds for all of its claimed serums.
Additionally, the examiner notes that applicant has distinguished claims in the parent application 14503076, see 9/30/2014 claim set, as well as in other applications, between films, gels, serums and skin peels, yet here at least based on Example 13, Table 32, a serum appears to be able to overlap and/or encompass these other forms, and the examiner does not understand the metes and bounds of what is claimed as a “serum” given this previous distinction, the description of serums in Table 32, the lack of a clear definition, and the current disclosure overall which does not address oil-based liquid serums.
Further to this point, Daithankar et al., Indian Journal of Biotechnology, vol. 4, Jan 2005, pp 115-121, cited in 7/11/22 IDS and copy provided paginated 1-7 pages, teaches
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(from page 5).
If the instantly claimed smaller silk fibroin protein fragments share this property of forming a thin film over the stratum corneum, does what is claimed as a “serum” encompass oil-based liquids, water-based liquids, and also any of these that comprise or form a film? Clarification is required to better understand the metes and bounds of what is claimed as a serum, including where appropriate amendments to any claim that is directed to a “serum”.
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 46-53 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.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not merely a wish or plan for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566.
The claimed subject matter is not supported by an adequate written description. There are insufficient guidance, structure/function relationships such as correlations between a particular structure and a function, and/or other relevant disclosure, nor examples that are representative of the diversity of the genera encompassed by the variants in the claims under examination.
Applicant is alerted that "a sufficient description of a genus ... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus." AriadPharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010). A "generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus." Id. at 1349. “[M]erely drawing a fence around a perceived genus is not a description of the genus.” AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014). “One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus.” Id. “Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus.” Id.
In the instant case, claim 46 is directed to a “composition comprising silk protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.”
Although the specification at para 142 of the corresponding PGPUB 20190070088 broadly states, “A unique feature of the SPF compositions of the present disclosure are shelf stability (they will not slowly or spontaneously gel when stored in an aqueous solution and there is no aggregation of fragments and therefore no increase in molecular weight over time), from 10 days to 3 years depending on storage conditions, percent silk, and number of shipments and shipment conditions,” there is no demonstration of this in the application as filed for compositions comprising silk fibroin fragments in the claimed particular average WAMW range of silk fibroin fragments, “from between about 17 kDa to about 38 kDa”, and having “a polydispersity of between about 1.5 and about 3.0.” Nor does claim 46 contain any limitations pertaining to its functional requirement that indicate under what conditions the claimed compositions comprising a representative number of species of silk fibroin fragments in this particular weight range of silk fibroin fragments would meet the functional requirement. The quotation from para 142 itself indicates that this “shelf stability” of not gelling, etc., depends on multiple factors including storage conditions (presumably and reasonably including temperature) and percent silk. Other factors, such as pH, and additives, also would be expected to affect the claimed functional result limitation, as clearly indicated by Example 2, Table, 19, and Example 6, as well as other examples, however many of these examples do not indicate the average WAMW of the silk fibroin fragments, whereas other examples, e.g., 12-15, 18, 19, use 25 kDa fragment size, which is in the claimed range).
Additionally, Rockwood et al., Nat Protoc. 2011 Sep 22 6(10), 40 pages, at page 23, regarding a 7 to 8% silk solution from native silk cocoons that was prepared by boiling the cocoons in sodium carbonate for 30 minutes, rinsing, treating with LiBr, dialysis and centrifugation, per preceding pages, teaches that “The silk solution can be stored at 4°C for at least a month. Depending on the purity, stored silk will eventually gel but gelation times will vary.” Although Rockwood does not teach the weight average molecular weight of these silk fibroin fragments, and based on comparing Rockwood’s processing to the processing in the instant application Rockwood’s silk fibroin fragments likely have higher WAMW than those claimed, Rockwood strongly suggests that many silk fragments solutions stored at 4 degrees C will not gelate within 10 days (Applicant’s own data also supporting this, see for example Table 19, comparing samples 1 with 6, 2 with 7, 3 with 8). Rockwood per the quotation above also teaches that impurities are another factor in whether a solution will or will not gelate within 10 days.
The description requirement of the patent statute 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 claim 46 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.
Claims 47-53 under examination also are rejected on the above bases, depending from claim 46.
Additionally, because it is known in the art that a serum as used by applicant, in the sense of a preparation for cosmetic use on skin rather than a component of blood or other fluid in a living body, can be of two broad types – oil-based liquids and water-based liquids, see second page of “Skin serum: What it can and can’t do,” Harvard Health Publishing, 2018, 6 pages, and because applicant has only taught and disclosed a water-based liquid type of “hydrating” serum that includes hyaluronic acid, applicant is not in possession of all types of serums that are currently encompassed by claim 50.
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 46-50 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over KR20130053494A (“494”) published 5/23/13, copy of specification provided with English machine translation made by Espacenet translation.
Claim 46 is directed to a “composition comprising silk protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.”
The 494 Examples 1 and 2 teach processing and purification of silkworm cocoon of Bombyx mori, including per Example 1, 50 times the amount of water was added to the silkworm cocoon from which the pupa had been removed, heated at 120 degrees Celsius for 20 minutes, washed with clean water, and dried to obtain pure silk fibroin protein from which sericin protein had been removed, per Example 2, in which the refined silk fibroin protein obtained in Example 1 was placed in a 5M calcium chloride solution, and ethanol was added while heating to 90 degrees Celsius to completely dissolve and hydrolyze the silk fibroin protein, where large foreign substances such as pupae fragments were removed by layering gauze and other materials, and insoluble substances were removed using filter paper (Whatman No. 1), after which calcium chloride was removed using the following methods a) water dialysis, b) an electro-desalting method, c) ultrafiltration, and d) gel chromatography, the 494 reference stating that calcium chloride was successfully removed in all methods, and the same results could be obtained in subsequent operations. Thereafter a polymeric silk fibroin peptide solution from which calcium chloride had been removed was freeze-dried to produce a powder. PLEASE NOTE that such silk fibroin peptide solution is an aqueous solution relevant to instant claim 49.
The 494 Example 3, determined that the weight-average molecular weight of the polymeric silk peptide of the polymeric silk peptide prepared in Example 2 above, as calculated by gel permeation chromatography, was 24 kDa, see para 28.
The 494 thus teaches processing that includes purification steps to remove inorganic (e.g., calcium chloride) and organic (e.g., sericin) residues that absent evidence to the contrary meets the respective 0 to 500 ppm ranges of instant claim 46.
