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 .
Claim Rejections 35 USC 112(B)
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 5-18 and 16-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Independent claim 1 is drawn to the limitation “wherein the introduction ratio of the gelatin mixture is 30% mol to 50% mol.” The specification defines the introduction ratio as the molar ratio of the content of imino groups to which alkyl groups are bound (* NH-CHR¹R²) in the hydrophobized gelatin to the content of amino groups (-NH2) in the gelatin 1 before hydrophobization.”
The molar ratio claimed is for the claimed for a product, the claimed material (not the process of making) is drawn to a gelatin mixture (hereinafter “GM”). Claim 5 states “the introduction ratio of the second gelatin is higher than that of the gelatin mixture.” However, introduction ratio would have to measure measures how many functional groups (*--NH-L-CHR1R2) are successfully attached to a gelatin residue to form gelatin 2, the imino-alkyl-bound gelatin, which only has an introduction ratio when it is being formed, not when it is being mixed with the gelatin 1 to form the claimed product, which is a material comprising a particle including the crosslinked product, which is the gelatin mixture (GM). Therefore, the introduction ratio of the gelatin 2 when combined to form the gelatin 2 residues is not a part of the claimed composition.
It is unclear how this introduction ratio for gelatin 2 is present in the gelatin mixture composition that has an introduction ratio of 30 mol % to 50 mol%. Clarification is required.
Claims 8, 18 and 19 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. These claims are drawn to “a total mass of the first gelatin to the second gelatin is 35 mass% to 90 mass%.”
Because the mass% requires that the molar ratio be used to calculate the mass % of the second gelatin to the total mass of the raw material and hydrophobized gelatin mass%
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This calculation is not clear because it treats the hydrophobized gelatin and the second gelatin as two different percentages, and they cannot be in the gelatin mixture product claimed, as gelatin 2 would not have the same introduction ratio in the claimed product. Clarification is required.
Claims 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention
The terms “good,” and “poor” in claim 13 are a relative terms which render the claim indefinite. The term “poor” 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. The specification only says that is must be less soluble in the gelatin mixture than the “good” solvent. However, the term “good” is also relative, and only refers to a solvent in which gelatin mixture can “easily be dissolved.” The term “easily” is also a relative term. As such, claim 13 requires clarification as to the solvent properties.
Claim Rejections 35 USC 102(A)(1)
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.
Claim(s) 1-12 and 15-20 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Taguchi, T. (US2020/0206382).
Taguchi teaches a wound dressing material comprising a particle comprising a crosslinked gelatin derivative, the gelatin derivative comprising the structure represented by the following formula (1):
GltnNH—CHR1R2(1) [0011]. This reference teaches that “Gltn” represents a gelatin residue, R1 represents an alkyl group having 1-17 carbon atoms, and R2 represents a hydrogen atom or an alkyl group having 1-17 carbon atoms, and the particle size ranges from 1 to 1,000 μm, which can be used in applications for spraying to the shape of wound [0011]. This reference further teaches that the particle has an alkyl group to be highly adhesive even to the wet tissues and can be prepared without using a dispersion medium or a crosslinking agent to be applicable to the tissues without worrying about adverse effects caused by residues or decomposition products thereof [0011].
Taguchi teaches starting original/first gelatin ( “gelatin 1’) is dissolved in water or an aqueous solvent at a concentration of from 5 to 50 wt/v % by heating at 40 to 90° C [0042-0044]. Taguchi teaches that examples of the water soluble organic solvent include alcohols having 1 to 3 carbon atoms and esters having 1 to 3 carbon atoms, and preferably ethanol is used [0042-0043].
This reference further teaches a derivatization step, where gelatin obtained in the step (1), has a derivatizing agent with an alkyl group added and a mixture is obtained, which is then subjected to a reaction while stirring. Taguchi teaches that as the derivatizing agent, with an aldehyde or a ketone having the alkyl group is used such as dodecanal, tetradecanal, and decyl ethyl ketone is reacted at 30 to 80° C., from 0.5 to 12 hours [0044-0045]. This reference teaches that the gelatin derivative (“hereinafter Gelatin 2”) having the alkyl group bonded to an amino group of the gelatin via a Schiff base (GltnN═CR1R2) can be obtained only by stirring and that the aldehyde is used in an amount of from 1 to 4 times the stoichiometric amount corresponding to a desired derivatization ratio, preferably, 1 to 2 times [0045].
Taguchi teaches a purification step, where a large excess amount of a “poor” solvent such as cold ethanol is added, or the reaction solution is added to cold ethanol to precipitate a gelatin derivative. After isolating the precipitate by filtration, it is washed with ethanol or the like to obtain a final mixed gelatin product [0047-0048].
This meets the limitation of claims 1-4, 7 and 15 where gelatin 1 (normal residue) is crosslinked with gelatin 2 (derivatized) having formula I, where L is a bond, R1 represents an alkyl group having 1-17 and R2 represents an alkyl group having 1-17 or a hydrogen atom. As discussed above, the “introduction ratio,” is simply a degree of derivatization, which is defined by Taguchi in the same exact was as the specification as “a ratio of derivatization in the gelatin derivative is defined as a molar % of the imino group to which the alkyl group bonded relative to the amino group in the original gelatin, and ranges from 20 to 80 mol %, preferably from 30 to 70 mol %.” In other words, this reference teaches a molar ratio of imino group/amino group in the obtained gelatin derivative ranges from 20/80 to 80/20, preferably from 30/70 to 70/30, which is within the range of 30 to 50 mol% for the same gelatin mixture as claimed.