The 494 also, importantly, teaches purification steps starting with the same silkworm cocoon of Bombyx mori and ends with a 24 kDa the weight-average molecular weight of the polymeric silk peptide, so falls within the instantly claimed weight range of claim 46.
The 494 does not explicitly teach the claimed polydispersity range, nor the functional limitation of the last two lines of claim 46.
As to the latter, because this can be reasonably met by maintaining a low concentration of such 24 kDa WAMW product of the 494 at low temperature, such as 0.01 percent fibroin solution at 4 degrees Celsius, such functional limitation is met absent evidence to the contrary. Please also see rejections above as to this functional limitation.
As to the claimed polydispersity range, this is either anticipated by the 494 – applicant can provide evidence to the contrary by appropriate and valid experiments showing a difference if such were to exist (however following all of the 494 method alternatives), or would have been obvious at least given the different possible purification variations set forth in the 494, such as to method of calcium chloride removal and their individual effects on additionally removing small peptides, the reasonable technical effect of such being to alter the polydispersity to a tighter range that falls within the “between about 1.5 and about 3.0” of claim 46.
Therefore claim 46 is rejected.
Claim 47 also is rejected based on the 494 removing sericin to within the range of claim 47. This is based at least on the 494 Example 1, which states “…and dried to obtain pure silk fibroin protein from which sericin protein had been removed,” noting this statement is after the heating for 20 minutes at 120 degrees Celsius in 50 times the amount of water to silkworm cocoon, after which there was washing with clean water, and also noting that if this removed all measurable sericin, the lack of sericin therein would reasonably be met by the “about” of claim 47’s “about 0.01% (w/w)” lower limit of claim 47’s sericin range.
Claim 48 also is rejected based on the dried powder as well as the aqueous solution of the 494 methods of purification being homogeneous as to the mixture of silk protein fragments, homogenous to some degree of homogeneity (absent evidence to the contrary), so meeting “substantially homogeneous”. Please also see rejection above regarding this term.
Claim 49 also is rejected based on a polymeric silk fibroin peptide solution from which calcium chloride had been removed is an aqueous solution (such as and at least when subjected to water dialysis, see above) prior to being freeze-dried to produce a powder. Also, the 24 kDa silk fibroin fragment dissolved in 0.2M sodium phosphate buffer solution of the ‘494’s Example 3 at para 27 is an aqueous solution, this an additional basis for rejection of claim 49 and this also is the basis for rejection of claim 50, this solution comprising the 24 kDa silk protein fragments falling within what is interpreted as a “serum”.
Claim 50 is rejected on the same basis as claim 46, noting that the 494 Example 3 provides the 24 kDa silk fibroin fragment in a phosphate buffer, so is a serum in that the silk fibroin fragment treats diabetes (and, additionally, phosphate is a nutrient).
Claim 51 is rejected under 35 U.S.C. 103 as obvious over KR201300523494A (“494”) published 5/23/13, copy of specification provided with English machine translation made by Espacenet translation, in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.”
The 494 teaches consumption of its silk product, but not its concentration in a solution that includes a serum in the latter’s broad context.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
Whether for oral consumption of the 494 silk protein of 24 kDa to provide in a viscous or gel form, or for providing such silk protein for use in the formulation of Lim, for cosmetic use, the claimed concentration would have been obvious based on applying a known concentration when preparing an aqueous form of the silk protein of the 494, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations).
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected under 35 U.S.C. 103 as obvious over KR201300523494A (“494”) published 5/23/13, copy of specification provided with English machine translation made by Espacenet translation, in view of US 2008/0268066, Yie et al., published 10/30/08 (Yie).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.”
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
The 494 teaches administration of its 24 kDa silk fibroin to treat diabetes by lowering glycated hemoglobin to estimate the average blood sugar level over a certain period, pages 31-36. Such administration was effective compared to the control. Id.
However, the 494 does not state in what form the 24 kDa silk fibroin was administered – dry, liquid, etc., nor that this was combined with other components that treat diabetes.
Yie, however, teaches composition preparations of its invention that can be a liquid medicament, para 87, and that include both vitamins C and E, para 18, vitamin E, para 53, and vitamin C, para 73, and elsewhere, also see also claim 1 which includes both of these, in a “combined formulation for preventing and/or treating diabetes …”. Yie teaches the content of Vitamin C is in the range of 10-2000 mg, but does not specify a percent concentration when in liquid form. The claim 53 concentration range would overlap with this range of Yie based on the amount of liquid, and therefore would have been obvious or achievable by routine experimentation. There is no criticality established for claim 53’s broad range1.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the 494 and Yie teach their respective components to be used to treat diabetes. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
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 46-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9187538 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of limitations of the reference patent claims 1 and 4 include all limitations of instant claims 46-49, see table below, and as to instant claim 50 a serum as best understood includes an aqueous solution comprising a component that can provide a therapeutic benefit to a human skin, which one or more of the claimed silk fibroin peptide fragments can provide, absent evidence to the contrary.
17861936 (instant application)
US 9187538
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1.A composition comprising: pure silk fibroin-based protein fragments having about 0.01% (w/w) to about 10% (w/w) sericin, wherein the fragments have an average weight average molecular weight ranging from 17 kDa to 38 kDa; wherein the fragments have a polydispersity of between 1.5 and 3.0; wherein the composition is substantially homogeneous; wherein the composition includes between 0 ppm to 500 ppm of inorganic residuals; wherein the composition includes between 0 ppm to 500 ppm of organic residuals; and wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in a solution for at least 10 days
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
4. The composition of claim 1 wherein the solution is an aqueous solution.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9187538 (reference patent), as applied above to claims 46 and 50, and further in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.” This is not claimed in the reference patent claims.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
The claimed concentration range would have been obvious, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations), based on applying the teachings of Lim to the composition of reference patent claim 1.
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9187538 (reference patent), as applied above to claims 46 and 50, and further in view of in view of US 20070243148, Andre and Renimel, published 10/18/07 (AR).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.” The reference patent claims do not teach these limitations, although reference patent claim vitamin C, see claim 7.
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
AR teaches that cosmetically active ingredients include vitamin C and vitamin E, and so that these can be combined with its other active ingredients, para 20, claim 14.
The claim 53 concentration range is broad, extending from “about 0.5 wt% to about 30.0 wt%” – so that from less than 1 percent to almost one-third of the total composition is vitamin C or a derivative thereof. A value within this range for any number of aqueous compositions, serum compositions, would have been achievable by routine experimentation. There is no criticality established for claim 53’s broad range2.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the reference patent and AR teach their respective components for use in skin treatments, the reference patent clearly providing this in multiple locations of the specification, supporting that the claimed compositions would encompass these. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
Claims 46-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9511012 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim 46’s upper limit of average WAMW of “about 38kDa” is close to or overlaps (when interpreting the breadth imparted by “about”) the reference patent claim’s lower limit average WAMW of “about 39kDa” (please see MPEP 2144.05) and because the combination of limitations of the reference patent claims 1 and 4 include all limitations of instant claims 46-49, see table below, and as to instant claim 50 a serum as best understood includes an aqueous solution comprising a component that can provide a therapeutic benefit to a human skin, which one or more of the claimed silk fibroin peptide fragments can provide, absent evidence to the contrary.
17861936 (instant application)
US 9511012
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1. A composition comprising: pure silk fibroin-based protein fragments having about 0.01% (w/w) to about 10% (w/w) sericin, wherein the fragments have an average weight average molecular weight ranging from about 39 kDa to about 80 kDa, wherein the fragments have a polydispersity of from about 1.5 to about 3.0, wherein the composition is substantially homogeneous, wherein the composition includes between 0 ppm to 500 ppm of inorganic residuals, wherein the composition includes between 0 ppm to 500 ppm of organic residuals, and wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in a solution for at least 10 days.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
4. The composition of claim 1 wherein the solution is an aqueous solution.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9511012 (reference patent), as applied above to claims 46 and 50, and further in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.” This is not claimed in the reference patent claims.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
The claimed concentration range would have been obvious, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations), based on applying the teachings of Lim to the composition of reference patent claim 1.
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9511012 (reference patent), as applied above to claims 46 and 50, and further in view of in view of US 20070243148, Andre and Renimel, published 10/18/07 (AR).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.” The reference patent claims do not teach these limitations, although reference patent claims vitamin C, see claim 7.
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
AR teaches that cosmetically active ingredients include vitamin C and vitamin E, and so that these can be combined with its other active ingredients, para 20, claim 14.
The claim 53 concentration range is broad, extending from “about 0.5 wt% to about 30.0 wt%” – so that from less than 1 percent to almost one-third of the total composition is vitamin C or a derivative thereof. A value within this range for any number of aqueous compositions, serum compositions, would have been achievable by routine experimentation. There is no criticality established for claim 53’s broad range.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the reference patent and AR teach their respective components for use in skin treatments, the reference patent clearly providing this in multiple locations of the specification, supporting that the claimed compositions would encompass these. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
Claims 46-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9517191 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of limitations of the reference patent claims 1 and 4 include all limitations of instant claims 46-49, see table below, and as to instant claim 50 a serum as best understood includes an aqueous solution comprising a component that can provide a therapeutic benefit to a human skin, which one or more of the claimed silk fibroin peptide fragments can provide, absent evidence to the contrary.
17861936 (instant application)
US 9517191
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1. A composition comprising: pure silk fibroin-based protein fragments having about 0.01% (w/w) to about 10% (w/w) sericin, wherein the fragments have an average weight average molecular weight ranging from about 17 kDa to about 38 kDa, wherein the fragments have a polydispersity of from about 1.5 to about 3.0, wherein the composition is substantially homogeneous, wherein the composition includes between 0 ppm to 500 ppm of inorganic residuals, wherein the composition includes between 0 ppm to 500 ppm of organic residuals, and wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in a solution for at least 10 days.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
4. The composition of claim 1 wherein the solution is an aqueous solution.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9517191 (reference patent), as applied above to claims 46 and 50, and further in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.” This is not claimed in the reference patent claims.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
The claimed concentration range would have been obvious, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations), based on applying the teachings of Lim to the composition of reference patent claim 1.
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9517191 (reference patent), as applied above to claims 46 and 50, and further in view of in view of US 20070243148, Andre and Renimel, published 10/18/07 (AR).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.” The reference patent claims do not teach these limitations, although reference patent claims vitamin C, see claim 7.
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
AR teaches that cosmetically active ingredients include vitamin C and vitamin E, and so that these can be combined with its other active ingredients, para 20, claim 14.
The claim 53 concentration range is broad, extending from “about 0.5 wt% to about 30.0 wt%” – so that from less than 1 percent to almost one-third of the total composition is vitamin C or a derivative thereof. A value within this range for any number of aqueous compositions, serum compositions, would have been achievable by routine experimentation. There is no criticality established for claim 53’s broad range.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the reference patent and AR teach their respective components for use in skin treatments, the reference patent clearly providing this in multiple locations of the specification, supporting that the claimed compositions would encompass these. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
Claims 46-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9522107 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim 46’s upper limit of average WAMW of “about 38kDa” overlaps the reference patent claim’s lower limit of 35 kDa average WAMW (please see MPEP 2144.05) and because the combination of limitations of the reference patent claims 1 and 4 include all limitations of instant claims 46-49, see table below, and as to instant claim 50 a serum as best understood includes an aqueous solution comprising a component that can provide a therapeutic benefit to a human skin, which one or more of the claimed silk fibroin peptide fragments can provide, absent evidence to the contrary.
17861936 (instant application)
US 9522107
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1. A composition comprising: pure silk fibroin-based protein fragments having about 0.01% (w/w) to about 10% (w/w) sericin, wherein the fragments have an average weight average molecular weight ranging from about 35 kDa to about 40 kDa, wherein the fragments have a polydispersity of from about 1.5 to about 3.0, wherein the composition is substantially homogeneous, wherein the composition includes between 0 ppm to 500 ppm of inorganic residuals, where-in the composition includes between 0 ppm to 500 ppm of organic residuals, and wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in a solution for at least 10 days.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
4. The composition of claim 1 wherein the solution is an aqueous solution.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9522107 (reference patent), as applied above to claims 46 and 50, and further in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.” This is not claimed in the reference patent claims.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
The claimed concentration range would have been obvious, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations), based on applying the teachings of Lim to the composition of reference patent claim 1.
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9522107 (reference patent), as applied above to claims 46 and 50, and further in view of in view of US 20070243148, Andre and Renimel, published 10/18/07 (AR).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.” The reference patent claims do not teach these limitations, although reference patent claims vitamin C, see claim 7.
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
AR teaches that cosmetically active ingredients include vitamin C and vitamin E, and so that these can be combined with its other active ingredients, para 20, claim 14.