Claims 5, 6, 8 and 16-20 are met because R1 is an alkyl and R2 is hydrogen or an alkyl, and L is a bond. Additionally, gelatin 2 is a derivatized Gltn residue and it is in the claimed product, which does not contain gelatin 2 after it’s reaction to form the crosslinked composition. Gelatin 2 alone, by definition, only has a separate introduction ratio when outside of the claimed composition in a different reaction.
Claims 9-11 are met because Taguchi teaches alkali -treated Alaskan pollock gelation with endotoxin was used to create gelatin derivatives of formula 1 [0034; 0080; claims 1-3]. Claim 12 is met because this reference teaches that it is used to spray wounds on the body [0011].
Claim(s) 1-20 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Taguchi, T. (WO2020137903, now US12,440,488, Application No 17/414,510 cited to here as PG Pub. US 2020/00621179).
Taguchi teaches a powder of particles containing a crosslinked gelatin derivative, wherein the gelatin derivative has a structure represented by formula (1): GltnNH-L-CHR1R2, where in the formula, Gltn represents a residue of gelatin, L represents a single bond or a divalent linking group, R1 represents a hydrocarbon group having 1-20 carbon atoms, and R2 represents a hydrogen atom or a hydrocarbon group having 1-20 carbon atoms [abstract].
This reference teaches the “derivatization rate” is the molar ratio of the content of the imino groups (*—NH-L-CHR1R2) in a gelatin derivative, to which an alkyl group is attached directly or via a linking group, relative to the content of the amino groups in the original gelatin [0067]. The derivatization rate of the gelatin derivative is not particularly limited, but generally preferably 20 to 80 mol %, more preferably 30 to 70 mol %. In other words, the imino group/amino group (molar ratio) in the obtained gelatin derivative is preferably 20/80 to 80/20, more preferably 30/70 to 70/30. This meets the limitations of claims 1-4, 7 and 15, which teach the same material having particles where the raw material gelatin 1 has the derivatized gelatin (gelatin 2) added to crosslink the gelatin 1 and gelatin 2 and form a gelatin mixture that is 20/80 to 80/20, which overlaps the claimed mol % range and where L is a bond, R1 is an alkyl R2 is an alkyl or hydrogen. Claims 5, 6, 8 and 16-20 are met because R1 is an alkyl and R2 is hydrogen or an alkyl, and L is a bond. As discussed, gelatin 2 is a derivatized Gltn residue and it is in the claimed product, which does not contain gelatin 2 after it’s reaction to form the crosslinked composition. Gelatin 2 by definition only has a separate introduction ratio when outside of the claimed composition, which has no bearing on the patentability of the instantly claimed composition of 5, 6, 8 and 16-20.
Claims 9-11 are met because this reference teaches that the gelatin is derived from of alkali-treated low endotoxin gelatin derived from Alaska Pollack [0011-0013; 0143; claims 4-6]. Claim 12 is met because Taguchi teaches that the gelatin mixture may be sprayed onto tissue [0015; 0097; 0137].
Taguchi teaches a method of making a gelatin powder comprising: dissolving the original gelatin and the gelatin derivative each in a water/dimethylsulfoxide (DMSO) mixed solvent (volume ratio 1:1, the same hereinafter) at 0.1% by mass/volume, respectively, and 100 μl of the solutions were dispensed into 48-well plates, and to these solutions, 100 μl of 0.1% by volume/volume triethylamine dissolved in a water/DMSO mixed solvent was added, and the mixtures were stirred [0148-0149]. This reference teaches that an introduction ratio of hexyl groups in the gelatin derivative was determined by the following formula to be 76.8 mol % [0150]. Next this reference teaches that after dissolving the gelatin derivative with a water bath at 50° C., the mixture was diluted up to 10 mL with water and the content (final concentration) of the gelatin derivative in the gelatin solution was adjusted [0155] Next, ethanol (EtOH) was added dropwise with stirring by a stirrer bar at room temperature until the gelatin solution was cloudy, in order to obtain a gelatin solution containing intermediate particles.
Finally, the gelatin solution was left still in a freezer (−30° C.) for 2 hours or more. The vial was then removed from the freezer, and the opening of the vial was covered with wipes, and the gelatin solution was lyophilized to obtain an intermediate powder containing intermediate particles. The resulting intermediate powder was then crosslinked by heating at 150° C. for 6 hours to obtain each powder [0156-0157].
This meets the limitations of claim 13 because both gelatins are mixed together in a “good” solvent, i.e., water/DMSO, and then a “poor” solvent was added dropwise to precipitate the intermediate particles, which were then lyophilized into a powder, and heated to crosslink the gelatin particles.
Claim 14 is met because this reference teaches heating the intermediate particles.
As such, the claimed method of 13 and 14 is met.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANETTE M LIEB whose telephone number is (571)270-3490. The examiner can normally be reached M-F 10-7.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANETTE M LIEB/Primary Examiner, Art Unit 1654
Claim Rejections 35 USC 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