The claim 53 concentration range is broad, extending from “about 0.5 wt% to about 30.0 wt%” – so that from less than 1 percent to almost one-third of the total composition is vitamin C or a derivative thereof. A value within this range for any number of aqueous compositions, serum compositions, would have been achievable by routine experimentation. There is no criticality established for claim 53’s broad range.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the reference patent and AR teach their respective components for use in skin treatments, the reference patent clearly providing this in multiple locations of the specification, supporting that the claimed compositions would encompass these. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
Claims 46-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9545369 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim 46’s lower limit of average WAMW of “about 17 kDa” is close to or overlaps (when interpreting the breadth imparted by “about”) the reference patent claim’s upper limit average WAMW of “about 16 kDa” (please see MPEP 2144.05) and because the combination of limitations of the reference patent claims 1 and 4 include all limitations of instant claims 46-49, see table below, and as to instant claim 50 a serum as best understood includes an aqueous solution comprising a component that can provide a therapeutic benefit to a human skin, which one or more of the claimed silk fibroin peptide fragments can provide, absent evidence to the contrary.
17861936 (instant application)
US 9545369
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1. A composition comprising: pure silk fibroin-based protein fragments having about 0.01% (w/w) to about 10% (w/w) sericin, wherein the fragments have an average weight average molecular weight ranging from about 6 kDa to about 16 kDa, wherein the fragments have a polydispersity of from about 1.5 to about 3.0, wherein the composition is substantially homogeneous, wherein the composition includes between 0 ppm to 500 ppm of inorganic residuals, wherein the composition includes between 0 ppm to 500 ppm of organic residuals, and wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in a solution for at least 10 days.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
4. The composition of claim 1 wherein the solution is an aqueous solution.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9545369 (reference patent), as applied above to claims 46 and 50, and further in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.” This is not claimed in the reference patent claims.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
The claimed concentration range would have been obvious, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations), based on applying the teachings of Lim to the composition of reference patent claim 1.
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9545369 (reference patent), as applied above to claims 46 and 50, and further in view of in view of US 20070243148, Andre and Renimel, published 10/18/07 (AR).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.” The reference patent claims do not teach these limitations.
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
AR teaches that cosmetically active ingredients include vitamin C and vitamin E, and so that these can be combined with its other active ingredients, para 20, claim 14.
The claim 53 concentration range is broad, extending from “about 0.5 wt% to about 30.0 wt%” – so that from less than 1 percent to almost one-third of the total composition is vitamin C or a derivative thereof. A value within this range for any number of aqueous compositions, serum compositions, would have been achievable by routine experimentation. There is no criticality established for claim 53’s broad range.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the reference patent and AR teach their respective components for use in skin treatments, the reference patent clearly providing this in multiple locations of the specification, supporting that the claimed compositions would encompass these. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
Claims 46-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10588843 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim 46’s upper limit of average WAMW of “about 38kDa” is close to or overlaps (when interpreting the breadth imparted by “about”) the reference patent claim’s lower limit average WAMW of “about 39kDa” (please see MPEP 2144.05) and because the limitations of the reference patent claim 1 include all limitations of instant claims 46-49, see table below, and as to instant claim 50 a serum as best understood includes an aqueous solution comprising a component that can provide a therapeutic benefit to a human skin, which one or more of the claimed silk fibroin peptide fragments can provide, absent evidence to the contrary. Please note that the ordinary and customary meaning of the last reference to “a solution” in claim 1 of the reference patent would reasonably be an aqueous solution given that this claim is directed to “an aqueous pharmaceutical formulation”.
17861936 (instant application)
US 10588843
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1. An aqueous pharmaceutical formulation comprising: a composition comprising silk fibroin-based protein fragments having about 0.01% (w/w) to about 10% (w/w) sericin, wherein the fragments have an average weight average molecular weight ranging from about 39 kDa to about 80 kDa, wherein the fragments have a polydispersity of from about 1.5 to about 3.0, wherein the composition is substantially homogeneous, wherein the composition includes between 0 ppm to 500 ppm of inorganic residuals, wherein the composition includes between 0 ppm to 500 ppm of organic residuals, and wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in a solution for at least 10 days.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10588843 (reference patent), as applied above to claims 46 and 50, and further in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.” This is not claimed in the reference patent claims.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
The claimed concentration range would have been obvious, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations), based on applying the teachings of Lim to the composition of reference patent claim 1.
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10588843 (reference patent), as applied above to claims 46 and 50, and further in view of in view of US 20070243148, Andre and Renimel, published 10/18/07 (AR).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.” The reference patent claims do not teach these limitations.
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
AR teaches that cosmetically active ingredients include vitamin C and vitamin E, and so that these can be combined with its other active ingredients, para 20, claim 14.
The claim 53 concentration range is broad, extending from “about 0.5 wt% to about 30.0 wt%” – so that from less than 1 percent to almost one-third of the total composition is vitamin C or a derivative thereof. A value within this range for any number of aqueous compositions, serum compositions, would have been achievable by routine experimentation. There is no criticality established for claim 53’s broad range.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the reference patent and AR teach their respective components for use in skin treatments, the reference patent clearly providing this in multiple locations of the specification, supporting that the claimed compositions would encompass these. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
Claims 46-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10610478 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim 46’s upper limit of average WAMW of “about 38kDa” overlaps the reference patent claim’s lower limit average WAMW of “about 35 kDa” (please see MPEP 2144.05) and because the limitations of the reference patent claim 1 include all limitations of instant claims 46-49, see table below, and as to instant claim 50 a serum as best understood includes an aqueous solution comprising a component that can provide a therapeutic benefit to a human skin, which one or more of the claimed silk fibroin peptide fragments can provide, absent evidence to the contrary. Please note that the ordinary and customary meaning of the last reference to “a solution” in claim 1 of the reference patent would reasonably be an aqueous solution given that this claim is directed to “an aqueous pharmaceutical formulation”.
17861936 (instant application)
US 10610478
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1. An aqueous pharmaceutical formulation comprising: a composition comprising silk fibroin-based protein fragments having about 0.01% (w/w) to about 10% (w/w) sericin, wherein the fragments have an average weight average molecular weight ranging from about 35 kDa to about 40 kDa, wherein the fragments have a polydispersity of from about 1.5 to about 3.0, wherein the composition is substantially homogeneous, wherein the composition includes between 0 ppm to 500 ppm of inorganic residuals, wherein the composition includes between 0 ppm to 500 ppm of organic residuals, and wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in a solution for at least 10 days.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10610478 (reference patent), as applied above to claims 46 and 50, and further in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.” This is not claimed in the reference patent claims.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
The claimed concentration range would have been obvious, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations), based on applying the teachings of Lim to the composition of reference patent claim 1.
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10610478 (reference patent), as applied above to claims 46 and 50, and further in view of in view of US 20070243148, Andre and Renimel, published 10/18/07 (AR).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.” The reference patent claims do not teach these limitations.
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
AR teaches that cosmetically active ingredients include vitamin C and vitamin E, and so that these can be combined with its other active ingredients, para 20, claim 14.
The claim 53 concentration range is broad, extending from “about 0.5 wt% to about 30.0 wt%” – so that from less than 1 percent to almost one-third of the total composition is vitamin C or a derivative thereof. A value within this range for any number of aqueous compositions, serum compositions, would have been achievable by routine experimentation. There is no criticality established for claim 53’s broad range.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the reference patent and AR teach their respective components for use in skin treatments, the reference patent clearly providing this in multiple locations of the specification, supporting that the claimed compositions would encompass these. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
Claims 46-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10987294 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the average WAMW ranges of instant claim 46 and reference patent claim 1 are identical and because the limitations of the reference patent claim 1 include all limitations of instant claims 46-49, see table below, and as to instant claim 50 a serum as best understood includes an aqueous solution comprising a component that can provide a therapeutic benefit to a human skin, which one or more of the claimed silk fibroin peptide fragments can provide, absent evidence to the contrary. Please note that the ordinary and customary meaning of the last reference to “a solution” in claim 1 of the reference patent would reasonably be an aqueous solution given that this claim is directed to “an aqueous pharmaceutical formulation”.
17861936 (instant application)
US 10987294
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1. An aqueous pharmaceutical formulation comprising: a composition comprising silk fibroin-based protein fragments having about 0.01% (w/w) to about 10% (w/w) sericin, wherein the fragments have an average weight average molecular weight ranging from about 17 kDa to about 38 kDa, wherein the fragments have a polydispersity of from about 1.5 to about 3.0, wherein the composition is substantially homogeneous, wherein the composition includes between 0 ppm to 500 ppm of inorganic residuals, wherein the composition includes between 0 ppm to 500 ppm of organic residuals, and wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in a solution for at least 10 days.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10987294 (reference patent), as applied above to claims 46 and 50, and further in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.” This is not claimed in the reference patent claims.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
The claimed concentration range would have been obvious, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations), based on applying the teachings of Lim to the composition of reference patent claim 1.
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10987294 (reference patent), as applied above to claims 46 and 50, and further in view of in view of US 20070243148, Andre and Renimel, published 10/18/07 (AR).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.” The reference patent claims do not teach these limitations.
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
AR teaches that cosmetically active ingredients include vitamin C and vitamin E, and so that these can be combined with its other active ingredients, para 20, claim 14.
The claim 53 concentration range is broad, extending from “about 0.5 wt% to about 30.0 wt%” – so that from less than 1 percent to almost one-third of the total composition is vitamin C or a derivative thereof. A value within this range for any number of aqueous compositions, serum compositions, would have been achievable by routine experimentation. There is no criticality established for claim 53’s broad range.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the reference patent and AR teach their respective components for use in skin treatments, the reference patent clearly providing this in multiple locations of the specification, supporting that the claimed compositions would encompass these. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
Claims 46-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11298310 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the average WAMW ranges of reference patent claim 1 extend across and make obvious the slightly wider range of instant claim 46, and because the limitations of the reference patent claim 1 include all limitations of instant claims 46-49, see table below, except for the solution in which gelation or color or turbidity change is evaluated (“evaluation solution”) is not specified as aqueous – this however supported by the meanings and usage in the specification which refers only to aqueous solutions (at least 106 times, there being no reference to oil-based or solvents other than water when preparing solutions)3, the “substantially devoid of sericin” absent evidence to the contrary, or the between 0 ppm to about 500 ppm of organic residuals meeting or making obvious instant claim 47’s limitation, and as to instant claim 50 a serum as best understood includes an aqueous solution comprising a component that can provide a therapeutic benefit to a human skin, which one or more of the claimed silk fibroin peptide fragments can provide, absent evidence to the contrary. Reference patent claim 4 also supports, in view of the specification solutions being aqueous, that the evaluation solution also is aqueous.
17861936 (instant application)
US 11298310
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1. A composition comprising silk fibroin protein fragments having an average weight average molecular weight selected from 15 kDa to 20 kDa, from 20 kDa to 25 kDa, or from 25 kDa to 30 kDa, and a polydispersity from about 1.5 to about 3.0, wherein: the silk fibroin protein fragments are substantially devoid of sericin; the composition is substantially homogeneous; the composition includes between 0 ppm to about 500 ppm of inorganic residuals and between 0 ppm to about 500 ppm of organic residuals; and the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in a solution for at least 10 days.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11298310 (reference patent), as applied above to claims 46 and 50, and further in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.” This is not claimed in the reference patent claims.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
The claimed concentration range would have been obvious, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations), based on applying the teachings of Lim to the composition of reference patent claim 1.
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11298310 (reference patent), as applied above to claims 46 and 50, and further in view of in view of US 20070243148, Andre and Renimel, published 10/18/07 (AR).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.” The reference patent claims do not teach these limitations.
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
AR teaches that cosmetically active ingredients include vitamin C and vitamin E, and so that these can be combined with its other active ingredients, para 20, claim 14.
The claim 53 concentration range is broad, extending from “about 0.5 wt% to about 30.0 wt%” – so that from less than 1 percent to almost one-third of the total composition is vitamin C or a derivative thereof. A value within this range for any number of aqueous compositions, serum compositions, would have been achievable by routine experimentation. There is no criticality established for claim 53’s broad range.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the reference patent and AR teach their respective components for use in skin treatments, the reference patent clearly providing this in multiple locations of the specification, supporting that the claimed compositions would encompass these. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
Claims 46-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11298311 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the average WAMW ranges of 40 kDa to 45 kDa in reference patent claim 1 is close (or overlaps given instant claim 46’s “about 38 kDa”) so renders obvious this range of instant claim 46, and because the limitations of the reference patent claim 1 include all limitations of instant claims 46-49, see table below, except for the solution in which gelation or color or turbidity change is evaluated (“evaluation solution”) is not specified as aqueous – this however supported by the meanings and usage in the specification which refers only to aqueous solutions (at least 106 times, there being no reference to oil-based or solvents other than water when preparing solutions)4, the “substantially devoid of sericin” absent evidence to the contrary, or the between 0 ppm to about 500 ppm of organic residuals meeting or making obvious instant claim 47’s limitation, and as to instant claim 50 a serum as best understood includes an aqueous solution comprising a component that can provide a therapeutic benefit to a human skin, which one or more of the claimed silk fibroin peptide fragments can provide, absent evidence to the contrary. Reference patent claim 4 also supports, in view of the specification solutions being aqueous, that the evaluation solution also is aqueous.
17861936 (instant application)
US 11298311
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1. A composition comprising silk fibroin protein fragments having an average weight average molecular weight selected from selected from 40 kDa to 45 kDa, from 45 kDa to 50 kDa, or from 50 kDa to 55 kDa, and a polydispersity from about 1.5 to about 3.0, wherein: the silk fibroin protein fragments are substantially devoid of sericin; the composition is substantially homogeneous; the composition includes between 0 ppm to about 500 ppm of inorganic residuals and between 0 ppm to about 500 ppm of organic residuals; and the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in a solution for at least 10 days.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11298311 (reference patent), as applied above to claims 46 and 50, and further in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.” This is not claimed in the reference patent claims.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
The claimed concentration range would have been obvious, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations), based on applying the teachings of Lim to the composition of reference patent claim 1.
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11298311 (reference patent), as applied above to claims 46 and 50, and further in view of in view of US 20070243148, Andre and Renimel, published 10/18/07 (AR).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.” The reference patent claims do not teach these limitations.
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
AR teaches that cosmetically active ingredients include vitamin C and vitamin E, and so that these can be combined with its other active ingredients, para 20, claim 14.
The claim 53 concentration range is broad, extending from “about 0.5 wt% to about 30.0 wt%” – so that from less than 1 percent to almost one-third of the total composition is vitamin C or a derivative thereof. A value within this range for any number of aqueous compositions, serum compositions, would have been achievable by routine experimentation. There is no criticality established for claim 53’s broad range.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the reference patent and AR teach their respective components for use in skin treatments, the reference patent clearly providing this in multiple locations of the specification, supporting that the claimed compositions would encompass these. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
Claims 46-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7-9 of U.S. Patent No. 11857663 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the average WAMW ranges of reference patent claim 1 include the instantly claimed range, and because the limitations of the reference patent claim 1 include all limitations of instant claims 46-49, see table below, except a) for the solution in which gelation or color or turbidity change is evaluated (“evaluation solution”) is not specified as aqueous – this however is supported by the meanings and usage in the specification which refers only to aqueous solutions (at least 106 times, there being no reference to oil-based or solvents other than water when preparing solutions)5, and b) the “substantially devoid of sericin” absent evidence to the contrary, or the between 0 ppm to about 500 ppm of organic residuals meeting or making obvious instant claim 47’s limitation, and as to instant claim 50 a serum as best understood includes an aqueous solution comprising a component that can provide a therapeutic benefit to a human skin, which one or more of the claimed silk fibroin peptide fragments can provide, see reference patent claims 7-9 (not reproduced below), absent evidence to the contrary.
17861936 (instant application)
US 11857663
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1. A composition comprising lyophilized silk fibroin protein fragments that are substantially devoid of sericin, the silk fibroin protein fragments having an average weight average molecular weight selected from about 17 kDa to about 38 kDa, about 35 kDa to about 40 kDa, about 40 kDa to about 45 kDa, about 45 kDa to about 50 kDa, about 50 kDa to about 55 kDa, or about 39 kDa to about 80 kDa, and a polydispersity of about 1.5 to about 3.0, wherein, prior to being lyophilized, the silk fibroin protein fragments: form a substantially homogeneous solution comprising between 0 ppm to about 500 ppm of inorganic residuals and between 0 ppm to about 500 ppm of organic residuals, and do not spontaneously or gradually gelate and do not visibly change in color or turbidity when in a solution for at least 10 days.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
See reference patent claims 7-9
Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11857663 (reference patent), as applied above to claims 46 and 50, and further in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.” This is not claimed in the reference patent claims.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
The claimed concentration range would have been obvious, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations), based on applying the teachings of Lim to the composition of reference patent claim 1.
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11857663 (reference patent), as applied above to claims 46 and 50, and further in view of in view of US 20070243148, Andre and Renimel, published 10/18/07 (AR).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.” The reference patent claims do not teach these limitations.
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
AR teaches that cosmetically active ingredients include vitamin C and vitamin E, and so that these can be combined with its other active ingredients, para 20, claim 14.
The claim 53 concentration range is broad, extending from “about 0.5 wt% to about 30.0 wt%” – so that from less than 1 percent to almost one-third of the total composition is vitamin C or a derivative thereof. A value within this range for any number of aqueous compositions, serum compositions, would have been achievable by routine experimentation. There is no criticality established for claim 53’s broad range.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the reference patent and AR teach their respective components for use in skin treatments, the reference patent clearly providing this in multiple locations of the specification, supporting that the claimed compositions would encompass these. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
Claims 46-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11857664 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the average WAMW ranges of reference patent claim 1 include the instantly claimed range, and because the limitations of the reference patent claim 1 include all limitations of instant claims 46-49, see table below, except a) for the solution in which gelation or color or turbidity change is evaluated (“evaluation solution”) is not specified as aqueous – this however is supported by the meanings and usage in the specification which refers only to aqueous solutions (at least 106 times, there being no reference to oil-based or solvents other than water when preparing solutions)6, and b) the “substantially devoid of sericin” absent evidence to the contrary, or the between 0 ppm to about 500 ppm of organic residuals meeting or making obvious instant claim 47’s limitation.
17861936 (instant application)
US 11857664
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1.A substantially solid composition comprising silk fibroin protein fragments that are substantially devoid of sericin, the silk fibroin protein fragments having an average weight average molecular weight selected from about 17 kDa to about 38 kDa, about 35 kDa to about 40 kDa, about 40 kDa to about 45 kDa, about 45 kDa to about 50 kDa, about 50 kDa to about 55 kDa, or about 39 kDa to about 80 kDa, and a polydispersity of about 1.5 to about 3.0, wherein the silk fibroin protein fragments, when in a solution: form a substantially homogeneous solution comprising between 0 ppm to about 500 ppm of inorganic residuals and between 0 ppm to about 500 ppm of organic residuals, and do not spontaneously or gradually gelate and do not visibly change in color or turbidity for at least 10 days.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11857664 (reference patent), as applied above to claims 46 and 50, and further in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.” This is not claimed in the reference patent claims.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
The claimed concentration range would have been obvious, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations), based on applying the teachings of Lim to the composition of reference patent claim 1.
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11857664 (reference patent), as applied above to claims 46 and 50, and further in view of in view of US 20070243148, Andre and Renimel, published 10/18/07 (AR).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.” The reference patent claims do not teach these limitations.
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
AR teaches that cosmetically active ingredients include vitamin C and vitamin E, and so that these can be combined with its other active ingredients, para 20, claim 14.
The claim 53 concentration range is broad, extending from “about 0.5 wt% to about 30.0 wt%” – so that from less than 1 percent to almost one-third of the total composition is vitamin C or a derivative thereof. A value within this range for any number of aqueous compositions, serum compositions, would have been achievable by routine experimentation. There is no criticality established for claim 53’s broad range.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the reference patent and AR teach their respective components for use in skin treatments, the reference patent clearly providing this in multiple locations of the specification, supporting that the claimed compositions would encompass these. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
Claims 46-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 7 of U.S. Patent No. 11649585 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because as to the silk based proteins or fragments of the coating the broader average WAMW range of reference patent claim 1 includes the instantly claimed range, see MPEP 2144.05 regarding “lie inside”, and because the limitations of the reference patent claim 1 as to the silk based proteins or fragments include all limitations of instant claims 46-49, see table below, except for the solution in which gelation or color or turbidity change is evaluated (“evaluation solution”) is not specified as aqueous – this however is supported at least by the specification at para 351 immediately before Table 1, additionally there being no reference to oil-based or solvents other than water when preparing solutions)7. As clear below, reference patent claim 2 sets forth the same sericin range as instantly claimed in instant claim 47.
17861936 (instant application)
US 11649585
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1. An article comprising a fiber or yarn having a coating, wherein the article is a fabric, wherein the coating comprises silk based proteins or fragments thereof having a weight average molecular weight range of about 5 kDa to about 144 kDa, wherein the proteins or protein fragments, prior to coating the fabric, do not spontaneously or gradually gelate and do not visibly change in color or turbidity when in a solution for at least 10 days, and wherein the article exhibits an overall moisture management capability selected from the group consisting of greater than 0.05, greater than 0.10, greater than 0.15, greater than 0.20, greater than 0.25, greater than 0.30, greater than 0.35, greater than 0.40, greater than 0.50, greater than 0.60, greater than 0.70, and greater than 0.80.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
2. The article of claim 1, wherein the silk based proteins or fragments thereof comprise silk fibroin-based proteins or protein fragments having about 0.01% (w/w) to about 10% (w/w) sericin.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
7. The article of claim 1, wherein the silk based proteins or protein fragments thereof have an average weight average molecular weight range selected from the group consisting of about 5 to about 10 kDa, about 6 kDa to about 16 kDa, about 17 kDa to about 38 kDa, about 39 kDa to about 80 kDa, about 60 to about 100 kDa, and about 80 kDa to about 144 kDa, and wherein the silk based proteins or fragments thereof have a polydispersity of between about 1.5 and about 3.0.
49. An aqueous solution comprising the composition of claim 46.
Claims 46-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 11453975 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because as to the silk based proteins or fragments of the coating the reference patent claim 1’s average WAMW ranges includes the instantly claimed range, and because the limitations of the reference patent claim 1 as to the silk based proteins or fragments include all limitations of instant claims 46-49, see table below, except for a) the solution in which gelation or color or turbidity change is evaluated (“evaluation solution”) is not specified as aqueous – this however is supported at least by the specification at para 351 immediately before Table 1, additionally there being no reference to oil-based or solvents other than water when preparing solutions)8, this also rendering obvious instant claim 49, and b) there is no specific limitation as to “substantially homogenous” however given the lack of clear meaning and metes and bounds of such limitation it would appear to be met during routine processing absent evidence to the contrary. As clear below, reference patent claim 3 sets forth the same sericin range as instantly claimed in instant claim 47.
17861936 (instant application)
US 11453975
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1. An article comprising a fiber or yarn having a coating, wherein the coating comprises silk based proteins or fragments thereof having an average weight average molecular weight selected from about 5 to about 10 kDa, about 6 kDa to about 16 kDa, about 17 kDa to about 38 kDa, about 39 kDa to about 80 kDa, about 60 to about 100 kDa, or about 80 kDa to about 144 kDa, wherein the silk based proteins or fragments thereof have a polydispersity of between about 1.5 and about 3.0, and wherein the silk based proteins or protein fragments thereof, prior to coating the fiber or yarn, do not spontaneously or gradually gelate and do not visibly change in color or turbidity when in a solution for at least 10 days.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
3. The article of claim 1, wherein the silk based proteins or fragments thereof comprise silk fibroin fragments having about 0.01% (w/w) to about 10% (w/w) sericin.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
Claims 46, 48 and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12371848 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because as to the silk based proteins or fragments of the coating the reference patent claim 1’s average WAMW ranges includes the instantly claimed range, and because the limitations of the reference patent claim 1 as to the silk based proteins or fragments include all limitations of instant claims 46, 48 and 49, see table below, except for a) the solution in which gelation or color or turbidity change is evaluated (“evaluation solution”) is not specified as aqueous – this however is supported at least by the specification at para 351 immediately before Table 1, additionally there being no reference to oil-based or solvents other than water when preparing solutions)9, this also rendering obvious instant claim 49, and b) there is no specific limitation as to “substantially homogenous” however given the lack of clear meaning and metes and bounds of such limitation it would appear to be met during routine processing absent evidence to the contrary.
17861936 (instant application)
US 12371848
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1. An article comprising a fabric having a coating, the coating comprising silk fibroin fragments having a weight average molecular weight selected from between about 5 kDa to about 10 kDa, about 6 kDa to about 16 kDa, about 17 kDa to about 38 kDa, about 39 kDa to about 80 kDa, about 60 to about 100 kDa, or about 80 kDa to about 144 kDa, wherein the silk fibroin fragments have a polydispersity of between about 1.5 and about 3.0, wherein the silk fibroin fragments, prior to coating the fabric, do not spontaneously or gradually gelate and do not visibly change in color or turbidity when in a solution for at least 10 days, and wherein the article exhibits an accumulative one-way moisture transport index greater than 40%, greater than 60%, greater than 80%, greater than 100%, greater than 120%, greater than 140%, greater than 160%, or greater than 180%.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
Claims 46-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Patent No. 11878070 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the broad average WAMW range of reference patent claim 1 encompasses the instantly claimed range and reference patent claim 8 further limits this to being very close to the instantly claimed range, completely overlapping it, and because the limitations of the reference patent claim 1 include all limitations of instant claims 46-49, see table below, except a) the “substantially devoid of sericin” absent evidence to the contrary, meets or makes obvious instant claim 47’s limitation, b) the between 0 ppm to about 500 ppm of inorganic residuals and the between 0 ppm to about 500 ppm of organic residuals are not specified but are met by the “substantially devoid of sericin” for the organic residuals limitation, both are supported in the specification and, alternatively, would be reasonably expected for use in a moisturizing composition for application to skin, and as to instant claim 50 a serum as best understood includes an aqueous solution comprising a component that can provide a therapeutic benefit to a human skin, which one or more of the claimed silk fibroin peptide fragments can provide, even if with about 0.1% oil which is allowed per reference patent claim 1.
17861936 (instant application)
US 11878070
46. A composition comprising:
silk fibroin protein fragments having an average weight average molecular weight selected from between about 17 kDa to about 38 kDa, and a polydispersity of between about 1.5 and about 3.0;
0 to 500 ppm of inorganic residuals; and
0 to 500 ppm of organic residuals,
wherein the composition does not spontaneously or gradually gelate and does not visibly change in color or turbidity when in an aqueous solution for at least 10 days.
1.A moisturizing composition comprising: about 0.001% to about 6% (w/v) of silk fibroin-based protein fragments that are substantially devoid of sericin, about 0.1% to about 25% (v/v) of an oil, and about 99% to about 70% (v/v) water; wherein a pH of the moisturizing composition is in the range of about 1.0 to about 8.0, wherein the silk fibroin-based protein fragments have an average weight average molecular weight ranging from about 5 kDa to about 80 kDa, and wherein the silk fibroin-based protein fragments have a polydispersity of between about 1.5 and about 3.0, and wherein the silk fibroin-based protein fragments do not spontaneously or gradually gelate and do not visibly change in color or turbidity when in an aqueous solution for a period of time in the range of four weeks to 52 weeks at room temperature.
11. The moisturizing composition of claim 1, wherein the silk fibroin-based protein fragments have an average weight average molecular weight ranging from about 17 kDa to about 40 kDa.
47. The composition of claim 46, wherein the silk fibroin protein fragments comprise about 0.01% (w/w) to about 10% (w/w) sericin.
48. The composition of claim 46, wherein the composition is substantially homogeneous.
49. An aqueous solution comprising the composition of claim 46.
50. A serum comprising the composition of claim 46.
See reference patent claims 7-9
Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11878070 (reference patent), as applied above to claims 46 and 50, and further in view of US 2010/0112058 A1, Lim et al., published 5/6/10 (“Lim”).
The rejection of claims 46 and 50 are set forth above.
Claim 51, depending from claim 50 which depends from claim 46, limits the concentration of silk fibroin fragments in the serum “from about 0.1 wt. % to about 6.0 wt. %.” This is not claimed in the reference patent claims.
Lim teaches hydrogels comprising a composition for a hydrogel mask pack, wherein such composition comprises about 4 to about 6 percent by weight of fibroin, with a substantial remainder amount of water, see claims 1 and 7.
The claimed concentration range would have been obvious, with a reasonable expectation of success, additionally there being no evidence of criticality of the claimed range (rather, the range appears to be what typically is suitable for forming solutions or gels with silk fibroin given the tendency to form hydrogels at higher concentrations), based on applying the teachings of Lim to the composition of reference patent claim 1.
Accordingly, claim 51 would have been obvious.
Claims 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11878070 (reference patent), as applied above to claims 46 and 50, and further in view of in view of US 20070243148, Andre and Renimel, published 10/18/07 (AR).
The rejection of claims 46 and 50 are set forth above.
Claim 52 depends from claim 50 and lists further additives including Vitamin E, and claim 53 also depends from claim 50 and further comprises “from about 0.5 wt. % to about 30.0 wt. % of vitamin C or a derivative thereof.” The reference patent claims do not teach these limitations.
“Serum” is interpreted herein for purposes of rejection as any liquid-comprising composition that comprises one or more therapeutic and/or restorative compounds.
AR teaches that cosmetically active ingredients include vitamin C and vitamin E, and so that these can be combined with its other active ingredients, para 20, claim 14.
The claim 53 concentration range is broad, extending from “about 0.5 wt% to about 30.0 wt%” – so that from less than 1 percent to almost one-third of the total composition is vitamin C or a derivative thereof. A value within this range for any number of aqueous compositions (even including some oil), serum compositions, would have been achievable by routine experimentation. There is no criticality established for claim 53’s broad range.
It would have been obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, as here both the reference patent and AR teach their respective components for use in skin treatments, the reference patent clearly providing this in multiple locations of the specification, supporting that the claimed compositions would encompass these. As stated in MPEP 2144.06 “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
Accordingly, claims 52 and 53 would have been obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH FISCHER whose telephone number is (571)270-7925, and whose direct facsimile number is (571)270-8925. The examiner can normally be reached on Monday to Friday, 9:00 AM to 5:00 PM, however noting that the examiner will not normally be working on Monday/Tuesday and on Wednesday-Friday on alternating weeks, but will promptly answer messages upon his return to work.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached on 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH FISCHER/Primary Examiner, Art Unit 1658
1 Almost opposite to criticality, about 30% vitamin C is near its maximum solubility at 20 degrees Celsius. So almost the entire range of solubility is claimed. See page 2 of INCHEM Ascorbic Acid, 2024, 2 pages, copy provided.
2 Almost opposite to criticality, about 30% vitamin C is near its maximum solubility at 20 degrees Celsius. So almost the entire range of solubility is claimed. See page 2 of INCHEM Ascorbic Acid, 2024, 2 pages, copy provided. This footnote is not repeated for rejections under this section, but applies to all.
3 Please see MPEP 2111.01 III, and note that use of solvent in the evaluation solution other than water would introduce a range of variations in outcomes not shown nor addressed in the specification.
4 Please see MPEP 2111.01 III, and note that use of solvent in the evaluation solution other than water would introduce a range of variations in outcomes not shown nor addressed in the specification.
5 Please see MPEP 2111.01 III, and note that use of solvent in the evaluation solution other than water would introduce a range of variations in outcomes not shown nor addressed in the specification.
6 Please see MPEP 2111.01 III, and note that use of solvent in the evaluation solution other than water would introduce a range of variations in outcomes not shown nor addressed in the specification.
7 Please see MPEP 2111.01 III, and note that use of solvent in the evaluation solution other than water would introduce a range of variations in outcomes not shown nor addressed in the specification.
8 Please see MPEP 2111.01 III, and note that use of solvent in the evaluation solution other than water would introduce a range of variations in outcomes not shown nor addressed in the specification.
9 Please see MPEP 2111.01 III, and note that use of solvent in the evaluation solution other than water would introduce a range of variations in outcomes not shown nor addressed in the specification.
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